As filed with the U.S. Securities and Exchange Commission on August 14, 2026.

Registration No. 333-          

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM F-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

OPTIMI HEALTH CORP.
(Exact name of Registrant as specified in its charter)

Not Applicable
(Translation of Registrant’s Name into English)

269 David Brown Way
Princeton, B.C. V0X 1W0
Canada
(778) 761-4551
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

Cogency Global Inc.
122 East 42nd Street, 18^th Floor New York, NY 10168
(800) 221-0102
(Names, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement the same offering. ☐

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.

Emerging growth company ☒

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the registration statement shall become effective on such date as the U.S. Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the U.S. Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state or jurisdiction where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS

SUBJECT TO COMPLETION, DATED AUGUST 14, 2026

Optimi Health Corp.
Up to 21,943,260 Common Shares

This prospectus relates to the potential offer and sale from time to time by Seven Knots, LLC, a Montana limited liability company (“Seven Knots” or the “Selling Shareholder”), of up to 21,943,260 common shares, with no par value (“common shares”), of Optimi Health Corp., a corporation incorporated under the Business Corporations Act (British Columbia) (“we,” “our,” “us” or the “Company”). The common shares being offered by the Selling Shareholder are outstanding or issuable pursuant to a certain common shares purchase agreement, dated August 13, 2026, by and between us and the Selling Shareholder (the “Purchase Agreement”) and upon conversion of the Seven Knots Commitment Notes (as defined below). See “The Seven Knots Transaction” for a description of the Purchase Agreement, the Seven Knots Commitment Notes and the related transactions. Such common shares include (a) up to 21,276,593 common shares (the “Seven Knots Purchase Shares”) that we may elect, in our sole discretion, to issue and sell to Seven Knots, from time to time from and after the Seven Knots Commencement Date (as defined below) under the Purchase Agreement, and subject to applicable stock exchange rules (assuming a price of $4.68 per share, which was the closing price of the common shares on The Nasdaq Capital Market (“Nasdaq”) on August 11, 2026) and (b) up to 666,667 common shares (assuming the common shares to be issued and sold at the floor price of $3.00) (the “Seven Knots Commitment Shares”) issuable upon conversion of the Seven Knots Commitment Notes (as defined below) as consideration for it entering into the Purchase Agreement. Such registration does not mean that the Selling Shareholder will actually offer or sell any of these common shares. We will not receive any proceeds from the sales of the above common shares by the Selling Shareholder; however, we will receive proceeds under the Purchase Agreement if we sell common shares to the Selling Shareholder.

The Selling Shareholder is an “underwriter” within the meaning of the Securities Act of 1933, as amended (the “Securities Act”). The Selling Shareholder is offering these common shares for resale. The Selling Shareholder may sell all or a portion of these common shares from time to time in market transactions through any market on which the common shares are then traded, in negotiated transactions or otherwise, and at prices and on terms that will be determined by the then prevailing market price or at negotiated prices directly or through a broker or brokers, who may act as agent or as principal or by a combination of such methods of sale. The Selling Shareholder will receive all proceeds from the sale of the common shares. For additional information on the methods of sale, you should refer to the section entitled “Plan of Distribution.” We will pay certain expenses associated with the registration of the securities covered by this prospectus, as described in the section entitled “Plan of Distribution.”

We are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of the common shares by the Selling Shareholder. Additionally, we will not receive any proceeds from the issuance or sale of common shares upon conversion of the Seven Knots Commitment Notes. As consideration for the Selling Shareholder’s commitment to purchase the Seven Knots Purchase Shares, upon the terms of and subject to satisfaction of the conditions set forth in the Purchase Agreement, we issued to Seven Knots a convertible note on August 13, 2026, in the principal amount of $1.5 million, which does not bear interest and matures 24 months after issuance (the “Initial Commitment Note”) and we have agreed to issue to Seven Knots a convertible note in the principal amount of $500,000, which does not bear interest and matures 24 months after issuance (the “Additional Commitment Note” and together with the Initial Commitment Note, the “Seven Knots Commitment Notes”), after the aggregate gross proceeds from the Selling Shareholder pursuant to the Purchase Agreement equal or exceed $7 million. We may receive up to $100 million in aggregate gross proceeds from the Selling Shareholder under the Purchase Agreement in connection with sales of the common shares to the Selling Shareholder pursuant to the Purchase Agreement from time to time after the date of this prospectus. However, the actual proceeds from the Selling Shareholder may be less than this amount depending on the number of common shares sold and the price at which the common shares are sold.

This prospectus provides you with a general description of such securities and the general manner in which the Selling Shareholder may offer or sell the securities. More specific terms of any securities that the Selling Shareholder may offer or sell may be provided in a prospectus supplement that describes, among other things, the specific amounts and prices of the securities being offered and the terms of the offering. The prospectus supplement may also add, update or change information contained in this prospectus.

Our common shares are listed on Nasdaq under the symbol “OPTH” and in Canada on the Canadian Securities Exchange (the “CSE”) under the symbol “OPTI” and in Germany on the Frankfurt Stock Exchange (the “FSE”) under the symbol “8BN”. On August 11, 2026, the last reported sale price of the common shares on Nasdaq was $4.68 (rounded to the nearest hundredths place), on the CSE was C$6.57 (rounded to the nearest hundredths place), and on the FSE was €$4.05 (rounded to the nearest hundredths place).

The 21,943,260 common shares being offered for resale in this prospectus represent approximately 383.2% of our total outstanding common shares as of the date of this prospectus. The sale of all the securities being offered in this prospectus could result in a significant decline in the public trading price of the common shares and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that such sales may have on the prevailing market price of the common shares. Despite such a decline in the public trading price, the Selling Shareholder may still experience a positive rate of return on the securities it purchased due to the differences in the purchase prices of which it purchased the common shares above.

We are an “emerging growth company” and a “foreign private issuer” as those terms are defined under the U.S. federal securities laws, and, as such, are eligible for reduced public company reporting requirements. See “Prospectus Summary—Implications of Being an Emerging Growth Company” and “Prospectus Summary—Implications of Being a Foreign Private Issuer.”

Investing in our securities involves a high degree of risk. See “Risk Factors” beginning on page 11 of this prospectus before making your investment decision.

Neither the U.S. Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Prospectus dated              , 2026

TABLE OF CONTENTS

Neither we nor the Selling Shareholder have authorized anyone to provide any information other than that contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we may have referred you. We and the Selling Shareholder take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We and the Selling Shareholder have not authorized any other person to provide you with different or additional information. Neither we nor the Selling Shareholder are making an offer to sell the common shares in any jurisdiction where the offer or sale is not permitted. This offering is being made in the United States and elsewhere solely on the basis of the information contained in this prospectus.

For investors outside the United States: Neither we nor the Selling Shareholder has done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities and the distribution of this prospectus outside the United States.

RISK FACTORS

Investing in our securities involves a high degree of risk. The following risk factors describe circumstances or events that could have a negative effect on our business, financial condition or operating results. You should carefully consider the risks described below, together with all of the other information included in this prospectus, before making an investment decision. If any of the following risks actually occur, our business, financial condition or results of operations could suffer. The risks set out below are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently believe are not material could also impair our business, financial condition or results of operations. In that case, the trading price of our securities could decline, and you may lose all or part of your investment.

Risks Related to Government Regulations

We face various controlled substance regulatory compliance risks.

Psychedelic products and treatments, production and distribution are a new and emerging industry with substantial existing regulations and uncertainty as to future regulations. There is no assurance we will be able to derive meaningful revenue from our investment in psychedelic compounds, or that regulatory frameworks will support our business expansion, as the impact of various legislative regimes on our business plans and operations is uncertain. Our current and future product candidates are or may be subject to controlled substance laws and regulations in the territories where the product will be produced, manufactured, marketed, and sold, such as Canada and the United States. Failure to comply with these laws and regulations, or the cost of compliance, may adversely affect the results of our business operations, both during clinical development and post approval, and our financial condition. In addition, there is no guarantee that the applicable legislation regulating the research and development and manufacture of controlled substances in the jurisdictions where we operate now or in the future will create or allow for the growth opportunities we currently anticipate.

There is no guarantee that the legislative frameworks governing the research and development of controlled substances will enable the growth opportunities we currently anticipate. Our involvement in psychedelic product development positions us within a nascent, highly regulated and increasingly competitive industry that is evolving rapidly. Given the rapid pace of regulatory, market and scientific developments, new risks may emerge that management cannot foresee or adequately assess, potentially resulting in outcomes that differ materially from those expressed in any forward-looking statements. Regulatory uncertainty remains a key challenge; for example, approval pathways for substances such as MDMA and psilocybin differ significantly by jurisdiction, and there is no assurance of future regulatory acceptance in the United States or other target markets.

Additionally, the processing, manufacturing, packaging, labeling, advertising and distribution of our products are subject to oversight by regulatory authorities in each jurisdiction where our products are sold. These regulatory agencies may assert jurisdiction over any of our products and may not accept the evidence we provide to demonstrate product safety or efficacy. Regulatory bodies may also determine that a specific product or ingredient poses an unacceptable health risk, which could prohibit its sale or restrict the claims we are permitted to make. Additionally, we may be prevented from disseminating third-party literature in support of our products if it fails to meet applicable regulatory standards. Regulatory authorities may further require the withdrawal or recall of a product from the market. Any such action could result in significant costs, lost revenue, liability exposure and adverse impacts on our growth trajectory.

Achievement of our business objectives is subject to compliance with regulatory requirements enacted and enforced by governmental authorities and obtaining and maintaining all required regulatory approvals. We will incur costs and have ongoing obligations related to regulatory compliance, and, depending upon the jurisdictions in which we are conducting our business, those costs and obligations may be significant. Failure to comply with applicable laws, regulations and permits, license or approval requirements may result in enforcement actions thereunder, including orders issued by regulatory or judicial authorities causing operations to cease or be curtailed, and may include corrective measures requiring capital expenditures, installation of additional equipment, or remedial actions. Our industry and market are also subject to numerous legal challenges, which may significantly affect the financial condition of market participants and which cannot be reliably predicted. We may be required to compensate those suffering loss or damage by reason of our operations and may have civil or criminal fines or penalties imposed for violations of applicable laws or regulations.

We cannot predict the timeline required to secure all appropriate regulatory approvals or licenses for our business or the extent of testing and documentation that may be required by governmental authorities. Any delays in obtaining, or failing to obtain, required regulatory approvals or licenses may significantly delay or impact the research and development activities and could have a material adverse effect on our business, results of operations and financial condition. In addition, changes in regulations, more vigorous enforcement thereof or other unanticipated events could require extensive changes to our operations, increased compliance costs or give rise to material liabilities, which could have a material adverse effect on our business, results of operations and financial condition.

The marketability of any product may also be affected by numerous factors that are beyond our control and which cannot be predicted, including, in particular, changes to government regulations, such as those relating to taxes and other government levies which may be imposed on us. The current Canadian federal and provincial restrictions on the marketing and promotion of drugs, and medical services and the regulation of the import, export, production, distribution, possession and sale of controlled substances and precursor chemicals in Canada may limit the ability to effectively advertise and promote our products and business.

We may not be able to receive and maintain our licenses.

Our operations require us to obtain licenses, and in some cases, renewals of existing licenses and the issuance of permits by certain governmental authorities in Canada. We believe that we currently hold or have applied for all necessary licenses and permits to carry out the activities that we are currently conducting under applicable laws and regulations, and also believe that we are complying in all material respects with the terms of such licenses and permits. In addition, we will endeavor to apply for, as the need arises, all necessary licenses and permits to carry on the activities we expect to conduct in the future. However, our ability to obtain, sustain or renew any such licenses and permits on acceptable terms is subject to changes in regulations and policies and to the discretion of the applicable authorities or other governmental agencies in the jurisdictions where we conduct our business. Any loss of interest in any such required license or permit, or the failure of any governmental authority to issue or renew such licenses or permits upon acceptable terms, could have a material adverse impact on us.

Our ability to cultivate, extract, formulate and conduct research in psychedelic substances in Canada is dependent on our ability to obtain federal licenses from Health Canada, including the Dealer’s Licence and Precursor’s Licence. Licenses, once issued, are subject to ongoing compliance and reporting requirements. Our ability to fabricate, package, label and export to certain jurisdictions is dependent on our ability to maintain the Health Canada issued Drug Establishment Licence which is also subject to ongoing compliance requirements. Failure to comply with the requirements would have a material adverse impact on our business, financial condition and operating results. There is also no assurance we will be able to obtain any required new licenses or approvals from Health Canada or that the licence remains recognized based on changes outside of our control. There can be no guarantee that Health Canada will continue to issue the Dealer’s Licence, Precursor Licence, Drug Establishment Licence or any other licenses to us. Government licenses are currently, and in the future will be, required in connection with our operations, in addition to other unknown permits and approvals which may be required. To the extent such permits and approvals are required and not obtained, we may be prevented from operating and/or expanding our business, which could have a material adverse effect on our business, financial condition and results of operations.

We cannot predict the time required to secure all appropriate regulatory approvals for our products or the extent of testing and documentation that may be required by governmental authorities. Any delays in obtaining, or failure to obtain the necessary regulatory approvals will significantly delay the development of our markets and products and could have a material adverse effect on our business, results of operations and financial condition.

If we violate any laws and regulations related to controlled substances or precursors, we may face material adverse repercussions.

In Canada, under the CDSA, psilocybin and MDMA are currently Schedule III and Schedule I substances, respectively. One of the precursors for our research grade MDMA is subject to restrictions under the precursor regulations and, for that reason, we hold a Precursor Licence for import in the event that we require a source from outside Canada. Our operations are conducted in strict compliance with the laws and regulations regarding our activities with such controlled substances. As such, all facilities engaged with such substances by or on behalf of us in Canada do so under current licenses, permits and approvals, as applicable, issued by appropriate Canadian federal, provincial, territorial, and local governmental agencies. In the United States, under the U.S. Controlled Substances Act, psilocybin and MDMA are currently Schedule I substances, meaning they cannot be commercialized or prescribed for medical use and are subject to strict regulatory requirements.

While we are focused on psychedelics, specifically psilocybin and MDMA inspired compounds, we do not have any direct or indirect involvement with the illegal selling, production or distribution of any substances in the jurisdictions in which we operate and do not intend to have any such involvement. A violation of any applicable laws and regulations, such as the CDSA, Narcotic Control Regulations, or of similar legislation in the jurisdictions in which we operate could result in significant fines, penalties, administrative sanctions, convictions or settlements arising from civil proceedings initiated by either government entities in the jurisdictions in which we operate, or private citizens or criminal charges, as well as result in reputational damage. Any such violations could have an adverse effect on our business, results of operations and financial condition. In addition, allegations of violations of applicable laws and regulations, even if ultimately determined to be unfounded, could result in reputational harm, increased scrutiny from regulatory authorities, and other adverse effects on our business, financial condition and results of operations.

We may be materially adversely impacted by changes in legislative and regulatory policies in jurisdictions where we sell our products and operate.

The change in the U.S. administration may result in legislative and regulatory changes that could have a material adverse effect on us and our financial condition. In particular, there is uncertainty regarding U.S. tariffs and support for existing treaty and trade relationships, including with Canada. The U.S. government has made proposals that are intended to address trade imbalances, which include encouraging increased production in the United States. These proposals could result in increased customs duties and tariffs, including on pharmaceutical products originating from Canada, and the renegotiation of some U.S. trade agreements. An increase in customs duties and tariffs with respect to any of our planned imports could negatively impact our financial performance. Any potential changes in trade policies in the United States and the potential corresponding actions by other countries in which we do business could adversely affect our financial performance. Implementation by the U.S. government of new legislative or regulatory policies could impose additional costs on us, decrease U.S. demand for our products, or otherwise negatively impact us, which may have a material adverse effect on our business, financial condition and operations. In addition, this uncertainty may adversely impact: (i) the ability of companies to transact business with companies such as us; (ii) our profitability; (iii) regulation affecting the life sciences industry; (iv) global stock markets (including the CSE and Nasdaq); and (v) general global economic conditions. All of these factors are outside of our control but may nonetheless lead us to adjust our strategy in order to compete effectively in global markets, which may be costly or hard to achieve. Changes in government policy, enforcement actions, or regulatory delays could materially impact business operations and expansion plans. Additionally, our planned product expansion into the U.S. depends on regulatory rescheduling and state and federal legislation allowing MDMA-assisted therapy to move from experimental to commercial use, which is uncertain. Scheduling and rescheduling determinations by the DEA are dependent on FDA approval. During the review process, and prior to approval, the FDA may determine that it requires additional data, either from non-clinical or clinical studies, including with respect to whether, or to what extent, the substance has abuse potential. This may introduce a delay into the FDA approval and any potential rescheduling process and there is no assurance that the DEA will make a favorable rescheduling decision. If the DEA does not reschedule Schedule I ingredients contained in our products in a manner which would facilitate expansion into the U.S., this will have a material adverse impact on the scope the market for our products produced in Canada.

Furthermore, changes in government, legislative or regulatory policies in Australia could have a material adverse effect on our business. Changes in product scheduling, including those products permitted for therapeutic use and changes to the indications for which those products are permitted, could affect our ability to sell our product in the Australian market. Additions or changes to a Therapeutics Good Standard for any of our products could also impact our ability to product, test and release those products to comply with such Therapeutics Good Standard. As data is currently being amalgamated based on the performance of the products, and competitor’s products for use by Authorised Prescribers in Australia, it is possible that data analysis will lead the Australian government to open up access or alternatively halt or suspend access to these medicines with the Authorised Prescribers Scheme.

Changes in government, legislative or regulatory policies in Canada could have a material adverse effect on our business. If the government of Canada decides to revoke or restrict eligibility for certain substances for the Special Access Programme program or if there is a change in how medical conditions are defined for Special Access Programme access, or if a mandate is put in place to increase regulatory scrutiny for Special Access Programme requests or clinical trials, this could mean slower turn around times for approvals for our client’s usage for our products.

In addition, although we do not conduct clinical trials ourselves, we are indirectly affected by the actions or failures of third parties conducting clinical trials using our products. Regulatory authorities such as the FDA, Health Canada and other comparable agencies require that clinical trials comply with applicable protocols, legal and regulatory standards and GCP guidelines, which govern the design, conduct, monitoring and reporting of human clinical trials. These authorities conduct periodic inspections of sponsors, investigators, clinical sites and institutional review boards (“IRBs”) to ensure compliance.

If our clients or their contractors fail to meet these standards, the resulting data may be deemed unreliable, potentially requiring additional clinical trials and delaying regulatory approval. We cannot guarantee that any trial involving our products will be found compliant upon inspection. Delays in the initiation, conduct or completion of any clinical trial of our product candidates will increase our costs, slow down the product candidate development and approval process and delay or potentially jeopardize our ability to commence product sales and generate revenue. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. In the event we identify any additional product candidates to pursue, there is no assurance of the necessary regulatory approvals to allow clinical trials to begin in a timely manner, if at all. Any of these events could have a material adverse effect on our business, prospects, financial condition and results of operations.

We face various risks related to product liability and/or regulatory action.

As we continue to grow, we may distribute or import products from other countries that are designed to be ingested by humans. As such, we face an inherent risk of exposure to product liability claims, regulatory action and litigation if our products are alleged to have caused damages, loss or injury. In addition, the future sale of our products involves the risk of injury to consumers due to tampering by unauthorized third parties or product contamination. A product liability claim or regulatory action against us could result in increased costs, could adversely affect our reputation with our clients and consumers generally, and could have a material adverse effect on our results of operations and financial condition. There can be no assurances that we will be able to obtain or maintain product liability insurance in the future on acceptable terms or with adequate coverage against potential liabilities. Such insurance is expensive and may not be available in the future on acceptable terms, or at all.

We may be required to pay for losses or injuries purportedly or actually caused by our products. In the event that our products are found to cause any injury or damage, we will be subject to substantial liability. This liability may exceed the funds available by us and result in the failure of our business.

Even though we are not aware of any actual or potential product liability claims against us at this time, our business exposes us to potential product liability, recalls and other liability risks. We can provide no assurance that such potential claims will not be asserted against us. A successful liability claim or series of claims brought against us could have a material adverse effect on our business, financial condition and results of operations. Although we believe we have adequate product liability insurance, we cannot provide any assurances that we will be able to obtain or maintain adequate product liability insurance in the future on acceptable terms, if at all, or that such insurance will provide adequate coverage against potential liabilities. Claims or losses in excess of any product liability coverage could have a material adverse effect on our business, financial conditional and results of operations.

Factors involving regulatory agencies that are outside our control, including disruptions at the FDA and other U.S. or foreign government agencies caused by funding shortages, staffing limitations, policy changes or other operational constraints could cause delays in our product candidate development plans, or otherwise prevent new products and services from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business, financial condition and operating results.

The ability of the FDA and comparable foreign authorities to review and approve new products or take action with respect to other regulatory matters can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and statutory, regulatory and policy changes. Average review times at the FDA and comparable foreign authorities have fluctuated in recent years as a result. In addition, government funding of the FDA and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. Additionally, the current U.S. presidential administration has adopted certain policies and issued executive orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA, and it remains unclear the degree to which those efforts will limit or otherwise adversely affect the FDA’s ability to conduct routine activities. Current or future staff reductions could significantly impact the ability of the FDA and comparable foreign authorities to timely review and process our regulatory submissions and could reduce capacity for inspections and compliance oversight, which could have a material adverse effect on our business. Similarly, any current or future staff reductions could prevent the timely review of the patent applications we may file in the future by the United States Patent and Trademark Office (“USPTO”), which could delay the issuance of any U.S. patents to which we might otherwise be entitled. Other policy changes that may result from the change in administration may also delay or limit the ability to obtain necessary regulatory approvals, including but not limited to proposed reorganization of regulatory authorities having jurisdiction over controlled substances, changes to prioritization of review for approval, changes to scientific considerations in the approval process, and general treatment of certain drug classes, including but not limited to controlled substances. These delays or lapses in regulatory engagement could negatively impact our development timelines and increase the risk of non-compliance with applicable laws and regulations, any of which could have a material adverse effect on our business, financial condition and results of operations.

Our products may be subject to regulatory quotas.

The DEA through its quota system limits the availability of the active ingredients in certain of our products and, as a result, our ability to procure or manufacture these ingredients may not be sufficient to complete clinical trials, or other demand. Schedule I controlled substances are considered to present the highest risk of abuse and their handling (including manufacture, research, shipment, storage, sale and use) are subject to a high degree of federal and state oversight and regulation. The amount of Schedule I substances that may be procured and manufactured is limited by the DEA through its quota system. DEA establishes quotas applicable to the individual manufacturer and applicable to the industry in the aggregate. Quotas for these substances may not be sufficient to complete clinical trials or to meet other demand. There is a risk that federal statutes and DEA regulations concerning applicable quotas may interfere with the supply of drugs used in clinical trials for our product candidates, and, in the future, the ability to manufacture and distribute our products in the volume needed to meet demand.

Canada does not have a formal quota system analogous to that which exists in the United States, but our ability to market and sell our Canadian-manufactured products in the United States may be inherently limited by DEA quotas on production, manufacturing, procurement, and importation, which apply to Schedule I substances.

Risks Related to Our Business and Industry

Our industry and market are relatively new.

We operate our business in a relatively new industry and market. While we have active sales in Australia, there is no guarantee that our revenue streams will be sustainable or sufficient to support long-term growth within Australia and beyond. There is also no assurance we will be able to derive meaningful revenue from our investment in psychedelic drugs, or to pursue that business to the extent currently proposed or at all. Adoption of psychedelic-assisted therapy is subject to stigma, legal uncertainty, and physician hesitancy, which could slow commercial penetration. Broader acceptance of these treatments depends on continued scientific validation, regulatory approval, and shifts in public perception.

In addition to being subject to general business risks, we must continue to build brand awareness in this industry and market through significant investments in our strategy, production capacity, quality assurance and compliance with regulations. There is no assurance that the industry and market will continue to exist and grow as currently estimated or anticipated or function and evolve in the manner consistent with management’s expectations and assumptions. Any event or circumstance that adversely affects our industry and market could have a material adverse effect on our business, financial conditions and results of operations.

We have a limited operating history, and we may not be able to manage our growth.

We have a relatively limited operating history in our industry upon which our business and future prospects may be evaluated. We are subject to all of the business risks and uncertainties associated with any new business enterprise, including the risk that we will not achieve our operating goals. In order for us to meet future operating and debt service requirements, we will need to be successful in our growing, marketing and sales efforts. Additionally, where we experience increased production and future sales, our current operational infrastructure may require changes to scale our business efficiently and effectively to keep pace with demand and achieve long-term profitability. If our products and services are not accepted by new customers, our operating results may be materially and adversely affected.

In order to manage growth and change in strategy effectively, we must: (a) maintain adequate systems to meet future customer demands; (b) expand sales and marketing, distribution capabilities and administrative functions; (c) expand the skills and capabilities of our current management team; and (d) attract and retain qualified employees. While we intend to focus on managing our costs and expenses over the long term, we expect to invest to support our growth and may have additional unexpected costs. We may not be able to expand quickly enough to exploit potential market opportunities.

We have a history of operating losses, and there is no assurance that we will be able to achieve profitability, raise additional financing or continue as a going concern.

We have suffered recurring losses from operations and have a net capital deficiency that raise substantial doubt about our ability to continue as a going concern. During the nine months ended June 30, 2026 and the fiscal year ended September 30, 2025, we incurred a net loss of C$5,552,091 (US$3,147,661) and C$3,712,031 (US$2,665,349), respectively, and have not yet achieved profitable operations. We continue to incur significant expenses related to ongoing operations and building our business infrastructure and may not achieve profitable operations for the foreseeable future. We have an accumulated deficit as of June 30, 2026 of C$31,360,001 (US$22,076,734) since our inception. Our ability to continue as a going concern is dependent upon our attaining and maintaining profitable operations and raising additional capital as needed, but there can be no assurance that we will be able to raise sufficient financing. These uncertainties may cast significant doubt on our ability to continue as a going concern.

To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. Revenue from the sale of any product candidate for which regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for the product, the acceptance of the product by physicians and patients, the ability to obtain reimbursement at any price and whether we own the commercial rights for that territory. Our growth strategy depends on our ability to generate revenue. In addition, if the number of addressable patients is not as anticipated, the indication or intended use approved by regulatory authorities is narrower than expected, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved. Even if we are able to generate revenue from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations.

We cannot provide any assurance that we will be able to secure additional funding from public or private offerings or debt financings on terms acceptable to us, if at all, and any debt financing we undertake could subject us to restrictive covenants that limit our operational flexibility and could adversely affect our business and financial condition. Any new securities that we may issue in the future may be sold on terms more favorable for our new investors than the terms of this offering. Newly issued securities may include preferences, superior voting rights, and the issuance of warrants or other convertible securities that will have additional dilutive effects.

Further, we may incur substantial costs in pursuing future capital and/or financing, including investment banking fees, legal fees, accounting fees, printing and distribution expenses and other costs. We may also be required to recognize non-cash expenses in connection with certain securities we may issue, such as convertible notes and warrants, which will adversely impact our financial condition and results of operations. Our ability to obtain needed financing may be impaired by such factors as the weakness of capital markets, and the fact that we have not been profitable, which could impact the availability and cost of future financings. For example, market volatility resulting from, among other factors, the imposition of tariffs and retaliatory tariffs, military conflicts, such as ongoing conflicts in the Middle East, as well as, Russia’s war in Ukraine, and other factors that are currently unknown or not yet material could also adversely impact our ability to raise or access funds as and when needed. If adequate funds are not available to us on a timely basis, we may be required to delay, limit or discontinue one or more research or development programs or the potential commercialization of any approved products or be unable to expand operations or otherwise capitalize on business opportunities, as desired, which could materially affect our business, prospects, financial condition and results of operations.

If we are unable to obtain additional financing and on acceptable terms, we could be forced to delay, limit or discontinue product candidate development and sales efforts.

Developing and manufacturing biopharmaceutical products is expensive and time-consuming, and we expect to require substantial additional capital to conduct research for our current and future programs, seek regulatory approvals for our product candidates and launch and commercialize any products for which we receive regulatory approval, including growing our commercial sales, marketing and distribution organization. We regularly assess the ongoing development of our programs and may, from time to time, delay, limit or otherwise discontinue a program in order to allocate resources towards our existing programs, more developed programs or new investments.

Based on our current operating plan, we estimate that our existing cash, marketable securities and committed term loan funding, as well as the funds raised in this offering, will be sufficient to fund operations for the next 12 months. However, our operating plan has changed, and may continue to change, as a result of many factors, some of which may be currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, sales of assets or programs, other sources, such as joint ventures, strategic collaborations or license and development agreements, or a combination of these approaches. We also may opportunistically seek additional capital following this offering if market conditions are favorable or if we have specific strategic considerations. For example, we anticipate that we will need to raise additional funds to continue preparing for market entry to the United States after the next 12 months as we do not expect to gain market entry to the United States within the next 12 months. Due to the uncertainty around the extent and timing of regulatory approval in the United States, we cannot currently estimate the amount of additional funds that will be needed to prepare for market entry to the United States. Any such additional fundraising efforts for us may divert our management’s attention from their day-to-day responsibilities, which may adversely affect our ability to develop and commercialize our product candidates or any future product candidates we may identify and pursue. Moreover, such financing may result in dilution to shareholders, imposition of debt covenants and repayment obligations or other restrictions that may adversely affect our business. Any new securities that we may issue in the future may be sold on terms more favorable for our new investors than the terms of this offering. Newly issued securities may include preferences, superior voting rights, and the issuance of warrants or other convertible securities that will have additional dilutive effects. We cannot assure that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to us. Further, we may incur substantial costs in pursuing future capital and/or financing, including investment banking fees, legal fees, accounting fees, printing and distribution expenses and other costs. We may also be required to recognize non-cash expenses in connection with certain securities we may issue, such as convertible notes and warrants, which will adversely impact our financial condition and results of operations. Our ability to obtain needed financing may be impaired by such factors as the weakness of capital markets, and the fact that we have not been profitable, which could impact the availability and cost of future financings. If the amount of capital we are able to raise from financing activities, together with our revenues from operations, is not sufficient to satisfy our capital needs, we may have to reduce our operations accordingly.

Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.

Our future funding requirements, both short-term and long-term, will depend on many factors, including, but not limited to:

We may be subject to product recalls.

Manufacturers, producers and distributors of products are sometimes subject to the recall of their products for a variety of reasons, including risk to health or safety, product defects, such as contamination, unintended harmful side effects or interactions with other substances, packaging safety and inadequate or inaccurate labeling. If any of our products are recalled due to an alleged product defect or for any other reason, we could be required to incur the unexpected expense of the recall and any legal proceedings that might arise in connection with the recall. We may lose a significant amount of sales and may not be able to replace those sales at an acceptable margin or at all. In addition, a product recall may require significant management attention.

Although we have detailed procedures and GMP controls in place for testing our products, there can be no assurance that any quality, potency or contamination problems will be detected in time to avoid unforeseen product recalls, regulatory action or lawsuits. Additionally, if we are subject to recall, our image and reputation could be harmed. A recall for any of the foregoing reasons could lead to decreased demand for our products and could have a material adverse effect on our results of operations and financial condition. Additionally, product recalls may lead to increased scrutiny of our operations by regulatory agencies, requiring further management attention, potential loss of applicable licenses and potential legal fees and other expenses.

We face increasing competition in our industry.

We face increasing competition in the markets in which we operate. Some of our competitors are more established than us and may have more resources than us and be better positioned to develop superior product features and technological innovations and able to better adapt to market trends than us. These competitors may receive regulatory approvals before us, introduce alternative treatments, or secure larger market shares. Our ability to compete depends on, among other things, high product quality, short lead time, timely delivery, competitive pricing, range of product offerings and superior customer service and support. Increased competition may require us to reduce prices or increase costs and may have a material adverse effect on our financial condition and results of operations. Any decrease in the quality of our products or level of service to customers or any occurrence of a price war among our competitors and us may adversely affect our business and results of operations.

Competition in the psychedelics industry is growing as various public and private companies enter the market. As a result of this competition, some of which is with large, well established companies with substantial capabilities and significant financial and technical resources, we may be unable to compete successfully in the future. There can be no assurance that we will be able to grow or sustain our business in the presence of these competitive conditions.

At the same time, because the psychedelics industry is in a nascent stage with uncertain boundaries, there is a lack of information about comparable companies available for potential investors to review in deciding about whether to invest in us and, few, if any, established companies whose business model we can follow or upon whose success we can build. Accordingly, investors will have to rely on their own judgement in deciding about whether to invest in us. There can be no assurance that our estimates are accurate or that the market size is sufficiently large for our business to grow as projected, which may negatively impact our financial results.

Our product candidates represent novel and innovative potential therapeutic areas, and negative perception of any of our products or product candidates that we develop could adversely affect our ability to conduct our business, obtain regulatory approvals or identify alternate regulatory pathways to market for such product candidate.

Our product candidates represent novel and innovative potential therapeutic areas, including substances like MDMA and psilocybin that might be controversial, overlooked or underused. Our success will depend upon physicians who specialize in the treatment of mental health disorders, including TRD and other neurological indications targeted by our product candidates. Additionally, our success will depend on physicians prescribing potential treatments that involve the use of our product candidates, if approved, in lieu of, or in addition to, existing treatments with which they are more familiar and for which greater clinical data may be available. Our product candidates may not be successful in gaining physician acceptance, which would adversely impact our ability to commercialize our product candidates, even if approved. The success of our products will also depend on consumer acceptance and adoption of our products that are commercialized, which is not guaranteed.

In addition, responses by the Canadian government or other governments like the U.S. federal and state governments to negative public perception or ethical concerns may result in new legislation or regulations that could limit our ability to develop or commercialize any of our products, obtain or maintain regulatory approval, identify alternate regulatory pathways to market or otherwise achieve profitability. More restrictive statutory regimes, government regulations or negative public opinion would have an adverse effect on our business, financial condition, results of operations and prospects and may delay or impair the development and commercialization of our product candidates or demand for any products we may develop.

Finally, there is no assurance that we will be able to achieve brand awareness in any of our target regions. In addition, we must develop successful marketing, promotional and sales programs in order to sell our products. If we are not able to develop successful marketing, promotional and sales programs, then such failure will have a material adverse effect on our business, financial condition and operating results.

Our product candidates contain psychedelic substances, the use of which may generate public controversy. Adverse publicity or public perception regarding our current or future product candidates may negatively influence the success of these therapies.

Our product candidates contain psychedelic substances that may generate public controversy. Political and social pressures and adverse publicity could lead to delays in approval of, and increased expenses for, our current product candidates and any future product candidates we may develop. Opponents of these compounds may seek restrictions on marketing and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate negative publicity in an effort to persuade the medical community to reject these products, if approved. Adverse publicity from misuse may adversely affect the commercial success or market penetration achievable by our product candidates. Anti-psychedelic protests have historically occurred and may occur in the future and generate media coverage. Political pressures and adverse publicity could lead to delays in, and increased expenses for, and limit or restrict the introduction and marketing of, our product candidates or any future therapeutic candidates.

If our product candidates or any future therapeutic candidates are approved for commercial sale in the United States or other jurisdictions in which we intend to market our product candidates, we will be highly dependent upon consumer perceptions of the safety and quality of our product candidates. We may face limited adoption if third-party therapy sites, therapists or patients are unwilling to try such a novel treatment given that some of our product candidates are from substances that might be controversial, overlooked or underused. There has been a history of negative media coverage regarding psychedelic substances, including compounds in many of our product candidates, which may affect the public’s perception of our product candidates. In addition, compounds in most of our product candidates may elicit intense psychological experiences, and this could deter patients from choosing this course of treatment, if our product candidates were approved. Our business could be adversely affected if we were subject to negative publicity or if any of our product candidates, if approved, or any similar product candidates distributed by other companies prove to be, or are asserted to be, harmful to patients. Because of our dependence upon consumer perception, any adverse publicity associated with illness or other adverse effects resulting from patients’ use or misuse of any of our product candidates, if approved or any similar products distributed by other companies could have a material adverse impact on our business, prospects, financial condition and results of operations.

Future adverse events in research into depression and other mental health disorders, such as substance use disorder and anxiety, on which we focus our research efforts, or the pharmaceutical industry more generally, could also result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of our product candidates. Any increased scrutiny could delay or increase the costs of obtaining regulatory approval for our product candidates or any future product candidates.

We have a limited number of products, and we may not be able to successfully develop new products.

Historically, our revenue is derived almost exclusively from sales of mushroom-based natural health products. We now derive revenue from the sale of limited pharmaceutical products. However, our success will depend, in part, on our ability to develop, introduce and market new and innovative products. If there is a shift in consumer demand, we must meet such demand through new and innovative products, or else our business will fail. Our ability to develop, market and produce new products is subject to us having substantial capital. There is no assurance that we will be able to develop new and innovative products or have the capital necessary to develop such products.

Further, because we have limited financial resources and access to funding, we have to make decisions regarding the allocation of capital and resources across our business. For example, we may forego or delay pursuit of certain product candidates or business opportunities that later may prove to have greater commercial potential than our current or future development programs and product candidates. In addition, our decisions concerning the allocation of research, collaboration, management and financial resources toward particular programs or product candidates may not lead to the development of viable commercial product candidates, and may divert resources, including personnel, away from more advantageous opportunities or from our other current programs. Similarly, our decisions to delay, terminate or collaborate with third parties in respect of certain product candidates and development programs could also prove not to be optimal and could cause us to miss valuable opportunities with no resulting benefit. If our assessment of the market potential of our product candidates or trends in the pharmaceutical or biotechnology industries proves to be inaccurate, our business, financial condition and results of operations could be materially adversely affected.

We face product pricing risks.

As the market for our products matures, or as new or existing competitors introduce new products or services that compete with us, we may experience pricing pressure and be unable to renew our agreements with existing customers or attract new customers at prices that are consistent with our pricing model and operating budget. If this were to occur, it is possible that we would have to change our pricing model or reduce prices, which could harm revenue, gross margin and operating results. In addition, reimbursement and pricing negotiations with healthcare providers and insurers regarding our products may impact our profitability. The adoption of psychedelic treatments within the healthcare industry depends on pricing structures, insurance coverage and regulatory acceptance, which remain uncertain. Further, there is a risk of long-term price compression as generic drug manufacturers enter the market for MDMA, psilocybin and other similar psychoactive drugs, which could have a materially adverse impact on our business, financial condition and results of operations.

We face foreign currency risks.

As a company with global operations, fluctuations in currency exchange rates and inflationary pressures may affect operational expenses and profitability. Unfavorable exchange rate movements could impact the cost of raw materials, international sales, and financial reporting. In particular, the strengthening or weakening of the Canadian dollar versus other currencies will impact the translation of our net revenues generated in these foreign currencies into Canadian dollars. We import certain ingredients in our products from foreign countries, and may be forced to pay higher rates for our ingredients as a result of the weakening of the Canadian dollar.

We could experience distribution or supply chain interruptions.

We are susceptible to risks relating to distributor and supply chain interruptions. Distribution in Canada is largely accomplished through independent contractors, and, therefore, an interruption (e.g., a labor strike) for any length of time affecting such independent contractors may have a significant impact on our ability to sell our products. Limited GMP-qualified suppliers could create production bottlenecks and lead to disruptions in our supply chain. Supply chain interruptions, including a production or inventory disruption, could impact product quality and availability. Inherent to producing products is a potential for shortages or surpluses in future years if demand and supply are materially different from long-term forecasts. We monitor category trends and regularly reviews maturing inventory levels, but there can be no assurance that our estimates will be correct.

We rely on third party manufacturers and suppliers.

We rely on outside sources to manufacture our products including suppliers of critical raw materials and GMP-compliant testing services, shipping services and other suppliers to support the GMP facility. Dependence on third-party suppliers for raw material inputs and compliance with GMP standards creates potential risks related to production delays or quality control issues. Dependence on third-party laboratories for testing our finished products to GMP standards also creates risks related to release delays or quality control issues. Additionally, our failure to deliver either components or finished goods on a timely basis could have a material adverse effect on our business. Our ability to maintain consistent supply and meet regulatory requirements depends on factors outside of our control, including supplier reliability and raw material availability. As these are third parties over which we will have little or no control, the failure of such third parties to provide components or testing services on a timely basis could have a material adverse effect on our business, financial condition and operating results.

Our suppliers, service providers and distributors may elect, at any time, to breach or otherwise cease to participate in supply, service or distribution agreements, or other relationships, on which our operations rely. Loss of our suppliers, service providers or distributors would have a material adverse effect on our business and operational results. We currently rely on certain third party laboratories. Disruption of operations at any one of these facilities could adversely affect inventory supplies and our ability to meet product delivery deadlines.

We are currently party to and may seek to enter into additional collaborations, licenses and other similar arrangements and may not be successful in maintaining existing arrangements or entering into new ones, and even if we are, we may not realize the benefits of such relationships.

We are currently party to license and collaboration agreements with a number of universities and pharmaceutical companies, and we expect to enter into additional agreements as part of our business strategy. We anticipate relying upon strategic collaborations for marketing and commercializing our existing product candidates, if approved, and we may sell product offerings through strategic partnerships with pharmaceutical and biotechnology companies. The success of our current and any future collaboration arrangements may depend heavily on the efforts and activities of our collaborators. Collaborations are subject to numerous risks, such as:

Management of our relationships with collaborators requires and, in the future, is expected to continue to require:

Additionally, we may seek to enter into additional collaborations, joint ventures, licenses and other similar arrangements for the development or commercialization of our product candidates, due to capital costs required to develop or commercialize the product candidate or manufacturing constraints. We may not be successful in our efforts to establish such collaborations for our product candidates because our research and development pipeline may be insufficient, our product candidates may be deemed to be at too early of a stage of development for collaborative effort or third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy or significant commercial opportunity. If we are unable to establish or manage such strategic collaborations on terms favorable to us in the future, our research and development efforts and potential to generate revenue may be limited. In addition, we face significant competition in seeking appropriate strategic partners, and the negotiation process can be time consuming and complex. Further, any future collaboration agreements may restrict us from entering into additional agreements with potential collaborators. We cannot be certain that, following a strategic transaction or license we will achieve an economic benefit that justifies such transaction.

Even if we are successful in our efforts to establish such collaborations, the terms that we agree upon may not be favorable to us and we may not be able to maintain such collaborations if, for example, development or approval of a product candidate is delayed, the safety of a product candidate is questioned or sales of an approved product candidate are unsatisfactory.

In addition, any potential future collaborations may be terminable by our strategic partners, and we may not be able to adequately protect our rights under these agreements. Furthermore, strategic partners may negotiate for certain rights to control decisions regarding the development and commercialization of our product candidates, if approved, and may not conduct those activities in the same manner as we do. Any termination of collaborations we enter into in the future, or any delay in entering into collaborations related to our product candidates, could delay the development and commercialization of our product candidates and reduce their competitiveness if they reach the market, which could have a material adverse effect on our business, financial condition and results of operations.

We may face shortages in our raw materials.

One of our main products is derived from psychedelic mushrooms which are cultivated, harvested and dried at our facilities. Accordingly, we must grow enough mushrooms so that the products can be produced to meet the demand of our customers. A shortage of inputs, quality control issue with inputs to mushroom growing operations, issues in storage or culture of inputs, contamination or the loss of a key genetic, or a poor harvest could result in loss of sales and damage to us. If we become unable to harvest on a timely basis and at commercially reasonable prices, and are unable to produce mushrooms at a substantially equivalent cost, in substantially equivalent volumes and quality, and on a timely basis, we will be unable to meet customer demand. In particular, we will be unable to source mushrooms from an alternative grower with the necessary regulatory approvals in a timely manner, which would have a material adverse effect on our business, financial condition and operating results.

In addition to the mushroom input, which we supply internally, both of our drug products are derived from commercially available GMP-qualified ingredients including the active MDMA, excipients, capsules and packaging components. We are currently reliant on a key supplier for our API inputs, and any disruption in API inflow will have a material adverse effect on our business. Consequently, a subsequent change in API supplier may require additional regulatory approvals and increase the cost and timing of our product development. If we and/or our suppliers become unable to acquire materials, especially API, at commercially reasonable prices, and are unable to find one or more replacement suppliers at a substantially equivalent cost, in substantially equivalent volumes and quality, and on a timely basis, we will likely be unable to meet customer demand, which could have a material adverse effect on our business, financial condition and operating results.

Our success depends on the performance of our management and our employees.

Our success is largely dependent on the performance of our directors and officers. The loss of the services of any of these persons could have a materially adverse effect on our business and prospects. There is no assurance that we can maintain the services of our directors, officers or other qualified personnel required to operate our business.

We do not maintain key person insurance on any of our directors or officers, and, as result, we would bear the full loss and expense of hiring and replacing any director or officer in the event of the loss of any such persons by their resignation, retirement, incapacity, or death, as well as any loss of business opportunity or other costs suffered by us from such loss of any director or officer.

The loss of any member of our management team, or of our key individuals, could have a material adverse effect on our business and results of operations. In addition, an inability to hire, or the increased costs of new personnel, including members of executive management, could have a material adverse effect on our business and operating results. At present and for the near future, we depend upon a relatively small number of contractors to develop, market, sell and support our products. The expansion of marketing and sales of our products will require us to find, hire and retain additional capable personnel who can understand, explain, market and sell our products. There is intense competition for capable personnel in all of these areas and we may not be successful in attracting, training, integrating, motivating, or retaining new personnel, vendors, or subcontractors for these required functions. New employees often require significant training and security clearances, and, in many cases, take significant time before they achieve full productivity. As a result, we may incur significant costs to attract and retain contractors, including significant expenditures related to salaries and benefits and compensation expenses related to equity awards, and may lose new employees to our competitors or other companies before we realize the benefit of our investment in recruiting and training them. In addition, if and when we move into new jurisdictions, we will need to attract and recruit skilled contractors in those areas.

Our directors and officers may have conflicts of interest with us.

Our directors and officers may serve as directors or officers of other similar companies or have significant shareholdings in other similar companies, and, to the extent that such other companies may participate in ventures in which we may participate, our directors may have a conflict of interest in negotiating and concluding terms respecting the extent of such participation. This could potentially result in the diversion of opportunities from us to other entities or persons with which any such director or officer is associated or has an interest, rather than offering such opportunities to us. To the extent that such conflicts of interest are approved by the disinterested directors or are not adequately disclosed, it could result in the loss of potential opportunities. Furthermore, while an effort has been made, and will continue to be made, to engage in transactions and enter into agreements with affiliated persons and other related parties on terms as favorable to us as they could have been if obtained from non-affiliated persons, there will always be an inherent conflict of interest between our interests and those of our affiliates and related parties if they have any interest adverse to ours. We may be adversely impacted if any related party agreement or transaction has been made, or is made in the future, on unfavorable terms. In the event that such a conflict of interest arises at a meeting of the directors, a director who has such a conflict will abstain from voting for or against the approval of such participation or such terms in accordance with the Business Corporations Act (British Columbia). In accordance with the laws of British Columbia, the directors of a company are required to act honestly, in good faith and in the best interests of such company.

For example, Bryan Safarik currently serves as a director and the president and chief operating officer and Jacob Safarik currently serves as the chief financial officer, respectively, of BC Green, a private Canada federally licensed cannabis production company. On July 23, 2020, we entered into an industrial ground lease agreement with BC Green for the Industrial Ground underlying our Facilities in Princeton, British Columbia, which was amended and restated on September 1, 2021 and was further amended on July 1, 2025 to extend the term of the lease to June 30, 2030 and to include three additional options to renew the agreement for successive terms of five years commencing on July 1, 2030.

Natural disasters, public health crises, political crises and other catastrophic events or other events outside of our control may adversely affect our business.

Any natural disaster-related disruptions or other events outside of our control could negatively affect our business and harm our operating results. In addition, if our facilities, or the facilities of our suppliers, third-party service providers or customers are affected by natural disasters, such as earthquakes, tsunamis, power shortages or outages, floods or monsoons, public health crises, such as pandemics and epidemics, political crises, such as terrorism, war, political instability or other conflict, or other events outside of our control, our business and operating results could suffer. Moreover, these types of events could negatively impact consumer spending in the impacted regions or, depending upon the severity, globally, which could adversely impact our operating results. Similar disasters occurring at our vendors’ manufacturing facilities could impact our reputation and our consumers’ perception of our brand.

We currently report our financial results under IFRS, which differs in certain significant respects from U.S. generally accepted accounting principles.

We report our financial statements under IFRS and expect to continue to do so for so long as we continue to qualify as a foreign private issuer. There are, and there may in the future be, certain significant differences between IFRS and U.S. GAAP, including differences related to revenue recognition, intangible assets, share-based compensation expense, income tax and earnings per share. As a result, our financial information and reported earnings for historical or future periods could be significantly different if they were prepared in accordance with U.S. GAAP. In addition, we do not intend to provide a reconciliation between IFRS and U.S. GAAP unless it is required under applicable law. As a result, you may not be able to meaningfully compare our financial statements under IFRS with those companies that prepare financial statements under U.S. GAAP.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

We are subject to certain reporting requirements of the Exchange Act. Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to management, recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected.

The availability of adequate third-party payer coverage and reimbursement for newly approved drugs is uncertain, and failure to obtain adequate coverage and reimbursement from third-party payers could impede our ability to market any future products we may develop and could limit our ability to generate revenue.

There is significant uncertainty related to the third-party payer coverage and reimbursement of newly approved drugs. The commercial success of our future products in both Canada and international markets depends on whether such third-party coverage and reimbursement are available for our product candidates. Governmental payers, health maintenance organizations, managed care, pharmacy benefit and other third-party payers are increasingly attempting to manage their healthcare expenditures by limiting both coverage and the level of reimbursement of new drugs and, as a result, they may not cover or provide adequate reimbursement for our product candidates, which is essential for most patients to be able to afford treatments. These payers may not view our future products as cost-effective, and coverage and reimbursement may not be available to our customers, may not be sufficient to allow our future products to be marketed on a competitive basis and will impact our ability to successfully commercialize our product candidates. Government authorities and third-party payers are exerting increasing influence and control on costs, known as cost containment, on their decisions regarding the use of, and coverage and reimbursement levels for, particular medications and treatments. In particular, third-party payers may limit the covered indications. This trend in cost-control initiatives in the United States and other countries could cause us to decrease the price we might establish for products, and monitor and control company profits, which could result in lower than anticipated product revenues. If the prices for our drug candidates decrease or if governmental and other third-party payers do not provide adequate coverage or reimbursement, our prospects for revenue and profitability will suffer.

If the market opportunities for our product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer. Our ability to successfully identify patients and acquire a significant market share will be necessary for us to achieve profitability and growth.

We focus research and product development on treatments for mental health disorders, including TRD and PTSD. Our projections of both the number of individuals who are affected by our target disorder indications and have the potential to benefit from treatment with our product candidates are based on estimates. These estimates have been derived from a variety of sources, including the scientific literature, and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these disorders. The number of patients may turn out to be lower than expected. The effort to identify patients with these mental health disorders we seek to treat is in early stages, and we cannot accurately predict the number of patients for whom treatment might be possible. Additionally, the potentially addressable patient population for our product candidates that we may identify may be limited or may not be amenable to treatment with our product candidates, and new patients may become increasingly difficult to identify or gain access to, which would adversely affect our results of operations and our business. Further, even if we obtain significant market share for our product candidates, because the potential target populations may be small, we may never achieve profitability.

If we are unable to effectively execute our growth strategies and manage risks associated with expanding the scale of our operations, our ability to grow our business and establish our international markets may be negatively affected.

To accomplish our growth strategies and manage the future growth of our operations, we will need to improve our operational and financial systems and internal controls, and expand, train and manage our growing employee base.

As we transition from early-stage operations to a more mature pharmaceutical model, we must invest in the development and refinement of operational infrastructure, including enterprise resource planning, inventory control, and financial reporting systems that can withstand audit scrutiny across multiple regulatory agencies.

The expansion of our workforce will require disciplined hiring, training, and retention strategies to ensure technical competency in highly regulated and scientific functions. Our ability to recruit and retain personnel with the requisite expertise may impair our capacity to meet compliance and supply obligations.

We will need to maintain and expand our relationships with our customers, suppliers and other third parties. Furthermore, as we enter new markets, we may face new market, technological, operational and regulatory risks and challenges with which we are unfamiliar.

We must also maintain and strengthen our commercial relationships with healthcare providers, clinical research organizations, contract manufacturing partners, and government stakeholders. Disruption in any of these partnerships — particularly those supporting our controlled substance supply chain -could compromise product availability, impact revenue forecasts, or damage our regulatory standing.

If we are unsuccessful in managing these complexities, the effect could result in delayed product launches, failed market entries, regulatory non-compliance, and reduced investor confidence, all of which would materially impair our long-term growth trajectory and financial performance.

Cyberattacks or other failures in our telecommunications or information technology systems, or those of our collaborators, contracted research organizations, third-party logistics providers, distributors or other contractors or consultants, could result in information theft, data corruption and significant disruption of our business operations which could materially affect our results.

We, our programs, our collaborators, our contracted research organizations, third-party logistics providers, distributors and other contractors and consultants rely on information technology, or IT, systems and networks to process, transmit and store electronic information, including but not limited to intellectual property, confidential information, proprietary business information, preclinical and clinical trial data and personal information in connection with our business activities (referred to herein collectively as “confidential information”). Our IT systems and those of current and future third parties on which we rely may fail and are vulnerable to breakdown, breach, interruption or damage from cyber incidents, employee error or malfeasance, misconfigurations, “bugs” or other vulnerabilities, theft or misuse, sophisticated nation-state and nation-state-supported actors, unauthorized access, natural disasters, terrorism, war, telecommunication and electrical failures or other compromises. As use of digital technologies has increased, cyber incidents, including third parties gaining access to employee accounts using stolen or inferred credentials, computer malware (e.g. ransomware), viruses, spamming, social engineering or phishing attacks, denial-of-service attacks or other means, and deliberate attacks and attempts to gain unauthorized access to computer systems and networks, have increased in frequency, intensity, and sophistication. These threats pose a risk to the security of our, our programs’, our collaborators’, our contracted research organizations’, third-party logistics providers’, distributors’ and other contractors’ and consultants’ systems and networks, and the confidentiality, availability and integrity of our confidential information. There can be no assurance that we will be successful in preventing cyberattacks or successfully mitigating their effects. There can also be no assurance that our, our programs’, our collaborators’, our contracted research organizations’, third-party logistics providers’, distributors’ and other contractors’ and consultants’ cybersecurity risk management program and processes, including policies, controls or procedures, will be fully implemented, complied with or effective in protecting our systems, networks and confidential information.

The risk of a security breach or disruption, particularly through cyberattacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity, and sophistication of attempted attacks and intrusions from around the world have increased. In addition, varying parts of our workforce are currently working remotely on a part or full time basis. This could increase our cyber security risk, create data accessibility concerns, and make us more susceptible to communication disruptions. We may not be able to anticipate all types of security threats, and we may not be able to implement preventive measures effective against all such security threats. The techniques used by cyber criminals change frequently, may not be recognized until launched, and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizations or hostile foreign governments or agencies. We may also experience security incidents that may remain undetected for an extended period. Even if identified, we may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly using tools and techniques that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence. Similarly, there can be no assurance that our collaborators, contracted research organizations, third-party logistics providers, distributors and other contractors and consultants will be successful in protecting our clinical and other data that is stored on their systems. Any loss of clinical trial data from our clients’ completed or ongoing clinical trials for any of our product candidates could result in delays in our development and regulatory approval efforts and significantly increase our costs to recover or reproduce the data. We and certain of our service providers are from time to time subject to cyberattacks and security incidents. We have experienced and expect to continue to experience actual and attempted cyberattacks of our IT networks, such as through phishing scams and ransomware. Although we do not believe that we have experienced any significant system failure, accident or cybersecurity incidents to date, we cannot guarantee that we will not experience such incidents in the future. Any adverse impact to the availability, integrity or confidentiality of our or third-party systems or confidential information can result in legal claims or proceedings (such as class actions), regulatory investigations and enforcement actions, fines and penalties, negative reputational impacts that cause us to lose existing or future customers, and/or significant incident response, system restoration or remediation and future compliance costs. Any or all of the foregoing could materially adversely affect our business, results of operations, and financial condition.

Any cyberattack that leads to unauthorized access, use, or disclosure of confidential information, data breach or destruction or loss of confidential information could result in a violation of applicable Canadian, U.S. and international privacy, data protection and other laws and regulations, require us to notify affected individuals or supervisory authorities, subject us to litigation and governmental investigations, proceedings and regulatory actions by federal, state and local regulatory entities in Canada and the United States and by international regulatory entities, cause our exposure to material civil and/or criminal liability and cause us to breach our contractual obligations, which could result in significant legal and financial exposure and reputational damages. As cyber threats continue to evolve, we may be required to incur significant additional expenses in order to implement further data protection measures or to remediate any information security vulnerability. Further, our general liability insurance and corporate risk program may not cover all potential claims to which we are exposed and may not be adequate to indemnify us for all liability. There can be no assurance that the limitations of liability in our contracts would be enforceable or adequate or would otherwise protect us from liabilities or damages as a result of the events referenced above. We also cannot be certain that our existing insurance coverage will continue to be available on acceptable terms or in amounts sufficient to cover the potentially significant losses that may result from a security incident or breach or that the insurer will not deny coverage wholly or in part, of any future claim. Accordingly, if our cybersecurity measures, and those of our service providers, fail to protect against unauthorized access, attacks and the mishandling of data by our employees and third-party service providers, then our business, financial condition, results of operations and prospects could be adversely affected. There can be no assurance that our cybersecurity risk management program and processes, including our policies, controls or procedures, will be fully implemented, complied with or effective in protecting our systems and information.

Our business is subject to economic, political, regulatory and other risks associated with international operations.

As a company incorporated in British Columbia, Canada, with business outside of Canada, we are subject to risks associated with international operations. Our business strategy involves obtaining regulatory approval for and to commercialize our product candidates in patient populations outside Canada, and we may hire sales representatives and conduct physician and patient association outreach activities outside Canada. Doing business internationally involves a number of risks, including, but not limited to:

Any of these factors could significantly harm our potential international expansion and operations, and, consequently, our results of operations.

Risks Related to Drug Development

We face various risks associated with drug development.

We are engaged in the research of growing psilocybin mushrooms and undertaking extractions from these mushrooms with a view to ultimately developing patents and other intellectual property rights related to mushroom cultivation, extraction and formulation. We are also engaged in the research and development of MDMA capsules and the intellectual property related to MDMA formulation. However, it is uncertain whether any of our current or future product development efforts will prove to be successful and meet applicable regulatory requirements, and whether any of our future product candidates will receive the requisite regulatory approvals, be capable of being manufactured at a reasonable cost or be successfully marketed. To achieve profitable operations, we alone or with others, must successfully develop, gain regulatory approval for, and market our current and future products. To obtain regulatory approvals for our product candidates being developed and to achieve commercial success, clinical trials must demonstrate that the product candidates are safe for human use and that they demonstrate efficacy. The impact of legislative regimes on our business remains uncertain, particularly as regulatory bodies continue to develop and refine their approaches to psychedelic research and commercialization.

Many product candidates never reach the stage of clinical testing and even those that do have only a small chance of successfully completing clinical development and gaining regulatory approval. Product candidates may fail for a number of reasons, including being unsafe for human use or due to the failure to provide therapeutic benefits equal to or better than the standard of treatment at the time of testing. Unsatisfactory results obtained from a particular study relating to a research and development program may cause us or our collaborators to abandon commitments to that program. Positive results of early pre-clinical research may not be indicative of the results that will be obtained in later stages of pre-clinical or clinical research. Similarly, positive results from early-stage clinical trials may not be indicative of favorable outcomes in later-stage clinical trials, and we can make no assurance that any future studies, if undertaken, will yield favorable results.

If we are successful in developing our current and future product candidates into approved products, we will still experience many potential obstacles, which would affect our ability to successfully market and commercialize such approved products, such as the need to develop or obtain manufacturing, marketing and distribution capabilities, price pressures from third-party payers or proposed changes in health care systems. If we are unable to successfully market and commercialize our products, our financial condition and results of operations may be materially and adversely affected.

As of the date hereof, the clinical effectiveness and safety of any of our developmental products is not yet fully supported by clinical data and the medical community has not yet developed a large body of peer reviewed literature that supports the safety and efficacy of similar products. If future studies call into question the safety or efficacy of our products, our business, financial condition, and results of operations could be adversely affected. Our success depends on achieving necessary regulatory approvals, which involve stringent regulatory hurdles and potential delays.

We can make no assurance that any future studies, if undertaken, will yield favorable results. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in later-stage clinical trials after achieving positive results in early-stage development, and we cannot be certain that it will not face similar setbacks. These setbacks have been caused by, among other things, pre-clinical findings made while clinical trials were underway or safety or efficacy observations made in clinical trials, including previously unreported adverse events.

Our products are in preclinical or clinical development with third parties, which is a lengthy and expensive process with uncertain outcomes. We cannot give any assurance that any of our future product candidates will be successfully developed and/or receive regulatory approval, which is necessary before they can be commercialized.

Before obtaining marketing approval from regulatory authorities in most jurisdictions for the sale of our product candidates, our product candidates must undergo extensive preclinical and clinical testing to evaluate their safety and efficacy for human use. We are not, and do not intend to be the clinical trial applicant for any study, rather, third parties currently conduct preclinical and clinical studies of our product candidates. Such testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the development process. Some of our product candidates are in the preclinical stage, and their risk of failure is high. Before our clients commence clinical trials for our product candidates, they must complete extensive preclinical testing and studies that support the planned Clinical Trial Applications (“CTAs”) in Canada or Investigational New Drug Applications (“INDs”) in the United States or similar applications in other jurisdictions. We cannot be certain of the timely completion or outcome of clients’ preclinical testing and studies and cannot predict if Health Canada, the FDA or other regulatory authorities will accept the proposed clinical programs or if the outcome of preclinical studies will ultimately support the further development of the programs. As a result, we cannot be sure that we will be able to submit CTAs, INDs or similar applications for our clinical programs on the timelines we expect, if at all, and we cannot be sure that submission of CTAs, INDs or similar applications will result in Health Canada, the FDA or other regulatory authorities allowing clinical trials to begin.

Moreover, the results of preclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials our clients commence may not be predictive of the results of the later-stage clinical trials. The results of preclinical studies and clinical trials in one set of patients or disorder indications, or from preclinical studies or clinical trials that we did not lead, may not be predictive of those obtained in another. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the dosing regimen and other clinical trial protocol details and the rate of dropout among clinical trial participants. In addition, preclinical and clinical data are often susceptible to various interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval. A number of companies in the pharmaceutical, biopharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies, and any such setbacks in our clinical development could have a material adverse effect on our business and operating results. Even if early-stage clinical trials are successful, our clients may need to conduct additional clinical trials of our product candidates in additional patient populations or under different treatment conditions before we are able to seek approvals from Health Canada, the FDA or other comparable foreign regulatory authorities to market and sell these product candidates. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization.

In addition, clinical trial design for our product candidates can be complex given their characteristics, and may not be accepted by the FDA. For example, clients will need to design clinical trials for certain product candidates to evaluate efficacy across a range of doses. Additionally, clients may utilize an “open-label” trial design for some of their future clinical trials. An open-label trial is one where both the patient and investigator know whether the patient is receiving the test article or either an existing approved drug or placebo. Open-label trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label studies are aware that they are receiving treatment. Open-label trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. Patients selected for early clinical studies often include the most severe sufferers, and their symptoms may have been bound to improve notwithstanding the new treatment. In addition, open-label trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The opportunity for bias in clinical trials as a result of open-label design may not be adequately handled and may cause any of our trials that utilize such design to fail or to be considered inadequate and additional trials may be necessary to support future marketing applications. Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that other jurisdiction. To the extent that the results of the trials are not satisfactory to Health Canada, the FDA or comparable foreign regulatory authorities for support of a marketing application, clients may be required to expend significant resources, which may not be available to them, to conduct additional trials in support of potential approval of our product candidates.

We cannot be certain that our product candidates will be successful in clinical trials. Our clients’ inability to successfully complete preclinical and clinical development could result in additional costs to us and negatively impact our ability to obtain approval and to generate revenue. Our future success is dependent on our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize product candidates. In addition, even if such clinical trials are successfully completed, we cannot guarantee that Health Canada, the FDA or comparable foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval. In addition, Health Canada, the FDA and other regulatory authorities’ policies with respect to clinical trials may change and additional government regulations may be enacted.

If we, as supplier, or our clients are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, our development plans may be impacted.

We may not achieve publicly announced milestone expectations and forecasts according to schedule, or at all.

From time to time, we may announce the timing of certain events that we expect to occur, such as the anticipated timing of results from our clients’ clinical trials. These statements are forward-looking and are based on the best estimates of management at the time relating to the occurrence of such events. However, the actual timing of such events may differ from what has been publicly disclosed. The timing of events such as a client’s initiation or completion of a clinical trial, filing of an application to obtain regulatory approval or announcement of additional clinical trials for a product candidate may ultimately vary from what is publicly disclosed. These variations in timing may occur as a result of different events, including the nature of the results obtained during a clinical trial or during a research phase, timing of the completion of clinical trials or any other event having the effect of delaying the publicly announced timeline. Further, any U.S. rescheduling delays or changes in Australian and Canadian policies may impact our market timelines. We undertake no obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise, except as otherwise required by law. Any variation in the timing of previously announced milestone expectations and forecasts could have a material adverse effect on our business plan, financial condition or operating results.

We rely on third parties to conduct clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.

We currently rely, and expect to continue to rely, on third parties, including our clients and their contracted research organizations, clinical data management firms, medical institutions and clinical investigators, to conduct research, preclinical studies, and clinical trials involving our product candidates. These third parties are responsible for designing, executing and overseeing the clinical development and regulatory submission processes. Any of these third parties may terminate their engagements or fail to fulfill their contractual obligations. If any such relationships end, we may not be able to secure alternative arrangements on commercially reasonable terms, or at all, which could delay or impair development and commercialization timelines for our products.

Although we do not conduct clinical trials ourselves, we may remain indirectly affected by the actions or failures of these third parties. Regulatory authorities such as the FDA, Health Canada and other comparable agencies require that clinical trials comply with applicable protocols, legal and regulatory standards and GCP guidelines, which govern the design, conduct, monitoring and reporting of human clinical trials. These authorities conduct periodic inspections of sponsors, investigators, clinical sites and IRBs to ensure compliance. If our clients or their contractors fail to meet these standards, the resulting data may be deemed unreliable, potentially requiring additional clinical trials and delaying regulatory approval. We cannot guarantee that any trial involving our products will be found compliant upon inspection.

Additionally, under applicable regulations, our clients are responsible for registering clinical trials and reporting results in accordance with jurisdictional requirements. In Canada, for example, all Health Canada-authorized trials must be registered in a clinical trial registry meeting World Health Organization standards before the enrollment of participants, and summary results must be submitted to the same registry. In the United States, certain trials must be registered on ClinicalTrials.gov, and results of completed trials must be posted within specified timeframes. Noncompliance can lead to fines, adverse publicity and civil or criminal penalties.

Even if our clients complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time consuming and uncertain and may prevent us from obtaining approvals for the potential commercialization of our product candidates.

Any product candidates we may develop and the activities associated with their development and potential commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by Health Canada, the FDA and other comparable foreign regulatory authorities. Failure to obtain marketing authorization for a product candidate will prevent us from commercializing the product candidate in a given jurisdiction.

We currently expect to rely on our clients to file and support the applications necessary to gain marketing authorizations for our products in jurisdictions where we cannot supply our products directly. Securing regulatory approval requires the submission of preclinical and clinical data from our clients and supporting information to the various regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy, or with respect to biological products in the U.S., the product candidate’s safety, purity and potency. Securing regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Any product candidates we develop may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use, if approved.

The process of obtaining marketing authorizations, in Canada, the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Changes in marketing authorization policies during the development period, changes in or the enactment of additional statutes or regulations or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. Health Canada, the FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that clients’ data are insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable. If we experience delays in obtaining approval, or if we fail to obtain approval of any product candidates we may develop, the commercial prospects for those product candidates may be harmed, and our ability to generate revenues will be materially impaired.

Research and development of drugs targeting the central nervous system (“CNS”) is particularly difficult and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others, which may reduce the likelihood our product candidates are ultimately approved and therefore may have a material adverse effect on our business and operating results.

Discovery and development of new drugs targeting brain health disorders are particularly difficult and time-consuming, evidenced by the higher failure rate for new drugs for brain health disorders compared with most other areas of drug discovery. Any such setbacks in our clients’ clinical development could have a material adverse effect on our business and operating results. In addition, our later stage clinical trials may present challenges related to conducting adequate and well-controlled clinical trials, including designing an appropriate comparator arm in trials given the potential difficulties related to maintaining the blinding during the trial or placebo or nocebo effects.

Due to the inherent complexity of the human brain and the central nervous system, it is often challenging to predict or fully understand why a drug, including psilocybin, MDMA or any other product candidates, may demonstrate therapeutic benefits in some patients but not others, or why individuals may respond differently to the same treatment. The impact and complexities that arise from comingling therapeutic treatments with psychotherapy is an added variable not present in traditional medical treatments. Moreover, most of the patients treated in our clients’ clinical trials have previously been treated with the same drugs, other drugs or therapies, introducing additional variabilities. These factors collectively complicate the evaluation of prior treatment effects and make it more difficult to assess the true efficacy of our product candidates.

If our clients encounter difficulties enrolling patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

Third parties’ identification and qualification of trial participants to participate in clinical studies is critical to our success. The timing of our clients’ clinical trials depends on, among other things, the speed at which they can recruit trial participants to participate in testing our product candidates and their ability to enroll a sufficient number of patients who remain in the trial until its conclusion. Delays in enrollment and withdrawals from the trial may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates. If trial participants are unwilling to participate in our studies because of negative publicity from adverse events in our trials or other trials of similar products, or those related to specific therapeutic area, or for other reasons, including competitive clinical studies for similar patient populations, the timeline for recruiting trial participants, conducting studies, and obtaining regulatory approval of potential products may be delayed. These delays could result in increased costs, delays in advancing our product candidate development, delays in testing the effectiveness of these product candidates, or termination of the clinical studies altogether.

Our clinical client partners may not be able to identify, recruit and enroll a sufficient number of trial participants, or those with required or desired characteristics to achieve diversity in a study, to complete their clinical studies in a timely manner. Patient and subject enrollment is affected by factors including:

If our clients have difficulty enrolling sufficient numbers of patients to conduct clinical trials as planned, they may need to delay or terminate clinical trials, either of which would have an adverse effect on our business.

Use of our product candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or halt their clinical development, prevent their regulatory approval, cause our clients to suspend or discontinue clinical trials, cause us to abandon a product candidate, limit their commercial potential, if approved, or result in other significant negative consequences that could severely harm our business, prospects, financial condition and results of operations.

As is the case with pharmaceuticals generally, it is likely that there may be unexpected or undesirable side effects, adverse effects and other risks associated with the use of our product candidates. Results of clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by these product candidates could cause our clients or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by Health Canada, the FDA or other comparable foreign regulatory authorities. The side effects related to the product candidate could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition, results of operations and prospects significantly.

Moreover, if our product candidates are associated with undesirable side effects in preclinical studies or clinical trials or have characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow indications or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for the product candidate if approved. Our clients may also be required to modify or terminate their study plans based on findings in preclinical studies or clinical trials. Many product candidates that initially show promise in early-stage testing may later be found to cause side effects that prevent further development. As we work to advance existing product candidates and to identify new product candidates, we cannot be certain that later testing or trials of product candidates that initially showed promise in early testing will not be found to cause similar or different unacceptable side effects that prevent their further development.

It is possible that as our product candidates are tested in larger, longer and more extensive clinical trials, or as the use of these product candidates becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other adverse effects that were not observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, may be reported by subjects. If such side effects become known later in development or upon approval, if any, such findings may harm our business, financial condition, results of operations and prospects significantly.

Additionally, adverse developments in clinical trials or use in the Authorised Prescribers Scheme in Australia of pharmaceutical, biopharmaceutical or biotechnology products conducted by others may cause Health Canada, the FDA or other regulatory oversight bodies to suspend or terminate our clinical trials or to change the requirements for approval of any of our product candidates.

In addition to side effects caused by the product candidate, the administration process, such as psychotherapy, or related procedures also can cause adverse side effects. If any such adverse effects occur, our clients’ clinical trials could be suspended or terminated. If our clients are unable to demonstrate that any adverse effects were caused by the administration process or related procedures, Health Canada, the FDA or other regulatory authorities could order us to cease further development of, or deny approval of, a product candidate for any or all targeted indications. Even if our clients can demonstrate that all future serious adverse events are not product-related, such occurrences could affect patient recruitment or the ability of enrolled patients to complete the trial. Moreover, if our clients elect, or are required, to not initiate, delay, suspend or terminate any future clinical trial of any of our product candidates, the commercial prospects of such product candidates may be harmed, and our ability to generate product revenues from any of these product candidates may be delayed or eliminated. Any of these occurrences may harm our ability to develop other product candidates, and may harm our business, financial condition, results of operations and prospects significantly.

Additionally, if any of our product candidates receive marketing authorization, Health Canada, the FDA or other regulatory authorities could impose contraindications or a boxed warning in the labeling of the product. For any of our drug product candidates receiving marketing authorization, Health Canada, the FDA or other regulatory authorities could require us to adopt a risk evaluation and mitigation strategy (“REMS”) or similar risk management measures and could apply elements to assure safe use to ensure that the benefits of the product outweigh its risks, which may include, among other things, a Medication Guide outlining the risks of the product for distribution to patients and a communication plan to health care practitioners. Furthermore, if we or others later identify undesirable side effects caused by our product candidates if approved, several potentially significant negative consequences could result, including:

Any of these occurrences could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and may harm our business, financial condition, results of operations and prospects significantly.

Even if any of our current or future product candidates receive regulatory approval in the United States, any such product candidates may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.

We have never commercialized a product in the United States, and even if any of our current or future product candidates is approved by the appropriate regulatory authorities for marketing and sale, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payers and others in the medical community. Physicians may be reluctant to take their patients off their current medications and switch their treatment regimen. Further, patients often acclimate to the treatment regime that they are currently taking and do not want to switch unless their physicians recommend switching products or they are required to switch due to lack of coverage and adequate reimbursement. In addition, even if we are able to demonstrate our product candidates’ safety and efficacy to the FDA and other regulators, safety or efficacy concerns in the medical community may hinder market acceptance.

Efforts to educate the medical community and third-party payers on the benefits of our product candidates may require significant resources from our partners, including management time and financial resources, and may not be successful. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

Sales of medical products also depend on the willingness of physicians to prescribe the treatment, which is likely to be based on a determination by these physicians that the products are safe, therapeutically effective and cost effective. In addition, the inclusion or exclusion of products from treatment guidelines established by various physician groups and the viewpoints of influential physicians can affect the willingness of other physicians to prescribe the treatment. We cannot predict whether physicians, physicians’ organizations, hospitals, other healthcare providers, government agencies or public or private insurers will determine that any of our products is safe, therapeutically effective and cost effective as compared with competing treatments. If any product candidates we develop do not achieve an adequate level of acceptance, they may not generate significant product revenue, and we may not become profitable.

For any of our current or future product candidates that obtain regulatory approval, any failure to achieve market acceptance or commercial success would adversely affect our business prospects. In addition, for any approved product, any negative perception of such product once commercialized, or of a similar product developed by a competitor, may adversely affect our reputation in the marketplace or among industry participants and our business prospects.

We currently, and may in the future continue to, rely on data from clinical trials for product candidates conducted outside the United States, and the FDA and other comparable foreign regulatory authorities may not accept data from such trials.

The acceptance of study data from clinical trials conducted outside the United States, Canada, Australia or another jurisdiction by the FDA or any comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to Good Clinical Practice (“GCP”) regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, if the applicable clinical trial was not otherwise subject to an IND, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCP and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA, or any comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA, or any comparable foreign regulatory authority, does not accept such data, it would result in the need for additional trials, which would be costly and time consuming and delay aspects of our business plan and may result in product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.

If we are unable to obtain regulatory approval in one or more jurisdictions for any product candidates that we may identify and develop, our business will be substantially harmed.

We cannot commercialize a product until the appropriate regulatory authorities have reviewed and approved the product candidate. Approval by the FDA and comparable regulatory authorities is lengthy and unpredictable and depends upon numerous factors, including substantial discretion of the regulatory authorities. Approval policies, regulations or the type and amount of preclinical or clinical data necessary to gain approval may change during the course of a product candidate’s development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. We cannot be certain that any of our future product candidates will receive regulatory approval or be successfully commercialized, even if they receive regulatory approval.

Obtaining marketing approval is an extensive, lengthy, expensive and inherently uncertain process, and regulatory authorities may delay, limit or deny approval of our product candidates for many reasons, including but not limited to:

The lengthy approval process, as well as the unpredictability of the results of clinical trials and evolving regulatory requirements, may result in our failure to obtain regulatory approval to market product candidates that we may pursue in the United States or elsewhere, which would significantly harm our business, prospects, financial condition and results of operations.

Furthermore, approval by the FDA in the United States, if obtained, does not ensure approval by regulatory authorities in other countries or jurisdictions. In order to market any products outside of Canada, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval processes vary among countries and can involve additional product testing and validation and additional or different administrative review periods from those in Canada, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In some cases, the price that we intend to charge for our products is also subject to approval.

Seeking foreign regulatory approval could result in difficulties and costs for us and require additional preclinical studies or clinical trials by our clients, which could be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our products in those countries. The foreign regulatory approval process involves all of the risks associated with FDA approval. We currently have three products approved for sale in Australia. If we fail to comply with regulatory requirements in any markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability to realize the full market potential of our products will be harmed.

We may be affected by negative results from clinical trials or studies conducted by third-parties.

From time to time, studies or clinical trials on various aspects of psychedelics are conducted by academic researchers, competitors or others. The results of these studies or trials, when published, may have a significant effect on the marketability of the substance that is the subject of the study. For example, the FDA rejected Resilient Pharmaceuticals, Inc.’s (formerly known as Lykos Therapeutics) application for MDMA-assisted therapy for PTSD on August 9, 2024. While we were not materially affected in that instance, there can be no assurance that similar events in the future will not have a materially adverse effect on our business. In particular, the publication of negative results of studies or clinical trials or the occurrence of adverse safety events related to psychedelics could adversely affect our operations, research, share price and ability to finance future operations.

Risks Related to Intellectual Property

If we are unable to maintain or obtain sufficient intellectual property protection in the future for our existing product candidates or any other product candidates that we may identify, or if the scope of the intellectual property protection we have or may obtain in the future is not sufficiently broad, our competitors could develop and commercialize product candidates similar or identical to ours, and our ability to successfully commercialize our existing product candidates and any other product candidates that we may pursue may be impaired.

As is the case with other pharmaceutical and biopharmaceutical companies, our success depends in large part on our ability to obtain and maintain protection of the intellectual property we may own solely and jointly with others, in Canada, the United States and other countries, with respect to our product candidates and technology. We may seek to protect our proprietary position by filing patent applications in Canada, the United States and abroad and by in-licensing intellectual property related to our existing product candidates, our various proprietary technologies and any other product candidates or technologies that we may identify.

Obtaining and enforcing pharmaceutical and biopharmaceutical patents is costly, time consuming and complex, and we may not be able to file and prosecute all necessary or desirable patent applications, or to maintain, enforce and license any patents that may issue from such patent applications, at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. We may not have the right to control the preparation, filing and prosecution of patent applications or to maintain the rights to patents licensed to third parties. Therefore, these potential patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal, technological and factual questions and has in recent years been the subject of much litigation. The standards that the Canadian Intellectual Property Office (“CIPO”), the USPTO and foreign counterparts use to grant patents are not always applied predictably or uniformly. Any future patent applications may not result in patents being issued that protect our product candidates or technology, in whole or in part, or which effectively prevent others from commercializing competitive product candidates. The coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if future patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our future owned or licensed patents by developing similar or alternative product candidates in a non-infringing manner.

In addition, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our future patents may be challenged in the courts or patent offices in Canada, the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical product candidates to ours, or limit the duration of the patent protection of our product candidates. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property portfolio may not provide us with sufficient rights to exclude others from commercializing drugs similar or identical to ours.

Third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts.

Our commercial success depends in part on our ability to develop, manufacture, market and sell any product candidates that we may develop and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and proprietary rights of third parties. However, our research, development and commercialization activities may be subject to claims that we infringe or otherwise violate patents or other intellectual property rights owned or controlled by third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions and inter partes re-examination proceedings before the CIPO, USPTO and corresponding foreign patent offices. Numerous Canadian, United States and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are pursuing development candidates. Our competitors in Canada, the United States and abroad, many of which have substantially greater resources and have made substantial investments in patent portfolios and competing technologies, may have applied for or obtained or may in the future apply for or obtain, patents that will prevent, limit or otherwise interfere with our ability to make, use and sell, if approved, our product candidates. The pharmaceutical and biotechnology industries have produced a considerable number of patents, and it may not always be clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform. If we were sued for patent infringement, we would need to demonstrate that our product candidates, products or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and we may not be able to do this. Proving invalidity may be difficult. For example, in Canada, proving invalidity in court requires a showing of clear and convincing evidence to overcome the presumption of validity that applies to issued patents. In addition, many companies in the biotechnology and pharmaceutical industries have employed intellectual property litigation as a means to gain an advantage over their competitors. As the biotechnology and pharmaceutical industries expand and more patents are issued, and as we gain greater visibility and market exposure as a public company, the risk increases that our existing product candidates and any other product candidates that we may identify may be subject to claims of infringement of the patent rights of third parties.

There may be other third-party patents or patent applications with claims to composition of matter, materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our existing or future product candidates. Further, we may not be aware of patents that have already been issued and that a third party, for example, a competitor in the fields in which we are developing our product candidates, might assert are infringed by our current or future product candidates, including claims to compositions, formulations, methods of manufacture or methods of use or treatment that cover our product candidates. It is also possible that patents owned by third parties of which we are aware, but which we do not believe are relevant to our product candidates and other proprietary technologies we may develop, could be found to be infringed by our product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our product candidates, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize such product candidates unless we obtained a license under the applicable patents, or until such patents expire.

Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy, the holders of any such patents may be able to block our ability to develop and commercialize the applicable product candidates unless we obtained a license or until such patents expires. In either case, such a license may not be available on commercially reasonable terms or at all, or it may be non-exclusive, which could result in our competitors gaining access to the same intellectual property rights.

Parties making claims against us may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk that some of our confidential information could be compromised by disclosure. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have material adverse effect on our ability to operate effectively.

If we obtain patents in the future and are not able to obtain patent term extension in Canada, Australia, the United States and other foreign countries, in order to extend the marketing exclusivity term of our product candidates, our business may be materially harmed.

For the United States, depending upon the timing, duration and specifics of FDA marketing approval of our product candidates, one of the U.S. patents covering each of such product candidates or the use thereof may be eligible for up to five years of patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments. The Hatch-Waxman Amendments allow a maximum of one patent to be extended per FDA approved product as compensation for the patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only those claims covering such approved drug product, a method for using it or a method for manufacturing it may be extended. Patent term extension also may be available in Canada under the Supplementary Protection Regulations, or in other foreign countries upon regulatory approval of our product candidates, such as the Supplementary Protection Certificates in Europe. In particular, a maximum of five and a half years of supplementary protection can be achieved in Europe for an active ingredient or combinations of active ingredients of a medicinal product protected by a basic patent, if a valid marketing authorization exists (which must be the first authorization to place the product on the market as a medicinal product) and if the product has not already been the subject of supplementary protection.

Nevertheless, we may not be granted patent term extension either in the United States or in any other country because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the term of extension, as well as the scope of patent protection during any such extension, afforded by the governmental authority could be less than we request. If we are unable to obtain patent term extension or restoration, or the term of any such extension is less than we request, the period during which we will have the right to exclusively market our product may be shortened, and our competitors may obtain approval of competing products following our patent expiration and may take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data to launch their product earlier than might otherwise be the case, and our revenue could be reduced, possibly materially, which would have a material adverse effect on our business, financial condition and results of operations.

Also, there are detailed rules and requirements regarding the patents that in the United States may be submitted to the FDA for listing in the Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book, or in Canada, with the Health Canada Patent Register. We may be unable to obtain patents covering our product candidates that contain one or more claims that satisfy the requirements for listing in the Orange Book (or in Canada, with the Patent Register). Even if we submit a patent for listing in the Orange Book or Patent Register, the FDA or Health Canada, respectively, may decline to list the patent, or a manufacturer of generic drugs may challenge the listing. If or when one of our product candidates is approved and a patent covering that product candidate is not listed in the Orange Book (or Patent Register in Canada), a manufacturer of generic drugs would not have to provide advance notice to us of any abbreviated new drug application (“ANDA”), filed with the FDA or any abbreviated new drug submission (“ANDS”) filed with Health Canada to obtain permission to sell a generic version of such product candidate.

If we are unable to protect the confidentiality of our trade secrets, the value of our product candidates and products could be materially adversely affected, and our business would be harmed.

We consider proprietary trade secrets, confidential know-how and unpatented know-how to be important to our business. We seek to protect our confidential proprietary information, in part, by entering into confidentiality agreements and invention assignment agreements with parties who have access to them, including our employees, consultants, scientific advisors, contractors, contracted research organizations, contract manufacturers, collaborators and other third parties, that are designed to protect our proprietary information. However, we cannot be certain that such agreements have been entered into with all relevant parties that may have or have had access to our trade secrets or proprietary technology, and we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets and other confidential proprietary technology, or independently develop substantially equivalent information and techniques. For example, any of these parties may breach the agreements and disclose our proprietary information, including trade secrets, and we may not be able to obtain adequate remedies for such breaches. We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective.

Unauthorized parties may also attempt to copy or reverse engineer certain aspects of our products that we consider proprietary. We may not be able to obtain adequate remedies in the event of such unauthorized use. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive and time consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. Trade secrets will also over time be disseminated within the industry through independent development, the publication of journal articles and the movement of personnel skilled in the art from company to company or academic institutions to industry scientific positions. Though our agreements with third parties typically restrict the ability of our advisors, employees, collaborators, licensors, suppliers, third-party contractors and consultants to publish data potentially relating to our trade secrets and proprietary information, our agreements may contain certain limited publication rights. In addition, if any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position. Despite employing the contractual and other security precautions described above, the need to share trade secrets increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. If any of these events occur or if we otherwise lose protection for our trade secrets, the value of such information may be greatly reduced and our competitive position, business, financial condition, results of operations and prospects would be harmed.

Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.

Because of the expense and uncertainty of litigation, we may conclude that, even if a third-party is infringing any future issued patents or other intellectual property rights, the risk-adjusted cost of bringing and enforcing such a claim or action may be too high or not in the best interest of our company or our shareholders, or it may be otherwise impractical or undesirable to enforce our intellectual property against some third parties. Our competitors or other third parties may be able to sustain the costs of complex patent litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. In such cases, we may decide that the more prudent course of action is to simply monitor the situation or initiate or seek some other non-litigious action or solution. In addition, the uncertainties associated with litigation could compromise our internal research programs, in-license needed technology or other product candidates, or enter into development partnerships that would help us bring our product candidates to market.

Risks Related to This Offering and Ownership of Our Common Shares

The sale or issuance of common shares to the Selling Shareholder will likely cause dilution and the sale of the common shares acquired by the Selling Shareholder, or the perception that such sales may occur, could cause the price of the common shares to fall.

On August 13, 2026, we entered into the Purchase Agreement with Seven Knots, pursuant to which Seven Knots has committed to purchase up to $100 million of our common shares. Concurrently, we issued to Seven Knots the Initial Commitment Note in the principal amount of $1.5 million, as consideration for its commitment to purchase common shares under the Purchase Agreement. We also agreed to issue to Seven Knots the Additional Commitment Note in the principal amount of $500,000 after the aggregate gross proceeds from the Selling Shareholder pursuant to the Purchase Agreement equal or exceed $7 million. The Seven Knots Commitment Notes are convertible into the Seven Knots Commitment Shares, on the terms and conditions set forth therein. The purchase price for the common shares that we may sell to Seven Knots will fluctuate based on the price of the common shares, based on the terms and conditions set forth under the Purchase Agreement. Thus, the actual gross proceeds from the sale by us to Seven Knots of all the common shares being registered for resale hereunder may be substantially less than the $100 million total purchase commitment available to us under the Purchase Agreement, which could materially adversely affect our liquidity. In addition, depending on market liquidity at the time, sales of such common shares, or the anticipation of such sales, may cause the trading price of the common shares to fall.

We generally have the right to control the timing and amount of any future sales of our common shares to Seven Knots. Sales of our common shares, if any, to Seven Knots will depend upon market conditions and other factors to be determined by us. We may ultimately decide to sell to Seven Knots all, some or none of the additional common shares that may be available for us to sell pursuant to the Purchase Agreement. If and when we do sell common shares to Seven Knots, after Seven Knots has acquired the common shares, Seven Knots may resell all, some or none of those common shares at any time or from time to time in its discretion. Therefore, sales to Seven Knots by us could result in substantial dilution to the interests of other holders of the common shares. Additionally, the sale of a substantial number of common shares to Seven Knots, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales. The 21,943,260 common shares being offered for resale in this prospectus represent approximately 383.2% of our total outstanding common shares as of the date of this prospectus, and do not represent all of the common shares we may sell to Seven Knots pursuant to the Purchase Agreement.

Furthermore, if we elect to issue and sell to Seven Knots more than the 21,276,594 common shares that we may elect to issue and sell to Seven Knots under the Purchase Agreement that are being registered for resale by Seven Knots hereunder, which we have the right, but not the obligation, to do, we must first file with the SEC one or more additional registration statements to register under the Securities Act for resale by Seven Knots such additional common shares we wish to sell from time to time under the Purchase Agreement, which the SEC must declare effective, in each case before we may elect to sell any additional common shares to Seven Knots under the Purchase Agreement. Any issuance and sale by us under the Purchase Agreement of a substantial amount of common shares in addition to the 21,276,594 common shares that we may elect to issue and sell to Seven Knots under the Purchase Agreement that are being registered for resale by Seven Knots hereunder could cause additional substantial dilution to our shareholders. The number of our common shares ultimately offered for sale by Seven Knots is dependent upon the number of common shares, if any, we ultimately sell to Seven Knots under the Purchase Agreement, and the sale of common shares under the Purchase Agreement may cause the trading price of our common shares to decline.

It is not possible to predict the actual number of common shares we will sell under the Purchase Agreement to Seven Knots, or the actual gross proceeds resulting from those sales.

Subject to certain limitations in the Purchase Agreement and compliance with applicable law, we have the discretion to deliver notices to Seven Knots at any time throughout the term of the Purchase Agreement. The actual number of common shares that are sold to Seven Knots may depend based on a number of factors, including the market price of the common shares during the sales period. Actual gross proceeds may be nominal, which may impact our future liquidity. Because the price per common share sold to Seven Knots will fluctuate during the sales period, it is not currently possible to predict the number of common shares that will be sold or the actual gross proceeds to be raised in connection with those sales.

Seven Knots will pay less than the then-prevailing market price for the common shares, which could cause the market price of the common shares to decline.

The purchase price of the common shares to be sold to Seven Knots pursuant to the Purchase Agreement is derived from the market price of the common shares on Nasdaq. Shares to be sold to Seven Knots pursuant to the Purchase Agreement will be purchased at a discounted price. As a result of this pricing structure, Seven Knots may sell the common shares they receive immediately after receipt of such shares, which could cause the market price of the common shares to decrease. See “The Seven Knots Transaction.”

Investors who buy shares at different times will likely pay different prices.

Pursuant to the Purchase Agreement, we will have discretion, subject to market demand, to vary the timing, prices, and numbers of common shares sold to Seven Knots. If and when we do elect to sell common shares to Seven Knots pursuant to the Purchase Agreement, after Seven Knots has acquired such shares, Seven Knots may resell all, some or none of such shares at any time or from time to time in its discretion and at different prices. As a result, investors who purchase shares from Seven Knots in this offering at different times will likely pay different prices for those shares, and so may experience different levels of dilution and in some cases substantial dilution and different outcomes in their investment results. Investors may experience a decline in the value of the common shares they purchase from Seven Knots in this offering as a result of future sales made by us to Seven Knots at prices lower than the prices such investors paid for their shares in this offering.

An active and liquid market for our common shares may fail to develop or be sustained, which could harm the market price of our common shares.

A liquid public market for our common shares may not develop, or if it is developed, may not be sustained. The lack of an active market may impair your ability to sell your common shares at the time you wish to sell them or at a price that you consider reasonable. An inactive market may also impair our ability to raise capital by selling shares and may impair our ability to acquire other businesses using our shares as consideration.

We are a foreign private issuer within the meaning of the rules under the Exchange Act, and, as such, we are exempt from certain provisions applicable to U.S. domestic public companies.

Because we qualify as a foreign private issuer under the Exchange Act, we are exempt from certain provisions of the securities rules and regulations in the United States that are applicable to U.S. domestic issuers, including:

We are required to file an annual report on Form 20-F within four months of the end of each fiscal year. In addition, we intend to publish our financial results on a quarterly basis, distributed pursuant to the rules and regulations of Nasdaq. Press releases relating to financial results and material events will also be furnished to the SEC on Form 6-K. However, the information we are required to file with or furnish to the SEC will be less extensive and less timely compared to the information required to be filed with the SEC by U.S. domestic issuers. As a result, you may not be afforded the same protections or information that would be made available to you were you investing in a U.S. domestic issuer.

As a foreign private issuer, we are permitted, and we rely on, exemptions from certain Nasdaq corporate governance standards applicable to U.S. domestic issuers. This may afford less protection to holders of our common shares than they would enjoy if we complied fully with the Nasdaq corporate governance listing standards.

We are exempted from certain corporate governance requirements of Nasdaq by virtue of being a foreign private issuer. As a foreign private issuer, we are permitted to follow the governance practices of our home country in lieu of certain corporate governance requirements of Nasdaq. As result, the standards applicable to us are considerably different from the standards applied to U.S. domestic issuers and could provide less protection to you than you would have under the Nasdaq rules applicable to domestic issuers.

Specifically, we rely on exemptions from the following Nasdaq corporate governance requirements:

As a result, you will not have the same protection afforded to shareholders of companies that are subject to these corporate governance requirements.

We may lose our foreign private issuer status in the future, which could result in significant additional costs and expenses and may impede our ability to maintain our listing on Nasdaq.

The determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter. If we lose our foreign private issuer status on a determination date, then, beginning on the first day of the fiscal year following the determination date, we would have to comply with U.S. federal proxy rules and other requirements, and our officers, directors and principal shareholders would become subject to the reporting and short-swing profit recovery provisions of Section 16 of the Exchange Act. In addition, we would lose our ability to rely upon exemptions from certain corporate governance requirements under the Nasdaq listing rules as well as our ability under the Exchange Act to present our financial statements pursuant to IFRS instead of pursuant to U.S. GAAP. In addition, on June 4, 2025, the SEC issued a concept release seeking public comment on whether to amend the current eligibility criteria for foreign private issuer status under the U.S. securities laws to better balance investor protection and capital formation. This marks the first comprehensive review of the FPI regulatory framework since 2008 and signals a potential material shift in the FPI regulatory framework. While no rule changes have been proposed yet, any future amendments could impact our eligibility to qualify as a foreign private issuer.

As a U.S. listed public company that would not qualify as a foreign private issuer, we would incur significant additional legal, accounting and other expenses that we would not incur as a foreign private issuer, as well as increased accounting, reporting and other expenses in order to maintain a listing on a U.S. securities exchange. If we lose our foreign private issuer status and are unable to devote adequate funding and the resources needed to maintain compliance with Nasdaq’s corporate governance requirements applicable to domestic issuers, we may become unable to maintain the listing of our common shares on Nasdaq.

We are subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are not emerging growth companies, and our shareholders could receive less information than they might expect to receive from more mature public companies.

We currently qualify as an “emerging growth company” under the JOBS Act. As a result, we will be permitted to, and we rely on, exemptions from certain disclosure requirements. These provisions include exemption from the auditor attestation requirement under Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) in the assessment of the emerging growth company’s internal control over financial reporting.

We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year during which we have total annual gross revenues of at least US$1.235 billion; (ii) the last day of our fiscal year following the fifth anniversary of the completion of our initial public offering in the United States; (iii) the date on which we have, during the preceding three year period, issued more than US$1.0 billion in non-convertible debt; or (iv) the date on which we are deemed to be a “large accelerated filer” under the Exchange Act, which could occur if the market value of our securities that are held by non-affiliates exceeds US$700 million as of the last business day of our most recently completed second fiscal quarter. Once we cease to be an emerging growth company, we will not be entitled to the exemptions provided in the JOBS Act discussed above.

Because we are subject to ongoing public reporting requirements for such time as we remain an emerging growth company that are less rigorous than Exchange Act rules for companies that are not emerging growth companies, our shareholders could receive less information than they might expect to receive from more mature public companies. We cannot predict if investors will find our securities less attractive if we elect to rely on these exemptions or if taking advantage of these exemptions would result in less active trading or more volatility in the price of our securities.

We expect to incur increased costs and become subject to additional rules and regulations as a result of being a public company in the United States.

We are a public company in the United States and expect to incur significant legal, accounting and other expenses. The Sarbanes-Oxley Act, as well as rules subsequently implemented by the SEC and Nasdaq, impose various requirements on the corporate governance practices of public companies in the United States. We expect these rules and regulations to increase our legal and financial compliance costs and to make some corporate activities more time-consuming and costly. We expect to incur significant expenses and devote substantial management effort toward ensuring compliance with the requirements of Section 404 and the other rules and regulations of the SEC. For example, as a result of becoming a public company in the United States, we will need to adopt specific policies regarding internal controls and disclosure controls and procedures. We also expect that operating as a public company in the United States will make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. In addition, we will incur additional costs associated with our public company reporting requirements in the United States. It may also be more difficult for us to find qualified persons to serve on our board of directors or as executive officers. We are currently evaluating and monitoring developments with respect to these rules and regulations, and we cannot predict or estimate with any degree of certainty the number of additional costs we may incur or the timing of such costs.

It may be difficult to enforce judgments or bring actions outside the United States against us and our directors.

We are a Canadian corporation, and our officers and directors are neither citizens nor residents of the United States. All or a substantial part of the assets of these persons are located outside the United States. As a result, it may be difficult or impossible for an investor to enforce in courts outside the United States judgments obtained in United States courts based upon the civil liability provisions of United States federal securities laws against these persons and us or to bring in courts outside the United States an original action to enforce liabilities based upon United States federal securities laws against these persons and us.

We may be subject to securities litigation, which is expensive and could divert our management’s attention.

In the past, companies that have experienced volatility in the market price of their securities have been subject to securities class action or other shareholder litigation. We may be the target of this type of litigation in the future. Even if such claims are without merit, litigation could result in substantial legal costs, divert management’s attention from the operation of our business and damage our reputation. In addition, while we maintain directors’ and officers’ liability insurance, our insurance coverage may not be sufficient to cover all costs, judgments, or settlements associated with such claims. If our insurance coverage is inadequate or unavailable, we may be exposed to significant liabilities, which could materially and adversely affect our financial condition and results of operations.

If we sell shares of our common shares in future financings, shareholders may experience immediate dilution, and, as a result, our stock price may decline.

We expect our expenses to increase significantly in the foreseeable future and we may from time to time issue additional common shares. These issuances may be at a discount from the current trading price of our common shares. As a result, our shareholders would experience immediate dilution upon the purchase of any of our common shares sold at such discount. In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of debt securities, preferred shares or common shares. If we issue common shares or securities convertible into common shares, our common shareholders will experience additional dilution and, as a result, our share price may decline.

Management will have broad discretion as to the use of the proceeds from any sales of common shares we make to Seven Knots pursuant to the Purchase Agreement and may use them in ways that may not enhance our operating results or the price of our common shares.

Although we will not receive any proceeds from the offer of the common shares for resale by Seven Knots pursuant to this prospectus, we will receive proceeds from the sale of common shares to Seven Knots pursuant to the Purchase Agreement. Because we have not designated the amount of net proceeds from the sale of common shares to Seven Knots pursuant to the Purchase Agreement to be used for any particular purpose, our management will have broad discretion as to the application of such net proceeds and could use them for purposes other than those contemplated hereby. Our management may use the net proceeds for corporate purposes that may not improve our financial condition or market value.

We do not currently intend to pay dividends on our common shares, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common shares.

We do not currently intend to pay any cash dividends on our common shares for the foreseeable future. Therefore, you are not likely to receive any dividends on your common share for the foreseeable future. Since we do not intend to pay dividends, your ability to receive a return on your investment will depend on any future appreciation in the market value of our common shares. There is no guarantee that our common share will appreciate or even maintain the price at which our holders have purchased such common shares.

If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our common shares, our share price and trading volume could decline.

The trading market for our common shares will be influenced by the research and reports that industry or securities analysts publish about us or our business. If no or few securities or industry analysts commence or continue coverage of us, the trading price for our common shares would be negatively impacted. In the event we obtain securities or industry analyst coverage, if any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, or our share performance, or if our operating results fail to meet the expectations of analysts, our share price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our share price or trading volume to decline.

We may not be able to maintain a listing of our common shares on the Nasdaq Capital Market.

We must meet certain financial and liquidity criteria to maintain a listing on the Nasdaq Capital Market; however, there is no guarantee that we will be able to satisfy these requirements. If we violate Nasdaq listing requirements, our common shares may be delisted. If we fail to meet any of Nasdaq’s listing standards, our common shares may be delisted. In addition to applying its enumerated listing standards, Nasdaq has broad discretionary authority over the initial and continued listing of securities on Nasdaq in order to maintain the quality of and public confidence in its market, to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and to protect investors and the public interest. Nasdaq may use this discretion to apply additional or more stringent criteria for the initial or continued listing of particular securities, or suspend or delist particular securities based on any event, condition, or circumstance that exists or occurs that makes initial or continued listing of the securities on Nasdaq inadvisable or unwarranted in the opinion of Nasdaq, even though the securities meet all enumerated criteria for continued listing on Nasdaq. In addition, our Board of Directors may determine that the cost of maintaining our listing on a U.S. national securities exchange outweighs the benefits of such listing. A delisting of our common shares may materially impair our shareholders’ ability to buy and sell our common shares and could have an adverse effect on the market price of, and the efficiency of the trading market for, our common shares. The delisting of our common shares could significantly impair our ability to raise capital and the value of your investment.

In the future, we may be deemed to be a controlled foreign corporation.

If a United States person is treated as owning (directly, indirectly, or constructively) at least 10% of the value or voting power of our common shares, such person may be treated as a “United States shareholder” with respect to each “controlled foreign corporation” in our group. A United States shareholder of a controlled foreign corporation may be required to report annually and include in its U.S. taxable income its pro rata share of “Subpart F income,” “global intangible low-taxed income,” and investments in U.S. property by controlled foreign corporations, regardless of whether we make any distributions. We are not committing to assist investors in determining whether we or any of our non-U.S. subsidiaries is treated as a controlled foreign corporation or whether any investor is treated as a United States shareholder with respect to any such controlled foreign corporation, or to furnish to any United States shareholders with the information that may be necessary to comply with the aforementioned reporting and tax paying obligations. A United States investor should consult its advisors regarding the potential application of these rules to an investment in our common shares.

In the future, we may be classified as a passive foreign investment company for United States federal income tax purposes.

Generally, if for any taxable year 75% or more of our gross income is passive income, or at least 50% of the average quarterly value of our assets are held for the production of, or produce, passive income, we would be characterized as a passive foreign investment company (“PFIC”) for U.S. federal income tax purposes. Whether we are a PFIC for the current or any future taxable year is uncertain, as it will depend on our income and assets for each such year. We do not believe we were a PFIC for our most recently ended taxable year and based on current business plans and financial expectations, we do not expect to be a PFIC for our current taxable year. However, no assurance can be given concerning our PFIC status for our current taxable year and for any subsequent tax years. Accordingly, we may be classified as a PFIC in the future. If we are characterized as a PFIC, U.S. holders of our common shares may suffer adverse tax consequences. Prospective U.S. investors are strongly urged to consult their own tax advisors with respect to the impact of PFIC status on the purchase, ownership and disposition of common shares.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements concerning our business, operations and financial performance, as well as our plans, objectives and expectations for our business operations and financial performance and condition. All statements other than statements of historical facts included in this prospectus are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “plans”, “expects”, “projected”, “estimated”, “forecasts”, “anticipates”, “intend”, “guidance”, “outlook”, “potential”, “prospects”, “seek”, “aim”, “strategy”, “targets” or “believes”, or variations of such words and phrases or statements that certain future conditions, actions, events or results “will”, “may”, “could”, “would”, “should”, “might” or “can”, or negative versions thereof, “occur”, “continue” or “be achieved” and other similar expressions. In addition, statements that “we believe” or similar statements reflect our beliefs and opinions on the relevant subject.

Forward-looking statements include, but are not limited to, statements with respect to:

We have based these forward-looking statements largely on our current expectations, estimates, forecasts and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this prospectus, we cannot guarantee that the future results, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the section entitled “Risk Factors” and elsewhere in this prospectus for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required by law, including applicable Canadian and U.S. securities laws, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

This prospectus also contains certain data and information, which we obtained from various government and private publications. Although we believe that the publications and reports are reliable, we have not independently verified the data. Statistical data in these publications includes projections that are based on a number of assumptions. If any one or more of the assumptions underlying the market data is later found to be incorrect, actual results may differ from the projections based on these assumptions.

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this prospectus by these cautionary statements.

THE SEVEN KNOTS TRANSACTION

General

On August 13, 2026, we and Seven Knots entered into the Purchase Agreement, which provides that subject to the terms and conditions set forth therein, we may sell to Seven Knots up to $100 million of our common shares from time to time during the term of the Purchase Agreement (the “Total Purchase Commitment”). Capitalized terms used but not otherwise defined herein have the same meaning ascribed to them in the Purchase Agreement.

Under the terms and subject to the satisfaction of the conditions set forth in the Purchase Agreement, we have the right, but not the obligation, to sell to Seven Knots, and Seven Knots is obligated to purchase, up to the Total Purchase Commitment. Such sales of common shares by us, if any, will be subject to certain limitations as set forth in the Purchase Agreement, and may occur from time to time, at our sole discretion, during the Investment Period. The Investment Period commences on the effective date of this registration statement and expires on the date the Purchase Agreement is terminated. Seven Knots has no right to require us to sell any common shares to Seven Knots, but Seven Knots is obligated to accept each VWAP Purchase Notice prepared and delivered by us in accordance with the terms of and subject to the satisfaction of the conditions contained in the Purchase Agreement.

On any business day on which the prior trading day closing sale price of our common shares on Nasdaq is equal to or greater than $1.00 and on which we have directed Seven Knots to purchase common shares (the “VWAP Purchase Date” and such purchase, a “VWAP Purchase”), the purchase price per share (the “VWAP Purchase Price”) shall equal 97% of the lesser of (i) the lowest sale price of the common shares on the applicable VWAP Purchase Date and (ii) the VWAP during the applicable VWAP Purchase Period. Seven Knots’ maximum purchase obligation under any single VWAP Purchase shall not exceed 30% of the trading volume of the common shares during the applicable VWAP Purchase Period on the applicable VWAP Purchase Date (the “VWAP Purchase Maximum Amount”). In addition, Seven Knots’ aggregate committed obligation under any single VWAP Purchase shall not exceed $2 million in the aggregate for such VWAP Purchase. The Purchase Agreement also prohibits us from directing Seven Knots to purchase any common shares if those common shares, when aggregated with all other common shares then beneficially owned by Seven Knots and its affiliates, would result in Seven Knots having beneficial ownership of more than 4.99% of the outstanding common shares.

We also agreed to pay Seven Knots up to $35,000 for its reasonable out-of-pocket expenses, including the legal fees and disbursements of Seven Knots’ legal counsel, incurred in connection with the preparation, negotiation, execution and delivery of the transaction documents and Seven Knots’ due diligence investigation of us.

The Purchase Agreement contains customary representations, warranties, covenants, indemnification and termination provisions. Seven Knots has covenanted not to engage, directly or indirectly, in any short sales involving our securities or in any hedging of the common shares. The Purchase Agreement includes restrictions on our ability to make certain dilutive issuances during reference periods relating to VWAP Purchases, and restrictions on our ability to enter into “variable rate transactions” or other similar continuous offerings during the term of the Purchase Agreement.

The Purchase Agreement may be terminated by us at any time, at our sole discretion, upon one trading day’s prior written notice to Seven Knots, provided that we shall have paid all fees and amounts required to be paid prior to such termination, and provided further that prior to issuing any press release or making any public statement with respect to such termination, we shall consult with Seven Knots and its counsel on the form and substance of such disclosure. Seven Knots shall also have the right to terminate the Purchase Agreement upon ten trading days’ prior written notice to us in certain circumstances, including our material breach of the Purchase Agreement.

Upon entering into the Purchase Agreement, we agreed to issue Seven Knots the Initial Commitment Note, as consideration for Seven Knots’ execution and delivery of the Purchase Agreement and commitment to purchase common shares upon our direction thereunder. The Initial Commitment Note is a convertible promissory note in the principal amount of $1.5 million. No interest shall accrue on the unpaid principal balance of the Initial Commitment Note. We also agreed to issue to Seven Knots the Additional Commitment Note, which is a convertible note in the principal amount of $500,000, which does not bear interest, after the aggregate gross proceeds from the Selling Shareholder pursuant to the Purchase Agreement equal or exceed $7 million. The entire unpaid principal balance of the Seven Knots Commitment Notes shall be due and payable 24 months after their respective issuance dates (the “Maturity Date”).

Seven Knots may, in its sole discretion and upon written notice to us (a “Conversion Notice”), convert all or a portion of the entire unpaid principal balance of the Seven Knots Commitment Notes into a number of common shares (the “Seven Knots Commitment Shares”) equal to the conversion amount divided by an amount equal to 95% of the average VWAP of the common shares on Nasdaq during the 20 consecutive trading days ending on the trading day immediately preceding the date of the Conversion Notice (the “Conversion Price”), provided that in no event will the Conversion Price be less than the last closing price of the Common Shares on the Canadian Securities Exchange less the maximum permitted discount permitted by the Canadian Securities Exchange. Notwithstanding the foregoing, the Conversion Price shall not be less than $3.00 per share (the “Floor Price”). At the Floor Price of $3.00 per share, the Seven Knots Commitment Notes would be convertible into 666,667 common shares.

The conversion of the Initial Commitment Note and the Additional Commitment Note, respectively, will be limited to the extent that, upon such conversion, Seven Knots, together with its affiliates, would beneficially own more than 2.99% of the common shares issued and outstanding immediately after giving effect to such conversion (the “Beneficial Ownership Limitation”), provided that the Beneficial Ownership Limitation calculation is limited to common shares issuable upon such conversion and shall not be aggregated with any other common shares then beneficially owned Seven Knots, together with its affiliates.

On August 13, 2026, we and Joseph Gunnar & Co., LLC entered into a placement agency agreement (the “Agency Agreement”) in connection with the proposed transactions under the Purchase Agreement. Under the Agency Agreement, we agreed to pay a fee equal to 3% of the gross proceeds received from purchases by Seven Knots under the Purchase Agreement, and agreed that if we conduct any other fundraising activities involving Seven Knots or its affiliates within 12 months after our initial public offering in the U.S., we must pay a cash fee of 3% of the gross proceeds from that transaction.

On August 13, 2026, we and Seven Knots entered into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which we agreed to file a registration statement with the SEC covering the resale of common shares issuable upon conversion of the Seven Knots Commitment Notes and a portion of the shares issuable to Seven Knots pursuant to the Purchase Agreement.

Effect of Performance of the Purchase Agreement on Shareholders

All common shares that may be issued or sold by us to Seven Knots under the Purchase Agreement are expected to be freely tradable. The resale by Seven Knots of a significant amount of common shares at any given time, or the perception that these sales may occur, could cause the market price of the common shares to decline and be highly volatile. Sales of common shares to Seven Knots will depend upon market conditions and other factors to be determined by us. We may ultimately decide to sell to Seven Knots all, some or none of the common shares available for sale pursuant to the Purchase Agreement. If and when we do sell common shares to Seven Knots, after Seven Knots has acquired the common shares, Seven Knots may resell all, some or none of those common shares at any time or from time to time in its discretion. Therefore, sales to Seven Knots by us under the Purchase Agreement may result in substantial dilution to the interests of other holders of the common shares.

Pursuant to the terms of the Purchase Agreement, we have the right, but not the obligation, to direct Seven Knots to purchase up to $100 million of our common shares, subject to certain limitations. We have registered only a portion of the common shares issuable under the Purchase Agreement and, therefore, we may seek to issue and sell to Seven Knots under the Purchase Agreement more common shares than are offered under this prospectus. If we choose to do so, we must first register for resale under the Securities Act any such additional common shares, which could cause additional substantial dilution to our shareholders. The number of common shares ultimately offered for resale under this prospectus is dependent upon the number of common shares we direct Seven Knots to purchase under the Purchase Agreement.

The following table sets forth the amount of gross proceeds we would receive from Seven Knots from our sale of common shares to Seven Knots under the Purchase Agreement at varying purchase prices:

USE OF PROCEEDS

This prospectus relates to the common shares that may be offered and sold from time to time by the Selling Shareholder pursuant to the Purchase Agreement. The Selling Shareholder will receive all of the proceeds from the sale of the common shares offered for sale by it under this prospectus. We will not receive proceeds from the sale of the common shares by the Selling Shareholder through this prospectus. However, we will incur expenses in connection with the registration of the common shares offered hereby.

We may receive up to $100 million in gross proceeds pursuant to the Purchase Agreement. See “Plan of Distribution” elsewhere in this prospectus for more information. However, the actual proceeds may be less than this amount depending on the number of common shares sold and the price at which the common shares are sold.

We intend to use proceeds from any sales of common shares to Seven Knots under the Purchase Agreement for working capital and general corporate purposes, which may include, among other things, the acquisition of businesses, products, or technologies, and the repayment or refinancing of outstanding indebtedness. As of the date of this prospectus, we have no agreements or commitments with respect to any such acquisition, and we have not allocated a specific amount of proceeds toward the repayment of any particular indebtedness. Pending other uses, we intend to invest the net proceeds to us in investment-grade, interest-bearing securities such as money market funds, certificates of deposit, or direct or guaranteed obligations of the U.S. government, or hold as cash. We cannot specify with certainty all of the particular uses for the net proceeds that we will have from the sale of common shares pursuant to the Purchase Agreement. Therefore, our management will have broad discretion to determine the specific use for the net proceeds, and we may use the proceeds for purposes that are not contemplated at the time of this offering.

The Selling Shareholder will pay any underwriting fees, discounts, selling commissions, stock transfer taxes and certain legal expenses incurred by such Selling Shareholder in disposing of its common shares, and we will incur all costs associated with this prospectus and the registration statement of which it is a part.

DIVIDEND POLICY

We have not previously declared or paid any cash dividend or dividend in kind and we have no plan to declare or pay any dividends in the near future on our common shares. We currently intend to retain most, if not all, of our available funds and any future earnings to finance the operation, development and expansion of the business. Any future declaration and payment of cash dividends or other distributions of capital will be at the discretion of our Board of Directors and will depend on our financial condition, results of operations, contractual restrictions, capital requirements, business prospects, and any other factors that our Board deems relevant in making such a determination.

DILUTION

The sale of common shares to the Selling Shareholder pursuant to the Purchase Agreement will have a dilutive impact on our shareholders. In addition, the lower the price of the common shares is at the time we exercise our right to issue and sell common shares to Selling Shareholder, the more of the common shares we will issue to raise our desired amount of proceeds from the sale, and the greater the dilution to our existing shareholders.

The price that the Selling Shareholder will receive for the common shares when resold pursuant to this prospectus will depend upon the timing of sales and will fluctuate based on the trading price of the common shares.

We calculate net tangible book value per common share by dividing our net tangible book value, which is tangible assets less total liabilities, by the number of our outstanding common shares. Dilution represents the difference between the portion of the amount per common share paid by purchasers of common shares in this offering and the as adjusted net tangible book value per common share immediately after giving effect to this offering. As of June 30, 2026, our net tangible book value was C$17,638,039 (US$12,416,782), or C$3.08 (US$2.17) per common share.

After giving effect to the assumed sale of 21,276,594 common shares for the Seven Knots Purchase Shares and after deducting estimated offering expenses payable by us, including the 3% fee payable to Joseph Gunnar & Co., LLC as placement agent in connection with the Purchase Agreement, the as adjusted net tangible book value as of June 30, 2026 would have been approximately $109 million, or $4.04 per common share. This represents an immediate increase in net tangible book value of $1.87 per common share to existing shareholders and an immediate dilution of $0.64 per common share to new investors purchasing common shares in this offering. The following table illustrates this substantial and immediate per share dilution to new investors.

The following table illustrates this dilution on a per common share basis:

The discussion and table above assume no exercise of outstanding options or warrants. To the extent that options or warrants are exercised, you may experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our shareholders.

CORPORATE HISTORY AND STRUCTURE

We were incorporated under the Business Corporations Act (British Columbia) on May 27, 2020 under the name “1251418 B.C. Ltd.”. We changed our name to “Optimi Health Corp.” on August 17, 2020. Optimi Health Corp. owns all of the issued and outstanding equity securities of Optimi Labs Inc., a company incorporated under the Business Corporations Act (British Columbia) (“Optimi Labs”), Optimi Nutraceuticals Corp., a company incorporated under the Business Corporations Act (British Columbia) (“Optimi Nutraceuticals”) and Optimi Australia Pty. Ltd., an Australian proprietary company limited by shares (“Optimi Australia”). Optimi Labs is our operating subsidiary that is in the business of operating our manufacturing facilities and our related research and development initiatives and sales and marketing efforts. Optimi Australia acts as our operating subsidiary in Australia, assisting with distribution efforts, clinic education and management of customers and accounts in Australia. Optimi Nutraceuticals formerly acted as our retail subsidiary, providing consumers with high quality, natural, plant-based products; however, this business unit has been permanently wound down to focus our efforts on our pharmaceutical grade manufacturing business.

Financing Activities

Following incorporation, we were capitalized by completing the First Private Placement, which raised C$1,000,000 and was completed on July 6, 2020.

On September 11, 2020, we closed the Special Warrant Private Placement, issuing 17,963,005 Special Warrants for gross proceeds of C$4,490,751. Each Special Warrant entitled the holder to acquire, without further payment, one SW Unit and was automatically deemed exercised on January 12, 2021. There are no Special Warrants outstanding as of the date of this prospectus. In connection with the Special Warrant Private Placement, we issued 25,150 broker units. Each broker unit was exercisable until September 11, 2021 at a price of C$0.25 for one Common Share and one Common Share purchase warrant, with each such warrant exercisable at C$0.40 per Common Share until September 11, 2021. The broker units and resulting warrants have been fully exercised.

On February 25, 2021, we announced the closing of our initial public offering in Canada of 27,600,000 units at a price of C$0.75 per unit for aggregate gross proceeds of C$20,700,000, with each unit composed of one Common Share and one-half of one Common Share purchase warrant (each, an “IPO Warrant”). The Common Shares and IPO Warrants commenced trading on the CSE on February 25, 2021 under the symbols “OPTI” and “OPTI.WT”, respectively.

On October 7, 2022, we issued 5,692,308 units at a price of C$0.325 per unit, for gross proceeds of C$1,850,000. Each unit consisted of one Common Share and one half of a Common Share purchase warrant. Each warrant was exercisable at C$0.50 for a period of two years from the date of issuance.

On August 4, 2023, we issued 100,000 common share purchase warrants as consideration for the entry into a loan agreement and general security agreement with Catcher Investments Ltd., a company controlled by John James Wilson, a director and non-executive Chair of the Board. The loan is secured against the assets of the Company and bears interest at a rate of 7.5% per annum, payable by us to Catcher Investments Ltd. quarterly on the last business day of every fiscal quarter until the loan is repaid. The loan will mature, and all outstanding principal shall be payable, on August 4, 2026. Each share purchase warrant entitles the holder to purchase one Common Share at a price of C$0.50 for a period of three years from the date of issuance.

On August 29, 2023, we issued 100,000 common share purchase warrants as consideration for the entry into a loan agreement and general security agreement with two independent third party lenders. The loan is secured against the assets of the Company and bears interest at a rate of 7.5% per annum, payable by us to the lenders quarterly on the last business day of every fiscal quarter until the loan is repaid. The loan will mature, and all outstanding principal shall be payable, on August 29, 2026. Each share purchase warrant entitles the holder to purchase one Common Share at a price of C$0.50 for a period of three years from the date of issuance.

On November 1, 2023, we issued 100,000 common share purchase warrants as consideration for the entry into a loan agreement and general security agreements with an independent third party. The loan is secured against the assets of the Company and bears interest at a rate of 7.5% per annum, payable by us to the lender quarterly on the last business day of every fiscal quarter until the loan is repaid. The loan will mature, and all outstanding principal shall be payable, on April 30, 2025. Each share purchase warrant entitles the holder to purchase one Common Share at a price of C$0.50 for a period of three years from the date of issuance.

On February 23, 2024, we issued 1,850,033 units at a price of C$0.30 per unit, for gross proceeds of C$555,009. Each unit consisted of one Common Share and one-half of a common share purchase warrant. Catcher Investments Ltd., a company controlled by John James Wilson, and Cathay Visions Enterprises Ltd., a company controlled by Dane Stevens, subscribed for 333,333 units and 1,000,000 units, respectively.

On May 10, 2024, we issued 1,333,334 units at a price of C$0.30 per unit, for gross proceeds of C$400,000. Each unit consisted of one Common Share and one-half of a common share purchase warrant. Catcher Investments Ltd., a company controlled by John James Wilson, and Cathay Visions Enterprises Ltd., a company controlled by Dane Stevens, subscribed for 666,667 units each.

On May 29, 2024, we issued 1,816,633 units at a price of C$0.30 per unit, for gross proceeds of C$544,990. Each unit consisted of one Common Share and one-half of a common share purchase warrant. Each warrant entitles the holder to purchase one Common Share at a price of C$0.40 and is exercisable for two years from the date of issuance, subject to an accelerated expiry provision.

On August 15, 2024, we issued 1,796,666 units at a price of C$0.30 per unit, for gross proceeds of C$538,999.80. Each unit comprised of one Common Share and one-half of a common share purchase warrant. Each warrant entitles the holder to acquire one Common Share at C$0.40 for two years from the date of issuance, subject to an accelerated expiry provision. Cathay Visions Enterprises Ltd., a company controlled by Dane Stevens, subscribed for 333,333 of these units.

On January 24, 2025, we issued 1,316,668 units at a price of C$0.30 per unit for gross proceeds of C$395,000. Each unit is comprised of one Common Share and one-half of one transferable common share purchase warrant. Each whole warrant entitles the holder to acquire one Common Share at C$0.40 for two years from the date of issuance, subject to an accelerated expiry provision. Catcher Investments Ltd., a company controlled by John James Wilson, and Cathay Visions Enterprises Ltd., a company controlled by Dane Stevens, subscribed for 583,334 units and 733,334 units, respectively.

On July 24, 2025, we issued 3,450 unsecured convertible debentures at a price of C$1,000 per convertible debenture for gross proceeds of C$3,450,000. The convertible debentures bear interest at a rate of 15.0% per annum, calculated and payable quarterly in arrears in cash, maturing July 24, 2026, twelve months from the date of issuance, unless extended by and at the option of the holders for a further twelve months. The principal amount of each convertible debenture is convertible into our common shares at a conversion price of C$0.15, being the closing price of our common shares on the CSE on July 16, 2025, the date preceding the execution by each holder of the subscription agreement for the convertible debentures. On maturity, any outstanding principal amount of the convertible debentures, plus any accrued and unpaid interest thereon, will be repaid by the Company in cash or, at the option of the holders, through the issuance of our common shares. Catcher Investments Ltd., a company controlled by John James Wilson, and Cathay Visions Enterprises Ltd., a company controlled by Dane Stevens, subscribed for 3,000 convertible debentures and 450 convertible debentures, respectively.

On July 24, 2025, we issued 400,000 common share purchase warrants as consideration for the entry into a loan amendment with an independent third party to an original loan agreement dated November 1, 2023. Each warrant is exercisable at C$0.25 for a period of two years from the date of issuance. Under the terms of the loan amendment the maturity date was extended from April 30, 2025 to April 30, 2026.

Our Board of Directors approved a reverse share split with a share split ratio of 1-for-30 (“Reverse Share Split”), which became effective on May 19, 2026. The Reverse Share Split was intended to allow us to meet the minimum share price requirement of Nasdaq.

On May 21, 2026, we completed our initial public offering in the United States, which was conducted in connection with the uplisting of our common shares to the Nasdaq Capital Market. We issued 2,400,000 common shares at a price of US$6.25 per share. The aggregate gross proceeds to us from the offering were US$15 million, before deducting underwriting discounts and offering expenses.

Buildout of the Facilities in Princeton, British Columbia

On July 23, 2020, we entered into an industrial ground lease agreement with BC Green for the Industrial Ground underlying our Facilities situated in Princeton, British Columbia, which was amended and restated on September 1, 2021 and was further amended on July 1, 2025 to extend the term of the lease to June 30, 2030 and to include three additional options to renew the agreement for successive terms of five years commencing on July 1, 2030. Bryan Safarik currently serves as a director and the president and chief operating officer and Jacob Safarik currently serves as the chief financial officer, respectively, of BC Green, a private Canadian federally licensed cannabis production company.

Pursuant to the terms of the Lease Agreement, during the term of the Lease Agreement, as extended and renewed from time to time, the title to and ownership of the Facilities (including all alterations, additions, changes, substitutions or improvements thereto) shall be vested in us and shall automatically vest in the name of BC Green at the expiry or earlier termination of the Lease Agreement. In June 2022, we completed the construction of the Facilities, which are two GMP-capable 10,000 sq. ft. purpose-built mushroom cultivation and processing facilities in Princeton, British Columbia. We continue to invest in automated production technologies at the Facilities to enhance scalability and cost efficiency.

Dealer’s Licence

We currently hold a Dealer’s Licence issued under the CDSA authorizing our possession of limited quantities of psilocybin, psilocin, and MDMA (as well as other controlled substances), as well as our production, assembly, sale and delivery of products containing the same within the confines of the regulatory framework prescribed by Health Canada. The Dealer’s Licence enables us to conduct research and development with in-house scientific and quality teams.

Precursors Licence

We were granted a Precursors Licence by Health Canada in December 2023 authorizing our import of 3,4-METHYLENEDIOXYPHENYL-2-PROPANONE (a chemical precursor for MDMA synthesis).

Drug Establishment Licence

In May 2024, we received a DEL for the fabrication, packaging, labeling and sale of our MDMA and psilocybin capsules as well as extraction of our psilocybin mushrooms to generate active pharmaceutical ingredients. As Health Canada is a participant in several Mutual Recognition Agreements (“MRAs”) for drug and medicinal products, our GMP-compliant manufacturing processes may be accepted by other regulatory authorities in participating jurisdictions, which may facilitate international distribution of our psilocybin and MDMA drug products. Examples of countries covered by MRAs include the Netherlands, Norway and the United Kingdom. We may consider these markets in the future. The DEL confirms that our Canadian facilities conform to Health Canada’s GMP compliance standards and those jurisdictions with equivalent GMP standards. The DEL differentiates us from other psychedelic manufacturers in the space and enables us to provide competitively priced products for human therapeutic use within the GMP psychedelics market. The DEL allows us flexibility to adapt to international licensing demands and changes in legislation and also gives our clients and patients assurance of a fully GMP product. Canadian companies without a DEL may not be issued export permits to supply Australia, or other countries where a market is established. In the Authorised Prescribers Scheme, authorized psychiatrists will be able to prescribe MDMA-assisted therapy for patient suffering from PTSD and psilocybin-assisted therapy for patients suffering from TRD. All products supplied to the Authorised Prescribers Scheme should be certified GMP compliant as per the Therapeutic Goods Administration of Australia.

Clinical Trials and Related Approvals

We currently are not the clinical trial applicant for any study. Rather, our third-party partners conduct preclinical and clinical studies of our product candidates and produce data upon which we rely.

In February 2024, we announced our supplier partnership with Tel Aviv University to supply GMP-compliant MDMA and psilocybin for research and clinical development on the effects of MDMA in animal models of alcohol addiction.

In May 2024, we entered into a letter of intent with ATMA CENA Healthcare Solutions relating to the supply of natural psilocybin extract for a phase II clinical trial in patients with major depressive disorder. In February 2025, we entered into a definitive supply agreement with ATMA CENA Healthcare Solutions. We are awaiting confirmation from ATMA CENA Healthcare Solutions regarding next steps under the agreement and expect to supply psilocybin extract in connection with their planned clinical trial.

In June 2024, Health Canada issued three export permits to us to supply patients under Australia’s Authorised Prescribers Scheme. Two of these permits are active, and one has since expired. In particular, we received export permits for shipment of 160 doses of MDMA and psilocybin for patients with PTSD and TRD to Australia.

In September 2024, the first patients were dosed in Australia’s Authorised Prescribers Scheme in Australia with our MDMA capsules for PTSD.

In November 2025, we announced we were selected to supply the MDMA capsules for MAPS Israel’s Healing October 7th project, which includes a clinical trial for PTSD that has received formal approval from the Israeli Ministry of Health. The open-label, multicenter, non-inferiority study will evaluate the safety and effectiveness of individual versus group MDMA-assisted therapy for PTSD in patients diagnosed in the context of recent collective trauma. The trial is being conducted as part of MAPS Israel’s Healing October 7th initiative, which supports survivors, veterans, and community-based care. The study will enroll 168 participants, with initial approval already granted by the Israeli Ministry of Health for the first 20 patients.

Intellectual Property and Trademark Protection

On September 16, 2020, we applied for trademark protection for “Optimi” and “Optimi Health” in Canada and the United States and were granted trademark protection for “Optimi” and “Optimi Health” in Canada on January 12, 2024. We received a non-final office action letter from the United States Patent and Trademark Office, objecting to the registration of the “Optimi” and “Optimi Health” marks due to the likelihood of confusion with four prior U.S. registered trademarks. We have also received a cease and desist letter from a U.S. public company, alleging that the use and attempted registration of the “Optimi” and “Optimi Health” marks infringes the registered trademarks of the U.S. company. At this time, we do not intend to continue to pursue registration of the “Optimi” and “Optimi Health” marks in the U.S. due to the anticipated costs and time required. We may file a petition to revive the trademark applications in the future.

Other Key Events

On April 1, 2021, we obtained the symbol “OPTHF” to commencing trading on the OTCPINK market in the United States.

On April 6, 2021, we commenced trading on the Frankfurt Stock Exchange under the symbol “8BN”.

In April 2024, we completed validated GMP production of 5mg natural psilocybin extract capsules with a certificate of analysis (“COA”).

In May 2024, we completed validated GMP production of MDMA 40mg & 60mg capsules with a COA. In addition, we received an export permit issued by Health Canada for our first international shipment of MDMA to Israel. In addition, in June 2024, we secured an import certificate from Mind Med Australia for 160 doses of MDMA and psilocybin capsules for therapeutic use in Australian patients.

In September 2024, upon receipt of our inaugural shipment into Australia, our MDMA capsules became available for prescription in Australia through the Authorised Prescribers Scheme.

In April 2025, we received our FDA Establishment Identifier (FEI) number, which is a key regulatory step for engaging in FDA filings and commercial supply into the United States.

Combined with our GMP certification and Health Canada DEL, we are in position to advance our strategy to supply MDMA and psilocybin into clinical, research and future commercial markets, in compliance with U.S. laws and requisite approvals for such activities.

In April 2025, we engaged mdi Consultants, Inc. to act as our U.S. agent for foreign manufacturers who intend to or are importing pharmaceuticals to the United States and or Official Correspondent, another key regulatory step for engaging in FDA filings and eventual commercial supply into the United States.

In May 2025, we completed our largest international export to date of MDMA capsules to Australia, supporting the treatment of PTSD under the Authorised Prescriber Scheme. The shipment, conducted in partnership with Mind Medicine Australia, included 1,000 GMP MDMA capsules in both 40mg and 60mg strengths.

In September 2025, we commercially launched our natural psilocybin capsules in Australia, which are now being prescribed to patients with TRD under the Authorised Prescribers Scheme. We completed an initial shipment of 1,000 psilocybin capsules.

In January 2026, we exported 1,000 capsules of 5mg psilocybin product and 1,000 capsules of 60mg MDMA to Australia.

In June 2026, we completed our first export of naturally derived psilocybin to the United Kingdom in support of a planned Phase 2 clinical trial. The shipment comprises psilocybin biomass and finished 5mg psilocybin capsules — the same formulation currently prescribed to patients in Australia for TRD.

In June 2026, we completed our third commercial shipment of 5mg psilocybin capsules to Australia since the September 2025 launch of our psilocybin commercial program, comprising 1,000 capsules of 5mg psilocybin being prescribed in Australia for TRD.

Our Corporate Information

Our principal executive offices are located at 269 David Brown Way, Princeton, British Columbia, V0X 1W0. Our telephone number at this address is (778) 761-4551. Our registered and records office is located at 2054 Dowad Drive, Squamish, British Columbia, V8B 0Y8. Our agent for service of process in the United States, Cogency Global Inc., is located at 122 East 42nd Street, 18th Floor, New York, NY 10168.

Investors should contact us for any inquiries through the address and telephone number of our principal executive office. Our principal website is www.optimihealth.ca. The information contained on, or accessible through, our website is not a part of this prospectus.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion together with our condensed interim consolidated financial statements for the nine month period ended June 30, 2026 and 2025 and the audited consolidated financial statements for the year ended September 30, 2025 and 2024 and the related notes included elsewhere in this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus contains forward-looking statements that are based on our current expectations, estimates and projections about our business and operations. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors, including those which we discuss under “Risk Factors” and elsewhere in this prospectus. See also “Special Note Regarding Forward-Looking Statements.”

The condensed interim consolidated financial statements for the nine month period ended June 30, 2026 and 2025 and the audited consolidated financial statements for the years ended September 30, 2025 and 2024 are prepared pursuant to IFRS. As permitted by the rules of the SEC for foreign private issuers, we do not reconcile our financial statements to U.S. generally accepted accounting principles.

Overview

We are a Canadian GMP compliant, pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. We specialize in controlled substances with our products being MDMA and psilocybin derived from botanical sources. With a vertically integrated approach, we own two approximately 10,000-square-foot production facilities on leased land in Princeton, British Columbia and operate under a DEL awarded by Health Canada. Our DEL certifies that our facilities and quality management systems comply with GMP for the formulation of designated drug products and the manufacture of certain active pharmaceutical ingredients (“API”) from plant sources. Additionally, we hold a DL under Canada’s Narcotic Control Regulations, allowing us to possess, produce, assemble, sell and deliver psilocybin and other psychedelic substances within the regulated framework set forth by Health Canada. The DL allows us to possess up to 20kg of psilocybin and 200g of psilocin (equivalent to approximately 2,000kg of dried full-body psilocybin-containing mushrooms) and 2kg of MDMA. We also hold a Precursor Licence under Canada’s Precursor Regulations allowing us to import 3,4-Methylenedioxyphenyl-2-Propanone if used in the synthesis of MDMA.

The legal status of psychedelic drugs varies by country and our various licenses allow us to supply markets where it is legal and position ourselves for new markets. Our products are currently available in Australia where psilocybin and MDMA have been rescheduled to allow prescription by an Authorized Prescriber only for TRD and PTSD. In Canada, our products are available via the SAP, which we are authorized to supply as a provision of our DL whereby sale or provision to the holder of a Controlled Drugs and Substances Act subsection 56(1) exemption is not prohibited for licensed dealers to provide psilocybin and MDMA in relation to an SAP authorization. The SAP patient authorization process has been successfully achieved for MDMA products. Our psilocybin product is currently in phase 2b clinical trials in Canada conducted by third parties. In all other countries, access is restricted to approved clinical trials, including in Israel, one of our planned target markets, where our MDMA product is currently in phase 2 clinical trials conducted by third parties. We are currently restricted from selling our products in the United States, another one of our planned target markets, where psilocybin and MDMA are considered Schedule I “controlled” or “scheduled” substances, meaning their manufacture, importation, exportation, domestic distribution, storage, sale and legitimate use is subject to a significant degree of regulation by the DEA. While our MDMA and botanical psilocybin products are currently being accessed in Canada and Australia, in any new market, a regulatory approval would be required for our products – be that a clinical trial application approval, a marketing authorization approval or access via a change to regulatory access for these products.

Our DEL enables us to supply validated psilocybin API, psilocybin drug products and MDMA drug products to patients in Australia under the Authorised Prescribers Scheme. Through strategic collaborations and ongoing compliance with global regulatory authorities, we aim to expand our product availability to additional jurisdictions where psychedelic-assisted therapies are gaining regulatory approval.

The key differentiator of a DEL is that it enables our MDMA and psilocybin capsules to be prescribed by authorized physicians in Australia for the treatment of PTSD and TRD. Unlike most companies in the psychedelic sector that remain in clinical or pre-commercial phases, we are currently supplying regulated medicines under prescription in certain markets – supported by a DEL that also permits the legal manufacture and international export of both products.

As part of our commitment to innovation and broadening accessibility to psychedelic-based therapies, we continuously refine our production methodologies, invest in advanced extraction technologies and enhance our regulatory compliance frameworks to remain ahead of industry standards. By prioritizing sustainable and responsible production practices, we are dedicated to becoming a global leader in the psychedelic pharmaceutical sector. Our research initiatives focus on optimizing extraction efficiency, improving formulation stability, and ensuring scalable manufacturing techniques that align with future market expansion plans. Although we do not currently own any patents, nor do we have any pending patent applications related to our MDMA and botanical psilocybin products, the design, formulation, and large-scale manufacture of these products are founded on—and would be materially impaired without—a comprehensive body of proprietary know-how, specialized production methodologies, and rigorously safeguarded trade secrets that we protect through internal controls and confidentiality agreements.

Principal Factors Affecting Our Results of Operations

Our operational and financial performance is primarily driven by our ability to execute on the manufacture and distribution of regulated psychedelic substances within the constraints of evolving global regulatory frameworks. We have established a defensible and scalable GMP platform, secured relevant licensing under Health Canada and demonstrated commercial supply capabilities to authorized markets, currently only to Australia. Our near-term results will be influenced by regulatory developments in key jurisdictions, order volume from existing partners, cost optimization through automation and disciplined capital deployment. As international access expands, we believe we are well positioned to scale responsibly and grow our share of the emerging global market for psychedelic-assisted therapies.

The operational and financial factors below materially affect our results of operations. Unlike traditional biotechnology issuers focused solely on clinical development, our performance is influenced by our role as a GMP-certified manufacturer with regulatory clearance to produce and export controlled substances, including MDMA and psilocybin, for legal therapeutic use in international markets.

Commercial Manufacturing and Export Activity

Our revenue-generating operations depend primarily on the manufacture and export of MDMA and psilocybin drug products produced under our DEL. We are currently supplying commercial and investigational quantities of drug product to authorized markets, including Australia, where prescribers may access these compounds under the Authorised Prescriber Scheme.

As we expand into new jurisdictions and scale production capacity, the volume and consistency of export orders will directly impact revenue recognition, working capital utilization and gross margin performance. Our operational results are also sensitive to delivery timelines, batch release schedules, and the regulatory conditions under which orders are fulfilled.

Production Capacity and Operational Efficiency

Our ability to fulfill export orders and achieve meaningful gross margins depends on the efficiency of our manufacturing operations. Key performance drivers include capsule throughput, process yield, batch consistency and the integration of new automation technologies.

Implementation of automated encapsulation and bottling equipment is expected to significantly increase capacity while reducing unit cost. The timing of these automation upgrades and their impact on operational efficiency will affect our margins, cost of goods sold, and ability to serve additional markets.

Cost of Goods and Input Supply Chain

The cost and availability of raw materials—including precursor chemicals for MDMA synthesis and cultivation inputs for psilocybin production—affect both our production cost structure and delivery lead times. These inputs are subject to compliance with controlled substance regulations and international sourcing constraints.

Although current input pricing is stable under existing contracts, fluctuations in chemical precursor availability, changes in controlled substance import/export policy or disruptions in agricultural input supply chains may affect our production cost and timing. Our financial performance is dependent on effective supply chain management, inventory planning and procurement discipline.

Regulatory Licensing and Compliance

Our operational continuity is dependent on maintaining full regulatory compliance with Health Canada, including our Drug Establishment Licence, Controlled Substances Licence, and adherence to GMP obligations. Compliance with these licenses and Health Canada inspections directly impacts our ability to manufacture, release, and export finished drug product.

In addition, our FDA Facility Establishment Identifier (“FEI”) registration and U.S. Agent appointment (mdi Consultants, Inc.) are critical to our future commercial participation in the U.S. market, particularly in the event of U.S. Drug Enforcement Administration (“DEA”) rescheduling of MDMA or psilocybin. Our results of operations will be materially impacted by the speed and extent of U.S. regulatory change, as well as our ability to rapidly activate supply chains and commercial relationships in the U.S. market.

Strategic Partnerships and Market Access

Our ability to grow revenue is also dependent on our partnerships with distributors, prescribers and clinical research sponsors. We are currently engaged in commercial supply agreements with entities in Australia and are supporting multiple research-stage collaborations. The scale, structure and renewability of these partnerships are central to our forward sales visibility and revenue growth.

As additional jurisdictions begin permitting regulated access to psychedelic-assisted therapies, we anticipate expanding our partnership model, which may include distribution, licensing or data-sharing arrangements. Our operational results will be influenced by the pace of these expansions and the cost structures attached to third-party engagements.

Research Support, Formulation Development, and Technical Upgrades

Although we are not currently a drug development company, we incur research-related costs in the areas of stability studies, shelf-life validation, analytical testing and formulation refinement. These costs are capitalized or expensed based on regulatory requirements and are expected to increase modestly as we support expanded shelf-life targets, international regulatory submissions, or technical method updates.

We also maintain internal technical teams dedicated to continuous process improvement, which may incur project-based costs related to method revalidation, equipment calibration or IT system integration. These initiatives are essential to long-term compliance and efficiency.

Capital Expenditure and Financing Strategy

Our ability to execute on scaling plans—particularly increased manufacturing automation, warehousing upgrades and regulatory submissions in new jurisdictions—is dependent on access to capital. As of the date hereof, we have operated with a lean capital structure, prioritizing core infrastructure and essential quality systems.

Future capital allocation decisions, including any equity raises, debt facilities or strategic investments, will impact our working capital, margin trajectory, and the timing of expansion milestones. Our ability to raise capital on favorable terms will affect our capacity to participate meaningfully in global supply opportunities.

Key Components of Our Results of Operations

The following section presents the key components of our results of operations by the nature of corresponding operating activities for the periods indicated.

Revenue

The following table sets forth a breakdown of our revenue by nature, each expressed in the absolute amount and as a percentage of our total revenues, for the periods indicated.

Our drug products and licensing revenue include the sale of GMP psychedelic substances, including MDMA and psilocybin, for research and therapeutic applications and licensing of intellectual property.

We have historically generated revenue from the sale of nutraceutical products. We are in the process of permanently winding down the business segment that was responsible for the sale of nutraceutical products. We consider the assets, liabilities and operations of this business segment to be immaterial to our overall consolidated operations. While this business did contribute a significant portion of our historical revenue, it generated a net loss overall. The winding down of this business will bolster our financial performance given its history of recurring losses.

The following table sets forth a breakdown of our revenue by geography, each expressed in the absolute amount and as a percentage of our total revenues, for the periods indicated.

Cost of Sales

The following table sets forth a breakdown of our cost of sales by nature, each expressed in the absolute amount and as a percentage of our total cost of sales, for the periods indicated.

Our cost of sales consists of finished goods drug products, finished goods nutraceutical products, impairment of inventory and others. During the year ended September 30, 2025, we elected to take a provision against mushroom biomass inventory due to the aging of the inventory. The cost of inventory of C$225,900 (US$162,203) was recorded through cost of sales and the fair value component of $83,715 (US$60,110) was recorded through the fair value adjustment of biological assets and inventory.

Expenses

The following table sets forth a breakdown of our expenses by nature, each expressed in the absolute amount and as a percentage of our total expenses, for the periods indicated.

Amortization and depreciation expenses relates to the natural deterioration of plant and equipment due to the passage of time.

Bank charges and interest relates to interest and accretion on the Company’s loans and bank fees. Consulting expenses include amounts paid or payable to management and third-party consultants.

Consumables, supplies and overhead relate to facility operating costs not capitalized to biological assets or inventory.

Professional fees relate to legal and audit fees. Wages and benefits include amounts paid to management and employees.

Results of Operations

The following tables set forth a summary of our consolidated results of operations for the periods indicated. This information should be read together with our consolidated financial statements and related notes included elsewhere in this prospectus. The operating results in any period are not necessarily indicative of the results that may be expected for any future period.

Nine-Month Period Ended June 30, 2026 Compared to Nine-Month Period Ended June 30, 2025

Nine-Month Period Ended June 30, 2026

During the nine-month period ended June 30, 2026, the Company generated a net loss of $5,552,091 (US$3,908,547). The main factors that contributed to the loss in the fiscal period were amortization expense of $721,386 (US$507,839), bank charges and interest of $787,245 (US$554,203), consulting of $940,620 (US$662,175), investor relations of $1,166,558 (US$821,231), and wages and benefits of $753,267 (US$530,283).

During the period ended June 30, 2026, the Company issued 2,400,000 common shares in relation to an underwritten public offering to list its common shares on the Nasdaq Capital Market. for gross proceeds of $20,700,000 (USD$15,000,000), before deducting underwriting discounts and offering expenses. In connection with the offering, the Company issued 96,000 warrants to the underwriter exercisable into a common share at $10.35 (USD$7.5) per warrant.

During the period ended June 30, 2026, the Company repaid $1,000,000 (US$703,977) in loans and settled $450,000 (US$316,790) in convertible debt through issuance of 100,000 common shares.

Nine-Month Period Ended June 30, 2025

During the nine-month period ended June 30, 2025, the Company generated revenue of $490,330 and a net loss of $2,362,664. The main factors that contributed to the loss in the fiscal period were amortization expense of $679,622, consulting of $614,887, research and development costs of $203,498, and wages and benefits of $858,934 offset by debt forgiveness recovery of $903,951 related to certain directors forgiving debts owed from the Company.

During the period ended June 30, 2025, the Company received $395,000 in proceeds from a private placement and received $908,000 in proceeds related to a convertible debt financing completed subsequent to the period ended June 30, 2025.

Year Ended September 30, 2025 Compared to Year Ended September 30, 2024

Year Ended September 30, 2025

During the year ended September 30, 2025, the Company generated revenue of $426,301 (US$306,097) and a net loss of $3,712,031 (US$2,665,348). The main factors that contributed to the loss in the fiscal year were amortization expense of $950,348 (US$682,378), bank charges and interest of $531,680 (US$381,762), consulting of $819,067 (US$588,114), and wages and benefits of $1,092,498 (US$784,447).

During the year ended September 30, 2025, the Company received debt forgiveness of $1,417,615 (US$1,017,890) of which certain directors forgave $1,331,052 ($US955,735) in accounts payable.

Year Ended September 30, 2024

During the year ended September 30, 2024, the Company generated revenue of $389,850 and a net loss of $6,035,859. The main factors that contributed to the loss in the fiscal year were amortization expense of $867,947, consulting of $1,122,812, and wages and benefits of $1,667,152.

Liquidity and Capital Resources

The Company’s future capital requirements will depend upon many factors including, without limitation, its ability to produce, market and sell its products, consumer demand for its products, the Company’s ability to secure required financing, and in the event consumer demand is strong for its products, the Company’s ability to expand its business to facilitate this demand. The Company has limited capital resources and has historically relied upon the sale of equity securities for cash required for research and development purposes, for acquisitions and to fund the administration of the Company. The Company intends to finance its future requirements through a combination of debt and/or equity issuances. There is no assurance that the Company will be able to obtain such financings or obtain them on favorable terms. These uncertainties cast significant doubt on the Company’s ability to continue as a going concern. The condensed interim consolidated financial statements do not include any adjustments related to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. Such adjustments could be material.

The following table sets forth a summary of our cash flows for the periods presented.

Nine-Month Period Ended June 30, 2026 and June 30, 2025

Operating Activities

Net cash used in operating activities was C$3,822,124 (US$2,609,690) for the nine-months ended June 30, 2026, primarily due to net loss of C$5,552,091 (US$3,908,547), adjusted for certain non-cash items and changes in non-cash working capital items. Adjustments for such non-cash items primarily include amortization and depreciation of C$721,386 (US$507,839) and loan accretion of C$94,500 (US$66,526). The amount was further adjusted by changes in non-cash working capital items that had a positive effect on cash flow, primarily an increase in amounts due to related parties of C$1,059,852 (US$746,112).

Net cash used in operating activities was C$1,249,866 for the nine-months ended June 30, 2025, primarily due to net loss of C$2,362,664, adjusted for certain non-cash items and changes in non-cash working capital items. Adjustments for such non-cash items primarily include amortization and depreciation of C$679,522 and loan accretion of C$134,500. The amount was further adjusted by changes in non-cash working capital items that had a positive effect on cash flow, primarily an increase in amounts due to related parties of C$507,421.

Investing Activities

Net cash used in investing activities was C$36,859 (US$25,948) for the nine-months ended June 30, 2026, which was attributed to plant and equipment expenditures of lab equipment purchased for the Facilities.

Net cash used in investing activities was C$15,551 for the nine-months ended June 30, 2025, which was attributed to plant and equipment expenditures of lab equipment purchased for the Facilities.

Financing Activities

Net cash provided by financing activities was C$15,787,251 (US$11,113,870) for the nine-months ended June 30, 2026, which related to financing of $20,700,000 (US$15,000,000) in gross proceeds from its public offering, less share issue costs of $3,874,049 (US$2,727,243), repayment of $1,000,000 (US$703,977) in loans, and $38,700 (US$27,244) on payments of lease obligations.

Net cash provided by financing activities was C$1,250,290 for the nine-months ended June 30, 2025, which was primarily attributed to shares issued for private placement of C$395,000, subscriptions received in advance of $908,000, less deferred financing costs of (C$21,210) and payment of lease obligations of (C$31,500).

Year Ended September 30, 2025 and September 30, 2024

Operating Activities

Net cash used in operating activities was C$2,627,901 (US$1,886,911) in fiscal year 2025, primarily due to net loss of C$3,712,031(US$ 2,665,349), adjusted for certain non-cash items and changes in non-cash working capital items. Adjustments for such non-cash items primarily include amortization and depreciation of C$950,348 (US$682,378) and loan accretion of C$166,000 (US$ 119,193), which was offset by debt forgiveness of C$1,417,615 (US$1,017,890). The amount was further adjusted by changes in non-cash working capital items that had a positive effect on cash flow, primarily an increase in amounts due to related parties of C$670,110 (US$481,159).

Net cash used in operating activities was C$4,281,693 in fiscal year 2024, primarily due to net loss of C$6,035,859, adjusted for certain non-cash items and changes in non-cash working capital items. Adjustments for such non-cash items primarily include amortization and depreciation of C$867,947 and loan accretion of C$184,750, which was offset by unrealized gain in fair value of biological assets of C$119,448. The amount was further adjusted by changes in non-cash working capital items that had a positive effect on cash flow, primarily an increase in amounts due to related parties of C$786,378.

Investing Activities

Net cash used in investing activities was C$88,375 (US$63,456) for fiscal year 2025, which was attributed to plant and equipment expenditures of lab equipment purchased for the Facilities.

Net cash used in investing activities was C$154,024 for fiscal year 2024, which was attributed primarily to plant and equipment expenditures of lab equipment purchased for the Facilities.

Financing Activities

Net cash provided by financing activities was C$3,757,681 (US$2,698,127) for fiscal year 2025, which was primarily attributed to proceeds from convertible debentures of C$3,450,000 (US$ 2,477,203) and private placements, net of share issue costs, of C$395,000 (US$283,622).

Net cash provided by financing activities was C$3,194,599 for fiscal year 2024, which was primarily attributed to private placements, net of share issue costs, of C$2,036,599 and proceeds from loans of C$1,000,000 and exercise of warrants for proceeds of C$200,000.

Capital Commitments and Contractual Obligations

We have lease commitments for the Industrial Ground. Cash commitments for minimum lease payments in relation to the Industrial Ground leases as at June 30, 2026 were payable as follows:

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet financial guarantees or other off-balance sheet commitments to guarantee the payment obligations of any third parties. We have not entered into any derivative contracts that are indexed to our shares and classified as shareholder’s equity or that are not reflected in our financial statements. Furthermore, we do not have any retained or contingent interest in assets transferred to an unconsolidated entity that serves as credit, liquidity or market risk support to such entity. We do not have any variable interest in any unconsolidated entity that provides financing, liquidity, market risk or credit support to us or engages in leasing, hedging or product development services with us.

Quantitative and Qualitative Disclosures About Market Risk

We examine the various financial instrument risks to which we are exposed and assess the impact and likelihood of these risks. These risks arise from the normal course of operations and all transactions undertaken are to support our ability to continue as a going concern. Management manages and monitors these exposures to ensure appropriate measures are implemented in a timely and effective manner. The risks associated with financial instruments and the policies on how to mitigate these risks are set out below.

Interest rate risk

Interest rate risk is the risk that future cash flows will fluctuate as a result of changes in market interest rates. Interest rate risk is limited to potential decreases in the interest rate offered on cash held with chartered Canadian financial institutions. We consider this risk to be limited, as we hold no assets or liabilities subject to variable rates of interest.

Credit risk

Credit risk is the risk of financial loss to us if a customer or counterparty to a financial instrument fails to meet its contractual obligations. The financial instruments that potentially subject us to credit risk consist of cash and cash equivalents and trade receivables. We limit exposure by maintaining our cash with major Canadian commercial banks and credit unions.

Liquidity risk

Liquidity risk is the risk that we will be unable to meet our financial obligations as they become due. We are reliant upon equity issuances and loans as our main sources of cash. We manage liquidity risk by maintaining an adequate level of cash to meet our ongoing obligations. We continuously review our actual expenditures, forecast cash flows and match the maturity dates of our cash to capital and operating needs. All of our existing commitments are budgeted and funded as at the date of the consolidated financial statements. All financial liabilities have contractual maturities of less than one year and are subject to normal trade terms with the exception of our lease liabilities, which matures based on the lease agreement, and loans payable, which have terms ranging from one and a half to three years.

Currency risk

We are not exposed to financial risk related to the fluctuation of foreign exchange rates.

Critical Accounting Judgments and Estimates

The preparation of consolidated financial statements in conformity with IFRS requires management to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported revenues and expenses during the year. Actual results may differ from these estimates. Significant estimates and judgments are evaluations and assumptions about the future and other sources of estimation uncertainty that management has made, which could result in a material adjustment to the carrying amounts of assets and liabilities. Significant estimates and judgments used in the preparation of these consolidated financial statements include, but are not limited to, the following:

Going concern

The assessment of whether the concern assumption is appropriate requires management to take into account all available information about the future, which is at least, but not limited to, twelve months from the end of the reporting period.

Provisions and contingencies

The amount recognized as a provision, including legal, contractual, constructive, and other exposures or obligations, is the best estimate of the consideration required to settle the related liability, including any related interest charges, taking into account the risks and uncertainties surrounding the obligation. In addition, contingencies will only be resolved when one or more future events occur or fail to occur. Therefore, assessment of contingencies inherently involves the exercise of significant judgment and estimates of the outcome of future events. We assess our liabilities and contingencies based upon the best information available.

Impairment of property, plant and equipment

Management considers both external and internal sources of information in determining if there are any indications that our property, plant and equipment is impaired. Management considers the market, economic and legal environment in which we operate that are not within our control and affect the recoverable amount of our plant. Management considers the manner in which the property, plant and equipment is being used or is expected to be used an indication of economic performance of the assets.

Valuation of inventory

Inventories are valued at the lower of cost and net realizable value except for biological inventory which includes a fair value component. Purchased inventory is accounted for using the weighted average purchase cost of the components that comprise finished goods inventory. Net realizable value is the estimated selling price in the ordinary course of business, less estimated costs of completion and the estimated costs to sell.

Valuation of share-based payments

We use the Black-Scholes option pricing model for valuation of share-based compensation. Option pricing models require the input of subjective assumptions including expected price volatility, interest rate and forfeiture rate. Changes in the input assumptions can materially affect the fair value estimate our earnings and equity reserves. We estimate volatility based on our historical share prices, excluding specific time frames in which volatility was affected by specific transactions that are not considered to be indicative of the entities’ expected share price volatility.

Biological assets and inventory

In calculating the value of the biological assets, management is required to make a number of estimates, including estimating the stage of growth of the mushrooms up to the point of harvest, harvesting costs, selling costs, sales price, wastage and expected yields for the mushrooms. In calculating final inventory values, management is required to determine an estimate of spoiled or expired inventory and compare the inventory cost versus net realizable value. The cost and fair value of biological assets are capitalized to the extent that their cost and fair value will be recoverable.

Loans payable

The identification of loan components is based on interpretation of the substance of the contractual arrangement and therefore, requires judgment from management. The separation of the components affects the initial recognition of the loans payable at issuance and the subsequent recognition of interest on the liability component. The determination of the fair value of the liability component is also based on a number of assumptions, including contractual future cash flows and discount rate.

Estimated useful lives of property, plant and equipment

Depreciation of property, plant and equipment is dependent upon estimates of useful lives which are determined through the exercise of judgment.

Recent Accounting Pronouncements

Certain pronouncements have been issued by the IASB that are effective for the Company’s accounting period beginning on October 1, 2023. The Company reviewed these updates and determined that none are applicable or consequential to the Company and have been excluded from the discussion within these material accounting policies. Additionally, the Company did not adopt any new accounting policies during the fiscal year ended September 30, 2025.

Standards Issued But Not Yet Effective

IFRS 18, Presentation and Disclosure of Financial Statements (“IFRS 18”), which will replace IAS 1 Presentation of Financial Statements, aims to improve how companies communicate in their financial statements, with a focus on information about financial performance in the statement of profit or loss, in particular additional defined subtotals, disclosures about management-defined performance measures and new principles for the aggregation and disaggregation of information. IFRS 18 is accompanied by limited amendments to the requirements of IAS 7 Statement of Cash Flows. IFRS 18 is effective from January 1, 2027. Companies are permitted to apply IFRS 18 before that date.

BUSINESS

Overview

We are a Canadian GMP compliant, pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. We specialize in controlled substances with our products being MDMA and psilocybin derived from botanical sources. With a vertically integrated approach, we own two approximately 10,000-square-foot production facilities on leased land in Princeton, British Columbia and operate under a DEL awarded by Health Canada. Our DEL certifies that our facilities and quality management systems comply with GMP for the formulation of designated drug products and the manufacture of certain active pharmaceutical ingredients (“API”) from plant sources. Additionally, we hold a DL under Canada’s Narcotic Control Regulations, allowing us to possess, produce, assemble, sell and deliver psilocybin and other psychedelic substances within the regulated framework set forth by Health Canada. The DL allows us to possess up to 20kg of psilocybin and 200g of psilocin (equivalent to approximately 2,000kg of dried full-body psilocybin-containing mushrooms) and 2kg of MDMA. We also hold a Precursor Licence under Canada’s Precursor Regulations allowing us to import 3,4-Methylenedioxyphenyl-2-Propanone if used in the synthesis of MDMA.

The legal status of psychedelic drugs varies by country and our various licenses allow us to supply markets where it is legal and position ourselves for new markets. Our products are currently available in Australia where psilocybin and MDMA have been rescheduled to allow prescription by an Authorized Prescriber only for TRD and PTSD. In Canada, our products are available via the SAP, which we are authorized to supply as a provision of our DL whereby sale or provision to the holder of a Controlled Drugs and Substances Act subsection 56(1) exemption is not prohibited for licensed dealers to provide psilocybin and MDMA in relation to an SAP authorization. The SAP patient authorization process has been successfully achieved for MDMA products. Our psilocybin product is currently in phase 2b clinical trials in Canada conducted by third parties. In all other countries, access is restricted to approved clinical trials, including in Israel, one of our planned target markets, where our MDMA product is currently in phase 2 clinical trials conducted by third parties. We are currently restricted from selling our products in the United States, another one of our planned target markets, where psilocybin and MDMA are considered Schedule I “controlled or “scheduled” substances, meaning their manufacture, importation, exportation, domestic distribution, storage, sale and legitimate use is subject to a significant degree of regulation by the DEA. While our MDMA and botanical psilocybin products are currently being accessed in Canada and Australia, in any new market, a regulatory approval would be required for our products – be that a clinical trial application approval, a marketing authorization approval or access via a change to regulatory access for these products.

Our DEL enables us to supply validated psilocybin API, psilocybin drug products and MDMA drug products to patients in Australia under the Authorised Prescribers Scheme. Through strategic collaborations and ongoing compliance with global regulatory authorities, we aim to expand our product availability to additional jurisdictions where psychedelic-assisted therapies are gaining regulatory approval.

The key differentiator of a DEL is that it enables our MDMA and psilocybin capsules to be prescribed by authorized physicians in Australia for the treatment of PTSD and TRD. Unlike most companies in the psychedelic sector that remain in clinical or pre-commercial phases, we are currently supplying regulated medicines under prescription in certain markets – supported by a DEL that also permits the legal manufacture and international export of both products.

As part of our commitment to innovation and broadening accessibility to psychedelic-based therapies, we continuously refine our production methodologies, invest in advanced extraction technologies and enhance our regulatory compliance frameworks to remain ahead of industry standards. By prioritizing sustainable and responsible production practices, we are dedicated to becoming a global leader in the psychedelic pharmaceutical sector. Our research initiatives focus on optimizing extraction efficiency, improving formulation stability and ensuring scalable manufacturing techniques that align with future market expansion plans. Although we do not currently own any patents, nor do we have any pending patent applications related to our MDMA and botanical psilocybin products, the design, formulation, and large-scale manufacture of these products are founded on—and would be materially impaired without—a comprehensive body of proprietary know-how, specialized production methodologies, and rigorously safeguarded trade secrets that we protect through internal controls and confidentiality agreements.

Description of Principal Products

We are licensed to provide GMP psychedelic substances, including MDMA and psilocybin, for research and therapeutic applications in certain countries. On May 24, 2024, we were awarded a DEL. Securing a DEL positions us as a pharmaceutical company with a strong portfolio of government approved licenses for controlled substances.

The DEL confirms that our Canadian facilities conform to Health Canada’s GMP compliance standards. The DEL differentiates us from other psychedelic manufacturers in the space and enables us to provide competitively priced products for human therapeutic use within the GMP psychedelics market. The DEL allows us flexibility to adapt to international licensing demands and changes in legislation and also gives our clients and patients assurance of a fully GMP product. Canadian companies without a DEL may not be issued export permits to supply Australia or other countries where a market is established.

Our MDMA capsules are manufactured for use by patients in Australia’s Authorised Prescribers Scheme, as well as licensed entities conducting clinical trials around the world. It is available in two dosages (40mg and 60mg) in hard gelatine capsule format for oral administration. Our product is stable over extended periods in HDPE (High Density Polyethylene) bottles at room temperature under both real-time and accelerated storage conditions for up to 24 months for all chemical and microbial attributes. The API remains stable under both real-time and accelerated storage conditions for up to 24 months for all chemical and microbial attributes. The MDMA capsules and API conform to the Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024 published by the Australian regulatory agency.

Our psilocybin extract (API) is manufactured for use in qualified patients with TRD within the Authorised Prescribers Scheme, as well as licensed entities conducting clinical trials around the world. It is formulated into 5mg hard HPMC capsule format for patients in Australia via oral administration. For clinical studies, a 10mg capsule is also available for clinical trials requiring a second dose format for study. The API product has maintained its original potency level without any degradation during stability testing of nine months. The psilocybin API and capsules conform to the Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024.

For each of the active products, we also have developed matching placebo capsules in order to facilitate clinical trials of our clients. The capsule size and color are the same, while the inner component is a mannitol blend without active ingredient.

All product development is in accordance with guidelines established by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) and the requirements of GMP.

Some of our recent key developments include:

We have historically, through Optimi Nutraceuticals, developed a nutraceutical brand that focuses on the health and wellness food markets. We sold our products directly to consumers, through Amazon and through distributors/brokers. However, this business was wound down in fiscal 2025 to focus our efforts on our pharmaceutical grade manufacturing business

We have evolved into a pharmaceutical grade manufacturer of MDMA and psilocybin capsules, with the ability to supply to authorized subscribers in Australia. Currently, we are only authorized to supply Australia’s Authorised Prescribers Scheme for those indications where psilocybin and MDMA are rescheduled as well as any approved clinical trial (currently approved trials in Canada and Israel).

Further, as a Canadian-based manufacturer, we can enter the U.S. market by exporting MDMA and psilocybin products, for clinical trials, research and development and for therapies contingent upon their rescheduling and approval for medical use in the U.S. This process involves compliance with both Canadian and U.S. regulations governing the export and import of controlled substances. Currently, these products are available in Canada via the Special Access Program (“SAP”).

Canadian Regulatory Compliance

Controlled Substances Licence: We currently hold a valid Dealer’s Licence under the CDSA, authorizing the production and distribution of MDMA and psilocybin for scientific or medical purposes.

Export Permit: For each shipment to any jurisdiction outside of Canada, we are required to obtain an export permit from Health Canada, which requires the submission of an import permit issued to the importer by the appropriate regulatory authority in receiving jurisdiction. These permits ensure that the export complies with Canadian regulations in respect of the export of controlled substances and/or precursor chemicals and the import regulations of the receiving jurisdiction. Export permits authorizing commercial exportation are only issued to licensed dealers, licensed producers or registered dealers.

DEL: We possess a DEL, which authorizes the fabrication, packing, labeling, distribution and/or wholesale of medical grade MDMA and psilocybin drug formulations and psilocybin active pharmaceutical ingredients in compliance with GMP standards.

U.S. Regulatory Compliance

FDA Approval: Prior to importing our products into the U.S. in the future, MDMA and psilocybin must be approved by the FDA for medical use. This involves:

IND: The process of conducting clinical trials with a new drug product generally cannot begin until a company has submitted the appropriate regulatory authorities an application to do so and the required number of days have lapsed without objection from the applicable regulatory authority (in certain jurisdictions, a no objection letter or approval may be required before the clinical trial can proceed). In the U.S., this application is called an investigational new drug study, or “IND”, and in Canada and most European countries, a clinical trial application, or “CTA.” For the U.S., the sponsor of the study must submit the results of the non-clinical tests, manufacturing information, analytical data and available clinical data or literature, within the IND, to the FDA. Some information may be omitted from the IND in instances where prior FDA findings of safety or efficacy of a drug product are being relied upon. Even once the IND is submitted, non-clinical testing may continue to occur. An IND becomes effective automatically 30 days after receipt of the document by the FDA, unless within that time the FDA raises concerns or questions, in which case a clinical hold may be put in place until the concerns are adequately addressed by the study sponsor with the FDA.

GMP: Ensuring that our manufacturing processes meet FDA’s GMP standards to guarantee product quality and consistency.

DEA Import Permit: The DEA requires U.S. based entities intending to import controlled substances to obtain a DEA registration authorizing the importation of specific substances. For each shipment, the registered importer must secure an import permit from the DEA, confirming compliance with U.S. regulations.

Rescheduling: Products which involve Schedule I controlled substances under the U.S. Controlled Substances Act must be rescheduled.

Australian Regulatory Compliance

The Australian Poisons Standard governs the classification (“scheduling”) and control of poisons, including those for therapeutic use. This scheduling system controls how medicines are made available to the public. Medicines and chemicals are classified into schedules according to the level of regulatory control over the availability of the medicine or chemical, required to protect public health and safety. In 2023, Australia announced that for TRD and PTSD, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs). For all other uses, they will remain in Schedule 9 (Prohibited Substances), which largely restricts their supply to clinical trials.

To access products containing MDMA or psilocybin, the psychiatrist must be registered as a specialist with the Medical Board of Australia as well as be an Authorised Prescriber for each product they want to access. The source and compliance of the intended drug to be prescribed will be assessed in the application for product including if the source is GMP and that the quality standard for the products are met.

Australia has published quality standards for both APIs and drug products that are prescribed under the Scheme – Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024 and Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024 and prescribers are responsible for ensuring their supply chain conforms to these requirements.

Collaborative Importation Strategy

U.S. Importer Partnership: We aim to establish a partnership with a U.S.-based importer who holds the necessary DEA registration. This collaborator will handle the importation process, including obtaining import permits and ensuring adherence to DEA regulations.

Anticipating Rescheduling and Market Entry

Monitoring Regulatory Changes: We aim to stay informed about developments regarding the rescheduling of MDMA and psilocybin by U.S. authorities, as this will impact the legality of importation and distribution.

Pre-Approval Preparations: We aim to engage with regulatory consultants to prepare the necessary documentation and ensure that all manufacturing practices align with both Health Canada and FDA requirements.

Facilities

We own and operate two 10,000 sq. ft, state-of-the-art pharmaceutical-grade mushroom cultivation and drug processing facilities in Princeton, British Columbia (the “Facilities”), purpose-built to meet the highest standards of product quality, regulatory compliance, and operational excellence. The Facilities are being used for cultivation, processing, extraction, formulation, packaging and labeling, research and distribution of psilocybin and other psychedelic substances approved by Health Canada. Scale efficiencies are technically and commercially viable through state-of-the-art horticultural lighting and sensor technology intended to maximize production per square foot. We currently house a genetics bank of more than 200 varieties of psilocybe cubensis and other species.

Our infrastructure and quality systems are aligned with Canadian regulatory requirements, including Drug Establishment Licence and Dealer’s Licence standards, and are operated to Good Manufacturing Practice guidelines.

Our Facilities are designed to support all critical stages of production and testing, with specialized spaces that ensure environmental and product integrity:

Operations

Our operations encompass the full production lifecycle, from cultivation and extraction to formulation and distribution. We maintain state-of-the-art Facilities in Princeton, British Columbia that integrate climate-controlled growing rooms with automated environmental controls and one-way airflow, ensuring consistent high-quality yields.

We also operate a fully equipped analytical laboratory, featuring high-performance liquid chromatography (“HPLC”), mass spectrometry, and stability testing equipment. This enables in-house testing on various stages of production, with the goal of eventually being able to release certificates of analysis (“COAs”) for both psychedelic substances. We currently have a production capacity scalable to 500,000 or more doses annually of MDMA and 1,000,000 5mg doses of psilocybin.

MDMA Production

We have an active Class A Precursor Licence from Health Canada that allows for the purchase or production of controlled materials that are used for synthesis of MDMA. Synthesis of R&D-grade MDMA has been completed.

Manufacturing of the product was performed on a 32 g scale (87% yield). Further scale up and process validation are in process. Once completed, Master Batch Records (“MBRs”) will be generated and the synthesis process will be added to the current DEL. Further, testing methodologies have been developed for identification of MDMA, assay of MDMA content, assay of chloride content, microbial content and water content.

Manufacture of formulated products of specific dosages (i.e., capsules) has been validated and is recognized as GMP-certified under our DEL. For MDMA, capsules have been manufactured and validated at 40 and 60 mg dosages as a scale of 4000 and 2800 capsules, respectively. MBR’s have been developed and optimized for the process.

Testing methodologies for the MDMA encapsulated products have been developed that allow for release of product into clinical trials in certain countries and the Authorised Prescribers Scheme in Australia. These tests include dosage array, content uniformity, dissolution, disintegration, microbial content and water content. As of the date of this prospectus, we have capabilities to manufacture 40mg and 60mg MDMA capsules.

Psilocybin Production

Psilocybin is a naturally occurring psychedelic product prodrug compound produced by more than 200 species of mushrooms, collectively known as “magic mushrooms”. The most potent are members of the genus Psilocybe, such as P. azurescens, P. semilanceata, and P. cyanescens, but psilocybin has also been isolated from about a dozen other genera. Psilocybin is quickly converted by the body to psilocin, which has mind-altering effects similar, in some respects, to those of LSD. Our Dealer’s Licence allows us to possess up to 20kg of pure psilocybin.

In fiscal year 2023, we commenced production and harvest of psilocybin mushrooms to be used for commercial purposes. Although we can sell our raw mushroom biomass, we further process the raw mushroom biomass into psilocybin extract.

GMP production of 2-5% Psilocybin Spectrum Mushroom Extract has been validated and is recognized as GMP-certified under our DEL. MBRs have been developed for production of 100 and 400 g batches of extract. Key steps in the process are: processing of dry mushrooms (input from Good Agricultural and Collection Practices (“GACP”) mushroom cultivation at the Company), extraction with solvent, filtration, removal of solvent and processing of final product. Greater than 80% recovery of psilocybin is achieved. Extract is a fine powder that is amendable for further processing into an encapsulated product. Stability studies have been completed 2-8ºC and at 25ºC and show that the psilocybin content is stable for up to 12 and 6 months, respectively. Testing methodologies have been developed for key application parameters (potency of psilocybin and psilocin, water content) and safe use as per pharmacopeia requirements (microbial content, heavy metals, aflatoxins, residual solvents). Testing methods are applicable with current international standards for use of pharma-grade products, including for specific use of psilocybin products under the Authorised Prescribers Scheme in Australia.

In May 2026, we completed a production run of naturally derived psilocybin extract measuring approximately 6% psilocybin content, representing the highest purity achieved to date. The milestone reflects sustained gains across our cultivation program, drawing on a proprietary library of more than 200 distinct mushroom genetics maintained at our facilities. For 2-5% Psilocybin Full Spectrum Mushroom Extract, capsules have been manufactured and validated at 5 mg psilocybin dosage at 1000 capsule scale. Larger dosage formats have been generated (10 mg) under R&D conditions and are available to be manufactured under GMP for clinical programs. A higher dosage format will be developed once market demand has been evaluated. In line with the MDMA encapsulation process, scale up to 4000 capsules is planned. Testing methodologies for psilocybin encapsulated products have been developed that allow for release of product into clinical trials in certain countries and the Authorised Prescribers Scheme in Australia. These tests include dosage array, content uniformity, dissolution, disintegration, microbial content and water content.

In June 2026, we completed a GMP production run of our 5mg psilocybin finished drug product — the same formulation already prescribed to patients in Australia for the treatment of TRD, with an updated bottling configuration to improve ease of use for prescribers and patients in the Australian market. As of the date of this prospectus, we have (i) confirmed one year stability testing for our psilocybin extract API; (ii) received finished product test results and a COA for GMP natural psilocybin extract; (iii) signed a psilocybin supply agreement with Matai Medical Research; (iv) secured Import Permit from Mind Medicine Australia for 160 doses of psilocybin capsules to be exported to Australia; (v) received a “No Objection Letter” from Health Canada, permitting the use of our GMP natural psilocybin extract capsules in a phase 2 clinical trial; and (vi) commercially launched our natural psilocybin capsules in Australia, completing an initial shipment of 1,000 capsules, to be prescribed to patients with TRD under the Authorised Prescribers Scheme.

Currently, we have capabilities to manufacture both 5mg and 10mg capsules of psilocybin. Our 5mg natural psilocybin extract capsule is set to be used in a phase 2 clinical trial for major depressive disorder. This trial could validate our drug development initiative for psilocybin as a safe and viable treatment for depression.

Psilocybin Mushroom Cultivation Summary

Overview

We operate a Canada federally licensed psilocybin mushroom cultivation facility in British Columbia, in compliance with GMP. The facility is purpose-built for the scalable production of pharmaceutical-grade mushroom biomass and psilocybin extract. The cultivation program is governed by standardized operating procedures (“SOPs”), with environmental control systems, genetic tracking, batch-level traceability and microbiological surveillance integrated throughout the production lifecycle. Our psilocybin cultivation operation is highly controlled with all process steps documented and aligned with pharmaceutical production practices. Through environmental controls, validated genetics, microbial surveillance, and SOP-driven production, we deliver pharmaceutical-grade biomass suitable for standardized extraction, clinical trial formulation, and therapeutic applications in regulated markets.

Genetic Library and Strain Validation

We maintain a curated library of genetically isolated Psilocybe species. Each strain is phenotyped, catalogued and preserved in sterile slant cultures. Prior to commercial production, strains are evaluated through internal R&D protocols, which assess:

Cultivation Process

All stages of mushroom production—from inoculation to drying—are governed by detailed SOPs and performed in controlled environments. First, grain (typically millet or rye) is hydrated, drained, and sterilized. Upon cooling, the sterile grain is inoculated with verified mycelial culture under a Class II biosafety cabinet. Inoculated grainspawn is incubated until full colonization (typically 10–14 days). Next, substrate is formulated with hardwood sawdust and soybean hulls to achieve a certain moisture content. The material is sterilized in filter-patch grow bags. After sterilization and cooling, bags are aseptically inoculated with grain spawn by weight under ISO 8 HEPA-filtered conditions, sealed, labeled, and incubated. Next, colonized substrate is incubated at a certain temperature with a certain relative humidity (RH). Bags remain sealed during this period, which lasts 12–18 days. Progress is monitored by visual inspection and random bag sampling prior to transfer to fruiting. Then, substrate bags are transferred to climate-controlled fruiting chambers. Air filters are removed to allow gas exchange. Environmental controls are maintained via programmable HVAC systems. Mushrooms typically begin pinning within 7-14 days, depending on strain. Next, fruits are hand-harvested at optimal maturity (veil break and cap flattening) using sterile tools under full personal protective equipment. Biomass is weighted, batch-logged, and transferred for immediate drying. Finally, harvested mushrooms are dried on stainless-steel mesh trays with continuous airflow. Drying proceeds until water activity (Aw) falls below a certain level. The dried product is vacuum-sealed in food-grade Mylar, labeled with full batch and strain information, and stored in secure, climate-controlled vaults. Retained samples are archived for stability testing.

Traceability and Regulatory Compliance

Each cultivated batch is linked to a Batch Production Record (“BPR”) documenting the entire lifecycle from Spore/genetic to mother culture to finished product. Records include inoculation logs, incubation parameters, harvest data, drying output and final yield metrics.

Warehousing and Distribution

We hold all products for sale in our level 8 secure vault on the premises until such time as clients are ready for shipment. Distribution is performed according to strict protocols whereby the licensing of the receiver is reviewed and shipment chain of custody is in place prior to shipment. Only approved carriers for controlled substances are used for shipments of these products.

Quality Control

Sanitation and quality controls are implemented at all critical stages in order to have strict controls on quality control parameters, especially microbials. The benefits of the indoor cultivation space allow us to have tight controls on the environment, testing and inputs to the cultivation process, such as:

Gowning procedures include sleeve guards, sterile gloves, lab coats and boot covers.

Our infrastructure allows for operational control, ensuring products are consistently manufactured to quality and regulatory specifications.

Our GMP-compliant Quality Management System (“QMS”) supports every stage of production and release, ensuring that all activities meet GMP, GACP and regulatory standards. Key elements include:

To ensure the highest standard of product quality, we employ a stage-gated release process:

Our infrastructure and systems have been successfully validated through Health Canada licensing processes and internal performance audits. Our facility operates with a mindset of continuous improvement, ensuring that quality systems are not only compliant today but built to support future scale-up and international regulatory requirements.

Our robust facility, combined with a mature and comprehensive quality system, positions us to reliably produce, test, and release products to the highest standards of safety, efficacy and regulatory compliance. We are operationally ready to scale as market demand grows.

Research and Development

We were initially focused on the research and development of functional mushroom (non-psychedelic) cultivation and extraction. We are now focused on the research into mushroom-derived psilocin and psilocybin. This research is designed to investigate the use of psilocin and psilocybin in the treatment of mental illness, addiction, and other health conditions if and as permitted by applicable laws and regulations. We are also researching and producing a MDMA formulation that is used in clinical studies for PTSD and other applications.

We hold a Dealer’s Licence that allows us to possess, produce, assemble, sell, and deliver psilocybin and other psychedelic substances within the regulated framework set forth by Health Canada. The Dealer’s Licence allows us to possess up to 20kg of psilocybin and 200g of psilocin (which is estimated to be equal to approximately 2000kg of dried full-body psilocybin-containing mushrooms) and 2kg of MDMA. We have submitted and received approval for an additional 16 psychedelic substances providing opportunity for us to pursue research opportunities and clinical trial supply as opportunities arise.

We also hold a Controlled Substances Licence issued by Health Canada to possess, produce, assemble, sell, and deliver the following controlled substances in the specified quantities:

Controlled Substance

We possess a fully-equipped analytical laboratory capable of conducting analytical testing for our psychedelic products release, as well as for use by third parties as a source of additional revenue. We hold the authorization for third-party cannabis testing, but have not yet implemented the GLP and GMP systems and validation requirements in order to perform this testing under GMP.

Further, to enhance our internal testing capabilities, we have completed the acquisition of advanced analytical instrumentation designed to significantly increase in-house productivity. This equipment includes stability chambers, gas chromatography-mass spectrometry with flame ionization detection (GC-MS-FID), backup high-performance liquid chromatography systems (HPLC), instrumentation supporting inductively coupled plasma mass spectrometry (ICP-MS), formulation support equipment, and all necessary tools for full panel microbial testing. Our next steps for implementation of the laboratory include development and validation of the methodologies according to USP or EP standards, validation of the instrumentations and software, staffing the laboratory, and completing the QMS requirements for GMP. There are also infrastructure requirements to put in place some of the larger instrumentation. After these efforts are completed, we will be equipped to generate complete Certificates of Analysis (COAs) for our psychedelic product lines as well as third party testing.

Our analytical capabilities encompass a range of assays, including potency testing via high-performance liquid chromatography (HPLC) with diode array detection. This allows for simultaneous quantification of multiple substances at various wavelengths. We also perform identity through thin layer chromatography (TLC), ultraviolet-visible (UV-Vis) spectroscopy, and mass spectrometry, ensuring comprehensive characterization of our materials. We also intend to bring in house stability testing of our products. Our stability chambers have been installed and licensed by Health Canada as storage devices for controlled substances. To complete this program we require validation of the chambers and the supporting lab infrastructure to bring stability in house.

On the production side, we are advancing the scale up of the encapsulation program by validating an automatic encapsulator for use on our products as order volumes increased. We are advancing an intellectual property strategy that targets innovation in the areas of delivery mechanisms, extraction techniques, synthetic compound isolation, novel formulations, and testing protocols specific to mushroom-based products. To accelerate this work, we actively engage in both academic collaborations and strategic development partnerships.

For example, through a partnership with Mind Medicine Australia, we will have access to relevant patient outcomes and evidence pertaining to the use of MDMA & psilocybin as a treatment for PTSD and TRD. This data will allow us to collect relevant information for global NDA submissions using real patient outcomes for both indications.

On March 22, 2024, we entered into the Collaborative Research Agreement with the Kwantlen Polytechnic University, whereby we and Kwantlen Polytechnic University agreed to conduct a research project relating to the genetic identification of psilocybin containing mushrooms. This is in support of an ongoing research program relating to genomics and metabolomic solutions for agriculture in British Columbia, as part of a Build Innovation Enhancement grant by the Natural Sciences and Engineering Resources Council to Kwantlen Polytechnic University. During this project we were able to successfully cultivate over 200 species of psilocybin containing mushrooms and create a genetic bank that is unparalleled. We are also expanding our research partnerships beyond Canada and Australia into Israel and the U.S.

Recent Regulatory Communications

We are in the process of completing our Drug Master File (“DMF”) in Canada for psilocybin. Recently, we received a “No Objection Letter” from Health Canada to supply our 5mg psilocybin drug candidate to ATMA CENA Healthcare Solutions for a phase 2B clinical study. This critical documentation showcases our commitment to regulatory compliance and transparency, laying the foundation for streamlined communication with regulatory authorities.

DMFs are submissions to Health Canada and the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products, therefore allowing parties interested in our drug candidates to reference our material without having to disclose DMF contents. DMFs become “plug and play” documentation which supports a clinical trial application intending to have us supply our drug candidates.

Sales and Marketing

On February 28, 2023, we signed purchase orders with Mind Medicine Australia Limited (“Mind Medicine”) to ensure that patients in Australia with treatment resistant PTSD have access to medical grade GMP MDMA and patients with TRD have access to GMP grade psilocybin as part of therapy through their authorized treating psychiatrists.

On February 28, 2023, we entered into a supply agreement (the “Supply Agreement” ) with KMT Pharmaceuticals Pty Ltd (“KMT Pharmaceuticals”), an Australian company, with Mind Medicine acting as guarantor. Pursuant to the Supply Agreement, we have agreed to supply certain encapsulated products to KMT Pharmaceuticals for distribution in Australia. The Supply Agreement includes an exclusivity provision under which we will not supply MDMA or psilocybin products to any other party in Australia, and KMT Pharmaceuticals agrees not to source such products from third parties. This restriction does not apply to the supply of such products for clinical trials, provided that we notify the proposed purchaser of KMT Pharmaceuticals’ existence and its ability to supply those products. Either party may terminate the exclusivity arrangement with nine months’ written notice. The Supply Agreement has a term of five years and may be terminated earlier by either party for cause, including insolvency, breach of confidentiality, or regulatory non-compliance, or without cause upon nine months’ notice. There are no minimum purchase requirements under the Supply Agreement. Payment terms require a 25% deposit within ten business days of invoice issuance and the remaining 75% within twenty business days of product delivery. Mind Medicine guarantees the payment obligations of KMT Pharmaceuticals under the Supply Agreement.

MDMA and psilocybin drug candidates have been produced, encapsulated, and packaged entirely inside of our Facilities in compliance with GMP standards and the first commercial shipment of MDMA capsules was fulfilled in August 2024.

On November 3, 2023, we entered into a supply agreement with Sunshine Earth Labs Ltd., whereby we committed to manufacturing and supplying it with full spectrum API and encapsulated psilocybin product, and encapsulated MDMA products for a period of five years. Under the terms of the agreement, each purchase quantity order will be determined on a case-by-case basis to meet the evolving needs of the market.

On March 22, 2024, we entered into an international natural psilocybin supply agreement with New Zealand-based Matai Medical Research Institute (“Matai”), on behalf of the Tu Wairua Project, whereby we agreed to provide Matai with a quantity of our validated GMP full spectrum natural psilocybin extract. We completed our initial shipment to Matai in December 2024.

On September 3, 2025, we announced the commercial launch of our natural psilocybin capsules in Australia, which are now being prescribed to patients with TRD under the Authorised Prescribers Scheme. We completed an initial shipment of 1,000 psilocybin capsules, each containing 5mg of standardized naturally-derived psilocybin. Mind Medicine will oversee distribution and patient coordination through Australia’s network of clinics and hospitals.

In June 2026, we completed our third commercial shipment of 5mg psilocybin capsules to Australia since the September 2025 commercial launch, comprising 1,000 capsules currently prescribed for TRD under the Authorized Prescriber Scheme. The capsules were produced start to finish in-house at our wholly owned GMP facility in Princeton, British Columbia, under our Health Canada DEL, and shipped under a Health Canada export authorization.

Also in June 2026, we completed our first export of naturally derived psilocybin to the United Kingdom, comprising psilocybin biomass and finished 5mg psilocybin capsules — the same formulation prescribed in Australia for TRD — in support of a planned Phase 2 clinical trial.

We are actively engaged in identifying and closing further supply deals with international and domestic partners seeking GMP drug substance and encapsulated drug candidates. This includes negotiations with partners in Canada, Australia, the United States and Israel. We will supply a phase 2b study in Canada led by ATMA CENA Healthcare Solutions. This is a phase 2 study assessing the efficacy of psilocybin-assisted psychotherapy when administered to frontline mental healthcare workers suffering from major depressive disorder related to COVID-19. The enrollment will be 200 patients divided into cohorts of 12 patients and is the first clinical supply deal for us approved by Health Canada using our natural psilocybin extract 5mg capsules.

Intellectual Property

Our success depends on our ability to protect our core technology and intellectual property. We utilize a combination of trademarks, copyrights, trade secrets and confidentiality policies to protect our proprietary rights in our MDMA and botanical psilocybin drug products. We currently do not own any patents and we do not have any pending patents. We applied to register the trademark “Optimi Health” and “Optimi” with the Canadian Intellectual Property Office and the USPTO on September 16, 2020, and obtained registration with the Canadian Intellectual Property Office on January 12, 2024.

We received a non-final office action letter from the USPTO, objecting to the registration of the “Optimi” and “Optimi Health” marks due to the likelihood of confusion with four prior U.S. registered trademarks. We have also received a cease and desist letter from a U.S. public company, alleging that the use and attempted registration of the “Optimi” and “Optimi Health” marks infringes the registered trademarks of the U.S. company. At this time, we do not intend to continue to pursue registration of the “Optimi” and “Optimi Health” marks in the U.S. due to the anticipated costs and time required. We may file a petition to revive the trademark applications in the future.

Raw Materials

We source all materials used in the manufacture of our MDMA and psilocybin drug products through GMP-qualified and licensed (where required) suppliers, in accordance with our DEL, Controlled Substances Licence, and the applicable provisions of the Food and Drug Regulations and Controlled Drugs and Substances Act.

MDMA Production Inputs

For GMP MDMA production, the API inputs are sourced from a GMP-compliant vendor approved in our quality management system with a quality agreement in place and periodically audited by us. Each shipment is subject to incoming quality control procedures including identification testing, Certificate of Analysis (CoA) verification, and documentation review prior to use. Material receipt, storage, and inventory controls are conducted in accordance with our controlled substance handling standard operating procedures.

For R&D MDMA production, all precursor chemicals including 3,4-METHYLENEDIOXYPHENYL-2-PROPANONE are obtained from approved vendors or equivalent international suppliers under valid permits.

Other non-controlled inputs include GMP-grade excipients and capsules, and various small scale chemicals, solvents and reagents. All non-controlled inputs are available from multiple vendors and interchangeable if required for scale or quality.

Psilocybin Production Inputs

Psilocybin is produced using in-house cultivated psilocybe mushrooms under our Controlled Substances Licence and under GACP. All non-active inputs (e.g., culture media, solvents, processing agents) are sourced from qualified suppliers. These inputs are reviewed by the quality assurance department against internal specifications and COAs. The cultivation and drying process uses raw material inputs that are qualified by quality assurance and generally readily available from large scale farm suppliers.

Extraction, and purification are carried out within our GMP-compliant facility and the inputs include solvents and reagents that have been risk assessed for use in human drug products and are available from multiple vendors and interchangeable if required for scale or quality.

Quality Assurance and Supply Chain Management

To date, we have not encountered material disruptions in the availability or quality of raw materials. All inventory levels are reviewed routinely under our inventory control program (SOP INV-005 “Inventory Control of CDS and GMP Materials”), with safety stock maintained for high-risk materials.

Although input costs have remained stable under existing contracts, we recognize that certain raw materials, including certain solvents or agricultural inputs, may be subject to supply chain volatility due to regulatory, political, or enforcement-related factors.

All sourcing, testing, and documentation procedures comply with Health Canada’s Good Manufacturing Practices Guidelines, relevant guidance on precursor and controlled substance handling, and our internal SOPs and QA systems.

Employees

As of June 30, 2026, we have six full time employees, four part-time employees and one independent contractor, in addition to the Board of Directors and the Advisory Board (as described in the section immediately following). All of our employees are based in Canada. We believe that we maintain a good working relationship with our employees, and we have not experienced any major labor disputes.

Advisory Board

In order to prudently pursue the development of our business, we have appointed an advisory board (the “Advisory Board”) comprised of technical experts and global leaders in the health, wellness and consumer goods industries, as set forth below. The Advisory Board provides advice to the Board of Directors and senior management on an ad hoc basis. There are no formal rules or procedures governing the Advisory Board. We paid members of the Advisory Board a one-time share-based payment vested over a period of three years when they first joined the Advisory Board. Additional compensation after joining the Advisory Board may be made at the discretion of the Board of Directors. The names of the individuals who serve on the Advisory Board and a summary of their relevant experience and qualifications to serve the Company in such capacity are included below.

Chip Wilson

Chip Wilson is a Canadian businessman and philanthropist, who has founded several retail apparel companies, most notably yoga-inspired athletic apparel company Lululemon Athletica (NASDAQ: LULU). Wilson is widely considered to be the creator of the athleisure trend.

Harley Pasternak

As a fitness and nutrition specialist, Mr. Pasternak’s client roster includes Ariana Grande, Lady Gaga, Rihanna, Kim Kardashian, Halle Berry, Katy Perry, Megan Fox, Robert Downey Jr., Robert Pattinson, Adam Levine, Jessica Simpson, Charlie Puth, Gwen Stefani, Ke$ha, Hilary Duff and Jennifer Hudson. He currently stars on the E! channel’s Revenge Body with Khloe Kardashian, makes regular appearances as a fitness contributor to Good Morning America on ABC, and formerly starred on ABC’s The Revolution, and as a judge on Top Model. Mr. Pasternak has made worldwide speaking appearances in over 30 countries and is a bestselling fitness and diet author published in 14 languages in over 25 countries. He holds a Master of Science in Exercise Physiology and Nutritional Sciences from the University of Toronto and an Honors Degree in Kinesiology from University of Western Ontario. He is also certified by The American College of Sports Medicine and The Canadian Society of Exercise Physiology, and served as an exercise and nutrition scientist for Canada’s Department of National Defense.

Edward Safarik

Mr. Safarik is a Member in good standing of the Law Society of British Columbia and former Founder, President and CEO of Ocean Fisheries Limited. Mr. Safarik offers extensive past board experience including six year board member of Genome BC, Chairman of the Fisheries Counsel of Canada, Co-chair of the Food Agriculture/Fisheries Initiative on Sustainable Economic Fisheries, Founder and Chairman of the Herring Conservation & Research Society of BC (HCRS), and a member of the Pacific Scientific Advice Review Committee (PSARC) and the Herring Industry Advisory Board (HIAB).

Dr. Azim Jamal

Dr. Jamal is the chief executive officer and co-founder of Pacific Reach, established in 2014, and is responsible for leading all business activities for that company. He is a respected industry leader who has extensive experience overseeing a diverse portfolio of business investments including hotels, commercial properties and seniors care communities. For over 20 years, Dr. Jamal was the president and chief executive officer of Retirement Concepts. Over that time, he grew that company from two small seniors care communities in Chilliwack and Victoria to 25 communities across British Columbia, Alberta and Quebec, making Retirement Concepts one of the largest and most respected seniors care companies in Canada. In 2004, Dr. Jamal purchased the Sheraton Vancouver Guildford to diversify Pacific Reach’s portfolio into alternative classes of real estate. This portfolio is now consolidated under the Pacific Reach banner and includes hotel properties such as the iconic Rosewood Hotel Georgia, multifamily and office assets located in Vancouver, Toronto, Los Angeles and Phoenix. Most recently, Dr. Jamal has joined the board of directors at a television production company, Thunderbird Studios.

Dr. Jamal is a former family physician who graduated as a medical doctor from the University of British Columbia in 1994. After practicing as a family physician in Greater Vancouver, Dr. Jamal went on to found Dermal Laser Centers — a chain of medical aesthetic clinics, which he subsequently sold. He is a member of the Young Presidents’ Organization in Vancouver, B.C., a recipient of the Ernst & Young Entrepreneur of the Year Award and a winner of the Business in Vancouver Top 40 Under 40 Outstanding Achievement Award.

Elfi Daniel-Ivad

Ms. Daniel-Ivad formerly served as Head of Submissions, Regulatory at Eurofins Experchem Laboratories Inc. In this role, she led a team of regulatory professionals in the development of regulatory submission strategies for NHPs, OTC drugs, cosmetics, medical devices, food products, site licenses, medical establishment licenses and applicants to become licensed producers and dealers of federally controlled substances.

Harrison Newlands

Mr. Newlands has extensive experience in business development and corporate strategy of high growth companies and has led numerous strategic initiatives such as mergers and acquisitions, private and public company fund raises, as well as developing and executing growth strategies across North America. He is skilled in entrepreneurship, business development, corporate strategy, venture capital and capital markets. Mr. Newlands is a partner at North King Capital.

Regulatory Environment

Controlled Substances

The psychoactive substances, psilocybin, psilocin, and MDMA are controlled in Canada under the CDSA and associated regulations in addition to being subject to the FD Act. The CDSA is the federal statute that provides a framework for the control of substances that can alter mental processes and may produce harm to health or society when diverted to an illegal market or misused. Unless otherwise authorized by regulations or exempted in accordance with section 56, the trafficking, possession for the purposes of trafficking, import, export, and production of all controlled substances and possession of controlled substances listed in Schedules I through III are prohibited.

The Precursor Control Regulations, SOR/2002-359 (“PCR”) set out a framework within which activities with precursor chemicals are regulated. Under the PCR, a license is required for any person to produce, package, sell, provide, import, export, and possess for the purpose of export Class A precursors, and a registration is required for any person to produce for the purpose of sale, import and export Class B precursors. The PCR also specify record keeping, security and reporting requirements for licensed or registered dealers.

We currently hold a Precursor Licence issued by Health Canada for 3,4-Methylenedioxyphenyl-2-propanone (a Class A precursor), the precursor chemical used in the synthesis of Methylenedioxymethamphetamine, more commonly known as MDMA. This Precursor Licence permits us to import 3,4-Methylenedioxyphenyl-2- propanone.

In addition, we currently hold the Dealer’s Licence issued by Health Canada under the CDSA which authorizes us to possess, produce, assemble, sell, and deliver psilocybin, psilocin and MDMA within the regulated framework set forth by Health Canada and the terms of the license itself. The Dealer’s Licence allows Optimi Labs to possess up to 20 kg of psilocybin and 200 g of psilocin (which is estimated to be equal to approximately 2000 kg of dried full-body psilocybin-containing mushrooms) and 2kg of MDMA. Optimi Labs has submitted and received approval for an additional 16 psychedelic substances providing opportunity for us to pursue research opportunities and clinical trial supply as opportunities arise.

Drugs for Export

Prior to December 8, 2022, it was possible for manufacturers of drugs for export only to invoke section 37 of the FD Act and thereby avoid most Canadian requirements imposed by the FD Act and the Food and Drug Regulations thereunder, including in relation to a DEL. However regulatory changes meant that as of December 8, 2022, many of the provisions of the FDR are prescribed under Section 37 of the FD Act, including the requirements of Division 1A of Part C. This part imposes requirements for exporter of a drug product to another country – which is considered a sale in Canada. As such, to export a drug, a DEL that authorizes the sale of the drug in Canada is required. We undertook the process to obtain the DEL in 2023 and was awarded the DEL in 2024. This regulatory change allows Canada to meet its international obligations in ensuring that “export only” drugs still meet the high standards of GMP which protect human health.

The DEL confirms that our Canadian facilities conform to Health Canada’s GMP compliance standards. The DEL differentiates us from other psychedelic manufacturers in the space and enables us to provide competitively priced products for human therapeutic use within the GMP psychedelics market. The DEL allows us flexibility to adapt to international licensing demands and changes in legislation and also gives our clients and patients assurance of a fully GMP product. Canadian companies without a DEL may not be issued export permits to supply Australia or other countries where a market is established.

Australia’s Authorised Prescribers Scheme allows authorized psychiatrists in Australia to prescribe MDMA assisted therapy for patients suffering from PTSD and Psilocybin Assisted therapy for patients suffering from TRD. Australia has published quality standards for both APIs and drug products that are prescribed under the Scheme—Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024 and Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024 and prescribers are responsible for ensuring their supply chain conforms to these requirements. We have updated the product specifications, where required, to conform to the orders.

See “Risk Factors- Risks Related to Government Regulations” for more information on the various regulatory risks we face.

Market for Products

Australian Total Addressable Market (TAM) and Production Capacity Overview

Australia has emerged as one of the first regulated jurisdictions globally for psychedelic-assisted therapies following the July 1, 2023 rescheduling of MDMA and psilocybin for prescription use in treatment-resistant patients under the Authorised Prescribers Scheme. We believe that Australia’s early adoption of regulated psychedelic therapies, combined with our scalable GMP manufacturing operations, provides us with a first-mover advantage in capturing meaningful patient volume, generating near-term revenue and validating products in real-world clinical environments. We are strategically positioned to address a significant portion of this early-stage market through our existing manufacturing capabilities.

MDMA-Assisted Therapy for PTSD

According to the Australian Bureau of Statistics, an estimated 5.7% of Australians aged 16–85 experience PTSD within a 12-month period, equating to approximately 1.48 million individuals nationwide. Taking a conservative estimated prevalence of PTSD among Australian adults of approximately 5%, results in an approximate addressable market of approximately 1,000,000 individuals nationwide. Standard treatment protocols for MDMA-assisted psychotherapy typically involve three treatment sessions, each requiring an approximate dose of 160mg of MDMA. Based on this protocol, each patient requires approximately nine capsules per course of therapy (comprising six 60mg capsules and three 40mg capsules).

For a 1,000,000-patient PTSD population, the total capsule demand would equate to approximately 9,000,000 capsules per year.

Psilocybin-Assisted Therapy for Treatment Resistant Depression (TRD)

In parallel, Australia’s rescheduling of psilocybin enables the prescription of psilocybin-assisted therapy for patients suffering from TRD. According to Royal Australian College of Practitioners, the estimated TRD patient population in Australia is approximately 300,000 individuals, based on broader depression prevalence rates and the expected 30% of cases classified as treatment-resistant.

A standard psilocybin therapy protocol typically involves two treatment sessions, each utilizing a 25mg dose. Based on our 5mg capsule format, each patient would require approximately ten capsules for a complete treatment course.

To fully service the 300,000-patient TRD market, approximately 3,000,000 5mg capsules would be required.

Separately, per ScienceDirect and the Royal Australian College of General Practitioners, based on an approximate depression prevalence rate of 5.9% (approximately 1.3 million Australians) and established clinical estimates that approximately 30% of patients with depression are treatment-resistant, the TRD population in Australia is estimated at approximately 390,000 individuals.

United States Total Addressable Market (TAM) and Production Capacity Overview

In the United States, based on current production levels, we believe we can supply up to 100,000 PTSD patients (36,000g – 54,000g of MDMA) with MDMA therapy and 200,000 TRD (10,000g – 15,000g of psilocybin) patients with psilocybin therapy annually. As regulatory frameworks evolve, our scalable production platform, early GMP infrastructure and global export readiness position us to expand market share and revenue across multiple jurisdictions.

In the United States, the rescheduling of MDMA and psilocybin would be expected to catalyze the formation of a regulated commercial market for psychedelic-assisted therapies. Both substances have been part of therapies which have historically received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, and multiple late-stage trials are progressing toward New Drug Application (“NDA”) submissions. Our GMP infrastructure, FDA drug establishment registration (FEI) and U.S. Agent designation (mdi Consultants, Inc.) will enable lawful cross-border positioning in advance of DEA rescheduling or controlled access frameworks.

According to the National Institute of Mental Health, approximately 3.6% of U.S. adults experience PTSD in a given year, equating to an estimated 12.3 million individuals. Existing first-line therapies, including SSRIs and trauma-focused psychotherapies, exhibit limited efficacy in a meaningful subset of patients. MDMA-assisted psychotherapy has emerged from Phase 3 trials as a credible potential alternative, with durable clinical response rates exceeding those of conventional pharmacologic treatments.

For TRD, clinical literature indicates that approximately 30.9% of individuals diagnosed with Major Depressive Disorder (MDD) are considered treatment-resistant. With MDD affecting approximately 28.3 million U.S. adults annually (8.3% of the adult population), the estimated TRD patient population is approximately 8.7 million individuals. Psilocybin, currently under investigation in multi-site Phase 3 trials, has demonstrated rapid-onset and durable responses in TRD populations. These figures define the U.S. total addressable patient base across two distinct but adjacent indications.

A standard MDMA-assisted therapy protocol for PTSD involves three sessions, with an average dose of 160mg per session, totaling approximately 480mg per patient across the full course of treatment. Using a capsule formulation of 60mg and 40mg doses, this equates to roughly nine capsules per patient (six 60mg + three 40mg). To treat the entire U.S. PTSD patient population, an estimated 110.7 million capsules would be required (12.3 million × 9).

Similarly, for psilocybin, a standard TRD treatment protocol typically involves two 25mg sessions, totaling 50mg per patient. In our current 5mg capsule format, this corresponds to 10 capsules per patient. Based on an estimated TRD population of 8.7 million individuals, full national demand would require approximately 87 million capsules annually.

The United States represents a strategically critical and commercially significant jurisdiction for psychedelic-assisted therapies, particularly those targeting PTSD and TRD. With high prevalence rates, persistent treatment gaps, and expanding regulatory openness toward novel therapeutics, the U.S. market is positioned to become the largest global demand center for MDMA- and psilocybin-based interventions. By virtue of our regulatory footprint, current production capabilities, and strategic infrastructure, we believe we are equipped to engage in early-stage cross-border supply and to scale participation as regulatory, policy and clinical frameworks evolve.

Regulatory Status and U.S. Entry Pathway

We hold a valid DEL issued by Health Canada, authorizing the GMP-compliant manufacture, testing, and release of controlled substances. In addition, we are registered with the FDA and have been issued a Facility Establishment Identifier (“FEI”) number, formally recognizing its presence within the FDA Drug Registration and Listing System. This registration and future successful FDA inspection will enable the lawful shipment of active pharmaceutical ingredients and finished dosage forms into the United States for approved use by authorized institutions under applicable investigational or expanded access frameworks.

Pursuant to 21 C.F.R. § 207.69, we have appointed mdi Consultants, Inc. as our designated U.S. Agent. mdi Consultants, Inc. is responsible for interfacing with the FDA on our behalf, including for purposes of facility inspection coordination, document submission, and compliance communications. These elements—FDA registration, FEI assignment, and U.S. Agent appointment—form the required regulatory architecture for future lawful foreign manufacturer participation in the U.S. supply chain.

Both MDMA and psilocybin have been part of therapies which have historically received Breakthrough Therapy Designation from the FDA, entitling such therapies to expedited regulatory review. MDMA is expected to be re-submitted for New Drug Application (“NDA”) approval upon successful completion of Resilient Pharmaceuticals, Inc.’s (formerly known as Lykos Therapeutics) Phase 3 clinical trial, with psilocybin to follow on a similar trajectory upon the completion of Compass Pathways phase 3 clinical trials. In the event of FDA approval of NDAs related to therapies involving psilocybin and/or MDMA, such potential approvals may prompt rescheduling by the DEA under the Controlled Substances Act. Upon rescheduling, we will be able to pursue expanded commercial supply arrangements with licensed U.S. distributors, prescribers, and healthcare institutions.

Current Production Capacity

Under our GMP infrastructure, we currently have the capacity to support:

These capacity figures are supported by completed release testing, validated stability data and observed production yields from active export orders fulfilled under the Australian Authorised Prescriber scheme. Our facility maintains validated SOPs for weighing, encapsulation, environmental control, and packaging, all operated in compliance with GMP standards set forth by Health Canada and internationally recognized under PIC/S.

Strategic Positioning in the U.S. Market

We are one of the only vertically integrated psychedelic manufacturers globally that currently meets the following three criteria for entering the U.S. market: (i) regulatory clearance to manufacture controlled substances under a DL and DEL in Canada; (ii) FDA drug establishment registration and an assigned FEI number; and (iii) formal representation by a qualified U.S. Agent. These attributes will allow us in the future to be able to:

This capacity represents a first-mover foothold in a market where the majority of companies remain in pre-revenue clinical phases and lack commercial production authorization.

With a regulatory framework that meets Health Canada requirements, a validated GMP facility, and a track record of commercial exports to authorized jurisdictions, we believe we are better positioned among our peer group to support early-stage entry into the United States. The combination of licensed production in other jurisdictions, cross-border readiness, and scalable output defines a credible platform for participation in what may become the world’s largest regulated psychedelic therapy market.

Competitive Conditions

Currently, there are high barriers to entry into the market for pharmaceutical drug manufacturing of controlled substances such as MDMA and botanical psilocybin. High regulatory standards and rigorous compliance requirements limit new entrants. The high cost and complexity of manufacturing GMP-certified controlled substances presents an additional hurdle for companies seeking entry into our market. Further, our intellectual property, formulation expertise and strategic partnerships create a barrier around us from competitors.

Future Developments

We believe we are strategically positioned to supply pharmaceutical-grade MDMA and psilocybin capsules to regulated treatment providers in the United States immediately following rescheduling and FDA approval events.

We intend to prepare for full abbreviated new drug application (“ANDA”) filings to access broader generic market channels post-exclusivity. This dual-pathway strategy enables both early revenue generation and long-term commercial positioning within the emerging psychedelic therapeutics sector.

Strategic Pathway to Generic MDMA and Psilocybin Supply Post-Rescheduling

Before we may supply MDMA or psilocybin into the United States market, two regulatory events must occur: (i) MDMA and/or psilocybin must be rescheduled from Schedule I to a lower schedule (e.g., Schedule II or III) under the Controlled Substances Act, and (ii) the FDA must approve an innovator-branded version of the compound, such as the products under development by Resilient Pharmaceuticals, Inc. (formerly known as Lykos Therapeutics) or Compass Pathways Plc. Following FDA approval, the innovator product would be listed as a Reference Listed Drug (“RLD”) in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). Upon the occurrence of both events, lawful prescription, manufacturing, and distribution activities would be permissible in the United States under federal law within certain regulatory constraints.

Immediate Supply Pathway

Following rescheduling and FDA approval of a branded product and upon our obtaining and maintaining (i) a partnership with a third-party holding a DEA-licensed drug manufacturing establishment, (ii) an FDA Establishment Identifier (FEI) number, and (iii) compliance with current Good Manufacturing Practices (cGMP), we would be positioned to supply capsules into the United States market independently of formal ANDA pathways. Though we would not promote or commercialize products for off-label use, off-label prescribing by licensed physicians in the United States is lawful and does not require additional FDA approvals. Pharmacies, clinics, and treatment providers may procure substances that meet quality and controlled substance requirements from licensed manufacturers. Under this framework, we would not promote off-label uses but would lawfully supply capsules that meet all applicable DEA and FDA standards. We believe this pathway would enable early revenue generation concurrent with the clinical adoption of psychedelic-assisted therapies.

Mid-Term Pathway – ANDA Submission for Generic Drug Approval

Following expiration of marketing exclusivity periods applicable to the RLD (typically five years for new chemical entities), we intend to prepare and submit one or more ANDAs referencing the approved MDMA or psilocybin products. ANDA submissions would require us to demonstrate bioequivalence to the RLD and submit complete chemistry, manufacturing, and controls (CMC) data, stability data, and labeling materials. Approval of an ANDA would permit broader commercial distribution within the formal generic pharmaceutical supply chain, including access to formulary listings, insurance reimbursement, and pharmacy distribution channels.

Impact of Marketing Exclusivity and Market Exclusivity

Marketing exclusivity refers to regulatory protections awarded to an innovator product following FDA approval that prevent the FDA from accepting or approving competing ANDA submissions for a defined period. Typical exclusivity periods for new chemical entities extend five years. Market exclusivity, by contrast, reflects practical commercial dominance achieved through branding, payer contracts, and clinical adoption independent of regulatory protections. While marketing exclusivity bars generic approval through an ANDA for a limited time, it does not prevent DEA-licensed partners from supplying the same active pharmaceutical ingredients under lawful off-label frameworks, subject to compliance with federal controlled substance laws.

Key Regulatory and Commercial Considerations

Our ability to supply MDMA and psilocybin capsules would require strict compliance with Health Canada manufacturing, recordkeeping, reporting and diversion control regulations and export into the U.S. would require compliance with the DEA requirement for import and other FDA requirements. While off-label prescribing is lawful under United States law, marketing for off-label indications is prohibited. Pricing pressures, reimbursement limitations, and physician adoption rates could impact early revenue realization. Any further rescheduling actions by the DEA and FDA that reclassify MDMA or psilocybin into less restrictive schedules could materially improve commercial access and market penetration opportunities. Patent protections held by the innovator sponsors could delay generic ANDA approvals but would not prevent us from manufacturing and supplying separate non-infringing formulations for lawful use.

Properties

We are headquartered in Princeton, British Columbia. The following table sets forth the location, approximate size, primary use and lease term of our leased Industrial Land as of June 30, 2026.

Legal Proceedings

We are currently not party to any material legal or arbitration proceedings, which may have, or have had in the recent past, significant effects on our financial position or profitability.

MANAGEMENT

Directors and Executive Officers

The following table sets forth certain information regarding our directors and executive officers as of the date of this prospectus. Unless otherwise stated, the business address of our directors and executive officers is our principal executive offices at 269 David Brown Way, Princeton, British Columbia, V0X 1W0.

Dane Stevens

Mr. Stevens has served as our Chief Executive Officer since October 2024 and our Chief Marketing Officer and Director since May 2020. Mr. Stevens is an entrepreneur with 18 years of experience in product sourcing, development, management, manufacturing, and quality control, he is the founder of multiple successful wholesale and direct-to-consumer jewelry businesses, including Cavalier Jewelers Limited (“Cavalier Jewelers”). He developed an integral understanding of effective sourcing and reliable distribution by vertically integrating all areas of the jewelry supply chain. To ensure product quality and viability, Mr. Stevens guided the growth of operations internationally throughout South America and Asia, setting up partnership offices to source gemstones and diamonds directly. Mr. Stevens’ experience in digitalizing, modernizing, and operating in today’s retail landscape allowed Cavalier Jewelers to achieve year-over- year growth, both online and in-person, in a highly competitive business arena.

Jacob Safarik

Mr. Safarik has served as our Chief Financial Officer and Director since May 2020. He is currently our Interim Chief Financial Officer. Mr. Safarik has over 16 years of experience in accounting, project finance, business development and quality assurance. He graduated from McGill University with a Bachelor of Commerce degree and is a Chartered Professional Accountant. Mr. Safarik is also a co-founder of BC Green and currently serves as its Chief Financial Officer.

Bryan Safarik

Mr. Safarik has served as our Chief Operating Officer and Director since May 2020. Mr. Safarik has over 19 years of experience in senior management roles, and he is also the founder and president of a number of profitable private companies. Mr. Safarik’s experience highlights include developing operational efficiencies in Ocean Fisheries Ltd.’s fresh packing and canning facilities before most notably serving as Director of Marine Operations prior to the company’s sale to the Jim Pattison group, where he oversaw fishing operations, logistics and quota management. After assisting with the successful sale of Ocean Fisheries Ltd., he co-founded BC Green, where he currently serves as a director and President and Chief Operating Officer. Mr. Safarik received a Bachelor of Science degree from Wingate University. Mr. Safarik is an employee and provides services on a part time (50%) basis to the Company, or such greater or lesser amount of time as may be required.

John James Wilson

Mr. Wilson has served as our Chairman since May 2020. Mr. Wilson is the current Chief Executive Officer and Co-Founder of Ride Cycle Club, an indoor cycling studio with locations in Toronto and Vancouver, and a Partner at Very Polite Agency, an international integrated communications and creative agency, headquartered in Vancouver, B.C. Mr. Wilson is also the founder of Reyal Performance, a men’s performance skincare and supplements company headquartered in Vancouver, B.C. Mr. Wilson’s previous experience includes leading the international expansion of the apparel brand Kit and Ace, in addition to developing the businesses’ brand, and e-commerce and retail platforms. Mr. Wilson now focuses on strategic growth initiatives and development for his operating companies, in addition to independent strategic investments and philanthropy.

Jason Mosberian

Mr. Mosberian has served as our independent director since December 2025. Mr. Mosberian graduated from the Sauder School of Business at the University of British Columbia and earned his CPA designation in 2011 working in audit in public practice for six years. He currently serves as Senior Vice President at BFL Canada and has over a decade of experience providing tailored risk management and insurance solutions to clients in various industries, including manufacturing, distribution and life sciences.

The Company has previously engaged BFL Canada as a broker for its purchase of director and officer insurance products. Mr. Mosberian’s title of Senior Vice President is related to his division specifically, namely the Construction Department in Vancouver. Mr. Mosberian was not involved with the Company’s file and will not be involved with the Company’s file at BFL Canada.

Relationships Among Officers and Directors

Jacob Safarik, our Interim Chief Financial Officer and Director, is the brother of Bryan Safarik, our Chief Operating Officer and Director. There are no other family relationships among our officers and directors.

Employment Arrangements

Compensation of Dane Stevens

We have an arrangement with Dane Stevens with an effective date of April 1, 2021, as approved by the Board on May 6, 2021 (the “Stevens Agreement”), pursuant to which Mr. Stevens provides his services to the Company. In consideration for his services, Mr. Stevens receives an annual salary of C$75,000 and may be awarded cash or share bonuses.

Compensation of Jacob Safarik

We entered into an employment agreement with Jacob Safarik dated as of July 2, 2021, confirming the compensation arrangement effective as of April 1, 2021, and as amended on August 1, 2023, pursuant to which Mr. Safarik provides his services as Interim Chief Financial Officer of the Company (the “Jacob Safarik Agreement”). In consideration for his services, Mr. Safarik receives an annual salary of C$150,000; is eligible for bonus or incentive payments at the discretion of the Board; is entitled to participate in the Equity Plan; the reimbursement of professional fees, dues and reasonable business expenses; four weeks’ vacation each calendar year; and reimbursement of up to 50% of insured life and health benefits, such benefits to be reasonable and to be commensurate with market comparatives for his position. The Company may terminate the Jacob Safarik Agreement at any time and without any notice of termination for just cause. The Company may terminate the Jacob Safarik Agreement without just cause by providing the greater of: (i) the minimum amount of notice of termination or pay in lieu of notice of termination as required by the applicable employment standards legislation; or (ii) three (3) months of pay in lieu of notice of termination. Mr. Safarik may resign his employment at any time by providing the Company with two (2) weeks written notice of resignation, in which case the Company may elect, in its sole discretion, to direct Mr. Safarik not to attend at work for any portion of the notice period in which case the Company’s sole obligation will be to continue Mr. Safarik’s salary during the shorter of the balance of the notice period provided by Mr. Safarik and the minimum notice of termination required by the applicable employment standards legislation.

Compensation of Bryan Safarik

We entered into an employment agreement with Bryan Safarik dated as of July 2, 2021, confirming the compensation arrangement effective as of April 1, 2021, and as amended on August 1, 2023, pursuant to which Mr. Safarik provides his services as Chief Operating Officer of the Company (the “Bryan Safarik Agreement”). In consideration for his services, Mr. Safarik receives an annual salary of C$150,000; is eligible for bonus or incentive payments at the discretion of the Board; is entitled to participate in the Equity Plan; the reimbursement of professional fees, dues and reasonable business expenses; four weeks’ vacation each calendar year; and reimbursement of up to 50% of insured life and health benefits, such benefits to be reasonable and to be commensurate with market comparatives for his position. The Company may terminate the Bryan Safarik Agreement at any time and without any notice of termination for just cause. The Company may terminate the Bryan Safarik Agreement without just cause by providing the greater of: (i) the minimum amount of notice of termination or pay in lieu of notice of termination as required by the applicable employment standards legislation; or (ii) three (3) months of pay in lieu of notice of termination. Mr. Safarik may resign his employment at any time by providing the Company with two (2) weeks written notice of resignation, in which case the Company may elect, in its sole discretion, to direct Mr. Safarik not to attend at work for any portion of the notice period in which case the Company’s sole obligation will be to continue Mr. Safarik’s salary during the shorter of the balance of the notice period provided by Mr. Safarik and the minimum notice of termination required by the applicable employment standards legislation.

Clawback Policy

We have adopted a compensation recovery policy that is compliant with Nasdaq listing rules as required by the Dodd-Frank Act.

Board of Directors

Our Board of Directors consists of five directors, including one independent director, namely Jason Mosberian. A director is not required to hold any of our common shares to qualify to serve as a director. The listing rules of the Nasdaq Stock Market, LLC (the “Nasdaq Listing Rules”) generally require that a majority of an issuer’s board of directors must consist of independent directors. However, the rules permit foreign private issuers like us to follow “home country practice” in certain corporate governance matters. We rely on this “home country practice” exception and do not have a majority of independent directors serving on our Board of Directors.

A director who is in any way, whether directly or indirectly, interested in a contract or proposed contract with our company is required to declare the nature of his interest at a meeting of our directors. A director may vote in respect of any contract, proposed contract, or arrangement notwithstanding that he may be interested therein, and if he does so his vote shall be counted and he may be counted in the quorum at any meeting of our directors at which any such contract or proposed contract or arrangement is considered.

Director Independence

The Board has evaluated the independence of each director in accordance with the Nasdaq Listing Rules. The Nasdaq definition of “independence” includes a series of objective tests, such as the director or director nominee is not, and was not during the last three years, an employee of the Company and has not received certain payments from, or engaged in various types of business dealings with, the Company. In addition, as further required by the Nasdaq Listing Rules, the Board has made a subjective determination as to each independent director that no relationships exist which, in the opinion of the Board, would interfere with such individual’s exercise of independent judgment in carrying out his responsibilities as a director. In making these determinations, the Board reviewed and discussed information provided by the directors with regard to each director’s business and personal activities as they may relate to Company and its management, including the beneficial ownership of our share capital by each non-employee director and any transactions with the Company involving them. As a result, the Board has affirmatively determined that Jason Mosberian is independent in accordance with the Nasdaq Listing Rules.

Board Committees

We have established an audit committee and a compensation committee of our Board of Directors. We have adopted a charter for each of the committees, which will be available on our website. Each committee’s members and functions are described below.

Audit Committee

Our audit committee consists of three directors, namely, Jason Mosberian, John James Wilson and Dane Stevens. We have determined that Jason Mosberian satisfies the “independence” requirements of Section 5605(c)(2) of the Nasdaq Listing Rules. We are relying on the phase-in exemption permitted under Nasdaq listing rules for the requirement of a fully independent audit committee. Jason Mosberian is the chairperson of our audit committee. We have also determined that Jason Mosberian qualifies as an “audit committee financial expert” within the meaning of the applicable rules and regulations of the SEC.

The audit committee oversees our accounting and financial reporting processes and the audits of our financial statements. The audit committee is responsible for, among other things:

Compensation Committee

Our compensation committee consists of three directors, namely, Jason Mosberian, John James Wilson and Jacob Safarik. We have determined that Jason Mosberian satisfies the “independence” requirements of Section 5605(c)(2) of the Nasdaq Listing Rules. Jason Mosberian is the chairperson of our compensation committee.

Because we are a “foreign private issuer” under the corporate governance rules of the Nasdaq Capital Market, we are not required to have a compensation committee and our compensation committee is not required to be fully independent, although if such rules change in the future or we no longer meet the definition of a foreign private issuer under the current rules, we will adjust the composition of the compensation committee accordingly in order to comply with such rules.

Our compensation committee assists the Board of Directors in discharging its responsibilities with respect to setting director and senior executive compensation and assessing and making recommendations to the Board regarding certain compensation related matters as delegated by the Board of Directors. The objective of the Board of Directors in setting compensation levels is to attract and retain individuals of high caliber to serve the Company, to motivate their performance in order to achieve the Company’s strategic objectives and to align the interests of the executive officers with the long-term interests of the shareholders. These objectives are designed to ensure that the Company’s business continues to grow and develop.

The Board of Directors sets the compensation received by the executive officers so as to be generally competitive with the compensation received by persons with similar qualifications and responsibilities who are engaged by other companies of corresponding size and stage of development, asset bases, number of employees and market capitalization. The Board has considered a number of peer group companies active in the mushroom, indoor cultivation and consumer products groups in determining compensation.

Compensation of Directors and Officers

We pay each of our independent directors a cash retainer of C$36,000 per year, with an additional cash retainer of C$129,000 per year to the Non-Executive Chair of the Board. In addition, the members of each committee of the Board receive a cash fee of C$1,000 per Audit Committee or Compensation Committee meeting. The independent directors are also eligible for equity-based compensation at the discretion of the Board.

Our directors do not have service contracts with us relating to their position as a director that provide for benefits upon termination of their position as a member of the Board.

The following tables set forth all compensation paid or accrued, payable, awarded, granted, given or otherwise provided, directly or indirectly, by the Company or any subsidiary thereof, to each executive officer and director of the Company, for each of the two most recently completed fiscal years ended September 30, 2025 and 2024.