As filed with the U.S. Securities and Exchange Commission on July 17, 2026.

Registration No. 333-

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

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

_____________________________________________

NuvOx Therapeutics, Inc.
(Exact name of registrant as specified in its charter)

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1635 E. 18th Street
Tucson, AZ 85719
(520) 624-6688
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

_____________________________________________

Rong Wang
President and Chief Executive Officer
NuvOx Therapeutics, Inc.
1635 E. 18th Street
Tucson, AZ 85719
(520) 624-6688
(Name, address, including zip code, and telephone number, including area code, of agent for service)

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With 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, please 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 for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, 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 of 1933, as amended, or until the registration statement shall become effective on such date as the 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. We may not sell these securities until the registration statement filed with the 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 jurisdiction where the offer or sale is not permitted.

2,860,000 Shares
Common Stock

This is the initial public offering of shares of common stock of NuvOx Therapeutics, Inc. Prior to this offering, there has been no public market for our common stock. We anticipate that the initial public offering price of our shares will be between $6.00 and $8.00.

We intend to apply to list our common stock on the NYSE American (“NYSE American”) under the symbol “NUOX.” This offering is contingent upon final approval by the NYSE American of our listing.

We are an “emerging growth company” and a “smaller reporting company” as defined under the federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements.

Investing in our common stock involves a high degree of risk. Please read “Risk Factors” beginning on page 16 of this prospectus. Neither the 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.

(1)      We have agreed to pay the underwriters for certain expenses incurred by them. See “Underwriting” beginning on page 162 of this prospectus for more information about the compensation payable to the underwriters, including reimbursable expenses.

We have granted a 45-day option to the representative of the underwriters to purchase up to 429,000 additional shares of common stock solely to cover over-allotments, if any.

The underwriters expect to deliver the shares to purchasers on or about             , 2026.

ThinkEquity

The date of this prospectus is            , 2026

Table of Contents

We have not, and the underwriters have not, authorized anyone to provide any information to you or to make any representations other than those contained in this prospectus, any amendment or supplement to this prospectus, or in any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, and only under circumstances and in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date on the front cover of this prospectus regardless of the time of delivery of this prospectus or of any sale of common stock. Our business, financial condition, results of operations and prospects may have changed since the date on the front cover of this prospectus.

Neither we nor the underwriters have taken any action to 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 in jurisdictions outside of the United States who come into possession of this prospectus must inform themselves about and observe any restrictions relating to this offering and the distribution of this prospectus.

For investors outside the United States: We have not, and the underwriters have not, done anything that would permit this offering or possession or distribution of this prospectus or any applicable free writing 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 and any applicable free writing prospectus must inform themselves, and observe any restrictions relating to, the offering of the common stock and the distribution of this prospectus outside the United States.

Through and including            , 2026 (25 days after the date of this prospectus), all dealers that buy, sell or trade shares of our common stock, whether or not participating in this offering, may be required to deliver a prospectus. This delivery requirement is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

Trademarks and Tradenames

We use our registered trademarks and trade names in this prospectus. This prospectus also includes trademarks, trade names and service marks that are the property of other organizations. Solely for convenience, trademarks and trade names referred to in this prospectus appear without the and ™ symbols, but those references are not intended to indicate that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

GLOSSARY OF SELECTED TERMS

Unless the context otherwise requires, references in this section to the “Company,” “NuvOx,” “NuvOx Therapeutics,” “we,” “us” and “our” refer to NuvOx Therapeutics, Inc. In addition, as used in this prospectus, unless otherwise noted or the context otherwise requires, references to the following capitalized terms have the meanings set forth below:

“ALS” means amyotrophic lateral sclerosis.

“API” means an active pharmaceutical ingredient.

“ARDS” means acute respiratory distress syndrome.

“CMO” means a contract manufacturing organization.

“CPR” means cardiopulmonary resuscitation.

“CRO” means a contract research organization.

“DMF” means a drug master file.

“EMA” means the European Medicines Agency, an agency of the European Union in charge of the evaluation and supervision of medicinal products.

“Exchange Act” means the Securities Exchange Act of 1934, as amended.

“FDA” means the U.S. Food and Drug Administration, which is a federal agency of the United States Department of Health and Human Services.

“FDCA” means the Federal Food, Drug and Cosmetic Act.

“GBM” means glioblastoma multiforme, a form of brain cancer.

“GCP” means good clinical practice, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical trials.

“GMP” means good manufacturing practice regulations promulgated by the FDA. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.

“IND” means an investigational new drug application.

“IRB” means an Institutional Review Board, which is a group that has been formally designated to review and monitor biomedical research involving human subjects.

“NDA” means new drug application.

“MI” means myocardial infarction.

“REMS” means a risk evaluation and mitigation strategy which is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

“SAEs” means serious adverse effects.

“SEC” means the U.S. Securities and Exchange Commission.

“SUSAR” means a Suspected Unexpected Serious Adverse Reaction, which is a serious adverse reaction that is unexpected based on safety information and suspected to be related to product candidate.

“Securities Act” means the Securities Act of 1933, as amended.

“TBI” means traumatic brain injury.

“TNK” means Tenecteplase, a single-bolus recombinant fibrinolytic agent used to manage intravascular clots.

“TPA” means a tissue plasminogen activator.

RISK FACTORS

Investing in our common stock involves a high degree of risk. You should carefully consider the following risks and uncertainties, together with all the other information in this prospectus, including our financial statements and the related notes included elsewhere in this prospectus, before purchasing our common stock. If any of the following risks actually occurs, our business, operating results, financial condition, liquidity and prospects could be materially adversely affected. As a result, the trading price of our common stock could decline and you could lose part or all of your investment.

The risks and uncertainties described below are not the only ones we face. Our business, financial condition and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described below. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, operating results, financial condition, liquidity and prospects. Any one or more of such factors could directly or indirectly cause our actual results of operations and financial condition to vary materially from past or anticipated future results of operations and financial condition. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, results of operations and stock price. References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future.

Risks Related to Our Financial Position and Need for Capital

We are a development-stage company with a limited operating history.

We are a development-stage, company with only a limited operating history upon which to base an evaluation of our current business and future prospects and how we will respond to competitive, financial or technological challenges. We are subject to all the usual risks and uncertainties of a development-stage company with limited capital and other resources to develop new therapeutic products to serve a competitive market. We are subject to the additional risk that our activities are dependent on the successful development of our product candidate, NanO2, for use in treating various human diseases, regulatory approval of this product candidate, broad market acceptance of this product candidate, the potential challenges to protection afforded our intellectual property covering this product candidate, and the ability to manage operations effectively and attract, retain, and motivate qualified personnel.

Since our inception in 2008, we have focused substantially all of our efforts and financial resources on raising capital and on development and clinical testing of our product candidate. We have not yet obtained approval for any product candidate. We have to complete additional clinical trials and receive regulatory approval of our product candidate before commercial sales of any product candidate can commence.

The likelihood of success of our business plan must be considered in light of the problems, substantial expenses, difficulties, complications and delays frequently encountered in connection with building and expanding clinical development of our pharmaceutical businesses and the regulatory and competitive environment in which we operate. Pharmaceutical product development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive business.

Therefore, we are and expect for the foreseeable future to be, subject to all the significant risks and uncertainties inherent in a clinical-stage, pre-revenue biopharmaceutical business seeking regulatory approval for its product candidates. As a result, we still must establish many functions necessary to operate a business, including conducting necessary clinical trials, continuing product and technology development, implementing financial systems and controls and personnel recruitment. Even if we achieve regulatory approval of our product candidate or any other product candidates that we develop (of which no assurances can be given), we will need to establish commercial operations, which is also risky and uncertain.

Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the clinical stage of development. Potential investors should carefully consider the risks and uncertainties that a company with a limited operating history will face. In particular, potential investors should consider that we cannot assure you that we will be able to:

•        successfully complete the clinical trials necessary to obtain regulatory approval for the marketing of our product candidate, NanO2;

•        secure acceptance of our product candidate in the medical community and with third-party payors and consumers;

•        if approved for commercial sale, launch commercial sales of our product candidate, whether alone or in collaboration with others;

•        successfully build an internal sales force meeting our requirements for the marketing and sale of our product candidate, NanO2, or outsource such function to one or more third parties;

•        successfully manufacture our clinical product and establish commercial drug supply, or outsource such function to one or more third parties;

•        secure market exclusivity and/or adequate intellectual property protection for our product candidate;

•        attract, retain and grow an experienced management, board and scientific advisory team;

•        successfully implement or execute our current business plan, and we cannot assure you that our business plan is sound; and

•        raise sufficient funds in the capital markets to effectuate our business plan.

If we cannot successfully execute any one or more of the foregoing, our business may not succeed and your investment will be adversely affected.

We have no products approved for commercial sales and a limited operating history upon which to evaluate our ability to commercialize our product candidate.

We are a development-stage company and our success is dependent upon our ability to obtain regulatory approval for and commercialize our product candidate, NanO2, and we have not demonstrated an ability to perform the functions necessary for the approval or successful commercialization of any product candidate. We have yet to demonstrate our ability to overcome the risks frequently encountered in our industry and are still subject to many of the risks common to such enterprises, including our ability to implement our business plan, market acceptance of our proposed business and product, under-capitalization, cash shortages, limitations with respect to personnel, financing and other resources, competition from better funded and experienced companies, and uncertainty of our ability to generate revenues. Historical sales of products typically provide potential investors information regarding revenue, market acceptance and penetration of the product, pricing considerations, and gross and operating margins. Because we have not made any sales of our product candidate there is only limited information upon which investors can evaluate our business, prospects, or future operating results, which would normally aid investors in making an informed judgment as to the merits of a purchase our securities or the management skills or competence of our management.

There is no assurance that our activities will be successful or will result in any revenues or profit, and the likelihood of our success must be considered in light of the stage of our development. In addition, no assurance can be given that we will be able to consummate our business strategy and plans, or that financial, technological, market, or other limitations may force us to modify, alter, significantly delay, or significantly impede the implementation of such plans. We have insufficient results for investors to use to identify historical trends. Investors should consider our prospects in light of the risk, expenses and difficulties we will encounter as an early-stage company. Our revenue and income potential are unproven and our business model is continually evolving. We are subject to the risks inherent to the operation of a new business enterprise, and cannot assure you that we will be able to successfully address these risks.

We have a history of operating losses and expect to continue to incur substantial losses for the foreseeable future. We may never become profitable or, if achieved, be able to sustain profitability.

To date, we have not generated any significant revenue from sales of products, we have incurred net losses in each year of our operations. We incurred net losses of $6.9 million and $12.3 million for the three months ended March 31, 2026 and on March 31, 2025, respectively, and $16.6 million and $6.6 million for the years ended December 31, 2025 and December 31, 2024, respectively. We expect to continue to incur significant operating losses in connection with the development and potential future commercialization of NanO2. Our accumulated deficit as of March 31, 2026 and December 31, 2025 was $43.1 million and $36.3 million, respectively. Substantially all of our revenue has been obtained through non-dilutive grant funding from institutions such as the NIH, and to a lesser extent by conducting research services for the DoD and BARDA. We expect to continue to incur operating losses until such time, if ever, as we are able to achieve sufficient levels of revenue from operations. Our ability to achieve profitability will depend on regulatory approval of our product candidate and if approved, the market acceptance of our product and our capacity to develop, introduce and sell our product to our targeted markets. There can be no assurance that we will ever generate significant sales or achieve profitability. 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. 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 ability to get reimbursement at any price and whether we own the commercial rights for that territory. If the number of addressable patients is not as significant as we anticipate, the indication approved by regulatory authorities is narrower than we expect, 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 do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Accordingly, the extent of future losses and the time required to achieve profitability, if ever, cannot be predicted at this point.

In addition, upon taking office in January 2025, the Trump Administration effectively prevented the NIH and the DoD from reviewing and awarding new SBIR grants, and possibly paying out funds under already awarded SBIR grants, including for research or other projects. To date, we have not received any communications from the DoD, BARDA or NIH regarding availability of the funds disclosed as being awarded to us or our third party collaborators other than from BARDA that it did not extend the time of expiration of the contract and, therefore, approximately $0.4 million was forfeited because the term of the grant expired before research was completed. Although the SBIR program has been re-authorized through September 30, 2031, no assurances can be provided that we will receive any of the funds that we have already been granted or that we may be granted or receive any additional funds in the future or that the program will be funded in the future. If the U.S. government takes any other actions to limit funds available for life science or healthcare research or other projects, it may affect certain of our and our current, or potential, collaborators and may have a material adverse impact on our business, financial condition and results of operations.

Even if we succeed in developing and commercializing one or more product candidates, we expect to incur substantial losses for the foreseeable future and may never become profitable. We also expect to continue to incur significant operating and capital expenditures and anticipate that our expenses will increase substantially in the foreseeable future as we:

•        continue to undertake the next stage or pivotal clinical trial for our product candidate;

•        seek regulatory approvals for our product candidate;

•        implement additional internal systems and infrastructure; and

•        hire additional personnel.

We may not be able to generate revenue or achieve profitability in the future. Our failure to achieve or maintain profitability would likely negatively impact the value of our securities and could prevent us from continuing as a going concern.

Even if we can secure such arrangements, we may continue to have obligations and expenses that exceed the revenue generated by these marketed products.

Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.

The opinion of our independent registered public accounting firm included elsewhere in this prospectus includes an emphasis-of-matter paragraph regarding substantial doubt about our ability to continue as a going concern. As described in Note 1 of our accompanying audited financial statements for the years ended December 31, 2025 and December 31, 2024, and Note 1 to our accompanying unaudited financial statements for three months ended March 31, 2026 and 2025, there is substantial doubt that we can continue as an ongoing business for the twelve months from the date that the financial statements were issued based on our current development plans and our operating requirements and us having suffered recurring losses from operations and having a net capital deficiency. Our financial statements do not include any adjustments that may result from the outcome of this uncertainty. Our continuation as a going concern is contingent upon our ability to obtain additional financing and to generate revenue and cash flow to meet our obligations on a timely basis. If we cannot raise the necessary capital to continue as a viable entity, we could experience a material adverse effect on our business and our stockholders may lose some or all of their investment in us.

Our cash, cash equivalents and the proceeds of this offering will only fund our operations for a limited time, and we will need to raise additional capital to fund our planned pivotal Phase III clinical trials and to support our development and commercialization efforts for our product candidate, NanO2.

If we do not succeed in raising additional funds on acceptable terms, we will be unable to complete our current clinical trials or commence planned future trials or obtain approval of our product candidate from the FDA and other regulatory authorities. In addition, we could be forced to delay, discontinue or curtail product development, forego sales and marketing efforts, and forego licensing in attractive business opportunities. We estimate that we will require a total of up to $6.0 million for the completion of our currently ongoing Phase IIb trial in GBM, for the supply of our product candidate necessary to complete the currently ongoing investigator sponsored Phase IIb stroke trial and our current ongoing Phase Ib respiratory distress trial. In addition, we will require significant financing in order to fund our planned Phase II ARDS trial, pivotal Phase III clinical trial for GBM, our pivotal trial of NanO2 for the treatment of patients with ischemic stroke and other expenditures that we will need to incur in order to file our application with the FDA and we intend to use a portion of the proceeds from this offering to prepare these more advanced trials and complete the planned Phase II ARDS trial. However, the proceeds from this offering will not be sufficient to completed multiple more advanced trials. Additionally, we will require additional funds for general and administrative expenses anticipated to be incurred over the next three years. If we are unable to raise a sufficient amount of additional funds beyond this offering, we may be unable to complete the clinical trials as planned.

We will also need to raise additional capital to expand our business to meet our long-term business objectives.

Our cash and cash equivalents balance at July 6, 2026 will not be sufficient to fund operations for at least the next twelve months. However, we believe that our existing cash and cash equivalents, combined with the anticipated net proceeds from this offering, will be sufficient in the aggregate to meet our anticipated cash requirements for at least the next twelve months. We will, however, require additional financing as we continue to execute our business strategy, including for the initiation of enrollment of patients and completion of our planned pivotal Phase III trial in stroke. Our liquidity may be negatively impacted as a result of a research and development cost increases in addition to general economic and industry factors.

We anticipate that, to the extent that we require additional liquidity, it will be funded through non-dilutive funding, the incurrence of additional indebtedness, additional equity financings, collaboration and licensing arrangements, or a combination of these potential sources of liquidity. In addition, we may raise additional funds to finance future cash needs through grant funding. If we raise additional funds by issuing equity securities or convertible debt, our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. The covenants under future credit facilities may limit our ability to obtain additional debt financing. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our products, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to us.

We cannot be certain that additional funding will be available on acceptable terms, or at all. Any failure to raise capital in the future could have a negative impact on our financial condition and our ability to pursue our business strategies. If we choose to pursue additional indications and/or geographies for any of our products or product candidates or otherwise expand more rapidly than we presently anticipate, we may also need to raise additional capital sooner than expected.

Our present and future capital requirements will depend on many factors, including:

•        the outcome, timing and cost of our Phase III clinical trials to obtain regulatory approval for NanO2;

•        the degree and rate of market adoption of our products, if approved;

•        the emergence of new, competing technologies and products;

•        the costs of R&D activities we undertake to develop new products and indications;

•        the costs of commercialization activities, including sales, marketing and manufacturing;

•        the costs of building an internal sales force meeting our requirements for the marketing and sale of our product candidates, if approved, unless outsourced;

•        our ability to collaborate with third parties on the development and commercialization of our product candidates and products;

•        the level of working capital required to support our growth; and

•        our need for additional personnel, information technology or other operating infrastructure to support our growth and operations as a public company.

Unfavorable U.S. or global economic conditions could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and financial markets. A severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for our technologies and our ability to raise additional capital when needed on favorable terms, if at all. Ongoing inflation in world economies may adversely affect us by increasing the costs associated with performing research and development on internal research initiatives and partnered programs. We may experience significant increases in the prices of labor, consumables, and other costs of doing business. In an inflationary environment, such cost increases may outpace our expectations, causing us to use cash faster than forecasted. A weak or declining economy may also strain our partners, possibly resulting in supply disruption, or cause delays in their payments to us. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

In addition, the global macroeconomic environment could be negatively affected by, among other things, pandemics or epidemics, instability in global economic markets, instability in the global credit markets, supply chain weaknesses, instability in the geopolitical environment as a result of the Russian war with Ukraine, the recent escalation of the conflicts in the Middle East, including between the U.S./Israel and Iran, military or other action taken by the United States in foreign countries and other political tensions, and foreign governmental debt concerns. The invasion of Ukraine by Russia and the escalation of the conflict in the Middle East, particularly the escalation of the Israel-Hamas and Israel/U.S.-Iran conflicts, and the resulting measures that have been taken, and could be taken in the future, by NATO, the United States, the United Kingdom, the EU, Israel, Iran and its neighboring states and other countries have created global security concerns that could have a lasting impact on regional and global economies. Although the length and impact of the ongoing conflicts are highly unpredictable, they could lead to market disruptions, including significant volatility in commodity prices, credit and capital markets, as well as supply chain interruptions and increased cyber-attacks against U.S. companies. Additionally, any resulting sanctions could adversely affect the global economy and financial markets and lead to instability and lack of liquidity in capital markets.

Changes to trade policy, including tariff and customs regulations, or failure to comply with such regulations may have an adverse effect on our reputation, business, financial condition and results of operations.

Changes in U.S. or international social, political, regulatory and economic conditions or in laws and policies governing trade, manufacturing, development and investment in the countries where we currently conduct our business could adversely affect our business, reputation, financial condition and results of operations. Changes or proposed changes in U.S. or other countries’ trade policies may result in restrictions and economic disincentives on international trade. Changes to U.S. policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. The U.S. government has recently imposed, or is currently considering imposing, tariffs on certain trade partners, including China, where we have engaged a vendor. Additionally, the United States has recently imposed significant tariffs on imports from other countries, including a baseline tariff of 10% on imports into the United States and higher tariffs on multiple designated countries, such as “reciprocal” tariffs at varying rates. Such tariffs have prompted retaliatory measures from several countries, which may further escalate. Certain of these tariffs have been subsequently paused or modified, and the situation remains fluid. While pharmaceutical products are currently excluded from the baseline and “reciprocal” tariffs imposed by the United States, such tariffs still apply to the raw materials and other products necessary for the manufacture and formulation of our product candidates. In addition, the U.S. Department of Commerce has initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, to determine the effects of importing pharmaceuticals and pharmaceutical ingredients on national security. This investigation may lead to the imposition of tariffs on pharmaceutical imports, consistent with the current U.S. administration’s stated policy objective of reshoring pharmaceutical manufacturing to the United States. Further, in July 2025, the United States and the EU announced the framework of a trade agreement that generally imposes a 15% tariff on imports from the EU. Under this agreement, pharmaceutical products would not be subject to any future Section 232 investigation duties in excess of this 15% rate. The U.S. Supreme Court is currently considering legal challenges to tariffs imposed under the International Emergency Economic Powers Act, such as the baseline and reciprocal tariffs discussed above. The outcome of this decision could impact trade agreements entered into by the United States and the wider tariff environment in which we operate.

Tariffs, reciprocal tariffs, economic sanctions, embargoes, import or export licensing requirements and other changes in U.S. trade policy have in the past and could in the future trigger additional retaliatory actions by affected countries. Further, any emerging protectionist or nationalist trends (whether regulatory, or consumer-driven) either in the United States or in other countries could affect the trade environment. Our business, like many other corporations, would be impacted by changes to the trade policies of the United States and foreign countries (including governmental action related to tariffs, international trade agreements, or economic sanctions). Such changes have the potential to adversely impact the U.S. economy or certain sectors thereof, the global economy, and our industry, and as a result, could have a material adverse effect on our business, financial condition and results of operations.

A prolonged U.S. federal government shutdown could materially and adversely affect our business and operations.

Any disruption in the operations of the U.S. government, including as a result of the recent or future temporary or prolonged shutdowns resulting from the failure of Congress to enact appropriations bills or raise the federal debt ceiling, could materially and adversely affect our business, operations and financial condition. Recently, beginning on October 1, 2025, the U.S. federal government shut down and remained shut down through November 12, 2025, and again beginning on January 31, 2026 through February 3, 2026, during which times certain regulatory agencies, such as the FDA and the SEC, furloughed critical employees and stopped critical activities. Additionally, on October 10, 2025, the U.S. government implemented substantial layoffs and workforce reductions in connection with the federal government shutdown, which resulted in the suspension or delay of various government-funded programs. Furthermore, the recent federal government shutdowns have resulted, and may continue for a prolonged period of time to result, in reduced availability of government services, and suspension or delay of activities by key agencies that regulate, fund, or interact with our business, including the SEC, the FDA, the Department of Health and Human Services, and the U.S. Patent and Trademark Office, or USPTO. As a result, the review and approval of our filings, applications, and submissions could be delayed, and we may be unable to access or rely upon certain government data or systems. In particular, it may lead to disruptions and delays in FDA’s review and oversight of our product candidates and impact the FDA’s ability to provide timely feedback on our development program or pending applications.

Additionally, a prolonged or future shutdown of the U.S. federal government could materially impact the operations of the SEC. For example, the SEC announced that during the recent U.S. federal government shutdowns, it would not review or declare registration statements effective. In the event of an extended shutdown, the SEC may operate with limited staff or suspend certain functions altogether, which could delay the review or effectiveness of our filings, including registration statements or other financing-related disclosures. Such delays could adversely affect our ability to complete this offering and/or to access the public markets and obtain necessary capital in order to properly capitalize and continue to fund our operations.

Government shutdowns, if prolonged, can significantly impact the ability of government agencies upon which rely, such as the FDA and SEC, to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Even the threat of a government shutdown or prolonged budget negotiation uncertainty may adversely affect the broader U.S. economy, investor confidence, and capital markets. Such conditions could negatively impact our access to financing, timing of capital-raising transactions, and the liquidity or trading volume of our securities. Accordingly, the current or future federal government shutdowns, or uncertainty regarding the continuity of government operations, could have a material adverse effect on our business, results of operations, and stock price.

Federal budget and debt-ceiling disputes may adversely affect capital markets and our financing activities.

Moreover, the uncertainty surrounding government funding debates and debt-ceiling negotiations can negatively affect market conditions, investor sentiment, and the liquidity of small-cap and microcap issuers such as ours. If market volatility or trading disruptions were to occur during the current or future government shutdowns, our ability to execute at-the-market offerings or other financing transactions under our effective shelf registration statement or through private equity offerings could be materially impaired.

Accordingly, any federal government shutdown or protracted budget impasse could materially and adversely affect our regulatory compliance, financing options and capabilities, and overall financial condition.

Our clinical trial accruals are based on estimates, and if these estimates are inaccurate, our results of operations could be adversely affected.

We are required to estimate our expenses resulting from our obligations under contracts with clinical sites, CROs, and other third-party service providers in connection with our clinical trials. Our clinical trial accrual methodology is based on estimates of costs that are subject to significant judgment and uncertainty, and our financial results could be materially affected if our estimates prove to be incorrect.

We conduct clinical trials at various clinical sites, each of which operates under an agreement that governs the financial terms of the arrangement, including the timing and conditions under which amounts become payable based on completion of Case Report Forms, or CRFs, for each patient visit. The terms and conditions of these agreements vary significantly from site to site. Certain agreements provide for automatic milestone payments based on completed CRFs, while others require “query-free” CRFs before payments become due. Additionally, certain clinical sites submit invoices for reimbursement while others do not, which creates further variability in the timing of our recognition of, and ability to accurately estimate, our obligations.

We record accruals for clinical site expenses when we determine that the underlying obligation is both probable and reasonably estimable, based on our analysis of the completion history and experience with queries on CRFs at each site. We review and adjust these estimates on a quarterly basis utilizing clinical data available to us at that time. However, the complexity of our contractual arrangements, variability in billing practices among sites, the volume of patient visits across our clinical programs, and the inherent time lag between when services are rendered and when we receive sufficient documentation or invoices may result in our estimates differing materially from actual amounts incurred in any given reporting period.

If our estimates of clinical trial accruals are incorrect, we may be required to restate our expenses (as we were required to do for the year ended December 31, 2024) or record significant adjustments in future periods, which could have a material adverse effect on our results of operations and financial condition. In addition, inaccurate estimates could impair our ability to forecast future operating expenses and cash requirements, which could adversely affect our ability to manage our capital resources and could cause our results to differ from the expectations of securities analysts or investors, potentially causing a decline in the trading price of our common stock.

Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

We currently have only one product candidate, NanO2, in clinical development and our business is dependent upon the success of NanO2, which requires additional clinical testing before we can seek regulatory approval and potentially launch commercial sales. We do not have any other product candidates or have any other products in clinical development.

Our business and future success depends upon our ability to obtain regulatory approval of and then successfully commercialize our product candidate, NanO2. Our main focus and the investment of a significant portion of our efforts and financial resources is expected to be in the development of our product candidate, NanO2, for which we have completed the enrollment and treatment of patients in a Phase IIb GBM trial, the University of Glasgow is enrolling patients in a Phase IIb trial relating to its use for the treatment of stroke, and we are enrolling patients in a Phase Ib respiratory distress trial. We believe that the net proceeds from this offering, combined with our current cash and cash equivalents balance, will provide us with the necessary funding to complete the three trials mentioned above, further conduct a planned Phase II ARDS trial, as well as to provide additional working capital, and to begin to prepare for a pivotal Phase III GBM trial. Even though we are pursuing a marketing authorization pathway based on specific FDA input and guidance, there are many uncertainties known and unknown that may affect the timing and outcome of the trials, including adequate patient enrollment, adequate supply of our product candidate, potential changes in the regulatory landscape and the results of the trial being successful, and FDA acceptance of the data to support approval. Completion of our clinical trials, as well as those conducted by third parties to which we supply our product candidate, over which we have very little control, may be delayed, and any such delays could result in increased costs or otherwise negatively impact our business or results of operations. Additionally, the FDA may reject the application or issue a complete response letter rather than approval, including for reasons that it disagrees with our interpretation of the data or that it finds our single pivotal trial insufficient evidence of clinical efficacy. The FDA may also ask us to conduct another pivotal trial, and/or to furnish additional testing and analyses before it can consider approving the product.

The research, development, testing, manufacturing, labeling, approval, sale, marketing, advertising and promotion, pricing, export, import and distribution of our product candidate is and will remain subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries that each have differing regulations to the extent that we apply to market our product candidate in other countries. We are not permitted to market any product in the United States unless and until we receive approval from the FDA, or in any other countries unless and until we receive the requisite approval from regulatory authorities in such countries.

We also may rely on third parties to conduct the appropriate clinical trials, and their failure to adhere to protocol or perform in accordance with applicable law could result in delays and would have a negative effect on our regulatory submission.

Our future success depends heavily on our ability to successfully manufacture, develop, obtain regulatory approval, and commercialize NanO2, which may never occur. We currently generate no revenue from our product candidate, and we may never be able to develop or commercialize a marketable drug.

We have limited resources and are currently focusing the majority of our efforts on developing NanO2 for particular indications. As a result, we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.

We are currently focusing the majority of our resources and efforts on developing NanO2. As a result, because we have limited resources, we may forgo or delay the pursuit of opportunities for other indications or with other product candidates that may have greater commercial potential. In addition, we are focusing our efforts on select indications for NanO2. Our resource allocation decisions may cause us to fail to capitalize on viable commercial drugs or profitable market opportunities. Our spending on current and future clinical research and development activities for NanO2 for certain indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target markets for NanO2, we may relinquish valuable rights to our product candidates or programs through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate or program.

Development of a product candidate intended for use in combination with an already approved therapy may present increased complexity and more or different challenges than development of a product candidate for use as a single agent or monotherapy.

Among other uses, we are developing our product candidate, NanO2, for use in the treatment of GBM in combination with approved therapies, such as chemotherapy, which may present additional challenges. For example, the FDA may require us to use more complex clinical trial designs, to evaluate the contribution of each product and product candidate to any observed effects. It is possible that the results of these trials could show that most or any positive results are attributable to the already approved product. Moreover, following product approval, the FDA may require that products used in conjunction with each other be cross-labeled. To the extent that we do not have rights to already approved products, this may require us to work with another company to satisfy such a requirement. Moreover, developments related to the already approved therapies may impact our clinical trials for the combination as well as our commercial prospects should we receive marketing approval. Such developments may include changes to the approved therapy’s safety or efficacy profile, changes to the availability of the approved therapy, and changes to the standard of care. We may choose to develop NanO2 and our other product candidates in combination with other approved or clinical-stage therapies, in which case similar developmental risks as to combination trials would apply to such product candidates in the clinical development and commercial approval processes.

Our efforts to develop our product candidate may not generate data sufficient to support an application for regulatory approval.

Clinical trials are difficult to design and implement, can take many years to complete and are uncertain as to outcome. Success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results. There is no guarantee that later trials will meet their endpoints, or demonstrate superiority to placebo, current standard of care or any other therapy. A failure of one or more of our clinical trials can occur at any stage of testing. Our product candidate may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining regulatory approval or prevent or limit commercial use with respect to one or all targeted indications. In addition, we may experience other numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent our ability to continue development. Development-stage risks include the following:

•        we may not be able to provide acceptable evidence of the safety and efficacy of our product candidates or an acceptable benefit/risk profile for our product candidate;

•        we may not be able to successfully manufacture drug supplies for our clinical trial;

•        the results of our clinical trial may not be satisfactory or may not meet the level of statistical or clinical significance required by the FDA, EMA, or other comparable foreign regulatory authorities to demonstrate safety and effectiveness;

•        we may not be able to determine the optimal dosing of our product candidate for targeted indications; and

•        patients in our clinical trials may suffer adverse effects that are deemed related to or caused by our product candidates, leading us or regulatory authorities to stop clinical trials temporarily or permanently.

We have safety data from the two separate completed Phase Ib/IIa human clinical trials of NanO2 as well as safety data from our ongoing Phase IIb GBM clinical trial, the investigator sponsored Phase IIb stroke clinical trial, and our Phase Ib respiratory distress trial. The two Phase Ib/IIa human clinical trials enrolled a small number of patients and may not be representative of a larger trial population.

In the Phase Ib/IIa stroke trial, there were eight (8) SAEs that occurred in four (4) patients. None of the SAEs were determined to be related to NanO2. These eight (8) SAEs included abdominal pain, cerebrovascular accident, confusional state, depression, cardiac pacemaker replacement, pneumonia, and migraine.

In the Phase Ib/IIa GBM trial, there were a total of nine (9) SAEs, none of which were unexpected. These nine (9) SAEs occurred in five (5) patients. These nine (9) SAEs included: atypical pneumonia, radiation necrosis, motor dysfunction, pyrexia, platelet count decrease, and syncope. Out of the nine (9) SAEs, six (6) SAEs that occurred in three (3) patients were determined to be unrelated or unlikely related to NanO2, which include atypical pneumonia, pyrexia, and syncope. Three (3) SAEs that occurred in three (3) patients were determined to be possibly or probably related to NanO2, consisting of radiation necrosis, motor dysfunction, and platelet count decrease.

In the ongoing Phase IIb GBM trial, as of July 6, 2026, there have been forty-nine (49) SAEs that occurred in twenty-five (25) patients. These SAEs consist of: anorectal infection, brain oedema, necrosis, central nervous system necrosis, embolism, hemiparesis, fall, dizziness, seizure, mental status changes, pulmonary embolism, platelet count decrease, muscular weakness, peripheral swelling, deep vein thrombosis, type 2 diabetes mellitus, pancytopenia, intracranial hemorrhage, cerebral hemorrhage, hypoxia, pneumonia, pneumonitis, hydrocephalus, febrile neutropenia, pleural effusion, small intestinal obstruction, and device related infection.

Of the forty-nine (49) SAEs, forty-seven (47) SAEs in twenty-five (25) patients were determined to be unrelated or unlikely be related to NanO2 or placebo. These forty-seven (47) SAEs consisted of: anorectal infection, brain oedema, necrosis, central nervous system necrosis, embolism, fall, dizziness, seizure, mental status changes, pulmonary embolism, platelet count decrease, muscular weakness, peripheral swelling, deep vein thrombosis, type 2 diabetes mellitus, pancytopenia, intracranial hemorrhage, cerebral hemorrhage, hypoxia, pneumonia, pneumonitis, hydrocephalus, febrile neutropenia, pleural effusion, small intestinal obstruction, and device related infection.

Of the forty-nine (49) SAEs, two (2) SAEs, consisting of hemiparesis and mental status changes, in two (2) patients were determined to possibly be related to NanO2 or placebo, both of which resolved without sequelae.

In 2023, the NIHR awarded a grant to physicians at the University of Glasgow and NHS Greater Glasgow and Clyde’s Queen Elizabeth University Hospital funds to conduct a 150-subject trial in ischemic stroke in the United Kingdom. The first patient was treated in December 2025. To date, seventeen (17) patients have been treated. As of July 6, 2026, there have been three (3) SAEs. Two of the SAEs, ischemic stroke and subarachnoid haemorrhage, were determined to be not related to NanO2 or placebo. The other SAE, hypotension, was determined to be related to NanO2 or placebo. None of the foregoing SAEs are unexpected. However, based on regulation in UK, a SUSAR report was still submitted for the hypotension SAE. Since the Phase IIb stroke trial is randomized and placebo controlled, it is blinded and a final determination regarding the cause of the SAEs has not been made.

Our Phase Ib respiratory distress trial commenced in 2025. It is an open label, dose escalation trial with three cohorts, each of which has six (6) patients. Dosing of the first and second cohorts has been completed. Two (2) SAEs, upper GI bleeding and chronic obstructive pulmonary disease, were reported in one (1) patient in cohort 1 and one (1) patient in cohort 2. Neither of these SAEs were related to NanO2 and both were resolved without sequalae.

It is possible that unexpected treatment emergent SAEs could arise in ongoing or future trials of NanO2, which could pose safety concerns. If unacceptable safety concerns or other adverse events, or AEs, arise in the development of a product candidate, our clinical trials could be suspended or terminated or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of such product candidate for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims. Inadequate training in recognizing or managing the potential side effects of a product candidate could result in patient deaths. Any of these occurrences may harm our business, financial condition and prospects significantly.

Positive results from early clinical or preclinical studies of our product candidates are not necessarily predictive of the results of later preclinical studies and any future clinical trials of our product candidates. If we cannot show positive results or replicate any positive results from our earlier clinical or preclinical studies of our product candidates in our future clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize our product candidates.

In order to obtain marketing approval for any of our product candidates, we must demonstrate the safety and efficacy of the product candidate for the relevant clinical indication or indications through clinical trials as well as additional supporting data. If our product candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

Any positive results from clinical and preclinical studies of our product candidates may not necessarily be predictive of the results from later preclinical studies and clinical trials. Similarly, even if we are able to complete our planned future clinical trials of our product candidates according to our current development timeline, the positive results from such preclinical studies and clinical trials of our product candidates may not be replicated in subsequent preclinical studies or clinical trial results. Further, some of the clinical trials for which our product candidate is provided to patients, such

as the Phase IIb stroke trial, are investigator initiated trials, where the investigators, rather than us, sponsor the trial. As such, we have very little control over such trials and cannot verify the detailed procedures or results through which the trials are conducted.

Many companies in the pharmaceutical industry have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development and we cannot be certain that we will not face similar setbacks. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain regulatory approval. Subjects in our planned clinical trials may suffer significant AEs or other side effects not observed in our preclinical studies.

We have tested the dosing frequency and route of administration of our product candidate in clinical and preclinical studies, which have informed our dosing strategy for certain future clinical trials. However, such dose and route of administration may not result in sufficient exposure or pharmacological effect in future studies and may lead to unforeseen toxicity not previously observed in clinical and preclinical testing. Further, if our planned clinical trials of our product candidates fail to demonstrate efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

It is possible that unexpected treatment emergent SAEs could arise in ongoing or future trials of NanO2, which could pose safety concerns. If significant AEs or other side effects are observed in any of our future clinical trials, we may have difficulty recruiting patients to the related clinical trial, patients may drop out of the trial, or we may be required to abandon the trial or our development efforts of that product candidate altogether. We, the FDA, or other applicable regulatory authorities, or an institutional review board may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects. Some potential therapeutics developed in the pharmaceutical industry that initially showed therapeutic promise in early-stage studies have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude the drug from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance of and reimbursement for the approved product due to its tolerability versus other therapies. Any of these developments could materially harm our business, financial condition and prospects.

Further, if any of our product candidates obtains marketing approval, toxicities associated with our product candidates may also develop after such approval and lead to a requirement to conduct additional clinical safety trials, additional warnings being added to the labeling, significant restrictions on the use of the product or the withdrawal of the product from the market. We cannot predict whether our product candidates will cause toxicities in humans that would preclude or lead to the modification or revocation of regulatory approval.

Interim, topline and preliminary data from our clinical trials that we announce or publish may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials, such as the interim data from clinical trials of NanO2. These interim updates are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the topline results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. In addition, we may report interim analyses of only certain endpoints rather than all endpoints. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse changes between interim data and final data could significantly harm our business and prospects. Further, additional disclosure of interim data by us or by our competitors in the future could result in volatility in the price of our common stock.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the preliminary or topline data that we report differ from late, final or actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, NanO2 or any other future product candidates may be harmed, which could harm our business, financial condition, results of operations and prospects.

The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.

Our ongoing clinical trials are being undertaken in the United States and a Phase IIb trial of NanO2 in approximately 150 stroke patients in the United Kingdom is underway. The acceptance of trial data by the FDA, EMA or other comparable foreign regulatory authorities from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions. In cases where data from United States clinical trials are intended to serve as the basis for marketing approval in the foreign countries outside the United States, the standards for clinical trials and approval may be different. There can be no assurance that any United States or foreign regulatory authority would accept data from trials conducted outside of its applicable jurisdiction. If the FDA, EMA or any applicable 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 which may result in our product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.

Even if we successfully complete our clinical trials, we may not receive regulatory approval for NanO2, and we may not be able to commercialize our product candidate and our ability to generate revenue will be limited.

The research, development, testing, manufacturing, labeling, packaging, storage, approval, sale, marketing, advertising and promotion, pricing, export, import and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, which regulations differ from country to country. We are not permitted to market our product candidate in the United States until we receive approval from the FDA and in non-U.S. markets until we receive the requisite approval from comparable regulatory agencies in such countries. Of the large number of drugs in development, only a small number are submitted for approval to the FDA and even fewer are eventually approved for commercialization. We may not succeed at gaining regulatory approval, or at commercialization, which would materially harm our business.

Receipt of necessary regulatory approval is subject to a number of risks, including the following:

•        the data collected from pre-clinical and clinical trials may not be sufficient to support the submission of an application or other submission or to obtain regulatory approval in the United States or elsewhere;

•        the FDA may determine that data collected from pre-clinical and clinical trials conducted outside of the United States may not be adequately representative of U.S. patient populations, and may require us to conduct additional trials within the United States;

•        the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies and product; and

•        the relevant laws, approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

We cannot guarantee that regulators will agree with our assessment of the results of our clinical trials or that such trials will be considered by regulators to have shown safety or efficacy of our product candidates. The FDA, EMA and other regulators have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional clinical trials, or pre-clinical or other testing. In addition, varying interpretations of the data obtained from pre-clinical and clinical testing could delay, limit or prevent regulatory approval of a product candidate. Failure to obtain regulatory marketing approval for our product candidates in any indication will prevent us from commercializing the product candidate, and our ability to generate revenue will be materially impaired.

The process of obtaining regulatory approvals is expensive, often takes many years, if approval is obtained at all, and can vary substantially based upon, among other things, the type, complexity and novelty of the product candidates involved, the jurisdiction in which regulatory approval is sought and the substantial discretion of the regulatory authorities. Changes in regulatory review for a submitted product application may cause delays in approval or rejection of an application. Regulatory approval obtained in one jurisdiction does not necessarily mean that a product candidate will receive regulatory approval in all jurisdictions in which we may seek approval, but the failure to obtain approval in one jurisdiction may negatively impact our ability to seek or gain approval in a different jurisdiction. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of NanO2 or any future product candidates will be harmed.

Even if we obtain regulatory approval, we will still face ongoing regulatory requirements and NanO2 may face future development and regulatory difficulties.

Even if we receive regulatory approval of NanO2 or any future product candidates, we will be subject to ongoing regulatory obligations, such as post market surveillance and current GMP requirements, and continued regulatory review, which may result in significant additional expense. We may also be subject to regulatory enforcement including product discontinuation, fines and penalties if we fail to comply with regulatory requirements or experience unanticipated problems with product candidates. In addition, third parties on whom we rely must comply with regulatory requirements, and any non-compliance on their part may negatively impact our business, assuming we obtain regulatory authorization at all.

Any regulatory approvals that we receive for product candidates will require surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a Risk Evaluation and Mitigation Strategy, or REMS, in order to approve product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. Any approval of our products could also be accompanied by a post marketing commitment or post marketing requirement by FDA to conduct additional post approval studies. The FDA could also require a boxed warning, sometimes referred to as a Black Box Warning on the product label to identify a particular safety risk, which could affect commercial efforts to promote and sell the product. In addition, if the FDA or a comparable foreign regulatory authority approves product candidates, the manufacturing processes, labeling, packaging, distribution, AE reporting, storage, advertising, promotion, import, export and recordkeeping for product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with current GMPs and GCPs for any clinical trials that we conduct post-approval. We are also subject to certain user fees imposed by the regulatory agencies. Later discovery of previously unknown problems with product candidates, including AEs of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

•        import alerts or automatic detentions;

•        restrictions on the marketing or manufacturing of product candidates, withdrawal of the product from the market, or product recalls;

•        fines, warning letters or holds on clinical trials;

•        refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of approvals;

•        labeling changes;

•        product seizure or detention, or refusal to permit the import or export of product candidates;

•        injunctions or the imposition of civil or criminal penalties; and

•        inability to obtain government contracts.

The FDA’s and other regulatory authorities’ policies may change, such as those required by the 21st Century Cures Act, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of NanO2 or any future product candidates. In addition, it is unclear what changes, if any, the new presidential administration may bring. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

Clinical trials are very expensive, time-consuming and difficult to design and implement.

As part of the regulatory process, we must conduct clinical trials for our product candidates to demonstrate safety and efficacy to the satisfaction of the FDA and other regulatory authorities. As we advance NanO2 or any future product candidates we expect that our expenses will increase. The number and design of the clinical trials that will be required varies depending upon the product candidate, the condition being evaluated, current medical strategies and the trial results themselves. Therefore, it is difficult to accurately estimate the cost of the clinical trials. Clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time consuming. We estimate that clinical trials of product candidates including NanO2, will take at least several years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. The commencement and completion of clinical trials may be delayed or prevented by several factors, including but not limited to:

•        unforeseen safety issues;

•        failure to determine appropriate dosing;

•        greater than anticipated cost of our clinical trials;

•        failure to demonstrate effectiveness during clinical trials;

•        slower than expected rates of subject recruitment or difficulty obtaining investigators;

•        subject drop-out or discontinuation;

•        import delays of clinical trial materials;

•        inability to monitor subjects adequately during or after treatment;

•        our personnel or third-party contractors, including, without limitation, CROs failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner

•        reaching agreements with prospective CROs, and trial sites, both of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•        insufficient or inadequate supply or quality of product candidates or other necessary materials to conduct our trials;

•        potential additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, or other studies requested by regulatory agencies;

•        problems engaging IRBs, to oversee trials or in obtaining and maintaining IRB approval of studies;

•        imposition of clinical hold or suspension of our clinical trials by regulatory authorities; and

•        inability or unwillingness of medical investigators to follow our clinical protocols.

In addition, we or the FDA may suspend or terminate our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in our IND submissions or the conduct of these trials. Therefore, we cannot predict with any certainty when, if ever, future clinical trials will commence or be completed.

We may experience delays in the enrollment of patients in any of our clinical trials. Delays in the enrollment of patients in any or all of our clinical trials could increase our development costs, cause the loss of non-dilutive funding, and delay completion of our clinical trials and associated regulatory submissions.

We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or other regulatory authorities. Even if we are able to enroll a sufficient number of patients in our clinical trials, if the pace of enrollment is slower than we expect, the development costs for our product candidates may increase, and the completion of our trials may be delayed or our trials could become too expensive to complete.

Further, in our current and future clinical trials, we may rely on non-dilutive funding from government agencies to offset partial or all clinical trial cost. Our current Phase IIb stroke trial is supported by a grant from United Kingdom to the investigators, and is an investigator sponsored trial. Delays in the enrollment of the patients may cause grantor to withdraw or forfeit partial of the grant, and the trial may not be able to enroll sufficient patients to reach its ending point.

We are dependent on technologies we license for the development of all of our product candidates, and if we lose the right to license such technologies our ability to develop our products would be harmed.

We currently are dependent on our license with the University of Arkansas for the development and commercialization of our product candidate for stroke. Our current license imposes, and any future licenses we enter into are likely to impose, various development, funding, royalty, diligence, sublicensing, insurance, enforcement and other obligations on us. If we breach the terms of the University of Arkansas license, including any failure to make payments required thereunder, the licensor has the right to terminate the license. If our license is terminated for any reason, the development of the products contemplated by the license would be delayed, or suspended altogether, while we seek to license similar technology or develop new non-infringing technology, development of our product candidate could be delayed or terminated and we may not be able to negotiate additional licenses on acceptable terms, if at all, which would have a material adverse effect on our business.

We rely and expect to continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties, regulatory obligations, or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.

We depend and will depend upon independent investigators and collaborators, such as universities, medical institutions, CROs and strategic partners to conduct our preclinical and clinical trials under agreements with us. We have and will have to negotiate budgets and contracts with CROs and trial sites, which may result in delays to our development timelines and increased costs. We have in the past and will continue to rely heavily on these third parties over the course of our clinical trials, and we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with applicable protocols, legal, regulatory, ethical and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to comply with current GCPs. Regulatory authorities enforce these current GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of these third parties fail to comply with applicable protocols or current GCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with the current GCP regulations. In addition, our clinical trials may need to be conducted with products produced under current GMP regulations and will require a large number of test patients. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

In addition, the execution of clinical trials, and the subsequent compilation and analysis of the data produced, requires coordination among various parties. In order for these functions to be carried out effectively and efficiently, it is imperative that these parties communicate and coordinate with one another. Moreover, these third parties may also have relationships with other commercial entities, some of which may compete with us. If the third parties or consultants conducting our clinical trials do not perform their contractual duties or obligations, experience work stoppages, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy of the

clinical data they obtain is compromised due to the failure to adhere to our clinical trial protocols or GCPs, or for any other reason, we may need to conduct additional clinical trials or enter into new arrangements with alternative third parties, which could be difficult, costly or impossible, and our clinical trials may be extended, delayed or terminated or may need to be repeated. In addition, in certain cases we may not always have full ownership of the data produced or the intellectual property generated from the clinical trials being conducted by these various parties for commercial usage. In such cases, we would intend to seek a licensing agreement from these third parties on reasonable terms. No assurance can be given, however, that we will be able to secure any such licensing arrangement. If any of the foregoing were to occur, we may not be able to obtain, or may be delayed in obtaining, regulatory approval for and will not be able to, or may be delayed in our efforts to, successfully commercialize any future product candidates being tested in such trials.

Any third parties retained to perform services in connection with our clinical trials will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our ongoing preclinical, clinical and nonclinical programs. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical studies or other drug development activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

Switching or adding third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus. In addition, there is a natural transition period when a new third party commences work, and the switching or adding of third parties may not always occur at such times. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.

Our manufacturing processes are not yet validated by the FDA or EMA.

We have established manufacturing processes that comply with current GMP regulations for the manufacture of our product candidates. Before we may obtain regulatory approval of our product candidates, these processes need to be inspected to the satisfaction of audit/review by FDA or EMA. Such audit may reveal issues and delay the approval of the product candidates. Further, these processes may need to be scaled up to meet the volume production required to serve the anticipated market for the product candidates. Although we believe the processes can be successfully scaled up, there can be no assurance that the processes can be successfully scaled up. Even if the processes are scaled up to economically meet the anticipated market demand for the product candidates, the processes must also be validated to the satisfaction of the FDA or EMA. If we are unable to do so, we must incur additional expenses to re-engineer its processes, resulting in a delay in the regulatory approval of the product candidates, both of which would adversely affect our finances and financial prospects.

We rely on one vendor as the sole supplier of dodecafluoropentane, the API in NanO2 which could result in a supply chain shortage.

We rely on one vendor, FluoroMed, L.P., as the sole supplier of dodecafluoropentane, the API in NanO2. While we believe an alternative supply of dodecafluoropentane can be obtained, changing vendors would likely cause material delays and result in additional costs. If for any reason FluoroMed, L.P. is unable to provide us with sufficient quantities of dodecafluoropentane, and as a result we are unable to manufacture and supply sufficient quantities of NanO2, or if we should encounter delays or other difficulties with other third parties on which we rely for our supply chain, our business, prospects, operating results, and financial condition may be materially harmed.

We intend to retain a third-party contract manufacturer for our product candidates, which could result in the commercialization of product candidates being delayed, adversely affected or terminated, or may result in the need for us to incur significantly higher costs, which could materially harm our business.

We intend to produce NanO2 at a larger scale with a third-party manufacturer prior to filing for product approval with the FDA. There can be no assurance that we will be able to successfully scale up manufacturing. This new scale will require new regulatory approval from the FDA, and timing of approval, if obtained, cannot be certain. In addition, there is no

assurance that NanO2 can be successfully manufactured at a larger liter scale in a cost-efficient manner. In accordance with current GMP requirements, changing manufacturers will require validation of the new manufacturing processes and procedures, and may require further preclinical studies or clinical trials to show comparability between the materials produced by different manufacturers. Changing a third-party contract manufacturer may be difficult, if not impossible for us, and could be extremely costly if we do make such a change, which could result in our inability to manufacture NanO2 for an extended period of time and a delay in the development of NanO2. Further, in order to maintain our development timelines in the event of a change in a third-party contract manufacturer, we may incur significantly higher costs to manufacture NanO2.

If the manufacturer upon which we rely fails to comply with stringent regulations, we may face delays in the development and commercialization of, or be unable to meet demand for, our product candidates and may lose potential revenues.

Any problems or delays that we experience or any third party contract manufacturers experiences in preparing for commercial-scale manufacturing of a product candidate or component may result in a delay in product development timelines and FDA or comparable foreign regulatory authority approval of the product candidate or may impair our ability to manufacture commercial quantities or such quantities at an acceptable cost and quality, which could result in the delay, prevention, or impairment of clinical development and commercialization of our product candidates and may materially harm our business, financial condition, results of operations, stock price and prospects.

In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current GMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents. Although we do not have day-to-day control over our contract manufacturers’ compliance with these requirements, we are responsible for ensuring compliance with such requirements, including our conduct of periodic audits to enable us to stay informed of a manufacturer’s compliance with applicable laws, regulations, product approvals, and other standards such as contract specifications. Our failure, or the failure of any contract manufacturers that we retain, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, revocation of licenses, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which would significantly and adversely affect supplies of our product candidates and our business. If a contract manufacturer’s facilities do not pass a pre-approval inspection or do not have a current GMP compliance status acceptable to the FDA or a comparable foreign regulatory authority, or receive satisfactory audits from us as the sponsor, our product candidate will not be approved.

In addition, application holders must obtain FDA approval for product and manufacturing changes, depending on the nature of the change. Moreover, in the United States, the distribution of product samples to physicians must comply with the requirements of the U.S. Prescription Drug Marketing Act. In addition, our marketed products will have to comply with the Drug Supply Chain Security Act of 2013, which requires drug companies to enable electronic tracking of their products though the U.S. supply chain.

Any deviations from regulatory requirements may also require remedial measures that may be costly and/or time-consuming for us or a third-party to implement and that may include the temporary or permanent suspension of a clinical trial or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business. Any delays in obtaining products or product candidates that comply with the applicable regulatory requirements may result in delays to product approvals, and commercialization. It may also require that we conduct additional trials.

Even if approved, NanO2 may not have labeling that allows us to successfully commercialize it.

The commercial success of NanO2 and any of our future product candidates will depend in significant measure upon our ability to obtain approval from the FDA and other regulatory authorities of labeling describing a product candidate’s expected features or benefits. Regulatory authorities may approve NanO2 for fewer or more limited indications than we request or may approve NanO2 with labeling that does not include the labeling claims necessary or desirable for the successful commercialization of that indication. Failure to achieve approval from the FDA or other regulatory authorities of product labeling containing certain types of information on features or benefits of our products, or

the safety of our products, will prevent or substantially limit our advertising and promotion of such features in order to differentiate our product candidates or any future product candidates from those products already existing in the market. This may make it difficult or impossible to achieve commercial success.

If our product candidate is approved, our success depends on our commercialization efforts, which may not be achieved. If we are unable to commercialize our product candidate, or experience significant delays in doing so, our business could be materially harmed.

Assuming that our product candidate is approved by the FDA, we will invest a significant portion of our efforts and financial resources into the development and commercialization of NanO2. Product revenues from our product candidate, NanO2, which will not be realized until after regulatory approval, if ever, will depend on the successful development, regulatory approval and eventual commercialization of these product candidates. The success of our product candidate will depend on several factors, including the following:

•        receipt of marketing approvals for our product candidate from the FDA and similar regulatory authorities outside the United States;

•        obtaining product indications, other labeling information and product attributes that are acceptable and attractive to the medical community, third-party payors and patients;

•        our ability to manufacture product commercially at acceptable costs;

•        establishing and maintaining commercial manufacturing arrangements with third parties;

•        successfully commercializing our product candidate, if approved, whether alone or in collaboration with others;

•        a continued acceptable safety and efficacy profile of the product candidate following approval;

•        meeting any and all post approval commitments by the sponsor and post approval requirements of FDA or other applicable regulatory authorities; and

•        obtaining, maintaining, enforcing and defending intellectual property rights and claims and available product exclusivities.

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidate, which would materially harm our business. In addition, even if we obtain regulatory approvals for NanO2, the timing or scope of any approval may prohibit or reduce our ability to commercialize NanO2 successfully. For example, if the approval process takes too long, we may miss market opportunities and give other companies the ability to develop competing products, new technologies, or establish market dominance. Also, any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render NanO2 not commercially viable. For example, regulatory authorities may grant approval contingent on the performance of costly post-marketing clinical trials or, outside the U.S., they may not accept or approve the price we intend to charge for NanO2. Further, the FDA or comparable foreign regulatory authorities may place conditions on approvals, such as risk management plans and REMS, to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the product application must submit a proposed REMS; the FDA will not approve the product application without an approved REMS, if required. A REMS could include medication guides, physician communication plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA may also require a REMS for an approved product when new safety information emerges. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of NanO2. Moreover, product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following the initial marketing of the product. Any of the foregoing scenarios could materially harm the commercial success of NanO2.

Our potential future product candidate, NanO2, may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in industry and the medical community necessary for commercial success.

The commercial success of any potential future product candidates, including NanO2, for which we may obtain marketing approval from the FDA or other regulatory authorities will depend upon their acceptance by the medical community, industry and third-party payors as clinically useful, cost-effective and safe. The degree of market acceptance of any drug depends on a number of factors, such as:

•        effectively competing with other therapies;

•        the prevalence and severity of any side effects;

•        success of patients in well-controlled clinical trials compared to real-world success of patients post FDA approval;

•        our ability to educate and increase physician awareness of the benefits of our products relative to competing drugs;

•        the willingness of physicians and healthcare organizations to change their current treatment practices,

•        the willingness of hospitals and hospital systems to include our product candidates as treatment options;

•        efficacy and potential advantages compared to alternative treatments;

•        the price we charge for our product candidates;

•        interpretations of the results of our clinical trials;

•        the status of our products on the formularies of third-party payers;

•        convenience and ease of administration compared to alternative treatments;

•        the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

•        the willingness of the target patient population to pay for our products, including co-pays under their health coverage plans;

•        the strength of marketing and distribution support; and

•        the availability of third-party coverage and adequate reimbursement.

The failure to attain market acceptance among the medical community, patients and third-party payors may have an adverse impact on our operations and profitability.

Orphan Drug Designation does not translate to approval and, even if we obtain FDA approval, we may not enjoy marketing exclusivity or other expected benefits.

Although we have been granted orphan drug designation for NanO2 for certain indications this does not mean FDA will approve our application for commercialization of our product candidate or that orphan designation may not be revoked. Even if we obtain FDA approval, we may not be able to obtain or maintain orphan drug exclusivity for NanO2. We may not be the first to obtain marketing approval of NanO2 for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if we are unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties may be approved for the same condition, or the competitive product is otherwise outside the scope of exclusivity. Even after an orphan drug is approved, the FDA can subsequently approve the same drug with the same active moiety for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care or the manufacturer of the product with orphan exclusivity is unable to maintain sufficient product

quantity. Orphan drug designation neither shortens the development time or materially shortens regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process, nor does it prevent competitors from obtaining approval of the same product candidate for indications other than those in which orphan drug designation have been granted.

We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may negatively impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition.

The development and commercialization of new drug products is highly competitive. Moreover, we will face competition in therapeutics focused on oxygen enhancement as well as therapeutics focused on the same indications that we are targeting. Our competitors may be able to develop other compounds, drugs, cellular or gene therapies that are able to achieve similar or better results or approvals for additional indications for which we may not be able to gain approval. We may face competition with respect to any product candidates that we seek to develop or commercialize in the future from major pharmaceutical companies and specialty pharmaceutical companies worldwide. Potential competitors also include academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and commercialization. Furthermore, we may compete with other biopharmaceutical or biotechnology companies for clinical trial partners and sites to conduct our clinical trials, which could negatively impact our ability to secure sites at which we can complete our pre-clinical and clinical trials or enrollment in our trials.

There are a number of pharmaceutical and biotech companies that are currently pursuing the development of products for the indications that NuvOx is targeting for. See the section of this prospectus entitled “Business — Competition.”

Many of our current or potential competitors, either alone or with their strategic partners, have significantly greater financial resources and expertise in research and clinical development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, manufacturing and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive than any products that we may develop. Furthermore, currently approved products could be discovered to have application for treatment of the same disease indications as our product candidates, which could give such products significant regulatory and market timing advantages over any of our product candidates. Our competitors also may obtain FDA, EMA or other regulatory approval for their products more rapidly than we may obtain approval for ours and may obtain orphan product exclusivity from the FDA for indications our product candidates are targeting, which could result in our competitors establishing a strong market position before we are able to enter the market. Additionally, products or technologies developed by our competitors may render our potential product candidates uneconomical or obsolete, and we may not be successful in marketing any product candidates we may develop against competitors.

In addition, we could face litigation or other proceedings with respect to the scope, ownership, validity and/or enforceability of our patents relating to our competitors’ products and our competitors may allege that our products infringe, misappropriate or otherwise violate their intellectual property. See “Risks Related to Our Intellectual Property.” The availability of our competitors’ products could limit the demand, and the price we are able to charge, for any products that we may develop and commercialize.

We are subject, directly or indirectly, to federal and state obligations and regulations applicable to our marketing practices. If we are unable to comply, or have not complied, with such laws, we could face substantial penalties.

Our marketing and sales operations are subject to various federal and state fraud and abuse laws, including, without limitation, the federal and state anti-kickback statutes and false claims laws. With respect to sales and marketing activities by us or any future partner, advertising and promotional materials must comply with FDA rules in addition to other applicable federal, state and local laws in the United States and similar legal requirements in other countries. We also are subject,

directly or indirectly through our customers and partners, to various fraud and abuse laws, including, without limitation, the U.S. Federal Healthcare Program Anti-Kickback Statute, U.S. False Claims Act, and similar state laws, which impact, among other things, most of our interactions with customers, including our proposed sales, marketing, and scientific/educational grant programs. We are also subject to complex laws and regulation regarding reporting and payment obligations as a result of our participation in the U.S. Medicaid Drug Rebate Program, the Federal Supply Schedule of the U.S. Department of Veterans Affairs, and other government drug programs. All of these activities are also potentially subject to U.S. federal and state consumer protection and unfair competition laws. Similar requirements exist in many of these areas in other countries. If investigated, we could be forced to incur substantial expense responding to the investigation and defending our actions. If unsuccessful in our defense, we could be found to be in violation and subject to substantial fines and penalties.

If serious adverse effects are identified with our product candidate or any of our approved products, we may need to modify or abandon our development of that product candidate, discontinue sale of an approved product, or change our labeling to reflect new safety risks.

It is impossible to guarantee when, or if, any of our product candidates will be determined by the FDA to be safe enough to receive regulatory approval, and if so, remain safe enough to maintain regulatory approval. It is impossible to guarantee that safety issues that may arise during development, or during post marketing pharmacovigilance, will not significantly decrease the commercial potential of our product candidates. In addition, there can be no assurance that our clinical trials will identify all relevant safety issues. We have safety data from the two separate completed Phase Ib/IIa human clinical trials of NanO2 as well as safety data from our current Phase IIb GBM clinical trial, the investigator sponsored Phase IIb stroke clinical trial, and our Phase Ib respiratory distress trial. The two Phase Ib/IIa human clinical trials enrolled a small number of patients and may not be representative of a larger trial population. In the Phase Ib/IIa stroke trial, there were eight (8) SAEs that occurred in four (4) patients. None of the SAEs were determined to be related to NanO2. These eight (8) SAEs included abdominal pain, cerebrovascular accident, confusional state, depression, cardiac pacemaker replacement, pneumonia, and migraine.

In Phase Ib/IIa GBM trial there were a total of nine (9) SAEs, none of which were unexpected. These nine (9) SAEs occurred in five (5) patients. These nine (9) SAEs included: atypical pneumonia, radiation necrosis, motor dysfunction, pyrexia, platelet count decrease, and syncope. Out of the nine (9) SAEs, six (6) SAEs that occurred in three (3) patients were determined to be unrelated or unlikely related to NanO2, which include atypical pneumonia, pyrexia, and syncope. Three (3) SAEs that occurred in three (3) patients were determined to be possibly or probably related to NanO2, consisting of radiation necrosis, motor dysfunction, and platelet count decrease.

In the ongoing Phase IIb GBM trial, as of July 6, 2026, there have been forty-nine (49) SAEs that occurred in twenty-five (25) patients. These SAEs consist of: anorectal infection, brain oedema, necrosis, central nervous system necrosis, embolism, hemiparesis, fall, dizziness, seizure, mental status changes, pulmonary embolism, platelet count decrease, muscular weakness, peripheral swelling, deep vein thrombosis, type 2 diabetes mellitus, pancytopenia, intracranial hemorrhage, cerebral hemorrhage, hypoxia, pneumonia, pneumonitis, hydrocephalus, febrile neutropenia, pleural effusion, small intestinal obstruction, and device related infection.

Of the forty-nine (49) SAEs, forty-seven (47) SAEs in twenty-five (25) patients were determined to be unrelated or unlikely be related to NanO2 or placebo. These forty-seven (47) SAEs consisted of: anorectal infection, brain oedema, necrosis, central nervous system necrosis, embolism, fall, dizziness, seizure, mental status changes, pulmonary embolism, platelet count decrease, muscular weakness, peripheral swelling, deep vein thrombosis, type 2 diabetes mellitus, pancytopenia, intracranial hemorrhage, cerebral hemorrhage, hypoxia, pneumonia, pneumonitis, hydrocephalus, febrile neutropenia, pleural effusion, small intestinal obstruction, and device related infection.

Of the forty-nine (49) SAEs, two (2) SAEs, consisting of hemiparesis and mental status changes, in two (2) patients were determined to possibly be related to NanO2 or placebo, both of which resolved without sequelae.

The University of Glasgow commenced an investigator sponsored Phase IIb trial of NanO2 to treat patients with strokes in 2025. The NIHR awarded a grant to physicians at the University of Glasgow and NHS Greater Glasgow and Clyde’s Queen Elizabeth University Hospital funds to conduct a 150-subject trial in ischemic stroke in the United Kingdom. To date, seventeen (17) patients have been treated. As of July 6, 2026, there have been three (3) SAEs. Two (2) of the SAEs, ischemic stroke and subarachnoid haemorrhage, were determined to be not related to NanO2 or placebo. The other SAE, hypotension, was determined to be related to NanO2 or placebo. None of the foregoing SAEs are unexpected. However, based on regulation in UK, a SUSAR report was still submitted for the hypotension SAE. Since the Phase IIb stroke trial is randomized and placebo controlled, it is blinded and a final determination regarding the cause of the SAEs has not been made.

Our Phase Ib respiratory distress trial commenced in 2025. It is an open label, dose escalation trial with three cohorts, each of which has six (6) patients. Dosing of the first and second cohorts has been completed. Two (2) SAEs, upper GI bleeding and chronic obstructive pulmonary disease, were reported in one (1) patient in cohort 1 and one (1) patient in cohort 2. Neither of these SAEs were related to NanO2 and both were resolved without sequalae.

See “Business — Clinical Trials Data” for a detailed discussion of the SAEs in our clinical trials. It is possible that unexpected treatment emergent SAEs could arise in ongoing or future trials of NanO2, which could pose safety concerns. Known or previously unidentified adverse effects can adversely affect regulatory approvals or marketing of approved products. In such an event, we might need to abandon marketing efforts or development of that product or product candidate or enter into a partnership to continue development.

If AEs of unanticipated severity or frequency are identified, FDA or other regulatory agencies may impose restrictions on that product or us, including requiring withdrawal of the product from the market. Among other legal and administrative actions, a regulatory agency may:

•        mandate modifications to product labelling or promotional materials or require us to provide corrective information to healthcare practitioners;

•        withdraw any regulatory approvals;

•        place any ongoing clinical trials on clinical hold;

•        refuse to approve pending applications or supplements to approved applications filed by us, our partners or our potential future partners;

•        impose restrictions on operations, including costly new manufacturing, licensing or packaging requirements; or

•        seize or detain products or require a product recall.

In addition, the occurrence of any of the foregoing, even if promptly remedied, could (1) negatively impact the perception of us or the relevant product among the medical community, patients or third-party payors and (2) result in product liability litigation that could result in the company paying substantial amounts of money in settlements or verdicts.

Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC 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. In this regard, the Trump Administration has announced reductions to the FDA staff.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, earlier this year, in 2025 and in other recent years, including in 2018 and 2019, the U.S. government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, upon completion of this offering and in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize NanO2 and affect the prices we may obtain.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval for NanO2, restrict or regulate post-approval activities and affect our ability to profitably sell NanO2. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We do not know whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of NanO2, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

In the United States, under the Medicare Modernization Act, or the MMA, Medicare Part D provides coverage to the elderly and disabled for outpatient prescription drugs by approving and subsidizing prescription drug plans offered by private insurers. The MMA also authorizes Medicare Part D prescription drug plans to use formularies where they can limit the number of drugs that will be covered in any therapeutic class. The Part D plans use their formulary leverage to negotiate rebates and other price concessions from drug manufacturers. Also under the MMA, Medicare Part B provides coverage to the elderly and disabled for physician-administered drugs on the basis of the drug’s average sales price, a price that is calculated according to regulatory requirements and that the manufacturer reports to Medicare quarterly.

Both Congress and the Centers for Medicare & Medicaid Services, or CMS, the agency that administers the Medicare program, from time to time consider legislation, regulations, or other initiatives to reduce drug costs under Medicare Parts B and D. For example, under the 2010 Affordable Care Act, drug manufacturers are required to provide a 50% discount on prescriptions for branded drugs filled while the beneficiary is in the Medicare Part D coverage gap, also known as the “donut hole.” The Bipartisan Budget Act of 2018 increased the manufacturer’s subsidy under the program from 50% to 70% of the negotiated price, beginning in 2019. There have been legislative proposals to repeal the “non-interference” provision of the MMA to allow the CMS to leverage the Medicare market share to negotiate larger Part D rebates. Further cost reduction efforts could decrease the coverage and price that we receive for NanO2 and could seriously harm our business. Private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement under the Medicare program may result in a similar reduction in payments from private payors.

The 2010 Affordable Care Act is intended to broaden access to health Insurance and reduce or constrain the growth of healthcare spending. Further, the Affordable Care Act imposes a significant annual fee on companies that manufacture or import branded prescription drug products. It also increased the amount of the rebates drug manufacturers must pay to state Medicaid programs, required that Medicaid rebates be paid on managed Medicaid utilization, and increased the additional rebate on “line extensions” (such as extended-release formulations) of solid oral dosage forms of branded products. The law also contains substantial provisions affecting fraud and abuse compliance and transparency, which may require us to modify our business practices with healthcare practitioners and incur substantial costs to ensure compliance.

Many members of the Republican Party have consistently opposed the Affordable Care Act since it was signed. Efforts to repeal the Act have been attempted numerous times and some portions of the Act have been amended in 2017 and 2018. It is unclear whether further amendments or repeal will be effectuated and what the effect on the healthcare sector will be. In addition to potential changes to the Affordable Care Act, there are indications that the Medicaid and Medicare programs may be restructured, which could lead to a reduction in coverage and reimbursement of prescription drugs. While we are unable to predict what legislation, if any, may potentially be enacted, to the extent that future changes affect how our product candidates could be paid for and/or reimbursed by the government and private payers, our business could be adversely affected.

In addition, other legislative changes have been proposed and adopted in the United States since the Affordable Care Act was enacted. The current administration is pursuing policies to reduce regulations and expenditures across government including at HHS, which include the FDA and CMS, and related agencies. For example, on May 12, 2025, President Trump issued an Executive Order that, among other things, required HHS, within 30 days, to establish and communicate to drug manufacturers most-favored-nation, or MFN, price targets designed to bring drug prices for American patients in line with those in comparably developed nations. If significant progress towards MFN pricing is not achieved, the Executive Order requires HHS to propose a rulemaking to implement MFN pricing. Recently,

on December 23, 2025, CMS issued proposed regulations to establish, under the Center for Medicare and Medicaid Innovation, two mandatory MFN demonstration models under Medicare Parts B and D, respectively. If these rules or other MFN pricing rules are finalized, they are likely to reduce prices of at least some drugs in the United States, if they are also sold in comparator countries. Even if we do not market drugs in such countries, we will be indirectly affected if our drugs competed with drugs whose prices were reduced as a result of MFN pricing initiatives.

Several states have adopted or are considering adopting laws that require pharmaceutical companies to provide notice prior to raising prices and to justify price increases. We expect that additional healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value of certain development projects and reduce our profitability.

If we market any of our products in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal penalties.

The FDA and other government authorities enforce laws and regulations that require that the promotion of pharmaceutical products be consistent with the approved prescribing information. While physicians may prescribe an approved product for a so-called “off-label” use under the practice of medicine, it is unlawful for a pharmaceutical company to promote its products in a manner that is inconsistent with its approved label and any company which engages in such conduct may be subject to significant liability. Similarly, industry codes in the EU and other foreign jurisdictions prohibit companies from engaging in off-label promotion and regulatory agencies in various countries enforce violations of the code with civil penalties. While we intend to ensure that our promotional materials are consistent with our label, regulatory agencies may disagree with our assessment and may issue untitled letters, warning letters or may institute other civil or criminal enforcement proceedings. In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal healthcare fraud and abuse laws have been applied in recent years to restrict certain marketing practices in the pharmaceutical industry. These laws include the U.S. Federal Healthcare Program Anti-Kickback Statute, U.S. False Claims Act and similar state laws. Because of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of these laws.

The U.S. Federal Healthcare Program Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid or other federally financed healthcare programs. This statute has been interpreted broadly to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Although there are several statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Our practices may not, in all cases, meet all of the criteria for safe harbor protection from anti-kickback liability. Moreover, recent health care reform legislation has strengthened these laws. For example, the Affordable Care Act, among other things, amends the intent requirement of the U.S. Federal Healthcare Program Anti-Kickback Statute and criminal health care fraud statutes; a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the Affordable Care Act provides that the government may assert that a claim including items or services resulting from a violation of the U.S. Federal Healthcare Program Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the U.S. False Claims Act. Federal false claims laws, including the U.S. False Claims Act, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government.

Over the past few years, pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety of alleged promotional and marketing activities, such as: allegedly providing free trips, free goods, sham consulting fees and grants and other monetary benefits to prescribers; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in off-label promotion that caused claims to be submitted to Medicare or Medicaid for non-covered, off-label uses; using a charity as an illegal conduit to cover the copays of Medicare patients; and submitting inflated best price information to the Medicaid Drug Rebate Program to reduce liability for Medicaid rebates.

Other restrictions under applicable U.S. federal and state healthcare laws and regulations may include the following:

•        the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

•        HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or the HITECH Act, and its implementing regulations, also imposes obligations, including mandatory contractual terms, on certain types of people and entities with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

•        the federal Physician Payment Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report payments and other transfers of value to physicians and teaching hospitals, as well as certain ownership and investment interests held by physicians and their immediate family, which includes annual data collection and reporting obligations; and

•        analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.

Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures to federal and state agencies. State and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts. Tracking and reporting may be burdensome and require a significant expenditure to comply with applicable requirements.

Our ability to generate product revenues will be diminished if our products sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement.

Our ability to commercialize our products, alone or with collaborators, will depend in part on the extent to which reimbursement will be available from:

•        government and health administration authorities;

•        private health maintenance organizations and health insurers; and

•        other healthcare payers.

Patients generally expect that products such as ours are covered and reimbursed by third-party payors for all or part of the costs and fees associated with their use. If such products are not covered and reimbursed then patients may be responsible for the entire cost of the product, which can be substantial. Therefore, health care providers generally do not prescribe products that are not covered and reimbursed by third-party payors in order to avoid subjecting their patients to such financial liability. The existence of adequate coverage and reimbursement for the products by government and private insurance plans is central to the acceptance of NanO2 and any future products we provide.

During the past several years, third-party payors have undertaken cost-containment initiatives including different payment methods, monitoring health care expenditures, and anti-fraud initiatives. For some governmental programs, such as Medicaid, coverage and reimbursement differ from state to state, and some state Medicaid programs may not pay an adequate amount for NanO2 or any of our other products or may make no payment at all. Furthermore, the health care industry in the United States has experienced a trend toward cost containment as government and private insurers seek to control health care costs by imposing lower payment rates and negotiating reduced contract rates with service providers. Therefore, we cannot be certain that our services will be reimbursed at a level that is sufficient to meet our costs.

In the United States, the principal decisions about reimbursement for new products are typically made by CMS. Private payors tend to follow CMS to a substantial degree. However, no uniform or consistent policy of coverage and reimbursement for drug products exists among third-party payors. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor as well as from state to state. Consequently, obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that must be played out across many jurisdictions and different entities and that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Furthermore, coverage policies and third-party reimbursement rates may change at any time, and may be affected by future healthcare reform measures. Patients are unlikely to use NanO2 or any future product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of NanO2 or any future product candidates.

We intend to seek approval to market NanO2 and future product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for NanO2 or any future product candidates, we will be subject to rules and regulations in those jurisdictions. In some foreign countries, particularly those in the EU, the pricing of drugs is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. In addition, market acceptance and sales of product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for product candidates and may be affected by existing and future health care reform measures.

Third-party payors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably. In particular, in the Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, among other things, revised the methodology by which rebates owed by manufacturers to the state and federal government for covered outpatient drugs, including product candidates, under the Medicaid Drug Rebate Program are calculated, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs, and provided incentives to programs that increase the federal government’s comparative effectiveness research.

In addition, in August 2022, the Inflation Reduction Act of 2022, or the IRA, was signed into law. The IRA includes multiple provisions that may impact the prices of drug products throughout the United States. Under the IRA, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the product’s price increases faster than the rate of inflation. This calculation is made on a product-by-product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug or biological product that is paid for by Medicare Parts B or D. Starting in payment year 2026, CMS will negotiate drug prices annually for a select number of single source Part D drugs without generic or biosimilar competition, and starting in payment year 2028, CMS will begin negotiating drug prices for a select number of Part B drugs. The negotiated price may not exceed a statutory ceiling price. Only high-expenditure single-source biologics that have been approved for at least 11 years (seven years for single-source drugs) are eligible to be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year. If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease. For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare Part D products in 2023, negotiations began in 2024, and the negotiated maximum fair price for each product has been announced. In addition, CMS has selected and announced the negotiated maximum fair price for 15 additional Medicare Part D drugs which will become effective in 2027. For 2028, CMS has selected an additional 15 drugs, comprised of drugs covered under Medicare Part D and, for the first time, drugs payable under Medicare Part B. For 2029 and subsequent years, 20 Part B or D drugs will be selected. The negotiated prices have represented, and will continue to represent, a significant discount from average prices to wholesalers and direct purchasers. Ultimately, the IRA’s impact on the biopharmaceutical industry in the United States remains uncertain, in part because of multiple ongoing lawsuits against CMS brought by large pharmaceutical companies and other stakeholders (e.g., the U.S. Chamber of Commerce). The IRA and any additional federal or state

health care reform measures could limit the amounts that third-party payers will pay for future health care products and services, and, in turn, could significantly reduce the projected value of certain development projects and reduce our profitability.

There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future, particularly in light of the new presidential administration in the United States, and any proposed changes to healthcare laws that could potentially affect our clinical development or regulatory strategy. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

•        the demand for NanO2, or future product candidates, if we obtain regulatory approval;

•        our ability to set a price that we believe is fair for our products;

•        our ability to generate revenue and achieve or maintain profitability;

•        the level of taxes that we are required to pay; and

•        the availability of capital.

Any reduction in reimbursement from Medicare, Medicaid or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability.

We currently have limited distribution, marketing, support and sales capabilities and plan to rely on third-party distribution partners for the distribution, marketing, support and sales of our products which could delay or limit our ability to generate revenue.

We plan to either utilize third-party service providers or partners or establish a sales force for the distribution and marketing and sales of our product candidates, if approved. If utilizing third-party service providers or partners, upon launch, we intend to promote utilizing third-party collaborations in addition to building our own commercial infrastructure in anticipation of the approval of NanO2. Reliance on third-party service providers may prevent our direct control of key aspects of those critical functions including regulatory compliance, import and export operations, supply chain security, warehousing and inventory management, distribution, contract administration, invoicing, sales deductions administration, accounts receivable management and call center management. Any future distribution partners may hold significant control over important aspects of the commercialization of our products, including market identification, regulatory compliance, marketing methods, pricing, composition of sales force and promotional activities.

We may not be able to control the amount and timing of resources that any future third-party distribution partners may devote to our products, or prevent any third party from pursuing the development of alternative technologies or products that compete with our products, except to the extent our contractual arrangements protect us against such activities. Also, we may not be able to prevent any other third-party from withdrawing its support of our products.

If third-party service providers fail to comply with applicable laws and regulations, fail to meet expected deadlines, encounter natural or other disasters at their facilities or otherwise fail to perform their services to us in a satisfactory or predicted manner, or at all, our ability to deliver product to meet commercial demand could be significantly impaired. In addition, we may use third parties to perform various other services for us relating to sample accountability and regulatory monitoring, including AE reporting, safety database management and other product maintenance services. If the quality or accuracy of the data maintained by these service providers is insufficient, our ability to continue to market our products could be jeopardized or we could be subject to regulatory sanctions, and any indemnity we may receive from such third-party service providers could be limited by such provider’s ability to pay and otherwise might not be sufficient to cover all losses we may experience.

If we endeavour to establish a sales force to market NanO2 and are not successful in doing so, our ability to generate sales and profits will be limited.

If we establish a sales force, although certain of our employees have commercialization experience, as a company we do not have an internal sales force and we currently have only limited commercial capabilities. We will have to establish an internal specialty sales force for the promotion and sale of NanO2, if approved. Establishing a pharmaceutical sales force is a difficult undertaking. Experienced and competent sales representatives and sales managers must be recruited, hired, trained, assigned appropriate territories, managed and compensated in such a way that they can achieve success in selling products to a sophisticated audience of healthcare professionals who frequently have little or no time to spend with sales personnel. In addition, our prospective sales force must compete against the sales forces of some of the largest and most successful pharmaceutical companies in the world, who will be promoting competing products. If we fail to hire and field a high-quality sales force, we may be unable to generate expected revenues and profits.

In addition, there are significant expenses and risks involved with establishing our own sales and marketing capabilities, including our ability to hire, retain and appropriately incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities could delay any product launch, which would adversely impact the commercialization of our product candidates. For example, if we recruit any sales representatives or establish marketing capabilities prior to commercial launch and the commercial launch is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

In addition to our own internal sales force, we may choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our product candidates. To the extent we commercialize our product candidates by entering into agreements with third-party collaborators, we may have limited or no control over the sales, marketing and distribution activities of these third parties, in which case our future revenues would depend heavily on the success of the efforts of these third parties. If we are not successful in commercializing NanO2 or any future product candidates, either on our own or through collaborations.

Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of employee fraud or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to: (i) comply with the laws of the FDA and other similar foreign regulatory bodies; (ii) provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies; (iii) comply with manufacturing standards we have established; (iv) comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or (v) report financial information or data accurately or to disclose unauthorized activities to us. Any such misconduct or noncompliance could negatively affect the FDA’s review of our regulatory submission, including delaying approval or disallowance of certain information to support the submission, and/or delay a federal or state healthcare programs or a commercial insurer’s determination regarding the availability of future reimbursement for our product candidate. If we obtain FDA approval of our product candidate and begin commercializing those products in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase. These laws may impact, among other things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.

In addition to the risk of employee fraudulent or illegal activities in operations and commercial activities, our employees, independent contractors, or consultants may not comply with our financial controls, causing significant loss in our financial assets. If that happens, we will face consequences for not having financial resources to conduct our operations.

It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations. In addition, the approval and commercialization of any product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

We plan to rely on collaborations and license arrangements with third parties to commercialize, market and promote our marketed products which may limit our ability to generate revenue and adversely affect our profitability.

We plan to rely on collaboration and other agreements with third parties with respect to our product candidates and future marketed products. Our current or any future collaborations or license arrangements may not be successful. With respect to the product candidates we have licensed, we depend upon collaborations with third parties to develop these product candidates in the licensed territories and we will depend substantially upon third parties to commercialize these product candidates. If we are unable to maintain current collaborations or enter into additional collaborations with established pharmaceutical or pharmaceutical service companies to provide the services we need, we may not be able to successfully commercialize our products.

Our research and development activities could be affected or delayed as a result of shortages in animal availability or possible restrictions on animal testing. Compliance with governmental regulations regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization of our products.

Certain laws and regulations may require us to test our product candidates on animals before initiating clinical trials involving humans. Failure to access or a significant delay in accessing animal research models that meet our needs or that fulfill regulatory requirements may materially adversely affect our ability to advance our preclinical and clinical programs and successfully develop our product candidates, and this could result in significant harm to our business.

Additionally, animal testing activities have been the subject of controversy and adverse publicity. Animal rights groups and other organizations and individuals have attempted to stop animal testing activities by pressing for legislation and regulation in these areas and by disrupting these activities through protests and other means. To the extent the activities of these groups are successful, our research and development activities may be interrupted, delayed or become more expensive.

The Animal Welfare Act, or the AWA, is the federal law that covers the treatment of certain animals used in research. Currently, the AWA imposes a wide variety of specific regulations that govern the humane handling, care, treatment and transportation of certain animals by producers and users of research animals, most notably relating to personnel, facilities, sanitation, cage size, and feeding, watering and shipping conditions. Third parties with whom we contract are subject to registration, inspections and reporting requirements under the AWA. Furthermore, some states have their own regulations, including general anti-cruelty legislation, which establish certain standards in handling animals. Comparable rules, regulations, and or obligations exist in many foreign jurisdictions. If we or our contractors fail to comply with regulations concerning the treatment of animals used in research, we may be subject to fines and penalties and adverse publicity, and our operations could be adversely affected.

Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.

Although our focus as this time is primarily on the U.S. market, our future profitability will depend, in part, on our ability to commercialize NanO2 in foreign markets for which we intend to rely on collaborations with third parties. If we commercialize NanO2 in foreign markets, we would be subject to additional risks and uncertainties, including:

•        our customers’ ability to obtain reimbursement in foreign markets;

•        our inability to directly control commercial activities because we are relying on third parties;

•        the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements;

•        different medical practices and customs in foreign countries affecting acceptance in the marketplace;

•        import, export and foreign licensing requirements;

•        different packaging and labeling requirements;

•        longer accounts receivable collection times;

•        longer lead times for shipping;

•        language barriers for technical training;

•        differing and/or reduced protection of intellectual property rights in some foreign countries;

•        foreign currency exchange rate fluctuations; and

•        the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.

Foreign sales of NanO2 could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs, any of which may adversely affect our results of operations.

General Company-Related Risks

If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop NanO2 or any future product candidates, conduct our clinical trials and commercialize our product candidates or any future products we develop.

Our management team has expertise in many different aspects of fundraising, drug development and commercialization. We believe that our future success is highly dependent upon the contributions of our senior management, including without limitation Rong Wang, our Chief Executive Officer, Dr. Evan Unger, our Co-Founder and Executive Chairman, and Jennifer Johnson, our Chief Operating Officer. We do not have “key person” life insurance policies for any of our officers, management team or advisors. The loss of services of any of these individuals could delay or prevent the successful development of our product pipeline, completion of our planned clinical trials or the commercialization of NanO2 or any other future products we develop, which could adversely affect our operating results.

We will need to hire additional personnel, including experienced marketing and sales representatives, as we expand our clinical development and commercial activities. We could experience difficulties attracting and retaining qualified employees in the future. For example, competition for qualified personnel in the pharmaceuticals field is intense due to the limited number of individuals who possess the skills and experience required by our industry. Other pharmaceutical companies with which we compete for qualified personnel have greater financial and other resources, different risk profiles, and a longer history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high-quality candidates than what we have to offer. We may not be able to attract and retain quality personnel on acceptable terms, or at all. In addition, to the extent we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information or that their former employers own their research output. If we are unable to continue to attract and retain high-quality personnel, the rate and success at which we can develop and commercialize product candidates could be limited.

Our Executive Chairman may have actual or potential conflicts of interest because of his equity interests in or positions with other entities.

Dr. Unger, our Executive Chairman, serves as an executive and holds a majority of the equity interests in Microvascular Therapeutics, or MVT, a therapeutics company that is developing microbubbles and fluorocarbon emulsions for use with ultrasound for imaging and therapy, which could create, or appear to create, potential conflicts of interest if we and MVT compete for funding, face decisions that could have implications for both us and MVT or in connection with the allocation of Dr. Unger’s time between our company and MVT. Dr. Unger may not be able to devote attention to our company at times when needed due to such other role. Additionally, we and MVT and are both located at E. 18th Street, Tucson, AZ 85719. The two companies share certain costs such as utilities and maintenance of the building. As a result, there are certain balances between MVT and us as receivables and payables. Also, Dr. Unger has an approximately $259,000 payable (from the 2016 to 2017 time period) to us for his equity holdings in our company, as part of the related party balance. On June 30, 2024 we, the lessor, Dr. Unger and MVT entered into a 3-way netting agreement, such that any payables from MVT to the Company can be netted against the Company’s lease payable to the landlord. The aforementioned payable to us from Dr. Unger of approximately $259,000 is also netted against our lease payable to the landlord. As a result of the foregoing, there may be inherent, albeit non-specific, potential conflicts involved in the participation by Dr. Unger in the management of both companies and our boards of directors, which will oversee questions of possible conflicts of interest and compensation. In addition, as a matter of practicality, efficiency and appropriate accounting, the costs of certain services are allocated, which creates inter-company obligations. This may create a conflict between the advice provided to such entities and the fiduciary responsibilities owed to us. There can be no assurance that such conflicts will be resolved in our favor, which could adversely impact our business or prospects.

We will need to increase the size of our organization, and we may experience difficulties in managing this growth.

As of July 6, 2026, we had nine employees who work full-time and two consultants. We will need to continue to expand our managerial, operational, finance and other resources to manage our operations, commercialize NanO2 or any other product candidates, if approved, and continue our development activities. Our management and personnel systems and facilities currently in place may not be adequate to support this future growth. Our need to effectively execute our growth strategy requires that we:

•        manage any of our future clinical trials effectively;

•        identify, recruit, retain, incentivize and integrate additional employees;

•        manage our internal development efforts effectively while carrying out our contractual obligations to third parties; and

•        continue to improve our operational, financial and management controls, reporting systems and procedures.

Due to our limited financial resources and our limited experience in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our development and strategic objectives or disrupt our operations.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any future products we develop.

We face an inherent risk of product liability as a result of the clinical testing of NanO2 and any of our future product candidates. We will face further risk if we commercialize NanO2 or any of our product candidates. For example, we may be sued if any product we sell or any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot

successfully defend ourselves against product liability claims, we may incur substantial losses or be required to limit commercialization of our products. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

•        decreased demand for our product candidates or products we develop, including NanO2;

•        termination of clinical trial sites or entire trial programs;

•        injury to our reputation and significant negative media attention;

•        withdrawal of clinical trial participants or cancellation of clinical trials;

•        significant costs to defend the related litigation;

•        a diversion of management’s time and our resources;

•        substantial monetary awards to trial participants or patients;

•        regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions;

•        loss of revenue;

•        the inability to commercialize any products we develop; and

•        a decline in our share price.

Our inability to obtain and maintain sufficient product liability insurance at an acceptable cost and scope of coverage to protect against potential product liability claims could prevent or inhibit the commercialization of NanO2 or any future products that we develop. We currently carry product liability insurance covering our clinical trials. Although we maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions and deductibles, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Moreover, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. If and when we obtain approval for marketing NanO2, we intend to expand our insurance coverage to include the sale of NanO2, however, we may be unable to obtain this liability insurance on commercially reasonable terms.

Our business and operations would suffer in the event of computer system failures.

Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization, or on cloud-based networks on which we may store our data. The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusions, 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. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our current or future product development programs. For example, the loss of clinical trial data from completed or any future ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, damage to our reputation, and the further development of our product candidates could be delayed.

Any failure to maintain the security of information relating to our patients, customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise, could expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm our reputation.

In connection with the pre-clinical and clinical development, sales and marketing of our products and services, we may from time to time transmit confidential information. We also have access to, collect or maintain private or confidential information regarding our clinical trials and the patients enrolled therein, employees, and suppliers, as well as our business. Cyberattacks are rapidly evolving and becoming increasingly sophisticated. It is possible that computer hackers and others might compromise our security measures, or security measures of those parties that we do business with now or in the future and obtain the personal information of patients in our clinical trials, vendors, employees and suppliers or our business information. A security breach of any kind, including physical or electronic break-ins, computer viruses and attacks by hackers, employees or others on our computers, servers or any cloud-based networks on which we may store our data could expose us to risks of data loss, litigation, government enforcement actions, regulatory penalties and costly response measures, and could seriously disrupt our operations. Any resulting negative publicity could significantly harm our reputation, which could cause us to lose market share and have an adverse effect on our results of operations.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain sufficient exclusivity and/or patent protection for our product candidates, or if the scope of the exclusivity or patent protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to commercialize our product candidates successfully may be adversely affected.

Our success depends in large part on our ability to obtain and maintain exclusivity for our proprietary product candidates through market and data exclusivity granted by regulatory agencies in the United States and other countries with respect to our proprietary product candidates as well as through patent protection. If we do not adequately protect our intellectual property, competitors may be able to erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability. To protect our proprietary position, we file patent applications in the United States and abroad related to our novel product candidates that are important to our business. The patent application and approval process are expensive and time-consuming. We may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

The patent position of pharmaceutical companies generally is highly uncertain. In addition, the determination of patent rights with respect to pharmaceutical compounds commonly involves complex legal and factual questions, which has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.

Assuming the other requirements for patentability are met, currently, the first to file a patent application is generally entitled to the patent. However, prior to March 16, 2013, in the United States, the first to invent was entitled to the patent. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our patents, or that we were the first to file for patent protection of such inventions.

Moreover, because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, our patents may be challenged in the courts or patent offices in the United States and abroad. For example, we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in post-grant review procedures, oppositions, derivations, re-examinations, inter partes review or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights of others. An adverse determination in any such challenges may result in loss of exclusivity 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 technology and products, or limit the duration of the patent protection of our technology and products. In addition, 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.

Our rights to administer our product candidate may be limited by other patent filings. In July 2019, we entered into a material transfer agreement with the University of Florida, or UofFL, under which we provided to UofFL our NanO2 product, as well as information regarding handling, administration and dosing. We further contributed to experimental design regarding UofFL studies using our product. UofFL’s studies later demonstrated utility. We thereafter prepared and provided to UofFL for comments a draft patent application covering the studies. However, we later learned that UofFL had filed its own patent application with claims directed at the use of our API for patients requiring cardiac protection. If the UofFL patents issue, then we will be prohibited from selling NanO2 for cardiac protection unless we obtain a license from UofFL and there can be no assurance that such a license will be granted on favorable terms, if at all.

Our future patent applications may not result in patents being issued which protect our product candidates, in whole or in part, or which effectively prevent others from commercializing competitive products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. In addition, the laws of foreign countries may not protect our rights to the same extent or in the same manner as the laws of the United States.

Even if our 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 patents by developing similar or alternative technologies or products in a non-infringing manner. Our competitors may also seek approval to market their own products similar to or otherwise competitive with our products. Alternatively, our competitors may seek to market generic versions of any approved products by submitting application to the FDA in which they claim that patents owned or licensed by us are invalid, unenforceable or not infringed. In these circumstances, we may need to defend or assert our patents, or both, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid or unenforceable, or that our competitors are competing in a non-infringing manner. Thus, even if we have valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives.

Depending upon the timing, duration and conditions of FDA marketing approval of our product candidates, one or more of our U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. However, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for that product will be shortened compared to expectations and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced, possibly materially. Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case.

To date, we have not engaged intellectual property counsel to conduct a freedom to operate analysis.

While we have engaged intellectual property counsel to assist in protecting our patent ownership rights, to date, we have not had intellectual property counsel conduct a freedom to operate analysis regarding our NanO2 product. As a result, we cannot be certain that we will not be exposed to third party legal claims, liabilities and/or litigation actions when we seek to develop, make and market products using our NanO2 technology.

Elements of our intellectual property are in the form of trade secrets not patents.

Aspects of the Company’s intellectual property are contained in certain methodologies, protocols and processes, and related technical information and know-how pertaining to the manufacture of product candidates that we presently treat as trade secrets. While trade secrets provide a degree of protection for its intellectual property, trade secret protection does not allow us to prevent others from independently developing or using those methodologies and information, although that protection does allow us to prevent any third party from using trade secrets that are misappropriated from us. In addition, while we have implemented certain protocols to protect our trade secrets, these protocols may be

suitable for an emerging growth company with few employees but may not be sufficient for a larger enterprise engage in the manufacture and distribution of pharmaceutical products. Even if we develop enhanced protocols as we grow our operations, those protocols do not ensure trade secret status.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our patents, trademarks, copyrights or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time consuming and divert the time and attention of our management and scientific personnel. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents, in addition to counterclaims asserting that our patents are invalid or unenforceable, or both. In any patent infringement proceeding, there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our patent claims do not cover the invention. An adverse outcome in a litigation or proceeding involving our patents could limit our ability to assert our patents against those parties or other competitors, and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Any of these occurrences could adversely affect our competitive business position, business prospects and financial condition.

Similarly, if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our common stock. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings.

If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.

Our commercial success depends, in part, on our ability to develop, manufacture, market and sell our product candidates without infringing the intellectual property and other proprietary rights of third parties. If any third-party patents or patent applications are found to cover our product candidates or their methods of use, we may not be free to manufacture or market our product candidates as planned without obtaining a license, which may not be available on commercially reasonable terms, or at all.

There is a substantial amount of intellectual property litigation in the pharmaceutical industry, and we may become party to, or threatened with, litigation or other adversarial proceedings regarding intellectual property rights with respect to our product candidates, including interference and other administrative proceedings before the USPTO. Third parties may assert infringement claims against us based on existing or future intellectual property rights. The outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance. The pharmaceutical industry has produced a significant 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. In the United States, proving invalidity (except in proceedings before the USPTO) requires a showing of clear

and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and the time and attention of our management and scientific personnel could be diverted in pursuing these proceedings, which could significantly harm our business and operating results. In addition, we may not have sufficient resources to bring these actions to a successful conclusion.

If we are found to infringe a third-party’s intellectual property rights, we could be forced, including by court order, to cease developing, manufacturing or commercializing the infringing product candidate or product. Alternatively, we may be required to obtain a license from such third-party in order to use the infringing technology and continue developing, manufacturing or marketing the infringing product candidate. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In addition, we could be found liable for monetary damages, including treble damages and attorney’’ fees if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical industry involves both technological and legal complexity and is therefore costly, time consuming and inherently uncertain. Recent patent reform legislation in the United States and other countries, including the Leahy-Smith America Invents Act, or the Leahy-Smith Act, signed into law in September 2011, could increase those uncertainties and costs. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents. In addition, the Leahy-Smith Act has transformed the U.S. patent system into a “first to file” system. The first-to-file provisions, however, only became effective in March 2013. Accordingly, it is not yet clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could make it more difficult to obtain patent protection for our inventions and increase the uncertainties and costs surrounding the enforcement or defense of our or our collaboration partner’s issued patents, all of which could harm our business, results of operations and financial condition.

The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. Additionally, there have been recent proposals for additional changes to the patent laws of the United States and other countries that, if adopted, could impact our ability to enforce our proprietary technology. Depending on future actions by the U.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. Noncompliance resulting in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction, can, in many cases, be cured by payment of a late fee or by other means in accordance with the applicable rules. If we fail to maintain the patents and patent applications covering our product candidates, our competitive position would be adversely affected.

We may not be able to enforce our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive. The requirements for patentability may differ in certain countries, particularly in developing countries. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may obtain patent protection, but where patent enforcement is not as strong as that in the United States. These products may compete with our products in jurisdictions where we do not have any issued or licensed patents or where any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from competing with us.

Moreover, our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in foreign intellectual property laws. Additionally, laws of some countries outside of the United States and Europe do not afford intellectual property protection to the same extent as the laws of the United States and Europe. Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. This could make it difficult for us to stop the infringement of our patents or the misappropriation of our other intellectual property rights. For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. Consequently, we may not be able to prevent third parties from practicing our inventions in certain countries outside the United States and Europe. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, if our ability to enforce our patents to stop infringing activities is inadequate. These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and resources from other aspects of our business. Furthermore, while we intend to protect our intellectual property rights in major markets for our products, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our products. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate.

Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.

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. With respect to NanO2, we have 10 issued U.S. patents directed to NanO2. The expiration dates of the patents vary. We expect to seek extensions of patent terms in the United States and, if available, in other countries where we are prosecuting patents. In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the normal expiration of the patent, which is limited to the approved indication (or any additional indications approved during the period of extension). However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. If this occurs, our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case.

We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.

We anticipate that many of the people that we expect to hire as employees, including our one current employee, were previously employed at other pharmaceutical companies. Some of these employees may have executed proprietary rights, non-disclosure and non-competition agreements, or similar agreements, in connection with such previous employment. Although we try to ensure that our employees do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these employees have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such third-party. Litigation may be necessary to defend against such claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel or sustain damages. Such intellectual property rights could be awarded to a third-party, and we could be required to obtain a license from such third-party to commercialize our technology or products. Such a license may not be available on commercially reasonable terms or at all. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

In addition, while we typically require our employees, consultants and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own, which may result in claims by or against us related to the ownership of such intellectual property. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to our senior management and scientific personnel.

We currently have a single location as basis of manufacturing, and do not have backup facility.

We currently reside in a building in Tucson, Arizona. Such building includes office space, and an ISO7/ISO5 clean room, from which we manufacture clinical product. We do not have a backup facility for production. The operation can be interrupted by damage to the building such as loss of power, damage by weather, or act of God. While we have proper insurance coverage and adopted certain risk mitigation steps such as end product and raw material storage in off-site locations, any unforeseen interruptions to the facility will delay our clinical development schedule.

Risks Related to Ownership of Our Common Stock

An active public trading market for our common stock may not develop or be sustained.

Prior to this offering, there has been no public market or active private market for trading shares of our common stock. We intend to list our common stock on the NYSE American in connection with this offering; however, an active trading market may not develop following the completion of this offering or, if developed, may not be sustained. The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. The lack of an active market may also reduce the price of shares of common stock. An inactive market may impair our ability to raise capital by selling shares and our ability to use our capital stock to acquire other companies or technologies. We cannot predict the prices at which our common stock will trade. The initial public offering price of our common stock may not bear any relationship to the market price at which our common stock will trade after this offering.

We cannot be assured that we will be able to maintain our listing on a national securities exchange.

We anticipate that our securities will be listed on a national securities exchange, upon consummation of this offering. We cannot be assured that we will continue to comply with the rules, regulations or requirements governing the listing of our common stock on such national securities exchange or that our securities will continue to be listed on a national securities exchange in the future. If the national securities exchange upon which our common stock is listed should determine after initial listing that we fail to meet its requirements, we may be subject to a delisting action by such national securities exchange. Nonetheless, this offering is contingent upon our obtaining such listing and, in the event such listing is not approved, this offering will be terminated.

Even if we are successful in completing this offering, if the national securities exchange upon which our common stock is listed delists our securities from trading on its exchange at some future date, we could face significant material adverse consequences, including:

•        a limited availability of market quotations for our securities;

•        reduced liquidity with respect to our securities;

•        a determination that our common stock is a “penny stock” which will require brokers trading in our ordinary shares to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our ordinary shares;

•        a limited amount of news and analyst coverage for our company; and

•        a decreased ability to issue additional securities or obtain additional financing in the future.

Our stock price may be extremely volatile, and your investment in our common stock could suffer a decline in value.

You should consider an investment in our common stock risky and invest only if you can withstand a significant loss and wide fluctuations in the market value of your investment. Investors who purchase our common stock may not be able to sell their shares at or above the purchase price. Security market prices for securities of pharmaceutical companies have been highly volatile. In addition, the volatility of pharmaceutical company stocks often does not correlate to the operating performance of the companies represented by such stocks. Some of the factors that may cause the market price of our common stock to fluctuate include:

•        adverse results or delays in our clinical trials;

•        the timing or delay of achievement of our clinical, regulatory, partnering and other milestones, such as the commencement of clinical development, the completion of a clinical trial, the receipt of regulatory approval or the establishment or termination of a commercial partnership for one or more of our product candidates;

•        announcement of FDA approval or non-approval of our product candidates or delays in the FDA review process;

•        actions taken by regulatory agencies with respect to our product candidates, our clinical trials or our sales and marketing activities;

•        the commercial success of any product approved by the FDA or its foreign counterparts;

•        regulatory developments in the United States and foreign countries;

•        changes in the structure of healthcare payment systems;

•        any intellectual property infringement lawsuit involving us;

•        announcements of technological innovations or new products by us or our competitors;

•        market conditions for the biotechnology or pharmaceutical industries in general;

•        changes in financial estimates or recommendations by securities analysts or other third parties, including blogs, articles, message boards and social and other media;

•        “short squeezes”;

•        sales of large blocks of our common stock, large stockholders exiting their position in our common stock or an increase or decrease in the short interest in our common stock;

•        sales of our common stock by our executive officers, directors and significant stockholders;

•        direct sales of our common stock through financing arrangements;

•        restatements of our financial results and/or material weaknesses in our internal controls;

•        the loss of any of our key scientific or management personnel; and

•        announcements regarding the ongoing exploration of the strategic options available to us.

The stock markets in general, and the markets for biotechnology stocks in particular, have experienced extreme volatility and price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of particular companies. These broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance. In the past, class action litigation has often been instituted against companies whose securities have experienced periods of volatility in market price. Any such litigation brought against us could result in substantial costs, which would hurt our financial condition and results of operations, divert management’s attention and resources, and possibly delay our clinical trials or commercialization efforts.

Anti-takeover provisions in our charter documents, and under Delaware law, could make an acquisition of our company more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our common stock.

Provisions in our amended and restated certificate of incorporation and amended and restated bylaws may have the effect of delaying or preventing a change of control or changes in our management. Our amended and restated certificate of incorporation and amended and restated bylaws include provisions that:

•        authorize our board of directors to issue, without further action by the stockholders, shares of undesignated preferred stock with terms, rights, and preferences determined by our board of directors that may be senior to our common stock;

•        require that any action to be taken by our stockholders be effected at a duly called annual or special meeting and not by written consent;

•        specify that special meetings of our stockholders can be called only by our board of directors, the chairperson of our board of directors, or our Chief Executive Officer;

•        establish an advance notice procedure for stockholder proposals to be brought before an annual meeting, including proposed nominations of persons for election to our board of directors;

•        prohibit cumulative voting in the election of directors;

•        establish that our board of directors is divided into three classes — Class I, Class II, and Class III — with the classes serving staggered three-year terms;

•        provide that, so long as our board of directors is classified, directors may only be removed for cause;

•        provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; and

•        require the approval of our board of directors or the holders of two-thirds of our outstanding shares of voting stock to amend our bylaws and certain provisions of our certificate of incorporation.

These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management. In addition, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which generally, subject to certain exceptions, prohibits a Delaware corporation from engaging in any of a broad range of business combinations with any “interested” stockholder for a period of three years following the date on which the stockholder became an “interested” stockholder. Any of the foregoing provisions could limit the price that investors might be willing to pay in the future for shares of our common stock, and they could deter potential acquirers of our company, thereby reducing the likelihood that you would receive a premium for your shares of our common stock in an acquisition.

Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware or the federal district court for the District of Delaware is the exclusive forum for certain disputes between us and our stockholders, which could result in increased costs for our stockholders to bring a claim and could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated certificate of incorporation and amended and restated bylaws provide that, unless the Company consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, in the event that the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware or other state courts of the State of Delaware) is the exclusive forum for (i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a claim of breach of fiduciary duty owed by, any director, officer, employee or agent of the Company to the Company or our stockholders; (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws; or (iv) any action asserting a claim against us or any director, officer of employee that is governed by the internal affairs doctrine of the law of the State of Delaware; provided that,

In addition, as permitted by Section 145 of the DGCL, our amended and restated bylaws and the indemnification agreements that we have entered into with each of our current executive officers and intend to enter into with our directors and certain other officers, among other things provide that:

•        We will indemnify our directors and executive officers for serving us in those capacities, or for serving as a director, officer, employee or agent of other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that we may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to our best interest and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.

•        We may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law.

•        We will be required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.

•        The rights conferred in our bylaws will not be exclusive. We may not retroactively amend our bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.

As a result, claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

We do not intend to pay dividends in the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.

We have never declared or paid any cash dividends on our common stock. We currently intend to retain all available funds and any future earnings for use in the operation of our business and do not anticipate paying any dividends on our common stock in the foreseeable future. Any determination to pay dividends in the future will be at the discretion of our board of directors. Consequently, your only opportunity to achieve a return on your investment in our company will be if the market price of our common stock appreciates and you sell your shares at a profit. There is no guarantee that the price of our common stock that will prevail in the market after this offering will ever exceed the price that you pay. For additional information about our dividend policy, see the section entitled “Dividend policy” elsewhere in this prospectus.

We have limited experience operating as a publicly traded company.

Only a few of the members of our management team have experience managing a publicly traded company, interacting with public company investors, and complying with laws pertaining to public companies. Our management team may not successfully or efficiently manage our transition to being a public company subject to significant regulatory oversight and reporting obligations under the federal securities laws and the continuous scrutiny of securities analysts and investors. These new obligations and constituents will require significant attention from our senior management and could divert their attention away from the day-to-day management of our business, which could adversely affect our business, financial condition, and operating results.

We will incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.

As a public company, we will incur legal, accounting and other expenses that we did not incur as a private company. We will be subject to the reporting requirements of the Exchange Act and will be required to comply with the applicable requirements of the Sarbanes Oxley Act of 2002, or SOX, and the Dodd-Frank Wall Street Reform and Consumer Protection Act. The listing requirements of the NYSE American, and the rules of the SEC, require that we satisfy certain corporate governance requirements. Our management and other personnel will need to devote a substantial amount of time to ensure that we comply with all of these requirements. Moreover, the reporting requirements, rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. Any changes we make to comply with these obligations may not be sufficient to allow us to satisfy our obligations as a public company on a timely basis, or at all. These reporting requirements, rules and regulations, coupled with the increase in potential litigation exposure associated with being a public company, could

CORPORATE CONVERSION/INCORPORATION

Our board of directors elected to convert NuvOx Pharma, L.L.C. from an Arizona limited liability company into a Delaware corporation, NuvOx Therapeutics, Inc., which conversion was completed on January 31, 2023. In order to consummate the corporate conversion/incorporation, on December 29, 2022, the Certificate of Incorporation of NuvOx Therapeutics, Inc. was filed with the Secretary of State of State of Delaware. In connection with the corporate conversion/incorporation, effective as of January 31, 2023, all outstanding (i) Series A-1 Preferred Units of NuvOx Pharma, L.L.C. were exchanged for shares of Series A-1 Preferred Stock of NuvOx Therapeutics, Inc., (ii) Series A-2 Preferred Units and Class A-2 Units of NuvOx Pharma, L.L.C. were exchanged for shares of Series A-2 Preferred Stock of NuvOx Therapeutics, Inc., and (iii) Common Units of NuvOx Pharma, L.L.C. were exchanged for shares of common stock of NuvOx Therapeutics, Inc., or collectively, the LLC Units. In connection with the corporate conversion/incorporation, the 2021 Notes were amended to provide that the notes will become convertible into shares of NuvOx Therapeutics, Inc. instead of the LLC Units.

No U.S. federal taxable income or taxable gain was expected as a result of our conversion from an Arizona limited liability company into a Delaware corporation.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains “forward-looking statements.” We use words such as “could,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project,” and other similar expressions to identify some forward-looking statements, but not all forward-looking statements include these words. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. Accordingly, any such statements are qualified in their entirety by reference to the information described under the caption “Risk Factors” and elsewhere in this prospectus.

The forward-looking statements contained in this prospectus are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments, and other factors we believe are appropriate under the circumstances. As you read and consider this prospectus, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (many of which are beyond our control), and assumptions. Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance anticipated in the forward-looking statements. We believe these factors include, but are not limited to, those described under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Should one or more of these risks or uncertainties materialize, or should any of these assumptions prove incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements.

Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this prospectus to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances. New factors that could cause our business not to develop as we expect emerge from time to time, and it is not possible for us to predict all of them. Further, we cannot assess the impact of each currently known or new factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

MARKET, INDUSTRY AND OTHER DATA

This prospectus includes market and industry data and forecasts that we have derived from independent consultant reports, publicly available information, various industry publications, and our internal data and estimates.

Our internal data and estimates are based upon information obtained from trade and business organizations and other contacts in the markets in which we operate and our management’s understanding of industry conditions. Although we believe that such information is reliable, we have not had this information verified by any independent sources.

USE OF PROCEEDS

We estimate that the net proceeds from the sale of 2,860,000 shares of our common stock in this offering will be approximately $17.4 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, based on an assumed initial public offering price of $7.00 per share, which is the midpoint of the price range set forth on the cover page of this prospectus. If the underwriters exercise in full their option to purchase 429,000 additional shares of common stock, we estimate that the net proceeds to us from this offering will be approximately $20.2 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, based on an assumed initial public offering price of $7.00 per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

Each $1.00 increase (decrease) in the assumed initial public offering price of $7.00 per share of common stock would increase (decrease) the net proceeds to us from this offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $2.6 million, assuming that the number of shares we are offering, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of shares of common stock we are offering. Each increase (decrease) of 1,000,000 in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $6.4 million, assuming the assumed initial public offering price per share, as set forth on the cover page of this prospectus, remains the same.

We expect to use the net proceeds from this offering as follows: (i) approximately $5.0 million to fund through clinical trial completion the current Phase IIb clinical trial in GBM; (ii) approximately $0.5 million to fund product candidate supply through clinical trial completion for the current Phase IIb clinical trial in stroke; (iii) approximately $0.5 million to fund through clinical trial completion the current Phase Ib clinical trial in respiratory distress; (iv) approximately $1.0 million to prepare for a pivotal Phase III trial for the administration of NanO2 to treat patients with GBM; (v) approximately $6.0 million to fund the Phase II ARDS trial that is already allowed by Health Canada; and (vi) to use the remaining funds for ongoing development of our product candidates and for working capital.

As of the date of this prospectus, we cannot predict with certainty all of the particulars of the proceeds to be received upon completion of the offering, or the amounts we will actually spend on the uses set forth above. We may find it necessary or advisable to reallocate the net proceeds of this offering; however, any reallocation will be substantially limited to the categories set forth above. The expected use of the net proceeds from this offering represent our intentions based upon our current plans and business conditions. The amounts and timing of our actual expenditures may vary significantly depending on a number of factors, including the progress of our development and commercialization efforts, the status of and results from our clinical trials, and any collaborations that we may enter into with third parties for our products or product candidates, as well as any unforeseen cash needs. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering. We have no current understandings, agreements or commitments for any material acquisitions or licenses of any products or product candidates, businesses or technologies.

Pending our application of the net proceeds from this offering, we plan to invest the net proceeds in a variety of capital preservation investments, including short and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

DIVIDEND POLICY

We have never declared or paid, and we do not anticipate declaring or paying in the foreseeable future, any cash dividends on our capital stock. We intend to reinvest any earnings in developing and expanding our business. Any future determination relating to the declaration and payment of dividends will be at the discretion of our board of directors and will depend on then-existing conditions, including our operating results, financial conditions, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant.

CAPITALIZATION

The following table sets forth our cash and equivalents and capitalization as of March 31, 2026:

•        on an actual basis;

•        on a pro forma basis to give effect to (i) the issuance of additional 2024 Notes in the principal amount of $375,000 subsequent to March 31, 2026 and the receipt of the net proceeds from such issuance; (ii) the issuance of additional 2025 Notes in the principal amount of $687,500, together with warrants, subsequent to March 31, 2026 and the receipt of the net proceeds from such issuance; (iii) the conversion of the outstanding shares of Series A-1 Preferred Stock and Series A-2 Preferred Stock into an aggregate of 3,194,993 shares of our common stock; (iv) the conversion of $7,873,371 in principal amount and accrued interest as of July 6, 2026 outstanding under the 2021 Notes and 2023 Notes into an aggregate of 2,394,527 shares of our common stock at a conversion rate of $3.288 per share; (v) the conversion of $2,787,623 in principal amount and accrued interest as of July 6, 2026 outstanding under the 2024 Notes into an aggregate of 861,041 shares of common stock at a conversion rate of $3.237 per share; (vi) the conversion of $1,426,599 in principal amount and accrued interest as of July 6, 2026 outstanding under the 2025 Notes into an aggregate of 350,632 shares of our common stock at a conversion rate of $4.071 per share; (vii) the conversion of the $150,000 Convertible Grant Liability into 45,620 shares of our common stock, at conversion price of $3.288 per share, together with a corresponding reduction in liabilities of the fair value of the Convertible Grant Liability in the amount of $320,000; (viii) the effectiveness of the Certificate of Validation filed with the Delaware Secretary of State on June 16, 2026 and certified by the State of Delaware on July 2, 2026, to increase the number of shares of Series A-2 Preferred Stock to 2,347,136 shares, effective as of January 31, 2026, and the corresponding removal of the liability of $1,081,371 that resulted from the issuance on January 31, 2026 of shares of Series A-2 Preferred Stock in excess of the number of designated shares of Series A-2 Preferred Stock; and (ix) the filing and effectiveness of our amended and restated certificate of incorporation immediately prior to the completion of this offering; and

•        on a pro forma as adjusted basis to additionally give effect to the pro forma adjustments and the sale of 2,860,000 shares of common stock in this offering, assuming an initial public offering price of $7.00 per share of common stock (the mid-point of the price range set forth on the cover page of this prospectus), and our receipt of approximately $17.4 million in net proceeds after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The information set forth in the table below is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering as determined at pricing. You should read the information in this table together with our audited financial statements and related notes and unaudited interim condensed financial statements and related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing elsewhere in this prospectus.

($ in thousands, except share and per share data):

____________

(1)      As of March 31, 2026, the Company had inadvertently issued 144,558 shares of Series A-2 Preferred Stock in excess of the designated shares allowed to be issued pursuant to the Company’s Certificate of Incorporation. This error was caused by the elective conversion of 2021 and 2023 Notes in the aggregate principal amount of $402,500 into 149,688 shares of Series A-2 Preferred Stock between January 1, 2026 and March 31, 2026. Shares of Series A-2 Preferred Stock in excess of the designated amount are classified as a liability on the accompanying balance sheet. The financial statements herein reflect the share counts as operationally intended and recorded in the capitalization table. The Company filed a certificate of validation with Secretary of State of Delaware on June 16, 2026, which was certified by State of Delaware on July 2, 2026, to increase the authorized shares of Series A-2 preferred stock to 2,347,136 shares.

The number of shares of our common stock outstanding before and after this offering reflected in the tables and discussion above prospectus is based on 3,389,022 shares of common stock outstanding as of March 31, 2026, and excludes the following, as of March 31, 2026:

•        610,567 shares of common stock issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $0.93 per share;

•        85,357 shares of common stock issuable upon the exercise of outstanding warrants, at an exercise price of $4.071 per share;

•        558,508 shares of common stock reserved for future issuance under the 2023 Plan; and

•        143,000 shares of common stock issuable upon the exercise of the Representative’s Warrants to be granted to the representative of the underwriters upon completion of this offering at an exercise price equal to 125% of the initial offering price of the common stock.

Each $1.00 increase (decrease) in the assumed initial public offering price of $7.00 per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase (decrease) the amount of cash, additional paid-in capital, total stockholders’ equity (deficit) and total capitalization on a pro forma as adjusted basis by approximately $2.6 million, assuming the number of shares, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of one million shares offered by us would increase (decrease) cash, total stockholders’ equity (deficit) and total capitalization on a pro forma as adjusted basis by approximately $6.4 million, assuming the assumed initial public offering price of $7.00 per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Each one million increase in the number of shares offered by us together with a concomitant $1.00 increase in the assumed initial public offering price of $7.00 per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase each of cash and total stockholders’ (deficit) equity by approximately $10.0 million after deducting underwriting discounts and commissions and any estimated offering expenses payable by us. Conversely, each one million decrease in the number of shares offered by us together with a concomitant $1.00 decrease in the assumed initial public offering price of $7.00 per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) would decrease each of cash and total stockholders’ (deficit) equity by approximately $8.2 million after deducting underwriting discounts and commissions and any estimated offering expenses payable by us. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.

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

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes to those statements included elsewhere in this prospectus. This discussion and analysis and other parts of this prospectus contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives, expectations, forecasts and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the section titled “Risk Factors” and elsewhere in this prospectus. You should carefully read the “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”

Overview

We are a clinical-stage biopharmaceutical company developing innovative oxygen therapeutic solutions for the treatment of diseases where hypoxia, or lack of oxygen, plays a critical role. Our product candidate is NanO2, the API of which is dodecafluoropentane. NanO2, is administered intravenously as an emulsified liquid, containing nano-sized droplets that after entering the body, due to the human body temperature, convert to a gas, which enables them to deliver more oxygen than when in the liquid state. Due to the fact that the size of the NanO2 particle is approximately 30 times smaller than a red blood cell, the NanO2 particle can partition into tissue, deliver oxygen and further facilitate oxygen transfer from red blood cell to tissue.

NanO2 has been administered in patients with acute ischemic stroke and GBM in two separate completed Phase I/IIa human clinical trials. The FDA has allowed Phase IIb human clinical trials in both stroke and GBM. NanO2 received orphan drug designation status for the treatment of GBM in 2015 and sickle cell anemia in 2016.

We have completed an open-label Phase Ib/IIa human clinical trial of NanO2 for the treatment of GBM in 11 patients in Australia, and a randomized, placebo-controlled Phase Ib/IIa clinical trial of NanO2 in the United States for the treatment of acute ischemic stroke in 24 patients. In our Phase Ib/IIa trial in GBM, 11 brain cancer patients were treated with radiation therapy. Median overall survival for the GBM patients was 591 days, compared to the historical control overall survival of 444 days, reflecting an approximate five-month overall survival increase. The trial also demonstrated an approximately 40% improvement in the progression free survival. In our Phase Ib/IIa trial for the treatment of acute ischemic stroke, 24 patients were treated in a placebo-controlled dose escalation manner. Using a 30 and 90 days mRS (modified Rankin Scale) showed clinical improvement with a p-value of 0.01 and 0.03, respectively.

We have completed the enrollment and treated 93 patients in a Phase IIb clinical trial administering NanO2 in the United States to treat GBM and are now in the follow up period. This trial has been partially funded by the National Cancer Institute. The University of Glasgow has commenced an investigator sponsored Phase IIb trial administering NanO2 supplied by us in the United Kingdom. To date, the University of Glasgow has treated seventeen (17) patients in this trial. We also commenced dosing patients in a Phase Ib trial administering NanO2 to respiratory distress patients in Canada in the second quarter of 2025. To date, the first and second cohorts of this Phase Ib trial have been completed, and a total of twelve (12) patients have been treated. This Phase Ib trial is expected to be followed by a Phase II trial for ARDS patients, which has already been allowed by Health Canada. Our intention is to use the net proceeds of this offering to complete all three trials, to conduct our planned Phase II ARDS trial, as well as to commence preparation for a pivotal Phase III trial for the administration of NanO2 to treat patients with GBM.

We have been funded by $21.4 million in private financing and $10.8 million of non-dilutive funding from granting agencies. In addition, we have been granted an additional $1.7 million of non-dilutive funding that has not yet been received. Further, $0.4 million of non-dilutive funding was granted but forfeited because the term of the grant expired before research was completed. An additional $2.0 million in grant funding has been awarded to our third-party collaborators to conduct trials for which we will supply NanO2. Granting agencies include the NIH, the DoD, and BARDA in the United States, as well as the NIHR in the United Kingdom. Included in the $2.0 million in grant funding that has been awarded to our third-party collaborators is a grant by the NIHR of $1.4 million to investigating physicians to conduct a Phase IIb trial of NanO2 in approximately 150 stroke patients in the United Kingdom. Out

of these grant fundings, approximately $10.8 million has been used to date and $1.7 million remains available for use. These agencies use extensive scientific peer review in deciding which projects to fund that could impact human disease.

Recent Developments

From January 1, 2026 through July 6, 2026, we received net proceeds of $430 thousand from the sale of 2024 Notes and $1.2 million from the sale of 2025 Notes and the accompanying warrants, as described in more detail below.

Results of Operations

Revenue from Product Sales

To date, we have not generated any revenue from product sales, and we do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.

Grant Revenue

From time to time, we receive certain grant award funding to support our continuing research and development efforts. For government assistance in which no specific US GAAP applies, we account for such transactions as revenue and by analogy to a grant model under FASB ASC Topic 958-605, Not-for-Profit Entities — Revenue Recognition, or ASC 958-605. Under such a model, we recognize the impact of government assistance on the Consolidated Statements of Income upon complying with the conditions of the grant. We were awarded two types of assistance, grants based on milestones and cost reimbursement grants. For the year ended December 31, 2025, grant revenue was derived from both types of grants. For the year ended December 31, 2024, all grant revenue was derived from cost reimbursement grants. For the three months ended March 31, 2026, our grant revenue was derived fully from cost reimbursement grants. For the three months ended March 31, 2025, our grant revenue was derived from both types of the grants. We consider these grants to be operating revenue as they support our primary operating activities. Our accounting policy recognizes revenue from these contracts as we incur qualifying expenses for R&D under the cost reimbursement grants or achieve milestones under the milestone based grants. Revenues and related expenses are presented as gross in the statements of operations as we have determined we control the arrangement as the primary obligor under the arrangements relative to the research and development services we perform.

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery efforts, manufacturing, and the development of our product candidates. We expense research and development costs as incurred, which include:

•        expenses incurred to conduct the necessary preclinical studies and clinical trials required to obtain regulatory approval;

•        expenses incurred under agreements with CROs that are primarily engaged in the oversight and conduct of our drug discovery efforts and preclinical studies, clinical trials and CMOs that are primarily engaged to provide preclinical and clinical drug substance and product for our research and development programs;

•        other costs related to acquiring and manufacturing materials in connection with preclinical studies and clinical trial materials, including manufacturing validation batches, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;

•        payments made in cash or equity securities under third-party licensing, acquisition and option agreements;

•        consultant-related and employee-related expenses, including salaries and benefits, travel and stock-based compensation expense for employees engaged in research and development functions;

•        costs related to compliance with regulatory requirements; and

•        allocated facilities-related costs, depreciation and other expenses, which include rent and utilities.

We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. Any nonrefundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are expensed as the related goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.

Our direct external research and development expenses consist primarily of external costs, such as fees paid to outside consultants, CROs, CMOs and research laboratories in connection with our preclinical development, process development, manufacturing, and clinical development activities. Our direct research and development expenses also include fees incurred under license, acquisition, and option agreements. We primarily use internal resources to manage our preclinical development, process development, manufacturing, and clinical development activities. These employees work across multiple programs.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses, including manufacturing, will increase substantially over the next several years as we commence our planned clinical trials for our assets, as well as conduct other preclinical and clinical development, including submitting regulatory filings for other potential product candidates. In addition, we expect our discovery research efforts, and our related personnel costs will increase and, as a result, we expect our research and development expenses, including costs associated with stock-based compensation, will increase above historical levels. In addition, we may incur additional expenses related to milestone and royalty payments payable to third parties with whom we may enter into license, acquisition and option agreements to acquire the rights to future product candidates.

At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from any of our product candidates. The successful development and commercialization of our product candidates is highly uncertain. This uncertainty is due to the numerous risks and uncertainties associated with product development and commercialization, including the uncertainty of the following:

•        the scope, progress, outcome and costs of our preclinical development activities, clinical trials and other research and development activities;

•        establishing an appropriate safety and efficacy profile with IND enabling studies;

•        successful patient enrollment in and the initiation and completion of clinical trials;

•        the timing, receipt and terms of any marketing approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;

•        the extent of any required post-marketing approval commitments to applicable regulatory authorities;

•        establishing clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers in order to ensure that we or our third-party manufacturers are able to make drug supply successfully;

•        development and timely delivery of clinical-grade and commercial-grade drug substance and drug formulations that can be used in our clinical trials and for commercial launch;

•        obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights; significant and changing government regulation;

•        launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; and

•        maintaining a continued acceptable safety profile of our product candidates following approval, if any, of our product candidates.

Any changes in the outcome of any of these variables with respect to the development of our product candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries, consultant fees, vendor fees, travel and stock-based compensation expense for personnel in executive, business development, finance, human resources, legal, information technology, pre-commercial and support personnel functions. General and administrative expenses also include direct and allocated facility-related costs as well as insurance costs and professional fees for legal, patent, consulting, investor and public relations, accounting and audit services.

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates and prepare for potential commercialization activities. We also anticipate that we will incur significantly increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company. Additionally, if and when we believe a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and other employee-related expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of that product candidate.

Other (Expense) Income

Other (expense) income consists primarily of interest expense associated with the small business administration loan on our balance sheet, changes in the fair value of our convertible instruments, and interest income from our cash equivalent and short-term investment.

Results of operations for the three months ended March 31, 2026 and 2025

The following table summarizes our results of operations for the periods presented (in thousands):

Revenues

Total revenue for the three months ended March 31, 2026 increased 30% to approximately $238 thousand, as compared to $183 thousand for the three months ended March 31, 2025. During the three months ended March 31, 2025, we earned $150 thousand based on achieved milestones from our BARDA contract and $33 thousand revenue from our DoD contract. During the three months ended March 31, 2026, revenue from our DoD contract increased by approximately $13 thousand to $47 thousand. We have earned $189 thousand from the NIH liquid biopsy/biomarker grant that we were awarded in September 2025. We also earned approximately $2 thousand of new service-agreement revenue. The service revenue was earned from us providing engineering support for another life science company. For both periods, our revenue was comprised primarily of grant awards, with the first quarter of 2026 also including a small amount of service-agreement revenue. We receive grant revenue pursuant to contracts that we have with the NIH, the DoD and BARDA for research and development related activities. These awards were made under two types of assistance: milestone-based grants and cost-reimbursement grants. Associated expenses are recognized when research and development expenses are incurred. Revenues and related expenses are presented as gross grant revenue in the statements of operations. We plan to continue our efforts to secure future grant funding to support our ongoing research and development expenses.

Research and Development Expenses

The following table summarizes the changes in research and development expenses for the periods presented (in thousands):

Research and development expenses decreased by approximately $0.4 million, or 34%, to approximately $0.8 million for the three months ended March 31, 2026, compared to $1.2 million for the three months ended March 31, 2025. The decrease was primarily due to lower clinical trial costs, which declined by approximately $0.4 million (39%), together with decreases in laboratory expenses (approximately $56 thousand), professional fees (approximately $32 thousand), and facility-related and other costs (approximately $14 thousand). These decreases reflected the fact that our Phase IIb GBM completed enrollment and treatment in 2025. These decreases were partially offset by an increase of approximately $72 thousand (89%) in compensation and benefits.

General and administrative expenses

The following table summarizes the changes in general and administrative expenses for the periods presented (in thousands):

General and administrative expenses decreased by approximately $0.2 million, or 35%, to approximately $0.3 million for the three months ended March 31, 2026 compared to approximately $0.5 million for the three months ended March 31, 2025. The decrease was primarily due to a reduction of approximately $264 thousand (78%) in professional fees. This reduction of cost reflects a CFO consultant that we engaged during 2025, external CPA service cost in 2025 that we transferred in house after March 2025, and general cost-cutting efforts during the period, together with a decrease of approximately $37 thousand (45%) in facility-related and other expenses. These decreases were partially offset by an increase of approximately $131 thousand (202%) in compensation and benefits, related to accrued executive compensation.

Other (Expense) Income

The following table summarizes the changes in other (expense) income for the periods presented (in thousands):

Total other (expense) income decreased by approximately $4.8 million, or 44%, for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. The change in interest, net, moved from income of approximately $9 thousand in the prior-year period to expense of approximately $3 thousand in the current period. In both periods, we recognized a change in fair value of convertible instruments. Between the related party and 3rd party purchasers of these instruments, the change in fair value totaled $10.7 million for the period ending on March 31, 2025 compared to $5.9 million for the same period in 2026. Similarly, change in fair value of the warrants that are associated with these convertible instruments was $57 thousand in total for the period ended March 31, 2025, and was $89 thousand for the same period in 2026.

Results of operations for the years ended December 31, 2025 and 2024

The following table summarizes our results of operations for the periods presented (in thousands):

Revenues

Total revenue for the year ended December 31, 2025 increased 91% to approximately $1.0 million, as compared to $0.5 million for the twelve months ended December 31, 2024. The increase was largely due to a new NIH grant awarded for our liquid biopsy/biomarker study, earned grant revenue under our BARDA contract to support a Phase Ib respiratory distress trial, and increased expenses incurred under our DoD contract. For both years, our revenue was essentially entirely comprised of grant awards. We have contracts with the NIH, the DoD and BARDA for research and development related activities. We were awarded these grants based on two types of assistance: grants based on milestones and cost reimbursement grants. Associated expenses are recognized when incurred as research and development expenses. Revenues and related expenses are presented gross in the statements of operations. We plan to continue our efforts to secure future grant funding to support our ongoing research and developments costs.

Research and Development Expenses

The following table summarizes the changes in research and development expenses for the periods presented (in thousands):

Research and development expenses increased by approximately $0.8 million for the year ended December 31, 2025 compared to the year ended December 31, 2024. The increase was primarily due to higher clinical trial costs associated with the ongoing Phase IIb trial of NanO2 in GBM, as well as increased preclinical and clinical logistics costs supporting preparation for our planned Phase IIb stroke and Phase Ib respiratory programs. These increases were partially offset by decreases in consulting, laboratory supplies, and materials costs.

General and administrative expenses

The following table summarizes the changes in general and administrative expenses for the periods presented (in thousands):

General and administrative expenses remained relatively flat for the year ended December 31, 2025 compared to the year ended December 31, 2024. A reduction of approximately $219 thousand in professional fees is the net impact of savings from transition of outside CPA accounting services in house after March 2025, as well as less (non IPO related) professional work (costs related to IPO activity are recorded as assets under Deferring Offering Costs). This reduction was offset by an increase of $230 thousand related to accrued compensation for executives. Facility-related and other expenses also decreased by approximately $42 thousand in 2025 from cost-cutting measures.

Other (Expense) Income

The following table summarizes the changes in other (expense) income for the periods presented (in thousands):

Total other expense increased by approximately $9.7 million for the year ended December 31, 2025 compared to 2024. The increase was a result of an approximately $77 thousand decrease related to the interest earned, a decrease in other income of $31 thousand, a gain on extinguishment of warrants of $80 thousand during the year ended December 31, 2025 for which there was none in the prior year, and a gain on amendment of convertible instruments of $407 thousand for which there was none in the prior year, offset by an increase in net change in fair value of convertible instruments and related party by $10.0 million and increase in net change in fair value of warrant liability of $69 thousand.

Liquidity and Capital Resources

As of March 31, 2026, our cash, cash equivalents and short-term investments were approximately $0.3 million. As of December 31, 2025, our cash, cash equivalents and short-term investments were approximately $0.1 million. Subsequent to the year ended December 31, 2025, from January 1, 2026 through July 6, 2026, we raised $430 thousand from the sale of the 2024 Notes and $1.2 million from the sale of 2025 Notes and the accompanying warrants.

Since our inception, we have incurred significant operating losses. We have financed our operations from a combination of:

•        issuance and sale of convertible promissory notes;

•        issuance of convertible grant liability;

•        other debt borrowings sponsored by the United States Small Business Administration, or the SBA;

•        proceeds from the issuance of Preferred Stock; and

•        recognized grant revenue from funding arrangements with NIH, DoD and BARDA.

We are a development-stage company as we have not generated any product revenues to date and do not expect to have significant revenues until we are able to sell a product candidate after obtaining applicable regulatory approvals or we establish collaborations that provide funding, such as licensing fees, milestone payments, royalties, research funding or otherwise. To date, operations have been funded through grant funding, financing, convertible notes, and the subsequent conversion of some of those convertible notes. Our objectives, when managing capital, are to ensure there are sufficient funds available to carry out our research, development, and eventual commercialization programs. We do not hold any asset-backed commercial paper and our cash is not subject to any external restrictions. We manage liquidity risk by frequently monitoring actual and projected cash flows. Our board of directors reviews and approves our operating and capital budgets, as well as any material transactions not in the ordinary course of business. The majority of our accounts payable and accrued liabilities have maturities of less than six months. We are dependent on our ability to generate revenues from our future products or secure additional financing to continue our research and development activities and meet our ongoing obligations.

Since our inception, we have experienced operating losses and had a total accumulated deficit of $43.1 million as of March 31, 2026. As such, we believe that these conditions raise substantial doubt as to our ability to continue as a going concern within 12 months of the date the financial statements included elsewhere in this prospectus were issued. We estimate that we will require approximately $10.0 million of additional financing to continue our operations for the next 12 months from such date. Additional funding will be necessary to fund our research and development efforts to advance product candidates. We intend to seek additional funding through public and private financing, debt financing, collaboration agreements, strategic alliances and licensing agreements. There is no assurance of success in obtaining such additional financing on terms acceptable to us, if at all, and there is no assurance that we will be able to enter into collaborations or other arrangements. If we are unable to obtain funding, it could force us to delay, reduce or eliminate research and development programs and product portfolio expansion or commercialization efforts. These potential delays, reductions and eliminations could adversely affect future business prospects and the ability to continue operations.

Cash Flows

The following tables summarizes our sources and uses of cash for the periods presented (in thousands):

Cash Flows from Operating Activities

For the year ended December 31, 2025, cash used in operating activities decreased by approximately $1.7 million compared to the prior year driven by non-cash adjustments of approximately $11.9 million, vs. $2.1 million for the year ended in 2024. These adjustments primarily include: $10.0 million more fair value adjustment on total convertible instruments (including a convertible grant), offset by an approximately $0.4 million gain on amendment of convertible instrument.

In addition, there is an approximately (i) $200 thousand increase in stock-based compensation, (ii) $140 thousand in convertible grant liability, (iii) $80 thousand in warrant extinguishment, and (iv) $1.9 million working capital benefit, mainly due to a $1.8 million accounts payable to third parties and related party.

The benefits of the non-cash adjustment and working capital are offset by an increase of $10.0 million net loss.

For the three months ended March 31, 2026, net cash used in operating activities was approximately $0.5 million, a decrease of approximately $0.3 million (39%) from approximately $0.8 million used in the three months ended March 31, 2025. The decrease was primarily driven by (i) benefit of a lower net loss of approximately $5.4 million, (ii) benefit by an approximately $0.1 million of additional stock based compensation, offset by (iii) $4.8 million less fair value adjustment from convertible instruments and its associated warrants, and (iv) approximately $0.4 million decrease in working capital, in account payables and accrued expenses.

Cash Flows from Investing Activities

For the year ended December 31, 2025, cash provided by investing activities was $0 compared to approximately $1.4 million in 2024. The change was primarily due to a decrease in proceeds from maturities of held-to-maturity securities of approximately $3.0 million, partially offset by a decrease in purchases of held-to-maturity securities of approximately $1.6 million and a decrease in purchases of property and equipment of approximately $5 thousand.

For the three months ended March 31, 2026, cash flow from investment activities was minimal. For the three months ended March 31, 2025, there were no cash flows from investment activities.

Cash Flows from Financing Activities

For the year ended December 31, 2025, cash provided by financing activities decreased by approximately $0.6 million compared to the prior year. The decrease was primarily driven by lower proceeds from the issuance of convertible notes of approximately $0.4 million, and approximately $0.2 million deferred offering cost.

For the three months ended March 31, 2026, net cash provided by financing activities was approximately $0.4 million higher than the same period in 2025, driven by proceeds from the issuance of additional convertible notes during the three months ended March 31, 2026 which were $0.3 million higher than the proceeds from the issuance of additional convertible notes during the three months ended March 31, 2025.

Funding Requirements

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the clinical trials and preclinical activities of our product candidates. In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company. The timing and amount of our operating expenditures will depend largely on our ability to:

•        advance development of our clinical programs;

•        acquire or develop additional product candidates;

•        manufacture, or have manufactured on our behalf, our preclinical and clinical drug material and develop processes for late clinical stage and commercial manufacturing;

•        seek regulatory approvals for any product candidates that successfully complete clinical trials;

•        establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any product candidates for which we may obtain marketing approval and intend to commercialize on our own;

•        hire additional clinical, quality control and scientific personnel;

•        expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company; and

•        obtain, maintain, expand and protect our intellectual property portfolio.

Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:

•        the scope, progress, results and costs of researching and developing our product candidates, and conducting preclinical and clinical trials;

•        the costs, timing and outcome of regulatory review of our product candidates;

•        the costs, timing and ability to manufacture our product candidates to supply our preclinical development efforts and our clinical trials;

•        the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;

•        the costs of manufacturing commercial-grade product and necessary inventory to support commercial launch;

•        the ability to receive additional non-dilutive funding, including grants from organizations and foundations;

•        the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;

•        the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, expanding and enforcing our intellectual property rights and defending intellectual property-related claims;

•        our ability to establish and maintain collaborations on favorable terms, if at all; and

•        the extent to which we acquire or in-license other product candidates and technologies.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of public or private equity offerings, debt financings, governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, debt financing would result in fixed payment obligations.

If we raise additional funds through governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Contractual Obligations and Commitments

We enter into contracts in the normal course of business with CROs, CMOs, and other third parties for clinical trials, preclinical research studies, and testing and manufacturing services. These contracts are cancelable by us upon prior written notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation. The amount and timing of such payments are not known.

CMOs and CROs

We enter into contracts in the normal course of business with CMOs, CROs and other third parties for the manufacture of our product candidates and to support clinical trials and preclinical research studies and testing. These contracts are generally cancelable by us. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation. The amount and timing of such payments are to be determined.

Related Party Lease

Our manufacturing facility, lab and office are leased from ImaRX Investments, LLC, or the Lessor, which is 100% owned by Dr. Evan Unger, our Co-Founder, Executive Chairman and a major stockholder of ours, along with certain of his family members, who are also stockholders of the Company. The manufacturing facility, lab and office lease was entered into August 27, 2017, for a term of five years. We paid monthly rent of $1 to the Lessor and 1,285 common units to Dr. Unger under the original Lease Agreement.

The lease agreement was verbally amended in August 2022, which was memorialized in a new lease agreement on April 12, 2024. The base rent was increased to $5,425 per month for the lab and office and $6,129 for the manufacturing facility, with both rates subject to escalating rent payments of 4% per year. The amended lease expires on August 26, 2032, with an early termination period starting on April 30, 2026. The tenant has two renewal options for five years each. The lease payments are as follows: The base rent is approximately $5 thousand for the office space and approximately $6 thousand for the manufacturing facility space at the commencement of the lease. The rent for the manufacturing facility includes all prior improvements made by the Lessor and, on August 27, 2026, the base rent for the manufacturing facility will be reduced to the same price per rentable square foot per month as the laboratory office space at that time. In addition to base rent, we are also responsible for our portion of utility, taxes, operating expenses, and other costs. The lease payment is subject to a 4% increase each year.

The ROU assets and operating lease liabilities are valued using the discount cash flow method, using 6% as discount rate.

The minimum lease payments as of March 31, 2026, if we do not exercise the early termination clause, are as follows (in thousands):

Debt and warrant liability obligations as of March 31, 2026 and December 31, 2025 consisted of the following (in thousands):