UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended March 31, 2026

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report

For the transition period from ________ to ________

Commission file number: 001-42915

ALPS GROUP INC

(Exact name of Registrant as specified in its charter)

N/A

(Translation of Registrant’s name into English)

Cayman Islands

(Jurisdiction of incorporation or organization)

Unit E-18-01 & E-18-02, Level 18, Icon Tower (East)

No. 1, Jalan 1/68F, Jalan Tun Razak

50400 Kuala Lumpur

Wilayah Persekutuan, Malaysia

(Address of principal executive offices)

Dr. Tham Seng Kong

Telephone: +603-2163 1113

Unit E-18-01 & E-18-02, Level 18, Icon Tower (East)

No. 1, Jalan 1/68F, Jalan Tun Razak

50400 Kuala Lumpur

Wilayah Persekutuan, Malaysia

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Securities registered or to be registered pursuant to Section 12(g) of the Act.

None

(Title of Class)

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

None

(Title of Class)

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

As of March 31, 2026, the issuer had 166,400,314 Ordinary Shares, par value $0.0001 per share, issued and outstanding.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes ☐ No ☒

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Yes ☐ No ☒

Note - Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐

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

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

TABLE OF CONTENTS

INTRODUCTION

Except as otherwise indicated or required by context, references in this annual report to “we,” “us,” “our,” “our company,” “Alps,” “Alps Group,” “the Company” and “PubCo” are refer to Alps Group Inc and its subsidiaries and consolidated affiliated entity(ies).

Our consolidated financial statements are presented in U.S. dollars. All references in this annual report to “$,” “U.S. $”, “U.S. dollars”, “USD” and “dollars” mean U.S. dollars, unless otherwise noted.

We completed a Business Combination with Globalink on October 28, 2025. Pursuant to the terms of the Merger Agreement, the Business Combination between Globalink and Alps was effected in two steps: (i) Globalink merged with and into the Company, with into the Company remaining as the surviving publicly traded entity (the “Redomestication Merger”); and (ii) Merger Sub merged with and into Alps Holdco, resulting in Alps Holdco remaining as the surviving entity and a wholly-owned subsidiary of into the Company (the “Acquisition Merger”). The Company’s Ordinary Shares began trading on the Nasdaq Stock Market LLC (“Nasdaq”) under the symbol “ALPS” on October 31, 2025. Our Warrants are listed on the OTCID under the symbol “ALPWF.”

This annual report on Form 20-F includes our audited consolidated financial statements for the fiscal years ended March 31, 2026, March 31, 2025, and March 31, 2024.

In this annual report on Form 20-F, unless the context otherwise requires, references to:

FORWARD-LOOKING STATEMENTS

This annual report on Form 20-F (including information incorporated by reference herein, the “Report”) contains forward-looking statements that reflect our current expectations and views of future events. The forward-looking statements are contained principally in “Item 3. Key Information—D. Risk Factors,” “Item 4. Information on the Company—B. Business Overview,” and “Item 5. Operating and Financial Review and Prospects.” These forward-looking statements are made under the “safe-harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Known and unknown risks, uncertainties and other factors, including those listed under “Item 3. Key Information—D. Risk Factors,” may cause our actual results, performance, or achievements to be materially different from those expressed or implied by the forward-looking statements.

The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “goal,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and “ongoing,” or the negative of these terms, similar expressions or other comparable terminology intended to identify statements about the future. We have based these forward-looking statements largely on our current expectations and projections about future events that we believe may affect our financial condition, results of operations, business strategy, and financial needs. These forward-looking statements include statements relating to:

These forward-looking statements are based on information available as of the date of this Report, and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

You should not place undue reliance on these forward-looking statements. New risk factors and uncertainties emerge from time to time and it is not possible for our management to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business 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. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements.

This Report also contains statistical data and estimates that we obtained from industry publications and reports generated by third-party providers of market intelligence. These industry publications and reports generally indicate that the information contained therein was obtained from sources believed to be reliable, but do not guarantee the accuracy and completeness of such information.

Part I

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

Not applicable.

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE

Not applicable.

ITEM 3. KEY INFORMATION

Not applicable.

Not applicable.

Our business faces significant risks and uncertainties. You should carefully consider all of the information contained in this Annual Report, together with the other documents we file with or furnish to the SEC, including the risk factors described below, before deciding whether to invest in, or continue to hold, our securities. If any of the following risks, or other risks and uncertainties that are currently unknown to us or that we currently deem immaterial, materialize, our business, reputation, financial condition, results of operations, cash flows and the market price of our securities could be materially and adversely affected. The risk factors described below should not be regarded as a complete or exhaustive discussion of all the risks that we may face.

The risk factors set forth below relate to the business and operations of Alps Group Inc, its wholly owned subsidiary Alps Holdco, Alps Malaysia and their respective subsidiaries and consolidated affiliated entities (collectively, the “Company,” “Alps,” “we”, “us” and “our”). Where applicable, specific references to a company will refer to such company only.

Risks Related to Alps’ Business and Industry

Alps Group Inc is a recently formed public holding company with limited operating history, which may make it difficult to evaluate our business and prospects.

Alps Group Inc recently completed the Business Combination and operates as a holding company through Alps Life Sciences Inc., which in turn operates through Alps Global Holding Berhad and its subsidiaries. As a newly public company, Alps Group Inc. has limited operating history as a consolidated group, and investors have limited historical information upon which to evaluate our business, operations and prospects.

As a biotechnology entity, our product pipeline remains in the preclinical stage. Our activities have primarily focused on strategic planning, fundraising, intellectual property development, identifying new therapeutic targets, and advancing product candidates through various stages of research and development. Alps’ pipeline includes biologics and biopharmaceuticals, none of which have obtained regulatory approval, and none of our product candidates has commenced clinical trials.

As a result, Alps’ ability to successfully undertake and complete pivotal clinical trials, secure regulatory approvals, scale up manufacturing, or engage in effective sales and marketing for product commercialization remains unproven. Despite Alps’ significant investments in research, development, and operations, forecasting our future with any degree of certainty is more challenging than it would be as compared to a company with a more extensive operational history or closer proximity to commercialization.

In addition, we expect to face challenges associated with operating as an early-stage biotechnology company and a newly public company, including managing growth, prioritizing research and development initiatives, securing additional financing, complying with increased regulatory and reporting obligations, and executing our business strategy. Alps is also likely to face unexpected expenses and obstacles that could adversely impact its business. Failure to effectively mitigate these risks could adversely impact our business.

Alps will need to obtain substantial additional funding to complete the development of its product candidates.

We expect to continue to incur significant expenses in connection with our ongoing activities, particularly as we advance the research and development of our product candidates and technology platforms, including MyImmune, MyCelEst, and patient-derived organoid-based personalized cancer test development. The development of biotechnology products is capital-intensive and involves significant uncertainties, including the costs associated with research and development activities, regulatory requirements, manufacturing capabilities and potential commercialization efforts.

Following the successful completion of the Business Combination, Alps intends to use its available resources to support the development of its product candidates and technology platforms, as well as for other research and development activities, working capital, and general corporate purposes. In addition, as a newly listed public company, Alps expects to incur increased costs associated with legal, accounting, regulatory compliance, corporate governance and other obligations applicable to public companies.

As Alps continues to advance its research and development programs, it may require substantial additional funding through public or private equity offerings, debt financing, strategic collaborations, licensing arrangements or other sources. However, obtaining additional financing may result in dilution to our stockholders or impose burdensome debt covenants and repayment obligations. Our future capital requirements and the timing and amount of our operating expenditures will depend largely on:

The availability of additional funding on terms favorable to us is not guaranteed. Should we fail to secure the necessary capital in adequate amounts or under acceptable terms, we might be compelled to reduce our workforce significantly, delay, downscale, or cease the development or commercialization of our product candidates, or explore less desirable collaborations for our product candidates. Such scenarios could severely impact our business prospects, financial health, operational results, and lead to a decline in the market price of Alps’ securities.

Our liquidity position is exposed to risks arising from our near-term debt obligations, and failure to meet these obligations may materially harm our business.

We have $10,199,391 of total liabilities as at March 31, 2026, and we may incur additional indebtedness in the future for various reasons, including research and development programs, fluctuations in operating results, capital expenditures, potential acquisitions and other strategic initiatives.

Any indebtedness incurred by Alps could result in increased financial obligations and may adversely affect its financial flexibility. Such indebtedness may:

In addition, if Alps is unable to generate sufficient cash flows or obtain additional financing to satisfy its obligations, Alps may be required to delay, reduce or discontinue certain research and development activities or modify its business strategy. Any inability to manage its liquidity position or meet its financing obligations could materially and adversely affect Alps’ business, financial condition and results of operations.

Alps has identified a material weakness in its internal control over financial reporting and may identify additional material weaknesses in the future that may cause it to fail to meet its reporting obligations or result in material misstatements in its financial statements. If Alps fails to remediate its material weakness, Alps may not be able to report its financial results accurately or to prevent fraud.

Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with IFRS. A material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented or detected on a timely basis by the company’s internal controls.

Prior to the completion of the Business Combination, Alps Malaysia and its subsidiaries operated as a private group and had limited accounting and financial reporting personnel and resources compared with those typically available to a public company. As a private company, Alps Malaysia was not required to establish and evaluate its internal control over financial reporting in accordance with the standards applicable to public companies under Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”). Following the completion of the Business Combination, Alps Group Inc. became subject to the reporting requirements applicable to public companies under the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of the SEC.

In connection with our evaluation of internal control over financial reporting, we identified a material weakness primarily relating to (i) a lack of sufficient accounting and supervisory personnel with the appropriate level of technical accounting experience and training, (ii) limited supervision over external advisors providing technical accounting services, and (iii) inconsistent application of accounting processes and procedures by our accounting personnel. As a result, we may not always prevent or detect misstatements in our financial statements on a timely basis.

We have taken, and continue to take, measures to remediate the identified material weakness, including enhancing our accounting and financial reporting processes, strengthening documentation and control procedures, improving segregation of duties, enhancing personnel training relating to IFRS, SEC reporting requirements and internal controls, and appointing a Chief Financial Officer (“CFO”) to strengthen our finance leadership and support our obligations as a public company. However, the remediation process remains ongoing, and we cannot assure you that these measures will fully address the identified material weakness within the expected timeframe or that additional deficiencies will not be identified in the future.

If we fail to establish and maintain effective internal control over financial reporting, we may be unable to accurately report our financial results, prevent or detect material misstatements or fraud, or comply with our reporting obligations as a public company. In addition, our independent registered public accounting firm may disagree with management’s assessment of the effectiveness of our internal controls or identify additional deficiencies. Any failure to maintain effective internal controls could result in material misstatements in our financial statements, delays in financial reporting, regulatory scrutiny, loss of investor confidence, limitations on our ability to access capital markets and a decline in the market price of Alps’ securities.

We may not meet publicly announced product development objectives.

We sometimes estimate for planning purposes the timing of the accomplishment of various scientific, clinical, regulatory and other product development objectives. These milestones may include our expectations regarding the commencement or completion of scientific trials or clinical trials, the submission of regulatory filings or the achievement of commercialization objectives. From time to time, we may publicly announce the expected timing of some of these milestones, such as the completion of an ongoing clinical trial, the initiation of other clinical programs, receipt of marketing approval or a commercial launch of a product. The achievement of many of these milestones is outside of our control. All of these milestones are based on a variety of assumptions, which may cause the timing of achievement of the milestones to vary considerably from our estimates. If we fail to achieve announced milestones in the timeframes we expect, or at all, it may have a material adverse effect on our business, financial condition and results of operations and the price of our securities may be adversely affected.

Risks Related to Development of Our Product Candidates

The selection and prioritization of our product candidates for development are subject to change based on various factors. Abandoning a product candidate’s development or changing our development priorities could leave us without a viable replacement, impacting our business prospects.

Alps may determine to abandon the development of one or more of Alps’ product candidates, or we may change the prioritization of the development of certain product candidates, or Alps may select or acquire and prioritize the development of new product candidates. Alps’ choice and prioritization of product candidates for development will be influenced by a variety of factors, including but not limited to:

Alps faces challenges in developing its manufacturing capabilities and currently relies may rely on third-party manufacturers, exposing it to various risks including lack of accessibility, quality control, quantity limitations, manufacturing delays, contractual breaches or terminations.

The manufacturing of biotechnology product candidates is complex, requiring significant expertise and capital, including the development of advanced manufacturing facilities, which we currently lack. Unless Alps we can finance and develop its own our manufacturing facilities, we will need to depend on third-party manufacturers, with no guarantee of favorable terms or availability. Whether Alps manufactures products or rely relies on third parties, it faces risks including manufacturing delays, inability to meet quality and quantity requirements, regulatory compliance challenges, and potential contract breaches or terminations. Regardless of whether Alps manufactures or relies on third parties to manufacture products for Alps, Alps we will face all risks related to the manufacture of therapeutic products for use in medicine including the following risks:

In addition, Alps in the future may rely on third parties to perform release testing on Alps’ product candidates prior to delivery to patients. If these tests are not appropriately conducted and test data are not reliable, patients could be put at risk of serious harm which could result in product liability suits.

If Alps or any third-party manufacturers that Alps may engage were to encounter any of these difficulties, Alps’ ability to provide Alps’ product candidates to patients in clinical trials or to the medical marketplace would be jeopardized. Any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, could require Alps to either commence new clinical trials at additional expense or terminate clinical trials completely.

The regulatory authorities also may, at any time following approval of a product for sale, audit Alps’ manufacturing facilities or those of Alps’ third-party contractors. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of Alps’ product specifications or applicable regulations occurs independent of such an inspection or audit, Alps or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for Alps or a third party to implement and that may include the temporary or permanent suspension of a clinical study or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon Alps or third parties with whom we contract could materially harm Alps’ business.

Additionally, if supply from one approved manufacturer is interrupted, there could be a significant disruption in commercial supply. The regulatory agencies may also require additional studies if a new manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial costs and is likely to result in a delay in Alps’ desired clinical and commercial timelines.

Alps may not be able to manufacture product that meets release criteria due to sterility, identity or potency issues. Alps may not have access or be able to make the reagents necessary to manufacture the cells and Alps may not have access to adequate supply channels to transport and distribute the products. There are also risks that the cells may be destroyed by interruption in their cryopreservation by means of natural disasters such as earthquakes, power outages, or other unexpected events, or the cells may be determined to be unacceptable as a source of human cellular therapies for reasons Alps cannot envision. Alps cannot assure you that any stability or other issues relating to the manufacture of any of Alps’ product candidates or products will not occur in the future. If any of Alps’ master cell banks are lost or destroyed, including due to systems failure, Alps’ planned clinical trials would be severely delayed, and Alps would incur significant costs associated with obtaining new supply of cell banks. Accordingly, failures or difficulties faced at any level of Alps’ supply chain could adversely affect Alps’ business and delay or impede the development and commercialization of any of Alps’ product candidates or products and could have an adverse effect on Alps’ business, prospects, financial condition and results of operations.

There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing cell-based products for Alps. Accordingly, Alps’ cell-based products may have to compete with other cell-based products to access these manufacturing facilities. Future therapies that Alps may develop may compete with other product candidates and products for access to manufacturing facilities. Any performance failure on the part of Alps’ existing or future manufacturers could delay clinical development or marketing approval.

Each of these risks could delay Alps’ clinical trials, any regulatory approval of Alps’ product candidates, or the commercialization of Alps’ product candidates, and could result in higher costs or deprive Alps of potential product revenue.

Our current product candidates are in preclinical development and have never been tested in humans. One or all of our current product candidates may fail in clinical development or suffer delays that materially and adversely affect their commercial viability.

To date, none of our candidates has proceeded to clinical trials or been tested in humans. Our future profitability hinges on our ability to obtain regulatory approvals and successfully commercialize our product candidates, either independently or with partners.

Achieving commercial distribution for our product candidates requires extensive preclinical studies and clinical trials to prove their safety, purity, and efficacy in humans. Although we have observed positive outcomes observed in preclinical animal models for treatment of heart failure using iPSC-derived cardiomyocytes, these findings may not necessarily translate to similar success in future human clinical trials. There’s a risk that our product candidates may not exhibit the desired safety and efficacy in later stages of clinical development, even if they show promise in early trials. It is uncertain whether NPRA will authorize us to conduct clinical trials. Moreover, the completion and outcomes of our preclinical studies are unpredictable, and it is uncertain whether the NPRA or other regulatory bodies will approve our clinical programs, protocols, or support the further development of our preclinical programs for human testing.

Further, some or all of Alps’ product candidates under development may require the genetic modification of the pluripotent master cell banks. There is no certainty that a genetic modification will provide a long-term solution to transplant rejection, or that the modified cells will not cause unanticipated health risks to the patient that could delay or even halt the development of the products.

The preclinical development stage exposes us to inherent risks of failure associated with novel therapeutic approaches, targets, and action mechanisms. While we plan to initiate clinical trials for our leading candidates, there’s no assurance of progressing to clinical development for any candidate or of demonstrating clinical benefits in patient testing. Considering the costs, uncertainties, delays, and challenges typical for preclinical stage biotechnology company like us, our prospects should be evaluated accordingly.

We may not be able to access the financial resources to continue development of, or to enter into any collaborations for, any of our current or potential future product candidates. This may be exacerbated if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, a product candidate, such as:

Clinical trials are expensive, time-consuming and difficult to design and implement. There can be no assurance that our product candidates will be able to successfully complete clinical trials. The failure of our product candidates to complete clinical trials may have a material adverse effect on our business, financial condition, results of operations and prospects.

Human clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Because our current and potential future product candidates are based on new technologies and discovery approaches, we expect that they will require extensive research and development and have substantial manufacturing and processing costs. In addition, the NPRA or other regulatory authorities may require us to perform additional testing before commencing clinical trials and may be hesitant to allow us to enroll patients impacted with our targeted disease indications in our future clinical trials. If we are unable to enroll patients impacted by our targeted disease indications in our future clinical trials, we would be delayed in obtaining potential POC data in humans, which could extend our development timelines. In addition, costs to treat patients and to treat potential side effects that may result from our product candidates may be significant. Accordingly, our clinical trial costs are likely to be high and there is no assurance that our product candidates will successfully complete clinical trials. A failure to complete clinical trials could have a material adverse effect on our business, financial condition, results of operations and prospects.

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

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. We may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of clinical trials of our product candidates, and even once enrolled we may be unable to retain a sufficient number of patients to complete the trials. The enrollment of patients depends on many factors, including:

In addition, clinical trials of our product candidates may compete with other clinical trials for product candidates of other companies that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in trials of our product candidates may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect that clinical trials or our product candidates may be conducted at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site.

Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop our product candidates or could render further development impossible.

Compassionate use of stem cells therapies and/or other medical treatments and procedures provided by Alps may subject us to medical malpractices, result in injuries that lead to costly liability suits, and/or subject us to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any products and/or product candidates.

We have facilitated compassionate use of stem cells therapies in Malaysia, in accordance with the applicable laws and regulations established by the Malaysian regulatory authorities.

In Malaysia, the Control of Drugs and Cosmetics Regulations 1984, under the Sale of Drugs Act 1952, allows hospitals or physicians to apply for an exemption from license registration for importing or manufacturing products solely for treating patients with life-threatening conditions, as per Regulation 15(6). This regulatory pathway enables the compassionate use or named patient program, extending to patients already part of an approved clinical trial. The application criteria for such programs are stringent, necessitating the treatment to be for patients facing serious or immediate life-threatening conditions, with no alternative therapies available, among other considerations. While Alps strives to ensure its applications for compassionate use align with the requirements established by the Malaysian authorities, there remains a risk that regulatory perspectives may diverge from Alps’ interpretations. If Alps’ determination does not align with regulatory perspective and Alps becomes required to make compassionate use applications, Alps’ results of operations and project development timeline may be adversely affected.

The investigational nature of Alps’ products under compassionate use implies that their safety and efficacy profiles are not fully established, typically warranting their use within clinical trial settings. Post-trial access to investigational products is facilitated through the compassionate use program in Malaysia, which is strictly limited to participants of approved clinical trials involving CTIL and CTX, on a named patient basis. Our physicians are responsible for off-label compassionate use of our product candidates which requires comprehensive patient consent prior to treatment initiation.

Given these conditions, there is an inherent risk of future legal liabilities or damages stemming from the off-label compassionate use of our product candidates. Should adverse outcomes arise from such use, or if regulatory authorities interpret our compliance with compassionate use provisions differently, we may face lawsuits that could significantly impact our operations and financial standing. The legal and regulatory landscape for compassionate use is complex and subject to change, and our engagement in these programs, despite rigorous adherence to existing guidelines, may expose us to unforeseen liabilities. Our assumptions regarding the use of investigational products are based on the current interpretation of applicable regulations. However, if Alps fails to comply with the evolving legal and regulatory framework governing cell and gene therapy products, the Company may face regulatory scrutiny, investigations, fines, or other penalties, which could adversely affect our business, revenue projections, operations, and financial condition.

In addition, Alps’ provision of medical treatments and procedures entails inherent risks associated with medical malpractice, despite rigorous adherence to industry standards and best practices. There is a risk that patients may experience adverse outcomes, complications, or dissatisfaction with the provided medical care, leading to potential claims of medical malpractice. Such claims could arise from allegations of negligence, errors in diagnosis or treatment, failure to obtain informed consent, or breaches of duty of care. While Alps endeavors to maintain high standards of medical care and employs qualified healthcare professionals, there remains the possibility of human error, unforeseen complications, or adverse reactions to treatments. Moreover, factors beyond Alps’ control, such as patient-specific conditions, medical histories, or external environmental factors, may contribute to adverse outcomes or perceived medical malpractice.

Alps maintains medical malpractice insurance coverage to mitigate the financial risks associated with potential medical malpractice claims. However, there can be no guarantee that such insurance coverage will be adequate to fully indemnify Alps against all potential liabilities arising from medical malpractice claims. Such claim whether meritorious or not, could result in significant legal expenses, damage to reputation, and financial liabilities for Alps. Furthermore, adverse publicity stemming from medical malpractice claims may impact patient confidence, referral patterns, and overall business operations.

The commercial success of any of Alps’ current or future product candidates will depend upon the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community.

Even with approvals from the NPRA and comparable foreign regulatory authorities such as the FDA, the commercial success of Alps’ products will depend in part on the health care providers, patients, insurers, and third-party payors accepting Alps’ product candidates as medically useful, cost-effective, and safe. Any product that Alps bring to the market may not gain market acceptance by physicians, patients, insurers, third-party payors and other health care providers. The clinical development, commercialization, and marketing of our product candidates are at an early-stage, substantially research-oriented, and financially speculative. It is important to recognize that developing and bringing cell therapies to market is a challenging endeavor, with only a few companies achieving success thus far. Cell therapies, in general, carry inherent risks, including potential side effects, immune system responses, limited therapeutic efficacy, and high costs, which may hinder their regulatory approval or commercial adoption. Alps’ success hinges on several factors, including the establishment of a robust global market for cell therapies and its ability to carve out a competitive position within this evolving landscape with its product candidates.

Even if Alps, a collaborator, or a licensee of Alps’ technology successfully develop and obtain regulatory approval for Alps’ product candidates, the market may not understand or accept them. Alps’ product candidates represent novel treatments and are expected to compete with a number of more conventional products and therapies manufactured and marketed by others, including major pharmaceutical and biotechnology companies. The degree of market acceptance of any of Alps’ products will depend on a number of factors, including without limitation:

Even if a product displays a favorable efficacy and safety profile upon approval, market acceptance of the product will initially remain uncertain. Efforts to educate the medical community and third-party payors on the benefits of the products may require significant investment and resources and may never be successful. If Alps’ products fail to achieve an adequate level of acceptance by physicians, patients, third-party payors, and other health care providers, Alps will not be able to generate sufficient revenue to become or remain profitable.

If the use or misuse of Alps’ product candidates harm patients or is perceived to harm patients even when such harm is unrelated to Alps’ product candidates, Alps’ regulatory approvals could be revoked or could otherwise be negatively impacted, and Alps could be subject to costly and damaging product liability claims.

The use or misuse of any product candidates in future clinical trials and the sale of any products for which Alps obtain marketing approval exposes Alps to the risk of product liability claims. Product liability claims might be brought against Alps by consumers, healthcare providers, pharmaceutical companies, or others selling or otherwise coming into contact with Alps’ products. There is a risk that Alps’ product candidates may induce adverse events. If Alps cannot successfully defend against product liability claims, Alps could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:

Alps may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect Alps against losses due to liability. If and when Alps commence clinical trials or obtain regulatory and marketing approval for any product candidates, Alps intends to increase Alps’ insurance coverage to include clinical use or the sale of commercial products, as applicable; however, Alps may be unable to obtain product liability insurance on commercially reasonable terms or in adequate amounts. On occasion, large judgments have been awarded in lawsuits based on drugs or medical treatments that had unanticipated adverse effects. A successful product liability claim or series of claims brought against Alps could cause Alps’ stock price to decline and, if judgments exceed Alps’ insurance coverage or if the insurer refuses to cover and insure the claim, such factors could adversely affect Alps’ results of operations and business.

Alps’ business entails a significant risk of product liability, and its inability to obtain sufficient insurance coverage could have a material effect on its business, financial conditions, results of operations and prospects.

Alps does not currently have insurance coverage for all potential risks inherent in the business operations of its subsidiaries.

As Alps conducts preclinical studies and future clinical trials for its product candidates, it exposes itself to inherent risks associated with product development, testing, manufacturing, and marketing. Despite any future efforts to secure additional product liability insurance, there is no guarantee it will fully reimburse Alps for potential expenses or losses incurred from liability claims. If Alps obtains marketing approval for any of its product candidates, such claims could trigger regulatory investigations into the safety and effectiveness of the products, manufacturing processes, and facilities, or the marketing programs. This could potentially result in product recalls or more serious enforcement actions, limitations on approved indications, or even the suspension or withdrawal of approvals. A successful product liability claim or series of claims against Alps could cause a decline in its share price. If judgments exceed Alps’ insurance coverage, it could adversely affect its results of operations and business, including preventing or limiting the commercialization of any product candidates it develops.

Moreover, insurance coverage is becoming increasingly expensive, and in the future, Alps or any future collaborators may struggle to maintain adequate coverage at a reasonable cost or in sufficient amounts to protect against liability losses.

Any cell-based products that receive regulatory approval may be difficult and expensive to manufacture on a commercial scale.

Producing cell-based therapeutic products derived from pluripotent stem cells and mesenchymal cells for commercial use presents substantial challenges, as these cells have traditionally been generated only on a small scale. This scale is not sufficient for the mass commercialization required for widespread market penetration. Should Alps succeed in advancing cell-derived therapeutic products to the market, significant advancements in manufacturing facilities, processes, and technologies will be essential for commercial-level production. Given the complex nature of pluripotent stem cell and mesenchymal cell products, manufacturing them on a commercial scale is anticipated to be more costly compared to most existing drugs. This increased manufacturing cost necessitates setting higher prices for these products to cover costs and generate profit. However, if the pricing makes these products prohibitively expensive, healthcare institutions and professionals might hesitate to adopt them, potentially impacting the volume of sales needed for Alps to recover development costs and achieve profitability.

The manufacturing operations of some of our potential product candidates including but not limited to cosmetics products infused with exosomes are themselves dependent upon third-party suppliers, making us potentially vulnerable to supply shortages and price fluctuations, which could harm our business.

We are currently at the stage where we are able to derive exosomes from human Umbilical Cord Mesenchymal Stem Cells (hUMSCs) with our in-house facilities at MYCELEST. We are in the process of exploring the development of exosome infused products and have not developed or manufactured exosome infused products. At this time, we are not capable of manufacturing the finished cosmetics products such as facial masks and face serum infused with exosomes in-house. Accordingly, we expect to rely on third party manufacturers to produce any exosome infused products that we develop in the future. Such future reliance on third party manufacturers or suppliers could potentially expose us to risks that could harm our business, including:

Any interruption in the supply, or our inability to obtain substitute from alternate sources at acceptable prices in a timely manner, could harm our ability to perform procedures, fulfil customer orders and satisfy market demand until new sources of supply are identified and qualified. As of the date of this annual report, we have not entered into any contracts with third parties for the manufacture of finished cosmetic products.

Alps’ inability to distinguish the product candidates from other similar treatment or solutions may restrict market acceptance of its products and market share.

While our line of product candidates represents a relatively new entry into the Southeast Asia market, it may not possess striking novelty against its predecessors. Alps’ future success will depend on our ability to increase demand for its products by demonstrating to a broad spectrum of healthcare providers the potential performance advantages and cost-effectiveness of our products, and our inability to do so could have a material adverse effect on the business, financial condition, and results of operations. As a result, we generally are required to invest a significant amount of time and resources to educate healthcare administrators and other purchasers about the benefits of a product in comparison to competing products and technologies before completing a sale, if any.

Several factors could hinder healthcare professionals’ adoption of our product candidates, including doubts about product efficacy, costs and reliability. Healthcare administrators considering our technology must allocate time to grasp the innovation, gauge physician receptiveness, evaluate the financial implications for their practice, and become adept at introducing and utilizing our products. Without a pressing competitive need, administrators may not prioritize learning about our products’ potential advantages. Acceptance and adoption by healthcare professionals may be contingent on additional clinical evidence supporting our products’ safety and effectiveness or endorsements from respected figures within the healthcare community. Moreover, economic pressures, such as downturns, shifts in healthcare reimbursement policies, or market-specific competitive challenges, might deter healthcare organizations from investing in significant capital equipment or new technologies.

Risks Related to Our Intellectual Property

Alps relies on patents and intellectual property rights licensed from third parties to engage in research, development and commercialization activities. If we fail to maintain these licenses on terms favorable or otherwise acceptable to Alps, Alps’ ability to engage in research, development and commercialization activities may be materially impacted, resulting in a materially adverse effect on our business, financial condition and operational results.

Alps, its affiliate and/or subsidiaries holds licenses granting them rights to third-party intellectual property that is necessary or useful to its business. In particular, Alps has obtained licenses from certain individuals for intellectual property concerning stem cell and/or exosome processing technologies.    Alps may enter into additional licenses to third-party intellectual property in the future.

Alps’ licenses to such intellectual property rights may not provide exclusive or unrestricted rights in all fields of use and in all territories in which Alps may wish to develop or commercialize its products in the future and may restrict its rights to offer certain products in certain markets, including through non-compete provisions, or impose other obligations on Alps in exchange for its rights to the licensed intellectual property. In addition, Alps may not have full control over the maintenance, protection, enforcement or use of the intellectual property rights in-licensed from licensors, and therefore Alps may be reliant on the licensors to conduct such activities.

These in-licensed patents are critical to our research, development, and commercialization activities. Our success will depend in part on the ability of our licensors to obtain, maintain, and enforce patent protection for the licensed intellectual property. While these arrangements enable access to essential technology and intellectual property, they also pose several risks that could adversely affect our business, financial condition, and operational results, as follows:

Alps relies on in-licensed patents registered in China for research and development activities even though Alps operates its business from Malaysia. As such, there is a risk that these in-licensed patents will not constitute adequate protection and affect our ability to successfully develop and commercialize our products.

Alps relies on in-licensed patents from China to support its research, development, and commercialization activities. However, these patents provide protection solely within China and may not offer adequate protection in other region(s) where Alps operates. Currently, Alps operates and conducts all of its research and development activities in Malaysia. It also works with strategic research partners that are based in Malaysia and also expects to develop products for commercialization in Malaysia and other territories outside of China. As these in-licensed patents do not extend protection beyond China, Alps faces the possibility that competitors could develop similar or derivative products, potentially leading to market saturation and increased competition, impacting its ability to commercialize its own products successfully. In addition, there will always be a risk that competitors or other third parties could challenge the validity or enforceability of any patent issued or licensed or sublicensed to Alps, Alps’ ability to defend its intellectual property rights could be compromised. This may lead to delays or difficulties in bringing products to market, or even the inability to commercialize products entirely, particularly in regions where patent protection is absent or weak. Such challenges could significantly impact Alps’ long-term growth and ability to compete effectively in global markets.

If Alps, its subsidiaries, or associate companies fail to meet their obligations under license agreements, they risk losing the rights to critical technologies upon which the business depends.

Alps relies on license agreements with third parties, including research institutions, academic collaborators and other technology providers, for certain intellectual property rights and technologies that are important to its research and development activities. These agreements may impose various obligations on Alps, including payment obligations, development milestones, diligence requirements, confidentiality obligations, intellectual property protection obligations and other contractual commitments. If Alps, its subsidiary, or associate company fails to comply with their obligations under these license agreements, the relevant licensors may have the right to terminate the license or otherwise restrict Alps’ rights to use the licensed technologies. The loss of any such rights could prevent Alps from continuing to develop certain product candidates or technology platforms, require Alps to negotiate new or replacement licenses on less favorable terms, or result in delays, increased costs or the discontinuation of certain research and development activities.

In some cases, patent prosecution of our licensed technology is controlled solely by the licensor. If our licensors fail to obtain and maintain patent or other protection for the proprietary intellectual property we license from them, we could lose our rights to the intellectual property and our competitors could market competing products using the intellectual property.

In addition, the agreements under which Alps, its affiliate and/or subsidiaries currently licenses or otherwise obtains rights to intellectual property from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations, which may lead to disputes between Alps and its licensor, including:

The resolution of any contract disagreement that may arise could narrow what Alps believes to be the scope of its rights to the relevant intellectual property, or increase what Alps believes to be its financial or other obligations under the relevant agreement, either of which could have a material adverse effect on its business, financial condition, results of operations, and prospects. If Alps is required to engage in litigation to enforce or defend its rights under its license agreements, even if it is successful, such litigation could require significant financial resources, divert the attention of management and harm Alps’ business. Moreover, if disputes over intellectual property that Alps has licensed or otherwise obtained rights to prevent or impair Alps’ ability to maintain its current arrangements on commercially acceptable terms, or at all, Alps may be unable to successfully commercialize the affected product, which could have a material adverse effect on Alps’ business, financial condition, results of operations, and prospects.

Alps relies on intellectual property that is jointly developed with third parties which exposes Alps to risks associated with the failure of joint owners to maintain, protect, and enforce such intellectual property and divergent interests arising during the course of joint ownership.

Alps engages in collaborations and partnerships with other entities, including universities. Through these collaborations, we may jointly develop intellectual property that is crucial to our product development and commercialization efforts. While these partnerships can be instrumental in advancing our research and development capabilities, they also introduce significant risks associated with the joint ownership of intellectual property, including:

There is no certainty that Alps’ future patent applications will result in the successful registration of patents.

Alps may file additional new patent applications in the future seeking patent protection for new technology or products that Alps develops itself or jointly with others. However, there is no assurance that any of Alps’ licensed patent applications, or any patent applications that Alps may file in the future in the Malaysia or abroad, will result in the successful registration of such patents.

Navigating the patent application and maintenance process demands considerable investment and time, characterized by: