ACOG

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How ACOG rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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Summary of Risk Factors Risks Related to Commercialization and Manufacturing ● ZUNVEYL oral tablet formulation may fail to achieve the broad degree of adoption and use by physicians, patients, hospitals, healthcare payors and others in the medical community necessary for commercial success. ● The market opportunities for ZUNVEYL oral tablet formulation may be smaller than we anticipate. ● We rely on third-party suppliers to manufacture our product candidates, and we intend to rely on third parties to produce commercial supplies of ZUNVEYL and any other approved product.
Risks including periodic foreign economic downturns and political instability, which may adversely affect the Company’s ability to obtain materials and conduct business in Taiwan. ● Our product candidates have not previously been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale.
Risks Related to Our Financial Position ● We are a commercial stage biopharmaceutical company in the early stages of commercial development of our one product approved for commercial sale and have incurred significant losses since our inception.
Risks Related to Our Business Development ● Our business is heavily dependent on commercial success of of ZUNVEYL oral tablet formulation, our only FDA approved product, and the development and commercialization of any future product candidates that we may develop or acquire. ● We may not successfully expand our pipeline of product candidates.
If we are not successful in identifying, developing, in-licensing, acquiring or/and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired. ● We may encounter substantial delays in our preclinical studies and clinical trials or may not be able to conduct or complete our preclinical studies or clinical trials on the timelines we expect, if at all. ● Use of our therapeutic candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a therapeutic candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition. ● Interim “top-line” and preliminary data from studies or trials that we announce or publish from time to time may change as more data becomes available and are subject to audit and verification procedures that could result in material changes in the final data. ● We have conducted all of our clinical trials to date outside of the United States, and in the future plan to conduct clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials. ● If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates. ● We identified material weaknesses in our internal control over financial reporting which are in the process of being remediated, and if we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired.
Risks Related to Our Common Stock ● Our stock price may be volatile, and you may not be able to resell common stock at or above the price you paid. ● An active, liquid and orderly market for our common stock may not develop, and you may not be able to resell your common stock at or above the initial public offering price. ● We are an “emerging growth company” and a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to emerging growth companies and smaller reporting companies, our common stock may be less attractive to investors. ● Risks related to the Company being a “passive foreign investment company” under United States tax laws. ● If we sell common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline. ● Concentration of ownership of our voting securities, including common stock and Class B Preferred Series A Stock, among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions. ● Sales of a substantial number of our common stock in the public market could cause our stock price to fall. ● We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock; ● The Company has outstanding warrants denominated in both Canadian and U.S.
We may fail to comply with the rules that apply to public companies, including Section 404 of the Sarbanes-Oxley Act of 2002, which could result in sanctions or other penalties that could materially and adversely affect our business, financial condition, results of operations and prospects. ● Our business will be subject to the risks of climate change, natural catastrophic events, world events, and man-made problems such as power disruptions or terrorism Risks Related to Commercialization and Manufacturing ZUNVEYL oral tablet formulation may fail to achieve the broad degree of adoption and use by physicians, patients, hospitals, healthcare payors and others in the medical community necessary for commercial success.
The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including: ● the clinical indications for which the product is approved and patient demand for approved products that treat those indications; ● the safety and efficacy of our product as compared to other available therapies; ● the availability of coverage and adequate reimbursement from governmental healthcare plans or payors for any of our product candidates that may be approved; ● acceptance by physicians, operators of clinics and patients of the product as a safe and effective treatment; ● physician and patient willingness to adopt a new therapy over other available therapies to treat approved indications; ● overcoming any biases physicians or patients may have toward particular therapies for the treatment of approved indications; ● proper training and administration of our product candidates by physicians and medical staff; ● public misperception regarding the use of our therapies, if approved for commercial sale; ● patient satisfaction with the results and administration of our product candidates and overall treatment experience, including, for example, the convenience of any dosing regimen; ● the cost of treatment with our product candidates in relation to alternative treatments and reimbursement levels, if any, and willingness to pay for the product, if approved, on the part of insurance companies and other third-party payors, physicians and patients; ● the revenue and profitability that our products may offer a physician as compared to alternative therapies; ● limitations or warnings contained in the FDA-approved labeling for our products; ● any FDA requirement to undertake a REMS; ● the effectiveness of our sales, marketing and distribution efforts; ● adverse publicity about our products or favorable publicity about competitive products; and ● potential product liability claims.
For instance, the supply chains for our lead product candidate involve several manufacturers that specialize in specific operations of the manufacturing process, specifically, raw materials manufacturing, drug substance manufacturing and drug product manufacturing.
Relations between Taiwan and mainland China and other factors affecting military, political or economic conditions in Taiwan could materially and adversely affect our financial condition and results of operations, as well as the market price and the liquidity of our ordinary stock.
Our product candidates have not previously been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale.
In particular, we are working on developing a larger scale manufacturing process that is more efficient and cost-effective to commercialize our potential products, which may not be successful.
Our product candidates have not previously been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility, stability issues, lot consistency and timely availability of raw materials.
If any of our other product candidates receive regulatory approval, we expect to expand our sales organization with technical expertise and supporting distribution capabilities to commercialize each such product candidate, which will be expensive and time consuming.
Risks Related to Our Financial Condition We are a commercial biopharmaceutical company with one product approved for commercial sale and have incurred significant losses since our inception.
Our net losses were approximately $20.6 million and $14.6 million for the years ended December 31, 2025, and 2024, respectively.
As of December 31, 2025, we had an accumulated deficit of approximately $97.1 million.
We have only one product, ZUNVEYL formerly known as ALPHA-1062, approved for commercialization.
We have devoted substantially all our financial resources and efforts to the commercialization of ZUNVEYL and development of our other product candidates, including conducting preclinical studies and clinical trials.
We expect to continue to incur significant expenses and operating losses over the next several years and we continue the commercial roll out of ZUNVEYL and pursue our other product candidates.
We anticipate that our expenses will increase substantially for the foreseeable future as we: ● continue establish a commercialization infrastructure and scale up external manufacturing and distribution capabilities to commercialize ZUNVEYL oral tabulation formulation formerly known as ALPHA-1062 and any other product candidates for which we may obtain regulatory approval; ● conduct our ongoing and planned clinical trials of ALPHA-1062, as well as initiate and complete additional clinical trials; ● continue our clinical validation of ALPHA-1062 for moderate-to-severe Alzheimer’s disease and explore the potential of ALPHA-1062IN related to mTBI; ● adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products; ● maintain, expand and protect our intellectual property portfolio; ● hire additional clinical, manufacturing and scientific personnel; ● add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts; ● incur additional legal, accounting and other expenses in operating as a public company; and ● scale up our clinical and regulatory capabilities.
Our ability to continue to generate revenue and achieve profitability depends significantly on our ability to achieve commercial success with ZUNVEYL oral tablet formulation, our one FDA approved product, and continued development and commercialization of our other product candidates, if approved.
To date, we have generated approximately $6.8 million in revenue from the commercialization of ZUNVEYL To continue to generate revenue and become and remain profitable, we must succeed in the commercialization of ZUNVEYL and developing and eventually commercializing our other product candidates.
We have a limited operating history and no prior history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
To date, we have successfully obtained regulatory approval for only one product, ZUNVEYL oral tablets, and began to commercialize ZUNVEYL in 2025.
Prior to beginning commercialization efforts in 2025, we have no history of commercializing products.
We will need substantial capital to meet our financial obligations and to pursue our business objectives, including the continued commercialization of ZUNVEYL oral tablet formulation.
We expect to continue to incur significant expenses and operating losses over the next several years as we continue our commercialization activities for ZUNVEYL and our ongoing clinical trials of our other product candidates, initiate future clinical trials of our other product candidates, prepare for commercialization activities of our other product candidates and advance any of our other product candidates we may develop or otherwise acquire.
Our revenue is primarily derived from sales of ZUNVEYL as a result of our commercial development activities.
As of December 31, 2025, we had approximately $66.1 million in unrestricted cash and cash equivalents and have not generated positive cash flows from operations.
Based on our current business plans, we believe our existing cash and cash equivalents, will be sufficient for us to fund our ongoing operating expenses, commercialization expenses, and capital expenditures requirements through at least the next 12 months.
ZUNVEYL is expected to require substantial capital to continue our commercialization efforts and bring the product to market in the US.
We expect to incur significant commercialization expenses related to product manufacturing, sales, marketing, distribution, and continued R&D of ZUNVEYL.
Our foreign operations that are contracted in foreign currencies will be exposed to foreign exchange rate fluctuations as the financial results are translated from the local currency into U.S. dollars.
Specifically, the U.S. dollar cost of our operations in Canada, API manufacturing in Taiwan and manufacturing of ZUNVEYL in India is influenced by any movements in the currency exchange rate.
Currently, our revenue generating agreements are settled in U.S. dollars, however, we may in the future enter into revenue contracts in foreign currencies if and when we expand commercialization of ZUNVEYL.
The extent contracts related to our operating costs or revenue are settled in a foreign currency, if the U.S. dollar weakens against foreign currencies, the translation of these foreign currency denominated transactions could result in increased revenue decreased operating expenses and increased net income (decreased net loss).
Similarly, if the U.S. dollar strengthens against foreign currencies, the translation of these foreign currency denominated transactions could result in decreased revenue, increased operating expenses and decreased net income (increased net loss).
Risks Related to Our Business Development Our business is heavily dependent on the commercial success of ZUNVEYL oral tablet formulation, our only FDA approved product, and the development and commercialization of any future product candidates that we may develop or acquire.
The success of our business, including our ability to finance our Company and generate revenue in the future, will primarily depend on the commercial success of ZUNVEYL, our only FDA approved and commercially produced product, and the development, regulatory approval and commercialization of our other product candidates.

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Summary of Risk Factors Risks Related to Our Financial Position ● We are a commercial development stage biopharmaceutical company in the early stages of commercial development of our one product approved for commercial sale and have incurred significant losses since our inception.
Risks Related to Our Business Development ● Our business is heavily dependent on the successful commercialization of ZUNVEYL oral tablet formulation, our only FDA approved product, and the development and commercialization of any future product candidates that we may develop or acquire. ● We may not successfully expand our pipeline of product candidates.
If we are not successful in identifying, developing, in-licensing, acquiring or/and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired. ● We may encounter substantial delays in our preclinical studies and clinical trials or may not be able to conduct or complete our preclinical studies or clinical trials on the timelines we expect, if at all. ● Use of our therapeutic candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a therapeutic candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition. ● Interim “top-line” and preliminary data from studies or trials that we announce or publish from time to time may change as more data becomes available and are subject to audit and verification procedures that could result in material changes in the final data. ● We have conducted all of our clinical trials to date outside of the United States, and in the future plan to conduct clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials. ● If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates.
Risks Related to Commercialization and Manufacturing ● ZUNVEYL oral tablet formulation may fail to achieve the broad degree of adoption and use by physicians, patients, hospitals, healthcare payors and others in the medical community necessary for commercial success. ● The market opportunities for ZUNVEYL oral tablet formulation may be smaller than we anticipate. ● We rely on third-party suppliers to manufacture our product candidates, and we intend to rely on third parties to produce commercial supplies of ZUNVEYL and any other approved product.
Risks including periodic foreign economic downturns and political instability, which may adversely affect the Company’s ability to obtain materials and conduct business in Taiwan. ● Our product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale.
Risks Related to Our Common Shares and this Offering ● Our stock price may be volatile, and you may not be able to resell common shares at or above the price you paid. ● An active, liquid and orderly market for our common shares may not develop, and you may not be able to resell your common shares at or above the public offering price. ● We are an “emerging growth company” and a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to emerging growth companies and smaller reporting companies, our common stock may be less attractive to investors. ● Risks related to the Company being a “passive foreign investment company” under United States tax laws. ● If we sell common shares in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline. ● Concentration of ownership of our voting securities, including common shares and Class B Preferred Series A Shares, among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions. ● Sales of a substantial number of shares of our common shares in the public market could cause our stock price to fall. ● We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock; ● The Company has outstanding warrants denominated in both Canadian and U.S.
We may fail to comply with the rules that apply to public companies, including Section 404 of the Sarbanes-Oxley Act of 2002, which could result in sanctions or other penalties that could materially and adversely affect our business, financial condition, results of operations and prospects. ● Our business will be subject to the risks of climate change, natural catastrophic events, world events, and man-made problems such as power disruptions or terrorism Risks Related to Our Financial Condition We are a commercial development stage biopharmaceutical company in the early stages of commercial development of our one product approved for commercial sale and have incurred significant losses since our inception.
Our net losses were approximately $12.4 million and $13.8 million for the years ended December 31, 2024, and 2023, respectively.
As of December 31, 2024, we had an accumulated deficit of approximately $74 million.
We have only one product, ZUNVEYL formerly known as ALPHA-1062, approved for planned commercialization and have never generated any revenue from product sales.
We have devoted substantially all our financial resources and efforts to the development of our product candidates, including conducting preclinical studies and clinical trials.
We expect to continue to incur significant expenses and operating losses over the next several years.
We expect that it could be several years, if ever, before we have a commercialized product.
We anticipate that our expenses will increase substantially for the foreseeable future as we: ● establish a commercialization infrastructure and scale up external manufacturing and distribution capabilities to commercialize ZUNVEYL oral tabulation formulation formerly known as ALPHA-1062 and any other product candidates for which we may obtain regulatory approval; ● conduct our ongoing and planned clinical trials of ALPHA-1062, as well as initiate and complete additional clinical trials; ● continue our clinical validation of ALPHA-1062 for moderate-to-severe Alzheimer’s disease and explore the potential of ALPHA-1062IN related to mTBI; ● adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products; ● maintain, expand and protect our intellectual property portfolio; ● hire additional clinical, manufacturing and scientific personnel; ● add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts; ● incur additional legal, accounting and other expenses in operating as a public company; and ● scale up our clinical and regulatory capabilities.
Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve commercial success with ZUNVEYL oral tablet formulation, our one FDA approved product, and continued development and commercialization of our other product candidates, if approved.
To date, we have not generated any revenue from the commercialization of our product candidates.
We have only one product, ZUNVEYL oral tablets, approved for commercialization.
To generate revenue and become and remain profitable, we must succeed in the commercialization of ZUNVEYL and developing and eventually commercializing our other product candidates.
We have a limited operating history and have no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
To date, we have successfully obtained regulatory approval for only one product, ZUNVEYL oral tablets, and have not demonstrated our ability to manufacture a product on a commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization.
We will need substantial capital to meet our financial obligations and to pursue our business objectives, including the commercialization of ZUNVEYL oral tablet formulation.
We expect to continue to incur significant expenses and operating losses over the next several years as we complete our commercialization activities for ZUNVEYL and our ongoing clinical trials of our other product candidates, initiate future clinical trials of our other product candidates, prepare for commercialization activities of our other product candidates and advance any of our other product candidates we may develop or otherwise acquire.
Our revenue, if any, will be derived from sales of ZUNVEYL following our commercial development activities and our other products that we do not expect to be commercially available for the foreseeable future, if at all.
As of December 31, 2024, we had approximately $48.6 million in unrestricted cash and cash equivalents and have not generated positive cash flows from operations.
Based on our current business plans, we believe our existing cash and cash equivalents, will be sufficient for us to fund our ongoing operating expenses, pre-NDA approval commercialization expenses, and capital expenditures requirements through at least the next 12 months.
Full commercial launch of ZUNVEYL is expected to require substantial capital to continue our commercialization efforts and bring the product to market in the US.
We are proceeding with our commercial launch of our ZUNVEYL oral tablet product, where we expect to raise substantial additional capital to continue our commercialization efforts and bring the product to market in the US and continue development of our product candidates.
We expect to incur significant commercialization expenses related to product manufacturing, sales, marketing, distribution, and continued R&D.
Our foreign operations will be exposed to foreign exchange rate fluctuations as the financial results are translated from the local currency into U.S. dollars upon consolidation.
Specifically, the U.S. dollar cost of our operations in Canada, API manufacturing in Taiwan and conducting clinical trials in India is influenced by any movements in the currency exchange rate.
If the U.S. dollar weakens against foreign currencies, the translation of these foreign currency denominated transactions will result in increased revenue, operating expenses and net income.
Similarly, if the U.S. dollar strengthens against foreign currencies, the translation of these foreign currency denominated transactions will result in decreased revenue, operating expenses and net income.
Risks Related to Our Business Development Our business is heavily dependent on the successful commercialization of ZUNVEYL oral tablet formulation, our only FDA approved product, and the development and commercialization of any future product candidates that we may develop or acquire.
The success of our business, including our ability to finance our Company and generate revenue in the future, will primarily depend on the successful commercialization of ZUNVEYL, our only FDA approved product, and the development, regulatory approval and commercialization of our product candidates.
We cannot be certain that ZUNVEYL can be successfully commercialized or that our other product candidates will receive regulatory approval or be successfully commercialized even if we receive regulatory approval.
The clinical and commercial success of ZUNVEYL and any future product candidates that we may develop or acquire will depend on a number of factors, including the following: ● successfully commercializing ZUNVEYL, either independently or with marketing service providers; ● the effectiveness of our sales and marketing strategy and operations, and obtaining market acceptance of ZUNVEYL, including garnering market share from existing and future treatment alternatives; ● maintaining compliance with all regulatory requirements applicable to ZUNVEYL and our commercial activities, including the post-marketing requirements and post-marketing commitments required by the FDA; ● the continued acceptability of the safety profile of ZUNVEYL and the occurrence of any unexpected side effects, adverse reactions or misuse, including potential business impact such as the need to withdraw the product (either voluntarily or as mandated by the FDA), loss of support by the advocacy communities or loss of positive corporate reputation resulting in related unfavorable media coverage in these areas; ● our ability to raise any additional required capital on acceptable terms, or at all; ● our ability to complete an IND enabling studies and successfully submit INDs or comparable applications; ● initiation and timely completion of our preclinical studies and clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors; ● delays or difficulties in enrolling and retaining patients in our clinical trials; ● whether we are required by the FDA, or similar foreign regulatory agencies to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of our product candidates or any future product candidates; ● acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our product candidates by the FDA and similar foreign regulatory authorities; ● our ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities the safety, efficacy and acceptable risk to benefit profile of our product candidates or any future product candidates; ● the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates or future approved products, if any; ● achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to our product candidates or any future product candidates or approved products, if any; ● the ability of third parties with whom we contract to manufacture adequate clinical trial and commercial supplies of our product candidates or any future product candidates remain in good standing with regulatory agencies and develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices, or cGMPs; ● the convenience of our treatment or dosing regimen; ● the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities; ● acceptance by physicians, payors and patients of the benefits, safety and efficacy of our product candidates or any future product candidates, if approved, including relative to alternative and competing treatments; ● the willingness of physicians, operators of clinics and patients to utilize or adopt any of our product candidates or any future product candidates, if approved; ● our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; ● our ability to expand our products, including ZUNVEYL into multiple indications; ● the COVID-19 pandemic, which may result in clinical site closures, delays to patient enrollment, patients discontinuing their treatment or follow up visits or changes to trial protocols; ● our ability to successfully develop a commercial strategy and thereafter commercialize our other product candidates or any future product candidates in the United States and internationally, if approved for marketing, reimbursement, sale and distribution in such countries and territories, whether alone or in collaboration with others; ● patient demand for our product candidates, if approved, including patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; ● the actual market-size, ability to identify patients and the demographics of patients eligible for our product candidates, which may be different than expected; ● a continued acceptable safety profile following any marketing approval; ● our ability to compete with other therapies; ● our ability to establish and enforce intellectual property rights in and to our product candidates or any future product candidates; and ● our ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims.
Biogen’s Aduhelm, a monoclonal antibody administered via infusion, received accelerated approval from the FDA on June 7, 2021, but Biogen has announced that it will discontinue marketing Adelheim by the end of 2024.
The occurrence of any event or penalty described above may inhibit our ability to commercialize ZUNVEYL and adversely affect our business, financial condition, results of operations and prospects.
Further, even once completed the process to receive a NDA can be delayed or unsuccessful.
For example, we initially conducted our bioavailability and bioequivalence pivotal clinical trials of ALPHA-1062 in collaboration with Vimta Labs, Inc in Hyperabad, India.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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