Aligos Therapeutics (ALGS) risk factors, FY2025 10-K

Risks related to our limited operating history, financial position and need for additional capital

1. 01We have never generated revenue from product sales and may never be profitable for a full fiscal year
2. 02attracting, hiring and retaining qualified personnel
3. 03We will require substantial additional financing to achieve our goals, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts
4. 04any acquisitions or in-licensing of other programs or technologies30% rewritten
5. 05delay, limit, reduce or terminate our efforts to establish manufacturing and sales and marketing capabilities or other activities that may be necessary to commercialize any future approved products, or reduce our flexibility in developing or maintaining our sales and marketing strategy
6. 06Our recurring losses from operations and negative cash flows have raised substantial doubt regarding our ability to continue as a going concernNew
7. 07The report of our independent registered public accounting firm for the year ended December 31, 2025 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concernNew
8. 08Our operating results may fluctuate significantly, which will make our future results difficult to predict and could cause our results to fall below expectations
9. 09the timing and success or failure of nonclinical studies and clinical trials for our drug candidates or competing drug candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or collaboration partners92% rewritten
10. 10meaningful. Investors should not rely on our past results as an indication of our future performanceNew

Risks related to product development and regulatory process

1. 11Our use of clinically validated targets to pursue treatments of these indications and diseases does not guarantee efficacy or safety or necessarily reduce the risk that our current or future drug candidates will not achieve expected or functional levels of efficacy or achieve an acceptable safety profile
2. 12obtaining and maintaining healthcare coverage and adequate reimbursement from third-party payors
3. 13Nonclinical development is uncertain. Our nonclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize our drug candidates on a timely basis or at all, which would have an adverse effect on our business50% rewritten
4. 14delays due to global-scale potentially catastrophic events, including public health pandemics or epidemics, terrorism, war, and climate changes
5. 15The regulatory approval processes of the FDA, the EMA and comparable foreign authorities are lengthy, time-consuming, complex and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our drug candidates, our business will be substantially harmed
6. 16the approval policies or regulations of the FDA, the EMA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval
7. 17we may experience disruptions by man-made or natural disasters or public health pandemics or epidemics or other business interruptions77% rewritten
8. 18adequate funding to continue the clinical trial. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing approval of our drug candidatesNew
9. 19Our pursuit of potential treatments for chronic HBV infection is ongoing, but we may be unable to produce a therapy that successfully treats chronic HBV infection. Even if successful, we may be unable to obtain regulatory approval for and successfully commercialize our drug candidates29% rewritten
10. 20Our pursuit of potential treatments for MASH and obesity is ongoing, but we may be unable to produce a therapy that successfully treats MASH and/or obesity. Even if successful, we may be unable to obtain regulatory approval for and successfully commercialize our drug candidates30% rewritten
11. 21Our pursuit of potential therapies for COVID-19 is at an early stage
12. 22The results of nonclinical studies and early-stage clinical trials may not be predictive of future results
13. 23Interim, “topline” and preliminary data from our clinical trials may differ materially from the final data
14. 24If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
15. 25disruption by man-made or natural disasters, reduction of government funding for health care, or public health pandemics or epidemics or other business interruptions
16. 26Changes in methods of drug candidate manufacturing or formulation may result in additional costs or delay
17. 27our reputation may suffer
18. 28Even if a current or future drug candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
19. 29Adverse events in our therapeutic areas of focus, including hepatological indications and viral diseases, could damage public perception of our current or future drug candidates and negatively affect our business
20. 30Negative developments and negative public opinion of technologies on which we rely may damage public perception of our drug candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our drug candidates
21. 31injunctions or the imposition of civil or criminal penalties
22. 32Even if we obtain and maintain approval for our drug candidates from the FDA, we may never obtain approval outside the United States, which would limit our market opportunities
23. 33Risks associated with international trade policies (including with respect to tariffs) or our international operations, including seeking and obtaining approval to commercialize our drug candidates in foreign jurisdictions, could harm our business94% rewritten
24. 34We currently rely, and expect to continue to rely, on third parties located outside of the United States for the manufacture of certain drug candidates for clinical testing, as well as for manufacture of products that we may commercialize, if approvedNew
25. 35disruptions resulting from the impact of public health pandemics or epidemics (including, for example, the COVID-19 pandemic)New
26. 36In addition, there are complex regulatory, tax, labor and other legal requirements imposed by many of the individual countries in which we may operate, with which we will need to comply55% rewritten
27. 37If the market opportunities for our drug candidates are smaller than we believe or any approval we obtain is based on a narrower definition of the patient population, our business may suffer
28. 38If the market opportunities for our drug candidates are smaller than we estimate, it could have an adverse effect on our business, financial condition, results of operations and prospects34% rewritten
29. 39We intend to develop our current drug candidates, and expect to develop other future drug candidates, in combination with other therapies, which exposes us to additional risks
30. 40We face significant competition, and if our competitors develop and market products that are more effective, safer or less expensive than the drug candidates we develop, our commercial opportunities will be negatively impacted40% rewritten
31. 41Smaller and other early-stage companies may also prove to be significant competitors. In addition, academic research departments and public and private research institutions may be conducting research on compounds that could prove to be competitive
32. 42If any of our current or future drug candidates obtain regulatory approval, additional competitors could enter the market with generic versions of such products, which may result in a material decline in sales of our competing products23% rewritten
33. 43Even if we are able to commercialize any drug candidates, such products may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business
34. 44We may not be successful in our efforts to identify or discover other drug candidates and may fail to capitalize on programs or drug candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success
35. 45We may be required to make significant payments under our license agreements, including those with Emory University and KU Leuven56% rewritten
36. 46If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any approved products
37. 47Our inability to obtain sufficient product liability insurance at an acceptable cost or at all to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop, alone or with collaboration partners
38. 48Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to commercialize drug candidates for which we receive approval, may affect the prices we may obtain, and may have a material adverse effect on our business and results of operationsNew
39. 49laws, regulations, standards, or market perception of their requirements may have on our business and may not always be able to anticipate how to respond to these laws or regulationsNew
40. 50Our business and operations may suffer in the event that our information technology systems, or those used by our CROs or other contractors or consultants, fail or suffer security breaches78% rewritten

Risks related to reliance on third parties

1. 51if a current or future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program under such collaboration could be delayed, diminished or terminated
2. 52We may seek to establish additional collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans
3. 53In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators
4. 54If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies
5. 55form relationships with other entities, some of which may be our competitors
6. 56We may be delayed if we need to change the manufacturing process used by a third party. Further, if we change an approved manufacturing process, then we may be delayed if the FDA or a comparable foreign authority needs to review the new manufacturing process before it may be used
7. 57the lack of our ability to terminate such contracts quickly and without excessive expense, if no longer neededNew
8. 58Our future drug candidates and any products that we may develop may compete with other drug candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP requirements and that might be capable of manufacturing for us28% rewritten

Risks related to intellectual property

1. 59If we fail to comply with our obligations, including the obligation to make various milestone payments and royalty payments, under any of the agreements under which we license intellectual property rights from third parties, the licensor may have the right to terminate the licenseNew
2. 60the effects of termination
3. 61If we are unable to obtain licenses from third parties on commercially reasonable terms or at all, our business could be harmed
4. 62We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might subject us to infringement claims or adversely affect our ability to develop and market our drug candidates
5. 63Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time
6. 64We may not be able to protect our intellectual property rights throughout the world50% rewritten
7. 65Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates
8. 66We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents directed towards our technology and drug candidates could be found invalid or unenforceable if challenged
9. 67Furthermore, 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 this type of litigation
10. 68Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business
11. 69We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property
12. 70We may be subject to claims challenging the inventorship of our patents and other intellectual property
13. 71Intellectual property rights do not necessarily address all potential threats
14. 72Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent rights, if any, could be reduced or eliminated if we fail to comply with these requirements
15. 73Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
16. 74If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
17. 75If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected

Risks related to employee matters, managing our growth and other risks related to our business

1. 76We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy
2. 77We currently have no sales organization. If we are unable to establish sales capabilities on our own or through third parties, we may not be able to market and sell any products effectively, if approved, or generate product revenue
3. 78We will need to grow the size of our organization, and we may experience difficulties in managing this growth
4. 79expanding and enhancing our operational, financial and management controls, reporting systems and procedures
5. 80If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business
6. 81We, or the third parties upon whom we depend, may be adversely affected by earthquakes, wildfires, or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
7. 82Our employees, independent contractors, vendors, principal investigators, CROs, consultants and collaborators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading

Risks related to our common stock

1. 83The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for investors
2. 84investors’ general perception of us and our business
3. 85An active trading market for our shares may not be sustained. In the absence of an active trading market common stock, investors may not be able to sell their common stock at a price or at the time that they would like to sell
4. 86We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock
5. 87We are a “smaller reporting company,” and as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors94% rewritten
6. 88Our executive officers, directors and their affiliates have significant influence over our company, which will limit an investor’s ability to influence corporate matters and could delay or prevent a change in corporate control
7. 89The dual class structure of our common stock may limit the ability to influence corporate matters and may limit the visibility with respect to certain transactions
8. 90If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the market price of our common stock could decline
9. 91Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited35% rewritten
10. 92The trading market for our common stock relies, in part, on the research and reports that industry or financialNew
11. 93If we fail to implement and maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline37% rewritten
12. 94Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management37% rewritten
13. 95the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; andNew
14. 96Our amended and restated certificate of incorporation and amended and restated bylaws provide that we will indemnify our directors and officers, in each case to the fullest extent permitted by Delaware law
15. 97we may not retroactively amend our amended and restated bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents
16. 98Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies
17. 99Unfavorable global or domestic economic or political conditions could adversely affect our business, financial condition, stock price and results of operations33% rewritten
18. 100Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities
19. 101We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, violations of which can have serious negative consequences for our business
20. 102From time to time, we may consider strategic transactions, such as acquisitions of companies, asset purchases and out-licensing or in-licensing of intellectual property, products or technologies
21. 103Public health pandemics or epidemics, political instability, terrorist attacks, other acts of violence or war, or other unexpected events could materially and adversely impact us
22. 104Litigation or administrative proceedings could have a material adverse effect on our business, our financial condition and our results of operations
23. 105We incur significantly increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices74% rewritten
24. 106We may experience fluctuations in our tax obligations and effective tax rate, which could materially and adversely affect our results of operations