Allarity Therapeutics (ALLR) risk factors, FY2025 10-K

Risks Related to Our Business and Industry

1. 01We may become delinquent in our payments to Eisai. In consideration for extension of certain deadlines and payment obligations, we entered into several amendments to an Exclusive License Agreement with Eisai
2. 02Unstable global market and economic conditions may have serious adverse consequences on our business, financial condition and stock price
3. 03If we fail to satisfy the Nasdaq Capital Market continued listing requirements and do not regain compliance, our common stock will be delisted
4. 04We will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties in managing growth
5. 05We depend on our senior management team, and the loss of one or more of our executive officers or key employees or an inability to attract and retain highly skilled employees could adversely affect our business
6. 06Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
7. 07International operations may expose us to business, regulatory, political, operational, financial, pricing, tariffs, and reimbursement risks associated with doing business outside of the U.S
8. 08Our failure to successfully acquire, develop, and market additional therapeutic candidates could impair our ability to grow
9. 09We have obtained statistical data, market data and other industry data and forecasts used throughout this Annual Report from market research, publicly available information and industry publications which we believe are reliable

Risks Related to Our Financial Position and Need for Additional Capital

1. 10We have a limited operating history with no product revenues to date and a limited number of DRP ® biomarker development agreements, which may make it difficult to evaluate the success of our business to date and to assess our future viability
2. 11We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability
3. 12incur additional legal, accounting and other expenses in operating as a U.S. listed public company
4. 13We will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our drug development program for stenoparib or its commercialization efforts
5. 14Failure to achieve and maintain effective internal controls could have a material adverse effect on our business

Risks Related to the Discovery and Development of Stenoparib

1. 15Clinical trials are very expensive, time-consuming and difficult to design and implement, and involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials
2. 16We may encounter substantial delays in our preclinical studies or clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities
3. 17changes in regulatory requirements and guidance that require amending or submitting new clinical protocols
4. 18Our drug development costs will also increase if we experience delays in testing or obtaining marketing approvals. We do not know whether any of our preclinical studies or clinical trials will begin as planned, need to be restructured or be completed on schedule, if at all
5. 19If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
6. 20the risk that patients enrolled in clinical trials will drop out of the trials before completion
7. 21Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our current or planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our therapeutic candidate
8. 22the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us
9. 23We may expend our limited resources to pursue a particular therapeutic candidate or indication and fail to capitalize on therapeutic candidates or indications that may be more profitable or for which there is a greater likelihood of success
10. 24We have limited experience in drug discovery and drug development and may not receive regulatory approval to market stenoparib
11. 25our ability to compete with other therapies
12. 26the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval
13. 27Our therapeutic candidate portfolio includes small molecules that others have tried to develop into an approved commercialized drug. Our strategy to use our proprietary DRP® companion diagnostics platform to identify and subsequently clinically advance our therapeutic candidate
14. 28Smerud Medical Research International and Chosa ApS are responsible for the development of our LiPlaCis ® in conjunction with our DRP ® companion diagnostic
15. 29Delays in clinical testing could result in increased costs to us and delay our ability to generate revenue
16. 30manufacturing sufficient quantities and quality of a therapeutic candidate for use in clinical trials
17. 31any future collaborators that conduct clinical trials may face any of the above issues and may conduct clinical trials in ways they view as advantageous to themselves but that are suboptimal for us
18. 32have the drug removed from the market after obtaining marketing approval
19. 33Stenoparib may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any
20. 34Any of these events could prevent us from achieving or maintaining market acceptance of the particular therapeutic candidate or for particular indications of a therapeutic candidate, if approved, and could significantly harm our business, results of operations and prospects
21. 35Our proprietary DRP ® companion diagnostics platform may fail to help us select and treat likely responder patients for stenoparib or help us identify additional potential therapeutic candidates
22. 36Any failure by us to comply with existing regulations could harm our reputation and operating results
23. 37We may be subject to extensive regulations outside the U.S. and may not obtain marketing approvals for stenoparib in Europe and other jurisdictions
24. 38European and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers
25. 39Our inability to obtain or retain sufficient clinical trial liability insurance at an acceptable cost to protect against potential liability claims could prevent or inhibit our ability to conduct clinical trials for stenoparib

Risks Related to the Approval and Commercialization of Stenoparib

1. 40Even if we are successful in completing all preclinical studies and clinical trials, we may not be successful in commercializing stenoparib
2. 41If our drugs do not gain market acceptance, our business will suffer because we might not be able to fund future operations
3. 42the effectiveness of our sales and marketing efforts
4. 43We may in the future develop therapeutic candidates in combination with other therapies and that may expose us to additional risks
5. 44We may rely on orphan drug status to commercialize stenoparib, and even if orphan drug status is approved, such approval may not confer marketing exclusivity or other commercial advantages or expected commercial benefits
6. 45A Breakthrough Therapy designation by the FDA for stenoparib may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that stenoparib will receive marketing approval
7. 46A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process
8. 47Failure to obtain marketing approval in foreign jurisdictions would prevent stenoparib from being marketed abroad
9. 48Our business strategy involving drug development includes the development of a companion diagnostic using our proprietary DRP ® companion diagnostics platform for stenoparib. We intend to file a PMA for stenoparib if, and when, we decide to pursue the submission of an NDA for stenoparib
10. 49We operate in a highly competitive and rapidly changing industry
11. 50If we are unable to develop satisfactory sales and marketing capabilities, we may not succeed in commercializing stenoparib
12. 51Even if we obtain regulatory approvals to commercialize stenoparib, stenoparib may not be accepted by physicians or the medical community in general
13. 52availability of reimbursement codes and coverage in select jurisdictions, and future changes to reimbursement policies of government and third-party payors
14. 53Healthcare reform measures could hinder or prevent stenoparib's commercial success
15. 54Governmental efforts to pursue regulatory reform may limit the FDA ’ s ability to engage in oversight and implementation activities in the normal course, and that could negatively impact our business
16. 55Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize stenoparib and may affect the price we may set
17. 56Governments outside of the U.S. tend to impose strict price controls, which may adversely affect our revenues, if any
18. 57If we or any third-party manufacturers or contractors we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could harm our business
19. 58We may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our proprietary DRP ® companion diagnostics platform

Risks Related to Our Reliance on Third Parties

1. 59We, or third-party manufacturers on whom we rely, may be unable to successfully scale-up manufacturing of stenoparib in sufficient quality and quantity, which would delay or prevent us from developing and commercializing stenoparib
2. 60Our failure to find third-party collaborators to assist or share in the costs of drug development could materially harm our business, financial condition and results of operations
3. 61successfully commercializing stenoparib

Risks Related to Our Intellectual Property

1. 62If we do not obtain patent term extension for stenoparib or obtain a patent on our DRP ® companion diagnostic for stenoparib, our business may be materially harmed
2. 63Changes to patent laws in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect stenoparib
3. 64We or our licensors may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful
4. 65Third 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 have a material adverse effect on the success of our business
5. 66Intellectual property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract our personnel from their normal responsibilities
6. 67Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
7. 68If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business
8. 69the priority of invention of patented technology
9. 70We may not be able to protect our intellectual property and proprietary rights throughout the world
10. 71Intellectual property rights do not necessarily address all potential threats

Risks Related to Ownership of our Securities and Our Status as a Public Company

1. 72If our business developments and achievements do not meet the expectations of investors or securities analysts or for other reasons the expected benefits do not occur, the market price of our common stock traded on Nasdaq may decline
2. 73other events or factors, many of which are beyond our control
3. 74The price of our common stock has fluctuated substantially
4. 75other events or factors, many of which may be out of our control
5. 76Future sales, or the perception of future sales, by us or our stockholders in the public market could cause the market price for our common stock to decline
6. 77Because there are no current plans to pay cash dividends on shares of our common stock for the foreseeable future, you may not receive any return on investment unless you sell your shares of common stock for a price greater than that which you paid for it
7. 78There is no assurance that an active and liquid trading market in our common stock will develop
8. 79Our Certificate of Incorporation and our by-laws, and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline
9. 80provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum
10. 81We are an “ emerging growth company ” and a “ smaller reporting company ” and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies, which could make our common stock less attractive to investors
11. 82We may be at risk of securities class action litigation
12. 83Financial reporting obligations of being a public company in the U.S. require well defined disclosure and procedures and internal control over financial reporting that that are expensive and time-consuming requiring our management to devote substantial time to compliance matters
13. 84We may acquire other companies or technologies, which could divert our management ’ s attention, result in dilution to our stockholders and otherwise disrupt our operations and adversely affect our operating results
14. 85use of substantial portions of our available cash to consummate the acquisition
15. 86Market and economic conditions may negatively impact our business, financial condition and share price
16. 87Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or experience security breaches or other unauthorized or improper access
17. 88If securities or industry analysts do not publish or cease publishing research or reports about us, our business, or our market, or if they change their recommendations regarding our securities adversely, the price and trading volume of common stock could decline
18. 89Comprehensive tax reform bills could adversely affect our business and financial condition
19. 90Our share buyback program that was approved by the Board in March 2025 could affect our stock price and increase its volatility, and may reduce the market liquidity for our stock. The share buyback program may also materially impact the Company ’ s liquidity