MAIA Biotechnology (MAIA) risk factors, FY2024 10-K

Other

1. 01We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability
2. 02We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
3. 03The successful commercialization of THIO and any other candidate we develop will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels, and pricing policies
4. 04A variety of risks associated with operating internationally could materially adversely affect our business
5. 05We intend to rely on third parties to conduct, supervise and monitor our clinical trials. If those third parties do not successfully carry out their contractual duties, or if they perform in an unsatisfactory manner, it may harm our business
6. 06Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
7. 07Intellectual property rights do not address all potential threats to our competitive advantage
8. 08The limited public company experience of our management team could adversely impact our ability to comply with the reporting requirements of U.S. securities laws, which could have a materially adverse effect on our business

Risks Related to Our Financial Position and Need for Additional Capital

1. 09We have incurred losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability
2. 10acquire or in-license or invent other candidates or technologies
3. 11Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing
4. 12We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of THIO
5. 13Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
6. 14sales and marketing activities necessary for successful product commercialization. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products

Risks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

1. 15We are heavily dependent on the success of THIO, our most advanced candidate, which is still under clinical development, and if this drug does not receive regulatory approval or is not successfully commercialized, our business may be harmed
2. 16Pandemics, such as COVID-19, may adversely impact our business, results of operations, financial condition, liquidity and cash flows and that of our clients
3. 17Clinical trials are expensive, time-consuming and difficult to design and implement, and involve an uncertain outcome
4. 18manufacturing sufficient quantities of THIO for use in clinical trials
5. 19Interim, topline and preliminary data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
6. 20We may not be successful in our efforts to identify or discover additional product candidates in the future
7. 21The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for THIO or any other candidates, our business will be substantially harmed
8. 22the 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
9. 23permissible in certain circumstances, particularly in oncology, but such circumstances are exceptional and FDA may not agree with that proposed approach, and thus we may be required to conduct two phase 3 trials
10. 24the FDA or comparable foreign regulatory authorities may disagree with our efficacy interpretation of our drug; or
11. 25if the FDA determines that our labeling is false or misleading in any particular way
12. 26Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control
13. 27Results of preclinical studies, early clinical trials or analyses may not be indicative of results obtained in later trials
14. 28our reputation may suffer
15. 29The market opportunities for THIO, if approved, may be smaller than we anticipate
16. 30We have never obtained marketing approval for a development candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our development candidates
17. 31Even if we obtain regulatory approval for THIO or any development candidate, we will still face extensive and ongoing regulatory requirements and obligations and any development candidates, if approved, may face future development and regulatory difficulties
18. 32injunctions or the imposition of civil or criminal penalties
19. 33We may seek a Breakthrough Therapy designation for THIO from the FDA. However, we might not seek such designation or be granted the designation by the FDA if sought, and even if we are granted the designation, it may not lead to a faster development or regulatory review or approval process

Risks Related to Commercialization

1. 34We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively
2. 35form more advantageous strategic alliances
3. 36We may face early generic competition for THIO or our other products
4. 37on our investment in our product candidates. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates and may not be able to obtain a satisfactory financial return on our product candidates
5. 38Even if THIO or any candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success
6. 39any restrictions on the use of our product together with other medications
7. 40If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing THIO, if approved
8. 41any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel
9. 42unforeseen costs and expenses associated with creating an independent sales and marketing organization
10. 43certain expenses including, among others, expenses for travel, translation and insurance; and

Risks Related to Our Dependence on Third Parties

1. 44adequate CMO or another acceptable solution in time, our clinical trials could be delayed, or our commercial activities could be harmed
2. 45We intend to continue to rely on third parties to conduct, supervise and monitor our clinical trials. If those third parties do not successfully carry out their contractual duties, or if they perform in an unsatisfactory manner, it may harm our business
3. 46The number and type of our collaborations could adversely affect our attractiveness to future collaborators or acquirers and the loss of, or a disruption in our relationship with, any one or more collaborators could harm our business

Risks Related to Healthcare Laws and Other Legal Compliance Matters

1. 47Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our development candidates, if approved, and may affect the prices we may set
2. 48Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future. It is uncertain the extent to which any such changes may impact our business or financial condition
3. 49Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties
4. 50Any clinical trial programs we conduct or research collaborations we enter into in the European Economic Area may subject us to the General Data Protection Regulation
5. 51We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities
6. 52Recent legislation may materially adversely affect our financial condition, results of operations and cash flows
7. 53generally not changed, tax losses generated in calendar year 2018 and beyond will only be able to offset 80% of taxable income. This change may require us to pay federal income taxes in future years despite generating a loss for federal income tax purposes in prior years

Risks Related to Our Intellectual Property

1. 54our obligation to pay UTSW fees associated with the prosecution, maintenance, or filing of the patents and patent applications we have licensed
2. 55If we fail to comply with any of our obligations under the license agreements, or we are subject to a bankruptcy or dissolution, UTSW may have the right to terminate their respective license agreements, in which event we would not be able to market any product candidates covered by the licenses
3. 56the priority of invention of patented technology
4. 57Our proprietary position for our product candidates currently depends in part upon licenses to patents protecting methods of use, which may not prevent a competitor or other third party from using the same product candidate for another use
5. 58Our patents may be challenged in courts or in patent offices which could result in the invalidation, narrowing or unenforceability of our patents and our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours
6. 59We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop, manufacture and market our product candidates
7. 60Obtaining 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 protection could be reduced or eliminated for non-compliance with these requirements
8. 61We enjoy only limited geographical protection with respect to certain patents and we may not be able to protect our intellectual property rights throughout the world
9. 62If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries having similar legislation, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed
10. 63the patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on our business
11. 64If 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
12. 65We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms
13. 66We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties
14. 67Our proprietary information may be lost, or we may suffer security breaches

Risks Related to Our Employees, Managing Our Growth and Our Operations

1. 68Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel
2. 69We expect to expand our development, regulatory, and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
3. 70We may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources
4. 71Our business and operations would suffer in the event of system failures

Risks Relating to Our Common Stock

1. 72If we are unable to comply with the continued listing requirements of the NYSE American, then our Common Stock would be delisted from the NYSE American, which would limit investors’ ability to effect transactions in our Common Stock and subject us to additional trading restrictions
2. 73a limited amount of news and analyst coverage; and
3. 74We have a trading symbol for our common stock (“MAIA”) and our common stock is currently listed on the NYSE American
4. 75The price of our common stock may be volatile
5. 76changing economic conditions
6. 77We could be subject to securities class action litigation
7. 78Future sales of our common stock, or the perception in the public markets that these sales may occur, could cause the market price for our common stock to decline
8. 79We do not intend to pay dividends for the foreseeable future, and our ability to pay dividends to our stockholders is restricted by applicable laws and regulations
9. 80Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us
10. 81We may, in the future, issue additional capital stock, which would reduce investors’ percent of ownership and may dilute our share value
11. 82Certain stockholders who are also officers and directors of the Company may have significant control over our management
12. 83Anti-takeover protections in our amended and restated certificate of incorporation and our amended and restated bylaws, or our contractual obligations may discourage or prevent a takeover of our Company, even if an acquisition would be beneficial to our stockholders
13. 84establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted on by stockholders at stockholder meetings
14. 85We are considered a “smaller reporting company” and are exempt from certain disclosure requirements, which could make our stock less attractive to potential investors
15. 86In the case of an issuer who had annual revenue of less than $100 million during the most recently completed fiscal year for which audit financial statements are available, had a public float as calculated under paragraph (1) or (2) of this definition that was either zero or less than $700 million
16. 87We are considered an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may make our common stock less attractive to investors
17. 88Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters may materially impact reporting of our financial condition and results of operations
18. 89The lack of public company experience of our management team could adversely impact our ability to comply with the reporting requirements of U.S. securities laws, which could have a materially adverse effect on our business
19. 90Unanticipated changes in the insurance market or factors affecting self-insurance reserve estimates could have a material adverse effect on our business, financial condition and results of operations
20. 91We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability due to the ongoing military conflict between Russia and Ukraine and Israel and Hamas
21. 92Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our business, financial condition and results of operations