Marker Therapeutics (MRKR) risk factors, FY2025 10-K

Other

1. 01Risks Associated with Our Business

Risks Related to our Financial Position and Capital Needs

1. 02We are a clinical stage company with a history of operating losses, and we expect losses to continue for the indefinite future. These factors raise substantial doubt regarding our ability to continue as a going concern

Risks Related to the Development of our Product Candidates

1. 03All of our product candidates are in clinical development. If we are unable to successfully develop, receive regulatory approval for and commercialize our product candidates, or successfully develop any other product candidates, or experience significant delays in doing so, our business will be harmed
2. 04The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates
3. 05Preclinical studies and clinical trials are expensive, time-consuming, difficult to design and implement and involve an uncertain outcome. Further, we may encounter substantial delays in completing the development of our product candidates
4. 06The results of earlier preclinical and clinical trials may not be predictive of future clinical trial results
5. 07If we do not achieve our projected development goals in the timeframes we announce and expect, the commercialization of our products may be delayed
6. 08We may not obtain or maintain the benefits associated with orphan drug designation, including market exclusivity67% rewritten

Risks Related to Manufacturing

1. 09We rely on third-party vendors and contract manufacturing organizations to maintain and support our manufacturing and cell processing operations41% rewritten
2. 10No assurance can be given that we will be able to develop a new, FDA-compliant, more efficient, lower cost manufacturing process upon which our business plan to commercialize MAR-T cell-based product candidates is dependent

Risks Related to our Reliance on Third Parties

1. 11We rely on third parties for the clinical and, if approved, commercial manufacture of our product candidates. The third-party manufacturing facilities on which we rely may have limited capacity or fail to meet the applicable stringent regulatory requirementsNew
2. 12Our strategic relationship with BCM is dependent, in part, upon our ongoing relationship with key medical and scientific personnel and advisors
3. 13We may not be able to establish or maintain the third-party relationships, including strategic collaborations, that are necessary to develop, commercialize and/or market some or all of our product candidates
4. 14Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements

Risks Related to the Commercialization of our Product Candidates

1. 15Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients, healthcare payors and the medical community
2. 16If our product candidates are approved but fail to achieve market acceptance among physicians, patients, healthcare payors and the medical community, we may not be able to generate significant revenues, which would compromise our ability to become profitable
3. 17Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations
4. 18Our future success is highly dependent upon our key personnel, and our ability to attract, retain, and motivate additional qualified personnel. We will also be required to establish sales and marketing capabilities or enter into agreements with third parties to market and sell any approved products
5. 19The biotechnology and immunotherapy industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with more substantial enterprises35% rewritten
6. 20The market opportunities for our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small
7. 21New regulatory pathways for biosimilar competition could reduce the duration of market exclusivity for our products44% rewritten
8. 22If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates

Risks Related to Our Intellectual Property

1. 23If we are unable to protect our proprietary rights, we may not be able to compete effectively or operate profitably
2. 24The use of our technologies could potentially conflict with the rights of others
3. 25Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
4. 26We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world
5. 27We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties
6. 28If we fail to comply with any obligations under our existing license agreements or any future license agreements, or disputes arise with respect to those agreements, it could have a negative impact on our business and our intellectual property rights
7. 29We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
8. 30Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
9. 31Certain of our technologies are in-licensed from third parties, and the protection of those technologies is not entirely within our control
10. 32We rely upon patents and licensed technologies to protect our technology. We may be unable to protect our intellectual property rights, and we may be liable for infringing the intellectual property rights of others37% rewritten
11. 33protection against use of the patented invention by others. If we encounter such difficulties in protecting or are otherwise precluded from effectively protecting our intellectual property rights in foreign jurisdictions, our business prospects could be substantially harmedNew
12. 34We may be involved in lawsuits to protect or enforce our patents or the patents of our licensor, which could be expensive, time-consuming and unsuccessful
13. 35We may be unable to adequately prevent disclosure of trade secrets and other proprietary information
14. 36If we are unable to obtain licenses needed for the development of our product candidates, or if we breach any of the agreements under which we license rights to patents or other intellectual property from third parties, we could lose license rights that are important to our business

Risks Related to Government Regulation

1. 37Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions
2. 38Recently enacted and future legislation in the United States and other countries may affect the prices we may obtain for our product candidates and increase the difficulty and cost to commercialize our product candidates52% rewritten

Risks Related to our Securities

1. 39The price of our stock may be volatile
2. 40Sales of additional equity securities may adversely affect the market price of our common stock and your rights may be reduced. Our stockholders may experience dilution in the future and it may adversely affect the market price of our securities50% rewritten
3. 41We do not intend to pay cash dividends
4. 42From time to time, we may become involved in legal proceedings52% rewritten
5. 43disclosure of confidential or proprietary information, we could incur liability and the further development of our product candidates could be delayedNew
6. 44As a result of being a public company, we are obligated to develop and maintain proper and effective internal controls over financial reporting, and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our common stock
7. 45Our ability to use net operating losses and certain other tax attributes to offset future taxable income may be subject to limitation
8. 46Catastrophic events may disrupt our business
9. 47Our business and operations could be adversely affected by the effects of health epidemics, as was recently experienced in connection with the COVID-19 virus, which was declared by the World Health Organization as a global pandemic
10. 48Unfavorable global political or economic conditions could adversely affect our business, financial condition or results of operations
11. 49Changes in tax laws or regulations could materially adversely affect our company