Marker Therapeutics (MRKR) risk factors, FY2024 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
2. 03Adverse developments affecting financial institutions, companies in the financial services industry or the financial services industry generally, such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity
3. 04Valley Bank, or SVB, was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, or the FDIC, as receiver

Risks Related to the Development of our Product Candidates

1. 05All 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. 06The 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. 07Preclinical 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. 08The results of earlier preclinical and clinical trials may not be predictive of future clinical trial results
5. 09If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed
6. 10We may not obtain or maintain the benefits associated with orphan drug designation, including market exclusivity
7. 11in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation

Risks Related to Manufacturing

1. 12We rely on third-party vendors and contract manufacturing organizations to maintain and support our manufacturing and cell processing operations
2. 13trials, or our product candidates for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure
3. 14No 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. 15We may not realize the expected benefits from the transaction with Cell Ready
2. 16Our strategic relationship with BCM is dependent, in part, upon our ongoing relationship with key medical and scientific personnel and advisors
3. 17We 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. 18Our 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. 19Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients, healthcare payors and the medical community
2. 20If 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. 21Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations
4. 22Our 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. 23The 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 enterprises
6. 24primarily have educational objectives, they may develop proprietary technologies that lead to other FDA approved therapies or that secure patent protection that we may need for the development of our technologies and product candidates
7. 25The 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
8. 26New regulatory pathways for biosimilar competition could reduce the duration of market exclusivity for our products
9. 27are biosimilar to earlier versions of biological products. For example, the European Union has had an established regulatory pathway for biosimilars since 2005
10. 28If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
11. 29The multiple roles of Dr. Vera, our President, Chief Executive Officer, and Principal Financial and Accounting Officer, could limit his time and availability to us, and create, or appear to create, conflicts of interest

Risks Related to Our Intellectual Property

1. 30If we are unable to protect our proprietary rights, we may not be able to compete effectively or operate profitably
2. 31The use of our technologies could potentially conflict with the rights of others
3. 32Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
4. 33We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world
5. 34We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties
6. 35If 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. 36We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
8. 37Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
9. 38Certain of our technologies are in-licensed from third parties, and the protection of those technologies is not entirely within our control
10. 39We 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 others
11. 40We 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
12. 41We may be unable to adequately prevent disclosure of trade secrets and other proprietary information
13. 42If 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. 43Obtaining 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. 44Recently 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 candidates
3. 45reimbursement and access to, pharmaceutical products, may limit or delay our ability to commercialize our products, generate revenue or attain profitability
4. 46Preparing for and complying with these obligations requires us to devote significant resources, which may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf

Risks Related to our Securities

1. 47The price of our stock may be volatile
2. 48We completed a reverse stock split of our shares of common stock, which may reduce and may limit the market trading liquidity of the shares due to the reduced number of shares outstanding and may potentially have an anti-takeover effect
3. 49Sales 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 securities
4. 50financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves
5. 51We do not intend to pay cash dividends
6. 52From time to time, we may become involved in legal proceedings
7. 53fire, terrorism, successful breaches, personnel misconduct or error, or human or technological error, war and telecommunication and electrical failures
8. 54As 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
9. 55Our ability to use net operating losses and certain other tax attributes to offset future taxable income may be subject to limitation
10. 56Catastrophic events may disrupt our business
11. 57Our 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
12. 58Unfavorable global political or economic conditions could adversely affect our business, financial condition or results of operations
13. 59Changes in tax laws or regulations could materially adversely affect our company