Tenax Therapeutics (TENX) risk factors, FY2024 10-K

Risks Related to Our Business and Our Operations

1. 01We are limited in the number of products we can simultaneously pursue and therefore our survival depends on our success with a small number of product opportunities
2. 02We currently have no approved drug products for sale, and we cannot guarantee that we will ever have marketable drug products
3. 03We are required to conduct additional clinical trials, including the LEVEL and LEVEL-2 trials for oral levosimendan, which are expensive and time consuming, and the outcome of the clinical trials is uncertain
4. 04Delays in the enrollment and completion of clinical testing could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product candidates
5. 05lack of adequate funding to continue the clinical trial, including unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies, and increased expenses associated with the services of our CROs and other third parties
6. 06The market may not accept our products
7. 07any restrictions on the use of our products together with other medications
8. 08Any collaboration we enter with third parties to develop and commercialize any future product candidates may place the development of our product candidates outside our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us

Risks Related to Our Financial Position and Need for Additional Capital

1. 09the costs of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval
2. 10We may be required to make milestone and royalty payments to the licensor of the levosimendan intellectual property in connection with the development and commercialization of levosimendan, which could adversely affect the profitability of levosimendan, if approved
3. 11We expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance
4. 12our ability to attract and retain personnel, including our executive team, advisors and members of our Board of Directors; and
5. 13We have incurred losses since our inception, expect to continue to incur losses in the foreseeable future, and may never become profitable

Risks Relating to Our Industry

1. 14Intense competition might render our cardiovascular and pulmonary product candidates noncompetitive or obsolete
2. 15Our activities are and will continue to be subject to extensive government regulation, which is expensive and time-consuming, and we will not be able to sell our products without regulatory approval
3. 16Discovery of previously unknown problems with our products, or unanticipated problems with our manufacturing arrangements, even after FDA and other regulatory approvals of our products for commercial sale, may result in the imposition of significant restrictions, including withdrawal of the product from the market
4. 17We may not receive all of the anticipated market exclusivity benefits of imatinib’s orphan drug designation, if we prioritize imatinib development in the future
5. 18Even after products are commercialized, we would expect to spend considerable time and money complying with federal and state laws and regulations governing their sale, and, if we are unable to fully comply with such laws and regulations, we could face substantial penalties
6. 19We are subject to uncertainty relating to healthcare reform measures and reimbursement policies that, if not favorable to our products, could hinder or prevent our products’ commercial success, if any of our product candidates are approved
7. 20Governments outside the United States tend to impose strict price controls and reimbursement approval policies, which may adversely affect our prospects for generating revenue outside the United States
8. 21Product liability lawsuits against us could cause us to incur substantial liabilities, limit sales of our existing products and limit commercialization of any products that we may develop
9. 22the inability to commercialize any products that we may develop
10. 23Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cybersecurity

Risks Related to Our Dependence on Third Parties

1. 24We do not own or operate any manufacturing facilities for the clinical- or commercial-scale production of our products
2. 25in a timely manner, we would experience a significant interruption in supply of levosimendan, which could negatively affect our clinical trial conduct and other product development efforts and timelines, financial condition, results of operations and cash flows
3. 26If we fail to attract and retain senior management and key scientific personnel, we may be unable to successfully develop and commercialize our product candidates
4. 27We expect to need to increase the size of our organization to further develop our product candidates, and we may experience difficulties in managing growth
5. 28improve our operational, financial and management controls, reporting systems and procedures
6. 29We currently have very limited marketing capabilities and no sales organization. If we are unable to establish sales and marketing capabilities on our own or through third parties, we will be unable to successfully commercialize our products, if approved, or generate product revenue
7. 30unforeseen costs and expenses associated with creating and sustaining an independent sales and marketing organization
8. 31business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement

Risks Related to Intellectual Property

1. 32Our success will depend in part on obtaining and maintaining effective patent and other intellectual property protection for our product candidates and proprietary technology
2. 33the patents of others may have an adverse effect on our business
3. 34We rely on confidentiality agreements that, if breached, may be difficult to enforce and could have a material adverse effect on our business and competitive position
4. 35We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use, our technology
5. 36difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents
6. 37Under current law, we may not be able to enforce all employees’ covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees
7. 38We may infringe or be alleged to infringe intellectual property rights of third parties

Risks Related to Owning Our Common Stock

1. 39Our share price has been volatile, and may continue to be volatile, which may subject us to securities class action litigation in the future
2. 40general economic and market conditions, including as a result of disruptive events broadly affecting society, and as a result of geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine
3. 41Investors may experience dilution of their ownership interests because of the future issuance of additional shares of our common stock or securities convertible into common stock
4. 42Anti-takeover provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult, which could discourage takeover attempts and lead to management entrenchment, and the market price of our common stock may be lower as a result
5. 43authorize the Board of Directors, by a majority vote, to amend the Bylaws
6. 44Our Bylaws contain an exclusive forum provision, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees, or agents
7. 45We have not paid cash dividends in the past and do not expect to pay dividends in the future. Any return on investment may be limited to the value of our common stock
8. 46Our ability to use our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be subject to certain limitations