TENAX THERAPEUTICS INC
For the period ended Dec 31, 2023. Filed Mar 28, 2024.
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FY2023 · Filed Mar 28, 2024
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PART I
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which represent our expectations or beliefs concerning future events. Forward-looking statements include statements that are predictive in nature, which depend upon or refer to future events or conditions, and/or which include words such as “believes,” “plans,” “intends,” “anticipates,” “estimates,” “expects,” “may,” “will” or similar expressions. In addition, any statements concerning future financial performance, ongoing strategies or prospects, and possible future actions, including any potential strategic transaction involving us, which may be provided by our management, are also forward-looking statements. These statements are not guarantees of future performance, and we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
Forward-looking statements are based on current expectations and projections about future events, actual events and results may differ materially from those expressed or forecasted in forward-looking statements due to a number of factors. You should understand that the following important factors, in addition to those discussed in under the heading “Risk Factors” included in Item 1A of Part I of this Annual Report on Form 10-K and in any of our filings with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, could affect our stock price or future results and could cause those results to differ materially from those expressed in such forward-looking statements:
| · | our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; |
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| · | our ongoing evaluation of strategic alternatives; |
| · | our ability to develop our current product candidates, and any product candidate which we may develop or in-license in the future; |
| · | our ability, our partners’ abilities, and third parties’ abilities to protect and assert intellectual property rights; |
| · | delays in the commencement, enrollment and completion of clinical testing, as well as the analysis and reporting of results from such clinical testing; |
| · | the success of clinical trials of our product candidates; |
| · | the need to obtain regulatory approval of our product candidates; |
| · | potential risks related to any collaborations we may enter into for our product candidates; |
| · | any delays in regulatory review and approval of product candidates in development; |
| · | our ability to establish an effective sales and marketing infrastructure; |
| · | our estimates regarding the potential market opportunity for our product candidates; |
| · | competition from existing products or new products that may emerge; |
| · | the ability to receive regulatory approval or commercialize our products; |
| · | potential side effects of our product candidates that could delay or prevent commercialization; |
| · | potential product liability claims and adverse events; |
| · | potential liabilities associated with hazardous materials; |
| · | our ability to maintain adequate insurance policies; |
| · | our dependence on third-party manufacturers and clinical research organizations (“CROs”); |
| · | our ability to establish or maintain collaborations, licensing or other arrangements; |
| · | costs related to and outcomes of potential litigation; |
| · | compliance with obligations under intellectual property licenses with third parties; |
| · | our ability to adequately support future growth; |
| · | our ability to attract and retain personnel, including our executive team, advisors and members of our Board of Directors; and |
| · | geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine |
The forward-looking statements in this Annual Report on Form 10-K represent our views as of the date such statements are made. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date such statements are made.
NOTES
All references in this Annual Report on Form 10-K to the “Company,” “Tenax”, “we”, “our” and “us” means Tenax Therapeutics, Inc.
This Annual Report on Form 10-K contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Annual Report on Form 10-K, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other company.
Our business is subject to significant risks and uncertainties that make an investment in us speculative and risky. Below we summarize what we believe are the principal risk factors, but these are not the only risks we face, and you should carefully review and consider the full discussion of our risk factors in the section titled “Risk Factors”, together with the other information in this Annual Report on Form 10-K. If any of the following risks materializes (or if any of those listed elsewhere in this Annual Report on Form 10-K materialize), our business, reputation, financial condition, results of operations, revenue, and future prospects could be seriously harmed. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business.
Risks Related to Our Financial Position and Need for Additional Capital
| • | Our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern. |
| • | We will require substantial additional funding to further develop our product candidates, including to complete the LEVEL trial, which includes an open label extension phase, to complete a subsequent Phase 3 trial of TNX-103, and to initiate or complete the imatinib Phase 3 trial. Failure to obtain this necessary capital when needed on acceptable terms, or at all, or execute on alternative strategic paths, could force us to delay, limit, reduce or terminate our clinical trials, product development efforts and business operations. |
| • | Our ongoing exploration of alternative strategic paths may not result in entering into or completing transactions, and the process of reviewing alternative strategic paths or their conclusion could adversely affect our stock price. |
| • | If we do not successfully complete strategic transactions, should this be deemed necessary, our Board of Directors may decide to pursue a dissolution and liquidation of our Company. |
| • | Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock. |
| • | We 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. |
| • | We have incurred losses since our inception, expect to continue to incur losses in the foreseeable future, and may never become profitable. |
Risks Related to Our Business Strategy and Operations
| • | We 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. |
| • | A pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19, or another coronavirus or similar disrupting illness, may materially and adversely affect our business and our financial results. |
| • | If we fail to attract and retain personnel, we may be unable to successfully develop and commercialize our product candidates. |
Risks Related to Drug Development and Commercialization
| • | We currently have no approved drug products for sale, and we cannot guarantee that we will ever have marketable drug products. |
| • | We are required to conduct additional clinical trials, including the LEVEL trial for oral levosimendan, which are expensive and time consuming, and the outcomes of the clinical trials are uncertain. |
| • | The market may not accept our products. |
| • | Nonfinal results from our clinical trials announced or published from time to time on an interim, preliminary, or “top-line” basis, may differ from results reported as more patient data become available, and these results are subject to audit and verification procedures that could result in material changes in the final data. |
| • | Any 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. |
| • | Delays 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 of our product candidates. |
Risks Relating to Our Industry
| • | Intense competition might render our product candidates noncompetitive or obsolete. |
| • | Our 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. |
| • | We may not receive all of the anticipated market exclusivity benefits of imatinib’s orphan drug designation, if we prioritize imatinib’s development in the future. |
| • | Even 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. |
| • | We 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. |
| • | Governments 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. |
| • | Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop. |
| • | Our 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
| • | We have historically and we will continue to rely significantly on third parties to conduct our nonclinical testing and clinical studies and other aspects of our development programs. |
| • | We depend on third parties to formulate and manufacture our products. |
| • | We currently have no marketing capabilities and no sales organization. |
Risks Related to Intellectual Property
| • | Our success will depend in part on obtaining and maintaining effective patent and other intellectual property protection for our product candidates and proprietary technology. |
| • | We 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. |
| • | We 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. |
| • | Under current law, we may not be able to enforce all employees’ covenants not to compete. |
| • | We may infringe or be alleged to infringe intellectual property rights of third parties. |
Risks Related to Owning Our Common Stock
| • | Our share price has been volatile, and may continue to be volatile, which may subject us to securities class action litigation in the future. |
| • | Anti-takeover provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult. |
| • | Our bylaws contain an exclusive forum provision for certain disputes, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees, or agents. |
| • | We 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. |
| • | Our ability to use our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be subject to certain limitations. |
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