New Risk • Aug 04
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 44% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$74m net loss in 3 years). New Risk • Jul 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$82m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding). Aankondiging • May 14
Tenax Therapeutics, Inc. Appoints So-Young Kim, Md, as Executive Vice President Tenax Therapeutics, Inc. announced that In May 2026, Tenax also appointed So-Young Kim, MD, as Executive Vice President of Clinical Development and Strategy. Dr. Kim has extensive industry experience spanning global drug development and commercial strategy at Bayer AG, with a deep focus on cardiovascular and cardiometabolic medicine. New Risk • May 13
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 11% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (63% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$102m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Aankondiging • May 05
Tenax Therapeutics, Inc. Appoints Timothy Healey as Chief Commercial Officer, Effective May 4, 2026 Tenax Therapeutics, Inc. announced the appointment of Timothy Healey, MBA, as Chief Commercial Officer, effective May 4, 2026. Mr. Healey is a seasoned pharmaceutical executive who has developed and implemented innovative launch and commercialization models throughout his career. He most recently served as Chief Commercial Officer at Eversana Life Science Services, where he led the launch and commercialization efforts for a number of biopharmaceutical companies preparing for their initial commercial entry. Prior to Eversana, Mr. Healey served as Senior Vice President, Commercial at Lantheus where he led a global staff spanning all commercial functions across the company’s product portfolio. Previously, he served as Vice President, US Virology at AbbVie and, before that, as Senior Vice President, Commercial at AMAG Pharmaceuticals. His commercial leadership experience has earned him some of the industry’s highest honors during his career, including being named Brandweek’s “Marketer of the Year” and leading a team that received Medical Marketing & Media’s “Brand Team of the Year” award. Mr. Healey received a BS from Boston College and an MBA from Babson College. Aankondiging • Apr 24
Tenax Therapeutics, Inc. Announces Chief Financial Officer Changes Tenax Therapeutics, Inc. announced the appointment of Thomas R. Staab, II as Chief Financial Officer (CFO), effective May 11, 2026. Mr. Staab brings over 25 years of leadership experience across management and corporate finance roles in the healthcare industry. He will replace Thomas McGauley, who has served as interim CFO since December 2024. Mr. Staab is a highly qualified healthcare executive with over 25 years in various financial leadership positions at publicly-listed companies. He most recently served as CFO and Secretary of LENSAR until May 2026, and Senior Vice President, CFO and Treasurer at BioCryst Pharmaceuticals from July 2011 to February 2020. Prior to BioCryst, Mr. Staab served as Executive Vice President, CFO and Treasurer at Inspire Pharmaceuticals through its approximately $430 million acquisition by Merck. Previously, he served as acting CFO and Treasurer at Triangle Pharmaceuticals through its $464 million acquisition by Gilead. Before joining the healthcare industry, Mr. Staab worked for PricewaterhouseCoopers providing audit and business advisory services to national and multi-national corporations in various industries. He received a BS in Business Administration and a Master of Accounting from the University of North Carolina at Chapel Hill. Mr. Staab is a Certified Public Accountant. Aankondiging • Apr 23
Tenax Therapeutics, Inc., Annual General Meeting, Jun 02, 2026 Tenax Therapeutics, Inc., Annual General Meeting, Jun 02, 2026. Location: at the companys principle executive office, at 101 glen lennox drive, suite 300, north carolina, chapel hil United States New Risk • Mar 11
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 40% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$41m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). New Risk • Jan 15
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$54m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Aankondiging • Dec 18
Tenax Therapeutics Announces Result of Prespecifed Blinded Sample Size Assessment Tenax Therapeutics, Inc. announced that the prespecified Blinded Sample Size Re-estimation (BSSR) of level demonstrated the trial is powered at well over 90% to detect a 25 meter change in 6-minute walk distance (6MWD), the primary endpoint. Based on these results, Tenax confirmed the target enrollment remains unchanged, and reiterated that enrollment is expected to complete in the first half of 2026.VEL is an ongoing, registrational Phase 3 clinical trial evaluating TNX-103 (oral levosimendan) in patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) in the United States and Canada. The prespecified, blinded review of the standard deviation in 6MWD change observed in the first 150 randomized, placebo-controlled patients, yielded a result of less than the assumed 55 meters. LEVEL-2 (NCT07288398) is a global, Phase 3, double-blind, randomized, placebo-controlled study of TNX-103. The clinical trial plans to enroll approximately 540 PH-HFpEF patients, randomized 2:1 to receive TNX-103 or placebo. The primary endpoint of the study is change from baseline in 6MWD at Week 26. In addition, Tenax announced it will initiate a global, multi-center, long-term, open-label extension (OLE) study. The OLE study will provide patients enrolled in levosimendan clinical trials continued access to TNX-103 after study completion and until potential availability of a commercialized product. Levosimendan (TNX-101, TNX-102, TNX-103). Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection portion (PH-HFpEF). TNX-103 (oral Levosimendan) is currently being evaluated in level and level of efficacy assessment, to provide the FDA and other global regulators a robust safety database to support their ultimate risk/benefit analysis at the approval stage. Price Target Changed • Dec 17
Price target increased by 11% to US$22.20 Up from US$20.00, the current price target is an average from 5 analysts. New target price is 89% above last closing price of US$11.76. Stock is up 113% over the past year. The company is forecast to post a net loss per share of US$1.37 next year compared to a net loss per share of US$1.15 last year. Recent Insider Transactions • Dec 12
Chief Medical Officer & Director recently bought US$51k worth of stock On the 9th of December, Stuart Rich bought around 5k shares on-market at roughly US$10.16 per share. This transaction amounted to 77% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger purchase from another insider worth US$58k. Insiders have collectively bought US$189k more in shares than they have sold in the last 12 months. Recent Insider Transactions • Nov 20
Key Executive recently bought US$58k worth of stock On the 17th of November, Thomas McGauley bought around 8k shares on-market at roughly US$7.27 per share. This trade did not impact their existing holding. This was the largest purchase by an insider in the last 3 months. This was Thomas' only on-market trade for the last 12 months. Aankondiging • Sep 16
Tenax Therapeutics Announces European Patent Office Intention to Grant Patent Covering Use of Levosimendan in PH-HFpEF Tenax Therapeutics, Inc. announced that the European Patent Office (EPO) has notified Tenax of its Intention to Grant a patent that will provide intellectual property (IP) protection for TNX-103 (oral levosimendan), and other formulations of levosimendan, as well as its active metabolites, for use in pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF). Once granted, this patent will provide Tenax with protection in Europe through 2040, and may qualify for an additional European patent term beyond 2040. "This patent will protect the use of levosimendan in PH-HFpEF, including TNX-103, in Europe, where prevalence estimates indicate the number of patients currently suffering from this disease approximates the number estimated in North America. This patent protects an important commercial opportunity for Tenax. Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection portion (PH-HFpEF"). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax's Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral Levosimendan) is currently being evaluated in level, a Phase 3, double-blind, randomized, placebo-controlled clinical trial in patients with PH- HFpEF. Price Target Changed • May 15
Price target increased by 16% to US$18.85 Up from US$16.30, the current price target is an average from 4 analysts. New target price is 231% above last closing price of US$5.70. Stock is up 61% over the past year. The company is forecast to post a net loss per share of US$3.72 next year compared to a net loss per share of US$1.15 last year. Aankondiging • Apr 11
Tenax Therapeutics, Inc., Annual General Meeting, Jun 11, 2025 Tenax Therapeutics, Inc., Annual General Meeting, Jun 11, 2025. Location: 101 glen lennox drive, suite 300, north carolina., chapel hill United States Breakeven Date Change • Mar 26
No longer forecast to breakeven The 5 analysts covering Tenax Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$1.04m in 2027. New consensus forecast suggests the company will make a loss of US$52.0m in 2027. Board Change • Feb 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. Independent Director Robyn Hunter was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Breakeven Date Change • Dec 31
Forecast to breakeven in 2027 The 5 analysts covering Tenax Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.04m in 2027. Average annual earnings growth of 53% is required to achieve expected profit on schedule. New Risk • Oct 14
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$13m Forecast net loss in 3 years: US$7.6m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (over 10x increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$7.6m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$11.5m market cap). Aankondiging • Aug 12
Tenax Therapeutics, Inc. announced that it has received $99.681169 million in funding from a group of investors On August 12, 2024, Tenax Therapeutics, Inc. closed the transaction. the private placement included participation from certain institutional and accredited healthcare investors, raising gross proceeds of approximately $100 million. Aankondiging • Aug 08
Tenax Therapeutics, Inc. announced that it expects to receive $99.681169 million in funding from a group of investors Tenax Therapeutics, Inc. announced that it has entered into a securities purchase agreement for an oversubscribed private placement financing to issue an aggregate of 1,450,661 shares of the Company’s common stock and pre-funded warrants to purchase an aggregate of 31,882,671 shares of common stock, along with accompanying warrants to purchase an aggregate of 16,666,666 shares of common stock at an issue price of $2.99 per share and $2.99 per warrant for the aggregate gross proceeds of $99,681,169? on August 6, 2024. The transaction will include participation from new investors led by BVF Partners L.P. and other investors such as Venrock Healthcare Capital Partners, Janus Henderson Investors, Vivo Capital, LLC, Vestal Point Capital, LP, Velan Capital Partners LP, ADAR1 Capital Management, LLC, Stonepine Capital Management LLC and Sphera Biotech. The accompanying warrant have an exercise price of $4.50 and the pre-funded warrants are exercisable at any time after their original issuance and will not expire. The Company paid the Placement Agents a cash fee of 6% of the aggregate gross proceeds raised in the Private Placement, certain capital market advisory fees, and reimbursement of certain expenses and legal fees. The securities to be issued in connection with the private placement described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended. New Risk • Aug 07
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (over 6x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$5.72m market cap). Minor Risk Share price has been volatile over the past 3 months (11% average weekly change). New Risk • May 14
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 19% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 6x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$6.95m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Aankondiging • Apr 28
Tenax Therapeutics, Inc., Annual General Meeting, Jun 07, 2024 Tenax Therapeutics, Inc., Annual General Meeting, Jun 07, 2024, at 09:00 US Eastern Standard Time. Location: 101 Glen Lennox Drive, Suite 300, Chapel Hill North Carolina United States Agenda: To elect the directors named in the proxy statement for a one-year term expiring in 2025 or until their successors have been elected and qualified; to approve amendment no. 1 to 2022 stock incentive plan to increase the number of shares authorized for issuance under the plan by 400,000 shares; to ratify the appointment of cherry Bekaert LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; and to consider and take action upon such other matters as may properly come before the meeting or any adjournment or postponement thereof. New Risk • Feb 15
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$7.0m Forecast net loss in 3 years: US$4.1m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (28% average weekly change). Shareholders have been substantially diluted in the past year (over 14x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$7.41m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$4.1m net loss in 3 years). Aankondiging • Feb 08
Tenax Therapeutics Enrolls First Patient in Phase 3 Level Study Evaluating TNX-103 (Oral Levosimendan) for the Treatment of Pulmonary Hypertension in PH-HFpEF Patients Tenax Therapeutics, Inc. announced that the first patient has enrolled in the Company's Phase 3 level Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) (NCT05983250). As previously disclosed, the FDA does not require Tenax conduct a long-term, cardiovascular outcomes trial in this population, significantly reducing the costs and time for the registration of TNX-103. The extensive levosimendan patent estate includes protections through at least 2040 of all therapeutic doses of the proprietary oral formulation (TNX-103) being evaluated in level, as well as I.V. and subcutaneous formulations, in patients with PH-HFpEF. The level study will evaluate six-minute walking distance (6MWD) as the primary endpoint, and will enroll a total of 152 patients. The Phase 3 program for TNX-103 has been designed to exceed the minimal clinically important difference, and satisfy the U.S. Food and Drug Administration's request for subject drug exposure of 300 patients for 6 months and 100 patients for 1 year (these are minimum requirements per ICH guidelines). Aankondiging • Jan 13
Tenax Therapeutics Receives Non-Compliance Notice from Nasdaq On January 11, 2024, Tenax Therapeutics, Inc. (the “Company”) received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) regarding compliance with Nasdaq Listing Rule 5550(a)(4) (the “Rule”) which requires the Company to have a minimum of 500,000 publicly held shares. The letter from Nasdaq indicated that according to its calculations, as of January 3, 2024, the day after the Company effected a 1-for-80 reverse split of its common stock, the Company no longer meets the requirements of the Rule. This notice of noncompliance has no immediate impact on the continued listing or trading of the Company’s securities on the Nasdaq Capital Market, which will continue to be listed and traded on Nasdaq, subject to the Company’s compliance with the other Nasdaq continued listing requirements. In accordance with Nasdaq rules, the company has until February 26, 2024 to provide the Staff with a specific plan to achieve and sustain compliance with all listing requirements of The Nasdaq Capital Market, including the time frame for completion of this plan. After reviewing plan, Nasdaq will provide written notice of their decision. If Nasdaq does not accept plan, the company will have the opportunity to appeal their decision to a hearings panel. The company intend to consider options available To achieve compliance with the Nasdaq listing rules and provide plan to Nasdaq by February 26, 2024. There can be no assurance that will be able to achieve and sustain compliance with the publicly held shares requirement or will otherwise be in compliance with the other listing standards for The Nasdaq Capital Market. Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 2 analysts covering Tenax Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$35.5m in 2026. Average annual earnings growth of 58% is required to achieve expected profit on schedule. Aankondiging • Dec 02
Tenax Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $36 million. Tenax Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $36 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Warrants
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Aankondiging • Nov 18
Tenax Therapeutics, Inc. Appoints Javed Butler to its PH-HFpEF Scientific Advisory Board Tenax Therapeutics, Inc. announced the appointment of Javed Butler, M.D., M.P.H, M.B.A., to the Company’s PH-HFpEF Scientific Advisory Board (SAB). Javed Butler is the President of the Baylor Scott and White Research Institute and Senior Vice President for Baylor Scott and White Health. He is also the Distinguished Professor of Medicine at the University of Mississippi in Jackson, MS. Dr. Butler earlier served as the Patrick H. Lehan Chair in Cardiovascular Research, and Professor and Chairman of the Department of Medicine at the University of Mississippi, where he was also Professor of Physiology and Biophysics. He was previously Charles A. Gargano Chair in Cardiovascular Research and Director of the Division of Cardiovascular Medicine and Co-Director of the Heart Institute at Stony Brook University, New York; Director for Heart Failure Research at Emory University; and Director of the Heart and Heart-Lung Transplant Programs at Vanderbilt University. He received his medical degree from the Aga Khan University and then completed residency training at Yale University, cardiology fellowship and advanced heart failure and transplant fellowships at Vanderbilt University, and cardiac imaging fellowship at the Massachusetts General Hospital at the Harvard Medical School. He received a Master of Public Health degree from Harvard University, and an MBA from Emory University. Aankondiging • Nov 15
Tenax Therapeutics, Inc. Announces FDA Clearance of IND for TNX-103 for the Treatment of Pulmonary Hypertension with Heart Failure Tenax Therapeutics, Inc. announced that the U.S. Food and Drug Administration has reviewed and cleared the Company’s Investigational New Drug (IND) Application for TNX-103 (oral levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF), enabling the Company to launch its LEVEL trial, and initiate Phase 3 sites in the fourth quarter of 2023. First Phase 3 study of TNX-103 in PH-HFpEF patients to start in Fourth Quarter 2023 (The LEVEL Study), FDA agreement that 6MWD will be the primary endpoint for both Phase 3 studies, Phase 3 program designed to satisfy FDA’s request for subject drug exposure of 300 patients for 6 months, 100 patients for 1 year (minimum requirements per ICH guidelines), No FDA requirement for a cardiovascular outcomes trial, Oral levosimendan use in PH-HFpEF is protected by USPTO granted patent that will not expire until the end of 2040, There are no FDA-approved treatments for PH-HFpEF, with an estimated prevalence of more than 2,000,000 patients in North America by 2030. Tenax Therapeutics and its CRO partner have already selected more than two-thirds of the research sites targeted to participate in the LEVEL Study, including many of the leading cardiovascular centers in the United States and Canada. Every investigative site that enrolled patients in the HELP Study has been invited to participate in LEVEL, and already 90% have agreed to take part. Levosimendan is a unique potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action. Initially discovered and developed by Orion Corporation in Finland, intravenous levosimendan is approved in 58 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Tenax Therapeutics has North American rights to develop and commercialize IV (TNX-101), subcutaneous (TNX-102), and oral (TNX-103) formulations of levosimendan. Results of Tenax Therapeutics’ Phase 2 HELP trial of levosimendan in patients with pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF) demonstrated that IV levosimendan produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that forms the basis for the Phase 3 investigation of Tenax Therapeutics’ potential therapy. To date, no other drug therapy has improved exercise tolerance in patients with PH associated with HFpEF, “a growing epidemic with high morbidity and mortality and no treatment. The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development” (AHA Scientific Advisory, “A Call to Action,” 2022). Tenax Therapeutics is developing novel dosing and a unique formulation of imatinib mesylate, a kinase inhibitor that has received FDA’s orphan designation (March 2020) for the treatment of pulmonary arterial hypertension (PAH). The IMPRES trial, a previous Phase 3 trial, demonstrated that oral imatinib may produce a markedly greater, and much more durable, treatment effect on exercise tolerance, than any other available PAH treatment, alone or in combination, based on the results observed in those patients who were maintained on the full imatinib dose for the majority of the trial. Despite the availability of several classes of pulmonary vasodilators, no existing treatment has been shown to halt progression or induce regression of the disease. Imatinib acts on underlying cellular proliferative pathways associated with PAH and has the potential to be approved as a disease modifying therapy for PAH. New Risk • Nov 14
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 85% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (85% average weekly change). Shareholders have been substantially diluted in the past year (over 9x increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$14.8m market cap). Aankondiging • Oct 01
The Nasdaq Stock Market LLC Grants Tenax Therapeutics's Request for an Extension Through March 25, 2024 to Evidence Compliance with the $1.00 Per Share Requirement for Continued Inclusion on the Nasdaq Capital Market On September 28, 2023, Tenax Therapeutics, Inc. (the “Company”) received formal notice that the Nasdaq Stock Market LLC (“Nasdaq”) granted the Company’s request for an extension through March 25, 2024 (the “Extension Notice”) to evidence compliance with the $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). If at any time before March 25, 2024, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of ten consecutive business days, Nasdaq will provide the Company with written confirmation of compliance with the Bid Price Rule. As previously disclosed, on March 29, 2023, Nasdaq notified the Company that the Company no longer satisfied the Bid Price Rule and was therefore subject to delisting (the “Original Notification”). The Company had 180 days, or until September 25, 2023, to achieve compliance with the Bid Price Rule. The Company applied for an extension of the compliance period with Nasdaq, as permitted under the Original Notification. The Company indicated to Nasdaq that it met the continued listing requirement for market value of publicly-held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the Bid Price Rule, and provided notice of its intention to cure the deficiency during the extended compliance period by effecting a reverse stock split, if necessary. If the Company does not regain compliance with the Bid Price Rule by March 25, 2024, Nasdaq will provide written notice to the Company that its common stock is subject to delisting. At that time, the Company may appeal the determination to a Nasdaq hearings panel. The request for a hearing will stay any suspension or delisting action pending the issuance of the hearing panel’s decision. The Extension Notice has no effect at this time on the listing of the Company’s common stock, which will continue to trade on The Nasdaq Capital Market. The Company is currently evaluating its options for regaining compliance. There can be no assurance that the Company will be able to regain compliance with the Bid Price Rule, even if it maintains compliance with the other listing requirements. Aankondiging • Jul 22
Tenax Therapeutics Issues U.S. Patent for Oral Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) Tenax Therapeutics, Inc. announced that the United States Patent and Trademark Office (USPTO) has granted a new method of use patent for oral levosimendan (TNX-103) in the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF), expiring in 2040. The issued patent (U.S. Patent No. 11,701,355) covers the use of oral levosimendan for the treatment of PH-HFpEF and provides exclusivity through December 2040. The '355 patent further builds upon the Company's substantial IP, which also includes issued U.S. patents for the use of intravenous (U.S. Patent No. 11,607,412) and subcutaneous (U.S. Patent No. 11,213,524) formulations of levosimendan for the treatment of PH-HFpEF. This is the most commonly seen patient in pulmonary hypertension referral centers, and yet not a single therapy has been approved for them. Finally, the unmet need of these patients may now be addressed. Aankondiging • Jun 01
Tenax Therapeutics, Inc. Receives a Notice of Allowance from the United States Patent and Trademark Office for its Patent Application Tenax Therapeutics, Inc. announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application with claims covering the use of TNX-103, oral levosimendan, titled: “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).” The patent, once granted, will have a patent term through December 2040. It will provide the Company with substantial added intellectual property (IP) protection in the United States; Tenax will now have secured IP rights surrounding the use of oral, subcutaneous, and intravenous (IV) administration of levosimendan for the treatment of PH-HFpEF. The patent covering the use of oral levosimendan for the treatment of PH-HFpEF is based on key discoveries from the HELP Study, in which levosimendan-treated PH-HFpEF patients benefited from a statistically significant improvement in 6-minute walk distance of 29 meters (p=0.03) when compared with placebo. When transitioning to the oral daily formulation after a lengthy treatment with the weekly IV formulation, the 6-minute walk results improved further. Price Target Changed • Feb 16
Price target increased by 16% to US$110 Up from US$95.00, the current price target is an average from 2 analysts. New target price is 11,931% above last closing price of US$0.91. Stock is down 93% over the past year. The company is forecast to post a net loss per share of US$8.00 next year compared to a net loss per share of US$31.56 last year. Aankondiging • Feb 02
Tenax Receives Notice of Allowance for U.S. Patent Application Covering Use of IV Levosimendan in Pulmonary Hypertension with Heart Failure and Preserved Ejection Fraction (PH-HFpEF) Tenax Therapeutics, Inc. announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application with claims covering the use of IV levosimendan in the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The new claims were made in Tenax Therapeutics’ patent application titled “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).” The patent is expected to last until 2040 and will provide the Company with substantial added intellectual property (IP) protection for the use of levosimendan in the treatment of PH-HFpEF patients in the United States. This Notice of Allowance further builds upon the Company’s significant IP for levosimendan, which includes U.S. Patent No. 11,213,524 that was issued in January 2022 and covers all medical uses in humans of the subcutaneous formulation of levosimendan. The results of the HELP Study showed that levosimendan-treated PH-HFpEF patients benefited from a statistically significant improvement in 6-minute walk distance of 29 meters (p=0.03) when compared with placebo. When transitioning to the oral daily formulation after a lengthy treatment with the weekly IV formulation, the 6-minute walk results improved further. FDA has confirmed to Tenax Therapeutics that the six-minute walk distance endpoint is acceptable for a Phase 3 registration program for the treatment of PH-HFpEF. Levosimendan is a unique potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action. Initially discovered and developed by Orion Corporation in Finland, intravenous levosimendan is approved in over 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Tenax Therapeutics has North American rights to develop and commercialize IV (TNX-101), subcutaneous (TNX-102), and oral (TNX-103) formulations of levosimendan. Results of Tenax Therapeutics’ Phase 2 trial of levosimendan in patients with pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF) demonstrated that IV levosimendan produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that forms the basis for the Phase 3 investigation of Tenax Therapeutics’ potential groundbreaking therapy. To date, no other drug therapy has improved exercise tolerance in patients with PH associated with HFpEF, recently referred to as the greater unmet need in cardiovascular disease. Tenax Therapeutics is developing novel dosing and a unique formulation of imatinib mesylate, a kinase inhibitor that has received FDA’s orphan designation (March 2020) for the treatment of pulmonary arterial hypertension (PAH). The IMPRES trial, a previous Phase 3 trial, demonstrated that oral imatinib may produce a markedly greater, and much more durable, treatment effect on exercise tolerance, than any other available PAH treatment, alone or in combination, based on the results observed in those patients who were maintained on the full imatinib dose for the majority of the trial. Despite the availability of several classes of pulmonary vasodilators, no existing treatment has been shown to halt progression or induce regression of the disease. Imatinib acts on underlying cellular proliferative pathways associated with PAH and has the potential to be the first disease modifying therapy for PAH. Board Change • Nov 17
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 5 experienced directors. 1 highly experienced director. Independent Chairman Gerry Proehl is the most experienced director on the board, commencing their role in 2014. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Breakeven Date Change • Aug 19
Forecast to breakeven in 2023 The 2 analysts covering Tenax Therapeutics expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 65% to 2022. The company is expected to make a profit of US$250.0k in 2023. Price Target Changed • Jun 01
Price target decreased to US$4.00 Down from US$4.75, the current price target is provided by 1 analyst. New target price is 506% above last closing price of US$0.66. Stock is down 67% over the past year. The company is forecast to post a net loss per share of US$0.44 next year compared to a net loss per share of US$1.58 last year. Board Change • Apr 27
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 3 experienced directors. 1 highly experienced director. Independent Chairman Gerry Proehl is the most experienced director on the board, commencing their role in 2014. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Dec 30
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 5 experienced directors. No highly experienced directors. Independent Chairman Gerry Proehl is the most experienced director on the board, commencing their role in 2014. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Breakeven Date Change • Nov 30
Forecast to breakeven in 2022 The 2 analysts covering Tenax Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$4.85m in 2022. Average annual earnings growth of 43% is required to achieve expected profit on schedule. Price Target Changed • Nov 27
Price target increased to US$4.75 Up from US$4.23, the current price target is provided by 1 analyst. New target price is 277% above last closing price of US$1.26. Stock is up 13% over the past year. The company is forecast to post a net loss per share of US$1.61 next year compared to a net loss per share of US$1.33 last year. Executive Departure • Sep 15
Independent Director James Mitchum has left the company On the 8th of September, James Mitchum's tenure as Independent Director ended after 6.0 years in the role. As of June 2021, James still personally held only 1.30k shares (US$2.7k worth at the time). A total of 5 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Board Change • Jul 31
High number of new directors Independent Chairman Gerry Proehl was the last director to join the board, commencing their role in 2021. Executive Departure • Jul 15
CEO & Director Anthony DiTonno has left the company On the 13th of July, Anthony DiTonno's tenure as CEO & Director of the company ended after 3.1 years in the role. We don't have any record of a personal shareholding under Anthony's name. A total of 4 executives have left over the last 12 months. The current median tenure of the management team is 3.08 years. Under Anthony's leadership, the company delivered a total shareholder return of -68%. Executive Departure • Jun 14
Independent Director Chris Rallis has left the company On the 11th of June, Chris Rallis' tenure as Independent Director ended after 9.5 years in the role. We don't have any record of a personal shareholding under Chris' name. A total of 3 executives have left over the last 12 months. The current median tenure of the management team is 3.00 years. Executive Departure • Jun 14
Independent Director Gregory Pepin has left the company On the 11th of June, Gregory Pepin's tenure as Independent Director ended after 11.8 years in the role. We don't have any record of a personal shareholding under Gregory's name. A total of 3 executives have left over the last 12 months. The current median tenure of the management team is 3.00 years. Executive Departure • Jun 14
Independent Chairman Ronald Blanck has left the company On the 11th of June, Ronald Blanck's tenure as Independent Chairman ended after 11.5 years in the role. We don't have any record of a personal shareholding under Ronald's name. A total of 3 executives have left over the last 12 months. The current median tenure of the management team is 3.00 years. Price Target Changed • Apr 10
Price target increased to US$4.75 Up from US$4.23, the current price target is an average from 2 analysts. New target price is 128% above last closing price of US$2.08. Stock is up 253% over the past year. Is New 90 Day High Low • Feb 10
New 90-day high: US$2.78 The company is up 181% from its price of US$0.99 on 11 November 2020. The American market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 23% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$28.44 per share. Is New 90 Day High Low • Jan 20
New 90-day high: US$2.36 The company is up 95% from its price of US$1.21 on 21 October 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 22% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$27.77 per share. Is New 90 Day High Low • Dec 30
New 90-day high: US$1.98 The company is up 29% from its price of US$1.54 on 30 September 2020. The American market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 16% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$8.66 per share. Is New 90 Day High Low • Oct 23
New 90-day low: US$1.18 The company is down 1.0% from its price of US$1.19 on 24 July 2020. The American market is up 8.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$15.55 per share.