TENX Tenax Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Levosimendan
Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF)
|
Phase 2
Phase 2
|
Phase 2 top-line data released June 2, 2020. Primary endpoint (Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise) not met. Various secondary endpoints met. Phase 3 trial planned.
|
|
Levosimendan
Reduce the incidence of low cardiac output syndrome during cardiac surgery
|
Phase 3
Phase 3
|
Phase 3 top line data released January 31, 2017 - primary endpoints not met.
|
|
Levosimendan
Septic shock
|
Phase 2b
Phase 2b
|
Phase 2b trial did not meet primary endpoint.
|
Latest News
-
View Full Article Hide Full Article
- 84% of PH-HFpEF patients responded to levosimendan based on prespecified criteria in the initial open-label lead-in phase
- Levosimendan improved cardiovascular hemodynamics and exercise capacity in PH-HFpEF patients
- Levosimendan produced a significant improvement in 6-minute walk distance and is the only therapy to produce such a result in a randomized, double-blind, placebo-controlled trial of PH-HFpEF patients
- Levosimendan was well tolerated in PH-HFpEF patients
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardio-pulmonary diseases with high unmet medical need, today announced the publication of positive data from the company's Phase 2 HELP Study that evaluated levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The new publication is titled Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Placebo-Controlled HELP Trial and was published in the Journal of American College of Cardiology: Heart Failure (https://www.jacc.org/doi/pdf/10.1016/j.jchf.2021.01.015).
The HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Study was designed as a randomized placebo-controlled trial to evaluate the hemodynamic and clinical effects of weekly levosimendan IV infusions in PH-HFpEF patients. This 6-week study design evaluated invasive cardiovascular hemodynamics as well as secondary clinical endpoints including a 6-minute walk test.
Results reported in the publication include an impressive responder rate of 84% during the open-label phase as 37 of 44 patients met responder criteria and were randomized to levosimendan (n=18) or placebo (n=19). Compared with placebo, levosimendan did not significantly reduce the primary endpoint of exercise-PCWP (-1.4 mmHg, 95% CI -7.8, 4.8, p=0.65), but effectively reduced PCWP measured across all exercise stages (-3.9±2.0 mmHg, p=0.047). Levosimendan treatment resulted in a 29.3 meter (95% CI [2.5, 56.1], p=0.033) improvement in 6 MWD compared to placebo. The authors concluded that further study of levosimendan in PH-HFpEF patients is warranted since levosimendan is the first drug to demonstrate improved cardiovascular hemodynamics and a statistically significant increase in six-minute walk distance seen compared to placebo
Dr. Daniel Burkhoff, MD PhD, Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at Cardiovascular Research Foundation led the blinded hemodynamic core lab and analysis for the HELP trial and is the first author on the publication. Dr. Burkhoff stated "The cardiovascular hemodynamic effects seen in this trial following levosimendan administration were impressive, especially in the first 24 hours. The reductions in cardiac filling pressures and associations with improved exercise performance are important early markers of clinical benefit and signify meaningful improvements in the wellbeing of PH-HFpEF patients. Levosimendan has the potential to have a major impact on the treatment of PH-HFpEF."
Dr. Stuart Rich, Chief Medical Officer at Tenax Therapeutics and Principal Investigator of the study stated "PH-HFpEF, which is Group 2 Pulmonary Hypertension, is a progressive and fatal disease with no effective medical treatments. Previous attempts to identify an effective treatment from clinical trials using approved pulmonary vasodilators have all failed. This is the first multi-center, randomized, placebo-controlled trial in PH-HFpEF patients to report a statistically significant improvement in 6-minute walk distance. Levosimendan has unique pulmonary vascular and cardiovascular properties which we identified as central to its clinical efficacy. The fact that 84% of the patients enrolled in the initial lead-in phase had a significant hemodynamic response at rest and with exercise during cardiac catheterization provides confidence that levosimendan may be an important treatment for these patients who have a large unmet need."
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer and K-ATP Channel activator that works through a unique mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
About Imatinib
Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company's control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company's control that could impact the Company's continued compliance with Nasdaq listing requirements; the impact of management changes on the Company's business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company's filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 31, 2021 as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210409005040/en/
-
View Full Article Hide Full Article
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that Ronald R. Blanck, D.O., Gregory Pepin and Chris A. Rallis have voluntarily agreed to step down from the Board of Directors of Tenax Therapeutics, effective as of the Annual Meeting of Stockholders of Tenax, currently scheduled for June 10, 2021, retiring after years of service to the Board.
The retirements of Dr. Blanck and Messrs. Pepin and Rallis from the Board were voluntary decisions as part of a Board refreshment program. This program included the onboarding of four new directors in the first quarter of calendar 2021, as previously announced by Tenax. The Tenax Board will maintain 12 members until the Annual Meeting of Stockholders, which will then be reduced to nine members upon their retirement from the Board.
Dr. Blanck has served on the Tenax Board since 2009 and as Chairman since 2011. Gerald Proehl, who has served on the Tenax Board since April 2014, shall assume role of Chairman upon Dr. Blanck's retirement from the Board. Mr. Pepin has served as a director since August 2009, and Mr. Rallis has served as a director since 2011.
"We would like to honor and thank Ron, Gregory and Chris for their stellar service to Tenax's Board, its management and, most importantly, its shareholders. Each of them has contributed their invaluable experience and sound judgment in guiding the company through times of opportunity and challenge. Each has been integral to strategically positioning Tenax for continued success and shareholder value-creation," said Anthony DiTonno, Chief Executive Officer of Tenax Therapeutics.
"I want to express my deep appreciation for their participation in and willingness to support our board refreshment program," said Gerald Proehl. "In particular, we appreciate them agreeing to an overlapping time period of service with the new Board members to ensure continuity of strong, independent leadership as we focus on creating shareholder value." Mr. Proehl continued, "Ron, Chris and Gregory provided important leadership since joining the Tenax board, resulting in a specialty pharmaceutical company with two late clinical stage products that may provide important treatment options for patients with cardiovascular diseases. I speak for the entire Tenax Board in thanking each of them for their dedication and years of service."
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
About Imatinib
Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company's control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company's control that could impact the Company's continued compliance with Nasdaq listing requirements; the impact of management changes on the Company's business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company's filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 31, 2021 as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210407005941/en/
-
View Full Article Hide Full Article
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today reported financial results for the year ended December 31, 2020 and provided a business update.
"Now that the merger with PH Precision Medicine is complete, we have clinical development programs in group one and group two Pulmonary Hypertension patients," stated Anthony DiTonno, Chief Executive Officer of Tenax, "which represent more than 70% of the overall market."
"Having acquired the oral formulation rights of Levosimendan from our agreement with Orion, we have set up an open label transition study to determine the dose we will take into Phase 3 trials in 2022. The Phase 2 HELP trial still has patients in the open label phase of the trial. We will be bringing those patients back to their clinics and converting them to the oral dosage form. We believe an oral dosage form will be more convenient to patients and provide more consistent blood levels of drug as opposed to weekly IV administration."
"With respect to the imatinib program, we continue to make good progress on developing a formulation that will address previous GI-related side effects associated with its oral administration. We remain highly enthusiastic that imatinib, when formulated correctly, will show substantial clinical benefit in the pulmonary arterial hypertension (PAH) patient population, with the potential to be the first disease-modifying therapy for this indication. As we finalize our plans, we will provide additional updates."
Recent Highlights
- On March 2, 2021, Tenax announced the appointment of four new members to its board of directors: June Almenoff, MD, PhD, Michael Davidson, MD, Declan Doogan, MD, and Stuart Rich, MD. Together, these highly accomplished professionals will provide the Board with significant scientific and commercial perspectives that will prove invaluable as we execute on our long-term corporate strategy. Over the next several months, Tenax expects to advance its two leading pipeline assets into late-stage clinical testing, so the expansion of its board to include such expertise from both the medical community and the pharmaceutical industry could not come at a better time for the company and its shareholders.
- On January 19, 2021, Tenax announced the acquisition of PH Precision Med (PHPM), a privately-held clinical stage biotech company focused on developing imatinib for the treatment of pulmonary arterial hypertension (PAH). The FDA has granted Orphan Drug Designation for imatinib for the treatment of PAH, an indication with a high unmet medical need. The acquisition of PHPM immediately expands Tenax's pipeline to include a second de-risked Phase 3 ready candidate with the potential to be the first disease modifying treatment of PAH.
- On January 15, 2021, Tenax appointed Stuart Rich, MD, co-founder of PHPM, Chief Medical Officer of Tenax Therapeutics. Dr. Rich currently serves as Professor of Medicine at Northwestern University Feinberg School of Medicine, and Director of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute. He previously served as FDA Cardio-Renal Advisory Committee Member. His many years of experience as an FDA advisory committee member provides Tenax with an extraordinary knowledge of pulmonary hypertension disease mechanisms and modern regulatory strategies. With his appointment, Tenax is well positioned to maximize the clinical potential of imatinib and advance the clinical development of levosimendan for PH-HFpEF, which together have the potential to address significant unmet needs and large market opportunities.
Financial Results
- Research and development expenses for the year ended December 31, 2020 were $4.6 million, compared to $3.5 million for the year ended December 31, 2019.
- General and administrative expenses for year ended December 31, 2020 were $5.3 million, compared to $5.1 million for the year ended December 31, 2019.
- Net loss for the year ended December 31, 2020 was $9.9 million, or $1.33 per share, compared to a net loss of $8.4 million, or $1.35 per share, for the year ended December 31, 2019.
- Cash, cash equivalents and marketable securities totaled $6.7 million as of December 31, 2020, compared with $5.4 million as of December 31, 2019.
-
Management expects that current cash, cash equivalents and marketable securities will be sufficient to fund current operations through the third quarter of 2021.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
About Imatinib
Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company's control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company's control that could impact the Company's continued compliance with Nasdaq listing requirements; the impact of management changes on the Company's business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company's filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 31, 2021 as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
TENAX THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Year ended December 31,
2020
2019
Operating expenses General and administrative $
5,307,206
$
5,084,111
Research and development 4,560,724
3,471,153
Total operating expenses 9,867,930
8,555,264
Net operating loss 9,867,930
8,555,264
Interest expense 1,627
-
Other income, net (18,166
)
(160,901
)
Net loss $
9,851,391
$
8,394,363
Unrealized loss on marketable securities 528
58
Total comprehensive loss $
9,851,919
$
8,394,421
Net loss per share, basic and diluted $
(1.33
)
$
(1.35
)
Weighted average number of common shares outstanding, basic and diluted 7,416,215
6,195,444
TENAX THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
December 31, 2020
December 31, 2019
ASSETS Current assets Cash and cash equivalents $
6,250,241
$
4,905,993
Marketable securities 462,687
493,884
Prepaid expenses 82,578
780,952
Total current assets 6,795,506
6,180,829
Right of use asset 58,778
169,448
Property and equipment, net 5,972
6,559
Other assets 8,435
8,435
Total assets $
6,868,691
$
6,365,271
LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $
757,856
$
1,661,054
Accrued liabilities 1,240,616
871,341
Note payable 120,491
-
Total current liabilities 2,118,963
2,532,395
Long term liabilities Lease liability -
60,379
Note payable 124,166
-
Total long term liabilities 124,166
60,379
Total liabilities 2,243,129
2,592,774
Commitments and contingencies; see Note F Stockholders' equity Preferred stock, undesignated, authorized 4,818,654 shares; See Note E Series A Preferred stock, par value $.0001, issued 5,181,346 shares; outstanding 210 and 38,606, respectively -
4
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 12,619,369 and 6,741,860, respectively 1,262
674
Additional paid-in capital 250,644,197
239,939,797
Accumulated other comprehensive (loss) gain (70
)
458
Accumulated deficit (246,019,827
)
(236,168,436
)
Total stockholders' equity 4,625,562
3,772,497
Total liabilities and stockholders' equity $
6,868,691
$
6,365,271
View source version on businesswire.com: https://www.businesswire.com/news/home/20210331005976/en/
-
View Full Article Hide Full Article
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardio-pulmonary diseases with high unmet medical need, today announced that management will present a company overview and hold virtual investor meetings at the H.C. Wainwright Global Life Sciences Virtual Conference being held March 9-10, 2021.
The pre-recorded presentation will be available for viewing on-demand beginning March 9 at 7:00 A.M. (EST). This presentation will also be available on the Investors section of Tenax Therapeutics' website at tenaxthera.com.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
About Imatinib
Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company's control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company's control that could impact the Company's continued compliance with Nasdaq listing requirements; the impact of management changes on the Company's business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company's filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 30, 2020, and its quarterly report on Form 10-Q filed on November 16, 2020, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210304005101/en/
-
View Full Article Hide Full Article
- New Board appointments strengthen Tenax with world-class expertise in cardiovascular drug development, commercial strategy, and business development
- New Directors will provide significant guidance as Tenax is poised to advance its two leading drug candidates into late-stage clinical testing
- Transformational step as Tenax strengthens its positioning as a leading specialty pharmaceutical company focused on cardio-pulmonary therapeutics
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardio-pulmonary diseases with high unmet medical need, today announced the appointment of four new members to its board of directors: June Almenoff, MD, PhD, Michael Davidson, MD, Delcan Doogan, MD, and Stuart Rich, MD.
"We are thrilled to welcome June, Michael, Declan and Stuart to our Board of Directors," said Anthony DiTonno, Chief Executive Officer of Tenax Therapeutics. "Together, these highly accomplished professionals will provide the Board with significant scientific and commercial perspectives that will prove invaluable as we execute on our long-term corporate strategy. Over the next several months, we expect to advance our two leading pipeline assets into late-stage clinical testing, so the expansion of our board to include such expertise from both the medical community and the pharmaceutical industry could not come at a better time for our company and our shareholders."
The Tenax pipeline includes two de-risked, Phase 3 ready drug candidates: (1) a reformulation of imatinib for the treatment of pulmonary arterial hypertension (WHO Group 1) with the potential to be the first disease modifying treatment for this indication, and (2) an oral formulation of levosimendan for the treatment of pulmonary hypertension (WHO Group 2), recently in-licensed from Orion. Intravenous Levosimendanwas already approved by the EMA in 2002 for treatment of acute heart failure.
About New Board Members
Dr. Almenoff is an accomplished biopharma executive with over 20 years of senior leadership experience. She served as President and Chief Medical Officer of Furiex Pharmaceuticals, which was acquired by Actavis plc (now AbbVie) for $1.2B. Furiex developed eluxadoline (Viberzi®), which is approved in both the United States and Europe. Prior to joining Furiex, Dr. Almenoff was at GlaxoSmithKline (GSK) for 12 years, where she held various positions of increasing responsibility. She was a Vice President in the Clinical Safety Organization, chaired a PhRMA-FDA working group, and worked in the area of scientific licensing. Dr. Almenoff also led the development of pioneering systems for minimizing risk in drug development, which have been widely adopted by industry and regulators. Dr. Almenoff led or contributed to numerous regulatory submissions and product approvals. She is currently Chief Scientific Officer of RedHill Biopharma (NASDAQ:RDHL). She also serves on the investment advisory board of the Harrington Discovery Institute and the boards of Brainstorm Cell Therapeutics (NASDAQ:BCLI) and Kurome Therapeutics. Dr. Almenoff has strong expertise in translational medicine, clinical development, commercial strategy, and business development, and has previously advised biotech boards and management in these areas. .
Dr. Almenoff received her B.A. cum laude from Smith College and graduated with AOA honors from the M.D.-Ph.D. program at the Icahn (Mt. Sinai) School of Medicine. She completed post-graduate medical training at Stanford University Medical Center and served on the faculty of Duke University School of Medicine. She is an adjunct professor at Duke, a Fellow of the American College of Physicians (FACP) and has authored close to 60 publications.
Dr. Michael Davidson was the Founder and former Chief Scientific Officer of Corvidia Therapeutics, which was recently acquired by Novo-Nordisk for $2.1 billion. Dr. Davidson also serves as Clinical Professor and Director of the Lipid Clinic at the University of Chicago Pritzker School of Medicine. He is a leading expert in the field of Lipidology and was named in The Best Doctors in America for the past 10 years. Dr. Davidson was the co-founding Chief Medical Officer of Omthera Pharmaceuticals in 2008, which was later acquired by Astra Zeneca Pharmaceutical in 2013 for $443M. He also founded the Chicago Center for Clinical Research, which became the largest investigator site in the United States and was acquired by Pharmaceutical Product Development in 1996. His research background encompasses both pharmaceutical and nutritional clinical trials including extensive research on statins, novel lipid-lowering drugs, and omega-3 fatty acids. Dr. Davidson is board-certified in internal medicine, cardiology, and clinical lipidology and served as President of the National Lipid Association from 2010 to 2011. He received his BA/MS from Northwestern University and MD from The Ohio State University School of Medicine.
Dr. Declan Doogan has over 30 years of industry experience in both major pharma and biotech. He was the Senior Vice President and Head of Worldwide Development at Pfizer, where many multibillion-dollar programs were delivered (e.g., Viagra, Lipitor and Zoloft). He has held a number of executive positions in Pfizer in the U.S., the U.K. and Japan. Since leaving Pfizer in 2007 he has been engaged in executive roles in small pharma. Declan was CMO and acting CEO of Amarin (AMRN: Nasdaq), transforming it from a failing neuroscience company to a vibrant cardiovascular company with a market capitalization of over one billion dollars before his departure. He is Chairman and co-founder of Biohaven (BHVN:NYSE) and an investor in emerging biotechnology and technology companies. He holds a number of Board appointments, principally in pharma companies, and is also a visiting professor at Glasgow University Medical School. Dr. Doogan received his medical degree from Glasgow University in 1975. He is a Fellow of the Royal College of Physicians and the Faculty Pharmaceutical Medicine and holds a Doctorate of Science at the University of Kent in the U.K.
Dr. Stuart Rich joined the Company as Chief Medical Officer in 2021 from PHPrecisionMed (PHPM), where he was a co-founder and held the positions of Chief Executive Officer and Director from October 2018 until January 2021. Prior to PHPM, Dr. Rich served as the Chief Medical Officer (part-time) of United Therapeutics from October 2003 until December 2004. Dr. Rich currently serves as Professor of Medicine at Northwestern University Feinberg School of Medicine and as senior faculty of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute. Dr. Rich was co-founder of the Pulmonary Vascular Research Institute and a member of the Board of Trustees, a U.K. based charity, and a member of the Board of Directors of the Cardiovascular Medical and Research Foundation, a U.S. based charity. Prior to Northwestern University, Dr. Rich was the Professor of Medicine and Chief of the Section of Cardiology at the University of Illinois College of Medicine in Chicago from July 1980 until July 1996, was Professor of Medicine at the Rush Heart Institute of the Rush University School of Medicine from July 1996 until September 2004, and was Professor of Medicine at the Section of Cardiology of the University of Chicago Pritzker School of Medicine from September 2004 until July 2015. Dr. Rich received his B.S. in Biology at the University of Illinois and his M.D. at Loyola University Stritch School of Medicine, and he completed his residency in medicine at the Washington University of St. Louis and his fellowship in cardiology at the University of Chicago.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
About Imatinib
Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company's control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company's control that could impact the Company's continued compliance with Nasdaq listing requirements; the impact of management changes on the Company's business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company's filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 30, 2020, and its quarterly report on Form 10-Q filed on November 16, 2020, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210302005083/en/