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TENX: Tenax Picks Up PH Precision Med

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By John Vandermosten, CFA

NASDAQ:TENX

Tenax Acquires PH Precision Med

Tenax Therapeutics, Inc. (NASDAQ:TENX) announced yesterday the acquisition of privately held, clinical stage PH Precision Med (PHPM) in an equity deal valued at approximately $21.6 million1. PHPM was founded by Dr. Stuart Rich with the intent to develop imatinib, a tyrosine kinase inhibitor (TKI), in pulmonary arterial hypertension (PAH) (Group 1). Imatinib is a relatively mature compound that has been approved in a number of indications including chronic myeloid leukemia and gastrointestinal stromal tumors. The drug has also been investigated in other indications including pulmonary hypertension where it was shown to reduce both the smooth muscle hypertrophy and hyperplasia of the pulmonary vasculature in a variety of disease processes, including portopulmonary hypertension. Despite some favorable results, the sponsor of this work, Novartis, did not continue studies from the trial due to gastric intolerance side effects. With high dropout rates, insufficient data was generated to support a new drug application (NDA). Despite the setback, Dr. Stuart Rich, an expert in the field of PAH, continued to see promise in imatinib. With an entire patient population still without any disease-modifying treatment available, he founded PHPM to support imatinib’s continued development. After working closely on the development of levosimendan, both Tenax management and Dr. Rich recognized a synergistic fit leading to the acquisition and Dr. Rich’s appointment as Chief Medical Officer.

PHPM’s shareholders will be issued approximately 12.1 million equity shares as consideration for the deal. This is comprised of 1,892,905 shares of Tenax common stock, which is ~15% of Tenax’ shares outstanding and 10,232 shares of Class B Preferred Stock which convert to 10,232,000 shares of common stock. Based on the closing price of Tenax on January 18, 2021 of $1.78, this is value at approximately $21.6 million.

Tenax has scheduled a conference call on Thursday after the close to discuss the acquisition in more detail. Call information:

Time: 4:30 pm ET, January 21, 2021

Dial in: (877) 405-1242

Conference ID: 13715313

About Tenax

Tenax is a pharmaceutical company focused in the cardiovascular and pulmonary space targeting diseases with high unmet medical need. Tenax owns North American development and commercialization rights for levosimendan, a calcium sensitizer that works through a unique triple mechanism of action. Before the acquisition of PHPM, levosimendan was Tenax’ sole candidate, which completed Phase II trials and is now preparing for Phase III.

As of our last update, Tenax had just reported third quarter results and shared analysis from its recently completed Phase II HELP trial of levosimendan in pulmonary hypertension, associated with heart failure with preserved ejection fraction (PH-HFpEF). The company has elected to switch to oral levosimendan for use in the registrational trial. During the quarter, Tenax also raised $8.0 million and added Steven Boyd and Keith Maher, M.D. from Armistice Capital to its board.

Imatinib

Imatinib is a tyrosine kinase inhibitor, a 2-phenyl amino pyrimidine derivative, that suppresses the proliferation of cancer cells by targeting BRC-ABL tyrosine kinase. It was originally developed to treat chronic myeloid leukemia. Imatinib’s inhibition of PDGF2 receptors and c-KIT3 suggested that it may be effective in PAH, and demonstrated reversal of experimentally induced PH, as well as pulmonary vasodilatory effects in vivo. Proapoptotic effects were also observed on pulmonary artery smooth muscle cells from patients with idiopathic (unknown cause) PAH.

Imatinib was evaluated by Novartis in Phase III trials for PAH; however, high dropout rates due to gastric intolerance prevented regulatory approval. Gastric intolerance is well known and documented in oncology settings, but the trials were conducted under the supervision of cardiopulmonary specialists whom may not have expected or been equipped to address the side effects. Tenax management has guided towards a planned new formulation of imatinib that is designed to combat gastric intolerance as the team prepares for a potential pivotal Phase III trial. A raise or strategic partnership would be necessary to execute on the Phase III trial of imatinib in PAH, the protocol for which has already received a nod from the FDA. PHPM met with the FDA in May of 2019 and confirmed trial design and endpoints with the regulatory agency.

Acquiring PH Precision Med

Tenax management has worked closely with Dr. Stuart Rich as an expert consultant in the development of levosimendan and it was through collaboration that the merger of the two companies was realized. PHPM’s objectives were closely aligned with Tenax, with Tenax’ focus on the cardiopulmonary space, and a significant unmet need in PAH patients. Imatinib had already been vetted in preclinical and clinical work, and with the exception of an unsuccessful Phase III under Novartis, has shown promise in being a potential disease-altering agent for PAH. The drug, a tyrosine kinase inhibitor, had caught the eye of Dr. Stuart Rich, amidst a sea of similar pulmonary vasodilators. As an expert in the field, Dr. Rich has had involvement in practically all tried therapies in PAH, all of which have been pulmonary vasodilators. As a tyrosine kinase inhibitor, imatinib has a different mechanism of action, and can potentially succeed as a disease modifying agent. Dr. Rich has also worked closely with the FDA, providing valuable insight into the regulatory process. We expect imatinib to follow approval using the Orphan Drug pathway, which provides seven years of exclusivity in the United States and ten years in the EU.

Effect on Tenax

Acquisition of PHPM and imatinib broadens Tenax’ reputation as a pulmonary hypertension company. With the addition of Dr. Stuart Rich, Tenax now has significantly added to its medical and regulatory expertise that we expect this will expedite the advancement and approval of the company’s two candidates.

Summary

With the acquisition of PHPM, Tenax’ portfolio has exposure to two pulmonary hypertension drugs in Group 1 and Group 2 of the disease. With the addition of imatinib, a ready-for-Phase III, de-risked candidate, and the appointment of Dr. Stuart Rich to the management team as Chief Medical Officer the company has positioned itself for continued success in pulmonary hypertension and the advancement of promising candidates in this space.

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1. Value of acquisition approximated based on of shares and closing price as of 1/18/21

2. Platelet derived growth factor

3. CD117 transmembrane tyrosine kinase receptor