TENX: TNX-103 & TNX-201 Near Ready for Phase III

By John Vandermosten, CFA

NASDAQ:TENX

READ THE FULL TENX RESEARCH REPORT

Clinical Program Update

On January 4, 2022, Tenax Therapeutics, Inc. TENX provided an update on TNX-102 (subcutaneous levosimendan), TNX-103 (oral levosimendan) and TNX-201 (enteric-coated imatinib in PAH).

Tenax has received a Notice of Allowance from the USPTO¹ for subcutaneous administration of levosimendan (TNX-102). The patent is expected to be issued in January 2022 and will cover subcutaneous administration of levosimendan for treatment of health conditions of any kind. If granted, the patent would expire at end of 2039, assuming no patent term extension. A Canadian patent of the same name, titled Pharmaceutical compositions for subcutaneous administration of levosimendan is pending approval.

Tenax also announced the completion of the IV to oral levosimendan transition (TNX-103) for patients currently enrolled in the open label extension rollover study (TNX-LVO-05) who advanced from the Phase II HELP trial. The goal of the extension was to determine the safety and tolerability of oral levosimendan and establish an oral dose that would maintain its efficacy. All patients in the extension successfully shifted from IV to oral without any unexpected safety issues or serious drug related adverse events. Data from the extension confirms that oral levosimendan, when dosed at 3-4 mg per day, was safe, well-tolerated, and maintained the efficacy of IV levosimendan therapy in PH-HFpEF patients. Multiple measures of efficacy confirmed that oral levosimendan is comparable or possibly more effective than the weekly IV regimen in this group of patients.

Tenax updated on its TNX-201 (enteric-coated imatinib in PAH) program. The pharmacokinetic (PK) assessment in healthy volunteers has been completed. The PK study assessed imatinib versus its enteric-coated formulation to help ensure optimal efficacy and tolerance in its upcoming Phase III trial, anticipated to start in 2H:22. Tenax also announced that it had selected a large, global contract research organization (CRO) partner, which has successfully completed over 20 PAH projects including multiple Phase III trials. Key Opinion Leader (KOL) and site engagement is expected to commence early this year.

To conclude the announcement, Tenax reported the formation of a Scientific Advisory Board for imatinib, chaired by Dr. Anna Hemnes of Vanderbilt University, and including Dr. Robert Frantz of the Mayo Clinic, Dr. Bradley Maron of Harvard University, and Dr. John Ryan of the University of Utah. The members are globally renowned scientists with deep experience in PAH clinical trials as well as translational science in pulmonary vascular disease.

FDA Clears IND for Imatinib in PAH

See our April 9^th report for background on imatinib. The asset was acquired as part of Tenax' purchase of PH Precision Med (PHPM), completed on January 15, 2021 in a deal valued at approximately $21.6 million. Dr. Stuart Rich, a globally recognized expert in the field of pulmonary arterial hypertension (PAH), founded PHPM to support the development of imatinib. Imatinib, a tyrosine kinase inhibitor, offers a different mechanism of action in contrast to other failed pulmonary vasodilators. While the compound has only been clinically evaluated once in PAH, imatinib is a relatively mature TKI that has been approved in a number of indications with the first in chronic myeloid leukemia. The drug was originally discovered in 1992 by Brian Druker, who sought a drug that, rather than be nonspecifically cytotoxic, targeted the cancer itself.

In 2001² Novartis commercialized imatinib in leukemia as Gleevec, and in 2015 the drug generated $4.6 billion in sales before patent expiry in 2016. Novartis launched multiple trials for imatinib in PAH and by 2013, had advanced the candidate as far as Phase III, when unforeseen dropouts attributable to gastric intolerance sidetracked further advancement. Despite some favorable results, Novartis did not re-initiate studies in PAH, likely due to pending patent expiry, as imatinib was already a commercial success for Novartis in leukemia.

Imatinib is potentially the first disease modifying agent in PAH. Due to the GI issues observed in Novartis' unsuccessful Phase III and prior to Tenax' acquisition, a reformulation of oral imatinib was proposed to bypass the stomach and release the drug in the small intestine. A Phase I PK study is underway for the new formulation. Based on consultations with the FDA, Tenax management believes only one successful Phase III trial will be necessary to obtain market approval.

On October 6, 2021, Tenax announced that the FDA had cleared Tenax' IND application for a novel (oral) formulation of imatinib. The PK study compared the original formulation to the new oral formulation that is designed to address challenges that Novartis faced, bypassing the stomach and associated gastric discomfort. In the most recent January 2022 press release, Tenax announced that it anticipates starting the Phase III imatinib trial in 2H:22.

Interview with Tenax CEO and CMO

On October 7, 2021, Zacks' analyst John Vandermosten interviewed Tenax' Chief Executive Officer, Chris Giordano and Chief Medical Officer, Dr. Stuart Rich. The replay from the interview is available here. The interview discussed background on the pulmonary hypertension market, Tenax' two candidates, levosimendan and imatinib, and longer term prospects for the programs.

Milestones

➢ HELP Topline data - June 2020

➢ End of Phase II Meeting with FDA - October 2020

➢ Acquisition of PHPM - January 2021

➢ FDA clearance of IND for imatinib (TNX-201) in PAH - October 2021

➢ Initiation of Phase I PK trial for imatinib in PAH - October 2021

➢ PK and formulation results for imatinib in PAH - 4Q:21

➢ Site selection and enrollment for imatinib PAH trial - 1H:22

➢ Launch Phase III imatinib in PAH - 2H:22

➢ Launch Phase III levosimendan in PH-HFpEF - 2022

➢ Imatinib PH trial topline report - 2024

➢ Completion of Phase III in PH-HFpEF - 2024

Summary

Tenax updated investors on progress with its clinical assets TNX-102 (subcutaneous levosimendan), TNX-103 (oral levosimendan), and TNX-201 (enteric-coated imatinib in PAH). Tenax received a Notice of Allowance from the USPTO for TNX-102 with patent expected to be issued in January 2022 and anticipated expiry in 2039. Tenax also announced the completion of patient transition from the Phase II HELP study to the open-label extension where multiple measures of efficacy confirmed that oral levosimendan is comparable or even possibly more effective than the weekly IV regimen. Tenax also updated investors regarding TNX-201 announcing that the PK assessment in healthy volunteers has been completed, which has informed modifications to the TNX-102 formulation in anticipation of the 2H:22 start to Phase III trial in PAH. Additionally, Tenax has selected a CRO partner and formed a Scientific Advisory Board to support the candidate.

With imatinib's recent IND clearance, and two Phase III trials expected in the coming quarters, Tenax is a bright spot in our coverage universe with substantial upside and limited competition in the PAH areas its candidates are targeting.

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1. US Patent and Trademark Office

2. https://www.hcp.novartis.com/products/gleevec/gleevechcp/

3. TENX Interview - YouTube

4. Source: Tenax Therapeutics October 2021 Corporate Presentation