READ THE FULL TENX RESEARCH REPORT
Tenax Therapeutics, Inc. TENX reported fiscal year 2021 results on March 29, 2022 via its filing of Form 10-K with the SEC. The company also issued a press release on March 31st summarizing its business update. The release stressed the expected benefits to Tenax' two development programs from optimizing the oral formulations of imatinib and levosimendan. The company also highlighted two upcoming presentations at the American College of Cardiology Scientific Sessions.
Highlights for the fourth quarter and to-date include:
➢ Interview with Tenax CEO and CMO - October 2021
➢ Clearance of Investigational New Drug (IND) application for imatinib in PAH - October 2021
➢ Alphanumeric designation established for company assets - October 2021
◦ TNX-201 for oral enteric coated imatinib
◦ TNX-103 for oral levosimendan
◦ TNX-102 for subcutaneous levosimendan
➢ TNX-102 patent allowed by USPTO - January 2022
➢ Transition to oral levosimendan open label extension completed - January 2022
➢ Formation of Scientific Advisory Board - January 2022
➢ US patent granted for subcutaneous TNX-102 (levosimendan) - January 2022
➢ Robyn Hunter appointed to Board - January 2022
Tenax produced no revenues in 2021 and incurred operating expenses of $32.7 million resulting in net loss of ($32.5) million, or ($1.58) per share.
For the year ended December 31, 2021 versus the same ended December 31, 2020:
➢ General and administrative expenses totaled $7.6 million, up 43% from $5.3 million primarily due to in-creases in personnel costs, namely severance costs with the departure of the former CEO, and legal and professional fees;
➢ Research and development expenses were $25.1 million, up 451% from $4.6 million on with the major portion attributed to recognition of $21.8 million in in-process R&D acquired as part of the merger with PHPM;
➢ Net loss was ($32.5) million versus ($9.8) million, or ($1.58) and ($0.95) per share, respectively.
At the end of the year, cash and equivalents totaled $5.6 million, compared to $6.2 million at the end of 2020. Following forgiveness of the PPP, Tenax holds no debt on its balance sheet. Cash burn for the year totaled $10.8 million versus $9.3 million last year.
American College of Cardiology Scientific Sessions
Tenax announced that drug candidates levosimendan and imatinib will be featured in presentations given at the American College of Cardiology (ACC) Scientific Sessions on April 3rd and 4th. Tenax' scientific advisory board member Barry Borlaug, MD will be presenting data from the Phase II HELP trial1 in a presentation entitled "Helping PH-HFpEF Patients Walk Further with Levosimendan." His presentation will be part of the session "A Whole New World in Pulmonary Hypertension: Randomized Clinical Trial Updates For 2022" held April 3rd. Professor Stuart Rich, Tenax' Chief Medical Officer, will be presenting on April 4th at the "Back to the Future: Old Drugs with a New Purpose in PAH" session. Dr. Rich's presentation is called "Next-generation Tyrosine Kinase Inhibitors for PAH" where he will review the mechanisms underlying the TKI class.
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.
Summary
Highlights for the fourth quarter and to-date included clearance of imatinib's IND in PAH, allowance and grant of the TNX-102 patent by the USPTO, formation of Tenax' Scientific Advisory Board, and Robyn Hunter's appointment to the Board. In the clinical trial realm, Tenax completed the 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 superior to the weekly IV regimen. The PK assessment in healthy volunteers has been completed, informing TNX-102 formulation Phase III trial in PAH starting in 2H:22. 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. Discussion of HELP trial in our report here.
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