Bullish indicating open at $55-$60, IPO prices at $37
SOUTH SAN FRANCISCO, Calif. - Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology firm focused on developing treatments for heart disease, has announced updates on its ongoing MyPEAK-1 Phase 1b/2 clinical trial for TN-201. This gene therapy is under investigation for the potential treatment of MYBPC3-associated hypertrophic cardiomyopathy (HCM).
The independent Data and Safety Monitoring Board (DSMB) has endorsed the continuation of the trial, recommending dose escalation and broadening of the eligibility criteria. The trial has completed dosing its first cohort with a 3E13 vg/kg dose, showing a tolerability profile consistent with other gene therapies at this dose and no unexpected adverse reactions. Following this, the DSMB has approved dose escalation to a 6E13 vg/kg dose, and enrollment for the second cohort is in progress.
The MyPEAK-1 study aims to establish the safety profile of TN-201 and explore its potential in treating different populations by increasing the protein levels of MyBP-C, which is deficient in patients with MYBPC3-associated HCM. The trial has adjusted its protocol to include a baseline biopsy, expand eligibility to include obstructive HCM patients, and increase the study size, potentially reaching 24 adult participants.
Initial data from the first cohort is scheduled to be reported in December 2024, focusing on safety, tolerability, cardiac biopsy analyses, and changes in cardiac biomarkers from baseline. The trial is also collecting data on TN-201’s effects on imaging biomarkers, heart function, exercise capacity, functional status, and patient quality of life.
In addition, Tenaya has shared insights into the disease burden of pediatric MYBPC3-associated HCM. Data presented at the HCM Society Scientific Sessions revealed that out of nearly 1,800 individuals with this condition in the SHaRe database, 13% were diagnosed before age 18, with 50% experiencing significant morbidity by age 40. This highlights the need for new genetic medicines that can impact outcomes significantly.
Tenaya's TN-201 has received Fast Track, Orphan Drug, and Rare Pediatric Drug Designations from the U.S. Food and Drug Administration, as well as orphan medicinal product designation from the European Commission. The company continues to study pediatric MYBPC3-associated HCM through the MyClimb natural history study.
This report is based on a press release statement from Tenaya Therapeutics, Inc.
In other recent news, Tenaya Therapeutics has been making significant strides with its gene therapy program. Canaccord Genuity maintained a Buy rating on the company's shares, focusing on the upcoming clinical data readout for Tenaya's lead gene therapy program, TN-201. The data, expected in the fourth quarter of 2024, will provide an early indication of the therapy's efficacy and safety. This marks Tenaya's transition to a clinical-stage entity, with the potential to significantly influence the company's valuation.
In addition to these developments, Tenaya has seen major changes to its board composition and the introduction of a new 2024 Inducement Equity Incentive Plan. The plan allows for the issuance of 1,200,000 shares of common stock, aimed at attracting new employees or as part of merger and acquisition agreements. The company has also announced the upcoming departure of Leone Patterson, its Chief Financial and Business Officer, triggering a search for a new CFO.
Analysts from William Blair and Canaccord Genuity have provided their views on Tenaya, with the former initiating coverage with an Outperform rating and the latter maintaining a Buy rating. Lastly, H.C. Wainwright maintained a Buy rating on Tenaya, reflecting optimism about the company's progress in developing treatments for hypertrophic cardiomyopathy. These are the recent developments shaping the trajectory of Tenaya Therapeutics.
InvestingPro Insights
As Tenaya Therapeutics (NASDAQ: TNYA) advances its clinical trials for TN-201, investors should consider the company's financial position and market performance. According to InvestingPro data, Tenaya has a market capitalization of $168.03 million, reflecting its status as a small-cap biotechnology company focused on developing novel treatments for heart disease.
InvestingPro Tips highlight that Tenaya "holds more cash than debt on its balance sheet" and "liquid assets exceed short term obligations." These factors are crucial for a clinical-stage biotech company, as they provide financial flexibility to continue funding research and development efforts, including the ongoing MyPEAK-1 Phase 1b/2 clinical trial.
However, it's important to note that Tenaya is "quickly burning through cash" and is "not profitable over the last twelve months," with an operating income of -$126.95 million in the last twelve months as of Q2 2024. This is typical for early-stage biotech companies investing heavily in clinical trials and drug development.
The stock's recent performance has been challenging, with a -51.92% price total return over the past three months. This volatility is reflected in another InvestingPro Tip, which notes that "stock price movements are quite volatile." Investors should be aware that biotech stocks often experience significant price fluctuations, especially around clinical trial updates and regulatory decisions.
For those interested in a deeper analysis, InvestingPro offers 11 additional tips for Tenaya Therapeutics, providing a more comprehensive view of the company's financial health and market position.
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