On Friday, Piper Sandler confirmed its Overweight rating on Tenaya Therapeutics Inc (NASDAQ:TNYA) with a steady price target of $40.00. The firm’s endorsement follows Tenaya’s recent announcement that the Data Safety Monitoring Board (DSMB) has approved the continuation of dosing in the second cohort of their clinical study at a dose of 6E13 vg/kg.
The analyst from Piper Sandler noted that this development reduces the risk associated with the top-line data expected in December. Tenaya has made several protocol adjustments that could expand the treatment’s applicability to both non-obstructive hypertrophic cardiomyopathy (nHCM) and obstructive hypertrophic cardiomyopathy (oHCM) patients who do not have implantable cardioverter defibrillators (ICDs).
These changes are also aimed at enhancing the safety profile of TN-201, Tenaya’s therapeutic candidate, and increasing the pool of eligible patients.
The protocol alterations include modifications to cardiac biopsies, which are intended to provide greater flexibility across different dosing regimens. This approach is designed to improve the understanding of the kinetics of expression and subsequently raise the probability of success (PoS) for the therapy.
The Piper Sandler analyst also highlighted the potential market opportunity presented by pediatric MYBPC3 HCM patients, estimating there are approximately 3,000 such patients in the United States alone. This demographic could represent an additional value proposition for Tenaya Therapeutics.
In summary, Piper Sandler’s analysis suggests that the recent developments and upcoming top-line data in December present a favorable buying opportunity for investors. The firm remains bullish on the prospects of Tenaya Therapeutics’ shares ahead of the anticipated data release.
In other recent news, Tenaya Therapeutics has seen significant advancements in its MyPEAK-1 Phase 1b/2 clinical trial for TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy. The Data Safety Monitoring Board has approved the progression to Cohort 2, which involves a higher dose of the therapy, and expanded the eligibility criteria for participants.
Additionally, Tenaya has made several protocol adjustments, including the addition of a baseline biopsy and the potential increase in the number of participants from nine to 24 adults.
Tenaya anticipates the release of initial results from Cohort 1 by the end of 2024, which will provide crucial safety data and insights from cardiac biopsies. Analyst firms H.C. Wainwright, Canaccord Genuity, and Leerink Partners have maintained positive outlooks on Tenaya, with price targets of $18, $16, and $8, respectively.
Tenaya has also introduced a new 2024 Inducement Equity Incentive Plan, allowing for the issuance of 1,200,000 shares of common stock. Furthermore, the company announced the upcoming departure of Leone Patterson, its Chief Financial and Business Officer, and is now in the process of searching for a new CFO.
InvestingPro Insights
Recent data from InvestingPro sheds additional light on Tenaya Therapeutics’ financial position and market performance. The company’s market capitalization stands at $169.61 million, reflecting its current valuation in the biotech sector. Notably, Tenaya’s stock has shown significant volatility, with a 21.47% return over the past week, but a substantial decline of 49.88% over the last six months.
InvestingPro Tips highlight that Tenaya holds more cash than debt on its balance sheet, which could provide financial flexibility as it advances its clinical programs. This is particularly relevant given the company’s ongoing clinical study and protocol adjustments mentioned in the article. However, it’s important to note that Tenaya is quickly burning through cash, a common characteristic of biotech companies in the development stage.
Investors should be aware that analysts do not anticipate the company to be profitable this year, aligning with the pre-revenue stage of many clinical-stage biotech firms. For those seeking more comprehensive analysis, InvestingPro offers 8 additional tips for Tenaya Therapeutics, providing deeper insights into the company’s financial health and market position.
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