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SAN DIEGO - Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology firm currently valued at $74 million, has released interim data from its RIDGE study on arrhythmogenic right ventricular cardiomyopathy (ARVC) due to PKP2 gene mutations. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, despite its stock falling nearly 90% over the past year. The data, presented at the Heart Rhythm Society’s annual meeting, indicates a high burden of arrhythmias in patients despite current treatments and suggests that a large majority may be eligible for Tenaya’s TN-401 gene therapy.
The RIDGE study, which is the largest of its kind, has enrolled over 175 patients across multiple countries. Interim analysis of 144 adults showed that 83 percent experienced significant premature ventricular contractions, and 49 percent had a history of ventricular tachycardia, despite standard-of-care treatments. Furthermore, 60 percent of patients with MRI data available showed disease progression. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 4.22, indicating robust ability to fund its clinical programs.
The study also found low rates of preexisting immunity to AAV9 antibodies, which is the vector used in Tenaya’s TN-401 gene therapy, with 93 percent of patients showing AAV9 neutralizing antibody titers ≤1:40. This finding is significant as it implies that most patients in the study could potentially be treated with the TN-401 therapy.
The RIDGE-1 Phase 1b clinical trial of TN-401 is currently underway, aiming to enroll up to fifteen adults with PKP2-associated ARVC. Tenaya plans to report safety and biopsy data from the first cohort of RIDGE-1 patients later in the year.
Tenaya’s TN-401 gene therapy, which has received Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration, is designed to deliver a functional PKP2 gene to the heart to address the genetic cause of the disease. The RIDGE natural history study is expected to serve as a control arm in assessing the efficacy of TN-401.
This progress in gene therapy for ARVC represents a potential shift in the treatment of a condition that is often diagnosed before age 40 and can lead to sudden cardiac arrest. While the company’s financial health score is currently rated as weak by InvestingPro, three analysts have recently revised their earnings estimates upward for the upcoming period, suggesting growing confidence in the company’s potential. The information in this article is based on a press release statement from Tenaya Therapeutics, Inc. Discover 12 additional exclusive insights about TNYA with an InvestingPro subscription.
In other recent news, Tenaya Therapeutics, Inc. disclosed its fourth-quarter 2024 earnings, with a reported earnings per share (EPS) of ($0.28) and a full-year EPS of ($1.31), slightly outperforming analyst expectations. The company concluded the year with $61.4 million in cash reserves and an additional $48.89 million from a recent financing round, which is expected to support operations into mid-2026. Tenaya also announced a public offering of common stock and warrants, with Leerink Partners and Piper Sandler as joint bookrunning managers. In its clinical endeavors, Tenaya reported positive preclinical data for its gene therapy candidate TN-201, aimed at treating hypertrophic cardiomyopathy, and is progressing with its MyPEAK-1 Phase 1b/2 clinical trial. The company is also advancing its second gene therapy program, TN-401, with initial data expected in the second half of 2025. Analysts at Canaccord Genuity and H.C. Wainwright have adjusted their price targets for Tenaya to $6 and $5, respectively, maintaining a Buy rating despite the revisions. Meanwhile, Tenaya has received a notification from Nasdaq regarding a potential delisting due to its stock price not meeting the minimum bid price requirement. The company is exploring options to address this issue and sustain its Nasdaq listing.
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