Core Insights - Tenaya Therapeutics aims to build on positive interim results from its TN-201 gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) in 2025, with plans to report longer-term follow-up data in 2026 [1][3] - The company raised $60 million in Q4 2025 to support its operations through mid-2027 [1][7] Clinical Development Updates - Tenaya expects to share interim data for Cohort 2 of the MyPEAK-1 trial and updates from Cohort 1 in the first half of 2026, with one-year data for Cohort 1 and two-year data for Cohort 2 anticipated in the second half of 2026 [6][12] - The MyPEAK-1 trial has shown that TN-201 was well tolerated, with no dose-limiting toxicities and significant increases in MyBP-C protein levels observed [6][8] - The RIDGE-1 trial for TN-401 is also progressing, with initial positive data reported and plans for further patient enrollment following a review by the Data Safety Monitoring Board (DSMB) [12][14] Financial Position - As of Q3 2025, Tenaya had $56.3 million in cash and equivalents, and the additional $60 million raised is expected to fund operations through mid-2027 [7][1] Regulatory and Strategic Plans - The company plans to pursue regulatory alignment for its lead gene therapy programs, TN-201 and TN-401, throughout 2026 [1][12] - Tenaya's gene therapies have received various designations from the FDA, including Fast Track and Orphan Drug designations, indicating their potential significance in treating rare diseases [8][11]

Core Viewpoint - Tenaya Therapeutics is experiencing bearish pressure on its stock following the announcement of a public offering and interim clinical trial data for its gene therapy candidates [2][3][8]. Group 1: Stock Performance - Tenaya Therapeutics stock is trading lower, down 37.44% to 85 cents, with a session volume of 42.39 million compared to the average volume of 3.51 million [1][8]. Group 2: Public Offering - The company priced its underwritten public offering of 50 million units at $1.20 per unit, aiming for gross proceeds of $60 million [2]. - Each unit consists of one share and a warrant to purchase one share of common stock at an exercise price of $1.50 per share [2]. Group 3: Clinical Developments - Proceeds from the public offering will be used to fund the development of clinical and early-stage product candidates, particularly TN-201 and TN-401, as well as for working capital [3]. - Interim data from the RIDGE-1 Phase 1b/2 trial of TN-401 for arrhythmogenic right ventricular cardiomyopathy (ARVC) was shared, showing safety and efficacy results [3][4]. - TN-401 was well tolerated, with increased PKP2 protein expression in two of three patients and meaningful improvements in arrhythmia burden [5][6]. - No incidents of thrombotic microangiopathy or cardiotoxicities were reported, and no ICD shocks or arrhythmias associated with TN-401 have occurred [6][7]. - The FDA has removed the clinical hold on the MyPEAK-1 Phase 1b/2a trial of TN-201, which targets MYBPC3-associated hypertrophic cardiomyopathy [7].

Core Points - Tenaya is presenting initial data from Cohort 1 of the RIDGE-1 Phase Ib/II clinical trial for TN-401 gene therapy aimed at treating PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC) [1][2] Group 1 - The presentation is led by Michelle Corral, Vice President of Corporate Communications and Investor Relations at Tenaya [1] - Key executives participating in the call include Faraz Ali (CEO), Dr. Kathy Ivey (SVP of Research), and Dr. Whit Tingley (Chief Medical Officer) [2] - A PDF of the presentation slides is available on Tenaya's website in the Investor Relations section [2] Group 2 - The information shared during the call includes forward-looking statements reflecting the company's perspective as of December 11, 2025 [3] - Investors are cautioned against placing undue reliance on the forward-looking statements due to inherent assumptions [3] - The company will not be taking questions during this call due to the launch [4]

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Core Insights - Tenaya Therapeutics announced interim data from the RIDGE™-1 Phase 1b/2 clinical trial of TN-401 gene therapy for arrhythmogenic right ventricular cardiomyopathy (ARVC), showing promising safety and efficacy results in early patients [1][3] Group 1: Clinical Trial Results - TN-401 was well tolerated at a dose of 3E13 vg/kg, with no dose-limiting toxicities observed [4] - Initial data indicated a significant increase in PKP2 protein expression from baseline in two of three patients, with a mean increase of 10% by Week 8 [12] - Clinically meaningful reductions in arrhythmia burden were observed, with Patient 1 experiencing a 46% decrease in premature ventricular contractions (PVCs) and Patient 2 showing an 89% decrease, along with a reduction of non-sustained ventricular tachycardia (NSVT) counts from 78 to zero [12] Group 2: Safety and Tolerability - Adverse events were generally mild and asymptomatic, with no serious adverse events (SAEs) related to TN-401 treatment reported in the cohort [6][5] - No incidents of thrombotic microangiopathy (TMA) or cardiotoxicities were observed, and all patients have tapered off immunosuppressive medicines [6] - Biopsies demonstrated robust transduction and expression of TN-401 in all patients within the first eight weeks [6] Group 3: Future Developments - Tenaya management plans to host a webcast conference call to discuss the TN-401 data on December 11, 2025 [9] - The RIDGE-1 trial aims to enroll up to fifteen adults diagnosed with PKP2-associated ARVC, assessing the safety, tolerability, and preliminary clinical efficacy of TN-401 [14] - TN-401 has received Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration, indicating its potential significance in treating ARVC [13]

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced it has received official notification from the U.S. Food and Drug Administration (FDA) that the clinical hold on the MyPEAK-1™ Phase 1b/2a clinical trial of TN-201 has been removed. All concerns raised by the FDA related ...

Core Insights - The conference call is focused on the interim clinical data from the MyPEAK-1 Phase Ib/IIa trial of TN-201 for MYBPC3-associated hypertrophic cardiomyopathy (HCM) [2] - The data was presented at the American Heart Association's scientific sessions, highlighting advancements in HCM care [2] Company Overview - Tenaya Therapeutics is led by CEO Faraz Ali and Chief Medical Officer Dr. Whit Tingley, who are participating in the conference call to discuss the clinical trial data [3]

Tenaya Therapeutics Conference Call Summary Company Overview - **Company**: Tenaya Therapeutics (NasdaqGS:TNYA) - **Focus**: Gene therapy programs, specifically TN-201 for myBPC3-associated hypertrophic cardiomyopathy (HCM) Key Industry Insights - **Condition**: myBPC3-associated HCM is the most common genetic form of hypertrophic cardiomyopathy, affecting approximately 120,000 individuals in the U.S. alone [doc id='14'][doc id='30'] - **Unmet Need**: There are no approved therapies targeting the underlying genetic cause of this condition, particularly for the non-obstructive form, which accounts for 70% of myBPC3 cases [doc id='15'] Core Points from the Call - **Clinical Trial Update**: The interim data from the MyPeak-1 phase 1b/2a clinical trial of TN-201 was presented at the American Heart Association's scientific sessions [doc id='2'][doc id='5'] - **Data Presentation**: Dr. Melinda Tsai presented promising interim data, highlighting the significant unmet need in HCM care [doc id='5'] - **Dosing and Safety**: TN-201 has been well tolerated at both tested doses (3E13 and 6E13 vector genome per kilogram), with no dose-limiting toxicities reported [doc id='19] - **Biopsy Results**: Increased myBPC3 protein levels were observed in all patients, indicating a dose-responsive manner [doc id='8'] - **Clinical Activity**: Early signs of clinical activity were noted, with multiple measures of disease moving towards normalization [doc id='8'][doc id='27'] Regulatory and Development Updates - **FDA Interaction**: The FDA requested protocol amendments to minimize site-to-site variability, leading to a clinical hold on patient enrollment [doc id='10'][doc id='11'] - **Safety Monitoring**: The independent Data Safety Monitoring Board endorsed the continuation of the trial prior to the FDA's request [doc id='10'] - **Immunosuppression Protocol**: Adjustments were made to the immunosuppressive regimen to optimize patient safety and reduce steroid use without increasing adverse events [doc id='12'][doc id='21'] Clinical Data Highlights - **Patient Cohorts**: Six patients from cohorts one and two were analyzed, all exhibiting severe disease and requiring cardiac defibrillator devices [doc id='17'] - **Biomarker Improvements**: Cardiac troponin levels improved by as much as 74%, indicating reduced cardiac injury [doc id='23'] - **Hypertrophy Measures**: Significant reductions in left ventricular mass index (LVMI) and left ventricular posterior wall thickness were observed, with reductions ranging from 12-39% [doc id='25'][doc id='34] - **New York Heart Association Class**: All patients improved to class one, indicating no limitations from symptoms by one year post-treatment [doc id='26'] Future Outlook - **Next Steps**: Continued monitoring of clinical data maturation and resumption of dosing after protocol changes are implemented [doc id='9'][doc id='44'] - **Pivotal Studies**: Plans to engage with regulators for potential late-stage development in adults and pediatric patients are anticipated in 2026 [doc id='43'] Additional Considerations - **Comparative Analysis**: The severity of cohort one patients is significantly higher than those in peer studies, emphasizing the need for genetic intervention [doc id='31'] - **Protocol Consistency**: The FDA's focus on protocol uniformity is seen as a positive step towards ensuring patient safety across studies [doc id='61'] This summary encapsulates the key points discussed during the Tenaya Therapeutics conference call, highlighting the company's advancements in gene therapy for hypertrophic cardiomyopathy and the ongoing regulatory considerations.

Scaling new heights in the fight against heart disease November 10, 2025 Forward-looking statement This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management's beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or qua ...

Gene Therapy Development - The company is focused on developing gene therapies for heart diseases, with lead candidates TN-201 for MYBPC3-associated hypertrophic cardiomyopathy (HCM) and TN-401 for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC) currently in clinical testing stages [96][106]. - TN-201 has shown an average increase of 4% in MyBP-C protein levels from the first biopsy to Week 52 in Cohort 1, with a 14% increase observed in the first evaluable patient of Cohort 2 after 12 weeks [101]. - Cardiac Troponin I levels declined by as much as 74% from baseline to normal or near-normal levels in all Cohort 1 patients, indicating significant improvement in cardiac function [102]. - The FDA has granted Fast Track, Orphan Drug, and Rare Pediatric Drug Designations for TN-201, which also received orphan medicinal product designation from the European Commission [105]. - TN-401 has also received Orphan Drug and Fast Track designations from the FDA, along with orphan medicinal product designation from the European Commission [110]. - The independent data safety monitoring board (DSMB) endorsed the safety profile of TN-201, allowing for expansion cohorts to proceed in the MyPEAK-1 trial [98]. - The company aims to advance its lead gene therapy product candidates, TN-201 and TN-401, and transition into late-stage clinical development [142]. Financial Performance - Research and development expenses decreased to $15.4 million for the three months ended September 30, 2025, down from $20.4 million in 2024, representing a 25% decline [121]. - General and administrative expenses were $5.6 million for the three months ended September 30, 2025, compared to $6.4 million in 2024, a decrease of 12% [124]. - Net loss for the three months ended September 30, 2025, was $20.3 million, an improvement from a net loss of $25.6 million in the same period of 2024, reflecting a 21% reduction [126]. - For the nine months ended September 30, 2025, total research and development expenses were $53.8 million, down from $68.1 million in 2024, a decrease of 21% [129]. - Interest income for the nine months ended September 30, 2025, was $2.1 million, compared to $3.9 million in 2024, a decline of 46% [131]. - The company had cash, cash equivalents, and investments totaling $56.3 million as of September 30, 2025, with an accumulated deficit of $584.8 million [134]. - The net loss for the nine months ended September 30, 2025 was $70.4 million, compared to a net loss of $87.3 million for the same period in 2024 [144][145]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $54.3 million, compared to $72.1 million for the same period in 2024, indicating a reduction in cash outflow [144][145]. - The company reported a net cash provided by investing activities of $56.2 million for the nine months ended September 30, 2025, primarily from marketable securities [146]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $50.2 million, mainly from a follow-on offering [148]. Grants and Funding - The company received a Clinical Grant of $8.0 million from the California Institute for Regenerative Medicine to support the ongoing Phase 1b RIDGE-1 clinical trial of TN-401 [108]. - The company was awarded an $8 million grant from CIRM in February 2025 to support the RIDGE-1 project, contingent on achieving certain clinical milestones [135]. - The company completed a follow-on offering on March 5, 2025, raising approximately $48.8 million in net proceeds [137]. - As of September 30, 2025, the company had the right to draw down $10.0 million under a Loan Agreement with Silicon Valley Bank [136]. - The company recognized $1.5 million in connection with the CIRM grant for the nine months ended September 30, 2025 [135]. Operational Plans - The company maintains complete ownership of process development and quality control for its gene therapy candidates, producing all necessary clinical trial material at its cGMP-certified facility [116]. - The company plans to establish commercial-scale manufacturing capabilities and expand operational, financial, and information systems to support future product development [142]. - The company expects to continue incurring operating losses and will require substantial additional funding to complete the development and commercialization of its product candidates [140]. Market Position and Challenges - The company remains classified as an emerging growth company and a smaller reporting company, with annual revenue below $100 million [153][155]. - The company may face challenges in raising additional funds due to global economic conditions and market volatility [141]. - The company has not engaged in any off-balance sheet arrangements since inception [150].