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Tenaya Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update

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Tenaya Therapeutics (NASDAQ: TNYA) reported Q3 2024 financial results and provided updates on its gene therapy programs. The company completed dosing of the first three patients in Cohort 1 of the MyPEAK-1 trial for TN-201, with the Data Safety Monitoring Board endorsing dose escalation to Cohort 2. Initial data from Cohort 1 will be reported in December 2024. The company reported a net loss of $25.6 million ($0.30 per share) and had cash and investments of $79.5 million as of September 30, 2024, sufficient to fund operations into second half of 2025. R&D expenses were $20.4 million, down from $23.1 million in Q3 2023.

Tenaya Therapeutics (NASDAQ: TNYA) ha riportato i risultati finanziari del terzo trimestre del 2024 e fornito aggiornamenti sui suoi programmi di terapia genica. L'azienda ha completato la somministrazione ai primi tre pazienti del Coorte 1 del trial MyPEAK-1 per TN-201, con il Comitato di Monitoraggio della Sicurezza dei Dati che ha approvato l'aumento della dose al Coorte 2. I dati iniziali del Coorte 1 saranno riportati a dicembre 2024. L'azienda ha riportato una perdita netta di 25,6 milioni di dollari (0,30 dollari per azione) e disponeva di liquidità e investimenti per 79,5 milioni di dollari al 30 settembre 2024, sufficienti a finanziare le operazioni fino alla seconda metà del 2025. Le spese per ricerca e sviluppo sono state di 20,4 milioni di dollari, in calo rispetto ai 23,1 milioni di dollari del terzo trimestre 2023.

Tenaya Therapeutics (NASDAQ: TNYA) informó sobre los resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre sus programas de terapia génica. La empresa completó la dosificación de los primeros tres pacientes en el Cohorte 1 del ensayo MyPEAK-1 para TN-201, con la Junta de Monitoreo de Seguridad de Datos respaldando la escalada de dosis al Cohorte 2. Los datos iniciales del Cohorte 1 se reportarán en diciembre de 2024. La empresa reportó una pérdida neta de 25,6 millones de dólares (0,30 dólares por acción) y tenía efectivo e inversiones de 79,5 millones de dólares hasta el 30 de septiembre de 2024, suficiente para financiar operaciones hasta la segunda mitad de 2025. Los gastos en I+D fueron de 20,4 millones de dólares, por debajo de los 23,1 millones de dólares en el tercer trimestre de 2023.

테나야 테라퓨틱스 (NASDAQ: TNYA)는 2024년 3분기 재무 결과를 보고하고 유전자 치료 프로그램에 대한 업데이트를 제공했습니다. 회사는 TN-201에 대한 MyPEAK-1 시험의 코호트 1에서 첫 세 명의 환자의 용량 투여를 완료하였으며, 데이터 안전성 모니터링 위원회는 코호트 2로의 용량 증가를 승인했습니다. 코호트 1의 초기 데이터는 2024년 12월에 보고될 예정입니다. 회사는 2,560만 달러의 순손실 (주당 0.30달러)을 보고하였으며, 2024년 9월 30일 기준으로 7950만 달러의 현금 및 투자 자산을 보유하고 있어 2025년 하반기까지 운영 자금을 지원할 수 있습니다. 연구개발 비용은 2040만 달러로, 2023년 3분기의 2310만 달러에서 감소했습니다.

Tenaya Therapeutics (NASDAQ: TNYA) a annoncé les résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur ses programmes de thérapie génique. L'entreprise a terminé l'administration de dose aux trois premiers patients du Cohorte 1 de l'essai MyPEAK-1 pour TN-201, le Comité de Surveillance de la Sécurité des Données ayant approuvé l'escalade de dose au Cohorte 2. Les données initiales du Cohorte 1 seront présentées en décembre 2024. L'entreprise a rapporté une perte nette de 25,6 millions de dollars (0,30 dollar par action) et disposait de 79,5 millions de dollars en liquidités et investissements au 30 septembre 2024, suffisants pour financer ses opérations jusqu'à la seconde moitié de 2025. Les dépenses en R&D étaient de 20,4 millions de dollars, en baisse par rapport à 23,1 millions de dollars au troisième trimestre 2023.

Tenaya Therapeutics (NASDAQ: TNYA) hat die Finanzresultate für das dritte Quartal 2024 gemeldet und Aktualisierungen zu seinen Gentherapieprogrammen bereitgestellt. Das Unternehmen hat die Dosisverabreichung an die ersten drei Patienten in Kohorte 1 der MyPEAK-1-Studie für TN-201 abgeschlossen, und das Daten-Sicherheitsmonitoringkomitee hat die Dosissteigerung auf Kohorte 2 genehmigt. Erste Daten aus Kohorte 1 werden im Dezember 2024 berichtet. Das Unternehmen berichtete von einem Nettoverlust von 25,6 Millionen Dollar (0,30 Dollar pro Aktie) und verfügte zum 30. September 2024 über 74,5 Millionen Dollar in Bargeld und Investitionen, was ausreicht, um die Betriebe bis zur zweiten Hälfte des Jahres 2025 zu finanzieren. Die F&E-Ausgaben betrugen 20,4 Millionen Dollar, ein Rückgang von 23,1 Millionen Dollar im dritten Quartal 2023.

Positive
  • DSMB endorsed dose escalation for TN-201 gene therapy trial
  • Secured $45 million credit facility with Silicon Valley Bank
  • Reduced quarterly net loss to $25.6M from $29.1M year-over-year
  • Obtained US patent for ARVC treatment method, valid until 2040
  • Expanded trial eligibility criteria to enhance enrollment
Negative
  • Operating losses continue with $25.6M net loss in Q3
  • Cash runway only extends into second half of 2025
  • R&D expenses remain high at $20.4M despite reduction

Insights

The Q3 results show a mixed financial picture. While the company reduced its net loss to $25.6 million from $29.1 million year-over-year, with lower R&D and G&A expenses, the cash position of $79.5 million only provides runway into H2 2025. The secured $45 million credit facility with SVB offers additional flexibility but remains undrawn.

The company's progress with TN-201 gene therapy trials and positive DSMB safety review are promising developments. However, investors should note that clinical-stage biotech companies typically require substantial capital to reach commercialization. The expanded trial eligibility criteria could accelerate enrollment but may also increase costs.

The new patent protection for the ARVC treatment program through 2040 strengthens the company's intellectual property position, potentially adding long-term value.

The DSMB's endorsement for dose escalation in the MyPEAK-1 trial and protocol modifications represent significant clinical progress. The expansion to include obstructive HCM patients and those without ICDs widens the potential patient pool and could accelerate enrollment. The SHaRe registry data highlighting 50% significant morbidity by age 40 in MYBPC3-associated pediatric HCM patients underscores the urgent medical need.

The upcoming December data readout from Cohort 1 will be important in validating the therapy's potential. The addition of baseline biopsies and modified biopsy timing should provide better insights into TN-201's mechanism of action and expression patterns. The rare pediatric disease designation adds regulatory advantages and potential priority review voucher eligibility.

Data Safety and Monitoring Board Endorsed Dose Escalation and Broadening of Inclusion Criteria in the MyPEAKTM-1 Phase 1b/2 Trial of TN-201 Gene Therapy

Initial TN-201 Data from Cohort 1 of MyPEAK-1 to be Reported in December 2024

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (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 reported financial results for the third quarter ended September 30, 2024, and provided a corporate update.

“We are pleased to share meaningful progress on our lead TN-201 gene therapy program during the third quarter, including an early positive safety update and DSMB clearance to dose escalate to Cohort 2 in the MyPEAK-1 study. We remain on track to report early clinical data from the first three patients from Cohort 1 of this study in December,” said Faraz Ali, Chief Executive Officer of Tenaya. “We also shared updates to MyPEAK-1 study eligibility criteria that are expected to enhance enrollment and adjustments to the timing and frequency of cardiac biopsies that are expected to support deeper insights into TN-201 expression going forward. Overall, these updates create positive momentum going into the year-end data release, as well as for future updates in 2025.”

Business and Program Updates
TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)

  • Tenaya completed dosing of the first three patients at the 3E13 vg/kg dose (Cohort 1) in MyPEAK-1 clinical trial with no unexpected events or toxicities associated with study drug observed. Safety data from Cohort 1 were reviewed by an independent Data Safety and Monitoring Board (DSMB) that recommended that Tenaya proceed with planned dose escalation to 6E13 vg/kg (Cohort 2), per protocol.
    • MyPEAK-1 is a Phase 1b/2 multi-center, open-label, dose-escalation trial designed to assess safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-201 in treating patients with HCM caused by mutations in the MYBPC3 gene. The study is being conducted in the U.S. with ten clinical sites activated.
  • Tenaya implemented changes to the MyPEAK-1 protocol intended to support future development, including adding a baseline biopsy; expanding trial participant eligibility to include obstructive HCM patients and patients without implantable cardioverter defibrillators (ICDs); and increasing the potential number of total patients enrolled in the dose expansion portion of the clinical trial.
  • Tenaya anticipates sharing interim results from MyPEAK-1, including safety and tolerability, analyses of cardiac biopsy, as well as changes from baseline in cardiac biomarkers, from the first cohort of patients in December 2024.
  • At the virtual HCM Society’s Scientific Sessions in September, Tenaya presented data from a study conducted in partnership with the Sarcomeric Human Cardiomyopathy Registry (SHaRe) describing the higher disease burden faced by MYBPC3-associated pediatric HCM patients, with 50% experiencing significant morbidity by age 40.
  • In July, TN-201 was granted rare pediatric disease designation by the U.S. Food and Drug Administration for the treatment of MYBPC3-associated HCM in individuals under the age of 18. Tenaya has enrolled more than 200 retrospective and prospective patients across 29 sites in the MyClimb Natural History Study intended to better characterize MYBPC3-associated pediatric HCM patients.

TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

  • Tenaya has activated six clinical sites in RIDGETM -1 clinical trial and has been screening potential patients for participation. RIDGE-1 is a global multicenter, open-label, dose-escalation trial designed to assess safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-401 for the treatment of ARVC caused by mutations to the PKP2 gene. Tenaya has also activated more than 20 sites in 6 countries in the RIDGE seroprevalence and natural history study.
  • In October 2024, the U.S. Patent and Trademark Office issued U.S Patent Number 12,104,165 (the ’165 patent). The ’165 patent is directed to a method of treating an arrhythmogenic right ventricular cardiomyopathy (ARVC) with an AAV9 virion encoding the PKP2 protein. The ’165 patent provides method of treatment protection for Tenaya’s PKP2 gene therapy program for the treatment of ARVC and is expected to expire no earlier than 2040.

Corporate

  • In August 2024, Tenaya entered into a $45 million credit facility with Silicon Valley Bank (SVB). Tenaya has not drawn on the credit facility and is under no obligation to do so.

Third Quarter 2024 Financial Highlights

  • Cash Position and Guidance: As of September 30, 2024, cash, cash equivalents and investments in marketable securities were $79.5 million. Tenaya estimates sufficient funds are available to support planned company operations into the second half of 2025.
  • Research & Development (R&D) Expenses: R&D expenses were $20.4 million for the quarter ended September 30, 2024, compared to $23.1 million for the comparable period in 2023. Non-cash stock-based compensation included in R&D expense was $2.0 million for the quarter ended September 30, 2024, compared to $1.9 million for the comparable period in 2023.
  • General & Administrative (G&A) Expenses: G&A expenses were $6.4 million for the quarter ended September 30, 2024, compared to $7.8 million for the comparable period in 2023. Non-cash stock-based compensation included in G&A expense was $1.9 million for the quarter ended September 30, 2024, compared to $2.2 million for the comparable period in 2023.
  • Net Loss: Net loss was $25.6 million, or $0.30 per share for the quarter ended September 30, 2024, compared to a net loss of $29.1 million, or $0.39 per share, for the comparable period in 2023.

About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya employs a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of genetic medicines aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. Tenaya’s pipeline includes TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), TN-301, a small molecule HDAC6 inhibitor intended for heart failure with preserved ejection fraction (HFpEF), and multiple early-stage programs in preclinical development. For more information, visit www.tenayatherapeutics.com.

Forward Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “on track,” “expected,” “future,” “planned,” “potential,” “anticipates,” “estimates” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, planned timing of sharing initial data from MyPEAK-1 and additional clinical data readouts; the impact of MyPEAK-1 protocol changes on enrollment and insights into TN-201 expression; Tenaya’s plans and expectations regarding its clinical development efforts and activities, including site activation, enrolling and dosing patients and generating data for MyPEAK-1 and RIDGE-1 and the RIDGE natural history study; expectations regarding patent coverage for TN-401; the sufficiency of Tenaya’s cash resources to fund the company into the second half of 2025; and statements made by Tenaya’s chief executive officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: availability of data at the referenced times; the timing and progress of Tenaya’s clinical trials; unexpected concerns that may arise as a result of the occurrence of adverse safety events in Tenaya’s clinical trials; the potential failure of Tenaya’s product candidates to demonstrate safety and/or efficacy in clinical testing; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Tenaya’s ability to comply with specified operating covenants and restrictions in its loan agreement; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to comply with specified operating covenants and restrictions in its loan agreement; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contact
Michelle Corral
VP, Corporate Communications and Investor Relations
IR@tenayathera.com

Investors
Anne-Marie Fields
Precision AQ (formerly Stern Investor Relations)
annemarie.fields@precisionaq.com

Media
Wendy Ryan
Ten Bridge Communications
wendy@tenbridgecommunications.com

 TENAYA THERAPEUTICS, INC.

Condensed Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
 
  
  Three Months Ended September 30,  Nine Months Ended September 30, 
  2024  2023  2024  2023 
Operating expenses:            
Research and development $20,350  $23,091  $68,054  $75,173 
General and administrative  6,361   7,829   23,242   24,574 
Total operating expenses  26,711   30,920   91,296   99,747 
Loss from operations  (26,711)  (30,920)  (91,296)  (99,747)
Other income, net:            
Interest income  1,080   1,776   3,925   5,586 
Other income (loss), net  (3)  1   78   12 
Total other income, net  1,077   1,777   4,003   5,598 
Net loss before income tax expense  (25,634)  (29,143)  (87,293)  (94,149)
Income tax expense            
Net loss $(25,634) $(29,143) $(87,293) $(94,149)
Net loss per share, basic and diluted $(0.30) $(0.39) $(1.04) $(1.28)
Weighted-average shares used in computing net loss per share, basic and diluted  86,162,841   73,924,937   84,290,747   73,579,200 
 


 Condensed Balance Sheet Data
(In thousands)
(Unaudited)
 
  September 30,  December 31, 
  2024  2023 
Cash, cash equivalents and marketable securities $79,469  $104,642 
Total assets $140,582  $170,515 
Total liabilities $27,980  $31,091 
Total liabilities and stockholders’ equity $140,582  $170,515 
 

FAQ

What were Tenaya Therapeutics (TNYA) Q3 2024 financial results?

Tenaya reported a net loss of $25.6 million ($0.30 per share), with R&D expenses of $20.4 million and cash position of $79.5 million as of September 30, 2024.

When will Tenaya (TNYA) report initial data from the MyPEAK-1 trial?

Tenaya plans to report initial data from Cohort 1 of the MyPEAK-1 trial in December 2024.

What is the cash runway for Tenaya Therapeutics (TNYA)?

Tenaya estimates its current cash position will support planned operations into the second half of 2025.

What was the DSMB decision for TNYA's TN-201 trial?

The Data Safety Monitoring Board recommended proceeding with planned dose escalation to 6E13 vg/kg (Cohort 2) following review of Cohort 1 safety data.

Tenaya Therapeutics, Inc.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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SOUTH SAN FRANCISCO