Tenaya Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update
Rhea-AI Summary
Tenaya Therapeutics (NASDAQ: TNYA) reported Q1 2026 results and a business update on May 6, 2026. Cash and cash equivalents were $80.9M as of March 31, 2026, and Tenaya expects funding into the second half of 2027 including a $10.0M upfront from an Alnylam collaboration. The company highlighted upcoming clinical readouts for TN-201 and TN-401, preclinical TN-301 DMD data, FDA Rare Pediatric and Orphan designations for TN-301, and expanded research with Alnylam with milestones up to $1.1B.
Positive
- Cash of $80.9M as of March 31, 2026
- $10.0M upfront from Alnylam collaboration; milestones up to $1.1B
- Upcoming one-year and cohort data for TN-401 and TN-201 in 2Q–May 2026
- TN-301 received Rare Pediatric and Orphan Drug designations for DMD
Negative
- Cash runway covers operations only into the second half of 2027
- Net loss of $19.3M in Q1 2026 (still operating loss)
- R&D spend declined to $14.8M in Q1 2026 from $21.1M in Q1 2025
News Market Reaction – TNYA
In the May 7 session, TNYA gained 7.37%, reflecting a notable positive market reaction. Argus tracked a peak move of +6.8% during that session. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 11 | Earnings and update | Positive | +4.0% | Q4 2025 results, early gene therapy readouts and Alnylam collaboration details. |
| Nov 10 | Earnings and update | Positive | +11.7% | Q3 2025 results with reduced expenses, narrowed loss and trial progress. |
| Aug 06 | Earnings and update | Positive | -1.7% | Q2 2025 results with trial milestones and extended cash runway. |
| May 07 | Earnings and update | Positive | -2.1% | Q1 2025 results, interim MyPEAK-1 data and cash plus equity raise. |
| Mar 10 | Earnings and update | Positive | +6.8% | Q4 2024 results, RIDGE-1 progress and extended runway via offering. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings releases have often been received positively, but there is a mixed pattern with several instances of negative next-day reactions despite constructive updates.
Recent earnings and financial updates for TNYA have highlighted steady clinical progress in TN-201 and TN-401, advancement of TN-301, and repeated extensions of cash runway through offerings and partnerships. Historical earnings events on Mar 11 2026, Nov 10 2025, and Mar 10 2025 produced positive price reactions, while Q2 and Q1 2025 updates saw mild declines. Today’s Q1 2026 report continues the themes of narrowing losses and funding visibility into the second half of 2027.
Key Terms
phase 1b/2 medical
hypertrophic cardiomyopathy medical
arrhythmogenic right ventricular cardiomyopathy medical
hdac6 inhibitor medical
orphan drug designation regulatory
rare pediatric disease designation regulatory
induced pluripotent stem cells medical
gene editing medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
One-Year Cohort 1 Data and Initial Cohort 2 Data from RIDGE™-1 Phase 1b/2 Trial of TN-401 for PKP2-Associated ARVC to be Presented at ASGCT 2026
New Data from Both Cohorts of the MyPEAK™-1 Phase 1b/2 Trial of TN-201 for Adults with MYBPC3-Associated HCM Expected in the Second Quarter 2026
Preclinical Data at MDA 2026 Highlighted TN-301’s Activity in Duchenne Muscular Dystrophy Disease Models; Distinct Mechanism of HDAC6 Inhibition Supportive of TN-301’s Potential in Multiple Indications
Entered Research Collaboration with Alnylam to Identify and Validate Genetic Targets for Cardiovascular Conditions
SOUTH SAN FRANCISCO, Calif., May 06, 2026 (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 financial results for the first quarter ended March 31, 2026, and provided a corporate update.
“We are entering a catalyst-rich period for Tenaya, with multiple clinical milestones expected across our lead gene therapy programs throughout 2026. Building on the encouraging initial readouts we reported in 2025, we believe the additional data expected this year from both TN-201 and TN-401 may support alignment on registrational pathways for these novel gene therapies,” said Faraz Ali, Chief Executive Officer of Tenaya.
Mr. Ali continued, “While our focus remains on the advancement of TN-201 and TN-401 for patients suffering from these genetic cardiomyopathies, we also announced meaningful steps in the direction of our next horizon of opportunities to address unmet patient needs and to create value for stockholders. We presented new preclinical data for TN-301, our clinical-stage small molecule candidate, in Duchenne muscular dystrophy adding to the body of compelling preclinical evidence for the broad clinical utility of this molecule in multiple prevalent and rare cardiac and cardiac-adjacent indications. Advancing TN-301 toward a trial in patients reflects our commitment to building a diversified portfolio grounded in mechanistic insight and translational rigor. The recently announced collaboration with Alnylam also reinforces the strength of Tenaya's innovation engine and expands the reach and impact of our modality-agnostic research capabilities.”
Business and Program Updates
TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
- On May 9, 2026, at the upcoming European Society of Cardiology (ESC) Heart Failure Conference, in Barcelona, Spain, Milind Desai, M.D., Director of the Hypertrophic Cardiomyopathy Center, Vice Chair of the Heart, Vascular & Thoracic Institute at Cleveland Clinic, and principal investigator for the MyPEAK-1 clinical trial, will present insights that emerged early in the trial that enabled reductions in the cumulative dose and duration of immune suppressive medications, even when TN-201 is administered at the higher dose.
- Per the MyPEAK-1 protocol, sirolimus and prednisone are administered prophylactically in patients receiving TN-201 gene therapy, accompanied by post dose tapering in conjunction with monitoring of liver enzyme levels – an early indicator of potential complement system activation. Investigators found that minor adjustments, including administering sirolimus earlier, reducing the starting dose of prednisone and monitoring patients weekly, led to faster tapering and an overall decrease in the burden of immunosuppression.
- The ESC-HF presentation offers more detail on the immunosuppressive regimen results previously reported in November 2025 and includes safety data for the first seven patients enrolled in MyPEAK-1. The optimized regimen and monitoring protocols that were successfully deployed in MyPEAK-1 are also being utilized in the RIDGE-1 clinical trial of TN-401.
- Tenaya expects to report interim MyPEAK-1 data for Cohort 2 (6E13 vg/kg) and updates from Cohort 1 (3E13 vg/kg) in the second quarter of 2026.
- In January, Tenaya resumed enrollment and screening in MyPEAK-1 following implementation of modest protocol amendments in alignment with U.S. Food and Drug Administration (FDA) input.
- At the American Society of Gene and Cell Therapies (ASGCT) Annual Meeting, taking place May 11-15, 2026, in Boston, MA, Tenaya will present results from a survey exploring parental perceptions of gene therapy treatment for children with cardiomyopathies. This work was conducted by Tenaya in partnership with DDC Clinic and Children’s Cardiomyopathy Foundation. The poster presentation is scheduled for May 12, 2026.
TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
- Data from the ongoing RIDGE-1 Phase 1b/2 clinical trial of TN-401 in adults with ARVC due to variants in the PKP2 gene have been accepted as a late-breaking presentation at the upcoming ASGCT Annual Meeting. The presentation, scheduled for Friday, May 15, is expected to include one-year data for Cohort 1 (3E13 vg/kg) and initial Cohort 2 (6E13 vg/kg).
- Tenaya management plans to conduct a webcast conference call on Friday, May 15, 2026, at 10:30 a.m. EDT / 7:30 am PDT following the Late Breaker Session. The webcast conference call, including an accompanying slide presentation, will be accessible from the Investor section of the Tenaya website at www.tenayatherapeutics.com.
- In January, the RIDGE-1 data and safety monitoring board (DSMB) reviewed all available data for the six patients that have received TN-401 gene therapy. The DSMB determined that TN-401 had an acceptable safety profile and endorsed continued enrollment of patients in RIDGE-1 expansion cohorts at either dose.
TN-301 – Small Molecule HDAC6 Inhibitor for the Potential Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF) and Related Cardiac, Metabolic, or Muscular Diseases
- In March 2026, Tenaya presented encouraging preclinical data comparing TN-301, the company’s highly selective HDAC6 inhibitor, with givinostat, an approved pan-HDAC inhibitor, in well-established preclinical models of Duchenne muscular dystrophy (DMD) at the Muscular Dystrophy Association’s 2026 Clinical and Scientific Congress.
- Results of the study showed that:
- TN-301 treatment at doses as low as 3 mg/kg improved grip strength to wild-type levels within five weeks, whereas mdx mice treated with givinostat (10 mg/kg, approximating clinical exposures) failed to reach wild-type performance.
- TN-301-mediated functional improvements were accompanied by reductions in circulating creatine kinase and favorable changes in gene expression, indicating reduced muscle cell injury.
- In cardiomyocytes derived from human DMD-induced pluripotent stem cells, TN-301 corrected calcium handling abnormalities and mitochondrial dysfunction, while givinostat exacerbated these established drivers of DMD cardiomyopathy.
- TN-301 was granted both Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of DMD from U.S. Food and Drug Administration.
- In 2026, Tenaya plans to advance TN-301 toward clinical trials in patients in order to generate proof-of-activity data, with HFpEF and DMD being among the most promising potential indications identified to date.
Research
- In March 2026, Tenaya entered into a multi-target research collaboration with Alnylam Pharmaceuticals to identify and validate novel genetic targets aimed at treating cardiovascular disease.
- Under the terms of the collaboration agreement, in April 2026, Tenaya received an upfront payment of
$10.0M and may be eligible for future development, regulatory and sales-based milestones totaling up to$1.1 billion , in addition to reimbursement of associated research costs.
- Under the terms of the collaboration agreement, in April 2026, Tenaya received an upfront payment of
- Updated results of preclinical studies characterizing TN-501, a gene editing therapeutic candidate intended for the treatment of PLN-R14del-associated dilated cardiomyopathy (DCM) will be presented at ASGCT on Thursday, May 14, 2026. TN-501 is designed to specifically inactivate the pathogenic phospholamban (PLN) R14del allele while preserving healthy function.
First Quarter 2026 Financial Highlights
- Cash: As of March 31, 2026, cash and cash equivalents were
$80.9 million . Tenaya expects that such resources, along with the$10.0 million upfront payment from the Alnylam collaboration, will be sufficient to fund planned operations into the second half of 2027. - Research & Development (R&D) Expenses: R&D expenses were
$14.8 million for the first quarter of 2026, compared to$21.1 million for the same period in 2025. Non-cash stock-based compensation included in R&D expense was$1.2 million for the first quarter of 2026 compared to$2.0 million for the same period in 2025. - General & Administrative (G&A) Expenses: G&A expenses were
$5.4 million for the first quarter of 2026 compared to$6.5 million for the same period in 2025. Non-cash stock-based compensation included in G&A expense was$1.0 million for the first quarter of 2026 and$1.7 million for the same period in 2025. - Net Loss: Net loss was
$19.3 million , or$0.09 loss per share, for the first quarter ended March 31, 2026, compared to a net loss of$26.9 million , or$0.24 per share, for the same period in 2025.
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’s pipeline includes clinical-stage candidates TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM); TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC); and TN-301, a highly specific small molecule HDAC6 inhibitor with broad potential clinical utility in cardiac, metabolic and muscular conditions, including heart failure with preserved ejection fraction (HFpEF) and Duchenne muscular dystrophy (DMD). Tenaya has employed a suite of integrated internal capabilities including modality agnostic target discovery and validation, to generate a portfolio of novel medicines based on genetic insights, aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. 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 “expected,” “believe,” “may,” “focused,” “commitment,” “will,” “plans,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, planned timing for sharing data from RIDGE-1 and MyPEAK-1 and the expected content of such data releases; the potential for additional data from Tenaya’s TN-201 and TN-401 programs to support regulatory alignment on registrational pathways; Tenaya’s focus on the advancement of TN-201 and TN-401; Tenaya’s commitment to the building a diversified portfolio and advance TN-301 toward clinical trials; the potential for Tenaya to receive development, regulatory and sales-based milestone payments, as well as research reimbursement under the collaboration with Alnylam; planned presentation for TN-501; the sufficiency of Tenaya’s cash resources to fund the company into the second half of 2027; 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; the potential for the FDA to conclude at any time that Tenaya’s clinical programs may not have an appropriate risk/benefit profile; Tenaya’s ability to enroll and maintain patients in clinical trials; 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 ability to achieve the expected benefits from the collaboration with Alnylam; the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration with Alnylam; Tenaya’s continuing compliance with applicable legal and regulatory requirements; regulatory developments in the United States and foreign countries; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; 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 and platform technology; 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.
Tenaya Contacts
Michelle Corral
VP, Corporate Communications and Investor Relations
IR@tenayathera.com
Investors
Anne-Marie Fields
Precision AQ
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 March 31, | |||||||
| 2026 | 2025 | ||||||
| Revenue | |||||||
| Collaboration revenue | $ | 225 | $ | — | |||
| Operating expenses: | |||||||
| Research and development | 14,843 | 21,076 | |||||
| General and administrative | 5,447 | 6,462 | |||||
| Total operating expenses | 20,290 | 27,538 | |||||
| Loss from operations | (20,065 | ) | (27,538 | ) | |||
| Other income, net: | |||||||
| Interest income | 793 | 635 | |||||
| Other income, net | — | 39 | |||||
| Total other income, net | 793 | 674 | |||||
| Net loss before income tax expense | (19,272 | ) | (26,864 | ) | |||
| Income tax expense | — | — | |||||
| Net loss | $ | (19,272 | ) | $ | (26,864 | ) | |
| Net loss per share, basic and diluted | $ | (0.09 | ) | $ | (0.24 | ) | |
| Weighted-average shares used in computing net loss per share, basic and diluted | 216,883,164 | 109,869,278 | |||||
| Condensed Balance Sheet Data (In thousands) (Unaudited) | |||||
| March 31, | December 31, | ||||
| 2026 | 2025 | ||||
| Cash and cash equivalents | $ | 80,887 | $ | 100,547 | |
| Total assets | $ | 135,070 | $ | 146,921 | |
| Total liabilities | $ | 28,881 | $ | 23,656 | |
| Total liabilities and stockholders’ equity | $ | 135,070 | $ | 146,921 | |
