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Tenaya Therapeutics Q3 2026 loss narrows to $18.9M

Cash resources are expected to fund planned operations into the fourth quarter of 2027 as pivotal trial planning continues.

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Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
8-K

Rhea-AI Filing Summary

Tenaya Therapeutics, Inc. reported a third-quarter 2026 net loss of $18.9 million, or $0.08 per share, compared with $20.3 million, or $0.12 per share, in the prior-year quarter. Cash and cash equivalents were $66.8 million as of September 30, 2026; Tenaya expects these resources to fund planned operations into the fourth quarter of 2027. Collaboration revenue was $1.7 million, research and development expense was $14.9 million, and general and administrative expense was $5.6 million.

In September 2026, the FDA granted TN-401 regenerative medicine advanced therapy designation for PKP2-associated ARVC. By year end, Tenaya plans to report longer-term TN-201 data, including one-year Cohort 2 and two-year Cohort 1 durability data, and additional TN-401 interim data, including one-year Cohort 2 and Cohort 1 durability data. Tenaya intends to provide year-end updates on regulatory discussions about pivotal trial planning for both programs and intends to initiate at least one company-sponsored TN-301 Phase 2 trial in the second half of 2027.

1 point · 0 major

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 0 points

How the balance works

Positive

  • Moderate pointQuarterly net loss declined to $18.9 million from $20.3 million a year earlier.

Negative

  • None.

Filing Explained

At September 30, cash was below its December 31 level, while the nine-month statements reported an impairment loss.

Tenaya's balance sheet reports cash and equivalents of $66,797 on September 30, 2026, compared with $100,547 on December 31, 2025; the reported cash balance was lower at quarter-end than at year-end.

For the nine months ended September 30, 2026, Tenaya reported a net loss of $81,603, including $22,487 of impairment loss; net loss for the comparable 2025 period was $70,422.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Cash and cash equivalents $66.8 million As of September 30, 2026; expected to fund planned operations into the fourth quarter of 2027
Collaboration revenue $1.7 million Third quarter of 2026
Research and development expense $14.9 million Third quarter of 2026, compared with $15.4 million in the third quarter of 2025
General and administrative expense $5.6 million Third quarter of 2026; $5.6 million in the third quarter of 2025
Net loss $18.9 million Third quarter of 2026, compared with $20.3 million in the third quarter of 2025
Net loss per share $0.08 per share Third quarter of 2026, compared with $0.12 per share in the third quarter of 2025
Regenerative Medicine Advanced Therapy (RMAT) designation regulatory
"granted Regenerative Medicine Advanced Therapy (RMAT) designation to TN-401"
A Regenerative Medicine Advanced Therapy (RMAT) designation is a U.S. regulatory status given to certain cell, gene, or tissue-based treatments that show promise for serious conditions and early clinical evidence of benefit. It signals that regulators will provide extra guidance and expedited review steps—like giving a promising project a “fast pass” through some development checkpoints—which can shorten time to market and reduce regulatory risk, making the program more valuable and noteworthy to investors.
pivotal trial medical
"explore late-stage pivotal trial plans for TN-201"
A pivotal trial is a key test of a new medicine or treatment to see if it works and is safe enough to be approved by health authorities. It's like a final exam for a new product, and passing it is essential for bringing the treatment to the public.
durability data medical
"durability data for Cohort 1 at two years"
HDAC6 inhibitor technical
"Small Molecule HDAC6 Inhibitor"
An HDAC6 inhibitor is a drug that blocks the activity of the HDAC6 enzyme, which helps control how cells manage certain proteins and switch genes on or off. Think of HDAC6 as a combination of a light switch and a cleaning crew inside cells; inhibiting it can change cell behavior and reduce harmful protein buildup. Investors care because this mechanism underlies potential treatments for cancers, neurodegenerative and inflammatory diseases, so it shapes clinical risk, development timelines and market opportunity.
Net loss $18.9 million Compared with $20.3 million in the third quarter of 2025
Net loss per share $0.08 per share Compared with $0.12 per share in the third quarter of 2025
Research and development expense $14.9 million Compared with $15.4 million in the third quarter of 2025
General and administrative expense $5.6 million $5.6 million in the third quarter of 2025
Guidance

Tenaya expects cash and cash equivalents of $66.8 million as of September 30, 2026 to fund planned operations into the fourth quarter of 2027.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What was TNYA's net loss in Q3 2026?

Tenaya reported a $18.9 million net loss, or $0.08 loss per share, for the third quarter ended September 30, 2026. In the third quarter of 2025, net loss was $20.3 million, or $0.12 per share.

How much cash did TNYA report, and how long does it expect it to last?

Cash and cash equivalents were $66.8 million as of September 30, 2026. Tenaya expects those resources to fund planned operations into the fourth quarter of 2027.

Which TN-201 and TN-401 trial data does TNYA expect by year end?

For the MyPEAK-1 trial, Tenaya plans to report one-year data for Cohort 2 and durability data for Cohort 1 at two years. For the RIDGE-1 trial, it expects additional interim data, including one-year Cohort 2 data and Cohort 1 durability data.

What supported the FDA's TN-401 RMAT designation?

The FDA granted TN-401 Regenerative Medicine Advanced Therapy designation in September 2026 for PKP2-associated ARVC. The designation was supported by positive interim data from the ongoing RIDGE-1 Phase 1b/2 clinical trial.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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0001858848falseNONE00018588482026-11-042026-11-04

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 04, 2026

 

 

Tenaya Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40656

81-3789973

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

171 Oyster Point Boulevard

Suite 500

 

South San Francisco, California

 

94080

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 825-6990

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

TNYA

 

Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 


Item 2.02 Results of Operations and Financial Condition.

On November 4, 2026, Tenaya Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2026 (“Earnings Press Release”). The full text of the Earnings Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
No.

 

Description

 

 

99.1

 

Press Release of Tenaya Therapeutics, Inc., dated November 4, 2026

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

TENAYA THERAPEUTICS, INC.

 

 

 

By:

 

 

/s/ Jennifer Drimmer Rokovich

 

 

 

 

Jennifer Drimmer Rokovich

 

 

 

 

General Counsel and Secretary

Date: November 4, 2026

 

 

 

 

 

 


Exhibit 99.1

img92481827_0.jpg

Tenaya Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update

 

Received Regenerative Medicine Advanced Therapy (RMAT) Designation from U.S. FDA for TN-401 Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy

 

TN-201 and TN-401 Program Updates on Upcoming Data Readouts and Regulatory Interactions for Pivotal Trial Planning Anticipated by Year-End

 

Current Cash Position Provides Planned Runway into Fourth Quarter 2027

 

SOUTH SAN FRANCISCO, Calif., November 4, 2026 – 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 third quarter ended September 30, 2026, and provided a corporate update.

 

“As we celebrate the tenth anniversary of Tenaya, we are entering one of the most important periods in the Company’s history,” said Faraz Ali, Chief Executive Officer of Tenaya. “The forthcoming data updates from TN-201 and TN-401, together with regulatory feedback on potential pivotal development pathways, are expected to inform potential opportunities to advance these programs toward late-stage development. We are also preparing to share our vision for TN-301’s potential and future clinical development. Collectively, these milestones are expected to provide important clarity on the path forward for our portfolio and capital allocation decisions, defining the next phase of growth for Tenaya.”

 

Business and Program Updates

 

TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)

•
Tenaya plans to report longer-term follow-up data from the MyPEAK™-1 clinical trial by year end, including one-year data for Cohort 2 and durability data for Cohort 1 at two years.
•
Tenaya is in ongoing discussions with regulatory authorities with an additional interaction planned to explore late-stage pivotal trial plans for TN-201 and intends to provide an update by year end.

 

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

•
In September 2026, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to TN-401 for the treatment of PKP2-associated ARVC. The RMAT designation was supported by the positive interim data from the ongoing RIDGE™-1 Phase 1b/2 clinical trial.
•
Tenaya expects to report additional interim data from the RIDGE-1 clinical trial by year end, including one-year data for Cohort 2 and durability data for Cohort 1.
•
Tenaya management has been engaging with regulators and has upcoming meetings scheduled to discuss late-stage pivotal trial planning for TN-401. The company plans to provide an update on the feedback received from its discussions, along with the additional TN-401 data, by year end.

 

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


•
Tenaya is currently conducting study-enabling work to support the advancement of TN-301 toward Phase 2 clinical trials in patients. The company intends to initiate at least one company-sponsored Phase 2 clinical trial in the second half of 2027.

 

Third Quarter 2026 Financial Highlights

•
Cash: As of September 30, 2026, cash and cash equivalents were $66.8 million. Tenaya expects that such resources will be sufficient to fund planned operations into the fourth quarter of 2027.
•
Research & Development (R&D) Expenses: R&D expenses were $14.9 million for the third quarter of 2026, compared to $15.4 million for the same period in 2025. Non-cash stock-based compensation included in R&D expense was $0.8 million for the third quarter of 2026, compared to $1.5 million for the same period in 2025.
•
General & Administrative (G&A) Expenses: G&A expenses were $5.6 million for each of the third quarters of 2026 and 2025. Non-cash stock-based compensation included in G&A expense was $0.9 million for the third quarter of 2026, compared to $1.4 million for the same period in 2025.
•
Net Loss: Net loss was $18.9 million, or $0.08 loss per share, for the third quarter ended September 30, 2026, compared to a net loss of $20.3 million, or $0.12 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 “anticipated,” “potential,” “expected,” “vision,” “plans,” “intends,” “will,” 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; planned timing for providing regulatory updates on the TN-201 and TN-401 programs; the therapeutic potential for TN-201 as a treatment for MYBPC3-associated HCM, TN-401 as a treatment for PKP2-associated ARVC and TN-301 as a treatment for HFpEF or other related cardiac, metabolic, or muscular diseases; the impact of data and regulatory feedback on the pivotal development pathways for TN-201 and TN-401; the impact of the future clinical development plan for TN-301 and pivotal pathways for TN-201 and TN-401 on Tenaya’s overall portfolio and capital allocation decisions; the sufficiency of Tenaya’s cash resources to fund the company into fourth quarter 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 by patients who received Tenaya products; 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 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 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 September 30,

 

 

Nine Months Ended September 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

1,697

 

 

$

—

 

 

$

3,032

 

 

$

—

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

14,866

 

 

 

15,363

 

 

 

46,313

 

 

 

53,809

 

General and administrative

 

 

5,648

 

 

 

5,573

 

 

 

16,501

 

 

 

18,747

 

Impairment loss

 

 

666

 

 

 

—

 

 

 

22,487

 

 

 

—

 

Loss on lease termination, net

 

 

—

 

 

 

—

 

 

 

1,368

 

 

 

—

 

Loss on disposal of property and equipment

 

 

89

 

 

 

—

 

 

 

89

 

 

 

—

 

Total operating expenses

 

 

21,269

 

 

 

20,936

 

 

 

86,758

 

 

 

72,556

 

Loss from operations

 

 

(19,572

)

 

 

(20,936

)

 

 

(83,726

)

 

 

(72,556

)

Other income, net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

635

 

 

 

658

 

 

 

2,126

 

 

 

2,107

 

Other (loss) income, net

 

 

(1

)

 

 

3

 

 

 

(3

)

 

 

27

 

Total other income, net

 

 

634

 

 

 

661

 

 

 

2,123

 

 

 

2,134

 

Net loss before income tax expense

 

 

(18,938

)

 

 

(20,275

)

 

 

(81,603

)

 

 

(70,422

)

Income tax expense

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Net loss

 

$

(18,938

)

 

$

(20,275

)

 

$

(81,603

)

 

$

(70,422

)

Net loss per share, basic and diluted

 

$

(0.08

)

 

$

(0.12

)

 

$

(0.37

)

 

$

(0.48

)

Weighted-average shares used in computing net loss per share, basic and diluted

 

 

226,006,534

 

 

 

163,345,972

 

 

 

220,188,197

 

 

 

145,531,495

 

 

 

 

Condensed Balance Sheet Data

(In thousands)

(Unaudited)

 

 

 

September 30,

 

 

December 31,

 

 

 

2026

 

 

2025

 

Cash and cash equivalents

 

$

66,797

 

 

$

100,547

 

Total assets

 

$

76,681

 

 

$

146,921

 

Total liabilities

 

$

22,164

 

 

$

23,656

 

Total liabilities and stockholders’ equity

 

$

76,681

 

 

$

146,921

 

 

 

 


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