The accompanying notes are an integral part of these unaudited condensed financial statements.

The accompanying notes are an integral part of these unaudited condensed financial statements.

The accompanying notes are an integral part of these unaudited condensed financial statements.

The accompanying notes are an integral part of these unaudited condensed financial statements.

Notes to Unaudited Condensed Financial Statements

Q30001858848false--12-312 years10.5http://fasb.org/srt/2025#ChiefExecutiveOfficerMember0001858848tnya:TwoThousandAndTwentyOneEquityIncentivePlanMember2024-12-310001858848tnya:SiliconValleyBankLoanAgreementMemberus-gaap:SubsequentEventMember2025-10-012025-10-310001858848tnya:OfficeAndLaboratorySpaceMembertnya:SouthSanFranciscoCaliforniaMember2024-06-012024-06-300001858848us-gaap:ResearchAndDevelopmentExpenseMember2025-01-012025-09-3000018588482025-04-012025-06-300001858848tnya:TwoThousandAndTwentyOneEquityIncentivePlanMember2025-09-300001858848us-gaap:AdditionalPaidInCapitalMember2024-09-300001858848tnya:OtherMember2025-07-012025-09-300001858848us-gaap:CommonStockMember2024-03-310001858848us-gaap:AdditionalPaidInCapitalMember2024-03-3100018588482023-12-310001858848tnya:OutstandingStockOptionsAndAwardsMember2025-09-3000018588482025-01-242025-01-240001858848srt:MinimumMember2025-01-012025-09-300001858848us-gaap:RetainedEarningsMember2025-07-012025-09-300001858848srt:MaximumMember2024-01-012024-09-300001858848us-gaap:RetainedEarningsMember2024-01-012024-03-310001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-03-310001858848us-gaap:CommonStockMember2025-04-012025-06-300001858848us-gaap:RetainedEarningsMember2024-04-012024-06-3000018588482025-11-040001858848tnya:AtTheMarketOfferingMember2025-01-012025-03-310001858848tnya:ClinicalMember2025-07-012025-09-300001858848us-gaap:RetainedEarningsMember2023-12-310001858848tnya:SiliconValleyBankLoanAgreementMember2024-08-0600018588482024-07-012024-09-300001858848tnya:FollowOnOfferingMembertnya:SeriesBWarrantMember2025-03-050001858848tnya:TwentyTwentyFourInducementEquityIncentivePlanMember2025-09-300001858848srt:MinimumMembertnya:WorkforceReductionMember2025-09-300001858848us-gaap:RestrictedStockMembertnya:TwoThousandAndTwentyOneEquityIncentivePlanMember2024-12-310001858848tnya:FollowOnOfferingMember2024-01-012024-03-310001858848us-gaap:FurnitureAndFixturesMember2025-09-300001858848us-gaap:ComputerEquipmentMember2024-12-310001858848tnya:FollowOnOfferingMember2025-01-012025-03-310001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-07-012025-09-300001858848us-gaap:CommonStockMember2024-06-300001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-09-3000018588482024-01-012024-03-310001858848us-gaap:CommonStockMember2024-09-300001858848us-gaap:LeaseholdImprovementsMember2024-12-310001858848us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMembertnya:UsTreasurySecuritiesNotIncludedWithCashAndCashEquivalentsMember2024-12-310001858848us-gaap:DebtInstrumentRedemptionPeriodThreeMembertnya:SiliconValleyBankLoanAgreementMember2024-08-062024-08-060001858848srt:ChiefExecutiveOfficerMember2025-02-062025-02-060001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-06-300001858848us-gaap:DebtInstrumentRedemptionPeriodFiveMembertnya:SiliconValleyBankLoanAgreementMember2024-08-062024-08-060001858848us-gaap:CommonStockMember2025-06-300001858848us-gaap:MoneyMarketFundsMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2025-09-300001858848tnya:SiliconValleyBankLoanAgreementMembertnya:LenderWarrantMember2025-09-300001858848us-gaap:AdditionalPaidInCapitalMember2024-04-012024-06-300001858848us-gaap:ConstructionInProgressMember2025-09-300001858848tnya:WorkforceReductionMember2024-05-140001858848tnya:SiliconValleyBankLoanAgreementMember2025-09-300001858848us-gaap:RetainedEarningsMember2024-07-012024-09-300001858848us-gaap:FairValueMeasurementsRecurringMember2024-12-310001858848tnya:SiliconValleyBankLoanAgreementMemberus-gaap:DebtInstrumentRedemptionPeriodOneMembertnya:LenderWarrantMember2024-01-012024-06-300001858848tnya:SharesAvailableForFurtherIssuanceUnderInducementPlanMember2025-09-300001858848us-gaap:RetainedEarningsMember2025-09-300001858848us-gaap:RetainedEarningsMember2024-03-3100018588482025-02-280001858848tnya:SiliconValleyBankLoanAgreementMembersrt:MaximumMembertnya:LenderWarrantMember2025-09-300001858848tnya:UnionCityCaliforniaMember2021-02-012021-02-280001858848tnya:OtherMember2024-07-012024-09-300001858848us-gaap:AdditionalPaidInCapitalMember2025-04-012025-06-300001858848us-gaap:AccountingStandardsUpdate202307Member2025-09-300001858848us-gaap:AdditionalPaidInCapitalMember2025-07-012025-09-300001858848tnya:OutstandingStockOptionsAndRestrictedStockUnitsMember2024-01-012024-09-300001858848tnya:SharesAvailableForFurtherIssuanceUnderThe2021EmployeeStockPurchasePlanMember2025-09-300001858848us-gaap:FurnitureAndFixturesMember2024-12-310001858848us-gaap:GeneralAndAdministrativeExpenseMember2025-07-012025-09-300001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-06-3000018588482024-12-310001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-03-310001858848us-gaap:RestrictedStockMembersrt:MinimumMember2025-01-012025-09-300001858848us-gaap:RetainedEarningsMember2024-12-310001858848tnya:FollowOnOfferingMember2025-03-050001858848us-gaap:DebtInstrumentRedemptionPeriodFourMembertnya:SiliconValleyBankLoanAgreementMember2024-08-062024-08-060001858848tnya:FollowOnOfferingMember2024-02-120001858848us-gaap:RestrictedStockMembertnya:TwoThousandAndTwentyOneEquityIncentivePlanMember2025-01-012025-09-300001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-12-310001858848tnya:SiliconValleyBankLoanAgreementMember2024-08-0600018588482025-01-012025-03-310001858848us-gaap:EquipmentMember2025-09-300001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-04-012025-06-300001858848tnya:FollowOnOfferingMember2024-02-122024-02-120001858848tnya:ClinicalMember2024-01-012024-09-300001858848us-gaap:AdditionalPaidInCapitalMember2024-12-310001858848tnya:OfficeAndLaboratorySpaceMembertnya:SouthSanFranciscoCaliforniaMember2025-01-012025-09-300001858848tnya:SiliconValleyBankLoanAgreementMember2025-09-300001858848us-gaap:FairValueInputsLevel2Memberus-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2024-12-310001858848tnya:OfficeAndLaboratorySpaceMembertnya:SouthSanFranciscoCaliforniaMember2016-12-310001858848tnya:OutstandingSeriesAAndBWarrantsMember2025-01-012025-09-300001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-12-3100018588482024-09-300001858848us-gaap:ResearchAndDevelopmentExpenseMember2025-07-012025-09-300001858848us-gaap:ComputerEquipmentMember2025-09-300001858848us-gaap:RetainedEarningsMember2025-04-012025-06-300001858848us-gaap:RetainedEarningsMember2024-09-3000018588482025-03-310001858848tnya:OutstandingSeriesAAndSeriesBWarrantsMember2025-09-300001858848tnya:FollowOnOfferingMembertnya:PreFundedWarrantMember2024-02-120001858848us-gaap:AdditionalPaidInCapitalMember2025-03-310001858848tnya:SiliconValleyBankLoanAgreementMember2024-08-062024-08-060001858848tnya:OutstandingLenderWarrantMember2024-01-012024-09-300001858848us-gaap:ResearchAndDevelopmentExpenseMember2024-07-012024-09-300001858848srt:MaximumMembertnya:WorkforceReductionMember2025-09-300001858848us-gaap:CommonStockMember2024-12-310001858848tnya:WorkforceReductionMember2025-09-300001858848us-gaap:ResearchAndDevelopmentExpenseMember2024-01-012024-09-300001858848us-gaap:ManufacturingFacilityMember2025-09-300001858848tnya:ManufacturingMember2024-01-012024-09-300001858848us-gaap:CommonStockMember2024-07-012024-09-300001858848tnya:FollowOnOfferingMembertnya:PreFundedWarrantMember2024-12-3100018588482025-06-3000018588482025-02-062025-02-060001858848tnya:FollowOnOfferingMembertnya:SeriesAWarrantMember2025-03-050001858848tnya:OutstandingLenderWarrantMember2025-01-012025-09-300001858848us-gaap:CommonStockMember2024-01-012024-03-310001858848tnya:ManufacturingMember2024-07-012024-09-300001858848tnya:ClinicalMember2024-07-012024-09-300001858848tnya:UnionCityCaliforniaMember2021-02-280001858848us-gaap:AdditionalPaidInCapitalMember2023-12-310001858848tnya:ManufacturingMember2025-07-012025-09-300001858848srt:MinimumMember2024-01-012024-09-300001858848us-gaap:RetainedEarningsMember2024-06-300001858848us-gaap:EquipmentMember2024-12-3100018588482025-09-300001858848tnya:SiliconValleyBankLoanAgreementMembertnya:LenderWarrantMember2024-06-300001858848us-gaap:RestrictedStockMembertnya:TwoThousandAndTwentyOneEquityIncentivePlanMember2025-09-300001858848us-gaap:RetainedEarningsMember2025-01-012025-03-310001858848us-gaap:EmployeeStockMember2025-09-300001858848us-gaap:CommonStockMember2025-03-310001858848us-gaap:MoneyMarketFundsMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-310001858848tnya:FollowOnOfferingMember2025-03-052025-03-0500018588482025-07-012025-09-3000018588482024-01-012024-09-300001858848us-gaap:AdditionalPaidInCapitalMember2025-09-300001858848tnya:OutstandingStockOptionsAndRestrictedStockUnitsMember2025-01-012025-09-300001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-07-012024-09-300001858848us-gaap:AdditionalPaidInCapitalMember2025-06-300001858848tnya:SharesAvailableForFurtherIssuanceUnderThe2021EquityIncentivePlanMember2025-09-300001858848tnya:FollowOnOfferingMember2025-01-012025-09-300001858848us-gaap:CommonStockMember2025-01-012025-03-310001858848us-gaap:DebtInstrumentRedemptionPeriodTwoMembertnya:SiliconValleyBankLoanAgreementMember2024-08-062024-08-060001858848tnya:WorkforceReductionMember2024-12-310001858848us-gaap:DebtInstrumentRedemptionPeriodOneMembertnya:SiliconValleyBankLoanAgreementMember2024-08-062024-08-060001858848tnya:ManufacturingMember2025-01-012025-09-300001858848us-gaap:FairValueMeasurementsRecurringMember2025-09-300001858848tnya:ClinicalMember2025-01-012025-09-300001858848us-gaap:GeneralAndAdministrativeExpenseMember2024-07-012024-09-300001858848srt:MinimumMembersrt:ChiefExecutiveOfficerMember2025-02-060001858848us-gaap:AdditionalPaidInCapitalMember2024-01-012024-03-310001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-09-300001858848tnya:AtTheMarketSalesAgreementMember2025-01-012025-01-310001858848tnya:OtherMember2024-01-012024-09-300001858848tnya:FollowOnOfferingMemberus-gaap:SubsequentEventMember2025-03-052025-10-310001858848us-gaap:RetainedEarningsMember2025-03-310001858848us-gaap:CommonStockMember2023-12-310001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-01-012024-03-310001858848tnya:FollowOnOfferingMember2024-01-012024-09-300001858848us-gaap:CommonStockMember2025-07-012025-09-3000018588482025-02-060001858848tnya:AtTheMarketOfferingMember2025-01-012025-09-300001858848us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember2024-12-310001858848us-gaap:CommonStockMember2024-04-012024-06-300001858848us-gaap:RetainedEarningsMember2025-06-300001858848srt:MaximumMember2025-01-012025-09-300001858848us-gaap:CommonStockMembertnya:AtTheMarketSalesAgreementMember2025-01-012025-01-310001858848us-gaap:AdditionalPaidInCapitalMember2024-06-300001858848us-gaap:EmployeeStockMember2021-07-3100018588482024-06-3000018588482024-03-310001858848tnya:LenderWarrantMember2025-09-300001858848tnya:AtTheMarketSalesAgreementMemberus-gaap:CommonStockMember2025-09-300001858848tnya:FollowOnOfferingMemberus-gaap:SubsequentEventMember2025-10-012025-10-310001858848us-gaap:CommonStockMembertnya:AtTheMarketSalesAgreementMember2022-08-102022-08-100001858848us-gaap:LeaseholdImprovementsMember2025-09-300001858848tnya:AtTheMarketOfferingMember2024-01-012024-09-300001858848tnya:OutstandingLenderWarrantMember2025-09-300001858848us-gaap:CommonStockMember2025-09-3000018588482025-01-012025-09-3000018588482024-04-012024-06-300001858848tnya:SiliconValleyBankLoanAgreementMembersrt:MaximumMember2025-09-300001858848us-gaap:EmployeeStockMember2025-01-012025-09-300001858848us-gaap:GeneralAndAdministrativeExpenseMember2025-01-012025-09-300001858848tnya:OtherMember2025-01-012025-09-300001858848tnya:TwoThousandAndTwentyOneEquityIncentivePlanMember2025-01-012025-09-300001858848us-gaap:ConstructionInProgressMember2024-12-310001858848us-gaap:AdditionalPaidInCapitalMember2024-07-012024-09-300001858848us-gaap:RestrictedStockMembersrt:MaximumMember2025-01-012025-09-300001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-04-012024-06-300001858848us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-01-012025-03-310001858848us-gaap:GeneralAndAdministrativeExpenseMember2024-01-012024-09-300001858848tnya:OfficeAndLaboratorySpaceMembertnya:SouthSanFranciscoCaliforniaMember2016-12-012016-12-310001858848us-gaap:AdditionalPaidInCapitalMember2025-01-012025-03-310001858848us-gaap:ManufacturingFacilityMember2024-12-31xbrli:purexbrli:sharestnya:Employeetnya:Optiontnya:Segmenttnya:RenewalOptioniso4217:USDiso4217:USDxbrli:shares

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to _________

Commission File Number: 001-40656

TENAYA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)


Delaware	81-3789973
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
171 Oyster Point Boulevard, Suite 500 South San Francisco, CA	94080
(Address of principal executive offices)	(Zip Code)

(650) 825-6990

(Registrant’s telephone number, including area code)

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 Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 4, 2025, the registrant had 166,505,885 shares of common stock, $0.0001 par value per share, outstanding.

Table of Contents


		Page
	PART I—FINANCIAL INFORMATION

Item 1.	Financial Statements (Unaudited)	5
	Condensed Balance Sheets as of September 30, 2025 and December 31, 2024	5
	Condensed Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2025 and 2024	6
	Condensed Statements of Stockholders’ Equity for the three and nine months ended September 30, 2025 and 2024	7
	Condensed Statements of Cash Flows for the nine months ended September 30, 2025 and 2024	9
	Notes to Unaudited Condensed Financial Statements	10
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	31
Item 4.	Controls and Procedures	31

	PART II—OTHER INFORMATION
Item 1.	Legal Proceedings	33
Item 1A.	Risk Factors	33
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	87
Item 3.	Defaults Upon Senior Securities	87
Item 4.	Mine Safety Disclosures	87
Item 5.	Other Information	87
Item 6.	Exhibits	88
SIGNATURES		89

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (Quarterly Report), contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, investors can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements include, but are not limited to, statements about:

•

our vision to change the treatment paradigm for heart disease;

•

the ability of our ongoing preclinical studies and ongoing or planned clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;

•

the timing, dosing, patient enrollment and populations, progress, and results of preclinical studies and ongoing or planned clinical trials for our current product candidates and other product candidates we may develop;

•

the timing, scope and likelihood of regulatory filings and approvals, including timing of investigational new drugs (INDs), clinical trial applications (CTAs), U.S. Food and Drug Administration (FDA) approvals, and final regulatory approval of our current product candidates and any other future product candidates;

•

our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical trials;

•

the impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business, including the development of our product candidates;

•

the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;

•

our manufacturing, commercialization, and marketing capabilities and strategy;

•

our competitive position and the success of competing therapies that are or may become available;

•

our plans relating to the further development of our product candidates, including additional indications and targets we may pursue and whether we out-license or partner with third parties to develop our product candidates;

•

the impact of existing laws and regulations and regulatory developments in the United States (U.S.), Europe and other jurisdictions;

•

our intellectual property position, including the scope and length of protection we are able to establish and maintain for intellectual property rights covering our current product candidates and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;

•

our continued reliance on third parties to conduct additional preclinical studies and clinical trials of our product candidates, and for the development and manufacture of our product candidates for preclinical studies and clinical trials;

•

our ability to obtain, and negotiate favorable terms of, any collaboration, partnership, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

•

the pricing and reimbursement of our current product candidates and other product candidates we may develop, if approved, including any increase in demand as a result of the availability of reimbursement from the government and third-party payors;

•

the rate and degree of market acceptance and clinical utility of our current product candidates and other product candidates we may develop;

•

our estimates regarding expenses, operating losses, future revenue, cash outlays, capital requirements and needs for additional financing, including expenses arising as a result of being a public company;

•

our financial performance;

•

our facilities;

•

the period over which we estimate our existing cash, cash equivalents and investments in marketable securities will be sufficient to fund our future operating expenses and capital expenditure requirements;

•

the impact of critical accounting policies on investor’s ability to understand our financial performance; and

•

our expectations regarding the period during which we will remain an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (JOBS Act).

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, investors should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.

In addition, statements such as “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements.

TENAYA THERAPEUTICS, INC.

Condensed Balance Sheets

(In thousands)

(Unaudited)


	September 30,			December 31,
	2025			2024
ASSETS
Current assets:
Cash and cash equivalents	$	56,312		$	4,323
Short-term investments in marketable securities		—			57,123
Prepaid expenses and other current assets		4,927			5,929
Total current assets		61,239			67,375
Property and equipment, net		29,440			35,858
Operating lease right-of-use assets		10,057			11,890
Other noncurrent assets		4,244			4,817
Total assets	$	104,980		$	119,940
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	2,843		$	5,162
Accrued and other current liabilities		7,441			8,035
Operating lease liabilities, current		2,926			2,778
Total current liabilities		13,210			15,975
Operating lease liabilities, noncurrent		8,601			10,830
Other noncurrent liabilities		301			281
Total liabilities		22,112			27,086
Commitments and contingencies (Note 4)
Stockholders’ equity:
Common stock		16			8
Additional paid-in capital		667,685			607,229
Accumulated other comprehensive income (loss)		—			28
Accumulated deficit		(584,833	)		(514,411	)
Total stockholders’ equity		82,868			92,854
Total liabilities and stockholders’ equity	$	104,980		$	119,940

TENAYA THERAPEUTICS, INC.

Condensed Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Operating expenses:
Research and development	$	15,363		$	20,350		$	53,809		$	68,054
General and administrative		5,573			6,361			18,747			23,242
Total operating expenses		20,936			26,711			72,556			91,296
Loss from operations		(20,936	)		(26,711	)		(72,556	)		(91,296	)
Other income, net:
Interest income		658			1,080			2,107			3,925
Other income (loss), net		3			(3	)		27			78
Total other income, net		661			1,077			2,134			4,003
Net loss before income tax expense		(20,275	)		(25,634	)		(70,422	)		(87,293	)
Income tax expense		—			—			—			—
Net loss		(20,275	)		(25,634	)		(70,422	)		(87,293	)
Other comprehensive loss:
Net unrealized gain (loss) on marketable securities		1			143			(28	)		182
Comprehensive loss	$	(20,274	)	$	(25,491	)	$	(70,450	)	$	(87,111	)
Net loss per share, basic and diluted	$	(0.12	)	$	(0.30	)	$	(0.48	)	$	(1.04	)
Weighted-average shares used in computing net loss per share, basic and diluted		163,345,972			86,162,841			145,531,495			84,290,747

TENAYA THERAPEUTICS, INC.

Condensed Statements of Stockholders’ Equity

(In thousands, except share data)

(Unaudited)


	Common Stock				Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Capital		Loss			Deficit			Equity
Balance as of January 1, 2025		86,542,340	$	8	$	607,229	$	28		$	(514,411	)	$	92,854
Issuance of common stock and warrants in follow-on offering, net of issuance costs of $3,699		75,000,000		8		48,793		—			—			48,801
Issuance of common stock upon vesting of restricted stock units		295,191		—		—		—			—			—
Issuance of common stock in connection with at-the market sales, net of issuance costs of $280		822,566		—		912		—			—			912
Stock-based compensation		—		—		3,731		—			—			3,731
Other comprehensive loss		—		—		—		(38	)		—			(38	)
Net loss		—		—		—					(26,864	)		(26,864	)
Balance as of March 31, 2025		162,660,097	$	16	$	660,665	$	(10	)	$	(541,275	)	$	119,396
Issuance of common stock pursuant to employee stock purchase plan		119,998		—		70		—			—			70
Issuance of common stock upon vesting of restricted stock units		196,007		—		—		—			—			—
Stock-based compensation		—		—		3,636		—			—			3,636
Other comprehensive income		—		—		—		9			—			9
Net loss		—		—		—		—			(23,283	)		(23,283	)
Balance as of June 30, 2025		162,976,102	$	16	$	664,371	$	(1	)	$	(564,558	)	$	99,828
Issuance of common stock upon exercise of stock options and vesting of restricted stock units		260,933		—		24		—			—			24
Issuance of common stock upon exercise of warrants		507,500		—		356		—			—			356
Stock-based compensation		—		—		2,934		—			—			2,934
Other comprehensive income		—		—		—		1			—			1
Net loss		—		—		—		—			(20,275	)		(20,275	)
Balance as of September 30, 2025		163,744,535	$	16	$	667,685	$	—		$	(584,833	)	$	82,868


	Common Stock				Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Capital		Income (Loss)			Deficit			Equity
Balance as of January 1, 2024		68,330,342	$	7	$	542,805	$	(106	)	$	(403,282	)	$	139,424
Issuance of common stock and pre-funded warrants, net of issuance costs of $3,236		8,888,890		1		46,761								46,762
Issuance of common stock upon exercise of stock options and vesting of restricted stock units		246,708		—		11		—			—			11
Issuance of common stock upon exercise of pre-funded warrants		1,051,594		—		1		—			—			1
Stock-based compensation		—		—		4,224		—			—			4,224
Other comprehensive loss		—		—		—		(14	)		—			(14	)
Net loss		—		—		—		—			(32,228	)		(32,228	)
Balance as of March 31, 2024		78,517,534	$	8	$	593,802	$	(120	)	$	(435,510	)	$	158,180
Issuance of common stock pursuant to employee stock purchase plan		320,951		—		554		—			—			554
Issuance of common stock upon exercise of stock options and vesting of restricted stock units		28,952		—		30		—			—			30
Stock-based compensation		—		—		4,611		—			—			4,611
Other comprehensive income		—		—		—		53			—			53
Net loss		—		—		—		—			(29,431	)		(29,431	)
Balance as of June 30, 2024		78,867,437	$	8	$	598,997	$	(67	)	$	(464,941	)	$	133,997
Issuance of common stock upon exercise of stock options and vesting of restricted stock units		353,079		—		14		—			—			14
Issuance of warrant		—		—		175		—			—			175
Stock-based compensation		—		—		3,907		—			—			3,907
Other comprehensive income		—		—		—		143			—			143
Net loss		—		—		—		—			(25,634	)		(25,634	)
Balance as of September 30, 2024		79,220,516	$	8	$	603,093	$	76		$	(490,575	)	$	112,602

TENAYA THERAPEUTICS, INC.

Condensed Statements of Cash Flows

(In thousands)

(Unaudited)


	Nine Months Ended September 30,
	2025			2024
Cash flows from operating activities:
Net loss	$	(70,422	)	$	(87,293	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		6,609			6,379
Amortization (accretion) of premium (discount) on marketable securities		411			56
Stock-based compensation		10,301			12,742
Non-cash operating lease expense		1,833			2,655
Other		293			243
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		714			1,026
Other noncurrent assets		573			600
Accounts payable		(1,961	)		120
Accrued and other current liabilities		(594	)		(5,453	)
Operating lease liabilities		(2,081	)		(3,188	)
Net cash used in operating activities		(54,324	)		(72,113	)
Cash flows from investing activities:
Purchases of property and equipment		(551	)		(821	)
Purchases of marketable securities		—			(85,058	)
Proceeds from sales of marketable securities		10,958			—
Proceeds from maturities of marketable securities		45,743			72,890
Other		—			17
Net cash provided by (used in) investing activities		56,150			(12,972	)
Cash flows from financing activities:
Proceeds from issuance of common stock, pre-funded warrants, and warrants in follow-on offering, net of issuance costs		48,801			46,762
Proceeds from exercise of stock options and employee stock purchase plan		94			609
Proceeds from exercise of warrants		356			—
Proceeds from exercise of prefunded warrants		—			1
Proceeds from at-the-market sales, net of issuance costs		912			—
Net cash provided by financing activities		50,163			47,372
Net change in cash, cash equivalents and restricted cash		51,989			(37,713	)
Cash and cash equivalents and restricted cash at beginning of period		4,742			46,363
Cash and cash equivalents and restricted cash at end of period	$	56,731		$	8,650
Components of cash, cash equivalents and restricted cash:
Cash and cash equivalents	$	56,312		$	8,231
Restricted cash included in other noncurrent assets		419			419
Cash, cash equivalents and restricted cash	$	56,731		$	8,650
Supplemental disclosure of non-cash investing and financing activities:
Property and equipment included in accounts payable and accrued and other current liabilities	$	—		$	334
Issuance of warrant in connection with Loan Agreement	$	—		$	175

TENAYA THERAPEUTICS, INC.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

Organization and Description of the Business

Description of the Business

Tenaya Therapeutics, Inc. (the Company) was incorporated in the state of Delaware in August 2016 and is headquartered in South San Francisco, California. The Company is a clinical-stage biotechnology company focused on discovering, developing and delivering curative therapies that address the underlying drivers of heart disease. The Company’s lead product candidates include TN-201, a gene therapy for myosin binding protein C3-associated hypertrophic cardiomyopathy, TN-401, a gene therapy for plakophilin 2-associated arrhythmogenic right ventricular cardiomyopathy, and TN-301, a small molecule for heart failure with preserved ejection fraction.

Liquidity

The Company has incurred net losses since inception and expects such losses to continue in the future as it conducts research and development activities. As of September 30, 2025, the Company had an accumulated deficit of $584.8 million. The Company incurred a net loss of $70.4 million and $87.3 million during the nine months ended September 30, 2025 and 2024, respectively. The Company had $56.3 million of cash, cash equivalents and investments in marketable securities as of September 30, 2025.

On August 6, 2024, the Company entered into a Loan Agreement with Silicon Valley Bank (SVB), a division of First-Citizens Bank & Trust Company (the Loan Agreement). As of September 30, 2025, under the Loan Agreement, the Company has the right to draw down $10.0 million at its discretion until December 31, 2025, and up to an additional $20.0 million that may be available at SVB's discretion, subject to specified conditions. See Note 6, Term Loan, for further details.

On March 5, 2025, the Company completed an underwritten offering of its common stock and accompanying warrants. The Company received net proceeds of approximately $48.8 million, after deducting underwriting discounts and commissions of approximately $3.2 million and other offering expenses of approximately $0.5 million. See Note 7, Stockholders' Equity, for further details. Subsequently, the Company issued an aggregate of 3,268,750 shares of its common stock upon the cash exercise of warrants issued in the underwritten offering for aggregate proceeds of approximately $2.3 million, including $1.9 million in October 2025. See Note 7, Stockholders' Equity, for further details on Company's warrants.

In March 2025, the Company announced cost containment measures, including a committed plan to reduce its workforce (the 2025 Workforce Reduction), in alignment with its focus on generating data from the clinical trials of TN-201 and TN-401. See Note 11, Workforce Reduction, for further details.

The Company believes that savings from these measures and future cost containment initiatives to be taken as necessary, combined with existing cash, cash equivalents and short-term investments as of September 30, 2025, along with the $10.0 million of funds available under its Loan Agreement with SVB, and the $1.9 million of proceeds from warrant exercises in October 2025, will be sufficient to fund the Company’s operations for at least the next twelve months following the date these condensed financial statements are filed with the Securities and Exchange Commission (SEC). Management also recognizes the need to raise additional capital to fully implement the Company's business plan. The Company may seek to raise capital through equity financings, debt financings, license agreements, collaborative agreements or other sources of financing. There is no assurance, however, that any additional financing or any revenue-generating license or collaboration will be available when needed or that the Company will be able to obtain financing or enter into a license or collaboration on terms acceptable to the Company, or at all. The condensed financial statements do not reflect any adjustments relating to the outcome of this uncertainty.

Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and follow the requirements of the SEC for

interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted.

The interim condensed balance sheet as of September 30, 2025, the interim condensed statements of operations and comprehensive loss, stockholders’ equity and cash flows for the nine months ended September 30, 2025 and 2024 are unaudited. These unaudited interim condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and reflect all adjustments that are necessary for the fair statement of the Company’s financial position, results of operations and cash flows for the interim periods presented. The condensed results of operations for the nine months ended September 30, 2025, are not necessarily indicative of the results to be expected for the full year or for any other future annual or interim period. The condensed balance sheet as of December 31, 2024, included herein was derived from the audited financial statements as of that date. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and the related notes thereto for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 10, 2025.

Use of Estimates

The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to, accrued expenses related to research and development activities. The Company bases its estimates on historical experience, the current economic environment, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions.

Significant Accounting Policies

There have been no material revisions to the Company’s significant accounting policies described in Note 2, Summary of Significant Accounting Policies, to the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

CIRM Grant

In February 2025, the Company announced it was awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical trial of TN-401. The award is payable to the Company upon achievement of certain clinical milestones. Additionally, if CIRM determines, in its sole discretion, that the Company has not complied with the terms and conditions of the grant, CIRM may suspend or permanently cease disbursements. Funds received under this grant may only be used for allowable project costs specifically identified with the CIRM-funded project. Such costs can include, but are not limited to, salary for personnel, itemized supplies, consultants, and itemized clinical study costs. Under the terms of the grant, the Company will co-fund the research project with CIRM and the amount of the Company's co-funding requirement is predetermined as a part of the award. The Company accounts for the grant under Accounting Standards Codification (ASC) 450-30, Gain Contingencies, and records the funds against the research and development expenses as the milestones are achieved. For the nine months ended September 30, 2025, the Company recognized $1.5 million in connection with the grant.

Recently Adopted Accounting Standards

In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update (ASU) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. In addition, ASU 2023-07 enhances interim disclosure requirements, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, provides new segment disclosure requirements for entities with a single reportable segment, and contains other disclosure requirements. ASU 2023-07 is effective for annual periods beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The adoption of ASU 2023-07 did not have any effect on the Company's financial

statements. See Note 12, Segment Reporting to our financial statements for the disclosure pursuant to the adoption of ASU 2023-07.

Recently Issued Accounting Pronouncements Not Yet Adopted

In July 2025, the FASB issued ASU No. 2025-05, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets (ASU 2025-05), which provides a practical expedient for entities to estimate expected credit losses on current accounts receivable and current contract assets arising from revenue transactions accounted for under ASC 606. ASU 2025-05 is effective for the Company for annual periods beginning after December 15, 2025, and interim periods within those annual periods. Early adoption is permitted. The Company is evaluating the impact of this standard on its financial statements and related disclosures.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement (Topic 220): Reporting Comprehensive Income - Expense Disaggregation Disclosures, Disaggregation of Income Statement Expenses (ASU 2024-03), which requires public companies to disclose, in interim and annual reporting periods, additional information about certain expenses in the financial statements. The amendments in this ASU will be effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is evaluating the impact of this standard on its financial statements and related disclosures.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. The Company is evaluating the impact of this standard on its financial statements and related disclosures.

Balance Sheet Components

Property and Equipment, Net

Property and equipment, net consists of the following:


	September 30,			December 31,
	2025			2024
	(In thousands)
Leasehold improvements	$	26,217		$	26,159
Laboratory equipment		19,845			19,770
Manufacturing equipment		19,485			17,738
Construction in progress		—			1,915
Computer equipment and software		1,874			1,664
Furniture and fixtures		902			902
Total property and equipment	$	68,323		$	68,148
Less: accumulated depreciation and amortization		(38,883	)		(32,290	)
Total property and equipment, net	$	29,440		$	35,858

Depreciation and amortization expense for the three months ended September 30, 2025 and 2024 was $1.9 million and $2.1 million, respectively. Depreciation and amortization expense for the nine months ended September 30, 2025 and 2024 was $6.6 and $6.4 million, respectively.

Accrued and Other Current Liabilities

Accrued and other current liabilities consist of the following:


	September 30,		December 31,
	2025		2024
	(In thousands)
Accrued compensation and related expenses	$	4,893	$	5,595
Accrued research and development expenses		1,831		1,446
Accrued professional services		382		432
Accrued taxes		149		348
Other current liabilities		186		214
Total accrued and other current liabilities	$	7,441	$	8,035

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following:


	September 30,		December 31,
	2025		2024
	(In thousands)
Prepaid expenses	$	3,937	$	5,087
Other current assets		990		842
Total prepaid expenses and other current assets	$	4,927	$	5,929

Commitments and Contingencies

Facility Leases

In December 2016, the Company entered into a lease agreement for office and laboratory space in South San Francisco, California. The lease was initially set to expire in May 2025 with two five-year renewal options. In June 2024, the Company amended the lease to extend the term to November 2027. Pursuant to the terms of the amended lease, the Company has one remaining five-year renewal option.

In February 2021, the Company entered into a lease agreement for office and manufacturing space in Union City, California. The lease commenced in May 2021 and has a ten-year term with one five-year renewal option.

Information related to operating lease activity during the three and nine months ended September 30, 2025 was as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
	(In thousands)
Operating lease cost	$	889	$	1,356	$	2,667	$	3,506
Variable lease cost		410		377		1,043		1,079
Total lease cost	$	1,299	$	1,733	$	3,710	$	4,585

Operating lease right-of-use assets obtained in exchange for lease obligations					$	—	$	5,302
Cash paid for amounts included in the measurement of lease liabilities					$	2,914	$	4,039

As of September 30, 2025, the Company’s operating leases had a weighted average remaining lease term of 4.2 years and a weighted average discount rate of 9.0%. As of December 31, 2024, the Company’s operating leases

had a weighted average remaining lease term of 4.8 years and a weighted average discount rate of 8.9%. Future minimum lease payments under the Company’s operating leases as of September 30, 2025 were as follows:


	Amount
	(In thousands)
2025 (three months remaining)	$	947
2026		3,864
2027		3,775
2028		1,471
2029		1,515
Thereafter		2,491
Total undiscounted future minimum lease payments	$	14,063
Imputed interest		(2,536	)
Total operating lease liabilities	$	11,527

Purchase Commitments

The Company enters into contractual agreements with various suppliers in the normal course of its business, including vendors that provide machinery and equipment. All contracts are terminable, with varying provisions regarding termination. In general, if a contract with a specific vendor were to be terminated, the Company would only be obligated for the products or services that the Company had received up to the time of termination.

Indemnification

From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the financial statements indicates that it is probable that a liability had been incurred at the date of the financial statements and (ii) the range of loss can be reasonably estimated. The Company was not involved in any material litigation as of September 30, 2025 and December 31, 2024.

In the normal course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amounts of future payments the Company could be required to make under these provisions is not determinable. In addition, the Company has entered into indemnification agreements with its directors and certain officers that may require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. As of September 30, 2025 and December 31, 2024, the Company did not have any material indemnification claims that were probable or reasonably possible and, consequently, has not recorded any related liabilities.

Stock-Based Compensation

2024 Inducement Equity Incentive Plan

In September 2024, the Board of Directors (the Board) adopted the Company's 2024 Inducement Equity Incentive Plan (the Inducement Plan), and subject to the adjustment provisions of the Inducement Plan, reserved 1,200,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Plan. The Inducement Plan allows the Company to make equity awards to prospective employees of the Company as an inducement to such individual’s commencement of employment with the Company.

Total shares reserved and available for grant under the Inducement Plan as of September 30, 2025, are 525,000.

2021 Equity Incentive Plan

Under the Company’s 2021 Equity Incentive Plan (the 2021 Plan), 4,000,000 shares of the Company’s common stock were initially reserved for issuance of equity awards to employees, directors, and consultants, under

terms and provisions established by the Board. The number of shares of common stock available for issuance under the 2021 Plan automatically increases on the first day of January for a period of ten years, commencing on January 1, 2022, in an amount equal to the lesser of: 4,000,000 shares; 4% of the outstanding shares of the Company’s common stock as of the last day of the immediately preceding year; or such other amount as the board of directors may determine.

The total number of shares reserved and available for grant under the 2021 Plan as of September 30, 2025 is 1,785,929.

Repricing

On January 22, 2025, the Compensation Committee of the Company's Board approved a repricing of certain outstanding vested and unvested stock option awards under the Amended and Restated 2016 Equity Incentive Plan (the 2016 Plan) and 2021 Plan for eligible employees and certain other service providers (the Repricing Participants). The per share exercise price of eligible stock option awards was reduced to $1.21, the closing price of the Company's common stock on January 24, 2025 (the Repricing Effective Date). To receive the benefit of the repricing, Repricing Participants were required to remain a Service Provider (as such term is defined in the 2016 Plan or 2021 Plan) through the period (the Retention Period) that began on the Repricing Effective Date and ended on July 24, 2025 (the Retention Date) and not exercise any of their repriced stock options prior to the Retention Date. Option holders who exercised their repriced stock options prior to the Retention Date were required to pay the original exercise price per share of such repriced options. No other changes were made to the terms and conditions of the eligible stock option awards. The stock option repricing impacted 4.1 million stock option awards and affected 89 employees and service providers.

On February 6, 2025, the Company's Board approved an option repricing applicable to Faraz Ali, the Company's Chief Executive Officer, with terms mirroring the aforementioned repricing approved on January 22, 2025, except that for Mr. Ali, the options eligible for repricing were limited to options with exercise prices higher than $5.25 per share. The total number of shares underlying Mr. Ali’s repriced options was 915,875 shares.

The repricing resulted in a total incremental stock-based compensation expense of $1.3 million, which was calculated using the Black-Scholes option pricing model, of which $1.0 million is associated with vested repriced options as of the Retention Date and were recognized on a straight-line basis over the Retention Period. The remaining $0.3 million of the incremental stock-based compensation expense is associated with unvested repriced options beyond the Retention Period and will be recognized on a straight-line basis over the remaining original vesting periods. For the nine months ended September 30, 2025, the Company recognized $1.0 million of incremental stock-based compensation expense.

Stock Option Activity

The following table summarizes stock option activity:


	Shares			Weighted Average Exercise Price
				(in dollars)
Outstanding as of December 31, 2024		9,253,976		$	6.51
Granted		3,829,175		$	0.90
Exercised		(20,095	)	$	1.21
Cancelled		(814,142	)	$	5.78
Outstanding as of September 30, 2025		12,248,914		$	1.93

The weighted average exercise price of options outstanding as of September 30, 2025 includes the effect of repricing.

Stock option awards granted to employees generally vest over a four-year period. The contractual term of stock option awards is generally 10 years from the grant date.

Stock Option Valuation

The fair value of the Company’s stock option awards is estimated on the date of grant using the Black-Scholes option pricing model using the following assumptions:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2025	2024	2025	2024
Expected term (in years)	6.1	N/A	5.5 – 6.1	6.0 – 6.1
Expected volatility	90%	N/A	87% – 91%	92% – 93%
Risk-free interest rate	3.7%	N/A	3.7% – 4.5%	3.9% – 4.5%
Expected dividend yield	—%	N/A	—%	—%

N/A - not applicable as no stock option awards were granted in the period presented.

Restricted Stock Units

Restricted stock units (RSUs) are awards that entitle the holder to receive freely tradable shares of the Company’s common stock upon the completion of a specific period of continued service. RSUs generally vest over a two to four year period and are subject to forfeiture if employment terminates prior to the release of vesting restrictions. RSUs are valued at the market price of the underlying common stock on the date of grant. The Company recognizes noncash compensation expense for the fair value of RSUs on a straight-line basis over the requisite service period of the awards. The following table summarizes activity of RSUs granted to employees with service-based vesting under the 2021 Plan.


	Shares			Weighted Average Grant Date Fair Value per Share
				(in dollars)
Unvested as of December 31, 2024		1,354,178		$	4.14
Granted		1,497,678		$	1.17
Vested		(732,036	)	$	3.05
Forfeited		(382,553	)	$	2.75
Unvested as of September 30, 2025		1,737,267		$	2.34

2021 Employee Stock Purchase Plan

Under the Company's 2021 Employee Stock Purchase Plan (the ESPP), the Company initially reserved 800,000 shares for future issuance. The number of shares of common stock available for issuance under the ESPP automatically increases on the first day of each fiscal year for a period of ten years beginning with 2022 in an amount equal to the lesser of: 800,000 shares; 1% of the outstanding shares of the Company’s common stock as of the last day of the immediately preceding year; or such other amount as the Board may determine. As of September 30, 2025, 2,345,079 shares were reserved for future issuance under the ESPP. Under the Company’s ESPP, employees are generally eligible to participate and can purchase shares on each purchase date established semi-annually through payroll deductions at the lower of 85% of the fair market value of the Company’s stock at the commencement of the offering period or each purchase date of the offering period. Each offering period spans 6 months. The ESPP permits eligible employees to purchase common stock through payroll deductions for up to 15%

of qualified compensation, up to an annual limit of $25,000 per the Internal Revenue Service. For the nine months ended September 30, 2025 and 2024, the stock-based compensation expense for ESPP was not material.

Stock-Based Compensation

The following table summarizes stock-based compensation recognized in the Company’s condensed statements of operations and comprehensive loss:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
Research and development	$	1,485	$	2,048	$	5,405	$	6,283
General and administrative		1,449		1,859		4,896		6,459
Total stock-based compensation	$	2,934	$	3,907	$	10,301	$	12,742

Term Loan

Loan Agreement

On August 6, 2024, the Company entered into the Loan Agreement with SVB. Pursuant to the terms of the Loan Agreement, term loans in an aggregate principal amount of up to $45.0 million may be made under multiple tranches. The tranches can be drawn as follows: the first tranche of up to $15.0 million became available on the closing date but expired on June 30, 2025; the second, third, and fourth tranches, in amounts of $5.0 million, $2.5 million, and $2.5 million, respectively, became available in October 2024, December 2024, and September 2025, respectively, upon the achievement of certain clinical milestones and are available for draw down through December 31, 2025; and the final tranche of $20.0 million may be available for draw down through July 31, 2026, on such terms as may be agreed by the parties and subject to approval by SVB's credit committee and subject to SVB's discretion. With the exception of the final tranche, and subject to achievement of the applicable milestones and other requirements with respect to each tranche, draw downs are at the Company's election. As of September 30, 2025, the Company has not drawn any funds under the Loan Agreement.

Interest will accrue on the term loan advances at a rate per annum that is equal to the greater of 8.50% and the prime rate and will be payable monthly in arrears. Principal payments on any term loan advances that are borrowed would commence on January 1, 2026, subject to extension to July 1, 2026, upon the satisfaction of certain milestones.

As security for its obligations under the Loan Agreement, the Company granted SVB a security interest in substantially all of the assets of the Company, other than its intellectual property.

Stockholders' Equity

Lender Warrant

In connection with the Loan Agreement, the Company issued to SVB a warrant to purchase up to 171,848 shares of our common stock (the Lender Warrant). The Lender Warrant became exercisable for 73,649 shares upon closing (the Initial Lender Warrant), which represented 0.075% of the Company's common stock and common stock equivalents outstanding as of the day before the closing, on a fully-diluted basis, at an exercise price of $2.55 per share. The Initial Lender Warrant was classified as equity and its fair value was recorded in the stockholders’ equity section of the balance sheet. On June 30, 2025, following the expiration of the first tranche of $15.0 million, 49,099 shares subject to the Lender Warrant became unexercisable. The Lender Warrant will become exercisable for up to an additional 49,100 shares pro-rated based on amounts actually advanced for the various tranches under the Loan Agreement (the Remaining Lender Warrant). The Remaining Lender Warrant under the Loan Agreement is considered an outstanding instrument upon closing of the Loan Agreement for accounting purposes. In accordance with ASC 815-40, Derivatives and Hedging - Contracts in Entity's Own Equity, the Remaining Lender Warrant is recognized at its fair value as a warrant liability given the variable settlement amount of the warrant shares and included in other non-current liabilities within the condensed balance sheets. The Lender Warrant expires on August 6, 2034.

“At-the-Market” Equity Offering

On August 10, 2022, the Company entered into a sales agreement (the Sales Agreement) with Leerink Partners LLC to establish an “at-the-market” (ATM) offering defined in Rule 415 under the Securities Act. Pursuant to the Sales Agreement, the Company is permitted to offer and sell, from time to time, shares of its common stock having a maximum aggregate offering price of up to $75.0 million. In January 2025, the Company sold 822,566 shares of our common stock under the ATM offering for net proceeds of $0.9 million, after deducting commissions and offering costs of $0.3 million. As of September 30, 2025, the Company may issue and sell up to approximately $69.8 million of common stock under the ATM offering.

Follow-On Offering

On March 5, 2025, the Company completed an underwritten public offering of 75,000,000 units, priced at a public offering price of $0.70 per unit, with each unit consisting of one share of its common stock, a warrant to purchase one share of its common stock at an exercise price of $0.80 per share, which will be immediately exercisable and will expire five years from the date of issuance (a Series A Warrant) and a warrant to purchase one-half of a share of its common stock at an exercise price of $0.70 per share, which will be immediately exercisable and expire on June 30, 2026 (a Series B Warrant), under its registration statement on Form S-3 (File No. 333-266741). The Company received net proceeds of approximately $48.8 million, after deducting underwriting discounts and commissions of approximately $3.2 million and other offering expenses of approximately $0.5 million.

The Company analyzed the Series A and Series B Warrants under ASC 480, Distinguishing Liabilities from Equity, and ASC 815-40, Derivatives and Hedging - Contracts in Entity's Own Equity, and concluded that the Series A and Series B Warrants are not liabilities, are indexed to its own stock and meet all other conditions for equity classification. Accordingly, the Company has classified the Series A and Series B Warrants as permanent equity.

On February 12, 2024, the Company completed an underwritten offering of 8,888,890 shares of its common stock at a price of $4.50 per share and, to an investor in lieu of common stock, pre-funded warrants to purchase 2,222,271 shares of its common stock at a price of $4.499 per pre-funded warrant. The Company received net proceeds of approximately $46.8 million, after deducting underwriting discounts and commissions of approximately $3.0 million and offering expenses of $0.2 million. As of December 31, 2024, all pre-funded warrants have been exercised for an exercise price of $0.001 per share.

As of September 30, 2025, total shares of common stock reserved for issuance, on an as-if converted basis, are as follows:


	September 30, 2025
Outstanding stock options and awards		13,986,181
Outstanding Lender Warrant		122,749
Outstanding Series A and Series B Warrants		111,992,500
Shares available for further issuance under the 2024 Inducement Equity Incentive Plan		525,000
Shares available for further issuance under the 2021 Equity Incentive Plan		1,785,929
Shares available for further issuance under the 2021 Employee Stock Purchase Plan		2,345,079
Total		130,757,438

Fair Value Measurements

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:

Level 1 - Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.

Level 2 - Inputs other than quoted market prices included in Level 1 are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.

Level 3 - Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.

The following tables summarize the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy:


		September 30, 2025
	Valuation Hierarchy	Amortized Cost		Unrealized Gain		Unrealized Loss		Fair Value
		(In thousands)
Assets:
Cash equivalents:
Money market funds	Level 1	$	53,465	$	—	$	—	$	53,465
Total financial assets		$	53,465	$	—	$	—	$	53,465


		December 31, 2024
	Valuation Hierarchy	Amortized Cost		Unrealized Gain		Unrealized Loss			Fair Value
		(In thousands)
Assets:
Cash equivalents:
Money market funds	Level 1	$	1,289	$	—	$	—		$	1,289
Marketable securities:
U.S. treasuries	Level 1		49,135		28		(12	)		49,151
Commercial paper	Level 2		3,974		3		—			3,977
Government agencies bonds	Level 2		3,987		8		—			3,995
Total financial assets		$	58,385	$	39	$	(12	)	$	58,412

Money market funds and U.S. treasury securities are classified as Level 1 because they are valued using quoted market prices in active markets for identical assets. Financial instruments classified within Level 2 of the fair value hierarchy are valued based on observable inputs or can be derived from non-binding quotes from the Company’s investment managers, which are based on proprietary valuation models of independent pricing services. These models generally use inputs such as observable market data, quoted market prices for similar instruments, or historical pricing trends of a security relative to its peers.

The Company believes it is more likely than not that its marketable securities in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. To date, the Company has not recorded any allowance for credit losses on its investment securities. Based upon its quarterly impairment review, the Company determined that the unrealized losses were not attributed to credit risk but were primarily driven by the broader change in interest rates.

The Company's financial liability measured at fair value on a recurring basis consists of the Remaining Lender Warrant issued in connection with the Loan Agreement (see Note 7, Stockholders' Equity). The fair value of the warrant liability was determined based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The Company utilized the Black-Scholes option valuation model to fair value the warrant liability. The fair value is estimated using the Black-Scholes option-pricing model and adjusted for the likelihood of draw downs. The expected term is based on the remaining contractual term of the warrant. The Company estimates its expected stock volatility based on the historical volatility of a set of peer companies, which are publicly traded, and expects to continue to do so until it has adequate historical data regarding the volatility of its own publicly-traded stock price. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of measurement for time periods approximately equal to the expected term of the Lender Warrant. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash dividends and does not expect to pay cash dividends in the foreseeable future. The warrant

liability is subject to re-measurement at each balance sheet date, and any change in fair value is recognized as a gain or loss in our statement of operations and comprehensive loss. During the three and nine months ended September 30, 2025, the fair value of the warrant liability and its change were not material.

The carrying amount of the Company’s remaining financial assets and liabilities, which include cash, receivables and payables, approximate their fair values due to their short-term nature.

Income Taxes

For the nine months ended September 30, 2025 and 2024, the Company did not record any income tax expense or benefit. The Company has recorded a full valuation allowance against its U.S. federal and state deferred tax assets as the Company believes it is more likely than not that the benefit will not be realized.

10.

Net Loss Per Share

Basic and diluted loss per share are computed by dividing net loss by the weighted-average number of common shares outstanding during the reporting period. The following potentially dilutive securities were not included in the calculation of diluted net loss per share as of the periods presented because the effect would have been anti-dilutive:


	September 30,
	2025		2024
Outstanding stock options and restricted stock units		13,986,181		11,146,572
Outstanding Lender Warrant		122,749		171,848
Outstanding Series A and B Warrants		111,992,500		—
Total		126,101,430		11,318,420

11.

Workforce Reduction

In March 2025, the Company announced cost containment measures, including a committed plan to reduce its workforce (the 2025 Workforce Reduction), in alignment with the Company's focus on generating data from the MyPEAKTM-1 and RIDGETM-1 clinical trials of TN-201 and TN-401, respectively. In connection with the 2025 Workforce Reduction, the Company estimated that it would incur approximately $1.6 million to $2.7 million of aggregate charges, primarily related to employee cash severance and continuing health benefits. During the nine months ended September 30, 2025, the Company recognized $1.2 million of the total estimated charges. The Company expects to recognize substantially all of the remaining charges by the end of the first quarter of 2026.

On May 14, 2024, the Company announced cost containment measures, including a committed plan to reduce its workforce (the 2024 Workforce Reduction) by approximately 22%. The cost containment measures align with the Company's focus on generating data from its clinical-stage gene therapy programs. The 2024 Workforce Reduction was completed as of September 30, 2024. During the year ended December 31, 2024, the Company recognized $1.4 million of aggregate charges, primarily related to employee cash severance and continuing health insurance benefits.

12.

Segment Reporting

The Company is a clinical-stage biotechnology company focused on discovering, developing and delivering curative therapies that address the underlying drivers of heart disease and has one operating and reportable segment. The Company’s chief operating decision maker (CODM) is the chief executive officer.

The statement of operations includes research and development expenses, general and administrative costs, interest income, and income taxes; the Company has not generated any revenue. In addition to reviewing the expenses in the Company’s statement of operations, the CODM is regularly provided with operating expenses by function. The CODM does not review assets at a different asset level or category than the amounts disclosed in the Company’s balance sheet. The Company’s long-lived assets are located in the United States.

The following table provides information about the Company’s operating expenses by function and includes a reconciliation to net loss.


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Operating expenses:
Research and development
Clinical	$	4,065		$	6,307		$	15,410		$	20,629
Research		3,579			5,158			13,681			16,306
Manufacturing (pre-commercial)		4,107			5,139			13,631			18,323
Other		3,612			3,746			11,087			12,796
Total Research and development	$	15,363		$	20,350		$	53,809		$	68,054
General and administrative		5,573			6,361			18,747			23,242
Total operating expenses		20,936			26,711			72,556			91,296
Loss from operations		(20,936	)		(26,711	)		(72,556	)		(91,296	)
Other income, net:
Interest income		658			1,080			2,107			3,925
Other income (loss), net		3			(3	)		27			78
Total other income, net		661			1,077			2,134			4,003
Net loss before income tax expense		(20,275	)		(25,634	)		(70,422	)		(87,293	)
Income tax expense		—			—			—			—
Net loss	$	(20,275	)	$	(25,634	)	$	(70,422	)	$	(87,293	)

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and related notes thereto for the year ended December 31, 2024, included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 10, 2025.

In addition to historical financial information, this discussion and analysis and other parts of this report contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended, based upon current expectations that involve risks, uncertainties and assumptions. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the section titled “Risk Factors” under Part II, Item 1A. below. You should carefully read the “Risk Factors” to gain an understanding of the factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”

Overview

We are a clinical-stage biotechnology company focused on discovering, developing and delivering potentially curative therapies that address the underlying drivers of heart disease. Our vision is to change the treatment paradigm for heart disease, and in doing so improve and extend the lives of millions of patients.

We are advancing a deep and diverse modality agnostic pipeline of targeted therapies for heart conditions discovered internally using our extensive target identification and validation and genetic medicine design and manufacturing capabilities. All of our programs are currently in the clinical or preclinical stage; we do not have any products approved for sale and have not generated any revenue to date.

We are primarily focused on development of our lead investigational product candidates, TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), and TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). Each candidate is currently in the clinical testing stage to establish the safety profile of two different doses in adults with disease due to pathogenic/likely pathogenic mutations. We anticipate that data generated in the next year will inform late-stage development by characterizing each candidates’ safety and tolerability profile, ability to transduce target heart cells, and produce the lacking protein underlying disease to slow – or even halt – disease progression. Where our discovery efforts lead to product candidates intended for relatively prevalent indications, such as TN-301, our small molecule histone deacetylase-6 (HDAC6) inhibitor for heart failure with preserved ejection fraction (HFpEF), our strategy is to out-license or partner with third parties.

TN-201 is our investigational gene therapy for individuals with HCM due to MYBPC3gene mutations. These mutations result in a deficiency of myosin binding protein (MyBP-C), which in turn can cause the heart walls of affected individuals to become significantly thickened, leading to fibrosis, abnormal heart rhythms, cardiac dysfunction, heart failure and death. HCM is a chronic, progressive condition and those diagnosed with the disease often experience significant impairment in overall quality of life and may be at higher risk for serious complications and co-morbidities. TN-201 utilizes a recombinant adeno-associated virus serotype 9 (AAV9) capsid and is designed to deliver a working MYBPC3 gene to specific cells of the heart in order to produce MyBP-C and thereby potentially slow or even reverse the course of MYBPC3-associated HCM following a single infusion.

MyPEAKTM-1 is our Phase 1b/2a multi-center, open-label clinical trial, designed to assess the safety, tolerability and efficacy of a one-time intravenous infusion of TN-201. Enrollment and dosing in both the 3E13 vg/kg dose (Cohort 1) and 6E13 vg/kg dose (Cohort 2) cohorts are complete. In summer 2025, the independent data safety monitoring board (DSMB) for the MyPEAK-1 trial reviewed all available safety data from the first six patients dosed with TN-201. The DSMB determined that TN-201 had an acceptable safety profile and endorsed proceeding into expansion cohorts at either dose level, per protocol. We have since dosed one additional patient at the 6E13 vg/kg dose level with no new meaningful safety events associated with TN-201.

In November 2025, we presented interim data from MyPEAK-1 during the Late-Breaking Science: Main Event session at the American Heart Association’s (AHA) Scientific Sessions 2025. Interim data presented at AHA included safety, biopsy and efficacy results for the three patients enrolled in Cohort 1 with follow-up ranging from Week 52-78, and safety and available assessments for the patients in Cohort 2 who have post-dose assessments

ranging from Week 12-26 as of the July 2025 data cut off. Patient 5 was lost to further follow-up after week 12. TN-201 was generally well tolerated across both dose cohorts and no dose-limiting toxicities were observed. Reversible, asymptomatic liver enzyme elevations (Grade 1-3) were the most common treatment-related adverse events (AEs) reported. There were two treatment-related AEs classified as serious either due to inpatient administration of steroids or extended monitoring; a Grade 2 transaminase elevation that responded to steroids and a Grade 1 elevation of complement factors that resolved without additional intervention. Adjustments to monitoring and immunosuppression during Cohort 1 resulted in faster tapers and lower cumulative corticosteroid doses in Cohort 2, despite the higher TN-201 dose.

Biopsy data demonstrated that TN-201 transduction and mRNA expression were robust. DNA and RNA analyses of all three patients in Cohort 1 show evidence of sustained presence of TN-201 DNA in the heart and increasing mRNA expression over time. MyBP-C protein levels also increased over time across all patients in both cohorts for whom serial biopsies were available. In Cohort 1 patient protein levels increased by an average of 4% from the first biopsy taken to Week 52. The first evaluable patient in Cohort 2 (Patient 6) demonstrated a clear dose response, and early MyBP-C expression increased by 14% after only 12 weeks post-dose. Of note, Patient 6 had a greater than 2-fold increase in cardiac transduction and expression at Week 12 relative to the averages for these measures observed across Cohort 1.

All patients with greater than 26 weeks of follow-up demonstrated improvement in at least one parameter of disease, across biomarkers, hypertrophy and heart failure symptoms. Cardiac Troponin I, a predictive risk factor of cardiac AEs such as ventricular arrhythmias, sudden cardiac death, and progression to end-stage heart failure, declined by as much as 74% from baseline, to normal or near-normal levels in all Cohort 1 patients. NT-proBNP, a biomarker of cardiac muscle strain, improved or remained stable in two of three Cohort 1 patients. Cardiac Troponin I remained within the normal range and NT-proBNP remained stable for Patient 4 from Cohort 2 at their Week 26 assessment. All three patients in Cohort 1 now have evidence of significant improvement in one or more measures of hypertrophy at Week 52, with notable reductions in left ventricular posterior wall thickness (LVPWT) of between 21% and 39%. LVPWT for Patient 4 in Cohort 2 was stable at Week 26. Greater LVPWT is an independent risk factor for reduced long-term survival after septal myectomy. Two out of three Cohort 1 patients saw reductions from baseline in left ventricular mass index (LVMI) of between 12% and 22% at Week 52. LVMI for Patient 4 in Cohort 2 was stable at Week 26. NYHA classification, a measure of the impact of heart failure symptoms on activities of daily living, improved in all patients by at least one class by Week 26, and all Cohort 1 patients are now NYHA Class I (asymptomatic). Longer-term follow-up for all patients is required to further inform our understanding of TN-201’s potential as a treatment for MYBPC3-associated HCM.

Following proactive correspondence with the U.S. Food and Drug Administration (FDA) relating to future development plans for TN-201, on November 7, 2025, we announced that the FDA placed MyPEAK-1 on clinical hold requesting an amendment to the protocol primarily to standardize activities related to patient monitoring and management of the immunosuppression regimen across trial sites. We are working swiftly and collaboratively with the FDA to resolve the clinical hold and intend to resume dosing once the protocol changes have been implemented at trial sites. We do not expect this action to impact data milestones or development timelines for TN-201.

To support our development efforts for TN-201 we are conducting two noninterventional studies: a study evaluating seroprevalence to AAV9 antibodies among adults with MYBPC3-associated HCM, and MyClimb, a prospective and retrospective global natural history study focused on pediatric patients with MYBPC3 mutation-associated cardiomyopathy. The seroprevalence study has completed enrollment. Initial data from the seroprevalence study indicated that antibodies to AAV9 in the majority of participants were below the eligibility threshold that would allow for participation in MyPEAK-1. The MyClimb natural history study is following patient medical history to characterize the outcomes, burden of illness, risk factors, quality of life, and biomarkers associated with disease progression in pediatric patients. MyClimb complements existing disease registries focused primarily on adult patient HCM populations and may support and expedite the development of TN-201 in the pediatric patient population. Initial data from MyClimb indicated that 93% of participants had the nonobstructive HCM phenotype, for which there are currently no approved treatment options and that genotypic status was a significant predictor of risk. The data also revealed that left ventricular mass index may serve as a surrogate marker for poor long-term outcomes and as an appropriate marker to evaluate the early effectiveness of TN-201’s potential in a future pivotal trial.

The FDA has granted TN-201 Fast Track, Orphan Drug and Rare Pediatric Drug Designations. TN-201 has also received orphan medicinal product designation from the European Commission (EC).

TN-401 is our AAV9-based gene therapy for the treatment of ARVC due to disease-causing variants in the PKP2 gene. ARVC, also known as arrhythmogenic cardiomyopathy, or ACM, is a chronic, progressive disease characterized by frequent, severe, and potentially life-threatening ventricular arrhythmias. The disease is associated with adverse heart remodeling, fibrosis, cardiac dysfunction, significant impairment to patients’ overall quality of life, as well as an elevated risk of sudden cardiac death. PKP2 mutations are the most common genetic cause of ARVC and result in insufficient expression of a protein needed for proper functioning of the desmosomal complex that maintains physical connections and electrical signaling between heart muscle cells. TN-401 utilizes a recombinant AAV9 capsid and is designed to deliver a working PKP2 gene to specific cells of the heart in order to produce plakophilin protein and thereby potentially slow or even reverse the course of PKP2-associated ARVC following a single infusion.

RIDGETM-1 is our Phase 1b multi-center, open-label clinical trial, designed to assess the safety, tolerability and efficacy of a one-time intravenous infusion of TN-401. In July 2025, safety data from the first three RIDGE-1 patients dosed at the 3E13 vg/kg dose (Cohort 1) were reviewed by an independent DSMB which endorsed both dose escalation to the 6E13 vg/kg dose cohort (Cohort 2) and expanding enrollment in Cohort 1. Enrollment in Cohort 2 is now complete and we may enroll additional patients at the 3E13 vg/kg dose (Cohort 1). Additional enrollment at the 6E13vg/kg dose (Cohort 2) will be considered following a review of all available safety data by the DSMB. Initial clinical data from Cohort 1 is expected before year end.

In February 2025, we were awarded a Clinical Grant (Clin2) of $8.0 million from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, and gene therapy research. Proceeds from the grant will help fund clinical trial costs for our ongoing Phase 1b RIDGE-1 clinical trial of TN-401 gene therapy. RIDGE-1 is being conducted at multiple clinical trial sites with ARVC expertise at leading cardiology centers in the U.S. and United Kingdom.

In support of our development efforts for TN-401, we initiated RIDGE, a global noninterventional study to collect natural history and seroprevalence to AAV9 antibodies data among ARVC patients who carry pathogenic or likely pathogenic PKP2 gene mutations. Interim data from RIDGE, believed to be the largest natural history study of adults with PKP2-associated ARVC was presented at Heart Rhythm Society’s annual meeting in April 2025. Adults with PKP2-associated ARVC experience a high burden of arrhythmias despite treatments with anti-arrhythmic medications, beta blockers and the anti-arrhythmic flecainide, as well as surgical interventions such as ablation and ICD placement. Further, current treatments appeared to do little to halt or prevent progressive structural changes to the heart that occur as a result of PKP2 mutations. A large majority of adults with PKP2-associated ARVC would be eligible to participate in our ongoing Phase 1b RIDGE-1 clinical trial of TN-401 gene therapy based on low levels of antibodies to AAV9.

TN-401 has received Orphan Drug and Fast Track designation from the FDA and orphan medicinal product designation from the EC.

TN-301 is our small molecule HDAC6 inhibitor initially discovered and validated as having cardioprotective qualities in preclinical studies of a rapidly worsening mouse model of BAG3 mutant dilated cardiomyopathy (DCM). HDAC6 is a cytoplasmic enzyme known to regulate diverse cellular processes. Based on TN-301’s multi-modal mechanism of action, TN-301 may have future potential in a number of cardiometabolic conditions.

Extensive in vitro and in vivo studies have shown that TN-301 addresses diverse pathological processes with direct and systemic benefits in models of HFpEF. In comparative studies, selective HDAC6 inhibition as a single agent has been shown to have similar efficacy to empagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor which is approved for the treatment of HFpEF and co-administration of our HDAC6 inhibition with a SGLT2 inhibitor in a HFpEF mouse model demonstrated additive benefit.

We shared positive data from our Phase 1 clinical trial of TN-301 in healthy participants at the 2023 Heart Failure Society of America Annual Scientific Meeting. TN-301 was generally well tolerated across the broad range of doses studied. Pharmacokinetic results showed overall dose proportionality with a half-life supportive of once-daily dosing. Increasing doses and exposures with TN-301 correlated with increased pharmacodynamic effects. There were no changes in histone acetylation with TN-301 underscoring the selectivity of TN-301 for HDAC6 and potentially reducing the risk of off target effects. Taken together, these data support continued development of TN-301 as a potential treatment for patients with HFpEF and other severe diseases - including those outside of cardiology- in which inflammation, fibrosis and metabolic dysregulation may be implicated. We believe late-stage

clinical development of TN-301 for more prevalent indications is best suited for development by or with a well-resourced partner.

In addition to our clinical-stage candidates, we have multiple early-stage programs using various therapeutic approaches, including gene addition, gene editing, gene silencing, and cellular regeneration to address other forms of rare and/or prevalent heart disease.

Early on in our company history, we invested in differentiated capabilities to enable modality-agnostic target identification and validation, anchored in human genetics and the use of human disease models. That proprietary expertise has directly informed the design, optimization and production of our pipeline. To support our initial focus on gene therapy candidates, we internalized expertise in capsid engineering, novel promoter constructs and manufacturing anchored on the use of AAVs as the method of delivery to the heart with the aim of increasing the safety and efficacy of our product candidates and accelerating early-stage discovery and preclinical optimization across modalities.

For the production of our lead gene therapy candidates, we maintained complete ownership of process development, analytical development, and quality control and have already produced all necessary clinical trial material needed for our current clinical trials at our Good Manufacturing Practice (cGMP)-certified Genetic Medicines Manufacturing Center in Union City, California.

Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024:

The following table summarizes our results of operations for the periods presented:


	Three Months Ended September 30,						$			%
(in thousands, except percentages)	2025			2024			Change			Change
Operating expenses:
Research and development	$	15,363		$	20,350		$	(4,987	)	(25%)
General and administrative		5,573			6,361			(788	)	(12%)
Total operating expenses		20,936			26,711			(5,775	)	(22%)
Loss from operations		(20,936	)		(26,711	)		5,775		(22%)
Other income, net:

Tenaya Therapeutics, Inc. 10-Q