Tenaya Therapeutics, Inc.

Previous wording

For programs arising out of our modality agnostic drug discovery platform that address relatively rare conditions our strategy is to develop, manufacture and commercialize at least some of these programs on our own, although we may selectively consider partnerships to access technology, accelerate our progress, or improve our global reach to patients. For example, in March 2026, we entered into a multi-target research collaboration with Alnylam Pharmaceuticals, Inc. (Alnylam), to identify and validate novel gene targets for the potential treatment of cardiovascular disease. Importantly, this agreement takes advantage of our modality agnostic discovery know-how and provides reimbursement for research efforts. Where our discovery efforts lead to product candidates intended for relatively prevalent indications, our strategy is to out-license or partner such programs.

Current wording

For programs arising out of our modality agnostic drug discovery platform that address relatively rare conditions our strategy is to develop and commercialize at least some of these programs on our own, although we may selectively consider partnerships to access technology, accelerate our progress, or improve our global reach to patients. Where our discovery efforts lead to product candidates intended for relatively prevalent indications, our strategy is to out-license or partner such programs. Our core capabilities and expertise offer additional opportunities for collaboration. In March 2026, we entered into a multi-target research collaboration with Alnylam Pharmaceuticals, Inc. (Alnylam), to identify and validate novel gene targets for the potential treatment of cardiovascular disease in exchange for a $10 million upfront payment, reimbursement for research efforts and up to $1.1 billion in development and commercial milestones payments. Our genetic medicines manufacturing know-how provides the basis for licensing, collaboration, and/or other agreements with global contract development and manufacturing and/or life science reagent companies.

Previous wording

MyPEAKTM-1 is our Phase 1b/2 multi-center, open-label clinical trial, designed to assess the safety, tolerability and efficacy of a one-time intravenous infusion of TN-201. We have completed enrollment in MyPEAK-1 necessary to characterize dose response and inform dose selection for late-stage clinical trials, including three patients at the 3E13 vg/kg dose (Cohort 1), three at the 6E13 vg/kg dose (Cohort 2) and additional patients in the 6E13 vg/kg dose expansion cohort. Other than Patient 5, all patients have completed every scheduled visit and remain in the trial.

Current wording

MyPEAKTM-1 is our Phase 1b/2 multi-center, open-label clinical trial, designed to assess the safety, tolerability and efficacy of a one-time intravenous infusion of TN-201. We have completed enrollment in MyPEAK-1 necessary to characterize dose response and inform dose selection for late-stage clinical trials, including three patients at the 3E13 vg/kg dose (Cohort 1), three at the 6E13 vg/kg dose (Cohort 2) and additional patients in the 6E13 vg/kg dose expansion cohort.

Previous wording

In June 2026, we presented new interim safety and efficacy data from MyPEAK-1 as of a May 2026 data cut off. Data shared included 78-104 weeks of follow-up for the three Cohort 1 patients and 26-52 weeks of follow-up for four patients dosed with TN-201 at 6E13 vg/kg. Among the latest findings reported, six patients evaluable for efficacy endpoints demonstrated improvements in multiple clinical parameters of disease including echocardiographic (ECG) measures of hypertrophy, and one or more measures of symptom burden. Cardiac troponin, a known risk factor for cardiac-related morbidities or mortality, improved or remained stable in five of six patients and NT-pro BNP, a measure of heart muscle strain, improved in three patients. ECG measures of left ventricular structure showed decreases in multiple measures of left ventricular hypertrophy, a defining characteristic of HCM. All six evaluable patients achieved reductions in left ventricular mass index (LVMI) and five of six demonstrated reductions in one or more measures of wall thickness. Decreases in LVMI were durable through two years for the first two Cohort 1 patients and decreases among Cohort 2 patients were observed at an earlier timepoint post-dose compared to Cohort 1 patients.

Current wording

In June 2026, we presented new interim safety and efficacy data from MyPEAK-1 as of a May 2026 data cut off. Data shared included 78-104 weeks of follow-up for the three Cohort 1 patients and 26-52 weeks of follow-up for four patients dosed with TN-201 at 6E13 vg/kg. Other than Patient 5, all patients have completed every scheduled visit and remain in the trial. Among the latest findings reported, six patients evaluable for efficacy endpoints demonstrated improvements in multiple clinical parameters of disease including echocardiographic (ECG) measures of hypertrophy, and one or more measures of symptom burden. Cardiac troponin, a known risk factor for cardiac-related morbidities or mortality, improved or remained stable in five of six patients and NT-pro BNP, a measure of heart muscle strain, improved in three patients. ECG measures of left ventricular structure showed decreases in multiple measures of left ventricular hypertrophy, a defining characteristic of HCM. All six evaluable patients achieved reductions in left ventricular mass index (LVMI) and five of six demonstrated reductions in one or more measures of wall thickness. Decreases in LVMI were durable through two years for the first two Cohort 1 patients and decreases among Cohort 2 patients were observed at an earlier timepoint post-dose compared to Cohort 1 patients.

Previous wording

We expect to present one-year Cohort 2 data and two-year Cohort 1 data from MyPEAK-1 in the fourth quarter of 2026. We are also engaging with regulatory authorities to obtain feedback on pivotal trial plans for TN-201 and plan to provide an update on progress in the fourth quarter of 2026.

Current wording

We expect to present one-year Cohort 2 data and two-year durability data for Cohort 1 from MyPEAK-1 by year end. We are also in ongoing discussions with regulatory authorities, with an additional interaction planned to explore late-stage pivotal trial plans for TN-201, and intend to provide an update by year end.

Previous wording

Despite advances in the treatment of the obstructive HCM in recent years with the approval of cardiac myosin inhibitors, there are no approved treatments for those with the non-obstructive form of disease or those diagnosed before the age of 18. Recognizing the urgent medical need among pediatric patients, we initiated MyClimb, a retrospective and prospective natural history study of pediatric patients 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. MyClimb completed enrollment of more than 200 individuals and is believed to be the largest study of pediatric individuals with MYBPC3-associated HCM ever conducted. Initial data indicated that 93% of participants had the nonobstructive HCM phenotype, for which there are currently no approved treatment options and that genotype was a significant predictor of risk. The data also revealed that LVMI 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.

Current wording

Despite advances in the treatment of the obstructive HCM in recent years with the approval of cardiac myosin inhibitors, there are no approved treatments for those with the non-obstructive form of disease and limited options for those diagnosed before the age of 18. Recognizing the urgent medical need among pediatric patients, we initiated MyClimb, a retrospective and prospective natural history study of pediatric patients 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. MyClimb completed enrollment of more than 200 individuals and is believed to be the largest study of pediatric individuals with MYBPC3-associated HCM ever conducted. Initial data indicated that 93% of participants had the nonobstructive HCM phenotype, for which there are currently no approved treatment options and that genotype was a significant predictor of risk. The data also revealed that LVMI 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.

Previous wording

We expect to present interim Cohort 2 results in the fourth quarter of the year. We are also engaging with regulators on late-stage pivotal trial planning for TN-401 and plan to provide an update on the status of our discussions in the fourth quarter of 2026.

Current wording

We expect to present interim data by year end, including one-year data for Cohort 2 and durability data for Cohort 1. We are also engaging with regulators and have upcoming meetings scheduled to discuss late-stage pivotal trial planning for TN-401. We plan to provide an update on the feedback received from our discussions by year end.

Previous wording

TN-401 has received Orphan Drug and Fast Track designation from the FDA. TN-401 has also received orphan medicinal product designation from the EC and was granted PRIME designation by the EMA.

Current wording

TN-401 has received Orphan Drug, Fast Track and Regenerative Medicine Advanced Therapy designation from the FDA. TN-401 has also received orphan medicinal product designation from the EC and was granted PRIME designation by the EMA.

Previous wording

We plan to advance TN-301 toward clinical trials in patients in order to generate proof-of-activity data, with HFpEF and DMD being among the most promising potential indications identified to date. We also intend to share additional details regarding TN-301 development plans in the fourth quarter of 2026, and to initiate at least one company-sponsored proof-of-activity Phase 2 clinical trial in the second half of 2027. Consistent with our strategy, we believe that TN-301’s late-stage development and commercialization in large indications would best be led by a strategic pharmaceutical partner with global resources to explore the full potential of the molecule.

Current wording

We plan to advance TN-301 toward clinical trials in patients in order to generate proof-of-activity data, with HFpEF and DMD being among the most promising potential indications identified to date. We are currently conducting enabling toxicology work to support such advancement and plan to initiate at least one company-sponsored Phase 2 clinical trial in the second half of 2027. Consistent with our strategy, we believe that TN-301’s late-stage development and commercialization in large indications would best be led by a strategic pharmaceutical partner with global resources to explore the full potential of the molecule.

Previous wording

Collaboration revenue for the three months ended June 30, 2026 was $1.1 million, compared to none in the prior year period. The increase consisted of $0.7 million from the recognition of revenue associated with upfront fees and $0.4 million from reimbursements for research and development activities under collaboration arrangements entered into during the first quarter of 2026.

Current wording

Collaboration revenue for the three months ended September 30, 2026 was $1.7 million, compared to none in the prior year period. The increase consisted of $1.1 million from the recognition of revenue associated with upfront fees and $0.6 million from reimbursements for research and development activities under collaboration arrangements entered into during the first quarter of 2026.

Previous wording

Research and development activities account for a significant portion of our operating expenses. Research and development expenses relate primarily to discovery and development of our research programs, product candidates and proprietary platform technology, and are recognized as incurred. Internal research and development costs include, among others, employee-related costs (including salaries, benefits and stock-based compensation for employees engaged in research and development functions), laboratory supplies, other non-capital equipment utilized for in-house research, and allocated overhead costs. External research and development expenses include, among others, fees paid to contract research organizations to execute preclinical studies and clinical trials on our behalf, and consulting fees. In connection with the closure of the GMMC Facility, our external research and development expenses may include fees paid to third-party contract development manufacturing organizations for future process development and manufacturing activities. We do not allocate our costs by research program, product candidate or proprietary platform technology, as a significant amount of research and development expenses represent internal costs, which are deployed across our programs, product candidates, proprietary platform technology, and other activities.

Current wording

Research and development activities account for a significant portion of our operating expenses. Research and development expenses relate primarily to discovery and development of our research programs, product candidates and proprietary platform technology, and are recognized as incurred. Internal research and development costs include, among others, employee-related costs (including salaries, benefits and stock-based compensation for employees engaged in research and development functions), laboratory supplies, other non-capital equipment utilized for in-house research, and allocated overhead costs. External research and development expenses include, among others, fees paid to contract research organizations to execute preclinical studies and clinical trials on our behalf, and consulting fees. In connection with the closure of our Genetic Medicines Manufacturing Center (GMMC), our external research and development expenses may include fees paid to third-party contract development manufacturing organizations (CDMOs) for future process development and manufacturing activities. We do not allocate our costs by research program, product candidate or proprietary platform technology, as a significant amount of research and development expenses represent internal costs, which are deployed across our programs, product candidates, proprietary platform technology, and other activities.

Previous wording

The process of conducting the necessary research to advance through the clinical stages and ultimately obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we cannot reasonably estimate or know the nature, timing or estimated costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates. The level of our research and development expenses over the next twelve months will be subject to operational decisions made following data generated from our MyPEAK-1 and RIDGE-1 clinical trials and our ability to achieve regulatory alignment on our pivotal trial plans for our TN-201 and TN-401 programs.

Current wording

The process of conducting the necessary research to advance through the clinical stages and ultimately obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we cannot reasonably estimate or know the nature, timing or estimated costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates. The level of our research and development expenses over the next twelve months will be subject to operational decisions made following data generated from our MyPEAK-1 and RIDGE-1 clinical trials and our ability to achieve regulatory alignment on our pivotal trial plans for our TN-201 and TN-401 programs, as well as our Phase 2 development plans for TN-301.

Previous wording

We will continue to incur legal, accounting, insurance and other expenses in operating our business as a public company, including costs associated with regulatory and compliance activities. As with our research and development, the level of our general and administrative expenses over the next twelve months will be subject to operational decisions made following data generated from our MyPEAK-1 and RIDGE-1 clinical trials and our ability to achieve regulatory alignment on our pivotal trial plans for our TN-201 and TN-401 programs.

Current wording

We will continue to incur legal, accounting, insurance and other expenses in operating our business as a public company, including costs associated with regulatory and compliance activities. As with our research and development, the level of our general and administrative expenses over the next twelve months will be subject to operational decisions made following data generated from our MyPEAK-1 and RIDGE-1 clinical trials and our ability to achieve regulatory alignment on our pivotal trial plans for our TN-201 and TN-401 programs, as well as our Phase 2 development plans for TN-301.

Previous wording

Interest income primarily consists of interest earned on our cash and cash equivalents balances. In the prior-year period, interest income also included amounts earned on marketable securities. Interest income was $1.5 million and $1.4 million for the six months ended June 30, 2026 and 2025, respectively, and remained relatively consistent between periods.

Current wording

Interest income primarily consists of interest earned on our cash and cash equivalents balances. Interest income remained relatively consistent at $0.6 million and $0.7 million for the three months ended September 30, 2026 and 2025, respectively.

Previous wording

Net loss for the three months ended June 30, 2026, was $43.4 million, compared to a net loss of $23.3 million for the three months ended June 30, 2025.

Current wording

Net loss for the three months ended September 30, 2026, was $18.9 million, compared to a net loss of $20.3 million for the three months ended September 30, 2025.

Previous wording

General and administrative expenses were $5.4 million and $6.7 million for the three months ended June 30, 2026 and 2025, respectively. The decrease of $1.3 million, or 19%, was primarily due to a $0.9 million decrease in stock-based compensation expense and lower professional fees.

Current wording

General and administrative expenses were $16.5 million and $18.7 million for the nine months ended September 30, 2026 and 2025, respectively. The decrease of $2.2 million, or 12%, was primarily due to a $2.2 million decrease in stock-based compensation expense.

Previous wording

During the three months ended June 30, 2026, we recognized a net loss on lease termination of $1.4 million in connection with the termination of the lease for our Union City manufacturing facility. The loss primarily reflected the forfeiture of the facility’s security deposit and a brokerage commission incurred in connection with the lease termination, partially offset by gains associated with the remeasurement of the operating lease right-of-use asset and lease liability and the derecognition of the related asset retirement obligation liability. No comparable loss was recognized in the prior-year periods.

Current wording

During the nine months ended September 30, 2026, we recognized a net loss on lease termination of $1.4 million in connection with the termination of the lease for our Union City manufacturing facility. The loss primarily reflected the forfeiture of the facility’s security deposit and a brokerage commission incurred in connection with the lease termination, partially offset by gains associated with the remeasurement of the operating lease right-of-use asset and lease liability and the derecognition of the related asset retirement obligation liability. No comparable loss was recognized in the prior-year periods.

Previous wording

Interest income primarily consists of interest earned on our cash and cash equivalents balances. In the prior-year period, interest income also included amounts earned on marketable securities. Interest income was $0.7 million and $0.8 million for the three months ended June 30, 2026 and 2025, respectively. The decrease of $0.1 million was primarily due to the absence of discount accretion on marketable securities in the current-year period.

Current wording

Interest income primarily consists of interest earned on our cash and cash equivalents balances. Interest income remained relatively consistent at $2.1 million for each of the nine months ended September 30, 2026 and 2025.

Previous wording

Net loss for the six months ended June 30, 2026, was $62.7 million, compared to a net loss of $50.1 million for the six months ended June 30, 2025.

Current wording

Net loss for the nine months ended September 30, 2026, was $81.6 million, compared to a net loss of $70.4 million for the nine months ended September 30, 2025.

Previous wording

Since our inception, we have generated limited collaboration revenue and no product revenue, and we have incurred significant net losses and negative cash flows from operations. From our inception through June 30, 2026, we have funded our operations primarily from the sale and issuance of our equity securities. As of June 30, 2026, we had cash and cash equivalents of $78.1 million and an accumulated deficit of $667.7 million.

Current wording

Since our inception, we have generated limited collaboration revenue and no product revenue, and we have incurred significant net losses and negative cash flows from operations. From our inception through September 30, 2026, we have funded our operations primarily from the sale and issuance of our equity securities. As of September 30, 2026, we had cash and cash equivalents of $66.8 million and an accumulated deficit of $686.6 million.

Previous wording

establish relationships with contract development manufacturing organizations (CDMOs) to support commercial-scale manufacturing;

Current wording

establish relationships with CDMOs to support commercial-scale manufacturing;

Previous wording

Net cash used in operating activities for the six months ended June 30, 2026 was $22.8 million, which consisted primarily of a net loss of $62.7 million, partially offset by $31.7 million in non-cash charges and a net change in operating assets and liabilities of $8.2 million. The change in net operating assets and liabilities was primarily due to an increase of contract liabilities of $9.7 million, partially offset by a decrease of in accounts payable and accrued expenses and other current liabilities of $1.5 million. Cash flows from operations are generally impacted by the timing of payments to vendors and vendor payment terms. The non-cash charges primarily consisted of loss on impairment of $21.8 million, stock-based compensation of $3.9 million and depreciation and amortization of $3.5 million.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026 was $40.5 million, which consisted primarily of a net loss of $81.6 million, partially offset by $35.0 million in non-cash charges and a net change in operating assets and liabilities of $6.2 million. The change in net operating assets and liabilities was primarily due to an increase of contract liabilities of $8.5 million, partially offset by a decrease in operating lease liabilities of $2.6 million. Cash flows from operations are generally impacted by the timing of payments to vendors and vendor payment terms. The non-cash charges primarily consisted of loss on impairment of $22.5 million, stock-based compensation of $5.6 million and depreciation and amortization of $3.9 million.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2025 was $38.7 million, which consisted primarily of a net loss of $50.1 million and a net change in operating assets and liabilities of $2.4 million, partially offset by $13.3 million in non-cash charges. The change in net operating assets and liabilities was primarily due to a decrease in accounts payable and accrued expenses and other current liabilities of $3.0 million. Cash flows from operations are generally impacted by the timing of payments to vendors and vendor payment terms. The non-cash charges primarily consisted of stock-based compensation of $7.4 million and depreciation and amortization of $4.7 million.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 was $54.3 million, which consisted primarily of a net loss of $70.4 million and a net change in operating assets and liabilities of $3.3 million, partially offset by $18.6 million in non-cash charges. The change in net operating assets and liabilities was primarily due to a decrease in accounts payable and accrued expenses and other current liabilities of $2.6 million. Cash flows from operations are generally impacted by the timing of payments to vendors and vendor payment terms. The non-cash charges primarily consisted of stock-based compensation of $10.3 million and depreciation and amortization of $6.6 million.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2026 was $0.2 million, which consisted of purchases of property and equipment.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2026 was $0.1 million, which consisted of purchases of property and equipment, partially offset by proceeds from sales of property and equipment.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2025 was $47.3 million, which consisted primarily of proceeds from maturities of marketable securities of $36.9 million and sales of marketable securities of $11.0 million.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2025 was $56.2 million, which consisted primarily of proceeds from maturities of marketable securities of $45.7 million and sales of marketable securities of $11.0 million.

Previous wording

Net cash provided in financing activities for the six months ended June 30, 2026 was approximately $0.5 million, which consisted primarily of proceeds from exercise of warrants, partially offset by payments of accrued offering costs.

Current wording

Net cash provided in financing activities for the nine months ended September 30, 2026 was approximately $6.9 million, which consisted primarily of $4.9 million proceeds from exercise of warrants and $2.4 million net proceeds from at-the-market sales, partially offset by payments of accrued offering costs.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $49.8 million, which primarily consisted of net proceeds of $48.8 million from our March 2025 follow-on offering.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 was $50.2 million, which primarily consisted of net proceeds from our March 2025 follow-on offering of $48.8 million.

Previous wording

There have been no material changes from the contractual obligations and commitments previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

Current wording

Other than the early termination of the Union City lease in connection with the closure of our GMMC, as discussed in Note 5, Commitments and Contingencies, to our condensed financial statements, there have been no material changes from the contractual obligations and commitments previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

Previous wording

A summary of our critical accounting policies and estimates is presented in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025. There were no material changes to our critical accounting policies and estimates during the three months ended June 30, 2026.

Current wording

A summary of our critical accounting policies and estimates is presented in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025. There were no material changes to our critical accounting policies and estimates during the three and nine months ended September 30, 2026.