Arrhythmogenic Right Ventricular Dysplasia

- Acoramidis treatment led to a highly significant reduction in all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) at Month 30 compared with placebo - Additionally, results from a Phase 3 trial in adults with ATTR-CM conducted in Japan were presented, with no ACM events reported over the 30 month treatment period in participants administered acoramidis - Greater transthyretin (TTR) stabilization has been associated with improved clinical outcomes for patients, and in ATTRibute-CM, acoramidis, a near-complete stabilizer of TTR, demonstrated a significant impact on mortality, hospitalizations, and quality of life including: - An early and sustained improvement relative to placebo in time to first event (CVH or ACM) with a separation of event rates starting at Month 3- A 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30- A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30 PALO ALTO, Calif., Sept. 27, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, presented a post-hoc analysis evaluating the effect of acoramidis on the composite endpoint of ACM and recurrent CVH events in its Phase 3 ATTRibute-CM study in ATTR-CM at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2024. ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis, an investigational, near-complete, orally-administered, small molecule stabilizer of TTR. “We are proud to share the results of this post-hoc analysis demonstrating a highly significant reduction in all-cause mortality and the sum of recurrent CV-related hospitalizations in patients with ATTR-CM at 30 Months in the ATTRibute-CM trial,” said Jonathan Fox, M.D., Ph.D., chief medical officer of BridgeBio Cardiorenal. “At BridgeBio, we believe in the importance of both data transparency and continued communication of additional details of this landmark trial, especially to assist physicians choosing ATTR-CM therapies for their patients who rely on their healthcare provider’s recommendations. By conducting and presenting multiple analyses, we hope to both advance the clinical science around ATTR-CM trials and highlight the potential for acoramidis to be a meaningful treatment option for patients.” The analysis, shared by Daniel Judge, M.D., professor of medicine and cardiology at the Medical University of South Carolina in an oral presentation, included: A 42% reduction in composite ACM and recurrent CVH events at 30 months observed with acoramidis treatment compared to placebo by applying a negative binomial regression model (post-hoc) (p=0.0005)A 42% reduction in the total number of ACM and recurrent CVH events per patient observed over 30 months with acoramidis treatment compared to placeboA 30.5% hazard reduction in ACM and recurrent CVH events at 30 months observed with acoramidis treatment compared to placebo by applying the Andersen-Gill model (post-hoc) (p=0.0008) “This post-hoc analysis provides further evidence that near-complete TTR stabilization with acoramidis can improve clinical outcomes for patients with ATTR-CM. The reduction of hospitalizations and all-cause mortality seen in ATTRibute-CM heightens the case for acoramidis as a first-line therapy given its potential to improve the overall quality of life for patients,” said Dr. Judge. Additionally, during the Annual Scientific Session of the Japanese College of Cardiology (JCC), Jin Endo, M.D., Ph.D., Keio University School of Medicine of Tokyo, Japan presented positive results from the Phase 3 trial of acoramidis in adults with ATTR-CM conducted by Alexion, AstraZeneca Rare Disease in Japan, which has exclusive rights to commercialize acoramidis in Japan. No mortality was reported over the treatment period of 30 months. Results showed consistency with the ATTRibute-CM results, including survival, CVH and other measures of physical function (measured by six-minute walk test) and quality of life (measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score) at 30 months. Based on the positive results from ATTRibute-CM, BridgeBio submitted a New Drug Application to the U.S. Food and Drug Administration, which has been accepted with a PDUFA action date of November 29, 2024, and a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025. About BridgeBio Pharma, Inc.BridgeBio Pharma Inc. (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers, and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, Twitter and Facebook. BridgeBio Forward Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking 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 (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the impact of acoramidis on clinical outcomes, potential benefits of acoramidis, including its efficacy and potential to improve the quality of life for patients and the potential outcomes and expected timing of regulatory reviews by the U.S. Food and Drug Administration and the European Medicines Agency reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our preclinical studies and clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, the U.S. Food and Drug Administration or such other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of our collaborations, potential volatility in our share price, uncertainty regarding any impacts due to global health emergencies, including delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and rising interest rates, on our business operations and expectations, as well as those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Media Contact:Vikram Balicontact@bridgebio.com (650)-789-8220

- In participants who switched from tafamidis and placebo in the ATTRibute-CM study to acoramidis in its open-label extension (OLE), there was a mean of 3.0mg/dL increase in serum transthyretin (TTR) at Month 1 of the OLE (n=21) and mean of 3.4mg/dL increase in serum TTR at Month 6 of the OLE (n=18) - Increased serum TTR at Day 28 of ATTRibute-CM was correlated with reduced risk of all-cause mortality (ACM), cardiovascular mortality (CVM), and cardiovascular-related hospitalization (CVH) in transthyretin amyloid cardiomyopathy (ATTR-CM) - Greater stabilization has been shown to improve clinical outcomes for patients, and in ATTRibute-CM, acoramidis, a near-complete stabilizer of TTR, demonstrated a significant impact on mortality, hospitalizations, and quality of life including: -An early and sustained improvement relative to placebo in time to first event (CVH or ACM) starting at Month 3-A 42% reduction in composite CVH and ACM events relative to placebo at Month 30-A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30 PALO ALTO, Calif., Aug. 30, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, presented additional data from an analysis of its Phase 3 ATTRibute-CM and open-label extension study of acoramidis in ATTR-CM at the European Society of Cardiology (ESC) 2024. ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of TTR. The data on change from baseline in serum TTR levels in participants receiving acoramidis versus those receiving tafamidis in the placebo group in ATTRibute-CM at Month 30, as well as serum TTR levels in patients who transitioned from placebo and tafamidis to acoramidis in the OLE study, were presented by Mathew Maurer, M.D. of Columbia University Irving Medical Center. In participants who switched from tafamidis and placebo in the ATTRibute-CM study to acoramidis in its OLE, there was a mean of 3.0mg/dL increase in serum TTR at Month 1 of the OLE (n=21, p=0.01) and mean of 3.4mg/dL increase in serum TTR at Month 6 of the OLE (n=18, p=0.01). TTR plays an important role in the body transporting thyroxine and vitamin A, and higher TTR levels are associated with less heart failure and better survival. BridgeBio previously shared results demonstrating that acoramidis treatment resulted in increased serum TTR levels by Day 28 that were sustained and were correlated with a reduced risk of ACM, CVM, and CVH in ATTR-CM participants through Month 30. This includes the following results: For every 5mg/dL increase in serum TTR level at Day 28 after treatment initiation, the risk of death through Month 30 was reduced by 30.9% (by the logistic model) and 26.1% (by the Cox proportional hazards model), showing a statistically significant correlation between increasing serum TTR and decreasing risk of deathFor each 1 mg/dL, increase in serum TTR on Day 28 after treatment initiation, there was a 5.5% risk reduction in cardiovascular death observed through Month 30For each 1 mg/dL, increase in serum TTR at Day 28 after treatment initiation was associated with a 4.7% lower risk of a first cardiovascular hospitalization over 30 months “The data shared show that switching from tafamidis to acoramidis resulted in an increase in serum TTR, which has been associated with improved outcomes in patients with ATTR-CM,” said Dr. Maurer. “In a future arena of multiple disease modifying therapies for ATTR-CM, such data may provide a rationale for monitoring of patients with serum transthyretin levels and using these data in choosing a specific treatment.” Additionally, as part of the ongoing partnership with the Cardiovascular Data Science (CarDS) Lab, Rohan Khera, M.D., M.S., cardiologist-data scientist at Yale School of Medicine will be presenting about the artificial intelligence tools being deployed in the TRACE AI Network Study. The BridgeBio-partnered initiative will provide a scalable screening toolkit for ATTR-CM across large, diverse health systems to quantify the potential prevalence of undiagnosed ATTR-CM among all patients undergoing routine cardiovascular evaluation, specifically among key socioeconomic and demographic subpopulations. Based on the positive results from ATTRibute-CM, BridgeBio submitted a New Drug Application to the U.S. Food and Drug Administration, which has been accepted with a PDUFA action date of November 29, 2024, and a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025. BridgeBio has granted exclusive rights to Bayer to commercialize acoramidis for ATTR-CM in Europe. About BridgeBio Pharma, Inc.BridgeBio Pharma Inc. (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers, and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, Twitter and Facebook. BridgeBio and Bayer European License for Acoramidis – About the CollaborationIn March 2024, BridgeBio granted Bayer exclusive license to commercialize acoramidis as a treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in Europe. Acoramidis is an investigational, highly potent and selective small molecule, under development as an orally administered transthyretin (TTR) stabilizer for the treatment of patients with ATTR-CM a progressive fatal disease presenting as an infiltrative, restrictive cardiomyopathy resulting in heart failure. This partnership leverages Bayer’s long legacy of expertise in cardiovascular disease and its established European cardiovascular infrastructure paired with BridgeBio’s leadership in the emerging field of ATTR-CM. BridgeBio Forward Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking 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 (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the impact of acoramidis on clinical outcomes, including risk of death, cardiovascular death and hospitalization rates; potential benefits of acoramidis, including increases in serum TTR; the statements related to the planned actions and decisions of the U.S. Food and Drug Administration and the European Medicines Agency regarding our New Drug Application and Marketing Authorization Application submissions for acoramidis for the treatment of ATTR-CM; and the potential outcomes and expected timing of regulatory reviews by the U.S. Food and Drug Administration and the European Medicines Agency, and the corresponding statistically significant benefits on clinical event outcomes; and the clinical, therapeutic and market potential of our clinical development program and timeline for acoramidis reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations our product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, the U.S. Food and Drug Administration or such other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of our collaborations, potential volatility in our share price, uncertainty regarding any impacts due to global health emergencies, including delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and rising interest rates, on our business operations and expectations, as well as those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Media Contact:Vikram Balicontact@bridgebio.com(650)-789-8220

Received Rare Pediatric Disease Designation from U.S. Food and Drug Administration for TN-201 for MYBPC3-associated Hypertrophic Cardiomyopathy Received UK Clearance to Initiate Clinical Testing of TN-401 for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy Established $45 Million Credit Facility with Silicon Valley Bank to Provide Financial Flexibility Ahead of Multiple Potential Milestones SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results for the second quarter ended June 30, 2024, and provided a corporate update. “We remain laser focused on advancing our lead gene therapy candidates, as we prepare to report initial data from our first-in-human study of TN-201 in the second half and to dose the first patient in our Phase 1b trial of TN-401 in the fourth quarter of 2024. Our focus on clinical execution now and in the future is evident with more than forty sites in seven countries across our interventional and natural history studies for both programs, and with the recent receipt of rare pediatric disease designation for MYBPC3-associated HCM in infants, children and adolescents,” said Faraz Ali, Chief Executive Officer of Tenaya. “Consistent with that focus, we have taken important steps to increase our financial flexibility in anticipation of additional clinical data readouts in 2025.” Business and Program UpdatesTN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM) Screening and enrollment continue in MyPEAK™-1, a Phase 1b multi-center, open-label, dose-escalation trial designed to assess safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-201 with a total of nine clinical sites activated. Tenaya anticipates sharing interim Phase 1b results from the first cohort of patients in MyPEAK-1 in the second half of 2024.TN-201 was granted rare pediatric disease designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the treatment of MYBPC3-associated HCM in children, adolescents and young adults. The FDA defines rare pediatric diseases as rare diseases (those with fewer than 200,000 cases in the United States) that are serious or life threatening and primarily affect individuals under 18 years of age. This is the first RPDD to be granted for MYBPC3-associated HCM. As a result of being granted RPDD, if TN-201 is approved to treat MYBPC3-associated HCM in patients under age 18, Tenaya may qualify to receive a priority review voucher that may be redeemed to receive priority review for a different product, or which may be transferred or sold to another sponsor. In 2021, Tenaya initiated a non-interventional natural history study, know as MyClimb, designed to understand MYBPC3-associated HCM in infants, children and teens which is ongoing at more than twenty sites in the U.S., Canada, and Europe. TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) Tenaya has activated four clinical sites in RIDGE™-1 and plans to begin dosing patients in the trial during the fourth quarter of 2024. RIDGE-1 is a global multicenter, open-label, dose-escalation trial designed to assess safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-401 for the treatment of ARVC caused by mutations to the PKP2 gene.Tenaya received clearance of its Clinical Trial Application by the U.K.'s Medicines and Healthcare Products Regulatory Agency and plans to activate RIDGE-1 clinical sites in the U.K.In June 2024, Tenaya shared interim data from the ongoing RIDGE™ seroprevalence and natural history study indicating that adults with PKP2-associated ARVC have low levels of preexisting antibodies to adeno-associated serotype 9 (AAV9), the viral vector used in TN-401. Forty-eight of 57 volunteers with PKP2-associated ARVC, or 84%, had neutralizing antibody titers of less than 1:20 and would meet eligibility criteria for RIDGE-1. These data were presented at the International Congress on Electrocardiology held in Lund, Sweden. Tenaya is currently enrolling adult PKP2-associated ARVC patients in the RIDGE natural history and seroprevalence study at 18 clinical sites across the U.S. and Europe. Research and Manufacturing In May 2024, Tenaya’s Research and Manufacturing teams presented multiple posters at the American Society for Gene and Cell Therapy meeting detailing continued innovations related to its core capabilities, including gene editing, capsid engineering, promoter and regulatory elements, and manufacturing science.In July 2024, Tenaya received a notice of allowance from the U.S. Patent and Trademarks Office for U.S. Application No. 18/468,594 covering a Tenaya-owned optimized vector encoding the DWORF protein. This patent provides composition of matter protections for Tenaya’s DWORF gene therapy program for the treatment of dilated cardiomyopathy and/or heart failure with reduced ejection fraction and is expected to expire no earlier than 2042. Corporate Updates Tenaya announced that Leone Patterson, Chief Financial and Chief Business Officer, will be departing from the company to transition to a new role effective August 14, 2024. The company has initiated a search process to appoint a successor. Chihiro Saito, CPA, Senior Vice President, Accounting and Financial Operations, will serve as interim principal accounting officer and Mr. Ali will serve as interim principal financial officer upon her departure.Tenaya announced the promotion of Kathy Ivey, Ph.D., to Senior Vice President, Research, and the departure of Timothy Hoey, Ph.D., formerly Tenaya’s Chief Scientific Officer. Dr. Hoey remains with the Company in an advisory capacity, including serving on Tenaya’s Scientific Advisory Board (SAB).Barry J. Byrne, M.D., Ph.D., Professor and Associate Chair of Pediatrics, Molecular Genetics & Microbiology Director, Powell Gene Therapy Center, University of Florida School of Medicine, was appointed to Tenaya’s SAB.Tenaya has substantially completed the implementation of previously announced cost containment measures intended to align spending with the company’s focus on driving toward clinical readouts for TN-201 and TN-401.Tenaya entered into a $45 million credit facility with Silicon Valley Bank (SVB). Under the terms of the loan agreement, Tenaya may draw up to $15 million upon closing, with up to an additional $30 million available upon the achievement of certain milestones and/or at SVB’s discretion. As of the closing of this transaction, Tenaya has not drawn on the credit facility and is under no obligation to do so. Leerink Partners served as an advisor to Tenaya on this transaction. Second Quarter 2024 Financial Highlights Cash Position and Guidance: As of June 30, 2024, cash, cash equivalents and investments in marketable securities were $99.3 million. Tenaya estimates that these funds will be sufficient to fund the company into the second half of 2025. The SVB credit facility provides the opportunity to further extend the company’s cash runway.Research & Development (R&D) Expenses: R&D expenses were $22.6 million for the quarter ended June 30, 2024, compared to $26.5 million for the comparable period in 2023. Non-cash stock-based compensation included in R&D expense was $2.2 million for the quarter ended June 30,2024 compared to $1.8 million for the comparable period in 2023.General & Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2024, were $8.2 million compared to $8.6 million for the comparable period in 2023. Non-cash stock-based compensation included in G&A expense was $2.4 million for the quarter ended June 30, 2024, compared to $2.1 million for the comparable period in 2023.Net Loss: Net loss was $29.4 million, or $0.34 per share for the quarter ended June 30, 2024, compared to a net loss of $33.3 million, or $0.45 per share, for the comparable period in 2023. About Tenaya TherapeuticsTenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Leveraging its integrated and interrelated Gene Therapy, Cellular Regeneration and Precision Medicine platforms and proprietary core capabilities, the company is advancing a pipeline of novel therapies with diverse treatment modalities for rare genetic cardiovascular disorders and more prevalent heart conditions. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development. For more information, visit www.tenayatherapeutics.com. Forward Looking Statements This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “focused,” “anticipates,” “plans,” “expects,” “estimates”, "may,” “will” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, Tenaya’s plans and expectations regarding its clinical development efforts and activities, including site activation, enrolling and dosing patients and generating data for MyPEAK-1 and RIDGE-1 and the RIDGE natural history study; the timing of executive departures and appointments; Tenaya’s potential to receive a priority review voucher; planned timing of sharing initial data from MyPEAK-1 and additional clinical data readouts; the clinical, therapeutic and commercial potential of, and expectations regarding, Tenaya’s product candidates; the sufficiency of Tenaya’s cash resources to fund the company into the second half 2025 and the availability of the credit facility to extend that runway; and statements made by Tenaya’s chief executive officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: the timing and progress of Tenaya’s clinical trials; availability of data at the referenced times; unexpected concerns that may arise as a result of the occurrence of adverse safety events in Tenaya’s clinical trials; the potential failure of Tenaya’s product candidates to demonstrate safety and/or efficacy in clinical testing; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to comply with specified operating covenants and restrictions in its loan agreement; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. ContactMichelle CorralVP, Corporate Communications and Investor RelationsIR@tenayathera.com InvestorsAnne-Marie FieldsPrecision AQ (formerly Stern Investor Relations)annemarie.fields@precisionaq.com Media Wendy Ryan Ten Bridge Communications wendy@tenbridgecommunications.com TENAYA THERAPEUTICS, INC. Condensed Statements of Operations (In thousands, except share and per share data) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Operating expenses: Research and development$22,649 $26,477 $47,704 $52,082 General and administrative 8,174 8,627 16,881 16,745 Total operating expenses 30,823 35,104 64,585 68,827 Loss from operations (30,823) (35,104) (64,585) (68,827)Other income, net: Interest income 1,393 1,837 2,845 3,810 Other income (loss), net (1) (2) 81 11 Total other income, net 1,392 1,835 2,926 3,821 Net loss before income tax expense (29,431) (33,269) (61,659) (65,006)Income tax expense — — — — Net loss$(29,431) $(33,269) $(61,659) $(65,006)Net loss per share, basic and diluted$(0.34) $(0.45) $(0.74) $(0.89)Weighted-average shares used in computing net loss per share, basic and diluted 85,706,501 73,399,847 83,344,414 73,249,702 Condensed Balance Sheet Data (In thousands)(Unaudited) June 30, December 31, 2024 2023 Cash, cash equivalents and marketable securities$99,303 $104,642 Total assets$163,185 $170,515 Total liabilities$29,188 $31,091 Total liabilities and stockholders’ equity$163,185 $170,515