TNYA Tenaya Therapeutics Inc.

10.29
+0.43  (+4%)
Previous Close 9.86
Open 9.85
52 Week Low 8.82
52 Week High 32
Market Cap $424,783,651
Shares 41,281,210
Float 28,593,271
Enterprise Value $132,055,616
Volume 260,849
Av. Daily Volume 138,766
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Drug Pipeline

Drug Stage Notes
TN-201
Hypertrophic cardiomyopathy (HCM)
Phase 1/2
Phase 1/2
IND and Phase 1/2 trial planned for 2H 2022.
TYA-11631
Heart failure with preserved ejection fraction (HFpEF)
Phase 1
Phase 1
IND and Phase 1 are planned for 2022.

Latest News

    • Company announces development candidate selection of its second gene therapy program, TN-401, targeting the leading genetic cause of arrhythmogenic right ventricular cardiomyopathy (gARVC)
    • IND applications for TN-201 and TN-301 (previously named TYA-11631) expected to be submitted in the second half of 2022
    • Appoints Jennifer Drimmer, J.D., as General Counsel

    Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today provided a 2022 business update including the selection of TN-401 as the development candidate for the treatment of Genetic Arrhythmogenic Right Ventricular Cardiomyopathy (gARVC) due to PKP2

    • Company announces development candidate selection of its second gene therapy program, TN-401, targeting the leading genetic cause of arrhythmogenic right ventricular cardiomyopathy (gARVC)
    • IND applications for TN-201 and TN-301 (previously named TYA-11631) expected to be submitted in the second half of 2022
    • Appoints Jennifer Drimmer, J.D., as General Counsel

    Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today provided a 2022 business update including the selection of TN-401 as the development candidate for the treatment of Genetic Arrhythmogenic Right Ventricular Cardiomyopathy (gARVC) due to PKP2 gene mutation. In addition, Tenaya appointed Jennifer Drimmer, J.D., as its General Counsel.

    "After an exciting year in 2021, Tenaya is off to a strong start in 2022 with the selection of TN-401 as a development candidate that provides new hope to patients and families fighting gARVC," said Faraz Ali, Chief Executive Officer of Tenaya. "With three therapeutic candidates now advancing toward the clinic, we look forward to another year of important milestones and operational and scientific progress. We also continue to strengthen the leadership team with the appointment of Jennifer who adds highly relevant experience, depth, and diversity. We have never been better positioned to deliver on our mission to fundamentally change the paradigm of treatment for both rare and prevalent forms of heart disease."

    Business and Program Updates

    • TN-401 - PKP2 Gene Therapy Program for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy (gARVC):
      • Tenaya has nominated TN-401 as a clinical drug candidate to treat patients carrying PKP2 gene mutations. Mutations of the PKP2 gene are the leading genetic cause of ARVC and can cause severe disease including significant arrhythmia and sudden cardiac death in adults and children. These mutations are estimated to affect more than 70,000 patients in the US alone. Based on publicly available information to date, we believe there are no approved disease-specific therapies.
      • Tenaya expects to present new preclinical data supporting the TN-401 program including dose-dependent efficacy, survival durability, and mechanistic insights at a scientific conference in 2022.
      • Tenaya has successfully scaled up production of TN-401 to 200L and is initiating IND enabling studies. Tenaya will also support establishment of a global natural history study in 2022 and expects to submit an IND in 2023.
    • TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic Cardiomyopathy (gHCM):
      • Tenaya has previously announced initiation of IND-enabling activities and expects to submit an IND to the FDA in the second half of 2022.
      • The safety and efficacy of TN-201 will initially be explored in symptomatic adult patients with MYBPC3 mutations and the non-obstructive form of HCM (nHCM). Approximately 70% of patients with truncating MYBPC3 mutations have the nHCM form of the disease where surgical myectomy is not an option and the unmet need is high.
      • Tenaya continues site activation and patient enrollment in the MyClimb global natural history study to support and potentially expedite the future evaluation of TN-201 in pediatric patients during clinical development after early safety has been established in adults.
      • TN-201 has been granted orphan drug designation by the FDA.
    • TN-301 – HDAC6 Inhibitor (Small Molecule for Heart Failure with Preserved Ejection Fraction):
      • Tenaya has continued to generate strong preclinical data supporting the multi-modal mechanism of action of TN-301 in multiple disease models and expects to present these at a scientific conference in 2022.
      • Tenaya has previously announced initiation of IND-enabling activities and a cGMP manufacturing campaign and expects to submit an IND to the FDA in the second half of 2022.
      • The safety, tolerability, pharmacokinetics, and pharmacodynamics of TN-301 will initially be assessed in healthy volunteers, as well as possibly in pre-diabetic participants to assess target engagement and proof of activity.
    • Manufacturing:
      • Tenaya expects its state-of-the-art, modular cGMP manufacturing facility in Union City, California will become operational in the first half of 2022, and will support the production of drug product at multiple scales for clinical studies for all AAV-based programs, including TN-201 and TN-401.
    • Leadership Team:
      • Tenaya continues to strengthen its leadership team with the appointment of Jennifer Drimmer, J.D., as its General Counsel. Jennifer has more than 17 years of experience including public company expertise and executive leadership in corporate governance, contracting, mergers and acquisitions, and legal operations. She previously served as Senior Vice President of Corporate Legal Affairs and Secretary at Exelixis, Inc. (NASDAQ:EXEL) responsible for leading the corporate governance and public company reporting functions. Ms. Drimmer received her B.A. from the University of California, San Diego, and her J.D. from the University of California, Davis School of Law.

    About Tenaya Therapeutics

    Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. 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 "expects" and "will," and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, statements regarding the expected timing of IND applications for TN-201, TN-301 and TN-401, statements regarding the potential of and expectations regarding Tenaya's product candidates and programs, including TN-201, TN-301 and TN-401, statements regarding the cGMP manufacturing facility, expectations with respect to various scientific conferences, the sufficiency of projected cash flows, and statements 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: 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; the timing, progress and results of preclinical studies for TN-201, TN-301, TN-401 and Tenaya's other programs; Tenaya's ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Tenaya's manufacturing and operations, including preclinical studies and planned clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; 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 reliance on third parties; 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.

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  1. Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today announced the appointments of Karah Parschauer, J.D., to its Board of Directors and of Joanna Auch as Senior Vice President of People and Culture.

    "Tenaya is at an important inflection point in our growth and maturity. We are now a public company with more than 100 employees who represent our commitment to internalize critical capabilities, including cGMP manufacturing and clinical development," said Faraz Ali, CEO of Tenaya. "Both Karah and Joanna are strong leaders who bring highly relevant strategic and operational experiences to Tenaya, and who also…

    Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today announced the appointments of Karah Parschauer, J.D., to its Board of Directors and of Joanna Auch as Senior Vice President of People and Culture.

    "Tenaya is at an important inflection point in our growth and maturity. We are now a public company with more than 100 employees who represent our commitment to internalize critical capabilities, including cGMP manufacturing and clinical development," said Faraz Ali, CEO of Tenaya. "Both Karah and Joanna are strong leaders who bring highly relevant strategic and operational experiences to Tenaya, and who also add to the diversity of our Board and our leadership team. We welcome their contributions as Tenaya advances TN-201 and TYA-11631 towards INDs in 2022."

    "I am delighted to join Tenaya's Board of Directors at this important moment in the company's history," said Ms. Parschauer. "Tenaya is very well-positioned to take what the industry has learned from drug development efforts for rare diseases and gene therapies and to now apply that knowledge to advance potentially disease-modifying therapies for patients and families fighting severe genetic cardiomyopathies."

    Ms. Parschauer has nearly 20 years of relevant experience, including with biopharmaceutical companies, with proven success in corporate governance, mergers and acquisitions, and leading organizations through growth and transformation. She currently serves as Chief Legal Officer and Executive Vice President at Ultragenyx Pharmaceutical Inc., a global biopharmaceutical company advancing a diverse portfolio of approved therapies and product candidates – including gene therapies – for ultra-rare genetic diseases. Her previous experience includes over a decade in roles of increasing responsibility at Allergan plc. Ms. Parschauer began her legal career at Latham & Watkins LLP. She is currently a member of the Board of Directors for Evolus, Inc. (NASDAQ:EOLS) and Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB). Ms. Parschauer earned her B.A. from Miami University and J.D. from Harvard Law School.

    Ms. Auch brings over 15 years of human resources experience across various industries, including pharmaceutical, healthcare and technology. She most recently served as Head of Human Resources for North America at Santen, Inc., a global pharmaceutical company focused on ophthalmology, where among other responsibilities she led the human resources integration for two acquisitions. Ms. Auch earned her B.A. from San Jose State University and is a member of CSHRP, Community for Strategic HR Partnerships. She will report to Tenaya's CEO in a newly created role leading all aspects of human resources including talent acquisition and management, culture and values, compensation and benefits and organizational effectiveness.

    About Tenaya Therapeutics

    Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. 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 "expects" and "will," and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, statements by Tenaya's chief executive officer and its board members. 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: 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; the timing, progress and results of preclinical studies for TN-201, TYA-11631 and Tenaya's other programs; Tenaya's ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Tenaya's manufacturing and operations, including preclinical studies and planned clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; 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 reliance on third parties; 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.

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  2. Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today announced changes to its Board of Directors including the addition of June Lee, M.D., and the transition of JJ Kang, Ph.D., who will be stepping down after five years of service.

    "We are thrilled to welcome Dr. Lee to our Board at an important inflection point as we continue our transition towards becoming a clinical-stage company," said Faraz Ali, CEO of Tenaya. "Dr. Lee brings a wealth of highly relevant strategic and operational development experience to Tenaya and is well-positioned to support us in our mission to bring new hope to individuals and…

    Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today announced changes to its Board of Directors including the addition of June Lee, M.D., and the transition of JJ Kang, Ph.D., who will be stepping down after five years of service.

    "We are thrilled to welcome Dr. Lee to our Board at an important inflection point as we continue our transition towards becoming a clinical-stage company," said Faraz Ali, CEO of Tenaya. "Dr. Lee brings a wealth of highly relevant strategic and operational development experience to Tenaya and is well-positioned to support us in our mission to bring new hope to individuals and families fighting both rare and prevalent forms of heart disease."

    Dr. Lee was most recently Founder and CEO of Esker Therapeutics. She previously served as Executive Vice President, Chief Development Officer and Chief Operating Officer of MyoKardia from 2017 to 2020. In this role, Dr. Lee built and led a world-class global development organization to advance novel therapies for cardiomyopathies through clinical development. She was previously also therapeutic area head for early clinical development in cardiovascular, metabolism, respiratory, and infectious diseases at Genentech. She currently serves on the Advisory Board for Johns Hopkins University Center for Therapeutic Translation, serves as a Board Director for Eledon Pharmaceuticals Inc. and for GenEdit, and is a member of the Scientific Advisory Board for Foresite Labs. Dr. Lee completed a Bachelor of Science in chemistry at Johns Hopkins University, an M.D. at the School of Medicine at the University of California, Davis, and her clinical training in internal medicine and pulmonary & critical care at UCLA and UCSF.

    "I am very pleased to join Tenaya at such a pivotal time for the company and for the entire field of precision medicine therapies for heart disease," said Dr. Lee. "I look forward to helping Tenaya realize the full potential of its differentiated science and capabilities in order to advance potentially transformative medicines through clinical development and towards future approvals."

    In addition, Dr. Kang has decided to resign from Tenaya's Board to focus on her current role as CEO of Appia Bio and as a Venture Partner at The Column Group. Dr. Kang helped launch Tenaya in 2016 and has since served as a valued Board member. She also served in the capacity of interim Tenaya President for the first two years of the company's history.

    "We cannot thank Dr. Kang enough for her many contributions to Tenaya over the last five years as a pre-clinical stage company," said David Goeddel, Ph.D., Chair of Tenaya's Board of Directors and Managing Partner at The Column Group. "We now welcome Dr. Lee to our Board and look forward to her contributions in support of Tenaya's future evolution and growth."

    About Tenaya Therapeutics

    Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. 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 "expects" and "will," and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, statements by Tenaya's chief executive officer and its board members. 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: 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; the timing, progress and results of preclinical studies for TN-201 and Tenaya's other programs; Tenaya's ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Tenaya's manufacturing and operations, including preclinical studies and planned clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; 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 reliance on third parties; 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.

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  3. Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, announced today that Faraz Ali, Chief Executive Officer, will participate in the following conference:

    33rd Annual Piper Sandler Healthcare Conference
    November 29 – December 2, with a fireside chat webcast available beginning Monday, November 22, 2021 at 10:00 a.m. ET / 7:00 a.m. PT

    About Tenaya Therapeutics

    Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes…

    Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, announced today that Faraz Ali, Chief Executive Officer, will participate in the following conference:

    33rd Annual Piper Sandler Healthcare Conference

    November 29 – December 2, with a fireside chat webcast available beginning Monday, November 22, 2021 at 10:00 a.m. ET / 7:00 a.m. PT

    About Tenaya Therapeutics

    Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. For more information, visit www.tenayatherapeutics.com.

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  4. - Initiated global natural history study for pediatric patients with MYBPC3 mutation to support clinical development of TN-201 gene therapy

    - Presented preclinical data supporting both TN-201 and PKP2 gene therapy programs at the European Society of Gene and Cell Therapy conference demonstrating significant and durable disease reversal and survival in severe murine models of disease

    - Initiated cGMP manufacturing to support the IND filing for TYA-11631 small molecule for HFpEF

    Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today reported business and program updates and third quarter 2021 financial results…

    - Initiated global natural history study for pediatric patients with MYBPC3 mutation to support clinical development of TN-201 gene therapy

    - Presented preclinical data supporting both TN-201 and PKP2 gene therapy programs at the European Society of Gene and Cell Therapy conference demonstrating significant and durable disease reversal and survival in severe murine models of disease

    - Initiated cGMP manufacturing to support the IND filing for TYA-11631 small molecule for HFpEF

    Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today reported business and program updates and third quarter 2021 financial results.

    "The third quarter of 2021 was a significant marker in Tenaya's history with the successful completion of our IPO, and it also represented a period of growth for the company as we continued to make progress on our key pipeline programs and operations," said Faraz Ali, CEO of Tenaya. "We are pleased to announce the initiation of our global natural history study for pediatric patients with MYBPC3 mutations, as this supports our TN-201 gene therapy program as well as our evolution towards becoming a clinical-stage company. The initiation of cGMP manufacturing for TYA-11631 is an important operational milestone and another step in the direction of our vision for modality-agnostic drug discovery. The first-ever presentation of data supporting our PKP2 gene therapy program at an important scientific conference provides new hope for individuals and families fighting the leading genetic cause of Arrhythmogenic Right Ventricular Cardiomyopathy, a severe disease with high unmet need."

    Business and Program Updates

    • TN-201 – MYBPC3 Gene Therapy Program for Genetic HCM (gHCM):
      • Pre-clinical data on the treatment in a severe MYBPC3 mutant mouse model of gHCM with TN-201 demonstrating extended survival to 18 months after a single dose and continued improvement in functional measures was presented at the annual meeting of the European Society of Gene and Cell Therapy (ESGCT) in October 2021.
      • Tenaya has initiated a global natural history study to improve our understanding of disease progression and unmet need in individuals carrying mutations in the MYBPC3 gene, with an initial focus on pediatric patients under the age of 18. For additional information about the natural history study, please visit www.clinicaltrials.gov using Identifier NCT05112237. These efforts may support the evaluation of Tenaya's TN-201 gene therapy product candidate in this patient population during clinical development.
      • Tenaya has initiated IND-enabling activities and intends to submit an investigational new drug (IND) application or clinical trial application (CTA) to the U.S. Food and Drug Administration (FDA) or European Medicine Agency (EMA), respectively, in 2022.
    • TYA-11631 – HDAC6 Inhibitor (HDAC6i) Small Molecule for Heart Failure with Preserved Ejection Fraction (HFpEF)
      • Tenaya has initiated cGMP manufacturing activities to support the production of TYA-11631 at larger scales. Tenaya had previously announced initiation of IND-enabling activities and intends to submit an IND to the FDA in 2022.
    • PKP2 Gene Therapy Program for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
      • Pre-clinical data on the treatment of a severe mouse model of ARVC due to PKP2 gene mutations with Tenaya's gene therapy product construct demonstrated prevention of symptoms and continued, significant improvement in functional measures and survival benefit at 15 weeks after a single dose as presented in a poster at ESGCT. Mutations due to the PKP2 gene are the leading genetic cause of ARVC, a severe disease estimated to effect more than 70,000 patients in the US alone and with no approved disease-specific therapies.
    • Strong balance sheet with net proceeds of $188.5 million from the sale of 13.8 million shares of its common stock in the Company's initial public offering (IPO), bringing cash, cash equivalents and investments in marketable securities to $280.5 million as of September 30, 2021.

    Third Quarter 2021 Financial Highlights

    • Cash Position: As of September 30, 2021, Tenaya had cash, cash equivalents and investments in marketable securities of $280.5 million which included net proceeds from the Company's IPO in August 2021. Tenaya expects its current cash, cash equivalents and investments in marketable securities will be sufficient to fund its current operating plan at least into the second half of 2023.
    • Research & Development (R&D) Expenses: R&D expenses were $12.9 million for the third quarter of 2021. Non-cash stock-based compensation included in R&D expense was $0.3 million for the third quarter of 2021.
    • General & Administrative (G&A) Expenses: G&A expenses were $5.4 million for the third quarter of 2021. Non-cash stock-based compensation included in G&A expense was $0.6 million for the third quarter of 2021.
    • Net Loss: Net loss was $18.3 million, or $0.68 on a per share basis, for the third quarter of 2021.

    About Tenaya Therapeutics

    Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. 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. Such forward-looking statements include, among other things, statements regarding the potential of and expectations regarding Tenaya's product candidates and programs, including TN-201 and TYA-11631; statements regarding the expected timing of IND and CTA submissions to the FDA or EMA, respectively, for Tenaya's product candidates; statements regarding the sufficiency of Tenaya's cash, cash equivalents and investments in marketable securities to fund its operating plan; and statements by Tenaya's chief executive officer. Words such as "expects," "intends," "potential," "utility," and "will," and similar expressions are intended to identify forward-looking statements. 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. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: 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 clinical stage company including the potential for Tenaya's product candidates to cause serious adverse events; Tenaya's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates for heart failure patients or other patient populations; the timing, progress and results of preclinical studies and clinical trials for TN-201 and TYA-11631 and Tenaya's other product candidates and programs; Tenaya's ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Tenaya's manufacturing and operations, including preclinical studies and clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; Tenaya's ability to develop a proprietary drug discovery platform to build a pipeline of product candidates; 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 reliance on third parties; 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 the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    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,

     

     

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    12,944

     

     

    $

    8,480

     

     

    $

    33,440

     

     

    $

    22,735

     

    General and administrative

     

     

    5,356

     

     

     

    1,972

     

     

     

    13,202

     

     

     

    5,855

     

    Total operating expenses

     

     

    18,300

     

     

     

    10,452

     

     

     

    46,642

     

     

     

    28,590

     

    Loss from operations

     

     

    (18,300

    )

     

     

    (10,452

    )

     

     

    (46,642

    )

     

     

    (28,590

    )

    Other income (expense), net:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    23

     

     

     

    7

     

     

     

    41

     

     

     

    82

     

    Change in fair value of convertible preferred stock tranche liability

     

     

     

     

     

    151

     

     

     

     

     

     

    75

     

    Other income (expense), net

     

     

    15

     

     

     

    (1

    )

     

     

    31

     

     

     

    356

     

    Total other income (expense), net

     

     

    38

     

     

     

    157

     

     

     

    72

     

     

     

    513

     

    Net loss before income tax expense

     

     

    (18,262

    )

     

     

    (10,295

    )

     

     

    (46,570

    )

     

     

    (28,077

    )

    Income tax expense

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss

     

     

    (18,262

    )

     

     

    (10,295

    )

     

     

    (46,570

    )

     

     

    (28,077

    )

    Other comprehensive loss:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Unrealized loss on marketable securities

     

     

    (23

    )

     

     

     

     

     

    (23

    )

     

     

     

    Comprehensive loss

     

    $

    (18,285

    )

     

    $

    (10,295

    )

     

    $

    (46,593

    )

     

    $

    (28,077

    )

    Net loss per share, basic and diluted

     

    $

    (0.68

    )

     

    $

    (10.29

    )

     

    $

    (4.75

    )

     

    $

    (29.65

    )

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

     

     

    26,895,716

     

     

     

    1,000,052

     

     

     

    9,808,162

     

     

     

    947,009

     

    TENAYA THERAPEUTICS, INC.

    Condensed Balance Sheets

    (In thousands)

     

     

    September 30,

     

     

    December 31,

     

     

     

    2021

     

     

    2020

     

    ASSETS

     

    (Unaudited)

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    117,077

     

     

    $

    128,535

     

    Investments in marketable securities

     

     

    163,388

     

     

     

     

    Prepaid expenses and other current assets

     

     

    4,357

     

     

     

    1,429

     

    Total current assets

     

     

    284,822

     

     

     

    129,964

     

    Property and equipment, net

     

     

    30,891

     

     

     

    17,185

     

    Operating lease right-of-use assets

     

     

    12,006

     

     

     

     

    Restricted cash, non-current

     

     

    547

     

     

     

    547

     

    Other non-current assets

     

     

    3,528

     

     

     

    465

     

    Total assets

     

    $

    331,794

     

     

    $

    148,161

     

    LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    6,171

     

     

    $

    1,017

     

    Accrued expenses and other current liabilities

     

     

    5,607

     

     

     

    3,161

     

    Deferred rent and other lease liabilities, current

     

     

     

     

     

    863

     

    Operating lease liabilities, current

     

     

    1,914

     

     

     

     

    Total current liabilities

     

     

    13,692

     

     

     

    5,041

     

    Deferred rent and other lease liabilities, non-current

     

     

     

     

     

    3,662

     

    Operating lease liabilities, non-current

     

     

    14,307

     

     

     

     

    Other non-current liabilities

     

     

    96

     

     

     

    19

     

    Total liabilities

     

     

    28,095

     

     

     

    8,722

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

    Convertible preferred stock

     

     

     

     

     

    220,754

     

    Stockholders' equity (deficit):

     

     

     

     

     

     

     

     

    Common stock

     

     

    4

     

     

     

     

    Additional paid-in capital

     

     

    433,112

     

     

     

    1,584

     

    Notes receivable from stockholders

     

     

    (12

    )

     

     

    (87

    )

    Accumulated other comprehensive loss

     

     

    (23

    )

     

     

     

    Accumulated deficit

     

     

    (129,382

    )

     

     

    (82,812

    )

    Total stockholders' equity (deficit)

     

     

    303,699

     

     

     

    (81,315

    )

    Total liabilities, convertible preferred stock and stockholders' equity (deficit)

     

    $

    331,794

     

     

    $

    148,161

     

     

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