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Tenaya Therapeutics Announces Research Leadership Updates
Newsfilter· 2024-06-27 21:00
Core Insights - Tenaya Therapeutics, a clinical-stage biotechnology company, announced leadership changes in its research team, including the promotion of Kathy Ivey, Ph.D., to Senior Vice President of Research and the transition of Timothy Hoey, Ph.D., to an advisory role [2][10] - Barry J. Byrne, M.D., Ph.D., a pediatric cardiologist and genetic therapy expert, has joined Tenaya's Scientific Advisory Board, bringing valuable expertise in genetic therapies for heart diseases [9][12] Leadership Changes - Kathy Ivey has been with Tenaya since its formation in 2016 and has led the company's genetic medicines discovery efforts, overseeing programs in gene therapy, gene editing, and regenerative medicine [3][11] - Timothy Hoey, who served as Chief Scientific Officer since 2017, will remain with the company in an advisory capacity after stepping down from his role [2][10] - Jin-Long Chen, Ph.D., is stepping down from the Board of Directors after over seven years of service to focus on other commitments [4][10] Company Mission and Pipeline - Tenaya Therapeutics aims to discover, develop, and deliver potentially curative therapies targeting the underlying causes of heart disease [13] - The company is advancing a pipeline that includes TN-201 for MYBPC3-associated hypertrophic cardiomyopathy, TN-401 for PKP2-associated arrhythmogenic right ventricular cardiomyopathy, and TN-301, a small molecule HDAC6 inhibitor for heart failure with preserved ejection fraction [13]
Tenaya Therapeutics Announces Research Leadership Updates
GlobeNewswire News Room· 2024-06-27 21:00
Pediatric Cardiologist and Genetic Therapy Expert Barry J. Byrne, M.D., Ph.D., Joins Scientific Advisory Board SOUTH SAN FRANCISCO, Calif., June 27, 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 announced changes to its Research leadership team, including new appointments to the company's Scientific Advisory Boar ...
Tenaya Therapeutics to Participate at the TD Cowen Genetic Medicines & RNA Summit
Newsfilter· 2024-06-18 20:30
SOUTH SAN FRANCISCO, Calif., June 18, 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 announced that Faraz Ali, Chief Executive Officer, will participate in the TD Cowen Genetic Medicines & RNA Summit on Friday, June 21, 2024, at 11:20 am ET. The live presentation will be webcast and may be accessed from the Investo ...
Tenaya Therapeutics(TNYA) - 2024 Q1 - Quarterly Report
2024-05-14 20:15
Commission File Number: 001-40656 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ TENAYA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 81-3789973 (St ...
Tenaya Therapeutics(TNYA) - 2024 Q1 - Quarterly Results
2024-05-14 20:09
Exhibit 99.1 Tenaya Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update Initial Data from Ongoing MyPEAK TM-1 Phase 1b of TN-201 Expected in Second Half of 2024 Clinical Sites Activated for RIDGE TM-1 Phase 1b Clinical Trial of TN-401 Announced Cost Containment Measures in Alignment with Focus on Generating Data from Clinical-Stage Gene Therapy Programs Raised $47 Million Net Proceeds in First Quarter Financing; Current Cash Runway into Second Half of 2025 SOUTH SAN FRANCI ...
Tenaya Therapeutics(TNYA) - 2023 Q4 - Annual Report
2024-03-18 20:10
Financial Performance - The company reported total operating expenses of $131.2 million for the year ended December 31, 2023, an increase of 4% from $125.6 million in 2022[483]. - The company incurred a net loss of $124.1 million for the year ended December 31, 2023, compared to a net loss of $123.7 million in 2022, reflecting a marginal increase of $419, or 0%[491]. - Net cash used in operating activities for the year ended December 31, 2023, was $102.1 million, compared to $104.4 million in 2022[501][502]. - Net cash provided by investing activities for the year ended December 31, 2023, was $48.7 million, down from $83.7 million in 2022[503][504]. - Net cash provided by financing activities for the year ended December 31, 2023, was $4.0 million, significantly lower than $77.8 million in 2022[505]. - The company expects to incur operating losses in the foreseeable future, with operating expenses anticipated to remain relatively flat over the next twelve months[497]. Research and Development - Research and development expenses were $98.0 million in 2023, up 4% from $94.5 million in 2022, primarily due to an increase of $8.9 million in personnel-related costs[485]. - The company initiated dosing in the MyPeak-1 Phase 1b clinical trial for TN-201 in October 2023, with initial data expected in the second half of 2024[473]. - The FDA cleared the IND application for TN-401 in October 2023, with patient dosing planned to begin in the second half of 2024[476]. - TN-301 showed positive results in a Phase 1 clinical trial, demonstrating good tolerability and pharmacokinetic properties supportive of once-daily dosing[479]. - The company plans to advance its lead gene therapy product candidates, TN-201 and TN-401, and expand clinical trials into late-stage development[498]. Funding and Capital - The company completed a follow-on offering on February 12, 2024, raising approximately $46.5 million from the sale of 8,888,890 shares at $4.50 per share[493]. - The company raised approximately $76.9 million from the purchase of an additional 2,816,409 shares of common stock after deducting underwriting discounts and commissions[495]. - As of December 31, 2023, the company has approximately $71.0 million available for issuance under its "at-the-market" equity offering[496]. Company Status and Classification - The company has not generated any revenue to date and has an accumulated deficit of $403.3 million as of December 31, 2023[492]. - The company is classified as an emerging growth company and a smaller reporting company, with annual revenue below $100 million and market value of stock held by non-affiliates less than $700 million[517][519]. Lease Obligations - The company has future minimum lease payments of approximately $5.1 million and $10.9 million remaining on its South San Francisco and Union City leases, respectively[506]. Off-Balance Sheet Arrangements - The company has not engaged in any off-balance sheet arrangements since inception[509]. Interest Income - Interest income increased significantly by 261% to $7.1 million in 2023, up from $2.0 million in 2022, primarily due to higher interest rates on investments[490].
Tenaya Therapeutics(TNYA) - 2023 Q4 - Annual Results
2024-03-18 20:08
[Overview and Key Milestones](index=1&type=section&id=Tenaya%20Therapeutics%20Reports%20Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Results%20and%20Provides%20Business%20Update) Tenaya Therapeutics reported Q4/FY2023 results, emphasizing genetic medicine progress and extended cash runway [Corporate Update and 2024 Outlook](index=1&type=section&id=Corporate%20Update) Tenaya reported Q4/FY2023 results, highlighting genetic medicine progress, upcoming trial data, and extended cash runway - Initial data from the MyPeak™-1 Phase 1b trial of TN-201 for HCM is expected in the **second half of 2024**[1](index=1&type=chunk) - The first patient in the RIDGE™-1 Phase 1b trial of TN-401 for ARVC is expected to be dosed in the **second half of 2024**[1](index=1&type=chunk) - Net proceeds of **$47 million** from a recent financing extended the company's cash runway into the **second half of 2025**[1](index=1&type=chunk) - CEO Faraz Ali highlighted key 2023 achievements, including IND clearances for TN-201 and TN-401, dosing the first patient with TN-201, and in-house cGMP manufacturing of clinical trial materials[2](index=2&type=chunk) [Clinical Program Updates](index=1&type=section&id=Business%20and%20Program%20Updates) Tenaya provides updates on its gene therapy programs for HCM and ARVC, and its small molecule program for HFpEF [TN-201 for MYBPC3-Associated HCM](index=1&type=section&id=TN-201%20%E2%80%93%20Gene%20Therapy%20for%20MYBPC3-Associated%20Hypertrophic%20Cardiomyopathy%20%28HCM%29) MyPEAK-1 Phase 1b trial for TN-201 dosed its first patient in October 2023, with initial data expected in H2 2024 - The first patient in the MyPEAK-1 Phase 1b trial was dosed in **October 2023**[3](index=3&type=chunk) - Initial data on safety, tolerability, and clinical efficacy from the first cohort is anticipated in the **second half of 2024**[3](index=3&type=chunk) - Interim data from a related study indicated that low levels of preexisting neutralizing antibodies to AAV9 could make a majority of MYBPC3-associated HCM patients eligible for TN-201[4](index=4&type=chunk) [TN-401 for PKP2-Associated ARVC](index=2&type=section&id=TN-401%20%E2%80%93%20Gene%20Therapy%20for%20PKP2-Associated%20Arrhythmogenic%20Right%20Ventricular%20Cardiomyopathy%20%28ARVC%29) Tenaya plans to initiate TN-401 RIDGE-1 Phase 1b trial dosing in H2 2024, following FDA Fast Track Designation - Patient dosing in the RIDGE-1 Phase 1b clinical trial is on track to begin in the **second half of 2024**[9](index=9&type=chunk) - TN-401 received **Fast Track Designation** from the U.S. FDA in **November 2023**[9](index=9&type=chunk) [TN-301 Small Molecule for HFpEF](index=2&type=section&id=TN-301%20%E2%80%93%20Small%20Molecule%20HDAC6%20Inhibitor%20for%20Heart%20Failure%20with%20Preserved%20Ejection%20Fraction%20%28HFpEF%29) TN-301, an HDAC6 inhibitor, showed positive Phase 1 results with good tolerability, once-daily dosing potential, and additive preclinical benefits - Phase 1 results showed TN-301 was generally well-tolerated with a half-life supportive of **once-daily dosing**[9](index=9&type=chunk) - Robust pharmacodynamic effects, including **HDAC6 inhibition**, were observed and correlated with increasing doses[9](index=9&type=chunk) - New preclinical data showed **additive benefits** when combining TN-301 with empagliflozin in validated HFpEF mouse models[9](index=9&type=chunk) [Financials and Corporate Developments](index=2&type=section&id=Financials%20and%20Corporate%20Developments) This section details Tenaya's Q4/FY2023 financial performance, including expenses, net loss, and recent financing activities [Fourth Quarter and Full Year 2023 Financial Highlights](index=2&type=section&id=Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Highlights) Tenaya reported a **$124.1 million** net loss for FY2023, with **$98.0 million** in R&D expenses and **$104.6 million** cash Full Year 2023 Financial Summary | Metric | Full Year 2023 | | :--- | :--- | | R&D Expenses | $98.0 million | | G&A Expenses | $33.2 million | | Net Loss | $124.1 million | | Net Loss Per Share | $1.68 | Q4 2023 Financial Summary | Metric | Q4 2023 | | :--- | :--- | | R&D Expenses | $22.9 million | | G&A Expenses | $8.6 million | | Net Loss | $29.9 million | | Net Loss Per Share | $0.40 | [Financing and Cash Runway](index=2&type=section&id=Follow-on%20Financing) Tenaya secured **$46.5 million** in February 2024 financing, extending its cash runway into H2 2025 - Completed a follow-on offering in February 2024 with net proceeds of **$46.5 million**[7](index=7&type=chunk) - As of **December 31, 2023**, cash, cash equivalents, and marketable securities were **$104.6 million**[8](index=8&type=chunk) - The company expects its current funds to be sufficient to support operations into the **second half of 2025**[8](index=8&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents Tenaya's condensed statements of operations and balance sheet data [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) For FY2023, total operating expenses increased to **$131.2 million**, resulting in a net loss of **$124.1 million** or **($1.68)** per share Annual Statement of Operations (in thousands, except per share data) | Account | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | $98,038 | $94,537 | | General and administrative | $33,155 | $31,084 | | **Total operating expenses** | **$131,193** | **$125,621** | | Interest income | $7,056 | $1,954 | | **Net loss** | **$(124,084)** | **$(123,665)** | | Net loss per share, basic and diluted | $(1.68) | $(2.76) | | Weighted-average shares used | 73,786,126 | 44,823,597 | [Condensed Balance Sheet Data](index=6&type=section&id=Condensed%20Balance%20Sheet%20Data) As of December 31, 2023, cash, cash equivalents, and marketable securities were **$104.6 million**, with total assets at **$170.5 million** Balance Sheet Highlights (in thousands) | Account | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $104,642 | $204,230 | | Total assets | $170,515 | $278,945 | | Total liabilities | $31,091 | $35,569 |
Tenaya Therapeutics(TNYA) - 2023 Q3 - Quarterly Report
2023-11-08 21:21
Financial Performance - Net loss for Q3 2023 was $29.1 million, compared to a net loss of $30.7 million in Q3 2022, reflecting a decrease of $1.6 million[95]. - The net loss for the nine months ended September 30, 2023, was $94.1 million, compared to a net loss of $90.1 million in 2022, reflecting a 4% increase in losses[100]. - Cash used in operating activities was $80.1 million for the nine months ended September 30, 2023, slightly improved from $81.7 million in 2022[109]. - The company had cash, cash equivalents, and investments in marketable securities totaling $128.1 million as of September 30, 2023, with an accumulated deficit of $373.3 million[101]. - The company expects ongoing increases in expenses and operating losses due to continued product development and regulatory approval efforts[104]. Research and Development - Research and development expenses for Q3 2023 were $23.1 million, a decrease of 3% from $23.8 million in Q3 2022[86]. - Research and development expenses increased to $75.2 million for the nine months ended September 30, 2023, up from $68.8 million in 2022, representing a 9% increase[97]. - The company expects research and development expenses to remain flat for the remainder of 2023[90]. - TN-201, a gene therapy for hypertrophic cardiomyopathy, began dosing patients in a Phase 1b trial in October 2023, with initial data expected in 2024[78]. - TN-401, a gene therapy for arrhythmogenic right ventricular cardiomyopathy, received FDA clearance for clinical testing in October 2023[80]. - TN-301, a small molecule for heart failure with preserved ejection fraction, showed positive Phase 1 trial results, indicating robust HDAC6 inhibition[82]. - The company has initiated two non-interventional studies to support the development of TN-201, focusing on MYBPC3-associated cardiomyopathy[79]. - The Genetic Medicines Manufacturing Center is strategically located near research labs to support clinical studies and AAV-based gene therapies[85]. Expenses - General and administrative expenses increased to $7.8 million in Q3 2023, up 4% from $7.5 million in Q3 2022, primarily due to higher stock-based compensation[92]. - General and administrative expenses rose to $24.6 million in 2023, compared to $22.3 million in 2022, marking a 10% increase primarily due to higher stock-based compensation[98]. Income and Financing - Interest income rose significantly by 198% to $1.8 million in Q3 2023, up from $596,000 in Q3 2022, driven by higher interest rates on investments[86]. - Interest income surged to $5.6 million in 2023, a 509% increase from $917,000 in 2022, driven by higher interest rates on investments[99]. - The company raised $3.7 million from financing activities in 2023, primarily from at-the-market sales[113]. - The company has not generated any revenue since inception and relies on equity securities for funding operations[101]. Regulatory and Reporting Status - The company qualifies as a smaller reporting company under Rule 12b-2 and is not required to provide certain disclosures[122]. - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K[121]. - The company has reduced disclosure obligations regarding executive compensation due to its status as a smaller reporting company[121].
Tenaya Therapeutics(TNYA) - 2023 Q2 - Quarterly Report
2023-08-09 20:26
[PART I—FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section presents the unaudited financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures for the company [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements for Tenaya Therapeutics, Inc. as of June 30, 2023, including balance sheets, statements of operations, stockholders' equity, and cash flows, reporting a **$65.0 million** net loss and **$151.6 million** in cash and equivalents Condensed Balance Sheet Summary (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total Current Assets** | $138,906 | $193,754 | | Cash and cash equivalents | $75,565 | $95,272 | | **Total Assets** | $220,754 | $278,945 | | **Total Current Liabilities** | $20,917 | $24,248 | | **Total Liabilities** | $30,814 | $35,569 | | **Total Stockholders' Equity** | $189,940 | $243,376 | Condensed Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $26,477 | $20,876 | $52,082 | $45,031 | | General and administrative | $8,627 | $7,743 | $16,745 | $14,742 | | **Loss from operations** | $(35,104) | $(28,619) | $(68,827) | $(59,773) | | **Net loss** | $(33,269) | $(28,397) | $(65,006) | $(59,453) | Condensed Statement of Cash Flows Summary (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(56,510) | $(54,186) | | Net cash provided by investing activities | $33,146 | $46,644 | | Net cash provided by financing activities | $3,678 | $275 | | **Net change in cash, cash equivalents and restricted cash** | $(19,686) | $(7,267) | - As of June 30, 2023, the company had an accumulated deficit of **$344.2 million** and held **$151.6 million** in cash, cash equivalents, and marketable securities; management believes these funds are sufficient to support operations for at least the next twelve months[28](index=28&type=chunk)[29](index=29&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes the company's financial condition and operations, detailing its clinical-stage biotechnology business, lead product candidates, increased operating expenses, and liquidity, confirming sufficient funds for the next twelve months - Tenaya is a clinical-stage biotechnology company focused on developing curative therapies for heart disease, with a pipeline including gene therapies and small molecules[73](index=73&type=chunk) - Lead product candidates include: **TN-201** (gene therapy for HCM, Phase 1b trial expected Q3 2023, data 2024); **TN-301** (small molecule for HFpEF, Phase 1 topline data Q4 2023); **TN-401** (gene therapy for ARVC, IND submission expected H2 2023)[75](index=75&type=chunk)[76](index=76&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) - The company has established an in-house cGMP manufacturing facility, the Genetic Medicines Manufacturing Center, to support its portfolio of gene therapy and cellular regeneration candidates[82](index=82&type=chunk) - As of June 30, 2023, the company had **$151.6 million** in cash, cash equivalents, and marketable securities, believed sufficient to fund operations for at least the next twelve months[98](index=98&type=chunk)[101](index=101&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Operating expenses and net loss increased for both three and six-month periods ended June 30, 2023, primarily driven by higher research and development and general and administrative expenses Comparison of Three Months Ended June 30, 2023 and 2022 (in thousands) | Metric | 2023 | 2022 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $26,477 | $20,876 | $5,601 | 27% | | General and administrative | $8,627 | $7,743 | $884 | 11% | | **Total operating expenses** | $35,104 | $28,619 | $6,485 | 23% | | **Net loss** | $(33,269) | $(28,397) | $(4,872) | 17% | Comparison of Six Months Ended June 30, 2023 and 2022 (in thousands) | Metric | 2023 | 2022 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $52,082 | $45,031 | $7,051 | 16% | | General and administrative | $16,745 | $14,742 | $2,003 | 14% | | **Total operating expenses** | $68,827 | $59,773 | $9,054 | 15% | | **Net loss** | $(65,006) | $(59,453) | $(5,553) | 9% | - The increase in R&D expenses for the six months ended June 30, 2023, was primarily driven by a **$5.7 million** increase in employee-related costs (higher stock-based compensation and 2022 tax credits) and a **$2.0 million** increase in facility and laboratory costs[94](index=94&type=chunk)[97](index=97&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) The company primarily funds operations through equity sales, holding **$151.6 million** in cash and equivalents as of June 30, 2023, with recent capital raises including a **$76.9 million** offering and **$3.9 million** from an ATM offering, sufficient for the next twelve months but requiring future funding - The company completed an underwritten public offering in November 2022, receiving total net proceeds of **$76.9 million**[99](index=99&type=chunk) - Through its "at-the-market" (ATM) equity offering, the company sold 535,767 shares during Q2 2023, resulting in proceeds of **$3.9 million**, net of commissions[100](index=100&type=chunk) - Net cash used in operating activities was **$56.5 million** for the first six months of 2023, compared to **$54.2 million** for the same period in 2022, primarily driven by the net loss[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Tenaya Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[119](index=119&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes in internal control over financial reporting during the quarter - Management concluded that as of the end of the period, the company's disclosure controls and procedures are effective to provide reasonable assurance that required information is recorded, processed, and reported in a timely manner[120](index=120&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[121](index=121&type=chunk) [PART II—OTHER INFORMATION](index=26&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section covers legal proceedings, risk factors, unregistered sales of equity securities, and other miscellaneous information including exhibits [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings expected to adversely affect its business - The company is not currently involved in any material legal proceedings[125](index=125&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant investment risks, including the company's early development stage, history of losses, need for capital, uncertain drug development, manufacturing challenges, competition, and intellectual property concerns - The company is in the early stages of development with a limited operating history, has only completed one clinical trial, and has no products approved for commercial sale[127](index=127&type=chunk)[128](index=128&type=chunk) - The company has a history of significant net losses (**$344.2 million** accumulated deficit as of June 30, 2023) and expects to continue incurring losses for the foreseeable future[127](index=127&type=chunk)[131](index=131&type=chunk) - Substantial additional capital is required to finance operations; failure to raise capital when needed could force the company to delay, reduce, or eliminate research and development programs[127](index=127&type=chunk)[137](index=137&type=chunk) - Drug development is a lengthy, expensive, and uncertain process; preclinical and clinical trials may not demonstrate the required safety and efficacy, and early positive results may not be predictive of future success[127](index=127&type=chunk)[164](index=164&type=chunk) - The company faces risks related to manufacturing its complex gene therapy products, both in-house and through third parties, and must comply with significant government regulations (cGMP)[127](index=127&type=chunk)[198](index=198&type=chunk)[203](index=203&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=73&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred during the period, and the **$188.5 million** net proceeds from the August 2021 IPO remain unchanged in their planned use - There were no sales of unregistered securities in the period[386](index=386&type=chunk) - The company's IPO on August 3, 2021, generated net proceeds of **$188.5 million**; there has been no material change in the planned use of these proceeds[387](index=387&type=chunk) [Item 3. Defaults Upon Senior Securities](index=73&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable to the company [Item 4. Mine Safety Disclosures](index=73&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company [Item 5. Other Information](index=73&type=section&id=Item%205.%20Other%20Information) No other information is reported in this section [Item 6. Exhibits](index=74&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including bylaws, compensation plans, officer certifications, and XBRL data files [Signatures](index=76&type=section&id=SIGNATURES) This section contains the required signatures for the filing
Tenaya Therapeutics(TNYA) - 2023 Q1 - Quarterly Report
2023-05-10 20:35
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ Commission File Number: 001-40656 TENAYA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 81-3789973 (St ...