Tenaya Therapeutics(TNYA) - 2023 Q4 - Annual Results

Overview and Key Milestones Tenaya Therapeutics reported Q4/FY2023 results, emphasizing genetic medicine progress and extended cash runway Corporate Update and 2024 Outlook 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] - 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] - Net proceeds of $47 million from a recent financing extended the company's cash runway into the second half of 2025[1] - 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] Clinical Program Updates 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 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] - Initial data on safety, tolerability, and clinical efficacy from the first cohort is anticipated in the second half of 2024[3] - 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] TN-401 for PKP2-Associated ARVC 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] - TN-401 received Fast Track Designation from the U.S. FDA in November 2023[9] TN-301 Small Molecule for HFpEF 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] - Robust pharmacodynamic effects, including HDAC6 inhibition, were observed and correlated with increasing doses[9] - New preclinical data showed additive benefits when combining TN-301 with empagliflozin in validated HFpEF mouse models[9] Financials and Corporate Developments 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 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 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] - As of December 31, 2023, cash, cash equivalents, and marketable securities were $104.6 million[8] - The company expects its current funds to be sufficient to support operations into the second half of 2025[8] Financial Statements This section presents Tenaya's condensed statements of operations and balance sheet data Condensed Statements of Operations 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 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 |