Tyra Biosciences(TYRA) - 2024 Q2 - Quarterly Results

Business and Pipeline Highlights Tyra Biosciences advanced its pipeline in Q2 2024 with significant milestones, including FDA IND clearance for TYRA-430 and positive preclinical data for TYRA-300, while preparing for key clinical updates and corporate transitions - The FDA cleared the Investigational New Drug (IND) application for TYRA-430, an FGFR4/3 biased inhibitor for hepatocellular carcinoma (HCC)[1][6] - Reported positive preclinical proof-of-concept for TYRA-300 in hypochondroplasia (HCH), showing increases in long bone length[1][4] - Key catalysts expected in the second half of 2024 include initial Phase 1 results for the SURF301 study and an IND submission for TYRA-300 in achondroplasia (ACH)[1][4] - Announced a transition plan for the Chief Medical Officer (CMO) and strengthened the Board's Science & Technology Committee with new expert members[1][3][7] TYRA-300 Program Updates The TYRA-300 program is advancing with the SURF301 oncology study, a planned Phase 2 study in achondroplasia, and expanded development into hypochondroplasia following positive preclinical results - The SURF301 Phase 1/2 study in FGFR3+ solid tumors is advancing, with initial Phase 1 results anticipated at a scientific congress in 2H 2024[3][4] - An Investigational New Drug (IND) application for a Phase 2 trial of TYRA-300 in children with achondroplasia is on track for submission in 2H 2024[4] - Development has expanded into hypochondroplasia (HCH) after preclinical models demonstrated TYRA-300 increased long bone length and bound to the HCH altered protein[4] - The FDA has granted TYRA-300 Orphan Drug Designation (ODD) and Rare Pediatric Designation (RPD) for the treatment of achondroplasia[11] TYRA-200 Program Updates The Phase 1 SURF201 study of TYRA-200 is actively enrolling and dosing patients with advanced intrahepatic cholangiocarcinoma and other solid tumors with activating FGFR2 gene alterations - The Phase 1 SURF201 study is actively enrolling patients to evaluate the safety, tolerability, and preliminary antitumor activity of TYRA-200[5] - The target patient population includes adults with advanced intrahepatic cholangiocarcinoma and other solid tumors with activating FGFR2 gene alterations[5] TYRA-430 Program Updates The FDA cleared the IND for TYRA-430, an FGFR4/3-biased inhibitor, enabling initiation of a Phase 1 clinical study in advanced hepatocellular carcinoma and other solid tumors - The FDA cleared the IND to begin a Phase 1, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors[6] - TYRA-430 has the potential to be a first-in-class biomarker-driven, targeted therapy for HCC, where no such approved therapies currently exist[6] Corporate Developments Tyra Biosciences announced new independent director appointments to its Board and a planned transition for its Chief Medical Officer, with a search for a successor underway - Appointed Susan Moran, M.D., M.S.C.E. and S. Michael Rothenberg, M.D., Ph.D. as independent directors to the Board[7] - Chief Medical Officer (CMO) Hiroomi Tada, M.D., Ph.D., will depart by the end of the year, transitioning to an advisor, with an external search for a replacement in progress[7] Q2 2024 Financial Performance Tyra Biosciences reported an increased net loss of $18.7 million in Q2 2024 due to higher R&D and G&A expenses, while maintaining a strong cash position of $373.8 million expected to fund operations through at least 2026 Summary of Financial Results Q2 2024 net loss increased to $18.7 million from $13.3 million in Q2 2023, driven by higher R&D and G&A expenses, while the company maintained a robust cash position of $373.8 million Financial Metric Comparison | Financial Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Net Loss | $18.7 million | $13.3 million | | R&D Expenses | $18.0 million | $12.2 million | | G&A Expenses | $5.5 million | $3.9 million | - As of June 30, 2024, cash, cash equivalents, and marketable securities totaled $373.8 million[10] - The current cash position is expected to fund operations through at least 2026[10] Condensed Balance Sheet As of June 30, 2024, the balance sheet reflects a significant increase in liquidity and total assets, with cash, cash equivalents, and marketable securities growing to $373.8 million from $203.5 million at year-end 2023 Balance Sheet Data | Balance Sheet Data (in thousands) | June 30, 2024 (unaudited) | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $373,796 | $203,469 | | Working capital | $368,192 | $196,338 | | Total assets | $392,461 | $225,857 | | Total stockholders' equity | $376,043 | $204,262 | Condensed Statements of Operations For the three months ended June 30, 2024, Tyra reported a net loss of $18.7 million or ($0.32) per share, an increase from $13.3 million or ($0.31) per share in the prior year, reflecting increased R&D investment Statements of Operations | Statement of Operations (in thousands, except per share data) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | | :--- | :--- | :--- | | Research and development | $17,997 | $12,162 | | General and administrative | $5,535 | $3,852 | | Loss from operations | ($23,532) | ($16,014) | | Net loss | ($18,702) | ($13,272) | | Net loss per share, basic and diluted | ($0.32) | ($0.31) | About the Company and Forward-Looking Statements Tyra Biosciences is a clinical-stage biotechnology company developing precision medicines using its SNÅP platform, with the report including standard forward-looking statements regarding inherent risks in drug development - Tyra is a clinical-stage biotech focused on developing precision medicines targeting Fibroblast Growth Factor Receptor (FGFR) biology[13] - The company's in-house SNÅP platform enables rapid drug design to predict and overcome acquired resistance to existing therapies[9][13] - The press release contains forward-looking statements regarding clinical development timelines, potential benefits of product candidates, and financial runway, which are subject to risks and uncertainties[14]