Tyra Biosciences(TYRA) - 2025 Q2 - Quarterly Results

Company Overview & Q2 2025 Highlights Tyra Biosciences reported Q2 2025 results, highlighting clinical progress in SURF302 and a strong financial position through 2027 Introduction and Strategic Focus Tyra Biosciences announced Q2 2025 results, emphasizing clinical advancements in SURF302 and a robust financial outlook through 2027 - Dosed the first patient in SURF302 for intermediate risk non-muscle invasive bladder cancer (IR NMIBC)[1] - $296.3 million in cash, cash equivalents, and marketable securities at Q2 2025 provides a financial runway through at least 2027[1] - Strategic focus on transforming bladder cancer and skeletal dysplasia treatment by precisely targeting FGFR3 with dabogratinib[2] About Tyra Biosciences Tyra Biosciences is a clinical-stage biotech company developing next-generation precision medicines targeting FGFR biology using its SNÅP platform - A clinical-stage biotechnology company focused on developing next-generation precision medicines targeting large opportunities in FGFR biology[13] - Utilizes its in-house precision medicine platform, SNÅP, for rapid and precise drug design to predict genetic alterations causing acquired resistance[13] - Lead precision medicine, dabogratinib, is a potential first-in-class selective FGFR3 inhibitor designed to avoid toxicities associated with inhibition of FGFR1, FGFR2, and FGFR4[13] Pipeline and Program Updates Tyra Biosciences is advancing its pipeline with key updates on dabogratinib for IR NMIBC and achondroplasia, and progress on TYRA-430 and TYRA-200 programs Dabogratinib (TYRA-300) Dabogratinib, an oral FGFR3-selective inhibitor, is Tyra's lead precision medicine for IR NMIBC and achondroplasia, showing interim proof-of-concept - Dabogratinib (formerly TYRA-300) is an oral investigational FGFR3-selective inhibitor for IR NMIBC and ACH treatment[3] - It is TYRA's lead precision medicine candidate from its SNÅP platform, demonstrating interim clinical proof-of-concept in metastatic urothelial cancer (mUC)[8] - Designed to avoid toxicities associated with FGFR1, FGFR2, and FGFR4 inhibition, while being agnostic for FGFR3 gatekeeper mutations[13] SURF302 (IR NMIBC) The SURF302 study is evaluating dabogratinib's efficacy and safety in FGFR3-altered intermediate risk non-muscle invasive bladder cancer patients - Dosed the first patient in the Phase 2 NMIBC Study – SURF302, an open-label clinical study[3] - Evaluating efficacy and safety of dabogratinib in participants with FGFR3-altered low-grade, IR NMIBC[3] - Primary endpoint is complete response (CR) rate at three months, with participants randomized to 50 mg QD or 60 mg QD[3] BEACH301 (Achondroplasia) The BEACH301 study is a Phase 2 dose-escalation/expansion study enrolling children with achondroplasia to assess dabogratinib - Advanced Phase 2 ACH Study - BEACH301, a multicenter, open-label, dose-escalation/dose-expansion study[3] - Enrolling children ages 3 to 10 with achondroplasia with open growth plates, including treatment-naïve and prior growth-accelerating therapy cohorts[3] - Currently enrolling a safety sentinel cohort of up to 3 participants per dose level in children ages 5 to 10[3] SURF301 (Metastatic Urothelial Cancer) Dabogratinib continues evaluation in Part B of SURF301 for metastatic urothelial cancer, preparing for potential future Phase 2 studies - Dabogratinib continued evaluation in Part B of SURF301 (NCT05544552)[3] - Evaluation at potentially therapeutic QD doses is in preparation for potential future Phase 2 studies in mUC[3] Preclinical Results Preclinical results for dabogratinib presented at ENDO 2025 showed significant improvements in bone growth and skull development in FGFR3-driven models - Presented preclinical results at ENDO 2025, summarizing dabogratinib's effects across three genetic contexts[3] - Dabogratinib significantly improved the size and shape of the skull and foramen magnum in Fgfr3Y367C/+ mice[3] - Studies demonstrated a significant increase in bone growth in two independent FGFR3-driven preclinical models and wild-type mice, supporting broader development in skeletal dysplasias beyond ACH[3] Upcoming Clinical Milestones Key upcoming clinical milestones include dosing the first child in BEACH301 in Q3 2025 and initial SURF302 complete response data in 1H 2026 - BEACH301: dose first child with achondroplasia – 3Q 2025[11] - SURF302: topline initial three-month complete response data – 1H 2026[11] TYRA-430 TYRA-430, an oral FGFR4/3-biased inhibitor, is advancing in the Phase 1 SURF431 study for FGF19+/FGFR4-driven cancers, including HCC - Advanced Phase 1 SURF431 Study with ongoing patient dosing[4] - TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers[4] - Believed to address a significant unmet need in advanced hepatocellular carcinoma (HCC), lacking approved biomarker-driven, targeted therapies[4] TYRA-200 TYRA-200, an FGFR1/2/3 inhibitor, is progressing in the Phase 1 SURF201 study for advanced solid tumors with activating FGFR2 gene alterations - Advanced Phase 1 SURF201 Study, continuing to enroll and dose adults[5] - TYRA-200 is an FGFR1/2/3 inhibitor potent against activating FGFR2 gene alterations and resistance mutations[5] - The SURF201 study evaluates maximum tolerated dose, recommended Phase 2 dose, and preliminary antitumor activity in advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 alterations[12] SNÅP Platform TYRA continues to advance its proprietary in-house precision medicine discovery engine, SNÅP, for targeted oncology and genetically defined conditions - TYRA continued to advance its in-house precision medicine discovery engine, SNÅP[6] - The SNÅP platform is used to develop therapies in targeted oncology and genetically defined conditions[6] Second Quarter 2025 Financial Results Tyra Biosciences reported increased net loss in Q2 2025 due to higher R&D and G&A expenses, maintaining a strong cash position Financial Summary Tyra Biosciences reported a net loss of $28.1 million for Q2 2025, driven by increased R&D and G&A expenses, with a strong cash position of $296.3 million Q2 2025 Financial Highlights | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :-------------------------------- | :-------------------- | :-------------------- | :------------- | | Research and Development (R&D) Expenses | $24.3 | $18.0 | +$6.3 (+35%) | | General and Administrative (G&A) Expenses | $7.1 | $5.5 | +$1.6 (+29%) | | Net Loss | $(28.1) | $(18.7) | $(9.4) | | Cash, Cash Equivalents, and Marketable Securities | $296.3 (as of June 30, 2025) | N/A | N/A | - R&D expenses increased due to start-up and enrollment activities for BEACH301, SURF302, and SURF431, alongside increased CMC and personnel-related costs[11] - G&A expenses increased primarily due to higher personnel-related costs, including non-cash stock-based compensation[11] Condensed Balance Sheet Data Total assets decreased to $321.5 million by June 30, 2025, from $363.6 million at December 31, 2024, mainly due to reduced marketable securities Condensed Balance Sheet Data (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $98,490 | $91,966 | | Marketable securities | $197,781 | $249,475 | | Total current assets | $302,155 | $347,463 | | Total assets | $321,499 | $363,558 | | Total current liabilities | $13,770 | $14,594 | | Total liabilities | $19,352 | $20,407 | | Total stockholders' equity | $302,147 | $343,151 | Condensed Statements of Operations and Comprehensive Loss Net loss increased to $28.1 million in Q2 2025 from $18.7 million in Q2 2024, driven by higher operating expenses and lower interest income Condensed Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research and development | $24,309 | $17,997 | $49,273 | $35,199 | | General and administrative | $7,143 | $5,535 | $14,029 | $10,654 | | Total operating expenses | $31,452 | $23,532 | $63,302 | $45,853 | | Loss from operations | $(31,452) | $(23,532) | $(63,302) | $(45,853) | | Interest and other income, net | $3,354 | $4,830 | $7,057 | $8,959 | | Net loss | $(28,098) | $(18,702) | $(56,245) | $(36,894) | | Net loss per share, basic and diluted | $(0.47) | $(0.32) | $(0.95) | $(0.67) | - Total operating expenses increased to $31,452 thousand for the three months ended June 30, 2025, from $23,532 thousand for the same period in 2024[21] - Interest and other income, net, decreased to $3,354 thousand in Q2 2025 from $4,830 thousand in Q2 2024[21] Forward-Looking Statements This section outlines the inherent risks and uncertainties associated with Tyra Biosciences' forward-looking statements regarding its pipeline and financial projections Disclaimer and Risk Factors This disclaimer highlights that forward-looking statements are subject to inherent business risks, including clinical trial uncertainties and regulatory challenges - Statements regarding pipeline advancement, growth, potential to transform treatment, and development of precision medicines are forward-looking[15] - Actual results may differ from forward-looking statements due to inherent business risks, including interim clinical trial results not being indicative of final outcomes, potential for proof-of-concept to fail, and delays in trials[15] - Other risks include unexpected adverse side effects, inadequate efficacy, regulatory developments, and the ability to obtain and maintain intellectual property protection[15][16]