On August 14, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the second quarter ended June 30, 2025, and highlighted recent corporate progress (Press release, Tyra Biosciences, AUG 14, 2025, View Source [SID1234655318]).
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"We see significant opportunity to transform the treatment of bladder cancer and skeletal dysplasia by precisely targeting FGFR3. With BEACH301 open for enrollment and SURF302 advancing in intermediate-risk non-muscle invasive bladder cancer, we’re building a franchise with dabogratinib around the power of FGFR3 selectivity and sensitivity," said Todd Harris, CEO of TYRA. "Backed by a strong balance sheet, we’re well positioned to deliver meaningful Phase 2 readouts in SURF302 and BEACH301.
Second Quarter 2025 and Recent Corporate Highlights
Dabogratinib (TYRA-300)
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Dabogratinib (formerly TYRA-300) is an oral investigational FGFR3-selective inhibitor being developed for the treatment of IR NMIBC and ACH.
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Dosed first patient in Phase 2 NMIBC Study – SURF302. SURF302 is an open-label Phase 2 clinical study evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered low-grade, IR NMIBC. Participants will be randomized initially to treatment with dabogratinib at 50 mg once-daily (QD) (Cohort 1) or treatment with dabogratinib at 60 mg QD (Cohort 2). The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, median duration of response, recurrence free survival, progression free survival, safety and tolerability.
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Advanced Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating dabogratinib in children ages 3 to 10 with achondroplasia with open growth plates. The study will enroll children who are treatment-naïve (Cohort 1) and those who have received prior growth-accelerating therapy (Cohort 2) at multiple sites across the globe. Each of these cohorts is expected to enroll up to 10 participants per dose level (0.125, 0.25, 0.375, 0.50 mg/kg) for up to 12 months. The study is now enrolling a safety sentinel cohort of up to 3 participants per dose level in children ages 5 to 10.
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Phase 1/2 mUC Study – SURF301. Dabogratinib continued to be evaluated in Part B of SURF301 (NCT05544552) at potentially therapeutic QD doses in preparation for potential future Phase 2 studies.
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Presented preclinical results at ENDO 2025. The late-breaking poster that was presented summarized the results of dabogratinib across three genetic contexts: wild-type mice, the Fgfr3Y367C/+ mouse model of ACH, and the Fgfr3N534K/+ mouse model of hypochondroplasia. Among other things, dabogratinib significantly improved the size and shape of the skull and foramen magnum in Fgfr3Y367C/+ mice. These studies demonstrate that dabogratinib led to a significant increase in bone growth in two independent FGFR3-driven preclinical models, as well as in wild-type mice, and provide further support to broaden the development of dabogratinib into skeletal dysplasias beyond ACH.
TYRA-430
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Advanced Phase 1 SURF431 Study. TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. Patient dosing is ongoing in SURF431, a Phase 1, multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations. We believe TYRA-430 has the potential to address a significant unmet need in HCC, where there are no approved biomarker-driven, targeted therapies.
TYRA-200
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Advanced Phase 1 SURF201 Study. TYRA-200 is an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The SURF201 study continues to enroll and dose adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations.
SNÅP Platform and Pipeline
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TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.
Second Quarter 2025 Financial Results
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Cash, Cash Equivalents and Short-Term Investments. As of June 30, 2025, TYRA had cash, cash equivalents, and marketable securities of $296.3 million. TYRA’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2027.
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Research and Development (R&D) Expenses. R&D expenses for the three months ended June 30, 2025 were $24.3 million compared to $18.0 million for the same period in 2024. The increase was associated with start-up and enrollment activities for BEACH301, SURF302 and SURF431, as well as increased CMC and personnel-related costs, including non-cash stock-based compensation.
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General and Administrative (G&A) Expenses. G&A expenses for the three months ended June 30, 2025 were $7.1 million compared to $5.5 million for the same period in 2024. The increase was primarily driven by higher personnel-related costs, including non-cash stock-based compensation.
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Net Loss. Second quarter net loss was $28.1 million compared to $18.7 million for the same period in 2024.
Upcoming Clinical Milestones for Dabogratinib
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BEACH301: dose first child with achondroplasia – 3Q 2025
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SURF302: topline initial three-month complete response data – 1H 2026
About Dabogratinib (formerly TYRA-300)
Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasia that has demonstrated interim clinical proof-of-concept results in metastatic urothelial cancer (mUC). The current planned clinical development for dabogratinib includes Phase 2 clinical trials for IR NMIBC (SURF302) and pediatric achondroplasia (BEACH301), and potentially mUC.
Please visit the Patients page of our website for more information on our clinical trials.
About TYRA-430
TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 study (SURF431) is a multicenter, open-label, first-in-human study of TYRA-430 and is currently enrolling and dosing adults with advanced HCC and other solid tumors with activating FGF/FGFR pathway aberrations (NCT06915753).
About TYRA-200
TYRA-200 is an oral, investigational, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The Phase 1 clinical study of TYRA-200, SURF201 (NCT06160752), is a multi-center, open label study designed to evaluate the maximum tolerated dose and the recommended Phase 2 dose of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling and dosing adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2.