On March 2, 2026 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 fourth quarter and full-year ended December 31, 2025 and highlighted recent corporate progress.
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"At TYRA, we are following the science," said Todd Harris, Ph.D., CEO of TYRA. "The strength of the genetic and biological validation behind FGFR3 gives us conviction to concentrate our resources and strategy around indications where this target plays a central role. Through our "dabogratinib 3×3" strategy, we are deliberately deploying capital toward high unmet needs – low grade upper tract urothelial carcinoma (LG-UTUC), intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and achondroplasia (ACH) – where selective FGFR3 inhibition has the potential to make a meaningful impact for patients, while creating significant potential long-term value."
"Oral dabogratinib reflects years of deliberate molecular optimization to achieve highly selective FGFR3 inhibition with a profile designed to balance potency, safety and convenience," said Doug Warner, MD, Chief Medical Officer of TYRA. "The clinical data generated to date – with more than 100 participants dosed – reinforces our confidence in its potential efficacy and tolerability and supports once-daily (QD) dosing across our targeted indications. We believe this target profile positions oral dabogratinib to deliver meaningful benefit for patients, and we look forward to expanding our clinical database this year."
Fourth Quarter and Recent Corporate Highlights
Dabogratinib 3×3 Strategy
TYRA is focused on executing our "dabogratinib 3×3" strategy: developing the first orally available, FGFR3 selective inhibitor in 3 future potentially pivotal clinical studies to support regulatory submissions with the aim to commercialize in 3 potential blockbuster indications: LG-UTUC, IR NMIBC and ACH.
"In Q4 2025, we prioritized our portfolio to maximize potential return on invested capital," commented Alan Fuhrman, Chief Financial Officer of TYRA. "Exiting metastatic bladder cancer allows us to focus financial and operational resources on the three core indications within our "dabogratinib 3×3" strategy that we believe offer the most compelling risk-adjusted opportunities."
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Phase 2 LG-UTUC Study – SURF303. SURF303 is a Phase 2a/b, multicenter, open-label study designed with pivotal intent to evaluate the efficacy and safety of oral dabogratinib at two QD doses in participants with LG-UTUC, a rare cancer where approximately 85% of tumors are driven by FGFR3. Study startup is ongoing, and the first patient is anticipated to be dosed in 2026.
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Phase 2 IR NMIBC Study – SURF302. SURF302 is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib at two QD doses in participants with FGFR3-altered low-grade IR NMIBC. TYRA opened additional US and international trial sites in Q4 2025, and the Company expects to report initial three-month complete response data by the end of 1H 2026.
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Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating oral dabogratinib in children ages 3 to 10 with achondroplasia. The study is enrolling a safety sentinel cohort of at least 3 participants per dose level in children ages 5 to 10, and TYRA has successfully cleared two of the four dose levels with no safety events to report. The Company remains on track and is expected to report interim results from the safety sentinel cohort – which will include 6-month average height velocity data and safety results – in 2H 2026.
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Phase 1/2 mUC Study – SURF301. At ASCO (Free ASCO Whitepaper) GU 2026, TYRA presented a poster detailing the response, safety, pharmacokinetics/pharmacodynamics and circulating tumor DNA data from the SURF301 mUC study. These translational data were leveraged to select doses that have the potential to achieve the target product profiles for efficacy and safety in the SURF303, SURF302 and BEACH301 studies. TYRA is planning to publish final Phase 1 results from SURF301 in a future scientific publication. The SURF301 study is no longer recruiting patients.
Corporate
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Strengthened Leadership Team. In Q4 2025, TYRA announced the appointments of Bhavesh Ashar as Chief Operating Officer, and Heather Faulds as Chief Regulatory Officer. Together, Mr. Ashar and Ms. Faulds will be essential in advancing oral dabogratinib through potentially global Phase 2 studies in skeletal dysplasia and urothelial cancers, and preparing for future potential pivotal studies.
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.
Fourth Quarter and Full-Year 2025 Financial Results
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Cash, Cash Equivalents and Short-Term Investments. As of December 31, 2025, TYRA had cash, cash equivalents and marketable securities of $256.0 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 December 31, 2025 were $28.2 million compared to $22.2 million for the same period in 2024, and $102.9 million for the full year 2025 compared to $80.1 million for the same period in 2024. The increases were primarily associated with development activities for oral dabogratinib, reflecting ongoing BEACH301 and SURF302 clinical trials and start-up costs for SURF303, as well as development expenditures for SURF431.
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General and Administrative (G&A) Expenses. G&A expenses for the three months ended December 31, 2025 were $8.3 million compared to $7.6 million for the same period in 2024, and $29.8 million for the full year 2025 compared to $24.1 million for the same period in 2024. The increases were primarily driven by higher compensation and other personnel costs driven by headcount growth.
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Net Loss. Fourth quarter net loss was $33.8 million compared to $25.6 million for the same period in 2024, and $119.9 million for the full year 2025 compared to $86.5 million for the same period in 2024.
Upcoming Clinical Milestones:
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SURF303: dose first patient with LG-UTUC – 2026
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SURF302: initial three-month complete response data – end of 1H 2026
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BEACH301: initial results from safety sentinel cohort – 2H 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 Phase 2 development for the treatment of urologic cancers and skeletal dysplasias, specifically LG-UTUC, IR NMIBC and ACH. We believe dabogratinib was the first orally available, FGFR3 selective inhibitor to enter clinical development and it has been studied in more than 100 patients to date across multiple clinical studies. To date, oral dabogratinib has demonstrated very positive target engagement with FGFR3, favorable anti-tumor effects and safety results in oncology, and an optimized QD dosing regimen.
Oral dabogratinib is currently advancing in three Phase 2 clinical trials for LG-UTUC (SURF303), IR NMIBC (SURF302), and ACH (BEACH301). The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia.
Please visit the Patients page of our website for more information on our clinical trials.
(Press release, Tyra Biosciences, MAR 2, 2026, View Source [SID1234663184])