TYRA

- Advanced "dabogratinib 3x3" strategy to pursue 3 late-stage clinical studies in LG-UTUC, IR NMIBC and ACH - - First LG-UTUC patient dosed with dabogratinib in SURF303; initial results expected in 2027 - - Initial Ph2 data readout from SURF302 expected in August 2026 (n>20 enrolled to date) - - Initial Ph2 data readout from safety sentinel cohort in BEACH301 expected in Q4 2026 (4th dose level cleared) - - Cash, cash equivalents and marketable securities of $383.5 million at Q1 2026; runway into 2H 2028 - CARLSBAD, Calif., May 13, 2026 /PRNewswire/ -- 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, today reported financial results for the first quarter ended March 31, 2026, and highlighted recent corporate progress. "Our dabogratinib '3x3' strategy continues to advance with steady progress across all three programs," said Todd Harris, Ph.D., Chief Executive Officer of TYRA. "We are taking a differentiated, data-driven approach by aligning our development strategy with the patient journey in FGFR3-driven diseases and conditions. The dosing of the first patient in SURF303 marks an important milestone, as we initiate a potentially registrational study in LG-UTUC that could support TYRA's first NDA submission. With multiple clinical data readouts expected this year, we remain focused on unlocking the full potential of selective FGFR3 inhibition with oral dabogratinib." Doug Warner, M.D., Chief Medical Officer of TYRA, commented, "In urologic cancers, we see a significant opportunity to address what we believe is a very challenging treatment paradigm for patients that is currently dominated by procedure-based, intravesical therapies. We are developing dabogratinib as a once-daily (QD) oral therapy designed to maintain continuous pressure on the tumor and, if successful, may represent a meaningful shift in how these patients are treated." Dr. Warner continued, "In achondroplasia, we believe our approach with oral dabogratinib may also be transformational. Recently presented data demonstrate that prenatal dosing further delayed premature fusion of synchondroses and increased the area of the foramen magnum. These data expand our perspective on the potential benefits of earlier FGFR3 inhibition a...

- Launched "dabogratinib 3x3" strategy to pursue 3 late-stage clinical studies in LG-UTUC, IR NMIBC and ACH, 3 potential blockbuster indications - - Interim Ph2 data readouts on track: SURF302 expected by end of 1H'26 and BEACH301 in 2H '26 - - Cash, cash equivalents and marketable securities of $256.0 million at Q4 2025; runway through at least 2027 - CARLSBAD, Calif., March 2, 2026 /PRNewswire/ -- 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, today reported financial results for the fourth quarter and full-year ended December 31, 2025 and highlighted recent corporate progress. "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 3x3" 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 3x3 Strategy TYRA is focused on executing our "dabogratinib 3x3" 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 indicati...

- Dosed first patients with dabogratinib in BEACH301 and SURF302; interim results from both studies expected in 2026 - - Expanded development of dabogratinib into low-grade upper tract urothelial carcinoma (LG-UTUC); IND cleared with U.S. FDA - - Cash, cash equivalents, and marketable securities of $274.9 million at Q3 2025; runway through at least 2027 - CARLSBAD, Calif., Nov. 5, 2025 /PRNewswire/ -- 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, today reported financial results for the third quarter ended September 30, 2025, and highlighted recent corporate progress. "Our focus remains on patients – those living with skeletal dysplasia and bladder cancer who need improved, precise options of care," said Todd Harris, Ph.D., CEO of TYRA. "Enrollment continues to progress across our BEACH301 and SURF302 Phase 2 studies, reflecting strong engagement from the clinical and patient communities. We are also expanding the Phase 2 development of dabogratinib into low-grade upper tract urothelial carcinoma, where FGFR3 alterations occur in approximately 85% of LG-UTUC cases, further reinforcing our commitment to addressing FGFR3-driven disorders." Dr. Harris continued, "We believe 2026 will be a pivotal year for TYRA. We expect to report interim Phase 2 results that could validate dabogratinib's broad potential across achondroplasia, IR-NMIBC and LG-UTUC." Third Quarter 2025 and Recent Corporate Highlights Dabogratinib (formerly TYRA-300) Dabogratinib is an oral investigational FGFR3-selective inhibitor being developed for the treatment of pediatric achondroplasia (ACH), low-grade intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and LG-UTUC. TYRA previously reported interim clinical proof-of-concept results in metastatic urothelial cancer (mUC) – dabogratinib demonstrated encouraging anti-tumor activity and was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities. Enrolling 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 is enrolling a safety sentinel cohort of at least 3 participants p...

- Dosed first patient in SURF302 for intermediate risk non-muscle invasive bladder cancer (IR NMIBC) - - Cash, cash equivalents, and marketable securities of $296.3 million at Q2 2025; runway through at least 2027 - CARLSBAD, Calif., Aug. 14, 2025 /PRNewswire/ -- 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, today reported financial results for the second quarter ended June 30, 2025, and highlighted recent corporate progress. "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) Dabogratinib (formerly TYRA-300) is an oral investigational FGFR3-selective inhibitor being developed for the treatment of IR NMIBC and ACH. 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. 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....

CARLSBAD, Calif., July 8, 2025 /PRNewswire/ -- 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, announced today that a late-breaking abstract has been accepted for presentation at The Endocrine Society's Annual Meeting (ENDO 2025), taking place July 12-15, 2025 in San Francisco, CA. Details of the poster presentation are below: Title: "TYRA-300 Promotes Bone Growth In Two Mouse Models Of FGFR3-related Skeletal Dysplasia" Abstract: SUN-730 Presenting Author: Jacqueline H. Starrett, Ph.D., Tyra Biosciences Date/Time: July 13, 2025, 12:00 PM - 1:30 PM, ENDOExpo: Poster Area Session: Session P70 - BONE AND MINERAL METABOLISM: Rare Bone and Genetic Disorders More information on ENDO 2025 can be found at the meeting website. The TYRA poster at ENDO 2025 will be available here following the conference: https://ir.tyra.bio. About TYRA-300 TYRA-300 is the Company's lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 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). TYRA-300's planned clinical development includes three Phase 2 clinical trials: SURF302 for intermediate risk non-muscle invasive bladder cancer (IR NMIBC), BEACH301 for pediatric achondroplasia and SURF301 for mUC. Please visit the Patients page of our website for more information on our clinical trials. About Tyra Biosciences Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. The Company's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. TYRA's expertise in FGFR biology has created a differentiated pipeline with three clinical-stage programs in targeted oncology and genetically defined conditions. The Company's lead precision medicine stemming from SNÅP, TYRA-300, is a potential first-in-class selective FGFR3 inhibitor th...

- BEACH301 study of TYRA-300 for Pediatric Achondroplasia (ACH) Open for Enrollment - - Initiated patient dosing in SURF431 study of TYRA-430 for hepatocellular carcinoma (HCC) - - Cash, cash equivalents, and marketable securities of $318.9 million at Q1 2025; runway through at least 2027 - CARLSBAD, Calif., May 8, 2025 /PRNewswire/ -- 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, today reported financial results for the first quarter ended March 31, 2025, and highlighted recent corporate progress. "In 2025, we are focused on clinical execution across our portfolio of next-generation precision therapies for oncology and skeletal dysplasia. We continued to advance TYRA-300 for ACH and intermediate risk non-muscle invasive bladder cancer and will begin dosing in BEACH301 and SURF302 in the second quarter," stated Todd Harris, CEO of TYRA. "In addition, our SURF431 study is now underway, and we dosed the first HCC patient with TYRA-430, our oral FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers." First Quarter 2025 and Recent Corporate Highlights TYRA-300 Advanced Clinical Evaluation of TYRA-300 and Published Preclinical Research. TYRA continued to progress TYRA-300, an oral, investigational FGFR3-selective inhibitor, for the treatment of intermediate risk non-muscle invasive bladder cancer (IR NMIBC), pediatric achondroplasia (ACH), and metastatic urothelial cancer (mUC). Advanced Phase 2 ACH Study - BEACH301 - Open for Enrollment. The study is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating TYRA-300 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 treatment-naïve participants per dose level in children ages 5 to 10. Advanced Phase 2 NMIBC Study Activities – SURF302. SURF302 is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300...

- Three INDs cleared by US FDA for TYRA's proprietary precision small molecules - - TYRA-300 to be evaluated in three Phase 2 studies: SURF302 for Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC), BEACH301 for pediatric achondroplasia (ACH) and SURF301 for metastatic urothelial cancer (mUC) - - Cash, cash equivalents, and marketable securities of $341.4 million at YE 2024; runway through at least 2027 - CARLSBAD, Calif., March 27, 2025 /PRNewswire/ -- 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, today reported financial results for the fourth quarter and full year ended December 31, 2024, and highlighted recent corporate progress. "2024 was a momentous year for TYRA and the patient communities we serve, highlighted by the positive interim results from our SURF301 study, which demonstrated a combination of high anti-tumor activity with favorable tolerability results in very sick, heavily pre-treated cancer patients. Importantly, the oncology doses tested in SURF301 are significantly higher than those to be tested in BEACH301, giving us confidence as we advance TYRA-300 in ACH," said Todd Harris, CEO of TYRA. "Our conviction in TYRA-300 has never been stronger and we are working diligently to advance this potential best-in-class agent for multiple high-value indications in oncology and skeletal dysplasia into three Phase 2 studies in NMIBC, ACH and mUC." Fourth Quarter and Full Year 2024 and Recent Corporate Highlights TYRA-300 Advanced Clinical Evaluation of TYRA-300 into Three Phase 2 Studies. During 2024, TYRA progressed TYRA-300, an oral, investigational FGFR3-selective inhibitor, for the treatment of IR NMIBC, mUC and ACH, and achieved the following milestones: Cleared Phase 2 NMIBC IND with US FDA – SURF302. TYRA expanded the clinical development of TYRA-300 into NMIBC to address the unmet needs in this cancer population for an efficacious, orally available therapy. SURF302 is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with T...