TYRA

TYRA's mission is to make dabogratinib the clear first-line treatment choice for patients with LG IR NMIBC Favorable safety and tolerability results support chronic dosing potential No clinically significant hyperphosphatemia, nail toxicity or ocular toxicity; low frequency of transaminase TEAEs ( 79% ORR and 64% best overall response CR rate with 60 mg QD in combined single and multiple marker lesion patients (n=14), with 100% ORR and 75% best overall response CR rate with 60 mg QD in single marker lesion patients (n=8), supporting planned adjuvant Phase 3 strategy First patient treated in Phase 2 SURF303 study in LG UTUC achieved a 3-month CR with 60 mg QD Conference call today, September 9, at 8 am ET to discuss results CARLSBAD, Calif., Sept. 9, 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 announced initial results from SURF302, its Phase 2 study evaluating oral dabogratinib in patients with FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC). The study provided clinical proof of concept for selective oral FGFR3 inhibition and identified 60 mg once-daily (QD) as the potential dose supporting TYRA's planned registrational adjuvant development strategy. Approximately 70% of patients with LG IR NMIBC do not receive adjuvant therapy intended to reduce recurrence, despite evidence that intravesical treatment lowers recurrence risk. Instead, many patients choose surveillance, or "watch and wait", because existing therapies involve repeated catheterization and office-based procedures that can make the burden of treatment outweigh its perceived benefit. TYRA believes oral dabogratinib, if approved, has the potential to change that paradigm by offering patients a convenient, once-daily oral therapy. "We are extremely excited to report initial results from SURF302 today as we work to advance what we believe could become the first once-daily oral therapy for patients with low-grade IR NMIBC," said Todd Harris, Ph.D., Chief Executive Officer of TYRA Biosciences. "These results belong first and foremost to the patients participating in SURF302 and the investigators and study teams who have made this research possible. We're incredibly grateful for their partnership." "SURF302 has effectively given us two studies in one, informing dual settings in which dabogratinib could potentially be used. Patients with a single marker lesion — whose minimal disease most closely mirrors the adjuvant setting (where no tumor is left behind) and historical marker lesion studies — achieved a 100% overall response rate (ORR) (8/8) with 60 mg QD, including a 75% complete response (CR) rate as best overall response (BOR), demonstrating the activity of this dose for our planned Phase 3 adjuvant study," said Doug Warner, M.D., Chief Medical Officer of TYRA. "Patients with multiple marker lesions carry a higher tumor burden, more representative of an ablative setting, and our preliminary exposure-response analyses suggest that higher drug exposure may be important there. Dabogratinib's favorable safety results to date give us the opportunity to evaluate a higher dose in that setting. Taken together, these data have meaningfully expanded our understanding of dabogratinib as we look to continue to advance development into Phase 3 studies." "As a community-based urologist, one of the greatest challenges isn't identifying patients who could benefit from therapy—it's that many choose surveillance because the burden of repeated catheterization and intravesical treatments outweighs the perceived benefit," said Mark Silva, M.D., Greater Boston Urology. "Too often, those patients are simply waiting to recur. A well-tolerated once-daily oral therapy could fundamentally change that conversation – giving patients an option they may be more willing to accept, and giving physicians the chance to intervene before the next recurrence rather than react after it occurs." Initial safety and tolerability results. As of the August 31, 2026 data cutoff, initial safety and tolerability results for oral dabogratinib were favorable across the 60 mg QD (n=22) and 50 mg QD (n=22) dose cohorts. Most treatment-emergent adverse events (TEAEs) were Grade 1 or 2, with Grade 3 TEAEs in 3 participants (14%) at 60 mg and 2 participants (9%) at 50 mg. Grade 3 treatment-related AEs occurred in 2 of 44 participants (4.5%) across both cohorts, both at 50 mg QD, with none at 60 mg QD. There were no Grade 4 or 5 TEAEs. TYRA believes these results are consistent with the potential for chronic once-daily administration. At 60 mg QD, there were no dose reductions or treatment-related discontinuations. No clinically significant hyperphosphatemia, nail toxicity, or ocular toxicity was observed. TEAEs were generally manageable. Initial efficacy results. As of the August 31, 2026 data cutoff, 26 participants were evaluable for efficacy across the 60 mg QD (n=14) and 50 mg QD (n=12) cohorts (participants who received study treatment and had undergone at least the month 3 disease assessment). All responses below are subject to change with continued treatment and follow-up. Combined Single and Multiple Marker Lesion Response Single Marker Lesion Response All 3-month CRs with 6-month assessments remained in response at 6 months (n=5). The first participant in the study remained in CR at 12 months and continued on study drug at 14 months. Dose-optimization and registrational strategy. Preliminary exposure-response analyses across the 50 mg QD and 60 mg QD cohorts showed an ORR of 86% (12/14) among participants with a target steady-state exposure above the AUC threshold of 2500 ng‧hr/mL, compared with 58% (7/12) among participants below the threshold. The exposure-response relationship was most apparent among participants with multiple marker lesions, while responses in participants with a single marker lesion occurred across the observed exposure range — supporting 60 mg QD in the planned adjuvant setting, where disease burden is minimal, and the evaluation of a higher dose in the ablative setting. TYRA plans to complete enrollment in the 60 mg QD cohort and initiate a 70 mg QD cohort to explore dabogratinib in the ablative setting. TYRA also plans to engage health authorities on Phase 3 study design and dose selection and, subject to that feedback, to continue preparations for a planned registrational adjuvant study. Initial observation from SURF303 in LG UTUC. In SURF303, TYRA's Phase 2 study evaluating oral dabogratinib in patients with low-grade upper tract urothelial cancer (LG UTUC), the first patient treated achieved a complete response at the 3-month assessment with 60 mg QD, with no observed TEAEs and remained on study drug as of the August 31, 2026 data cutoff. Conference Call and Webcast TYRA is hosting a conference call and webcast today, September 9, 2026, at 8:00 am ET to discuss the initial SURF302 study results with oral dabogratinib. Participants may access a live webcast of the call and the associated slide presentation following the conclusion of the call on the "For Investors" page of the TYRA website at https://ir.tyra.bio. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 90 days. About SURF302 SURF302 (NCT06995677) is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib in adults with FGFR3-altered low-grade IR NMIBC. The study includes dose-optimization cohorts and is designed to support the potential development of dabogratinib as an adjuvant therapy. Key endpoints include best overall response, complete response at three months, time to recurrence, duration of response, recurrence-free survival, progression-free survival, safety and tolerability. For more information, please visit the Patients page of the Company's website at https://tyra.bio/patients/ or https://clinicaltrials.gov/study/NCT06995677. About Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC) Bladder cancer is one of the most common cancers in the United States, with more than 760,000 people living with the disease. Many patients are diagnosed with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC), a disease characterized by frequent tumor recurrence that often requires repeated surveillance and surgical intervention over many years. Current treatment typically includes transurethral resection of bladder tumor (TURBT) followed by intravesical chemotherapy administered through repeated bladder catheterization. Despite evidence that adjuvant intravesical therapy can reduce recurrence, approximately 70% of patients with LG IR NMIBC do not receive treatment intended to prevent recurrence, highlighting a significant unmet medical need for more accessible and better-tolerated treatment options. Dabogratinib is the only investigational oral FGFR3-selective therapy currently in clinical development for patients with FGFR3-altered IR NMIBC. About Dabogratinib 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 low-grade upper tract urothelial carcinoma (LG UTUC), IR NMIBC and achondroplasia (ACH). TYRA believes dabogratinib was the first orally available, FGFR3-selective inhibitor to enter clinical development, and it has been studied in more than 200 individuals to date across multiple clinical and healthy volunteer studies. Oral dabogratinib is currently advancing in three Phase 2 clinical trials: SURF303 in LG UTUC, SURF302 in IR NMIBC and BEACH301 in ACH. The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia. 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. TYRA's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help TYRA design and predict which candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. TYRA's expertise in FGFR biology has created a differentiated pipeline with clinical-stage programs in targeted oncology and genetically defined conditions. TYRA's lead precision medicine stemming from SNÅP, oral dabogratinib, is a potential first-in-class selective FGFR3 inhibitor in development for LG UTUC, IR NMIBC and ACH. TYRA is also developing TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, in the SURF431 study for advanced hepatocellular carcinoma, and TYRA-200, an oral, investigational FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma. TYRA is based in Carlsbad, California. For more information, please visit www.tyra.bio and engage with TYRA on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this press release that are not historical facts are forward-looking statements, including, but not limited to, statements regarding: the potential safety, efficacy, tolerability and therapeutic benefits of dabogratinib; the potential for dabogratinib to change the treatment paradigm for patients with FGFR3-altered LG IR NMIBC, to reduce recurrence, or to become a first-in-class once-daily oral therapy for FGFR3-altered LG IR NMIBC; the interpretation, significance and clinical implications of the initial SURF302 results, including observations regarding overall response rate, complete response, durability of response, dose-response relationships, exposure-response analyses and safety; the clinical significance of the initial response observed in the SURF303 study; the continued clinical development of dabogratinib, including continued enrollment at 60 mg, evaluation of the 70 mg dose cohort, and discussions with the U.S. Food and Drug Administration and other global health authorities regarding dose selection and Phase 3 study design; the timing, design and initiation of future clinical trials, including a potential registrational adjuvant study; and the potential commercial opportunity for dabogratinib. These forward-looking statements are based on TYRA's current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation: initial or interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available; preliminary pharmacokinetic, pharmacodynamic and exposure-response analyses may not be predictive of future clinical outcomes or later-stage studies; early clinical observations from SURF303, including those from an individual participant, may not be predictive of future results; the safety and efficacy observed to date may not continue in ongoing or future studies; TYRA's ability to successfully enroll, conduct and complete its clinical trials; the timing and outcome of interactions with the FDA and other regulatory authorities on TYRA's plans to advance to a registrational adjuvant study, which may differ from TYRA's expectations; the ability to obtain regulatory approval for dabogratinib; and the other risks and uncertainties described under the heading "Risk Factors" in TYRA's Annual Report on Form 10-K and in subsequent filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. TYRA undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events or otherwise, except as required by applicable law. ContactAmy [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tyra-biosciences-reports-initial-phase-2-surf302-results-supporting-the-first-potential-oral-innovation-in-lg-ir-nmibc-with-dabogratinib-302872937.html

CARLSBAD, Calif., Sept. 4, 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 announced that it will host a conference call and webcast on Wednesday, September 9, 2026 at 8:00 am ET to discuss initial clinical results from the SURF302 Phase 2 study evaluating oral dabogratinib for intermediate risk non-muscle invasive bladder cancer (IR NMIBC). Conference Call and Webcast Information TYRA is hosting a conference call and webcast on September 9, 2026, at 8:00 am ET. Participants may access a live webcast of the call and the associated slide presentation on the "For Investors" page of the TYRA website at https://ir.tyra.bio. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 90 days. 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. TYRA's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help TYRA design and predict which candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. TYRA's expertise in FGFR biology has created a differentiated pipeline with clinical-stage programs in targeted oncology and genetically defined conditions. TYRA's lead precision medicine stemming from SNÅP, oral dabogratinib, is a potential first-in-class selective FGFR3 inhibitor in development for LG-UTUC, IR NMIBC and ACH. TYRA is also developing TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, in the SURF431 study for advanced hepatocellular carcinoma, and TYRA-200, an oral, investigational FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma. TYRA is based in Carlsbad, California. For more information, please visit www.tyra.bio and engage with TYRA on LinkedIn. ContactAmy [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tyra-biosciences-to-host-conference-call-on-initial-results-of-oral-dabogratinib-from-the-surf302-phase-2-study-for-ir-nmibc-on-september-9-2026-302870004.html

- Initial Ph2 data from SURF302 expected in September 2026 (n>40 enrolled to date) - - Initial Ph2 data from safety sentinel cohort (aggregate of ~25 children) in BEACH301, including new 5th dose level, now expected end of Q1 2027 - - Appointed Jonathan Day as EVP, Clinical Development to advance skeletal dysplasia strategy - - Cash, cash equivalents and marketable securities of $353.9 million at Q2 2026; runway into 2H 2028 - CARLSBAD, Calif., Aug. 4, 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 second quarter ended June 30, 2026, and highlighted recent corporate progress. "September marks an important milestone for TYRA as we prepare to share initial clinical data from SURF302 evaluating oral dabogratinib in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). Patients with IR NMIBC often endure a lifelong cycle of recurrent disease, repeated surgical procedures, catheterization, and ongoing surveillance, highlighting the need for more convenient and effective treatment options. We believe dabogratinib has the potential to redefine the treatment paradigm as the first targeted oral therapy for FGFR3-driven IR NMIBC, addressing the underlying biology of the disease while offering the convenience of an oral therapy," said Todd Harris, PhD, President and Chief Executive Officer of TYRA. Dr. Harris continued, "Beyond SURF302, we continue to advance our broader pipeline, including progressing BEACH301 to a fifth dose level in achondroplasia, and strengthening our skeletal dysplasia leadership with the addition of Jonathan Day, whose work was instrumental in the development of vosoritide. Across our portfolio, we remain focused on realizing the full potential of oral dabogratinib for patients with FGFR3-driven conditions and diseases." "Over the past decade, I've had the privilege of helping advance therapies that have transformed the treatment landscape for children with achondroplasia. I believe there is still meaningful opportunity to further improve outcomes, and TYRA's highly selective approach to FGFR3 inhibition offers a compelling opportunity to do just that," commented Dr. Day, TYRA's newly appointed Executive Vice President, Clinical Development. "I'm excited to join the team and help advance dabogratinib as we work to develop a differentiated oral therapy for children with achondroplasia and their families." Second Quarter and Recent Corporate Highlights Dabogratinib 3x3 Strategy In the second quarter of 2026, TYRA continued to advance its "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 indications: LG-UTUC, IR NMIBC and ACH. 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 (60 mg and 80 mg) in participants with low-grade upper tract urothelial carcinoma (LG-UTUC), a rare cancer where approximately 85% of tumors are driven by FGFR3. Initial results from this study are expected in 2027. 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 (50 mg and 60 mg) in participants with FGFR3-altered low-grade IR NMIBC. The Company will host a conference call and webcast in September 2026 to report initial results from the SURF302 study, including safety results from more than 40 patients and efficacy from more than 20 patients in the aggregate at both QD dose levels. 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 (ACH). The study has enrolled the safety sentinel cohort and successfully cleared four dose levels, with no notable safety events reported to date. Given the favorable safety profile seen to date across dose levels 1 through 4 in BEACH301, the Data Safety Monitoring Committee authorized the opening of a fifth dose level to evaluate 0.625 mg/kg in the safety sentinel cohort. Initial results from the safety sentinel cohort, including 6-month annualized height velocity and safety data for dose levels 1-5, which will include an aggregate of approximately 25 children, are expected to be reported at the end of Q1 2027. Corporate Appointed Jonathan Day as EVP, Clinical Development for Skeletal Dysplasia Conditions. In June 2026, TYRA appointed Jonathan Day, MBBS, PhD, FFPM, FESC, as Executive Vice President, Clinical Development, where he will lead the Company's development program and clinical strategy for oral dabogratinib in skeletal dysplasia conditions. Dr. Day is a physician-scientist and pharmaceutical executive with extensive experience leading late-stage clinical development programs in rare diseases. At BioMarin Pharmaceutical, he served as Head of R&D for the Skeletal Conditions Business Unit (previously Group Vice President, Late-Stage Clinical Development), where he led the global clinical development strategy for the company's skeletal dysplasia portfolio, including vosoritide (Voxzogo) for achondroplasia. Before joining BioMarin, Dr. Day was Vice President and Global Medical Lead for Acute Cardiovascular Care at The Medicines Company, and earlier served as Medical Director for the UK & Ireland at AstraZeneca. Prior to industry, he trained in cardiothoracic surgery and completed a PhD at Imperial College London focused on thrombin inhibition and cardiovascular medicine. He is also a Fellow of the European Society of Cardiology and the Faculty of Pharmaceutical Medicine. Amended ATM Sales Agreement. In August 2026, TYRA entered into an amended sales agreement with TD Securities (USA) LLC, under which TYRA may sell up to the amount registered on an effective registration statement under which the offering is made, subject to other limitations. Pursuant to the amended sales agreement, as of the date hereof, TYRA may sell an additional $250.0 million of shares of its common stock from time to time in "at-the-market" offerings. SNÅP Platform and Pipeline 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 Financial Results Cash, Cash Equivalents and Marketable Securities. As of June 30, 2026, TYRA had cash, cash equivalents and marketable securities of $353.9 million. The Company's current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans into the second half of 2028. Research and Development (R&D) Expenses. R&D expenses for the three months ended June 30, 2026 were $39.2 million compared to $24.3 million for the same period in 2025. The increase was primarily associated with development activities for oral dabogratinib, supporting the ongoing SURF303, SURF302 and BEACH301 clinical trials, partially offset by a decrease in development activities for other programs. There were also increases in personnel expenses, driven by headcount growth to support expanding clinical and development activities, and expenses for facilities and other costs. General and Administrative (G&A) Expenses. G&A expenses for the three months ended June 30, 2026 were $9.8 million compared to $7.1 million for the same period in 2025. The increase was primarily driven by higher compensation and other personnel costs, driven by headcount growth. Net Loss. Second quarter net loss was $45.6 million compared to $28.1 million for the same period in 2025. Upcoming Anticipated Clinical Milestones: SURF303: initial results – 2027 SURF302: initial results from both dose cohorts – September 2026 BEACH301: initial results from dose levels 1-5 of safety sentinel cohort – end of Q1 2027 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 200 individuals to date across multiple clinical and healthy volunteer studies. 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. 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. TYRA's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help TYRA design and predict which candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. TYRA's expertise in FGFR biology has created a differentiated pipeline with clinical-stage programs in targeted oncology and genetically defined conditions. TYRA's lead precision medicine stemming from SNÅP, oral dabogratinib, is a potential first-in-class selective FGFR3 inhibitor in development for LG-UTUC, IR NMIBC and ACH. TYRA is also developing TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, in the SURF431 study for advanced hepatocellular carcinoma, and TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the expected advancement of our pipeline and our growth; the potential to execute on our "dabogratinib 3x3 strategy"; the potential to develop next-generation precision medicines and their potential to be first-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates, including the potential for them to be blockbusters; the expected trial design, timing and phase of development of our product candidates, including timing for data readouts and patient dosing and the potential for trials to be registrational or global; the potential for SNÅP to develop therapies; our commercialization plan for oral dabogratinib; and our expected cash runway. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: initial or interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of oral dabogratinib; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, recruitment, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for oral dabogratinib or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; regulatory and legislative developments in the United States and foreign countries, including with respect to healthcare and trade policies; we may not realize the benefits associated with Orphan Drug Designation or Rare Pediatric Disease Designation; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; our ability to establish marketing and sales capabilities to successfully commercialize any approved products; we may use our capital resources sooner than we expect; geopolitical instability, war, inflation and interest rate changes; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Amy [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tyra-biosciences-reports-second-quarter-2026-financial-results-and-recent-highlights-302842952.html

- 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 as we advance BEACH301. We have now cleared the fourth dose level in our safety sentinel cohort and remain on track to report initial results in the fourth quarter of this year." First Quarter and Recent Corporate Highlights Dabogratinib 3x3 Strategy In the first quarter of 2026, TYRA advanced its "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 indications: LG-UTUC, IR NMIBC and ACH. 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 low grade upper tract urothelial carcinoma (LG-UTUC), a rare cancer where approximately 85% of tumors are driven by FGFR3. The Company has dosed the first patient in SURF303, with initial results expected in 2027. 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 intermediate risk non-muscle invasive bladder cancer (IR NMIBC). To date, there are more than 20 patients enrolled at US and international trial sites, and the Company expects to report initial three-month complete response data from both dose cohorts in August 2026. 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 (ACH). The study has enrolled the safety sentinel cohort and has successfully cleared four dose levels, with no notable safety events reported to date. The study remains on track, with initial results from the safety sentinel cohort, including 6-month average height velocity and safety data, expected in the fourth quarter of 2026. Presented Clinical Progress and New Preclinical Results at Key Scientific/Medical Meetings. During the first quarter of 2026 and in April, TYRA presented posters on dabogratinib for urologic cancers (SURF302 and SURF303 trials-in-progress) at the 2026 ASCO® Genitourinary (GU) Cancers Symposium (ASCO GU), and the European Association of Urology Congress (EAU 26). TYRA will also present a trials-in-progress poster on SURF302 at the 2026 American Urologic Association (AUA) meeting. In May 2026, at the Fusion Conference on FGFR Biology, TYRA presented new preclinical results with oral dabogratinib for the treatment of ACH. When administered to pregnant mice from embryonic day 14.5 through birth then to Fgfr3Y367C/+ neonates postnatally, dabogratinib significantly increased the foramen magnum area and resulted in open synchondroses. Prenatal plus postnatal treatment further delayed premature fusion of the synchondroses compared with the postnatal alone treatment protocol (Starrett et al., 2025). Posters associated with these meetings can be accessed on the TYRA website. Corporate Appointed Habib Dable to Board of Directors. In April 2026, TYRA announced the appointment of Habib Dable to its Board of Directors. Mr. Dable brings more than 30 years of leadership experience across the global biopharmaceutical industry, including deep expertise in building and scaling blockbuster franchises and guiding companies through transformative growth. Mr. Dable most recently served as President and Chief Executive Officer of Acceleron Pharma Inc., where he led the company through a period of significant growth culminating in its acquisition by Merck in 2021. Prior to Acceleron, Mr. Dable spent 22 years at Bayer AG in positions of increasing responsibility, including President of U.S. Pharmaceuticals and Executive Vice President, Global Head of Specialty Medicine. During his tenure, he provided leadership across multiple therapeutic areas, including ophthalmology, neurology, hematology, and cardiology, and oversaw the global launch of EYLEA®. Mr. Dable currently serves as an advisor at RA Capital Management, L.P. Strengthened Balance Sheet with ATM Utilization. In the first quarter of 2026, TYRA received $147.9M in net proceeds, after deducting fees and other expenses, following utilization of the Company's "at-the-market" offering program, issuing and selling 4,690,532 shares of common stock to a large investment management firm. SNÅP Platform and Pipeline TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions. First Quarter Financial Results Cash, Cash Equivalents and Short-Term Investments. As of March 31, 2026, TYRA had cash, cash equivalents and marketable securities of $383.5 million. The Company's current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans into the second half of 2028. Research and Development (R&D) Expenses. R&D expenses for the three months ended March 31, 2026 were $33.5 million compared to $25.0 million for the same period in 2025. The increase was primarily associated with development activities for oral dabogratinib, reflecting ongoing BEACH301 and SURF302 clinical trials and start-up costs for SURF303, partially offset by a decrease in development activities for other programs. Personnel expenses also increased, driven by headcount growth to support expanding clinical and development activities. General and Administrative (G&A) Expenses. G&A expenses for the three months ended March 31, 2026 were $8.5 million compared to $6.9 million for the same period in 2025. The increase was primarily driven by higher compensation and other personnel costs, driven by headcount growth. Net Loss. First quarter net loss was $39.3 million compared to $28.1 million for the same period in 2025. Upcoming Anticipated Clinical Milestones: SURF303: initial results – 2027 SURF302: initial three-month complete response data – August 2026 BEACH301: initial results from safety sentinel cohort – Q4 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. 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. 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. TYRA's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help TYRA design and predict which candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. TYRA's expertise in FGFR biology has created a differentiated pipeline with clinical-stage programs in targeted oncology and genetically defined conditions. TYRA's lead precision medicine stemming from SNÅP, oral dabogratinib, is a potential first-in-class selective FGFR3 inhibitor in development for LG-UTUC, IR NMIBC and ACH. TYRA is also developing TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, in the SURF431 study for advanced hepatocellular carcinoma, and TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the expected advancement of our pipeline and our growth; the potential to execute on our "dabogratinib 3x3 strategy"; the potential to develop next-generation precision medicines and their potential to be first-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates, including the potential for them to be blockbusters; the expected trial design, timing and phase of development of our product candidates, including timing for data readouts and patient dosing and the potential for trials to be registrational or global; the potential for SNÅP to develop therapies; our commercialization plan for oral dabogratinib; and our expected cash runway. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: initial or interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of oral dabogratinib; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, recruitment, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for oral dabogratinib or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; regulatory and legislative developments in the United States and foreign countries, including with respect to healthcare and trade policies; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; our ability to establish marketing and sales capabilities to successfully commercialize any approved products; we may use our capital resources sooner than we expect; geopolitical instability, war, inflation and interest rate changes; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Amy [email protected]       View original content to download multimedia:https://www.prnewswire.com/news-releases/tyra-biosciences-reports-first-quarter-2026-financial-results-and-recent-highlights-302770335.html

- 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 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 3x3" strategy that we believe offer the most compelling risk-adjusted opportunities." 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. 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. 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. Phase 1/2 mUC Study – SURF301. At ASCO 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 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 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 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. 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. 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. 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: SURF303: dose first patient with LG-UTUC – 2026 SURF302: initial three-month complete response data – end of 1H 2026 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. 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. TYRA's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help TYRA design and predict which candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. TYRA's expertise in FGFR biology has created a differentiated pipeline with clinical-stage programs in targeted oncology and genetically defined conditions. TYRA's lead precision medicine stemming from SNÅP, oral dabogratinib, is a potential first-in-class selective FGFR3 inhibitor in development for LG-UTUC, IR NMIBC and ACH. TYRA is also developing TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, in the SURF431 study for advanced hepatocellular carcinoma, and TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the expected advancement of our pipeline and our growth; the potential to execute on our "dabogratinib 3x3 strategy"; the potential to develop next-generation precision medicines and their potential to be first-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates, including the potential for them to be blockbusters; the potential to create significant long-term value and maximize return on invested capital and the potential for selected indications to provide the most compelling risk-adjusted opportunities; the expected trial design, timing and phase of development of our product candidates, including timing for data readouts and patient dosing and the potential for trials to be registrational or global; the potential for SNÅP to develop therapies; our commercialization plan for oral dabogratinib; and our expected cash runway. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of oral dabogratinib; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, recruitment, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for oral dabogratinib or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; regulatory and legislative developments in the United States and foreign countries, including with respect to healthcare and trade policies; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; our ability to establish marketing and sales capabilities to successfully commercialize any approved products; we may use our capital resources sooner than we expect; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Amy Conrad [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tyra-biosciences-reports-fourth-quarter-and-full-year-2025-financial-results-and-recent-highlights-302701497.html

- 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 per dose level in children ages 5 to 10. The Company remains on track to report interim results from the safety sentinel cohort in 2H 2026. Enrolling Phase 2 NMIBC Study – SURF302. SURF302 is a Phase 2 open-label clinical study evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered low-grade IR NMIBC. The Company remains on track to report initial three-month complete response data in 1H 2026. Expanded Development into LG-UTUC – SURF303. TYRA advanced dabogratinib into LG-UTUC, where FGFR3 alterations occur in approximately 85% of cases. An Investigational New Drug application (IND) was cleared by the US Food and Drug Administration (FDA) to enable a Phase 2 study of dabogratinib in LG-UTUC patients (SURF303), which is expected to be initiated in 2026. Phase 1/2 mUC Study – SURF301. Dabogratinib continues to be evaluated in Part B of SURF301 at potentially therapeutic once-daily doses in support of determining an optimal dose for mUC. TYRA-430 Advanced Phase 1 HCC Study – SURF431. TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The SURF431 study continues to enroll and dose adults with 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 Advanced Phase 1 ICC Study – SURF201. 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 (ICC) and other advanced solid tumors with activating FGFR2 gene alterations. SNÅP Platform and Pipeline TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions. Third Quarter 2025 Financial Results Cash, Cash Equivalents and Short-Term Investments. As of September 30, 2025, TYRA had cash, cash equivalents and marketable securities of $274.9 million. TYRA's current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2027. Research and Development (R&D) Expenses. R&D expenses for the three months ended September 30, 2025 were $25.5 million compared to $22.7 million for the same period in 2024. The increase was primarily associated with start-up and enrollment activities for BEACH301, SURF302 and SURF431. General and Administrative (G&A) Expenses. G&A expenses for the three months ended September 30, 2025 were $7.5 million compared to $5.9 million for the same period in 2024. The increase was primarily driven by higher personnel-related costs, including non-cash stock-based compensation. Net Loss. Third quarter net loss was $29.9 million compared to $24.0 million for the same period in 2024. Upcoming Clinical Milestones: BEACH301: initial results from safety sentinel cohort – 2H 2026 SURF302: initial three-month complete response data – 1H 2026 SURF303: initiate Phase 2 study – 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 skeletal dysplasia and cancer that has demonstrated interim clinical proof-of-concept results in mUC. The current planned clinical development for dabogratinib includes Phase 2 clinical trials for pediatric achondroplasia (BEACH301), intermediate risk (IR) non-muscle invasive bladder cancer (SURF302), low-grade upper tract urothelial carcinoma (SURF303) and potentially future mUC clinical trials. The FDA has granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation to dabogratinib for the treatment of achondroplasia. 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 at least 3 participants per dose level in children ages 5 to 10. SURF302 is a Phase 2, open-label, 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. SURF303 will be a Phase 2, open-label, clinical study evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered LG-UTUC. This study has not yet begun enrolling patients. About TYRA-430 TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 clinical 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. 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, 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. 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. TYRA'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 clinical-stage programs in targeted oncology and genetically defined conditions. TYRA's lead precision medicine stemming from SNÅP, dabogratinib, is a potential first-in-class selective FGFR3 inhibitor. Dabogratinib's current planned clinical development includes BEACH301 for pediatric ACH, SURF302 for IR NMIBC, SURF303 for LG-UTUC and potentially mUC. TYRA is also developing TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, in the SURF431 study for advanced HCC, and TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the expected advancement of our pipeline and our growth; the potential to initiate Phase 2 studies of dabogratinib in LG-UTUC and mUC and the timing thereof, and to develop next-generation precision medicines and their potential to be first-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates; the expected trial design, timing and phase of development of our product candidates, including timing for data readouts and patient dosing; the potential for SNÅP to develop therapies; and our expected cash runway. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of dabogratinib; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, recruitment, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for dabogratinib or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; unfavorable results from preclinical studies; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; we may use our capital resources sooner than we expect; unstable market and economic conditions and changes in healthcare legislation, tariffs and trade policies may adversely affect our business and financial condition and the broader economy and biotechnology industry; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Amy Conrad [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tyra-biosciences-reports-third-quarter-2025-financial-results-and-highlights-302606089.html

- 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, 0.25, 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. 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. 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 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 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 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 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. 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. 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. 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 BEACH301: dose first child with achondroplasia – 3Q 2025 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. 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. TYRA'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 clinical-stage programs in targeted oncology and genetically defined conditions. TYRA's lead precision medicine stemming from SNÅP, dabogratinib, is a potential first-in-class selective FGFR3 inhibitor that is designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for FGFR3 gatekeeper mutations. Dabogratinib's current planned clinical development includes SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia, and potentially future mUC studies. TYRA is also developing TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, in the SURF431 study for advanced HCC, and TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the expected advancement of our pipeline and our growth; the potential to transform the treatment of bladder cancer and skeletal dysplasia, develop dabogratinib in skeletal dysplasias beyond ACH, pursue and initiate Phase 2 studies of dabogratinib in mUC, and develop next-generation precision medicines and their potential to be first-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates; the expected trial design, timing and phase of development of our product candidates, including timing for data readouts and patient dosing; the potential for SNÅP to develop therapies; and our expected cash runway. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of dabogratinib; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, recruitment, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for dabogratinib or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; unfavorable results from preclinical studies; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; we may use our capital resources sooner than we expect; unstable market and economic conditions and changes in healthcare legislation, tariffs and trade policies may adversely affect our business and financial condition and the broader economy and biotechnology industry; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Amy Conrad [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tyra-biosciences-reports-second-quarter-2025-financial-results-and-highlights-302530524.html SOURCE Tyra Biosciences

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 that is designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for FGFR3 gatekeeper mutations. TYRA-300's planned clinical development includes three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for mUC. TYRA is also developing TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn. Contact: Amy Conrad [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tyra-biosciences-announces-late-breaking-poster-presentation-on-tyra-300-preclinical-results-at-endo-2025-302500095.html SOURCE Tyra Biosciences

- 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 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 TYRA-300 at 50 mg once-daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability. Advanced Phase 1/2 mUC Study – SURF301. TYRA-300 is currently being evaluated in Part B of SURF301 (NCT05544552) at potentially therapeutic QD doses in preparation for potential future Phase 2 studies. Preclinical Results with TYRA-300 Published in JCI Insight. In April 2025, preclinical results with TYRA-300 were published in JCI Insight 2025 in a manuscript titled "TYRA-300, an FGFR3 selective inhibitor, promotes bone growth in two FGFR3-driven models of chondrodysplasia." TYRA-300 was evaluated in three genetic contexts: wild-type mice, the Fgfr3Y367C/+ mouse model of ACH, and the Fgfr3N534K/+ mouse model of HCH. In each model, TYRA-300 treatment increased naso-anal length, tibia and femur length. In the two FGFR3-altered models, TYRA 300-induced growth partially restored the disproportionality of long bones. Histologic analysis of the growth plate in Fgfr3Y367C/+ mice revealed that TYRA-300 mechanistically increased both proliferation and differentiation of chondrocytes. Importantly, TYRA-300 also significantly improved the size and shape of the skull and foramen magnum in Fgfr3Y367C/+ mice. These studies demonstrate that TYRA-300 led to a significant increase in bone growth in two independent FGFR3-driven preclinical models, as well as in wild-type mice. TYRA-200 Advanced Phase 1 SURF201 Study. TYRA-200 is an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. SURF201 (Study in PrevioUsly Treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752) is a multi-center, open label study designed to evaluate the safety, tolerability, and pharmacokinetics of TYRA-200 and determine the optimal and maximum tolerated dose and recommended Phase 2 dose, as well as evaluate the preliminary antitumor activity of TYRA-200. 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. TYRA-430 Initiated Patient Dosing in Phase 1 Study – SURF431. TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. Patient dosing has commenced 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 (NCT06915753). SURF431 is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TYRA-430 and determine the maximum tolerated dose and recommended Phase 2 dose, as well as evaluate the preliminary antitumor activity of TYRA-430. We believe TYRA-430 has the potential to address a significant unmet need in HCC, where there are no approved biomarker-driven, targeted therapies. SNÅP Platform and Pipeline TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions. First Quarter 2025 Financial Results Cash, Cash Equivalents and Short-Term Investments. As of March 31, 2025, TYRA had cash, cash equivalents, and marketable securities of $318.9 million. The Company's current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2027. Research and Development (R&D) Expenses. R&D expenses for the three months ended March 31, 2025 were $25.0 million compared to $17.2 million for the same period in 2024. The increase was primarily driven by higher clinical costs associated with start-up activities for BEACH301, SURF302 and SURF431, as well as increased CMC and personnel-related costs, including non-cash stock-based compensation. General and Administrative (G&A) Expenses. G&A expenses for the three months ended March 31, 2025 were $6.9 million compared to $5.1 million for the same period in 2024. The increase was primarily driven by higher personnel-related costs, including non-cash stock-based compensation. Net Loss. First quarter net loss was $28.1 million compared to $18.2 million for the same period in 2024. Upcoming Anticipated Milestones and Events BEACH301: dose first child with ACH with TYRA-300 – Q2 2025 SURF302: dose first IR NMIBC patient with TYRA-300 – Q2 2025 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, including achondroplasia and hypochondroplasia. In oncology, TYRA-300 is being evaluated in mUC and IR NMIBC. In mUC, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552). The study is designed to determine the optimal and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. In October 2024, TYRA reported interim clinical proof-of-concept data in mUC from SURF301. TYRA has received IND clearance from the US FDA to proceed with its SURF302 clinical trial in patients with IR NMIBC. In skeletal dysplasia, TYRA-300 has demonstrated positive preclinical results in achondroplasia and hypochondroplasia, and its BEACH301 clinical trial in children with achondroplasia is now enrolling. 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. 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 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 product candidates in clinical development 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 that is designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for the FGFR3 gatekeeper mutations. TYRA-300 is expected to be evaluated in three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for metastatic urothelial cancer. TYRA is also developing TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the expected advancement of our pipeline and our growth; the potential to develop next-generation precision medicines and their potential to be first-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates; the expected trial design, timing and phase of development of our product candidates, including timing for patient dosing; the potential for SNÅP to develop therapies; and our expected cash runway. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of TYRA-300; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, recruitment, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for TYRA-300 or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; unfavorable results from preclinical studies; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; we may use our capital resources sooner than we expect; unstable market and economic conditions may adversely affect our business and financial condition and the broader economy and biotechnology industry; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Amy Conrad [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tyra-biosciences-reports-first-quarter-2025-financial-results-and-highlights-302450446.html SOURCE Tyra Biosciences

- 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 TYRA-300 at 50 mg once-daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability. Cleared Phase 2 ACH IND with US FDA - BEACH301. 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 will initially enroll a safety sentinel cohort of up to 3 treatment-naïve participants per dose level in children ages 5 to 10. Reported Interim Clinical Proof-of-Concept Results in mUC Patients – SURF301. TYRA-300 demonstrated encouraging preliminary anti-tumor activity in a heavily pre-treated population: at ≥ 90 mg QD, 6 out of 11 (54.5%) patients with FGFR3+ mUC achieved a confirmed partial response (PR), with 100% disease control rate and sustained duration of activity; positive safety results were reported across all QD doses, with infrequent FGFR2/FGFR1-associated toxicities (data cutoff of August 15, 2024). TYRA-300 is being evaluated in Part B of SURF301 (NCT05544552) at potentially therapeutic QD doses in preparation for potential future Phase 2 studies. TYRA-200 Advanced Phase 1 SURF201 Study. TYRA-200 is an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752) is a multi-center, open label study designed to evaluate the safety, tolerability, and pharmacokinetics of TYRA-200 and determine the optimal and maximum tolerated dose and recommended Phase 2 dose, as well as evaluate the preliminary antitumor activity of TYRA-200. The SURF201 study is currently enrolling and dosing adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations. TYRA-430 Cleared Phase 1 IND with US FDA – SURF431. TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 study will be a 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 (SURF431). We believe TYRA-430 has the potential to address a significant unmet need in HCC, where there are no approved biomarker-driven, targeted therapies. Corporate Strengthened Leadership Team and Board of Directors. In 2024, TYRA appointed Doug Warner, MD, as Chief Medical Officer, and Erik Goluboff, MD, as SVP, Clinical Development to lead the Company's oncology strategy and clinical development plans. In 2025, TYRA appointed accomplished drug developer Adele Gulfo to its Board of Directors, Sinette Heys as SVP, Clinical Operations to lead the Company's clinical operations team, and Will Charlton, MD, as SVP, Clinical Development to lead the Company's skeletal dysplasia clinical development group. SNÅP Platform and Pipeline TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, to develop therapies in targeted oncology and genetically defined conditions. Fourth Quarter and Full-Year 2024 Financial Results Cash, Cash Equivalents and Short-Term Investments. As of December 31, 2024, TYRA had cash, cash equivalents, and marketable securities of $341.4 million, compared to $203.5 million at the end of 2023. The increase was primarily due to the completion of a private placement financing for net proceeds of $199.6 million in the first quarter of 2024. The Company's current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2027. Research and Development (R&D) Expenses. Research and development expenses for the three months ended December 31, 2024 were $22.2 million compared to $20.7 million for the same period in 2023, and $80.1 million for the full year 2024 compared to $62.5 million for the same period in 2023. The increases were primarily driven by increased expenses incurred in connection with our ongoing and planned clinical trials and personnel-related costs, including stock-based compensation, partially offset by decreased drug manufacturing and preclinical costs. General and Administrative (G&A) Expenses. General and administrative expenses for the three months ended December 31, 2024 were $7.6 million compared to $5.0 million for the same period in 2023, and $24.1 million for the full year 2024 compared to $17.4 million for the same period in 2023. The increases were primarily driven by increased personnel-related costs, including stock-based compensation. Net Loss. Fourth quarter 2024 net loss was $25.6 million compared to $22.8 million for the same period in 2023, and $86.5 million for the full year 2024 compared to $69.1 million for the same period in 2023. Upcoming Anticipated Milestones and Events BEACH301: dose first child with achondroplasia with TYRA-300 – Q2 2025 SURF302: dose first NMIBC patient with TYRA-300 – Q2 2025 SURF431: dose first HCC patient with TYRA-430 – Q2 2025 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, including achondroplasia and hypochondroplasia. In oncology, TYRA-300 is being evaluated in mUC and IR NMIBC. In mUC, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552). The study is designed to determine the optimal and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. In October 2024, TYRA reported interim clinical proof-of-concept data in mUC from SURF301. TYRA has received IND clearance from the US FDA to proceed with its SURF302 clinical trial in patients with IR NMIBC. In skeletal dysplasia, TYRA-300 has demonstrated positive preclinical results in achondroplasia and hypochondroplasia, and its BEACH301 clinical trial in children with achondroplasia is now recruiting. 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 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752), is a multi-center, open label study designed to evaluate the maximum tolerated dose (MTD) 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. About TYRA-430 TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The US FDA has cleared Tyra's IND to proceed with a Phase 1 clinical study of TYRA-430. The Phase 1 study will be a multicenter, open-label, first-in-human study of TYRA-430 in advanced HCC and other solid tumors with activating FGF/FGFR pathway aberrations (SURF431). 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 product candidates in clinical development 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 that is designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for the FGFR3 gatekeeper mutations. TYRA-300 is expected to be evaluated in three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for metastatic urothelial cancer. TYRA is also developing TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the expected advancement of our pipeline and our growth; the potential to develop next-generation precision medicines and their potential to be first-in-class and/or best-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates; the expected trial design, timing and phase of development of our product candidates, including timing for patient dosing; the potential for SNÅP to develop therapies; and our expected cash runway. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of TYRA-300; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, recruitment, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for TYRA-300 or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; unfavorable results from preclinical studies; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; we may use our capital resources sooner than we expect; unstable market and economic conditions may adversely affect our business and financial condition and the broader economy and biotechnology industry; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Amy Conrad [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/tyra-biosciences-reports-fourth-quarter-and-full-year-2024-financial-results-and-highlights-302413623.html SOURCE Tyra Biosciences