Tyra Biosciences FY Conference Summary Company Overview - **Company**: Tyra Biosciences (NasdaqGS:TYRA) - **Focus**: Development of dabogratinib, an FGFR3 inhibitor for various indications including bladder cancer and skeletal dysplasias Key Points Drug Development and Indications - **Dabogratinib** is being explored for multiple uses, initially in metastatic bladder cancer and now expanding to earlier-stage bladder cancer and bone growth disorders like achondroplasia [3][4] - The drug targets **FGFR3** alterations, which are prevalent in specific cancer types and skeletal dysplasias [4] - Tyra is focusing on high-value opportunities with strong validation, particularly in low-grade upper tract urothelial carcinoma and intermediate-risk non-muscle invasive bladder cancer [4] Clinical Data and Safety - Tyra has conducted a Phase I trial demonstrating significant reduction in FGFR1 and FGFR2-associated toxicities, with a favorable safety profile compared to existing treatments [5][11] - Over 100 patients have been dosed, with ongoing studies to ensure safety and efficacy [11][12] - The drug has shown a favorable toxicity profile, with low-grade diarrhea being the most common side effect, which is manageable [15][16] Efficacy Expectations - Tyra anticipates improved efficacy in achondroplasia, aiming for additional growth benefits beyond current treatments [10][21] - The company is testing various doses (10, 20, 30, and 40 mg) to optimize growth outcomes while minimizing risks [29][31] - The expected outcomes for achondroplasia include significant height increases, with a target of achieving growth rates comparable to existing therapies [21][24] Bladder Cancer Focus - Tyra is prioritizing intermediate-risk non-muscle invasive bladder cancer due to the high prevalence of FGFR3 positivity (over 70%) in this group, which is crucial for treatment efficacy [42][47] - The company aims to reduce the need for invasive TURBT procedures, which are costly and burdensome for patients [50][63] - Tyra's oral therapy could significantly lower recurrence rates and improve patient quality of life compared to current treatment options [69][70] Future Trials and Pipeline - Tyra has multiple ongoing trials, including SURF301, SURF302, SURF303, and BEACH301, with data expected in the second half of the year for achondroplasia and mid-year for non-muscle invasive bladder cancer [87][88] - The company is also exploring new indications for FGFR3 and maintaining an active discovery program for additional therapeutic options [89] Market Potential - The unmet need in conditions like UTUC (upper tract urothelial carcinoma) is significant, with an estimated 40% of patients potentially losing their kidneys due to ineffective treatments [79][81] - Tyra's oral treatment could provide a compelling alternative, potentially leading to a market opportunity similar to that of Gleevec as the patient population grows [84] Conclusion - Tyra Biosciences is positioned to make significant advancements in the treatment of bladder cancer and skeletal dysplasias with its FGFR3 inhibitor, dabogratinib, focusing on safety, efficacy, and patient quality of life while addressing substantial unmet medical needs in these areas [90]