Tyra Biosciences Conference Call Summary Company Overview - **Company**: Tyra Biosciences (NasdaqGS:TYRA) - **Focus**: Precision small molecule medicine, specifically targeting FGFR3 with their lead drug, dabogratinib [2][4] Key Points and Arguments Drug Development and Clinical Trials - **Dabogratinib**: An FGFR3 selective inhibitor recently cleared for a phase two study in upper tract urothelial carcinoma, with ongoing trials for intermediate risk NMIBC and achondroplasia [2][3] - **Market Opportunity**: The FGFR3 positive bladder cancer market is estimated to be over $5 billion, with a significant unmet need in patients, particularly in the intermediate risk NMIBC setting [3][4] - **Efficacy Data**: Erdafitinib, a competitor, has shown a 35.3% overall response rate (ORR) at 8-9 mg dose, while a lower dose in the NMIBC setting yielded an 89% complete response (CR) rate [5][6] Competitive Landscape - **Unique Position**: Tyra is the only company advancing an FGFR3 selective oral drug, which is expected to have a better safety profile compared to existing treatments that affect FGFR1, 2, and 4 [4][6] - **Safety Profile**: Dabogratinib demonstrated significantly reduced toxicity compared to erdafitinib, with lower rates of common side effects such as nail disorders and hyperphosphatemia [6][8] Market Dynamics - **Urologist Engagement**: There is strong enthusiasm among urologists for oral therapies, as they can enhance practice revenue through in-office dispensing, similar to oral prostate cancer drugs [10][11] - **Switch Market Potential**: The treatment landscape is expected to shift towards oral options, with urologists likely to prefer oral therapies for recurrent patients rather than invasive procedures [29][30] Achondroplasia Program - **Growth Impact**: FGFR3 inhibition has shown potential to improve annualized height velocity (AHV) in children with achondroplasia, with Tyra aiming to exceed the 6 cm/year benefit seen in competitors [15][18] - **Preclinical Validation**: Studies indicate that targeting FGFR3 can lead to significant growth without severe toxicity, suggesting a favorable therapeutic window [17][19] Future Milestones - **Data Readouts**: Tyra expects to provide data on NMIBC and achondroplasia in 2026, with a well-financed position into 2028, holding $275 million [24] - **Regulatory Path**: Positive data could lead to a rapid transition to registrational studies, similar to competitors' paths [32][33] Additional Important Insights - **Unmet Needs in Upper Tract Urothelial Carcinoma**: This area presents a high burden of unmet need, with a significant percentage of patients being FGFR3 positive [12][13] - **Community Engagement**: There is a strong interest from the medical community in Tyra's studies, indicating a robust pipeline and potential for successful patient recruitment [21][23] This summary encapsulates the critical aspects of Tyra Biosciences' conference call, highlighting the company's strategic focus, competitive advantages, and future opportunities in the biotech landscape.

Core Insights - Tyra Biosciences is advancing its clinical programs, particularly focusing on dabogratinib for treating conditions like pediatric achondroplasia and bladder cancer, with interim results expected in 2026 [1][2][8] Clinical Development - The company has dosed the first patients in its Phase 2 studies, BEACH301 and SURF302, with expectations for interim results in 2026 [1][2] - Dabogratinib is being expanded into low-grade upper tract urothelial carcinoma (LG-UTUC), where FGFR3 alterations are present in approximately 85% of cases, with an IND cleared by the FDA [1][4][8] - The BEACH301 study is evaluating dabogratinib in children aged 3 to 10 with achondroplasia, while SURF302 focuses on FGFR3-altered low-grade intermediate risk non-muscle invasive bladder cancer [4][10] Financial Overview - As of September 30, 2025, Tyra Biosciences reported cash, cash equivalents, and marketable securities totaling $274.9 million, providing a runway through at least 2027 [1][10] - Research and development expenses for Q3 2025 were $25.5 million, an increase from $22.7 million in Q3 2024, primarily due to start-up and enrollment activities [10][19] - The net loss for Q3 2025 was $29.9 million, compared to $24.0 million for the same period in 2024 [10][19] Pipeline and Future Plans - The company is also developing TYRA-430, an FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, and TYRA-200, an FGFR1/2/3 inhibitor for advanced intrahepatic cholangiocarcinoma [4][12][14] - Upcoming milestones include initial results from the safety sentinel cohort of BEACH301 in 2H 2026 and initial three-month complete response data from SURF302 in 1H 2026 [10][11]

Tyra Biosciences (TYRA) Conference Summary Company Overview - **Company**: Tyra Biosciences (TYRA) - **Focus**: Discovery and development of selective FGFR3 inhibitors for cancer and achondroplasia treatment - **Key Products**: Lead compound is an FGFR3 selective inhibitor, dabogratinib (formerly TYR3-100) Pipeline Initiatives - **Active Phase II Trials**: - **Bladder Cancer**: Targeting intermediate risk FGFR3 positive non-muscle invasive bladder cancer (NMIBC) with a patient population of approximately 700,000 in the US, where FGFR3 positivity is 70-80% [5][11] - **Achondroplasia**: Addressing skeletal dysplasia caused by FGFR3 alterations, which leads to significant health complications [6][11] Study Design and Efficacy - **NMIBC Study**: - Phase II study randomizing patients to receive either 50 mg or 60 mg of dabogratinib daily [12] - Primary endpoint: 3-month complete response (CR) rate; secondary endpoints include duration of response and time to recurrence [12] - Anticipated CR rate benchmark is around 70% based on expert feedback [26] - **Achondroplasia Study**: - Initiated with a focus on pediatric dosing, starting at 0.125 to 0.5 mg/kg [73] - Emphasis on FGFR3 selectivity to optimize growth and reduce complications associated with the condition [78][86] Safety and Tolerability - **Dabogratinib Safety Profile**: - Demonstrated a pristine safety profile with low-grade adverse events (AEs) such as diarrhea and asymptomatic ALT/AST elevations [19][40] - No hyperphosphatemia observed at doses of 50-60 mg, contrasting with other pan FGFR inhibitors [40][64] Competitive Landscape - **Comparison with Other Treatments**: - Dabogratinib shows a significantly improved safety profile compared to erdafitinib, with lower rates of nail toxicity and stomatitis [63] - The oral administration of dabogratinib is expected to enhance patient adherence compared to intravesical therapies [50][51] Market Dynamics - **Community Channel Dynamics**: - The evolution of oral therapies in urology, supported by EuroGPO, has facilitated the adoption of oral drugs in community practices [55][58] - Oral drug spend in urology has reportedly increased from 5% to 15% since 2008, with indications that it may be as high as 40% today [57] Future Outlook - **Prioritization of Trials**: - The company is focusing on the intermediate risk NMIBC and achondroplasia settings due to larger patient populations and unmet needs [70][72] - Future discussions with the FDA regarding the metastatic urothelial carcinoma setting are planned, but current focus remains on ongoing Phase II trials [69][72] Key Takeaways - Tyra Biosciences is advancing innovative treatments for bladder cancer and achondroplasia with a strong emphasis on safety and patient convenience - The company is well-positioned in the market with a promising pipeline and a clear strategy for commercialization and patient engagement - Ongoing studies are expected to provide critical data that will shape the future of treatment options in these therapeutic areas [21][72]

Core Insights - Tyra Biosciences has initiated the BEACH301 Phase 2 clinical study for dabogratinib, the only oral FGFR3-selective inhibitor in development for achondroplasia, marking a significant milestone in the treatment of this condition [1][2][3] Company Overview - Tyra Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision medicines targeting FGFR biology, utilizing its in-house SNÅP platform for drug design [9] - Dabogratinib is the lead candidate from Tyra's pipeline, designed to be a first-in-class oral FGFR3-selective inhibitor, with ongoing clinical trials for both pediatric achondroplasia and cancer [7][9] Clinical Study Details - The BEACH301 study will evaluate dabogratinib in children aged 3 to 10 with achondroplasia, enrolling treatment-naïve participants and those who have received prior therapies [4][5] - The study aims to assess safety, tolerability, and growth velocity changes, with a focus on improving the quality of life for children with achondroplasia [5][6] Market Context - Achondroplasia affects approximately 1 in 15,000 to 40,000 children, with around 250,000 individuals impacted globally, highlighting a significant unmet medical need [2][6] - The FGFR3 G380R mutation is responsible for about 99% of achondroplasia cases, indicating a targeted therapeutic approach could be beneficial [2][6]

Group 1 - Tyra Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation precision medicines targeting Fibroblast Growth Factor Receptor (FGFR) biology [2] - The company utilizes its in-house precision medicine platform, SNÅP, for rapid and precise drug design, predicting genetic alterations that may cause resistance to existing therapies [2] - Tyra's lead product, dabogratinib, is a potential first-in-class selective FGFR3 inhibitor designed to minimize toxicities associated with other FGFR inhibitors [2] Group 2 - Current clinical development plans for dabogratinib include studies for intermediate risk non-muscle invasive bladder cancer, pediatric achondroplasia, and potential future studies for metastatic urothelial cancer [2] - Tyra is also developing TYRA-430, an oral FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, and TYRA-200, an oral FGFR1/2/3 inhibitor for metastatic intrahepatic cholangiocarcinoma [2] - The company will participate in investor events, including a virtual fireside chat on August 21, 2025, and the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025 [1]