Tyra Biosciences (TYRA) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Strategic focus and drug development

• Precision medicine approach using in-house SNÅP Chemistry platform led to the creation of dabogratinib, targeting FGFR3 for urothelial cancers and growth disorders.

• Current focus is on intermediate-risk NMIBC, upper tract urothelial carcinoma (UTUC), and achondroplasia, with NMIBC representing the largest unmet need.

• Oral administration offers a significant advantage over existing therapies that require invasive procedures, addressing the main patient and physician concern of procedural burden.

• Market opportunity for dabogratinib is estimated at over $5 billion, with potential to become the first-line choice for both patients and physicians.

Clinical data and efficacy highlights

• Phase II data showed a clear dose response, with 79% response rate at 60 mg and a 64% complete response (CR) rate, improving over time as partial responses convert to CRs.

• In patients with a single marker lesion, 100% overall response rate (ORR) and 75% CR rate were observed, matching or exceeding results from the THOR-2 study with oral erdafitinib.

• Multiple marker lesions proved harder to treat, suggesting higher doses may be needed for ablative settings, but the main market focus remains adjuvant therapy at 60 mg.

• Durability of response is expected to be excellent, with 100% durability observed in patients who achieved CR and remained on drug, based on current and comparative data.

Phase III planning and competitive positioning

• Phase III will use a 60 mg dose in an adjuvant setting, targeting disease-free survival (DFS) as the primary endpoint, with secondary endpoints at 12 and 24 months.

• Modeling suggests a high probability of phase III success, even under conservative assumptions, with projected DFS up to 80% and a hazard ratio of 0.6.

• Dabogratinib is positioned as a best-in-class oral therapy, with robust data supporting its use over competitors like TAR-210 and intravesical therapies.

• Additional 15 patients at 60 mg will provide further durability data before phase III launch.