Tyra Biosciences (TYRA) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Key clinical insights and program updates

• Focused on high-value indications with strong FGFR3 validation: intermediate risk non-muscle invasive bladder cancer (NMIBC), low-grade upper tract urothelial carcinoma (UTUC), and achondroplasia.

• Phase I data for dabogratinib in metastatic settings showed reduced FGFR1/2 toxicities and lower diarrhea rates compared to competitors.

• Over 100 patients dosed; comprehensive preclinical and chronic toxicity studies support a favorable safety profile.

• Dose selection is informed by robust modeling and clinical data, aiming for optimal efficacy with minimal side effects.

• Four open trials: SURF301, SURF302, SURF303, and BEACH301, with key data readouts expected mid- and late-year.

Achondroplasia and bone growth disorder strategy

• Achondroplasia program leverages dose-response data, targeting improved height velocity and daily function benefits.

• Doses in BEACH301 trial range from 10 to 40 mg, aiming for safe, effective growth without excessive risk.

• Genetic validation supports targeting up to 40 mg, mirroring natural single allele FGFR3 knockouts.

• Efficacy benchmarks set by recent BridgeBio data; goal is to exceed 7 cm annual height velocity at higher doses.

Bladder cancer (NMIBC) and UTUC development rationale

• Intermediate risk NMIBC chosen due to high FGFR3 positivity and lower progression risk; oral FGFR3 inhibitors expected to reduce recurrence and invasive procedures.

• Current standard of care is burdensome, involving frequent invasive procedures and high recurrence rates.

• Oral therapy could significantly reduce treatment burden and recurrence, with economic incentives for community urologists to prescribe.

• Phase II aims for ≥70% complete remission rate, translating to high disease-free survival and reduced TURBT procedures.

• UTUC program targets kidney-sparing outcomes, with registrational trial (SURF303) set to begin soon.