Tyra Biosciences (TYRA) investor relations material

Strategic program updates

• Advancing late-stage development for dabogratinib in three FGFR3-driven indications: intermediate-risk NMIBC (data in August), achondroplasia (Q4 data), and low-grade UTUC (data next year).

• The SURF302 study in NMIBC will report initial efficacy and safety data in August, targeting a 70% CR rate as a benchmark for phase III advancement.

• Achondroplasia program cleared all four dose levels with no safety signals; six-month height velocity data expected in Q4, aiming for >7 cm/year at higher doses.

• UTUC program targets a single-arm study for full approval, with initial data expected in 2027; focus is on kidney-sparing outcomes.

• Well-financed to advance at least one indication to NDA, with plans to raise additional capital for phase III trials if phase II data are positive.

Clinical and commercial differentiation

• Oral dabogratinib offers a unique, less invasive alternative to intravesical therapies, addressing significant patient treatment burden.

• Efficacy benchmark set by erdafitinib (THOR-2 study) with 89% CR and 100% durability at 12 months, but with high toxicity; dabogratinib aims for similar efficacy with improved tolerability.

• Community urologists are receptive to oral therapies due to in-office dispensing, aligning with economic incentives and patient preference.

• Pricing strategy references innovative targeted therapies like erdafitinib and TAR-210, with potential premium for FGFR3 selectivity and oral administration.

• Market opportunity is significant, with intermediate-risk NMIBC and UTUC representing large, underserved populations.

Safety and efficacy expectations

• Anticipates low rates of grade 3 liver toxicity at lower doses, with overall safety profile expected to be favorable and comparable to approved localized therapies.

• Durability of response is a key differentiator; oral therapy allows for ongoing tumor suppression, potentially leading to superior long-term outcomes versus device-based approaches.

• Achondroplasia program aims to exceed benchmarks set by infigratinib, targeting >7 cm/year height velocity at six months.

• For UTUC, even modest CR or PR rates with good tolerability could drive broad adoption due to poor standard of care and high unmet need.

• Enrollment and site activation for UTUC are progressing, with major centers like MD Anderson and Cleveland Clinic participating.