Tyra Biosciences (TYRA) investor relations material

Pipeline and clinical progress

• Lead drug dabogratinib, an FGFR3 selective inhibitor, is advancing in phase II studies for upper tract urothelial carcinoma, intermediate risk NMIBC, and achondroplasia.

• FGFR3 is a key genetic driver in bladder cancers and skeletal dysplasias, with high positivity rates in early-stage disease.

• Achondroplasia and other FGFR3-driven short stature conditions represent significant opportunities for targeted therapy.

• Dabogratinib is the only oral FGFR3 selective drug in clinical development for these indications.

• Phase II studies are enrolling, with initial data readouts expected in the first half of next year for NMIBC and in the second half for achondroplasia.

Efficacy and safety data

• Erdafitinib, a pan-FGFR inhibitor, showed high efficacy but significant toxicity due to off-target effects; dabogratinib aims to match efficacy with improved safety.

• Dabogratinib demonstrated a marked reduction in FGFR1/2-related toxicities, such as nail disorders and hyperphosphatemia, compared to erdafitinib.

• At 40 and 60 mg doses, dabogratinib showed a clean safety profile, with minimal liver enzyme elevations.

• The ongoing NMIBC study is testing 50 and 60 mg doses, targeting efficacy similar to erdafitinib but with better tolerability.

• Initial 3-month complete response data from 20-30 patients is expected by mid-next year.

Market opportunity and physician adoption

• FGFR3-driven bladder cancers represent a multi-billion dollar market due to high unmet need and patient volume.

• Oral therapies are increasingly favored by urologists, who have adapted their practices to benefit economically from in-office dispensing.

• The oral option is expected to drive a dynamic switch market, with physician and patient preferences shaping adoption.

• Expansion into upper tract urothelial carcinoma addresses a high-burden, hard-to-treat population with few alternatives.

• The oral FGFR3 inhibitor could offer a Gleevec-like opportunity for long-term disease management.