Tyra Biosciences (TYRA) Goldman Sachs 45th Annual Global Healthcare Conference summary

Strategic focus and pipeline overview

• Emphasis on developing small molecule precision medicines targeting the FGFR family, especially FGFR3, using the proprietary SNAP chemistry platform.

• TYRA-300, initially for oncology, showed promising preclinical results in achondroplasia, prompting a planned phase II IND submission in the second half of the year.

• TYRA-200 is in clinical trials for FGFR2-positive cholangiocarcinoma, and TYRA-430 is advancing through IND-enabling studies.

Achondroplasia and FGFR3-driven short stature

• Achondroplasia is caused by FGFR3 overactivity, leading to short stature and significant clinical complications.

• Current treatments like vosoritide and infigratinib show modest improvements in annualized height velocity (AHV), but a substantial gap remains to average stature.

• TYRA-300 aims for more potent and selective FGFR3 inhibition, potentially improving efficacy and tolerability over pan-FGFR inhibitors.

• Preclinical models show TYRA-300 normalizes bone architecture and growth plate structure, supporting its clinical advancement.

• The phase II trial will focus on AHV at 6, 12, and 24 months, with exploratory endpoints on functional and clinical outcomes, and follow-up to final height.

Oncology opportunities and competitive differentiation

• TYRA-300 is designed to avoid the gatekeeper resistance mutation, a limitation of current pan-FGFR inhibitors.

• FGFR3-positive urothelial cancer represents a large, under-addressed market, with current drugs like erdafitinib limited by tolerability and short duration of response.

• TYRA-300 demonstrates high selectivity for FGFR3, reduced off-target effects, and retains activity against resistance mutations in preclinical models.

• Early clinical data show tumor shrinkage at lower doses and avoidance of hyperphosphatemia, with further data expected in the second half of the year.

• The oral formulation of TYRA-300 targets both non-muscle invasive and metastatic bladder cancer, aiming for improved durability and patient adherence.