Tyra Biosciences (TYRA) investor relations material

Strategic overview and late-stage pipeline

• Three potential blockbuster indications for dabogratinib are advancing into late-stage development, targeting validated FGFR3-driven diseases with significant unmet needs.

• Dabogratinib is positioned as a highly selective, well-tolerated FGFR3 inhibitor, aiming to address toxicity issues seen with less selective drugs.

• The company’s Dabo 3x3 strategy focuses on intermediate-risk NMIBC, UTUC, and achondroplasia, each representing large or underserved patient populations.

Clinical development and upcoming milestones

• In intermediate-risk NMIBC, a pivotal data readout is expected in August, targeting a 70% CR rate with strong tolerability to support phase III advancement.

• Over 20 patients have been enrolled in the current study, with efficacy and safety data to inform go/no-go decisions and potential dose adjustments.

• The UTUC program has dosed its first patient, with initial data expected next year; the registrational path is streamlined due to high FGFR3 positivity and unmet need.

• Achondroplasia studies have cleared the fourth dose cohort, with a six-month efficacy readout planned for Q4 next year.

Market opportunity and competitive landscape

• Intermediate-risk NMIBC represents a market comparable in size to EGFR-positive lung cancer, with 35,000 new FGFR3-positive patients annually in the US.

• Oral therapy is expected to be highly disruptive, offering advantages over current procedural and intravesical treatments, and aligning with physician and patient incentives.

• In UTUC, oral options are favored by physicians for kidney-sparing potential, with even modest CR rates expected to drive significant uptake.

• Achondroplasia market research suggests potential for premium pricing if best-in-class efficacy benchmarks are exceeded.