Celcuity (CELC) Status Update summary

Clinical trial results and efficacy

• Gedatolisib plus fulvestrant and palbociclib, and gedatolisib plus fulvestrant, both met primary endpoints in the Phase 3 VIKTORIA-1 trial, showing significant improvement in progression-free survival (PFS) for HR positive, HER2 negative, PIK3CA wild-type advanced breast cancer patients.

• Median PFS was 9.3 months for the triplet regimen (HR=0.24) and 7.4 months for the doublet (HR=0.33), compared to 2 months for fulvestrant alone.

• These results represent the most favorable hazard ratios and highest incremental PFS improvements ever reported in this patient population for second-line therapy.

• Both regimens were well tolerated, with lower discontinuation rates and improved safety profiles compared to earlier studies and other approved combinations.

• Positive trends in overall survival were observed, despite data immaturity and patient crossover.

Scientific and competitive landscape

• Current second-line therapies for this population offer limited benefit, with median PFS typically 2–4 months.

• No prior prospective trial has shown benefit for PAM pathway inhibitors in PIK3CA wild-type cancers post-CDK4/6 inhibitor therapy.

• Gedatolisib regimens outperformed all approved and investigational therapies in this setting, with unprecedented hazard ratios and PFS improvements.

• The drug’s efficacy is independent of PIK3CA mutation status, supporting its broad potential.

• IV administration was not a barrier to usage, and safety and quality of life were preserved.

Market opportunity and commercialization

• Approximately 34,000 patients move to second-line treatment after CDK4/6 inhibitors annually in the US, with 60% being PIK3CA wild-type.

• The estimated market opportunity is $5 billion in served market revenue potential.

• Gedatolisib’s IV administration may facilitate smoother reimbursement compared to oral drugs.

• Market preparation includes engaging key opinion leaders, payers, advocacy groups, and building distribution, reimbursement, patient support, and operational infrastructure.

• Strategic and tactical launch plans are in place, with ongoing team building and supply chain development.