Cogent Biosciences (COGT) investor relations material

Executive summary

• Achieved major milestones with three NDAs submitted for bezuclastinib following positive pivotal trial results in GIST and Systemic Mastocytosis indications, with FDA decisions anticipated in late 2026.

• Building a commercial organization and onboarding expert teams in preparation for potential U.S. launch of bezuclastinib in H2 2026, pending regulatory approval.

• Expanding pipeline includes Phase 1 studies for ErbB2 and PI3Kα inhibitors, preclinical programs targeting KRAS and JAK2 mutations, and plans to submit INDs for these in 2026.

Financial highlights

• Net loss for Q2 2026 was $96.4 million, up from $73.5 million year-over-year; net loss for the six months ended June 30, 2026 was $193.8 million, compared to $145.5 million for the same period in 2025.

• Operating expenses for Q2 2026 totaled $102.6 million, up from $75.6 million year-over-year, driven by R&D and commercial readiness investments.

• Cash, cash equivalents, and marketable securities totaled $792.3 million as of June 30, 2026; pro forma cash balance of $865.9 million including post-quarter ATM proceeds.

• Accumulated deficit reached $1,382.2 million as of June 30, 2026.

Outlook and guidance

• Cash position, including post-quarter ATM proceeds, expected to fund operations into late 2028, covering potential FDA approvals and commercial launches.

• Anticipates increased expenses as commercialization and clinical development activities expand.

• Preliminary results from the SUMMIT extension trial expected by end of 2026.