Enliven Therapeutics (ELVN) Q3 2026 earnings summary

Executive summary

• FDA alignment on ENABLE-2’s final design supports a planned Phase 3 start before year-end 2026; the trial will evaluate relcobatinib in previously treated CML.

• Relcobatinib remains the lead clinical program; ELVN-002 development was discontinued and the program is exploring strategic alternatives.

• Phase 1 ENABLE data were presented at four hematology meetings; preclinical findings on selectivity and resistant-mutation activity appeared in Leukemia.

• Relcobatinib was adopted as the nonproprietary name for ELVN-001; Kristine Ball joined the Board of Directors.

Financial highlights

• Q3 2026 operating expenses were $36.0M vs. $25.1M YoY; net loss was $27.7M vs. $20.1M, and loss per share was $0.36 vs. $0.32.

• 9M 2026 operating expenses were $101.1M vs. $85.4M; net loss was $83.8M vs. $74.0M, and loss per share was $1.21 vs. $1.35.

• Cash, cash equivalents and marketable securities totaled $884.4M at September 30, 2026, vs. $462.6M at December 31, 2025.

• No product or other revenue has been generated; meaningful revenue is not expected unless product candidates are approved and commercialized.

Outlook and guidance

• Cash and marketable securities are expected to fund operations into 2030; a separate filing disclosure says the current operating plan provides at least 12 months of funding from filing.

• ENABLE-2 is planned to enroll ~450 adults, randomized 1:1 to relcobatinib 80 mg once daily or investigator-selected dasatinib, nilotinib or bosutinib.

• Primary endpoint is MMR at Week 24, potentially supporting accelerated approval; MMR at Week 96 is the key secondary endpoint that could support full approval.

• R&D and G&A expenses are expected to increase substantially as clinical development, staffing, manufacturing and potential commercialization needs grow.