Enliven Therapeutics (ELVN) Goldman Sachs 45th Annual Global Healthcare Conference summary

Pipeline overview and strategy

• Two lead programs, ELVN-001 (BCR-ABL inhibitor for CML) and ELVN-002 (HER2 inhibitor), are in phase 1 studies with initial data released; focus is on proof of concept and combination therapy development for both assets.

• ELVN-001 targets CML, showing promising early efficacy and tolerability in heavily pretreated, resistant patients, with data comparable to or better than existing therapies like Scemblix and bosutinib.

• ELVN-002 is being developed for HER2-positive cancers, with a focus on combination regimens post-Enhertu; monotherapy and combination data are expected to mature next year.

• Strategic resource allocation prioritizes advancing ELVN-001 and ELVN-002, with a third IND-stage asset on hold pending further evaluation or partnership.

• Cash management and maximizing value from lead programs are guiding near-term development decisions.

Clinical data highlights and competitive positioning

• ELVN-001 demonstrated clear anti-CML activity and strong tolerability, with no grade 3 non-hematological AEs and no dose reductions at higher exposures.

• Efficacy in late-line, heavily pretreated CML patients is comparable to Scemblix, with a higher proportion of prior ponatinib and asciminib exposure in the study population.

• Safety and quality of life are emphasized due to the chronic nature of CML; ELVN-001 aims to fit into earlier line settings as data matures.

• For ELVN-002, preclinical and early clinical data show promising target coverage, minimal liver toxicity, and potential for better efficacy and combination flexibility compared to tucatinib.

• The HER2 program targets large post-Enhertu populations, with colorectal and breast cancer as key indications for future proof of concept.

Upcoming milestones and regulatory plans

• Next ELVN-001 data update expected at ESH CML or ASH conferences this year, with a major data catalyst in 2025 targeting 60-100 patients and longer follow-up.

• Registrational strategy for ELVN-001 involves a second-line plus setting, modeled after ASC4FIRST, with established endpoints for accelerated and full approval.

• ELVN-002 will present monotherapy and combination data in HER2-positive tumors, with a focus on differentiating from tucatinib and exploring large market opportunities.

• Strategic partnerships may be considered to unlock full value in HER2-positive indications, especially in breast cancer.

• Ongoing assessment of pipeline assets and resource allocation to ensure focus on lead programs through key milestones next year.