Enliven Therapeutics (ELVN) TD Cowen 45th Annual Healthcare Conference summary

Company overview and pipeline focus

• Focuses on small molecule discovery in precision oncology, with two clinical-stage assets in global phase I trials.

• Lead asset ELVN-001 targets BCR-ABL for chronic myeloid leukemia (CML), with promising proof-of-concept data.

• ELVN-002 is a selective HER2 irreversible inhibitor, aiming to improve upon tucatinib in HER2-positive cancers.

• Strategic alternatives are being considered for ELVN-002 due to development complexity and costs.

Clinical data and upcoming milestones

• ELVN-001 showed favorable safety and efficacy in late-line CML patients, including those resistant to prior therapies.

• 44% of evaluable patients achieved major molecular response (MMR) by 24 weeks; 23% induction rate in those not in MMR at baseline.

• Safety profile is favorable, with low rates and severity of hematologic and non-hematologic adverse events.

• Mid-year 2024 update will include data from 60+ patients, doubling the efficacy dataset.

Competitive landscape and regulatory context

• ELVN-001 efficacy and safety compare favorably to SCEMBLIX (asciminib), even in more heavily pretreated populations.

• SCEMBLIX's rapid adoption and broad approval highlight a large, growing CML market and regulatory de-risking.

• Market opportunity for BCR-ABL TKIs estimated at $12–15 billion globally, with $9 billion in the U.S. alone.