Olema Pharmaceuticals (OLMA) TD Cowen 46th Annual Health Care Conference summary

Strategic focus and pipeline overview

• Focused on transforming care for ER-positive, HER2-negative breast cancer with lead asset palazestrant, a complete estrogen receptor antagonist in pivotal trials OPERA-01 (second/third line, monotherapy) and OPERA-02 (first line, combination with ribociclib).

• OPERA-01 readout expected in fall; OPERA-02 enrolling ~1,000 patients, earliest readout in 2028.

• Second asset, OP-3136 (KAT6A/B, VII inhibitor), in phase I/II for multiple cancers; first monotherapy data expected Q2.

• Palazestrant’s unique properties include high exposure, oral dosing, and strong combinability with targeted agents.

• Building a US-focused commercial presence, seeking global partners for ex-US markets.

Clinical data and differentiation

• Palazestrant shows superior steady-state exposure and receptor occupancy compared to class peers.

• Demonstrated median progression-free survival (PFS) of 7.3 months (ESR1 mutant) and 5.5 months (wild type) in heavily pre-treated populations.

• Activity in both ESR1 mutant and wild type populations distinguishes palazestrant from other SERDs.

• In post-CDK4/6 setting, median PFS reached 14 months (mutant) and over 9 months (wild type), exceeding other combinations.

• OP-3136 aims for improved tolerability over Pfizer’s KAT6 inhibitor by increased selectivity.

Market opportunity and commercial strategy

• ER+/HER2- breast cancer represents a multi-billion dollar market: $5B in second/third line, $10B+ in first line, with adjuvant potentially larger.

• Duration of treatment is a key driver of market size; significant PFS improvements could double market opportunity.

• Potential phase III trial for OP-3136 in 2028; pivotal OPERA-01 readout could enable launch as early as next year.

• Ended year with ~$500M cash, supporting execution through multiple data readouts.