Olema Pharmaceuticals (OLMA) 7th Annual Evercore ISI HealthCONx Conference summary

Key clinical insights and differentiation

• Palazestrant is positioned as a complete estrogen receptor antagonist and degrader (CERAN/SERD), aiming to outperform prior therapies by targeting both AF1 and AF2 domains, unlike some competitors that only target AF2.

• Monotherapy data showed median PFS of 7 months in ESR1 mutant and 5.5 months in wild-type, with notable activity in both populations, differentiating from competitors.

• Combination studies with ribociclib enrolled over 60 patients, with all having at least six months of follow-up; data to be presented at San Antonio.

• Comparisons to studies like MAINTAIN and postMONARCH suggest adding CDK4/6 inhibitors post-progression can extend PFS from 2–3 months to 5–7 months.

• Ongoing and planned studies include combinations with PI3K inhibitors, everolimus, and KAT6, with preclinical data showing strong synergy, especially with KAT6.

Strategic partnerships and financial updates

• Announced a major clinical trial collaboration with Novartis to supply ribociclib for a 1,000-patient frontline phase III study (OPERA-02), starting mid-next year.

• Secured $250 million in equity private placement, bringing pro forma cash to over $400 million, funding operations through key readouts and NDA preparation.

• OPERA-01 study expected to read out in 2026, with potential U.S. launch targeted for late 2027.

• Actively evaluating additional business development and licensing opportunities, especially for assets synergistic with breast cancer focus.

Pipeline milestones and future outlook

• KAT6 IND filing planned by end of 2024, with clinical development to begin early next year; initial monotherapy and combination data expected as dose escalation progresses.

• Anticipates further updates on ribociclib combo data in 2025, and ongoing news flow from competitive landscape, including EMBER-3, Pfizer KAT6, and Roche persevERA studies.

• Focused on demonstrating benefit in ESR1 wild-type patients, with attention to underlying mutations such as PI3K or AKT.

• Positioned to advance both palazestrant and KAT6 programs through phase I/II, with strong interest expected from potential partners as data matures.