Olema Pharmaceuticals (OLMA) Conference Transcript

Summary of Olema Pharmaceuticals (OLMA) Conference Call - September 02, 2025 Company Overview - Company: Olema Pharmaceuticals - Focus: Targeted oncology, specifically treatment of ER positive, HER2 negative breast cancer - Lead Asset: Palisestrant, a complete estrogen receptor antagonist [4][5] Pipeline and Trials OPERA-One Trial - Phase: Three - Focus: Second/third line treatment for advanced metastatic breast cancer - Patient Population: Patients who have progressed after initial therapy with CDK4/6 and aromatase inhibitors - Expected Readout: Second half of next year - Market Opportunity: Estimated between $2 billion to $5 billion depending on patient population (mutant only vs. mutant and wild type) [6][5] - Progression-Free Survival (PFS): - ESR1 mutant population: over 7 months median PFS - ESR1 wild type population: 5.5 months median PFS [6] OPERA-Two Trial - Phase: Three - Focus: First line treatment comparing ribociclib plus palisestrant versus ribociclib plus aromatase inhibitor - Market Opportunity: Estimated over $15 billion - Expected Enrollment Start: Soon, with updated data presentation at ESMO in October [6][7] - PFS Data: Over a year median PFS in the post-CDK4/6 setting, unprecedented [7] Additional Molecules - OP-3136: A CAT6 inhibitor in phase one, progressing as a monotherapy and in combination with fulvestrant and palisestrant [8][9] Collaborations and Agreements - Collaboration with Pfizer: Clinical trial supply agreement to combine palisestrant with Pfizer's CDK4 selective molecule, atormaciclib [9][10] - Operational and Financial Impact: - Total trial cost for OPERA-Two: approximately $500 million - Collaboration with Novartis to provide Kisqali, offsetting costs [63][64] Clinical Strategy and Differentiation - Treatment Paradigm: Aim to delay chemotherapy by using targeted agents [10] - Combination Therapy: Palisestrant is expected to enhance the efficacy of existing treatments, particularly in the wild type setting [11][12] - Regulatory Approval Threshold: Aiming for a 6-month improvement in median PFS compared to current standards [37][91] Safety and Tolerability - Neutropenia: Single-digit rates of reversible neutropenia observed, manageable in combination therapies [92][93] - Tolerability Profile: Expected to be similar to existing therapies, with no significant new safety concerns [94] Future Directions - Exploration of Other Indications: Potential expansion into prostate and lung cancers based on preclinical activity [109][110] - Upcoming Data: Anticipated updates from ongoing trials and presentations at medical meetings to generate interest and support enrollment [28][31] Conclusion - Olema Pharmaceuticals is positioned to make significant advancements in the treatment of ER positive, HER2 negative breast cancer with its lead asset, palisestrant, and ongoing clinical trials. The company is leveraging strategic collaborations to enhance its pipeline and reduce operational costs while aiming for regulatory approval through robust clinical data.