Olema Pharmaceuticals (NasdaqGS:OLMA) FY Conference Transcript

Summary of Olema Pharmaceuticals FY Conference Call Company Overview - Company: Olema Pharmaceuticals (NasdaqGS:OLMA) - Focus: Oncology, specifically breast cancer - Lead Asset: Palazestrant, a selective estrogen receptor degrader (SERD) in two phase 3 trials: OPERA-01 and OPERA-02 [2][30] Key Trials and Developments - OPERA-01: - Focuses on second- and third-line treatment for ER-positive HER2-negative breast cancer - Expected data readout in the second half of 2026 - Control arm includes Exemestane or Fulvestrant [2][32] - OPERA-02: - First-line trial combining palazestrant with ribociclib (Kisqali) - Currently enrolling patients [2][30] - KAT6 Inhibitor (OP-3136): - Phase 1/2 program exploring monotherapy and combination therapies with fulvestrant and palazestrant [3] Industry Context - Recent advancements in the SERD space, particularly from Roche's lidERA trial, have renewed investor confidence in estrogen receptor targeting agents [4][5] - The SERD landscape has seen mixed results, with many agents failing to demonstrate efficacy in wild-type estrogen receptors [12][16] Competitive Landscape - EMERALD Trial: - First oral SERD (Orsurdu) showed efficacy only in ESR1 mutant patients [7][9] - Roche Trials: - acelERA and evERA trials showed varying results, with giredestrant demonstrating activity in mutant but not wild-type settings [11][14] - Upcoming persevERA trial results are anticipated to influence perceptions of OPERA-02's potential success [39] Market Potential - The potential market for palazestrant in the wild-type endocrine-resistant population is estimated at $5 billion in the U.S. [36] - The differentiation of palazestrant as a complete antagonist may provide a unique advantage over other SERDs [15][36] Formulation and Administration - Both OPERA-01 and OPERA-02 trials utilize a tablet formulation of palazestrant, with a consistent dose of 90 mg [46] - Previous phase 1/2 data included both tablet and capsule formulations, with overlapping bioavailability [48] Future Outlook - Anticipated data from the KAT6 study and ongoing trials in 2026 [50] - Continued focus on understanding the efficacy and tolerability of palazestrant in various patient populations [52]