Olema Pharmaceuticals (OLMA) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Key developments in SERD/CERAN therapies

• Recent data confirm efficacy of SERD/CERAN drugs in both adjuvant and metastatic ER-positive, HER2-negative breast cancer, especially when combined with other agents.

• Attrition in the SERD class has left only a few promising candidates, with palazestrant showing superior exposure and combinability.

• Giredestrant and camizestrant are also complete antagonists, while others like elacestrant are SERMs, not CERANs.

• Combination with CDK4/6 inhibitors is critical, and palazestrant demonstrates strong combinability without significant PK alterations.

• Ongoing and upcoming trials (persevERA, OPERA-01, OPERA-02) will further clarify efficacy in various patient populations.

Clinical trial insights and strategic planning

• PersevERA and SERENA-4 trial results will inform future trial designs and statistical assumptions for control arms.

• OPERA-01 is designed to address both ESR1 mutant and wild type populations, aiming for a two-month improvement in median PFS over standard care.

• Combination data with ribociclib show promising PFS, especially in ESR1 wild type and mutant populations.

• The company is prepared to adapt trial designs based on emerging data and may expand to additional second-line combination studies.

• Commercial build-out is focused on the U.S., with plans to seek a global partner for broader distribution.

Pipeline expansion and competitive positioning

• KAT6 inhibitor program targets KAT6A, KAT6B, and KAT7, with reduced activity on KAT5/8 to minimize side effects.

• First clinical data for the KAT6 program will be presented in Q2, with potential applications in breast, prostate, and lung cancers.

• Preclinical data suggest strong synergy when combining KAT6 inhibitors with palbociclib.

• The company maintains collaborations with Novartis and Pfizer but is open to acquisition if strategic opportunities arise.

• Market opportunities are significant, with the wild type segment representing a $5B+ market and potential to double with successful combinations.