Olema Pharmaceuticals (OLMA) H.C. Wainwright 28th Annual Global Investment Conference summary

Lead asset and clinical development

• Palazestrant is a complete estrogen receptor antagonist with high exposure and favorable tolerability, designed for ER+, HER2- breast cancer.

• Two phase III trials are ongoing: OPERA-01 (second/third-line, fully enrolled, readout in Q1 2027) and OPERA-02 (first-line, enrolling well).

• OPERA-01 targets both ESR1 mutant and wild-type populations, aiming to address unmet needs in both.

• Phase II data showed 5.5 months median PFS in wild-type and 7.3 months in mutant ESR1, exceeding prior benchmarks.

• Combination with ribociclib in phase II showed 12.2 months median PFS post-CDK4/6, outperforming other agents.

Competitive landscape and differentiation

• Other oral SERDs have shown benefit mainly in ESR1 mutant patients; palazestrant aims for broader efficacy due to complete antagonism.

• Differentiation is based on greater than two months prolongation of PFS and efficacy in both mutant and wild-type populations.

• Market opportunity for second/third-line is estimated at $5 billion, with wild-type representing a larger share.

• First-line metastatic combination market is valued at over $10 billion.

• No protocol changes to OPERA-02 yet, pending review of recent control arm data from SERENA-4.

Pipeline expansion and collaborations

• OP-3136, a KAT6 inhibitor, showed favorable tolerability and single-agent activity in breast and prostate cancer.

• Combination trials with fulvestrant and palazestrant in breast cancer are ongoing, with data expected in the first half of next year.

• Collaboration with Bayer to test OP-3136 and NUBEQA in castration-resistant prostate cancer, targeting androgen inhibitor resistance.

• Clinical trial collaboration with Pfizer for atirmociclib (CDK4 inhibitor) is fully enrolled; data timing depends on maturation and partner agreement.

• Anticipating future shifts in standard of care by evaluating combinations with next-generation targeted agents.