Olema Pharmaceuticals (OLMA) investor relations material

Strategic priorities and clinical development

• Focused on advancing palazestrant, a complete estrogen receptor antagonist and SERD, in two phase III trials: OPERA-01 (second/third-line, monotherapy) and OPERA-02 (first-line, in combination with ribociclib).

• OPERA-01 is expected to read out in the second half of next year, while OPERA-02 is currently enrolling and will take several years to complete.

• KAT6 inhibitor (OP-3136) is in phase I/II, being tested as monotherapy and in combination with fulvestrant and palazestrant, with data expected mid-next year.

• All ongoing and future studies are using the 90 mg tablet formulation of palazestrant, chosen for similar exposure and better tolerability.

• Market opportunity for palazestrant is estimated at $5 billion in the U.S. if efficacy in wild-type endocrine-resistant patients is confirmed.

Industry landscape and trial results

• Recent positive interim results from Roche's lidERA adjuvant trial have renewed investor confidence in SERDs, especially for wild-type, endocrine-sensitive populations.

• Previous SERD trials (EMERALD, VERITAC-2, acelERA, EMBER-3, evERA) showed efficacy mainly in ESR1-mutant patients, with limited benefit in wild-type due to incomplete antagonism or suboptimal dosing.

• Palazestrant has shown evidence of activity in both mutant and wild-type settings, attributed to higher exposure and complete antagonism.

• Dose selection for OPERA-01 was based on overlapping exposure and tolerability between 90 mg and 120 mg, with 90 mg moving forward after DSMB and FDA review.

• The field is closely watching the upcoming persevERA first-line trial from Roche, as its outcome may influence expectations for OPERA-02.

Competitive differentiation and future outlook

• OPERA-01 is unique in testing efficacy in both ESR1-mutant and wild-type endocrine-resistant populations as independent endpoints.

• Palazestrant's long half-life and tablet formulation offer advantages in exposure and GI tolerability over competitors.

• Combination studies with novel agents (KAT6 inhibitor, atiramisiclib) are ongoing, with data expected in the coming year.

• The company anticipates a busy 2026, with multiple data readouts and potential market expansion.

• Regulatory and clinical success in both mutant and wild-type populations could shift the standard of care in ER-positive, HER2-negative breast cancer.