Olema Pharmaceuticals (OLMA) Company Report

Olema Oncology's lead asset, palazestrant, is in two Phase III trials for ER-positive, HER2-negative breast cancer: OPERA-01 (second/third-line, potential $5 billion market) with a readout in the second half of 2026 and potential US launch in late 2027, and OPERA-02 (first-line, >$10 billion market) with anticipated top-line data in 2028.
The company is advancing OP-3136, a KAT6 inhibitor, with initial Phase I monotherapy results expected in the first half of 2026 and a potential Phase III trial start in 2028, targeting a $5 billion market opportunity in breast cancer.
Olema maintains a strong financial position with over $500 million in cash, projected to fund operations into the second half of 2028.
The strategy for palazestrant includes independent commercialization in the United States and seeking a collaborator for international markets.

Jan 13, 2026, 7:15 PM

Transcript

Olema Oncology Provides Update on Clinical Programs and Market Opportunities at J.P. Morgan Healthcare Conference

OLMA

New Projects/Investments

Guidance Update

Product Launch

Olema Oncology is focused on developing treatments for ER-positive, HER2-negative breast cancer with two programs in clinical trials.
Its lead asset, palazestrant, is in two Phase III trials: OPERA-01 (second/third-line monotherapy, targeting a $3 billion-$5 billion market opportunity) with top-line readout expected in the second half of 2026 and potential US launch late 2027; and OPERA-02 (first-line in combination with ribociclib, addressing a $10 billion-plus market opportunity) with top-line data possibly in 2028.
The company's second program, OP3136 (a KAT6 inhibitor), is in Phase I, with initial results anticipated late in the first half of 2026, targeting a $5 billion opportunity in breast cancer alone.
Olema maintains a strong financial position with over $500 million in cash, projected to fund operations into the second half of 2028.

Jan 13, 2026, 7:15 PM

Transcript

Olema Provides Update on Clinical Pipeline and Market Opportunities at JPMorgan Healthcare Conference

OLMA

New Projects/Investments

Guidance Update

Product Launch

Olema's lead asset, palazestrant, a complete estrogen receptor antagonist, is in two Phase III trials for ER-positive, HER2-negative breast cancer.
The OPERA-01 trial (second/third-line monotherapy) is expected to read out in the second half of 2026, with a potential US launch in late 2027, targeting a $3 billion-$5 billion market opportunity.
The OPERA-02 trial (first-line in combination with ribociclib) anticipates top-line data possibly in 2028 and approval in 2029, with a market opportunity exceeding $10 billion.
Olema also has OP3136, a KAT6 inhibitor, in Phase I, with initial results expected in the first half of 2026 and a potential Phase III trial in breast cancer in 2028.
The company reports a favorable cash position with over $500 million, projected to fund operations into the second half of 2028.

Jan 13, 2026, 7:15 PM

Transcript

Olema Pharmaceuticals Reports Strong Cash Position and Key Pipeline Progress

OLMA

Guidance Update

New Projects/Investments

Product Launch

Olema Pharmaceuticals announced preliminary unaudited cash, cash equivalents, and marketable securities of greater than $500 million as of December 31, 2025.
The company anticipates top-line data in Fall 2026 from the pivotal Phase 3 OPERA-01 trial for Palazestrant monotherapy in 2/3L metastatic breast cancer, with potential approval and U.S. launch in 2027.
For Palazestrant in combination with ribociclib in 1L metastatic breast cancer, top-line data from the pivotal Phase 3 OPERA-02 trial is anticipated in 2028, followed by potential approval and U.S. launch in 2029.
Olema is also advancing OP-3136, a KAT6 inhibitor, with initial clinical results expected in 2026.

Jan 12, 2026, 9:44 PM

8-K

Olema Oncology Provides Update on Palazestrant and Pipeline Development

OLMA

New Projects/Investments

Product Launch

Guidance Update

Olema Oncology's lead asset, palazestrant, a complete estrogen receptor antagonist and SERD, is in two Phase 3 trials: OPERA-01 (second- and third-line monotherapy, with read out in the second half of next year) and OPERA-02 (first-line, combining with ribociclib/Kisqali, enrolling now).
The OPERA-01 trial has selected a 90-milligram dose for its approximately 500 patients in the second- and third-line setting, with a PFS endpoint.
Olema is also advancing a KAT6 inhibitor (OP-3136) in a Phase 1/2 program, with data expected mid-year next year.
The recent positive interim readout of Roche's lidERA adjuvant trial has increased investor confidence in the SERD space, and the upcoming persevERA first-line trial readout in Q1 next year is expected to positively influence sentiment for Olema's OPERA-02.
Olema's palazestrant is differentiated by its seven-day half-life and high exposure, contrasting with other SERDs that faced issues like short half-life (Sanofi's amcenestrant) or dose reductions due to tolerability (Roche's giredestrant).

Dec 3, 2025, 9:40 PM

Transcript

Olema Oncology Provides Updates on Palazestrant Clinical Trials and Pipeline

OLMA

New Projects/Investments

Guidance Update

Olema Oncology's lead asset, palazestrant, a complete estrogen receptor antagonist and SERD, is currently in two Phase 3 trials: OPERA-01 (second- and third-line monotherapy, with readout expected in the second half of next year) and OPERA-02 (first-line combination with ribociclib).
The OPERA-01 trial for palazestrant will utilize a 90 mg dose, which was recommended by the data monitoring committee and agreed upon by the FDA.
The upcoming persevERA trial readout from Roche in Q1 next year is considered a significant indicator for Olema's first-line OPERA-02 trial, as both target the wild-type endocrine-sensitive population.
Olema is also developing a KAT6 inhibitor, OP-3136, in Phase 1/2 as monotherapy and in combination with fulvestrant and palazestrant, with data expected mid-year next year.

Dec 3, 2025, 9:40 PM

Transcript

Olema Oncology Provides Updates on Palazestrant Trials and Upcoming Data Readouts

OLMA

New Projects/Investments

Guidance Update

Olema Oncology's lead asset, palazestrant, a complete estrogen receptor antagonist and SERD, is in two Phase III trials: OPERA-01 (second- and third-line monotherapy) and OPERA-02 (first-line combination with ribociclib/Kisqali).
The OPERA-01 trial is expected to read out in the second half of 2026, with the 90 mg dose of palazestrant selected for all future trials.
The Roche lidERA adjuvant trial's positive interim readout has increased investor confidence in the SERD space, positively impacting expectations for Olema's first-line trial, OPERA-02.
Key upcoming data readouts include the Roche persevERA first-line trial in Q1 2026, Olema's KAT6 data mid-2026, and atiramisiclib with palazestrant combination data in spring 2026.

Dec 3, 2025, 9:40 PM

Transcript

Olema Pharmaceuticals Announces Follow-On Public Offering

OLMA

Olema Pharmaceuticals, Inc. entered into an underwriting agreement on November 18, 2025, for a follow-on public offering of 10,000,000 shares of its common stock at a public offering price of $19.00 per share.
The offering is expected to generate approximately $190.0 million in gross proceeds for the company, before deducting underwriting discounts and estimated offering expenses, assuming no exercise of the underwriters' option.
The underwriters have an option, exercisable for 30 days, to purchase up to an additional 1,500,000 shares of common stock at the public offering price.
The closing of the offering is anticipated to occur on November 20, 2025.

Nov 19, 2025, 10:20 PM

8-K

Olema Pharmaceuticals Provides Update on Breast Cancer Pipeline and Market Opportunity

OLMA

Guidance Update

New Projects/Investments

Olema Pharmaceuticals is focused on developing treatments for estrogen receptor positive, HER2 negative breast cancer with its lead molecule, palazestrant, a complete estrogen receptor antagonist.
Palazestrant is currently in two Phase 3 trials: OPERA-01 (second/third-line monotherapy), with a readout expected in H2 2026, and OPERA-02 (first-line metastatic in combination with ribociclib), with an earliest possible readout in late 2028.
The company's KAT6 inhibitor, OP3136, is in a Phase 1 trial, and the first readout from this portion is anticipated in late H1 2026.
Olema estimates the market opportunity for palazestrant in the first-line setting could reach $15 billion-$20 billion globally by 2030, and the second/third-line setting represents about a $5 billion market in the United States alone.

Nov 19, 2025, 9:00 AM

Transcript

Olema Pharmaceuticals Provides Update on Breast Cancer Pipeline and Market Opportunities

OLMA

New Projects/Investments

Guidance Update

Olema Pharmaceuticals is focused on developing better treatment options for estrogen receptor positive, HER2 negative breast cancer with its lead molecule, palazestrant, a complete estrogen receptor antagonist.
Palazestrant is currently in two pivotal Phase III trials: OPERA-01 (2nd/3rd-line monotherapy) with a readout expected in the 2nd half of 2026, and OPERA-02 (1st-line combination with ribociclib) with an earliest possible readout in late 2028.
The company's KAT6 inhibitor, OP3136, is in a Phase I trial, with the first readout from the monotherapy portion anticipated in the late 1st half of 2026.
Olema estimates the market opportunity for the 1st-line breast cancer setting at $10 billion-$15 billion globally (potentially $15 billion-$20 billion by 2030) and the 2nd/3rd-line setting at approximately $5 billion in the United States alone.
Recent positive data from Roche's LIDARA trial is viewed as supportive for the potential of next-generation SERDs in the endocrine-sensitive population, and Olema's Phase II data for palazestrant plus ribociclib demonstrated strong progression-free survival of 14 months in ESR1 mutant and almost 10 months in ESR1 wild type.