Olema, Bayer to test OP-3136 with NUBEQA in mCRPC
Rhea-AI Filing Summary
Olema Pharmaceuticals has entered a clinical trial collaboration and supply agreement with Bayer to test its investigational KAT6 inhibitor OP-3136 with Bayer’s androgen receptor inhibitor NUBEQA (darolutamide) in metastatic castration-resistant prostate cancer.
The planned Phase 1b/2 study will evaluate safety, tolerability, and preliminary anti-tumor activity of the combination in approximately 36 patients with mCRPC and is expected to start in the second half of 2026. Bayer will supply darolutamide, while Olema will lead the trial.
All clinical data and inventions related to the combination will be jointly owned, and Olema will retain full global commercial and marketing rights to OP-3136. This is the first clinical collaboration for OP-3136 and extends its development beyond breast cancer into prostate cancer.
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Insights
Early-stage Olema–Bayer trial broadens OP-3136 into prostate cancer but remains exploratory.
The agreement pairs Olema’s KAT6 inhibitor OP-3136 with Bayer’s NUBEQA (darolutamide) in metastatic castration-resistant prostate cancer. A Phase 1b/2 study in about 36 patients will examine safety, tolerability, and preliminary anti-tumor activity, with Olema leading execution and Bayer supplying drug.
Joint ownership of data and inventions, alongside Olema’s retention of global commercial and marketing rights to OP-3136, preserves upside for Olema if results are favorable. However, the trial is early phase and focused on signals rather than definitive outcomes, so economic impact depends on future data and any subsequent development decisions.
The company highlights this as the first clinical collaboration for OP-3136, building on its ongoing monotherapy and combination work in solid tumors and ER+/HER2- metastatic breast cancer. Readouts from the existing Phase 1 program, including the poster at the May 30, 2026 ASCO meeting, will help frame expectations for the new combination study.
8-K Event Classification
Key Figures
Key Terms
metastatic castration-resistant prostate cancer medical
KAT6 inhibitor medical
Phase 1b/2 study medical
complete estrogen receptor (ER) antagonist (CERAN) medical
selective estrogen receptor degrader (SERD) medical
lysine acetyltransferase 6 (KAT6) medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Olema Pharmaceuticals (OLMA) announce in its agreement with Bayer?
What is the design of Olema’s new OP-3136 and darolutamide prostate cancer study?
Who will own the data and rights from Olema’s OP-3136 and NUBEQA combination study?
How does this Bayer collaboration fit into Olema’s broader OP-3136 program?
What type of drug is OP-3136 in Olema’s pipeline?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On May 26, 2026, Olema Pharmaceuticals, Inc. (the "Company") issued a press release announcing that it had entered into a new clinical trial collaboration and supply agreement (the “Agreement”) with Bayer Consumer Care AG ("Bayer"). A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
As described above, on May 26, 2026, the Company announced that it had entered into the Agreement with Bayer. Pursuant to the Agreement, the Company and Bayer will evaluate in a Phase 1b/2 study the safety, tolerability, and preliminary anti-tumor activity of OP-3136, the Company's novel KAT6 inhibitor, in combination with NUBEQA® (darolutamide), Bayer’s androgen receptor inhibitor, in approximately 36 patients with metastatic castration-resistant prostate cancer (mCRPC). The clinical trial is expected to initiate in the second half of 2026. Bayer will supply darolutamide for use in the Phase 1b/2 study and the Company will lead the conduct of the study. All clinical data and inventions related to the combined use of OP-3136 and darolutamide will be jointly owned. The Company will maintain full global commercial and marketing rights to OP-3136. This Agreement is the first clinical collaboration for OP-3136.
Forward Looking Statements
Statements contained in Item 8.01 of this Current Report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include, but are not limited to, those related to the Company’s planned Phase 1b/2 study of the safety, tolerability, and preliminary anti-tumor activity of OP-3136 in combination with darolutamide and those related to ownership of clinical data, commercial rights, marketing rights and inventions relating to the combined use of OP-3136 and darolutamide. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of the Company could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, and other filings and reports that the Company makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, the Company assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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99.1 |
Press Release, dated May 26, 2026 of Olema Pharmaceuticals, Inc. |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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OLEMA PHARMACEUTICALS, INC. |
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May 26, 2026 |
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/s/ Sean Bohen, M.D., Ph.D. |
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Sean Bohen, M.D., Ph.D. |
Exhibit 99.1
Olema Oncology Announces Clinical Trial Collaboration and Supply Agreement with Bayer to Evaluate OP-3136 in Combination with NUBEQA® (darolutamide) in Metastatic Castration-Resistant Prostate Cancer
SAN FRANCISCO, May 26, 2026 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced a clinical trial collaboration and supply agreement with Bayer AG (“Bayer”) to evaluate OP-3136, Olema’s investigational lysine acetyltransferase 6 (KAT6) inhibitor, in combination with NUBEQA® (darolutamide), Bayer’s androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1b/2 study is designed to assess the safety, tolerability, and preliminary anti-tumor activity of OP-3136 in combination with darolutamide in approximately 36 patients with mCRPC.
“We are very pleased to partner with Bayer to explore the combination of OP-3136 with darolutamide in metastatic castration-resistant prostate cancer, which is an aggressive disease characterized by poor clinical outcomes,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “This agreement represents the first clinical collaboration for OP-3136 and builds upon our ongoing Phase 1/2 study of this novel KAT6 inhibitor as a monotherapy in multiple solid tumor types and in combination with fulvestrant and palazestrant in ER+/HER2- metastatic breast cancer. We look forward to advancing OP-3136 in combination with darolutamide in the clinic as we work to bring better medicines to patients living with cancer.”
Under the terms of the agreement, Bayer will supply darolutamide for use in the Phase 1b/2 study and Olema will lead the conduct of the study. All clinical data and inventions related to the combined use of OP-3136 and darolutamide will be jointly owned. Olema will maintain full global commercial and marketing rights to OP-3136.
As previously announced, Olema will present initial clinical data from the Phase 1 study of OP-3136 in a poster presentation on May 30, 2026 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor
(ER) antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com.
About OP-3136
OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical study.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “intend,” “may,” “on track,” “potential,” “upcoming,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to potential benefits of the collaboration between Olema and Bayer, including the evaluation of OP-3136 in combination with darolutamide for the treatment of metastatic castration-resistant prostate cancer; the initiation, progress, design, and timing of the planned Phase 1b/2 clinical study; the potential of OP-3136 as a novel KAT6 inhibitor, including as a monotherapy and in combination with other therapies; the potential therapeutic effects and clinical benefits of OP-3136, alone or in combination, in multiple solid tumor types; Olema’s ability to successfully conduct the clinical study and advance OP-3136 in the clinic; and the potential for OP-3136, alone or in combination, to provide improved treatment options or outcomes for patients living with cancer. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Annual Report on Form 10-K for the year ended December 31, 2025, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements.
Media and Investor Relations Contact
Courtney O’Konek
Vice President, Corporate Communications
Olema Oncology
media@olema.com