Olema Pharmaceuticals (OLMA) expands Pfizer breast cancer trial collaboration

Rhea-AI Filing Summary

Olema Pharmaceuticals, Inc. reported that it has entered into a new clinical trial collaboration and supply agreement with Pfizer Inc. to study a combination treatment for certain breast cancers. The companies plan a Phase 1b/2 study evaluating the safety and combinability of palazestrant with atirmociclib, Pfizer’s investigational, highly selective CDK4 inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer.

Under the agreement, Pfizer will supply atirmociclib for the study, while Olema will lead the conduct of the trial. All clinical data and inventions related to the combined use of atirmociclib and palazestrant will be jointly owned, and Olema will retain full global commercial and marketing rights to palazestrant. This is the second clinical trial agreement between the two companies, following an earlier collaboration formed in November 2020.

Insights

Biopharma strategy analyst

Olema expands its Pfizer collaboration into a new combination breast cancer study while keeping full rights to palazestrant.

The agreement pairs Olema’s palazestrant with Pfizer’s investigational CDK4 inhibitor atirmociclib in a planned Phase 1b/2 study for ER+/HER2- metastatic breast cancer. Pfizer will supply atirmociclib, and Olema will lead the conduct of the trial, which focuses on safety and how well the two drugs can be used together. This builds on an existing relationship dating back to a 2020 collaboration evaluating palazestrant with palbociclib (IBRANCE).

All clinical data and inventions relating to the combined use of atirmociclib and palazestrant will be jointly owned, but Olema keeps full global commercial and marketing rights to palazestrant. That structure lets Olema potentially benefit from successful combination data without giving up control of its key asset. Actual impact will depend on study outcomes and any future regulatory or commercial steps that could follow from this program.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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

Date of Report (Date of earliest event reported): September 02, 2025

Olema Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-39712	30-0409740
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
780 Brannan Street
San Francisco, California				94103
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: 415 651-3316

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		OLMA		The Nasdaq Global Select Market

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 September 2, 2025, 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 Pfizer Inc. (“Pfizer”). 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 Securities Exchange Act of 1934, as amended (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 of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

As described above, on September 2, 2025, the Company announced that it had entered into the Agreement with Pfizer. Pursuant to the Agreement, the Company and Pfizer will evaluate in a Phase 1b/2 study the safety and combinability of palazestrant plus atirmociclib, Pfizer’s investigational, highly selective-CDK4 inhibitor, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (“ER+/HER2-”) metastatic breast cancer. Pfizer will supply atirmociclib for use in the Phase 1b/2 study and the Company will lead the conduct of the study. All clinical data and inventions relating to the combined use of atirmociclib and palazestrant resulting from the study will be jointly owned, with the Company maintaining full global commercial and marketing rights to palazestrant.

This Agreement is the Company’s second clinical trial agreement with Pfizer. The companies’ previous agreement was established in November 2020 to evaluate palazestrant in combination with palbociclib (IBRANCE®) in patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer.

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 Olema’s planned Phase 1b/2 study of the safety and combinability of palazestrant plus atirmociclib and those related to ownership of clinical data, commercial rights, marketing rights and inventions relating to the combined use of palazestrant and atirmociclib. 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and other 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release, dated September 2, 2025, of Olema Pharmaceuticals, Inc.
104		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.

			Olema Pharmaceuticals, Inc.
Date:	September 2, 2025	By:	/s/ Shane Kovacs
			Shane Kovacs Chief Operating and Financial Officer

FAQ

What did Olema Pharmaceuticals (OLMA) announce with Pfizer in this 8-K?

Olema Pharmaceuticals, Inc. reported that it entered into a new clinical trial collaboration and supply agreement with Pfizer Inc. to evaluate palazestrant in combination with Pfizer’s investigational CDK4 inhibitor atirmociclib in a Phase 1b/2 study for ER+/HER2- metastatic breast cancer.

What is the focus of the new Olema–Pfizer clinical trial collaboration?

The new collaboration focuses on a Phase 1b/2 study to evaluate the safety and combinability of palazestrant plus atirmociclib, Pfizer’s investigational, highly selective CDK4 inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer.

Who will lead the Phase 1b/2 study between Olema (OLMA) and Pfizer?

Under the agreement, Olema will lead the conduct of the Phase 1b/2 study, while Pfizer will supply atirmociclib for use in the trial.

How are data and rights allocated in the Olema–Pfizer atirmociclib collaboration?

All clinical data and inventions relating to the combined use of atirmociclib and palazestrant will be jointly owned by Olema and Pfizer, and Olema will maintain full global commercial and marketing rights to palazestrant.

Is this Olema’s first collaboration agreement with Pfizer?

No. This is Olema’s second clinical trial agreement with Pfizer. An earlier agreement, established in November 2020, was to evaluate palazestrant in combination with palbociclib (IBRANCE) in patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer.

Does this 8-K for Olema Pharmaceuticals include any financial results?

No. The 8-K describes a clinical trial collaboration and supply agreement with Pfizer and related forward-looking statements. It does not present revenue, earnings, or other financial results.