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~~October 0218, 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~~October 218, 2025, ~~Olema Pharmaceuticals, Inc. (~~the “Company”) issued a press release announcing ~~that~~new itdata ~~had~~from ~~entered~~its ~~into~~Phase a1b/2 ~~new~~trial ~~clinical~~of ~~trial~~palazestrant ~~collaboration~~in ~~and~~combination ~~supply~~with ~~agreement~~ribociclib in patients with estrogen receptor-positive (~~the~~ER+), ~~“Agreement”~~human epidermal growth factor receptor 2-negative (HER2-) ~~with~~advanced ~~Pfizer~~or ~~Inc.~~metastatic breast cancer (~~“Pfizer”~~MBC). A copy of the press release is ~~attached~~furnished as Exhibit 99.1 to this Current Report on Form 8-K.

~~The~~On ~~information~~October ~~in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section~~ 18, of2025, the ~~Securities~~Company ~~Exchange~~made ~~Act~~available ofon ~~1934,~~its aswebsite ~~amended~~a ~~(the~~presentation ~~“Exchange Act”) or otherwise subject~~ to ~~the liabilities of that section, nor shall it~~ be ~~deemed~~shared ~~incorporated~~with byinvestors ~~reference~~and inothers ~~any~~from ~~filing~~time ~~under~~to ~~the~~time. ~~Securities~~A ~~Act~~copy of ~~1933,~~this aspresentation ~~amended~~is orbeing ~~the~~furnished ~~Exchange Act, except~~ as ~~expressly~~Exhibit ~~set~~99.2 ~~forth~~to bythis ~~specific~~Current ~~reference~~Report inon ~~such~~Form ~~filing~~8-K.

The information in Exhibits 99.1 and 99.2 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 (the “Securities 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~~Trial ~~the safety and combinability~~ of ~~palazestrant~~Palazestrant ~~plus atirmociclib, Pfizer’s investigational, highly selective-CDK4 inhibitor,~~ in ~~patients~~Combination 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. Ribociclib

~~This~~In ~~Agreement~~October is2025, the Company’s ~~second~~presented ~~clinical~~updated ~~trial~~data ~~agreement~~from ~~with~~the ~~Pfizer.~~Phase ~~The~~1b/2 ~~companies’~~study ~~previous~~of ~~agreement was established in November 2020 to evaluate~~ palazestrant in combination with ~~palbociclib~~ribociclib ~~(IBRANCE®)~~ in patients with ~~recurrent, locally advanced or metastatic~~ ER+/HER2- ~~breast~~advanced ~~cancer~~or MBC.

~~Forward~~As ~~Looking~~of ~~Statements~~July 8, 2025, 72 patients were enrolled across the 90 mg and 120 mg palazestrant dose cohorts. 56 patients received 120 mg once-daily palazestrant and 16 patients received 90 mg once-daily palazestrant, all with the approved dose of ribociclib for metastatic breast cancer of 600 mg daily. 45 (63%) patients had prior treatment with CDK4/6i with endocrine therapy for advanced disease. 33% (15/45) of patients who had prior treatment with CDK4/6i in the advanced setting (2/3L) had an ESR1 mutation at baseline.

~~Statements~~In ~~contained~~the in90 ~~Item~~mg ~~8.01~~palazestrant ofdose ~~this~~cohort, ~~Current~~with ~~Report~~a onmedian ~~Form 8~~follow-Kup ~~regarding~~of ~~matters~~10.8 ~~that~~months, ~~are~~mPFS was not ~~historical~~reached. ~~facts~~In ~~are “forward-looking statements” within~~ the ~~meaning~~120 ofmg ~~Section~~palazestrant ~~27A~~dose ofcohort, ~~the~~with ~~Securities~~a ~~Act~~median offollow-up ~~1933 and Section 21E~~ of ~~the~~more ~~Securities~~than ~~Exchange~~19 ~~Act of 1934. Words such as “will” and similar expressions (as well as other words or expressions referencing future events~~months, ~~conditions~~mPFS ~~or circumstances)~~ are ~~intended~~mature. tomPFS ~~identify~~was ~~forward-looking statements~~15.5 ~~These~~months ~~statements~~for ~~include,~~all ~~but~~patients. ~~are~~mPFS ~~not~~was ~~limited to, those related to Olema’s planned Phase 1b/~~12.2 ~~study~~months offor ~~the safety and combinability of palazestrant plus atirmociclib and~~ those ~~related~~who toreceived ~~ownership~~prior oftreatment ~~clinical~~with ~~data~~CDK4/6i, ~~commercial~~including ~~rights,~~9.2 ~~marketing~~months ~~rights~~for ~~and~~patients ~~inventions~~with ~~relating~~ESR1 towild-type ~~the~~tumors ~~combined use of palazestrant~~ and ~~atirmociclib~~13.8 ~~Because~~months ~~such~~for ~~statements~~patients ~~deal~~ with ~~future~~tumors ~~events~~with ~~and~~ESR1 ~~are~~mutations. ~~based~~Across on72 ~~Olema’s~~patients ~~current expectations~~treated, ~~they~~90 ~~are~~mg ~~subject~~or to120 ~~various~~mg ~~risks~~of ~~and~~palazestrant ~~uncertainties,~~combined ~~and~~with ~~actual~~600 ~~results,~~mg ~~performance~~of orribociclib ~~achievements~~daily ofwas ~~Olema~~well ~~could~~tolerated ~~differ~~with ~~materially~~no ~~from~~new ~~those~~safety ~~described~~signals in or ~~implied~~increase ~~by the statements~~ in ~~this~~toxicity. ~~press~~Palazestrant ~~release.~~and ~~These~~ribociclib ~~forward-looking~~did ~~statements~~not ~~are~~demonstrate ~~subject~~any todrug-drug ~~risks~~interactions and ~~uncertainties,~~the ~~including,~~overall ~~without~~safety ~~limitation,~~profile ~~those~~was ~~discussed~~consistent inwith the ~~section~~established ~~titled~~safety ~~“Risk~~profile ~~Factors”~~of inribociclib ~~Olema’s~~plus ~~Quarterly~~an ~~Report~~endocrine ontherapy. ~~Form~~The 10majority of treatment-Qemergent ~~for~~adverse ~~the~~events ~~quarter~~were ~~ended~~grade ~~June~~1 ~~30,~~or ~~2025~~2, and ~~other~~the ~~filings~~severity and ~~reports~~incidence ~~that~~of ~~Olema~~adverse ~~makes~~events ~~from~~were ~~time~~consistent ~~to time~~ with the ~~U.S.~~expected ~~Securities~~safety ~~and~~profile ~~Exchange~~of ~~Commission.~~each 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 statementsdrug.

These data support the ongoing pivotal Phase 3 OPERA-02 clinical trial of palazestrant in combination with ribociclib in frontline ER+/HER2- MBC.

Forward-Looking Statements

Statements contained in this Current Report on Form 8-K, including the exhibit furnished herewith, regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “may,” “plan,” “potential,” “seek,” “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, but are not limited to, the potential beneficial characteristics, safety, tolerability, efficacy, and therapeutic effects of palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or MBC. 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 Current Report on Form 8-K, including the exhibits furnished herewith. 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~~October 218, 2025, of Olema Pharmaceuticals, Inc.
99.2		Investor Presentation, dated October 18, 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~~October 220, 2025	By:	/s/ Shane Kovacs
			Shane KovacsChief Operating and Financial Officer

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