Olema Pharmaceuticals Files 8-K

Ticker: OLMA · Form: 8-K · Filed: Oct 20, 2025 · CIK: 1750284

Olema Pharmaceuticals, INC. 8-K Filing Summary
FieldDetail
CompanyOlema Pharmaceuticals, INC. (OLMA)
Form Type8-K
Filed DateOct 20, 2025
Risk Levellow
Pages4
Reading Time5 min
Key Dollar Amounts$0.0001
Sentimentneutral

Sentiment: neutral

Topics: sec-filing, 8-k, regulation-fd

TL;DR

Olema Pharma dropped an 8-K, check it for news.

AI Summary

Olema Pharmaceuticals, Inc. filed an 8-K on October 20, 2025, reporting events that occurred on October 18, 2025. The filing primarily concerns Regulation FD disclosures, other events, and financial statements/exhibits. No specific material events or financial figures were detailed in the provided excerpt.

Why It Matters

This filing indicates Olema Pharmaceuticals is making disclosures to the SEC, which could contain important updates for investors regarding company events or financial status.

Risk Assessment

Risk Level: low — The provided text is a standard SEC filing header and does not contain specific material information that would indicate a change in risk.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing?

The filing is intended to report on Regulation FD disclosures, other events, and financial statements and exhibits as of October 18, 2025.

When was this 8-K report filed with the SEC?

The report was filed on October 20, 2025.

What is Olema Pharmaceuticals, Inc.'s principal executive office address?

The principal executive offices are located at 780 Brannan Street, San Francisco, California, 94103.

What is Olema Pharmaceuticals, Inc.'s telephone number?

The company's telephone number, including area code, is 415 651-3316.

What is the Standard Industrial Classification code for Olema Pharmaceuticals, Inc.?

The SIC code listed is 2834, which corresponds to Pharmaceutical Preparations.

Filing Stats: 1,132 words · 5 min read · ~4 pages · Grade level 12 · Accepted 2025-10-20 17:13:29

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On October 18, 2025, the Company issued a press release announcing new data from its Phase 1b/2 trial of palazestrant in combination with ribociclib in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. On October 18, 2025, the Company made available on its website a presentation to be shared with investors and others from time to time. A copy of this presentation is being furnished as Exhibit 99.2 to this Current Report on Form 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.

01 Other Events

Item 8.01 Other Events. Phase 1b/2 Trial of Palazestrant in Combination with Ribociclib In October 2025, the Company presented updated data from the Phase 1b/2 study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or MBC. As of 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. In the 90 mg palazestrant dose cohort, with a median follow-up of 10.8 months, mPFS was not reached. In the 120 mg palazestrant dose cohort, with a median follow-up of more than 19 months, mPFS are mature. mPFS was 15.5 months for all patients. mPFS was 12.2 months for those who received prior treatment with CDK4/6i, including 9.2 months for patients with ESR1 wild-type tumors and 13.8 months for patients with tumors with ESR1 mutations. Across 72 patients treated, 90 mg or 120 mg of palazestrant combined with 600 mg of ribociclib daily was well tolerated with no new safety signals or increase in toxicity. Palazestrant and ribociclib did not demonstrate any drug-drug interactions and the overall safety profile was consistent with the established safety profile of ribociclib plus an endocrine therapy. The majority of treatment-emergent adverse events were grade 1 or 2, and the severity and incidence of adverse events were consistent with the expected safety profile of each drug. 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

Forward-Looking Statements

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release, dated October 18, 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

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: October 20, 2025 By: /s/ Shane Kovacs Shane Kovacs Chief Operating and Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR

View on Read The Filing