# EDGAR Filing Document

**Accession Number:** 0001750284
**File Stem:** 0001750284-25-000007
**Filing Date:** 2025-9
**Character Count:** 15243
**Document Hash:** ac2e27a30e4159c41b37c051bcab0004
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001750284-25-000007.hdr.sgml**: 20250902

**ACCESSION NUMBER**: 0001750284-25-000007

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20250902

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250902

**DATE AS OF CHANGE**: 20250902

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Olema Pharmaceuticals, Inc.
- **CENTRAL INDEX KEY:** 0001750284
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 300409740
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39712
- **FILM NUMBER:** 251282924

**BUSINESS ADDRESS:**
- **STREET 1:** 780 BRANNAN STREET
- **CITY:** SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94103
- **BUSINESS PHONE:** (415) 651-3316

**MAIL ADDRESS:**
- **STREET 1:** 780 BRANNAN STREET
- **CITY:** SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94103

?xml version='1.0' encoding='ASCII'? 8-K

**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<br>

------

Olema Pharmaceuticals, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

------

---

| | | |
|:---|:---|:---|
| Delaware | 001-39712 | 30-0409740 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>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<br>

N/A<br>

**(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:**

---

| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>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 | [<u>Press Release, dated September 2, 2025, of Olema Pharmaceuticals, Inc</u>](olma-ex99_1.htm). |
| 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<br>Chief Operating and Financial Officer |

---

------

## Exhibit 99.1

![img39466132_0.jpg](img39466132_0.jpg)

**Exhibit 99.1**

**Olema Oncology Announces New Clinical Trial Agreement with Pfizer to Combine Palazestrant with Atirmociclib in ER+/HER2- Metastatic Breast Cancer**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*Study to explore the palazestrant-atirmociclib combination in approximately 35 patients with initiation anticipated in H2 2025* 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*Results to inform potential pivotal Phase 3 trial of novel combination in frontline metastatic breast cancer setting*

SAN FRANCISCO, September 2, 2025 (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 new clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) in metastatic breast cancer. The companies 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.

"We are excited to assess this combination in the clinic as we seek to establish palazestrant as a potential backbone endocrine therapy for metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Based on the promising profiles of palazestrant and atirmociclib to date, we look forward to evaluating the potential of this novel combination and, if successful, advancing to a pivotal trial in the frontline setting. With OPERA-01, our first pivotal study of palazestrant, underway and our OPERA-02 ribociclib combination trial in frontline metastatic breast cancer anticipated to initiate this quarter, we remain focused on achieving our goal of transforming the metastatic breast cancer treatment paradigm."

Under the terms of the agreement, Pfizer will supply atirmociclib for use in the Phase 1b/2 study and Olema 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 Olema maintaining full global commercial and marketing rights to palazestrant.

This announcement represents Olema'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.

**About Olema Oncology**<br>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 ER degrader (SERD), currently in a Phase 3 clinical trial called OPERA-01. 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 Palazestrant (OP-1250)**

Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01 and is anticipated to be evaluated in combination with ribociclib in the planned pivotal Phase 3 clinical trial, OPERA-02. Learn more at www.opera01study.com. Palazestrant has also been evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, and everolimus.

**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," "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 those related to the potential of palazestrant to become a backbone endocrine therapy for metastatic breast cancer, Olema's potential to transform the metastatic breast cancer treatment paradigm, the timing for initiation, enrollment, and results of Olema's existing and planned clinical trials, including OPERA-01 and OPERA-02, the potential beneficial characteristics, safety, tolerability, efficacy, and therapeutic effects of palazestrant as a single agent or in combination therapy, and the 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.

**Media and Investor Relations Contact**<br>Courtney O'Konek<br>Vice President, Corporate Communications<br>

------

Olema Oncology<br>media@olema.com

------