OLMA

EX-99.1

2 olma-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Olema Oncology Reports First Quarter 2026 Financial and Operating Results

• Top-line data from the Phase 3 OPERA-01 trial anticipated this fall; Phase 3 OPERA-02 trial continues to enroll patients

• First clinical data from OP-3136 Phase 1 study to be presented at ASCO

• Ended the first quarter with $505.3 million in cash, cash equivalents, and marketable securities

SAN FRANCISCO, May 12, 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 reported financial and operating results for the first quarter ended March 31, 2026.

“We continued to meaningfully advance our pipeline of novel therapies focused on transforming the metastatic breast cancer treatment paradigm during the first quarter, with top-line data from our Phase 3 OPERA-01 trial of palazestrant as a monotherapy expected this fall and initial Phase 1 clinical data for OP-3136 being presented at ASCO later this month,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “We continued patient enrollment in OPERA-02, our Phase 3 trial of palazestrant in combination with ribociclib in the frontline metastatic setting, while advancing our ongoing Phase 1/2 combination studies evaluating palazestrant as a potential combination endocrine therapy of choice for metastatic breast cancer. With important clinical data catalysts on the horizon this year, we believe that we are well-positioned to continue our transformation into a fully integrated oncology company with our first anticipated commercial launch next year.”

Recent Progress

• Presented two preclinical posters at the 2026 American Association for Cancer Research (AACR) Annual Meeting in April:

o The first demonstrated that palazestrant fully recruits the corepressor protein, NCoR1, in vitro, supporting complete estrogen receptor antagonism.

o The second reinforced that palazestrant in combination with OP-3136 drives synergistic anti-tumor activity in in vivo estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer models.

• Continued enrollment in the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer.

• Advanced enrollment in the Phase 1b/2 study evaluating palazestrant in combination with atirmociclib in ER+/HER2- metastatic breast cancer in collaboration with Pfizer.

Anticipated Upcoming Events

• Present initial clinical data from the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136 in a poster presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

• Present trial-in-progress poster for the ongoing pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer at ASCO.

• Report top-line data from the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer in the fall of 2026.

First Quarter 2026 Financial Results

Cash, cash equivalents, and marketable securities as of March 31, 2026, were $505.3 million.

Net loss for the quarter ended March 31, 2026 was $53.1 million, as compared to $30.4 million for the quarter ended March 31, 2025. The increase in net loss for the first quarter was related to higher spending on clinical development and research and corporate-related activities related to late-stage clinical trials for palazestrant and the advancement of OP-3136.

GAAP research and development (R&D) expenses were $49.2 million for the quarter ended March 31, 2026, as compared to $30.6 million for the quarter ended March 31, 2025. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and increased personnel-related costs, including an increase in non-cash stock-based compensation expense of $3.3 million, mainly due to higher grant prices in 2026 and higher headcount.

Non-GAAP R&D expenses were $42.7 million for the quarter ended March 31, 2026, excluding $6.6 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $27.3 million for the quarter ended March 31, 2025, excluding $3.3 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $8.8 million for the quarter ended March 31, 2026, as compared to $4.2 million for the quarter ended March 31, 2025. The increa

EX-99.1

2 olma-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Olema Oncology Reports Fourth Quarter and Full Year 2025 Financial and Operating Results

• On-track to report top-line data in the fall of 2026 from the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in patients with 2/3L ER+/HER2- metastatic breast cancer

• Advanced enrollment in the OPERA-02 pivotal Phase 3 trial of palazestrant in combination with ribociclib in patients with frontline ER+/HER2- metastatic breast cancer

• Initiated the Phase 1b/2 study of palazestrant in combination with Pfizer’s novel CDK4 inhibitor, atirmociclib, in patients with ER+/HER2- metastatic breast cancer

• Continued enrollment in the Phase 1 clinical study of OP-3136 in breast cancer and other solid tumors, with initial clinical data expected in Q2 2026

• Generated $218.5 million in gross proceeds from a follow-on public offering, further strengthening the Company’s balance sheet; ended 2025 with $505.4 million in cash, cash equivalents, and marketable securities

• Transformation into a fully-integrated oncology company underway in preparation for the Company’s first potential commercial launch in late 2027

SAN FRANCISCO, March 16, 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 reported financial and operating results for the fourth quarter and full year ended December 31, 2025.

“2025 was a year of strong execution across the business as we advanced palazestrant as a differentiated endocrine therapy across multiple regimens, highlighted by continued enrollment and strong investigator interest in our OPERA-01 and OPERA-02 trials,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “Our earlier-phase combination studies with palazestrant continue to advance and we are pleased to have initiated a Phase 1b/2 study with atirmociclib in collaboration with Pfizer, further demonstrating palazestrant’s potential as the combination endocrine therapy of choice in the metastatic setting.”

Bohen continued, “In November, we strengthened our balance sheet through a public offering that generated gross proceeds of approximately $218.5 million, enabling us to fund operations through numerous expected value-creating events with palazestrant. With initial clinical results from OP-3136 anticipated in Q22026, top-line data from OPERA-01 expected in the fall of this year, and commercial launch preparations underway for a potential approval in late 2027, we are entering an exciting chapter in Olema’s history. We remain focused on transforming the metastatic breast cancer treatment paradigm and delivering meaningful new treatment options to patients living with breast cancer and beyond.”

Recent Progress

• Initiated the Phase 1b/2 study evaluating palazestrant in combination with atirmociclib in estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer in collaboration with Pfizer.

• Presented a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2025.

• Continued enrollment in the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136, as a monotherapy and in combination with fulvestrant and palazestrant, in participants with advanced solid tumors.

• Completed an underwritten public offering of an aggregate of 11,500,000 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares, resulting in gross proceeds of approximately $218.5 million, before deducting underwriting discounts and commissions and estimated offering expenses.

Anticipated Upcoming Events

• Report initial clinical results for OP-3136 in Q2 2026 at a major medical conference.

• Report top-line data from the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in second- and third-line (2/3L) ER+/HER2- metastatic breast cancer in the fall of 2026.

Fourth Quarter and Full Year 2025 Financial Results

Cash, cash equivalents, and marketable securities as of December 31, 2025, were $505.4 million.

Net loss for the quarter and year ended December 31, 2025 was $46.1 million and $162.5 million, respectively, as compared to $33.6 million and $129.5 million for the quarter and year ended December 31, 2024, respectively. The increase in net loss for the fourth quarter was primarily related to increased spending on clinical development and research activities as a result of late-stage clinical trials for palazestrant, and the advancement of OP-3136, partially offset by higher interest income earned fr

8-K

0001750284false00017502842026-01-122026-01-12

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): January 12, 2026

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 2.02 Results of Operations and Financial Condition.

On January 12, 2026, Olema Pharmaceuticals, Inc. (the "Company") announced that its preliminary unaudited cash, cash equivalents and marketable securities as of December 31, 2025 were greater than $500 million.

The Company has not yet completed its fiscal year-end financial close process for the year ended December 31, 2025. This estimate of the Company’s cash, cash equivalents and marketable securities as of December 31, 2025 is preliminary, unaudited, and is subject to change upon completion of the Company’s financial closing procedures. Additional information and disclosures would be required for a more complete understanding of the Company’s financial position and results of operations as of December 31, 2025. The Company’s independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to this preliminary result and, accordingly, does not express an opinion or any other form of assurance about it. The information presented herein should not be considered a substitute for the financial information the Company files with the U.S. Securities and Exchange Commission (the "SEC") in its annual report on Form 10-K for the fiscal year ended December 31, 2025. The Company has no intention or obligation to update preliminary estimates of its cash, cash equivalents and marketable securities set forth above.

The information contained in this Current Report on Form 8-K under Item 2.02 is being 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 and will not be incorporated by reference in any filing by the Company under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, unless specifically identified as being incorporated therein by reference.

Item 7.01 Regulation FD Disclosure.

On January 12, 2026, the Company made available on its website a copy of the Company’s presentation to be shared with investors and others from time to time. The presentation is being furnished 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.

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 a