Olema Oncology Reports First Quarter 2025 Financial and Operating Results

   -- Pivotal Phase 3 OPERA-02 trial of palazestrant in combination with 
      ribociclib in frontline metastatic breast cancer on track for initiation 
      in 2025, supported by promising updated efficacy data from ongoing Phase 
      1b/2 study 
 
   -- Pivotal Phase 3 OPERA-01 trial of palazestrant monotherapy in 2/3L 
      metastatic breast cancer continues to advance with top-line data 
      anticipated in 2026; trial-in-progress poster to be highlighted at ASCO 
      Annual Meeting 
 
   -- Preclinical data for OP-3136 presented at AACR demonstrating anti-tumor 
      activity in ovarian, non-small cell lung, and prostate cancer models; 
      Phase 1 trial recruitment ongoing 
 
   -- Ended the first quarter with $392.7 million in cash, cash equivalents, 
      and marketable securities 

SAN FRANCISCO, May 13, 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 reported financial and operating results for the first quarter ended March 31, 2025.

"During the first quarter, we continued to make important operational progress advancing our pipeline and we enter the second quarter well-positioned across the business," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our focus remains on our pivotal palazestrant program, laying the foundation to successfully initiate OPERA-02 in frontline metastatic breast cancer, while advancing OPERA-01 towards an anticipated top-line readout next year. We were also pleased to present promising new preclinical data at AACR supporting the use of OP-3136, our potent KAT6 inhibitor, in a number of solid tumor applications beyond breast cancer. Investigator interest in our OP-3136 program remains strong and we are continuing to enroll patients in the Phase 1 study. With a clear strategy and strong balance sheet to support execution against our key priorities, we are working diligently to advance the promise of Olema's science and striving to change the treatment paradigm for endocrine-driven cancers."

Recent Progress

   -- Disclosed updated median progression-free survival (mPFS) from the 
      ongoing Phase 1b/2 study of palazestrant in combination with 
      cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) ribociclib in patients 
      with estrogen receptor-positive, human epidermal growth factor receptor 
      2-negative (ER+/HER2-) advanced or metastatic breast cancer at the TD 
      Cowen 45th Annual Health Care Conference in March, including a mPFS of 
      13.8 months among all patients treated with 120 mg of palazestrant and 
      600 mg of ribociclib daily (n=56) and 13.1 months in patients previously 
      treated with a CDK4/6i plus an endocrine therapy (n=40) as of a February 
      18, 2025 cutoff date. 
 
   -- Advanced the pivotal Phase 3 OPERA-01 trial of palazestrant as a 
      monotherapy in second- and third-line (2/3L) ER+/HER2- metastatic breast 
      cancer. 
 
   -- Continued enrollment in the Phase 1 study evaluating the safety, 
      tolerability, pharmacokinetics, pharmacodynamics, and preliminary 
      efficacy of OP-3136 in participants with advanced solid tumors. 
 
   -- Presented new preclinical data for OP-3136 at the American Association 
      for Cancer Research (AACR) Annual Meeting in April, demonstrating 
      anti-tumor activity in pre-clinical in vitro and in vivo ovarian, 
      non-small cell lung, and prostate cancer models, regardless of KAT6A 
      expression status, as well as synergy with standard of care drugs. 

Anticipated Upcoming Events

   -- Present trial-in-progress poster, "OPERA-01: A randomized, open-label, 
      phase 3 study of palazestrant (OP-1250) monotherapy vs standard-of-care 
      endocrine therapy for patients with ER+, HER2- advanced breast cancer 
      after endocrine and CDK4/6 inhibitor therapy," at the American Society of 
      Clinical Oncology (ASCO) Annual Meeting in June; report top-line data 
      from OPERA-01 in 2026. 
 
   -- Initiate the pivotal Phase 3 OPERA-02 trial of palazestrant in 
      combination with ribociclib in frontline metastatic breast cancer in 
      2025. 
 
   -- Present mature data from the Phase 1b/2 trial of palazestrant in 
      combination with ribociclib at an upcoming medical meeting. 

First Quarter 2025 Financial Results

Cash, cash equivalents, and marketable securities as of March 31, 2025, were $392.7 million.

Net loss for the quarter ended March 31, 2025 was $30.4 million, as compared to $31.0 million for the quarter ended March 31, 2024. The decrease in net loss for the first quarter was related to higher interest income earned from marketable securities, primarily offset by increased spending on clinical development and research activities as a result of late-stage clinical trials for palazestrant and the advancement of OP-3136.

GAAP research and development (R&D) expenses were $30.6 million for the quarter ended March 31, 2025, as compared to $29.9 million for the quarter ended March 31, 2024. The increase in R&D expenses was primarily related to increased spending on clinical operations and development-related activities as the Company continues to advance palazestrant through late-stage clinical trials, and clinical operations and development-related activities associated with the advancement of OP-3136, and personnel-related costs, partially offset by a one-time $5 million milestone payment incurred to Aurigene and a decrease in non-cash stock-based compensation expense of $0.1 million.

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. Non-GAAP R&D expenses were $26.5 million for the quarter ended March 31, 2024, which included a $5.0 million milestone payment in connection with the Aurigene Agreement and excluded $3.4 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 $4.2 million for the quarter ended March 31, 2025, as compared to $4.5 million for the quarter ended March 31, 2024. The decrease in G&A expenses was primarily due to a decrease in non-cash stock-based compensation expense of $0.4 million, offset by increased spending on corporate-related costs.

Non-GAAP G&A expenses were $3.2 million for the quarter ended March 31, 2025, excluding $1.1 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended March 31, 2024, excluding $1.5 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.

About Olema Oncology

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 trial. 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. Learn more at www.opera01study.com. Palazestrant is also being evaluated in multiple Phase 1/2 trials in combination with ribociclib, palbociclib, alpelisib, and everolimus. It will also be evaluated in combination with ribociclib in the planned pivotal Phase 3 trial, OPERA-02.

About OP-3136

OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug $(IND.AU)$ application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical trial.

Non-GAAP Financial Information

(MORE TO FOLLOW) Dow Jones Newswires

May 13, 2025 16:01 ET (20:01 GMT)