Olema Oncology Reports Fourth Quarter and Full Year 2024 Financial and Operating Results

   -- Pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in 
      patients with 2/3L metastatic breast cancer on track for top-line data in 
      2026 
 
   -- Pivotal Phase 3 OPERA-02 trial of palazestrant in combination with 
      ribociclib in patients with frontline metastatic breast cancer enabled by 
      new Novartis collaboration and $250 million equity private placement; 
      trial on track for initiation this year 
 
   -- Promising updated results from the ongoing Phase 1b/2 study of 
      palazestrant in combination with ribociclib in patients with ER+/HER2- 
      advanced or metastatic breast cancer presented at SABCS in December 2024; 
      updated mPFS presented at the TD Cowen Health Care Conference in March 
      2025; mature data expected to be presented this year at a major medical 
      meeting 
 
   -- OP-3136 Phase 1 trial initiated before the end of 2024; patients now 
      enrolling 
 
   -- Ended 2024 with $434.1 million in cash, cash equivalents, and marketable 
      securities 

SAN FRANCISCO, March 18, 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 fourth quarter and full year ended December 31, 2024.

"2024 was a productive year for Olema and we closed the year with significant positive momentum. We announced a new clinical trial collaboration and supply agreement with Novartis, raised approximately $250 million through an equity private placement with high-quality, long-term investors, presented compelling data supporting palazestrant in combination with ribociclib at SABCS, received clearance from the FDA for our IND application for OP-3136, and moved quickly to begin enrolling patients in the OP-3136 Phase 1 study before the end of the year," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Bolstered by a strong balance sheet, we are focused on exemplary execution throughout 2025. We plan to advance patient enrollment in the pivotal Phase 3 OPERA-01 trial in second- and third-line ER+/HER2- metastatic breast cancer, initiate our second pivotal Phase 3 trial, called OPERA-02, in frontline metastatic breast cancer, continue enrolling patients in the Phase 1 trial of OP-3136, present mature data from the Phase 1b/2 trial of palazestrant in combination with ribociclib, and further expand our capabilities through drug discovery and partnerships -- all to help patients living with cancer feel better, longer."

Recent Progress

   -- Presented new preclinical data demonstrating anti-tumor activity for 
      palazestrant in combination with capivasertib and everolimus as well as 
      new preclinical data for OP-3136 as a single agent and in combination 
      with palazestrant and other targeted agents at the EORTC-NCI-AACR 
      Symposium on Molecular Targets and Cancer Therapeutics in October. 
 
   -- Announced a new clinical trial collaboration and supply agreement with 
      Novartis in frontline metastatic breast cancer. 
 
   -- Successfully completed a $250 million equity private placement with new 
      and existing institutional and accredited investors. 
 
   -- Announced intention to proceed with OPERA-02, the Company's second 
      pivotal Phase 3 trial, of palazestrant in combination with 
      cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib in frontline 
      metastatic breast cancer. 
 
   -- Presented updated clinical results from the ongoing Phase 1b/2 study of 
      palazestrant in combination with ribociclib in patients with estrogen 
      receptor-positive, human epidermal growth factor receptor 2-negative 
      (ER+/HER2-) advanced or metastatic breast cancer at the San Antonio 
      Breast Cancer Symposium (SABCS) in December. Presented updated median 
      progression-free survival (mPFS) from this trial at the TD Cowen 45th 
      Annual Health Care Conference in March 2025. 
 
   -- Received clearance from the U.S. Food and Drug Administration (FDA) for 
      the Investigational New Drug $(IND.AU)$ application for OP-3136. 
 
   -- Initiated the Phase 1 clinical trial for OP-3136 and began enrolling 
      patients before year-end. 

Anticipated Upcoming Events

   -- Advance patient accrual in the pivotal Phase 3 OPERA-01 clinical trial of 
      palazestrant as a monotherapy in second- and third-line (2/3L) metastatic 
      breast cancer; top-line data are anticipated in 2026. 
 
   -- Initiate the pivotal Phase 3 OPERA-02 clinical trial of palazestrant in 
      combination with ribociclib in frontline metastatic breast cancer. 
 
   -- Present new preclinical data for OP-3136. 
 
   -- Present mature data from the Phase 1b/2 clinical trial of palazestrant in 
      combination with ribociclib at a medical meeting. 

Fourth Quarter and Full Year 2024 Financial Results

Cash, cash equivalents, and marketable securities as of December 31, 2024, were $434.1 million.

Net loss for the quarter and year ended December 31, 2024 was $33.6 million and $129.5 million, respectively, as compared to $26.8 million and $96.7 million for the quarter and year ended December 31, 2023, 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, the advancement of OP-3136, and lower interest income earned from marketable securities.

GAAP research and development (R&D) expenses were $32.3 million and $124.5 million for the quarter and year ended December 31, 2024, respectively, as compared to $25.9 million and $86.1 million for the quarterand year ended December 31, 2023. 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, research-related activities associated with the advancement of OP-3136, and personnel related costs, including an increase in non-cash stock-based compensation expense.

Non-GAAP R&D expenses were $27.7 million and $108.0 million for the quarter and year ended December 31, 2024, respectively, excluding $4.6 million and $16.5 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $23.0 million and $74.4 million for the quarter and year ended December 31, 2023, respectively, excluding $2.9 million and $11.8 million non-cash stock-based compensation expense, respectively. 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 $4.5 million and $17.7 million for the quarter and year ended December 31, 2024, respectively, as compared to $4.5 million and $18.8 million for the quarter and year ended December 31, 2023. The decrease in G&A expenses was primarily due to decreased spending on corporate-related costs, offset by an increase in non-cash stock-based compensation expense.

Non-GAAP G&A expenses were $2.8 million and $11.7 million for the quarter and year ended December 31, 2024, respectively, excluding $1.7 million and $6.0 million non-cash stock-based compensation expense, respectively. Non-GAAP G&A expenses were $3.1 million and $13.3 million for the quarter and year ended December 31, 2023, excluding $1.4 million and $5.5 million non-cash stock-based compensation expense, respectively. 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

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