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

Rhea-AI Summary

Olema Oncology (NASDAQ: OLMA) reported its Q4 and full year 2024 financial results, highlighting significant progress in its breast cancer treatment pipeline. The company ended 2024 with $434.1 million in cash and equivalents, bolstered by a $250 million equity private placement.

Key developments include the advancement of two pivotal Phase 3 trials: OPERA-01 for palazestrant monotherapy in metastatic breast cancer (top-line data expected 2026) and OPERA-02 for palazestrant with ribociclib in frontline treatment, supported by a new Novartis collaboration.

Financial results showed a net loss of $33.6 million for Q4 and $129.5 million for full-year 2024, compared to $26.8 million and $96.7 million in 2023, respectively. R&D expenses increased to $124.5 million for 2024, up from $86.1 million in 2023, reflecting expanded clinical development activities.

Positive

• Secured $250 million equity private placement strengthening financial position
• Strong cash position of $434.1 million at year-end 2024
• Established strategic collaboration with Novartis for OPERA-02 trial
• Advanced two Phase 3 trials for palazestrant in breast cancer treatment
• Successfully initiated Phase 1 trial for new compound OP-3136

Negative

• Increased net loss to $129.5 million in 2024 from $96.7 million in 2023
• R&D expenses rose 44.6% to $124.5 million in 2024
• Top-line data for main trial OPERA-01 not expected until 2026

Insights

Financial Analyst

Olema Oncology's financial results reveal strategic strengthening with a $250 million private placement and Novartis collaboration, significantly bolstering their balance sheet to $434.1 million in cash and marketable securities as of December 31, 2024. This provides an estimated 3+ year runway at current burn rates, with the company reporting $129.5 million in net loss for 2024 vs $96.7 million in 2023.

The increased R&D spend ($124.5 million vs $86.1 million in 2023) reflects appropriate investment in advancing two pivotal Phase 3 trials for palazestrant and initiating a Phase 1 trial for second asset OP-3136. Notably, G&A expenses decreased slightly to $17.7 million from $18.8 million despite expanded operations, indicating disciplined cost management in non-research areas.

The Novartis collaboration provides dual benefits: secured supply of ribociclib for combination studies and strategic validation from a major pharmaceutical partner. This positions Olema with multiple potential commercialization pathways - palazestrant as monotherapy in later-line treatment and in combination with ribociclib in the more valuable frontline setting.

With cash runway extending beyond key clinical milestones, including top-line Phase 3 OPERA-01 data in 2026, Olema has significantly de-risked its financial position while advancing a multi-asset, multi-pathway clinical strategy in breast cancer.

Oncology Expert

Olema's clinical development strategy for palazestrant demonstrates scientific sophistication through parallel development paths that target different treatment settings in ER+/HER2- breast cancer. The pivotal Phase 3 OPERA-01 trial evaluates palazestrant as monotherapy in second/third-line metastatic breast cancer, while OPERA-02 will investigate the combination with Novartis' ribociclib in the frontline setting.

The company's presentation of updated results from the Phase 1b/2 combination study at SABCS (San Antonio Breast Cancer Symposium) followed by updated median progression-free survival (mPFS) data at TD Cowen suggests positive clinical momentum, though specific efficacy metrics weren't disclosed in this release. The continued investment in this program indicates confidence in the emerging clinical profile.

The advancement of second compound OP-3136 into Phase 1 trials diversifies Olema's pipeline beyond a single-asset strategy, reducing clinical development risk. The presentation of preclinical data showing palazestrant's activity in additional combinations (with capivasertib and everolimus) at EORTC-NCI-AACR suggests the company is exploring broader applications.

From a clinical development perspective, Olema is executing a comprehensive approach to position palazestrant across multiple lines of therapy in breast cancer, with the Novartis collaboration enabling access to an established CDK4/6 inhibitor (ribociclib) for combination studies. The focus on both monotherapy and combination approaches reflects understanding of current treatment paradigms in breast cancer.

• 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 45^th Annual Health Care Conference in March 2025.
• Received clearance from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) 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 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) 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
The results presented in this press release include both GAAP information and non-GAAP information. As used in this release, non-GAAP R&D expense is defined by Olema as GAAP R&D expense excluding stock-based compensation expense, and non-GAAP G&A expense is defined by Olema as GAAP G&A expense excluding stock-based compensation expense. We use these non-GAAP financial measures to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. Other companies, including companies in our industry, may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures and not rely on any single financial measure to evaluate our business.

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,” “intend,” “may,” “potential,” “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 timelines for initiation and enrollment for potential clinical studies and for results of clinical trials of palazestrant and OP-3136 as a monotherapy and in combination trials, Olema’s financial condition and resources, results of operations, cash position and balance sheet strength, potential beneficial characteristics including but not limited to safety, tolerability, activity, efficacy and therapeutic effects of palazestrant, the combinability of palazestrant or OP-3136 with other drugs, and patient enrollment in our clinical trials. 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 Annual Report on Form 10-K for the year ended December 31, 2024, and future 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
Courtney O’Konek
Vice President, Corporate Communications
Olema Oncology
media@olema.com

Olema Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets Data
(in thousands)
		December 31,		December 31,
		2024		2023
Cash, cash equivalents and marketable securities		$	434,086	$	261,807
Total assets			450,979		276,945
Total current liabilities			41,758		21,621
Total liabilities			42,015		23,050
Total stockholders’ equity			408,964		253,895
Total liabilities and stockholders’ equity		$	450,979	$	276,945

Olema Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
	Three Months Ended December 31,							Twelve Months Ended December 31,
		2024			2023				2024			2023
Operating expenses:
Research and development (1)	$	32,299		$	25,872			$	124,517		$	86,140
General and administrative (2)		4,469			4,544				17,741			18,821
Total operating expenses		36,768			30,416				142,258			104,961
Loss from operations		(36,768)			(30,416)				(142,258)			(104,961)
Other income:
Interest income		3,294			3,551				12,682			8,325
Other income (expense)		(93)			93				102			(19)
Total other income		3,201			3,644				12,784			8,306
Net loss	$	(33,567)		$	(26,772)			$	(129,474)		$	(96,655)
Net loss per share, basic and diluted	$	(0.51)		$	(0.49)			$	(2.20)		$	(2.14)
Weighted average shares used to compute net loss per share, basic and diluted		65,793,359			54,783,945				58,743,522			45,247,098
Reconciliation of GAAP to Non-GAAP Information
(In thousands)
	Three Months Ended December 31,							Twelve Months Ended December 31,
		2024			2023				2024			2023
(1) Research and development reconciliation
GAAP research and development (3)	$	32,299		$	25,872			$	124,517		$	86,140
Less: share-based compensation expense		4,618			2,911				16,543			11,769
Non-GAAP research and development	$	27,681		$	22,961			$	107,974		$	74,371
(2) General and administrative reconciliation
GAAP general and administrative	$	4,469		$	4,544			$	17,741		$	18,821
Less: share-based compensation expense		1,705			1,440				6,039			5,487
Non-GAAP general and administrative	$	2,764		$	3,104			$	11,702		$	13,334
(3) Research and development expenses for the twelve-months ended December 31, 2024 include a $5.0 million milestone payment in connection to the Aurigene Agreement.

FAQ

What are the key milestones expected for Olema Oncology's (OLMA) OPERA-01 trial?

OPERA-01, testing palazestrant monotherapy in 2nd/3rd-line metastatic breast cancer, is expected to deliver top-line data in 2026.

How much did Olema Oncology (OLMA) raise in their 2024 private placement?

Olema raised approximately $250 million through an equity private placement with long-term investors.

What was Olema Oncology's (OLMA) cash position at the end of 2024?

Olema ended 2024 with $434.1 million in cash, cash equivalents, and marketable securities.

How did Olema's (OLMA) R&D expenses change in 2024 compared to 2023?

R&D expenses increased to $124.5 million in 2024 from $86.1 million in 2023, due to expanded clinical trials.

What is the significance of Olema's (OLMA) collaboration with Novartis?

The Novartis collaboration enables OPERA-02, a Phase 3 trial combining palazestrant with ribociclib for frontline metastatic breast cancer.