Olema Oncology Reports Third Quarter 2026 Financial and Operating Results
Higher trial enrollment, manufacturing activity and personnel costs contributed to the wider quarterly loss.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Olema Oncology (OLMA) reported a third-quarter 2026 net loss of $73.599 million while advancing its breast cancer clinical programs. The loss widened from $42.217 million a year earlier; loss per share increased to $0.73 from $0.49. Cash, cash equivalents and marketable securities totaled $413.771 million at September 30, down from $505.437 million at December 31, 2025.
Quarterly research and development expenses rose to $67.598 million from $39.951 million, while general and administrative expenses increased to $9.927 million from $5.926 million. Olema expects pivotal Phase 3 OPERA-01 results in the first quarter of 2027 and plans to begin enrolling an OP-3136/darolutamide study with Bayer in the fourth quarter of 2026. Enrollment continued in OPERA-02 and the OP-3136 program. Clinical combination-study data presentations are planned for December 2026. Jason O’Byrne was appointed chief financial officer.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point. Forward-looking: it has not happened yet and may not happen.Olema expects pivotal Phase 3 OPERA-01 top-line data in the first quarter of 2027.
- Moderate pointOPERA-02 enrollment is accelerating, Olema said, in the pivotal first-line metastatic breast cancer trial.
- Minor pointOP-3136 Phase 1b/2 enrollment continued, advancing the clinical program.
- Minor point. Forward-looking: it has not happened yet and may not happen.Olema plans fourth-quarter 2026 enrollment for OP-3136 with darolutamide in metastatic castration-resistant prostate cancer, collaborating with Bayer.
- Minor point. Forward-looking: it has not happened yet and may not happen.Olema plans December 2026 clinical data presentations for OP-3136/fulvestrant, palazestrant/everolimus and palazestrant/atirmociclib at SABCS.
3 minor points
- Minor point. Forward-looking: it has not happened yet and may not happen.Olema plans November 2026 preclinical data on selective KAT6A degradation in estrogen receptor-positive breast cancer.
- Minor pointInterest income increased to $4.054 million in Q3 2026 from $3.648 million a year earlier.
- Minor pointNine-month interest income increased to $13.337 million in 2026 from $12.214 million in 2025.
Negative
- Moderate pointQ3 net loss widened to $73.599 million in 2026 from $42.217 million in 2025.
- Moderate pointCash, equivalents and marketable securities declined to $413.771 million at September 30, 2026, from $505.437 million at year-end 2025.
- Moderate pointQ3 research and development expenses rose to $67.598 million in 2026 from $39.951 million in 2025.
- Minor pointQ3 loss per share increased to $0.73 in 2026 from $0.49 in 2025.
- Minor pointQ3 general and administrative expenses rose to $9.927 million in 2026 from $5.926 million in 2025.
9 minor points
- Minor pointNine-month net loss widened to $189.888 million in 2026 from $116.390 million in 2025.
- Minor pointNine-month loss per share increased to $1.89 in 2026 from $1.36 in 2025.
- Minor pointNine-month research and development expenses rose to $174.615 million in 2026 from $114.477 million in 2025.
- Minor pointNine-month general and administrative expenses rose to $28.075 million in 2026 from $14.137 million in 2025.
- Minor pointOther loss was $128,000 in Q3 2026, versus other income of $12,000 in Q3 2025.
- Minor pointNine-month other loss was $535,000 in 2026, versus other income of $10,000 in 2025.
- Minor pointTotal liabilities increased to $72.233 million at September 30, 2026, from $54.871 million at December 31, 2025.
- Minor pointStockholders’ equity declined to $368.837 million at September 30, 2026, from $478.559 million at December 31, 2025.
- Minor pointTotal assets declined to $441.070 million at September 30, 2026, from $533.430 million at December 31, 2025.
News Explained
Olema reports that its third-quarter weighted-average shares for loss per share were 101,092,706, including the effect of pre-funded warrants, versus 85,732,221 a year earlier; because the warrants convert into shares when exercised, exercise can add shares and dilute existing holders’ ownership.
Key Figures
- Cash, cash equivalents, and marketable securities
- $413.8 million
- As of September 30, 2026
- Net loss
- $73.6 million
- Q3 2026; versus $42.2 million in Q3 2025
- GAAP R&D expenses
- $67.6 million
- Q3 2026; versus $40.0 million in Q3 2025
- GAAP G&A expenses
- $9.9 million
- Q3 2026; versus $5.9 million in Q3 2025
- Net loss per share, basic and diluted
- $(0.73)
- Q3 2026; versus $(0.49) in Q3 2025
- OPERA-01 top-line data timing
- Q1 2027
- Pivotal Phase 3 trial
Previous Earnings Reports
-
Reported $461.1M cash and a $63.2M quarterly net loss; OPERA-01 top-line data remained expected in Q1 2027.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
pharmacokinetics medical
investigational new drug (ind) application regulatory
fast track designation regulatory
non-gaap financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
- On track to announce top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 2027
- Continued strong enrollment in the pivotal Phase 3 OPERA-02 trial and the Phase 1b/2 study of OP-3136
- Appointed Jason O’Byrne, MBA, as Chief Financial Officer
- Ended the third quarter with
$413.8 million in cash, cash equivalents, and marketable securities
SAN FRANCISCO, Nov. 10, 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 third quarter ended September 30, 2026.
“As we approach top-line data from our pivotal Phase 3 OPERA-01 trial in the first quarter of 2027, we remain confident in palazestrant’s potential to emerge as a differentiated endocrine therapy in second- and third-line metastatic breast cancer,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “Turning to our pivotal Phase 3 OPERA-02 trial in first-line metastatic breast cancer, momentum continues to build. Enrollment is accelerating, investigator interest is strong, and patients with frontline disease continue to require better therapeutic options. We believe that palazestrant, in combination with ribociclib, is well positioned to become the new standard of care in this setting. With its dual mechanism of action as a complete estrogen receptor antagonist and selective estrogen receptor degrader, optimal pharmacokinetic properties, encouraging clinical profile demonstrated to date, and potential for use both as a monotherapy and in combination with other agents, we believe palazestrant is uniquely positioned to transform the metastatic breast cancer treatment paradigm.”
Bohen continued, “Beyond preparing for the potential approval and commercialization of palazestrant, we remain encouraged by the potential of OP-3136, our novel KAT6 inhibitor, as it advances through clinical development across multiple indications and treatment combinations. We were also pleased to welcome Jason O’Byrne as Chief Financial Officer this quarter. His extensive experience in corporate strategy, capital markets, and financial management and operations will be invaluable as we prepare for key catalysts in 2027 and continue our transformation into a fully integrated oncology company.”
Anticipated Upcoming Events
- Present preclinical data on selective degradation of KAT6A in estrogen receptor-positive breast cancer at the 38th EORTC-NCI-AACR Symposium 2026 on Molecular Targets and Cancer Therapeutics (ENA) in November.
- Present data from the Phase 1b/2 study of OP-3136 in combination with fulvestrant, the Phase 1b/2 study of palazestrant in combination with everolimus, and the Phase 1b study of palazestrant in combination with atirmociclib, all in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer, at the 2026 San Antonio Breast Cancer Symposium (SABCS) in December.
- Initiate enrollment in the Phase 1b/2 study evaluating OP-3136 in combination with darolutamide in mCRPC in collaboration with Bayer in the fourth quarter of 2026.
- Report top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 2027.
Third Quarter 2026 Financial Results
Cash, cash equivalents, and marketable securities as of September 30, 2026, were
Net loss for the quarter ended September 30, 2026 was
GAAP research and development (R&D) expenses were
Non-GAAP R&D expenses were
GAAP G&A expenses were
Non-GAAP G&A expenses were
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 antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. 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 antagonist (CERAN) and selective estrogen receptor 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 in combination with ribociclib in the ongoing pivotal Phase 3 clinical trial, OPERA-02. Palazestrant is also being evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, everolimus, and atirmociclib.
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 study.
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,” “on track,” “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 initiation, progress, timing, enrollment, and results of Olema’s clinical trials and top-line data, including the expected timing of top-line data from Phase 3 OPERA-01 trial, the advancement of and patient enrollment in, as applicable, the Phase 3 OPERA-02 trial, and ongoing Phase 1/2 and Phase 1 studies; the potential for palazestrant to emerge as a differentiated endocrine therapy, in second- and third-line metastatic breast cancer, including its potential to become a new standard of care in combination with ribociclib in the first-line setting, across multiple regimens and to transform the metastatic breast cancer treatment paradigm; the potential beneficial characteristics, including the safety, tolerability, and efficacy of Olema’s product candidates, including palazestrant and OP-3136, alone and in combination with other agents; the sufficiency of experience of members of our management team; and Olema’s plans to become a fully integrated oncology company. 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 September 30, 2026, 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 | ||||||
| (Unaudited) | ||||||
| (In thousands) | ||||||
| September 30, | December 31, | |||||
| 2026 | 2025 | |||||
| Cash, cash equivalents and marketable securities | $ | 413,771 | $ | 505,437 | ||
| Total assets | 441,070 | 533,430 | ||||
| Total current liabilities | 69,233 | 51,802 | ||||
| Total liabilities | 72,233 | 54,871 | ||||
| Total stockholders’ equity | 368,837 | 478,559 | ||||
| Total liabilities and stockholders’ equity | $ | 441,070 | $ | 533,430 | ||
| Olema Pharmaceuticals, Inc. | ||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||
| (Unaudited) | ||||||||||||||
| (In thousands, except for share and per share data) | ||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||
| Operating expenses: | ||||||||||||||
| Research and development (1) | $ | 67,598 | $ | 39,951 | $ | 174,615 | $ | 114,477 | ||||||
| General and administrative (2) | 9,927 | 5,926 | 28,075 | 14,137 | ||||||||||
| Total operating expenses | 77,525 | 45,877 | 202,690 | 128,614 | ||||||||||
| Loss from operations | (77,525 | ) | (45,877 | ) | (202,690 | ) | (128,614 | ) | ||||||
| Other income: | ||||||||||||||
| Interest income | 4,054 | 3,648 | 13,337 | 12,214 | ||||||||||
| Other (loss) income | (128 | ) | 12 | (535 | ) | 10 | ||||||||
| Total other income | 3,926 | 3,660 | 12,802 | 12,224 | ||||||||||
| Net loss | $ | (73,599 | ) | $ | (42,217 | ) | $ | (189,888 | ) | $ | (116,390 | ) | ||
| Net loss per share, basic and diluted | $ | (0.73 | ) | $ | (0.49 | ) | $ | (1.89 | ) | $ | (1.36 | ) | ||
| Weighted average shares used to compute net loss per share, basic and diluted (3) | 101,092,706 | 85,732,221 | 100,609,258 | 85,553,078 | ||||||||||
| (1) Research and development expenses for the nine-months ended September 30, 2025 include a | ||||||||||||||
| (1) and (2) Used to reference to the table below. | ||||||||||||||
| (3) The weighted average shares used to compute net loss per share, basic and diluted include the effect from the pre-funded warrants. | ||||||||||||||
| Reconciliation of GAAP to Non-GAAP Information | ||||||||||||||
| (In thousands) | ||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||
| (1) Research and development reconciliation | ||||||||||||||
| GAAP research and development | $ | 67,598 | $ | 39,951 | $ | 174,615 | $ | 114,477 | ||||||
| Less: stock-based compensation expense | 7,693 | 2,582 | 23,155 | 9,592 | ||||||||||
| Non-GAAP research and development | $ | 59,905 | $ | 37,369 | $ | 151,460 | $ | 104,885 | ||||||
| (2) General and administrative reconciliation | ||||||||||||||
| GAAP general and administrative | $ | 9,927 | $ | 5,926 | $ | 28,075 | $ | 14,137 | ||||||
| Less: stock-based compensation expense | 4,389 | 1,668 | 11,978 | 3,728 | ||||||||||
| Non-GAAP general and administrative | $ | 5,538 | $ | 4,258 | $ | 16,097 | $ | 10,409 | ||||||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When does Olema expect OPERA-01 Phase 3 results?
Olema expects top-line OPERA-01 results in the first quarter of 2027. The pivotal Phase 3 trial evaluates palazestrant as a single agent.
What were Olema’s third-quarter 2026 net loss and cash balance?
Olema reported a $73.599 million net loss for the third quarter of 2026 and $413.771 million in cash, cash equivalents and marketable securities at September 30, 2026. The comparable quarterly net loss was $42.217 million in 2025.
What drove Olema’s higher third-quarter 2026 expenses?
Olema attributed higher expenses to clinical development, manufacturing and clinical supply activity, personnel costs and early preparations for potential palazestrant commercialization. Research and development stock-based compensation increased by $5.1 million; general and administrative stock-based compensation increased by $2.7 million, while professional fees increased by $1.0 million.