Olema Oncology Reports First Quarter 2026 Financial and Operating Results
Rhea-AI Summary
Olema Oncology (Nasdaq: OLMA) reported first quarter 2026 financial and operating results and highlighted upcoming clinical milestones in metastatic breast cancer.
The company ended the quarter with $505.3 million in cash and securities, while net loss increased to $53.1 million on higher R&D and G&A expenses supporting late-stage trials.
Top-line data from the pivotal Phase 3 OPERA-01 trial of palazestrant monotherapy are expected in fall 2026. Enrollment continues in the pivotal Phase 3 OPERA-02 trial of palazestrant plus ribociclib, and first clinical data from OP-3136 Phase 1 will be presented at ASCO 2026.
AI-generated analysis. Not financial advice.
Positive
- Cash, cash equivalents, and marketable securities totaled $505.3 million as of March 31, 2026
- Top-line data from pivotal Phase 3 OPERA-01 palazestrant monotherapy trial expected in fall 2026
- Pivotal Phase 3 OPERA-02 trial of palazestrant plus ribociclib continues enrolling frontline ER+/HER2- patients
- Initial clinical data from OP-3136 Phase 1 study to be presented at ASCO 2026
- Ongoing Phase 1b/2 combination study of palazestrant with atirmociclib in ER+/HER2- metastatic breast cancer
Negative
- Net loss increased to $53.1 million from $30.4 million year-over-year for Q1
- GAAP R&D expenses rose to $49.2 million from $30.6 million year-over-year
- GAAP G&A expenses increased to $8.8 million from $4.2 million year-over-year
News Market Reaction – OLMA
On the day this news was published, OLMA declined 5.99%, reflecting a notable negative market reaction. Argus tracked a trough of -8.8% from its starting point during tracking. Our momentum scanner triggered 57 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $79M from the company's valuation, bringing the market cap to $1.24B at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Two biotech peers in the momentum scan, including BCAX, are moving down (median move about -10.2%), while OLMA shows a modest -0.27% move with slightly elevated volume, indicating this earnings report landed amid broader sector weakness.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 16 | Earnings update | Positive | +9.6% | Q4 2025 results with $505.4M cash and follow-on raise of $218.5M. |
| Nov 10 | Earnings update | Positive | +4.2% | Q3 2025 results plus Pfizer combo deal and OPERA-02 initiation. |
| Aug 11 | Earnings update | Positive | +16.2% | Q2 2025 results with 90 mg dose selection and $361.9M cash. |
| May 13 | Earnings update | Positive | -3.9% | Q1 2025 results showing $392.7M cash and strong palazestrant data. |
| Mar 18 | Earnings update | Positive | -0.7% | FY 2024 results with $434.1M cash and two pivotal trials advancing. |
Earnings updates have often been catalysts, with three of the last five tagged earnings reports seeing positive next-day moves and two drawing negative reactions despite similar pipeline themes.
Over the past year, Olema’s earnings releases have consistently highlighted progress for palazestrant and OP‑3136 alongside rising R&D investment. Cash balances moved from $434.1M at 2024 year-end to $505.4M at 2025 year-end, with follow-on and private placements strengthening the balance sheet. Stock reactions around these events have been mixed, but prior quarters also emphasized the same Phase 3 OPERA-01/02 timelines and OP‑3136 first-in-human data that reappear in the current Q1 2026 report.
Historical Comparison
In the past five earnings releases, OLMA moved an average of 5.08% the next day, underscoring that quarterly financial and pipeline updates have been reliable volatility catalysts.
Earnings reports have traced a steady progression: palazestrant advancing from Phase 3 initiation toward OPERA‑01/02 readouts and OP‑3136 moving from preclinical work into Phase 1, backed by rising cash balances and growing R&D spend.
Market Pulse Summary
The stock moved -6.0% in the session following this news. A negative reaction despite this detailed earnings update would fit the mixed pattern seen in prior reports, where two of five tagged earnings events drew downside moves even as the pipeline advanced. The wider Q1 2026 net loss of $53.1M and higher GAAP R&D of $49.2M could reinforce concerns about spending, even with $505.3M in cash and multiple Phase 3 and Phase 1 milestones approaching.
Key Terms
phase 3 medical
phase 1 medical
phase 1b/2 medical
pharmacokinetics medical
pharmacodynamics medical
er+/her2- medical
kat6 inhibitor medical
AI-generated analysis. Not financial advice.
- 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:
- The first demonstrated that palazestrant fully recruits the corepressor protein, NCoR1, in vitro, supporting complete estrogen receptor antagonism.
- 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
Net loss for the quarter ended March 31, 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 continued advancement of Olema’s pipeline of product candidates, including palazestrant and OP-3136; the progress, timing, and results of Olema’s clinical trials, including the Phase 3 OPERA-01 and OPERA-02 trials and ongoing Phase 1/2 studies; the expected timing of data readouts, including top-line data from OPERA-01; the potential therapeutic effects and benefits of palazestrant and OP-3136, alone or in combination with each other or with other agents; Olema’s plans to become a fully integrated oncology company; and the timing and potential for a future commercial launch. 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 March 31, 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 | |||||||
| (In thousands) | |||||||
| March 31, | December 31, | ||||||
| 2026 | 2025 | ||||||
| Cash, cash equivalents and marketable securities | $ | 505,347 | $ | 505,437 | |||
| Total assets | 530,645 | 533,430 | |||||
| Total current liabilities | 47,167 | 51,802 | |||||
| Total liabilities | 50,167 | 54,871 | |||||
| Total stockholders’ equity | 480,478 | 478,559 | |||||
| Total liabilities and stockholders’ equity | $ | 530,645 | $ | 533,430 | |||
| Olema Pharmaceuticals, Inc. | ||||||
| Condensed Consolidated Statements of Operations | ||||||
| (In thousands, except for share and per share data) | ||||||
| Three Months Ended March 31, | ||||||
| 2026 | 2025 | |||||
| Operating expenses: | ||||||
| Research and development (1) | $ | 49,232 | $ | 30,624 | ||
| General and administrative (2) | 8,754 | 4,249 | ||||
| Total operating expenses | 57,986 | 34,873 | ||||
| Loss from operations | (57,986 | ) | (34,873 | ) | ||
| Other income: | ||||||
| Interest income | 4,776 | 4,524 | ||||
| Other income (expense) | 121 | (40 | ) | |||
| Total other income | 4,897 | 4,484 | ||||
| Net loss | $ | (53,089 | ) | $ | (30,389 | ) |
| Net loss per share, basic and diluted | $ | (0.52 | ) | $ | (0.36 | ) |
| Weighted average shares used to compute net loss per share, basic and diluted (3) | 102,800,098 | 85,426,223 | ||||
| (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 pre-funded warrants. | ||||||
| Reconciliation of GAAP to Non-GAAP Information | ||||||
| (In thousands) | ||||||
| Three Months Ended March 31, | ||||||
| 2026 | 2025 | |||||
| (1) Research and development reconciliation | ||||||
| GAAP research and development | $ | 49,232 | $ | 30,624 | ||
| Less: stock-based compensation expense | 6,571 | 3,301 | ||||
| Non-GAAP research and development | $ | 42,661 | $ | 27,323 | ||
| (2) General and administrative reconciliation | ||||||
| GAAP general and administrative | $ | 8,754 | $ | 4,249 | ||
| Less: stock-based compensation expense | 3,577 | 1,077 | ||||
| Non-GAAP general and administrative | $ | 5,177 | $ | 3,172 | ||
