Olema Oncology Reports Second Quarter 2025 Financial and Operating Results
Olema Oncology (Nasdaq: OLMA) has reported its Q2 2025 financial results and provided key operational updates. The company has selected 90 mg once-daily palazestrant for Part 2 of the OPERA-01 Phase 3 trial and the OPERA-02 Phase 3 trial in combination with ribociclib for breast cancer treatment.
Key financial metrics include $361.9 million in cash and equivalents, and a net loss of $43.8 million for Q2 2025, compared to $30.4 million in Q2 2024. R&D expenses increased to $43.9 million, primarily due to a $10 million milestone payment to Aurigene and increased clinical development activities.
The company expects to present mature data from the Phase 1b/2 study at ESMO 2025, initiate OPERA-02 in Q3 2025, and report OPERA-01 top-line data in H2 2026.
Olema Oncology (Nasdaq: OLMA) ha comunicato i risultati finanziari del secondo trimestre 2025 e fornito aggiornamenti operativi. La societ脿 ha selezionato palazestrant 90 mg una volta al giorno per la Parte 2 dello studio di Fase 3 OPERA-01 e per lo studio di Fase 3 OPERA-02 in combinazione con ribociclib per il trattamento del tumore al seno.
I principali indicatori finanziari includono $361.9 million in liquidit脿 e mezzi equivalenti, e una perdita netta di $43.8 million nel Q2 2025, rispetto a $30.4 million nel Q2 2024. Le spese di R&S sono aumentate a $43.9 million, principalmente a causa di un pagamento milestone di $10 million ad Aurigene e dell'intensificarsi delle attivit脿 di sviluppo clinico.
La societ脿 prevede di presentare dati maturi dallo studio di Fase 1b/2 all'ESMO 2025, avviare OPERA-02 nel Q3 2025 e comunicare i dati top-line di OPERA-01 nella seconda met脿 del 2026.
Olema Oncology (Nasdaq: OLMA) ha dado a conocer sus resultados financieros del segundo trimestre de 2025 y aport贸 actualizaciones operativas clave. La compa帽铆a ha seleccionado palazestrant de 90 mg una vez al d铆a para la Parte 2 del ensayo de Fase 3 OPERA-01 y para el ensayo de Fase 3 OPERA-02 en combinaci贸n con ribociclib para el tratamiento del c谩ncer de mama.
Los principales indicadores financieros incluyen $361.9 million en efectivo y equivalentes, y una p茅rdida neta de $43.8 million en el Q2 2025, frente a $30.4 million en el Q2 2024. Los gastos de I+D aumentaron a $43.9 million, principalmente por un pago por hitos de $10 million a Aurigene y por el incremento de la actividad de desarrollo cl铆nico.
La compa帽铆a espera presentar datos maduros del estudio de Fase 1b/2 en ESMO 2025, iniciar OPERA-02 en el Q3 2025 y comunicar los datos top-line de OPERA-01 en la segunda mitad de 2026.
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欤检殧 鞛 歆�響滊電� $361.9 million鞚� 順勱笀 氚� 順勱笀靹� 鞛愳偘瓿� 2025雲� 2攵勱赴 $43.8 million鞚� 靾滌啇鞁�(2024雲� 2攵勱赴 $30.4 million)鞚� 氤搓碃霅橃棃鞀惦媹雼�. 鞐瓣惮臧滊皽牍勲姅 $43.9 million鞙茧 歃濌皜頄堨溂氅�, 鞚措姅 欤茧 Aurigene鞐� 雽�頃� $10 million 攴滊鞚� 毵堨澕鞀ろ啢 歆�旮� 氚� 鞛勳儊 臧滊皽 頇滊彊 歃濌皜鞐� 旮办澑頃╇媹雼�.
須岇偓電� ESMO 2025鞐愳劀 1b/2靸� 鞐瓣惮鞚� 靹膘垯頃� 雿办澊韯半ゼ 氚滍憸頃橁碃, Q3 2025鞐� OPERA-02毳� 臧滌嫓頃橂┌, OPERA-01鞚� 韱彪澕鞚� 雿办澊韯半姅 2026雲� 頃橂皹旮办棎 氤搓碃頃� 瓴冹溂搿� 鞓堨儊頃橁碃 鞛堨姷雼堧嫟.
Olema Oncology (Nasdaq: OLMA) a publi茅 ses r茅sultats financiers du deuxi猫me trimestre 2025 et communiqu茅 des mises 脿 jour op茅rationnelles cl茅s. La soci茅t茅 a s茅lectionn茅 palazestrant 90 mg une fois par jour pour la Partie 2 de l'essai de phase 3 OPERA-01 et pour l'essai de phase 3 OPERA-02 en association avec le ribociclib dans le traitement du cancer du sein.
Les principaux indicateurs financiers incluent $361.9 million de tr茅sorerie et 茅quivalents, et une perte nette de $43.8 million pour le T2 2025, contre $30.4 million au T2 2024. Les d茅penses de R&D ont augment茅 脿 $43.9 million, principalement en raison d'un paiement li茅 脿 un jalon de $10 million 脿 Aurigene et de l'intensification des activit茅s de d茅veloppement clinique.
La soci茅t茅 pr茅voit de pr茅senter des donn茅es matures de l'茅tude de phase 1b/2 脿 l'ESMO 2025, de lancer OPERA-02 au T3 2025 et de communiquer les donn茅es top-line d'OPERA-01 au second semestre 2026.
Olema Oncology (Nasdaq: OLMA) hat seine Finanzergebnisse f眉r Q2 2025 vorgelegt und wichtige operative Neuigkeiten bekanntgegeben. Das Unternehmen hat palazestrant 90 mg einmal t盲glich f眉r Teil 2 der Phase-3-Studie OPERA-01 sowie f眉r die Phase-3-Studie OPERA-02 in Kombination mit Ribociclib zur Behandlung von Brustkrebs ausgew盲hlt.
Zu den wichtigsten Finanzkennzahlen geh枚ren $361.9 million an Zahlungsmitteln und Zahlungsmittel盲quivalenten sowie ein Nettoverlust von $43.8 million im Q2 2025 gegen眉ber $30.4 million im Q2 2024. Die F&E-Aufwendungen stiegen auf $43.9 million, haupts盲chlich bedingt durch eine $10 million Meilensteinzahlung an Aurigene und verst盲rkte klinische Entwicklungsaktivit盲ten.
Das Unternehmen erwartet, reife Daten aus der Phase-1b/2-Studie auf dem ESMO 2025 zu pr盲sentieren, OPERA-02 im Q3 2025 zu starten und die Topline-Daten von OPERA-01 in der zweiten H盲lfte 2026 zu berichten.
- None.
- Increased net loss to $43.8 million in Q2 2025 from $30.4 million in Q2 2024
- R&D expenses significantly increased to $43.9 million from $29.1 million year-over-year
- Top-line data from OPERA-01 not expected until second half of 2026
Insights
Olema's palazestrant program advances with dose selection and promising combinability potential, while maintaining strong cash position through expected 2026 readouts.
Olema Oncology has made significant progress in its breast cancer therapeutic pipeline, selecting the 90 mg once-daily dose of palazestrant for its pivotal Phase 3 programs. This dose selection for both the OPERA-01 monotherapy trial and upcoming OPERA-02 combination trial with ribociclib represents a critical advancement in the company's clinical strategy for treating ER+/HER2- metastatic breast cancer.
The company's focus on palazestrant's combinability is particularly noteworthy. This compound demonstrates potential as a backbone endocrine therapy that can be combined with multiple agents, which could position it as best-in-class if successful. The upcoming presentation of mature combination data with ribociclib at ESMO 2025 will provide important insights into this strategy.
Olema is simultaneously advancing OP-3136, their KAT6 inhibitor, which is generating strong investigator interest. This dual-pronged approach targeting both the estrogen receptor pathway and KAT6 mechanism represents a sophisticated clinical development strategy addressing multiple aspects of breast cancer pathophysiology.
The timeline for OPERA-01's topline data in second half of 2026 and the planned initiation of OPERA-02 in Q3 2025 establishes a clear development pathway. While these are relatively distant milestones, they provide a structured development plan with multiple potential value-creating readouts over the next 12-18 months.
Olema's strong $361.9M cash position supports clinical advancement through key 2026 milestones despite increased R&D spending and net losses.
Olema Oncology maintains a robust financial position with
The company reported a quarterly net loss of
R&D expenses rose significantly to
G&A expenses decreased slightly to
With multiple clinical milestones expected through 2026, including top-line data from OPERA-01 in H2 2026, Olema's current cash position appears sufficient to fund operations through these critical value-inflection points, assuming the current burn rate. The increase in R&D spending is appropriate given the advancing clinical programs and reflects standard industry progression for a company with late-stage oncology assets.
- Selected 90 mg once-daily palazestrant for Part 2 of the OPERA-01 Phase 3 monotherapy trial and for the OPERA-02 Phase 3 trial in combination with ribociclib
- OPERA-01 enrollment ongoing with top-line data expected in the second half of 2026; OPERA-02 on track to initiate in Q3 2025
- Mature data from the Phase 1b/2 study of palazestrant in combination with ribociclib to be presented at ESMO 2025
- Ended the second quarter with
$361.9 million in cash, cash equivalents, and marketable securities
SAN FRANCISCO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- (鈥淥lema鈥� or 鈥淥lema Oncology鈥�, 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 second quarter ended June 30, 2025.
"Having achieved regulatory alignment on the selected dose for our pivotal palazestrant program during the second quarter, we are focused on accelerating enrollment in OPERA-01, which is on track for top-line data in the second half of 2026, and initiating the OPERA-02 combination trial in the frontline setting,鈥� said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. 鈥淧alazestrant鈥檚 demonstrated activity and combinability with multiple compounds offers the potential for it to become a best-in-class, backbone endocrine therapy for metastatic breast cancer. Our Phase 1 study of OP-3136, our potent and selective KAT6 inhibitor, is also generating strong investigator interest and patient enrollment, reinforcing our leadership in developing novel therapies for breast cancer and beyond.鈥�
Recent Progress
- Selected 90 mg of once-daily palazestrant for Part 2 of the ongoing registrational OPERA-01 Phase 3 trial in second- and third-line (2/3L) estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer, and for the OPERA-02 Phase 3 trial in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer.
- Continued enrollment in the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136, as a monotherapy and in combination with fulvestrant and palazestrant, in participants with advanced solid tumors.
Anticipated Upcoming Events
- Present mature data from the Phase 1b/2 study of palazestrant in combination with ribociclib in ER+/HER2- metastatic breast cancer at the European Society of Medical Oncology (ESMO) Congress 2025 in a presentation entitled 鈥淧alazestrant (OP-1250) plus ribociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) advanced breast cancer (ABC)鈥�
- Initiate the OPERA-02 trial of palazestrant in combination with ribociclib in frontline metastatic breast cancer in Q3 2025.
- Report initial clinical results for OP-3136 in 2026.
- Report top-line data from OPERA-01 in the second half of 2026.
Second Quarter 2025 Financial Results
Cash, cash equivalents, and marketable securities of
Net loss for the quarter ended June 30, 2025 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 (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 study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit听.
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 and is anticipated to be evaluated in combination with ribociclib in the planned pivotal Phase 3 clinical trial, OPERA-02. Learn more at . Palazestrant has also been evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, and everolimus.
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 鈥渇orward-looking statements鈥� 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 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃ould,鈥� 鈥渆xpect,鈥� 鈥済oal,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渙n track,鈥� 鈥減otential,鈥� 鈥渦pcoming,鈥� 鈥渨ill鈥� 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 the receipt and presentation of results of clinical trials of palazestrant and OP-3136 each as a monotherapy and in combination trials, the potential for palazestrant to become a best-in-class, backbone endocrine therapy for metastatic breast cancer, Olema鈥檚 leadership and ability to develop novel therapies for breast cancer and beyond, Olema鈥檚 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 or OP-3136, and the combinability of palazestrant or OP-3136 with other drugs. Because such statements deal with future events and are based on Olema鈥檚 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 鈥淩isk Factors鈥� in Olema鈥檚 Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, 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鈥橩onek
Vice President, Corporate Communications
Olema Oncology
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| Olema Pharmaceuticals, Inc. | |||||||
| Condensed Consolidated Balance Sheets Data | |||||||
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| 听 | 听 | June 30, | December听31,听 | ||||
| 听 | 听 | 听 | 2025 | 听 | 听 | 2024 | 听 |
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| Cash, cash equivalents and marketable securities | 听 | $ | 361,913.00 | 听 | $ | 434,086.00 | 听 |
| Total assets | 听 | 听 | 382,002 | 听 | 听 | 450,979 | 听 |
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| Total current liabilities | 听 | $ | 33,164.00 | 听 | $ | 41,758.00 | 听 |
| Total liabilities | 听 | $ | 36,766.00 | 听 | $ | 42,015.00 | 听 |
| Total stockholders鈥� equity | 听 | $ | 345,236.00 | 听 | $ | 408,964.00 | 听 |
| Total liabilities and stockholders鈥� equity | 听 | 听 | 382,002 | 听 | 听 | 450,979 | 听 |
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| 听 | Three Months Ended June 30, | 听 | Six Months Ended June 30, | ||||||||||
| 听 | 听 | 2025 | 听 | 听 | 2024 | 听 | 听 | 听 | 2025 | 听 | 听 | 2024 | 听 |
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| Operating expenses: | 听 | 听 | 听 | 听 | 听 | ||||||||
| Research and development (1) | $ | 43,902 | 听 | $ | 29,109 | 听 | 听 | $ | 74,526 | 听 | $ | 58,992 | 听 |
| General and administrative (2) | 听 | 3,962 | 听 | 听 | 4,421 | 听 | 听 | 听 | 8,211 | 听 | 听 | 8,877 | 听 |
| Total operating expenses | 听 | 47,864 | 听 | 听 | 33,530 | 听 | 听 | 听 | 82,737 | 听 | 听 | 67,869 | 听 |
| Loss from operations | 听 | (47,864 | ) | 听 | (33,530 | ) | 听 | 听 | (82,737 | ) | 听 | (67,869 | ) |
| Other income: | 听 | 听 | 听 | 听 | 听 | ||||||||
| Interest income | 听 | 4,042 | 听 | 听 | 3,108 | 听 | 听 | 听 | 8,566 | 听 | 听 | 6,460 | 听 |
| Other income (loss) | 听 | 38 | 听 | 听 | 40 | 听 | 听 | 听 | (2 | ) | 听 | 57 | 听 |
| Total other income | 听 | 4,080 | 听 | 听 | 3,148 | 听 | 听 | 听 | 8,564 | 听 | 听 | 6,517 | 听 |
| Net loss | $ | (43,784 | ) | $ | (30,382 | ) | 听 | $ | (74,173 | ) | $ | (61,352 | ) |
| Net loss per share, basic and diluted | $ | (0.51 | ) | $ | (0.54 | ) | 听 | $ | (0.87 | ) | $ | (1.10 | ) |
| Weighted average shares used to compute net loss per share, basic and diluted (3) | 听 | 85,497,426 | 听 | 听 | 56,282,402 | 听 | 听 | 听 | 85,462,021 | 听 | 听 | 55,928,363 | 听 |
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| (3) The weighted average shares used to compute net loss per share, basic and diluted include the effect from the pre-funded warrants. | |||||||||||||
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| 听 | 听 | 2025 | 听 | 听 | 2024 | 听 | 听 | 听 | 2025 | 听 | 听 | 2024 | 听 |
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| (1) Research and development reconciliation | 听 | 听 | 听 | 听 | 听 | ||||||||
| GAAP research and development | $ | 43,902 | 听 | $ | 29,109 | 听 | 听 | $ | 74,526 | 听 | $ | 58,992 | 听 |
| Less: stock-based compensation expense | 听 | 3,709 | 听 | 听 | 4,233 | 听 | 听 | 听 | 7,010 | 听 | 听 | 7,645 | 听 |
| Non-GAAP research and development | $ | 40,193 | 听 | $ | 24,876 | 听 | 听 | $ | 67,516 | 听 | $ | 51,347 | 听 |
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| (2) General and administrative reconciliation | 听 | 听 | 听 | 听 | 听 | ||||||||
| GAAP general and administrative | $ | 3,962 | 听 | $ | 4,421 | 听 | 听 | $ | 8,211 | 听 | $ | 8,877 | 听 |
| Less: stock-based compensation expense | 听 | 983 | 听 | 听 | 1,491 | 听 | 听 | 听 | 2,060 | 听 | 听 | 2,988 | 听 |
| Non-GAAP general and administrative | $ | 2,979 | 听 | $ | 2,930 | 听 | 听 | $ | 6,151 | 听 | $ | 5,889 | 听 |
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FAQ
What is the status of Olema Oncology's (OLMA) OPERA-01 Phase 3 trial?
How much cash does Olema Oncology (OLMA) have as of Q2 2025?
What caused Olema Oncology's (OLMA) increased net loss in Q2 2025?
When will Olema Oncology (OLMA) initiate the OPERA-02 trial?
What will Olema present at ESMO 2025?
