Olema Oncology Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Olema Oncology (OLMA) reported Q3 2024 financial results with a cash position of $214.8 million as of September 30, 2024. The company recorded a net loss of $34.6 million, up from $21.5 million in Q3 2023, primarily due to increased R&D expenses of $33.2 million. The company presented new preclinical data for OP-3136, their KAT6 inhibitor, and continues enrollment in the OPERA-01 Phase 3 trial of palazestrant. Olema plans to submit an IND application for OP-3136 before year-end and initiate Phase 1 trials in early 2025.
Olema Oncology (OLMA) ha riportato i risultati finanziari del terzo trimestre 2024, con una posizione di cassa di 214,8 milioni di dollari al 30 settembre 2024. L'azienda ha registrato una perdita netta di 34,6 milioni di dollari, in aumento rispetto ai 21,5 milioni di dollari del terzo trimestre 2023, principalmente a causa dell'aumento delle spese per ricerca e sviluppo che ammontano a 33,2 milioni di dollari. L'azienda ha presentato nuovi dati preclinici per OP-3136, l'inibitore di KAT6, e continua l'arruolamento nella sperimentazione clinica di fase 3, OPERA-01, per il palazestrant. Olema prevede di presentare una domanda IND per OP-3136 entro la fine dell'anno e iniziare le sperimentazioni di fase 1 all'inizio del 2025.
Olema Oncology (OLMA) reportó los resultados financieros del tercer trimestre de 2024, con una posición de efectivo de 214,8 millones de dólares hasta el 30 de septiembre de 2024. La compañía registró una pérdida neta de 34,6 millones de dólares, un aumento respecto a los 21,5 millones de dólares en el tercer trimestre de 2023, principalmente debido al aumento de los gastos en I+D que ascienden a 33,2 millones de dólares. La empresa presentó nuevos datos preclínicos para OP-3136, su inhibidor de KAT6, y continúa con la inscripción en el ensayo de fase 3 OPERA-01 para palazestrant. Olema planea presentar una solicitud IND para OP-3136 antes de fin de año e iniciar ensayos de fase 1 a principios de 2025.
올레마 온콜로지 (OLMA)는 2024년 3분기 재무 결과를 보고하였으며, 2024년 9월 30일 기준 현금 보유액은 2억 1천4백 80만 달러입니다. 회사는 2023년 3분기의 2천1백 50만 달러에서 증가한 3천4백 60만 달러의 순손실을 기록하였으며, 이는 주로 3천3백 20만 달러의 연구 개발 비용 증가 때문입니다. 올레마는 KAT6 억제제인 OP-3136에 대한 새로운 전임상 데이터를 발표하였고, palazestrant의 OPERA-01 3상 시험의 등록을 계속하고 있습니다. 올레마는 연말 이전에 OP-3136에 대한 IND 신청서를 제출하고 2025년 초에 1상 시험을 시작할 계획입니다.
Olema Oncology (OLMA) a publié les résultats financiers du troisième trimestre 2024, avec une position de trésorerie de 214,8 millions de dollars au 30 septembre 2024. L'entreprise a enregistré une perte nette de 34,6 millions de dollars, en augmentation par rapport à 21,5 millions de dollars au troisième trimestre 2023, principalement en raison d'une augmentation des dépenses de R&D de 33,2 millions de dollars. L'entreprise a présenté de nouvelles données précliniques pour OP-3136, leur inhibiteur de KAT6, et continue l'inscription dans l'essai de phase 3 OPERA-01 pour le palazestrant. Olema prévoit de soumettre une demande IND pour OP-3136 avant la fin de l'année et de commencer des essais de phase 1 au début de 2025.
Olema Oncology (OLMA) hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht, mit einer liquiden Position von 214,8 Millionen Dollar zum 30. September 2024. Das Unternehmen verzeichnete einen Nettoverlust von 34,6 Millionen Dollar, ein Anstieg von 21,5 Millionen Dollar im dritten Quartal 2023, hauptsächlich aufgrund höherer F&E-Ausgaben von 33,2 Millionen Dollar. Das Unternehmen präsentierte neue präklinische Daten für OP-3136, ihren KAT6-Inhibitor, und setzt die Rekrutierung in der OPERA-01-Phase-3-Studie für Palazestrant fort. Olema plant, noch vor Jahresende einen IND-Antrag für OP-3136 einzureichen und Anfang 2025 Phase-1-Studien zu starten.
- Strong cash position of $214.8 million
- Advancement of OPERA-01 Phase 3 clinical trial for palazestrant
- Successful completion of IND-enabling studies for OP-3136
- Increased net loss to $34.6 million from $21.5 million YoY
- Higher R&D expenses at $33.2 million vs $19.5 million YoY
- Increased G&A expenses to $4.4 million from $3.9 million YoY
Insights
The Q3 results show significant financial developments with
The increased spending is strategically aligned with advancing both palazestrant trials and the KAT6 inhibitor program. While G&A expenses remained relatively controlled with a modest increase to
The pipeline progress shows promising momentum with multiple value-driving catalysts ahead. The upcoming presentation of palazestrant-ribociclib combination data at SABCS and the planned IND submission for OP-3136 represent significant near-term milestones. The preclinical data demonstrating synergistic effects between palazestrant and both everolimus and capivasertib suggests potential for expanded therapeutic applications.
The advancement of OP-3136, showing robust anti-tumor activity both as monotherapy and in combination with palazestrant, strengthens the company's oncology portfolio. The OPERA-01 Phase 3 trial remains on track for 2026 readout, positioning the company for potential market entry in the competitive breast cancer space.
- Presented compelling new preclinical data demonstrating anti-tumor activity for OP-3136, a novel KAT6 inhibitor, with enhanced activity of palazestrant combinations at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024)
- New clinical data for palazestrant (OP-1250) in combination with ribociclib to be presented at the San Antonio Breast Cancer Symposium (SABCS) in December
- IND submission for OP-3136 expected before year end; clinical study to initiate early 2025
- Cash, cash equivalents, and marketable securities of
$214.8 million as of September 30, 2024
SAN FRANCISCO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema”, “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 results for the third quarter ended September 30, 2024, and provided a corporate update.
“We look forward to presenting updated data from our ongoing Phase 2 clinical study of palazestrant in combination with ribociclib in frontline metastatic breast cancer patients at SABCS in December. The OPERA-01 Phase 3 clinical trial of palazestrant as a monotherapy in second/third-line patients continues to advance and we remain on track for top-line readout in 2026,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “At ENA 2024, we presented three new, robust preclinical data sets. Palazestrant demonstrated combinability and enhanced tumor suppression with both everolimus and capivasertib. OP-3136, our potent and selective KAT6 inhibitor, demonstrated robust anti-tumor activity as a single agent, as well as synergy and enhanced anti-tumor activity in combination with palazestrant. These data reinforce our belief in the potential of OP-3136 as an exciting new therapy for breast and other cancers, and we remain on track to submit the IND application before year end.”
Recent Progress
- Continued enrollment of patients in OPERA-01, the pivotal Phase 3 clinical trial of palazestrant as a monotherapy in second/third-line ER+/HER2- metastatic breast cancer.
- Presented preclinical data for OP-3136 and palazestrant at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) in Barcelona, Spain.
- Initiated Phase 1b/2 clinical study of palazestrant in combination with everolimus.
- Successfully completed Investigational New Drug (IND)-enabling studies for OP-3136.
Anticipated Upcoming Milestones
- Present updated Phase 2 data showing palazestrant in combination with ribociclib at the San Antonio Breast Cancer Symposium (SABCS) in December 2024.
- Submit the IND application for OP-3136 to the U.S. Food and Drug Administration (FDA) before year-end; initiate the Phase 1 clinical study for OP-3136 in early 2025.
Third Quarter 2024 Financial Results
Cash, cash equivalents, and marketable securities as of September 30, 2024, were
Net loss for the quarter ended September 30, 2024, 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 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, CNS penetration, and combinability with 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 both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). For more information on OPERA-01, please visit www.opera01study.com.
About OP-3136
OP-3136 is a novel, orally available small molecule that potently and selectively inhibits 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 CDK4/6 inhibitors. Olema has successfully completed IND-enabling studies in support of a potential Investigational New Drug (IND) application with the FDA and expects to initiate Phase 1 clinical trials for OP-3136 in early 2025.
About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for women living with cancer. 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 a potent KAT6 inhibitor (OP-3136). Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com.
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,” “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 (OP-1250) and OP-3136, each as a monotherapy and in combination trials, Olema’s financial condition and resources, results of operations, cash position, potential beneficial characteristics including but not limited to safety, tolerability, activity, efficacy and therapeutic effects of palazestrant, the potential of palazestrant to advance the standard of care for women living with cancer, combinability with other drugs, palazestrant, or OP-3136, and the sufficiency and timing of Olema’s preclinical program, including the potential beneficial characteristics of its KAT6 inhibitor compounds and the timing of a potential IND application and advancement into clinical development for OP-3136. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.
| Olema Pharmaceuticals, Inc. | ||||||
| Condensed Consolidated Balance Sheets Data | ||||||
| (in thousands) | ||||||
| September 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Cash, cash equivalents and marketable securities | $ | 214,763 | $ | 261,807 | ||
| Total assets | 230,173 | 276,945 | ||||
| Total current liabilities | 30,700 | 21,621 | ||||
| Total liabilities | 31,262 | 23,050 | ||||
| Total stockholders’ equity | 198,911 | 253,895 | ||||
| Total liabilities and stockholders’ equity | $ | 230,173 | $ | 276,945 | ||
| Olema Pharmaceuticals, Inc. | ||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||
| Three Months Ended September 30, | Nine Months Ended June 30, | |||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||
| Operating expenses: | ||||||||||||||
| Research and development (1) | $ | 33,226 | $ | 19,453 | $ | 92,218 | $ | 60,268 | ||||||
| General and administrative (2) | 4,395 | 3,889 | 13,272 | 14,277 | ||||||||||
| Total operating expenses | 37,621 | 23,342 | 105,490 | 74,545 | ||||||||||
| Loss from operations | (37,621 | ) | (23,342 | ) | (105,490 | ) | (74,545 | ) | ||||||
| Other income: | ||||||||||||||
| Interest income | 2,928 | 1,919 | 9,388 | 4,774 | ||||||||||
| Other income (expense) | 138 | (79 | ) | 195 | (112 | ) | ||||||||
| Total other income | 3,066 | 1,840 | 9,583 | 4,662 | ||||||||||
| Net loss | $ | (34,555 | ) | $ | (21,502 | ) | $ | (95,907 | ) | $ | (69,883 | ) | ||
| Net loss per share, basic and diluted | $ | (0.60 | ) | $ | (0.48 | ) | $ | (1.80 | ) | $ | (1.66 | ) | ||
| Weighted average shares used to compute net loss per share, basic and diluted | 57,262,803 | 44,977,161 | 53,194,081 | 41,999,978 | ||||||||||
| Reconciliation of GAAP to Non-GAAP Information | ||||||||||||||
| (In thousands) | ||||||||||||||
| Three Months Ended September 30, | Nine Months Ended June 30, | |||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||
| (1) Research and development reconciliation | ||||||||||||||
| GAAP research and development (3) | $ | 33,226 | $ | 19,453 | $ | 92,218 | $ | 60,268 | ||||||
| Less: share-based compensation expense | 4,280 | 2,801 | 11,925 | 8,858 | ||||||||||
| Non-GAAP research and development | $ | 28,946 | $ | 16,652 | $ | 80,293 | $ | 51,410 | ||||||
| (2) General and administrative reconciliation | ||||||||||||||
| GAAP general and administrative | $ | 4,395 | $ | 3,889 | $ | 13,272 | $ | 14,277 | ||||||
| Less: share-based compensation expense | 1,346 | 1,304 | 4,334 | 4,047 | ||||||||||
| Non-GAAP general and administrative | $ | 3,049 | $ | 2,585 | $ | 8,938 | $ | 10,230 | ||||||
| (3) Research and development expenses for the nine-months ended September 30, 2024 include a | ||||||||||||||
IR and Media Contact
Courtney O’Konek, Vice President, Corporate Communications
media@olema.com
FAQ
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