Financial Performance - Olema reported net losses of $129.5 million and $96.7 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $435.1 million as of December 31, 2024[604]. - The net loss for the year ended December 31, 2024, was $129.5 million, compared to a net loss of $96.7 million in 2023, representing an increase of $32.8 million[621]. - The company reported total comprehensive loss for 2024 was $129,678,000, compared to $94,495,000 in 2023, indicating a 37.2% increase in comprehensive losses[681]. - The company reported a net loss of $129.5 million for 2024, with $124.5 million attributed to research and development expenses and $17.7 million to general and administrative expenses[647]. - The net cash used in operating activities for the year ended December 31, 2024, was $104.4 million, compared to $83.7 million in 2023, reflecting an increase of approximately 25%[646]. Research and Development - The lead product candidate, palazestrant, has shown strong anti-tumor activity in clinical studies involving over 400 patients, with favorable pharmacokinetics and tolerability[596]. - Olema initiated the pivotal Phase 3 clinical trial OPERA-01 for palazestrant in November 2023, with top-line results anticipated in 2026[597]. - The Phase 1 clinical trial for the second product candidate, OP-3136, has been cleared by the U.S. FDA and is currently enrolling patients[601]. - Research and development expenses are expected to increase substantially as the company advances its clinical product pipeline[615]. - Research and development expenses for the year ended December 31, 2024, were $124.5 million, an increase of $38.4 million from $86.1 million in 2023, primarily due to increased spending on clinical operations and personnel-related costs[623][624]. Financial Position - As of December 31, 2024, the company had $434.1 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $435.1 million[627]. - Cash, cash equivalents, and marketable securities totaled $434.1 million as of December 31, 2024, up from $261.8 million in 2023, representing a 66% increase[658]. - The company raised approximately $130.0 million from a private placement of common stock in September 2023, with net proceeds of approximately $129.7 million after expenses[628]. - The company expects to finance its cash needs through equity offerings, debt financings, collaborations, and licensing arrangements until substantial product revenues are generated[644]. - The company anticipates that its product candidates will not be commercially available for several years, necessitating continued reliance on additional financing[643]. Operating Expenses - Total operating expenses for 2024 were $142.3 million, up from $105.0 million in 2023, reflecting an increase of $37.3 million[621]. - General and administrative expenses decreased to $17.7 million in 2024 from $18.8 million in 2023, a reduction of $1.1 million attributed to decreased corporate-related costs[624]. - The company expects to incur significant and increasing losses as it continues to advance its product candidates and scale up external manufacturing capacity[605]. Capital Structure - The company issued pre-funded warrants classified as equity, recorded within additional paid-in capital[728]. - The total number of shares reserved for issuance under various stock plans increased from 12,336,755 in 2023 to 25,556,135 in 2024, indicating a strategic focus on employee incentives[746]. - The weighted average shares used to compute net loss per share increased to 58,743,522 in 2024 from 45,247,098 in 2023, a rise of 29.8%[680]. Risks and Challenges - The Company is subject to risks common to late-stage biopharmaceutical companies, including successful product development and regulatory approval[690]. - The Company continues to monitor the impact of geopolitical and macroeconomic factors on its operational and financial performance[697]. - The company may face dilution of existing stockholders' ownership interests if additional capital is raised through equity or convertible debt securities[644]. Lease and Facility Obligations - The Company has operating leases for research and development and office facilities, with fixed lease payments recognized over the expected lease term[712]. - The Company has a total future minimum lease payment of $1.508 million as of December 31, 2024, with lease liabilities at present value amounting to $1.429 million[778]. - The Company recorded total operating lease expenses of $1.532 million for the year ended December 31, 2024, compared to $1.601 million in 2023, reflecting a decrease of approximately 4.3%[778].

Financial Results - Olema Pharmaceuticals reported financial results for the year ended December 31, 2024[6] - The press release detailing the financial results was issued on March 18, 2025[9] Company Information - The company is listed on the Nasdaq Global Select Market under the symbol OLMA[5]

Core Insights - Olema Pharmaceuticals reported significant progress in 2024, including a new collaboration with Novartis, raising approximately $250 million, and advancing multiple clinical trials for its lead product, palazestrant [2][6]. Financial Performance - As of December 31, 2024, Olema had cash, cash equivalents, and marketable securities totaling $434.1 million, an increase from $261.8 million in 2023 [8][21]. - The net loss for Q4 2024 was $33.6 million, compared to $26.8 million in Q4 2023, while the total net loss for the year was $129.5 million, up from $96.7 million in 2023 [9][22]. - GAAP research and development (R&D) expenses for Q4 2024 were $32.3 million, compared to $25.9 million in Q4 2023, with total R&D expenses for the year at $124.5 million, up from $86.1 million in 2023 [10][22]. Clinical Development - The pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in patients with second- and third-line ER+/HER2- metastatic breast cancer is on track for top-line data in 2026 [5]. - The OPERA-02 trial, evaluating palazestrant in combination with ribociclib in frontline metastatic breast cancer, is set to initiate in 2025, enabled by the Novartis collaboration and the recent equity private placement [5][6]. - The Phase 1 trial for OP-3136 was initiated before the end of 2024, with patient enrollment currently ongoing [5][6]. Research and Development Highlights - Olema presented updated clinical results for palazestrant in combination with ribociclib at major conferences, demonstrating promising efficacy in ER+/HER2- advanced or metastatic breast cancer [6]. - New preclinical data showed anti-tumor activity for palazestrant in combination with other agents, further supporting its therapeutic potential [6][15]. Strategic Partnerships - The collaboration with Novartis includes a clinical trial agreement and supply agreement, enhancing Olema's capabilities in developing treatments for metastatic breast cancer [6][14].

Core Insights - Olema Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on targeted therapies for breast cancer and other conditions [1][3] - The company will present at the TD Cowen 45 Annual Health Care Conference on March 5, 2025 [1] - Olema's lead product candidate, palazestrant (OP-1250), is currently in a Phase 3 clinical trial called OPERA-01 [3] Company Overview - Olema Oncology is dedicated to transforming the standard of care for patients with breast cancer [3] - The company is advancing a pipeline of novel therapies by leveraging expertise in endocrine-driven cancers and mechanisms of acquired resistance [3] - Olema is headquartered in San Francisco, California, with operations in Cambridge, Massachusetts [3]

Core Insights - Olema Pharmaceuticals has appointed Shawnte M. Mitchell as Chief Legal Officer and Corporate Secretary, bringing extensive experience in the biotechnology industry [1][2] - The company is focused on advancing its late-stage palazestrant programs and OP-3136 KAT6 program through clinical development [2][3] - Olema is committed to transforming the standard of care for breast cancer patients with a pipeline of novel therapies [3] Company Overview - Olema Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of targeted therapies for breast cancer and other conditions [1][3] - The lead product candidate, palazestrant (OP-1250), is currently in a Phase 3 clinical trial called OPERA-01, and the company is also developing a potent KAT6 inhibitor (OP-3136) [3] Leadership Background - Shawnte M. Mitchell has 20 years of experience in the healthcare and life sciences sectors, previously serving as Chief Legal Officer at Genomatica and holding senior legal positions at Zogenix and Aptevo Therapeutics [2] - Ms. Mitchell's expertise includes regulatory, commercial, intellectual property, and business development matters, which will support Olema's strategic priorities [2]

SAN FRANCISCO, Nov. 25, 2024 (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 announced that it will present new data from the Phase 1b/2 clinical study of palazestrant (OP-1250) in combination with CDK4/6 inhibitor ribociclib at the San Antonio Breast Cancer Symposium (SABCS 2024) being held December 10- ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-39712 OLEMA PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) De ...

Financial Reporting and Disclosure - Olema Pharmaceuticals reported financial results for the quarter ended September 30, 2024 [5] - The press release detailing the financial results was dated November 12, 2024 [4] - The financial results are included in Exhibit 99.1, which is incorporated by reference [5] - The information in Item 2.02, including the press release, is not deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 [6] Executive Signatory - The report was signed by Shane Kovacs, Chief Operating and Financial Officer, on November 12, 2024 [8]

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 DecemberIND submission for OP-3136 expected before year end; clinical study to initiate early 2025Cash, cash equivale ...

SAN FRANCISCO, Nov. 06, 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 announced that its management team will participate in the following upcoming investor conferences: Jefferies London Healthcare ConferenceDate: Wednesday, November 20, 2024, at 1:30 p.m. GMT (8:30 a.m. ET)Location: London, UKForma ...