Financial Performance - Olema reported net losses of $30.4 million for Q1 2025, compared to $31.0 million for Q1 2024, with an accumulated deficit of $465.5 million as of March 31, 2025[135]. - The net loss for Q1 2025 was $30.4 million, compared to a net loss of $31.0 million in Q1 2024, reflecting an improvement of $0.6 million[158]. - General and administrative expenses for Q1 2025 were $4.2 million, a decrease of $0.2 million from $4.5 million in Q1 2024, mainly due to a reduction in non-cash stock-based compensation[156]. - Research and development expenses for Q1 2025 were $30.6 million, an increase of $0.7 million from $29.9 million in Q1 2024, primarily due to increased spending on clinical operations and personnel-related costs[155]. - The company has not generated any revenue from product sales since inception and expects to incur significant operating losses for the foreseeable future[165]. - The company has not generated any revenue from product sales to date and does not expect meaningful revenue until regulatory approval and commercialization of product candidates occur[168]. Research and Development - The ongoing Phase 3 clinical trial of palazestrant (OP-1250) is expected to yield top-line results in 2026[128]. - The median progression-free survival (mPFS) for patients treated with palazestrant and ribociclib was reported at 13.8 months, with 40 out of 56 patients having prior treatment with a CDK4/6 inhibitor[131]. - Olema's second product candidate, OP-3136, has entered Phase 1 clinical trials after receiving IND clearance from the FDA in late 2024[132]. - Olema plans to continue its research and development efforts for palazestrant and OP-3136, as well as seek regulatory approvals for successful candidates[139]. - The company anticipates increased research and development and general administrative costs as it conducts additional studies and trials for its product candidates[165]. Funding and Capital Requirements - The company expects to require substantial additional funding to support ongoing operations and product development[138]. - The company entered into a loan agreement increasing the credit facility from $50.0 million to $100.0 million, with $25.0 million currently available[160]. - The company raised approximately $250.0 million through a private placement of common stock in November 2024, netting approximately $237.0 million after expenses[161]. - Future capital requirements will depend on various factors, including the pace of development efforts and the ability to establish collaborations on favorable terms[174]. - The company may need to rely on additional financing through equity offerings, debt financings, collaborations, and licensing arrangements[172]. Cash Flow and Liquidity - As of March 31, 2025, the company had $392.7 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $465.5 million[159]. - As of March 31, 2025, the company expects its cash, cash equivalents, and marketable securities will fund its operating plan for at least the next 12 months[169]. - Net cash used in operating activities for the three months ended March 31, 2025, was $43.979 million, compared to $23.496 million for the same period in 2024[175]. - Net cash used in investing activities for the three months ended March 31, 2025, was $45.083 million, primarily due to purchases of marketable securities[178]. - Net cash provided by financing activities for the three months ended March 31, 2025, was $0.222 million, mainly from the exercise of stock options[179]. Operational Outlook - The company anticipates significant and increasing operating losses as it advances its product candidates and operates as a public entity[137]. - Olema relies on third parties for manufacturing and does not plan to establish its own manufacturing facilities[134]. - The company anticipates significant commercialization expenses if marketing approval for product candidates is obtained[171]. - The company has no outstanding debt as of March 31, 2025, and currently has no financing commitments expected to affect liquidity over the next five years[167]. - There were no material changes to critical accounting policies and market risk disclosures during the three months ended March 31, 2025[181][182].

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Olema Pharmaceuticals, Inc. announced Q1 2025 financial results via a press release (Exhibit 99.1), furnished but not 'filed' - The company reported its financial results for the quarter ended March 31, 2025[6](index=6&type=chunk) - The press release (Exhibit 99.1) containing the financial results is furnished and not deemed 'filed' for liability purposes under the Securities Exchange Act of 1934[6](index=6&type=chunk)[7](index=7&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists exhibits filed with the Form 8-K, primarily Exhibit 99.1, the press release of financial results Exhibits Filed | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release, dated May 13, 2025, of Olema Pharmaceuticals, Inc. | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

Core Insights - Olema Pharmaceuticals reported financial and operational results for Q1 2025, highlighting progress in its clinical pipeline and financial position [1][2]. Recent Progress - The pivotal Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib for frontline metastatic breast cancer is on track for initiation in 2025, supported by updated efficacy data from the ongoing Phase 1b/2 study [6]. - The OPERA-01 trial of palazestrant monotherapy in 2/3L metastatic breast cancer continues to advance, with top-line data expected in 2026 [6]. - New preclinical data for OP-3136, a KAT6 inhibitor, was presented at AACR, showing anti-tumor activity in various solid tumor models, with ongoing Phase 1 trial recruitment [6][7]. Financial Results - As of March 31, 2025, Olema had $392.7 million in cash, cash equivalents, and marketable securities [5]. - The net loss for Q1 2025 was $30.4 million, a slight decrease from $31.0 million in Q1 2024, attributed to higher interest income offset by increased clinical development spending [8]. - GAAP R&D expenses were $30.6 million for Q1 2025, up from $29.9 million in Q1 2024, primarily due to increased clinical operations and development activities [9]. - Non-GAAP R&D expenses were $27.3 million for Q1 2025, compared to $26.5 million in Q1 2024 [10]. Anticipated Upcoming Events - The company plans to present a trial-in-progress poster for OPERA-01 at the ASCO Annual Meeting in June and report top-line data in 2026 [7]. - The initiation of the OPERA-02 trial is expected in 2025 [7].

Activity in preclinical models of ovarian, prostate, and non-small cell lung cancer supports potential utility of OP-3136, a KAT6 inhibitor, in indications beyond breast cancerPatient recruitment ongoing in Phase 1 trial of OP-3136 as a monotherapy and in combination regimens in multiple solid tumor typesData to be presented at 2025 AACR Annual Meeting SAN FRANCISCO, April 25, 2025 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (("Olema" or "Olema Oncology", NASDAQ:OLMA), a clinical-stage biopharmaceutical ...

Core Viewpoint - Olema Pharmaceuticals, Inc. (OLMA) has shown a significant price increase of 21% over the past four weeks, with a mean price target of $26.71 indicating a potential upside of 433.1% from the current price of $5.01 [1] Price Targets and Analyst Consensus - The average price target consists of seven estimates ranging from a low of $20 to a high of $30, with a standard deviation of $3.45, suggesting a high degree of agreement among analysts [2] - The lowest estimate indicates a potential increase of 299.2%, while the most optimistic estimate suggests a 498.8% upside [2] - A low standard deviation indicates that analysts have a high degree of consensus regarding the stock's price movement direction and magnitude [9] Earnings Estimates and Analyst Optimism - Analysts are optimistic about OLMA's earnings prospects, as indicated by a strong agreement in revising EPS estimates higher, which correlates with near-term stock price movements [11] - The Zacks Consensus Estimate for the current year has increased by 5.5% over the past month, with two estimates going higher and no negative revisions [12] - OLMA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating strong potential for upside [13]

Group 1 - Olema Pharmaceuticals, Inc. (OLMA) has experienced a significant downtrend, with a stock decline of 30.2% over the past four weeks, but it is now in oversold territory, indicating a potential for a turnaround [1] - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2] - The current RSI for OLMA is 27.57, suggesting that the heavy selling pressure may be exhausting itself, which could lead to a reversal in the stock's trend [5] Group 2 - There is strong consensus among sell-side analysts regarding OLMA's ability to report better earnings than previously predicted, with a 12.2% increase in the consensus EPS estimate over the last 30 days [7] - OLMA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for price appreciation [8]

Group 1 - Olema Pharmaceuticals, Inc. is focused on developing treatment options for breast cancer, particularly the most common molecular subtype [1] - The company is currently in late-stage clinical trials, indicating significant progress in its drug development pipeline [1] Group 2 - The article emphasizes the importance of understanding the science behind biotech investments to avoid potential pitfalls [1]

Core Insights - Olema Pharmaceuticals is set to present preclinical data on OP-3136, a selective KAT6 inhibitor, at the AACR Annual Meeting, showcasing its anti-tumor activity in various cancer models [1][2] Group 1: OP-3136 Details - OP-3136 is a novel, orally available small molecule that selectively inhibits lysine acetyltransferase 6 (KAT6), which is an epigenetic target involved in breast and other cancers [3] - Preclinical studies indicate that OP-3136 exhibits significant anti-proliferative activity in ER+ breast cancer models and shows synergistic effects with endocrine therapies such as palazestrant and CDK4/6 inhibitors [3] - The FDA cleared the Investigational New Drug (IND) application for OP-3136 in December 2024, and the Phase 1 clinical trial is currently enrolling patients [3] Group 2: Company Overview - Olema Oncology is a clinical-stage biopharmaceutical company focused on improving treatment standards and outcomes for patients with breast cancer and other related conditions [4] - The company is advancing a pipeline of novel therapies, including its lead product candidate, palazestrant (OP-1250), which is currently in a Phase 3 clinical trial [4] - Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts [4]

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]