Olema Pharmaceuticals(OLMA)

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Olema Pharmaceuticals(OLMA) - 2025 Q1 - Quarterly Report
2025-05-13 20:15
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].
Olema Pharmaceuticals(OLMA) - 2025 Q1 - Quarterly Results
2025-05-13 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 13, 2025 Olema Pharmaceuticals, Inc. (Exact name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation) 780 Brannan Street San Francisco, California 94103 (Address of Principal Executive Offices) (Zip Code) Registrant's Telephone Number, Including Area Cod ...
Olema Oncology Reports First Quarter 2025 Financial and Operating Results
GlobeNewswire News Room· 2025-05-13 20:01
Pivotal Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in frontline metastatic breast cancer on track for initiation in 2025, supported by promising updated efficacy data from ongoing Phase 1b/2 studyPivotal Phase 3 OPERA-01 trial of palazestrant monotherapy in 2/3L metastatic breast cancer continues to advance with top-line data anticipated in 2026; trial-in-progress poster to be highlighted at ASCO Annual MeetingPreclinical data for OP-3136 presented at AACR demonstrating anti-tumor ...
Olema Oncology Announces New Preclinical Data for OP-3136 Demonstrating Anti-Tumor Activity in Multiple Solid Tumor Models at AACR 2025
Newsfilter· 2025-04-25 17:00
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 ...
Wall Street Analysts Think Olema Pharmaceuticals (OLMA) Could Surge 433.13%: Read This Before Placing a Bet
ZACKS· 2025-04-24 14:55
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]
After Plunging -30.16% in 4 Weeks, Here's Why the Trend Might Reverse for Olema Pharmaceuticals (OLMA)
ZACKS· 2025-04-10 14:35
A downtrend has been apparent in Olema Pharmaceuticals, Inc. (OLMA) lately with too much selling pressure. The stock has declined 30.2% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround.Here is How to Spot Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical ind ...
Olema Pharmaceuticals: Maybe Not Differentiated, But Could Find A Niche In A Valuable Market
Seeking Alpha· 2025-04-08 20:25
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]
Olema Oncology to Present Preclinical Data for OP-3136, a Potent KAT6 Inhibitor, Demonstrating Anti-Tumor Activity in Multiple Solid Tumor Models at the 2025 AACR Annual Meeting
GlobeNewswire· 2025-03-25 20:31
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]
Olema Pharmaceuticals(OLMA) - 2024 Q4 - Annual Report
2025-03-18 20:15
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].
Olema Pharmaceuticals(OLMA) - 2024 Q4 - Annual Results
2025-03-18 20:10
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]