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Olema Pharmaceuticals(OLMA) - 2024 Q4 - Annual Report

Financial Performance - Olema reported net losses of 129.5millionand129.5 million and 96.7 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of 435.1millionasofDecember31,2024[604].ThenetlossfortheyearendedDecember31,2024,was435.1 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 96.7millionin2023,representinganincreaseof96.7 million in 2023, representing an increase of 32.8 million[621]. - The company reported total comprehensive loss for 2024 was 129,678,000,comparedto129,678,000, compared to 94,495,000 in 2023, indicating a 37.2% increase in comprehensive losses[681]. - The company reported a net loss of 129.5millionfor2024,with129.5 million for 2024, with 124.5 million attributed to research and development expenses and 17.7milliontogeneralandadministrativeexpenses[647].ThenetcashusedinoperatingactivitiesfortheyearendedDecember31,2024,was17.7 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 83.7millionin2023,reflectinganincreaseofapproximately2583.7 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 38.4millionfrom38.4 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 434.1millionincash,cashequivalents,andmarketablesecurities,withanaccumulateddeficitof434.1 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of 435.1 million[627]. - Cash, cash equivalents, and marketable securities totaled 434.1millionasofDecember31,2024,upfrom434.1 million as of December 31, 2024, up from 261.8 million in 2023, representing a 66% increase[658]. - The company raised approximately 130.0millionfromaprivateplacementofcommonstockinSeptember2023,withnetproceedsofapproximately130.0 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 142.3million,upfrom142.3 million, up from 105.0 million in 2023, reflecting an increase of 37.3million[621].Generalandadministrativeexpensesdecreasedto37.3 million[621]. - General and administrative expenses decreased to 17.7 million in 2024 from 18.8millionin2023,areductionof18.8 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 1.508millionasofDecember31,2024,withleaseliabilitiesatpresentvalueamountingto1.508 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 1.532millionfortheyearendedDecember31,2024,comparedto1.532 million for the year ended December 31, 2024, compared to 1.601 million in 2023, reflecting a decrease of approximately 4.3%[778].