Olema Pharmaceuticals, Inc. reported a net loss of $129.4 million for the year ended December 31, 2024, compared to a net loss of $96.7 million in 2023. Research and development expenses increased significantly to $124.5 million in 2024 from $86.1 million in 2023, primarily due to increased spending on clinical trials for palazestrant and research on OP-3136, as well as higher personnel costs. General and administrative expenses decreased slightly to $17.7 million in 2024 from $18.8 million in 2023. Other income increased to $12.8 million in 2024 from $8.3 million in 2023, mainly due to higher interest income on marketable securities.
The company's lead product candidate, palazestrant, is in late-stage clinical development as both a monotherapy and in combination with other targeted agents. In November 2023, Olema initiated OPERA-01, a pivotal Phase 3 trial of palazestrant as a monotherapy, anticipating top-line results in 2026. A Phase 1b/2 trial of palazestrant combined with ribociclib showed a median progression-free survival that was not reached as of November 22, 2024, with a 6-month progression-free survival rate of 73%. Updated results from this trial, presented at the San Antonio Breast Cancer Symposium in December 2024, supported the initiation of OPERA-02, a Phase 3 trial of palazestrant in combination with ribociclib, expected to begin in 2025. This trial will be supported by a clinical trial collaboration and supply agreement with Novartis Pharma AG, which will provide ribociclib.
Olema's second product candidate, OP-3136, a KAT6 inhibitor, entered Phase 1 clinical trials in late 2024 after receiving Investigational New Drug application clearance from the FDA. Pre-clinical data presented at the EORTC-NCI-AACR Symposium in October 2024 demonstrated OP-3136's anti-tumor activity as a single agent and in combination with palazestrant. As of January 31, 2025, Olema employed 96 full-time employees, including 28 with Ph.D. or M.D. degrees. The company has no products currently approved for commercial sale and has not generated revenue from product sales.
The company's cash, cash equivalents, and marketable securities totaled $434.1 million as of December 31, 2024. Olema also has a credit facility with First-Citizens Bank & Trust Company for up to $100 million, with $25 million available as of December 31, 2024. The company anticipates needing substantial additional funding to complete the development and commercialization of its product candidates. The company's financial statements were prepared on a going concern basis, although the company acknowledges that its incurred losses and negative cash flows from operations raise substantial doubt about its ability to continue as a going concern over the long term. The company's future success depends on the successful development, regulatory approval, and commercialization of its product candidates.
About Olema Pharmaceuticals, Inc.
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