Olema Oncology Q2 2024 Financial Results and Corporate Update

Olema Pharmaceuticals, Inc. (Olema Oncology) has recently shared its financial results for the second quarter ending June 30, 2024, along with significant corporate updates. This clinical-stage biopharmaceutical company, dedicated to the development of targeted therapies for women's cancers, highlighted several key achievements and future milestones.

In May 2024, Olema presented promising interim clinical results from its study of palazestrant (OP-1250) in combination with ribociclib at the European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress in Berlin, Germany. The Phase 1b/2 trial demonstrated that the combination was well tolerated, with no new safety concerns or increased toxicity. Additionally, the study observed a clinical benefit rate (CBR) of 85% across 13 eligible patients. Further updates on this combination are anticipated to be presented at a future medical meeting.

Olema also showcased a trial-in-progress poster for its OPERA-01 Phase 3 monotherapy clinical trial, targeting second and third-line ER+/HER2- advanced or metastatic breast cancer, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

Another notable accomplishment for Olema during this period was the successful completion of investigational new drug (IND)-enabling studies for OP-3136, a novel KAT6 inhibitor. The company plans to file an IND application with the U.S. Food and Drug Administration (FDA) by late 2024 and is scheduled to present additional pre-clinical data in the fourth quarter of the year.

For the second quarter of 2024, Olema reported cash, cash equivalents, and marketable securities totaling $239.1 million. The company's net loss for the quarter was reported at $30.4 million, an increase from the $20.1 million net loss for the same period in 2023. This increase in net loss is attributed to heightened expenditure on clinical development for palazestrant and advancements in the KAT6 inhibitor program, as well as general administrative activities. Partially offsetting these costs was a rise in interest income from marketable securities.

Research and development (R&D) expenses for Olema were $29.1 million in the second quarter of 2024, up from $18.0 million in the same quarter of the previous year. This increase was driven by escalated spending on late-stage clinical trials for palazestrant and research activities for the KAT6 inhibitor program, as well as personnel-related costs. Non-GAAP R&D expenses, which exclude stock-based compensation, were $24.9 million compared to $15.0 million in the second quarter of 2023.

General and administrative (G&A) expenses for the quarter were $4.4 million, an increase from $3.6 million in the previous year, reflecting higher corporate costs and stock-based compensation. Excluding stock-based compensation, non-GAAP G&A expenses were $2.9 million, up from $2.4 million in 2023.

Looking ahead, Olema plans to initiate a Phase 1b/2 clinical study of palazestrant in combination with the mTOR inhibitor everolimus in the third quarter of 2024. The company also expects to present pre-clinical data supporting the IND application for OP-3136 and file the application with the FDA by the end of the year. Additionally, updated Phase 2 clinical study results for the palazestrant-ribociclib combination are anticipated at a future medical meeting.

Palazestrant (OP-1250), Olema's lead candidate, is an orally-available small molecule that functions as both a complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD). It is currently being investigated for recurrent, locally advanced, or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has shown anti-tumor efficacy, favorable pharmacokinetics, tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. The FDA has granted it Fast Track designation for treating ER+/HER2- metastatic breast cancer that has progressed following endocrine therapy.

Olema Oncology's commitment to improving cancer treatment for women is exemplified through its continuous efforts in advancing a pipeline of novel therapies targeting endocrine-driven cancers and mechanisms of acquired resistance. The company is headquartered in San Francisco and operates from Cambridge, Massachusetts.