Olema Oncology Announces Q1 2024 Financial Results and Corporate Update

Olema Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company committed to advancing targeted therapies for women's cancers, has released its financial results for the first quarter ending March 31, 2024. The company has also provided significant corporate updates.

"Our mission at Olema is uniquely focused on advancing the standard of care for women living with cancer," noted Sean P. Bohen, M.D., Ph.D., President and CEO of Olema Oncology. He highlighted the company's progress with palazestrant, an oral complete ER antagonist, and OP-3136, a novel KAT6 inhibitor. Bohen expressed optimism about the potential of palazestrant to emerge as a preferred endocrine therapy for advanced or metastatic breast cancer. The company plans to present new clinical data on palazestrant in combination with ribociclib at the ESMO Breast Cancer Annual Congress 2024.

During the first quarter of 2024, Olema completed enrollment for 60-patient Phase 1b/2 studies of palazestrant in combination with ribociclib and palbociclib. They also named OP-3136 as a development candidate, demonstrating significant anti-tumor activity in preclinical ER+ breast cancer models, both alone and in combination with other treatments. Additionally, data on the design, discovery, and optimization of palazestrant was published in Molecular Cancer Therapeutics.

Looking ahead, Olema plans to present interim Phase 1b/2 clinical results of palazestrant combined with ribociclib at the ESMO Breast Cancer Annual Congress in May 2024. They will also present a trial-in-progress poster on OPERA-01, a Phase 3 monotherapy clinical trial for ER+/HER2- advanced or metastatic breast cancer, at the ASCO Annual Meeting in June 2024. The company is set to initiate a Phase 1b/2 study of palazestrant in combination with everolimus in the third quarter of 2024. An IND application for OP-3136 is expected to be filed with the FDA by late 2024.

Financially, Olema reported cash, cash equivalents, and marketable securities totaling $249.0 million as of March 31, 2024. The net loss for the quarter was $31.0 million, up from $28.3 million for the same period in 2023. The increase in net loss is primarily attributed to higher research and clinical development expenses due to late-stage trials for palazestrant and the advancement of the KAT6 inhibitor program. However, this was partly offset by reduced spending on general administration and increased interest income from marketable securities.

GAAP research and development (R&D) expenses were $29.9 million for the quarter, compared to $22.8 million in the previous year, driven by a $5.0 million milestone payment related to the Aurigene Agreement and increased clinical development activities. Non-GAAP R&D expenses, which exclude non-cash stock-based compensation, were $26.5 million, up from $19.7 million the previous year.

General and administrative (G&A) expenses under GAAP were $4.5 million, down from $6.8 million a year earlier. The reduction was mainly due to decreased corporate and legal costs and lower personnel expenses, including a one-time restructuring charge from the first quarter of 2023. Non-GAAP G&A expenses, excluding non-cash stock-based compensation, were $3.0 million, compared to $5.2 million in the previous year.

Olema also announced a webcast and conference call for analysts and investors to review the data presented at the ESMO Breast Cancer Annual Congress 2024 on May 15, 2024, at 8:00 a.m. ET.

Palazestrant (OP-1250) is a novel, orally-available small molecule functioning as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is under investigation for treating recurrent, locally advanced, or metastatic ER-positive, HER2-negative breast cancer. Palazestrant has shown efficacy in clinical studies, blocking ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer. It is being evaluated as a single agent in an ongoing Phase 3 clinical trial (OPERA-01) and in combination studies with CDK4/6 inhibitors, a PI3Ka inhibitor, and an mTOR inhibitor.

Olema Oncology is headquartered in San Francisco with operations in Cambridge, Massachusetts. The company is focused on leveraging its expertise in endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance to develop novel therapies.