On May 8, 2024 Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, Olema Oncology, MAY 8, 2024, View Source [SID1234642887]).

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"Our mission at Olema is uniquely focused on advancing the standard of care for women living with cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We are excited for the achievements we are making both with palazestrant, our oral complete ER antagonist program, and now with our KAT6 inhibitor program, OP-3136. We believe palazestrant has the potential to become the backbone endocrine therapy-of-choice for advanced or metastatic breast cancer, and we look forward to presenting new clinical data in combination with ribociclib at the 2024 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress later this month."

First Quarter 2024 Highlights

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Completed enrollment of 60-patient Phase 1b/2 studies of palazestrant (OP-1250) in combination with each of ribociclib and palbociclib.
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Nominated OP-3136, an orally bioavailable KAT6 inhibitor, as a development candidate. OP-3136 demonstrated potent anti-tumor activity alone and in combination with both palazestrant and CDK4/6 inhibitors in preclinical ER+ breast cancer models.
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Announced publication of data in Molecular Cancer Therapeutics describing the design, discovery and optimization of palazestrant.

Upcoming Milestones

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Present interim Phase 1b/2 clinical results of palazestrant in combination with ribociclib at ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress 2024, May 15-17, 2024, in Berlin, Germany.
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Present trial-in-progress poster on OPERA-01, a pivotal Phase 3 monotherapy clinical trial in the second- and third-line setting of ER+/HER2- advanced or metastatic breast cancer, at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, May 31-June 4, 2024, in Chicago, IL.
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Initiate Phase 1b/2 clinical study of palazestrant in combination with mTOR inhibitor, everolimus, in Q3 2024.

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File an Investigational New Drug (IND), application with the U.S. Food and Drug Administration (FDA) for OP-3136 in late 2024 and advance clinical development.

First Quarter 2024 Financial Results

Cash, cash equivalents and marketable securities as of March 31, 2024, were $249.0 million.

Net loss for the quarter ended March 31, 2024, was $31.0 million, as compared to $28.3 million for the quarter March 31, 2023. The increase in net loss for the first quarter was primarily related to increased spending on research and clinical development-related activities as a result of late-stage clinical trials for palazestrant and the advancement of our KAT6 inhibitor program. This increase was offset by decreased spending on general and administrative activities and higher interest income earned from marketable securities.

GAAP research and development (R&D) expenses were $29.9 million for the quarter ended March 31, 2024, as compared to $22.8 million for the quarter ended March 31, 2023. The increase in R&D expenses was primarily related to a $5.0 million milestone payment incurred in connection with the exclusive global licensing agreement entered into in June 2022 between Olema and Aurigene (Aurigene Agreement) associated with the advancement of our KAT6 inhibitor program, and increased spending on clinical development-related activities, as we continue to advance palazestrant into late-stage clinical trials. The increase was offset by decreased spending on clinical pharmacology studies and nonclinical research programs and a one-time restructuring charge recorded in the first quarter of 2023.

Non-GAAP R&D expenses were $26.5 million for the quarter ended March 31, 2024, which included a $5.0 million milestone payment in connection to the Aurigene Agreement and excluded $3.4 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $19.7 million for the quarter ended March 31, 2023, excluding $3.1 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $4.5 million for the quarter ended March 31, 2024, as compared to $6.8 million for the quarter ended March 31, 2023. The decrease in G&A expenses was primarily due to decreased spending on corporate- and legal-related costs, and personnel-related expenses, including a one-time restructuring charge recorded in the first quarter of 2023.

Non-GAAP G&A expenses were $3.0 million for the quarter ended March 31, 2024, excluding $1.5 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $5.2 million for the quarter ended March 31, 2023, excluding $1.5 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

ESMO Breast Cancer Investor Conference Call

Olema will host a webcast and conference call for analysts and investors to review the data being presented at ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress 2024 on Wednesday, May 15, 2024, at 8:00 a.m. ET (2:00 p.m. CEST). Please register for the webcast by visiting the Investors & Media section of Olema’s website at olema.com.

About Palazestrant (OP-1250)

Palazestrant (OP-1250) is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). For more information, please visit www.opera01study.com.