On August 6, 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 second quarter ended June 30, 2024, and provided a corporate update (Press release, Olema Oncology, AUG 6, 2024, View Source [SID1234645429]).
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"The clinical data we presented at the ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in May demonstrated that the palazestrant-ribociclib combination was well tolerated with no new safety signals or enhancement of toxicity. The preliminary efficacy data is highly encouraging and we look forward to updating with more mature efficacy," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "The OPERA-01 Phase 3 clinical trial for palazestrant as a monotherapy in second/third-line metastatic breast cancer is ongoing, and later this year we are looking forward to presenting new data on our KAT6 inhibitor, OP-3136, and filing an Investigational New Drug (IND) application with the FDA."
Second Quarter 2024 Highlights
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Presented interim Phase 1b/2 clinical results of palazestrant (OP-1250) in combination with ribociclib at the ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress 2024 in Berlin, Germany. Results showed palazestrant in combination with ribociclib was well tolerated with no new safety signals or enhancement of toxicity and no meaningful impact on drug exposure of either therapy. In addition, a preliminary clinical benefit rate (CBR) of 85% was observed across 13 CBR-eligible patients.
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Presented 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 in Chicago, IL.
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Successfully completed IND-enabling studies for OP-3136 in support of a potential IND filing in late 2024
Upcoming Milestones
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Initiate Phase 1b/2 clinical study of palazestrant in combination with mTOR inhibitor, everolimus, in the third quarter of 2024.
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Present pre-clinical data supporting the Investigational New Drug (IND) application for OP-3136, an orally-bioavailable KAT6 inhibitor, anticipated in the fourth quarter of 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.
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Present updated Phase 2 clinical study results for palazestrant in combination with CDK4/6 inhibitor, ribociclib, anticipated at a future medical meeting.
Second Quarter 2024 Financial Results
Cash, cash equivalents and marketable securities as of June 30, 2024, were $239.1 million.
Net loss for the quarter ended June 30, 2024, was $30.4 million, as compared to $20.1 million for the quarter ended June 30, 2023. The increase in net loss for the second quarter was primarily related to increased spending on clinical development and research activities as a result of late-stage clinical trials for palazestrant and the advancement of our KAT6 inhibitor program, as well as general and administrative activities. The increase was partially offset by higher interest income earned from marketable securities.
GAAP research and development (R&D) expenses were $29.1 million for the quarter ended June 30, 2024, as compared to $18.0 million for the quarter ended June 30, 2023. The increase in R&D expenses was primarily related to increased spending on clinical development activities as we continue to advance palazestrant into late-stage clinical trials, research-related activities associated with the advancement of our KAT6 inhibitor program, and personnel related costs, including non-cash stock-based compensation expense of $1.3 million.
Non-GAAP R&D expenses were $24.9 million for the quarter ended June 30, 2024, which excluded $4.2 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $15.0 million for the quarter ended June 30, 2023, excluding $3.0 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 $4.4 million for the quarter ended June 30, 2024, as compared to $3.6 million for the quarter ended June 30, 2023. The increase in G&A expenses was primarily due to increased spending on corporate-related costs, and an increase in non-cash stock-based compensation expense of $0.3 million.
Non-GAAP G&A expenses were $2.9 million for the quarter ended June 30, 2024, excluding $1.5 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $2.4 million for the quarter ended June 30, 2023, excluding $1.2 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.
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 on OPERA-01, please visit www.opera01study.com.