On August 8, 2023 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, 2023, and provided a corporate update (Press release, Olema Oncology, AUG 8, 2023, View Source [SID1234633985]).

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"Olema is on track to deliver on significant milestones this year, including initiating our first pivotal Phase 3 trial, OPERA-01, which will test palazestrant (OP-1250) as a monotherapy in the second- and third-line metastatic setting, as well as presenting new data from our ongoing monotherapy and combination clinical studies," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We are actively engaged in start-up activities for our OPERA-01 Phase 3 clinical trial, with enrollment expected to begin in the fourth quarter. Among other upcoming milestones, we look forward to presenting our mature Phase 2 monotherapy data as part of an oral presentation at the ESMO (Free ESMO Whitepaper) Congress in Madrid in October. Our goal with palazestrant remains to significantly improve upon current standard-of-care endocrine therapy as the backbone treatment for metastatic breast cancer."

Recent Corporate Highlights

● Presented interim Phase 1b/2 clinical study results of palazestrant in combination with a CDK4/6 inhibitor (palbociclib) at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Annual Congress in Berlin, Germany. Results demonstrated no dose-limiting toxicities and no observed drug-drug interaction, with an overall tolerability profile of the combination consistent with the FDA-approved label of palbociclib plus an endocrine agent.
● Presented trials-in-progress poster from the ongoing Phase 1b/2 dose escalation and dose expansion study of palazestrant in combination with CDK4/6 inhibitor, ribociclib or PI3Ka inhibitor, alpelisib at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

Upcoming Milestones

● Present palazestrant Phase 2 monotherapy clinical study results as an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 in Madrid, Spain, on October 22, 2023.
● Present palazestrant interim Phase 1b/2 clinical study results in combination with CDK4/6 inhibitor, palbociclib, in the fourth quarter of 2023.

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● Present palazestrant interim Phase 1b clinical study results in combination with CDK4/6 inhibitor, ribociclib, in the fourth quarter of 2023.
● Initiate OPERA-01, Olema’s first pivotal Phase 3 clinical trial, testing palazestrant as a monotherapy in second- and third-line metastatic breast cancer, anticipated in the fourth quarter of 2023.

Second Quarter 2023 Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2023, were $167.4 million, a reduction of approximately $18.6 million from the quarter ended March 31, 2023. Olema anticipates that this balance will be sufficient to fund operations into the second quarter of 2025.

Net loss for the quarter ended June 30, 2023, was $20.1 million, as compared to $32.9 million for the same period of the prior year. The decrease in net loss was primarily related to decreased spending on discovery research activities including a one-time upfront payment of $8.0 million to Aurigene Pharmaceuticals in June 2022 pursuant to the exclusive global license agreement entered into in June 2022 between the Company and Aurigene Pharmaceuticals (the Aurigene Agreement), and general and administrative activities including a reduction in corporate- and legal-related costs, which were primarily offset by increased spending on clinical development and operations-related activities as we continue to advance palazestrant into late-stage clinical development.

GAAP research and development (R&D) expenses were $18.0 million for the quarter ended June 30, 2023, as compared to $27.1 million for the quarter ended June 30, 2022. The decrease was primarily due to decreased spending on (i) preclinical research programs, which included the $8.0 million upfront payment in connection with the Aurigene Agreement incurred and paid in June 2022, (ii) clinical pharmacology-related costs, and (iii) personnel-related expenses, which primarily related to lower headcount as a result of the restructuring and portfolio prioritization during the first quarter of 2023, and a decrease of approximately $0.2 million in non-cash stock-based compensation expense. Total decreases were primarily offset by increased spending on clinical operations-related activities as we continue to advance palazestrant into late-stage clinical trials.

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. Non-GAAP R&D expenses were $23.8 million for the quarter ended June 30, 2022, excluding $3.2 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found in the tables below.

GAAP general and administrative (G&A) expenses were $3.6 million for the quarter ended June 30, 2023, as compared to $6.2 million for the quarter ended June 30, 2022. The decrease in G&A expenses was primarily due to decreased spending on (i) corporate- and legal-related costs, and (ii) personnel-related expenses, primarily due to lower headcount as a result of the restructuring and portfolio prioritization, and a decrease of approximately $0.3 million in 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. Non-GAAP G&A expenses were $4.7 million for the quarter ended June 30, 2022, 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 in the tables below.