On May 9, 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 first quarter ended March 31, 2023, and provided a corporate update (Press release, Olema Oncology, MAY 9, 2023, View Source [SID1234631285]).

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"We are on track for the initiation of our first pivotal Phase 3 clinical trial in the second half of this year," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our ongoing Phase 2 studies continue to generate data in support of our underlying thesis that OP-1250 has the potential to become a best-in-class complete estrogen receptor antagonist and improve upon the current standard of care in the treatment of ER+/HER2- metastatic breast cancer. We look forward to presenting our next clinical update at the 2023 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in mid-May, and we believe we are well-positioned to achieve our goal to significantly improve endocrine therapy for women living with breast cancer."

Anticipated Upcoming Milestones

● Present interim Phase 2 clinical study results of OP-1250 in combination with CDK4/6 inhibitor (palbociclib) at the 2023 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in Berlin, Germany, in a poster presentation on May 12, 2023.
● Present trials-in-progress clinical study overview of OP-1250 in combination with ribociclib or alpelisib in a poster presentation at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, June 2-6, 2023, in Chicago, IL.
● Initiate a pivotal Phase 3 monotherapy clinical trial in the second- and third-line setting of ER+/HER2- advanced or metastatic breast cancer in the second half of 2023.
● Present Phase 2 monotherapy clinical study results in the second half of 2023.
● Present Phase 1b clinical study results of OP-1250 in combination with CDK4/6 inhibitor (ribociclib) in the second half of 2023.

First Quarter 2023 Financial Results

Cash, cash equivalents and marketable securities as of March 31, 2023, were $186.0 million. Olema anticipates that this balance will be sufficient to fund operations into 2025.

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Net loss for the quarter ended March 31, 2023, was $28.3 million, as compared to $23.0 million for same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development (R&D) activities, and personnel-related costs, including a one-time restructuring charge of $2.8 million. The increase in R&D spending was partially offset by a decrease in general and administrative (G&A) costs.

GAAP R&D expenses were $22.8 million for the quarter ended March 31, 2023, as compared to $16.0 million for the quarter ended March 31, 2022. The increase in R&D expenses was primarily related to increases in advancing ongoing clinical studies of OP-1250 and associated manufacturing costs, nonclinical research and discovery program activities, and personnel-related expenses, including a one-time restructuring charge of $1.8 million.

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. Non-GAAP R&D expenses were $12.9 million for the quarter ended March 31, 2022, respectively, excluding $3.1 million non-cash stock-based compensation expense, respectively. 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 $6.8 million for the quarter ended March 31, 2023, as compared to $7.2 million for the quarter ended March 31, 2022. The decrease in G&A expenses was primarily due to lower corporate costs, and personnel-related expenses, including non-cash stock-based compensation expense. The decrease in spending was partially offset by a one-time restructuring charge of $1.0 million.

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. Non-GAAP G&A expenses were $5.3 million for the quarter ended March 31, 2022, excluding $1.9 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.