On August 9, 2022 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported second quarter financial results for the period ended June 30, 2022, and provided a business update (Press release, Olema Oncology, AUG 9, 2022, View Source [SID1234617932]).

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"Our objective is for OP-1250 to become the endocrine therapy of choice for ER+ breast cancer and, based on the progress we are making across the program and receipt of Fast Track designation from FDA, we believe we are well on our way toward achieving that goal. Our enrollment continues to be robust and the emerging data show a favorable tolerability profile, encouraging early anti-tumor activity, and combinability with palbociclib," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "As we continue to generate more data, OP-1250 is revealing its potential, validating our confidence to move ahead our next set of trials and preparing for a pivotal monotherapy study next year. We are well capitalized into the second half of 2024, and we look forward to presenting more data as the year progresses."

Recent Corporate Highlights

Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for OP-1250 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. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process for the purpose of expediting the drug’s development, review and potential approval.
Announced interim data from Phase 1b monotherapy expansion of OP-1250 for ER+/HER2- breast cancer.
Based on pharmacokinetics, safety and tolerability, and encouraging early anti-tumor activity in Phase 1b monotherapy expansion, 120 mg once-daily dosing of OP-1250 was selected as the recommended Phase 2 dose (RP2D).
Following the selection of RP2D, Phase 2 enrollment continues and will include three cohorts: patients with measurable disease (N=50), patients with non-measurable disease (N=15) and patients with CNS metastasis (N=15).
Dose escalation in the Phase 1b combination study with the CDK4/6 inhibitor palbociclib continues, with evaluation at 120 mg OP-1250 ongoing. Combinability has been demonstrated across the completed dose escalation cohorts (30 mg, 60 mg and 90 mg OP-1250), including no dose limiting toxicities, no induced metabolism of palbociclib, and overall tolerability consistent with expected profile of palbociclib plus an endocrine therapy.
Announced an exclusive global license agreement with Aurigene Discovery Technologies Limited (Aurigene) to research, develop and commercialize novel small molecule inhibitors of an undisclosed oncology target.
Anticipated Milestones

Initiate a Phase 1b combination study with each of ribociclib, a CDK4/6 inhibitor, and alpelisib, a PI3Kɑ inhibitor, in the third quarter of 2022.
Present updated monotherapy and initial combination data with palbociclib at medical meetings in the fourth quarter of 2022, pending abstract acceptance.
Initiate a pivotal monotherapy study in second-line or later settings in mid-2023.
Present additional monotherapy and combination data in 2023.
Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2022, were $240.7 million. Olema anticipates that this balance will be sufficient to fund operations into the second half of 2024.
Net loss for the quarter ended June 30, 2022, was $32.9 million, compared to $16.4 million for the 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 activities, including the $8.0 million upfront payment to Aurigene, and an increase in general and administrative (G&A) costs.
GAAP research and development (R&D) expenses were $27.1 million for the quarter ended June 30, 2022, compared to $11.9 million for the same period of the prior year. The increase in R&D expenses was primarily related to the advancement of the development program for OP-1250 and an increase in nonclinical research and discovery program activities, including the $8.0 million upfront payment to Aurigene. Non-GAAP R&D expenses were $23.9 million for the quarter ended June 30, 2022, excluding $3.2 million of non-cash stock-based compensation expense. Non-GAAP R&D expenses were $9.6 million for the quarter ended June 30, 2021, excluding $2.3 million of 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 news release.
GAAP G&A expenses were $6.2 million for the quarter ended June 30, 2022, as compared to $4.6 million for the same period of the prior year. The increase in G&A expenses was primarily related to higher personnel-related expenses and other corporate costs. Non-GAAP G&A expenses were $4.7 million for the quarter ended June 30, 2022, excluding $1.5 million of non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended June 30, 2021, excluding $1.6 million of non-cash stock-based compensation expense.