On May 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 first quarter financial results for the period ended March 31, 2022 and provided a business update (Press release, Olema Oncology, MAY 9, 2022, View Source [SID1234613933]).

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"Following the successful completion of the Phase 1a dose escalation portion of our trial for OP-1250 late last year, we are pleased with the continued robust enrollment we are achieving across our development program. Both our Phase 1/2 monotherapy expansion study and the Phase 1b combination trial with palbociclib are advancing, and we expect to initiate additional combination trials later this year. In parallel, we plan to evaluate OP-1250’s potential in the treatment of patients with ER+/HER2+ breast cancer and CNS metastases, an important and underserved patient population with limited treatment options," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our knowledge and clinical experience with OP-1250 is rapidly expanding. We are fortunate to be supported by both a strong team and balance sheet as we approach potential near-term value drivers for our business. We look forward to presenting updated clinical data later this year."

Recent Corporate Highlights

Achieved target enrollment of 30 patients in Phase 1b monotherapy dose expansion at 60 mg and 120 mg dose levels (N=15 per cohort).

Enrolled initial dose cohorts in the dose escalation portion of the Phase 1b combination study with palbociclib and dose escalation of OP-1250 continues.

Presented two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 8-13, 2022. Data presented showed that 10 mg/kg OP-1250, a complete estrogen receptor (ER) antagonist (CERAN), alone or in combination with palbociclib, substantially inhibits primary tumor growth in an endocrine-resistant breast cancer model with ERα Y537S mutation. A second poster showed that OP-1250 is able to effectively reverse estradiol-induced transcriptional changes associated with the activated estrogen receptor in two ER+ cell lines, MCF7 and CAMA-1.
Anticipated Milestones

Select the Recommended Phase 2 Dose (RP2D) for OP-1250 in the second quarter of 2022, followed by initiation of the Phase 2 portion of the trial. Phase 2 will include enrollment across three cohorts: patients with measurable disease (N=50), patients with non-measurable disease (N=15) and patients with CNS metastasis (N=15).

Initiate additional Phase 1b combination studies with CDK4/6 and PI3Kα inhibitors in 2022.

Initiate Phase 1b study of OP-1250 in patients with ER+/HER2+ breast cancer and CNS metastases in the second half of 2022.

Present updated monotherapy and initial combination data for OP-1250.
Financial Results

Cash, cash equivalents and marketable securities as of March 31, 2022, were $267.9 million. Olema anticipates that this balance will be sufficient to fund operations into 2024.

Net loss for the quarter ended March 31, 2022, was $23.0 million, compared to $15.3 million for the same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, and an increase in general and administrative (G&A) costs.

GAAP research and development (R&D) expenses were $16.0 million for the quarter ended March 31, 2022, compared to $10.7 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, increase in nonclinical development activities, and higher personnel-related expenses, including non-cash stock-based compensation expenses. Non-GAAP R&D expenses were $12.9 million for the quarter ended March 31, 2022, excluding $3.1 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $9.0 million for the quarter ended March 31, 2021, excluding $1.7 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 news release.

GAAP G&A expenses were $7.2 million for the quarter ended March 31, 2022, as compared to $4.8 million for the same period of the prior year. The increase in G&A expenses was primarily related to higher personnel-related expenses, including non-cash stock-based compensation expenses, and other corporate costs. 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. Non-GAAP G&A expenses were $3.3 million for the quarter ended March 31, 2021, excluding $1.5 million non-cash stock-based compensation expense.