On February 28, 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 financial results for the fourth quarter and full year ended December 31, 2021 and provided a business update (Press release, Olema Oncology, FEB 28, 2022, View Source [SID1234609200]).

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"2021 was a transformative year for Olema. Our team made important progress against our strategic goals, culminating in the presentation of strong proof-of-concept data for OP-1250 in ER+ / HER2- breast cancer. The initial data, demonstrating OP-1250’s attractive pharmacokinetics, favorable tolerability and encouraging anti-tumor activity in a heavily pretreated patient population, validate OP-1250’s potential to become the endocrine therapy of choice for ER+ breast cancer. We are now actively expanding our clinical study enrollment and expect to be in a position to present more data later this year," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Importantly, we entered 2022 with a strong balance sheet, and as we continue to build our team and grow our capabilities, we are well positioned to advance our clinical development program and discovery efforts."

Recent Corporate Highlights

●Presented interim Phase 1a dose escalation data for OP-1250 from the ongoing Phase 1/2 clinical study. The initial data provide strong proof-of-concept supporting OP-1250’s potential as a once-daily oral monotherapy in women with recurrent, locally advanced, or metastatic ER+ / HER2- breast cancer, with OP-1250
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demonstrating highly attractive pharmacokinetics, favorable tolerability, and clear efficacy signals in a heavily pretreated patient population.
●Initiated monotherapy dose expansion at 60 mg and 120 mg dose levels. Each cohort will enroll approximately 15 patients with measurable disease, and findings will help inform the selection of a recommended Phase 2 dose (RP2D). Enrollment remains on track to complete in the first quarter of 2022.
●Initiated Phase 1b combination study with palbociclib, a CDK4/6 inhibitor. The dose escalation portion of the combination trial includes a starting dose of 30 mg OP-1250 once-daily and follows a standard 3+3 design.
●Presented nonclinical data on OP-1250 in a poster session at the San Antonio Breast Cancer Symposium (SABCS), held December 7-10, 2021. Data presented showed that the addition of OP-1250 to anti-HER2 agents, trastuzumab and tucatinib, improved the inhibition of tumor growth in nonclinical models of ER+ / HER2+ breast cancer.
●Appointed Naseem Zojwalla, M.D., as Olema’s new Chief Medical Officer. Dr. Zojwalla joins Olema from Turning Point Therapeutics and brings significant leadership in clinical development, operations and regulatory experience. Former CMO Pamela Klein, M.D., continues to work with Olema in a strategic advisory capacity and as a newly appointed member of the company’s Scientific Advisory Board.
●In December 2021, Olema was added to the NASDAQ Biotechnology Index (Nasdaq: NBI).
Anticipated Milestones

●Select the Recommended Phase 2 Dose (RP2D) for OP-1250 and initiate Phase 2 in the first half of 2022. The Phase 2 study includes 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 in 2022.
●Sean Bohen, M.D., Ph.D., President and CEO of Olema Oncology, is scheduled to present at the 42nd Annual Cowen Healthcare Conference on Monday, March 7, 2022 at 2:50 PM ET.
Fourth Quarter and Full Year 2021 Financial Results

●Cash, cash equivalents and marketable securities as of December 31, 2021 were $287.3 million. Olema anticipates that this balance of cash will be sufficient to fund operations into 2024.
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●Net loss was $21.6 million and $71.1 million for the quarter and year ended December 31, 2021, respectively, as compared to $10.1 million and $22.1 million for the quarter and year ended December 31, 2020, respectively. The increase in net loss related primarily to Olema’s continued investment in OP-1250, and an increase in general and administrative (G&A) infrastructure costs.
●GAAP research and development (R&D) expenses were $16.0 million and $51.1 million for the quarter and year ended December 31, 2021, respectively, as compared to $6.3 million and $13.7 million for the quarter and year ended December 31, 2020, respectively. The increase in R&D expenses was primarily related to the advancement of the ongoing Phase 1/2 clinical trial of OP-1250, increase in nonclinical development activities, higher personnel-related expenses and higher non-cash stock-based compensation expenses. Non-GAAP R&D expenses were $13.1 million and $41.8 million for the quarter and year ended December 31, 2021, respectively, excluding $2.9 million and $9.3 million non-cash stock-based compensation expense respectively. Non-GAAP R&D expenses were $4.8 million and $11.7 million for the quarter and year ended December 31, 2020, respectively, excluding $1.5 million and $2.0 million non-cash stock-based compensation expense respectively. The increase in R&D expenses was primarily related to the advancement of the ongoing Phase 1/2 clinical trial of OP-1250, increase in nonclinical development activities, higher personnel-related expenses and higher non-cash stock-based compensation expenses. 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 $5.8 million and $20.4 million for the quarter and year ended December 31, 2021, respectively, as compared to $3.8 million and $7.8 million for the quarter and year ended December 31, 2020, respectively. Non-GAAP G&A expenses were $4.1 million and $13.8 million for the quarter and year ended December 31, 2021, respectively, excluding $1.7 million and $6.6 million non-cash stock-based compensation expense respectively. The increase in G&A expenses was primarily related to an increase in personnel, public company-related expenses, other corporate costs and higher non-cash stock-based compensation expenses. Non-GAAP G&A expenses were $3.0 million and $6.7 million for the quarter and year ended December 31, 2020, excluding $0.9 million and $1.1 million non-cash stock-based compensation expense respectively. The increase in G&A expenses was primarily related to an increase in personnel, public company-related expenses, other corporate costs and higher non-cash stock-based compensation expenses.