On March 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 fourth quarter and full-year ended December 31, 2022, and provided a strategic update (Press release, Olema Oncology, MAR 9, 2023, View Source [SID1234628443]).
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"2022 was a successful year for Olema as we generated important clinical data advancing the opportunity for OP-1250, our complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD), as both a monotherapy and in combination with a CDK4/6 inhibitor. We continue to have confidence in OP-1250’s ability to become a best-in-class treatment option for ER+/HER2- metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We are committed to realizing the full potential of OP-1250, which we believe has demonstrated a clear, differentiated advantage as a complete ER antagonist and the potential endocrine therapy of choice. Given the challenging equity market environment, we made some difficult decisions regarding our organization and earlier-stage programs. As we sharpen our focus on the late-stage clinical development of OP-1250, we remain steadfast in our goal of bringing this potentially transformative therapy to women living with breast cancer."
Olema’s restructuring announced today is the result of a strategic decision to focus resources on the late-stage clinical development of OP-1250, which includes the initiation of the company’s first pivotal Phase 3 trial in the second half of this year. As a result of the restructuring, Olema’s workforce will be reduced by approximately 25%, affecting employees across research, early development, and general and administrative functions. Chief Business Officer Kinney Horn will be departing the company, and Cyrus Harmon, Ph.D., co-founder of Olema, will step down from his role as the Chief Research Officer and remain a member of Olema’s Board of Directors.
"I am grateful to our employees for their strong commitment to our mission and dedication to patients. I would like to thank Kinney for his important contributions to Olema since joining in 2020, and we wish him well in his future endeavors," continued Dr. Bohen. "Cyrus, who is a co-founder of Olema, has been an inspirational leader and was instrumental in the discovery and early development of OP-1250. His continued guidance as a member of the Board will be vital as we progress OP-1250 though late-stage development."
2022 Corporate Highlights
● Presented clinical results from a Phase 1/2 clinical study of OP-1250 at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2022), which demonstrated that, across 68 heavily pre-treated patients, OP-1250 was well tolerated with attractive pharmacokinetics and sustained drug exposure levels approximately 20 times that of fulvestrant at the 120 mg daily dose. In addition, OP-1250 demonstrated strong anti-tumor activity, with 41% of patients seeing reductions in target tumor lesions, and durable benefit with a 39% clinical benefit rate (CBR) at the 120 mg dose level on a maturing dataset. Six partial responses (four confirmed and two unconfirmed) were observed in 57 efficacy-evaluable patients.
● Presented clinical results from a Phase 1b combination study at the 2022 San Antonio Breast Cancer Symposium (SABCS), which demonstrated OP-1250’s combinability with palbociclib with a tolerability profile consistent with palbociclib in combination with an aromatase inhibitor or fulvestrant, no drug-drug interaction, and no induced metabolism of palbociclib.
● 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.
● Initiated a Phase 1b combination study with CDK4/6 inhibitor, ribociclib, and phosphoinositide 3-kinase alpha (PI3Ka) inhibitor, alpelisib.
● 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 Upcoming Milestones
● 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 combination with CDK4/6 inhibitor (palbociclib) clinical study results in the second quarter of 2023.
● Present Phase 2 monotherapy clinical study results in the second half of 2023.
● Present Phase 1b combination with CDK4/6 inhibitor (ribociclib) clinical study results in the second half of 2023.
Fourth Quarter and Full-Year 2022 Financial Results
Cash, cash equivalents and marketable securities as of December 31, 2022, were $204.4 million. Olema anticipates that this balance will be sufficient to fund operations into 2025.
Net loss was $26.2 million and $104.8 million for the quarter and year ended December 31, 2022, respectively, as compared to $21.6 million and $71.1 million for the quarter and year ended December 31, 2021, respectively. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development activities including an $8.0 million upfront payment to Aurigene in the second quarter, and an increase in general and administrative (G&A) costs.
GAAP research and development (R&D) expenses were $21.6 million and $82.3 million for the quarter and year ended December 31, 2022, respectively, as compared to $16.0 million and $51.1 million for the quarter and year ended December 31, 2021, respectively. 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, including an $8.0 million upfront payment to Aurigene in the second quarter, and personnel-related expenses due to higher headcount, including non-cash stock-based compensation expenses.
Non-GAAP R&D expenses were $18.2 million and $69.8 million for the quarter and year ended December 31, 2022, respectively, excluding $3.4 million and $12.5 million non-cash stock-based compensation expense, respectively. 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. 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 $5.6 million and $24.7 million for the quarter and year ended December 31, 2022, respectively, as compared to $5.8 million and $20.4 million for the quarter and year ended December 31, 2021, respectively. The increase in G&A expenses was primarily related to increases in personnel-related expenses due to higher headcount, including non-cash stock-based compensation expense, and public company-related expenses, including legal compliance and other corporate costs.
Non-GAAP G&A expenses were $4.1 million and $18.3 million for the quarter and year ended December 31, 2022, respectively, excluding $1.5 million and $6.4 million non-cash stock-based compensation expense respectively. Non-GAAP G&A expenses were $4.1 million and $13.8 million for the quarter and year ended December 31, 2021, excluding $1.7 million and $6.6 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.