On November 7, 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 third quarter ended September 30, 2023, and provided a corporate update (Press release, Olema Oncology, NOV 7, 2023, View Source [SID1234637152]).
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"With the recent oral presentation of our Phase 2 monotherapy clinical results at ESMO (Free ESMO Whitepaper) in Madrid, we are already experiencing increased awareness of and interest in our OPERA-01 Phase 3 monotherapy clinical trial," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our Phase 2 study of palazestrant in combination with ribociclib is now rapidly enrolling and we look forward to presenting new palazestrant combination data at SABCS in December, including a Poster Spotlight Discussion for our interim Phase 2 palbociclib combination clinical results. We are proud of the advancements we are making across our business, and as we progress our CERAN and KAT6 programs we remain focused on defining the next generation of targeted therapies for women’s cancers."
Recent Corporate Highlights
● OPERA-01, Olema’s first pivotal Phase 3 clinical trial testing palazestrant as a monotherapy in second- and third-line metastatic breast cancer is ongoing, including clinical site activation and first patient expected to be enrolled in the fourth quarter.
● Presented palazestrant Phase 2 monotherapy clinical study results as an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 in Madrid, Spain, on October 22, 2023. Results demonstrated that, across all 86 heavily pretreated patients, the median progression-free survival (PFS) was 4.6 months with a clinical benefit rate (CBR) of 40%; in patients with ESR1 mutations at baseline, the median PFS was 5.6 months with a CBR of 52%. In a subset analysis of 49 second- or third-line patients with or without prior chemotherapy, the median PFS was 7.2 months and CBR was 48% across all patients, and the median PFS was 7.3 months and CBR
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was 59% in ESR1-mutant patients. Study results support continued development of palazestrant in the OPERA-01 monotherapy Phase 3 pivotal trial.
● Announced the appointment of Mr. Scott Garland, who brings more than 30 years of biopharmaceutical industry experience with deep commercial and executive leadership expertise, to Olema’s Board of Directors.
● Announced the expansion of Olema’s clinical collaboration with Novartis Institutes for BioMedical Research, Inc. (Novartis), increasing the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib to approximately 60 patients.
● Presented new preclinical data regarding the discovery of novel compounds targeting KAT6, an epigenetic target that is dysregulated in breast and other cancers, at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), demonstrating anti-tumor activity in preclinical models of ER+ breast cancer.
● Completed a combined financing for up to $180 million including an equity private placement of approximately $130 million of common stock as well as a new senior secured credit facility with an aggregate principal amount of up to $50 million with Silicon Valley Bank, $25 million of which is currently available.
Upcoming Milestones
● Present palazestrant interim Phase 1b/2 clinical study results in combination with CDK4/6 inhibitor, palbociclib, as a Poster Spotlight Discussion at the 2023 San Antonio Breast Cancer Symposium (SABCS) in December 2023.
● Present palazestrant interim Phase 1b clinical study results in combination with CDK4/6 inhibitor, ribociclib, at SABCS.
● Present trial-in-progress poster for OPERA-01, a randomized, open-label, Phase 3, study of palazestrant vs. standard-of-care treatment for ER+/HER2- advanced or metastatic breast cancer after endocrine and CDK4/6 inhibitor therapy, at SABCS, which will provide details on the trial design, inclusion/exclusion criteria, and trial endpoints.
Third Quarter 2023 Financial Results
Cash, cash equivalents and marketable securities as of September 30, 2023, were $276.9 million.
Net loss for the quarter ended September 30, 2023, was $21.5 million, as compared to $22.7 million for the same period of the prior year. The decrease in net loss was primarily related to decreased spending on general and administrative activities, and higher interest income earned from the marketable securities, which were offset by increased spending on clinical operations and development-related activities as Olema continues to advance palazestrant into late-stage clinical trials.
GAAP research and development (R&D) expenses were $19.5 million for the quarter ended September 30, 2023, as compared to $17.6 million for the quarter ended September 30, 2022. The increase was primarily a result of increased spending on clinical operations and development-related activities as Olema continues to advance palazestrant into late-stage clinical development.
Non-GAAP R&D expenses were $16.7 million for the quarter ended September 30, 2023, excluding $2.8 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $14.8 million for the quarter ended September 30, 2022, excluding $2.8 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found in the tables below.
GAAP general and administrative (G&A) expenses were $3.9 million for the quarter ended September 30, 2023, as compared to $5.6 million for the quarter ended September 30, 2022. The decrease in G&A expenses was primarily due to decreased spending on (i) corporate- and legal-related costs, and (ii) personnel-related expenses, primarily due to lower headcount as a result of the restructuring and portfolio prioritization.
Non-GAAP G&A expenses were $2.6 million for the quarter ended September 30, 2023, excluding $1.3 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $4.1 million for the quarter ended September 30, 2022, excluding $1.5 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found in the tables below.