On November 8, 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 third quarter financial results for the period ended September 30, 2022, and provided a business update (Press release, Olema Oncology, NOV 8, 2022, View Source [SID1234623517]).

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"On the heels of presenting our preliminary monotherapy dose expansion study results at ENA 2022, and with initial combination study data coming later this quarter at SABCS, we believe OP-1250 has shown itself to be a highly differentiated CERAN/SERD that completely shuts down estrogen receptor (ER) transcriptional activity in both wild-type and ESR1 mutant receptors," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We have been granted Fast Track designation from the FDA in second- and third-line ER+/HER2- metastatic breast cancer, and we are rapidly generating more data in support of initiating our first pivotal Phase 3 monotherapy study mid-next year. As we enter the next stage of development and with an evolving competitive landscape, we are driven to continue our mission to improve outcomes for women living with cancer."

Recent Corporate Highlights

●Presented preliminary 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) in Barcelona, Spain.
●Study results demonstrated that across 68 heavily pre-treated patients at 60 mg and 120 mg once daily oral doses, OP-1250 was well tolerated with attractive pharmacokinetics (PK) and sustained drug exposure levels approximately 20 times that of fulvestrant at the 120 mg dose. In addition, OP-1250 demonstrated strong anti-tumor activity, with 41% of patients seeing reductions in target tumor lesions, and durable benefit. Six partial responses (four confirmed and two unconfirmed) were observed in 57 efficacy-evaluable patients.
●Following the selection of RP2D based on pharmacokinetics, safety and tolerability, and encouraging early anti-tumor activity, the Phase 2 monotherapy study is rapidly advancing with primary cohorts fully enrolled: patients with measurable disease (N=50) and patients with non-measurable disease (N=15).
●Dose escalation in the Phase 1b combination study with the CDK4/6 inhibitor palbociclib has completed, with Phase 2 dose expansion at 120 mg of OP-1250 in combination with palbociclib now
ongoing. Combinability has been demonstrated across the completed dose escalation cohorts (30 mg, 60 mg, 90 mg, and 120 mg of OP-1250), including no dose limiting toxicities, no change in exposure of palbociclib or OP-1250, and overall tolerability consistent with the expected profile of palbociclib plus an endocrine therapy.
●Initiated Phase 1b combination study with CDK 4/6 inhibitor, ribociclib, and phosphoinositide 3-kinase alpha (PI3Ka) inhibitor, alpelisib.
Anticipated Milestones

●Present preliminary Phase 1b dose escalation study data in combination with CDK4/6 inhibitor, palbociclib, at the 2022 San Antonio Breast Cancer Symposium in December.
●Continue combination studies with CDK4/6 inhibitors, palbociclib and ribociclib, and PI3Ka inhibitor, alpelisib.
●Present additional monotherapy and combination therapy data in 2023.
●Initiate pivotal Phase 3 monotherapy study in the second/third-line ER+/HER2- advanced or metastatic breast cancer in mid-2023.
Financial Results

●Cash, cash equivalents and marketable securities as of September 30, 2022, were $222.6 million. Olema anticipates that this balance will be sufficient to fund operations into the second half of 2024.
●Net loss for the quarter ended September 30, 2022, was $22.7 million, compared to $17.7 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, and an increase in general and administrative (G&A) costs.
●GAAP research and development (R&D) expenses were $17.6 million for the quarter ended September 30, 2022, compared to $12.5 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. Non-GAAP R&D expenses were $14.8 million for the quarter ended September 30, 2022, excluding $2.8 million of non-cash stock-based compensation expense. Non-GAAP R&D expenses were $10.1 million for the quarter ended September 30, 2021, excluding $2.4 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 $5.6 million for the quarter ended September 30, 2022, as compared to $5.2 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 $4.1 million for the quarter ended September 30, 2022, excluding $1.5 million of non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.5 million for the quarter ended September 30, 2021, excluding $1.7 million of non-cash stock-based compensation expense.