Full Press Release Details
Olema Oncology Reports Third Quarter 2021 Financial Results and Provides Corporate Update
SAN FRANCISCO, November 10, 2021 - 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, today provided an update on recent company developments and reported third quarter financial results for the period ended September 30, 2021.
"Our team has made great progress advancing OP-1250 through the dose escalation portion of our ongoing Phase 1/2 clinical trial and we look forward to presenting interim pharmacokinetic, safety, tolerability and initial efficacy data at the San Antonio Breast Cancer Symposium in December," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We are encouraged by the emerging clinical profile of OP-1250 and plan to initiate Phase 2 monotherapy expansion as well as the first planned Phase 1b combination trial with a CDK4/6 inhibitor in the first quarter of 2022."
"OP-1250 has the potential to be a differentiated, best-in-class complete estrogen receptor (ER) antagonist (CERAN) that we believe could become the backbone endocrine therapy of choice for ER+ breast cancer. As we enroll more patients, we look forward to generating additional clinical data in support of OP-1250's use both as monotherapy and in combination with other approved breast cancer treatments," continued Dr. Bohen.
Recent Corporate Highlights
Anticipated Milestones
Financial Highlights
About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, OP-1250, is an orally available small molecule with combined activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated as a single agent in an ongoing Phase 1/2 clinical trial in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Olema is based in San Francisco and has operations in Cambridge, Massachusetts.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as "anticipate," "expect," "intend," "will," "may," "goal," "estimate," "potential" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the development of OP-1250, including timelines related to data presentation, trial initiation and advancement, and enrollment, the beneficial characteristics, safety, efficacy and therapeutic effects of OP-1250, as well as the sufficiency of our financial resources. Because such statements deal with future events and are based on Olema's current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, the risk that Olema's ongoing or future clinical studies in humans may show that OP-1250 is not a tolerable and effective treatment for breast cancer and other risks and uncertainties affecting Olema, as well as those discussed in the section titled "Risk Factors" in Olema's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 to be filed on November 10, 2021 and future filings and reports that Olema makes from time to time with the United States Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.
Olema Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets Data
| September 30, | December 31, | ||
| 2021 | 2020 | ||
| (Unaudited) | (Audited) | ||
| Cash, cash equivalents and marketable securities | $ 305,954 | $ 338,549 | |
| Total assets | $ 309,795 | $ 342,722 | |
| Total liabilities | $ 8,901 | $ 4,585 | |
| Total stockholders' equity | $ 300,894 | $ 338,137 | |
| Total liabilities and stockholders' equity | $ 309,795 | $ 342,722 |
Olema Pharmaceuticals, Inc.
Condensed consolidated statements of operations and comprehensive loss
(In thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 12,523 | $ | 4,673 | $ | 35,125 | $ | 7,415 | ||||
| General and administrative | 5,239 | 3,195 | 14,609 | 3,982 | ||||||||
| Total operating expenses (1) | 17,762 | 7,868 | 49,734 | 11,397 | ||||||||
| Loss from operations | (17,762) | (7,868) | (49,734) | (11,397) | ||||||||
| Other income (expense): | ||||||||||||
| Interest income | 105 | 23 | 333 | 59 | ||||||||
| Interest expense | - | - | - | (653) | ||||||||
| Other income (expense) | (56) | 1 | (57) | 1 | ||||||||
| Total other income (expense), net | 49 | 24 | 276 | (593) | ||||||||
| Net loss | $ | (17,713) | $ | (7,844) | $ | (49,458) | $ | (11,990) | ||||
| Repurchase and retirement of Series A and Series A-1 convertible preferred stock | - | (1,869) | - | (1,869) | ||||||||
| Net loss attributable to common stockholders | $ | (17,713) | $ | (9,713) | $ | (49,458) | $ | (13,859) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.45) | $ | (3.71) | $ | (1.25) | $ | (5.29) | ||||
| Weighted average shares used to compute net loss per share attributable to common stockholders, basic and diluted | 39,607,745 | 2,617,543 | 39,450,655 | 2,617,543 |
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Research and development | $ | 2,405 | $ | 392 | $ | 6,427 | $ | 495 | ||||
| General and administrative | 1,752 | 190 | 4,859 | 241 | ||||||||
| Total | $ | 4,157 | $ | 582 | $ | 11,286 | $ | 736 |
Vice President, Communications and Investor Relations