Olema Oncology Reports Third Quarter 2024 Financial Results and Provides Corporate Update
OLMA 11.12.2024
Drug:OP-1250 palazestrant
Drug:OP-3136 OP-3136
Diseases:ER+ HER2- metastatic breast cancer
Date of Upcoming Event:2024-12-01
Name of Upcoming Event:San Antonio Breast Cancer Symposium (SABCS)
Date of Upcoming Event:2024-10-25
Name of Upcoming Event:36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024)
- Presented compelling new preclinical data demonstrating anti-tumor activity for OP-3136, a novel KAT6 inhibitor, with enhanced activity of palazestrant combinations at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024)
- New clinical data for palazestrant (OP-1250) in combination with ribociclib to be presented at the San Antonio Breast Cancer Symposium (SABCS) in December
- IND submission for OP-3136 expected before year end; clinical study to initiate early 2025
- Cash, cash equivalents, and marketable securities of
$214.8 million as ofSeptember 30, 2024
“We look forward to presenting updated data from our ongoing Phase 2 clinical study of palazestrant in combination with ribociclib in metastatic breast cancer patients at SABCS in December. The OPERA-01 Phase 3 clinical trial of palazestrant as a monotherapy in second/third-line patients continues to advance and we remain on track for top-line readout in 2026,” said
Recent Progress
- Continued enrollment of patients in OPERA-01, the pivotal Phase 3 clinical trial of palazestrant as a monotherapy in second/third-line ER+/HER2- metastatic breast cancer.
- Presented preclinical data for OP-3136 and palazestrant at the 36thEORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) in
Barcelona, Spain . - Initiated Phase 1b/2 clinical study of palazestrant in combination with everolimus.
- Successfully completed Investigational New Drug (IND)-enabling studies for OP-3136.
Anticipated Upcoming Milestones
- Present updated Phase 2 data showing palazestrant in combination with ribociclib at the San Antonio Breast Cancer Symposium (SABCS) in
December 2024 . - Submit the IND application for OP-3136 to the
U.S. Food and Drug Administration (FDA) before year-end; initiate the Phase 1 clinical study for OP-3136 in early 2025.
Third Quarter 2024 Financial ResultsCash, cash equivalents, and marketable securities as of
Net loss for the quarter ended
GAAP research and development (R&D) expenses were
Non-GAAP R&D expenses were
GAAP G&A expenses were
Non-GAAP G&A expenses were
About Palazestrant (OP-1250)Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted
About OP-3136OP-3136 is a novel, orally available small molecule that potently and selectively inhibits KAT6, an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and CDK4/6 inhibitors.
About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for women living with cancer.
Non-GAAP Financial InformationThe results presented in this press release include both GAAP information and non-GAAP information. As used in this release, non-GAAP R&D expense is defined by
Forward Looking StatementsStatements 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,” “believe,” “could,” “expect,” “goal,” “may,” “potential,” “upcoming,” “will” 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 timelines for initiation and enrollment for potential clinical studies and for results of clinical trials of palazestrant (OP-1250) and OP-3136, each as a monotherapy and in combination trials, Olema’s financial condition and resources, results of operations, cash position, potential beneficial characteristics including but not limited to safety, tolerability, activity, efficacy and therapeutic effects of palazestrant, the potential of palazestrant to advance the standard of care for women living with cancer, combinability with other drugs, palazestrant, or OP-3136, and the sufficiency and timing of Olema’s preclinical program, including the potential beneficial characteristics of its KAT6 inhibitor compounds and the timing of a potential IND application and advancement into clinical development for OP-3136. 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
| Condensed Consolidated Balance Sheets Data | ||||||
| (in thousands) | ||||||
, | , | |||||
| 2024 | 2023 | |||||
| Cash, cash equivalents and marketable securities | $ | 214,763 | $ | 261,807 | ||
| Total assets | 230,173 | 276,945 | ||||
| Total current liabilities | 30,700 | 21,621 | ||||
| Total liabilities | 31,262 | 23,050 | ||||
| Total stockholders’ equity | 198,911 | 253,895 | ||||
| Total liabilities and stockholders’ equity | $ | 230,173 | $ | 276,945 | ||
| Condensed Consolidated Statements of Operations | ||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||
| Operating expenses: | ||||||||||||||
| Research and development (1) | $ | 33,226 | $ | 19,453 | $ | 92,218 | $ | 60,268 | ||||||
| General and administrative (2) | 4,395 | 3,889 | 13,272 | 14,277 | ||||||||||
| Total operating expenses | 37,621 | 23,342 | 105,490 | 74,545 | ||||||||||
| Loss from operations | (37,621 | ) | (23,342 | ) | (105,490 | ) | (74,545 | ) | ||||||
| Other income: | ||||||||||||||
| Interest income | 2,928 | 1,919 | 9,388 | 4,774 | ||||||||||
| Other income (expense) | 138 | (79 | ) | 195 | (112 | ) | ||||||||
| Total other income | 3,066 | 1,840 | 9,583 | 4,662 | ||||||||||
| Net loss | $ | (34,555 | ) | $ | (21,502 | ) | $ | (95,907 | ) | $ | (69,883 | ) | ||
| Net loss per share, basic and diluted | $ | (0.60 | ) | $ | (0.48 | ) | $ | (1.80 | ) | $ | (1.66 | ) | ||
| Weighted average shares used to compute net loss per share, basic and diluted | 57,262,803 | 44,977,161 | 53,194,081 | 41,999,978 | ||||||||||
| Reconciliation of GAAP to Non-GAAP Information | ||||||||||||||
| (In thousands) | ||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||
| (1) Research and development reconciliation | ||||||||||||||
| GAAP research and development (3) | $ | 33,226 | $ | 19,453 | $ | 92,218 | $ | 60,268 | ||||||
| Less: share-based compensation expense | 4,280 | 2,801 | 11,925 | 8,858 | ||||||||||
| Non-GAAP research and development | $ | 28,946 | $ | 16,652 | $ | 80,293 | $ | 51,410 | ||||||
| (2) General and administrative reconciliation | ||||||||||||||
| GAAP general and administrative | $ | 4,395 | $ | 3,889 | $ | 13,272 | $ | 14,277 | ||||||
| Less: share-based compensation expense | 1,346 | 1,304 | 4,334 | 4,047 | ||||||||||
| Non-GAAP general and administrative | $ | 3,049 | $ | 2,585 | $ | 8,938 | $ | 10,230 | ||||||
| (3) Research and development expenses for the nine-months ended | ||||||||||||||
IR and Media ContactCourtney O’Konek, Vice President, Corporate Communicationsmedia@olema.com
