On November 3, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the third quarter of 2022 (Press release, Oncternal Therapeutics, NOV 3, 2022, View Source [SID1234622959]).
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"This past quarter was a pivotal one for Oncternal’s leading ROR1 programs, highlighted by initiation of the Company’s first global registrational clinical study for zilovertamab in MCL and the FDA clearance of the IND for ONCT-808, our ROR1 targeting CAR T product candidate, for the treatment of patients with advanced aggressive B-cell lymphoma," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "These exciting developments are backed by a strong clinical data foundation, as highlighted by acceptance of our zilovertamab Phase 1/2 data update in MCL and CLL for an oral presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December. We are now looking forward to ramping up site enrollment for our Phase 3 clinical study globally, to the initiation of our first CAR T Phase 1/2 study from which we expect an initial clinical data readout next year, and to the further advancement towards the clinic of ONCT-534, our DAARI product candidate that may address key resistance mechanisms in metastatic prostate cancer. We continue to exercise prudent cash management and expect our existing cash and cash equivalents will last into the first half of 2024."
Recent Highlights
Initiated the Phase 3 global registrational study of zilovertamab, Study ZILO-301 (NCT05431179), for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL)
Received a ‘Study May Proceed’ letter from the U.S. Food and Drug Administration (FDA), 30 days after submitting our Investigational New Drug (IND) application for our Phase 1/2 study of ONCT-808, an autologous chimeric antigen receptor (CAR) T therapy targeting ROR1, in patients with aggressive B-cell lymphoma, including those who have failed previous CD19 CAR T treatment
Expected Upcoming Milestones
Zilovertamab, our ROR1 antibody program
Opening of sites outside of the U.S. for global clinical registrational Phase 3 Study ZILO-301, in the first quarter of 2023
Interim clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in ongoing Phase 1/2 Study CIRM-0001, as oral presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2022
ONCT-808, lead candidate in our autologous ROR1-targeted CAR T cell therapy program
Initiation of Phase 1/2 Study in patients with aggressive B-cell lymphoma in the first quarter of 2023
Initial clinical data update in 2023
ONCT-534, lead candidate in our DAARI program
U.S. FDA pre-IND feedback in December 2022
Third Quarter 2022 Financial Results
Our grant revenue was $0.4 million for the third quarter ended September 30, 2022. Our grant revenue is derived from two research and development grant awards from the National Institutes of Health (NIH).
Our total operating expenses for the third quarter ended September 30, 2022 were $11.7 million, including $2.0 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $8.4 million, and general and administrative expenses for the quarter totaled $3.3 million. Net loss for the third quarter was $11.1 million, or a loss of $0.21 per share, basic and diluted.
As of September 30, 2022, we had approximately 55.5 million shares of common stock outstanding, $70.6 million in cash and cash equivalents and no debt. Based on our current operating plan, we believe these funds will be sufficient to fund our operations into the first half of 2024. Our cash guidance is subject to a number of assumptions, including those related to the pace of our research and clinical development programs, among other aspects of our business and the geopolitical environment.