On May 5, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the first quarter of 2022 (Press release, Oncternal Therapeutics, MAY 5, 2022, View Source [SID1234613650]).
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"In the first quarter, we continued to advance our robust pipeline towards important inflection points, including the planned initiation of our zilovertamab registrational Phase 3 study in patients with MCL in Q3 2022, the submission of an IND for our ROR1-targeting CAR-T cell therapy candidate ONCT-808 in mid-2022, and the execution of IND-enabling studies for ONCT-534, our DAARI product candidate that may address key resistance mechanisms in metastatic prostate cancer," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Substantial progress of our pipeline has been supported by solid collaborations with our partners and execution by our team, and is being carried out with a focus on prudent cash management. Very importantly, we narrowed our focus on hematological malignancies and prostate cancer, and deprioritized our ONCT-216 program, which helped extend our cash runway well into Q3 2023. We will continue to explore and evaluate all potential sources of capital to enable us to reach our milestones."
Recent Highlights
In January 2022, we announced that we reached consensus with the FDA on the design and major study details of the Phase 3 Study, ZILO-301, to treat patients with relapsed or refractory mantle cell lymphoma (MCL) with zilovertamab, an investigational anti-ROR1 monoclonal antibody, in combination with ibrutinib. The agency also provided positive feedback on the proposed key clinical and regulatory requirements of our development program for zilovertamab in patients with MCL.
In April 2022, we established a clinical manufacturing agreement with the Dana-Farber Cancer Institute to conduct cGMP cell preparation and manufacturing activities for use in first-in-human studies of our ROR1-targeting CAR-T cell therapy candidate ONCT-808.
In April 2022, we announced the deprioritization of further development of ONCT-216 and the discontinuation of enrollment in the Phase 1/2 study evaluating ONCT-216 in patients with relapsed or refractory Ewing sarcoma.
Expected Upcoming Milestones
Zilovertamab, our ROR1 antibody program
Initiation of global registrational Phase 3 Study, ZILO-301, in the third quarter of 2022
Interim clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in ongoing Phase 1/2 clinical study will be presented at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting
Initiation of Phase 1b investigator sponsored trial of zilovertamab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC) in mid-2022
ONCT-808, lead candidate in our autologous ROR1-targeted CAR-T cell therapy program
Investigational New Drug (IND) application submission in mid-2022
ONCT-534, lead candidate in our DAARI program
IND-enabling GLP toxicology studies and GMP manufacturing initiated in the second quarter of 2022
First Quarter 2022 Financial Results
Our grant revenue was $0.7 million for the first quarter ended March 31, 2022. Our grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to the University of California, San Diego and two research and development grant awards from the National Institutes of Health (NIH).
Our total operating expenses for the first quarter ended March 31, 2022 were $10.7 million, including $2.0 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $7.0 million, and general and administrative expenses for the quarter totaled $3.7 million. Net loss for the first quarter was $9.9 million, or a loss of $0.20 per share, basic and diluted.
As of March 31, 2022, we had approximately 49.4 million shares of common stock outstanding, $82.2 million in cash and cash equivalents and no debt. We believe these funds will be sufficient to fund our operations well into Q3 2023. Our cash guidance is subject to a number of assumptions, including those related to the severity and duration of the COVID-19 pandemic, and the pace of our research and clinical development programs, among other aspects of our business and the geopolitical environment.