Oncternal Therapeutics Provides Business Update and Announces Second Quarter 2022 Financial Results

On August 9, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the second quarter of 2022 (Press release, Oncternal Therapeutics, AUG 9, 2022, View Source [SID1234617922]).

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"The second quarter of 2022 was highlighted by an encouraging data update at ASCO (Free ASCO Whitepaper) from our Phase 1/2 study of zilovertamab plus ibrutinib in patients with MCL and CLL. We were especially excited by the results in MCL and CLL patients with loss of p53 function, which is a challenging population to treat with current standard of care BTK inhibitor monotherapy" said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We are now looking forward to critical near-term catalysts for the company, including the planned initiation of our Phase 3 Study ZILO-301, the submission of our IND for the first-in-human study of ONCT-808, our ROR1-targeting CAR expressing T cell therapy candidate, and the further advancement towards the clinic of ONCT-534, our Dual-Acting Androgen Receptor Inhibitor (DAARI) product candidate that may address key resistance mechanisms in metastatic prostate cancer. All this is underpinned by focused execution and prudent cash and resource management. We currently expect our cash runway will last into the first half of 2024."

Recent Highlights

In June 2022, we announced an interim clinical data update from the ongoing Phase 1/2 clinical trial of zilovertamab in combination with ibrutinib for patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) [NCT03088878] at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting:
Objective response rate (ORR) of 85% (23 of 27 evaluable patients) observed for patients with MCL treated with zilovertamab plus ibrutinib, which compares favorably to the historical ORR of 66% for ibrutinib monotherapy
Complete response (CR) rate of 41% for patients with MCL treated with zilovertamab plus ibrutinib (11 of 27 evaluable patients), which compares favorably to the historical ORR of 20% for ibrutinib monotherapy
Median progression-free survival (PFS) of 35.9 months for patients with MCL treated with zilovertamab plus ibrutinib at a median follow-up of 15.1 months, which compares favorably to the historical ibrutinib monotherapy median PFS of 12.8 months
In patients with MCL harboring mutated p53, median PFS of 17.3 months (95% CI: 2.9, NE), which compares favorably to the historical median PFS of 4.0 months (95% CI: 2.1, 8.3) for ibrutinib monotherapy
In patients with p53 pathway-deficient CLL, landmark PFS with zilovertamab plus ibrutinib of 100% at 24 months and 100% at 30 months, which compare favorably to the historical ibrutinib monotherapy landmark PFS of ~68% and ~55% at 24 months and 30 months, respectively. Mutations in or loss of p53 protein, which has been called the "guardian of the genome," is a well-known negative factor in many types of cancer, through genomic instability and loss of tumor suppression
The combination of zilovertamab and ibrutinib continued to be well tolerated, with a safety profile consistent with or improved compared with historical data for ibrutinib monotherapy
In June 2022, we established a clinical trial collaboration and supply agreement with Pharmacyclics, which includes the supply of ibrutinib to support our global registrational Phase 3 study ZILO-301, to treat patients with relapsed or refractory MCL with zilovertamab plus ibrutinib.
In April 2022, a Phase 1b investigator sponsored trial of zilovertamab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC) was initiated at the University of California, San Diego.
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.
Expected Upcoming Milestones

Zilovertamab, our ROR1 antibody program
Initiation of global registrational Phase 3 Study ZILO-301, in September 2022
Interim clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in ongoing Phase 1/2 clinical study CIRM-0001, in the fourth quarter of 2022
ONCT-808, lead candidate in our autologous ROR1-targeted CAR-T cell therapy program
Investigational New Drug (IND) application submission in August 2022
ONCT-534, lead candidate in our DAARI program
FDA pre-IND interactions in the fourth quarter of 2022
Second Quarter 2022 Financial Results
Our grant revenue was $0.2 million for the second quarter ended June 30, 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 second quarter ended June 30, 2022 were $12.0 million, including $1.7 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $8.8 million, and general and administrative expenses for the quarter totaled $3.2 million. Net loss for the second quarter was $11.7 million, or a loss of $0.23 per share, basic and diluted.

As of June 30, 2022, we had approximately 52.2 million shares of common stock outstanding, $78.9 million in cash and cash equivalents and no debt. 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 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.