On November 9, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported a business update and provided third quarter 2023 financial results (Press release, Oncternal Therapeutics, NOV 9, 2023, View Source [SID1234637409]).

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"We continue to execute on our plan to advance both ONCT-534, our dual-action AR inhibitor for patients with advanced prostate cancer who have relapsed or are refractory to treatment with AR pathway inhibitors, and ONCT-808, our ROR1-targeting autologous CAR T for patients with aggressive B cell lymphoma, including those who relapse after CD19 CAR T treatment, towards potential significant clinical inflection points by mid-2024," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We believe ONCT-534 can address a significant unmet medical need for patients with advanced metastatic prostate cancer, especially those with splice variants of the androgen receptor, mutations in the ligand-binding domain of the AR, or AR amplification, common mechanisms of resistance to treatment with approved AR pathway inhibitors. With ONCT-808, we have seen encouraging expansion and persistence of CAR expressing T cells in our first advanced B-NHL patient, which we believe has been associated with positive responses for other CAR T therapies. We look forward to presenting an initial data update by the end of 2023."

Recent Highlights

In October 2023, we announced that the first patient with metastatic castration-resistant prostate cancer (mCRPC) had been dosed in the Phase 1/2 dose escalation/dose expansion study of ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI)
In October 2023, the U.S. Food and Drug Administration granted fast track designation for the treatment of adult patients with relapsed or refractory mCRPC resistant to androgen receptor pathway inhibitors (ARPIs)
In September and October 2023, we announced the establishment and expansion of our Prostate Cancer Scientific Advisory Board (SAB), which includes distinguished academic and industry leaders in the prostate cancer field, who will provide guidance for the clinical development of ONCT-534

Expected Upcoming Milestones

ONCT-808, our autologous ROR1-targeted CAR T cell therapy
Initial clinical data available by the end of 2023
Additional clinical data readouts in 2024
ONCT-534, our dual-action androgen receptor inhibitor
Initial clinical data available in the first half of 2024

Third Quarter 2023 Financial Results
Our grant revenue was $0.2 million for the third quarter ended September 30, 2023. Our total operating expenses for the third quarter ended September 30, 2023 were $10.6 million, including $1.7 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $7.5 million, and general and administrative expenses for the quarter totaled $3.1 million. Interest income for the quarter totaled $0.5 million. Net loss for the quarter was $9.9 million, or a loss of $0.17 per share, basic and diluted. As of September 30, 2023, we had approximately 59.0 million shares of common stock outstanding, $40.3 million in cash, cash equivalents and short-term investments and no debt. We believe these funds will be sufficient to fund our operations into 2025.