On August 10, 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 second quarter 2023 financial results (Press release, Oncternal Therapeutics, AUG 10, 2023, View Source [SID1234634206]).

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"Oncternal is executing on its strategy to deliver significant value inflection points for our two clinical programs. The clearance of the IND for ONCT-534, our dual-action androgen receptor inhibitor, represents a major milestone for Oncternal and a new potential option for patients suffering from mCRPC. We have received support from top prostate cancer experts in the United States and Europe. We reiterate our guidance to dose the first patient later this year, with initial clinical data in the first half of 2024. Resistance to standard of care androgen receptor signaling inhibitors such as enzalutamide and abiraterone represents a significant unmet medical need. Pre-clinical studies have shown that ONCT-534 may directly address the most common resistance mechanisms, such as androgen receptor ligand-binding domain mutations and AR-V7 splice variants," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "The dosing of the first patient with ONCT-808, our ROR1 targeting autologous CAR T therapy, represents a significant milestone for patients suffering from aggressive B-cell lymphomas. We look forward to a data update later this year in this area of significant unmet medical need."

Recent Highlights

In August 2023, we received a ‘Study May Proceed’ letter from the U.S. Food and Drug Administration (FDA), less than 30 days after submitting our Investigational New Drug (IND) application for ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI) to support a Phase 1/2 clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC) who are resistant to currently available androgen receptor (AR) inhibitor drugs such as enzalutamide and abiraterone
In June 2023, we announced that the first patient has been dosed in the Phase 1/2 dose escalation/dose expansion study of ONCT-808, our ROR1 targeting autologous CAR T cell therapy (NCT05588440)
Expected Upcoming Milestones

ONCT-808, our autologous ROR1-targeted CAR T cell therapy
Initial clinical data available by the end of 2023
Additional clinical readouts in 2024
ONCT-534, our dual-action androgen receptor inhibitor
Phase 1/2 clinical study initiation in the third quarter of 2023
Initial clinical data available in the first half of 2024

Second Quarter 2023 Financial Results

Our grant revenue was $0.1 million for the second quarter ended June 30, 2023. Our total operating expenses for the second quarter ended June 30, 2023 were $9.7 million, including $1.7 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $6.6 million, and general and administrative expenses for the quarter totaled $3.1 million. Net loss for the first quarter was $9.0 million, or a loss of $0.15 per share, basic and diluted. As of June 30, 2023, we had approximately 58.7 million shares of common stock outstanding, $45.5 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.