On May 9, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported a business update and announced first quarter 2024 financial results (Press release, Oncternal Therapeutics, MAY 9, 2024, View Source [SID1234643012]).

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"We are encouraged by the fast pace of execution for our clinical programs, and we are looking forward to important clinical data readouts in the coming months. Our Phase 1/2 study of ONCT-534 in patients with R/R mCRPC has advanced swiftly through the initial dose escalation cohorts and we are optimistic, based on preclinical data, that the 300 mg dose may be within the active dose range for antitumor activity. We believe that the novel mechanism of action of ONCT-534, which includes interaction with both the N-terminal and ligand-binding domains of the AR has the potential to address important unmet needs of prostate cancer patients who have progressed after treatment with approved AR pathway inhibitors," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Our ROR1 CAR T Phase 1/2 study is now open and enrolling patients after implementing protocol amendments. We continue to be encouraged by the initial response signals we observed, and we look forward to reporting additional clinical data in patients with relapsed or refractory aggressive B cell lymphoma, including those who have relapsed after CD19 CAR T treatment."

Recent Highlights

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In April 2024, we announced that the first patient had been dosed in the fourth cohort of our Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the fourth dosing cohort will receive 300 mg of ONCT-534 taken orally each day. The fourth cohort is now fully enrolled with three subjects treated.
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Our dose escalation/dose expansion Phase 1/2 Study ONCT-808-101, evaluating our ROR1-targeting autologous CAR T cell therapy, ONCT-808, for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, is open and enrolling patients. Protocol changes that include modified eligibility criteria, increased monitoring for early infection, and evaluating lower doses have now been implemented.

Expected Upcoming Milestones

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ONCT-534, our dual-action androgen receptor inhibitor
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Initial clinical data update in the second quarter of 2024
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Additional clinical data readouts in the fourth quarter of 2024
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ONCT-808, our autologous ROR1-targeted CAR T cell therapy
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Clinical data update in mid-2024
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Additional clinical data readouts in the fourth quarter of 2024
First Quarter 2024 Financial Results

Our grant revenue was $0.6 million for the first quarter ended March 31, 2024. Our total operating expenses for the first quarter ended March 31, 2024 were $9.3 million, including $1.4 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $6.0 million, and general and administrative expenses for the quarter totaled $3.3 million. Net loss for the first quarter was $8.4 million, or a net loss of $2.83 per share, basic and diluted. As of March 31, 2024, we had approximately 3.0 million shares of common stock outstanding, $27.0 million in cash, cash equivalents and short-term investments and no debt. These funds are expected to be sufficient to fund our operations into the first quarter of 2025.