Oncternal Therapeutics Provides Business Update and Announces First Quarter 2023 Financial Results

On May 4, 2023 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 2023 financial results (Press release, Oncternal Therapeutics, MAY 4, 2023, View Source [SID1234631042]).

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"Oncternal is intensely focused on advancing our cell therapy and androgen receptor (AR) inhibitor programs to reach significant clinical inflection points over the coming months. We are excited about the potential of ONCT-808, our ROR1-targeting CAR T, as it builds on the extensive clinical experience with zilovertamab, as well as with zilovertamab vedotin, an antibody drug conjugate, which has shown that ROR1 can be targeted without unwanted off-tumor, on-target activity. We are also enthusiastic about our novel and first-in-class dual-action AR inhibitor, ONCT-534, which demonstrated in preclinical studies that its unique mechanism of action may address significant unmet needs related to AR-resistance mechanisms in patients with metastatic castrate-resistant prostate cancer (mCRPC). We expect to initiate a Phase 1/2 study of ONCT-534 shortly after an IND submission in mid-2023, and to report initial clinical data in the first half of 2024, well within our expected cash runway period," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Our decision to pause clinical development of zilovertamab with ibrutinib was a necessary step due to a major shift in the Bruton’s tyrosine kinase (BTK) inhibitor landscape, along with the announced plans by Abbvie to withdraw ibrutinib’s FDA accelerated approval in MCL. While we continue to actively explore options to develop zilovertamab through partnerships and collaborations, this decision allowed us to extend our expected cash runway into 2025 and support key clinical catalysts for our cell therapy and prostate cancer programs."

Recent Highlights

In January 2023, we obtained our first Institutional Review Board (IRB) approval for the Phase 1/2 study of ONCT-808 of our autologous ROR1 targeting CAR T for patients with aggressive B cell lymphoma (NCT05588440)
In March 2023, we concluded Investigational New Drug (IND)-enabling studies for ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI) to support a Phase 1/2 clinical trial in patients with mCRPC who are resistant to androgen receptor (AR) inhibitor drugs such as enzalutamide and abiraterone
In April 2023, we announced that the Phase 3 and the Phase 1/2 studies of zilovertamab in combination with ibrutinib will be closed, based on the rapidly changing commercial landscape for BTK inhibitors
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
U.S. IND application submission in mid-2023
Phase 1/2 clinical study initiation in the second half of 2023
Initial clinical data available in the first half of 2024

First Quarter 2023 Financial Results

Our grant revenue was $0.2 million for the first quarter ended March 31, 2023. Our total operating expenses for the first quarter ended March 31, 2023 were $12.3 million, including $1.9 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $9.0 million, and general and administrative expenses for the quarter totaled $3.3 million. Net loss for the first quarter was $11.5 million, or a loss of $0.20 per share, basic and diluted. As of March 31, 2023, we had approximately 58.7 million shares of common stock outstanding, $54.3 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.