On March 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 reported fourth quarter and full year 2022 financial results (Press release, Oncternal Therapeutics, MAR 9, 2023, View Source [SID1234628421]).
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"2022 was an important year for Oncternal. With the recent initiation of our Phase 1/2 clinical study for ONCT-808 in advanced hematological malignancies, and the upcoming filing of our IND for ONCT-534 in advanced prostate cancer, we expect to have three product candidates in the clinic later this year," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "The data presented at ASH (Free ASH Whitepaper) 2022 further validated the rationale for our Phase 3 study for patients with MCL, and also strengthened our belief that zilovertamab may provide a new treatment option for patients with CLL with 17p deletion or TP53 mutations, which is a substantial and highly underserved group of patients. We look forward to a catalyst-rich year ahead while continuing to exercise prudent cash management as we expect our existing cash resources will last into the first quarter of 2024."
Recent Highlights
In December 2022, we announced an interim clinical data update from ongoing Study CIRM-0001, a Phase 1/2 clinical trial of zilovertamab in combination with ibrutinib for the patients with relapsed or refractory (R/R) Mantle Cell Lymphoma (MCL) and treatment naïve or R/R chronic lymphocytic leukemia (CLL) [NCT03088878] at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 Annual Meeting.
Objective response rate (ORR) of 89% (25 of 28 evaluable patients) observed for patients with R/R MCL treated with zilovertamab plus ibrutinib, which compares favorably to the historical ORR of 66% for ibrutinib monotherapy
Complete response (CR) rate of 43% for R/R MCL patients treated with zilovertamab plus ibrutinib (12 of 28 evaluable patients), which compares favorably to the historical ORR of 20% for ibrutinib monotherapy
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
Median progression-free survival (PFS) had not been reached for R/R MCL patients with TP53 mutation treated with zilovertamab plus ibrutinib, with a landmark PFS of approximately 85% at 15 months, which compares favorably to the historical ibrutinib monotherapy median PFS of 4 months
Landmark PFS of 100% at 42 months for patients with CLL with 17p deletion or TP53 mutations treated with zilovertamab plus ibrutinib, which compares favorably to a recent data update from the ALPINE study of patients with R/R CLL, with a landmark PFS of 55.7% at 24 months for ibrutinib monotherapy, and 77.6% at 24 months for zanubrutinib monotherapy
Mutation in the TP53 gene is the most commonly acquired mutation in cancer, including hematological malignancies. TP53 aberrations are associated with markedly decreased survival and predict inadequate therapeutic response, thus being among the strongest predictive and prognostic factors guiding treatment decisions in CLL and MCL
In December 2022, we received helpful feedback from the FDA from our pre- Investigational New Drug (IND) meeting for ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI)
In January 2023, we obtained our first Institutional Review Board (IRB) approval for the Phase 1/2 study of ONCT-808, our autologous CAR-T targeting ROR1-expressing hematologic malignancies (NCT05588440)
Expected Upcoming Milestones
Zilovertamab, our ROR1 antibody
Opening of additional countries for global clinical registrational Phase 3 Study ZILO-301
Continuing evaluation of potential to treat patients with CLL & MCL and TP53 mutations and/or 17p deletions
ONCT-808, our autologous ROR1-targeted CAR T cell therapy
Initial clinical data available by the end of 2023
ONCT-534, our dual-action androgen receptor inhibitor
U.S. IND application submission planned in mid-2023
Fourth Quarter and Full Year 2022 Financial Results
Our grant revenue was $0.2 million for the fourth quarter ended December 31, 2022, and was $1.5 million for the full year 2022.
Our total operating expenses for the fourth quarter ended December 31, 2022 were $12.1 million, including $1.8 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 $3.3 million. Net loss for the fourth quarter was $11.4 million, or a loss of $0.20 per share, basic and diluted. For the full year 2022, total operating expenses were $46.4 million, including $7.4 million in non-cash stock-based compensation expense, and our net loss was $44.2 million, or a loss of $0.84 per share, basic and diluted.
As of December 31, 2022, we had approximately 57.5 million shares of common stock outstanding, $63.7 million in cash, cash equivalents and short-term investments and no debt. We believe these funds will be sufficient to fund our operations into the first quarter of 2024.