On March 10, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that fourth quarter and full year 2021 financial results (Press release, Oncternal Therapeutics, MAR 10, 2022, View Source [SID1234609951]).
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"This past year was a decisive one for Oncternal, as we reached consensus with the FDA on our Phase 3 clinical trial ZILO-301 of zilovertamab in patients with MCL, advanced our ROR1-targeting CAR-T cell therapy candidate ONCT-808 towards IND submission, and initiated IND-enabling studies for ONCT-534, our DAARI product candidate that may address key resistance mechanisms in metastatic prostate cancer," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We are focusing our resources on hematological malignancies and prostate cancer, areas of high unmet patient need where we believe our potentially first-in-class or best-in-class product candidates can make the greatest difference. We believe our strong balance sheet will enable us to advance these programs into mid-2023, as we navigate a historically challenging macro environment."
Recent Highlights
In January 2022, we announced that we reached consensus with the FDA on the design and major details of the Phase 3 Study ZILO-301 to treat patients with relapsed or refractory mantle cell lymphoma (MCL) with zilovertamab, an investigational anti-ROR1 monoclonal antibody, in combination with ibrutinib. The agency also provided positive feedback on the proposed key clinical and regulatory requirements of our development program for zilovertamab in patients with MCL.
In December 2021, we announced an interim clinical data update from the ongoing Phase 1/2 clinical trial of zilovertamab in combination with ibrutinib for patients with MCL and chronic lymphocytic leukemia (CLL) [NCT03088878] at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2021 Virtual Annual Meeting.
Objective response rate (ORR) of 81% (21 of 26 evaluable patients) observed for patients with MCL treated with zilovertamab plus ibrutinib, which compares favorably to the historical ORR of 66% for ibrutinib monotherapy
Complete response (CR) rate of 35% for MCL patients treated with zilovertamab plus ibrutinib (9 of 26 evaluable patients), which compares favorably to the historical ORR of 20% for ibrutinib monotherapy, and with CRs remaining durable for up to 32 months
Median progression-free survival (PFS) of 35.9 months for MCL patients with median follow-up of 14.4 months, which compares favorably to the historical ibrutinib monotherapy median PFS of 12.8 months
Landmark PFS of 100% at 36 months for CLL patients who had previously received one or two prior lines of therapy, which compares favorably to historical ibrutinib monotherapy PFS of ~ 75%
Median PFS had not been reached for CLL patients with one or two prior lines of therapy, and median PFS was 36.1 months for patients receiving > 2 prior lines of therapy, with a median follow-up of 29.0 months
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
In November 2021, we announced joining the Karolinska Institutet’s NextGenNK Competence Center to support our next generation ROR1-targeted cell therapy initiatives, and the establishment of a Cell Therapy Scientific Advisory Board, comprised of industry and academic leaders in the cell therapy field.
In October 2021, we presented encouraging preclinical data with ONCT-534, the lead candidate in our preclinical dual-action androgen receptor inhibitor (DAARI) program, during a virtual poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual
International Conference on Molecular Targets showing anti-tumor activity in preclinical studies relevant to important tumor resistance mechanisms, including those involving expression of the androgen receptor splice variant (AR-V7).
In November 2021, we announced an interim clinical data update from the ongoing Phase 1/2 clinical trial evaluating ONCT-216, an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins, in patients with relapsed or refractory Ewing sarcoma [CT02657005] at the Connective Tissue Oncology Society 2021 Virtual Annual Meeting. Two patients continue to demonstrate durable complete responses, including one patient with a durable CR for 24 months on treatment, and no evidence of disease off treatment after several months.
Expected Upcoming Milestones
Zilovertamab (ROR1 antibody) program
Initiation of global registrational Phase 3 Study ZILO-301 in the second quarter of 2022
Interim clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in ongoing Phase 1/2 clinical study in the second quarter of 2022
Have a Phase 1b investigator sponsored trial of zilovertamab plus docetaxel initiated for patients with metastatic castration-resistant prostate cancer (mCRPC) in mid-2022
ONCT-808, lead candidate in autologous ROR1-targeted CAR-T cell therapy program
Investigational New Drug (IND) application submission in mid-2022
ONCT-534, lead candidate in our DAARI program
IND-enabling GLP toxicology studies and GMP manufacturing initiated in the second quarter of 2022
ONCT-216 (ETS inhibitor) program
Updated interim clinical data for patients with Ewing sarcoma treated in the dose intensified expansion cohort in the fourth quarter of 2022
Fourth Quarter and Full Year 2021 Financial Results
Our grant revenue was $0.6 million for the fourth quarter ended December 31, 2021. Our grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to the University of California, San Diego and two research and development grant awards from the National Institutes of Health (NIH). For the full year 2021, grant revenue was $4.3 million.
Our total operating expenses for the fourth quarter ended December 31, 2021 were $8.6 million, including $1.7 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 $2.6 million. Net loss for the fourth quarter was $8.1 million, or a loss of $0.16 per share, basic and diluted. For the full year 2021, total operating expenses were $35.7 million, including $5.9 million in non-cash stock-based compensation expense, and our net loss was $31.3 million, or a loss of $0.64 per share, basic and diluted.
As of December 31, 2021, we had approximately 49.4 million shares of common stock outstanding. $90.8 million in cash and cash equivalents and no debt. We believe these funds will be sufficient to fund our operations into mid-2023. Our cash guidance is subject to a number of assumptions, including those related to the severity and duration of the COVID-19 pandemic, and the pace of our research and clinical development programs, among other aspects of our business and the geopolitical environment.