On May 7, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported first quarter 2020 financial results (Press release, Oncternal Therapeutics, MAY 7, 2020, View Source [SID1234557299]).
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"Despite the COVID-19 pandemic, we are pleased to see continuing progress for our promising oncology pipeline, as we recently reported deep clinical responses in 28.5% of patients with Ewing sarcoma treated with TK216 at the selected Phase 2 dose with or without vincristine, and a 50% complete response ("CR") rate in patients with Mantle Cell Lymphoma ("MCL") treated with cirmtuzumab plus ibrutinib," said James Breitmeyer, M.D., Ph.D., President and CEO, Oncternal. "Our team has worked closely with our clinical investigators to help ensure the safety of the patients and the clinical study staff, while preserving regulatory compliance and data quality. At this time, we do not expect delays to our previously articulated clinical data read-outs in 2020."
Recent Highlights
In April 2020, we announced an interim clinical data update for our ongoing, open-label, multicenter Phase 1 clinical trial of TK216, a targeted investigational small-molecule inhibitor of the E26 transformation-specific ("ETS") family of oncoproteins, in patients with relapsed or refractory Ewing sarcoma. As of the data cut-off date of March 26, 2020, seven patients treated at the recommended Phase 2 dose ("RP2D") of TK216 (200 mg/m2/day for 14 days without or with vincristine) were evaluable for clinical responses. Two of the seven patients (28.5%) had achieved partial responses ("PR"), one with a surgical CR, and one with 90% shrinkage of target lesions. Both responding patients remain on treatment, including one who has no evidence of disease after more than twelve months on study. Two patients had stable disease and three had progressive disease, for an overall clinical benefit of 57% (4/7).
In March 2020, we announced an interim clinical data update for cirmtuzumab, a monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1, in combination with ibrutinib in patients with relapsed/refractory MCL enrolled in our ongoing Phase 1/2 clinical trial. As of the data cut-off of March 6, 2020, we reported a 50% CR rate for the 12 evaluable patients and an 83% best objective response rate ("ORR", including CR or PR). Responses were determined by Cheson criteria, and one of the six patients with CR had a complete metabolic response by PET scan, with a bone marrow biopsy pending.
In February 2020, we presented ROR1 CAR-T preclinical data at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium. ROR1 CAR-T cell therapy demonstrated expansion, persistence and anti-tumor activity in an animal model of ROR1-expressing human leukemia. This research is being conducted by our collaborators at the University of California San Diego (UC San Diego) under a grant from the California Institute of Regenerative Medicine ("CIRM").
Oncternal’s first priority during the unprecedented public health emergency caused by the COVID-19 pandemic has been protecting the safety of the patients in our clinical trials, along with the safety of the staff at clinical sites and that of our own employees, while ensuring regulatory compliance and data integrity. Enrollment of new patients into our studies has slowed down, as most other drug developers are reporting, but we have continued to enroll additional patients into the Ewing sarcoma study recently despite COVID-19 related constraints. As of today, very few patients have discontinued their participation in our clinical trials because of COVID-19 concerns, and we remain on track to meet our previously disclosed expected clinical data milestones for 2020.
Expected Upcoming Milestones
TK216 program
Clinical data for 7-12 patients with Ewing sarcoma treated in the Phase 1 expansion cohort – in the second half of 2020
IND-enabling data in additional ETS-driven tumors – in the second half of 2020
Cirmtuzumab program
Clinical data update for patients with MCL, including for 15 or more patients treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study – in mid-2020
Clinical data update for patients with CLL, including 12-month follow-up for up to 34 patients treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study – in mid-2020
Clinical data update for patients with HER2-negative breast cancer in the ongoing Phase 1b study – in the second half of 2020
IND-enabling data in additional ROR1 expressing tumors – in the second half of 2020
ROR1 CAR-T program
First-in-human dosing in China – in the first half of 2021
First Quarter 2020 Financial Results
Our grant revenue was $0.6 million for the first quarter ended March 31, 2020. Our grant revenue is derived from a sub-award under a grant from CIRM to UC San Diego, which was awarded to advance our Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL or CLL.
Our total operating expenses for the first quarter ended March 31, 2020 were $5.3 million. Research and development expenses for the quarter totaled $2.7 million, and general and administrative expenses for the quarter totaled $2.6 million. Net loss for the first quarter was $4.7 million, or a loss of $0.31 per share, basic and diluted.
As of March 31, 2020, we had $16.0 million in cash and cash equivalents. We believe these funds will be sufficient to fund our operations into the fourth quarter of 2020. As of March 31, 2020, we had approximately 15.4 million shares of common stock outstanding.
Management Webcast
As previously announced, Oncternal will host a webcast today, May 7, 2020, at 3:00 p.m. ET (12:00 p.m. PT). The live webcast will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.