On November 7, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the third quarter ended September 30, 2019, and provided a business update (Press release, Oncternal Therapeutics, NOV 7, 2019, View Source [SID1234550676]).
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"We are excited about the potential of cirmtuzumab and TK216 in treating multiple types of hematologic and solid tumors, and by the encouraging interim results from our ongoing clinical trials of these product candidates," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We have now rounded out an experienced leadership team with key new hires and are focused on advancing our programs for the benefit of patients with cancer. We look forward to presenting additional interim clinical data for cirmtuzumab in patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL) and breast cancer, and for TK216 in patients with Ewing sarcoma, in the fourth quarter of 2019."
Recent Highlights
Opened randomized, Phase 2 clinical trial of cirmtuzumab in patients with CLL – In August, Oncternal announced the opening of a randomized, Phase 2 study of cirmtuzumab, its investigational anti-ROR1 monoclonal antibody, combined with ibrutinib in patients with CLL. The decision to open the Phase 2 portion of this ongoing Phase 1/2 clinical trial was based on favorable outcomes from the dose-finding and dose-confirming cohorts of the trial that included an observed interim objective response rate (ORR) of 100% for the first nine CLL patients with evaluable data receiving the recommended dosing regimen who completed 12 weeks of cirmtuzumab plus ibrutinib treatment in the dose-confirming cohort, and a well-tolerated safety profile consistent with that seen with ibrutinib alone.
Opened Phase 1b expansion cohort of a clinical trial of cirmtuzumab in patients with MCL – In October, Oncternal announced the opening of a Phase 1b expansion cohort of its clinical trial of cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL. The decision to open the expansion cohort in MCL was based on favorable interim results from the dose-finding cohort of the trial, which included complete responses observed in two patients who had failed multiple prior treatment regimens, and the observation that the combination was well-tolerated with a safety profile consistent with that seen with ibrutinib alone.
Reported first sustained objective response in a patient with Ewing sarcoma treated with TK216 in a Phase 1 clinical trial – In September, Oncternal announced the presentation of a case study of a patient with Ewing sarcoma who achieved a sustained response following treatment with TK216, Oncternal’s investigational, targeted ETS oncoprotein inhibitor, in the company’s ongoing Phase 1 clinical trial. The patient, who had metastatic, recurrent Ewing sarcoma, achieved a confirmed objective response following two cycles of TK216 therapy given as a single agent. The response was sustained and continued at six months of treatment, with the patient receiving TK216 and vincristine in subsequent treatment cycles. The final remaining residual tumor nodule was later surgically removed, leading to a surgical complete remission. Treatment with TK216 was well-tolerated by this patient.
Strengthened leadership team – In August and September, Oncternal announced appointments of Frank Hsu, M.D., as Chief Medical Officer, Rajesh Krishnan, Ph.D., as Senior VP, CMC and Manufacturing, Gunnar Kaufmann, Ph.D., as Chief Scientific Officer, and Igor Bilinsky, Ph.D., as Chief Business Officer.
Expected Upcoming Milestones
Cirmtuzumab program
Presentation of additional interim data from the ongoing Phase 1/2 clinical study of cirmtuzumab in combination with ibrutinib in patients with CLL or MCL at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 annual meeting in December 2019. The abstract for the presentation, which is entitled, "Cirmtuzumab, a ROR1 Targeted Mab, Reverses Cancer Stemness, and Its Combination with Ibrutinib is Safe and Effective: Planned Analysis of the CIRLL Phase 1/2 Trial for CLL and MCL," is available on the conference website
Presentation of interim data from the ongoing, investigator-sponsored Phase 1 clinical study of cirmtuzumab in combination with paclitaxel in patients with Her2 negative, metastatic or locally advanced unresectable breast cancer in the fourth quarter of 2019
TK216 program
Presentation of interim data from the ongoing Phase 1 clinical study of TK216 in patients with Ewing sarcoma at the Connective Tissue Oncology Society (CTOS) annual meeting in November 2019
ROR1 CAR-T program
Selection of a candidate CAR-T construct for hematologic malignancies in the first half of 2020
Financial Results for the Third Quarter 2019
Oncternal’s grant revenue was $0.5 million for the quarter ended September 30, 2019. The company’s 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, which was awarded to advance Oncternal’s Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with CLL or MCL.
The company’s total operating expenses for the third quarter ended September 30, 2019, were $5.5 million. Research and development expenses for the quarter totaled $3.1 million, and general and administrative expenses for the quarter totaled $2.4 million. Net loss for the third quarter was $4.9 million, or a loss of $0.32 per share, basic and diluted.
As of September 30, 2019, Oncternal had $23.1 million in cash and cash equivalents. The company believes these funds will be sufficient to fund its operations through the second quarter of 2020. As of September 30, 2019, Oncternal had approximately 15.4 million shares of common stock outstanding.
Management Webcast
Oncternal will host a webcast conference today, November 7, 2019, at 2:00 p.m. PST (5:00 p.m. EST) to review quarterly results and provide an update on the company’s development programs. 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.