On August 6, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported second quarter 2020 financial results (Press release, Oncternal Therapeutics, AUG 6, 2020, View Source [SID1234563184]).
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"We are extremely pleased by the progress achieved in our development programs and the enthusiasm that we have received from the medical community," said James Breitmeyer, M.D., Ph.D., President and CEO, Oncternal. "We are expecting additional data read-outs in our clinical trials in patients with MCL and Ewing sarcoma in the second half of this year, which we believe could be transformative for our company."
Recent Highlights
In May 2020, a data update from the ongoing Phase 1/2 clinical trial of cirmtuzumab in combination with ibrutinib was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Annual Meeting, showing a 58% complete response (CR) rate and 83% overall best objective response rate (ORR) for patients with relapsed/refractory MCL. The one patient who relapsed following prior CD19 CAR-T therapy achieved a CR on this study. Of the four patients who relapsed following a prior regimen that included ibrutinib, all four responded on this study, with two CRs and two partial responses. The combination of cirmtuzumab plus ibrutinib has been well tolerated, with adverse events consistent with those reported for ibrutinib treatment alone. Cirmtuzumab is an investigational, potentially first-in-class humanized monoclonal antibody that binds with high affinity to a biologically important epitope on ROR1 (Receptor-tyrosine kinase-like Orphan Receptor 1).
In June 2020, based on encouraging data presented at ASCO (Free ASCO Whitepaper) 2020, we announced an increased focus on our cirmtuzumab ROR1 antibody program for patients with MCL. We are amending the ongoing Phase 1/2 study clinical trial of cirmtuzumab with ibrutinib to increase enrollment of patients with MCL in the Phase 2 expansion cohort to at least 20 patients and to allow enrollment of patients with a broader range of prior ibrutinib treatments. We have requested a meeting with the U.S. Food and Drug Administration (FDA) to seek guidance on a potential accelerated approval pathway for cirmtuzumab plus ibrutinib in patients with relapsed/refractory MCL.
In June 2020, we announced that the FDA granted the company orphan drug designations of cirmtuzumab for treatment of MCL and for treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma.
In July 2020, we hosted a virtual scientific presentation on the current treatment landscape of MCL, along with a discussion of the cirmtuzumab MCL clinical dataset, with Dr. Michael Wang, professor of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center.
Enrollment has accelerated in the expansion cohort of our ongoing, open-label, multicenter Phase 1 clinical trial of TK216 for patients with relapsed/refractory Ewing sarcoma, despite the COVID-19 pandemic, following our announcement in April 2020 of an interim clinical data update, including deep responses in two patients. We now anticipate announcing clinical data for 12 to 16 patients dosed in this expansion cohort in the fourth quarter of 2020, above our previous guidance of data for 7 to 12 patients. TK216 is an investigational, potentially first-in-class targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins.
In May and July 2020, we announced an aggregate of $11.2 million in gross proceeds from registered direct offerings priced at-the-market under Nasdaq rules.
Expected Upcoming Milestones
TK216 (ETS inhibitor) program
Clinical data for 12 to 16 patients with Ewing sarcoma treated in the Phase 1 expansion cohort to be presented at a scientific conference – in the fourth quarter of 2020
Potential Investigational New Drug Application (IND)-supporting data in additional ETS-driven tumors to be available – in the second half of 2020
Cirmtuzumab (ROR1 antibody) program
Clinical data update for patients with MCL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study to be presented at a scientific conference – in the fourth quarter of 2020
Clinical data update for patients with CLL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study to be presented at a scientific conference – in the fourth quarter of 2020
Clinical data update for patients with HER2-negative breast cancer in the ongoing Phase 1b study to be presented at a scientific conference – in the first half of 2021
Potential IND-supporting data in additional ROR1 expressing tumors to be available – in the second half of 2020
ROR1 CAR-T program
First-in-human dosing in China – in 2021
Second Quarter 2020 Financial Results
Our grant revenue was $0.6 million for the second quarter ended June 30, 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 second quarter ended June 30, 2020 were $6.2 million. Research and development expenses for the quarter totaled $3.8 million, and general and administrative expenses for the quarter totaled $2.3 million. Net loss for the second quarter was $5.5 million, or a loss of $0.34 per share, basic and diluted.
As of June 30, 2020, we had $16.6 million in cash and cash equivalents. In addition, on July 21, 2020, we completed a registered direct offering priced at-the-market under Nasdaq rules, with gross proceeds of $6.2 million, before deducting placement agent’s fees and other estimated offering expenses. We believe our current funds will be sufficient to fund our operations into the second quarter of 2021. Following the offering, we had 19.9 million shares of common stock outstanding.
Management Webcast
As previously announced, Oncternal will host a webcast today, August 6, 2020, at 5:00 p.m. ET (2:00 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.