On November 4, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported third quarter 2020 financial results (Press release, Oncternal Therapeutics, NOV 4, 2020, View Source [SID1234569997]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In the third quarter we continued advancing our oncology pipeline while strengthening our balance sheet," said James Breitmeyer, M.D., Ph.D., President and CEO, Oncternal. "We expect to provide additional data updates on our clinical trials in patients with mantle cell lymphoma (MCL), Ewing sarcoma, and chronic lymphocytic leukemia (CLL) in the fourth quarter."
Recent Highlights
In July 2020, we hosted a virtual scientific presentation on the current treatment landscape of MCL, along with a discussion of our cirmtuzumab MCL clinical data set, with Dr. Michael Wang, professor of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center. A data update from our ongoing open-label Phase 1/2 clinical trial of cirmtuzumab in combination with ibrutinib that was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Annual Meeting in May 2020 showed a 58% complete response (CR) rate and 83% overall best objective response rate (ORR) for patients with relapsed/refractory MCL, as of the April 30, 2020 data cut-off date. 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 September 2020, we met with the U.S. Food and Drug Administration (FDA) and are in a dialogue with the FDA regarding potential accelerated approval pathways for cirmtuzumab plus ibrutinib in patients with relapsed/refractory MCL.
In September 2020, a data update from the ongoing open-label Phase 1 clinical trial of TK216 in patients with relapsed or refractory Ewing sarcoma was given as an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020. The presentation included interim data for 15 evaluable patients treated at the recommended Phase 2 dose as of the August 13, 2020 data cut-off date. Two of the 15 patients had achieved complete responses (CR), including one surgical CR. Both CRs were ongoing and the patients remained on treatment. Five patients had stable disease (SD), for a disease control rate (CR, partial response or SD) of 47%. TK216 is an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins.
In October 2020, we announced that the FDA granted Rare Pediatric Disease designation for TK216 for treatment of Ewing sarcoma.
In July and September 2020, we raised an aggregate of $10.1 million in net proceeds from a registered direct offering and an underwritten offering.
Expected Upcoming Milestones
TK216 (ETS inhibitor) program
Clinical data for over 16 patients with Ewing sarcoma treated in the ongoing expansion cohort to be presented at the Connective Tissue Oncology Society (CTOS) 2020 Virtual Annual Meeting on November 11, 2020
Preclinical data in additional ETS-driven tumors in the first half of 2021
Cirmtuzumab (ROR1 antibody) programs
Clinical data update for patients with MCL and CLL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study to be presented at the American Society for Hematology (ASH) (Free ASH Whitepaper) 2020 Virtual Annual Meeting on December 7, 2020
Clinical data update for patients with HER2-negative breast cancer in the ongoing Phase 1b study in the first half of 2021
Preclinical data in additional ROR1 expressing tumors in the first half of 2021
ROR1 CAR-T program
First-in-human dosing in China in 2021
Third Quarter 2020 Financial Results
Our grant revenue was $0.6 million for the third quarter ended September 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 third quarter ended September 30, 2020 were $5.0 million. Research and development expenses for the quarter totaled $3.0 million, and general and administrative expenses for the quarter totaled $1.9 million. Net loss for the third quarter was $4.4 million, or a loss of $0.22 per share, basic and diluted.
As of September 30, 2020, we had $21.3 million in cash and cash equivalents. We believe our current funds will be sufficient to fund our planned operations into the second quarter of 2021. As of September 30, 2020, we had 22.3 million shares of common stock outstanding.