Clinical-stage biopharmaceutical company Oncternal Therapeutics Inc. (ONCT:NASDAQ), which is focused on rapidly advancing a pipeline of new wave cancer treatments, yesterday announced operating and financial results for the fourth quarter and full year of 2020 for the period ended December 31, 2020.
Oncternal Therapeutics' President and CEO James Breitmeyer, M.D., Ph.D., began by commenting, "In 2021, we are advancing a deep pipeline of differentiated oncology assets. We have now initiated early-stage work in ROR1-targeting immunotherapies, including CAR-T and CAR-NK cell therapies, while moving forward the later-stage clinical development of cirmtuzumab, an antibody targeting ROR1, in MCL, which has generated encouraging data in this difficult to treat cancer. At the same time, we continue to evaluate TK216, an ETS inhibitor which has generated promising results in Ewing sarcoma."
"We have also strengthened our balance sheet by raising $125 million in 2020, which provides us with the runway to advance our promising programs into 2023. We have several key data read-outs pending in the second quarter this year," Dr. Breitmeyer added.
The company discussed several of its business highlights and mentioned that in January 2021, it entered into an agreement with Lentigen Technology Inc. to manufacture lentiviral vectors to support Oncternal's investigational ROR1-targeting CAR-T cell therapy program and additionally in the same month announced a research and development partnership formed with the Sweden-based Karolinska Institutet to advance novel ROR1-targeting CAR-T and CAR-NK cell therapies from the laboratory into the clinic.
The firm noted that "in December 2020, it announced an interim clinical data update from the ongoing Phase 1/2 clinical trial of cirmtuzumab, an investigational anti-ROR1 monoclonal antibody, in combination with ibrutinib in patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) at the American Society of Hematology 2020 Virtual Annual Meeting." The firm stated that in the study, "the best objective response rate of 87%, including complete response (CR) rate of 47%, was reported for 15 evaluable patients with relapsed/refractory (r/r) MCL."
The company also advised that "in November 2020, it announced an interim clinical data update from the ongoing Phase 1/2 clinical trial evaluating TK216, an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins, in patients with r/r Ewing sarcoma at the Connective Tissue Oncology Society 2020 Virtual Annual Meeting."
Oncternal pointed out as well that the U.S. Food and Drug Administration granted Rare Pediatric Disease designation for TK216 for use in treating Ewing sarcoma in October 2020.
Oncternal Therapeutics reported that in Q4/20 it had received grant revenue in the amount of 1.588 million, compared to $0.737 million in Q4/19. The firm added that for FY/20, total grant revenue was $3.375 million, versus $2.425 million in FY/19.
The company explained that "its grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to UC San Diego, which was awarded to advance its Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL or CLL."
The company noted that it spent a total of $2.986 million on Research and Development in Q4/20, compared to $2.568 million in Q4/19.
The company reported that in Q4/20 it posted a net loss of $2.558 million, or $0.09 per basic and diluted share, compared to a net loss of $4.156 million, or $0.27 per basic and diluted share in Q4/19.
The firm stated for FY/20 it registered a net loss in the amount of $17.2 million, or $0.85 per basic and diluted share, versus a net loss of $33.108 million, or $3.31 per share during FY/19.
The firm reported that it held $116.7 million in cash and cash equivalents on its balance sheet as of December 31, 2020, which it indicated will be sufficient to fund the company's operations into 2023.
Oncternal Therapeutics is based in San Diego, Calif., and is a clinical-stage biopharmaceutical company that is endeavoring to create a diverse pipeline of treatments for cancers with critical unmet medical needs. The firm stated that it concentrates its effort on drug development that targets potential yet untapped biological pathways implicated in cancer generation or progression.
According to the firm's website, "its drug development pipeline includes cirmtuzumab, a monoclonal antibody in Phase 1/2 development that inhibits the ROR1 receptor in various hematologic cancers; TK-216, a small-molecule in Phase 1 development that inhibits ETS-family oncoproteins, as a treatment for Ewing sarcoma, a rare pediatric cancer; and a CAR-T therapy that targets ROR1 currently in preclinical development as a potential treatment for solid tumors and hematologic cancers."
Oncternal Therapeutics started the day with a market cap of about $310.9 million with approximately 48.8 million shares outstanding. ONCT shares opened 6.75% higher today at $6.80 (+$0.43, +6.75%) over yesterday's $6.37 closing price. The stock has since traded today between $6.4905 and $7.89 per share and is currently trading at $7.57 (+$1.20, +18.84%).
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