On May 6, 2020 for patients with solid tumor cancers, reported financial results for the first quarter ended March 31, 2020, and recent corporate highlights (Press release, Checkpoint Therapeutics, MAY 6, 2020, View Source [SID1234561602]).
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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "In the first quarter of 2020, we continued to make progress with the development of cosibelimab, our lead antibody product candidate that is poised to be a potentially differentiated treatment from currently marketed PD-1 and PD-L1 antibodies. As announced in January, the U.S. Food and Drug Administration ("FDA") confirmed the registration submission pathway for cosibelimab in its initial indication of metastatic cutaneous squamous cell carcinoma ("CSCC") based on the ongoing multicenter Phase 1 clinical trial. We look forward to reporting additional interim data from this clinical trial later this year. Additionally, we recently announced that the U.S. Patent and Trademark Office issued a composition of matter patent for cosibelimab, which provides broad, foundational composition of matter protection for our antibody through at least May 2038. With these developments, we look forward to continuing to enroll CSCC patients in order to support our first marketing application submission based on this ongoing clinical trial."
Recent Corporate Highlights:
·In January 2020, Checkpoint announced confirmation of the registration path for cosibelimab in metastatic CSCC. FDA feedback supports the Company’s plan to submit a Biologics License Application ("BLA") based on data from the ongoing Phase 1 trial. Over one-third of enrollment is complete in the cohort of patients with metastatic CSCC.
·In April 2020, Checkpoint announced that the U.S. Patent and Trademark Office issued a composition of matter patent for cosibelimab. U.S. Patent No. 10,590,199 specifically covers the antibody, cosibelimab, or a fragment thereof, providing protection through at least May 2038, exclusive of any additional patent-term extensions that might become available.
Financial Results:
·Cash Position: As of March 31, 2020, Checkpoint’s cash and cash equivalents totaled $21.5 million, compared to $26.1 million as of December 31, 2019, a decrease of $4.6 million.
·Revenue: Revenue for the first quarter of 2020 was $1.0 million, compared to $0.4 million for the first quarter of 2019, an increase of $0.6 million.
·R&D Expenses: Research and development expenses for the first quarter of 2020 were $2.6 million, compared to $4.6 million for the first quarter of 2019, a decrease of $2.0 million. Research and development expenses for the first quarter of 2020 included $0.1 million of non-cash stock expenses, compared to $0.2 million in the first quarter of 2019.
·G&A Expenses: General and administrative expenses for the first quarter of 2020 were $1.7 million, essentially flat as compared to the first quarter of 2019. General and administrative expenses for the first quarter of 2020 included $0.5 million of non-cash stock expenses, compared to $0.6 million for the first quarter of 2019.
·Net Loss: Net loss attributable to common stockholders for the first quarter of 2020 was $3.3 million, or $0.06 per share, compared to a net loss of $5.9 million, or $0.18 per share, in the first quarter of 2019.