On August 12, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the second quarter ended June 30, 2022, and recent corporate highlights (Press release, Checkpoint Therapeutics, AUG 12, 2022, View Source [SID1234618250]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "Over the past few months, we have made substantial progress towards the regulatory submission for, and potential approval of, cosibelimab for the treatment of cutaneous squamous cell carcinoma ("cSCC"). Simultaneously, we continue to generate compelling clinical data with cosibelimab, most recently announcing positive interim results from our registration-enabling trial in locally advanced cSCC, with over half of the patients achieving a confirmed objective response. These impressive data follow the positive results reported in metastatic cSCC earlier this year. Importantly, we successfully completed our pre-BLA meetings with the FDA in July, reaching agreement on all key aspects discussed with regard to the upcoming BLA submission, including the inclusion of both the locally advanced and metastatic indications. We remain on target to submit the cosibelimab BLA in late 2022."

Mr. Oliviero, continued, "Also during the quarter, we continued to advance our commercial planning to enable a successful launch upon possible approval next year, and believe our price disruptive strategy could generate substantial market share for cosibelimab in the U.S. In parallel, we continue to engage in active discussions with multiple pharmaceutical companies with the goal of expanding access to cosibelimab to patients outside of the U.S."

Recent Corporate Highlights:

In May 2022, Checkpoint announced that it received Pediatric Investigation Plan product-specific waivers from the European Medicines Agency and the U.K. Medicines & Healthcare products Regulatory Agency for cosibelimab in cSCC. The waivers remove the requirement to conduct pediatric clinical studies to support cosibelimab marketing authorization applications in Europe.
In June 2022, the top-line results of the pivotal trial of cosibelimab in metastatic cSCC were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Data highlights presented include a confirmed objective response rate ("ORR") by independent central review in the modified intent to treat population of 48.7% (95% CI, 37.0-60.4) and 13.2% of patients achieved a complete response in target lesions. Cosibelimab was generally well tolerated with no unexpected safety signals.
Also in June 2022, Checkpoint announced positive interim results from its pivotal trial of cosibelimab in locally advanced cSCC. As of the March 2022 data cutoff, the confirmed ORR by independent central review in 31 patients was 54.8% (95% CI: 36.0, 72.7), substantially exceeding a clinically meaningful lower bound of the 95% two-sided confidence interval.
In July 2022, Checkpoint successfully completed two pre-BLA meetings with the FDA (chemistry, manufacturing and controls [CMC] and clinical/non-clinical). Based upon favorable interactions with the agency, the planned BLA submission will include both the metastatic and locally advanced indications. Checkpoint also reached agreement with the FDA on all key aspects discussed with regard to the content of the upcoming BLA submission.
Checkpoint is discontinuing its CONTERNO study, a global, randomized Phase 3 trial of cosibelimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer, due to the substantially longer enrollment period expected as a result of the ongoing conflict in Ukraine. The Company expects that the study will be wound down and closed over the coming months and all costs associated with the study to cease by the end of the fourth quarter.
Financial Results:

Cash Position: As of June 30, 2022, Checkpoint’s cash and cash equivalents totaled $30.9 million, compared to $41.5 million at March 31, 2022 and $54.7 million at December 31, 2021, a decrease of $10.6 million for the quarter and a decrease of $23.8 million for the first half of 2022.
R&D Expenses: Research and development expenses for the second quarter of 2022 were $12.1 million, compared to $7.2 million for the second quarter of 2021, an increase of $4.9 million. Research and development expenses for the second quarters of 2022 and 2021 each included $0.2 million of non-cash stock expenses.
G&A Expenses: General and administrative expenses for the second quarters of 2022 and 2021 each were $2.1 million. General and administrative expenses for the second quarter of 2022 included $0.5 million of non-cash stock expenses, compared to $0.9 million for the second quarter of 2021.
Net Loss: Net loss attributable to common stockholders for the second quarter of 2022 was $14.1 million, or $0.16 per share, compared to a net loss of $9.1 million, or $0.12 per share, in the second quarter of 2021. Net loss for the second quarter of 2022 included $0.7 million of non-cash stock expenses, compared to $1.0 million for the second quarter of 2021.