According to the Complaint, Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company that focuses on the acquisition, development, and commercialization of novel treatments for patients with solid tumor cancers in the U.S. and internationally. Checkpoint’s lead antibody product candidate is cosibelimab for the treatment of selected recurrent or metastatic cancers, including metastatic cSCC and locally advanced cSCC.

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) Checkpoint had overstated its oversight of, and/or its establishment of adequate manufacturing standards and controls over, its third-party contract manufacturers; (ii) accordingly, there were one or more issues with the Company’s third-party contract manufacturing organization (“CMO”) for cosibelimab; (iii) all the foregoing reduced the likelihood that the FDA would approve the cosibelimab BLA in its present form; (iv) as a result, the manufacturing, regulatory, and commercial prospects of cosibelimab were overstated; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.