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Tivic Health® Systems, Inc. (NASDAQ:TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing to complete the GMP manufacturing validation of the lead candidate from its TLR5 program, Entolimod™, for treatment of Acute Radiation Syndrome, or ARS, in preparation for filing a Biological Licensing application, or BLA, with the U.S. Food & Drug Administration.
Scorpius BioManufacturing, Inc. is an integrated contract development and manufacturing organization (CDMO) and subsidiary of Scorpius Holdings Inc. (OTC:SCPX), which will be the primary U.S. manufacturer for Entolimod™. Scorpius plans to utilize its scientific and technical expertise to validate the commercial manufacturing process for Tivic's lead candidate, Entolimod™.
The GMP Validation Program is valued at approximately $4.1 million and is inclusive of the following activities: cell line verification, legacy process verification, GMP scale-up production, drug product fill and finish, analytical development and qualification, and finally upstream and downstream optimization of the process. All of these activities are designed to ensure Tivic submits to the FDA a complete CMC (chemistry, manufacturing, and control) package for its Entolimod BLA.
