PharmaDrug Inc. announced that the company has now completed the significant ground-work, including sourcing and characterization of bulk materials, preparation of reference standards and qualification of all necessary analytical methodologies to support multi-kilogram, cGMP production of cepharanthine-2HCL drug substance for use in the final drug product production of PD-001, its patented, orally bioavailable version of cepharanthine. Completion of this lot, slated for September 2022, significantly advances the Company's efforts to support pre-clinical and clinical development, including to the commencement of potential Phase 2 clinical studies, for parallel indications in oncology and infectious disease. Consistent with these advancements, the Company has formally engaged Genvion Corporation to complete necessary ICH-compliant stability testing and forced degradation studies in support of future IND filings to the U.S. Food and Drug Administration (FDA).

On behalf of the Company, Genvion Corporation will take receipt of the cGMP drug substance and complete all manufacturing efforts necessary to produce the orally bioavailable clinical drug product, PD-001. Parallel Development Paths for Oncology and Infectious Disease Create Efficiency: Following submission of its Type B pre-IND meeting request and briefing package to the FDA, the Company received a written response regarding its clinical development plan for PD-001, as a potential oral antiviral pill for COVID-19 and variants of concern. PharmaDrug has executed on feedback, specifically as it related to necessary chemistry and manufacturing controls set by the regulator, to meaningfully advance its preclinical development programs for PD-001 as a potential treatment for infectious disease and oncology indications including prostate and esophageal cancers.