Business
Processa Pharmaceuticals Announces First Quarter 2022 Financial Results and Provides Corporate Update
Amended Next Generation Capecitabine study has restarted which will elucidate timelines for de novo formation of DPDExpanded efforts for enrollment in
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"Amended Next Generation Capecitabine study has restarted which will elucidate timelines for de novo formation of DPDExpanded efforts for enrollment in PCS499PCS12852 on target to complete enrollment by Q3 HANOVER, Md., May 12, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (\"Processa\" or the \"Company\"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient’s survival and/or quality of life, today announced financial results for the quarter ended March 31, 2022, and provided an update on its clinical programs. Dr. David Young, CEO and chairman of Processa, commented, “We are on track to get important data from all our clinical programs over the remainder of this year that will elucidate the path to registration for these programs that each have a market that could exceed $1 billion. The amended protocol for Next Generation Capecitabine will provide insights into the de novo formation of DPD by mid-summer and allow us to get to the MTD by year-end;Our expanded outreach to find and enroll patients in the PCS499 uNL trial has identified new potential patients to complete enrollment for our interim analysis cohort mid-summer and interim results by year-end;Enrollment in PCS12852 is going well and is expected to fully enroll patients and provide top line results before the end of the year; andWe expect to complete the initial development on the macromolecule assays that will be evaluated as potential biomarkers for PCS3117 and confirm our Regulatory Path with FDA by the end of the year.” Financial Results for the Quarter Ended March 31, 2022 We continue to manage our cash efficiently and had a cash balance of $14.4 million at March 31, 2022. We believe this will allow us to complete our three on-going clinical trials and fund our operations into the third quarter of 2023. During the three months ending on March 31, 2022 we spent cash of $1.8 million in our clinical trials and operations. For the three months ended March 31, 2022, we reported a net loss of $3.2 million, or $0.20 per share compared to a net loss of $2.1 million, or $0.14 per share for the same period of 2021. The increase in our net loss relates primarily to increased clinical trial costs we incurred. During the three months ended March 31, 2022, we ...