On May 13, 2021 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, reported financial results for the year ended March 31, 2021, and provides corporate update (Press release, Processa Pharmaceuticals, MAY 13, 2021, View Source [SID1234579939]).
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Dr. David Young, CEO and chairman of Processa, commented, "During the first quarter we made substantial progress advancing our three clinical in-licensed drugs, each with a potential market exceeding $1 billion. We expect first patients to be dosed with PCS6422 and PCS499 within the next six weeks, and to receive interim data for PCS6422 near the end of the third quarter of 2021 and interim data for PCS499 during the first quarter of 2022."
Recent Highlights and New Developments
We have selected 5 U.S. clinical sites to enroll patients with ulcerative necrobiosis lipoidica and started the screening process for our first patient in our Phase 2B trial "A Randomized, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PCS499 in Treating Ulcerations in Patients who Have Necrobiosis Lipoidica." In order to expedite enrollment for this rare condition, we are evaluating additional clinical sites both within and outside the U.S.
We are initiating clinical sites to enroll patients into our Phase 1B trial "A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors."
We have received guidance from the FDA and plan to submit an IND application in the third quarter of 2021. PCS12852 is a small molecule drug in development for the treatment of gastroparesis and functional gastrointestinal motility disorders.
In February 2021, we closed a private placement with institutional and accredited investors for gross proceeds of $10.2 million. We sold 1,321,132 shares of the common stock at a purchase price of $7.75 per share and received net proceeds of $9.9 million.
Upcoming Clinical Drug Development Milestones
First half of 2021
Dose our first patient in our PCS499 (Ulcerative NL) Phase 2B trial.
Dose our first patient in our PCS6422 (cancer) Phase 1B trial.
Second half of 2021
Submit our IND application for PCS12852 in Gastroparesis to FDA.
Begin our interim cohort results for PCS6422.
First half of 2022
• Obtain interim results from our PCS499 Phase 2B trial.
• Dose our first patient in a Phase 2A trial for PCS12852.
Financial Results for the first quarter of 2021
Our cash and cash equivalents totaled $23 million as of March 31, 2021, compared to $15.4 million as of December 31, 2020. We had 15.5 million shares of common stock outstanding as of March 31, 2021.
Our research and development expenses for the three months ended March 31, 2021 were $1.5 million compared to $501 thousand for the three months ended March 31, 2020. General and administrative expenses for the three months ended March 31, 2021 were $717 thousand compared to $484 thousand for the three months ended March 31, 2020. We reported a net loss for the three months ended March 31, 2021 of $2.1 million compared to a net loss for the comparable prior year period of $874 thousand. Our net loss per share for the three months ended March 31, 2021 was $0.14 compared to net loss per share for the three months ended March 31, 2020 of $0.16.
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