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For More Information: Patrick Lin plin@processapharma.com 925-683-3218 PROCESSA PHARMACEUTICALS TO MOVE FORWARD WITH A PCS499 PHASE 3 TRIAL AFTER A

Key Takeaway: FOR IMMEDIATE RELEASE For More Information: Patrick Lin plin@processapharma.com 925-683-3218 PHARMACEUTICALS TO MOVE FORWARD WITH A PCS499 PHASE 3 TRIAL AFTER A SUCCESSFUL FDA MEETING MD - March 30, 2020 - Processa Pharmaceuticals, Inc. (OTCQB: PCSA), announced the success

Full Press Release Details

FOR IMMEDIATE RELEASE For More Information:
Patrick Lin
plin@processapharma.com
925-683-3218
PHARMACEUTICALS TO MOVE FORWARD WITH A
PCS499 PHASE 3 TRIAL AFTER A SUCCESSFUL FDA MEETING
MD - March 30, 2020 - Processa Pharmaceuticals, Inc. (OTCQB: PCSA), announced
the successful completion of their meeting with the U.S. Food and Drug Administration (FDA) for PCS499, its investigational product
targeting the treatment of Necrobiosis Lipoidica (NL).
the meeting Processa and the FDA discussed the clinical program as well as the nonclinical and clinical pharmacology plans to
support the submission of the PCS499 New Drug Application (NDA) in the U.S. for the treatment of ulcers in NL patients. With input
from the FDA through a Special Protocol Assessment, Processa will be designing and conducting a Phase 3 trial to evaluate the
ability of PCS499 to completely close ulcers in patients with NL. Processa initially planned to begin recruiting for this trial
in Q4 2020 but with the COVID-19 pandemic, it is expected that this trial will begin recruiting patients in 2021. FDA will determine
if a second confirmatory Phase 3 trial is required after reviewing the results from this first trial.
are pleased with the outcome of the FDA meeting and the feedback we received from the FDA. We believe that the results from our
completed Phase 2 trial in NL patients, especially those with more severe ulcerated forms of NL, are encouraging and we appreciate
the guidance provided by the FDA regarding our next clinical trial and the requirements to support our NDA submission. We look
forward to working with the FDA in designing a Phase 3 trial that will demonstrate the efficacy and safety of PCS499 for a NDA
approval,'" said Dr. David Young, Chief Executive Officer at Processa.
is a chronic, disfiguring condition affecting the skin and tissue under the skin typically on the lower extremities with no currently
approved FDA treatments. More severe complications can occur, such as deep tissue infections and osteonecrosis threatening life
of the limb. Approximately 74,000 - 185,000 people in the United States and more than 200,000 - 500,000 people outside the
United States are affected by NL with the prevalence of open ulcers being approximately 30% of all NL patients. The degeneration
of tissue occurring at the NL lesion site is caused by a number of pathophysiological changes which has made it extremely difficult
to develop effective treatments for this condition. At this time there is no approved FDA treatment for NL and PCS499 could be
the first drug approved. PCS499 and its metabolites affect a number of biological pathways, several of which contribute to the
pathophysiology associated with NL.
Processa Pharmaceuticals, Inc.
mission of Processa has been to develop products where existing clinical evidence of efficacy already exists in unmet medical
need conditions, medical conditions where patients need treatment options that will improve survival and/or quality of life. The
Company has assembled a proven regulatory science development team, management team, and Board of Directors. The Processa development
team has been involved with more than 30 drug approvals by the FDA (including drug products targeted to orphan disease conditions)
and 100 FDA meetings. For more information, please visit http://www.processapharma.com.
release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking
statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those
expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically
the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ
from those contained in the forward-looking statements.
Last updated: Mar 30, 2020