Processa Pharmaceuticals Announces Third Quarter 2021 Results and Provides Corporate Update
November 11 2021 - 3:05PM
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 announces financial results for the quarter ended September
30, 2021, and provides a corporate update.
Dr. David Young, CEO and Chairman of Processa,
commented, “During the first three quarters we made substantial
progress advancing our three clinical drugs, each having a
potential market exceeding $1 billion. We initiated and commenced
enrollment in both PCS499 and PCS6422 (“Next Generation
Capecitabine”) and received a Safe to Proceed letter from FDA for
the PCS12852 IND. We recently reported results confirming our
hypothesis that inhibiting DPD produced significantly lower levels
of FBAL and demonstrated 50 times greater exposure than reported
for FDA approved capecitabine. We are amending the protocol in the
PCS6422 study to ascertain a more precise understanding of DPD in
the presence of capecitabine and expect these insights to
dramatically improve the safety and efficacy of one of the
cornerstones of chemotherapy.
While we have experienced slower than expected
enrollment in PCS499 and currently have three patients in the
trial, we are expanding our efforts and outreach to identify new
patients, and still anticipate completing the trial in 2022.”
Recent Highlights and New
Developments
- The Next Generation Capecitabine
Phase 1B trial confirmed our hypothesis and provided insight into
the importance of obtaining greater clarity on DPD inhibition and
de novo formation, which could possibly lead to a personalized or
precision medicine approach to treating cancer patients.
- We received clearance from FDA to
proceed with a Phase 2A trial for the treatment of Gastroparesis
and anticipate enrolling the first patient in the first half of
2022 and complete the conduct of the trial in 2022.
- We are conducting a critical review
of our clinical assets to assess opportunities to accelerate
development and approval timelines.
Financial Results for the
third quarter of
2021
Our cash and cash equivalents totaled
$19.1 million as of September 30, 2021, compared to
$15.4 million as of December 31, 2020. We had
15.7 million shares of common stock outstanding as of November
2, 2021.
Our research and development expenses for the
three months ended September 30, 2021 were $1.7 million compared to
$533 thousand for the same period in 2020. General and
administrative expenses for the three months ended September 30,
2021 were $1.3 million compared to $423 thousand for the same
period in 2020. We reported a net loss for the three months ended
September 30, 2021 of $3.0 million compared to a net loss for the
comparable prior year period of $3.1 million. Our net loss per
share for the three months ended September 30, 2021 was $0.19
compared to net loss per share for the three months ended September
30, 2020 of $0.55.
During the three months ended September 30, 2021
we incurred $51 thousand of final expense related to our licensing
of PCS3117 in June 2021. During the comparable period of 2020 we
incurred $2.0 million of non-cash expenses related to our licensing
of PCS12852.
Conference Call Information
To participate in this event, please dial in
approximately 5 to 10 minutes before the beginning of the call.
Date: November 11, 2021Time: 5:30 PMToll-Free:
1-855-327-6838 Toll / International: 1-604-235-2082 Conference ID:
10016982
The conference call will also be available via a
live, listen-only webcast and can be accessed through the Investor
Relations section of Processa Pharmaceuticals website at:
https://processapharmaceuticals.com/
About Processa Pharmaceuticals, Inc.
The mission of Processa is to develop products
with existing clinical evidence of efficacy for patients with unmet
or underserved medical conditions who need treatment options that
improve survival and/or quality of life. The Company uses these
criteria for selection to further develop its pipeline programs to
achieve high-value milestones effectively and efficiently. Active
clinical pipeline programs include: PCS6422 (metastatic colorectal
cancer and breast cancer), PCS499 (ulcerative necrobiosis
lipoidica) and PCS12852 (GI motility/gastroparesis). The members of
the Processa development team have been involved with more than 30
drug approvals by the FDA (including drug products targeted to
orphan disease conditions) and more than 100 FDA meetings
throughout their careers. For more information, visit the company’s
website at www.processapharma.com.
Forward-Looking Statements
This 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 registration
statement relating to the securities being sold in this offering,
which identifies important risk factors which could cause actual
results to differ from those contained in the forward-looking
statements.
For More Information: Michael
Floyd mfloyd@processapharma.com301-651-4256
Jason AssadInvestor
RelationsJassad@processapharma.com678-570-6791
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