Processa Pharmaceuticals Announces Second Quarter 2022 Financial Results and Provides Corporate Update
August 12 2022 - 9:30AM
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the
"Company"), a clinical stage company developing drugs for patients
who have unmet medical conditions and/or require better treatment
options to improve a patient’s survival and/or quality of life,
today announced financial results for the quarter ended June 30,
2022, and provided an update on its clinical programs.
Dr. David Young, President and CEO of Processa,
commented, “Our efforts to enhance enrollment through adding new
sites, extensive marketing campaigns and working with our CRO
partners are showing results:
- We expect to close out enrollment
for PCS12852 for Gastroparesis within the next month and present
top-line data from the trial before the end of the year.
- We now have a sufficient number of
patients in the screening queue for PCS6422 to complete our interim
cohorts which we believe will provide valuable insights on de novo
formation of DPD. We anticipate we will determine the maximum
tolerated dose by early 2023.
- Patients are beginning to show a
willingness to travel, and we are seeing increased patient activity
in our PCS499 ulcerative necrobiosis lipoidica (uNL) trial. We are
optimistic that we will enroll our interim analysis cohort before
the end of the year.
- As part of our efforts to increase
enrollment on our PCS499 trial, we recently launched a website to
increase awareness of uNL and to inform patients of the ongoing
Phase 2B Study of PCS499.
Advancing these 3 drugs in their respective
clinical trial allows us to obtain the clinical data to better
define each pivotal trial as well as provide us with more insight
into how FDA will review each of these products when we submit the
New Drug Applications to FDA.”
Financial Results for
the Six Months
Ended June 30,
2022
Our cash balance on June 30, 2022, was $12.1
million, which should be sufficient to complete our three on-going
clinical trials and fund our operations into the third quarter of
2023. During the six months ended June 30, 2022, we spent $4.1
million in cash for these three clinical trials and our operations.
This is significantly less than our GAAP net loss of $8.4 million
due to the effect of non-cash items like amortization and
stock-based compensation, and the application of amounts we had
prepaid to our CROs last year.
Our net loss for the six months ending on June
30, 2022, was $8.4 million or $0.53 per share compared to a net
loss of $5.3 million, or $0.35 per share for the same period of
2021. The increase in our net loss relates primarily to increased
clinical trial costs we incurred in our three ongoing trials. For
the six months ended June 30, 2022, we incurred $5.2 million in
research and development costs, an increase of $2.1 million when
compared to the same period of 2021. We anticipate clinical trial
costs will continue to increase for the rest of the year as our
trials continue to progress and we fund development activities for
the other drugs in our pipeline.
During the six months ending June 30, 2022, our
general and administrative expenses totaled $3.2 million compared
to $2.1 million for the same period in 2021. The increase related
primarily to increases in non-cash or stock-based compensation
costs, along with other operating and consulting costs. We
allocated $2.8 million of non-cash compensation costs between our
R&D and G&A costs, with the majority recorded as
G&A.
Our net cash used in operating activities during
the six months ended June 30, 2022, decreased by $300,000 to $4.1
million, compared to $4.4 million for the same period in 2021.
While we experienced increased GAAP costs related to our clinical
trials and operations, we continued to make use of equity
incentives to compensate our executive and development team,
thereby reducing our cash outflow, and we were able to apply
previously made advanced payments to our CROs against current trial
costs.
As of June 30, 2022, we had 15.8 million common shares
outstanding.
Conference Call Information
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Date: August 11, 2022Time: 4:30 p.m. ETToll Free:
877-545-0320International: 973-528-0002 Entry Code: 623559Live
Webcast: https://www.webcaster4.com/Webcast/Page/2572/46205
Conference Call Replay InformationToll-free:
877-481-4010International: 919-882-2331Replay Passcode: 46205Replay
Webcast: https://www.webcaster4.com/Webcast/Page/2572/46205
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 includes Next Generation Capecitabine
(formerly identified as PCS6422) for 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 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.
For More Information:Michael
Floydmfloyd@processapharma.com(301)651-4256
Patrick Lin(925)
683-3218plin@processapharma.com
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