Processa Pharmaceuticals Announces Third Quarter Financial Results and Provides Corporate Update
08 Novembre 2022 - 10:00PM
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the
"Company"), a diversified 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 September 30, 2022, and provided an update on its clinical
programs.
Dr. David Young, President and CEO of Processa,
commented, “We are delighted to report our push to enroll patients
in PCS12852 (Gastroparesis) and PCS6422 (Next Generation
Capecitabine) has helped us get critical data and report successful
preliminary results in both trials. The data from these trials will
help us design Phase 2B trials for both programs.
- Next Generation
Capecitabine (NGC) (a combination of PCS6422 and capecitabine): we
have identified lower capecitabine dosage regimens when
administered in NGC that will help avoid dose-limiting toxicities
such as hand-foot syndrome, yet provide approximately 50-times
greater potency than capecitabine alone. We will complete this
study in the near future and seek FDA confirmation of our plans to
implement the principles of the Project Optimus Oncology
Initiative, wherein the objective is to optimize dosing to achieve
a better balance between efficacy and safety than merely using the
maximum tolerated dose.
- PCS12852: we
have shown a statistical difference in the gastric emptying rate
between the 6 patients on 0.5 mg of PCS12852 and the 8 patients on
placebo at p-value < 0.10 with mild to moderate adverse events.
We anticipate having the analysis of the gastroparesis symptoms
completed by the end of the year.
All our energies have been directed towards the
completion of these trials that inform the next steps for these
much-needed therapies.
Advancing these 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 the FDA will review each of these products as we plan the
road maps for designing the studies for our New Drug Applications
to FDA.
Financial Results for the Nine
Months Ended September
30, 2022
Our cash balance on September 30, 2022, was $9.1
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 nine months ended September 30, 2022, we spent
$7.1 million in cash for these three clinical trials and in our
operations. This is significantly less than our GAAP net loss of
$14.4 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 nine months ended September
30, 2022, was $14.4 million or $0.90 per share compared to a net
loss of $8.2 million, or $0.54 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 nine months ended September 30, 2022, we incurred $8.3 million
in research and development costs, an increase of $3.5 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 nine months ending September 30,
2022, our general and administrative expenses totaled $6.1 million
compared to $3.4 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 $6.1 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 nine months ended September 30, 2022, increased by $1.1 million
to $7.1 million, compared to $6 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 September 30, 2022, we had 15.9 million
common shares outstanding.
Conference Call Information
To participate in this event, please log-on or
dial-in approximately 5 to 10 minutes before the beginning of the
call.
Date: November 8, 2022Time: 4:30 p.m. ETToll Free:
888-506-0062International: 973-528-0011Entry Code: 178912Live
Webcast: https://www.webcaster4.com/Webcast/Page/2572/46906
Conference Call Replay InformationToll-free:
877-481-4010International: 919-882-2331Replay Passcode: 46906Replay
Webcast: https://www.webcaster4.com/Webcast/Page/2572/46906
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 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
Grafico Azioni Processa Pharmaceuticals (NASDAQ:PCSA)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni Processa Pharmaceuticals (NASDAQ:PCSA)
Storico
Da Lug 2023 a Lug 2024