Processa Pharmaceuticals Announces Year-End 2021 Results and Provides Corporate Update
30 Marzo 2022 - 10:00PM
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 announced financial results for the year ended December 31,
2021, and provided a corporate update.
Dr. David Young, CEO and chairman of Processa,
commented, “Although COVID presented challenges for us and our
industry in 2021, we commenced and enrolled patients in PCS499 for
the treatment of uNL, PCS6422 (Next Generation Capecitabine) for
the treatment of GI cancer, and received clearance for an IND for
PCS12852 for gastroparesis. We were excited to learn that Next
Generation Capecitabine is fifty times more potent than presently
approved capecitabine and modified the protocol to further enhance
the efficacy and safety of Next Generation Capecitabine. In
addition, our modifications to the protocol now allow us to
evaluate the possibility of treating patients using an
individualized-personalized medicine approach for Next Generation
Capecitabine. We completed the administrative efforts to commence
our study in gastroparesis with the first patient to be dosed
imminently. These efforts will produce three catalytic data events
in the coming 9-10 months each in indications that could
potentially exceed markets of $1 billion.”
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 an individualized or personalized medicine approach to treating
cancer patients.
- We
have replaced non-performing sites and added remedial recruitment
procedures to our PCS499 Phase 2B trial and expect to complete
enrollment of the interim analysis cohort of patients
mid-2022.
- 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 while completing 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.
Upcoming Clinical Drug Development
Milestones
First half of 2022
- Phase 1B
Restart recruitment with improved dosing regimen of PCS6422
(Cancer) and obtain a preliminary analysis of DPD inhibition and de
novo formation timeline
- Phase 2B
Interim analysis cohort enrolled for PCS499
- First
Patient in (GI/gastroparesis) for PCS12852
- Complete
initial development of biomarker assays for PCS3117
Second half of 2022
-
Determine dosing regimens for Next Generation Capecitabine to
potentially improve the efficacy and safety for treatment in
patients with cancer (i.e., possible dosing regimens for both
PCS6422 and capecitabine)
- Interim
Cohort analysis and complete enrollment for PCS499
- Complete
enrollment and provide top-line data Q4’22 - Q1‘23 for
PCS12852
- Define
regulatory approval development paths for PCS3117 and PCS11T
Financial Results for
the Year Ended December 31,
2021
We continue to manage our cash efficiently and
as of December 31, 2021 we had a cash balance of $16.5 million.
During the year ending on December 31, 2021 we increased our cash
balance by $1.1 million compared to December 31, 2020 by raising
net proceeds of $9.8 million in a private placement in early 2021
and in our ATM offering offset by $8.7 million in costs we incurred
related to our three clinical trials and our spending for operating
and other related costs.
We define overhead as our general and
administrative expenses plus the salaries for our development and
administrative teams. Our cash outlay for overhead expenses for the
year ended December 31, 2021 was only $3.0 million. We accomplished
this in part by having the cash portion of our six executive team
members totaling only $525,000 for 2021. We are focused on
directing our cash toward activities that move our drug products
forward.
For the year ending on December 31, 2021 we
reported a net loss of $11.4 million, or $0.75 per share compared
to a net loss of $14.4 million, or $2.54 per share for the same
period of 2020. The primary reduction in our net loss was due a
decline in licensing activity in 2021 versus 2020. During 2021 we
licensed PCS3117 from Ocuphire Pharma. Inc. for cash and stock
totaling $567 thousand while in 2020, we incurred. $8.7 million
related to licensing PCS12852 from Yuhan Pharmaceuticals, PCS6422
from Elion Oncology and PCS11T from Aposense. Adjusting for
in-process research and development acquisition costs, our net loss
increased by $5.1 million for the year ended December 31, 2021
compared to the comparable period in 2020. This increase primarily
relates to increased clinical trial costs we incurred as we
progress with our clinical trials.
During the year ended December 31, 2021, we
incurred research and development expenses totaling $6.9 million
compared to $3.2 million for the same period in 2020. The increase
in our R&D costs of $3.7 million in 2021 was primarily due to
costs we incurred related to our active clinical trials. Our
general and administrative expenses totaled $4.7 million for the
year ended December 31, 2021 compared to $3.3 million for the same
period in 2020. The increase related primarily to increases in
professional and other consulting fees, as well as non-cash
stock-based compensation. Allocated between our R&D and G&A
costs is $3.4 million of non-cash compensation costs.
Conference Call Information
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Date: March 30, 2022Time: 4:30 p.m. ETToll Free:
888-506-0062International: 973-528-0011Entry Code: 837465Live
Webcast: https://www.webcaster4.com/Webcast/Page/2572/44826
Conference Call Replay Information
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Webcast: https://www.webcaster4.com/Webcast/Page/2572/44826
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
Patrick Linplin@processapharma.com925-683-3218
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