Processa Pharmaceuticals CEO Dr. David Young Issues Letter to Shareholders Providing Outlook for 2022
27 January 2022 - 12:15AM
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 released the following letter to shareholders from its Chief
Executive Officer Dr. David Young.
Dear Fellow Shareholder:
As we start a new year, I want to thank you for
your support and take this opportunity to share our accomplishments
in 2021 and our planned path forward. We believe 2022 will be a
transformative year for Processa as our multi-asset pipeline
continues to mature and we achieve important clinical
milestones.
Our pipeline is different from that of other
biotech companies because each of our drugs have a “de-risked”
development path forward which includes:
|
● |
targeting patients with unmet medical need conditions who either
have no treatment option or require better options to improve their
survival and/or quality of life; |
|
● |
some clinical evidence of efficacy and safety in the targeted
treatment population for the drug itself or a drug with similar
pharmacological properties; and |
|
● |
a more efficient Regulatory Science development path with greater
probability of success. |
Processa is a “drug development company” not a
drug discovery company. Our pipeline of drugs does not include a
new drug class or new drug target like many discovery companies.
Our efforts and energies are directed toward advancing each program
as efficiently as possible to the next development stage while
obtaining information that will assist us in ultimately obtaining
marketing authorization from regulatory agencies. Our past
experiences in previous companies have been well rewarded when we
have followed our Regulatory Science approach to focus on
development activities rather than the associated risks of drug
discovery.
The Processa Regulatory Science approach was
initially developed by Processa’s founders 30 years ago when they
were formally engaged by the FDA to conduct regulatory science
focused clinical programs that would become the foundation for
multiple FDA Guidance documents. Over the years, the Processa
Founders have refined this Regulatory Science approach resulting in
FDA approvals within almost every New Drug Division of the FDA.
We have invested our time and our own money in
Processa and its mission. We don’t believe value creation comes
from bloated payrolls for executives in the C-suite; it comes from
generating compelling clinical data. This is where we are
allocating our resources. After uplisting on the Nasdaq, we
demonstrated our personal commitments by limiting the combined cash
compensation for our six C-suite members to less than $600k
annually. This aligns our interests with our shareholders.
In 2022, our focus continues to be developing
our pipeline of drugs to obtain data that would allow us to
initiate multiple Phase 3 trials in 2023.
Accomplishments in 2021
Our four major goals at the start of 2021 were simple:
1. |
Initiate enrollment of PCS499 in our Phase 2B trial for the
treatment of ulcerative Necrobiosis Lipoidica (uNL) and enroll
enough patients to complete an interim analysis. |
|
|
|
We anticipated enrolling 8-10 patients for a six-month treatment
course before the end of 2021. Unfortunately, COVID-19 had a
significant impact on our study enrollment and only three patients
were enrolled. Patients who have suffered for months or years from
the serious but not life-threatening condition of uNL were neither
willing to take the risk of contracting a life-threatening case of
COVID-19 themselves nor risk passing it on to family members as a
result of required visits to our clinical sites. We also
experienced having patients scheduled for study screening dying of
COVID-19 before screening. Given the low enrollment rate, we
expanded our patient recruitment efforts in the second half of
2021. Even with slower than expected enrollment, we should still
meet our goal of initiating a Phase 3 pivotal trial in 2023. |
|
|
2. |
Initiate enrollment in our Next Generation Capecitabine (PCS6422
and capecitabine combination treatment) Phase 1B trial in Patients
with Advanced Refractory Gastrointestinal Tract Tumors and
determine if PCS6422 was successfully affecting the metabolism of
capecitabine. |
|
|
|
We initiated the trial and successfully completed the first 2
cohorts. The interim analysis of the data from these patients
demonstrated that PCS6422 successfully inhibited the metabolism of
capecitabine over 24-48 hours after administration of PCS6422 but
unfortunately did not inhibit the metabolism throughout the 7 days
of capecitabine treatment as desired. The first 2 cohorts provided
us with enough information to modify our trial so we can determine
more optimal regimens for both PCS6422 and capecitabine. We delayed
enrolling additional patients in 2021 until we finalize the
modification of our trial, expected to be submitted to FDA in the
first half of 2022. |
|
|
3. |
Obtain an IND for PCS12852 for the treatment of gastroparesis. |
|
|
|
Many of the drugs that currently address the gastroparesis
multibillion dollar market have serious side effects and can only
be taken for a short duration of time. The first step to guide the
development of PCS12852 is to evaluate the effect of PCS12852 on
the gastric emptying rate and the symptoms associated with
gastroparesis. An IND was submitted in 2021 and FDA notified us
that the Phase 2A trial was safe to proceed. A CRO was selected,
sites are being initiated and preparations are underway to begin
enrolling patients during the first half of 2022. |
|
|
4. |
In-license a drug such as PCS3117 that is closer to Phase 3 and NDA
than other drugs within our pipeline but still possess a
“de-risked” development path. |
|
|
|
PCS3117 was in-licensed in 2021. PCS3117 is a chemotherapeutic
agent similar to currently FDA approved Gemcitabine. PCS3117 has
been shown in preliminary studies to successfully treat pancreatic
cancer patients that are both resistant and responsive to
Gemcitabine. The drug has received Orphan Designation for the
treatment of pancreatic cancer. Our development plan for PCS3117
has been defined with alternate routes to approval depending on the
results of the next studies we plan to conduct. We have also begun
to define and develop biomarker assays that would help us identify
patients likely to have a better response to PCS3117 than
Gemcitabine. |
In addition to these achievements, in February
2021 we completed a private placement sale of 1,321,132 shares of
common stock at a purchase price of $7.75 per share for a total of
$10.2 million; and have expanded our development team with the
hiring of four highly qualified individuals.
Milestones for 2022
As we enter 2022, we have sufficient cash to
complete the three clinical trials briefly described below (i.e.,
PCS499 Phase 2B, PCS6422 Phase 1B, PCS12852 Phase 2A) and the
biomarker assay development for PCS3117. If we see opportunities in
the financing market, we could also strategically improve our cash
position by nominal use of our ATM financing.
1. |
PCS499 – With the expanded enrollment efforts, we expect to
complete our Phase 2B interim analysis and complete full enrollment
of all patients in 2022. This will allow us to complete the final
report on the Phase 2B trial in 2023 and communicate with FDA as we
initiate our Phase 3 trial in 2023. |
|
|
2. |
PCS6422 – We are finalizing the revised Phase 1B protocol for “Next
Generation Capecitabine” to first determine a more optimal DPD
inhibition regimen for PCS6422 followed by defining the Maximum
Tolerated Dose of capecitabine for the more optimal PCS6422 DPD
inhibition regimen. The revised protocol will be submitted to the
FDA in the first quarter of 2022 with the plan to restart
recruitment in the first half of 2022. We are expanding our
recruitment efforts for this program to complete recruitment of all
patients for this trial by the end of 2022. |
|
|
3. |
PCS12852 – The Phase 2A trial in gastroparesis patients has been
initiated with enrollment expected to begin soon. This study will
enroll 24 patients with enrollment completion expected by the end
of 2022. |
|
|
4. |
PCS3117 – We have started the development of biomarkers for PCS3117
in pancreatic cancer patients and expect to complete this during
the first half of 2022. Following completion of the biomarker
assays, we plan to begin a clinical trial evaluating the
biomarker’s role in PCS3117 treatment. |
|
|
5. |
PCS11T – The IND enabling development program for the treatment of
small cell lung cancer and gastrointestinal cancer is being
finalized for PCS11T with the expectation that these studies could
be initiated in 2022. |
|
|
6. |
All Programs – We hope to identify additional regulatory paths to
accelerate development and reduce development risks for some of our
pipeline drugs. |
In summary, at the core of our operation is the
application of our Regulatory Science approach, which in essence is
about designing and refining the development programs and clinical
studies given the data at hand and conducting development programs
through the eye of an FDA reviewer whose primary goal is to
evaluate approvability through the “Benefit/Risk” profile of a
drug. With our achievements in 2021 and expected progress in 2022,
in addition to evaluating the data as a scientist/clinician, we
will utilize our experience with the FDA to evaluate the studies,
data and programs as an FDA reviewer would, allowing the program
for each drug to be more efficiently developed while de-risking the
program at each step.
If you have any questions about our programs,
contact Michael Floyd (mfloyd@processapharma.com) or Patrick Lin
(plin@processapharma.com).
We look forward to an exciting 2022!
Sincerely,
David Young Pharm.D., Ph.D.CEO, Processa Pharmaceuticals
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 (gastroparesis/GI motility). 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 Floydmfloyd@processapharma.com301-651-4256
Jason AssadJassad@processapharma.com678-570-6791
Processa Pharmaceuticals (NASDAQ:PCSA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Processa Pharmaceuticals (NASDAQ:PCSA)
Historical Stock Chart
From Jul 2023 to Jul 2024