Processa Pharmaceuticals Provides Product Pipeline and Financial Update
28 Agosto 2024 - 9:00AM
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the
Company), a clinical-stage pharmaceutical company focused on
developing the next generation of chemotherapeutic drugs with
improved efficacy and safety, provides updates on its product
pipeline, upcoming milestones and business activities, and reports
financial results for the three and six months ended June 30, 2024.
“We made significant progress in advancing our
three development programs year-to-date, with a particular focus on
our lead candidate NGC-Cap,” said George Ng, Chief Executive
Officer of Processa Pharmaceuticals. “Upon receiving FDA clearance
of our NGC-Cap IND application, we initiated a Phase 2 clinical
trial in metastatic breast cancer. We look forward to enrolling
patients in this multicenter, open-label study and expect to have
an initial data readout in mid-2025.”
Key Program UpdatesProcessa is
focused on developing next-generation chemotherapies (NGC) by
improving widely used U.S. Food and Drug Administration
(FDA)-approved oncology drugs to extend a patient’s survival and/or
improve their quality of life. This is achieved by altering how
drugs are metabolized and/or distributed in the body, including how
they reach cancer cells. In addition, Processa utilizes its
Regulatory Science Approach, including the principles associated
with FDA’s Project Optimus Oncology initiative, in the development
of its NGC drug products to achieve a more favorable benefit-risk
profile.
Processa’s updated corporate presentation,
including its product pipeline, is available on the company’s
website.
- PCS6422: Next-Generation
Capecitabine (NGC-Cap)
- NGC-Cap is a combination of PCS6422
and capecitabine, which is the oral prodrug of the cancer drug
5-fluorouracil (5-FU). PCS6422 alters the metabolism of 5-FU,
resulting in more 5-FU distributed to cancer cells.
- In July 2024, the FDA cleared the
Company’s Investigational New Drug application (IND) application
for a Phase 2 trial with NGC-Cap in metastatic or advanced breast
cancer. Subsequently, Processa initiated the Phase 2 study
(NCT06568692) , which is a global, multicenter, open-label,
adaptive design trial comparing two different doses of NGC-Cap to
FDA-approved monotherapy capecitabine in approximately 60 to 90
patients. As agreed to with the FDA, the breast cancer indication
should lead to a more efficient development program while providing
a greater likelihood of approval.
- The NGC-Cap Phase 1b study
evaluated ascending doses of capecitabine when combined with a
fixed dose of PCS6422 in patients with advanced, relapsed or
refractory progressive gastrointestinal cancer. These patients had
to relapse from or fail all other treatments. NGC-Cap demonstrated
greater 5-FU exposure and lower fluoro-beta-alanine (FBAL) exposure
with a better or similar side-effect profile compared with
monotherapy capecitabine, as well as preliminary anti-tumor
activity. In all evaluable patients who received one dose of
PCS6422 and seven days of capecitabine, partial responses or stable
disease was observed in 66.7% (8 out of 12) of patients with
progression-free survival of approximately 5 to 11 months across
these patients.
- In April 2024, Processa presented
an abstract at the American Association for Cancer Research (AACR)
Annual Meeting 2024, including new Phase 1b data on NGC-Cap in
patients with advanced, relapsed or refractory progressive
gastrointestinal cancer. NGC-Cap demonstrated 5-10 times greater
5-FU exposure than monotherapy capecitabine at a significantly
lower dose, along with a favorable safety profile. As such, NGC-Cap
holds potential for improved efficacy in more patients due to a
higher distribution of 5-FU to cancer cells. Further, the extremely
low exposure of FBAL, the primary catabolite formed from the
metabolism of 5-FU, across all NGC-Cap doses resulted in fewer
catabolite-related side effects, with only one patient having Grade
1 hand-foot-syndrome, an FBAL side effect that often requires dose
modifications.
- PCS3117: Next-Generation
Gemcitabine (NGC-Gem)
- NGC-Gem is an oral analog of
gemcitabine (Gemzar®) that is converted to its active metabolite by
a different enzyme system, with potential for a positive response
in gemcitabine patients including those inherently resistant to or
who acquire resistance to gemcitabine.
- Processa is evaluating the
potential of NGC-Gem in patients with pancreatic and other cancers,
as well as ways to identify patients who are more likely to respond
to NGC-Gem than gemcitabine alone. The Company plans to meet with
the FDA in late 2024 or early 2025 to discuss potential trial
designs, including implementation of the Project Optimus
initiative.
- PCS11T: Next-Generation Irinotecan
(NGC-Iri)
- NGC-Iri is an analog of SN38, the
active metabolite of irinotecan, that is expected to have an
improved safety-efficacy profile in every type of cancer where
irinotecan is used.
- As announced
earlier this month, two studies in a human melanoma xenograft mouse
model measured SN-38 in tumors, plasma and other tissues following
administration of NGC-Iri, irinotecan and Onivyde®, the liposomal
formulation of irinotecan. One study compared NGC-Iri with
irinotecan, and the other compared irinotecan with Onivyde®. The
results found that mice administered NGC-Iri had greater
accumulation of SN-38 in the tumor compared with other tissues and
that less SN-38 accumulated in non-cancer tissues, which could lead
to improved efficacy with a more favorable adverse event profile
compared with irinotecan and Onivyde®.
- In April 2024, Processa presented a
second abstract at AACR titled “Application of phase 1 and
pre-clinical data to assist in determining the optimal dosage
regimen for cancer drugs using the principles of Project Optimus.”
This abstract describes the FDA Project Optimus Initiative and
draft optimal dosage regimen (ODR) guidance, which requires an ODR
justified by a dose-ranging efficacy and safety study, as opposed
to a maximum tolerated dose approach. Processa provided NGC-Iri
preclinical study examples to demonstrate how the shape of the
exposure-response relationships for safety and efficacy can be
determined from these pre-clinical studies. By better understanding
the exposure-response relationship earlier in the development
process, defining the recommended dose range and optimal dosage
regimen becomes easier in an efficacy-safety study, in a pivotal
study, and for FDA approval.
- The Company is currently evaluating
the manufacturing process and potential sites for NGC-Iri. In
addition, Processa is defining the potential paths to approval,
which include defining the target patient population and the type
of cancer, with the expectation to conduct IND-enabling toxicology
studies in 2025.
Second Quarter Financial
Results
Research and development expenses for the second
quarter of 2024 were $1.7 million, unchanged from the second
quarter of 2023. General and administrative expenses for the second
quarter of 2024 were $1.4 million, compared with $1.0 million for
the second quarter of 2023, primarily due to an increase in
professional fees.
The net loss for the second quarter of 2024 was
$3.0 million, or $1.01 per share, compared with the net loss for
the second quarter of 2023 of $2.6 million, or $1.94 per share. All
per-share figures reflect a 1-for-20 reverse stock split that was
effective as of January 22, 2024.
Cash and cash equivalents were $5.6 million as
of June 30, 2024.
About Processa Pharmaceuticals, Inc.
Processa is a clinical-stage pharmaceutical
company focused on developing the Next Generation Chemotherapy
(NGC) drugs with improved safety and efficacy. Processa’s NGC drugs
are modifications of existing FDA-approved oncology therapies
resulting in an alteration of the metabolism and/or distribution of
these drugs while maintaining the existing mechanisms of killing
the cancer cells. By combining its novel oncology pipeline with
proven cancer-killing active molecules and its Regulatory Science
Approach, Processa’s strategy is to develop more effective therapy
options with improved tolerability for cancer patients through an
efficient regulatory path.
For more information, visit our 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.
Company Contact:Patrick
Lin(925) 683-3218plin@processapharma.com
Investor Relations
Contact:Yvonne BriggsLHA Investor Relations(310)
691-7100ybriggs@lhai.com
[Financial Tables to follow]PROCESSA
PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands, except share
information) (unaudited)
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,571 |
|
|
$ |
4,706 |
|
Prepaid expenses and other |
|
|
1,907 |
|
|
|
926 |
|
Total Current Assets |
|
|
7,478 |
|
|
|
5,632 |
|
|
|
|
|
|
|
|
|
|
Property and Equipment, net |
|
|
2 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
Other Assets |
|
|
|
|
|
|
|
|
Lease right-of-use assets, net of accumulated amortization |
|
|
115 |
|
|
|
146 |
|
Security deposit |
|
|
6 |
|
|
|
6 |
|
Total Other Assets |
|
|
121 |
|
|
|
152 |
|
Total Assets |
|
$ |
7,601 |
|
|
$ |
5,787 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Current maturities of lease liabilities |
|
$ |
93 |
|
|
$ |
84 |
|
Accounts payable |
|
|
953 |
|
|
|
312 |
|
Due to licensor |
|
|
- |
|
|
|
189 |
|
Due to related parties |
|
|
- |
|
|
|
- |
|
Accrued expenses |
|
|
505 |
|
|
|
146 |
|
Total Current Liabilities |
|
|
1,551 |
|
|
|
731 |
|
Non-current Liabilities |
|
|
|
|
|
|
|
|
Non-current lease liabilities |
|
|
26 |
|
|
|
67 |
|
Total Liabilities |
|
|
1,577 |
|
|
|
798 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Common stock, par value $0.0001, 100,000,000 shares authorized:
2,873,883 issued and 2,868,883 outstanding at June 30, 2024; and
1,291,000 issued and 1,286,000 outstanding at December 31,
2023 |
|
|
1 |
|
|
|
- |
|
Additional paid-in capital |
|
|
87,429 |
|
|
|
80,658 |
|
Treasury stock at cost — 5,000 shares at June 30, 2024 and December
31, 2023 |
|
|
(300 |
) |
|
|
(300 |
) |
Accumulated deficit |
|
|
(81,106 |
) |
|
|
(75,369 |
) |
Total Stockholders’ Equity |
|
|
6,024 |
|
|
|
4,989 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
7,601 |
|
|
$ |
5,787 |
|
PROCESSA PHARMACEUTICALS,
INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except per share
data)(unaudited)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
1,730 |
|
|
$ |
1,688 |
|
|
$ |
3,270 |
|
|
$ |
3,343 |
|
General and administrative expenses |
|
|
1,352 |
|
|
|
1,026 |
|
|
|
2,622 |
|
|
|
3,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Loss |
|
|
(3,082 |
) |
|
|
(2,714 |
) |
|
|
(5,892 |
) |
|
|
(6,820 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income (Expense),
net |
|
|
72 |
|
|
|
102 |
|
|
|
155 |
|
|
|
185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Operating Loss Before
Income Tax Benefit |
|
|
(3,010 |
) |
|
|
(2,612 |
) |
|
|
(5,737 |
) |
|
|
(6,635 |
) |
Income Tax Benefit |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(3,010 |
) |
|
$ |
(2,612 |
) |
|
$ |
(5,737 |
) |
|
$ |
(6,635 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss per Common Share -
Basic and Diluted |
|
$ |
(1.01 |
) |
|
$ |
(1.94 |
) |
|
$ |
(2.11 |
) |
|
$ |
(5.34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Common Shares
Used to Compute Net Loss Applicable to Common Shares - Basic and
Diluted |
|
|
2,983,283 |
|
|
|
1,346,808 |
|
|
|
2,724,903 |
|
|
|
1,243,475 |
|
# # #
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