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 announces financial results for the year ended March 31,
2021, and provides corporate update.
Dr. David Young, CEO and chairman of Processa,
commented, “During the first quarter we made substantial progress
advancing our three clinical in-licensed drugs, each with a
potential market exceeding $1 billion. We expect first patients to
be dosed with PCS6422 and PCS499 within the next six weeks, and to
receive interim data for PCS6422 near the end of the third quarter
of 2021 and interim data for PCS499 during the first quarter of
2022.”
Recent Highlights and New Developments
- We have selected 5 U.S. clinical
sites to enroll patients with ulcerative necrobiosis lipoidica and
started the screening process for our first patient in our Phase 2B
trial “A Randomized, Double-blind, Placebo-Controlled Clinical
Trial to Evaluate the Efficacy and Safety of PCS499 in Treating
Ulcerations in Patients who Have Necrobiosis Lipoidica.” In order
to expedite enrollment for this rare condition, we are evaluating
additional clinical sites both within and outside the U.S.
- We are initiating clinical sites to
enroll patients into our Phase 1B trial “A Study of the Safety and
PK of PCS6422 (Eniluracil) with Capecitabine in Patients with
Advanced, Refractory GI Tract Tumors.”
- We have received guidance from the
FDA and plan to submit an IND application in the third quarter of
2021. PCS12852 is a small molecule drug in development for the
treatment of gastroparesis and functional gastrointestinal motility
disorders.
- In February 2021, we closed a
private placement with institutional and accredited investors for
gross proceeds of $10.2 million. We sold 1,321,132 shares of the
common stock at a purchase price of $7.75 per share and received
net proceeds of $9.9 million.
Upcoming Clinical Drug Development
Milestones
First half of 2021
- Dose our first patient in our PCS499 (Ulcerative NL) Phase 2B
trial.
- Dose our first patient in our PCS6422 (cancer) Phase 1B
trial.
Second half of 2021
- Submit our IND application for PCS12852 in Gastroparesis to
FDA.
- Begin our interim cohort results for PCS6422.
First half of 2022
• Obtain interim results from our PCS499 Phase 2B trial.• Dose
our first patient in a Phase 2A trial for PCS12852.
Financial Results for the first quarter
of 2021
Our cash and cash equivalents totaled
$23 million as of March 31, 2021, compared to
$15.4 million as of December 31, 2020. We had
15.5 million shares of common stock outstanding as of
March 31, 2021.
Our research and development expenses for the
three months ended March 31, 2021 were $1.5 million compared to
$501 thousand for the three months ended March 31, 2020. General
and administrative expenses for the three months ended March 31,
2021 were $717 thousand compared to $484 thousand for the three
months ended March 31, 2020. We reported a net loss for the three
months ended March 31, 2021 of $2.1 million compared to a net loss
for the comparable prior year period of $874 thousand. Our net loss
per share for the three months ended March 31, 2021 was $0.14
compared to net loss per share for the three months ended March 31,
2020 of $0.16.
Conference Call Information
To participate in this event, please dial in
approximately 5 to 10 minutes before the beginning of the call.
Date: May 13, 2021 Time: 5:30 p.m. ET Toll Free:
888-506-0062; Entry Code: 396394 International: 973-528-0011;
Entry Code: 396394Live
Webcast: https://www.webcaster4.com/Webcast/Page/2572/41274
Conference Call Replay InformationToll-free:
877-481-4010 International: 919-882-2331 Replay Passcode:
41274Replay
Webcast: https://www.webcaster4.com/Webcast/Page/2572/41274
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
well-defined criteria to select drugs for its pipeline in order to
achieve high-value milestones effectively and efficiently. Active
pipeline programs include: PCS499 (ulcerative necrobiosis
lipoidica), PCS12852 (GI motility/gastroparesis) and PCS6422
(metastatic colorectal cancer and breast cancer). 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 press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995 that reflect the current beliefs, expectations
and assumptions of the “Company regarding the future of the
Company’s business, our future plans and strategies, regulatory
approvals, clinical results, future financial condition and other
future conditions. All statements other than statements of
historical facts contained in this press release, including
expressed or implied statements regarding future results of
operations and financial position, business strategy, product
candidates, regulatory approvals, expected research and development
costs, planned preclinical studies and clinical trials, expected
results of clinical trials, and their timing and likelihood of
success, as well as plans and objectives of management for future
operations, are forward-looking statements. The words “if
approved,” “may,” “will,” “should,” “would,” “expect,” “plan,”
“anticipate,” “could,” “intend,” “target,” “project,”
“contemplate,” “believe,” “estimate,” “predict,” “potential” or
“continue” or the negative of these terms or other similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements include
information about qualitative assessments of available data,
potential benefits, expectations for clinical trials, and
anticipated timing of clinical trial readouts and regulatory
submissions. This information involves risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied by such statements. Risks and uncertainties
include, among other things, the uncertainties inherent in research
and development, including the ability to meet anticipated clinical
endpoints, commencement and/or completion dates for clinical
trials, including the impact of the COVID-19 pandemic on our
business, operations, and regulatory and clinical development
timelines, plans and expectations, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as risks
associated with preliminary and interim data, including the
possibility of unfavorable new clinical trial data and further
analyses of existing clinical trial data; the risk that clinical
trial data are subject to differing interpretations and
assessments, including during the peer review/publication process,
in the scientific community generally, and by regulatory
authorities. These and other risks and uncertainties are more fully
described in our periodic filings with the Securities and Exchange
Commission (“SEC”), including the risk factors described in the
section entitled “Risk Factors” in the quarterly and annual reports
that we file with the SEC. Any forward-looking statements that we
make in this press release speak only as of the date of this press
release. Except as required by law, we assume no obligation to
update forward-looking statements contained in this press release
whether as a result of new information, future events, or
otherwise, after the date of this press release.
For More Information: Michael Floyd (301)
651-4256 mfloyd@processapharma.com
James Carbonara Hayden IR (646)
755-7412 james@haydenir.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