Processa Pharmaceuticals Announces Year end 2020 Results and Provides Corporate Update
25 Marzo 2021 - 9:06PM
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 December 31,
2020, and provides corporate update.
Dr. David Young, CEO and chairman of Processa,
commented, “2020 was a transformational year for our company; we
in-licensed three exciting programs with potential markets
exceeding $1 billion for each drug, improved our balance sheet,
strengthened our management team and Board, up-listed to Nasdaq,
and prepared the foundation for successful execution for our three
clinical stage programs. I am delighted to report that we
anticipate the first patients to be dosed with PCS6422 and PCS499
in the second quarter of 2021 with interim data for PCS6422 near
the end of Q3 and for PCS499 in the first quarter of 2022.”
Recent Highlights and New Developments
- Selected 5 U.S.
clinical sites to enroll patients with ulcerative necrobiosis
lipoidica for 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.” Two to three additional clinical sites will
be selected in the future including sites outside the U.S.
- Entered into an
exclusive licensing agreement with Elion Oncology, Inc. to develop,
manufacture and commercialize PCS6422 (eniluracil) globally.
PCS6422 is an oral drug to be administered with fluoropyrimidine
cancer drugs (e.g., capecitabine, 5-FU). PCS6422 is designed to
decrease the breakdown of the cancer drugs, which, without such
intervention, reduce to inactive metabolites or metabolites that
are known to cause unwanted side effects and to interfere with the
anticancer activity.
- Entered into a
licensing agreement with Yuhan Corporation, a publicly traded South
Korean company, to license PCS12852, a small molecule drug in
development for the treatment of gastroparesis and functional
gastrointestinal motility disorders.
- Entered into a
licensing agreement with Aposense LTD to license PCS11T, a pro-drug
of SN38, the active metabolite of the widely used cancer drug
irinotecan, that deposits SN38 in the membranes of cancer cells
preferentially over normal cells.
- Appointed Dr.
Khalid Islam to the Company’s board of directors.
- Appointed Michael
Floyd as the Company’s chief operating officer.
- Uplisted to
Nasdaq.
- Closed an
underwritten public offering of 4,800,000 shares of common stock
for a price to the public of $4.00 per share with net proceeds of
$17.1 million.
- In February 2021
we closed a private placement with institutional and accredited
investors for $10.2 million. We sold 1,321,132 shares of the common
stock at a purchase price of $7.75 per share for $10.2 million in
the private placement and received net proceeds of $9.9
million.
Upcoming Clinical Drug Development
Milestones
First half of 2021
- Phase 1B First
Patient Dosed: PCS6422 (Cancer)
- Phase 2 First
Patient Dosed: PCS499 (Ulcerative NL)
Second half of 2021
- FDA IND
Submission: PCS12852 (GI/Gastroparesis)
- Interim Cohort
Results Begin: PCS6422
First half of 2022
• Interim Results: PCS499
• Phase 2A First Patient Dosed: PCS12852
Financial Results for the Year Ended December 31,
2020
General and administrative expenses were $3.3
million compared to $1.6 million for the year ended December 31,
2019. The increase in our general and administrative expenses was
primarily due to stock-based compensation.
Research and development expenses totaled $3.2
million compared to $2.3 million for the year ended December 31,
2019.
We also recorded $8.7 million dollars of costs
as the acquisition of in-process research and development related
to licensing agreements we executed for PCS6422, PCS12852 and
PCS11T. A total of $8.6 million of this amount was non-cash
consideration.
Our net loss was $14.4 million, compared to a
net loss of $3.4 million for the year ended December 31, 2019.
During 2020 we recorded non-cash expenses of $8.6 million for
acquired in-process research and development and $2.7 million of
stock-based compensation costs.
As of December 31, 2020, the Company had cash
and cash equivalents of $15.4. In February 2021, we closed a $10.2
million private placement receiving net proceeds of $9.9
million.
Following the close of the offering and related
transactions the Company will have 15.5 million common shares
outstanding.
Conference Call Information
To participate in this event, dial approximately
5 to 10 minutes before the beginning of the call.
Date: March 25, 2021 Time: 5:30 p.m. ET Toll Free: 877-545-0320;
Entry Code: 805295 International: 973-528-0016; Entry Code:
805295
Live
Webcast: https://www.webcaster4.com/Webcast/Page/2572/40452
Conference Call Replay Information
Toll-free: 877-481-4010 International: 919-882-2331 Replay
Passcode: 40452
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 used these
criteria for selection to further develop its pipeline programs to
achieve high-value milestones effectively and efficiently. Active
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 that 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 that
could cause actual results to differ from those contained in the
forward-looking statements.
For More Information: Michael Floyd (301)
651-4256 mfloyd@processapharma.com
James Carbonara Hayden IR (646) 755-7412
james@haydenir.com
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