Processa Pharmaceuticals Announces Third Quarter 2020 Results, Provides Corporate Update
November 12 2020 - 5:01PM
via InvestorWire -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA)
(“Processa” or the “Company”), a clinical-stage biopharmaceutical
company focused on the development of drug products that are
intended to provide treatment for and improve the survival and/or
quality of life for patients who have unmet medical needs or
conditions or who have no alternative treatment, today reports
financial results for the third quarter of 2020.
Dr. David Young, CEO and chairman of Processa, commented, “The
third quarter was a period of tremendous value creation. Over that
time, we in-licensed important clinical drug candidates PCS12852
and PCS6422, uplisted to Nasdaq and closed a $19.2 million public
offering. Due to those achievements, we now have sufficient funds
to complete three trials for three distinct markets, each exceeding
$1 billion. Importantly, we are developing products for which
existing clinical evidence of efficacy has already been
established. With key milestones to announce over the next 12-18
months, including interim data for PCS6422 in 3Q21 and PCS499 in
4Q21, we are excited about the near-term opportunity of increasing
shareholder value.”
Recent Highlights and New Developments
- Entered into an exclusive licensing agreement with Elion
Oncology, Inc. to develop, manufacture and commercialize eniluracil
(PCS6422) 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 functional
gastrointestinal (GI) disorders (FGID).
- 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. Net
proceeds to the Company were approximately $17.1 million.
Upcoming Clinical Drug Development
Milestones
1H 2021
- Phase 1B First
Patient Dosed: PCS6422 (Cancer)
- Phase 2B First
Patient Dosed: PCS499 (Ulcerative NL)
- FDA IND
Submission: PCS12852 (GI/Gastroparesis)
2H 2021
• Interim Cohort Results Begin:
PCS6422
• Interim Results: PCS499
• Phase 2A First Patient Dosed:
PCS12852
Financial Results for the Third Quarter Ended Sept. 30,
2020
General and administrative expenses were approximately $423
thousand for the quarter ended Sept. 30, 2020, compared to
approximately $419 thousand during the third quarter ended Sept.
30, 2019.
Research and development expense totaled approximately $533
thousand for the third quarter ended Sept. 30, 2020, compared to
approximately $585 thousand during the third quarter ended Sept.
30, 2019.
Net loss attributable to common stockholders for the third
quarter ended Sept. 30, 2020 was $3.1 million, compared to $864
thousand for the third quarter ended Sept. 30, 2019.
As of Sept. 30, 2020, the Company had cash and cash equivalents
of approximately $325 thousand. Subsequent to the quarter end,
Processa closed a $19.2 million gross proceeds public offering of
common stock resulting in net proceeds of approximately $17.1
million after deducting underwriting discounts and commissions and
other offering expenses payable by the Company.
Following the close of the offering and related transactions the
Company will have 13.8 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: Nov. 12, 2020 Time: 5:30 p.m. ET Dial-In
Information: Toll Free: 877-876-9176 International:
785-424-1670
Live
Webcast: https://www.webcaster4.com/Webcast/Page/2572/38528
Conference Call Replay Information
Toll-free: 877-481-4010 International: 919-882-2331
Replay Passcode: 38528
Replay
Webcast: https://www.webcaster4.com/Webcast/Page/2572/38528
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
Corporate Communications:InvestorBrandNetwork
(IBN) Los Angeles, California www.InvestorBrandNetwork.com
310.299.1717 Office Editor@InvestorBrandNetwork.com
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