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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): August 8, 2023
PROCESSA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware |
|
001-39531 |
|
45-1539785 |
(State
or Other Jurisdiction
of
Incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
|
|
7380
Coca Cola Drive, Suite 106,
Hanover,
Maryland |
|
21076 |
|
|
(Address
of Principal Executive
Offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (443) 776-3133
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common Stock, $0.0001 par
value per share |
|
PCSA |
|
Nasdaq Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of
Certain Officers
Appointment
of Chief Executive Officer
On
August 8, 2023, Processa Pharmaceuticals, Inc. (the “Company”) announced the appointment of Mr. George Ng as its Chief Executive Officer and a director. Dr. David Young will continue with the Company as a member of the Board of Directors
and as the Company’s President of Research and Development.
Mr.
Ng, age 48, most recently served as Board Director, President and Chief Operating Officer of Calidi Biotherapeutic Inc.
from February 1, 2022 until June 23, 2023. He is currently a partner at PENG Life Science Ventures since September 2013; a director,
co-founder, and Chief Business Officer at IACTA Pharmaceuticals, Inc. since January 2020; and lead director of Morphogenesis Inc.
since February 2020. His experience further includes serving in various executive-level or Board of Director positions
for multiple publicly-traded and private global biotechnology and pharmaceutical firms. Mr. Ng previously served as a director
of Inflammatory Response Research, Inc. from May 2019 to April 2020; Invent Medical Corp from July 2019 to January 2020; ImmuneOncia
Therapeutics Inc. from June 2016 to 2019; and Virttu Biologics Limited from April 2017 to April 2019. He was also the Executive Vice
President and Chief Administrative Officer of Sorrento Therapeutics, Inc. (Nasdaq: SRNE) from March 2015 to April 2019; the Co-Founder
and President, Business of Scilex Pharmaceuticals Inc. from September 2012 to April 2019; and the Senior Vice President and General
Counsel of BioDelivery Sciences International Inc. (Nasdaq: BDSI) from December 2012 to March 2015. SMr. Ng holds a JD degree
from the University of Notre Dame School of Law, as well as a B.A.S in Biochemistry and Economics from the University of California,
Davis.
In
connection with his employment, Mr. Ng will be paid an annual base salary of $400,000 and will be eligible to receive bonus compensation
of up to $100,000 contingent on Mr. Ng. meeting certain performance milestones during 2023 and 2024. In addition, the Compensation Committee
awarded 800,000 restricted stock units (“RSUs”) to Mr. Ng. Vesting for 400,000 RSUs occurs ratably over a three-year
period and represents the number of RSUs expected to be granted to Mr. Ng in 2023 and 2024. The remaining 400,000 RSUs will vest on the
achievement of certain performance metrics, with the first 200,000 performance-based RSUs vesting when gross proceeds of $10,000,000
is raised, and the second 200,000 performance-based RSUs vesting when additional gross proceeds of $10,000,000 is
raised. He will also be eligible for other benefits as described in the Employment Agreement
The
equity awards will be made pursuant to the Company’s 2019 Omnibus Incentive Plan and the Company’s Form of 2023 Restricted
Stock Unit Agreement.
There
are no arrangements or understandings between Mr. Ng and any other persons, pursuant to which he was appointed as Chief Executive Officer.
There are no family relationships between Mr. Ng and any director or executive officer, and he has no direct or indirect material interest
in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
Departure
of Chief Operating Officer
By
mutual agreement, Mr. R. Michael Floyd resigned
as Chief Operating Officer of the Company, effective August 31, 2023.
Item
7.01. Regulation FD Disclosure
A
press release dated August 8, 2023 announcing the Company’s new Chief Executive Officer is filed as Exhibit 99.1 to this Current
Report on Form 8-K and is incorporated by reference herein. The information in Item 7.01 of this current report, including Exhibit 99.1
attached hereto, is furnished and shall not be treated as filed for purposes of the Securities Exchange Act of 1934.
Safe
Harbor Statement
Information
provided in this Current Report on Form 8-K may contain statements relating to current expectations, estimates, forecasts and projections
about future events that are “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995.
These forward-looking statements generally relate to the Company’s plans, objectives and expectations for compensation matters
related to Mr. Ng’s service as the Company’s Chief Executive Officer and Mr. Ng’s start date. Actual future results
may differ materially from those projected as a result of certain risks and uncertainties. For a discussion of such risks and uncertainties,
see “Risk Factors” as described in the Company’s Annual Report for the year ended December 31, 2022 on Form 10-K filed
with the Commission on March 30, 2023, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 filed with
the Commission on May 15, 2023, and other reports on file with the Commission.
These
forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking
statements, whether as a result of new information, future events or otherwise.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits:
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
PROCESSA PHARMACEUTICALS, INC. |
|
|
|
Date: August 8, 2023 |
By: |
/s/ James
Stanker |
|
|
James Stanker |
|
|
Chief Financial Officer |
Exhibit 10.1
Exhibit
99.1
![](https://www.sec.gov/Archives/edgar/data/1533743/000149315223027122/ex99-1_001.jpg)
Processa
Pharmaceuticals Appoints Life Sciences Industry Veteran George Ng as Chief Executive Officer
HANOVER,
MD, August 8, 2023 (GLOBE NEWSWIRE) — Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”),
a clinical-stage pharmaceutical company focusing on developing the next generation of chemotherapeutic drugs to improve the efficacy
and safety for patients suffering from cancer, announces today that industry veteran George Ng has been appointed to serve as the Company’s
Chief Executive Officer and as a Board Director as of August 8, 2023. Dr. David Young will focus his efforts on the development of the
Next Generation Chemotherapy (NGC) drugs as President of Research and Development and as a board member.
“We
are thrilled to have George assume the leadership of our management team. His extensive managerial experience and proficiency in issues
and opportunities afforded small-cap publicly traded biotech companies makes him an ideal fit for our Company, and will ensure that we
continue executing our strategy, and create value for our stockholders,” commented Processa’s Chairman Justin Yorke. “Late
last year we changed our focus to concentrate on our Next Generation Chemotherapy drugs, with the intention of seeking partnering opportunities
for our non-oncology assets. As part of that transition, we have been evaluating how to best position Processa for long-term success
and determined now is the right time to transition to our next stage of corporate leadership. Given his oncology and drug development
expertise, Dr. Young has decided moving full-time to drug development will allow him to focus on advancing the development of our Next
Generation Chemotherapy drugs to subsequent FDA approval.”
“What
excites me about Processa is leading a team that is focused on changing the chemotherapy landscape so more cancer patients have better
treatment options. While many companies are developing novel ways to treat cancer, chemotherapy continues to be the standard of care,
and I believe our approach of modifying widely used already approved chemotherapy drugs by changing their distribution and/or metabolism
represents a significant opportunity not currently recognized by the market. I look forward to working with Dr. Young, the Processa team,
and the Board of Directors to provide better treatment for cancer patients by advancing our Next Generation Chemotherapy drugs and to
increase equity value held by all our shareholders,” stated Mr. Ng.
Mr.
Ng is a seasoned life sciences industry executive who joins Processa from his previous position as Board Director, President, and Chief
Operating Officer at Calidi Biotherapeutics, Inc. Mr. Ng is also a partner at PENG Life Science Ventures (PENG LSV). He has founded and/or
led multiple companies, including Scilex Pharmaceuticals, Inc. (now, Scilex Holding Co., a Nasdaq, publicly traded company), where he
was co-founder and President, and led the company through development, clinical trials, NDA submission, FDA approval, a $140 million
financing, commercial launch of the company’s first FDA-approved drug product, and ultimately, the company’s sale. Mr. Ng
has also been a board member and held executive level positions with several publicly traded and private global biotechnology and pharmaceutical
companies, including Sorrento Therapeutics, Inc., BioDelivery Sciences International, Inc., Spectrum Pharmaceuticals, Inc. and Alpharma,
Inc., which is now, a part of Pfizer Inc. In those roles, Mr. Ng helped lead the strategy, development, fundraising, and commercialization
efforts for multiple drug products.
Mr.
Ng earned a Juris Doctor degree in law from the University of Notre Dame School of Law and a Bachelor of Arts and Sciences dual degree
in Biochemistry & Economics from the University of California, Davis.
Dr.
Young added, “I realized when we transitioned to focusing on Next Generation Chemotherapy drugs that, given my oncology and drug
development experience, I needed to transition from the CEO role and focus full-time on drug development. I believe George’s experience
and background is exactly what we need to make my transition successful and move Processa forward while increasing shareholder value.
We have experienced, along with many of our peers, a significant decline in shareholder value over the last year. We are thankful to
have continued shareholder support, and I believe having George lead our Company will help us improve our shareholder value in the future.”
About
Processa Pharmaceuticals, Inc.
Processa
is a clinical stage pharmaceutical company focused on developing the Next Generation Chemotherapy drugs to improve the safety and efficacy
of cancer treatment. By combining Processa’s novel oncology pipeline with proven cancer-killing active molecules and the Processa
Regulatory Science Approach as well as experience in defining Optimal Dosage Regimens for FDA approvals, Processa not only will be providing
better therapy options to cancer patients but also increase the probability of FDA approval for its Next Generation Chemotherapy drugs.
Processa’s NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or
distribution of drugs while maintaining the existing mechanisms of killing the cancer cells. Our approach to drug development is based
on more than 30 years of drug development expertise to efficiently design and conduct clinical trials that demonstrate a positive benefit/risk
relationship. Using its proven Regulatory Science Approach, we have experience defining the Optimal Dosage Regimen using the principles
of the FDA’s Project Optimus Oncology initiative. The advantages of Processa’s Next Generation Chemotherapy drugs are expected
to include fewer patients experiencing side effects that lead to dose discontinuation; more significant cancer response; and a greater
number of patients who will benefit from each Next Generation Chemotherapy drug. Currently in our pipeline are three Next Generation
Chemotherapy drugs: Next Generation Capecitabine (PCS6422 and capecitabine to treat metastatic colorectal, gastrointestinal, breast,
pancreatic, and other cancers), Next Generation Gemcitabine (PCS3117 to treat pancreatic, lung, ovarian, breast, and other cancers),
and Next Generation Irinotecan (PCS11T to treat lung, colorectal, gastrointestinal, pancreatic, and other cancers).
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.
For
More Information:
Investors:
Bret
Shapiro
CORE
IR
ir@processapharma.com
Company
Contact:
Patrick
Lin
(925) 683-3218
plin@processapharma.com
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