Processa Pharmaceuticals, Inc 8-K, filed Aug 8, 2023
Processa Pharmaceuticals, Inc. (PCSA)
About this 8-K
Processa Pharmaceuticals, Inc filed this 8-K on August 8, 2023.
Items reported
- Item 5.02: Director or officer change, or executive pay
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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:
| Exhibit No. | Description | |
| 10.1 | Employment Agreement dated August 8, 2023 by and between George Ng and Processa Pharmaceuticals, Inc. | |
| 99.1 | Press Release dated August 8, 2023. | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL documents) |
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
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