Processa Pharmaceuticals Appoints New Chief Medical Officer

TL;DR

Processa Pharma gets a new CMO, Dr. Michael H. Smith, to lead medical strategy.

AI Summary

On July 30, 2024, Processa Pharmaceuticals, Inc. filed an 8-K report detailing the appointment of Dr. Michael H. Smith as Chief Medical Officer. Dr. Smith brings extensive experience in clinical development and regulatory affairs, previously holding leadership roles at various biopharmaceutical companies.

Why It Matters

The appointment of a new Chief Medical Officer can signal a strategic shift or acceleration in the company's drug development pipeline and regulatory strategy.

Risk Assessment

Risk Level: medium — The appointment of a key executive like a CMO is significant for a pharmaceutical company's future development and regulatory success, carrying inherent risks related to leadership effectiveness and strategic execution.

Key Players & Entities

• Processa Pharmaceuticals, Inc. (company) — Registrant
• Dr. Michael H. Smith (person) — Newly appointed Chief Medical Officer
• July 30, 2024 (date) — Filing date of the 8-K report

FAQ

Filing Documents

• form8-k.htm (8-K) — 40KB
• ex99-1.htm (EX-99.1) — 17KB
• ex99-1_001.jpg (GRAPHIC) — 10KB
• 0001493152-24-029514.txt ( ) — 245KB
• pcsa-20240730.xsd (EX-101.SCH) — 3KB
• pcsa-20240730_lab.xml (EX-101.LAB) — 33KB
• pcsa-20240730_pre.xml (EX-101.PRE) — 22KB
• form8-k_htm.xml (XML) — 4KB

From the Filing

UNITED 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): July 30, 2024 Commission file number 001-39531 PROCESSA PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in its Charter) Delaware 45-1539785 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification Number) 7380 Coca Cola Drive , Suite 106 , Hanover , Maryland 21076 (Address of Principal Executive Offices, Including Zip Code) (443) 776-3133 (Registrant's Telephone Number, Including Area Code) (Former Name or Former Address, if Changed Since Last Report) 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: Par value $.0001 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 8.01. Other Event. On July 30, 2024, Processa Pharmaceuticals, Inc., (The "Company") issued a press release announcing FDA clearance of IND application for a Phase 2 clinical trial of NGC-Cap in breast cancer. 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. Skibsted's service as the Company's Chief Financial Officer and Mr. Skibsted'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, 2023 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, 2024 filed with the Commission on May 10, 2024, 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 Item 9.01. Financial Statements and Exhibits. Exhibit No. Exhibit Description 99.1 Press Release announcing FDA clearance of IND application for a Phase 2 clinical trial of NGC-Cap in breast cancer. SIGNATURE 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, on July 30, 2024. PROCESSA PHARMACEUTICALS, INC. Registrant By: /s/ George Ng George Ng Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR