Processa Pharmaceuticals Inc 2024年度报告

FORM10-K ☒Annual Report under Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year endedDecember 31,2024 or ☐Transitional Report under Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission File Number001-39531 Processa Pharmaceuticals, Inc.(Exact name of registrant as specified in its charter) 7380 Coca Cola Drive,Suite 106,Hanover,Maryland21076(443)776-3133 Securities registered pursuant to Section 12(b) of the Exchange Act: Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes☐No☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filingrequirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 ofRegulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, oremerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” inRule 12b-2 of the Exchange Act. 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 orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its managements’ assessment of the effectiveness of its internal controlsover financial reporting under Section 404(b) of the Sarbanes Oxley Act (15 U.S.C 7262(b)) by the registered public accounting firm that prepared or issuedits audit report☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in thefiling reflect the correction of an error to previously issued financial statements.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ The aggregate market value of the voting and non-voting common equity held by non-affiliates on June 28, 2024, the last business day of the most recentlycompleted second quarter, based upon the closing price of Common Stock on such date as reported on Nasdaq Capital Market, was approximately $5.8million. The number of outstanding shares of the registrant’s common stock as of March 12, 2025 was5,269,240. DOCUMENTS INCORPORATED BY REFERENCE Table of Contents Part IItem 1.Business.5Item 1A.Risk Factors29Item 1B.Unresolved Staff Comments52Item 1C.Cybersecurity52Item 2.Properties.53Item 3.Legal Proceedings.53Item 4.Mine Safety Disclosures.53 Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and issuer Purchases of Equity Securities.53Item 6.[Reserved]55Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations.55Item 7A.Quantitative and Qualitative Disclosures About Market Risk.62Item 8.Financial Statements and Supplementary Data62Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure63Item 9A.Controls and Procedures63Item 9B.Other Information64Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspection64 Item 10.Directors, Executive Officers and Corporate Governance65Item 11.Executive Compensation70Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.76Item 13.Certain Relationships and Related Transactions, and Director Independence78Item 14.Principal Accounting Fees and Services78 GLOSSARY OF CERTAIN SCIENTIFIC TERMS The medical and scientific terms used in this Annual Report on Form 10-K have the following meanings: “Active Metabolite” means a drug that is processed by the body into an altered form which effects the body. “Agonist” means a chemical/drug that binds to a receptor in the body and activates that receptor to produce a biological response. “Analog” means a compound having a structure similar to that of an approved drug but differing from it with respect to a certain component of the moleculewhich may cause it to have similar or different effects on the body. “cGCP” means current Good Clinical Practices. The FDA and other regulatory agencies promulgate regulations and standards, commonly referred to ascurrent Good Clinical Practices, for designing, conducting, monitoring, auditing and reporting the results of clinical trials to ensure