Processa Pharmaceuticals Files 2023 Annual Report on Form 10-K

TL;DR

<b>Processa Pharmaceuticals filed its 2023 10-K, detailing financial data and subsequent events including warrant transactions.</b>

AI Summary

Processa Pharmaceuticals, Inc. (PCSA) filed a Annual Report (10-K) with the SEC on March 29, 2024. Processa Pharmaceuticals, Inc. filed its 10-K for the fiscal year ending December 31, 2023. The company was formerly known as Heatwurx, Inc., with a name change on October 28, 2011. The filing includes data related to common stock, additional paid-in capital, treasury stock, and retained earnings for fiscal years 2021, 2022, and 2023. Subsequent events noted include warrant and pre-funded warrant transactions in January 2024. Information on employee stock options and restricted stock grants is also detailed for 2022 and 2023.

Why It Matters

For investors and stakeholders tracking Processa Pharmaceuticals, Inc., this filing contains several important signals. This 10-K provides a comprehensive overview of Processa Pharmaceuticals' financial position and activities for the fiscal year 2023, including significant events that occurred shortly after year-end. Investors can use this filing to assess the company's financial health, equity structure, and recent corporate actions, such as warrant issuances, which may impact future share dilution and capital structure.

Risk Assessment

Risk Level: medium — Processa Pharmaceuticals, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is highly regulated and competitive, and the filing does not provide specific revenue or profitability figures, indicating a potential early-stage or development-focused business with inherent risks.

Analyst Insight

Review the full 10-K to understand the company's product pipeline, clinical trial status, and detailed financial statements to assess its long-term viability and investment potential.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-29 — Filing Date (As of date)
• 2011-10-28 — Name Change Date (Former company name date)

Key Players & Entities

• Processa Pharmaceuticals, Inc. (company) — Filer name
• Heatwurx, Inc. (company) — Former company name
• 2023-12-31 (date) — Fiscal year end
• 2024-03-29 (date) — Filing date
• 2024-01-22 (date) — Subsequent event date
• 2024-01-30 (date) — Subsequent event date

FAQ

Risk Factors

• Regulatory Environment [medium — regulatory]: The pharmaceutical industry is subject to extensive government regulation, which can impact product development, manufacturing, and marketing.
• Market Competition [medium — market]: The company faces intense competition from other pharmaceutical and biotechnology companies, which can affect market share and pricing.
• Funding and Liquidity [high — financial]: As a development-stage company, Processa Pharmaceuticals may require significant additional funding to support its operations and clinical trials, posing liquidity risks.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-29: Filing Date — Date the 10-K was officially filed with the SEC.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This filing provides the primary financial and operational overview for Processa Pharmaceuticals for the fiscal year 2023.)

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value per share PCSA The Nasdaq

Filing Documents

• form10-k.htm (10-K) — 1464KB
• ex4-4.htm (EX-4.4) — 21KB
• ex4-5.htm (EX-4.5) — 12KB
• ex21-1.htm (EX-21.1) — 4KB
• ex23-1.htm (EX-23.1) — 3KB
• ex31-1.htm (EX-31.1) — 17KB
• ex31-2.htm (EX-31.2) — 16KB
• ex32-1.htm (EX-32.1) — 9KB
• ex97-1.htm (EX-97.1) — 24KB
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• audit_001.jpg (GRAPHIC) — 5KB
• form10-kpipe_001.jpg (GRAPHIC) — 69KB
• 0001493152-24-011976.txt (&nbsp;) — 23538KB
• pcsa-20231231.xsd (EX-101.SCH) — 56KB
• pcsa-20231231_cal.xml (EX-101.CAL) — 55KB
• pcsa-20231231_def.xml (EX-101.DEF) — 243KB
• pcsa-20231231_lab.xml (EX-101.LAB) — 463KB
• pcsa-20231231_pre.xml (EX-101.PRE) — 373KB
• form10-k_htm.xml (XML) — 679KB

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations. 49 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk. 57 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 57 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 58 Item 9A.

Controls and Procedures

Controls and Procedures 58 Item 9B. Other Information 59 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspection 59 Part III Item 10. Directors, Executive Officers and Corporate Governance 59 Item 11.

Executive Compensation

Executive Compensation 59 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 60 Item 13. Certain Relationships and Related Transactions, and Director Independence 60 Item 14. Principal Accounting Fees and Services 60 Part IV Item 15. Exhibits, Financial Statement Schedules 60 Item 16. Form 10-K Summary 61

Signatures

Signatures 62 2 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 molecule which 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 as current Good Clinical Practices, for designing, conducting, monitoring, auditing and reporting the results of clinical trials to ensure that the data and results are accurate and that the rights and welfare of trial participants are adequately protected. "cGMP" means current Good Manufacturing Practices. The FDA and other regulatory agencies promulgate regulations and standards, commonly referred to as current Good Manufacturing Practices, which include requirements relating to quality control and quality assurance, as well as the corresponding maintenance of records and documentation. "CMO" means Contract Manufacturing Organization. "CRO" means Contract Research Organization. "Deuterated analog" means a small molecule in which one or more of the hydrogen atoms are replaced by deuterium. "EMA" means the European Medicines Agency. "FDA" means the Food and Drug Administration. "IND" means an Investigational New Drug Application. Before testing a new drug on human subjects, the company must file an IND with the FDA. Information must be produced on the absorption, distribution, metabolism, and excretion properties of the drug and detailed protocols for testing on human subjects must be submi

Risk Factors of this Annual Report

Item 1A. Risk Factors of this Annual Report. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable as of the date of this Form 10-K, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Form 10-K to conform these statements to new information, actual results or to changes in our expectations, except as required by law. You should read this Form 10-K and the documents that we reference in this Form 10-K and have filed with the SEC as exhibits with the understanding that our actual future results, levels of activity, performance, and events and circumstances may be materially different from what we expect. In this Form 10-K, "we," "us", "our", "Processa" and "the Company" refer to Processa Pharmaceuticals, Inc. and its subsidiary. 4 SUMMARY

RISK FACTORS

RISK FACTORS We are providing the following summary of the risk factors contained in our Form 10-K to enhance the readability and accessibility of our risk factor disclosures. We encourage our stockholders to carefully review the full risk factors contained in this Form 10-K in their entirety for additional information regarding the risks and uncertainties that could cause our actual results to vary materially from our recent results or from our anticipated future results . Risks Related to Our Financial Position and Need for Additional Capital We have a history of losses and we may never become profitable. We have limited cash resources and will require additional financing. Our

financial statements contain a statement regarding a substantial doubt about our ability

financial statements contain a statement regarding a substantial doubt about our ability to continue as a going concern. Our ability to use our net operating loss carryforwards and other tax attributes may be limited. Risks Relating to Clinical Development and Commercialization of Our Product Candidates We currently do not have, and may never develop, any FDA-approved, licensed or commercialized products. Our licenses are subject to termination by the licensor in certain circumstances. If we fail to comply with our obligations contained in the agreements under which we license intellectual property rights from third parties, we could lose important license rights. We depend entirely on the successful development of our product candidates, which have not yet demonstrated efficacy for their target indications in clinical trials. We may never be able to demonstrate efficacy for our product candidates, thus preventing us from licensing, obtaining marketing approval by any regulatory agency, and/or commercializing our product(s). We must successfully complete clinical trials for our product candidates before we can apply for marketing approval. We have little corporate history of conducting clinical trials. Our planned clinical trials or those of our collaborators may reveal significant adverse events, toxicities or other side effects not seen in our preclinical studies and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates. Even if we receive regulatory approval for any of our product candidates, we may not be able to successfully license or commercialize the product and the revenue that we generate from its sales, if any, may be limited. We are completely dependent on third parties to manufacture our product candidates, and our commercialization of our product candidates could be halted, delayed or made less profitable if those third parties fail to obtain manufacturing approva

View Full Filing

View this 10-K filing on SEC EDGAR