AIM ImmunoTech Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>AIM ImmunoTech Inc. has submitted its 2023 10-K filing, providing a comprehensive overview of its financial performance and operations for the fiscal year.</b>

AI Summary

AIM ImmunoTech Inc. (AIM) filed a Annual Report (10-K) with the SEC on April 1, 2024. AIM ImmunoTech Inc. filed its annual report for the fiscal year ending December 31, 2023. The company is incorporated in Florida and operates in the Biological Products sector. The filing covers the period from January 1, 2023, to December 31, 2023. Key financial statement data for 2023, 2022, and 2021 are included. The report details various equity and preferred stock members, including Series A Junior Participating Preferred Stock and Series B Convertible Preferred Stock.

Why It Matters

For investors and stakeholders tracking AIM ImmunoTech Inc., this filing contains several important signals. This 10-K filing is crucial for investors to assess AIM ImmunoTech's financial health, strategic direction, and potential risks as of December 31, 2023. The detailed financial data and disclosures within the report will inform investment decisions and provide insights into the company's progress in the biopharmaceutical sector.

Risk Assessment

Risk Level: medium — AIM ImmunoTech Inc. shows moderate risk based on this filing. The company operates in the highly regulated and competitive biopharmaceutical industry, facing risks related to clinical trial success, regulatory approvals, and market adoption of its products.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand AIM ImmunoTech's current financial position and future prospects.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-04-01 — Filing Date (Date of submission)
• 1934 Act — SEC Act (Governing legislation)
• 001-27072 — SEC File Number (Company's SEC file number)

Key Players & Entities

• AIM ImmunoTech Inc. (company) — Filer name
• 20231231 (date) — Fiscal year end
• 20240401 (date) — Filing date
• FL (location) — State of incorporation
• 2836 (industry) — Standard Industrial Classification
• HEMISPHERX BIOPHARMA INC (company) — Former company name

FAQ

Industry Context

AIM ImmunoTech operates within the biopharmaceutical industry, focusing on the development of therapeutics for cancer and immune-related diseases.

Regulatory Implications

As a publicly traded company, AIM ImmunoTech is subject to the reporting requirements of the Securities and Exchange Commission (SEC), including the annual filing of Form 10-K.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management discussion.
2. Analyze the company's business description and risk factors for potential investment considerations.
3. Compare the 2023 financial data with previous years to identify trends and performance changes.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-04-01: Filing Date — Date the 10-K report was officially filed with the SEC.

Year-Over-Year Comparison

This filing represents the annual report for the fiscal year ending December 31, 2023, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share AIM NYSE American Secur
• $15 million — h Atlas has committed to purchase up to $15 million of our Common Stock. Under the terms

Filing Documents

• form10-k.htm (10-K) — 2183KB
• ex4-25.htm (EX-4.25) — 31KB
• ex10-104.htm (EX-10.104) — 187KB
• ex10-105.htm (EX-10.105) — 103KB
• ex21-1.htm (EX-21.1) — 3KB
• ex23-1.htm (EX-23.1) — 3KB
• ex31-1.htm (EX-31.1) — 17KB
• ex31-2.htm (EX-31.2) — 18KB
• ex32-1.htm (EX-32.1) — 8KB
• ex32-2.htm (EX-32.2) — 8KB
• ex97-1.htm (EX-97.1) — 27KB
• ex97-1_001.jpg (GRAPHIC) — 9KB
• 0001493152-24-012058.txt (&nbsp;) — 9007KB
• aim-20231231.xsd (EX-101.SCH) — 62KB
• aim-20231231_cal.xml (EX-101.CAL) — 80KB
• aim-20231231_def.xml (EX-101.DEF) — 275KB
• aim-20231231_lab.xml (EX-101.LAB) — 503KB
• aim-20231231_pre.xml (EX-101.PRE) — 384KB
• form10-k_htm.xml (XML) — 1322KB

Business

ITEM 1. Business. 3

Risk Factors

ITEM 1A. Risk Factors. 22

Unresolved Staff Comments

ITEM 1B. Unresolved Staff Comments. 34

Cybersecurity

ITEM 1C. Cybersecurity 34

Properties

ITEM 2. Properties. 34

Legal Proceedings

ITEM 3. Legal Proceedings. 34

Mine Safety Disclosures

ITEM 4. Mine Safety Disclosures. 36 PART II ITEM 5. Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. 37

[Reserved]

ITEM 6. [Reserved] 38

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

ITEM 7. Management's Discussion and Analysis of Financial Condition and Results of Operations. 38

Quantitative and Qualitative Disclosures About Market Risk

ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk. 41

Financial Statements and Supplementary Data

ITEM 8. Financial Statements and Supplementary Data. 41

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. 42

Controls and Procedures

ITEM 9A. Controls and Procedures. 42

Other Information

ITEM 9B. Other Information. 42

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 42 PART III

Directors, Executive Officers and Corporate Governance

ITEM 10. Directors, Executive Officers and Corporate Governance. 43

Executive Compensation

ITEM 11. Executive Compensation. 48

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

ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 55

Certain Relationships and Related Transactions and Director Independence

ITEM 13. Certain Relationships and Related Transactions and Director Independence. 58

Principal Accountant Fees and Services

ITEM 14. Principal Accountant Fees and Services. 58 PART IV

Exhibits and Financial Statement Schedules

ITEM 15. Exhibits and Financial Statement Schedules. 59

Form 10-K Summary

ITEM 16. Form 10-K Summary. 67 2 PART I ITEM 1.

Business

Business GENERAL AIM ImmunoTech Inc. and its subsidiaries (collectively, "AIM", "Company", "we" or "us") are an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases and immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases. Our flagship products are Ampligen (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection (Interferon alfa). Ampligen has not been approved by the FDA or marketed in the United States. Ampligen is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome ("CFS"). Our primary business focus involves Ampligen. Ampligen is a double-stranded RNA ("dsRNA") molecule being developed for globally important cancers, viral diseases and disorders of the immune system. We are currently proceeding primarily in four areas: Conducting a randomized, controlled study to evaluate efficacy and safety of Ampligen compared to a control group to treat locally advanced pancreatic cancer patients. Evaluating Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor responses to checkpoint inhibitors. Exploring Ampligen's antiviral activities and potential use as a prophylactic or treatment for existing viruses, new viruses and mutated viruses thereof. Evaluating Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome ("ME/CFS") and fatigue and/or Post-COVID conditions of fatigue. We are prioritizing activities in an order related to t

"Business", Part I; Item 1A. "Risk Factors", Part I; Item 3. "Legal Proceedings", Part I

Item 1. "Business", Part I; Item 1A. "Risk Factors", Part I; Item 3. "Legal Proceedings", Part I and Part II; Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations". Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. We are in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and the presentation sets forth our current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. Some of the

RISK FACTORS

RISK FACTORS General Risk Related to our Business We may require additional financing which may not be available. We may continue to incur substantial losses and our future profitability is uncertain. Our drug and related technologies are investigational and subject to regulatory approval. If we are unable to obtain regulatory approval in a timely manner, or at all, our operations will be materially harmed and our stock adversely affected. The COVID-19 coronavirus or other global pandemics could adversely impact our business, including our clinical trials. We cannot predict the ultimate effects of the COVID-19 virus on our business. We may be subject to product liability claims from the use of Ampligen, Alferon N Injection, or other of our products which could negatively affect our future operations. We have limited product liability and clinical trial insurance. Uncertainty of health care reimbursement for our products. There are risks of liabilities associated with handling and disposing of hazardous materials. We rely upon information technology and any failure, inadequacy, interruption, or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively. The loss of services of key personnel could hurt our chances for success. GAAP requires estimates, judgements and assumptions which inherently contain uncertainties. We currently, and may in the future, have assets held at financial institutions that may exceed the insurance coverage offered by the Federal Deposit Insurance Corporation, and the loss of such assets would have a severe negative affect on our operations and liquidity. Risks Associated with Our Products The development of Ampligen is subject to significant risks. The development of Alferon N Injection is subject to significant risks. Possible side effects from the use of

View Full Filing

View this 10-K filing on SEC EDGAR