Operates clinical treatment programs in the U.S.; fiscal 2025 revenue was $88,000 with a net loss of $13,958,000, driven by substantial R&D and G&A expenses and large noncash warrant/derivative-related items.

# Company Name

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- Paste the text of Item 3 (Business) and any other sections you want included, or provide the company name and fiscal year so I can reference the exact 10-K.
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AIM ImmunoTech Inc. is a biotechnology company focused on developing innovative therapies for cancers, viral diseases, and immune deficiency disorders.

# AIM ImmunoTech Inc. Overview

## Company Profile
- **Name:** AIM ImmunoTech Inc.
- **Headquarters:** Ocala, Florida, USA
- **Incorporation:** Delaware
- **Primary Focus:** Research and development of therapeutics targeting cancers, viral diseases, and immune deficiency disorders.

## Key Products
### 1. Ampligen (Rintatolimod)
- **Description:** A double-stranded RNA (dsRNA) molecule intended for the treatment of various cancers, viral diseases, and immune disorders.
- **Current Status:** Not FDA approved in the U.S. but commercially available in Argentina for Chronic Fatigue Syndrome (CFS).
- **Clinical Focus Areas:**
  - Treatment for pancreatic cancer.
  - Potential enhancement of immune responses to checkpoint inhibitors in multiple cancer types.
  - Antiviral capabilities against existing and mutated viruses, specifically COVID-19 and avian influenza.

### 2. Alferon N Injection
- **Description:** An FDA-approved natural alpha-interferon product used for the treatment of refractory external genital warts.
- **Current Status:** While approved in the U.S. and Argentina, the production has been halted due to lack of finished goods inventory until new manufacturing processes are established.

## Market Presence and Financials
- **Number of Employees:** 21 full-time and 2 part-time employees.
- **Revenue (2024):** Approximately $170,000 generated from the Ampligen Cost Recovery Program.
- **Net Loss (2024):** Approximately $17.32 million, a decrease from a $28.96 million net loss in 2023.
- **Cash and Cash Equivalents (as of Dec 31, 2024):** Approximately $4 million in cash and cash equivalents.
- **Stockholders' Equity:** Below the minimum requirement for continued listing on the NYSE American, with a deficit of approximately $1.3 million.

## Customer Base
- AIM primarily serves patients with cancer, viral diseases, and chronic fatigue conditions. The number of customers, while not specified, can be inferred to be low due to the niche market of investigational drugs and therapies, as well as the nature of the Cost Recovery Program.

## Major Developments
- Engaged in various clinical trials across multiple countries to evaluate the efficacy of Ampligen for different indications.
- AMI is currently focusing on regulatory approvals and successful trials to enhance marketability and availability of products.
- The Company's operations and financial viability face challenges due to substantial debt and the need for additional funding to continue operations and clinical trials.

AIM ImmunoTech Inc. is navigating complex regulatory environments and competitive pressures in biopharma while striving for significant breakthroughs in the treatment of severe medical conditions with its innovative therapies.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutic products to combat cancers, viral diseases, and immune-deficiency disorders using nucleic acids and natural interferon.

## AIM ImmunoTech Inc. Overview

### Company Profile
- **Headquarters:** Ocala, Florida
- **Industry:** Immuno-pharma
- **Employees:** 26 full-time and 2 part-time employees

### Business Focus
AIM ImmunoTech Inc. is an immuno-pharma company specializing in the research and development of therapeutic products aimed at treating various types of cancers, viral diseases, and immune-deficiency disorders. The company emphasizes the development of nucleic acids and natural interferon to boost the human body's natural antiviral defense mechanisms.

### Key Products
1. **Ampligen (rintatolimod)**
   - A first-in-class double-stranded RNA (dsRNA) molecule.
   - **FDA Status:** Not approved for market in the U.S., but approved in Argentina for the treatment of severe Chronic Fatigue Syndrome (CFS).
   - **Research Focus:** Ampligen is being tested for its efficacy in several areas:
     - Locally advanced pancreatic cancer.
     - Other cancers to enhance responses to checkpoint inhibitors.
     - Antiviral applications against various viruses, including COVID-19 and Long COVID.
     - Management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

2. **Alferon N Injection**
   - A natural alpha interferon product approved for the intralesional treatment of refractory or recurring external genital warts.
   - Approved in both the U.S. and Argentina.

### Clinical Trials and Research
- AIM is progressing multiple clinical trials, including:
  - A randomized, controlled study for Ampligen in pancreatic cancer.
  - Studies to evaluate Ampligen's efficacy in managing viral diseases and ME/CFS.
  - A Phase 2 study (AMP-518) assessing Ampligen's impact on post-COVID conditions.

### Financials
- **Revenue:** AIM does not generate significant revenue, primarily due to the investigational status of its primary drug candidates and ongoing clinical trials.
- **Income:** The company has an accumulated deficit of approximately **$409.5 million** as of December 31, 2023.
- As of the same date, the company had approximately **$13.07 million** in cash and cash equivalents.

### Regulatory Designations
- Ampligen has received **Orphan Drug Designation** from the FDA for multiple indications, including CFS, HIV, and pancreatic cancer.
- The product is also patented in several countries, with numerous pending applications.

### Collaborations and Partnerships
- Collaborations with academic institutions and organizations (e.g., contracts with myTomorrows and clinical trials with leading cancer research centers).
- Partnership with GP Pharm for the commercialization of Ampligen in Latin America.

### Conclusion
AIM ImmunoTech Inc. is positioned at the intersection of biotechnology and drug development, focusing on groundbreaking products that harness the immune system to fight disease. Despite the challenges associated with drug approvals and market competition, the company's ongoing clinical trials and regulatory strategies aim to establish its products' efficacy and commercial viability.

AIM ImmunoTech Inc.

10-K / March 27, 2026

10-K / March 27, 2025

10-K / April 1, 2024

10-K / March 27, 2026

Company Name