AIM’s Business Overview and History
AIM ImmunoTech Inc. (AIM) is an immuno-pharma company headquartered in Ocala, Florida, focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases, and immune-deficiency disorders. The company has 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.
AIM ImmunoTech Inc., formerly known as Hemispherx Biopharma, Inc., was founded in 1969 and has since been dedicated to the research and development of therapeutics for various diseases. The company’s flagship products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa). Ampligen is a double-stranded RNA molecule that has shown potential in treating multiple conditions, while Alferon N Injection is the only natural-source, multi-species alpha interferon currently approved for sale in the United States and Argentina for the intralesional treatment of refractory or recurring external genital warts.
Throughout its history, AIM has faced several challenges in developing and commercializing its products. In 2013, the company received a Complete Response Letter from the FDA for its Ampligen New Drug Application (NDA) for Chronic Fatigue Syndrome (CFS), requesting additional clinical trials and data. Despite this setback, AIM pursued approval in Argentina and received it in 2016 for the treatment of severe CFS.
In 2019, AIM received clearance from the FDA to ship Ampligen to Argentina for commercial launch. However, the final approval process by the Argentine regulatory authority ANMAT has been delayed due to internal processes. Additionally, the production of new Alferon N Injection Active Pharmaceutical Ingredient has been on hold, and the company is uncertain about when, if ever, this product will be generally available for commercial sale.
Despite these challenges, AIM has continued to pursue various partnerships and collaborations to enable the potential availability of its products to patients worldwide. The company has maintained its focus on advancing its pipeline and exploring new applications for its core technologies.
Ampligen’s Potential in Pancreatic Cancer
One of AIM’s key focus areas is the development of Ampligen for the treatment of pancreatic cancer. In March 2022, the company announced positive data from a study evaluating Ampligen in patients with locally advanced or metastatic pancreatic cancer. The study found that Ampligen treatment enhanced peripheral immune activity, particularly involving type 1 conventional dendritic cells and T cells. Patients with stable disease exhibited pronounced overexpression of genes related to dendritic cell and T cell activation, and the expression of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen across all patients.
In October 2021, AIM submitted an Investigational New Drug (IND) application to the FDA for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. The FDA initially placed the study on clinical hold, but in March 2022, the company received notification that the clinical hold was released and cleared, allowing them to proceed with the study.
Recent developments in AIM’s pancreatic cancer program include promising data from the DURIPANC Phase 1b/2 study evaluating Ampligen in combination with durvalumab in metastatic pancreatic cancer. The 200mg dose was deemed safe, allowing progression to 400mg dosing. Of the six patients that reached the three-month evaluation point, five (83%) had stable disease, compared to 20% in historical controls. Preliminary progression-free survival data shows 15 months for the combination, compared to 12 months for Ampligen alone and 8 months for historical controls.
For the AMP-270 trial of Ampligen as maintenance therapy for locally advanced pancreatic cancer, the protocol has been edited and submitted to the FDA, and the clinicaltrials.gov listing has been updated. The company is now disseminating the new protocol to sites to begin the enrollment process.
Ampligen in Immuno-Oncology
AIM has also been exploring the potential of Ampligen as an immuno-oncology therapeutic. The company has been collaborating with the University of Pittsburgh’s chemokine modulation research initiative, which includes the use of Ampligen as a potential adjuvant to modify the tumor microenvironment with the goal of increasing anti-tumor responses to checkpoint inhibitors.
In March 2022, AIM announced that data from a Phase 1 study evaluating Ampligen as a component of a chemokine-modulating regimen in patients with recurrent platinum-sensitive ovarian cancer were published in the journal Clinical Cancer Research. The study results demonstrated evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function in the tumor microenvironment, which have been correlated with favorable tumor responses.
Recent updates on AIM’s ovarian cancer trials include the early conclusion of a trial combining Ampligen, cisplatin, and pembrolizumab due to impressive response rates and tumor infiltrating lymphocytes. Additionally, a Phase 2 study of Ampligen, cisplatin, and a dendritic cell vaccine is now open for recruitment.
Ampligen’s Antiviral Potential
AIM has also been investigating Ampligen’s potential as a broad-spectrum antiviral agent. Following the SARS-CoV-1 outbreak in 2002-2003, Ampligen exhibited excellent antiviral properties and a protective survival effect in studies of SARS-CoV-1-infected mice. The company believes that these results may extend to SARS-CoV-2, the virus that causes COVID-19, due to the significant genomic and pathogenic similarities between the two viruses.
In 2020, AIM entered into a specialized services agreement with Utah State University to support the university’s Institute for Viral Research in its research into SARS-CoV-2. The results from this collaboration showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal dosage levels.
Ampligen for ME/CFS and Post-COVID Conditions
AIM has long been focused on seeking FDA approval for the use of Ampligen to treat ME/CFS. In February 2013, the company received a Complete Response Letter from the FDA for its Ampligen NDA for ME/CFS, requesting additional clinical trials and data analyses. While developing a response to the FDA, AIM proceeded independently in Argentina and received approval of an NDA from ANMAT for the commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS in 2016.
In October 2020, AIM received Institutional Review Board (IRB) approval to expand its AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms, commonly referred to as “Long Haulers” or the post-COVID condition of fatigue.
In September 2024, AIM announced that an analysis of the complete clinical patient data from the AMP-518 clinical trial supported the belief in Ampligen as a potential therapeutic for people with the moderate-to-severe post-COVID condition of fatigue. The study found that Ampligen-treated subjects with a baseline 6-minute walk test (6MWT) less than 205 meters saw a mean improvement of 139 meters, compared to a mean improvement of 91 meters in the placebo group.
Recent updates on the post-COVID fatigue trial (AMP-518) include the approval of the final study report, with data to be posted to clinicaltrials.gov by the end of November. Exploratory biomarker data has been received, and the company is engaged in further analysis to identify the optimal patient population for future trials. Additionally, AIM has submitted Ampligen to be considered for inclusion in the RECOVER-TLC program at the NIH.
Financial Performance and Liquidity
For the year ended December 31, 2023, AIM reported annual revenue of $141,000, annual net loss of $19,445,000, annual operating cash flow of -$16,108,000, and annual free cash flow of -$16,379,000.
For the three months ended September 30, 2024, the company reported revenues of $35,000 from its Ampligen Cost Recovery Program, a decrease of $11,000 compared to the same period in 2023. This revenue was generated from the Expanded Access Program and the FDA-approved open-label treatment protocol, AMP-511, that allows patient access to Ampligen. The company did not have any Alferon N Injection finished goods product to commercially sell during this period.
Net loss for the three months ended September 30, 2024, was approximately $3.70 million, a decrease of $4.12 million or 53% compared to the same period in 2023. This decrease in net loss was primarily due to decreases in research and development expenses, general and administrative expenses, production costs, and an increase in gain on investments, partially offset by decreases in gain from the sale of income tax operating losses and increases in interest expense. The operating cash flow for this quarter was -$3,110,000, and the free cash flow was -$3,268,000, both showing significant improvement compared to the prior year quarter.
As of September 30, 2024, the company had approximately $7.20 million in cash, cash equivalents, and marketable securities, inclusive of approximately $6.29 million in marketable securities. This represents a decrease of $5.87 million from December 31, 2023. The company’s cash and cash equivalents specifically stood at $915,000.
AIM has suffered losses from operations and net cash used on operating activities for the three-month period ended September 30, 2024, and has a working capital deficit. These conditions raise substantial doubt regarding the company’s ability to continue as a going concern for a period of at least one year from the date of issuance of the unaudited condensed consolidated financial statements.
The company’s debt-to-equity ratio is 0.9381868131868132, indicating a relatively high level of debt compared to equity. The current ratio and quick ratio both stand at 0.7495049504950495, suggesting potential liquidity challenges in meeting short-term obligations.
AIM’s management has evaluated the conditions and their significance related to the company’s ability to meet its obligations. The primary cause of the working capital deficit was related to an accounts payable balance of $6.30 million, which includes $4.90 million in legal fees related to litigation. The company is currently negotiating with the law firm to reduce the prior billings. Additionally, AIM is continuing to negotiate the recovery of an additional $2.50 million from its secondary director and officer insurance coverage, which was initially denied. There is no assurance as to the timing or outcome of these efforts.
To address its liquidity needs, AIM entered into a $2.5 million unsecured promissory note in February 2024 with Streeterville Capital LLC. The note has an original issue discount of $781,250 and a stated interest rate of 10%. The company can redeem up to $250,000 per month beginning in August 2024.
Risks and Challenges
AIM faces several risks and challenges that investors should be aware of. The company’s primary product, Ampligen, has not been approved by the FDA or marketed in the United States, which creates significant uncertainty around its regulatory pathway and commercialization potential. The delay in the commercial launch of Ampligen in Argentina due to ANMAT’s internal processes also poses a risk to the company’s near-term revenue generation.
Additionally, AIM’s financial condition and liquidity constraints raise substantial doubt about its ability to continue as a going concern. The company’s ability to raise additional funding through its at-the-market offering, equity line of credit, or other sources is crucial to its continued operations and the advancement of its clinical programs.
Conclusion
AIM ImmunoTech is a company with a diverse pipeline focused on addressing significant unmet needs in the areas of oncology, virology, and autoimmune disorders. The company has made substantial progress in advancing Ampligen across multiple high-value indications, particularly in pancreatic cancer and immuno-oncology. While AIM faces financial and regulatory challenges, the positive data from its clinical trials and the potential of its core technologies underscore the company’s ability to drive long-term value for patients and shareholders, should it be able to resolve its current liquidity issues.
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