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AIM ImmunoTech, Inc.
AIM ImmunoTech Inc. is an immuno-pharma company primarily engaged in developing therapeutics for various significant diseases, including multiple types of cancers, immune disorders, and viral infections like COVID-19. The company's flagship product, Ampligen® (rintatolimod), is an immune-modulator under development for various indications. It's notable for its broad-spectrum activity and is currently involved in numerous clinical studies aimed at demonstrating its efficacy across multiple high-value disease areas, including oncology and chronic viral diseases.
NYSEAMERICAN: AIM
IR Website: aimimmuno.com
Headquarters: Ocala, FL
Investor Contact: aim@jtcir.com
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Summary
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AIM ImmunoTech Inc., an immuno-pharma company based in Ocala, Florida, is dedicated to the development of therapeutics for various cancers, immune deficiency disorders, and viral diseases, including COVID-19. The company has built a substantial portfolio of laboratory, pre-clinical, and clinical data focusing on nucleic acids and natural interferon to boost the human body's antiviral defenses and assist in developing therapies for specific cancers and chronic conditions.
AIM ImmunoTech's leading products are Ampligen® (rintatolimod) and Alferon N Injection® (Interferon alfa-n3). Ampligen® is a pioneering RNA-based drug targeting significant global health challenges, including various cancers and viral diseases. It is approved in Argentina for severe chronic fatigue syndrome (CFS) and is under evaluation for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-COVID conditions. Alferon N Injection® is approved in the U.S. for the intralesional treatment of refractory or recurrent external genital warts in adults and for a specific STD infection in Argentina, noted for being the only natural-source, multi-species alpha interferon approved for these conditions.
Press Releases
Social Media Updates
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Recent LinkedIn Posts
Recent Facebook, Instagram, Pinterest, TikTok, and X Posts
Investor Presentation
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To download the AIM ImmunoTech Inc. investor presentation, please fill out the form below.
Stock Chart (Intraday)
Stock Chart (Historical)
CEO Corner Videos & Virtual Investor Series
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The CEO Corner platform was launched in March 2024 to provide an additional and in-depth perspective on press releases, corporate developments, and development pipeline progress.
“Keeping our stakeholders well informed is absolutely essential to the future success of AIM ImmunoTech. CEO Corner is a new way for us to connect directly with both current and potential stockholders. CEO Corner segments will provide expanded perspective on press releases, clinical trials and other corporate advancements as we continue to push forward with our development pipeline. We believe in the future of Ampligen and are dedicated to growing value for all stakeholders," said CEO Tom Equels.
March 7, 2024 –
Welcome to the AIM CEO Corner
March 13, 2024 –
Oncology Overview
March 20, 2024 –
Ovarian Cancer
March 20, 2024 –
Virtual Investor Lunch Break: The AIM Opportunity
April 11, 2024 –
Top-line Interim Data from Recurrent Ovarian Cancer Study
Videos Source: Company Reports
Ampligen® - A Wide Variety of Potential Applications
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Generally well-tolerated with over 100,000 IV doses in humans
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Clinically tested in oncology as a single-agent therapeutic and in combination with other agents
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Potential in oncology to enhance the efficacy of PD-1 and PD-L1 checkpoint inhibitors1
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Phase 3 in ME/CFS completed in U.S. – NDA filing pending confirmatory Phase 3 following complete response letter; Approved for the treatment of severe CFS in Argentina
1: Animal experiments support expectations of human responses
Source: Company Reports
Additionally, Ampligen® induces a wide range of immunologic and anti-tumor activities, making it a potentially useful immuno-therapy targeting multiple cancers with high unmet needs.
Source: Company Reports
Source: Company Reports
Next Steps:
AIM ImmunoTech reports ongoing positive developments in its cancer treatment programs with Ampligen. Following initial promising data in 2022, recent studies have shown enhanced anti-tumor immunity in recurrent ovarian cancer as of April 2024. Additionally, positive findings from the study of Ampligen in pancreatic cancer have been published in the Journal of Clinical Cancer Research in March 2024. The company continues to explore and expand Ampligen’s therapeutic potential across various oncological applications.
In the video below, CEO Thomas Equels joined Proactive's Stephen Gunnion after the company announced the start of an NCI-funded Phase 2 study of its product candidate, Ampligen, in melanoma. Equels gave an overview of Ampligen and explained the process for the Phase 2 study and the steps AIM will take if it is successful. He also provided an overview of AIM's other programs with Ampligen.
Alferon N Injection®
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Alferon N Injection® continues to be an FDA-approved treatment for refractory or recurrent external condylomata acuminata. The commercial relaunch is pending the completion of the FDA's manufacturing approval process. Sales are expected to resume following a successful pre-approval inspection and obtaining the necessary supplemental approvals.
Strategic Partnerships
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AIM ImmunoTech has developed strategic partnerships with groups such as the University of Pittsburgh Medical Center as well as Erasmus MC in Rotterdam for their oncology treatment trials.
Source: Company Reports
Source: Company Reports
Market Potential
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AIM ImmunoTech believes that it has potential solutions for a number of different indications, both for use in isolation as well as in conjunction with another drug.
First, Ampligen is in late-stage trials for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Up to 2.5 million Americans are estimated to suffer from this malady, causing the U.S. economy an estimated $17 to $24 billion per year, according to the CDC.
Additionally, Ampligen is currently being studied for alleviating "long COVID"—the long-term issues some COVID patients suffer from. While there is not much long-term information to draw from, a recent UCLA study implies that around 30% of COVID patients have long-term symptoms.
Lastly, oncology: AIM ImmunoTech believes that it may have therapeutic solutions for numerous types of cancer. As a malady that impacts so many of us, the potential market for these therapeutics is enormous. Precedence Research estimates that the global market will balloon to over $580 billion annually in 2030, with a Compounded Annual Growth Rate (CAGR) of 8.2% this decade.
Source: Precedence Research
Current Pipeline
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Source: Company Reports
Strong Cash Position & Poised for Commercialization
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For biotech companies, securing sufficient funding is crucial to sustain development and regulatory approval processes, which are both time-intensive and costly. A lack of adequate funding is a common hurdle that prevents many biotech firms from bringing their candidates to market.
As of the end of 2023, AIM ImmunoTech is in a favorable position compared to many of its peers. With cash and cash equivalents of approximately $13.1 million, the company remains strategically poised with enough financial resources to pursue its clinical development goals and move towards the commercialization of its products.
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Source: Company Documents
While a strong cash position is no guarantee that its candidates will successfully move through the regulatory approval process, its cash position combined with a strong intellectual property stack puts it in a strong position for future success.
Source: Company Reports
SEC Filings
Management Overview
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![B2i Digital Featured Company_AIM ImmunoTech Inc_NYSE AIM_THOMAS K EQUELS](https://b2idigital.com/hs-fs/hubfs/Equels.png?width=200&name=Equels.png)
Thomas K. Equels, M.S. J.D.
Chief Executive Officer
THOMAS K. EQUELS is AIM ImmunoTech's Chief Executive Officer (since 2016), President (since 2015), and Executive Vice Chairman (since 2008). He has also been one of the company's Directors since 2008. Mr. Equels was formerly the President and Managing Director of the Equels Law Firm in Miami, Fla. For over a quarter century, he represented national governments, state governments and private companies in banking, insurance, aviation, pharmaceutical and construction matters. He also was, on numerous occasions, the court-appointed receiver to turn around distressed companies. Mr. Equels received his Juris Doctor degree with high honors from Florida State University. He received his Bachelor of Science, summa cum laude, from Troy University and also obtained his Master of Science Degree from Troy University. Mr. Equels began his professional career as a military pilot. He served in Vietnam and was awarded two Distinguished Flying Crosses, the Bronze Star, the Purple Heart, and fifteen Air Medals. In 2012, he was Knighted by Pope Benedict.
![B2i Digital Featured Company_AIM ImmunoTech Inc_NYSE AIM_David R Strayer](https://b2idigital.com/hs-fs/hubfs/Strayer.jpg?width=189&height=189&name=Strayer.jpg)
David R. Strayer, MD
Medical Officer
DR. DAVID R. STRAYER, MD, is the Chief Scientific & Medical Officer. He was appointed Chief Scientific Officer in February 2016 and has served as Medical Director since 1986. Based on his experience, Dr. Strayer is considered the foremost medical expert on Ampligen and Alferon in the world. He has served as Professor of Medicine at the Medical College of Pennsylvania and Hahnemann University from 1987 to 1998. Dr. Strayer is Board Certified in Medical Oncology and Internal Medicine with research interests in the fields of cancer and immune system disorders. He has served as principal investigator in studies funded by the Leukemia Society of America, the American Cancer Society, and the National Institutes of Health. Dr. Stayer attended the School of Medicine at the University of California at Los Angeles, where he received his MD in 1972.
![B2i Digital Featured Company_AIM ImmunoTech Inc_NYSE AIM_Peter W Rodino III](https://b2idigital.com/hs-fs/hubfs/Rodino.png?width=200&name=Rodino.png)
Peter W. Rodino III, JD
Chief Operating Officer, Executive Director for Governmental Relations, General Counsel, Secretary
PETER W. RODINO III has been a Director since July 2013. On September 30, 2016, Mr. Rodino resigned as a member of AIM ImmunoTech's Board to permit him to serve in a new capacity. Effective October 1, 2016, AIM retained Mr. Rodinoas as Executive Director for Governmental Relations and as General Counsel. As of October 16, 2019, Mr. Rodino assumed the role of Chief Operating Officer. Mr. Rodino has been AIM's Secretary since November 2016. Mr. Rodinohas broad legal, financial, and executive experience. In addition to being President of Rodino Consulting LLC and managing partner at several law firms during his many years as a practicing attorney, he served as Chairman and CEO of Crossroads Health Plan, the first major Health Maintenance Organization in New Jersey. He also has had experience as an investment executive in the securities industry and acted as a trustee in numerous Chapter 11 complex corporate organizations. Previously, as founder and president of Rodino Consulting, Mr. Rodino provided business and government relations consulting services to smaller companies with a focus on helping them develop business plans, implement marketing strategies, and acquire investment capital. Mr. Rodino holds a B.S. in Business Administration from Georgetown University and a J.D. degree from Seton Hall University.
![B2i Digital Featured Company_AIM ImmunoTech Inc_NYSE AIM_Robert Dickey IV](https://b2idigital.com/hs-fs/hubfs/Dickey.png?width=200&name=Dickey.png)
Robert Dickey IV
Chief Financial Officer
ROBERT DICKEY, IV has been AIM ImmunoTech's Chief Financial Officer since April 4, 2022. Mr. Dickey has more than 25 years of experience in C-suite financial leadership for life science and medical device companies, both private and public, ranging from preclinical development to commercial operations and across a variety of disease areas and medical technologies. Mr. Dickey has served as Managing Director at Foresite Advisors since March 2020, assuming responsibility for CFO advisory, financial analysis, capital raising, and transactional support/execution for public offerings and M&A services at life science companies and was previously a Managing Director at Danforth Advisors from August 2018 to March 2020. Both Foresite Advisors and Danforth Advisors provide financial support and investment advisory services. Mr. Dickey served as a member on the board of directors at Emmaus Life Sciences, a biopharmaceutical company, from July 2019 to August 2022; served as a member on the board of directors at Sanuthera, Inc., a privately held medical device company, from 2013 to 2017, and was employed as Chief Financial Officer of Motif Bio Plc., a NASDAQ and London AIM exchange-listed antibiotics company, from January 2017 to February 2018. Earlier in his career, Mr. Dickey spent 18 years in investment banking, primarily at Lehman Brothers, with a background split between mergers and acquisitions and capital markets transactions. Mr. Dickey was a senior vice president of the Company from 2008 until 2013. Throughout his career, he has demonstrated C-level (CFO, COO, and CEO) and Board-level experience in public, private, revenue stage, and development stage life sciences and medical device companies and has played a leading role in two start-ups. His prior career as an investment banker included 14 years at Lehman Brothers. Mr. Dickey is experienced in all stages of the business lifecycle, including start-up, high-growth and turnarounds, and in building businesses and achieving an exit. He also has international experience and expertise in public and private financings, M&A, partnering/licensing transactions, project management, and Chapter 11 reorganizations, as well as interacting with boards, VCs, shareholders, and Wall Street. Dickey has an MBA from The Wharton School and an AB from Princeton University.
![B2i Digital Featured Company_AIM ImmunoTech Inc_NYSE AIM_Christopher McAleer](https://b2idigital.com/hs-fs/hubfs/McAleer.jpg?width=200&height=199&name=McAleer.jpg)
Christopher McAleer, PhD
Scientific Officer
Risks & Disclosures
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This communication is neither an offer to sell nor a solicitation of an offer to buy, nor a recommendation of any securities of the company mentioned herein.
AIM ImmunoTech Inc. (the “Company”) and its counsel have reviewed the content of this page as well as the accompanying presentation (“Company Presentation”) displayed on this page. To the best of its knowledge, the Company does not believe this content to be misleading or inaccurate in any material respect, nor does it believe there are any material omissions with respect to such content. The Company does not believe the contents of the page or the Company Presentation to contain any non-public material information.
Information and opinions presented in the Company Presentation are provided by the Company, and makes no representation as to their accuracy or completeness. The information contained on this page is not intended to constitute any form of advice, and the information provided is not intended to provide a sufficient basis on which to make an investment decision. It is not investment research, nor does it constitute a research recommendation, as it does not constitute substantive research or analysis. This information is not to be relied upon in substitution for the exercise of independent judgment.
Information, opinions and estimates contained on this page or in the Company Presentation reflect judgments by the Company as of the original date of publication by the Company and are subject to change without notice. Past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied is made regarding future performance.
A complete description of the risks and uncertainties relating to the Company and its securities can be found in the company's filings with the U.S. Securities and Exchange Commission available for free at www.sec.gov.
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