Aim Immunotech - AIM STOCK NEWS

AIM ImmunoTech has announced that Dr. Paul Goepfert from the University of Alabama-Birmingham will lead a planned clinical study combining Ampligen and AstraZeneca's FluMist as an intranasal vaccine for influenza, including avian influenza. This follows a previous UAB trial where Ampligen, used as a vaccine adjuvant, increased immune response to seasonal variants by over 4-fold and induced cross-reactive protection against highly pathogenic avian influenza strains H5N1, H7N9, and H7N3.

The company has engaged Amarex Clinical Research to prepare an Investigational New Drug application and manage the clinical study. AIM is seeking industry or governmental grants for study funding, with CEO Thomas K. Equels highlighting the potential cost-effectiveness of this approach at approximately $10 million in development costs compared to potentially billions for new mRNA vaccine development.

AIM ImmunoTech (NYSE American: AIM) has received acceptance from the NYSE American for its compliance plan to meet minimum stockholders' equity requirements under Sections 1003(a)(ii) and 1003(a)(iii) of the American Company Guide. The company has been granted until June 11, 2026 to regain compliance with the NYSE's Continued Listings Standards. CEO Thomas K. Equels expressed satisfaction with the approval and mentioned ongoing developments in the company's oncology and antiviral pipelines.

AIM ImmunoTech (NYSE American: AIM) has appointed David Chemerow as an Independent Director to its Board of Directors, effective immediately. Chemerow brings over 40 years of finance, accounting, and operations leadership experience to the role.

Chemerow previously served as CFO, Treasurer, and Chief Revenue Officer at Comscore, and as COO and CFO of Rentrak until its 2016 merger with Comscore. He currently serves on the Board of Directors for Dunham's Athleisure and the Advisory Board of Huntington Outdoor.

The appointment was unanimously approved by AIM's Board. Board Chairman William Mitchell highlighted Chemerow's proven track record of leadership and financial acumen as valuable additions to AIM's mission. Chemerow expressed optimism about AIM's position in the immuno-pharma space, particularly noting Ampligen's potential across various high-value indications.

AIM ImmunoTech (NYSE American: AIM) has dosed the first new subject in Phase 2 of their Phase 1b/2 clinical trial studying the combination of Ampligen (rintatolimod) and AstraZeneca's Imfinzi (durvalumab) for treating late-stage pancreatic cancer. The trial, known as DURIPANC, is being conducted at the Erasmus Medical Center in the Netherlands.

Several subjects from Phase 1 who received the highest dose will also be included in Phase 2. The investigator-initiated, exploratory, open-label, single-center study expects to enroll up to 25 patients in the Phase 2 portion.

AIM CEO Thomas K. Equels expressed confidence in steady enrollment, noting that unlike many pancreatic cancer studies where accrual can be challenging, they expect consistent patient recruitment for this trial combining the TLR-3 agonist rintatolimod with the anti-PD-L1 immune checkpoint inhibitor durvalumab.

AIM ImmunoTech (NYSE American: AIM) has released a Virtual Investor segment featuring CEO Thomas K. Equels and Professor Casper H.J. van Eijck from Erasmus Medical Center discussing their Phase 1b/2 clinical trial DURIPANC. The trial investigates the combination of AIM's Ampligen® and AstraZeneca's Imfinzi® for treating late-stage pancreatic cancer.

The Erasmus MC Safety Committee has approved advancing to Phase 2 after reviewing Phase 1 safety data, which showed the combination treatment was generally well-tolerated with no treatment-related severe adverse events or dose-limiting toxicities. The study is being conducted as an investigator-initiated, exploratory, open-label, single-center trial in the Netherlands at Erasmus MC.

AIM ImmunoTech (NYSE American: AIM) has announced it will postpone its planned offering under Registration Statement Form S-1. The company will not proceed with the offering until after filing its Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

AIM ImmunoTech (NYSE American: AIM) has announced plans to advance Ampligen as a vaccine adjuvant for avian influenza. The company will conduct a follow-up clinical study combining Ampligen with AstraZeneca's FluMist nasal spray vaccine. This initiative builds on previous research at the University of Alabama-Birmingham, which showed that intranasal Ampligen administration after FluMist increased immune response by over four-fold and induced cross-reactive antibodies against highly pathogenic avian influenza strains H5N1, H7N9, and H7N3.

Pre-clinical studies demonstrated significant protective effects, with 50-100% survival rates against various H5N1 strains in mice. Non-human primate studies showed protection against H5N1 symptoms and generated neutralizing antibodies. Previous human trials indicated that intranasal Ampligen was generally well-tolerated with no serious treatment-related adverse events.

AIM ImmunoTech (NYSE American: AIM) has received Safety Committee approval to advance to Phase 2 of their Phase 1b/2 clinical trial studying the combination of Ampligen® and Imfinzi® for late-stage pancreatic cancer treatment. The approval follows positive Phase 1 safety data showing the combination therapy was generally well-tolerated with no severe treatment-related adverse events.

The DURIPANC study, conducted at Erasmus Medical Center in the Netherlands, will enroll up to 25 patients in Phase 2, including six patients from Phase 1. Early observations indicate improvements in quality of life, with some patients showing stable disease for 15+ months after starting FOLFIRINOX treatment. This is notable considering approximately 80% of similar patients at Erasmus MC typically show disease progression after three months without this treatment.

The study aims to address a significant unmet need in oncology, as pancreatic cancer claims approximately 50,000 American lives annually with currently no effective therapy available.

AIM ImmunoTech (NYSE American: AIM) has published final clinical study results for its AMP-518 Phase 2 trial evaluating Ampligen as a treatment for Post-COVID conditions. The study showed promising results, particularly for patients with moderate-to-severe Post-COVID fatigue.

Key findings revealed that Ampligen-treated patients with Long COVID demonstrated improved walking capacity compared to placebo groups. Specifically, patients with a baseline Six-Minute Walk Test (6MWT) less than 205 meters showed significant improvement, achieving a mean increase of 139 meters versus 91 meters in the placebo group (p <0.02).

The company highlighted recent NIH RECOVER initiative data showing that ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) prevalence is now five times higher than pre-pandemic levels due to COVID-19 infections. Based on these results, AIM plans to conduct a follow-up clinical trial focusing on patients with moderate or worse COVID-related fatigue or ME/CFS symptoms.