Aim Immunotech - AIM STOCK NEWS

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.

AIM ImmunoTech (NYSE American: AIM) comments on a new study published in the Journal of General Internal Medicine that reveals significant links between COVID-19 and ME/CFS. The study found that among COVID-19 infected participants, ME/CFS incidence was 15 times higher than pre-pandemic rates, with 4.5% prevalence among infected participants.

The company's drug Ampligen showed promising results in their AMP-518 clinical program for Post-COVID fatigue treatment. Patients with baseline Six-Minute Walk Test less than 205 meters showed significant improvement, with a mean increase of 139 meters compared to 91 meters in the placebo group (p<0.02).

Earlier data published in PLOS One demonstrated Ampligen's effectiveness in treating ME/CFS when administered early (2-8 years of symptom onset), with 51.2% of treated subjects showing at least 25% improvement in exercise duration (p=0.003).

AIM ImmunoTech (NYSE American: AIM) highlighted its 2024 achievements and outlined upcoming milestones for 2025-26. The company reported progress in Ampligen® clinical development programs, particularly in pancreatic cancer and Long-COVID treatments.

Key 2024 achievements include: commencement of the DURIPANC Phase 1b/2 study combining Ampligen with AstraZeneca's Imfinzi®; positive preliminary data from multiple pancreatic cancer trials; favorable results from a Phase 2 study in post-COVID fatigue; and completion of cGMP manufacturing of 9,042 Ampligen clinical vials.

Upcoming milestones include: completion of Phase 1b DURIPANC study in Q1 2025; launch of Phase 2 in early Q2 2025; initiation of multiple clinical trials across various cancers including melanoma, triple-negative breast cancer, and ovarian cancer; and publication of final post-COVID study results in Q1 2025. Several trials are partially funded by the National Cancer Institute, AstraZeneca, and Merck.

AIM ImmunoTech (NYSE: AIM) received a notice from NYSE American on December 11, 2024, indicating noncompliance with continued listing standards. The company fails to meet requirements for stockholders' equity of $4 million (Section 1003(a)(ii)) and $6 million (Section 1003(a)(iii)) after reporting losses in its five most recent fiscal years.

The stock will continue trading under 'AIM' with an added '.BC' designation indicating 'below compliance'. The company must submit a compliance plan by January 10, 2025, demonstrating how it will meet standards by June 11, 2026. If the plan is not submitted, accepted, or if progress isn't maintained, AIM could face delisting procedures.

AIM ImmunoTech (NYSE American: AIM) announced the election results from its 2024 Annual Meeting of Stockholders. Three incumbent directors - Nancy K. Bryan, Thomas K. Equels, and Dr. William M. Mitchell - were re-elected to the Board of Directors, along with new member Ted D. Kellner. The meeting achieved the required 40% quorum of outstanding shares entitled to vote.

Dr. Mitchell, Board Chairman, expressed gratitude to shareholders for their support and trust in the company's clinical development strategy, particularly regarding their lead drug candidate, Ampligen. The company aims to focus on supporting high-value cancer clinical development programs in areas with critical unmet needs.

AIM ImmunoTech (NYSE American: AIM) urges shareholders to vote 'FOR' all four incumbent Board members at the upcoming 2024 Annual Meeting scheduled for December 17, 2024. The company emphasizes that the current Board has the expertise to continue developing Ampligen and create long-term shareholder value. AIM warns against an Activist Group's attempt to gain Board control, which could potentially lead to over $5 million in self-reimbursements and disrupt ongoing clinical development progress. The company highlights its partnerships with major biopharmaceutical companies and research organizations, demonstrating Ampligen's potential. Both major proxy advisory firms, ISS and Glass Lewis, have noted the Activist Group's lack of a clear plan for AIM.