Aim Immunotech Stock Price, News & Analysis

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.

AIM ImmunoTech urges shareholders to vote 'FOR' all four incumbent board members at the upcoming 2024 Annual Meeting. The company highlights that leading proxy advisors ISS and Glass Lewis recommended against giving control to the dissident nominees, citing their lack of a detailed plan. The Activist Group seeks to reimburse themselves over $5 million in litigation expenses from failed takeover attempts without shareholder vote.

AIM defends its clinical development strategy of partnering with institutions like AstraZeneca and Merck, emphasizing that this approach preserves cash and reduces trial risks while maintaining Ampligen rights. The company criticizes the activist nominees' backgrounds, particularly highlighting concerns about Robert Chioini's past management issues and Todd Deutsch's connections.

AIM ImmunoTech (NYSE American: AIM) has secured Patent No. 2,032,813 from the Netherlands Patent Office for its drug Ampligen (rintatolimod) to treat post-COVID fatigue. The patent was granted to CEO Thomas K. Equels and Medical Officer David R. Strayer, who assigned it to the company.

Ampligen, an RNA product candidate designed to modulate the immune system, has shown broad-spectrum antiviral effects through stimulating innate immune response. The company recently reported positive topline results from its Phase 2 study (AMP-518) evaluating Ampligen's efficacy and safety in treating post-COVID fatigue. The drug was generally well-tolerated and showed preliminary evidence of reducing fatigue in subjects with post-COVID conditions.

Based on these results, AIM plans to conduct a follow-up clinical trial focusing on moderate-to-severe post-COVID fatigue patients.