Tillkännagivande • Aug 05
AIM ImmunoTech Advances Ampligen In DURIPANC Phase 2 Clinical Trial For Metastatic Pancreatic Cancer AIM ImmunoTech announced that the final subject has received their last dose of Ampligen (rintatolimod) under the study protocol, reaching this milestone ahead of schedule in the Phase 2 DURIPANC clinical trial evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. Following planned data collection, DURIPANC Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in the First Quarter 2027. DURIPANC’s primary endpoint is Clinical Benefit Rate (CBR), defined as the proportion of patients achieving stable disease, partial response or complete response at 24 weeks following initiation of combination therapy. Analysis of the DURIPANC Overall Survival Endpoint is expected to begin in June 2027, or 49 weeks after this final subject received their first dose. DURIPANC’s Secondary Endpoints include Overall Survival – the gold standard in oncology trials – as well as progression-free survival and a completed immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best clinical benefit and overall survival results, which could be critical to the design of a pivotal Phase 3 clinical trial. AIM saw encouraging results in a Dutch Ministry of Health-approved Named Patient Program that provided more than 50 post-standard of care pancreatic cancer patients with access to Ampligen as a monotherapy. While the program was not designed to assess efficacy and the findings were exploratory observations, analysis of biomarker stratifications was extremely promising. For example, Ampligen achieved a median Overall Survival of 34.8 months compared to 12.5 months for historical controls — for an improvement of 22.3 months — in the patient subset with immune biomarker Neutrophil/Lymphocyte ratios less than 4.5. DURIPANC is an investigator-initiated, exploratory, open-label, single-center Phase 2 study. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. In addition to the Primary Endpoint of clinical benefit rate, the secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life. Tillkännagivande • Jun 25
Aim Immunotech Highlights Clinical Progress and Key Milestones in Ampligen Pancreatic Cancer Program AIM ImmunoTech Inc. highlighted the significant progress achieved across its pancreatic cancer development program and outlined a series of anticipated milestones. At the center of AIM's strategy is Ampligen (rintatolimod), the Company's proprietary TLR3 agonist immunotherapy, which is being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca's PD-L1 inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. AIM believes Ampligen's unique mechanism of action and encouraging clinical observations to date position the program as a potentially differentiated immunotherapy approach in this difficult-to-treat disease. Over the past several months, AIM has delivered a series of meaningful achievements that have advanced Ampligen toward potential late-stage development: Completed Phase 2 DURIPANC enrollment ahead of schedule; Achieved the important clinical milestone of dosing the final patient in the study; Reported positive interim clinical updates from the ongoing trial; Continued to demonstrate a favorable safety profile with no significant toxicity reported in study updates; Advanced the program under a collaboration involving AstraZeneca and Erasmus Medical Center; Expanded and strengthened global intellectual property protection surrounding Ampligen and checkpoint inhibitor combinations; Maintained orphan drug designation for pancreatic cancer in major markets; Regained compliance with NYSE American continued listing standards; Strengthened the balance sheet through multiple financing transactions designed to support strategic clinical priorities. Ampligen's pancreatic cancer program is supported by a growing body of clinical evidence. The ongoing DURIPANC Phase 2 study builds upon prior clinical experience in late-stage pancreatic cancer, including a Dutch government approved named patient program where Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations. Recent interim updates from DURIPANC have continued to support management's confidence in the program, reinforcing the rationale for advancing Ampligen as a potential immunotherapy platform capable of activating innate immunity while potentially enhancing the effectiveness of checkpoint inhibition. The combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment. With enrollment completed and all subjects now receiving treatment, AIM is entering what management believes may be the most catalyst-rich period in the Company's recent history. Key anticipated milestones include: Additional clinical updates from the ongoing DURIPANC study; Primary Endpoint analysis anticipated to begin in December 2026, with topline results expected in the first quarter of 2027; Progression-free survival, overall survival and other secondary endpoint assessments expected to begin in June 2027; Continued immune monitoring and biomarker analyses; Regulatory interactions supporting future development planning; Further expansion of the Company's global intellectual property portfolio; Advancement of Phase 3 planning activities; Potential design and initiation activities associated with a registration-focused pivotal study. AIM has increasingly concentrated its resources on pancreatic cancer, which management believes represents the most significant opportunity to create long-term shareholder value. The Company has consistently communicated that advancing Ampligen toward a pivotal clinical program and ultimately a potential regulatory approval pathway remains its highest priority. With positive interim clinical progress, completed enrollment, orphan drug designations, strengthened intellectual property protection, strategic collaborations, and potential Phase 3 development, AIM believes it is entering a critical value-inflection period. As AIM advances through the remainder of 2026 and prepares for potential pivotal-stage development activities, management believes the Company is increasingly positioned as a unique oncology opportunity centered on one of the largest unmet needs in cancer treatment. Tillkännagivande • Jun 19
Aim Immunotech Achieves Clinical Milestone as Final Subject Receives First Dose in Phase 2 Duripanc Study in Metastatic Pancreatic Cancer AIM ImmunoTech Inc. announced that the final subject has received their first dose in the Phase 2 DURIPANC clinical trial evaluating Ampligen (rintatolimod) in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. With this final subject, Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in the First Quarter 2027. DURIPANC’s primary endpoint is Clinical Benefit Rate, defined as the proportion of patients achieving stable disease, partial response or complete response at 24 weeks following initiation of combination therapy. Analysis of Secondary Endpoints is expected to begin in June 2027, or 49 weeks after this final subject received their first dose. DURIPANC’s Secondary Endpoints include Overall Survival – the gold standard in oncology trials – as well as progression-free survival and immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best survival results, which could be critical to the design of a pivotal Phase 3 clinical trial. DURIPANC is a follow-up to the AIM/Erasmus Medical Center Named Patient Program utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival, particularly when broken down by biomarker stratifications: Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Progression-Free Survival of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in Progression-Free Survival. Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Overall Survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months in Overall Survival. Based upon stratification for immune marker CA 19-9 less than 1000, Progression-Free Survival of 13.1 months compared to 8.6 months for historical controls, for an improvement of 4.5 months in Progression-Free Survival. Based upon stratification for immune marker CA 19-9 less than 1000, Overall Survival of 24.1 months compared to 12.5 months for historical controls, for an improvement of 11.6 months in Overall Survival. These results were accompanied by consistent reports of improved quality of life. DURIPANC is an investigator-initiated, exploratory, open-label, single-center Phase 2 study. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. In addition to the Primary Endpoint of clinical benefit rate, the secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life. Tillkännagivande • Jun 16
AIM ImmunoTech Inc Regains NYSE American Compliance, Company Resolves Stockholder Equity Deficiency AIM ImmunoTech Inc. announced that it has received written notice from the NYSE American that AIM has regained compliance with NYSE American's continued listing standards related to stockholders' equity. On May 7, 2026, the Company entered into a warrant exercise inducement offer letter agreement with certain a holder of existing warrants, pursuant to which the holders agreed to exercise their warrants in cash at a reduced exercise price for aggregate gross proceeds of approximately $3.5 million in consideration of the Company's agreement to issue new warrants upon such exercise. On May 21, 2026, the Company issued and sold 7,519,351 shares of common stock, par value $0.001 per share, to certain investors for aggregate gross proceeds of approximately $2.4 million. On June 10, 2026, the Company issued and sold 2,554,119 shares of common stock and, in a concurrent private placement, 771,503 shares of common stock, pre-funded warrants to purchase up to 1,782,616 shares of common stock, and Class J warrants to purchase up to 10,216,476 shares of common stock to certain investors for aggregate gross proceeds of approximately $2.6 million. Following the closing of these transactions, the Company believes it currently has stockholders' equity in excess of the $6.0 million minimum requirement. The NYSE American formally notified the Company on June 12, 2026, confirming that the Company had successfully addressed and resolved all deficiencies related to Sections 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide. As a result, the “below compliance” (“.BC”) indicator will be removed from the Company's trading symbol for its common stock, and the Company will be removed from NYSE American's list of noncompliant issuers on its website. The Company will remain subject to NYSE American's continued listing monitoring procedures and remains committed to maintaining strong financial discipline and governance going forward. Tillkännagivande • Jun 02
AIM ImmunoTech Inc. Completes Enrollment in Phase 2 DURIPANC Clinical Trial for Ampligen Combined with Imfinzi in Metastatic Pancreatic Cancer AIM ImmunoTech Inc. announced a significant milestone in its pancreatic cancer development program, with enrollment of the final subject, barring disqualifying pre-treatment circumstances. The final planned subject is scheduled for treatment in mid-June, surpassing the Company's original enrollment target of July 2026 in the Phase 2 clinical trial of AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the DURIPANC study). The ahead-of-schedule enrollment milestone reinforces AIM’s emphasis on accelerating momentum and keeps the Company on track for a planned December 2026 evaluation of the study's primary endpoint, Clinical Benefit Rate (CBR), a key measure of treatment effectiveness in one of the deadliest and most difficult-to-treat cancers. AIM previously reported positive year-end interim results in DURIPANC and intends to publish its next interim report in the next two to three weeks. AIM remains on track to complete Ampligen dosing for all subjects in August, which should allow evaluation of the study's critical primary endpoint of Clinical Benefit Rate in December 2026. Clinical Benefit Rate is defined as stable disease, partial response, or complete response six months after initiation of combination therapy. The enrollment milestone further advances AIM's broader pancreatic cancer strategy, which includes ongoing Phase 3 clinical trial planning and continued expansion of its global regulatory and intellectual property position. The planned Phase 3 program is supported by positive published data from a Dutch government-approved Named Patient Program involving Ampligen-treated pancreatic cancer patients, as well as encouraging findings from the ongoing DURIPANC study. Collectively, these programs have generated clinical experience in more than 100 pancreatic cancer patients treated with Ampligen and continue to support the Company's strategy of advancing Ampligen toward pivotal-stage development. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study conducted through a collaboration among AIM ImmunoTech, AstraZeneca, and Erasmus Medical Center in the Netherlands. The primary objective of the study is to evaluate the CBR of the combination therapy. Secondary and exploratory objectives include assessing overall survival and progression-free survival, evaluating immune-monitoring through tissue biopsies and peripheral immune profiling, and measuring patient quality of life. Pancreatic cancer remains one of the most lethal malignancies worldwide and is projected to become the second leading cause of cancer-related deaths in the United States. Despite decades of research, treatment options remain limited, highlighting the urgent need for innovative therapeutic approaches that can improve survival and quality of life for patients. 
