Announcement • 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. Announcement • May 22
AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million. AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 7,519,351
Price\Range: $0.325
Transaction Features: Registered Direct Offering Announcement • May 20
AIM ImmunoTech Inc. has completed a Follow-on Equity Offering in the amount of $2.846758 million. AIM ImmunoTech Inc. has completed a Follow-on Equity Offering in the amount of $2.846758 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 155,874
Price\Range: $1.445796
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,025,292
Price\Range: $1.018814
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,019,570
Price\Range: $0.54729
Transaction Features: At the Market Offering Announcement • May 10
Aim Immunotech Inc Announces 50% Objective Response Rate in Upmc Recurrent Ovarian Cancer Phase 2 Clinical Trial AIM ImmunoTech Inc. announced the Final Primary Endpoint Report on Objective Response Rate data from a University of Pittsburgh Medical Center Phase 2 clinical trial – in which AIM and Merck Sharp & Dohme are collaborators – evaluating Ampligen (rintatolimod) in combination with checkpoint inhibition and chemotherapy in recurrent ovarian cancer—data that may signal a major step forward in overcoming resistance to immunotherapy. The study aimed to improve clinical outcomes by overcoming the immunosuppressive tumor microenvironment characteristic of ovarian cancer through locoregional and systemic immune activation strategies. This clinical trial was financially supported by a Merck grant. Topline results included: 50% Objective Response Rate (ORR), including 21% complete responses; 79% Clinical Benefit Rate; Median Overall Survival of 32.5 months; Durable responses exceeding 70+ months in select patients; No Grade 4 or 5 toxicities observed. Collection of additional secondary endpoint data including progression-free survival, time to disease progression and overall survival is expected to be completed in January 2027. Announcement • Apr 17
AIM ImmunoTech Enters Pivotal Value Inflection Phase with Planned Phase 3 Study of Ampligen in Pancreatic Cancer, Backed by Positive Clinical Signals, Orphan Drug Status, and Global IP AIM ImmunoTech Inc. highlighted accelerating momentum in its pancreatic cancer program, underscored by Phase 3 trial planning underway, encouraging Phase 2 clinical signals, and a rapidly strengthening global regulatory and intellectual property position. The Company recently announced a strategic agreement with the PPD clinical research business of Thermo Fisher Scientific to design its planned Phase 3 clinical trial of Ampligen in late-stage pancreatic cancer. This collaboration brings world-class clinical development expertise to support trial design and positions AIM to efficiently advance Ampligen into late-stage development. The planned Phase 3 program is supported by very positive published data from a Dutch government-approved Named Patient Program with Ampligen as a monotherapy in late-stage pancreatic ductal adenocarcinoma and reported encouraging data from the ongoing Phase 2 DURIPANC study, which is evaluating Ampligen in combination with AstraZeneca’s durvalumab. That ongoing study is showing promising improvement in progression-free survival and overall survival, as well as a favorable safety profile. Conducted in collaboration with AstraZeneca and Erasmus Medical Center, the study is expected to complete enrollment later this year and represents a key clinical validation step for our upcoming pivotal trial. As mentioned above, similar positive data was observed in the NPP, where Ampligen as a monotherapy was administered to 82 total patients and which had a significant positive findings on both progression-free and overall survival compared to historical controls. Pancreatic cancer represents a large and rapidly growing global market opportunity, with incidence rising and limited innovation over several decades. It is projected to become the second leading cause of cancer-related deaths in the United States, underscoring both the urgency and the commercial potential for new therapeutic options.
Ampligen, a selective TLR3 agonist, is designed to activate innate immunity and improve tumor responsiveness, making it a strong candidate for use as both a monotherapy and in combination with checkpoint inhibitors in multiple solid tumor types, and specifically with positive Phase 1/2 safety and efficacy data in combination with AstraZeneca’s durvalumab and Merck’s pembrolizumab in pancreatic cancer. The Company continues to expand its global IP portfolio. AIM recently obtained final approval of a Japanese patent covering Ampligen in combination with checkpoint inhibitors, which is set to expire in 2039. Existing patents in the United States and Europe also extend to 2039, with broad claims supporting combination use across multiple oncology indications. This IP estate positions Ampligen for long-term commercial protection across major markets. AIM’s IP portfolio includes orphan drug designations for pancreatic cancer in both the United States and Europe, and the Company announced in March 2026 that it would seek similar status in Japan. These designations provide potential market exclusivity upon approval, regulatory incentives, reduced development costs, and opportunities for accelerated development pathways, reinforcing the Company’s strategy and enhancing long-term value creation. AIM anticipates several near-term milestones that may serve as significant value drivers. These include the completion of Phase 2 DURIPANC enrollment and additional data updates; continued clinical data readouts; further IP expansion and regulatory progress; the potential for new developments from existing strategic collaborations; and the design, IND approval and commencement of a Phase 3 pivotal study in pancreatic cancer. Announcement • Mar 18
AIM ImmunoTech Inc Announces Final Approval Of Novel Cancer Therapy Patent In Japan Combining Ampligen With Checkpoint Inhibitors AIM ImmunoTech Inc. announced that the Japan Patent Office has fully approved a Japanese patent covering the Company’s proprietary use of Ampligen (rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer. The patent was granted in September 2025, but had to then pass a 6-month opposition period. Japan is one of the largest health markets in the world, with Japan and the United States expected to experience the greatest increase in global pancreatic cancer burden by 2030. The Japan patent expires December 20, 2039. The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad and encompass multiple cancer types – including pancreatic cancer. AIM also holds a U.S. patent (expires August 9, 2039) for methods involving the use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab). AIM also intends to expand its intellectual property portfolio by pursuing orphan drug designation in Japan for Ampligen in the treatment of pancreatic cancer. The Company already holds Orphan Drug designations for pancreatic cancer in the United States and the European Union. While the details of the designations vary by region, the purpose is to incentivize the development of therapies for unmet health needs, by providing various benefits and market exclusivity after a drug receives market approval. 
