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.

Pancreatic cancer remains one of the deadliest forms of cancer worldwide, with limited treatment options and an urgent need for innovative therapies capable of extending survival and improving quality of life. 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.

Execution Continues to Drive Momentum

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

     

These accomplishments represent important de-risking events that management believes support the advancement of Ampligen toward a potential registration-directed development pathway.

Growing Clinical Foundation Supports Advancement

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.

Importantly, the combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment.

Multiple Near-Term Catalysts Ahead

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

Management believes each of these milestones has the potential to further validate Ampligen's clinical profile and strengthen the Company's strategic position.

A Clear Focus on Shareholder Value Creation

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.

As the biotechnology sector continues to place significant value on late-stage oncology assets, AIM believes successful execution of its pancreatic cancer strategy could substantially enhance the value of the Ampligen franchise.

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.

"We have built meaningful momentum across every aspect of the Ampligen pancreatic cancer program," said Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. "Our focus remains clear: facilitate the DURIPANC study, continue generating meaningful clinical data, advance regulatory planning, and position Ampligen for a potential pivotal development pathway. We believe these efforts have the potential to unlock significant value for patients, partners and our stockholders."

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 today.