OCALA, Fla., August 10, 2026

AIM ImmunoTech Inc. reported its second-quarter 2026 financial results and highlighted continued progress in advancing Ampligen® (rintatolimod) toward planned Phase 3 development for metastatic pancreatic cancer. The company has completed patient enrollment and Ampligen dosing in the Phase 2 DURIPANC study, an important milestone ahead of anticipated clinical data in 2027. AIM expects data assessing clinical benefit from DURIPANC in Q1 2027, followed by Overall Survival data in Q3 2027. The company is positioning the results to support the design of a potential pivotal Phase 3 trial while continuing to evaluate additional opportunities for Ampligen in selected infectious disease programs, including potential government-supported research targeting Ebola virus disease. Pancreatic cancer remains the company’s primary strategic development focus..

Ampligen Program Advances Toward Potential Phase 3 Development

The DURIPANC Phase 2 study is evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in patients with metastatic pancreatic cancer. With enrollment and dosing now completed, the program is moving toward key efficacy and survival readouts. AIM also engaged Thermo Fisher Scientific’s PPD clinical research business to support study-design activities for a planned pivotal Phase 3 clinical trial. The company pointed to observations from Erasmus MC Cancer Institute that have included favorable safety findings, progression-free and overall survival trends, and reported quality-of-life outcomes. AIM also highlighted findings from a Dutch-government approved Named Patient Program, where Ampligen treatment in a selected immune biomarker population was associated with a reported median Overall Survival of 34.8 months compared with 12.5 months for historical controls. However, these findings are not equivalent to randomized Phase 3 evidence, making the upcoming DURIPANC results critical for determining whether the program can support a definitive registration strategy.

AIM Strengthens Financial Position Ahead of Clinical Milestones

AIM reported $9.9 million in cash and cash equivalents as of June 30, 2026, compared with approximately $3.0 million at the end of 2025, reflecting financing activities that strengthened the company’s balance sheet. Research and development expenses for the second quarter were approximately $589,000, down from $1.2 million in the same period of 2025, while general and administrative expenses increased to approximately $2.9 million from $1.5 million. The company reported a second-quarter net loss of approximately $3.8 million, or $0.43 per share, compared with a net loss of approximately $2.8 million, or $3.68 per share, in the prior-year quarter. AIM also reported that it had regained full compliance with NYSE American continued listing standards. The improved cash position is intended to provide additional resources for ongoing clinical development and preparations for potential Phase 3 execution.

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Ampligen Development Extends Beyond Pancreatic Cancer

While metastatic pancreatic cancer remains AIM ImmunoTech’s central strategic priority, the company is also pursuing selected opportunities to investigate Ampligen’s potential antiviral activity. AIM is planning government-focused initiatives evaluating Ampligen against Ebola virus disease, with the objective of potentially securing non-dilutive funding while limiting the financial impact on its primary oncology program. Ampligen is a double-stranded RNA immunomodulator and selective TLR3 agonist designed to stimulate immune responses and has been investigated across multiple clinical settings. The company’s near-term value proposition remains heavily dependent on the pancreatic cancer program, particularly the upcoming DURIPANC clinical results and whether those data provide sufficient evidence to justify a pivotal Phase 3 study. The 2027 clinical milestones therefore represent a significant inflection point for AIM as it seeks to translate earlier observations into controlled clinical evidence and advance Ampligen toward potential registration in pancreatic cancer.

Source:AIM ImmunoTech press release