Ampligen (rintatolimod) / AIM ImmunoTech - LARVOL DELTA

DURIPANC: Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (clinicaltrials.gov) - P1/2 | N=43 | Active, not recruiting | Sponsor: Joachim Aerts, MD PhD | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2026 ➔ Dec 2026

Checkpoint inhibition • Enrollment closed • Trial primary completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Neoadjuvant chemokine modulation of the tumor microenvironment (TME) in resectable metastatic colorectal cancer: Results from a phase I study. (ASCO 2026) - P1/2 | "The chemokine-modulating (CKM) regimen, consisting of IFNα, rintatolimod (a selective TLR3 agonist), and celecoxib (a COX-2 inhibitor), also suppresses CCL22, a Treg-attracting chemokine in the TME... Neoadjuvant CKM regimen is safe and feasible in resectable metastatic CRC and is associated with improved ratios of CD8+ CTLs to FoxP3+ Tregs in the TME. Further studies combining CKM with immune checkpoint inhibitors and/or chemotherapy are warranted to evaluate the impact of preoperative TME modulation on long-term oncologic outcomes in CRC."

Biomarker • Clinical • IO biomarker • Metastases • P1 data • Tumor microenvironment • Colorectal Cancer • Immune Modulation • Immunology • Leukopenia • Neutropenia • Oncology • Solid Tumor • CCL2 • CCL22 • CD8 • CXCL10 • CXCL11 • CXCL9 • FOXP3 • IFNA1

AIM ImmunoTech…announced three forms of patent protection in Europe and the United Kingdom covering the use of the Company’s drug Ampligen in the treatment of Long COVID, also known as post-viral long-term symptoms following infection with…SARS-CoV-2, with patent protection expected to extend through June 2041 (GlobeNewswire) - "The patent is being announced now that the nine-month opposition period under Article 99(1) of the European Patent Convention closed on August 25, 2026, with no opposition filed....The patent protection includes Austria, Belgium, Bulgaria, Germany, Denmark, Estonia, Finland, France, Italy, Lithuania, Luxembourg, Latvia, Malta, the Netherlands, Portugal, Romania, Slovenia and the United Kingdom. The granted claims cover therapeutic double stranded ribonucleic acid ('tdsRNA') for use in treating patients with Long COVID, including specific dosing regimens and delivery methods such as intranasal, intravenous, and inhalation administration."

Patent • Infectious Disease • Novel Coronavirus Disease

AIM ImmunoTech…announced that the United States Patent and Trademark Office has granted a patent covering the use of the Company's drug Ampligen in combination with the PD-1 checkpoint inhibitor pembrolizumab for the treatment of cancer (GlobeNewswire) - "This newly issued U.S. patent expires December 20, 2039....The newly issued patent's broadest claim covers methods of treating cancer, by giving Ampligen together with pembrolizumab, whether administered at the same time or at different times, where the combination produces a greater effect against the cancer than either treatment alone, or than would be expected simply by adding their individual effects together. Other claims in the patent specifically name pancreatic cancer, skin cancer, colorectal cancer, ovarian cancer, melanoma, breast cancer, triple negative breast cancer, head and neck tumor, bladder cancer, renal cell carcinoma, and lung cancer as types of cancers for which the combination use is claimed in the patent, but the broad claim's coverage is not limited to any cancer."

Patent • Bladder Cancer • Breast Cancer • Colorectal Cancer • Head and Neck Cancer • Melanoma • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Skin Cancer

Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC (clinicaltrials.gov) - P2 | N=90 | Suspended | Sponsor: AIM ImmunoTech Inc. | Trial completion date: Jan 2030 ➔ Mar 2031 | Trial primary completion date: Dec 2029 ➔ Feb 2031

Trial completion date • Trial primary completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

AIM ImmunoTech…Highlights Significant Operational Execution Advancing Ampligen Toward Planned Phase 3 Development in Pancreatic Cancer (GlobeNewswire) - "'We anticipate DURIPANC data on clinical benefit in Q1 2027 and on Overall Survival - the gold standard data point in oncology - in Q3 2027'....Engaged Thermo Fisher Scientific's PPD clinical research business to support study design of a planned pivotal Phase 3 clinical trial in metastatic pancreatic cancer."

New P3 trial • P2 data • Pancreatic Ductal Adenocarcinoma

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…durvalumab for the treatment of metastatic pancreatic cancer (GlobeNewswire) - "Following planned data collection, DURIPANC Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in Q1 2027....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."

P2 data • Trial status • Pancreatic Ductal Adenocarcinoma

Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Roswell Park Cancer Institute | N=25 ➔ 0 | Terminated ➔ Withdrawn

Enrollment change • Trial withdrawal • Oncology • Ovarian Cancer • Solid Tumor

AIM ImmunoTech Announces Release of New CEO Corner Segment Highlighting Growing Momentum Across Pancreatic Cancer Program (AIM ImmunoTech Press Release) - "In the segment, Mr. Equels highlights the urgent unmet need facing patients with pancreatic cancer, reviews recent progress across the Company’s DURIPANC Phase 2 clinical program evaluating Ampligen (rintatolimod) in combination with AstraZeneca’s Imfinzi (durvalumab), and discusses why AIM believes it is entering one of the most catalyst-rich periods in the Company’s history....Topics discussed include the successful completion of patient enrollment and dosing in the DURIPANC study, encouraging interim clinical observations, continued favorable safety findings, ongoing Phase 3 planning activities, the Company’s strategic collaboration with AstraZeneca and Erasmus Medical Center, expansion of AIM’s intellectual property portfolio and the broader potential of Ampligen to help overcome resistance in immunologically 'cold' tumors."

New P3 trial • Trial status • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Multiple Near-Term Catalysts Ahead (The Manila Times) - "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."

Clinical protocol • New P3 trial • P1/2 data • Trial status • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

AIM ImmunoTech Achieves Clinical Milestone as Final Subject Receives First Dose in Phase 2 DURIPANC Study in Metastatic Pancreatic Cancer (AIM ImmunoTech Press Release) - "Study results expected to support design and initiation of a pivotal Phase 3 clinical trial in 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 Q1 2027...Analysis of Secondary Endpoints is expected to begin in June 2027, or 49 weeks after this final subject received their first dose."

P2 data • Trial status • Pancreatic Cancer

Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Kalinski, Pawel, MD, PhD

New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

AIM ImmunoTech Inc…reported positive progress in a mid-year update from the ongoing Phase 2 clinical study evaluating 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) (GlobeNewswire) - "The published NPP data and the DURIPANC interim results support our belief that Ampligen has the potential to meaningfully extend survival and provide late-stage pancreatic cancer patients with a higher quality of life....in the NPP stratification of subjects with immune marker Neutrophil/Lymphocyte ratios less than 4.5, we saw overall median survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months – and with positive measures of quality of life. We are also diligently planning the next step in Ampligen's development, with an eye toward a pivotal Phase 3 clinical trial evaluating the experimental drug in combination with a PD-1 inhibitor in an effort to demonstrate its value across multiple endpoints, most importantly overall survival and progression-free survival."

New P3 trial • P2 data • Pancreatic Cancer

AIM ImmunoTech Completes Phase 2 DURIPANC Enrollment Milestone Ahead of Schedule, Advancing Ampligen Toward Critical Pancreatic Cancer Clinical Milestones (GlobeNewswire) - "Final subject meets enrollment criteria and is scheduled for mid-June treatment, more than one month ahead of original target...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."

Enrollment status • Pancreatic Ductal Adenocarcinoma

AIM ImmunoTech Posts Virtual Investor Key Opinion Leader Segment Spotlighting Ampligen Breakthrough Data in Pancreatic Cancer (GlobeNewswire) - "DURIPANC is a follow-up to the AIM/Erasmus MC Named Patient Program ('NPP') utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival data: (i) Progression-Free Survival ('PFS') of 12.6 months compared to 8.6 months for historical controls, for an improvement of 4 months in PFS; (ii) Overall Survival ('OS') of 19.7 months compared to 12.5 months for historical controls, for an improvement of 7.2 months in OS; (iii) Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, PFS of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in PFS."

P1/2 data • Pancreatic Ductal Adenocarcinoma

AIM ImmunoTech…announced the Final Primary Endpoint Report on Objective Response Rate data from a…Phase 2 clinical trial…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 (GlobeNewswire) - "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."

P2 data • Platinum sensitive • Ovarian Cancer

NCI-2019-01192: Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Nov 2026 ➔ Apr 2027 | Trial primary completion date: Jun 2025 ➔ Apr 2027

Biomarker • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

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 (GlobeNewswire) - "The planned Phase 3 program is supported by very positive published data from a Dutch government-approved Named Patient Program ('NPP') 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...the study is expected to complete enrollment later this year and represents a key clinical validation step for our upcoming pivotal trial...Looking ahead, AIM anticipates several near-term milestones that may serve as significant value drivers. These include...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."

Enrollment status • New P3 trial • P2 data • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

AIM expects to release the next DURIPANC update in June 2026 (GlobeNewswire)

P1/2 data • Pancreatic Ductal Adenocarcinoma

AIM ImmunoTech Announces Final Approval of Novel Cancer Therapy Patent in Japan Combining Ampligen with Checkpoint Inhibitors (GlobeNewswire) - "The patent was granted in September 2025, but had to then pass a 6-month opposition period...The Japan patent expires December 20, 2039...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."

Patent • Pancreatic Cancer

AIM ImmunoTech Inc...announced an agreement with the PPD clinical research business of Thermo Fisher Scientific to design AIM’s anticipated Phase 3 clinical trial in the use of the Company’s drug Ampligen in the treatment of late-stage pancreatic cancer. (GlobeNewswire)

Commercial • New P3 trial • Pancreatic Cancer

AIM ImmunoTech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and AstraZeneca’s Durvalumab in the Treatment of Metastatic Pancreatic Cancer (The Manila Times) - "Planned DURIPANC milestones: July 2026 - Complete subject enrollment; August 2026 - Complete full Ampligen dosing for all subjects; December 2026 - Evaluation of the Primary Endpoint of Clinical Benefit Rate, defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy; June 2027 - Evaluation of the Secondary Endpoints once last subject reaches week 49."

Trial status • Pancreatic Cancer

AIM ImmunoTech Inc...announced that Thomas K. Equels, MS JD, Chief Executive Officer of AIM, will participate in a Virtual Investor Closing Bell Event on Thursday, February 19, 2026, at 4:00 PM ET. (The Manila Times) - "Equels will focus on AIM’s clinical and regulatory strategy for its lead drug Ampligen, with an emphasis on the ongoing DURIPANC clinical trial in collaboration with AstraZeneca combining Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer."

Trial status • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

AIM ImmunoTech Inc…reported positive data in a year-end update from the ongoing Phase 2 clinical study evaluating 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) (GlobeNewswire) - "This is a follow-up Phase 2 to a 57-subject early access program ('EAP') of Ampligen as a monotherapy in late-stage pancreatic cancer, where Ampligen was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the standard of care. The EAP subjects also reported improved quality of life."

P2 data • Pancreatic Ductal Adenocarcinoma

Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients (clinicaltrials.gov) - P1/2 | N=4 | Terminated | Sponsor: Roswell Park Cancer Institute | N=64 ➔ 4 | Suspended ➔ Terminated; Low accrual

Enrollment change • Trial termination • Hematological Malignancies • Infectious Disease • Myelodysplastic Syndrome • Novel Coronavirus Disease • Oncology • Solid Tumor • CCL22