Ampligen (rintatolimod) / AIM ImmunoTech - LARVOL DELTA

Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=5 | Terminated | Sponsor: Roswell Park Cancer Institute | Trial completion date: Dec 2025 ➔ Jun 2025 | Active, not recruiting ➔ Terminated; Funding ended

Trial completion date • Trial termination • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Roswell Park Cancer Institute | Trial completion date: Apr 2026 ➔ Jun 2025 | Active, not recruiting ➔ Terminated; Funding completed

Trial completion date • Trial termination • Melanoma • Oncology • Solid Tumor

Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (clinicaltrials.gov) - P1/2 | N=25 | Terminated | Sponsor: Roswell Park Cancer Institute | Trial completion date: Jun 2026 ➔ Jun 2025 | Suspended ➔ Terminated | Trial primary completion date: Dec 2025 ➔ Jun 2025; lack of funding

Trial completion date • Trial primary completion date • Trial termination • Oncology • Ovarian Cancer • Solid Tumor

AIM ImmunoTech Granted U.S. Patent Covering Methods of Manufacturing Therapeutic dsRNA, Including Ampligen (GlobeNewswire) - "AIM ImmunoTech...announced the United States Patent and Trademark Office has granted U.S. patent No. 12312376, titled 'Therapeutic Double Stranded RNA and Methods for Producing the Same.' The patent expires January 25, 2041. The new patent covers methods involving the manufacture of a range of therapeutic double-stranded RNA (dsRNA) products, of which Ampligen is included. Combined with AIM’s multiple compositions and methods patents involving Ampligen, this manufacturing patent, along with AIM’s other issued patents, further secures the Company’s control over the synthesis and use of the first-in-class drug, and provides patent protection for manufacturing until 2041. The new patent significantly extends the potential development runway for the drug, securing AIM additional time to safely and confidently develop its drug program as it seeks U.S. Food and Drug Administration ('FDA') approval for Ampligen in any of a series of indications."

Patent • Oncology

Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=24 | Active, not recruiting | Sponsor: Robert Edwards | Recruiting ➔ Active, not recruiting | N=45 ➔ 24 | Trial primary completion date: Dec 2026 ➔ Jul 2024

Checkpoint inhibition • Enrollment change • Enrollment closed • Platinum sensitive • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov) - P2 | N=1 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Recruiting ➔ Active, not recruiting | N=24 ➔ 1 | Trial completion date: Nov 2027 ➔ Apr 2026 | Trial primary completion date: Nov 2027 ➔ Apr 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

Systemic Infusion of dsRNA (Rintatolimod) plus IFNa Selectively Enhances Intratumoral CTL Influx in Cancer Patients (IMMUNOLOGY 2025) - P1, P1/2, P2, P2a | "It showed very good tolerability, average 10.3-fold increase in intratumoral CTL markers and preliminary signals of clinical activity (1 objective response, 50% survival of >4 years), when followed by pembrolizumab. Analogous CTL increases were also seen on study NCT04081389 (neoadjuvant CKM/chemotherapy in TNBC) and NCT03403634 (liver-metastatic colon cancer). Ongoing studies NCT04093323 (PD1-resistant solid tumors), NCT02432378 (advanced ovarian cancer), test the clinical efficacy of concomitant application of CKM with PD1 blockade and/or DC vaccines.Keywords: Animals Human; Cells T Cells; Molecules Chemokines; Processes Cell Trafficking Chemotaxis"

Clinical • IO biomarker • Breast Cancer • Colon Cancer • Colorectal Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • TLR3

Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=5 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Recruiting ➔ Active, not recruiting | N=15 ➔ 5 | Trial completion date: Jun 2025 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast 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=30 | Recruiting | Sponsor: Roswell Park Cancer Institute | Suspended ➔ Recruiting | Trial completion date: May 2026 ➔ Nov 2026 | Trial primary completion date: May 2026 ➔ Nov 2026

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

Expected Upcoming, Value-Driving Milestones (GlobeNewswire) - "Phase 1/2a Study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for the Treatment of Patients with Metastatic or Unresectable Triple Negative Breast Cancer (NCT05756166); Grant funded by Merck and National Cancer Institute: Q2 2026: Expected completion of enrollment....Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT03734692); Grant funded by Merck: H1 2025: Completion of study, publication of data."

P2 data • Trial status • Ovarian Cancer • Triple Negative Breast Cancer

Expected Upcoming, Value-Driving Milestones (GlobeNewswire) - "Phase 1b/2 Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab with TLR-3 Agonist Ampligen in Patients with Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC) (NCT05927142); Funded through collaboration of AstraZeneca and Erasmus Medical Center: Q2/Q3 2026: Last patient enrolled in Phase 2...Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (NCT04093323); Grant funded by National Cancer Institute: H1 2025: First patient dosed."

Trial status • Melanoma • Pancreatic Ductal Adenocarcinoma

AIM ImmunoTech Inc. Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference (GlobeNewswire) - "As part of the event, AIM CEO Thomas K. Equels presented his...reasons why he believes the investment community and industry colleagues should pay attention to the Company in 2025: Progress in late-stage pancreatic cancer treatment with significant advancements in the Phase 1b/2 DURIPANC trial at Erasmus Medical Center in the Netherland...Rapid advancement across oncology pipeline with multiple key trials reaching or approaching major milestones....Ampligen’s overall potential as a broad-spectrum immunotherapy."

Pipeline update • Trial status • Pancreatic Cancer

AIM ImmunoTech Inc. Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference (GlobeNewswire) - "AIM ImmunoTech Inc...announced its participation in the Virtual Investor “Top 5 for ‘25” On-Demand Conference...investment community and industry colleagues should pay attention to the Company in 2025...Expanding research in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) research and post-COVID conditions, including the Company’s early recognition of the link between COVID-19 and ME/CFS-like conditions....Plans to advance Ampligen as a vaccine adjuvant for the growing and serious threat of bird flu as part of the Company’s antiviral priority development pipeline."

Pipeline update • Infectious Disease • Novel Coronavirus Disease

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. | Recruiting ➔ Suspended

Trial suspension • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Nov 2025 ➔ Nov 2027 | Trial primary completion date: Nov 2025 ➔ Nov 2027

IO biomarker • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • CD8

AIM Doses First New Subject in Phase 2 Study of Ampligen and Imfinzi as a Potential Combination Therapy for Late-Stage Pancreatic Cancer (GlobeNewswire) - "AIM ImmunoTech Inc...announced that the first new subject has been dosed in Phase 2 of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of late-stage pancreatic cancer ('DURIPANC'). Several subjects from Phase 1 who received the highest dose will also be included in Phase 2....DURIPANC is an investigator-initiated, exploratory, open-label, single-center study in the Netherlands at the Erasmus Medical Center. Up to 25 patients are expected to be enrolled in the Phase 2 portion of DURIPANC."

Trial status • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Erasmus Medical Center Safety Committee Grants Approval to Proceed with Phase 2 Study of Ampligen and Imfinzi as a Potential Combination Therapy for Late-Stage Pancreatic Cancer (GlobeNewswire) - "AIM ImmunoTech Inc...today announced Safety Committee approval to proceed with the Phase 2 portion of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of late-stage pancreatic cancer (DURIPANC)....The approval to proceed to Phase 2 was granted following the Safety Committee’s review of the complete Phase 1 safety data, which found the combination therapy to be generally well-tolerated with no treatment-related severe adverse events or dose-limiting toxicities....It is one of the highest unmet needs in oncology, and we are excited to see this clinical study at Erasmus Medical Center in the Netherlands move to Phase 2."

DSMB • Trial status • Pancreatic Cancer

Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: AIM ImmunoTech Inc. | Trial completion date: Jul 2028 ➔ Oct 2028 | Trial primary completion date: Jun 2028 ➔ Sep 2028

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

AIM ImmunoTech Highlights Key 2024 Achievements and Outlines Upcoming 2025-26 Value-Driving Milestones (GlobeNewswire) - "Phase 2 Ampligen Combined with Standard of Care (SOC) versus SOC Alone Following First-Line Therapy in Subjects with LAPC: Q1 2025: Buffet Cancer Center expected to enroll first subject; H1 2025: first subject dosed."

Trial status • Gastrointestinal Cancer • Pancreatic Cancer

AIM ImmunoTech Highlights Key 2024 Achievements and Outlines Upcoming 2025-26 Value-Driving Milestones (GlobeNewswire) - "Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma: H1 2025: First patient dosed; Phase 1/2a Study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for the Treatment of Patients with Metastatic or Unresectable Triple Negative Breast Cancer: Q2 2026: Expected completion of enrollment."

Trial status • Breast Cancer • Melanoma • Triple Negative Breast Cancer

AIM ImmunoTech Highlights Key 2024 Achievements and Outlines Upcoming 2025-26 Value-Driving Milestones (GlobeNewswire) - "Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer: H1 2025: Expected last patient dosed and completion of study; Phase 2 Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines: H1 2025: First patient dosed."

Trial status • Ovarian Cancer • Solid Tumor

AIM ImmunoTech Highlights Key 2024 Achievements and Outlines Upcoming 2025-26 Value-Driving Milestones (GlobeNewswire) - "Phase 1b/2 Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab with TLR-3 Agonist Ampligen in Patients with Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC): Q1 2025: Complete Phase 1b; Early Q2 2025: Launch of Phase 2; Q2/Q3 2026: Last patient enrolled in Phase 2."

Trial status • Gastrointestinal Cancer • Pancreatic Ductal Adenocarcinoma

Ampligen Co-Inventor and Former CEO Agrees to Join AIM Scientific Advisory Board if Kellner Group Nominees Are Elected (GlobeNewswire) - "The Kellner Group is pleased to announce that Dr. William A. Carter, MD, F.A.C.P., the founder and former CEO of AIM and inventor of Ampligen, has agreed to become Chairman of AIM’s Scientific Advisory Board in the event that the Kellner Group Nominees control the Board of Directors of AIM following the upcoming annual meeting. After meeting with Dr. Carter recently, Mr. Kellner remains convinced that Ampligen has great potential but only with a new AIM Board of Directors, and he asked Dr. Carter if he would be willing to serve on the intended Scientific Advisory Board, to which Dr. Carter agreed."

Clinical • Oncology • Solid Tumor

Systemic chemokine-modulatory regimen combined with neoadjuvant chemotherapy in patients with triple-negative breast cancer. (PubMed, J Immunother Cancer) - P1 | "Combined paclitaxel/CKM regimen was safe, with desirable TME changes and preliminary indications of promising pCR+ypTmic of 66%, comparable to the combination of NAC with pembrolizumab."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • FOXP3 • IFNA1 • TLR3

AIM ImmunoTech Announces Publication of Breast Cancer Data from Roswell Park Comprehensive Cancer Center in The Journal for ImmunoTherapy of Cancer (J Immunother Cancer, GlobeNewswire) - P1 | N=9 | NCT04081389 | "AIM ImmunoTech Inc...announced that data were published on Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating AIM ImmunoTech’s drug Ampligen...as a component of a chemokine-modulating (CKM) regimen in early-stage triple-negative breast cancer (TNBC). Results of the study were reported in The Journal for ImmunoTherapy of Cancer....'The results of this pilot study suggest that the Ampligen-containing chemokine modulation regimen is capable of modifying the tumor microenvironment and releasing cytokines that attract killer T-cells into the early-stage triple-negative breast cancer tumor.'"

P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer