On March 27, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the fourth quarter and full year 2024 and provided a business update (Press release, AIM ImmunoTech, MAR 27, 2025, View Source [SID1234651517]). The Company will host a conference call and webcast on Tuesday, April 1, 2025 at 8:30 AM ET (details below).
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"Our team made significant strides in advancing our development programs along with our collaborators over the course of 2024. As we look ahead, we will continue to execute our corporate and clinical strategies to further establish the foundation upon which we can secure the successful future of AIM and our drug Ampligen for the treatment of major-market unmet medical needs. We are focused on the successful execution of a number of key milestones expected over the course of the next 18 months with the goal of building long-term stockholder value," commented AIM Chief Executive Officer Thomas K. Equels.
Recent Highlights
Announced plans to conduct clinical study of the combination of Ampligen and AstraZeneca’s FluMist as an intranasal vaccine for influenza, including avian influenza (bird flu); Paul Goepfert, MD, of the University of Alabama-Birmingham, has agreed to act as the Principal Investigator for the study.
Announced Ted D. Kellner and David Chemerow as new members of AIM’s Board of Directors.
Erasmus Medical Center Safety Committee granted approval to proceed with the Phase 2 portion of the Phase 1b/2 clinical trial involving AIM’s Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of late-stage pancreatic cancer ("DURIPANC").
Commenced dosing in Phase 2 of the Phase 1b/2 DURIPANC clinical trial for treatment of late-stage pancreatic cancer.
Announced the final clinical study results for the "Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions" ("AMP-518") were published to ClinicalTrials.gov (See: NCT05592418).
Expanded patent portfolio with a U.S. compositions and methods patent for Ampligen for the treatment of endometriosis and a Netherlands compositions and methods patent covering Ampligen for use in the Post-COVID condition of fatigue.
Announced publication of data from Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating a combination therapy using Ampligen in early-stage triple-negative breast cancer (TNBC) in The Journal for ImmunoTherapy of Cancer.
Expected Upcoming, Value-Driving Milestones
Metastatic Pancreatic Ductal Adenocarcinoma
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
Refractory Melanoma
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
Stage 4 Triple Negative Breast Cancer
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
Advanced Recurrent Ovarian Cancer
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
Summary of Financial Highlights for Fiscal Year 2024
As of December 31, 2024, AIM reported cash, cash equivalents and marketable investments of $4.0 million, compared to $13.1 million as of December 31, 2023.
Research and development expenses for the year ended December 31, 2024, were $6.2 million, compared to $10.9 million for the year ended December 31, 2023.
General and administrative expenses for the year ended December 31, 2024, were $13.7 million, compared to $21.1 million for the year ended December 31, 2023.
Please refer to the full 10-K for complete details.
Conference Call and Webcast Details
The Company will host a conference call and webcast to discuss the Company’s Q4/FY2024 operational and financial results on Tuesday, April 1, 2025 at 8:30 AM ET.
The call will be hosted by Thomas K. Equels, Chief Executive Officer of AIM. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.