AIM ImmunoTech Inc (NYSE:AIM) posted second-quarter financial results that showed ample cash on hand, giving the company scope to achieve multiple clinical and regulatory milestones.
The Florida-based company’s lead candidate Ampligen (rintatolimod), an immuno-modulator with broad spectrum activity, is being developed to treat multiple types of cancers, immune disorders, and viral disorders, including coronavirus (COVID-19).
As of June 30, 2022, the Ocala, Florida-based immune-pharma company reported cash and equivalents of $34.5 million, compared to $32.1 million as of December 31, 2021. AIM said this is expected to fund the company through 2023.
READ: AIM ImmunoTech hails positive data from program evaluating Ampligen as maintenance therapy for pancreatic cancer
AIM narrowed its net loss from operations for the quarter to $4.9 million, or $0.10 per share, compared to $5.9 million, or $0.12 per share for the 2Q 2021.
In a statement accompanying the numbers, AIM CEO Thomas K. Equels said: “As the 2Q results demonstrate, we believe we are closer than ever to unlocking Ampligen’s commercial potential. Notably, we have recently seen the publication of positive clinical data regarding several unmet medical needs in highly lethal malignancies.”
“We have a strong clinical development program, sufficient operating capital and enough Ampligen to support new clinical trials. Despite ongoing headwinds for the biotech sector, we believe we are well-positioned to take advantage of the value-driving catalysts across our pipeline.”
Equels emphasized that the firm remains focused on delivering sufficient data on Ampligen in oncology, which the company believes could “contribute to significant value creation.”
Ampligen has shown in the clinic the potential for standalone efficacy in several solid tumors. Ampligen’s synergistic potential with checkpoint blockade therapeutics was first witnessed in pre-clinical mouse models of melanoma and pancreatic cancers. AIM now has data from two clinical studies — in advanced recurrent ovarian cancer and triple negative breast cancer — that show the drug may have similar anti-tumor activity in humans.
Ampligen is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the US.
Ampligen is also being used to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.
In addition, a follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen has enrolled up to 45 patients and numerous patients have commenced treatment.
Investors can learn more about Aim’s clinical program update on Ampligen targeting multiple cancers here.
Meanwhile, the US Food and Drug Administration (FDA) has authorized Ampligen in a clinical trial of patients with COVID-19 who have a pre-existing cancer. That Phase 1/2a study utilizing Ampligen is underway in the investigator-sponsored Phase 2 trial at the Roswell Park Comprehensive Cancer Center.
Separately, AIM is currently sponsoring an ongoing, FDA-authorized AMP-511 expanded access program (EAP) for Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) patients in the US. The firm has enrolled four post-COVID patients with new onset ME/CFS following acute COVID-19.
Following at least 12 weeks of Ampligen treatment, a statistical analysis of data indicated that the decrease in fatigue compared to baseline was statistically significant (p<0.002), despite the small number of patients.
Based on these early positive findings, AIM is working toward filing an investigational new drug (IND) application with the FDA for a Phase 2 study of Ampligen for the treatment of post-COVID conditions.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive