Special Note Regarding Forward-Looking Statements

Our primary present business focus involves Ampligen. Ampligen represents a dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system.

We currently are proceeding primarily in four areas:

? A randomized controlled study to evaluate efficacy and safety of Ampligen

compared to a control group to treat locally advanced pancreatic cancer

? Evaluate Ampligen in other cancers, as a potential therapy that modifies the

tumor microenvironment with the goal of increasing anti-tumor responses to

? Exploring Ampligen's antiviral activities and potential use as a prophylactic

or treatment for existing viruses, new viruses and mutated viruses thereof.

? Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome

("ME/CFS") and fatigue and/or difficulty thinking/concentrating as the

predominate Post-COVID conditions (as referenced on CDC website Sept. 16,

Please see "Ampligen as a Potential Antiviral" below.

Ampligen as a treatment for ME/CFS and Post-COVID Conditions

Please see "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ("ME/CFS")" below.

Our primary pharmaceutical product platform consists of Ampligen (rintatolimod), a first-in-class drug of large macromolecular double-stranded (ds) RNA (ribonucleic acid) molecules, and our FDA-approved natural alpha-interferon product, Alferon N Injection.

chemo-immunotherapy in advanced recurrent ovarian cancer were published in the

American Association for Cancer Research publication, Clinical Cancer Research

(Clin Cancer Res January 19 2022 DOI: 10.1158/1078-0432.CCR-21-3659). The

study results represent an important extension of prior studies using human

tumor explants that showed Ampligen's potentially important role as a TLR3

agonist acting synergistically with high-dose IFN? and celecoxib to

selectively enhance Teff cell-attractants while suppressing Treg-attractants

in the tumor microenvironment with a concomitant increase in the Teff/Treg

ratio. The importance of boosting the Teff/Treg ratio in the tumor

microenvironment is that it is associated with the conversion of 'cold' tumors

into 'hot' tumors, which have an increased sensitivity to chemo-immunotherapy

and an improved chance of showing tumor regression. The Phase 1 portion was

designed to establish intraperitoneal safety. The Phase 2 portion of the study

cisplatin, pembrolizumab, plus Ampligen; up to 45 patients to be enrolled;

enrollment has commenced, and numerous patients have commenced treatment. We

recently announced interim data from the study, which demonstrated that

evidence of increased biomarkers associated with T cell chemotaxis and

cytolytic function was seen when combining Ampligen, pembrolizumab and

cisplatin. Increases of these biomarkers in the tumor microenvironment have

been correlated with favorable tumor responses. Interim results announced

March 2022 detailed an observed clinical response rate of 61% includes two

complete and three partial tumor responses, plus three patients with stable

disease among the 13 evaluable patients. An important priority will be to

confirm these findings through continuing to enroll patients onto this study

? Stage 4 Metastatic Triple Negative Breast Cancer - Phase 1 study of metastatic

triple-negative breast cancer using chemokine modulation therapy, including

Ampligen and pembrolizumab. Eight patients were enrolled and 6 patients were

? The pre-determined primary endpoint of efficacy was met (increase in CD8 in

? Uniform increase of immune markers upon treatment was observed: CD8 mRNA

(6.1-fold; p-0.034), GZMB mRNA (3.5-fold; p=0.058), ratios of CD8 /FOXP3 and

GZMB/FOXP3 (5.7-fold; p=0.036, and 7.6-fold; p=0.024 respectively), thus

successfully meeting the pre-determined primary endpoint in the study

(increase in CD8 in TME).

? In addition, an increase in CTL attractants CXCL10 (2.6-fold; p=0.104) and

CCL5 (3.3-fold; p=0.019) was observed. In contrast, Treg marker FOXP3 or Treg

attractants CCL22 or CXCL12 were not enhanced.

? Three patients had stable disease lasting 2.4, 2.5 and 3.8 months, as of data

? An additional patient (non-evaluable) had a partial response (breast tumor

autoamputation) with massive tumor necrosis in the post-CKM biopsy.

? Stage 4 Colorectal Cancer Metastatic to the Liver - Phase 2a study of Ampligen

as a component of chemokine modulatory regimen on colorectal cancer metastatic

to liver; recruitment has been completed; 19 patients were enrolled and 12

patients were evaluable for the primary endpoint.

https://clinicaltrials.gov/ct2/show/NCT03403634. The key findings announced

? The study's primary endpoint was met, evidenced by increased CD8a expression

? Saw increase in the CD8a/CD4 (p=0.03), CD8a/FOXP3 (p<0.01) and GZMB/FOXP3

? The expression of CTL-attracting chemokines CCL5 (p=0.08), CXCL9 (p=0.05), and

CXCL10 (p=0.06) were increased, while expression of the Treg/MDSC attractant

CXCL12 (p=0.07) was decreased post-treatment.

? Median OS was 10.5 (90% CI 2.2-15.2) months, and the median PFS was 1.5 (90%

? No tumor responses were seen. The treatment was well tolerated. Of all

enrolled patients (N=19), adverse events were noted in 74% of patients, with

the most common being fatigue (58%). Grade 3 or higher adverse events were

? Early-Stage Prostate Cancer - Phase 2 study investigating the effectiveness

and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron

A) compared to no drug treatments in a randomized three-arm study of patients

with prostate cancer before undergoing radical prostatectomy. Patient

enrollment has been initiated in this study designed for up to 45 patients.

https://clinicaltrials.gov/ct2/show/NCT03899987

? Early-Stage Triple Negative Breast Cancer - Phase 1 study of chemokine

modulation plus neoadjuvant chemotherapy in patients with early-stage triple

negative breast cancer has received FDA authorization; the objective of this

study is to evaluate the safety and tolerability of a combination of Ampligen,

celecoxib with or without Intron A, when given along with chemotherapy; the

goal of this approach is to increase survival. This study is recruiting

patients designed for up to 24 patients, Interim results announced in March

2022 detailed data gathered from evaluating paclitaxel's impact on chemokine

production in the human breast tumor microenvironment (TME) and the ability of

a chemokine modulatory regimen (CKM) of Ampligen and Interferon-? to mitigate

potentially undesirable aspects of taxane chemotherapy. Based on the results,

The below Ampligen clinical trials are in the planning stages:

? Phase 2 Pancreatic Cancer Trial - In October 2021, AIM and Amarex submitted an

IND application with the FDA for a planned Phase 2 study of Ampligen as a

therapy for locally advanced or metastatic late-stage pancreatic cancer. The

FDA placed the study on Clinical Hold in November 2021 and provided valuable

feedback on the study design. We submitted our response to the Clinical Hold

in February 2022. In March 2022, we received notification from the FDA that

the Clinical Hold was released and cleared, meaning that we are now able to

proceed with the study. In April 2022, we executed a work order with Amarex to

? Refractory Melanoma - Phase 2 study that will evaluate polarized dendritic

cell vaccine, interferon alpha-2, Ampligen and celecoxib for the treatment of

HLA-A2+ refractory melanoma at Roswell Park. Up to 24 patients to be enrolled

? In December 2020, the FDA granted Ampligen Orphan Drug Designation status for

the treatment of pancreatic cancer. The Orphan Drug Designation program

provides orphan status to drugs and biologics which are defined as those

intended for the treatment, prevention or diagnosis of a rare disease or

condition, which is one that affects less than 200,000 persons in the United

States or meets cost recovery provisions of the act. The status helps

incentivize the treatment of therapies to treat unmet medical needs by

providing a company with seven years of exclusivity rights once a drug reaches

? In February 2021, our subsidiary, NV Hemispherx Biopharma Europe, received

formal notification from the European Commission ("EC") granting Orphan

Medicinal Product Designation for Ampligen as a treatment for pancreatic

cancer. Orphan products, once commercially approved in the European Union

("EU"), receive benefits including up to ten years of protection from market

competition from similar medicines with similar active component and indication

? Stimulation of interferon regulatory factors and activation of the interferon

? Production of immunomodulatory activity and

? Induction of the expression of MHC class I and II histocompatibility

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ("ME/CFS")

In June of 2020, we filed a provisional patent application for, among other discoveries, the use of Ampligen as a potential early-onset therapy for the treatment of COVID-19 induced chronic fatigue.

Ampligen as a Potential Antiviral

(https://journals.sagepub.com/doi/abs/10.1177/095632020601700505) found that

Ampligen reduced virus lung levels to below detectable limits.

(https://www.sciencedirect.com/science/article/pii/S0042682209005832

that, instead of 100% mortality, there was 100% protective survival using

We also entered into a specialized services agreement with Utah State University and have supplied Ampligen to support the University's Institute for Viral Research in its research into SARS-CoV-2. The Utah State results show that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

In November 2020, we entered into a Material Transfer and Research Agreement with Leyden Laboratories, B.V., ("Leyden Lab") to facilitate two proposed studies/research projects:

? An assessment of protective potential of intranasal administration of Ampligen

? Intravenous therapy - 200 mg of Ampligen or placebo, with five doses over a

treatment period of 17 days; and an

? Intranasal therapy - 1,250 ?g spray (625 ?g per nostril), with seven doses

In Europe, the EMA has approved the Orphan Medicinal Products Designation for Ampligen as a potential treatment of Ebola virus disease and for Alferon N Injection as a potential treatment of MERS.

In May 2021, we filed a U.S. Provisional Patent Application for Ampligen as a potential therapeutic to possibly slow, halt, or reverse the progression of Alzheimer's disease.

See "Note 10: Recent Accounting Pronouncements".

Three months ended March 31, 2022 versus three months ended March 31, 2021

? an increase of the quarterly revaluation of certain redeemable warrants of

Loss on investments for the three months ended March 31, 2022, and 2021 represents a loss of approximately $934,000, driven primarily from the unrealized loss on securities of $915,000.

Gain from sale of income tax operating losses

The quarterly income tax benefit for the three months ended March 31, 2022 amounted to a gain of approximately $190,000 compared to a gain of $181,000 for the three months ended March 31, 2021 due primarily to a deferred tax asset recorded in 2021 for the New Jersey NOL to be sold in 2022.

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