What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-08-14 compared with 2024-05-15 · 449 added, 315 removed, 882 unchanged (46% of the section changed)

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ImmunoTech Inc.

and its subsidiaries (collectively, “AIM”, “Company”, “we” or “us”) are

an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple

and its subsidiaries (collectively, “AIM”, “Company”, “we”, “us” or “our”)

are an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple

types of cancers, viral diseases and immune-deficiency disorders.

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of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

flagship products are Ampligen (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon

N Injection (Interferon alfa).

Ampligen has not been approved by the FDA or marketed in the United States.

Ampligen is approved for commercial

sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (“CFS”).

primary business focus involves Ampligen.

Ampligen is a double-stranded RNA (“dsRNA”) molecule being developed for globally

important cancers, viral diseases and disorders of the immune system.

flagship products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa).

Ampligen is a double-stranded RNA (“dsRNA”)

molecule being developed for globally important cancers, viral diseases and disorders of the immune system.

Ampligen has not been approved

by the FDA or marketed in the United States, but is approved for commercial sale in the Argentine Republic for the treatment of severe

Chronic Fatigue Syndrome (“CFS”).

are currently 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 patients.

Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment

clinical trials to evaluate the efficacy and safety of Ampligen for the treatment of pancreatic

Ampligen across multiple cancers as a potential therapy that modifies the tumor microenvironment

with the goal of increasing anti-tumor responses to checkpoint inhibitors.

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Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”)

and fatigue and/or Post-COVID conditions of fatigue.

and fatigue and/or the Post-COVID condition of fatigue.

are prioritizing activities in an order related to the stage of development, with those clinical activities such as pancreatic cancer,

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chronic fatigue-like symptoms that we refer to as Post-COVID conditions.

As of March 31, 2024, there were 10 patients enrolled in

this open-label, expanded access treatment protocol (including three patients with Post-COVID Conditions).

To date, there have been eight

such Post-COVID patients treated in the study.

AIM previously reported positive preliminary results based on data from the first four

Post-COVID Condition patients enrolled in the study.

The data show that, by week 12, compared to baseline, there was what the investigators

considered a clinically significant decrease in fatigue-related measures.

As of June 30, 2024, there were 8 patients enrolled in this

open-label, expanded access treatment protocol (including two patients with Post-COVID Conditions).

To date, there have been eight such

Post-COVID patients treated in the study.

AIM previously reported positive preliminary results based on data from the first four Post-COVID

Condition patients enrolled in the study.

The data show that, by week 12, compared to baseline, there was what the investigators considered

a clinically significant decrease in fatigue-related measures.

plan on a comprehensive follow through with the FDA regarding the use of Ampligen as a treatment for ME/CFS.

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to file the registration statement with the SEC pursuant to the Registration Rights Agreement.

Sales cannot commence until the registration

Sales could not commence until the registration

statement is declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions set forth

in the Purchase Agreement are satisfied.

The registration statement was declared effective and the final prospectus was filed on May

has no right to require us to sell any shares to Atlas, but Atlas is obligated to make purchases as we direct, subject to certain conditions.

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aggregate, more than 19.99% of the outstanding shares on the date that the Purchase Agreement was executed.

Before we could do that, we would need to obtain stockholder

Before we could do that,

we would need to obtain stockholder approval.

have agreed with Atlas that we will not enter into any “variable rate” transactions with any third party for a period defined

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which were filed as exhibits 10.104 and 10.105 to our 2023 Annual Report on Form 10-K.

Purchase Agreement

May 31, 2024, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering (the “Transactions”)

with a single accredited investor (the “Purchaser”), pursuant to which we will issue to the Purchaser, (i) in a registered

direct offering, 5,640,958 shares of our common stock (the “Shares”), par value $0.001 per share (“Common Stock”)

and (ii) in a concurrent private placement, we will issue to the Purchaser Class A common warrants to purchase an aggregate of up to

5,640,958 shares of its common stock (the “A Warrants”) at an exercise price of $0.363 per share and Class B common warrants

to purchase an aggregate of up to 5,640,958 shares of its common stock (the “B “Warrants” and, along with the A Warrants,

the “Common Warrants”) at an exercise price of $0.363 per share.

The A Warrants and B Warrants will not be exercisable for

six months after the issuance date and will expire, respectively, 24 months and five years and six months after the issuance date.

Common Warrants and the shares of common stock issuable upon the exercise of such warrants are offered pursuant to an exemption from

the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

received aggregate gross proceeds from the Transactions of approximately $2,047,688, before deducting fees to the Placement Agent and

other estimated offering expenses payable by us.

The Shares are being offered by us pursuant to a shelf registration statement on Form

S-3 (File No.

333-262280), which was declared effective on February 4, 2022 (as amended from time to time, the “Registration Statement”).

to the terms of the Purchase Agreement, subject to certain exceptions, we cannot issue any equity securities for 60 days following the

issuance date, provided that we will be able to utilize it’s at-the-market offering program with the Placement Agent after 30 days.

Additionally, we cannot enter into a variable rate transaction (other than the ATM program with the Placement Agent) for 120 days after

the issuance date.

In addition, our executive officers and each of our directors have entered into lock-up agreements with us pursuant

to which each of them has agreed not to, for a period of 90 days from the closing of the Transactions, offer, sell, transfer or otherwise

dispose of our securities, subject to certain exceptions.

exercise price of the Common Warrants, and the number of Common Warrant Shares, will be subject to adjustment in the event of any stock

dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants.

If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted

for us, and may exercise every right and power that we may exercise and will assume all of its obligations under the Common Warrants

with the same effect as if such successor entity had been named in the warrant itself.

Common Warrant Holders will have additional rights

defined in the Common Warrants.

The Common Warrants will be exercisable on a “cashless” basis only if there is not a current

registration statement permitting public resale.

In this regard, we have agreed to file a registration statement to register the resale

of the Common Warrant Shares as soon as practicable (and in any event within 45 calendar days) providing for the resale of the Shares

issued and issuable upon exercise of the Common Warrants.

We have agreed to use commercially reasonable efforts to cause such

registration statement to become effective within 181 days following the issuance date and to keep such registration statement effective

at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise thereof.

Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts” basis,

in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement Agency Agreement”),

by and between us and the Placement Agent.

Pursuant to the Placement Agency Agreement, the Placement Agent will be entitled to a cash

fee of 8% of the aggregate gross proceeds paid to the Company for the securities sold in the Transactions and reimbursement of certain

out-of-pocket expenses.

primary pharmaceutical product platform consists of Ampligen (rintatolimod), a first-in-class drug of large macromolecular double-stranded

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distributing Ampligen in Argentina.

Argentina has experienced hyper-inflation and recently devalued its currency

dollar by 50%.

Argentina has experienced hyper-inflation and recently devalued its currency to the U.S.

Contracts with GP Pharm are U.S.

dollar contracts and the parties must evaluate the impact of the recent devaluation

on its relationship.

dollar contracts and the parties must evaluate the impact of the recent devaluation on its relationship.

FDA has authorized an open-label expanded access treatment protocol (AMP-511) allowing patient access to Ampligen in a study under which

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with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms that we refer to as Post-COVID

As of March 31, 2024, there are 10 patients enrolled in this open-label expanded access treatment protocol.

In July 2022,

AIM reported positive preliminary results based on data from the first four Post-COVID Condition patients enrolled in the study.

data show that, by week 12, compared to baseline, the investigators observed what they considered a clinically significant decrease in

fatigue-related measures.

As of June 30, 2024, there are 8 patients enrolled in this open-label expanded access treatment protocol.

In July 2022, AIM

reported positive preliminary results based on data from the first four Post-COVID Condition patients enrolled in the study.

show that, by week 12, compared to baseline, the investigators observed what they considered a clinically significant decrease in fatigue-related

To date, there have been eight such Post-COVID patients treated in this study.

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Program of Research Excellence (“SPORE”).

2018, we completed production of two commercial-size batches of more than 16,000 vials of Ampligen, following its “Fill & Finish”

at Jubilant HollisterStier, the Contract Manufacturing Organization.

These lots passed all required testing for regulatory release for

human use and are being used for multiple programs, including:

2018, we completed production of two commercial-size batches of more than 16,000 vials of Ampligen, following its “Fill &

Finish” at Jubilant HollisterStier, the Contract Manufacturing Organization.

These lots passed all required testing for

regulatory release for human use and are being used for multiple programs, including:

the treatment of ME/CFS;

the pancreatic cancer EAP in the Netherlands;

the pancreatic cancer

EAP in the Netherlands;

and will continue to be used for ongoing and future clinical studies in oncology.

Additionally, two lots of Ampligen were manufactured

in December 2019 and January 2020 at Jubilant HollisterStier and we recently issued a purchase order for a total of $1,432,257 to manufacture

additional lots of Ampligen at Jubilant.

The current manufactured lots of Ampligen have been fully tested and released for commercial

product launch in Argentina and for clinical trials.

Additionally, in December 2020, we added Pii as a “Fill & Finish”

provider to enhance our capacity to produce Ampligen.

This addition amplifies our manufacturing capability by providing redundancy and

cost savings.

The contracts augment our active and in-process fill and finish capacity.

Lots of Ampligen were

manufactured in December 2019, January 2020 and March 2024.

Additionally, in December 2020, we added Pharmaceutics International

(“Pii”) as a “Fill & Finish” provider to enhance our capacity to produce Ampligen.

This addition amplifies our

manufacturing capability by providing redundancy and cost savings.

The contracts augment our active and in-process fill and finish

Immuno-Oncology

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The underway trials include:

Cancer Trial - The Phase 2 AMP-270 clinical trial is a randomized, open-label, controlled,

parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus

a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic

adenocarcinoma.

Pancreatic Cancer Trial

The Phase 2 AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study with the primary objective of

comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced

pancreatic adenocarcinoma.

Secondary objectives include comparing safety and tolerability.

is expected to enroll approximately 90 subjects in up to 30 centers across the U.S.

In March 2022, the FDA granted clearance to proceed with the study.

In April 2022, we executed

a work order with Amarex to manage the clinical trial.

In August 2022, we received IRB approval

of the trial protocol and so announced the trial’s commencement.

The authorization

to proceed with the Phase 2 pancreatic cancer clinical trial has been received with potential

sites in the Netherlands at Erasmus MC, and also at major cancer

research centers in the United States such as The Buffett Cancer Center at the University

of Nebraska Medical Center (UNMC).

The study is recruiting patients.

AMP-270 is expected to enroll

approximately 90 subjects in up to 30 centers across the U.S.

In March 2022, the FDA granted clearance to proceed with

In April 2022, we executed a work order with Amarex to manage the clinical trial.

In August 2022, we received IRB

approval of the trial protocol and so announced the trial’s commencement.

The authorization to proceed with the Phase 2

pancreatic cancer clinical trial has been received with potential sites in the Netherlands at Erasmus MC, and also at major cancer

research centers in the United States such as The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC).

D meeting package seeking the FDA guidance on expansion of inclusion criteria and treatment arms to be included was submitted to the

In June 2024, a written response to that meeting package was received from the FDA and the study protocol is currently being

amended based on the FDA comments.

The study is still recruiting patients under the current protocol.

( https://clinicaltrials.gov/ct2/show/NCT05494697 ).

Recurrent Ovarian Cancer

of the Phase 1 portion of a Phase 1/2 study of intraperitoneal 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:

The DURIPANC Study is a Phase 1b/2 clinical trial combining Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor

Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer.

The primary objective of the Phase 1b portion is to determine

the safety of combination therapy.

The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination

Investigators at Erasmus Medical Center in the Netherlands have completed the safety evaluation of patients enrolled in the first

dose level of the dose escalation design in the Phase 1b/2 study.

The combination of Ampligen and Imfinzi was found to be generally well-tolerated

with no severe adverse events (“SAE”) or dose-limiting toxicities.

Advanced Recurrent Ovarian Cancer

of the Phase 1 portion of a Phase 1/2 study of intraperitoneal 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 IFNα 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

The Phase 2 portion of the study is planned to be conducted in the future.

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 IFNα 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 is planned

to be conducted in the future.

https://clinicaltrials.gov/ct2/show/NCT02432378

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up to 45 patients to be enrolled;

enrollment has commenced, and numerous patients have commenced

In April 2024, researchers released topline data that saw an Objective Response

Rate (“ORR”) of 45% in platinum-sensitive subjects with recurrent ovarian cancer.

ORR includes complete response (“CR”) and partial response (“PR”)

to treatment.

There was a total Clinical Benefit Rate (“CBR”) of 55% when including

patients who experienced stable disease (“SD”).

Researchers also reported a median

Progression-Free Survival (“PFS”) of 7.8 months.

enrollment has commenced, and numerous patients have commenced treatment.

In April 2024, researchers released topline data that

saw an Objective Response Rate (“ORR”) of 45% in platinum-sensitive subjects with recurrent ovarian cancer.

complete response (“CR”) and partial response (“PR”) to treatment.

There was a total Clinical Benefit Rate

(“CBR”) of 55% when including patients who experienced stable disease (“SD”).

Researchers also reported a

median Progression-Free Survival (“PFS”) of 7.8 months.

Based on these results and other

research suggesting a similar effect in other solid tumor types, AIM sees an Ampligen combination

therapy as having potential across multiple types of cancers.

Additional clinical studies

are underway and planned in many of these types of tumors to further confirm these effects.”

https://clinicaltrials.gov/ct2/show/NCT03734692

research suggesting a similar effect in other solid tumor types, AIM sees an Ampligen combination therapy as having potential across

multiple types of cancers.

Additional clinical studies are underway and planned in many of these types of tumors to further confirm

these effects.” https://clinicaltrials.gov/ct2/show/NCT03734692

March 2021, we were granted a patent by the Netherlands Patent Office with granted patent claims that include, but are not limited to,

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Similar patents are pending in other countries.

4 Metastatic Triple Negative Breast Cancer - Phase 1 study of metastatic triple-negative

breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab.

patients were enrolled and 6 patients were evaluable.

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 evaluable.

https://www.clinicaltrials.gov/ct2/show/NCT03599453 .

The key findings announced in April 2022 included:

The key findings announced first in April 2022, and later published in November 2023, included:

pre-determined primary endpoint of efficacy was met (increase in CD8 in TME).

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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-0.034), 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).

p=0.024 respectively), thus successfully meeting the pre-determined primary

endpoint in the study (increase in CD8 in TME).

addition, an increase in CTL attractants CXCL10 (2.6-fold;

p=0.104) and CCL5 (3.3-fold;

was observed.

In contrast, Treg marker FOXP3 or Treg attractants CCL22 or CXCL12 were not

p=0.019) was observed.

In contrast, Treg

marker FOXP3 or Treg attractants CCL22 or CXCL12 were not enhanced.

patients had stable disease lasting 2.4, 2.5 and 3.8 months, as of data cut off September 1, 2021.

additional patient (non-evaluable) had a partial response (breast tumor autoamputation) with

massive tumor necrosis in the post-CKM biopsy.

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;

additional patient (non-evaluable) had a partial response (breast tumor autoamputation) with massive tumor necrosis in the post-CKM

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

in April 2022 included:

study’s primary endpoint was met, evidenced by increased CD8a expression post-treatment

The key findings announced in April 2022 included:

study’s primary endpoint was met, evidenced by increased CD8a expression post-treatment (p=0.046).

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

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.

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.

OS was 10.5 (90% CI 2.2-15.2) months, and the median PFS was 1.5 (90% CI 1.4, 1.8) months.

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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%).

3 or higher adverse events were rare (5%).

● 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

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 rare (5%).

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

The study is temporarily suspended due to the Merck discontinuation of Intron-A

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

The study is temporarily suspended

due to the Merck discontinuation of Intron-A production.

Roswell Park has had a Type-C meeting with the FDA and is currently performing

the necessary experiments to replace Intron-A with a generic alpha-interferon.

this trial to resume in the near future.

We expect this trial to resume in the near future.

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

● Early-Stage

Triple Negative Breast Cancer - The objective of this Phase 1 study is to evaluate the

safety and tolerability of a combination of Ampligen, celecoxib with or without Intron A,

when given along with chemotherapy in patients with early-stage triple negative breast cancer.

The now completed (as of September 2022) topline results from the study confirm the positive

findings that were previously presented at the 2022 Society for Immunotherapy of Cancer

(SITC) 37 th Annual Meeting in a poster presentation titled Safety and efficacy

of de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using

chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib) .

The primary endpoint

of the study was safety and tolerability.

The results demonstrated that treatment was well-tolerated

with mostly grade 1 or 2 treatment-related adverse events (TRAEs) without dose-limiting toxicities

(DLTs) or delayed or immune-related toxicities.

DLT was defined as grade 3 or higher toxicities

within the first 3 weeks.

Secondary endpoints included pCR rate where 5/9 (56%) of patients

attained pCR and 1 more patient attained ypTmic.

Tumor and blood biomarkers were also analyzed

in exploratory studies.

Triple Negative Breast Cancer - The objective of this Phase 1 study is to evaluate the safety and tolerability of a combination

of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy in patients with early-stage triple negative

breast cancer.

The now completed (as of September 2022) topline results from the study confirm

the positive findings that were previously presented at the 2022 Society for Immunotherapy of Cancer (SITC) 37 th Annual

Meeting in a poster presentation titled Safety and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple

negative breast cancer (TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib) .

primary endpoint of the study was safety and tolerability.

The results demonstrated that treatment was well-tolerated with mostly

grade 1 or 2 treatment-related adverse events (TRAEs) without dose-limiting toxicities (DLTs) or delayed or immune-related

DLT was defined as grade 3 or higher toxicities within the first 3 weeks.

Secondary endpoints included pCR rate where

5/9 (56%) of patients attained pCR and 1 more patient attained ypTmic.

Tumor and blood biomarkers were also analyzed in exploratory

https://clinicaltrials.gov/ct2/show/NCT04081389

Melanoma — Roswell Park Comprehensive Cancer Center (“Roswell Park”),

in a clinical trial fully funded by the National Cancer Institute (NCI), has commenced patient

enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant melanoma.

Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination

with tumor-selective chemokine modulation (“CKM”) comprised of Interferon alpha

2b, Ampligen (rintatolimod) and Celecoxib.

Up to 24 patients are to be enrolled.

was temporarily suspended due to the Merck discontinuation of Intron-A production but has

since resumed recruitment (See:

Melanoma — Roswell Park Comprehensive Cancer Center (“Roswell Park”), in a clinical trial fully funded by the

National Cancer Institute (NCI), has commenced patient enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant

The Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination with tumor-selective

chemokine modulation (“CKM”) comprised of Interferon alpha 2b, Ampligen (rintatolimod) and Celecoxib.

Up to 24 patients

are to be enrolled.

The study was temporarily suspended due to the Merck discontinuation of Intron-A production but has since resumed

recruitment (See:

https://www.clinicaltrials.gov/show/NCT04093323).

or Unresectable Triple Negative Breast Cancer – This phase ½a trial tests

the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod,

celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of

patients with triple negative breast cancer that has spread from where it first started (primary

site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable).

or Unresectable Triple Negative Breast Cancer – This phase 1/2a trial tests the safety, side effects, and best dose of chemokine

modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients

with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic)

or that cannot be removed by surgery (unresectable).

The study is recruiting subjects.

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the materials and information required to achieve fast-track status.

January 2023, we entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca.

the agreement, Erasmus MC is planning to perform an investigator-initiated clinical study, entitled “Combining anti-PD-L1 immune

checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy

DURIPANC Study,” in which it will use study drugs provided by both AstraZeneca and us.

In June 2023 we received the required

approvals from the Central Committee on Research Involving Human Subjects, which is the Competent Authority for the review of clinical

trials in the Netherlands, and the Medical Ethics Review Committee Erasmus MC, which is the governing ethics board.

The study is open

and is recruiting subjects.

Additionally:

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

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

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 market.

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

for use that are not shown to be clinically superior.

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 for use that are not shown to be clinically superior.

June 2021, Ampligen was featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal Cancers

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cancer cells”, including:

● Stimulation

of interferon regulatory factors and activation of the interferon signaling pathway,

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Opening for an

Anti-COVID-19 Opportunity in Cancer Patients?

” Cancers is a peer-reviewed, open access journal of oncology published

Anti-COVID-19 Opportunity in Cancer Patients ?” Cancers is a peer-reviewed, open access journal of oncology published

semimonthly online by MDPI.

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studies of SARS-CoV-1-infected mice, which is very similar to SARS-CoV-2, the novel virus that causes COVID-19.

Barnard 2006 study ( https://journals.sagepub.com/doi/abs/10.1177/095632020601700505 )

found that Ampligen reduced virus lung levels to below detectable limits.

Day 2009 study ( https://www.sciencedirect.com/science/article/pii/S0042682209005832 )

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

Barnard 2006 study ( https://journals.sagepub.com/doi/abs/10.1177/095632020601700505 ) found that Ampligen reduced virus lung

levels to below detectable limits.

Day 2009 study (https://www.sciencedirect.com/science/article/pii/S0042682209005832 ) found that, instead of 100% mortality,

there was 100% protective survival using Ampligen.

compared key transcription regulatory sequences of SARS-CoV-1 to SARS-CoV-2 and found significant similarities, suggesting highly probable

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All patients have completed the study and topline data was reported in February 2024.

May 9, 2023, we were granted a U.S.

Patent for a method for preventing or reducing antigenic drift or viral reassortment in a host animal

comprising determining if a host animal has been exposed to or infected by an avian influenza virus and administering to the exposed

host animal alpha-interferon.

Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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FDA and the CDC.

The CDC states on its website at https://www.cdc.gov/me-cfs/ that “ Myalgic encephalomyelitis/chronic

fatigue syndrome (ME/CFS) is a serious, long-term illness that affects many body systems.

People with ME/CFS are often not able to do

their usual activities.

At times, ME/CFS may confine them to bed.

People with ME/CFS have severe fatigue and sleep problems.

get worse after people with the illness try to do as much as they want or need to do.

This symptom is called post-exertional malaise

Other symptoms can include problems with thinking and concentrating, pain, and dizziness.

severe ME/CFS patients become completely disabled or totally bedridden and are afflicted with severe pain and mental confusion even at

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N Injection is the registered trademark for our injectable formulation of natural alpha interferon.

Alferon N Injection is the only

natural-source, multi-species alpha interferon currently approved for sale in the United States and Argentina for the intralesional

(within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of

age or older.

Alferon N Injection is also approved in Argentina for the treatment of refractory patients that failed or were

intolerant to treatment with recombinant interferons.

Argentina has experienced hyper-inflation and recently devalued its currency

Alferon N Injection is the only natural-source,

multi-species alpha interferon currently approved for sale in the United States and Argentina for the intralesional (within lesions)

treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older.

N Injection is also approved in Argentina for the treatment of refractory patients that failed or were intolerant to treatment with recombinant

Argentina has experienced hyper-inflation and recently devalued its currency to the U.S.

dollar by 50%.

Contracts with GP Pharm are U.S.

dollar contracts and the parties must evaluate the impact of the recent

devaluation on its relationship.

Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually

transmitted disease (“STD”).

According to the CDC, HPV is the most common sexually transmitted infection, with

approximately 79 million Americans — most in their late teens and early 20s — infected with HPV.

In fact, the CDC states

that “HPV is so common that nearly all sexually active men and women get the virus at some point in their lives.”

Although they do not usually result in death, genital warts commonly recur, causing significant morbidity and entail substantial

health care costs.

Contracts with GP

Pharm are U.S.

dollar contracts and the parties must evaluate the impact of the recent devaluation on its relationship.

Certain types

of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”).

the CDC, HPV is the most common sexually transmitted infection, with approximately 79 million Americans — most in their late teens

and early 20s — infected with HPV.

In fact, the CDC states that “HPV is so common that nearly all sexually active men and

women get the virus at some point in their lives.” Although they do not usually result in death, genital warts commonly recur,

causing significant morbidity and entail substantial health care costs.

are a group of proteins produced and secreted by cells to combat diseases.

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polymer (Ampligen intermediates) took place in 2019 at our New Brunswick facility.

Additionally, Jubilant manufactured two more lots

of Ampligen in December 2019 and January 2020.

The current manufactured lots of Ampligen have been fully tested and released for commercial

product launch in Argentina and for clinical trials.

In addition, we have supplied GP Pharm with the Ampligen required for testing and

ANMAT release.

Once final approval by ANMAT is obtained, we anticipate that GP Pharm will begin distributing Ampligen in Argentina.

Additionally, Jubilant manufactured three more lots

of Ampligen in December 2019, January 2020 and March 2024.

In addition, we have supplied GP Pharm with the Ampligen required for testing and ANMAT release.

Once final approval

by ANMAT is obtained, we anticipate that GP Pharm will begin distributing Ampligen in Argentina.

December 2020, we added Pii as a “Fill & Finish” provider to enhance our capacity to produce Ampligen.

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refine our approach to polymer production.

While we believe we have sufficient Ampligen API to meet current needs, we are also continually

exploring new efficiencies in order to maximize its ability to fulfill future obligations.

In March 2023, we submitted a work order for

a total of $1,432,257 to manufacture additional lots of Ampligen at Jubilant.

In March 2023, we submitted a purchase order

for a total of $1,432,257 to manufacture additional lots of Ampligen at Jubilant.

An additional lot was manufactured by Jubilant in December

second product, Alferon N Injection, is approved by the FDA for commercial sales in the United States for the treatment of genital warts.

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Ampligen” above).

The GP Pharm contract was extended in May 2021, and will now end on May 24, 2024.

In August 2021, ANMAT granted

a five-year extension to a previous approval to sell and distribute Ampligen to treat severe CFS in Argentina.

This extends the approval

The GP Pharm contract was extended in May 2021 with an end date of May 24, 2024;

we are in discussions with GP

Pharm to extend the agreement.

In August 2021, ANMAT granted a five-year extension to a previous approval to sell and distribute Ampligen

to treat severe CFS in Argentina.

This extends the approval until 2026.

May 2016, we entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V.

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Participants’ contributions to the 401(k) Plan may be matched by us at a rate determined annually by the Board of Directors.

participant immediately vests in his or her deferred salary contributions as well as the Company’s safe harbor contributions.

6% safe harbor matching contribution by us was reinstated effective January 1, 2021.

For the three months ending March 31, 2024 we made

approximately $43,800 in contributions, and for the year ending December 31, 2023 approximately $162,000 in contributions were made.

participant immediately vests in his or her deferred salary contributions as well as our safe harbor contributions.

A 6% safe harbor

matching contribution by us was reinstated effective January 1, 2021.

For the six months ending June 30, 2024 we made approximately $90,000

in contributions, and for the year ending December 31, 2023 approximately $162,000 in contributions were made.

Accounting Pronouncements

Recent Accounting Pronouncements”.

Accounting Policies and Estimates

Accounting Policies and Use of Estimates

have been no material changes in our critical accounting policies and estimates from those disclosed in Part II;

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Critical Accounting Policies” contained in our Annual

Report on Form 10-K for the year ended December 31, 2023.

Report on Form 10-K for the year ended December 31, 2023 except for the policies regarding “Distinguishing Liabilities from Equity” and “Derivative Instruments”.

Distinguishing

Liabilities from Equity

Company has adopted the guidance of ASC 480 in evaluating how it classifies and measures in its statement of financial position certain

financial instruments with characteristics of both liabilities and equity.

Under this guidance the Company evaluates free-standing financial

instruments to determine whether the instruments are classified as liabilities or equity.

The evaluation includes determining whether

the instruments are mandatorily redeemable, whether redemption includes a transfer of assets, and whether the redemption feature is conditional.

Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded

derivatives requiring bifurcation in accordance with ASC Topic 815, Derivatives and Hedging.

Derivative instruments are measured at fair

value at issuance and at each reporting date in accordance with ASC 820 with changes in fair value recognized in the period of change

in the consolidated statements of operations and comprehensive loss.

OF OPERATIONS

months ended March 31, 2024 versus three months ended March 31, 2023

net loss was approximately $5,817,000 and $3,661,000 for the three months ended March 31, 2024, and 2023, respectively, representing

an increase in loss of approximately $2,156,000 or 59%.

This increase in loss was primarily due to the following:

Months ended June 30, 2024 versus Three Months ended June 30, 2023

net loss was approximately $1,836,000 and $4,909,000 for the three months ended June 30, 2024, and 2023, respectively, representing a

decrease in loss of approximately $3,073,000 or 63%.

This decrease in loss was primarily due to the following:

increase in revenue of $8,000;

increase in interest and other income of $2,262,000;

decrease in research and development expenses of $1,808,000;

an increase in general and administrative expenses of $41,000;

decrease in gain from sale of Income tax operating loss of $328,000;

decrease in revenue of $9,000;

decrease in interest and other income of 118,000;

increase in loss on investments, net of $295,000;

increase in general and administrative expenses of $1,523,000;

decrease in loss on investments, net of $9,000;

increase in interest expense of $179,000;

increase in production costs of $8,000.

● a decrease in loss on sale of fixed assets of $23,000;

decrease in research and development expenses of $101,000.

loss per share was $ (0.12) and $(0.08) for the three months ended March 31, 2024, and 2023, respectively.

loss per share was $ (0.03) and $(0.10) for the three months ended June 30, 2024, and 2023, respectively.

The weighted average number

of shares of our common stock outstanding as of March 31, 2024, was 49,458,023 as compared to 48,399,950 as of March 31, 2023.

from our Ampligen® Cost Recovery Program were $40,000 and $49,000 for the three months ended March 31, 2024, and 2023, respectively,

representing a decrease of $9,000 which is primarily related to the fluctuation of patient participation.

the three months ended March 31, 2024 and 2023, we had no Alferon N Injection® Finished Good product to commercially sell and all

of shares of our common stock outstanding as of June 30, 2024, was 52,837,477 as compared to 48,411,251 as of June 30, 2023.

from our Ampligen® Cost Recovery Program were $50,000 and $42,000 for the three months ended June 30, 2024, and 2023, respectively,

representing an increase of $8,000 which is primarily related to the fluctuation of patient participation.

the three months ended June 30, 2024 and 2023, we had no Alferon N Injection® Finished Good product to commercially sell and all

revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access

to Ampligen® for treatment in an open-label safety study.

and Other Income

recovered $2,500,000 in Director and Officer (D&O) insurance proceeds during the quarter ended June 30, 2024 related to legal costs

expended during its successful defense in shareholder litigation matters in addition to $80,000 of interest earnings during the period.

During the quarter ended June 30, 2023, interest earnings were $318,000.

Interest earnings were higher during the second quarter of 2023

due to higher investment levels.

(loss) on Investments, net

(loss) on investments for the three months ended March 31, 2024, and 2023 was approximately $(92,000) and $203,000, respectively, reflecting

an increase in the loss on investments of approximately ($295,000).

(loss) on investments for the three months ended June 30, 2024, and 2023 was approximately $(85,000) and ($94,000), respectively, reflecting

a decrease in the loss on investments of approximately $9,000.

The increase in loss was due to the change in the fair value of equity

costs were approximately $8,000 and $0, respectively, for the three months ended March 31, 2024, and 2023, representing an increase

of $8,000 in production costs in the current period.

The increase was due primarily to the sale of the New Brunswick facility and

there was no production for the three months ended March 31, 2023 whereas there was production costs in the three months ended March 31,

costs were approximately $8,000 and $0, respectively, for the three months ended June 30, 2024, and 2023, representing an increase of

$8,000 in production costs in the current period.

was no production for the three months ended June 30, 2023 whereas there was production costs in the three months ended June 30, 2024.

(loss) from sale of income tax operating loss

quarterly income tax benefit for the three months ended March 31, 2024, was $0 compared to a gain of $255,000 for the three months ended

March 31, 2023.

quarterly income tax benefit for the three months ended June 30, 2024, was $0 compared to a gain of $328,000 for the three months ended

June 30, 2023.

This was due to the lifetime limit of $20,000,000 for the sale of the New Jersey NOL being reached and therefore no tax

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and Development Costs

Research and Development (“R&D”) costs for the three months ended March 31, 2024, were approximately $1,951,000, as compared

to $2,052,000 for the same period a year ago, reflecting a decrease of approximately $101,000.

The primary reason for the decrease in

R&D costs was a decrease in outside contractors of $229,000, as well a decrease in clinical expenses of $63,000 offset by an increase

in consultant fees of $112,000, salaries of $61,000, manufacturing expenses of $9,000, and insurance of $9,000.

Research and Development (“R&D”) costs for the three months ended June 30, 2024, were approximately $1,145,000, as

compared to $2,953,000 for the same period a year ago, reflecting a decrease of approximately $1,808,000.

The primary reason for the

decrease in R&D costs was a decrease in outside contractors of $1,521,000, as well as a decrease in clinical expenses of

$291,000, consulting expenses of $98,000 offset by an increase in salaries of $100,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the three months ended March 31, 2024, and 2023, were approximately $3,815,000

and Administrative (“G&A”) expenses for the three months ended June 30, 2024, and 2023, were approximately $2,591,000

and $2,550,000, respectively, reflecting an increase of approximately $41,000.

The increase in G&A expenses during the current

period was due primarily to an increase in legal professional fees of $1,571,000.

Interest Expenses

Interest expenses for the three

months ended March 31, 2024 was approximately $72,000 and there was no interest expense for the three months ended March 31, 2023.

increase in interest expense in the current period was due to the interest expense incurred related to the Note Purchase Agreement entered

into on February 16, 2024 with Streeterville.

The increase in G&A expenses for the three months

ended June 30, 2024 was due primarily to an increase of approximately $184,000 in investment banker fees offset by a decrease in professional

fees of approximately $144,000.

expenses for the three months ended June 30, 2024 was approximately $179,000 and there was no interest expense for the three months ended

June 30, 2023.

The increase in interest expense for the three months ended June 30, 2024 was due to the interest expense incurred related

to the Note Purchase Agreement entered into on February 16, 2024 with Streeterville.

Months ended June 30, 2024 versus Six Months ended June 30, 2023

net loss was approximately $7,653,000 and $8,570,000 for the six months ended June 30, 2024, and 2023, respectively, representing a decrease

in loss of approximately $917,000 or 11%.

This decrease in loss was primarily due to the following:

increase in interest and other income of $2,144,000;

decrease in loss on sale of fixed assets of $23,000;

decrease in research and development expenses of $1,909,000;

decrease in revenue of $1,000;

decrease in gain from sale of Income tax operating loss of $582,000;

increase in loss on investments, net of $286,000;

increase in general and administrative expenses of $1,565,000;

increase in interest expense of $251,000;

increase in production costs of $16,000.

loss per share was $ (0.15) and $(0.18) for the six months ended June 30, 2024, and 2023, respectively.

The weighted average number of

shares of our common stock outstanding as of June 30, 2024, was 51,161,956 as compared to 48,405,675 as of June 30, 2023.

from our Ampligen® Cost Recovery Program were $90,000 and $91,000 for the six months ended June 30, 2024, and 2023, respectively,

representing a decrease of $1,000 which is primarily related to the fluctuation of patient participation.

the six months ended June 30, 2024 and 2023, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue

was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to

Ampligen® for treatment in an open-label safety study.

and Other Income

recovered $2,500,000 in Director and Officer (D&O) insurance proceeds during the six months ended June 30, 2024 related to legal

costs expended during its successful defense in shareholder litigation matters in addition to $161,000 of interest earnings during the

During the six months ended June 30, 2023, interest earnings were $517,000.

Interest earnings were higher during the six months

ended June 30, 2023 due to higher investment levels during the period.

(loss) on Investments, net

(loss) on investments for the six months ended June 30, 2024, and 2023 was approximately $(177,000) and $109,000, respectively, reflecting

an increase in the loss on investments of approximately ($286,000).

The increase in loss was due to the change in the fair value of equity

costs were approximately $16,000 and $0, respectively, for the six months ended June 30, 2024, and 2023, representing an increase of

$16,000 in production costs in the current period.

was no production for the six months ended June 30, 2023 whereas there was production costs in the six months ended June 30, 2024.

(loss) from sale of income tax operating loss

quarterly income tax benefit for the six months ended June 30, 2024, was $0 compared to a gain of $582,000 for the six months ended June

This was due to the lifetime limit of $20,000,000 for the sale of the New Jersey NOL being reached and therefore no tax provision

was calculated in 2024.

and Development Costs

Research and Development (“R&D”) costs for the six months ended June 30, 2024, were approximately $3,096,000, as

compared to $5,005,000 for the same period a year ago, reflecting a decrease of approximately $1,909,000.

The primary reason for the

decrease in R&D costs was a decrease in outside contractors of $1,750,000, as well a decrease in software and IT expenses of

$125,000 and a decrease in clinical expenses of $354,000 offset by an increase in salaries of $252,000, office expense of $18,000, maintenance expense of $14,000, manufacturing expenses of $14,000, rent expense of $14,000 and

consulting expense of $14,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the six months ended June 30, 2024, and 2023, were approximately $6,406,000 and

$4,841,000, respectively, reflecting an increase of approximately $1,565,000.

The increase in G&A expenses for the six months ended

June 30, 2024 was due primarily to an increase in legal professional fees of approximately $1,428,000, investment banker fees of $314,000

and salaries of $62,000 offset by a decrease in insurance expense of $153,000, taxes & licenses of $50,000 and travel expenses of

expenses for the six months ended June 30, 2024 was approximately $251,000 and there was no interest expense for the six months ended

June 30, 2023.

The increase in interest expense for the six months ended June 30, 2024 was due to the interest expense incurred related

to the Note Purchase Agreement entered into on February 16, 2024 with Streeterville.

and Capital Resources

used in operating activities for the three months ended March 31, 2024, was approximately $4,815,000 compared to approximately $3,680,000

used in operating activities for the six months ended June 30, 2024, was approximately $7,823,000 compared to approximately

$5,838,000 for the same period in 2023, an increase of $1,985,000.

The primary reasons for this increase in cash used in operations in 2024 was

an increased net loss during the three months of $2,156,000, a decrease in gain from sale of income tax operating losses of $255,000

as well as in increase in loss on marketable investments of $295,000 which was partially offset by an increase of accrued expenses of $430,000, a decrease in accounting payable of 462,000, an increase in funds received from the 2023 sale of New Jersey net operating loss and received in 2024 of $1,184,000 and a decrease in prepaid expense of $118,000.

used in investing activities for the three months ended March 31, 2024, was approximately $158,000 compared to cash used in

investing activities in 2023 of approximately $78,000, representing a change of $80,000.

The primary reason for the change during

the current period is the net purchase and sale of marketable investments activity of $108,000 compared to $114,000 for the same

period in 2023, the loss on sale of property and equipment of $0 in the current period in 2024, compared with $29,000 in the same

period in 2023 as well as the purchase of patents in the current period in 2024 of $50,000 compared with the abandonment of patents in the same period in 2023 of $7,000.

provided by financing activities for the three months ended March 31, 2024, was approximately $2,829,000 compared to approximately

The primary reasons for this increase was an increase in cash

utilized for accounts payable of $2,762,000, accrued expenses of $909,000, as well as an increase in loss on issuance of warrants

of $458,000, loss on marketable investments of $286,000 which is partially offset by a decrease in net loss during the six months of

$917,000, a decrease in gain from sale of income tax operating losses of $582,000, prepaid expenses of $12,000 as well as a decrease

in funds received from the 2023 sale of New Jersey net operating loss and received in 2024 of $495,000.

provided by investing activities for the six months ended June 30, 2024, was approximately $668,000 compared to cash used in investing

activities for the six months ended June 30, 2023 of approximately $282,000, representing a change of $950,000.

The primary reason for

the change was the cash provided by the net purchase and sale of marketable investments activity of $947,000 compared to cash used in

the purchase of marketable investments of $114,000 for the same period in 2023, the loss on sale of property and equipment of $0 in the

current period in 2024, compared with $35,000 in the same period in 2023 as well as the net purchase and abandonment of patents in the

current period in 2024 of $279,000 compared with the net purchase and abandonment of patents in the same period in 2023 of $203,000 .

provided by financing activities for the six months ended June 30, 2024, was approximately $5,270,000 compared to approximately $105,000

for the same period in 2023, representing an increase of $5,165,000.

The primary reason for this increase was the receipt

of $2,500,000 in net proceeds from the notes payable, net of issuance cost as well as an increase in the sale of shares in the

current period in 2024 of $329,000 compared to $100,000 in the same period in 2023.

of March 31, 2024, we had approximately $10,942,000 in cash, cash equivalents and marketable investments, inclusive of approximately

$7,647,000 in marketable investments, representing an increase of approximately $2,128,000 from December 31, 2023.

The primary reason for this increase was the receipt of $2,367,000

in net proceeds from the notes payable, net of issuance cost, an increase in the sale of shares in the current period in 2024

of $856,000 compared to $105,000 in the same period in 2023 as well as an increase in warrant valuation of $2,047,000 in the current period in 2024.

of June 30, 2024, we had approximately $10,061,000 in cash, cash equivalents and marketable investments, inclusive of approximately

$6,507,000 in marketable investments, representing a decrease of approximately $3,009,000 from December 31, 2023.

We are currently

disputing Kirkland & Ellis accounts payable invoices.

This dispute involves amounts claimed which we believe require a reduction.

We are actively working to resolve this dispute by settlement, but there is no assurance as to the timing or

Depending on the resolution of this dispute, there may be a significant impact reducing the balance of the outstanding

Kirkland & Ellis invoices.

are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed

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a fixed rate of 3.0% of the gross sales price of Shares sold under the EDA.

For the three months ended March 31, 2024, we sold 564,568

For the six months ended June 30, 2024, we sold 1,294,678

shares under the EDA for total gross proceeds of approximately $626,094, which includes a 3.0% fee to Maxim of $18,783.

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fee to Maxim of $10,326.

Subsequent to the three months ended March 31, 2024, we sold 730,110 shares under the EDA for total gross proceeds

of $372,223, which includes a 3.0% fee to Maxim of $11,167.

We hope to raise additional funds through the EDA.

In addition, we raised

$2,500,000 in net proceeds from the sale of an unsecured Note and entered into an equity line of credit to raise up to 15.000,000 (see

addition, we raised $2,500,000 in net proceeds from the sale of an unsecured Note and entered into an equity line of credit to raise

up to 15,000,000 (see Overview;

The Atlas Equity Line of Credit above).

No assurance can be given as to the amount of funds that could be raised or

the potential dilution to current stockholders.

If we are unable to commercialize and sell Ampligen and/or recommence material sales

of Alferon N Injection, our operations, financial position and liquidity may be adversely impacted, and additional financing may be required.

There can be no assurances that, if needed, we will be able to raise adequate funds from the EDA or otherwise, or enter into licensing,

partnering or other arrangements to advance our business goals.

We may seek to access the public equity market whenever conditions are

favorable, even if we do not have an immediate need for additional capital at that time.

We are unable to estimate the amount, timing

or nature of future sales of outstanding common stock or instruments convertible into or exercisable for our common stock.

Any additional

funding may result in significant dilution and could involve the issuance of securities with rights, which are senior to those of existing

stockholders.

Under the terms of the Atlas Equity Line of Credit, we,

at our sole discretion, shall have the right to issue Put shares to the Investor at 95% of the Market Price of the shares on the day

Sales under the agreement are limited to a daily maximum of the lessor of:

$500,000, the Median Daily Trading volume, and a

beneficial ownership limitation of 4.99% and a maximum of 19.99% of the outstanding shares at the time of the agreement.

In April 2024,

we filed a registration statement with the SEC on Form S-1 registering a total of 9,975,000 shares for resale pursuant to the Atlas Agreements,

consisting of 9,636,400 shares that can be sold by us to Atlas and 338,600 shares that were issued to Atlas as Commitment Shares.

registration statement was declared effective and the final prospectus was filed on May 1, 2024.

As of June 30, 2024, a total of 759,685

shares have been issued pursuant to this agreement for a total of approximately $128,000.

Purchase Agreement

May 31, 2024, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering (the “Transactions”)

with a single accredited investor (the “Purchaser”), pursuant to which we will issue to the Purchaser, (i) in a registered

direct offering, 5,640,958 shares of our common stock (the “Shares”), par value $0.001 per share (“Common Stock”)

and (ii) in a concurrent private placement, we will issue to the Purchaser Class A common warrants to purchase an aggregate of up to

5,640,958 shares of its common stock (the “A Warrants”) at an exercise price of $0.363 per share and Class B common warrants

to purchase an aggregate of up to 5,640,958 shares of its common stock (the “B “Warrants” and, along with the A Warrants,

the “Common Warrants”) at an exercise price of $0.363 per share.

The A Warrants and B Warrants will not be exercisable for

six months after the issuance date and will expire, respectively, 24 months and five years and six months after the issuance date.

Common Warrants and the shares of common stock issuable upon the exercise of such warrants are offered pursuant to an exemption from

the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

received aggregate gross proceeds from the Transactions of approximately $2,047,688, before deducting fees to the Placement Agent and

other estimated offering expenses payable by us.

The Shares are being offered by us pursuant to a shelf registration statement on Form

S-3 (File No.

333-262280), which was declared effective on February 4, 2022 (as amended from time to time, the “Registration Statement”).

to the terms of the Purchase Agreement, subject to certain exceptions, we cannot issue any equity securities for 60 days following the

issuance date, provided that we will be able to utilize it’s at-the-market offering program with the Placement Agent after 30 days.

Additionally, we cannot enter into a variable rate transaction (other than the ATM program with the Placement Agent) for 120 days after

the issuance date.

In addition, our executive officers and each of our directors have entered into lock-up agreements with us pursuant

to which each of them has agreed not to, for a period of 90 days from the closing of the Transactions, offer, sell, transfer or otherwise

dispose of our securities, subject to certain exceptions.

exercise price of the Common Warrants, and the number of Common Warrant Shares, will be subject to adjustment in the event of any stock

dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants.

If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted

for us, and may exercise every right and power that we may exercise and will assume all of its obligations under the Common Warrants

with the same effect as if such successor entity had been named in the warrant itself.

Common Warrant Holders will have additional rights

defined in the Common Warrants.

The Common Warrants will be exercisable on a “cashless” basis only if there is not a current

registration statement permitting public resale.

In this regard, we have agreed to file a registration statement to register the resale

of the Common Warrant Shares as soon as practicable (and in any event within 45 calendar days) providing for the resale of the Shares

issued and issuable upon exercise of the Common Warrants.

We have agreed to use commercially reasonable efforts to cause such

registration statement to become effective within 181 days following the issuance date and to keep such registration statement effective

at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise thereof.

Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts” basis,

in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement Agency Agreement”),

by and between us and the Placement Agent.

Pursuant to the Placement Agency Agreement, the Placement Agent will be entitled to a cash

fee of 8% of the aggregate gross proceeds paid to the Company for the securities sold in the Transactions and reimbursement of certain

out-of-pocket expenses.

assurance can be given as to the amount of funds that could be raised or the potential dilution to current stockholders.

If we are unable

to commercialize and sell Ampligen and/or recommence material sales of Alferon N Injection, our operations, financial position and liquidity

may be adversely impacted, and additional financing may be required.

There can be no assurances that, if needed, we will be able to raise

adequate funds from the EDA or otherwise, or enter into licensing, partnering or other arrangements to advance our business goals.

may seek to access the public equity market whenever conditions are favorable, even if we do not have an immediate need for additional

capital at that time.

We are unable to estimate the amount, timing or nature of future sales of outstanding common stock or instruments

convertible into or exercisable for our common stock.

Any additional funding may result in significant dilution and could involve the

issuance of securities with rights, which are senior to those of existing stockholders.

See Part I, Item 1A - “Risk Factors;

We may require additional financing which may not be available ”

in our Annual Report on Form 10-K for the year ended December 31, 2023.

may require additional financing which may not be available ” in our Annual Report on Form 10-K for the year ended December

Quantitative and Qualitative Disclosures About Market Risk

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Item 2. Management’s Discussion and Analysis