3 unchanged sentences
of the Exchange Act.
−Removed: All statements, other than statements of historical fact, included or incorporated herein regarding our
−Removed: strategy, future operations, financial position, future revenues, projected costs, plans, prospects and objectives are
−Removed: forward-looking statements.
−Removed: Words such as “expect,” “anticipate,” “intend,” “plan,”
−Removed: “believe,” “seek,” “estimate,” “think,” “may,” “could,”
−Removed: “will,” “would,” “should,” “continue,” “potential,”
−Removed: “likely,” “opportunity” and similar expressions or variations of such words are intended to identify
−Removed: forward-looking statements but are not the exclusive means of identifying forward-looking statements and their absence does not mean
−Removed: that a statement is not forward-looking.
−Removed: Our forward-looking statements are not guarantees of performance, and actual results could
−Removed: vary materially from those contained in or expressed by such statements due to risks and uncertainties.
−Removed: These statements are based
−Removed: on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on
−Removed: information currently available to us.
+Added: All statements, other than statements of historical fact, included or incorporated herein regarding our strategy,
+Added: future operations, financial position, future revenues, projected costs, plans, prospects and objectives are forward-looking statements.
+Added: Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,”
+Added: “estimate,” “think,” “may,” “could,” “will,” “would,” “should,”
+Added: “continue,” “potential,” “likely,” “opportunity” and similar expressions or variations
+Added: of such words are intended to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements
+Added: and their absence does not mean that a statement is not forward-looking.
+Added: Our forward-looking statements are not guarantees of performance,
+Added: and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties.
+Added: statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results
+Added: and on information currently available to us.
Discussions containing these forward-looking statements may be found, among other places,
below in this Item 2:
−Removed: “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and
+Added: “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in
Other Information;
−Removed: “Risk Factors” of this report, and in the following sections of our Annual
−Removed: Report on Form 10-K for the year ended December 31, 2025:
+Added: “Risk Factors” of this report, and in the following sections of our Annual Report on
+Added: Form 10-K for the year ended December 31, 2025:
“Business”, Part I;
−Removed: Factors”, Part I;
+Added: “Risk Factors”,
“Legal Proceedings”, and Part II;
−Removed: “Management’s Discussion and
−Removed: Analysis of Financial Condition and Results of Operations”.
−Removed: Among other things, for those statements, we claim the protection
−Removed: of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
−Removed: Any forward-looking
−Removed: statements set forth in this Report speak only as of the date hereof.
−Removed: We do not undertake to update any of these forward-looking
−Removed: statements to reflect events or circumstances that occur after the date hereof.
−Removed: We are in various stages of seeking to determine
−Removed: whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency
−Removed: disorders and the Report sets forth our current and anticipated future activities.
−Removed: These activities are subject to change for a
−Removed: number of reasons.
−Removed: Significant additional testing and trials will be required to determine whether Ampligen® will be effective
−Removed: in the treatment of these conditions.
−Removed: Results obtained in animal models do not necessarily predict results in humans.
−Removed: Human clinical
−Removed: trials will be necessary to prove whether or not Ampligen® will be efficacious in humans.
−Removed: No assurance can be given as to
−Removed: whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors
−Removed: including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials.
−Removed: Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data
−Removed: or require additional funding.
−Removed: Among the studies are clinical trials that provide only preliminary data with a small number of
−Removed: subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield
−Removed: favorable results.
−Removed: Some of the world’s largest pharmaceutical companies are also working on treatments and cures for different
−Removed: types of cancers.
+Added: “Management’s Discussion and Analysis of Financial
+Added: Condition and Results of Operations”.
+Added: Among other things, for those statements, we claim the protection of safe harbor for forward-looking
+Added: statements contained in the Private Securities Litigation Reform Act of 1995.
+Added: Any forward-looking statements set forth in this Report
+Added: speak only as of the date hereof.
+Added: We do not undertake to update any of these forward-looking statements to reflect events or circumstances
+Added: that occur after the date hereof.
+Added: We are in various stages of seeking to determine whether Ampligen® will be effective in the treatment
+Added: of multiple types of viral diseases, cancers, and immune-deficiency disorders and the Report sets forth our current and anticipated future
+Added: These activities are subject to change for a number of reasons.
+Added: Significant additional testing and trials will be required
+Added: to determine whether Ampligen® will be effective in the treatment of these conditions.
+Added: Results obtained in animal models do not necessarily
+Added: predict results in humans.
+Added: Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans.
+Added: No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials
+Added: are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions
+Added: sponsoring other trials.
+Added: Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or
+Added: yield any useful data or require additional funding.
+Added: Among the studies are clinical trials that provide only preliminary data with a
+Added: small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies
+Added: will yield favorable results.
+Added: Some of the world’s largest pharmaceutical companies are also working on treatments and cures for
+Added: different types of cancers.
No assurance can be given that the use of Ampligen with these proposed treatments and cures will prove effective.
−Removed: No assurance can be given that future studies will not result in findings that are different from those reported in the studies
−Removed: referenced or incorporated by reference herein.
−Removed: Operating in foreign countries carries with it a number of risks, including
−Removed: potential difficulties in enforcing intellectual property rights.
−Removed: We cannot assure that our potential foreign operations will not be
−Removed: adversely affected by these risks.
+Added: No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced
+Added: or incorporated by reference herein.
+Added: Operating in foreign countries carries with it a number of risks, including potential difficulties
+Added: in enforcing intellectual property rights.
+Added: We cannot assure that our potential foreign operations will not be adversely affected by these
filings are available at www.aimimmuno.com.
35 unchanged sentences
cancer, as we believe that this path will potentially lead to the most lucrative outcome.
−Removed: Pancreatic cancer killed more than 100,000
−Removed: people in the American and European Union markets – and more than 450,000 people worldwide – as recently as 2022.
−Removed: looks at the global health problem of pancreatic cancer, we see a large market in an unmet medical need and with relatively little clinical
−Removed: This large unmet market is enhanced by an intellectual property program with broad-combination therapy patents in the United
−Removed: States, Japan and Europe, as well as market exclusivity provided by orphan drug designations in the United States and the European Union.
+Added: Each year pancreatic cancer kills more than
+Added: 100,000 people in the American and European Union markets and more than 450,000 people worldwide.
+Added: When AIM looks at the global health
+Added: problem of pancreatic cancer, we see a large market in an unmet medical need and with relatively little clinical competition.
+Added: unmet market is enhanced by an intellectual property program with broad-combination therapy patents in the United States, Japan and Europe,
+Added: as well as market exclusivity provided by orphan drug designations in the United States and the European Union.
is one of the areas of biotech known for multibillion-dollar mergers and acquisitions deals – large-market Phase 3 oncology clinical
−Removed: trials with positive data are always a focus for acquisition.
+Added: trials with positive data are a desirable focus for acquisition.
AIM strongly believes that such a Phase 3 study will be possible following
11 unchanged sentences
the promising progression-free survival and overall survival seen in Phase 1 of the study – which we believe supported advancement
−Removed: to the ongoing Phase 2 portion of the study – continue to be seen and enrollment is ongoing.
−Removed: Erasmus MC expects that detailed data
−Removed: will be published later this year.
−Removed: According to Erasmus MC, there has also been no significant toxicity – an encouraging safety
−Removed: profile for a post-chemo setting – and Ampligen subjects are consistently reporting “high” quality of life during treatment.
+Added: to the ongoing Phase 2 portion of the study – continue to be seen.
+Added: As of June 30, 2026, all subjects have been enrolled in the
+Added: study and have received the first dose of study medication.
+Added: Erasmus MC expects that detailed data will be published later this year.
+Added: According to Erasmus MC, there has also been no significant toxicity – an encouraging safety profile for a post-chemo setting –
+Added: and Ampligen subjects are consistently reporting “high” quality of life during treatment.
March 2026, the Company announced an agreement with the PPD clinical research business of Thermo Fisher Scientific to design AIM’s
73 unchanged sentences
Collaboration
−Removed: with Filaxis continues for commercial launch of Ampligen in Argentina.
−Removed: To successfully bring this to market, several key steps are necessary,
−Removed: including building disease awareness, providing medical education, securing appropriate reimbursement, developing effective market strategies,
−Removed: and finalizing manufacturing preparations for launch.
+Added: with Filaxis continues for commercial launch of Ampligen in Argentina and they are currently in the process of renewing the existing
+Added: To successfully bring this to market, several key steps are necessary, including building disease awareness, providing medical
+Added: education, securing appropriate reimbursement, developing effective market strategies, and finalizing manufacturing preparations for
economic landscape in Argentina has changed dramatically since then with the country experiencing significant hyper-inflation.
−Removed: in Argentina are U.S.
−Removed: dollar contracts, the parties must evaluate the impact of the devaluation on the relationship and the ability to
−Removed: go forward on a U.S.-dollar basis.
−Removed: The combination of the cost and frequency of treatments has rendered CFS treatments in Argentina cost
−Removed: prohibitive, at least for the time being.
−Removed: We will therefore focus our efforts with Filaxis on an approval in Argentina for pancreatic
−Removed: May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands-based company, for the commencement and management
−Removed: of an Early Access Program (“EAP”) in Europe and Turkey related to ME/CFS.
−Removed: Pursuant to the agreement, as amended,
−Removed: myTomorrows also is managing all Early Access Programs and Special Access Programs in Europe, Canada, and Turkey to treat pancreatic
−Removed: cancer and ME/CFS patients.
−Removed: The agreement was automatically extended for a period of 12 months on May 20, 2021 and will continue to
−Removed: be automatically extended for periods of 12 months every May 20 until terminated or the terms of the agreement are met.
+Added: As contracts in Argentina are U.S.
+Added: dollar contracts, the parties must evaluate the impact of the devaluation on the relationship and
+Added: the ability to go forward on a U.S.-dollar basis.
+Added: The combination of the cost and frequency of treatments has rendered CFS treatments
+Added: in Argentina cost prohibitive, at least for the time being.
+Added: We will therefore focus our efforts with Filaxis on an approval in Argentina
+Added: for pancreatic cancer.
+Added: May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands-based company, for the commencement and management of
+Added: an Early Access Program (“EAP”) in Europe and Turkey related to ME/CFS.
+Added: Pursuant to the agreement, as amended, myTomorrows
+Added: also is managing all Early Access Programs and Special Access Programs in Europe, Canada, and Turkey to treat pancreatic cancer and ME/CFS
+Added: The agreement was automatically extended for a period of 12 months on May 20, 2021 and will continue to be automatically extended
+Added: for periods of 12 months every May 20 until terminated or the terms of the agreement are met.
June 2018, Ampligen was cited as outperforming two other TLR3 agonists — poly IC and natural double stranded RNA — in creating
57 unchanged sentences
consider patent exclusivity as a crucial component of our business.
−Removed: As of March 31, 2026, we had 31 patents worldwide with 21 additional
+Added: As of June 30, 2026, we had 31 patents worldwide with 21 additional
pending patent applications comprising our intellectual property.
39 unchanged sentences
as we believe that this path will potentially lead to the most lucrative outcome.
−Removed: Pancreatic cancer killed more than 100,000 people in
−Removed: the American and European Union markets – and more than 450,000 people worldwide – as recently as 2022.
−Removed: AIM’s intellectual
−Removed: property portfolio includes orphan drug designations for pancreatic cancer in both the United States and Europe.
−Removed: The company announced
−Removed: in March 2026 that it would seek similar status in Japan.
+Added: Each year, pancreatic cancer kills more than 100,000
+Added: people in the American and European Union markets and more than 450,000 people worldwide.
+Added: AIM’s intellectual property portfolio
+Added: includes orphan drug designations for pancreatic cancer in both the United States and Europe.
+Added: The company announced in March 2026 that
+Added: it would seek similar status in Japan.
are currently two approved clinical studies utilizing Ampligen in the treatment of pancreatic cancer:
● NCT05927142
−Removed: - The DURIPANC Study is a Phase 1b/2 clinical trial combining Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint
−Removed: inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer.
−Removed: The primary objective of the Phase 1b portion
−Removed: was to determine the safety of combination treatment.
−Removed: Investigators at Erasmus Medical Center (“Erasmus MC”) in the
−Removed: Netherlands have completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding
−Removed: the combination therapy to be generally well-tolerated with no severe treatment-related adverse events or dose-limiting toxicities.
−Removed: In February 2025, we announced that the Erasmus MC Safety Committee had approved the clinical trial to move forward with Phase 2.
−Removed: July 2025, we announced a positive mid-year safety and efficacy update that included treatment of 14 subjects.
−Removed: There has been no
−Removed: significant toxicity reported.
−Removed: Three of the 14 subjects (~21%) have progression free survival (PFS) >6 months with an additional
−Removed: 3 subjects (21%) not yet progressed.
−Removed: Overall survival (OS) of >6 months in majority of eligible subjects (64%).
−Removed: In February 2026,
−Removed: we reported positive year-end interim clinical progress that included treatment of 18 subjects;
−Removed: promising PFS and OS continue to be
−Removed: Up to 25 patients are expected to be enrolled in the Phase 2 portion of DURIPANC.
−Removed: Enrollment and dosing are ongoing in Phase
−Removed: As of March 31, 2026, 24 patients have been treated in the study.
−Removed: In March 2026, we announced an agreement with the PPD clinical
−Removed: research business of Thermo Fisher Scientific to design AIM’s anticipated Phase 3 clinical trial in the use of Ampligen in the
−Removed: treatment of late-stage pancreatic cancer.
−Removed: Thermo Fisher Scientific Inc.
−Removed: is a global leader in scientific progress.
+Added: - The DURIPANC Study is a Phase 1b/2 clinical trial combining Ampligen with AstraZeneca’s
+Added: anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage
+Added: pancreatic cancer.
+Added: The primary objective of the Phase 1b portion was to determine the safety
+Added: of combination treatment.
+Added: Investigators at Erasmus Medical Center (“Erasmus MC”)
+Added: in the Netherlands have completed the safety evaluation of subjects enrolled in the first
+Added: dose level of the dose escalation design, finding the combination therapy to be generally
+Added: well-tolerated with no severe treatment-related adverse events or dose-limiting toxicities.
+Added: In February 2025, we announced that the Erasmus MC Safety Committee had approved the clinical
+Added: trial to move forward with Phase 2.
+Added: As of June 18, 2026, the final study subject had received
+Added: their first dose.
+Added: With this final subject, Primary Endpoint analysis is anticipated to begin
+Added: in December 2026 and topline results are anticipated in Q1 2027.
+Added: DURIPANC’s primary
+Added: endpoint is Clinical Benefit Rate (“CBR”), defined as the proportion of patients
+Added: achieving stable disease, partial response or complete response at 24 weeks following initiation
+Added: of combination therapy.
+Added: Additionally, in March 2026, the Company announced an agreement with
+Added: the PPD clinical research business of Thermo Fisher Scientific to design AIM’s anticipated
+Added: Phase 3 clinical trial in the use of Ampligen in the treatment of late-stage pancreatic cancer.
● NCT05494697
35 unchanged sentences
Hitting Two Targets with One
−Removed: Arrow?” International Hepato-Pancreato Biliary Association
+Added: “ International Hepato-Pancreato Biliary Association
● “ Rintatolimod
1 unchanged sentence
Opening for an Anti-COVID-19
−Removed: Opportunity in Cancer Patients?” Cancers
+Added: Opportunity in Cancer Patients?
Efforts in Other Cancers of Interest
1 unchanged sentence
Our clinical work in this area includes:
−Removed: Recurrent Ovarian Cancer (NCT02432378) - Results of the Phase 1 portion of a Phase 1/2 study
−Removed: of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer were published
−Removed: in the American Association for Cancer Research publication, Clinical Cancer Research (Clin
−Removed: Cancer Res January 19, 2022 DOI:
+Added: Recurrent Ovarian Cancer ( NCT02432378 ) - Results of the Phase 1 portion of a Phase
+Added: 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer were
+Added: published in the American Association for Cancer Research publication, Clinical Cancer Research
+Added: (Clin Cancer Res January 19, 2022 DOI:
10.1158/1078-0432.CCR-21-3659).
−Removed: The study results represent
−Removed: an important extension of prior studies using human tumor explants that showed Ampligen’s
−Removed: potential role as a TLR3 agonist acting synergistically with high-dose IFNα and celecoxib
−Removed: to selectively enhance Teff cell-attractants while suppressing Treg-attractants in the tumor
−Removed: microenvironment with a concomitant increase in the Teff/Treg ratio.
−Removed: The importance of boosting
−Removed: the Teff/Treg ratio in the tumor microenvironment is that it is associated with the conversion
−Removed: of ‘cold’ tumors into ‘hot’ tumors, which have an increased sensitivity
−Removed: to chemo-immunotherapy and an improved chance of showing tumor regression.
+Added: The study results
+Added: represent an important extension of prior studies using human tumor explants that showed
+Added: Ampligen’s potential role as a TLR3 agonist acting synergistically with high-dose IFNα
+Added: and celecoxib to selectively enhance Teff cell-attractants while suppressing Treg-attractants
+Added: in the tumor microenvironment with a concomitant increase in the Teff/Treg ratio.
+Added: The importance
+Added: of boosting the Teff/Treg ratio in the tumor microenvironment is that it is associated with
+Added: the conversion of ‘cold’ tumors into ‘hot’ tumors, which have an
+Added: increased sensitivity to chemo-immunotherapy and an improved chance of showing tumor regression.
+Added: The Phase 1 portion was designed to establish intraperitoneal safety.
The Phase 2 portion
−Removed: was designed to establish intraperitoneal safety.
−Removed: The Phase 2 portion of the study has been
−Removed: terminated due to lack of funding.
−Removed: Recurrent Ovarian Cancer (NCT03734692) - A Phase 2 study of advanced recurrent ovarian cancer
−Removed: using cisplatin, pembrolizumab, plus Ampligen;
−Removed: 27 patients enrolled, with 24 evaluable for response.
−Removed: 2026, we announced results from the UPMC Primary Endpoint Report.
+Added: of the study has been terminated due to lack of funding.
+Added: Recurrent Ovarian Cancer ( NCT03734692 ) - A Phase 2 study of advanced recurrent ovarian
+Added: cancer using cisplatin, pembrolizumab, plus Ampligen;
+Added: 27 patients enrolled, with 24 evaluable
+Added: for response.
+Added: In May 2026, we announced results from the UPMC Primary Endpoint Report .
The topline results included:
−Removed: 50% Objective Response Rate (ORR), including
−Removed: 21% complete responses;
+Added: 50% Objective Response Rate (ORR), including 21% complete responses;
79% Clinical Benefit Rate;
Median Overall Survival of 32.5 months;
−Removed: durable responses exceeding 70+ months in select
+Added: durable responses exceeding
+Added: 70+ months in select patients;
and no Grade 4 or 5 toxicities observed.
−Removed: Collection of additional secondary endpoint data including progression-free survival,
−Removed: time to disease progression and overall survival is expected to be completed in January 2027.
−Removed: Based on these results and other research
−Removed: suggesting a similar effect in other solid tumor types, AIM sees an Ampligen combination therapy as having potential across multiple types
−Removed: Additional clinical studies are being planned in these tumor types to further confirm these effects.
−Removed: 4 Metastatic Triple Negative Breast Cancer (NCT03599453) - Phase 1 study of metastatic triple-negative
−Removed: breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab.
−Removed: patients were enrolled and 6 patients were evaluable.
−Removed: The key findings announced in April
−Removed: 2022 and published in November 2023, included:.
−Removed: The pre-determined primary endpoint of efficacy
−Removed: was met (increase in CD8 in TME).
−Removed: Uniform increase of immune markers upon treatment was observed:
+Added: Collection of additional
+Added: secondary endpoint data including progression-free survival, time to disease progression
+Added: and overall survival is expected to be completed in January 2027.
+Added: Based on these results
+Added: and other research suggesting a similar effect in other solid tumor types, AIM sees an Ampligen
+Added: combination therapy as having potential across multiple types of cancers.
+Added: Additional clinical
+Added: studies are being planned in these tumor types to further confirm these effects.
+Added: 4 Metastatic Triple Negative Breast Cancer ( NCT03599453 ) - Phase 1 study of metastatic
+Added: triple-negative breast cancer using chemokine modulation therapy, including Ampligen and
+Added: pembrolizumab.
+Added: Eight patients were enrolled and 6 patients were evaluable.
+Added: The key findings
+Added: announced in April 2022 and published in November 2023, included:.
+Added: The pre-determined primary
+Added: endpoint of efficacy was met (increase in CD8 in TME).
+Added: Uniform increase of immune markers
+Added: upon treatment was observed:
CD8 mRNA (6.1-fold;
p-0.034), GZMB mRNA (3.5-fold;
−Removed: p=0.058), ratios of CD8 /FOXP3 and GZMB/FOXP3
+Added: ratios of CD8 /FOXP3 and GZMB/FOXP3 (5.7-fold;
p=0.036, and 7.6-fold;
−Removed: p=0.024 respectively), thus successfully meeting the pre-determined
−Removed: primary endpoint in the study (increase in CD8 in TME).
−Removed: In addition, an increase in CTL attractants
−Removed: CXCL10 (2.6-fold;
−Removed: p=0.104) and CCL5 (3.3-fold;
+Added: p=0.024 respectively),
+Added: thus successfully meeting the pre-determined primary endpoint in the study (increase in CD8
+Added: In addition, an increase in CTL attractants CXCL10 (2.6-fold;
+Added: p=0.104) and CCL5
p=0.019) was observed.
−Removed: In contrast, Treg marker
−Removed: FOXP3 or Treg attractants CCL22 or CXCL12 were not enhanced.
−Removed: Three patients had stable disease
−Removed: lasting 2.4, 2.5 and 3.8 months, as of data cut off September 1, 2021.
−Removed: An additional patient
−Removed: (non-evaluable) had a partial response (breast tumor autoamputation) with massive tumor necrosis
−Removed: in the post-CKM biopsy.
−Removed: 4 Colorectal Cancer Metastatic to the Liver (NCT03403634) - Phase 2a study of Ampligen as
−Removed: a component of chemokine modulatory regimen on colorectal cancer metastatic to liver;
−Removed: has been completed;
−Removed: 19 patients were enrolled and 12 patients were evaluable for the primary
+Added: In contrast, Treg marker FOXP3 or Treg attractants CCL22
+Added: or CXCL12 were not enhanced.
+Added: Three patients had stable disease lasting 2.4, 2.5 and 3.8 months,
+Added: as of data cut off September 1, 2021.
+Added: An additional patient (non-evaluable) had a partial
+Added: response (breast tumor autoamputation) with massive tumor necrosis in the post-CKM biopsy.
+Added: 4 Colorectal Cancer Metastatic to the Liver ( NCT03403634 ) - Phase 2a study of Ampligen
+Added: as a component of chemokine modulatory regimen on colorectal cancer metastatic to liver;
+Added: recruitment has been completed;
+Added: 19 patients were enrolled and 12 patients were evaluable
+Added: for the primary endpoint.
The key findings announced in April 2022 included.
−Removed: The study’s primary endpoint
−Removed: was met, evidenced by increased CD8a expression post-treatment (p=0.046).
−Removed: Increase in the
−Removed: CD8a/CD4 (p=0.03), CD8a/FOXP3 (p<0.01) and GZMB/FOXP3 (p<0.01) ratios.
−Removed: The expression
−Removed: of CTL-attracting chemokines CCL5 (p=0.08), CXCL9 (p=0.05), and CXCL10 (p=0.06) were increased,
−Removed: while expression of the Treg/MDSC attractant CXCL12 (p=0.07) was decreased post-treatment.
−Removed: 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.
+Added: primary endpoint was met, evidenced by increased CD8a expression post-treatment (p=0.046).
+Added: Increase in the CD8a/CD4 (p=0.03), CD8a/FOXP3 (p<0.01) and GZMB/FOXP3 (p<0.01) ratios.
+Added: The expression of CTL-attracting chemokines CCL5 (p=0.08), CXCL9 (p=0.05), and CXCL10 (p=0.06)
+Added: were increased, while expression of the Treg/MDSC attractant CXCL12 (p=0.07) was decreased
+Added: post-treatment.
+Added: OS was 10.5 (90% CI 2.2-15.2) months, and the median PFS was 1.5 (90% CI
+Added: 1.4, 1.8) months.
No tumor responses were seen.
The treatment was well tolerated.
−Removed: Of all enrolled patients
−Removed: (N=19), adverse events were noted in 74% of patients, with the most common being fatigue
+Added: enrolled patients (N=19), adverse events were noted in 74% of patients, with the most common
+Added: being fatigue (58%).
Grade 3 or higher adverse events were rare (5%).
● Early-Stage
−Removed: Prostate Cancer (NCT03899987) - Phase 2 study investigating the effectiveness and safety
−Removed: of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug
−Removed: treatments in a randomized three-arm study of patients with prostate cancer before undergoing
−Removed: radical prostatectomy.
−Removed: Patient enrollment was initiated in this study designed for up to
−Removed: The study was temporarily suspended due to the Merck discontinuation of Intron-A
−Removed: Roswell Park has had a Type-C meeting with the FDA and has performed the necessary
−Removed: experiments to replace Intron-A with a generic alpha-interferon.
−Removed: As of August 2025, the study
−Removed: is no longer recruiting patients.
+Added: Prostate Cancer ( NCT03899987 ) - Phase 2 study investigating the effectiveness and
+Added: safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to
+Added: no drug treatments in a randomized three-arm study of patients with prostate cancer before
+Added: undergoing radical prostatectomy.
+Added: Patient enrollment was initiated in this study designed
+Added: for up to 45 patients.
+Added: The study was temporarily suspended due to the Merck discontinuation
+Added: of Intron-A production.
+Added: Roswell Park has had a Type-C meeting with the FDA and has performed
+Added: the necessary experiments to replace Intron-A with a generic alpha-interferon.
+Added: 2025, the study is no longer recruiting patients.
A total of 12 patients were enrolled.
● Early-Stage
−Removed: Triple Negative Breast Cancer (NCT04081389) - The objective of this Phase 1 study is to evaluate
−Removed: the safety and tolerability of a combination of Ampligen, celecoxib with or without Intron
−Removed: A, when given along with chemotherapy in patients with early-stage triple negative breast
−Removed: The now completed (as of September 2022) topline results from the study confirm the
−Removed: positive findings that were previously presented at the 2022 Society for Immunotherapy of
−Removed: Cancer (SITC) 37th Annual Meeting in a poster presentation titled Safety and efficacy of
−Removed: de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using
−Removed: chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib).
−Removed: The primary endpoint
−Removed: of the study was safety and tolerability.
−Removed: The results demonstrated that treatment was well-tolerated
−Removed: with mostly grade 1 or 2 treatment-related adverse events (TRAEs) without dose-limiting toxicities
−Removed: (DLTs) or delayed or immune-related toxicities.
−Removed: DLT was defined as grade 3 or higher toxicities
−Removed: within the first 3 weeks.
−Removed: Secondary endpoints included pCR rate where 5/9 (56%) of patients
−Removed: attained pCR and 1 more patient attained ypTmic.
−Removed: Tumor and blood biomarkers were also analyzed
−Removed: in exploratory studies.
−Removed: Melanoma (NCT04093323) - Roswell Park Comprehensive Cancer Center (“Roswell Park”),
−Removed: in a clinical trial fully funded by the National Cancer Institute (NCI), has commenced patient
−Removed: enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant melanoma.
−Removed: Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination
−Removed: with tumor-selective chemokine modulation (“CKM”) comprised of Interferon alpha
−Removed: 2b, Ampligen (rintatolimod) and Celecoxib.
+Added: Triple Negative Breast Cancer ( NCT04081389 ) - The objective of this Phase 1 study
+Added: is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or
+Added: without Intron A, when given along with chemotherapy in patients with early-stage triple
+Added: negative breast cancer.
+Added: The now completed (as of September 2022) topline results from the
+Added: study confirm the positive findings that were previously presented at the 2022 Society for
+Added: Immunotherapy of Cancer (SITC) 37th Annual Meeting in a poster presentation titled Safety
+Added: and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer
+Added: (TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib).
+Added: endpoint of the study was safety and tolerability.
+Added: The results demonstrated that treatment
+Added: was well-tolerated with mostly grade 1 or 2 treatment-related adverse events (TRAEs) without
+Added: dose-limiting toxicities (DLTs) or delayed or immune-related toxicities.
+Added: DLT was defined
+Added: as grade 3 or higher toxicities within the first 3 weeks.
+Added: Secondary endpoints included pCR
+Added: rate where 5/9 (56%) of patients attained pCR and 1 more patient attained ypTmic.
+Added: blood biomarkers were also analyzed in exploratory studies.
+Added: Melanoma ( NCT04093323 ) - Roswell Park Comprehensive Cancer Center (“Roswell
+Added: Park”), in a clinical trial fully funded by the National Cancer Institute (NCI), has
+Added: commenced patient enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant
+Added: The Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine
+Added: in combination with tumor-selective chemokine modulation (“CKM”) comprised of
+Added: Interferon alpha 2b, Ampligen (rintatolimod) and Celecoxib.
Up to 24 patients are to be enrolled.
−Removed: was temporarily suspended due to the Merck discontinuation of Intron-A production but has
−Removed: since resumed recruitment.
−Removed: In June 2025, the study was terminated with 1 patient enrolled,
−Removed: funding completed.
−Removed: or Unresectable Triple Negative Breast Cancer (NCT05756166) - This phase 1/2a trial tests
−Removed: the safety, side effects, and best dose of chemokine modulation therapy (rintatolimod, celecoxib,
−Removed: and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients
−Removed: with triple negative breast cancer that has spread from where it first started (primary site)
−Removed: to other places in the body (metastatic) or that cannot be removed by surgery (unresectable).
+Added: The study was temporarily suspended due to the Merck discontinuation of Intron-A production
+Added: but has since resumed recruitment.
+Added: In June 2025, the study was terminated with 1 patient
+Added: enrolled, funding completed.
+Added: or Unresectable Triple Negative Breast Cancer ( NCT05756166 ) - This phase 1/2a trial
+Added: tests the safety, side effects, and best dose of chemokine modulation therapy (rintatolimod,
+Added: celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of
+Added: patients with triple negative breast cancer that has spread from where it first started (primary
+Added: site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable).
In June 2025, the study was terminated with 5 patients enrolled, funding ended.
11 unchanged sentences
The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2.
−Removed: Barnard 2006 study found that Ampligen reduced virus lung levels to below detectable limits.
+Added: Barnard 2006 study found that Ampligen reduced virus lung levels to below detectable
Day 2009 study found that, instead of 100% mortality, there was 100% protective survival
10 unchanged sentences
patients with COVID-19 infections.
−Removed: This clinical trial (NCT04379518), sponsored in collaboration with Roswell Park, was designed to test
−Removed: the safety of the combination regimen in patients with cancer and COVID-19, and the extent to which this therapy might promote clearance
−Removed: of the SARS-CoV-2 virus from the upper airway.
+Added: This clinical trial ( NCT04379518 ), sponsored in collaboration with Roswell Park, was designed
+Added: to test the safety of the combination regimen in patients with cancer and COVID-19, and the extent to which this therapy might promote
+Added: clearance of the SARS-CoV-2 virus from the upper airway.
The first patient enrolled and treated in November 2020.
−Removed: This study was amended to add
−Removed: 20 patients but ultimately terminated after low accrual.
+Added: This study was amended
+Added: to add 20 patients but ultimately terminated in January 2026 due to low accrual.
Roswell Park reported partial results from the study,
−Removed: The study was terminated in January 2026 with 4 patients enrolled due to low accrual.
+Added: 4 patients were enrolled.
January 2021, we entered into a Sponsor Agreement with the Center for Human Drug Research (“CHDR”) to manage a Phase 1 randomized,
35 unchanged sentences
was re-authorized in 2021, 2022, 2023, 2024, 2025 and 2026.
−Removed: At this time, we do not plan on passing this adjustment along to the patients in
−Removed: this program.
+Added: At this time, we do not plan on passing this adjustment along to the patients
+Added: in this program.
October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include
1 unchanged sentence
known as Post-COVID conditions.
−Removed: As of March 31, 2026, there were 4 patients enrolled in this open-label expanded access treatment
−Removed: protocol (including one patient with Post-COVID Conditions).
−Removed: In July 2022, AIM reported positive preliminary results based on data from
−Removed: the first four Post-COVID Condition patients enrolled in the study.
−Removed: The data show that, by week 12, compared to baseline, the investigators
−Removed: observed what they considered a clinically significant decrease in fatigue-related measures.
−Removed: To date, there have been eight such Post-COVID
−Removed: patients treated in this study.
+Added: As of June 30, 2026, there were 4 patients enrolled in this open-label expanded access treatment protocol
+Added: (including one patient with Post-COVID Conditions).
+Added: In July 2022, AIM reported positive preliminary results based on data from the first
+Added: four Post-COVID Condition patients enrolled in the study.
+Added: The data show that, by week 12, compared to baseline, the investigators observed
+Added: what they considered a clinically significant decrease in fatigue-related measures.
+Added: To date, there have been eight such Post-COVID patients
+Added: treated in this study.
November 2020, we announced the publication of statistically significant data detailing how Ampligen could have a considerable positive
175 unchanged sentences
OF OPERATIONS
−Removed: The Company’s operating results may fluctuate significantly depending on the pace of patient enrollment in
−Removed: our clinical trials, particularly the ongoing DURIPANC study for pancreatic cancer.
−Removed: Patient enrollment has varied, which directly impacts
−Removed: the timing and amount of clinical trial expenditures.
−Removed: Additionally, our ability to maintain compliance with NYSE American listing requirements
−Removed: and the trading status of our common stock may affect our ability to raise capital and, consequently, our ability to fund ongoing operations
−Removed: and clinical development activities.
−Removed: We cannot predict with certainty the timing of regulatory decisions or clinical trial outcomes, which
−Removed: represent material uncertainties that could significantly impact our future results of operations.
+Added: Company’s operating results may fluctuate significantly depending on the pace of patient enrollment in our clinical trials, particularly
+Added: the ongoing DURIPANC study for pancreatic cancer.
+Added: Patient enrollment has varied, which directly impacts the timing and amount of clinical
+Added: trial expenditures.
+Added: Additionally, our ability to maintain compliance with NYSE American listing requirements and the trading status of
+Added: our common stock may affect our ability to raise capital and, consequently, our ability to fund ongoing operations and clinical development
+Added: We cannot predict with certainty the timing of regulatory decisions or clinical trial outcomes, which represent material
+Added: uncertainties that could significantly impact our future results of operations.
following table sets forth, for the periods indicated, certain items in our Condensed Consolidated Statements of Income ($ in thousands):
−Removed: Three months ended March 31,
+Added: Three months ended June 30,
Clinical treatment programs – US
9 unchanged sentences
Interest Expense and Other Finance Costs
−Removed: Loss on change in fair value of warrant liability
−Removed: Loss on issuance of warrants
−Removed: Company’s net loss during the quarter ended March 31, 2026 was $3.0 million which was $682 thousand less than the $3.7 million
−Removed: loss for the quarter ended March 31, 2025.
−Removed: Included in the March 2026 loss was a $468 thousand loss on warrant valuations recognized
−Removed: prior to their reclassification from liability to equity as well as a $32 thousand loss on issuance of warrants related to the Rights
−Removed: These losses are not expected to be incurred moving forward.
−Removed: costs and expenses declined to $2.2 million for the quarter ended March 31, 2026, compared with $3.6 million
−Removed: for the quarter ended March 31, 2025, a decrease of $1.4 million and represents the primary driver for the overall decrease in net loss.
−Removed: and development costs declined to $482 thousand during the quarter ended March 31, 2026 compared with $1.1 million during the quarter
−Removed: ended March 31, 2025.
−Removed: During the first quarter of 2025, the Company decided to direct its focus and efforts on the development of Ampligen
−Removed: for the treatment of late-stage pancreatic cancer, with the belief that this path will potentially lead to the most lucrative outcome.
−Removed: As a result, the Company evaluated its patent portfolio and made a decision to reduce its annual maintenance fees and development of
−Removed: patents not meeting its current core objective.
−Removed: As a result, $335 thousand was charged to clinical expenses during the first quarter
−Removed: of 2025 related to prior costs of developing and maintaining patents not specific to the primary focus and was the largest component
−Removed: of the variance between the quarters.
−Removed: Additionally,
−Removed: fewer patients were enrolled in the Company’s Phase 2 testing for pancreatic cancer during the first quarter of 2026 than during
−Removed: the quarter ended March 31, 2025, which resulted in $88 thousand in reduced payments to Amarex, the principal administrator of several
−Removed: of AIM’s largest clinical studies.
−Removed: The timing and amount of clinical expenditures is dependent on recruiting patients and therefore
−Removed: can be difficult to project.
−Removed: and administrative costs for the quarter ended March 31, 2026 were $783 thousand below the first quarter of 2025 as a result of reduced
−Removed: During the quarter ended March 31, 2025, the Company was receiving final billings related to a shareholder dispute which
−Removed: was settled during the fourth quarter of 2024.
−Removed: expense was $304 thousand and $124 thousand for the three months ended March 31, 2026 and 2025, respectively.
+Added: The Company’s net loss for the quarter
+Added: ended June 30, 2026 was $3.8 million compared with a net loss of $2.8 million for the quarter ended June 30, 2025, an increase of $1.0
+Added: The increase in net loss was primarily attributable to offering related costs incurred in connection with multiple equity transactions
+Added: completed during the quarter, including placement agent fees, legal fees, accounting fees, and other direct transaction costs, as discussed
+Added: Total costs and expenses increased to $3.5 million
+Added: for the quarter ended June 30, 2026, compared with $2.7 million for the quarter ended June 30, 2025, an increase of approximately 32.5%.
+Added: 2026 Class H Inducement Transaction
+Added: May 7-8, 2026, the Company entered into inducement letter agreements with eight existing warrant holders pursuant to which such holders
+Added: agreed to immediately exercise an aggregate of 7,451,920 previously outstanding Class A through Class F Warrants at an exercise price
+Added: of $0.48 per share, generating gross proceeds to the Company of approximately $3.6 million.
+Added: In connection with the inducement, the Company
+Added: reduced the exercise price of the outstanding Class A through Class F Warrants to $0.48 per share.
+Added: In consideration for the immediate
+Added: exercises, the Company issued to such holders an aggregate of 14,903,840 new Class H Common Stock Purchase Warrants with an exercise
+Added: price of $0.60 per share and a five-year term commencing on the Stockholder Approval Date.
+Added: In connection with the inducement
+Added: transaction, the Company also issued 447,116 Placement Agent Warrants to Ladenburg Thalmann & Co., Inc.
+Added: with an exercise price of
+Added: $0.60 per share and a five-year term commencing on the issue date, issued pursuant to the Investment Banking Agreement dated April 9,
+Added: The Class H Warrants and Class H Placement Agent Warrants are equity-classified.
+Added: The Class H Warrants are not exercisable
+Added: until the Company obtains stockholder approval ( See Note 17:
+Added: Subsequent Events) and include
+Added: a beneficial ownership limitation of 4.99%, or 9.99% upon election, customary anti-dilution adjustments, cashless exercise rights if
+Added: there is no effective registration statement or available prospectus for resale of the underlying shares, and fundamental transaction
+Added: Company evaluated the temporary reduction in the exercise price of the Class A through Class F Warrants as a modification of freestanding
+Added: equity-classified written call options.
+Added: The incremental fair value effect of the modification was approximately $8,235 based on a class-by-class
+Added: analysis and was attributable to the Class A and Class C Warrants.
+Added: The aggregate fair value of the new Class H Warrants issued to the
+Added: exercising holders was approximately $6.6 million.
+Added: Accordingly, the aggregate value transferred to the exercising warrant holders was
+Added: approximately $6.6 million.
+Added: Company also incurred approximately $561 thousand of placement-agent costs in connection with the transaction, consisting of approximately
+Added: $363 thousand of cash placement-agent fees and approximately $198 thousand representing the fair value of the Class H Placement Agent
+Added: Total holder-side consideration and placement-agent costs associated with the transaction were therefore approximately $7.2
+Added: transaction generated gross exercise proceeds of approximately $3.6 million.
+Added: The Company recognized equity issuance costs equal to the
+Added: gross proceeds of the transaction, consisting of approximately $561 thouand of placement-agent costs and approximately $3.0 million of
+Added: holder-side inducement consideration.
+Added: The remaining approximately $3.6 million of value transferred to the exercising warrant holders
+Added: exceeded the proceeds available to absorb the transaction costs and was recognized as a deemed dividend.
+Added: Because the Company had an accumulated
+Added: deficit, the deemed dividend was recorded as a reduction of additional paid-in capital.
+Added: deemed dividend did not affect the Company’s net loss or total stockholders’ equity but was deducted in determining net loss
+Added: available to common stockholders for purposes of calculating basic earnings per share.
+Added: The noncash entries associated with the Class
+Added: H Warrants, the Existing Warrant modification, and the Class H Placement Agent Warrants also had no net effect on total stockholders’
+Added: After payment of the cash placement-agent costs, the transaction increased total stockholders’ equity by approximately
+Added: $3.2 million, representing the net cash proceeds received.
+Added: June 30, 2026 447,116 Placement Agent Warrants and 14,903,840 Class H Warrants were outstanding.
+Added: 2026 Class I Offering
+Added: May 21, 2026, the Company closed a registered direct offering (the ‘May 2026 Class I Offering’) of 7,519,351 registered shares of common
+Added: stock and Class I Common Stock Purchase Warrants to purchase up to 15,038,702 shares of common stock at an exercise price of $0.325 per
+Added: share, exercisable for a five-year period commencing on the Stockholder Approval Date.
+Added: combined offering price was $0.325 per share of common stock and accompanying Class I Warrants.
+Added: Although the Class I Securities Purchase
+Added: Agreement permitted each Purchaser to elect Pre-Funded Warrants in lieu of common stock, no Purchaser elected to receive Pre-Funded Warrants
+Added: at closing, and consequently no May 2026 Pre-Funded Warrants were issued.
+Added: Gross proceeds to the Company totaled approximately $2.4 million.
+Added: Thalmann & Co., Inc.
+Added: acted as the placement agent for the May 2026 Class I Offering and received an 8.0% cash commission of approximately
+Added: $196 thousand, a 0.75% management fee of approximately $18 thousand, reimbursement of expenses of $100 thousand, and 451,161 Placement
+Added: Agent Warrants exercisable at approximately $0.41 per share (125% of the offering price) for a five-year period from the effective date
+Added: of the Registration Statement.
+Added: The Class I Warrants and Class I Placement Agent Warrants are all classified within stockholders’ equity.
+Added: The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds between the common stock and the
+Added: Class I Warrants, resulting in allocations of approximately $939 thousand to common stock and $1.5 million to Class I Warrants.
+Added: I Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder
+Added: meeting to be held no later than July 21, 2026.
+Added: Subsequent Events)
+Added: June 30, 2026 there were 451,161 Placement Agent Warrants and 15,038,702 Class I Warrants outstanding.
+Added: 2026 Class J Offering
+Added: June 10, 2026, the Company closed a registered direct offering and concurrent private placement (the “June 2026 Class J Offering”)
+Added: of 2,554,119 registered shares of common stock, 771,503 unregistered shares of common stock, Pre-Funded Warrants to purchase up to 1,782,616
+Added: shares of common stock at a nominal exercise price of $0.001 per share (fully pre-funded at closing), and Class J Common Stock Purchase
+Added: Warrants to purchase up to 10,216,476 shares of common stock at an exercise price of approximately $0.52 per share, exercisable for a
+Added: five-year period commencing on the Stockholder Approval Date.
+Added: combined offering price was approximately $0.52 per share and accompanying warrant.
+Added: Gross proceeds to the Company totaled approximately
+Added: $2.6 million.
+Added: Thalmann & Co., Inc.
+Added: acted as the placement agent for the June 2026 Class J Offering and received an 8.0% cash commission of approximately
+Added: $212 thousand, a 0.75% management fee of approximately $20 thousand, reimbursement of expenses of $100 thousand, and 306,494 Placement
+Added: Agent Warrants exercisable at approximately $0.65 per share with a five-year term.
+Added: The Class J Warrants, June 2026 Pre-Funded Warrants,
+Added: and Class J Placement Agent Warrants are all classified within stockholders’ equity.
+Added: The Company applied the relative fair value method
+Added: per ASC 470-20-25-2 to allocate the gross proceeds among the common stock, Pre-Funded Warrants, and Class J Warrants.
+Added: J Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at
+Added: a stockholder meeting to be held no later than July 21, 2026 (concurrent with the Class I and Class H Warrants).
+Added: Subsequent Events)
+Added: For the three months ended June 30, 2026,
+Added: prefunded warrants were exercised for 1,300,828 shares of common stock.
+Added: At June 30, 2026 481,788 Pre-Funded Warrants, 306,494 Placement
+Added: Agent Warrants and 10,216,476 Class J Warrants were outstanding.
+Added: Subsequently, on August 4, 2026, a holder exercised pre-funded warrants to purchase 481,788 shares of common stock upon exercise of the
+Added: pre-funded warrants and received nominal cash proceeds from the exercise.
+Added: and development
+Added: and development costs declined to $589 thousand during the quarter ended June 30, 2026 compared with $1.2 million during the quarter
+Added: ended June 30, 2025.
+Added: Research costs declined as the Company completed a Phase II study in 2026 and shifted its focus toward a European
+Added: Pancreatic Cancer study which is funded by a grant and in collaboration with a major pharmaceutical interest.
+Added: The Company expects to
+Added: begin new studies shortly and the timing and amount of clinical expenditures is dependent on recruiting patients and therefore can be
+Added: difficult to project and lead to significant expense variations between periods.
+Added: and administrative
+Added: and administrative costs for the quarter ended June 30, 2026 were $1.5 million above those during the three months ended June 30, 2025
+Added: due to increases in issuance costs together with legal and accounting fees associated with the equity transactions
+Added: expense was $295 thousand and $149 thousand for the three months ended June 30, 2026 and 2025, respectively.
The increase in interest
7 unchanged sentences
The stated interest rate of the note is 10%.
+Added: Six months ended June 30,
+Added: Clinical treatment programs – US
+Added: Total Revenues
+Added: Costs and Expenses:
+Added: Production costs
+Added: Research and development
+Added: General and administrative
+Added: Total Costs and Expenses
+Added: Operating loss
+Added: Gain (Loss) on investments
+Added: Interest and other income
+Added: Interest Expense and Other Finance Costs
+Added: Loss on change in fair value of warrant liability
+Added: Company’s net loss for the six months ended June 30, 2026 was $6.8 million compared with a net loss of $6.5 million for the six
+Added: months ended June 30, 2025, an increase of $300 thousand.
+Added: The increase in net loss was primarily attributed to offering related costs
+Added: incurred in connection with multiple equity transactions completed during the period, including placement agent fees, legal fees, accounting
+Added: fees, and other direct costs, as discussed below.
+Added: These increased costs were partially offset by lower research and development expenses.
+Added: costs and expenses decreased to $5.8 million for the six months ended June 30, 2026, compared with $6.3 million for the six months ended
+Added: June 30, 2025, representing a decrease of approximately 8.2%.
+Added: 2026 Rights Offering
+Added: March 6, 2026, the Company completed a rights offering to its stockholders and to holders of certain of its outstanding options and warrants
+Added: that had the right to participate in the 2026 Rights Offering, as of February 10, 2026, the record date.
+Added: In the Rights Offering the Company
+Added: issued non-transferable subscription rights to purchase 1,842 Units.
+Added: Each Unit consists of one share of Series G Convertible Preferred
+Added: Stock (the “G Preferred”) and 2,000 warrants to purchase common stock (the “G Warrants”).
+Added: Each share of G Preferred
+Added: is convertible, at the option of the holder at any time, into a number of shares of common stock equal to the quotient of the stated
+Added: value of the Preferred Stock ($1 thousand) divided by $1.00, the conversion price.
+Added: Each G Warrant is exercisable for one share of common
+Added: stock at an exercise price of $1.00 per share from March 6, 2026, the date of issuance, through its expiration five years from the date
+Added: Maxim Group LLC acted as the Company’s dealer-manager.
+Added: The 2026 Rights Offering raised $1.8 million in gross proceeds.
+Added: the three months ended June 30, 2026, 149 shares of the Series G Preferred had been converted for 149,000 shares of common stock and
+Added: no Class G Warrants were exercised.
+Added: For the six months ended June 30, 2026, 1,313 shares of the Series G Preferred had been converted
+Added: for 1,313,000 shares of common stock, and 310,000 Class G Warrants had been exercised.
+Added: Subsequent to June 30, 2026, 8 shares of the G
+Added: Preferred had been converted to 8,000 shares of common stock.
+Added: At June 30, 2026 3,374,000 Class G Warrants and 529 Series G Preferred
+Added: were outstanding.
+Added: 2026 Class H Inducement Transaction
+Added: May 7-8, 2026, the Company entered into inducement letter agreements with eight existing warrant holders pursuant to which such holders
+Added: agreed to immediately exercise an aggregate of 7,451,920 previously outstanding Class A through Class F Warrants at an exercise price
+Added: of $0.48 per share, generating gross proceeds to the Company of approximately $3.6 million.
+Added: In connection with the inducement, the Company
+Added: reduced the exercise price of the outstanding Class A through Class F Warrants to $0.48 per share.
+Added: In consideration for the immediate
+Added: exercises, the Company issued to such holders an aggregate of 14,903,840 new Class H Common Stock Purchase Warrants with an exercise
+Added: price of $0.60 per share and a five-year term commencing on the Stockholder Approval Date.
+Added: In connection with the inducement
+Added: transaction, the Company also issued 447,116 Placement Agent Warrants to Ladenburg Thalmann & Co., Inc.
+Added: with an exercise price of
+Added: $0.60 per share and a five-year term commencing on the issue date, issued pursuant to the Investment Banking Agreement dated April 9,
+Added: The Class H Warrants and Class H Placement Agent Warrants are equity-classified.
+Added: The Class H Warrants are not exercisable
+Added: until the Company obtains stockholder approval ( See Note 17:
+Added: Subsequent Events) and include
+Added: a beneficial ownership limitation of 4.99%, or 9.99% upon election, customary anti-dilution adjustments, cashless exercise rights if
+Added: there is no effective registration statement or available prospectus for resale of the underlying shares, and fundamental transaction
+Added: Company evaluated the temporary reduction in the exercise price of the Class A through Class F Warrants as a modification of freestanding
+Added: equity-classified written call options.
+Added: The incremental fair value effect of the modification was approximately $8,235 based on a class-by-class
+Added: analysis and was attributable to the Class A and Class C Warrants.
+Added: The aggregate fair value of the new Class H Warrants issued to the
+Added: exercising holders was approximately $6.6 million.
+Added: Accordingly, the aggregate value transferred to the exercising warrant holders was
+Added: approximately $6.6 million.
+Added: Company also incurred approximately $561 thousand of placement-agent costs in connection with the transaction, consisting of approximately
+Added: $363 thousand of cash placement-agent fees and approximately $198 thousand representing the fair value of the Class H Placement Agent
+Added: Total holder-side consideration and placement-agent costs associated with the transaction were therefore approximately $7.2
+Added: transaction generated gross exercise proceeds of approximately $3.6 million.
+Added: The Company recognized equity issuance costs equal to the
+Added: gross proceeds of the transaction, consisting of approximately $561 thouand of placement-agent costs and approximately $3.0 million of
+Added: holder-side inducement consideration.
+Added: The remaining approximately $3.6 million of value transferred to the exercising warrant holders
+Added: exceeded the proceeds available to absorb the transaction costs and was recognized as a deemed dividend.
+Added: Because the Company had an accumulated
+Added: deficit, the deemed dividend was recorded as a reduction of additional paid-in capital.
+Added: deemed dividend did not affect the Company’s net loss or total stockholders’ equity but was deducted in determining net loss
+Added: available to common stockholders for purposes of calculating basic earnings per share.
+Added: The noncash entries associated with the Class
+Added: H Warrants, the Existing Warrant modification, and the Class H Placement Agent Warrants also had no net effect on total stockholders’
+Added: After payment of the cash placement-agent costs, the transaction increased total stockholders’ equity by approximately
+Added: $3.2 million, representing the net cash proceeds received
+Added: June 30, 2026 447,116 Placement Agent Warrants and 14,903,840 Class H Warrants were outstanding.
+Added: 2026 Class I Offering
+Added: May 21, 2026, the Company closed a registered direct offering (the ‘May 2026 Class I Offering’) of 7,519,351 registered shares of common
+Added: stock and Class I Common Stock Purchase Warrants to purchase up to 15,038,702 shares of common stock at an exercise price of $0.325 per
+Added: share, exercisable for a five-year period commencing on the Stockholder Approval Date.
+Added: combined offering price was $0.325 per share of common stock and accompanying Class I Warrants.
+Added: Although the Class I Securities Purchase
+Added: Agreement permitted each Purchaser to elect Pre-Funded Warrants in lieu of common stock, no Purchaser elected to receive Pre-Funded Warrants
+Added: at closing, and consequently no May 2026 Pre-Funded Warrants were issued.
+Added: Gross proceeds to the Company totaled approximately $2.4 million.
+Added: Thalmann & Co., Inc.
+Added: acted as the placement agent for the May 2026 Class I Offering and received an 8.0% cash commission of approximately
+Added: $196 thousand, a 0.75% management fee of approximately $18 thousand, reimbursement of expenses of $100 thousand, and 451,161 Placement
+Added: Agent Warrants exercisable at approximately $0.41 per share (125% of the offering price) for a five-year period from the effective date
+Added: of the Registration Statement.
+Added: The Class I Warrants and Class I Placement Agent Warrants are all classified within stockholders’ equity.
+Added: The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds between the common stock and the
+Added: Class I Warrants, resulting in allocations of approximately $939 thousand to common stock and $1.5 million to Class I Warrants.
+Added: I Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder
+Added: meeting to be held no later than July 21, 2026.
+Added: Subsequent Events)
+Added: June 30, 2026 there were 451,161 Placement Agent Warrants and 15,038,702 Class I Warrants outstanding.
+Added: 2026 Class J Offering
+Added: June 10, 2026, the Company closed a registered direct offering and concurrent private placement (the “June 2026 Class J Offering”)
+Added: of 2,554,119 registered shares of common stock, 771,503 unregistered shares of common stock, Pre-Funded Warrants to purchase up to 1,782,616
+Added: shares of common stock at a nominal exercise price of $0.001 per share (fully pre-funded at closing), and Class J Common Stock Purchase
+Added: Warrants to purchase up to 10,216,476 shares of common stock at an exercise price of approximately $0.52 per share, exercisable for a
+Added: five-year period commencing on the Stockholder Approval Date.
+Added: combined offering price was approximately $0.52 per share and accompanying warrant.
+Added: Gross proceeds to the Company totaled approximately
+Added: $2.6 million.
+Added: Thalmann & Co., Inc.
+Added: acted as the placement agent for the June 2026 Class J Offering and received an 8.0% cash commission of approximately
+Added: $212 thousand, a 0.75% management fee of approximately $20 thousand, reimbursement of expenses of $100 thousand, and 306,494 Placement
+Added: Agent Warrants exercisable at approximately $0.65 per share with a five-year term.
+Added: The Class J Warrants, June 2026 Pre-Funded Warrants,
+Added: and Class J Placement Agent Warrants are all classified within stockholders’ equity.
+Added: The Company applied the relative fair value method
+Added: per ASC 470-20-25-2 to allocate the gross proceeds among the common stock, Pre-Funded Warrants, and Class J Warrants.
+Added: J Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at
+Added: a stockholder meeting to be held no later than July 21, 2026 (concurrent with the Class I and Class H Warrants).
+Added: Subsequent Events)
+Added: the three months ended June 30, 2026, prefunded warrants were exercised for 1,300,828 shares of common stock.
+Added: At June 30, 2026 481,788
+Added: Pre-Funded Warrants, 306,494 Placement Agent Warrants and 10,216,476 Class J Warrants were outstanding.
+Added: Subsequently, on August 4, 2026, a holder exercised pre-funded warrants to purchase 481,788 shares of common stock upon exercise of the
+Added: pre-funded warrants and received nominal cash proceeds from the exercise.
+Added: and development
+Added: and development costs declined to $1.1 million during the six months ended June 30, 2026 compared with $2.3 million during the six months
+Added: ended June 30, 2025.
+Added: During the first quarter of 2025, the Company decided to direct its focus and efforts on the development of Ampligen
+Added: for the treatment of late-stage pancreatic cancer, with the belief that this path will potentially lead to the most lucrative outcome.
+Added: As a result, the Company evaluated its patent portfolio and made a decision to reduce its annual maintenance fees and development of
+Added: patents not meeting its current core objective.
+Added: As a result, $335 thousand was charged to clinical expenses during the first quarter
+Added: of 2025 related to prior costs of developing and maintaining patents not specific to the primary focus and was a significant factor in
+Added: the variance between the quarters.
+Added: Additionally,
+Added: the Company’s Phase 2 study for pancreatic cancer was put on hold in 2025, which resulted in reduced clinical costs during the first six months of 2026 than during the same time period in 2025.
+Added: The Company has shifted its focus toward a European Pancreatic Cancer study which is funded by a grant and in
+Added: collaboration with a major pharmaceutical interest.
+Added: The Company expects to begin a pivotal phase 3 clinical trial after the final DURIPANC study results
+Added: become available and a study protocol has been finalized and the timing and amount of
+Added: clinical expenditures is dependent on recruiting patients and therefore can be difficult to project and lead to significant expense
+Added: variations between periods.
+Added: and administrative
+Added: and administrative costs for the six months ended June 30, 2026 were $675 thousand above the six months ended June 30, 2025 as a result
+Added: of increases in issuance costs together with legal and accounting fees associated with the equity transactions.
+Added: During the six months
+Added: ended June 30, 2025, the Company was receiving final billings related to a shareholder dispute which was settled during the fourth quarter
+Added: of 2024 which reduced the impact of the additional fees incurred during the current year.
+Added: expense was $599 thousand and $273 thousand for the six months ended June 30, 2026 and 2025, respectively.
+Added: The increase in interest expense
+Added: is due to additional debt.
+Added: On November 18, 2025, the Company (“Borrower”) entered into a Note Purchase Agreement with Streeterville
+Added: Capital LLC (“Streeterville” or the “Lender”).
+Added: Under the terms of the agreement, Streeterville paid the Company
+Added: $2.5 million in exchange for an unsecured promissory Note with an Original Issue Discount of $781 thousand.
+Added: The Company will pay $3.3
+Added: million consisting of the principal amount of the Note, together with the original issue discount and $20 thousand of lender transaction
+Added: fees, no later than November 18, 2027.
+Added: The stated interest rate of the note is 10%.
and Capital Resources
2 unchanged sentences
Highly liquid assets
−Removed: Three months ended March 31,
+Added: Six months ended June 30,
Cash used in operating activities
2 unchanged sentences
Net change in cash
−Removed: balances increased by $2.8 million or 94.8% during the three months ended March 31, 2026, primarily the result of ongoing financing initiatives.
−Removed: The Company raised $1.8 million from a grant of rights offering, $2.0 million from its ATM offering, and $2.2 million from warrant exercises
−Removed: during the quarter ended March 31, 2026.
−Removed: Company will continue to make efforts to raise equity in order to reach compliance with the minimum stockholder equity requirement of
−Removed: Cash used by operating activities increased during the three months ended March 31, 2026 when compared to the three months
−Removed: ended March 31, 2025 primarily due to the utilization of cash for accounts payable.
−Removed: the quarter ended March 31, 2025, the Company utilized a portion of its investments to provide cash for operations.
−Removed: During the quarter
−Removed: ended March 31, 2026, the Company utilized financing activities to provide the necessary operating funds which caused a $935 thousand
+Added: balances increased by $6.9 million or 231.7% during the six months ended June 30, 2026, primarily the result of ongoing financing
+Added: The Company raised $1.8 million from a grant of rights offering, $2.5 million from its ATM offering, and $5.7 million
+Added: from warrant exercises, $1.6 million from the rights offering and $5.3 million from registered directs net of issuance costs during
+Added: the quarter ended June 30, 2026.
+Added: used by operating activities increased during the six months ended June 30, 2026 when compared to the six months ended June 30, 2025
+Added: primarily due to the utilization of cash for accounts payable and accrued expenses as well as administrative costs associated with equity
+Added: transactions.
+Added: the six months ended June 30, 2025, the Company utilized a portion of its investments to provide cash for operations.
+Added: During the six
+Added: months ended June 30, 2026, the Company utilized financing activities to provide the necessary operating funds which caused a $1.8 million
difference in cash from investing activities when comparing the periods.
−Removed: principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide
−Removed: the necessary funding to meet our obligations as they become due.
−Removed: As of March 31, 2026, we had $5.9 million in cash, cash equivalents
−Removed: and marketable investments, inclusive of $63 thousand in marketable investments, compared to $3.0 million as of December
−Removed: Ongoing operating losses combined with limited current working capital
−Removed: raised substantial doubt regarding our ability to continue as a going concern for a period of at least one year from the date of the issuance
−Removed: of these consolidated financial statements.
−Removed: See Note 1 to our Unaudited Condensed Consolidated Financial Statements.
−Removed: accompanying unaudited consolidated financial statements have been prepared assuming that we will continue as a going concern.
−Removed: 31, 2026, our current assets exceeded our current liabilities by $69 thousand which raised
−Removed: doubt about our ability to continue as a going concern.
−Removed: Additionally, at March 31, 2026, our stockholders’ equity was below
−Removed: the minimum requirements for continued listing on the NYSE American.
−Removed: See “Potential Delisting from the NYSE American” below.
−Removed: The small working capital balance, anticipated cash needs over the next 12 months and potential delisting raised substantial doubt about
−Removed: our ability to continue as a going concern.
+Added: principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to
+Added: provide the necessary funding to meet our obligations as they become due.
+Added: As of June 30, 2026, we had $10.0 million in cash, cash
+Added: equivalents and marketable investments, inclusive of $64 thousand in marketable securities, compared with $3.0 million as of December
September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature
6 unchanged sentences
payment changed to deposit status.
−Removed: At March 31, 2026, we had a remaining deposit of $184 thousand which may be used to offset future
−Removed: clinical research expenditures.
−Removed: This deposit is listed as a non-current asset on the balance sheet but could provide working capital
−Removed: if the timing of expenditures are realized within the next 12 months.
+Added: At June 30, 2026, we had a remaining deposit of $128 thousand which may be used to offset future clinical
+Added: research expenditures.
+Added: This deposit is listed as a non-current asset on the balance sheet but could provide working capital if the timing
+Added: of expenditures are realized within the next 12 months.
April 4, 2025, trading of the Company’s common stock had been suspended by NYSE American.
−Removed: Leading up to this event, the Company and
−Removed: Streeterville (the “Lender”) were in regular communication, regarding the potential impact on the loan agreements.
−Removed: On May 13, 2025, we entered into a Forbearance Agreement with the Lender pursuant to which, for a 1% fee and expenses, the Lender
−Removed: released the Company and its affiliates from all defaults under the Agreements through the date of the Forbearance Agreement and confirmed
−Removed: that, as a result, no Default Interest was due, with no adverse effect on liquidity.
+Added: Leading up to this event, the Company
+Added: and Streeterville (the “Lender”) were in regular communication, regarding the potential impact on the loan agreements.
+Added: May 13, 2025, we entered into a Forbearance Agreement with the Lender pursuant to which, for a 1% fee and expenses, the Lender released
+Added: the Company and its affiliates from all defaults under the Agreements through the date of the Forbearance Agreement and confirmed that,
+Added: as a result, no Default Interest was due, with no adverse effect on liquidity.
March 6, 2026, we completed a rights offering (the “2026 Rights Offering”) to our stockholders and to holders of certain
11 unchanged sentences
The maturity date for the Note was extended until June
+Added: 30, 2026, and then further extended to June 30, 2027.
Other than the maturity date extension, there were no other changes to the agreement.
+Added: On May 7, 2026, the Company entered into a warrant exercise inducement offer letter agreement with holders of (i) Class A and Class B
+Added: common stock purchase warrants issued on May 31, 2024 (the “Existing May 2024 Warrants”), exercisable for up to an aggregate of
+Added: 112,820 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), (ii) Class C and Class D Common
+Added: Stock purchase warrants issued on September 30, 2024 (the “Existing September 2024 Warrants”) exercisable for up to an aggregate
+Added: of 93,060 shares of Common Stock, and (iii) Class E and Class F Common Stock purchase warrants issued on July 31, 2025 (the “Existing
+Added: July 2025 Warrants” and together with the Existing May 2024 Warrants and the Existing September 2024 Warrants, the “Existing Warrants”)
+Added: exercisable for up to an aggregate of 8,514,048 shares of Common Stock.
+Added: The Existing May 2024 Warrants had an exercise price of $36.30
+Added: per share, the Existing September 2024 Warrants had an exercise price of $28.00, and the Existing July 2025 Warrants had an exercise price
+Added: Pursuant to the Inducement Letter, the Holders agreed
+Added: to exercise the Existing Warrants for cash at a reduced exercise price of $0.48 per share in consideration of the Company’s agreement
+Added: to issue the Holders new warrants to purchase up to a number of shares of Common Stock equal to 200% of the number of shares of Common
+Added: Stock issued pursuant to such Holder’s exercise of Existing Warrants, comprised of new Class H warrants to purchase up to 17,439,856
+Added: shares of Common Stock (the “Inducement Warrants” and the shares of Common Stock underlying the Inducement Warrants, the “Inducement
+Added: Warrant Shares”) with an exercise term of 5 years from the initial exercise date.
+Added: The initial exercise date of the Inducement Warrants
+Added: is the Stockholder Approval Date, and the exercise price thereof is $0.60 per share.
+Added: On May 8, 2026, the Company completed the Inducement
+Added: Transaction and received aggregate gross proceeds of approximately $3.6 million and issued the Inducement Warrants.
+Added: Ladenburg Thalmann & Co.
+Added: acted as placement
+Added: agent in connection with the Inducement Transaction and received a cash fee of approximately $286 thousand, equal to 8.0% of the aggregate
+Added: gross proceeds, $50 thousand for expenses incurred in connection with the offering, and approximately $27 thousand, representing a management
+Added: fee equal to 0.75% of the aggregate gross proceeds.
+Added: The Company also issued to the Placement Agent warrants to purchase up to 6.0% of
+Added: the aggregate number of shares of Common Stock issued upon exercise of the Existing Warrants pursuant to the Inducement Letter.
+Added: The Placement
+Added: Agent Warrants have substantially the same terms as the Inducement Warrants, except that the Placement Agent Warrants will be exercisable
+Added: until the five-year anniversary of the date of issuance, will have an exercise price equal to 125% of the Reduced Exercise Price, and
+Added: will include piggyback registration rights that are triggered if there is not an effective registration statement covering all of the
+Added: Placement Agent Warrant Shares while the Placement Agent Warrants are outstanding.
+Added: On May 21, 2026, the Company issued and sold 7,519,351
+Added: shares of common stock, par value $0.001 per share, and, in a concurrent private placement, Class I warrants to purchase up to 15,038,702
+Added: shares of common stock to certain investors for aggregate gross proceeds of approximately $2.4 million.
+Added: On June 10, 2026, the Company issued and sold 2,554,119
+Added: shares of common stock and, in a concurrent private placement, 771,503 shares of common stock, pre-funded warrants to purchase up to 1,782,616
+Added: shares of common stock, and Class J warrants to purchase up to 10,216,476 shares of common stock to certain investors for aggregate gross
+Added: proceeds of approximately $2.6 million
a research and development company, we are conducting research necessary to bring our product, Ampligen, to market.
3 unchanged sentences
history of success in these efforts, however, there is no assurance that we will be successful in attaining the necessary funding in
−Removed: Delisting from the NYSE American
+Added: with NYSE American
December 11, 2024, we received an official notice of noncompliance with the NYSE American’s continued listing requirements
−Removed: includes the need for us to have stockholders’ equity of $6 million or more.
−Removed: The NYSE American’s review showed that we were
−Removed: not in compliance with that requirement.
−Removed: As required, we submitted a plan (the “Plan”) to the NYSE American illustrating
−Removed: how we can regain compliance by June 11, 2026.
−Removed: The Plan includes a number of ways to raise capital.
−Removed: The NYSE American accepted our Plan
−Removed: on February 26, 2025.
−Removed: If we are not able to regain compliance by June 11, 2026, our common stock may be delisted from the NYSE American.
−Removed: As of March 31, 2026, our stockholders’ equity was $2.1 million.
−Removed: We must increase our stockholders’ equity to be at least
−Removed: $6 million to regain compliance with this rule.
−Removed: If we are not able to raise sufficient capital as set forth in the Plan or by other means,
−Removed: we may be unable to regain compliance with the NYSE American’s listing standards, and our securities could be subject to delisting.
−Removed: In the event that the price of our Common Stock drops to $0.10 per share, our Common Stock will automatically be delisted from the NYSE
+Added: specifically relating to a required stockholders’ equity of $6 million or more.
+Added: The NYSE American’s review showed that
+Added: we were not in compliance with that requirement.
+Added: We submitted a plan (the “Plan”) to the NYSE American detailing actions
+Added: we would take to regain compliance by June 11, 2026.
+Added: The NYSE American accepted our Plan on February 26, 2025.
+Added: If we had been unable to regain compliance by June 11, 2026, our common stock was subject to delisting from the NYSE American.
+Added: As of June 30, 2026, our
+Added: stockholders’ equity was $7.7 million.
April 30, 2025, the Company held a special meeting of stockholders and authorized the Company’s Board of Directors to effect a
5 unchanged sentences
of any fractional shares on a post-split basis.
−Removed: June 11, 2025, the Company was notified by the NYSE American that the Company had regained compliance with Section 1003(f)(v) of the NYSE American’s
−Removed: Company Guide (low selling price) and that trading in the Company’s Common Stock was reinstated on the NYSE American on June 17, 2025.
+Added: June 11, 2025, the Company was notified by the NYSE American that the Company had regained compliance with Section 1003(f)(v) of the
+Added: NYSE American’s Company Guide (low selling price) and that trading in the Company’s Common Stock was reinstated on the NYSE
+Added: American on June 17, 2025.
+Added: the third quarter of 2025, an agreement was reached with a vendor surrounding legal fees.
+Added: The agreement provided that $3 million of previously
+Added: billed fees would be forgiven in exchange for payments totaling $1.9 million.
+Added: The reduction was included as “other income”
+Added: and accounts payable was reduced.
+Added: January 20, 2026, the Company distributed a stock dividend of one share of our common stock for every 1,000 shares of common stock issued
+Added: and outstanding as of January 9, 2026, as well as one share of common stock for every 1,000 outstanding options or 1,000 warrants that
+Added: has a right to receive stock dividends.
+Added: The distribution was effected on January 20, 2026.
+Added: This resulted in a reset of the terms of our
+Added: Class E and Class F Warrants.
+Added: Per the reset, the exercise price of these warrants dropped to $1.439, additional warrants were issued
+Added: and a provision in these warrants that resulted in the classification of these warrants as a liability rather than equity was nullified.
+Added: This resulted in a $8.7 million increase in stockholders’ equity.
+Added: On May 7, 2026, the Company entered into a warrant
+Added: exercise inducement offer letter agreement with certain holders of existing warrants, pursuant to which the holders agreed to exercise
+Added: their warrants in cash at a reduced exercise price for aggregate gross proceeds of approximately $3.6 million in consideration of the
+Added: Company’s agreement to issue new warrants upon such exercise.
+Added: On May 21, 2026, the Company issued and sold 7,519,351
+Added: shares of common stock, par value $0.001 per share, and, in a concurrent private placement, Class I warrants to purchase up to 15,038,702
+Added: shares of common stock to certain investors for aggregate gross proceeds of approximately $2.4 million.
+Added: June 10, 2026, the Company issued and sold 2,554,119 shares of common stock and, in a concurrent private placement, 771,503 shares of
+Added: common stock, pre-funded warrants to purchase up to 1,782,616 shares of common stock, and Class J warrants to purchase up to 10,216,476
+Added: shares of common stock to certain investors for aggregate gross proceeds of approximately $2.6 million.
+Added: Following the closing of these
+Added: transactions, the Company believed it currently had stockholders’ equity in excess of the $6.0 million minimum requirement.
+Added: NYSE American formally notified the Company on June 12, 2026, confirming that the Company had successfully addressed and resolved all
+Added: deficiencies related to Sections 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide.
+Added: As a result, the “below compliance”
+Added: (“.BC”) indicator was removed from the Company’s trading symbol for its common stock, and the Company was removed from
+Added: NYSE American’s list of noncompliant issuers on its website.
+Added: The Company will remain subject to NYSE American’s continued
+Added: listing monitoring procedures and remains committed to maintaining strong financial discipline and governance going forward.
are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed
9 unchanged sentences
changes and/or additional studies.
−Removed: some six years after COVID-19 first appeared, the world has a number of vaccines and therapeutics.
−Removed: Our quest to prove the antiviral activities
−Removed: of Ampligen continues.
−Removed: If Ampligen has the broad-spectrum antiviral properties that we believe that it has, it could be a very valuable
−Removed: tool in treating variants of existing viral diseases, including COVID-19, or novel ones that arise in the future.
−Removed: Unlike most developing
−Removed: therapeutics which attack the virus, Ampligen works differently.
−Removed: We believe that it activates antiviral immune system pathways that fight
−Removed: not just a particular virus or viral variant, but other similar viruses as well.
+Added: AIM is actively working to explore the potential of Ampligen as an antiviral.
+Added: We believe that Ampligen’s ability to activate antiviral
+Added: immune system pathways could make the drug an effective broad-spectrum therapeutic tool against current viruses - such as SARS-CoV-2 -
+Added: and future viruses that may emerge either as variants, or as entirely new challenges.
present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future.
14 unchanged sentences
Cash Requirements
−Removed: the next 12 months, we anticipate that our primary cash requirements will include funding ongoing clinical trials for the DURIPANC study,
+Added: the next 12 months, we anticipate that our primary cash requirements will include funding ongoing clinical trials for pancreatic cancer,
general and administrative expenses, and debt service obligations.
−Removed: As of March 31, 2026, we had approximately $5.9 million in cash, cash
+Added: As of June 30, 2026, we had approximately $10.0 million in cash, cash
equivalents, and marketable securities.
7 unchanged sentences
equity offerings, debt financing, or collaborative arrangements with strategic partners.
+Added: As of June 30, 2026,
+Added: we did not have any off-balance sheet arrangements, as defined in Item 303(b) of Regulation S-K, that have or are reasonably likely to
+Added: have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations,
+Added: liquidity, capital expenditures or capital resources that is material to investors.
Sources of Funding
−Removed: Shelf Registration Statement and At-The-Market Offering with Maxim
−Removed: April 1, 2025, the Company entered into a new EDA, with Maxim (the “Sales Agreement”) pursuant to which it may issue and
−Removed: sell up to an aggregate of $3 million of the Company’s common stock from time to time through Maxim acting as agent.
−Removed: the terms of the Sales Agreement in no event will the Company, inter alia, issue or sell through the sales agreement such number or dollar
−Removed: amount of shares of common stock that would exceed the number or dollar amount of shares of common stock permitted to be sold under Form
−Removed: S-3 (including General Instruction I.B.6 thereof, if applicable).
−Removed: For the year ended December 31, 2025, the Company sold 155,874 shares
−Removed: under the EDA for total gross proceeds of $225 thousand, which includes a 3.0% fee to Maxim of $7 thousand.
−Removed: For the three months
−Removed: ended March 31, 2026, the Company sold 2,025,292 shares under the EDA for total gross proceeds of $2.1 million, which includes a 3.0%
−Removed: fee to Maxim of $62 thousand related to this agreement.
−Removed: See Note 15 - Subsequent Events for additional information on an amendment
−Removed: to this agreement.
−Removed: to the Sales Agreement, we will pay Maxim in cash, upon each sale of the common stock pursuant to the sales agreement, a commission in
−Removed: an amount equal to 3.0% of the aggregate gross proceeds from each sale of common stock.
−Removed: Because there is no minimum offering amount required
−Removed: as a condition to this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable
−Removed: at this time.
−Removed: We have agreed, under certain circumstances, to reimburse a portion of Maxim’s expenses, including legal fees up
−Removed: to a maximum of $50 thousand, and $5 thousand on a quarterly basis thereafter.
−Removed: shares under the sales agreement will only be offered after a prospectus related to such offering is filed with the SEC.
−Removed: the shares are offered, they will be offered pursuant to a shelf registration statement on Form S-3 (File No.
−Removed: 333-286319), which was
−Removed: declared effective on July 3, 2025.
−Removed: Company entered into a warrant exercise inducement offer letter agreement, dated May 7, 2026 with holders of (i) Class A and Class B
−Removed: warrants to purchase common stock, par value $0.001 per share, issued on May 31, 2024;
−Removed: (ii) Class C and Class D Common Stock purchase
−Removed: warrants issued on September 30, 2024;
−Removed: and (iii) Class E and Class F Common Stock purchase warrants issued on July 31, 2025.
−Removed: to the Inducement Letter, the Holders agreed to exercise the Existing Warrants for cash certain of their Existing Warrants to purchase
−Removed: an aggregate of 7,451,920 shares of Common Stock at a reduced exercise price of $0.48 per share in exchange for the Company’s agreement
−Removed: to issue new Class H warrants to purchase an aggregate of up to 14,903,840 shares of Common Stock at an exercise price of $0.60 per share,
−Removed: exercisable on or after the Stockholder Approval Date (as defined in the Inducement Letter) for a period of five years.
−Removed: May 8, 2026, the Company closed the Inducement Transaction and received aggregate gross proceeds of approximately $3.6 million and issued
−Removed: the Inducement Warrants.
+Added: Equity Distribution
+Added: Company plans to enter into a new Equity Distribution Agreement in August 2026.
Quantitative and Qualitative Disclosures About Market Risk
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.