AEMD 10-K & 10-Q changes, risk factors and insider trading

We have never been profitable. We did not generate any revenue during the fiscal years ended March 31, 20252026 and March 31, 2024.2025. In prior fiscal years we did recordrecorded revenue from government contracts.contracts, Wehowever, we do not currently have any research grants or contracts. It is possible that we may not be able to enter into future government contracts. Future profitability, if any, will require the successful commercialization of our Hemopurifier technology technology or any other product that we develop or from additional government contract or grant income we may obtain. We may not be able to successfully commercialize the Hemopurifier or any other products, and even if commercialization is successful, we may never be profitable. While Although we currently have over $5.5 million inhad cash and cash equivalents andof haveapproximately been$5.5 carryingmillion outas certainof expenseMarch reductions31, since November 2023, our planned additional expense reductions may not materialize and/or our2026, patient recruitment may occur more rapidly than expected along with the concomitant increases in expenses; therefore there is substantial doubt that our cash on hand will carry the company for 12 months beyond the filing date of the financial statements included in this Annual Report.

We do planexpect to accessseek theadditional capital through equity markets forfinancings additionaland capital,other potential sources of funding; however, there can be no assurance that wesuch financing will be ableavailable toon accessacceptable suchterms, additionalin capital.sufficient amounts, or at all.

We will require significant additional additional financing for our operations and for expected additional future clinical trials in the United States, IndiaStates and Australia, regulatory clearances, and continued research and development activities for the Hemopurifier and other future products. In addition, as we expand our activities, our overhead costs to support personnel, laboratory materials and infrastructure will increase. We may also choose to raise additional funds in debt or equity financings if they are available to us on reasonable terms to increase our working capital and to strengthen our financial position. Any sale of additional equity or convertible debt securities could result in dilution of the equity interests of our existing stockholders. Additionally, new investors may require that we and certain of our stockholders enter into voting arrangements that give them additional voting control or representation on our Board of Directors. If required financing is unavailable to us on reasonable terms, or at all, we may be unable to support our operations, including our research and development activities, which would have a material adverse effect on our ability to commercialize our products or continue our business.

WeThere mayis notsubstantial doubt currently orabout inour the future be ableability to continue as a going concern.

Delays, interruptions or the cessation of production production by our third-party suppliers of important materials or delays in qualifying new materials, hashave and may continue to prevent or delay our ability to manufacture our Hemopurifier.

We received approval from the the FDA for our IDE supplement to manufacture Hemopurifiers at our site in San Diego. The manufacturing of our Hemopurifier is difficult and and complex. To support our current clinical trial needs, we comply with and intend to continue to comply with current FoodGood Manufacturing Practices, or cGMP in the manufacture of our product. Our ability to adequately manufacture and supply our Hemopurifier in a timely mattermanner is dependent on the uninterrupted and efficient operation of our facilities and those of third parties producing raw materials and supplies upon which we rely in our manufacturing. The manufacture of our products may also be impacted by:

Any future interruption in the the manufacture and supply of our Hemopurifier could delay shipments of our Hemopurifier for use in clinical trials in the United States,States and, Australia and India.Australia.

Specifically, the Hemopurifier contains three critical components with limited supplier numbers. The base cartridge on which the Hemopurifier is constructed is sourced from Medica S.p.AS.p.A. and we are dependent on the continued availability of these cartridges. We currently purchase the diatomaceous earth from Janus Scientific Inc., our distributor; however, the product is manufactured by Imerys Minerals Ltd., which is the only supplier of this product. The GNA is sourced from Vector Laboratories, Inc. andAlthough also is available from otheralternate suppliers; however,exist Sigmaregulatory Aldrich is our only potential back up supplier at this timereview and approval would be required before we arecould inutilize thea processreplacement ofsource. working with the FDA to obtain regulatory approval for this supplier. AAny business interruption at any of these sources, including the interruption resulting from the delaydelays in obtaining FDA approval of our new GNA supplier, hasqualifying and mayobtaining continueany tonecessary regulatory approvals of alternate suppliers, could have a material impact on our ability to manufacture the Hemopurifier.

Even if we are successful in in developing the Hemopurifier and obtain FDA and other regulatory approvals necessary for commercialization, our products may not compete effectively with other successful products. Researchers are continually learning more about diseases, which may lead to new technologies for treatment. Our competitors may succeed in developing and marketing products that are either more effective than those that we may develop, alone or with our collaborators, or that are marketed before any products we develop are marketed. Our competitors include fully integrated pharmaceutical companies and biotechnology companies as well as universities and public and private research institutions. Many of the organizations competing with us have substantially greater capital resources, larger research and development staffsstaff and facilities, greater experience in product development and in obtaining regulatory approvals, and greater marketing capabilities than we do. If our competitors develop more effective pharmaceutical treatments for infectious disease or cancer, or bring those treatments to market before we can commercialize the Hemopurifier for such uses, we may be unable to obtain any market traction for our products, or the diseases we seek to treat may be substantially addressed by competing treatments. If we are unable to successfully compete against larger companies in the pharmaceutical industry, we may never generate significant revenue or be profitable.

To achieve the levels of production necessary to commercialize our Hemopurifier and any other future products, we will need to secure large-scale manufacturing agreements with contract manufacturers which comply with good manufacturing practice standards and other standards prescribed by various federal, state and local regulatory agencies in the United States and any other country of use. We have limited experience coordinating and overseeing the manufacture of medical device products on a large-scale.large scale. It is possible that manufacturing and control problems will arise as we attempt to commercialize our products and that manufacturing may not be completed in a timely manner or at a commercially reasonable cost. In addition, we may not be able to adequately finance the manufacture and distribution of our products on terms acceptable to us, if at all. If we cannot successfully oversee and finance the manufacture of our products if they obtain regulatory clearances, we may never generate revenue from product sales and we may never be profitable.

Our Hemopurifier product may be be made unmarketable prior to commercialization by us by new scientific or technological developments by others with new treatment modalities that are more efficacious and/or more economical than our products. TheCompanies homelandare securitydeveloping industrya iswide growingrange rapidlyof therapies, medical devices, immunotherapies, biologics, blood purification technologies and other treatment approaches that may compete with manythe competitorsHemopurifier for thatthe arepatient tryingpopulations and disease indications we seek to developaddress. products or vaccines to protect against infectious disease. Any oneAnyone of our competitors could develop a more effective product which would render our technology obsolete. Further, our ability to achieve significantcommercial and sustained penetrationacceptance of our keythe targetHemopurifier markets will dependdepends upon our success in developing or acquiring technologies developed by other companies, either independently, through joint ventures or through acquisitions. If we fail to develop or acquire, and manufacture and sell, products that satisfy our customers’ demands, or we fail to respond effectively to new product announcements by our competitors by quickly introducing competitive products, then market acceptance of our products could be reduced and our business could be adversely affected. Our products may not remain competitive with products based on new technologies.

We have 9 full-time employees. We utilize, whenever appropriate, consultants in order to conserve cash and resources. Although we believe that these employees and and consultants will be able to handle most of our additional administrative, research and development and business development in the near near term, we will nevertheless be required over the longer-term to hire highly skilled managerial, scientific and administrative personnel to fully implement our business plan and growth strategies. Due to the specialized scientific nature of our business, we are highly dependent upon our ability to attract and retain qualified scientific, technical and managerial personnel. Competition for these individuals, especially in San Diego, California, where many biotechnology companies are located, is intense and we may not be able to attract, assimilate or retain additional highly qualified personnel in the future. We may not be able to engage the services of qualified personnel at competitive prices or at all, particularly given the risks of employment attributable to our limited financial resources and lack of an established track record. Also, if we are required to attract personnel from other parts of the U.S. or abroad, we may have significant difficulty doing so due to the high cost of living in the Southern California area and due to the costs incurred with transferring personnel to the the area. If we cannot attract and retain qualified staffpersonnel, our product development, clinical development and executives,regulatory we willactivities could be unabledelayed toor developadversely affected, which could materially harm our productsbusiness, financial condition and achieveresults regulatory clearance,of and our business could fail.operations.

We will need to significantly expand our operations to implement our longer-term business plan and growth strategies. We will also be required to manage multiple relationships with various strategic partners, technology licensors, customers, manufacturers and suppliers, consultants and other third parties. This expansion and these expanded relationships will require us to significantly improve or replace our existing managerial, operational and financial systems, procedures and controls; to improve the coordination between our various corporate functions; and to manage, train, motivate and maintain a growing employee base. The time and costs to effectuate these steps may place a significant strain on our management personnel, systems and resources, particularly given the limited amount of financial resources and skilled employees that may be available at the time. We may not be able to institute, in a timely manner or at all, the improvements to our managerial, operational and financial systems, procedures and controls necessary to support our anticipated increased levels of operations and to coordinate our various corporate functions, or that we may not be able to properly manage, train, motivate and retain our anticipated increased employee base. If we cannot manage our growth initiatives, including our expansion of our clinical trials in IndiaAustralia and potentially in other countries, we will be be unable to commercialize our products on a large-scale in a timely manner, if at all, and our business could fail.

The directors and management of publicly traded corporations are increasingly concerned with the extent of their personal exposure to lawsuits and stockholder claims, as well as governmental and creditor claims which may be made against them, particularly in view of recent changes inevolving securities lawslaws, corporate imposinggovernance additional duties, obligationsrequirements and liabilities on management and directors.regulatory. Due to these perceived risks, directors and management are also becoming increasingly concerned with the availability of directors’ and officers’ liability insurance to pay on a timely basis the costs incurred in defending such claims. While we currently carry directors’ and officers’ liability insurance, such insurance is expensive and could be difficult to maintain in the future. If we are unable to continue or provide directors’ and officers’ liability insurance at affordable rates or at all, it may become increasingly more difficult to attract and retain qualified outside directors to serve on our Board of Directors. We may lose potential independent board members and management candidates to other companies in the biotechnology field that have greater directors’ and officers’ liability insurance to insure them from liability or to biotechnology companies that have revenues or have received greater funding to date which can offer greater compensation packages. The fees of directors are also rising in response to their increased duties, obligations and liabilities. In addition, our products could potentially be harmful to users, and we are exposed to claims of product liability including for injury or death. We have limited insurance and may not be able to afford robust coverage even as our products are introduced into the market. As a company with limited resources and potential exposures to management, we will have a more difficult time attracting and retaining management and outsideindependent independent directors than a more established public or private company due to these enhanced duties, obligations and potential liabilities.

Our business prospects depend on our ability to complete studies, commence and complete our planned clinical trials, including our ongoing andclinical plannedtrial studiesevaluating the Hemopurifier in patients with solid tumors inand cancer,any future clinical studies obtain satisfactory results, obtain required regulatory approvals and successfully commercialize our Hemopurifier product candidate. Completion of our clinical trials, announcement of results of the trials and our ability to obtain regulatory approvals could be delayed for a variety of reasons, including:

Any product for which we obtain clearance or approval, if any, and the manufacturing processes, reporting requirements, post-approval clinical data and promotional activities for such product, will be subject to continued regulatory review, oversight and periodic inspections by the FDA and other domestic and foreign regulatory bodies. In particular, we and our third-party suppliers may be required to comply with the FDA’s Quality Management System Regulation, or QSR.QMSR, which incorporates by reference ISO 13485:2016 and establishes quality management system requirements for medical device manufacturers. These FDArequirements regulations covergovern the methods and documentation of the design, testing, production, control, quality assurance, assurance, labeling, packaging, sterilization, storage and shipping of our products. Compliance with applicable regulatory requirements is subject to continual review and is monitored rigorously through periodic inspections by the FDA. If we, or our manufacturers, fail to adhere to QSR applicable quality system requirements in the United States, this could delay production of our products and lead to fines, difficulties in obtaining regulatory clearances, recalls, enforcement actions, including injunctive relief or consent decrees, or other consequences, which could, in turn, have a material adverse effect on our financial condition or results of operations.

In addition, the FDA assesses compliance with the QSRQMSR through periodic announced and unannounced inspections of manufacturing and other facilities. The failure by us us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in any of the following enforcement actions:

Any of these sanctions could have have a material adverse effect on our reputation, business, results of operations and financial condition. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements, which could result in our failure to produce our products on a timely basis and in the required quantities, if at all.

Under the FDA medical device reporting reporting regulations, medical device manufacturers are required to report to the FDA information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction of the device or one of our similar devices were to recur. If we fail to report these events to the FDA within the required timeframes, or at all, the FDA could take enforcement action against us. Any such adverse event involving our products also could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require thededication dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results.

If we or our manufacturers or or other third-party contractors fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to regulatory regulatory actions, which could affect our ability to successfully develop, market and sell our Hemopurifier product candidate or any future product candidates, if any, and could harm our reputation and lead to reduced or non-acceptance of our proposed product candidates by the market. Even technical recommendations or evidence by the FDA through letters, site visits, and overall recommendations to academia or biotechnology companies may make the manufacturing of a clinical product extremely labor intensive or expensive, making the product candidate no longer viable to manufacture in a cost-efficient manner. The modeclinical and operational requirements associated with administration of administrationthe Hemopurifier may makelimit thephysician productadoption, candidatepatient notacceptance commercially viable.or commercial viability. The required testing of the product candidate may make that candidate no longer commercially viable. The conduct of clinical trials trials, particularly those involving infectious agents, may be critiqued by the FDA, or a clinical trial site’s IRBIRB, orbiosafety Institutionalcommittees Biosafetyother Committee,oversight bodies, which may delay or make impossible clinical clinical testing of a product candidate. The IRB for a clinical trial may stop a trial or deem a product candidate unsafe to continue testing. testing. This would have a material adverse effect on the value of the product candidate and our business prospects.

We have not received, and may never receive, regulatory approval from the FDA to market athe medical deviceHemopurifier in the United States.States, Australia or other jurisdictions.

Before a new medical device can can be marketed in the United States, it must first receive a PMA or 510(k) clearance from the FDA, unless an exemption applies. A PMA submission, submission, which is a higher standard than a 510(k) clearance, is used to demonstrate to the FDA that a new or modified device is safe and effective. The 510(k) is used to demonstrate that a device is “substantially equivalent” to a predicate device, that is, one that has been cleared by the FDA. We expect that any product we seek regulatory approval for, including the Hemopurifier, will require a PMA. The FDA approval process involves, among other things, successfully completing clinical trials and filing for and obtaining a PMA. In addition, our clinical development activities in Australia are subject to oversight by the Therapeutic Goods Administration (“TGA”) and applicable ethics review bodies, and we may seek future regulatory approvals in Australia and other foreign jurisdictions. Regulatory authorities outside the United States may impose different requirements, standards and review processes than those imposed by the FDA and obtaining regulatory approval in one jurisdiction does not guarantee approval in another jurisdiction. The PMA process requires us to prove the safety and effectiveness of our products to the FDA’s satisfaction. This process, which includes preclinical studies and clinical trials, can take many years and requires the expenditure of substantial resources and may include post-marketing surveillance to establish the safety and efficacy of the product. Notwithstanding the effort and expense incurred, the process may never result in the FDA granting a PMA. Data obtained from preclinical studies and clinical trials are subject to varying interpretations that could delay, limit or prevent regulatory approval. Delays or rejections may also be encountered based upon changes in governmental policies for medical devices during the period of product development. The FDA can delay, limit or deny approval of a PMA application for many reasons, including:

Modifications to products that that are approved through a PMA application generally need FDA approval. Similarly, some modifications made to products cleared through a 510(k) may require a new 510(k). The FDA’s 510(k) clearance process usually takes from three to 12 months,months but may last longer. The process of obtaining a PMA is much costlier and more uncertain than the 510(k) clearance process and generally takes from one to three years, years, or even longer, from the time the application is submitted to the FDA until an approval is obtained. Any of our products considered to to be a class III device, which are considered to pose the greatest risk and the approval of which is governed by the strictest guidelines, will require the submission and approval of a PMA in order for us to market it in the United States. We also may design new products in the future that could require the clearance of a 510(k).

We are advancing product candidates under governmental policies that regulate the development and commercialization of medical treatment countermeasures against bioterror and pandemic threats. While we intend to pursue FDA market clearance to treat infectious bioterror and pandemic threats, it is often not feasible to conduct human studies against these deadly high threat pathogens. For example, the Hemopurifier is an investigational device that has not yet received FDA approval for any indication. We continue to investigate the potential for the use of the Hemopurifier in viral diseases under an open IDE and our FDA Breakthrough Designation for “…the treatment of life-threatening glycosylated viruses that are not addressed with an approved therapy.” We currently have an open FDA approved Expanded Access Protocol for the treatment of Ebola infected patients in the United States and a corresponding HealthCanadaHealth Canada approval in Canada. Based on our studies to date, we believe the Hemopurifier can potentially clear many viruses that are pathogenic in humans, including HCV, HIV, Monkeypox and Ebola.

Any research and development, pre-clinical testing and clinical trial activities involving our Hemopurifier and any additional products that we may develop are subject to extensive regulation and review by numerous governmental authorities both in the United States and abroad. Clinical studies must be conducted in compliance with FDA regulationsregulations, or the FDA may take enforcement action. The data collected from these clinical studies may may ultimately be used to support market clearance for these products. Even if our clinical trials are completed as planned, the results of of these trials may not support our product candidate claims and the FDA may not agree with our conclusions regarding the trial results. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and the later trials may not replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product candidate and may delay development of others. Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, our ability to commercialize our product candidates and generate revenues. It is also possible that patients enrolled in clinical clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

U.S. legislative or FDA or TGA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA and TGA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of future products. It is impossible to predict whether legislative changes will be enacted or FDA or TGA regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be on our product development efforts.

In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example, the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information.

In the ordinary course of our our business, we and third parties with whom we work may process proprietary, confidential and sensitive information, including personal data, data, intellectual property, trade secrets, and proprietary business information owned or controlled by ourselves or other third parties, or or collectively, Sensitive Information. We may use and share Sensitive Information with service providers and subprocessorssub processors and other third third parties with whom we work to help us operate our business. If we or such third parties with who we work have experienced, or in the future experience, any security incident(s) that result in any data loss; deletion or destruction; unauthorized access to; loss, unauthorized acquisition, disclosure, or exposure of, Sensitive Information, or other compromise related to the security, confidentiality, integrity of our, or their, information technology, software, services, communications or data, or collection, a Security Breach, it may result in an adverse impact on our business.

While we have implemented security security measures designed to protect against Security Breaches, these measures may not be effective. We take steps designed to detect, mitigate, mitigate, and remediate vulnerabilities in our information technology systems, including our products, hardware and/or software, including that that of third parties upon which we rely. We may not, however, detect or remediate all such vulnerabilities including on a timely basis. Further, Further, we may experience delays in developing and deploying remedial measures and patchedpatches designed to address any such identified vulnerabilities. Vulnerabilities could be exploited and result in a security incident.

Healthcare costs have risen significantly significantly over the past decade, and there have been and continue to be proposals by legislators, regulators and third-party payors to decreasecontrol costs.healthcare spending. Third-partyGovernment and third-party payors are increasingly challengingseek theto pricescontain chargedhealthcare forcosts medicalby productslimiting coverage, reducing reimbursement rates and servicesimplementing andother instituting cost containment measures tothat controlmay or significantly influenceaffect the purchaseadoption of new medical products and services.technologies.

Legislation could be adopted in in the future that limits payments for our products from governmental payors. In addition, commercial payors such as insurance companies,companies could adopt similar policies that limit reimbursement for medical device manufacturers’ products. Therefore, it is possible that our product or the procedures or patient care performed using our product will not be reimbursed at a cost-effective level. We face similar risks relating to adverse changes in reimbursement procedures and policies in other countries where we may market our products. Reimbursement and healthcare payment systems vary significantly among international markets. Our inability to obtain international reimbursement approval, or any adverse changes in the reimbursement policies of foreign payors, could negatively affect our ability to sell our products and have a material adverse effect on our business and financial condition.

We currently carry a limited amount of insurance to protect us from bodily injury or property damages arising from hazardous materials. Our product liability policy has a $5,000,000 limit of liability. For our facilities, our property policy provides $25,000 in coverage for contaminant clean-up or removal and $100,000 in coverage for damages to the premises resulting from contamination. Should we violate any regulations concerning the handling or use of hazardous materials,materials or should any injuries or death result from our use or handling of hazardous materials, we could be the subject of substantial lawsuits by governmental agencies or individuals. We may not have adequate insurance to cover all or any of such claims, if any. If we were responsible to pay significant damages for violations or injuries, if any, we might be forced to cease operations since such payments could deplete our available resources.

We are a medical therapeutic company company focused on developing the Hemopurifier® (HP), a clinical-stage immunotherapeutic device intendeddesigned forto applicationsaddress unmet needs in cancer,oncology, life-threatening viralinfectious infections, anddiseases, organ transplantation and other areasdisease ofstates significantin unmet needs. In human studies (164 sessions with 38 patients), the Hemopurifier was used safely and demonstrated the potential to remove enveloped viruses. In pre-clinical studies, the Hemopurifier has exhibited the capacity to remove harmfulwhich extracellular vesicles (EVs) contribute to disease progression. The Hemopurifier utilizes a proprietary lectin-based technology to bind and remove enveloped viruses and EVs from biological fluids, utilizingfluids. its proprietary lectin-based mechanism. These extracellular vesiclesEVs have been implicatedassociated with immune suppression, metastasis, and resistance to therapy in disease processes such as immune suppression and metastasis in cancercancer, as well as in the progression of severe life-threatening infectious diseases. In pre-clinical studies, the Hemopurifier has also demonstrated the ability to bind disease-associated extracellular vesicles (“EVs”) and a panel of enveloped viruses. The Hemopurifier has been evaluated in human studies, involving 173 treatment sessions in 44 patients with either viral infections or cancer. The device has been well tolerated with an adverse event profile that is consistent with extracorporeal therapy. In certain human studies designed to evaluate viral clearance from biological fluids, findings demonstrated the removal of enveloped viruses. The U.S. Food and Drug Administration (“FDA”) has designated granted the Hemopurifier as a “Breakthrough Device” designation for two independent indications:

We believe that the Hemopurifier may may be a substantial advancement in thepotential treatment offor patients with advanced and metastatic cancer through its designability to bind to and remove harmful remove harmful extracellular vesicles (“EVs”) particles that may promote thetumor growth and spread of tumors.metastasis. In October 2022, we formed a wholly-owned subsidiary in Australia to initially conduct oncology-related clinical research,research thenand seekpursue regulatory approval and commercializecommercialization ouropportunities for the Hemopurifier in Australia.

We previously completed an in vitro vitro binding study of extracellular vesicles fromutilizing cancer patient samples, to provideevaluate the Hemopurifier’s ability to remove EVs from plasma. Results from this translational study provided pre-clinical evidence tosupporting support our trialthe design and translational endpoints. Our study indicated positive results from this study, providing evidence that our Hemopurifier removes extracellular vesicles, or EVs, from plasma. This translational study provides pre-clinical evidence to support our phase 1 safety, feasibility and dose-finding clinical trials of our Hemopurifieroncology inclinical trial involving patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab).

We haveare launchedcurrently inconducting an Australiaa safety, feasibility and dose-finding clinical trialstrial ofin Australia evaluating the Hemopurifier in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab).treatment. The trial is designed to enroll approximately 9 to 18 participants. The primary endpoint of the approximately nine to 18-patients,trial is safety.safety, Exploratorywhile exploratory analyses will be conducted to explore the number of HP treatments required to produce sustained reductions of EVs as well as improve anti-tumor T cell activity. We plan to open a similarly designed trial in India.

We also believe that the Hemopurifier may can be partapplicable ofin the broad-spectrum treatment of life-threatening viral infections involving highly glycosylated, or carbohydrate coated, viruses thatfor which are not addressed with an alreadyno approved treatment.therapies exist. In small-scale or early feasibility human studies,studies conducted under FDA and international regulatory frameworks, the Hemopurifier has been used in the past to treat individuals infected with Ebola, human immunodeficiency virus, or HIV, hepatitis-C and Ebola.hepatitis-C and SARS-CoV-2.

Additionally,In invitro vitro,studies have demonstrated the ability of the Hemopurifier has been demonstrated to capture multiple enveloped viruses, including Ebola, Marburg virus, Zika, Lassa, MERS-CoV, Cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile, H1N1 swine flu, H5N1 bird flu, and the reconstructed 1918 Spanish flu virus. In several cases, these studies were conducted in collaboration with leading government or non-government research institutes.

The Hemopurifier has previously been studied under FDA and international regulatory frameworks for the treatment of severe SARS-CoV-2 infection. While we terminated our U.S. and India-based COVID-19 studies due to low ICU patient volume and shifting priorities, these programs demonstrated provided clinical experience real-world use ofwith the Hemopurifier in critically ill patients. We continue to maintain an open IDE for viral indicationsindications, preserving the ability to evaluate the Hemopurifier in response to preserve optionality for future outbreaks or emergent pathogens.

We have sufficient inventory of of Hemopurifiers to support our ongoing oncology trial in Australia as well as any near-term expansion of that study or potential trial activity in India.study. While we have received FDA approval to begin manufacturing at our San Diego facility under our IDE supplement, we are still awaiting FDA approval of a separate supplement to qualify an additional supplier of a key Hemopurifier component. We continue to work with the FDA on this process.

On May 12, 2025, the results of our pre-clinical ex vivo study entitled “Ex Vivo Removal of CD41 positive platelet microparticles from Plasma by a Medical Device containing a Galanthus nivalis agglutinin (GNA) affinity resin” were published in the pre-print vehicle bioRxiv. This manuscript has been submitted to a peer-reviewed publication for review.

Platelet -derivedPlatelet-derived extracellular vesicles (PD-EVs) are the most numerous EV population in the body and are released by platelets in response to a variety of stimuli. The cargo contained within these EVs have been noted to take part in damage to blood vessels, activation of immune cells and spread of tumor cells. Excessive levels of PD-EVs have been implicated in a myriad of diseases including cancer, lupus, systemic sclerosis, multiple sclerosis, Alzheimer’s disease, sepsis, acute COVID-19 and Long COVID.

We hypothesized that the Aethlon Hemopurifier which contains a propriety GNA affinity resin would remove platelet derived EVs from plasma. In this experiment two hundred milliliters onstudy, donated healthy human plasma werewas circulated overthrough the Aethlon HemoupurifierHemopurifier (HP) to simulate a clinical HP session. The study resultsdemonstrated showed aapproximately 98.5% removal of platelet -derivedplatelet-derived EVs at a timepoint equivalent to a 4-hourfour-hour HP treatment. The We believe the results of this study support the currentongoing Australian oncology Clinicalclinical Trialtrial inand Oncologymay as well as open thesupport investigation of the Hemopurifier in manyadditional disease indications.

Successful clinical development outcomesand ofregulatory human trialsapprovals will also be required bybefore the regulatoryHemopurifier agenciesmay ofbe certainmarketed in the United States or foreign countries where we plan to market and sell the Hemopurifier.jurisdictions. Some of our patents may expire before FDAregulatory approval or approval in a foreign country, if any, is obtained.obtained; However,however, we believethe Company believes that certainits existing patent portfolio and more recently issued patents and patent applications and/orwill other patents issuedcontinue to ussupport moreprotection recently will help protectof the proprietary nature of our Hemopurifier Hemopurifier treatment technology.

Consolidated operating expenses were $9,341,364$7,293,632 for the fiscal year ended March 31, 2026, compared to $9,341,365 for the fiscal year ended March 31, 2025, compareda todecrease of $12,636,568$2,047,733. The decrease for the fiscal year ended March 31, 2024, a decrease of $3,295,203. The $3,295,203 decrease in the fiscal year ended March 31, 20252026 was dueprimarily attributable to a decrease inlower payroll and related expenses of $1,086,087, $1,332,359, a decrease of $1,302,834 inlower professional fees of $414,910 and a decrease of $660,010 inlower general and administrative expenses.expenses of $546,736.

Payroll and related expenses decreased decreased by $1,332,359$1,086,087 for the fiscal year ended March 31, 2025,2026, compared to the prior year. The decrease was primarily driven by a $876,511$949,401 reduction in salaries and related expenses and a $804,136$136,686 decrease in stock-based compensation. The reduction in salary expense primarily reflects that thefiscal termination ofyear three2025 included partial-year salary and severance expense associated with two executives—one in the prior year, oneterminated in July 2024,2024 and oneOctober 2024, inrespectively, October 2024—as well as costs associated with non-executive employees affected by a workforce reduction of non-executive employees implemented in August 2024.2024, whereas Thesuch decreasecosts were not incurred in stock-based compensation was primarily due to the absence of accelerated vesting charges recognized in the priorfiscal year in connection with the termination of our former Chief Executive Officer, as well as lower stock-based compensation expense associated with the departure of executives and non-executive staff. The overall decrease was partially offset by an increase of $348,287 in severance expenses mostly related to the termination of two former executives.2026.

During the fiscal year ended March March 31, 20252026, we raised capital through a warrant inducement offeroffer, a PIPE financing and a publicregistered direct offering. In theaddition, during fiscal year ended March 31, 20242026, we raised moneyfiled througha registration statement on Form S-3 and amended our then existing At The Market Offering Agreement, or the 2022 ATM Agreement, with H.C. Wainwright & Co., LLC, orLLC. Wainwright.No sales were made under the ATM Agreement during fiscal year 2026. In October 2024, the S-3 registration statement underlying our Atprior TheATM Marketprogram Offering Agreement expiredexpired, and no additional sales could be made thereunder until the ATMnew wasregistration cancelled.statement on Form S-3 became effective.

We expect our clinical trial expenses expensesrelated forto the plannedour oncology trialsstudies in Australia and India to increasecontinue for the foreseeable future. WhileThese these increases areexpenses primarily related relate to trial activities,activities and manufacturing of additional Hemopurifiers may also be manufactured to support the studies.

In addition, we have entered intomaintain leases for our headquarters, laboratory and manufacturing facilities. We expectare ourcurrently rentevaluating paymentscertain tolease arrangements as we continue to assess increaseour foroperational the foreseeableand future.facility requirements.

THREE MONTHS ENDED DECEMBERJUNE 31,30, 20252026 COMPARED TO THE THREE MONTHS ENDED DECEMBERJUNE 31,30, 20242025

Consolidated operating expenses for the three months ended DecemberJune 31,30, 20252026 were approximately $2,062,000$1,579,202 compared to $1,815,000$1,792,390 for the three months ended DecemberJune 31,30, 2024.2025. This increase decrease of $247,000, $213,189, or 13.6%,11.9%, inprimarily thereflected 2025lower periodprofessional wasfees due to an increase of approximately $367,000 in payroll, which was partially offset by a $75,000 decrease inand general and administrative expenses and $44,835 decrease in professional fees.expenses.

OtherWe income,recorded primarilyother interestincome income,of totaled$31,290 for the three $43,871months ended June 30, 2026 compared to other income of $30,532 for the three months ended DecemberJune 31,30, 20252025. andOther $59,964income forin theboth threeperiods was monthsprimarily ended December 31, 2024 and is presented net of interest expense.income.

As a result of the changes in expensesfactors noted above, our net loss increaseddecreased to approximately $2,018,000$1,547,912 in the three months ended DecemberJune 31,30, 20252026 from approximately $1,755,000$1,761,858 in the three months ended DecemberJune 31,30, 2024.2025.

Basic and diluted loss attributable to common stockholders was ($2.45$4.05) for the three months ended DecemberJune 31,30, 2025,2026, compared to ($10.05$4.24) for the three-month period ended December 31,June 2024.30, 2025.

As of DecemberJune 31,30, 2025,2026, we had a cash balance of of $6,956,397$4,933,579 and working capital of $5,884,382.$4,574,872. This compares to a cash balance of $5,501,261$5,026,458 and working capital of $4,050,514$4,122,702 at March 31, 2025.2026.

We dobelieve not expectthat our existingcash and cash equivalents as of DecemberJune 30, 2026, together with the proceeds received from sales of our common stock under our S-1 registration statement ATM program 31, 2025,subsequent to June 30, 2026, will be sufficient to fund our planned operations for at least twelve months from the issuance date of these condensed consolidated financial statements.statements are issued.

In addition, we have entered intomaintain leases for our headquarters, laboratory and manufacturing facilities.facilities, all of which expire in March 2027. We expectare evaluating our rentfuture paymentsfacility requirements, including whether to renew or modify certain lease arrangements as we continue to increaseassess forour theoperational foreseeable future.needs.

There have been no changes to ourOur critical accounting policies and estimates are as discloseddescribed in our Annual Report on Form 10-K for the fiscal year ended March 31, 2025.2026. There have been no material changes to those critical accounting policies and estimates during the three months ended June 30, 2026.