Item 1. Business
ITEM 1. BUSINESS
Unless otherwise indicated
or the context otherwise requires, references to the “Company”, “Aethlon”, “we”, “us”
and “our” refer to Aethlon Medical, Inc.
Overview and Corporate History
Aethlon Medical, Inc., or
Aethlon, the Company, we or us, is a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious
diseases. The Aethlon Hemopurifier is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections.
In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression,
seed the spread of metastasis and inhibit the benefit of leading cancer therapies. The U.S. Food and Drug Administration, or FDA, has
designated the Hemopurifier as a “Breakthrough Device” for two independent indications:
· the treatment
of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with
cancer types in which exosomes have been shown to participate in the development or severity of the disease; and
· the treatment
of life-threatening viruses that are not addressed with approved therapies.
We believe the Hemopurifier
can be a substantial advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote
the growth and spread of tumors through multiple mechanisms. We are currently working with our new contract research organization, or
CRO, on preparations to conduct a clinical trial in Australia in patients with solid tumors, including head and neck cancer, gastrointestinal
cancers and other cancers.
On October 4, 2019, the FDA
approved our Investigational Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS, of the Hemopurifier
in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda). The primary endpoint for the EFS,
designed to enroll 10 to 12 subjects at a single center, is safety, with secondary endpoints including measures of exosome clearance and
characterization, as well as response and survival rates. This clinical trial, initially conducted at the UPMC Hillman Cancer Center in
Pittsburgh, PA, or UPMC, treated two patients. Due to lack of further patient enrollment, we and UPMC terminated this trial.
In January 2023, we entered
into an agreement with North American Science Associates, LLC, or NAMSA, a world leading MedTech CRO offering global end-to-end development
services, to oversee our clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement, NAMSA will
manage our clinical trials of the Hemopurifier for patients in the United States and Australia with various types of cancer tumors. We
anticipate that the initial clinical trials will begin in Australia.
We also believe the Hemopurifier
can be part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed
with an already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat
individuals infected with human immunodeficiency virus, or HIV, hepatitis-C and Ebola.
1
Additionally, in vitro, the
Hemopurifier has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus,
Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, Monkeypox virus
and the reconstructed Spanish flu virus of 1918. In several cases, these studies were conducted in collaboration with leading government
or non-government research institutes.
On June 17, 2020, the FDA
approved a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with
SARS-CoV-2/COVID-19, or COVID-19, in a New Feasibility Study. That study was designed to enroll up to 40 subjects at up to 20 centers
in the United States. Subjects had to have an established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or
ICU, and have acute lung injury and/or severe or life-threatening disease, among other criteria. Endpoints for this study, in addition
to safety, included reduction in circulating virus as well as clinical outcomes (NCT # 04595903). In June 2022, the first patient in this
study was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to lack of COVID-19 patients in the ICUs of our
trial sites, we terminated this study in 2022.
Under Single Patient Emergency
Use regulations, the Company has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated
with our Hemopurifier in our COVID-19 clinical trial discussed above.
We currently are experiencing
a disruption in our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September 30, 2022, and as previously disclosed,
we are dependent on FDA approval of qualified suppliers to manufacture our Hemopurifier. Our intended transition to a new supplier for
galanthus nivalis agglutinin, or GNA, a component of our Hemopurifier, is delayed as we work with the FDA for approval of our supplement
to our IDE, which is required to make this manufacturing change.
In October 2022, we launched
a wholly owned subsidiary in Australia, formed to conduct clinical research, seek regulatory approval and commercialize our Hemopurifier
in that country. The subsidiary will initially focus on oncology trials in Australia.
We also obtained Ethics Review
Board, or ERB, approval and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi
NCR, India, for a COVID-19 clinical trial at that location. One patient has completed participation in the Indian COVID-19 study. The
relevant authorities in India have accepted the use of the Hemopurifiers made with the GNA from our new supplier.
In May 2023, we also received
ERB approval from the Maulana Azad Medical College, or MAMC, for a second site for our clinical trial in India to treat severe COVID-19.
MAMC was established in 1958 and is located in New Delhi, India. MMAC is affiliated with the University of Delhi and is operated by the
Delhi government.
We also recently announced
that we also have begun investigating the use of our Hemopurifier in the organ transplant setting. Our objective is to confirm that the
Hemopurifier, in our translational studies, when incorporated into a machine perfusion organ preservation circuit, can remove harmful
viruses and exosomes from harvested organs. We have previously demonstrated the removal of multiple viruses and exosomes from buffer solutions,
in vitro, utilizing a scaled-down version of our Hemopurifier. This process potentially may reduce complications following transplantation
of the harvested organ, which can include viral infection, delayed graft function and rejection. We believe this new approach could be
additive to existing technologies that currently are in place to increase the number of viable organs for transplant.
2
Previously, we were the majority
owner of Exosome Sciences, Inc., or ESI, a company formed to focus on the discovery of exosomal biomarkers to diagnose and monitor life-threatening
diseases, and thus consolidated ESI in our consolidated financial statements. For more than four years, the primary activities of ESI
were limited to the payment of patent maintenance fees and applications. In September 2022, the Board of Directors of ESI and we, as the
majority stockholder of ESI, approved the dissolution of ESI.
Successful outcomes of human
trials will also be required by the regulatory agencies of certain foreign countries where we plan to market and sell the Hemopurifier.
Some of our patents may expire before FDA approval or approval in a foreign country, if any, is obtained. However, we believe that certain
patent applications and/or other patents issued more recently will help protect the proprietary nature of the Hemopurifier treatment technology.
In addition to the foregoing,
we are monitoring closely the impact of inflation, recent bank failures and the war in Ukraine on our business. Given the level of uncertainty
regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines
and future access to capital. The full extent to which inflation, recent bank failures and the war in Ukraine will impact our business,
results of operations, financial condition, clinical trials and preclinical research will depend on future developments, as well as the
economic impact on national and international markets that are highly uncertain.
We incorporated in Nevada
on March 10, 1999. Our executive offices are located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121. Our telephone
number is (619) 941-0360. Our website address is www.aethlonmedical.com.
The Mechanism of the Hemopurifier
The Hemopurifier is an affinity
hemofiltration device designed for the single-use removal of exosomes and life-threatening viruses from the human circulatory system.
In the United States, the Hemopurifier is classified as a combination product whose regulatory jurisdiction is the Center for Devices
and Radiological Health, or CDRH, the branch of FDA responsible for the premarket approval of all medical devices.
In our current applications,
our Hemopurifier can be used on the established infrastructure of continuous renal replacement therapy, or CRRT, and dialysis instruments
located in hospitals and clinics worldwide. It could also potentially be developed as part of a proprietary closed system with its own
pump and tubing set, negating the requirement for dialysis infrastructure. Incorporated within the Hemopurifier is a protein called a
lectin, that aids in binding exosomes and viruses.
The Hemopurifier - Clinical Trials In Viral Infections
The initial development of
the Hemopurifier was focused on viral infections. In non-clinical bench experiments using a laboratory version of the Hemopurifier, performed
in Company labs as well as in multiple other outside labs, including the Centers for Disease Control, or CDC, the United States Army Medical
Research Institute of Infectious Diseases, or USAMRIID, Battelle Memorial Research Institute and others, we have demonstrated that a miniature
version of the Hemopurifier can bind and clear multiple different glycosylated viruses. These viruses include HIV, HCV, Dengue, West Nile,
multiple strains of influenza, Ebola, Chikungunya, smallpox, monkeypox, multiple herpes viruses, a MERS-CoV related pseudovirus and others.
Initial clinical trials on
the Hemopurifier were conducted overseas on dialysis patients with HCV, with a subsequent EFS conducted in the United States under an
FDA approved IDE.
On March 13, 2017, we concluded
an FDA-approved EFS under an IDE in end stage renal disease patients on dialysis who were infected with HCV. The study was conducted at
DaVita MedCenter Dialysis in Houston, Texas. We reported that there were no device-related adverse events in enrolled subjects who met
the study inclusion-exclusion criteria. We also reported that an average capture of 154 million copies of HCV (in International Units,
I.U.) within the Hemopurifier during four-hour treatments. Prior to this approval, we collected supporting Hemopurifier data through investigational
human studies conducted overseas.
3
SARS-CoV-2/COVID-19
SARS-COV-2, the causative
agent of COVID-19 is a member of the coronavirus family, which includes the original SARS virus, SARS-CoV, and the MERS virus. SARS-CoV-2,
like all coronaviruses, is glycosylated. This suggests that the Hemopurifier could potentially clear it from biologic fluids, including
blood.
On June 17, 2020, the FDA
approved a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with
SARS-CoV-2/COVID-19 in a New Feasibility Study. That study was designed to enroll up to 40 subjects
at up to 20 centers in the United States. Subjects had to have an established laboratory diagnosis of COVID-19, be admitted to an ICU,
and have acute lung injury and/or severe or life threatening disease, among other criteria. Endpoints for this study, in addition to safety,
include reduction in circulating virus, as well as clinical outcomes (NCT # 04595903). In June 2022, the Company completed the treatment
protocol for its first patient in this study.
In
September 2021, we entered into an agreement with a leading global CRO to oversee our U.S. clinical studies investigating the Hemopurifier
for critically ill COVID-19 patients. Due to lack of COVID-19 patients in the ICUs of our trial sites, we terminated this study
in 2022.
Under
Single Patient Emergency Use regulations, we have also treated two patients with COVID-19 with the Hemopurifier, in addition to
the COVID-19 patient treated with our Hemopurifier in our COVID-19 clinical trial discussed above. We
published a manuscript reviewing case studies covering those two Single Patient Emergency Use treatments entitled “Removal of COVID-19
Spike Protein, Whole Virus, Exosomes and Exosomal microRNAs by the Hemopurifier® Lectin-Affinity Cartridge in Critically Ill Patients
with COVID-19 Infection.”
The
manuscript described the use of the Hemopurifier for a total of nine sessions in two critically ill COVID-19 patients. The first case
study demonstrated the improvement in the patient who was a SARS-COV-2 positive COVID-19 present at entry to the hospital, with associated
coagulopathy, or CAC, lung injury, inflammation, and tissue injury despite the absence of demonstrable COVID-19 viremia at the start of
treatment at Day 22 and having demonstrated strong viremia earlier in the patient’s disease cycle, suggesting that the significant
removal of exosomes contributed to the patient’s recovery. This patient received eight Hemopurifier treatments without complications
and eventually was weaned from a ventilator and was discharged from the hospital.
The
second patient case study demonstrated in vivo removal of SARS-CoV-2 virus from the blood stream of an infected patient. This patient
completed a six-hour Hemopurifier treatment without complications and subsequently was placed on continuous renal replacement therapy,
or CRRT. The patient ultimately expired three hours after being placed on CRRT because of the advanced stage of the patient’s disease.
In
May 2022, we announced the publication of a pre-print manuscript featuring data that demonstrated Aethlon's proprietary GNA affinity resin
was able to bind seven clinically relevant SARS-CoV-2 variants in vitro, including the Delta and Omicron variants. Viral capture efficiency
with the GNA affinity resin ranged from 53% to 89% for all variants tested. The GNA affinity resin is a key component of the Aethlon Hemopurifier®.
The manuscript is titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus nivalis Agglutinin"
and was published in bioRxiv.
We
previously commissioned Battelle Memorial Institute in 2008 to run a monkeypox virus, or MPV, in vitro study using a mini-Hemopurifier.
This study demonstrated that high concentrations of MPV (approximately 35 thousand cpu/ml) were rapidly depleted from cell culture fluids
when circulated through the Hemopurifier. The study data indicated that the Hemopurifier removed 44 percent of infectious MPV in the first
hour of testing, 82 percent after six hours, and 98 percent after 20 hours. The studies were conducted in triplicate and data verification
was provided by real-time polymerase chain reaction.
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The Hemopurifier – Clinical Trials Conducted Overseas in Viral
Infections
EBOLA Virus
In December of 2014, Time
Magazine named the Hemopurifier a “Top 25 Invention” as the result of treating an Ebola-infected physician at Frankfurt
University Hospital in Germany. The physician was comatose with multiple organ failure at the time of treatment with the Hemopurifier.
At the American Society of Nephrology Annual Meeting, Dr. Helmut Geiger, Chief of Nephrology at Frankfurt University Hospital reported
that the patient received a single 6.5 hour Hemopurifier treatment. Prior to treatment, viral load was measured at 400,000 copies/ml.
Post-treatment viral load reported to be at 1,000 copies/ml. Dr. Geiger also reported that 242 million copies of Ebola virus were captured
within the Hemopurifier during treatment. The patient ultimately made a full recovery. Based on this experience, the Company filed an
Expanded Access protocol with the FDA to treat Ebola virus infected patients in up to ten centers in the United States and a corresponding
protocol was approved by HealthCanada. These protocols remain open allowing Hemopurifier treatment to be offered to patients presenting
for care in both countries. In 2018, we applied for and were granted a Breakthrough Designation by the FDA “… for the treatment
of life-threatening viruses that are not addressed with approved therapies.”
Hepatitis C Virus (HCV)
Prior to FDA approval of the
IDE feasibility study, we conducted investigational HCV treatment studies at the Apollo Hospital, Fortis Hospital and the Medanta Medicity
Institute in India. In the Medanta Medicity Institute study, 12 HCV-infected individuals were enrolled to receive three six-hour Hemopurifier
treatments during the first three days of a 48-week peginterferon+ribavirin treatment regimen. The study was conducted under the leadership
of Dr. Vijay Kher. Dr. Kher’s staff reported that Hemopurifier therapy was well tolerated and without device-related adverse events
in the 12 treated patients.
Of these 12 patients, ten
completed the Hemopurifier-peginterferon+ribavirin treatment protocol, including eight genotype-1 patients and two genotype-3 patients.
Eight of the ten patients achieved a sustained virologic response, which is the clinical definition of treatment cure and is defined as
undetectable HCV in the blood 24 weeks after the completion of the 48-week peginterferon+ribavirin drug regimen. Both genotype-3 patients
achieved a sustained virologic response, while six of the eight genotype-1 patients achieved a sustained virologic response, which defines
a cure of the infection.
Hemopurifier - Human Immunodeficiency Virus (HIV)
In addition to treating Ebola
and HCV-infected individuals, we also conducted a single proof-of-principle treatment study at the Sigma New Life Hospital in an AIDS
patient who was not being administered HIV antiviral drugs. In the study, viral load was reduced by 93% as the result of 12 Hemopurifier
treatments (each four hours in duration) that were administered over the course of one month.
The Hemopurifier in Cancer
Our primary focus in recent
years has been on the evaluation of the Hemopurifier in cancer, where we have previously shown in non-clinical studies and in a COVID-19
emergency use patient that it is capable of clearing exosomes, which are subcellular particles that are secreted by both normal and malignant
cells. Tumor derived exosomes, have been shown in multiple laboratories to be critical components in the progression of cancers. They
can mediate resistance to chemotherapy, resistance to targeted agents such as trastuzumab (Herceptin), metastasis and resistance to the
newer immuno-oncology agents, such as pembrolizumab (Keytruda). Based on these observations and data, in November 2019 the FDA granted
us a second Breakthrough Designation “…for the treatment of individuals with advanced or metastatic cancer who are either
unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the
development or severity of the disease.”
U.S. GOVERNMENT CONTRACTS
We have recognized revenue
under the following government contracts/grants over the past two years:
Phase 2 Melanoma Cancer Contract
On September 12, 2019, the
National Cancer Institute, or NCI, part of the National Institutes of Health, or NIH, awarded to us an SBIR Phase II Award Contract, for
NIH/NCI Topic 359, entitled “A Device Prototype for Isolation of Melanoma Exosomes for Diagnostics and Treatment Monitoring”,
or the Award Contract. The Award Contract amount was $1,860,561 and, as amended, ran for the period from September 16, 2019 through September
15, 2022.
5
The work performed pursuant
to this Award Contract was focused on melanoma exosomes. This work followed from our completion of a Phase I contract for the Topic 359
solicitation that ran from September 2017 through June 2018, as described below. Following on the Phase I work, the deliverables in the
Phase II program involved the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.
The Award Contract ended on
September 15, 2022 and we presented the required final report to the NCI. As the NCI completed its close out review of the contract, we
recognized as revenue the $574,245 previously recorded as deferred revenue on our December 31, 2022 balance sheet.
Subaward with University of Pittsburgh
In December 2020, we entered
into a cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting
Exosomes to Improve Responses to Immune Therapy in HNNCC.” Our share of the award was $256,750. We did not record revenue related
to this subaward in the fiscal year ended March 31, 2023. We recorded $64,467of revenue related to this subaward in the fiscal year ended
March 31, 2022.
In October 2022, we agreed
with the University of Pittsburgh to terminate the subaward arrangement, effective as of November 10, 2022, since it related to our clinical
trial in head and neck cancer in which the University of Pittsburgh was unable to recruit patients. There are no provisions in the subaward
arrangement requiring repayment of cash received for work completed through November 10, 2022.
Research and Development Costs
A substantial portion of our
operating budget is used for research and development activities. The cost of research and development, all of which has been charged
to operations, amounted to approximately $2,745,000 and $2,341,000 in the fiscal years ended March 31, 2023 and 2022, respectively.
Intellectual Property
We currently own or have license
rights to a number of U.S. and foreign patents and patent applications and endeavor to continually improve our intellectual property position.
We consider the protection of our technology, whether owned or licensed, to the exclusion of use by others, to be vital to our business.
While we intend to focus primarily on patented or patentable technology, we also rely on trade secrets, unpatented property, know-how,
regulatory exclusivity, patent extensions and continuing technological innovation to develop our competitive position. We also own certain
trademarks.
Our success depends in large
part on our ability to protect our proprietary technology, including the Hemopurifier product platform, and to operate without infringing
the proprietary rights of third parties. We rely on a combination of patent, trade secret, copyright and trademark laws, as well as confidentiality
agreements, licensing agreements and other agreements, to establish and protect our proprietary rights. Our success also depends, in part,
on our ability to avoid infringing patents issued to others. If we were judicially determined to be infringing on any third-party patent,
we could be required to pay damages, alter our products or processes, obtain licenses or cease sales of products or certain activities.
To protect our proprietary
medical technologies, including the Hemopurifier product platform and other scientific discoveries, we have a portfolio of over 50 issued
patents and pending applications worldwide. We currently have five issued U.S. patents and 32 issued patents in countries outside of the
United States. In addition, we have thirteen patent applications pending worldwide related to our Hemopurifier product platform and other
technologies. We are seeking additional patents on our scientific discoveries.
6
It is possible that our pending
patent applications may not result in issued patents, that we will not develop additional proprietary products that are patentable, that
any patents issued to us may not provide us with competitive advantages or will be challenged by third parties and that the patents of
others may prevent the commercialization of products incorporating our technology. Furthermore, others may independently develop similar
products, duplicate our products or design around our patents. U.S. patent applications are not immediately made public, so it is possible
that a third party may obtain a patent on a technology we are actively using.
There is a risk that any patent
applications that we file and any patents that we hold or later obtain could be challenged by third parties and declared invalid or unenforceable.
For many of our pending applications, patent interference proceedings may be instituted with the U.S. Patent and Trademark Office, or
the USPTO, when more than one person files a patent application covering the same technology, or if someone wishes to challenge the validity
of an issued patent. At the completion of the interference proceeding, the USPTO will determine which competing applicant is entitled
to the patent, or whether an issued patent is valid. Patent interference proceedings are complex, highly contested legal proceedings,
and the USPTO’s decision is subject to appeal. This means that if an interference proceeding arises with respect to any of our patent
applications, we may experience significant expenses and delays in obtaining a patent, and if the outcome of the proceeding is unfavorable
to us, the patent could be issued to a competitor rather than to us. Third parties can file post-grant proceedings in the USPTO,
seeking to have issued patent invalidated, within nine months of issuance. This means that patents undergoing post-grant proceedings may
be lost, or some or all claims may require amendment or cancellation, if the outcome of the proceedings is unfavorable to us. Post-grant
proceedings are complex and could result in a reduction or loss of patent rights. The institution of post-grant proceedings against our
patents could also result in significant expenses.
Patent law outside the United
States is uncertain and in many countries, is currently undergoing review and revisions. The laws of some countries may not protect our
proprietary rights to the same extent as the laws of the United States. Third parties may attempt to oppose the issuance of patents to
us in foreign countries by initiating opposition proceedings. Opposition proceedings against any of our patent filings in a foreign country
could have an adverse effect on our corresponding patents that are issued or pending in the United States. It may be necessary or useful
for us to participate in proceedings to determine the validity of our patents or our competitors’ patents that have been issued
in countries other than the United States. This could result in substantial costs, divert our efforts and attention from other aspects
of our business, and could have a material adverse effect on our results of operations and financial condition. Outside of the United
States, we currently have pending patent applications or issued patents in Europe, India, Russia, Canada, Japan, Singapore and Hong Kong.
In addition to patent protection,
we rely on unpatented trade secrets and proprietary technological expertise. It is possible that others could independently develop or
otherwise acquire substantially equivalent technology, somehow gain access to our trade secrets and proprietary technological expertise
or disclose such trade secrets, or that we may not successfully ultimately protect our rights to such unpatented trade secrets and proprietary
technological expertise. We rely, in part, on confidentiality agreements with our marketing partners, employees, advisors, vendors and
consultants to protect our trade secrets and proprietary technological expertise. We cannot assure you that these agreements will not
be breached, that we will have adequate remedies for any breach or that our unpatented trade secrets and proprietary technological expertise
will not otherwise become known or be independently discovered by competitors.
Patents
The following table lists our issued patents and
patent applications, including their ownership status:
Patents Issued in the United States
PATENT #
PATENT NAME
ISSUANCE
DATE
OWNED OR
LICENSED
EXPIRATION
DATE
9,707,333
Extracorporeal removal of microvesicular particles
7/18/17
Owned
1/6/29
9,364,601
Extracorporeal removal of microvesicular particles
6/14/16
Owned
10/2/29
8,288,172
Extracorporeal removal of microvesicular particles
10/16/12
Owned
3/30/29
7,226,429
Method for removal of viruses from blood by lectin affinity hemodialysis
6/5/07
Owned
1/20/24
10,022,483
Method for removal of viruses from blood by lectin affinity hemodialysis
7/17/18
Owned
1/20/24
7
Patent Applications Pending in the United States
APPLICATION #
APPLICATION NAME
FILING
DATE
OWNED OR
LICENSED
16/415,713
Affinity capture of circulating biomarkers
5/17/19
Owned
17/301,666
Method for removal of viruses from blood by lectin affinity hemodialysis
4/09/21
Owned
16/459,220
Methods and compositions for quantifying exosomes
7/01/19
Owned
17/918,085
Devices and methods for treating a coronavirus infection and symptoms thereof
10/10/22
Owned
Foreign Patents
PATENT #
PATENT NAME
ISSUANCE
DATE
OWNED OR
LICENSED
EXPIRATION
DATE
2353399
Method for removal of viruses from blood by lectin affinity hemodialysis (Russia)
4/27/09
Owned
1/20/24
1624785
Method for removal of viruses from blood by lectin affinity hemodialysis (Belgium)
7/17/13
Owned
1/20/24
1624785
Method for removal of viruses from blood by lectin affinity hemodialysis (Ireland)
7/17/13
Owned
1/20/24
1624785
Method for removal of viruses from blood by lectin affinity hemodialysis (Italy)
7/17/13
Owned
1/20/24
1624785
Method for removal of viruses from blood by lectin affinity hemodialysis (Great Britain)
7/17/13
Owned
1/20/24
1624785
Method for removal of viruses from blood by lectin affinity hemodialysis (France)
7/17/13
Owned
1/20/24
1624785
Method for removal of viruses from blood by lectin affinity hemodialysis (Germany)
7/17/13
Owned
1/20/24
2516403
Method for removal of viruses from blood by lectin affinity hemodialysis (Canada)
8/12/14
Owned
1/20/24
2591359
Methods for quantifying exosomes (Germany)
3/01/17
Owned
7/07/31
2591359
Methods for quantifying exosomes (France)
3/01/17
Owned
7/07/31
2591359
Methods for quantifying exosomes (Great Britain)
3/01/17
Owned
7/07/31
2591359
Methods for quantifying exosomes (Spain)
3/01/17
Owned
7/07/31
2644855
Extracorporeal removal of microvesicular particles (Canada)
11/19/19
Owned
1/20/24
3061952
Extracorporeal removal of microvesicular particles (Canada)
7/19/22
Owned
1/20/24
1993600
Extracorporeal removal of microvesicular particles (Germany)
4/24/19
Owned
1/20/24
1993600
Extracorporeal removal of microvesicular particles (Switzerland)
4/24/19
Owned
1/20/24
1993600
Extracorporeal removal of microvesicular particles (Spain)
4/24/19
Owned
1/20/24
1993600
Extracorporeal removal of microvesicular particles (France)
4/24/19
Owned
1/20/24
1993600
Extracorporeal removal of microvesicular particles (Great Britain)
4/24/19
Owned
1/20/24
1993600
Extracorporeal removal of microvesicular particles (Italy)
4/24/19
Owned
1/20/24
1993600
Extracorporeal removal of microvesicular particles (Netherlands)
4/24/19
Owned
1/20/24
1993600
Extracorporeal removal of microvesicular particles (Sweden)
4/24/19
Owned
1/20/24
1126138
Extracorporeal removal of microvesicular particles (Hong Kong)
6/19/20
Owned
1/20/24
3517151
Extracorporeal removal of microvesicular particles (Switzerland)
4/21/21
Owned
1/20/24
3517151
Extracorporeal removal of microvesicular particles (Germany)
4/21/21
Owned
1/20/24
3517151
Extracorporeal removal of microvesicular particles (Denmark)
4/21/21
Owned
1/20/24
3517151
Extracorporeal removal of microvesicular particles (Spain)
4/21/21
Owned
1/20/24
3517151
Extracorporeal removal of microvesicular particles (France)
4/21/21
Owned
1/20/24
3517151
Extracorporeal removal of microvesicular particles (Great Britain)
4/21/21
Owned
1/20/24
3517151
Extracorporeal removal of microvesicular particles (Ireland)
4/21/21
Owned
1/20/24
3517151
Extracorporeal removal of microvesicular particles (Netherlands)
4/21/21
Owned
1/20/24
3517151
Extracorporeal removal of microvesicular particles (Sweden)
4/21/21
Owned
1/20/24
8
Pending Foreign Patent Applications
APPLICATION #
APPLICATION NAME
FILING
DATE
OWNED OR LICENSED
8139/DELNP/2008
Extracorporeal removal of microvesicular particles (exosomes) (India)
3/9/07
Owned
2939652
Brain specific exosome based diagnostics and extracorporeal therapies (Canada)
8/12/06
Owned
2021256402
Devices and methods for treating a coronavirus infection and symptoms thereof (Australia)
10/16/22
Owned
3178687
Devices and methods for treating a coronavirus infection and symptoms thereof (Canada)
9/29/22
Owned
21788894.0
Devices and methods for treating a coronavirus infection and symptoms thereof (Europe)
10/26/22
Owned
297109
Devices and methods for treating a coronavirus infection and symptoms thereof (Israel)
10/26/22
Owned
2023-505809
Devices and methods for treating a coronavirus infection and symptoms thereof (Japan)
10/12/22
Owned
11202253625T
Devices and methods for treating a coronavirus infection and symptoms thereof (Singapore)
9/29/22
Owned
Pending International Patent Applications
APPLICATION #
APPLICATION NAME
FILING
DATE
OWNED OR
LICENSED
PCT/US2022/077885
Devices and methods for treating a viral infection and symptoms thereof
10/11/22
Owned
Trademarks
APPLICATION NAME
FILING DATE
OWNED OR LICENSED
TAUSOME
7/24/2015
Owned
SANSAGITTA
7/8/2021
Owned
HEMOSAGITTA
1/13/2021
Owned
Trademarks
In addition to the Tausome,
Sansagitta and Hemosagitta trademarks noted in the above table, we also have trademark registrations in the United States for Hemopurifier
and Aethlon Medical, Inc., and obtained a trademark registration in India for Hemopurifier. We also have common law trademark rights in
Aethlon ADAPT™ and ELLSA™.
Licensing and Assignment Agreements
On November 7, 2006, we executed
an assignment agreement with the London Health Science Center Research, Inc. under which an invention and related patent rights for a
method to treat cancer were assigned to us. The invention provides for the "Extracorporeal removal of microvesicular particles"
for which the U.S. Patent and Trademark Office granted a patent (Patent No.8,288,172) in the United States as of October 2012. The agreement
provided for an upfront payment of 53 shares of unregistered common stock and a 2% royalty on any future net sales of all products or
services, the sale of which would infringe in the absence of the assignment granted under this agreement. We are also responsible for
paying certain patent application and filing costs. Under the assignment agreement, we own the patents until their respective expirations.
Under certain circumstances, ownership of the patents may revert to the London Health Science Center Research, Inc. if there is an uncured
substantial breach of the assignment agreement.
9
Industry & Competition
The industry for treating
infectious disease and cancer is extremely competitive, and companies developing new treatment procedures face significant capital and
regulatory challenges. As our Hemopurifier is a clinical-stage device, we have the additional challenge of establishing medical industry
support, which will be driven by treatment data resulting from human clinical studies. Should our device become market cleared by the
FDA or the regulatory body of another country, we may face significant competition from well-funded pharmaceutical organizations. Additionally,
we would likely need to establish large-scale production of our device in order to be competitive. We believe that our Hemopurifier is
a first-in-class therapeutic candidate and we are not aware of any affinity hemofiltration device being market cleared in any country
for the single-use removal of circulating viruses or tumor-derived exosomes.
Government Regulation
The Hemopurifier is subject
to regulation by numerous regulatory bodies, primarily the FDA, and comparable international regulatory agencies. These agencies require
manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling,
marketing, storage, distribution, advertising and promotion, and post-marketing surveillance reporting of medical devices. As the primary
mode of action of the Hemopurifier is attributable to the device component of this combination product, the CDRH has primary jurisdiction
over its premarket development, review and approval. Failure to comply with applicable requirements may subject a device and/or its manufacturer
to a variety of administrative sanctions, such as issuance of warning letters, import detentions, civil monetary penalties and/or judicial
sanctions, such as product seizures, injunctions and criminal prosecution.
FDA’s Pre-market Clearance and Approval
Requirements
Each medical device we seek
to commercially distribute in the United States will require either a prior 510(k) clearance, unless it is exempt, or a pre-market approval
from the FDA. Generally, if a new device has a predicate that is already on the market under a 510(k) clearance, the FDA will allow that
new device to be marketed under a 510(k) clearance; otherwise, a premarket approval, or PMA, is required. Medical devices are classified
into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each
medical device and the extent of control needed to provide reasonable assurance of safety and effectiveness. Class I devices are
deemed to be low risk and are subject to the general controls of the Federal Food, Drug and Cosmetic Act, such as provisions that relate
to: adulteration; misbranding; registration and listing; notification, including repair, replacement, or refund; records and reports;
and good manufacturing practices. Most Class I devices are classified as exempt from pre-market notification under section 510(k)
of the FD&C Act, and therefore may be commercially distributed without obtaining 510(k) clearance from the FDA. Class II devices
are subject to both general controls and special controls to provide reasonable assurance of safety and effectiveness. Special controls
include performance standards, post market surveillance, patient registries and guidance documents. A manufacturer may be required to
submit to the FDA a pre-market notification requesting permission to commercially distribute some Class II devices. Devices deemed
by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially
equivalent to a previously cleared 510(k) device, are placed in Class III. A Class III device cannot be marketed in the United
States unless the FDA approves the device after submission of a PMA. However, there are some Class III devices for which FDA has
not yet called for a PMA. For these devices, the manufacturer must submit a pre-market notification and obtain 510(k) clearance in orders
to commercially distribute these devices. The FDA can also impose sales, marketing or other restrictions on devices in order to assure
that they are used in a safe and effective manner. We believe that the Hemopurifier will be classified as a Class III device and as such
will be subject to PMA submission and approval.
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Pre-market Approval Pathway
A pre-market approval application
must be submitted to the FDA for Class III devices for which the FDA has required a PMA. The pre-market approval application process
is much more demanding than the 510(k) pre-market notification process. A pre-market approval application must be supported by extensive
data, including but not limited to technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA’s
satisfaction reasonable evidence of safety and effectiveness of the device.
After a pre-market approval
application is submitted, the FDA has 45 days to determine whether the application is sufficiently complete to permit a substantive review
and thus whether the FDA will file the application for review. The FDA has 180 days to review a filed pre-market approval application,
although the review of an application generally occurs over a significantly longer period of time and can take up to several years. During
this review period, the FDA may request additional information or clarification of the information already provided. Also, an advisory
panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as
to the approvability of the device.
Although the FDA is not bound
by the advisory panel decision, the panel’s recommendations are important to the FDA’s overall decision making process. In
addition, the FDA may conduct a preapproval inspection of the manufacturing facility to ensure compliance with the Quality System Regulation,
or QSR. The agency also may inspect one or more clinical sites to assure compliance with FDA’s regulations.
Upon completion of the PMA
review, the FDA may: (i) approve the PMA which authorizes commercial marketing with specific prescribing information for one or more
indications, which can be more limited than those originally sought; (ii) issue an approvable letter which indicates the FDA’s
belief that the PMA is approvable and states what additional information the FDA requires, or the post-approval commitments that must
be agreed to prior to approval; (iii) issue a not approvable letter which outlines steps required for approval, but which are typically
more onerous than those in an approvable letter, and may require additional clinical trials that are often expensive and time consuming
and can delay approval for months or even years; or (iv) deny the application. If the FDA issues an approvable or not approvable
letter, the applicant has 180 days to respond, after which the FDA’s review clock is reset.
Emergency Use Authorizations,
or EUAs, are granted by FDA in public health emergencies but allow use of the authorized device only during the period of the respective
public health emergency, and do not change the requirement to ultimately seek PMA approval after the authorization period has ended.
Clinical Trials
Clinical trials are almost
always required to support pre-market approval and are sometimes required for 510(k) clearance. In the United States, for significant
risk devices, these trials require submission of an application for an IDE to the FDA. The IDE application must be supported by appropriate
data, such as animal and laboratory testing results, showing it is safe to test the device in humans and that the testing protocol is
scientifically sound. The IDE must be approved in advance by the FDA for a specific number of patients at specified study sites. During
the trial, the sponsor must comply with the FDA’s IDE requirements for investigator selection, trial monitoring, reporting and recordkeeping.
The investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition
of investigational devices and comply with all reporting and recordkeeping requirements. Clinical trials for significant risk devices
may not begin until the IDE application is approved by the FDA and the appropriate institutional review boards, or IRBs, at the clinical
trial sites. An IRB is an appropriately constituted group that has been formally designated to review and monitor medical research involving
subjects and which has the authority to approve, require modifications in, or disapprove research to protect the rights, safety and welfare
of human research subjects. The FDA or the IRB at each site at which a clinical trial is being performed may withdraw approval of a clinical
trial at any time for various reasons, including a belief that the risks to study subjects outweigh the benefits or a failure to comply
with FDA or IRB requirements. Even if a trial is completed, the results of clinical testing may not demonstrate the safety and effectiveness
of the device, may be equivocal or may otherwise not be sufficient to obtain approval or clearance of the product.
11
Ongoing Regulation by the FDA
Even after a device receives clearance or approval
and is placed on the market, numerous regulatory requirements apply. These include:
·
establishment registration and device listing;
·
the QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
·
labeling regulations and the FDA prohibitions against the promotion of products for uncleared, unapproved or “off-label” uses and other requirements related to promotional activities;
·
medical device reporting regulations, which require that manufactures report to the FDA if their device may have caused or contributed to a death or serious injury, or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;
·
corrections and removal reporting regulations, which require that manufactures report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health; and
·
post market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and effectiveness data for the device.
Some changes to an approved
PMA device, including changes in indications, labeling or manufacturing processes or facilities, require submission and FDA approval of
a new PMA or PMA supplement, as appropriate, before the change can be implemented. Supplements to a PMA often require the submission of
the same type of information required for an original PMA, except that the supplement is generally limited to that information needed
to support the proposed change from the device covered by the original PMA. The FDA uses the same procedures and actions in reviewing
PMA supplements as it does in reviewing original PMAs.
Failure by us or by our suppliers
to comply with applicable regulatory requirements can result in enforcement action by the FDA or state authorities, which may include
any of the following sanctions:
·
warning or untitled letters, fines, injunctions, consent decrees and civil penalties;
·
customer notifications, voluntary or mandatory recall or seizure of our products;
·
operating restrictions, partial suspension or total shutdown of production;
·
delay in processing submissions or applications for new products or modifications to existing products;
·
withdrawing approvals that have already been granted; and
·
criminal prosecution.
12
The Medical Device Reporting
laws and regulations require us to provide information to the FDA when we receive or otherwise become aware of information that reasonably
suggests our device may have caused or contributed to a death or serious injury as well as a device malfunction that likely would cause
or contribute to death or serious injury if the malfunction were to recur. In addition, the FDA prohibits an approved device from being
marketed for off-label use. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label
uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including substantial
monetary penalties and criminal prosecution.
Newly discovered or developed
safety or effectiveness data may require changes to a product’s labeling, including the addition of new warnings and contraindications,
and also may require the implementation of other risk management measures. Also, new government requirements, including those resulting
from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or
approval of our products under development.
Healthcare Regulation
In addition to the FDA’s
restrictions on marketing of pharmaceutical products, the U.S. healthcare laws and regulations that may affect our ability to operate
include: the federal fraud and abuse laws, including the federal anti-kickback and false claims laws; federal data privacy and security
laws; and federal transparency laws related to payments and/or other transfers of value made to physicians (defined to include doctors,
dentists, optometrists, podiatrists and chiropractors) and other healthcare professionals (such as physicians assistants and nurse practitioners)
and teaching hospitals. Many states have similar laws and regulations that may differ from each other and federal law in significant ways,
thus complicating compliance efforts. For example, states have anti-kickback and false claims laws that may be broader in scope than analogous
federal laws and may apply regardless of payor. In addition, state data privacy laws that protect the security of health information may
differ from each other and may not be preempted by federal law. Moreover, several states have enacted legislation requiring pharmaceutical
manufacturers to, among other things, establish marketing compliance programs, file periodic reports with the state, make periodic public
disclosures on sales and marketing activities, report information related to drug pricing, require the registration of sales representatives,
and prohibit certain other sales and marketing practices. These laws may adversely affect our sales, marketing and other activities with
respect to any product candidate for which we receive approval to market in the United States by imposing administrative and compliance
burdens on us.
Because of the breadth of
these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business
activities, particularly any sales and marketing activities after a product candidate has been approved for marketing in the United States,
could be subject to legal challenge and enforcement actions. If our operations are found to be in violation of any of the federal and
state laws described above or any other governmental regulations that apply to us, we may be subject to significant civil, criminal, and
administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare
programs, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to
resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely
affect our ability to operate our business and our results of operations.
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. For example, in the United States, the Patient Protection and Affordable
Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, ACA, among other things, reduced and/or
limited Medicare reimbursement to certain providers and imposed an annual excise tax of 2.3% on any entity that manufactures or imports
medical devices offered for sale in the United States, with limited exceptions. However, the 2020 federal spending package permanently
eliminated, effective January 1, 2020, this ACA-mandated medical device tax. On June 17, 2021, the U.S. Supreme Court dismissed a challenge
on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed
by Congress. Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other
things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The
IRA also eliminates the "donut hole" under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary
maximum out-of-pocket cost and creating a new manufacturer discount program. It is possible that the ACA will be subject to judicial or
Congressional challenges in the future. It is unclear how such challenges and any additional healthcare reform measures will impact the
ACA.
13
Other legislative changes
have been proposed and adopted since the ACA was enacted. The Budget Control Act of 2011, as amended by subsequent legislation, further
reduces Medicare’s payments to providers by two percent through fiscal year 2032. These reductions may reduce providers’ revenues
or profits, which could affect their ability to purchase new technologies. Furthermore, the healthcare industry in the United States has
experienced a trend toward cost containment as government and private insurers seek to control healthcare costs by imposing lower payment
rates and negotiating reduced contract rates with service providers. In July 2021, the Biden Administration released an executive order,
“Promoting Competition in the American Economy,” which contained provisions relating to prescription drugs. On September 9,
2021, in response to this executive order, the U.S. Department of Health and Human Services, or HHS, released a Comprehensive Plan for
Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies
that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. Further, the IRA, among
other things (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare
and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions
will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges. HHS has and will continue
to issue and update guidance as these programs are implemented. It is currently unclear how the IRA will be implemented but is likely
to have a significant impact on the pharmaceutical industry. In addition, in response to the Biden administration’s October 2022
executive order, on February 14, 2023, HHS released a report outlining three new models for testing by the Center for Medicare and Medicaid
Innovation which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care. It
is unclear whether the models will be utilized in any health reform measures in the future.
Legislation could be adopted
in the future that limits payments for our products from governmental payors. It is possible that additional governmental action will
be taken to address the COVID-19 pandemic. In addition, commercial payors such as insurance companies, could adopt similar policies that
limit reimbursement for medical device manufacturers’ products.
Coverage and Reimbursement
In both the U.S. and international
markets, the use of medical devices is dependent in part on the availability of reimbursement from third-party payors, such as government
and private insurance plans. Healthcare providers that use medical devices generally rely on third-party payors to pay for all or part
of the costs and fees associated with the medical procedures being performed or to compensate them for their patient care services. Should
our Hemopurifier or any other products under development be approved for commercialization by the FDA, any such products may not be considered
cost-effective, reimbursement may not be available in the United States or other countries, if approved, and reimbursement may not be
sufficient to allow sales of our future products on a profitable basis. The coverage decisions of third-party payors will be significantly
influenced by the assessment of our future products by health technology assessment bodies. If approved for use in the United States,
we expect that any products that we develop, including the Hemopurifier, will be purchased primarily by medical institutions, which will
in turn bill various third-party payors for the health care services provided to patients at their facility. Payors may include the Centers
for Medicare & Medicaid Services, or CMS, which administers the Medicare program and works in partnership with state governments to
administer Medicaid, other government programs and private insurance plans. The process involved in applying for coverage and reimbursement
from CMS is lengthy and expensive. Further, Medicare coverage is based on our ability to demonstrate that the treatment is “reasonable
and necessary” for Medicare beneficiaries. Even if products utilizing our Aethlon Hemopurifier technology receive FDA and other
regulatory clearance or approval, they may not be granted coverage and reimbursement by any payor, including by CMS. Many private payors
use coverage decisions and payment amounts determined by CMS as guidelines in setting their coverage and reimbursement policies and amounts.
However, no uniform policy for coverage and reimbursement for medical devices exists among third-party payors in the United States. Therefore,
coverage and reimbursement can differ significantly from payor to payor.
14
Manufacturing
To date, manufacturing of
our Hemopurifier occurs in collaboration with a contract manufacturer based in California under current Good Manufacturing Practice, or
cGMP, regulations promulgated by the FDA. Our contract manufacturer is registered with the FDA. To date, our manufacture of the Hemopurifier
has been limited to quantities necessary to support our clinical studies.
Our costs of compliance with federal, state and
local environmental laws have been immaterial to date.
Sources and Availability of Raw Materials and the Names
of Principal Suppliers
Our Hemopurifiers were previously
assembled by Aethlon personnel in a cGMP manufacturing facility provided by Life Science Outsourcing, Inc, or LSO. Currently, we are in
the process of bringing our manufacturing operations in-house. Aethlon personnel assemble the various components of the Hemopurifier with
materials from our various suppliers, which are purchased and released by Aethlon. Specifically, the Hemopurifier contains three critical
components with limited available suppliers. The GNA lectin is sourced from Vector Laboratories Inc. and also is available from other
suppliers. We currently are experiencing a disruption in our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September
30, 2022, and as previously disclosed, we are dependent on FDA approval of qualified suppliers to manufacture our Hemopurifier. Our intended
transition to a new supplier for GNA is delayed as we work with the FDA for approval of our supplement to our IDE, which is required to
make this manufacturing change. The base cartridge on which the Hemopurifier is constructed is sourced from Medica S.p.A and we are dependent
on the continued availability of these cartridges. Although there are other suppliers, the process of qualifying a new supplier takes
time and regulatory approvals must be obtained. We currently purchase the diatomaceous earth from Janus Scientific, Inc., as the distributor;
however, the product is manufactured by Imerys Minerals Ltd. There potentially are other suppliers of this product, but as with the cartridges,
qualifying and obtaining required regulatory approvals takes time and resources.
Sales and Marketing
We do not currently have any
sales and marketing capability. With respect to commercialization efforts in the future, we intend to build or contract for distribution,
sales and marketing capabilities for any product candidate that is approved. From time to time, we have had and are having strategic discussions
with potential collaboration partners for our product candidates, although no assurance can be given that we will be able to enter into
one or more collaboration agreements for our product candidates on acceptable terms, if at all.
Product Liability
The risk of product liability
claims, product recalls and associated adverse publicity is inherent in the testing, manufacturing, marketing and sale of medical products.
We have limited clinical trial liability insurance coverage. It is possible that future insurance coverage may not be adequate or available.
We may not be able to secure product liability insurance coverage on acceptable terms or at reasonable costs when needed. Any liability
for mandatory damages could exceed the amount of our coverage. A successful product liability claim against us could require us to pay
a substantial monetary award. Moreover, a product recall could generate substantial negative publicity about our products and business
and inhibit or prevent commercialization of other future product candidates.
Employees
As of June 26, 2023, we had
15 full-time employees and no part-time employees. All of our employees are located in the United States. We do intend to hire additional
employees. We utilize, whenever appropriate, consultants in order to conserve cash and resources.
We believe our employee relations
are good. None of our employees are represented by a labor union or are subject to collective-bargaining agreements.
15