ITEM 1A. RISK FACTORS
An investment in our securities
involves a high degree of risk. You should carefully consider the risks described below as well as the other information in this Annual
Report before deciding to invest in or maintain your investment in our company. The risks described below are not intended to be an all-inclusive
list of all of the potential risks relating to an investment in our securities. Any of the risk factors described below could significantly
and adversely affect our business, prospects, financial condition and results of operations. Additional risks and uncertainties not currently
known or that are currently considered to be immaterial may also materially and adversely affect our business. As a result, the trading
price or value of our securities could be materially adversely affected and you may lose all or part of your investment.
Risks Relating to Our Financial Position and Need for Additional Capital
We have incurred significant losses and expect to continue to incur
losses for the foreseeable future.
We have
never been profitable. We have generated revenues during the fiscal years ended March 31, 2024 and March 31, 2023 in the amounts of $0
and $574,245, respectively, primarily from our contract with the NIH, which ended in September 2022. 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 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 we currently have over $9.1 million in cash and cash equivalents
and have been carrying out certain expense reductions since November 2023, our planned additional expense reductions may not materialize
and/or our 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 plan to access the equity
markets for additional capital, however, there can be no assurance that we will be able to access such additional capital.
We will require additional financing to sustain our operations, achieve
our business objectives and satisfy our cash obligations, which may dilute the ownership of our existing stockholders.
We will require significant additional
financing for our operations and for expected additional future clinical trials in the United States, India 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.
Our ability to raise additional
funds may be adversely impacted by our ability to remain listed on Nasdaq, the potential worsening global economic conditions and disruptions
to and volatility in the credit and financial markets in the United States, including due to bank
failures, actual or perceived changes in interest rates and economic inflation, and worldwide resulting from macroeconomic factors.
Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased
expenses and cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.
Risks Related to Our Business Operations
Delays, interruptions or the cessation of production
by our third-party suppliers of important materials or delays in qualifying new materials, has and may continue to prevent or delay our
ability to manufacture our Hemopurifier.
Most of the raw materials used
in the process for manufacturing our Hemopurifier are available from more than one supplier. However, there are materials within the manufacturing
and production process that come from single suppliers. We do not have written contracts with all of our single source suppliers, and
at any time they could stop supplying our orders. FDA review of a new supplier is required if these materials become unavailable from
our current suppliers. In the recent past, we experienced an interruption in the manufacturing of our Hemopurifier as we sought to transition
to a new supplier of galanthus nivalis agglutinin, or GNA, used in the manufacture of our Hemopurifier. We have not received the required
FDA approval of our IDE supplement for a new qualified supplier of the GNA and are working with the FDA to gain approval of this supplier.
Although we have resumed purchasing GNA from our prior supplier, it is possible that we could experience future disruptions from this
supplier as we work to qualify a second supplier. FDA review of the new second supplier could take several additional months to obtain.
In addition, an uncorrected impurity,
a supplier’s variation in a raw material or testing, either unknown to us or incompatible with its manufacturing process, or any
other problem with our materials, testing or components, would prevent or delay the release of our Hemopurifiers for use in our clinical
trials. For example, in late 2020, we identified during our device quality review procedures prior to product release that one of our
critical suppliers had produced a Hemopurifier component that was not produced to our specifications, although no affected Hemopurifiers
were released into our inventory or to any clinical trial sites. Any such future supplier issues could have a material adverse impact
on our business, results of operations and financial condition.
Difficulties in manufacturing our Hemopurifier
could have an adverse effect upon our expenses, our product revenues and our ability to complete our clinical trials.
We only recently received approval
from the FDA for our IDE supplement to manufacture Hemopurifiers at our site in San Diego. The manufacturing of our Hemopurifier is difficult
and complex. To support our current clinical trial needs, we comply with and intend to continue to comply with cGMP in the manufacture
of our product. Our ability to adequately manufacture and supply our Hemopurifier in a timely matter 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:
· natural disasters;
· changes in forecasts of future demand for product components;
· potential facility contamination by microorganisms or viruses;
· updating of manufacturing specifications;
· product quality success rates and yields; and
· global viruses and pandemics.
Any future interruption in the
manufacture and supply of our Hemopurifier could delay shipments of our Hemopurifier for use in clinical trials in the United States,
Australia and India.
Our products are manufactured
with raw materials that are sourced from specialty suppliers with limited competitors and we may therefore be unable to access the materials
we need to manufacture our products.
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.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. and also is available from other suppliers; however, Sigma Aldrich
is our only back up supplier at this time and we are in the process of working with the FDA to obtain regulatory approval for this supplier.
A business interruption at any of these sources, including the interruption resulting from the delay in obtaining FDA approval of our
new GNA supplier, has and may continue to have a material impact on our ability to manufacture the Hemopurifier.
We face intense competition in the medical device industry.
We compete with numerous U.S.
and foreign companies in the medical device industry, and many of our competitors have greater financial, personnel, operational and research
and development resources than we do. We believe that because the field of exosome research is burgeoning, multiple competitors are or
will be developing competing technologies to address exosomes in cancer. Progress is constant in the treatment and prevention of viral
diseases, so the opportunities for the Hemopurifier may be reduced there as well. Diagnostic technology may be developed that can supplant
diagnostics we are developing for viruses and cancer. Our commercial opportunities will be reduced or eliminated if our competitors develop
and market products for any of the diseases we target that:
· are more effective;
· have fewer or less severe adverse side effects;
· are better tolerated;
· are more adaptable to various modes of dosing;
· are easier to administer; or
· are less expensive than the products or product candidates we are developing.
Even if we are successful 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 staffs 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.
We have limited experience in identifying and working with large-scale
contracts with medical device manufacturers; manufacture of our devices must comply with good manufacturing practices in the United States.
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. 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 technology may become obsolete.
Our Hemopurifier product may 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. The homeland security industry is growing rapidly with many competitors
that are trying to develop products or vaccines to protect against infectious disease. Any one of our competitors could develop a more
effective product which would render our technology obsolete. Further, our ability to achieve significant and sustained penetration of
our key target markets will depend 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 are highly dependent on our key personnel, and if we are not successful
in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
Our ability to compete in the
highly competitive biotechnology and medical device industries depends upon our ability to attract and retain highly qualified managerial,
scientific, and medical personnel. We are highly dependent on our management, scientific, and medical personnel. The loss of the services
of any of our executive officers or other key employees and our inability to find suitable replacements could potentially harm our business,
prospects, financial condition or results of operations.
We do not currently carry key
man life insurance policies on any of our key executive officers which would assist us in recouping our costs in the event of the loss
of those officers. If any of our key officers were to leave us, it could make it impossible, if not cause substantial delays and costs,
to implement our long-term business objectives and growth.
Our inability to attract and retain qualified
personnel could impede our ability to achieve our business objectives.
We have 14 full-time employees.
We utilize, whenever appropriate, consultants in order to conserve cash and resources. Although we believe that these employees and
consultants will be able to handle most of our additional administrative, research and development and business development in the 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
area. If we cannot attract and retain qualified staff and executives, we will be unable to develop our products and achieve regulatory
clearance, and our business could fail.
We plan to expand our operations, which may
strain our resources; our inability to manage our growth could delay or derail implementation of our business objectives.
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 will 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 India and potentially in other countries, we will be
unable to commercialize our products on a large-scale in a timely manner, if at all, and our business could fail.
We do not have any experience in the organ transplant market and
face competition from entities more familiar with this business and our efforts may not succeed.
We are investigating whether
the Hemopurifier, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses, exosomes, RNA molecules,
cytokines, chemokines and other inflammatory molecules from recovered organs. This area is new to our product development and management
personnel, and we may not be successful in the organ transplant market where we do not have any experience. Even if we are successful
in developing our Hemopurifier for the organ transplant market, we may not be able to compete effectively or generate significant revenues
in this new area. Many companies of all sizes, including major pharmaceutical companies, specialized biotechnology companies, and traditional
healthcare providers, are engaged in redesigning organ transplant care. Competitors operating in this area may have substantially greater
financial and other resources, larger research and development staff, and more experience in this area. It is possible that, even if we
are successful in the organ transplant field, that the market will not accept our product, or that our product will generate significant
revenues for us.
As a public company with limited financial resources undertaking
the launch of new medical technologies, we may have difficulty attracting and retaining executive management and directors.
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 in securities laws
imposing additional duties, obligations and liabilities on management and directors. 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 outside independent
directors than a more established public or private company due to these enhanced duties, obligations and potential liabilities.
If we fail to comply with extensive regulations
of U.S. and foreign regulatory agencies, the commercialization of our products could be delayed or prevented entirely.
Our Hemopurifier product is subject
to extensive government regulations related to development, testing, manufacturing and commercialization in the United States and other
countries. The determination of when and whether a product is ready for large-scale purchase and potential use will be made by the U.S.
Government through consultation with a number of governmental agencies, including the FDA, the National Institutes of Health, the CDC
and the Department of Homeland Security. Our Hemopurifier has not received required regulatory approval from the FDA, or any foreign regulatory
agencies, to be commercially marketed and sold. The process of obtaining and complying with FDA and other governmental regulatory approvals
and regulations in the United States and in foreign countries is costly, time consuming, uncertain and subject to unanticipated delays.
Obtaining such regulatory approvals, if any, can take several years. Despite the time and expense exerted, regulatory approval is never
guaranteed. We also are subject to the following risks and obligations, among others:
· the FDA may require additional testing for safety and effectiveness;
· the FDA may change its approval policies and/or adopt new regulations.
Failure to comply with these or
other regulatory requirements of the FDA may subject us to administrative or judicially imposed sanctions, including:
· warning letters;
· civil penalties;
· criminal penalties;
· injunctions;
· product seizure or detention;
· product recalls; and
· total or partial suspension of productions.
Delays in successfully commencing or completing
our planned clinical trials could jeopardize our ability to obtain regulatory approval and sustain our operations.
Our business prospects depend
on our ability to complete studies, commence and complete our planned clinical trials, including our ongoing and planned studies in solid
tumors in cancer, 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:
· failure to obtain required approvals to commence our planned clinical trials;
· slow patient enrollment in our planned clinical trials;
· serious adverse events related to our Hemopurifier;
· unsatisfactory results of any clinical trial;
Our development costs will increase
if we have material delays in any clinical trial or if we need to perform more or larger clinical trials than planned. If the delays are
significant, or if any of our product candidates do not prove to be safe or effective or do not receive required regulatory approvals,
our financial results and the commercial prospects for our product candidates will be harmed. Furthermore, our inability to complete our
clinical trials in a timely manner could jeopardize our ability to obtain regulatory approval for our Hemopurifier or any other potential
product candidates.
If we or our suppliers fail to comply with ongoing
FDA or foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products could be
subject to restrictions or withdrawal from the market.
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 System
Regulation, or QSR. These FDA regulations cover the methods and documentation of the design, testing, production, control, quality 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 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 QSR through periodic announced and unannounced inspections of manufacturing and other facilities. The failure by 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:
· unanticipated expenditures to address or defend such actions;
· operating restrictions or partial suspension or total shutdown of production;
· refusal to grant export approval for our products; or
· criminal prosecution.
Moreover, the FDA strictly regulates
the promotional claims that may be made about approved products. In particular, a product may not be promoted for uses that are not approved
by the FDA as reflected in the product’s approved labeling. However, companies may share truthful and not misleading information
that is otherwise consistent with a product’s FDA approved labeling. 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 civil, criminal and administrative penalties.
Any of these sanctions could 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.
If our products, or malfunction of our products,
cause or contribute to a death or a serious injury, we will be subject to medical device reporting regulations, which can result in voluntary
corrective actions or agency enforcement actions.
Under the FDA medical device 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 the dedication of our time
and capital, distract management from operating our business, and may harm our reputation and financial results.
We outsource many of our operational and development
activities, and if any party to which we have outsourced certain essential functions fails to perform its obligations under agreements
with us, the development and commercialization of our Hemopurifier product candidate and any future product candidates that we may develop
could be delayed or terminated.
We rely on third-party consultants
or other vendors to manage and implement much of the day-to-day conduct of our clinical trials and the manufacturing our Hemopurifier
product candidate. Accordingly, we are and will continue to be dependent on the timeliness and effectiveness of the efforts of these third
parties. Our dependence on third parties includes key suppliers and third-party service providers supporting the development, manufacture
and regulatory approval of our Hemopurifier, as well as support for our information technology systems and other infrastructure. While
our management team oversees these vendors, failure of any of these third parties to meet their contractual, regulatory and other obligations
or the development of factors that materially disrupt the performance of these third parties could have a material adverse effect on our
business. For example, all of the key oversight responsibilities for the development and manufacture of our Hemopurifier are conducted
by our management team, but all other activities are the responsibility of third-party vendors.
If a clinical research organization
that we utilize is unable to allocate sufficient qualified personnel to our studies in a timely manner or if the work performed by it
does not fully satisfy the requirements of the FDA or other regulatory agencies, we may encounter substantial delays and increased costs
in completing our development efforts. Any manufacturer that we select may encounter difficulties in the manufacture of new products in
commercial quantities, including problems involving product yields, product stability or shelf life, quality control, adequacy of control
procedures and policies, compliance with FDA regulations and the need for further FDA approval of any new manufacturing processes and
facilities. If any of these occur, the development and commercialization of our Hemopurifier product candidate could be delayed, curtailed
or terminated, because we may not have sufficient financial resources or capabilities to continue such development and commercialization
on our own.
If we or our contractors or service providers
fail to comply with regulatory laws and regulations, we or they could be subject to regulatory actions, which could affect our ability
to develop, market and sell our Hemopurifier product candidate and any other future product candidates that we may develop, if any, and
may harm our reputation.
If we or our manufacturers or
other third-party contractors fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to 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 mode of administration may make the product candidate not commercially viable. The
required testing of the product candidate may make that candidate no longer commercially viable. The conduct of clinical trials may be
critiqued by the FDA, or a clinical trial site’s IRB or Institutional Biosafety Committee, which may delay or make impossible 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.
This would have a material adverse effect on the value of the product candidate and our business prospects.
We will need to outsource and rely on third
parties for the clinical development, sales and marketing of our Hemopurifier or any future product candidates that we may develop, and
our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties.
We do not have the required financial
and human resources to carry out on our own all the pre-clinical and clinical development for our Hemopurifier product candidate or any
other or future product candidates that we may develop, and do not have the capability and resources to market or sell our Hemopurifier
product candidate or any future product candidates that we may develop. Our business model calls for the partial or full outsourcing of
the clinical and other development, sales and marketing of our product candidates in order to reduce our capital and infrastructure costs
as a means of potentially improving our financial position. Our success will depend on the performance of these outsourced providers.
If these providers fail to perform adequately, our development of product candidates may be delayed and any delay in the development of
our product candidates would have a material and adverse effect on our business prospects.
We are and will be exposed to product liability
risks, and clinical and preclinical liability risks, which could place a substantial financial burden upon us should we be sued.
Our business exposes us to potential
product liability and other liability risks that are inherent in the testing, manufacturing and marketing of medical devices. Claims may
be asserted against us. A successful liability claim or series of claims brought against us could have a material adverse effect on our
business, financial condition and results of operations. We may not be able to continue to obtain or maintain adequate product liability
insurance on acceptable terms, if at all, and such insurance may not provide adequate coverage against potential liabilities. Claims or
losses in excess of any product liability insurance coverage that we may obtain could have a material adverse effect on our business,
financial condition and results of operations.
Our Hemopurifier product candidate
may be used in connection with medical procedures in which it is important that those products function with precision and accuracy. If
our product candidates, including our Hemopurifier, do not function as designed, or are designed improperly, we may be forced by regulatory
agencies to withdraw such products from the market. In addition, if medical personnel or their patients suffer injury as a result of any
failure of our products to function as designed, or our products are designed inappropriately, we may be subject to lawsuits seeking significant
compensatory and punitive damages. 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 obtained general clinical trial liability insurance coverage.
However, our 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 product recall or lawsuit seeking significant monetary damages may have a material
effect on our business and financial condition. Any liability for mandatory damages could exceed the amount of our coverage. Moreover,
a product recall could generate substantial negative publicity about our products and business and inhibit or prevent commercialization
of other future product candidates.
We have not received, and may never receive,
approval from the FDA to market a medical device in the United States.
Before a new medical device 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,
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. 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:
· inadequate compliance with preclinical, clinical or other regulations;
· our failure to meet the FDA’s statistical requirements for approval; and
Modifications to products 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, 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,
or even longer, from the time the application is submitted to the FDA until an approval is obtained. Any of our products considered 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).
Although we have received approval
to proceed with clinical trials of the Hemopurifier in the United States under the investigational device exemption, the current approval
from the FDA to proceed could be revoked, the study could be unsuccessful, or the FDA PMA approval may not be obtained or could be revoked.
Even if we obtain approval, the FDA or other regulatory authorities may require expensive or burdensome post-market testing or controls.
Any delay in, or failure to receive or maintain, clearance or approval for our future products could prevent us from generating revenue
from these products or achieving profitability. Additionally, the FDA and other regulatory authorities have broad enforcement powers.
Regulatory enforcement or inquiries, or other increased scrutiny on us, could dissuade some physicians from using our products and adversely
affect our reputation and the perceived safety and efficacy of our products.
The approval requirements for medical products
used to fight bioterrorism and pandemics are still evolving, and any products we develop for such uses may not meet these requirements.
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 HealthCanada approval in Canada. Based on our studies to
date, the Hemopurifier can potentially clear many viruses that are pathogenic in humans, including HCV, HIV, Monkeypox and Ebola.
For example, in June 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. This 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 had acute lung injury and/or severe or life-threatening disease, among other criteria. Due
to lack of COVID-19 patients in the ICUs of our trial sites, we terminated this study in 2022.
As a result of the termination
of our COVID-19 study due to lack of patients in the ICUs, we were unable to demonstrate the effectiveness of our treatment countermeasures
through controlled human efficacy studies in this U.S. study. Additionally, a change in government policies could impair our ability to
obtain regulatory approval for the Hemopurifier.
The results of our clinical trials may not support our product candidate
claims or may result in the discovery of adverse side effects.
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 regulations or the FDA may take enforcement action. The data collected from these clinical studies may
ultimately be used to support market clearance for these products. Even if our clinical trials are completed as planned, the results 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
trials will experience adverse side effects that are not currently part of the product candidate’s profile.
U.S. legislative or FDA 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 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 regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be on
our product development efforts.
Our current and future business activities are
subject to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security
and other healthcare laws and regulations, which could expose us to significant penalties.
We are currently and will in the
future be subject to healthcare regulation and enforcement by the U.S. federal government and the states in which we will conduct our
business if our product candidates are approved by the FDA and commercialized in the United States. In addition to the FDA’s restrictions
on marketing of approved 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. 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.
We and the third parties with whom we work are
subject to stringent and changing U.S. and foreign laws, rules, regulations and standards as well as policies, contracts and other obligations
related to data privacy and security. Our actual or perceived failure to comply with such obligations, or such failure by the third parties
with whom we work, could lead to regulatory investigations or actions, fines and penalties, a disruption of our clinical trials or commercialization
of our products, private litigation, including class claims, and mass arbitration demands, harm to our reputation, or other adverse effects
on our business or prospects.
In the ordinary course of business,
we collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share,
or collectively, “Process” or “Processing” personal data and other Sensitive Information (as defined below), including
proprietary and confidential business data, trade secrets, and intellectual property that we collect in connection with clinical trials,
as necessary to operate our business, for legal and marketing purposes, and for other business-related purposes. Our data Processing activities
may subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external
and internal privacy and security policies, representations, certifications, standards, publications, frameworks, contractual requirements
and other obligations related to data privacy and security collectively, “Data Protection Obligations”.
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 addition, over the past few
years, numerous U.S. states—including California, Virginia, Colorado, Connecticut, and Utah—have enacted comprehensive privacy
laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording
residents with certain rights concerning their personal data. As applicable, such rights may include the right to access, correct, or
delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated
decision-making. The exercise of these rights may impact our business and ability to provide our products and services. Certain states
also impose stricter requirements for processing certain personal data, including sensitive information, such as conducting data privacy
impact assessments. These state laws allow for statutory fines for noncompliance. For example, the California Consumer Privacy Act of
2018, or CCPA, applies to personal data of consumers, business representatives, and employees who are California residents, and requires
covered businesses to provide specific disclosures in privacy notices and honor requests of California residents to exercise certain privacy
rights. The CCPA also provides for fines of up to $7,500 per intentional violation and allows private litigants affected by certain data
breaches to recover significant statutory damages. The CCPA and other comprehensive U.S. state privacy laws exempt some data Processing
in the context of clinical trials, but these developments may further complicate compliance efforts, and increase legal risk and compliance
costs for us, the third parties with whom we work. Similar laws are being considered in several other states, as well as at the federal
and local levels, and we expect more states to pass similar laws in the future.
Outside the United States, an
increasing number of laws, regulations, and industry standards may govern data privacy and security. For example, the European Union’s
General Data Protection Regulation, or EU GDPR, and the United Kingdom’s GDPR, or UK GDPR, or collectively GDPR, Australia’s
Privacy Act, and India’s Information Technology Act and supplementary rules impose strict requirements for Processing personal data.
For example, under GDPR, companies can face private litigation related to Processing of personal data brought by classes of data subjects
or consumer protection organizations authorized at law to represent their interests, temporary or definitive restrictions on data Processing
or other corrective actions, and fines of up to the greater of 20 million Euros under the EU GDPR / 17.5 million pounds streamline under
the UK GDPR or 4% of their worldwide annual revenue, whichever is greater.
In addition, we may be unable
to transfer personal data from Europe and other jurisdictions to the United States or other countries due to data localization requirements
or limitations on cross-border data flows. Europe and other jurisdictions have enacted laws requiring data to be localized or limiting
the transfer of personal data to other countries. In particular, the European Economic Area, or EEA, and the United Kingdom, or UK, have
significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it generally believes
are inadequate. Other jurisdictions may adopt similarly stringent interpretations of their data localization and cross-border data transfer
laws. Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States
in compliance with law, such as the EEA’s standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum,
and the EU-U.S. Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who
self-certify compliance and participate in the Framework) these mechanisms are subject to legal challenges, and there is no assurance
that we can satisfy or rely on these measures to lawfully transfer personal data to the United States. If there is no lawful manner for
us to transfer personal data from the EEA, the UK, or other jurisdictions to the United States, or if the requirements for a legally-compliant
transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations,
the need to relocate part of or all of our business or data processing activities to other jurisdictions at significant expense, increased
exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners, vendors and other
third parties, and injunctions against our processing or transferring of personal data necessary to operate our business. Some European
regulators have ordered certain companies to suspend or permanently cease certain transfers of personal data out of Europe for allegedly
violating the EU GDPR’s cross-border data transfer limitations. Additionally, companies that transfer personal data to recipients
outside of the EEA and/or UK to other jurisdictions, particularly to the United States, are subject to increased scrutiny from regulators
individual litigants and activist groups.
We publish privacy policies and
may publish marketing materials and other statements, such as compliance with certain certifications or self-regulatory principles, regarding
data privacy and security. If these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair,
or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators, or other adverse consequences.
In addition to data privacy and
security laws, we are contractually subject to industry standards adopted by industry groups and may become subject to such obligations
in the future. We are also bound by other contractual obligations related to data privacy and security, and our efforts to comply with
such obligations may not be successful.
Data Protection Obligations, and
consumers’ data privacy expectations, are quickly changing, becoming increasingly stringent, and creating uncertainty. Additionally,
these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions.
Preparing for and complying with these obligations requires us to devote significant resources and may necessitate changes to our services,
information technologies, systems, and practices and to those of any third parties that process personal data on our behalf.
Although we endeavor to comply
with all applicable Data Protection Obligations, we may at times fail, or be perceived to have failed, to do so. Moreover, despite our
efforts, our personnel or third parties with whom we work may fail to comply with such obligations, which could negatively impact our
business operations and compliance posture.
If we or third parties fail, or
are perceived to have failed, to address or comply with applicable Data Protection Obligations, it could: increase our compliance and
operational costs; expose us to regulatory scrutiny, actions, fines and penalties; result in reputational harm; interrupt or stop our
clinical trials; result in litigation and liability; result in an inability to process personal data or to operate in certain jurisdictions;
harm our business operations or financial results or otherwise result in a material harm to our business, or other material adverse impact
on our business, results of operations and financial condition. Additionally, given that Data Protection Obligations impose complex and
burdensome obligations and that there is substantial uncertainty over the interpretation and application of these obligations, we may
be required to incur material costs, divert management attention, and change our business operations, including our clinical trials, in
an effort to comply, which could materially adversely affect our business operations and financial results.
Any of these events could have
a material adverse effect on our reputation, business, or financial condition, including but not limited to: loss of customers; interruptions
or stoppages in our business operations including, as relevant, clinical trials inability to process personal data or to operate in certain
jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry;
adverse publicity; or revision or restructuring of our operations.
If our information technology systems, or those
of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such
compromise, including but not limited to: regulatory investigations or actions; litigation; fines and penalties; disruptions of our business
operations; reputational harm; loss of revenue or profits; and other adverse consequences.
In the ordinary course of our
business, we and third parties with whom we work may process proprietary, confidential and sensitive information, including personal data,
intellectual property, trade secrets, and proprietary business information owned or controlled by ourselves or other third parties, or
collectively, Sensitive Information. We may use and share Sensitive Information with service providers and subprocessors and other 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.
Cyberattacks, malicious internet-based
activity and online and offline fraud are prevalent, continue to rise, and are increasingly difficult to detect. These threats come from
a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized criminal
threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors. Some actors
now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical
reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we and the third
parties with whom we work may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially
disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our goods and services.
We and the third parties with
whom we work are subject to a variety of evolving threats, including but not limited to social-engineering attacks, including through
deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks, supply-chain attacks, loss of data or
other information technology assets, adware, software bugs, malicious code, such as viruses and worms, employee theft or misuse, denial-of-service
attacks, such as credential stuffing, and ransomware attacks. We may also be the subject of viruses, malware, including as a result of
advanced persistent threat intrusions, server malfunction, software or hardware failures, loss of data or other computer assets, adware,
attacks enhanced or facilitated by AI, telecommunications failures, earthquakes, fires, floods, or other similar threats.
Ransomware attacks, including
by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe,
and can lead to significant interruptions in our operations, loss of Sensitive Information and income, reputational harm, and diversion
of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such
payments due to, for example, applicable laws or regulations prohibiting such payments.
Remote work has become more common
and has increased risks to our information technology systems and data, as more of our employees utilize network connections, computers,
and devices outside our premises or network, including working at home, while in transit and in public locations. Additionally, future
or past business transactions, such as acquisitions or integrations, could expose us to additional cybersecurity risks and vulnerabilities,
as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies.
Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and it
may be difficult to integrate companies into our information technology environment and security program.
In addition, our reliance on third-party
service providers could introduce new cybersecurity risks and vulnerabilities, including supply-chain attacks, and other threats to our
business operations. We rely on third-parties and their technologies to operate critical business systems to process Sensitive Information
in a variety of contexts, including, without limitation, cloud-based infrastructure, data center facilities, encryption and authentication
technology, employee email, content delivery to customers, and other functions. We also rely on third-party service providers to assist
with our clinical trials, provide other products or services, or otherwise to operate our business. Our ability to monitor these third
parties’ information security practices is limited, and these third parties may not have adequate information security measures
in place. If our third-party service providers experience a Security Breach or other interruption, we could experience adverse consequences.