OTC: RTGN

The
Company’s first two devices described below are being designed to foster the Company’s active pursuit of its mission to prevent
vision loss and blindness due to ocular diseases, including diabetic retinopathy and maculopathy:

1.
Retinal
Imaging Screening Device, a portable, retinal imaging system providing a wide field of view without requiring pupil dilation;
and

2.
RetinalCamTM,
an in-home/remote location patient-activated monitoring and imaging device offering real-time communication and alerting system for
physicians available 24/7 and does not require dilation of the consumer’s pupil. We intend to launch RetinalCamTM
by the end of 2026.

In
addition to the above medical devices, as announced in October 2023, we are engaged with Pearl IRB, a provider of diagnostic testing
services for its Institutional Review Board (“IRB”) to conduct a study to personalize medical evaluations for patients receiving
direct intraocular injections into their eyes as treatment for wet macular degeneration to help determine whether there is a genetic
basis for the success or the failure of the procedure and to help patients evaluate whether the treatment is necessary, which was previously
announced on October 30, 2023. We have engaged phlebotomists from Seven Springs Surgery Center to facilitate the blood draw process necessary
for the Pearl IRB study. We anticipate an expansion of the IRB to multistate physicians in the winter of 2026 and the initial analysis
by the first half of 2027, which will inform our clinical trial plans.

In
addition to the above medical device and IRB advancements, we continue to make progress in our planning/and guidance to move forward,
via our contracted clinical resource organization, to conduct pharmaceutical clinical studies for our two products

1.
RTG-2023 for the treatment of dry age-related
macular degeneration (dry AMD); and

2.
RTG-2024 for the treatment of Alzheimer’s
syndrome dementia.

Our
wholly owned subsidiary, DNA/GPS Inc., through pharmacogenetic mapping and testing is linking high resolution retinal imaging to retinal
and systemic disease biomarkers to enable the discovery and treatment of sight-threatening and systemic diseases using our proprietary
high resolution retinal imaging device. This genetic testing can also lead to drug re-purposing (i.e., new uses of previous drugs now
off patent based on genetics).

We
are developing a secure and interoperable database system for genetic information and images controlled by patients for use with their
physicians, the RetinalGenix Eye Care Anonymized AI database (RECADTM AI system). This database is being designed to combine pharmacogenetic
mapping capabilities with our retinal imaging capabilities on a secure information system controlled by the patient (like a patient electronic
health record), who can share information with their selected physicians.

To
date, we have devoted substantially all of our resources to organizing, business planning, raising capital, designing and developing
product candidates, and securing manufacturing and sales/distribution partners. We do not have any products approved for sale and have
not generated any revenue from product sales. We have funded our operations primarily through the private placement of common stock.

We
anticipate that we will need approximately an additional $7,000,000 to (i) complete and sell genetic testing products with our DNA/GPS
mapping technology; (ii) complete the product design and testing for the RetinalCamTM in our Imaging platform; (iii) develop
and advance the networking agreements with various service optical and clinical networking groups; and (iv) create and test our RetinalGenix
Eye Care Anonymized AI database (RECAD AI system). We intend to obtain such funds through the sales of our equity and debt securities
and/or through potential strategic partnerships; however, no assurance can be provided that funds will be available to us on acceptable
terms, if at all. We do not expect that the RetinalCamTM will require FDA approval.

We
expect to generate revenues from the sale of DNA/GPS’ laboratory developed consumer test kits. We do not expect to generate any
revenues from sales of the RetinalCamTM or the Patient Informational database (RECAD AI system), until we successfully complete
their development. In addition, we expect to incur additional costs associated with operating as a public company, including significant
legal, accounting, investor relations, compliance and other expenses.

As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such
time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through
public or private equity offerings, debt financings, strategic partnerships, collaborations and licensing arrangements or other capital
sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms or
at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial
condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant
rights to develop and market our product candidates.

6

We
issued shares of our common stock pursuant to a private placement raising approximately $3.0 million from the sale of 3,070,000 shares
of common stock from 2019 through January 2022. In October 2021, the registration statement on Form S-1 (the “Registration Statement”)
that we filed with the Securities and exchange Commission (the “SEC”) pursuant to which we registered for resale shares of
common stock, including shares of common stock issuable upon exercise of outstanding options and warrants was declared effective. No
funds were raised by the Company pursuant to the Registration Statement.

We commenced a private placement of common stock in
2024 at $2.25 per share. During the year ended December 31, 2025, the Company sold 232,444 of its common stock at $2.25 per share for
gross proceeds of $548,000, including $125,000 which was recorded as a stock subscription receivable at December 31, 2025, and was received
in January 2026. During 2024, we issued 290,262 shares of common stock and raised approximately $653,000, including $150,000 which was
recorded as a stock subscription receivable at December 31, 2024 and was received in January 2025. There can be no assurance that we will
be able to raise capital when needed.

Because
of the numerous risks and uncertainties we are unable to accurately predict the timing or amount of increased expenses or when or if
we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If
we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations
at planned levels and be forced to reduce or terminate our operations.

Strategic
Pillars:

The
Company’s strategic portfolio has 4 pillars:

1.Genetic
testing: Pharmacogenetic mapping, highlighting key health biomarkers for eye and systemic
diseases, through RetinalGenix’s DNA/GPS Inc and partnered organizations.

2.Retinal
Imaging platform: Retinal camera and operating system for economically capturing high definition
optical images for analysis by healthcare providers, using RetinalCamTM ,
existing clinical images and RetinalGenix’s Imaging System.

3.Patient
Informational database: Secure and interoperable database system for genetic information
and images controlled by patients for use with their physicians, using RetinalGenix Eye Care
Anonymized AI database (RECADTM AI system).

4.Pharmaceutical
Therapies: Developing pharmaceutical products for treating eye and systemic diseases with
partnered support, with RTG-2023 (dry age-related macular degeneration) and RTG-2024 (Alzheimer’s
syndrome dementia).

The
Company is working to bring these four pillars as described below together to empower the patient and their chosen physician(s) to make
better clinical decisions to improve eye and general health.

1)
Genetic Testing:

On
July 5, 2022, we entered into an Exchange Agreement (the “Exchange Agreement”) with Dr. Lawrence Perich pursuant to which
we acquired all the outstanding shares of DNA/GPS Inc., a pharmacogenetics company based in Tampa, Florida (“DNA/GPS”), in
exchange for the issuance of 2,000,000 shares of our common stock. We accounted for this transaction as an asset acquisition in the year
ending December 31, 2022, and recorded the estimated purchase consideration and related expenses as in process research and development
in the accompanying consolidated statement of operations.

Through
RetinalGenix’s DNA/GPS Inc and supported by partnered organizations, we are developing genetic testing kits. The DNA/GPS Inc. acquisition
secured the team to develop these genetic tests. Significant research has been enacted to identity key biomarkers of eye and systemic
diseases that correlate with genetic variations. With these identified biomarkers, we worked with a third-party to develop oral swab
genetic testing kits.

Patients
will be able to purchase and use these swab-based tests that will identify their genetic profiles with our third-party partner. These
genetic profiles will be independently evaluated to provide the patient a summary report showing their genetics compared to genetic norms.
This information will be provided to the patient who could share these results with their physicians or other care providers, where clinical
decisions are made regarding diagnosis, treatment and monitoring. In addition, this genetic information would also be fully and securely
anonymized to create a patient-blinded genetic profile to be shared back to RetinalGenix’s Eye Care Anonymized AI database for
future analysis and research (see # 3 below), which the patient can in the future access and securely share with their physicians or
others.

In
2026, we intend to begin selling these tests to patients. A third-party genetic testing company will provide manufacturing, distribution,
clinical processing and reporting services. An independent analytics company will provide the genetic readings and reports for patients.

Pearl
IRB Study

The
Company is engaged with Pearl IRB, a provider of diagnostic testing services for its Institutional Review Board (“IRB”) to
conduct a study to personalize medical evaluations for patients receiving direct intraocular injections into their eyes as treatment
for wet macular degeneration to help determine whether there is a genetic basis for the success or the failure of the procedure and to
help patients evaluate whether the treatment is necessary, which was previously announced on October 30, 2023.

The
study is enrolling patients and looks to evaluate up to 100 patients in 2026. The Company is working with a third-party lab company for
this trial. Once completed, additional clinical evaluation may be pursued, potentially leading to FDA submission for improving patient
selection of positive responders to this treatment for wet AMD in 2027.

This
study will also economically secure additional biomarkers for RetinalGenix, that can be reviewed and evaluated for future genetic and
systemic diseases research.

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2)
Retinal Imaging platform:

RetinalGenix
is developing a retinal camera and operating system for capturing optical images for analysis by healthcare providers. This platform
is being developed by third-party optical imaging consultants and a third-party medical device company.

This
RetinalCamTM is an economical portable camera for ophthalmic home screening and monitoring. This device will provide
remote general and home use, using real-time communication and alerting system for physicians available 24/7. This camera does not require
dilation of the consumer’s pupil. It is anticipated that in late 2026, the next generation of this camera will be completed by
a leading optical design, engineering, and fabrication firm. We do not believe FDA approval is required as the camera is used for screening
and monitoring.

Image
information from these RetinalCamTM units will be incorporated into RetinalGenix’s Imaging System for secure patient
and physician utilization. This Imaging System is being developed with a third-party, ADM Tronics Unlimited, Inc. (“ADM Tronics”).

Additionally,
this Imaging System can also utilize quality eye images (Fundus or OTC) from existing ophthalmic devices which will facilitate market
entry before our lower cost (with multiple unique advanced functions) RetinalCamTM further penetrates the market.

Images
taken by these RetinalCamTM in a clinical office setting, would be owned by the practitioner’s office. Images secured
by patients outside such clinics, would be owned and controlled by the patient, who could securely share such images with their doctors.

RetinalCamTM
images would also be securely anonymized to create a patient-blinded image that is shared back to RetinalGenix’s Eye Care Anonymized
AI database for future analysis and research (see # 3 below). These images and the genetics data would be anonymously secured within
this database.

3)
Patient Informational database, the RetinalGenix Eye Care Anonymized AI database (RECADTM AI system):

The
Company is developing a secure and interoperable database system for genetic information and images controlled by patients for use with
their physicians, the RetinalGenix Eye Care Anonymized AI database (RECADTM AI system). This database will combine pharmacogenetic
mapping capabilities with our retinal imaging capabilities on a secure information system controlled by the patient (like a patient electronic
health record), who can share information with their selected physicians.

The
anonymized system with privacy (HIPAA & PII) protections empowers users to control their health and medical information.

The
database is expected to allow patients to obtain their genetic, systemic biomarkers and imaging information privately, discreetly, and
confidentially.

While
this anonymized database protects personal information, the secure system is intended to identify, monitor, profile, and screen patients
for ocular and systemic diseases, including cardiovascular, stroke, diabetes, Alzheimer’s, dementia, and Parkinson’s, at
a fraction of the cost of existing methods.

These
features enable patients and physicians to improve healthcare access to data and benefit patient care decisions. This cost-effective
approach also expands the early detection of eye and health issues from specialized labs to thousands of locations, including hospitals,
nursing homes, community care centers, schools, pharmacies, assisted living, walk-in clinics, doctors’ offices, ambulatory surgery
centers, optical outlets, etc.

This
system will also facilitate better drug development, by creating future research opportunities using new tools and artificial intelligence
(AI) to see correlations and clinically significant learnings from the combined genetic data and optical images, that can enable new
discoveries to improve patient care. These learnings and future intellectual property could be important benefits for the Company.

4)
Pharmaceutical Therapies:

RetinalGenix
is continuing to make progress in its planning/and guidance to move forward, via our contracted clinical resource organization, to conduct
pharmaceutical clinical studies for our two products.

●RTG-2023
for the treatment of dry age-related macular degeneration (dry AMD); and

●RTG-2024
for the treatment of Alzheimer’s syndrome dementia.

For
future clinical development of these products, the Company is pursuing potential collaborations and partnerships with pharmaceutical
or other healthcare companies to support such clinical programs in the future.

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Market
Opportunity

Through
the eye, we believe we can improve sight and overall health economically for patients with their care providers.

Unmet
need – the early diagnosis of systemic diseases

●
6
in 10 adults in the US have a chronic disease, The leading causes of death and disability and leading drivers of $4.1
trillion in annual health care costs.

●
Lack
of cost-efficient and easy-to-operate high-resolution screening technology enabling early diagnosis

●
Inefficient,
requiring the patient to access specialty centers and approvals away from home

●
Sophisticated
technicians needed to implement MRI, CT, PET scan, ultrasound, echocardiogram, blood draws at specialty labs, retinal testing, etc.

●
Results
of diagnoses generally are not immediate or confidential

●
Diagnostic
equipment is based at universities, large clinics, and hospitals

●
Geographic
accessibility (Rural even more limited)

Worsening
Doctor-to-Patient Ratio

●
Delay
in early treatment of eye and systemic diseases

●
There
is expected to be physician workforce shortages throughout the country in 2030

●
Specialists
needed to interpret test results

●
Inefficient,
limited, and costly use of eyecare specialists

●
Staffing
shortages: The healthcare workforce is facing provider and nursing shortages in many geographies

●
Decreasing
medical professional population. The US faces a projected shortage of between 37,800 and 124,000 physicians within 12 years

●
30+
million people in the US are without health insurance

●
Worldwide,
4.5 billion people were not fully covered by essential health services

Escalating
Blindness/Ocular Disease

●
Escalating
blindness due to maculopathy, age-related macular degeneration (wet and dry), diabetic retinopathy and other eye diseases

●
Insufficient
number of ophthalmologists and optometrists worldwide <600,000

●
Lack
of early detection of central visual loss or changes due to therapeutic toxicity and various other causes

●
Drug
toxicity from many sources, including therapeutics, metabolic and infectious diseases, auto-immune and vascular disorders

RetinalCamtm
and Home/Remote Monitoring Market:

The
US Target market consists of thousands of locations including hospitals, nursing homes, community care centers, schools, pharmacies,
assisted living, walk-in clinics, doctors’ offices, ambulatory surgery centers, optical outlets, etc.

In
addition to age-related macular degeneration, we are addressing early detection of Diabetic Retinopathy (“DR”) which happens
when too much blood sugar (glucose) associated with diabetes damages the blood vessels in the retina. As a result, the retina does not
get enough oxygen and nutrients, and blood vessels can leak blood into the retina. According to the Mayo Clinic, DR is the leading cause
of new cases of blindness in people 20 to 74 years of age in the United States. According to the Centers for Disease Control and Prevention
(“CDC”) 2022 National Diabetes Statistics Report, more than 130 million adults are living with diabetes or prediabetes in
the United States. The American Diabetes Association reports that diabetic retinopathy is the most common diabetic eye disease and a
leading cause of blindness in American adults. The number of individuals with diabetic retinopathy is predicted to increase by nearly
50% to over 11 million people by 2030. According to the CDC, 34.2 million patients in the U.S. have diabetic maculopathy with 26.9 million
diagnosed and 7.3 million undiagnosed. In addition, 88 million adult Americans are pre-diabetics of which 84%, or 74 million, are undiagnosed.
Diabetic maculopathy affects 500 million patients globally.

Drug
Development market:

Age-Related
macular degeneration - Market size:

There
are two forms of Age-Related macular degeneration (AMD): wet and dry. The wet form is the leading cause of permanent central vision loss.
The dry form can progress to the wet type if not monitored closely by a doctor. There are 18 million cases of dry AMD in the US. Most
of those 18 million do not even know that they are at risk. 200 million people worldwide are estimated to have AMD, and by 2040, this
number is projected to rise to close to 300 million. The current estimated global market size is $16.8 billion in 2025 with about $7.1
billion in North America.

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Alzheimer’s
syndrome and related dementias - Market size:

Alzheimer’s
is the seventh leading cause of death in the United States and is projected to cost the U.S. economy nearly one trillion dollars by 2050.
In the United States alone there were 6.7 million in 2022 and projected to be 139 million by 2050. There are over 55 million people worldwide
living with dementia and 2020 a reach 78 million in 2023 and 139 million by 2050. The North American Alzheimer’s therapeutic market
size is estimated to be $13.7 billion by 2030. In 2022 there were 6.7 million cases in the US costing $345 billion in 2023 and that did
not include the value of unpaid caregiving. Over 11 million Americans provide unpaid care for people with Alzheimer’s or other
dementias. In 2022, unpaid caregivers provided an estimated 18 billion hours of care valued at $339.5 billion - nearly doubling the cost
burden of this disease.

Genetic
Tests -Pearl IRB for diagnostic testing services - Market size:

IRB
for diagnostic testing services to personalize medical evaluations for patients receiving treatment for wet macular degeneration. (AMD)

Currently,
the treatment for AMD mainly involves repeated intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs. Although
it can preserve vision, repeated injections are an invasive treatment modality, which may lead to serious complications and reduce patient
adherence to treatment.

Currently,
patients who suffer from blindness are receiving intravitreal injections that may or may not be effective in treating their condition.
Such injections are very expensive and can cost up to $2,000 per eye on average. Moreover, these injections need to be administered for
the rest of the patient’s life, which poses a significant financial burden for insurance companies as well as Medicare.

According
to the BrightFocus Foundation and JAMA Ophthalmology, approximately 20 million people in the United States have AMD, and nearly 1.5 million
Americans have the advanced form (wet) of the disease. For the 18.5 million with dry AMD who can progress to wet AMD, understanding their
genetic profiles may improve future clinical decisions.

Genetic
Testing for Biomarkers

Through
our DNA/GPS platform, we can assess millions of DNA snippets (a small portion of DNA associated with one or more genes or attributes)
more rapidly than most current providers and at a significantly reduced cost.

The
Company intends to offer DNA/RNA GPS™ laboratory home-use test kits to help evaluate a patient’s disease risk profile. The
data from these test kits may be combined in our RetinalGenix Eye Care Anonymized AI database (RECADTM AI system) to provide
a non-invasive and cost-effective way to assess disease risk. RetinalGeniX DNA/RNA/GPS™ laboratory home-use test kits will be available
for purchase via clinician offices, direct-to-consumers and distributors.

The
goal here is to facilitate better drug selection, analysis, and validation and enable the early detection of systemic diseases. Understanding
the structure and function of DNA has helped accelerate the investigation of disease pathways, assess an individual’s genetic susceptibility
to specific diseases, diagnose genetic disorders, and formulate new drugs. It is also critical to the identification of pathogens.

●
The
analysis of retinal imaging provides a non-invasive and cost-effective way to evaluate a patient’s disease risk profile

●
The
patient will update the database via an app, which includes current medical diagnosis, medications, illnesses, allergies, diet, and
lifestyle. Medical history software application (in development).

Competition

Devices:

In
the device market, the ophthalmic medical technology industries utilize rapidly advancing technologies and are characterized by intense
competition. There is a strong emphasis on intellectual property and proprietary products. In the device market, we face competition
from different sources including ophthalmic medical technology companies, academic institutions, government agencies, and public and
private research institutions.

Our
critical competitive differentiators within the medical device market segment include in-home and out-of-home monitoring, 24/7 real-time
auto-alert to physician’s office and home, simultaneous internal and external imaging, patient-operated (no technician needed),
voice-activated operation to conduct monitoring, physician referral network, embedded patient data directory, easily portable for home
monitoring use, high-resolution external imaging standard, high-resolution retinal imaging standard, price range (our pricing is well
below the industry average even for those devices that do not pose a direct competitive threat.), auto-compensation (no corrective lens
needed), no eye dilation is needed.

Genetic
Testing for Systemic and Ocular Diseases

Through
our DNA/GPS platform, we can assess millions of DNA snippets (a small portion of DNA associated with one or more genes or attributes)
more rapidly than most current providers and at a significantly reduced cost.

Combined
in our RetinalGenix Eye Care Anonymized AI database (RECADTM AI system), the genetic mapping and retinal imaging analyses
is being designed to provide a non-invasive and cost-effective way to assess disease risk.

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Therapeutic
drugs:

Candidate
RTG 2023 for Age-Related Macular Degeneration (Dry). There are no FDA-approved drugs to prophylactically treat or stop dry AMD.

Candidate
RTG 2024 for Alzheimer’s syndrome: There are 11 Alzheimer FDA-approved solutions, three for disease modifying and eight for symptom
management. The disease modifying category of products is expected to significantly grow in the coming years.

Many
of our competitors have significantly greater financial resources and expertise in research and development, medical device development
and obtaining regulatory approvals than us, as well as more established distribution networks and relationships with healthcare providers.
Mergers and acquisitions in the ophthalmic medical technology industries may result in even more resources being concentrated among a
smaller number of our competitors. These competitors also compete with us in recruiting and retaining qualified personnel, as well as
in acquiring technologies complementary to our products.

Manufacturing
and Distribution

In
December 2025, the Company contracted with third-party optical engineering designing consultants to develop the RetinalGenixTM
camera hardware. Development of these camera prototypes is expected to be available in 2026.

On
June 24, 2021, we entered into an Amended and Restated Master Services Agreement (“Master Services Agreement”) with ADM Tronics
Unlimited, Inc. (“ADM Tronics”), pursuant to which ADM Tronics will provide us with software design, engineer and provide
regulatory services related to RetinalGeniXTM and RetinalCamTM. This agreement has been renewed in 2025 to support
the ongoing new camera system development.

Avania
Clinical has been contracted as the initial advisor for therapeutic drug development, specifically for the RTG-2023 and RTG-2024 product
candidates. Additionally, we have formed an institutional review board to launch a 100-patient clinical study intended to validate the
relative suitability of anti-VEGF ocular injection treatments for patient candidates with wet AMD.

Intellectual
Property Portfolio

Our
success depends in large part on our ability to protect our proprietary technologies and information, and to operate without infringing
the proprietary rights of third parties. We intend to rely on a combination of patent, trade secret, trademark, and copyright laws, as
well as confidentiality and other agreements, to establish and protect our proprietary rights. In addition, we rely on trade secrets,
proprietary know-how, and continuing technological advances to develop and maintain our competitive position. Our goal is to obtain,
maintain and enforce patent protection for our products, preserve our trade secrets, and operate without infringing on the proprietary
rights of other parties.

Sublicense
Agreement with Sanovas Ophthalmology LLC

On
June 24, 2021, we entered into a sublicense agreement (“Sublicense Agreement”) with Sanovas Ophthalmology LLC (“Sanovas
Ophthalmology”), a company for which our Chief Executive Officer is also the managing member, pursuant to which Sanovas Ophthalmology
granted us an exclusive worldwide (“Territory”) license to certain intellectual property, including six patents, two patent
applications, and two trademark applications, licensed to Sanovas Ophthalmology by Sanovas Intellectual Property LLC relating to certain
technologies for eye and ocular visualization and monitoring (“Licensed IP”) for uses related to the screening, examination,
diagnosis, prevention and/or treatment of any eye disease, medical condition or disorder, or any disease, medical condition or disorder
affecting the eye. The Licensed IP which has been issued by the USPTO and relates to methods of use and systems expires on dates ranging
from September 2034 to December 2034, and the Licensed IP which is still pending before the USPTO also relates to methods of use and
systems. Pursuant to the Sublicense Agreement, commencing on the date of the first commercial sale of a Licensed Product (as defined
in the Sublicense Agreement), in each country in the Territory and continuing on a country by country basis until the expiration or termination
of the last Valid Claim (as defined herein) of a licensed patent in such country (the “Royalty End Date”), we shall pay Sanovas
Ophthalmology a royalty equal to a mid-single digit percentage of any Net Sales (as defined in the Sublicense Agreement) of any Licensed
Product. “Valid Claim” means an issued, unexpired patent claim contained in a licensed patent as long as the claim has not
been admitted by Sanovas Intellectual Property, LLC, the owner of the Licensed IP, or otherwise caused to be invalid or unenforceable
through reissue, disclaimer or otherwise, or held invalid or unenforceable by a tribunal or governmental agency of competent jurisdiction
from whose judgment no appeal is allowed or timely taken. The Sublicense Agreement shall continue until the Royalty End Date, unless
earlier terminated pursuant to its terms. The Sublicense Agreement may be terminated by either party if the other party materially breaches
the Sublicense Agreement in a manner that cannot be cured, or materially breaches the Sublicense Agreement in a manner that can be cured,
and such breach remains uncured for more than 30 days after the receipt by the breaching party of notice specifying the breach. Furthermore,
we may terminate the Sublicense Agreement at any time upon 90 days written notice to Sanovas Ophthalmology.

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Government
Regulations

Our
business is subject to extensive, complex, and rapidly changing federal and state laws and regulations. Various federal and state agencies
have discretion to issue regulations and interpret and enforce healthcare laws. While we believe we comply in all material respects with
applicable healthcare laws and regulations, these regulations can vary significantly from jurisdiction, and interpretation of existing
laws and regulations may change periodically. Federal and state legislatures also may enact various legislative proposals that could
materially impact certain aspects of our business.

United
States Regulations

In
the U.S., medical devices are subject to regulation by the FDA under the Federal Food, Drug, and Cosmetic Act (the “FDCA”)
and its implementing regulations. The FDCA and regulations govern, among other things, the design, manufacture, storage, recordkeeping,
approval, labeling, promotion, post-approval monitoring and reporting, distribution and import and export of medical devices. Failure
to comply with applicable requirements may subject a device and/or its manufacturer to a variety of administrative and judicial sanctions,
such as FDA refusal to grant requests for 510(k) clearance, de novo classification, or premarket approval of new products or modified
products, issuance of warning letters or untitled letters, mandatory product recalls, import detentions, civil monetary penalties, and/or
judicial sanctions, such as product seizures, injunctions, and criminal prosecution.

The
FDCA classifies medical devices into one of three categories based on the risks associated with the device and the level of control necessary
to provide reasonable assurance of safety and effectiveness. Class I devices are deemed to be low risk and are subject only to the general
regulatory controls. Class II devices are moderate risk. They are subject to general controls and may also be subject to special controls.
Class III devices are generally the highest risk devices. They are required to obtain premarket approval and comply with post-market
conditions of approval in addition to general regulatory controls.

We
believe RetinalGeniXTM is a Class II medical device that will require 510(k) clearance from the FDA. In addition, we believe
RetinalCamTM will be considered a Class II exempt medical device because it is non-diagnostic in nature, and therefore, we
do not anticipate needing 510(k) clearance from the FDA to market such product. Pursuant to FDA product classification codes for ophthalmic
cameras under 21 C.F.R. § 886.1120, “PJZ” cameras are prescription devices indicated only for the capture and storage
of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g.,
pediatrics, AMD patients, etc.), cannot contain any type of “diagnostic” or “aid in diagnosis” claims in the
indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet,
visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection
for Ophthalmic Instruments. PJZ cameras also have other design and performance characteristics that are described by FDA in the product
code description.

If
the RetinalGeniXTM were to be classified as a Class II medical device, such classification would require us to submit a premarket
notification submission to FDA prior to marketing. We anticipate the submission will require clinical evidence of safety and efficacy,
generated through a regulated, randomized clinical trial or field evaluation. FDA clearance for ophthalmological devices usually require
about 170 days.

We
intend to launch RetinalCamTM in 2027. We do not intend to apply for 510(k) clearance for RetinalGeniXTM because
we do not believe such clearance is necessary.

FDA
Pre-Market Authorization and Notification

Under
FDA regulations, all devices, including Class I devices, are subject to general controls, which are the basic authorities of the Medical
Device Amendments that provide the FDA with the means of regulating devices to ensure their safety and effectiveness (e.g., labeling,
facility registration and device listing and adherence to Quality System Regulation (“QSR”) requirements). For Class III
devices, a pre-market approval (“PMA”) application will be required unless the device is a pre-amendment device (on the market
prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) or is exempted from submission
of a PMA. In that case, a 510(k) will be the route to market. A 510(k) clearance will be granted if the submitted information establishes
that the proposed device is substantially equivalent to a legally marketed Class I or II medical device, or to a Class III medical device
for which the FDA has not required a PMA. The FDA may determine that a proposed device is not substantially equivalent to a legally marketed
device or that additional information or data are needed before a substantial equivalence determination can be made. A request for additional
data may require that clinical studies of the device’s safety and efficacy be performed.

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While
most Class I and some Class II devices may be marketed without prior FDA authorization, most other medical devices can be legally sold
within the U.S. only if the FDA has: (i) approved a PMA prior to marketing, generally applicable to most Class III devices; (ii) cleared
the device in response to a premarket notification, or 510(k) submission, generally applicable to Class I and II devices; or (iii) authorized
the device to be marketed through the de novo classification process, generally applicable for novel Class I or II devices. PMA
applications, 510(k) premarket notifications, and de novo requests require payment of substantial user fees that are modified
each fiscal year.

Commercial
distribution of a device for which a 510(k) notification is required may begin only after the FDA issues an order finding the device
to be substantially equivalent to a previously cleared device. Even in cases where the FDA grants a 510(k) clearance, it may take the
FDA between four and nine months from the date of submission to grant a 510(k) clearance, but may take longer.

A
“not substantially equivalent” determination, or a request for additional information, could delay the market introduction
of new products that fall into this category and could have a material adverse effect on our business, financial condition and results
of operations. For any of our products that are cleared through the 510(k) process, modifications or enhancements that could significantly
affect the safety or efficacy of the device or that constitute a major change to the intended use of the device will require new 510(k)
submissions.

Any
products manufactured or distributed by us are subject to pervasive and continuing regulation by the FDA, including record keeping requirements
and reporting of adverse experiences with the use of the device. Device manufacturers are required to register their establishments and
list their devices with the FDA and certain state agencies, and are subject to periodic inspections by the FDA and certain state agencies.
The FDCA requires devices to be manufactured to comply with applicable QSR regulations which impose certain procedural and documentation
requirements upon us with respect to design, development, manufacturing and quality assurance activities. The FDA enforces its requirements
by market surveillance and periodic visits, both announced and unannounced, to inspect or re-inspect equipment, facilities, laboratories
and processes to confirm regulatory compliance. These inspections may include the manufacturing facilities of subcontractors. Following
an inspection, the FDA may issue a report, known as a Form 483, listing instances where the manufacturer has failed to comply with applicable
regulations and/or procedures or, if observed violations are sufficiently severe and urgent, a warning letter. If the manufacturer does
not adequately respond to a Form 483 or warning letter, the FDA make take enforcement action against the manufacturer or impose other
sanctions or consequences.

We
are subject to unannounced inspections by the FDA and the Food and Drug Branch of the California Department of Public Health to determine
our compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of our subcontractors.

510(k)
Premarket Notification Pathway

Product
marketing in the U.S. for most Class II and a limited number of Class I devices typically follows the 510(k) premarket notification pathway.
To obtain 510(k) clearance, a manufacturer must submit a premarket notification demonstrating that the proposed device is substantially
equivalent to a legally marketed device, referred to as the “predicate device.” A predicate device may be a previously 510(k)-cleared
device placed in Class I or Class II via a finding of substantial equivalence to a lawfully marketed Class I or Class II device, or a
Class III device that was in commercial distribution before May 28, 1976 and for which the FDA has not yet called for PMA applications,
or a product previously placed in Class I or Class II through the de novo classification process. A finding of “substantial
equivalence” means the FDA must conclude that the proposed device has the same intended use as a predicate device, and it either
has the same technological characteristics, or it has different technological characteristics but submitted information (potentially
including clinical data) shows it is as safe and effective and does not raise different questions of safety and effectiveness as compared
to the predicate device.

The
FDA has a user fee goal to apply no more than 90 calendar review days to 510(k) submissions. During the process, the FDA may issue an
Additional Information request, which stops the clock. The applicant has no more than 180 days to respond (after which the submission
is automatically terminated). Therefore, the total review time could be up to a maximum of 270 days.

After
a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute
a major change in its intended use, requires a new 510(k) clearance or could require a PMA approval or de novo classification.
The FDA requires each manufacturer to make this determination in the first instance, but the FDA can review any such decision. If the
FDA disagrees with a manufacturer’s decision not to seek a new 510(k) clearance for the modified device, the agency may retroactively
require the manufacturer to seek 510(k) clearance, de novo classification, or PMA approval. The FDA also can require the manufacturer
to cease marketing and/or recall the modified device until 510(k) clearance or PMA approval is obtained.

13

Post-market
Requirements

After
a device is placed on the market, numerous general regulatory controls apply. These include: the QSR, labeling regulations, the medical
device reporting regulations (which require that manufacturers report to the FDA if their device may have caused or contributed to a
death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur),
and reports of corrections and removals regulations (which require manufacturers to report recalls or removals and field corrections
to the FDA if initiated to reduce a risk to health posed by the device or to remedy a violation of the FDCA). Failure to properly identify
reportable events or to file timely reports, as well as failure to address each of the observations to FDA’s satisfaction, can
subject a manufacturer to warning letters, recalls, or other sanctions and penalties.

Labeling
and promotional activities are subject to scrutiny by the FDA and by the Federal Trade Commission. The FDA actively enforces regulations
prohibiting marketing of products for unapproved uses. We and our products are also subject to a variety of state laws and regulations
in those states or localities where our products will be marketed. Any applicable state or local regulations may hinder our ability to
market our products in those states or localities. Manufacturers are also subject to numerous federal, state and local laws relating
to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous
or potentially hazardous substances. We may be required to incur significant costs to comply with such laws and regulations now or in
the future. Such laws or regulations may have a material adverse effect upon our ability to do business.

Advertising,
marketing and promotional activities for devices are also subject to FDA oversight and must comply with the statutory standards of the
FDCA, and the FDA’s implementing regulations. The FDA’s oversight authority review of marketing and promotional activities
encompasses, but is not limited to, direct-to-consumer advertising, healthcare provider-directed advertising and promotion, sales representative
communications to healthcare professionals, promotional programming and promotional activities involving electronic media. The FDA also
regulates industry-sponsored scientific and educational activities that make representations regarding product safety or efficacy in
a promotional context.

Manufacturers
of medical devices are permitted to promote products solely for the uses and indications set forth in the approved or cleared product
labeling. A number of enforcement actions have been taken against manufacturers that promote products for “off-label” uses
(i.e., uses that are not described in the approved or cleared labeling), including actions alleging that claims submitted to government
healthcare programs for reimbursement of products that were promoted for “off-label” uses are fraudulent in violation of
the Federal False Claims Act or other federal and state statutes and that the submission of those claims was caused by off-label promotion.
The failure to comply with prohibitions on “off-label” promotion can result in significant monetary penalties, revocation
or suspension of a company’s business license, suspension of sales of certain products, product recalls, civil or criminal sanctions,
exclusion from participating in federal healthcare programs, or other enforcement actions. In the United States, allegations of such
wrongful conduct could also result in a corporate integrity agreement with the U.S. government that imposes significant administrative
obligations and costs.

Violations
of the FDCA relating to the inappropriate promotion of approved products may lead to investigations alleging violations of federal and
state healthcare fraud and abuse and other laws, as well as state consumer protection laws.

For
a Class II or Class III device meeting certain requirements, the FDA also may require post-market surveillance requirements. Additionally,
the FDA may place conditions on a PMA-approved device that could restrict the distribution or use of the product. In addition, all classes
of devices must comply with quality-control, manufacture, packaging, and labeling procedures under the QSR, and manufacturers are subject
to periodic inspections by the FDA for compliance. Accordingly, manufacturers must continue to expend time, money, and effort in the
areas of production and quality control to maintain compliance with the QSR. The FDA may withdraw product approvals or recommend or require
product recalls if a company fails to comply with regulatory requirements.

Export
of our products is regulated by the FDA and subject to the FDCA, 21 U.S.C. §§381-384f, and other statutes FDA administers,
which greatly expanded the export of approved and unapproved United States medical devices. Some foreign countries require manufacturers
to provide a specific type of FDA export certificate (such as a Certificate to Foreign Government or Certificate of Exportability), which
may require the device manufacturer to certify the device is lawfully marketed in the United States, including in conformance with QSR
requirements, labeling regulations, premarket notification, and other requirements. The FDA will refuse to issue any export certificate
if significant outstanding QSR violations exist.

European
Union Regulations

In
the European Union (“EU”), there are four main medical device classes: I, IIa, IIb and III. Similar to the US classification
system, the EU classification system is a risk-based system, depending on the potential risk associated with the device. In the EU, we
believe the RetinalCamTM would be considered a Class IIa medical device, which would require the grant of a CE marking prior
to launching in the EU. To obtain a CE marking, the device manufacturer must be certified to ISO 13485, and the product must meet certain
harmonized standards for its design, development and testing. If the manufacturer is not self-certifying, outside agencies (known as
Notified Bodies) will be required to test and certify that the device meets the applicable requirements, including clinical evidence
of safe and effective use prior to the product being released for general market introduction.

14

U.S.
Drug Approval Process

In
the United States, the FDA regulates pharmaceutical and biological products under the Federal Food, Drug and Cosmetic Act, Public Health
Service Act (the “PHSA”), and implementing regulations. Products are also subject to other federal, state and local statutes
and regulations. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval
process or after approval, may subject an applicant to administrative or judicial sanctions. FDA sanctions could include, among other
actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls or withdrawals
from the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government
contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material
adverse effect on us. The process required by the FDA before a drug or biological product may be marketed in the United States generally
involves the following:

●
completion
of nonclinical laboratory tests and animal studies according to good laboratory practices, or GLPs, and applicable requirements for
the humane use of laboratory animals or other applicable regulations;

●
submission
to the FDA of an Investigational New Drug which must become effective before human clinical trials may begin;

●
performance
of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical
practices, or GCPs, and any additional requirements for the protection of human research subjects and their health information, to
establish the safety and efficacy of the proposed product for its intended use;

●
submission
to the FDA of an New Drug Application (NDA) for marketing approval that meets applicable requirements to ensure the continued safety,
purity, and potency of the product;

●
satisfactory
completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced, to assess compliance
with cGMP, to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality
and purity;

●
potential
FDA audit of the nonclinical trial and clinical study sites that generated the data in support of the NDA; and

●
FDA
review and approval, or licensure, of the NDA.

Before
testing any drug candidate in humans, the candidate enters the preclinical testing stage. Preclinical tests, also referred to as nonclinical
studies, include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential
safety and activity of the candidate. The conduct of the preclinical tests must comply with federal regulations and requirements including
GLPs. The clinical trial sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical
data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. Preclinical testing
may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA
raises concerns or questions regarding the proposed clinical trials and places the trial on a clinical hold within that 30-day time period.
In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA may also
impose clinical holds on a product candidate at any time before or during clinical trials due to safety concerns or non-compliance. If
the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by the FDA.
Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once begun,
issues will not arise that suspend or terminate such trials.

Clinical
trials involve the administration of the product candidate to healthy volunteers or patients under the supervision of qualified investigators,
generally physicians not employed by or under the trial sponsor’s control. Clinical trials are conducted under protocols detailing,
among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters
to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events
should occur. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND. Clinical trials must
be conducted and monitored in accordance with the FDA’s regulations composing the GCP requirements, including the requirement that
all research subjects provide informed consent. Further, each clinical trial must be reviewed and approved by an independent institutional
review board, or IRB, at or servicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting
the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical
trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the informed
consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial until
completed. Human clinical trials are typically conducted in three sequential phases; these phases may overlap or be combined:

●
Phase
1. The product candidate is initially introduced into healthy human volunteers and tested for safety. In the case of some products
for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy
volunteers, the initial human testing is often conducted in patients with the targeted disease.

●
Phase
2. The product candidate is evaluated in a limited patient population to identify possible adverse effects and safety risks,
to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage
and dosing schedule.

●
Phase
3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population
at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk to benefit ratio
of the product and provide an adequate basis for product labeling.

15

Post-approval
clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These clinical
trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for
long-term safety follow-up.

During
all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical
data, and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the
FDA. Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected adverse events,
any findings from other studies, tests in laboratory animals or in vitro testing that suggest a significant risk for human subjects,
or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator
brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies
for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven
calendar days after the sponsor’s initial receipt of the information. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed
successfully within any specified period, if at all. The FDA or the sponsor or its data safety monitoring board may suspend or terminate
a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable
health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not
being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpected serious
harm to subjects.

Concurrently
with clinical trials, companies usually complete additional studies and must also develop additional information about the physical characteristics
of the biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP
requirements. To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHSA emphasizes
the importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be
capable of consistently producing quality batches of the product candidate and, among other criteria, the sponsor must develop methods
for testing the identity, strength, quality, potency and purity of the final biological product. Additionally, appropriate packaging
must be selected and tested, and stability studies must be conducted to demonstrate that the biological product candidate does not undergo
unacceptable deterioration over its shelf life.

U.S.
Review and Approval Processes

After
the completion of clinical trials of a product, FDA approval of an NDA must be obtained before commercial marketing of the product. The
BLA must include results of product development, laboratory and animal studies, human trials, information on the manufacture and composition
of the product, proposed labeling and other relevant information. The FDA may grant deferrals for submission of data, or full or partial
waivers. The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept
the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.

Under
the Prescription Drug User Fee Act, or PDUFA, as amended, each NDA must be accompanied by a significant user fee. The FDA adjusts the
PDUFA user fees on an annual basis. PDUFA also imposes an annual program fee on approved products. Fee waivers or reductions are available
in certain circumstances, including a waiver of the application fee for the first application filed by a small business. No user fees
are assessed on NDA a for products designated as orphan drugs, unless the product also includes a non-orphan indication.

The
FDA has a Fast Track program that is intended to expedite or facilitate the process for reviewing new drugs and biological products that
meet certain criteria. Specifically, new biological products are eligible for Fast Track designation if they are intended to treat a
serious or life-threatening condition and demonstrate the potential to address unmet medical needs for the condition. Fast Track designation
applies to the combination of the product and the specific indication for which it is being studied. For a Fast Track biological product,
the FDA may consider review of completed sections of a NDA on a rolling basis provided the sponsor provides, and the FDA accepts, a schedule
for the submission of the completed sections of the NDA. Under these circumstances, the sponsor pays any required user fees upon submission
of the first section of the NDA. A Fast Track designated drug candidate may also qualify for priority review, under which the FDA reviews
the NDA in six months rather than ten months after it is accepted for filing.

Within
60 days following submission of the application, the FDA reviews a NDA submitted to determine if it is substantially complete before
the agency accepts it for filing. The FDA may refuse to file any NDA that it deems incomplete or not properly reviewable at the time
of submission, and may request additional information. In this event, the NDA must be resubmitted with the additional information. The
resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the
FDA begins an in-depth substantive review of the NDA. The FDA reviews the NDA to determine, among other things, whether the proposed
product is safe, potent, and/or effective for its intended use, and has an acceptable purity profile, and whether the product is being
manufactured in accordance with cGMP to assure and preserve the product’s identity, safety, strength, quality, potency and purity.
The FDA may refer applications for novel products or products that present difficult questions of safety or efficacy to an advisory committee,
typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application
should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers
such recommendations carefully when making decisions. During the product approval process, the FDA also will determine whether a Risk
Evaluation and Mitigation Strategy, or REMS, is necessary to assure the safe use of the biological product. If the FDA concludes a REMS
is needed, the sponsor of the NDA must submit a proposed REMS. The FDA will not approve a NDA without a REMS, if required.

16

Before
approving an NDA, the FDA will inspect the facilities at which the product is manufactured. The FDA will not approve the product unless
it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent
production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or
more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements and GCP requirements.
To assure cGMP and GCP compliance, an applicant must incur significant expenditure of time, money and effort in the areas of training,
record keeping, production, and quality control.

Notwithstanding
the submission of relevant data and information, the FDA may ultimately decide that the NDA does not satisfy its regulatory criteria
for approval and deny approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently
than we interpret the same data. If the agency decides not to approve the NDA in its present form, the FDA will issue a complete response
letter that describes all of the specific deficiencies identified in the NDA by the FDA. The deficiencies identified may be minor, for
example, requiring labeling changes, or major, for example, requiring additional clinical trials. Additionally, the complete response
letter may include recommended actions that the applicant might take to place the application in a condition for approval. If a complete
response letter is issued, the applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter, or
withdraw the application.

If
a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications
for use may otherwise be limited, which could restrict the commercial value of the product.

Further,
the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. The FDA may impose restrictions
and conditions on product distribution, prescribing, or dispensing in the form of a risk management plan, or otherwise limit the scope
of any approval. In addition, the FDA may require post marketing clinical trials, sometimes referred to as Phase 4 clinical trials, designed
to further assess a biological product’s safety and effectiveness, and testing and surveillance programs to monitor the safety
of approved products that have been commercialized.

In
addition, under the Pediatric Research Equity Act, an NDA or supplement to a NDA must contain data to assess the safety and effectiveness
of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each
pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partial
waivers.

Post-Approval
Requirements

Any
products for which we receive FDA approvals will be subject to continuing regulation by the FDA, including, among other things, record-keeping
requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product
sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among others, standards
for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the
product’s approved uses, known as ‘off-label’ use, limitations on industry-sponsored scientific and educational activities,
and requirements for promotional activities involving the internet. Although physicians may prescribe legally available products for
off-label uses, if the physicians deem to be appropriate in their professional medical judgment, manufacturers may not market or promote
such off-label uses.

In
addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval
to ensure the long-term stability of the product. cGMP regulations require among other things, quality control and quality assurance
as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from
cGMP. Manufacturers and other entities involved in the manufacture and distribution of approved products are required to register their
establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state
agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area
of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in restrictions
on a product, manufacturer, or holder of an approved NDA, including, among other things, recall or withdrawal of the product from the
market. In addition, changes to the manufacturing process are strictly regulated, and depending on the significance of the change, may
require prior FDA approval before being implemented. Other types of changes to the approved product, such as adding new indications and
claims, are also subject to further FDA review and approval.

The
FDA also may require post-marketing testing, known as Phase 4 testing, and surveillance to monitor the effects of an approved product.
Discovery of previously unknown problems with a product or the failure to comply with applicable FDA requirements can have negative consequences,
including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or
communications with doctors, and civil or criminal penalties, among others. Newly discovered or developed safety or effectiveness data
may require changes to a product’s approved 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 approval of our product candidates
under development.

17

Other
Healthcare Laws

In
addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws have been applied
to restrict certain general business and marketing practices in the pharmaceutical industry. These laws include anti-kickback, false
claims, transparency and health information privacy laws and other healthcare laws and regulations.

The
federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration
to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service
reimbursable under Medicare, Medicaid, or other federally financed healthcare programs. The Patient Protection and Affordable Care Act
as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA”) amended the intent element of the
federal Anti-Kickback Statute so that a person or entity no longer needs to have actual knowledge of the statute or specific intent to
violate it in order to commit a violation. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers
on the one hand and prescribers, purchasers and formulary managers, among others, on the other. Although there are a number of statutory
exceptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exceptions
and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases or recommendations
may be subject to scrutiny if they do not qualify for an exception or safe harbor. Additionally, the ACA amended the federal Anti-Kickback
Statute such that a violation of that statute can serve as a basis for liability under the federal civil False Claims Act. Federal civil
and criminal false claims laws, including the federal civil False Claims Act, prohibit any person or entity from knowingly presenting,
or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false
statement to have a false claim paid. This includes claims made to programs where the federal government reimburses, such as Medicare
and Medicaid, as well as programs where the federal government is a direct purchaser, such as when it purchases off the Federal Supply
Schedule. Pharmaceutical and medical device companies have been prosecuted under these laws for, among other things, allegedly providing
free product to customers with the expectation that the customers would bill federal programs for the product. In addition, certain marketing
practices, including off-label promotion, may also violate false claims laws. Most states also have statutes or regulations similar to
the federal Anti-Kickback Statute and civil False Claims Act, which apply to items and services reimbursed under Medicaid and other state
programs, or, in several states, apply regardless of the payor.

Other
federal statutes pertaining to healthcare fraud and abuse include the Civil Monetary Penalties Law statute, which prohibits, among other
things, the offer or payment of remuneration to a Medicaid or Medicare beneficiary that the offeror or payor knows or should know is
likely to influence the beneficiary to order or receive a reimbursable item or service from a particular supplier, and the additional
federal criminal statutes created by HIPAA, which prohibit, among other things, knowingly and willfully executing or attempting to execute
a scheme to defraud any healthcare benefit program or obtain by means of false or fraudulent pretenses, representations or promises any
money or property owned by or under the control of any healthcare benefit program in connection with the delivery of or payment for healthcare
benefits, items or services.

Further,
pursuant to the ACA, CMS issued a final rule that requires certain manufacturers of prescription drugs to collect and annually report
information on certain payments or transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists
and chiropractors), certain other health care professionals (such as physicians assistants and nurse practitioners) and teaching hospitals,
as well as ownership and investment interests held by physicians and their immediate family members. The reported data are made available
in searchable form on a public website on an annual basis. Failure to submit required information may result in civil monetary penalties.

Analogous
state and foreign anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare
items or services reimbursed by non- governmental third-party payors, including private insurers, or that apply regardless of payor.
In addition, several states now require prescription drug companies to report certain expenses relating to the marketing and promotion
of drug products and to report gifts and payments to individual healthcare practitioners in these states. Other states prohibit various
marketing-related activities, such as the provision of certain kinds of gifts or meals. Further, certain states require the posting of
information relating to clinical trials and their outcomes. In addition, certain states require medical device companies to implement
compliance programs and/or marketing codes.

Privacy
and Data Protection Laws

Data
privacy and security regulations by both the federal government and the states in which business is conducted may also be applicable.
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and its implementing
regulations, imposes requirements relating to the privacy, security and transmission of individually identifiable health information.
HIPAA requires covered entities to limit the use and disclosure of protected health information to specifically authorized situations
and requires covered entities to implement security measures to protect health information that they maintain in electronic form. Among
other things, HITECH made HIPAA’s security standards directly applicable to business associates, independent contractors or agents
of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered
entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable
to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts
to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

18

In
addition, state laws govern the privacy and security of health information in specified circumstances, many of which differ from each
other in significant ways and may not have the same effect, thus complicating compliance efforts. Certain state laws may be more stringent
or broader in scope, or offer greater individual rights, with respect to personal information, and such laws may differ from each other,
all of which may complicate compliance efforts. For example, the CCPA, which increases privacy rights for California residents and imposes
obligations on companies that process their personal information, came into effect on January 1, 2020. Among other things, the CCPA requires
covered companies to provide new disclosures to California consumers about their data collection, use and sharing practices and provide
such consumers new data protection and privacy rights, including the ability to opt out of certain sales of personal information. The
CCPA provides for civil penalties for violations, as well as a private right of action for certain data breaches that result in the loss
of personal information. This private right of action may increase the likelihood of, and risks associated with, data breach litigation.
On November 3, 2020, California voters approved a new privacy law, the CPRA, which significantly modifies the CCPA, including by expanding
consumers’ rights with respect to certain personal information and creating a new state agency to oversee implementation and enforcement
efforts. Many of the CPRA’s provisions will become effective on January 1, 2023. State laws are changing rapidly and there is discussion
in the U.S. of a new comprehensive federal data privacy law.

Healthcare
Reform

The
U.S. government and other governments have shown significant interest in pursuing continued healthcare reform. Any government-adopted
reform measures could adversely impact the pricing of healthcare products and services in the United States or internationally and the
amount of reimbursement available from governmental agencies or other third-party payors. Changes in applicable laws, rules, and regulations
or the interpretation of existing laws, rules, and regulations could impact our business in the future by requiring, for example: (i)
changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of
our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the
operation of its business. The continuing efforts of the U.S. and foreign governments, insurance companies, managed care organizations
and other payors of health care services to contain or reduce health care costs may adversely affect our ability to set prices for our
products which we believe are fair, and our ability to generate revenues and achieve and maintain profitability.

In
August 2022, the Inflation Reduction Act (“IRA”) was enacted, which, among other things, requires the U.S. Department of
Health and Human Services (“HHS”) to directly negotiate the selling price of a statutorily specified number of drugs and
biologics each year that CMS reimburses under Medicare Part B and Part D. The negotiated price may not exceed a statutory ceiling price.
Only high-expenditure single-source biologics that have been approved for at least 11 years (seven years for single-source drugs) are
eligible to be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year. For 2026,
the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare Part D products in 2023, negotiations
began in 2024, and the negotiated maximum fair price for each product has been announced. In addition, CMS has selected and announced
the negotiated maximum fair price for 15 additional Medicare Part D drugs which will become effective in 2027. For 2028, CMS has selected
an additional 15 drugs, comprised of drugs covered under Medicare Part D and, for the first time, drugs payable under Medicare Part B.
For 2029 and subsequent years, 20 Part B or D drugs will be selected. The negotiated prices have represented, and will continue to represent,
a significant discount from average prices to wholesalers and direct purchasers. The IRA also imposes rebates on Medicare Part B and
Part D drugs whose prices have increased at a rate greater than the rate of inflation, and in 2024, CMS finalized regulations for the
Medicare Part B and Part D inflation rebates. The IRA permits the Secretary of HHS to implement many of these provisions through guidance,
as opposed to regulation, for the initial years. Manufacturers that fail to comply with the IRA may be subject to various penalties,
including civil monetary penalties. These provisions have been, and may continue to be, subject to legal challenges. Although full economic
effect of the IRA on our business and the pharmaceutical industry in general is unknown at this time, it will likely have a significant
impact on the pharmaceutical industry and the pricing of our products and product candidates. Similarly, the adoption of restrictive
price controls in new jurisdictions, more restrictive controls in existing jurisdictions or the failure to obtain or maintain timely
or adequate pricing could also reduce our profitability. We expect pricing pressures will continue globally.

Additionally,
on April 15, 2025, the Trump Administration published Executive Order 14273, “Lowering Drug Prices by Once Again Putting Americans
First,” which generally directs the federal government to take measures to reduce drug prices. On May 12, 2025, the Trump Administration
published Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” which generally,
among other things, directs the federal government to establish and communicate most-favored-nation price targets to pharmaceutical manufacturers
to bring prices for American patients in line with comparably developed nations. Further, the Executive Order directs the federal government
to support regulatory paths to allow direct-to-patient sales for companies that meet these targets. It also states that the administration
will take additional aggressive action (for example, examining whether marketing approvals should be modified or rescinded or opening
the door for individual drug importation waivers) should manufacturers fail to offer American consumers the most-favored-nation lowest
price. It also directs the Secretary of Commerce and the U.S. Trade Representative to “take all necessary and appropriate action
to ensure foreign countries are not engaged in any act, policy, or practice that may be unreasonable or discriminatory or that may impair
United States national security including by suppressing the price of pharmaceutical products below fair market value in foreign countries.”
Recently, on December 23, 2025, CMS issued proposed regulations to establish, under the Center for Medicare and Medicaid Innovation,
two mandatory Most-Favored-Nation demonstration models under Medicare Parts B and D, respectively. If these rules or other Most-Favored-Nation
pricing rules are finalized, they are likely to reduce prices of at least some drugs in the United States, if they are also sold in comparator
countries. Even if we do not market drugs in such countries, we will be indirectly affected if our drugs competed with drugs whose prices
were reduced as a result of Most-Favored-Nation pricing initiatives.

In
addition, at the state level, legislatures have increasingly passed legislation and implemented regulations similar to those under consideration
at the federal level, as well as laws designed to control pharmaceutical and biotherapeutic product pricing, including restrictions on
pricing or reimbursement at the state government level, limitations on discounts to patients, marketing cost disclosure and transparency
measures, restrictions or other limitations on patient assistance, and, in some cases, policies to encourage importation from other countries
(subject to federal approval) and bulk purchasing. Certain states are also pursuing cost containment efforts through Prescription Drug
Affordability Boards (“PDABs”) and similar entities.

Employees-Human
Capital

As
of December 31, 2025, we had no employees. We utilize a certain portion of Sanovas’ sole employee (Jerry Katzman) for our business
and are allocated the proportion of payroll costs applicable to such usage from Sanovas. In addition, we utilize the services of other
consultants.

Effective
January 1, 2026, M. Cory Zwerling was appointed as Chief Financial Officer and Interim Chief Operating Officer. In March 2026, Mr. Zwerling
resigned.

19

Properties

In
September 2024, the Company entered into an office suite lease. The term of the lease is for a period of 12 months. The Lease auto-renews
for an additional 2 years, unless the Owner is notified. The Company intends to renew the lease. The payments under the lease commence
at $650 per month and escalates to $690 per month over the three years.

We
believe this arrangement is adequate for our current needs.

Legal
Proceedings

From
time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to
any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have
a material adverse effect on our business, operating results, cash flows or financial condition.

Corporate
Information

We
were incorporated in Delaware on November 17, 2017. Our principal executive offices are located at 409 Apollo Beach Blvd, Ste 6 Apollo
Beach, FL 33572-2281 and our telephone number is (415) 578-9583. Our website address is www.retinalgenix.com. The information
contained on our website is not incorporated by reference into this prospectus, and you should not consider any information contained
on, or that can be accessed through, our website as part of this prospectus or in deciding whether to purchase our securities.

Available
Information

Our
website address is www.retinalgenix.com. The contents of, or information accessible through, our website are not part of this
Annual Report on Form 10-K, and our website address is included in this document as an inactive textual reference only. We make our filings
with the SEC, including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments
to those reports, available free of charge on our website as soon as reasonably practicable after we file such reports with, or furnish
such reports to, the SEC. The public may read and copy the materials we file with the SEC at the SEC’s Public Reference Room at
100 F Street, NE, Washington, DC 20549. The public may obtain information on the operation of the Public Reference Room by calling the
SEC at 1-800-SEC-0330. Additionally, the SEC maintains an internet site that contains reports, proxy and information statements and other
information. The address of the SEC’s website is www.sec.gov. The information contained in the SEC’s website is not intended
to be a part of this filing.