RTGN 10-K & 10-Q changes, risk factors and insider trading
RetinalGenix Technologies Inc. · OTC · Surgical & Medical Instruments & Apparatus · CIK 1836295 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Healthcare reform measures could hinder or prevent the commercial success of our product candidates.”
New heading “A prolonged U.S. federal government shutdown could materially and adversely affect our business and operations.”
New heading “The pausing or termination of government grants by the United States government could have a major effect on the pharmaceutical industry, and as a result, our operations and prospects.”
New heading “Inadequate funding, government shutdowns, workforce reductions or other policy changes affecting the FDA, the SEC or other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.”
Removed heading “The future of drug negotiation prices under President Trump’s administration is uncertain.”
Removed heading “Legislative or regulatory reform of the health care system in the U.S. may adversely impact our business, operations or financial results.”
Largest changes
“Inflation rates, particularly in the United States, have increased recently to levels not seen in years, and increased inflation may result in increases in our operating costs (including our labor costs), reduced liquidity and limits on our ability to access credit or otherwise raise capital. In an inflationary environment, such cost increases may outpace our expectations, causing us to use cash faster than forecasted. …”see in full comparison
“Inadequate funding, government shutdowns, workforce reductions or other policy changes affecting the FDA, the SEC or other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.”see in full comparison
“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. …”see in full comparison
“Actual events involving reduced or limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds, have in the past and may in the future lead to market-wide liquidity problems.”see in full comparison
“Any disruption in the operations of the U.S. government, including as a result of the recent or future temporary or prolonged shutdowns resulting from the failure of Congress to enact appropriations bills or raise the federal debt ceiling, could materially and adversely affect our business, operations and financial condition. Recently, beginning on October 1, 2025, the U.S. …”see in full comparison
“Changes in U.S. or international social, political, regulatory and economic conditions or in laws and policies governing trade, manufacturing, development and investment in the countries where we currently conduct our business could adversely affect our business, reputation, financial condition and results of operations. Changes or proposed changes in U.S. or other countries’ trade policies may result in restrictions and economic disincentives on international trade. The U.S. government has recently imposed, or is currently considering imposing, tariffs on certain trade partners. …”see in full comparison
Full comparison: every changed paragraph (39)
An
investment in our common stock involves a high degree of risk. You should carefully consider the following risk factors and the
other other
information in this Annual Report on Form 10-K before investing in our common stock. Our business and results of operations
could be
seriously harmed by any of the following risks. The risks set out below are not the only risks we face. Additional risks
and uncertainties
not currently known to us or that we currently deem to be immaterial also may materially adversely affect our
business, financial condition
and/or operating results. If any of the following events occur, our business, financial condition and
results of operations could be
materially adversely affected. References to past events are provided by way of example only and
are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their
likelihood of occurring in the future. In such case, the value and trading price of our common stock could decline, and you may
lose all or part
of your investment.
We
were incorporated in November 2017, have a limited operating history, and our business is subject to all of the risks inherent in the
establishment of a new business enterprise. Our likelihood of success must be considered in light of the problems, expenses, difficulties,
complications and delays frequently encountered in connection with development and expansion of a new business enterprise. To date, we
have not designed a product that is ready for commercialization. Since inception,
we have incurred losses and expect to continue to operate
at a net loss for at least the next several years. Our net losses for the years
ended December 31, 2025 and December 31, 2024 were $2,428,595
and December 31, 2023, were $4,320,827 and $2,090,889,$4,320,827, respectively, and our accumulated deficit as of December
31, 20242025 and December 31, 20232024 was $15,430,022$17,858,617 and $11,109,195, $15,430,022,
respectively. There can be no assurance that the products under development
by us will be cleared for sale in the U.S. or elsewhere.
Furthermore, there can be no assurance that if such products are cleared they
will be successfully commercialized, and the extent of
our future losses and the timing of our profitability are highly uncertain. If
we are unable to achieve profitability, we may be unable
to continue our operations.
As
of December 31, 2024,2025, we had cash of $6,060.$14,774. In addition, as of December 31, 2024,2025, we had liabilities of $1,477,556.$2,323,652. As of the date
of of
this report, we do not have adequate resources to fund our operations for the next twelve months without advances from affiliates
or or
any future capital raising transactions. In fact, as of December 31, 2024,2025, we only had enough cash to run our operations for the next
few days.weeks. Although our current private placement is still open, we have not yet sold any securities throughsubsequent Marchto December 31, 2025.
We
have incurred losses every year and expect to continue to incur increased expenses. Our net losses for the year ended December 31,
20242025 and December 31, 2023,2024 were $4,320,827$2,428,595 and $2,090,889,$4,320,827, respectively, and our accumulated deficit as of December 31, 20242025 and
December 31, 20232024 was $15,430,022$17,858,617 and $11,109,195,$15,430,022, respectively. We anticipate that we will need approximately an additional
$6,000,000$7,000,000 to (i) complete product design and testing for the RetinalGeniXTM and RetinalCamTM and submit
RetinalGeniXTM for FDA clearance (we anticipate that the RetinalCamTM will not require FDA clearance); (ii)
complete the development and expansion of the software tools around the recently acquired DNA/GPS’ genetic mapping technology;
Pearl IRB anti-VEGF blood draw study, and (iii) build the infrastructure for our sustained growthgrowth. 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
rely on third-party suppliers to provide us with components that will be used in the products we are developing. For example, we rely
on third-party suppliers to provide us with sensors which will be used in both RetinalGeniXTM and RetinalCamTM.
Relying on third-party suppliers makes us vulnerable to component part failures or obsolescence and interruptions in supply including,
but not limited to, as a result of COVID-19,war or pandemics, either of which could impair our ability to develop our products in a timely manner.
Vendor Vendor
lead times to supply us with ordered components vary significantly and as a result of COVID-19 can exceed three months or more. We cannot
be sure that
our suppliers will furnish us required components when we need them or be able to provide us with sufficient components
to support the
development and manufacture of our products.
Our
future operations and successes depend in large part upon the strength of our management team. We rely heavily on the continued service
of Jerry Katzman, our President and Chief Executive Officer. We do not have an insurance policy on Dr. Katzman’s life; and we do
not have “key person” life insurance policies for any of our other officers or advisors. Accordingly, if Dr. Katzman terminates
his employment with us,us or is incapacitated or unable to perform his services, such a departure or inability to perform his services is
is expected to have a material adverse effect on our business. Our future success also depends on our ability to identify, attract, hire
or engage, retain and motivate other well-qualified financial, managerial, technical and regulatory personnel. There can be no assurance
that these professionals will be available in the market, or that we will be able to retain existing professionals or to meet or to continue
to meet their compensation requirements. Furthermore, the cost base in relation to such compensation, which may include equity compensation,
may increase significantly, which could have a material adverse effect on us. Failure to establish and maintain an effective management
team and work forceworkforce could adversely affect our ability to operate, grow and manage our business.
Continuing
concerns over U.S. health care reform legislation and energy costs, geopolitical issues, including those in Eastern Europe, the availability
and cost of credit and government
stimulus programs in the United States and other countries have contributed to increased volatility
and diminished expectations for the
global economy. These factors, combined with low business and consumer confidence,confidence couldand precipitatehigh unemployment,
precipitated an economic slowdown and recession.
recession and stagnant economy for more than a decade. Additionally, political changes in the U.S.
and elsewhere in the world have created a level of uncertainty in the markets. If the economic
climate does not improve or deteriorate,
our business, as well as the financial condition of our suppliers and our third-party payors,
could be adversely affected, resulting
in a negative impact on our business, financial condition and results of operations.
Changes in U.S. or international social, political, regulatory and economic conditions or in laws and policies governing trade, manufacturing, development and investment in the countries where we currently conduct our business could adversely affect our business, reputation, financial condition and results of operations. Changes or proposed changes in U.S. or other countries’ trade policies may result in restrictions and economic disincentives on international trade. The U.S. government has recently imposed, or is currently considering imposing, tariffs on certain trade partners. Tariffs, economic sanctions and other changes in U.S. trade policy have in the past and could in the future trigger retaliatory actions by affected countries, and certain foreign governments have instituted or are considering imposing retaliatory measures on certain U.S. goods. Further, any emerging protectionist or nationalist trends (whether regulatory- or consumer-driven) either in the United States or in other countries could affect the trade environment. Our business, like many other corporations, would be impacted by changes to the trade policies of the United States and foreign countries (including governmental action related to tariffs, international trade agreements, or economic sanctions). Such changes have the potential to adversely impact the U.S. economy or certain sectors thereof, the global economy, and our industry, and as a result, could have a material adverse effect on our business, financial condition and results of operations.
Inflation
rates, particularly in the United States, have increased recently to levels not seen in years, and increased inflation may result in
increases in our operating costs (including our labor costs), reduced liquidity and limits on our ability to access credit or otherwise
raise capital. In an inflationary environment, such cost increases may outpace our expectations, causing us to use cash faster than forecasted.
In addition, the Federal Reserve has raised, and may again raise, interest rates in response to concerns about inflation, which coupled
with reduced government spending and volatility in financial markets may have the effect of further increasing economic uncertainty and
heightening these risks.
Actual
events involving reduced or limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions
or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events
of these kinds, have in the past and may in the future lead to market-wide liquidity problems.
In
addition, the global macroeconomic environment could be negatively affected by, among other things, COVID-19 or other pandemics or epidemics, instability
instability in global economic markets, increased U.S. trade tariffs and trade disputes with other countries, instability in the global
credit markets, supply chain weaknesses, instability in the geopolitical environment
as a result of the withdrawal of the United Kingdom
from the European Union, the Russian invasion of Ukraine, the war in the Middle East
and other political tensions, and foreign governmental
debt concerns. Such challenges have caused, and may continue to cause, uncertainty
and instability in local economies and in global financial
markets.
We
are actively monitoring the effects these disruptions and increasing inflation could have on our operations. These conditions make it
extremely difficult for us to accurately forecast and plan future business activities.
The
future of drug negotiation prices under President Trump’s administration is uncertain.
The
future of drug price negotiations under the new Trump administration remains uncertain, with potential changes on the horizon. While
the Medicare Drug Price Negotiation Program, established by the Inflation Reduction Act during the Biden administration, is still in
effect, there are indications that modifications may be forthcoming. Any modifications may have an impact on our business.
We
may be subject to competition despite the existence of intellectual property we license or may, in the future, own. We can give no assurances
that our intellectual property claims will be sufficient to prevent third parties from designing around patents we license, or may in
the future ownown, or developing and commercializing competitive products. The existence of competitive products that avoid our intellectual
property rights could materially adversely affect our operating results and financial condition. Furthermore, limitations, or perceived
limitations, in our intellectual property rights may limit the interest of third parties to partner, collaborate or otherwise transact
with us, if third parties perceive a higher than acceptable risk to commercialization of our products.
The
laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many
companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions.
This could make it difficult for us to stop the infringement of our future patentspatents, or those that we license from our licensors, or the
misappropriation of our other intellectual property rights. For example, many foreign countries have compulsory licensing laws under
which a patent owner must grant licenses to third parties. In addition, many countries limit the enforceability of patents against certain
third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit.
Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain
outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection
in such countries.
Healthcare reform measures could hinder or prevent the commercial success of our product candidates.
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.
New laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, that relate to healthcare availability, methods of delivery or payment for products and services, or sales, marketing or pricing, may limit our potential revenue, and we may need to revise our research and development programs. The pricing and reimbursement environment may change in the future and become more challenging due to several reasons, including policies advanced by the current executive administration in the United States, new healthcare legislation or fiscal challenges faced by government health administration authorities. Specifically, in both the United States and some foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect our ability to sell our products profitably.
Legislative
or regulatory reform of the health care system in the U.S. may adversely impact our business, operations or financial results.
Our
industry is highly regulated and changes in law may adversely impact our business, operations or financial results. In March 2010, the
Patient Protection and Affordable Care Act, and a related reconciliation bill were signed into law. This legislation changes the current
system of healthcare insurance and benefits intended to broaden coverage and control costs. The law also contains provisions that will
affect companies in the medical device industry and other healthcare related industries by imposing additional costs and changes to business
practices. We cannot predict what healthcare reform initiatives may be adopted in the future. These reforms could have an adverse effect
on our ability to obtain timely regulatory approval for new products and on anticipated revenues from our products, both of which may
affect our overall financial condition.
Our
products,product candidates, development activities and manufacturing processes are subject to extensive and rigorous regulation by numerous government
agencies, including the FDA and comparable foreign agencies. To varying degrees, each of these agencies monitors and enforces our compliance
with laws and regulations governing the development, testing, manufacturing, labeling, marketing, distribution, and the safety and effectiveness
of our medical devices. The process of obtaining marketing approval or clearance from the FDA and comparable foreign bodies for new products,
or for enhancements, expansion of the indications or modifications to existing products, could:
A prolonged U.S. federal government shutdown could materially and adversely affect our business and operations.
Any disruption in the operations of the U.S. government, including as a result of the recent or future temporary or prolonged shutdowns resulting from the failure of Congress to enact appropriations bills or raise the federal debt ceiling, could materially and adversely affect our business, operations and financial condition. Recently, beginning on October 1, 2025, the U.S. federal government shut down and remained shut down through November 12, 2025, and again beginning on January 31, 2026 through February 3, 2026, during which times certain regulatory agencies, such as the FDA and the SEC, furloughed critical employees and stopped critical activities. Additionally, on October 10, 2025, the U.S. government implemented substantial layoffs and workforce reductions in connection with the federal government shutdown, which resulted in the suspension or delay of various government-funded programs. Furthermore, the recent federal government shutdown has resulted, and may continue for a prolonged period of time to result, in reduced availability of government services, and suspension or delay of activities by key agencies that regulate, fund, or interact with our business, including the SEC, the FDA, the Department of Health and Human Services, and the U.S. Patent and Trademark Office. As a result, the review and approval of our filings, applications, and submissions could be delayed, and we may be unable to access or rely upon certain government data or systems. In particular, it may lead to disruptions and delays in FDA’s review and oversight of our product candidates and impact the FDA’s ability to provide timely feedback on our development program or pending applications.
Additionally, a prolonged or future shutdown of the U.S. federal government could materially impact the operations of the SEC. For example, the SEC announced that during the recent U.S. federal government shutdowns, it would not review or declare registration statements effective. In the event of an extended shutdown, the SEC may operate with limited staff or suspend certain functions altogether, which could delay the review or effectiveness of our filings, including registration statements or other financing-related disclosures. Such delays could adversely affect our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue to fund our operations.
Government shutdowns, if prolonged, can significantly impact the ability of government agencies upon which rely, such as the FDA and SEC, to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Even the threat of a government shutdown or prolonged budget negotiation uncertainty may adversely affect the broader U.S. economy, investor confidence, and capital markets. Such conditions could negatively impact our access to financing, timing of capital-raising transactions, and the liquidity or trading volume of our securities. Accordingly, the current or future federal government shutdowns, or uncertainty regarding the continuity of government operations, could have a material adverse effect on our business, results of operations, and stock price.
The pausing or termination of government grants by the United States government could have a major effect on the pharmaceutical industry, and as a result, our operations and prospects.
In January 2025, a memo issued by the Office of Management and Budget, had disclosed a freeze on federal loans and grants. That memo has since been rescinded; however, future memos, executive orders or other actions by the government could result in the freeze of existing or new grants, or the termination of previously approved grants. Such actions could have a material adverse effect on the pharmaceutical industry as a whole, a portion of which relies on governmental grants, and as a result, on the Company’s operations and prospects.
Inadequate funding, government shutdowns, workforce reductions or other policy changes affecting the FDA, the SEC or other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Our business depends on timely interactions with the FDA, including the review of regulatory submissions, scheduling of formal meetings, and oversight of clinical trials. Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, policy changes and those related to the federal government shutdown, may result in reduced staffing or suspension of non-essential FDA operations, which could delay or cancel meetings with the FDA, hinder regulatory guidance, cause delays in the implementation or enforcement of regulatory requirements in a timely fashion or at all, and postpone the review of IND applications, NDAs, and BLAs. These disruptions may also affect the initiation, conduct, and monitoring of clinical trials, particularly those requiring FDA authorization or ongoing regulatory engagement. Interruptions in FDA activities could materially delay our development timelines, increase operational costs, and adversely impact our ability to complete our ongoing and planned clinical trials and to advance product candidates toward approval and commercialization. Any such delays or uncertainties may have a significant negative effect on our business, financial condition, and results of operations.
In addition, government funding of the FDA, SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable, and spending allocation priorities may undergo significant changes through congressional budgeting and appropriations processes. Disruptions at the FDA and other agencies may also extend the time necessary for new drugs to be reviewed and/or approved, which would adversely affect our business. For example, over the last several years, the U.S. government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough employees, experience substantial funding cuts and pause or delay critical activities. If a prolonged government shutdown occurs, it could, for example, significantly impact the ability of (i) the FDA and/or the USPTO to review and process regulatory submissions in a timely matter, and (ii) the National Institutes of Health (“NIH”) to conduct research or provide grants, all of which could have a material adverse effect on our business.
In addition, future government shutdowns could impact our ability to obtain necessary capital in order to properly capitalize and continue our operations. During such shutdowns, while the SEC’s EDGAR system remains operational, the unavailability of the SEC staff to review filings, issue and resolve comments, or declare registration statements effective may delay our ability to complete public offerings and obtain timely regulatory approvals. These delays could impact our access to capital markets, hinder strategic transactions, and create uncertainty around our disclosure obligations. Additionally, the lack of interpretive guidance or exemptive relief during a shutdown may increase legal and compliance risks.
Our
ability to generate incremental revenue growth will depend, in part, on the successful outcome of research and development activities,
which may include clinical trials that lead to the development of new products and new applications using our products. Our research
and development process is expensive, prolonged, and entails considerable uncertainty. Due to the complexities and uncertainties associated
with ophthalmic research and development, products we are currently developing may not complete the development process or obtain the
regulatory approvals required to market such products successfully. In addition, our research and development process has been slowed
by the impact of COVID-19, and should the COVID-19 economic restrictions worsen, it could delay and disrupt our research and development
processes even further.
As
of MarchApril 29,15, 2024,2026, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially own approximately
79% of our outstanding shares of common stock. As a result, these stockholders, acting together, would have the ability to control
the the
outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation
or sale
of all or substantially all of our assets. In addition, these stockholders, acting together, would have the ability to control
the management
and affairs of our company. Accordingly, this concentration of ownership might harm the market price of our common stock
by:
We
are an “emerging growth company” and will beare able to avail ourselves of reduced disclosure requirements applicable to emerging
growth companies, which could make our common stock less attractive to investors.
As
a publicly traded company we will incur significant additional legal, accounting and other expenses that we did not incur as a private
company. The obligations of being a public company in the U.S. require significant expenditures and will place significant demands on
our management and other personnel, including costs resulting from public company reporting obligations under the Exchange Act and the
rules and regulations regarding corporate governance practices, including those under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street
Reform and Consumer Protection Act. These rules require the establishment and maintenance of effective disclosure and financial controls
and procedures, internal control over financial reporting and changes in corporate governance practices, among many other complex rules
that are often difficult to implement, monitor and maintain compliance with. Moreover, despite recent reforms made possible by the JOBS
Act, the reporting requirements, rules, and regulations will make some activities more time-consuming and costly, particularly after
we are no longer an “emerging growth company.” In addition, we expect these rules and regulations to make it more difficult
and more expensive for us to obtain director and officer liability insurance. Our management and other personnel will need to devote
a substantial amount
of time to ensure that we comply with all of these requirements and to keep pace with new regulations, otherwise
we may fall out of compliance
and risk becoming subject to litigation, among other potential problems.
Management's Discussion & Analysis (MD&A)
New heading “Implications of Being a Smaller Reporting Company”
Removed heading “Recently Issued and Adopted Accounting Standards”
Largest changes
“We are a “smaller reporting company”, as defined in Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. …”see in full comparison
We expect to generate revenues in the future from the sale of DNA/GPS’ laboratory developed consumer test kits. We do not expect to generate any revenues fromsee in full comparisonproductsalesunlessofandthe RetinalCam or the Patient Informational database (RECAD AI system), until we successfully complete theirdevelopmentdevelopment.of RetinalCamTM, and we do not expect to generate any revenues from product sales unless and until we successfully obtain regulatory clearance for RetinalGenixTM.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.
General and administrative expensessee in full comparisonincreaseddecreased by$435,272$32,974 or48%,3%, to$1,333,930$1,300,956 for theyearsyear ended December 31,20242025 from$898,658$1,333,930 for the year ended December 31,2023.2024. Administrative costs consisting of costs related toexecutivesthe executive from Sanovas, were allocated based upon the amountamountof effort spent by such personnel on our business, and increased by approximately$135,000$31,000 over the20232024 levels. Salaries allocated totothe Company from Sanovas increased in20242025 since the majority of time spent by Sanovas’ sole employee were on Companyactivities.activities,TheandCompanysuchalsoemployeeincurredreceivedsignificantafeescontractualinsalary2023 as its portion of the legal costs in the Gerrans litigation matter described in Note D to the consolidated financial statements.increase. Other administrative expenses, specificallylegal and accounting fees, travel and marketing fees were higher because of marketing for thelegal, fund-raising activities and listing relatedexpenses.expenses were lower in 2025 as we had more less opportunities at that time, and less funding to procure certain operations.
We anticipate that we will need approximately an additionalsee in full comparison$6,000,000$7,000,000 to (i) complete and sell genetic testing products with our DNA/GPS mapping technology; (ii) complete the product design and testing forRetinalGenixTMthe RetinalCam; (iii) develop andRetinalCamTMadvance the networking agreements with various service optical andsubmitclinicalRetinalGenixTMnetworkingfor FDA clearance (we anticipate that the RetinalCamTM will not require FDA clearance); (ii) complete the development and expansion of the software tools around the recently acquired DNA/GPS’ genetic mapping technologygroups; and (iiiiv)buildcreatetheandinfrastructure fortest oursustainedRetinalGenixgrowth.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 RetinalCam will require FDA approval.
Full comparison: every changed paragraph (27)
We
are an ophthalmic research and development company focused on developing technologies to screen, monitor, diagnose and treat eye health
(ophthalmic,
optical, and sight-threatening disorders. Our mission is to prevent vision lossdisorders) and blindnessfacilitating duethe toearly diabetic retinopathydetection and maculopathytreatment of multiple systemic diseases
through two devices: (1) Retinal Imaging Screening Device, a portable, retinal imaging system providing a 200-degree fieldcombination of
view withouttherapeutic requiring pupil dilation;medications and (2)medical RetinalCamTM,device atechnologies, homewhile monitoringempowering patients and imagingtheir deviceclinicians offeringwith
secure real-time
communicationpersonal andhealthcare alerting system for physicians available 24/7.information.
Our mission is to prevent vision loss and blindness due to diabetic retinopathy and maculopathy, including the leading cause of retinal blindness (age related macula degeneration the dry and wet type).
We are actively pursuing our mission to prevent vision loss and blindness due to ocular diseases, including diabetic retinopathy and maculopathy, in ourfirst two devices:
We intend to launch RetinalCamTM in the second half 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 2026, 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
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 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.
We
anticipate that we will need approximately an additional $6,000,000$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
RetinalGenixTM the RetinalCam; (iii) develop and RetinalCamTMadvance the networking agreements
with various service optical and submitclinical RetinalGenixTMnetworking for FDA clearance (we anticipate that the
RetinalCamTM will not require FDA clearance); (ii) complete the development and expansion of the software tools around
the recently acquired DNA/GPS’ genetic mapping technologygroups; and (iiiiv) buildcreate theand infrastructure fortest our sustainedRetinalGenix growth.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 RetinalCam will require FDA approval.
We
expect to generate revenues in the future from the sale of DNA/GPS’ laboratory developed consumer test kits. We do not expect to
generate any revenues from product sales unlessof andthe RetinalCam or the Patient Informational database (RECAD AI system), until we successfully complete
their developmentdevelopment. of RetinalCamTM,
and we do not expect to generate any revenues from product sales unless and until we successfully obtain regulatory clearance for RetinalGenixTM.
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.
We
commenced a private placement of common stock in 2024,2024 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 havewas received in January 2026. During 2024, we issued 290,262 shares of common stock
and raised approximately
$653,000 ($653,000, including the $150,000 subscribedwhich was recorded as a stock subscription receivable at December 31, 2024 and
received in January 2025).2025. NoThere additionalcan sharesbe ofno commonassurance stock
werethat soldwe inwill 2025be throughable theto dateraise ofcapital thiswhen filing.needed.
Interest expense is principally the coupon interest rate charged on loans from stockholders.
Comparison
of the yearsyear ended December 31, 20242025 and 20232024
Research
and development expenses decreased by $150,912,$290,231, or 29%,78%, to $83,040 for the year ended December 31, 2025 from $373,271 for the yearsyear ended
December 31, 2024 from $524,183 for the year
ended December 31, 2023.2024. The decrease was primarily the result of a decrease in engineering and technology consultants, and pilot manufacturing
costs due to a lack of funds.
Stock-based
compensation expenses increaseddecreased by $1,945,578$1,569,192 or 293%,60%, to $2,609,786$1,040,594 for the yearsyear ended December 31, 20242025 from $664,208$2,609,786 for the year
ended December 31, 2023.2024. The increasedecrease was primarily due to the recognition of expense for warrants issued in the first quarter of 2024,
of which a significant portion was vested immediately. During 2025, there were a lesser amount of warrants issued as compared to 2024.
General
and administrative expenses increaseddecreased by $435,272$32,974 or 48%,3%, to $1,333,930$1,300,956 for the yearsyear ended December 31, 20242025 from $898,658$1,333,930 for the year
ended December 31, 2023.2024. Administrative costs consisting of costs related to executivesthe executive from Sanovas, were allocated based upon the
amount amount
of effort spent by such personnel on our business, and increased by approximately $135,000$31,000 over the 20232024 levels. Salaries allocated
to to
the Company from Sanovas increased in 20242025 since the majority of time spent by Sanovas’ sole employee were on Company activities.activities,
Theand Companysuch alsoemployee incurredreceived significanta feescontractual insalary 2023 as its portion of the legal costs in the Gerrans litigation matter described in Note
D to the consolidated financial statements.increase. Other administrative expenses, specifically legal and accounting fees, travel and marketing
fees were higher because of marketing for thelegal, fund-raising activities
and listing related expenses.expenses were lower in 2025 as we had more less opportunities at that time, and less funding to procure certain operations.
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 from the sale of common stock, loans and advances
from related parties and by utilizing Sanovas personnel and facilities. During the yearsyear ended December 31, 2024,2025, we received approximately$398,000
$35,000(net of advances$125,000 for stock subscribed in 2025 and invoices paid byin affiliates, $210,000 from the exercise of stock options and $503,000 pursuant to proceeds2026) from the sale of common stock.stock pursuant to a private placement and $150,000
pursuant to proceeds from a stock subscription receivable from 2024 that was paid in 2025. As of December 31, 2024,2025, we had cash of $6,060 $14,774
and liabilities of $1,477,556.$2,379,244. As of the date of this report,
we do not have adequate resources to fund our operations beyond DecemberApril 2025 2026
without considering any future capital raising transactions.
In fact, the cash held on December 31, 20242025 is expected to fund operations
only for a few days.weeks. Although our current private placement
is still open, we have not yet sold any securities fromafter January 1, 2025 through MarchDecember 31, 2025.
Cash
Flow Activities for the yearsyear ended December 31, 20242025 and 20232024
Net cash used in operating activities was $558,350 for the year ended December 31, 2025. The cash flow used in operating activities in 2025 was principally driven by the net loss of $2,428,595 offset in part by non-cash stock-based compensation expense of $1,040,594. In addition, Sanovas billed us for allocated costs and expenses paid on behalf of and allocated to us in the amount of $661,500 during the year ended December 31, 2025. Accounts payable increased by $162,680.
The
cash flow used in operating activities in 2023 was driven by the net loss of $2,090,889 offset in part by non-cash stock-based
compensation expenses of $664,208 and an increase in accounts payable and accrued liabilities and accrued interest of $413,280. In
addition, Sanovas billed us for allocated costs and expenses paid on behalf of and allocated to us in the amount of $561,640 during
the year ended December 31, 2023. During the year ended December 31, 2023, we received net cash advances from related parties of
$451,623, including $103,274 of net cash advances from Sanovas.
Net cash provided by financing activities was $567,064 and $747,996 during the year ended December 31, 2025 and 2024, respectively. During the year ended December 31, 2025, we received approximately $398,000 from the sale of common stock pursuant to a private placement and $150,000 pursuant to proceeds from the stock subscription receivable from 2024.
During
the year ended December 31, 2023, cash flow from financing operations of $451,623 was from advances from related parties, including $103,274 of net cash advances from Sanovas.
Recently
Issued and Adopted Accounting Standards
The
following pronouncement may have an impact on the accounting policies of the Company:
A
variety of proposed or otherwise potential accounting standards are currently under study by standard-setting organizations. Due to the
tentative and preliminary nature of those proposed standards, management has not determined whether the implementation of such proposed
standards would be material to our consolidated financial statements.
Implications of Being a Smaller Reporting Company
We are a “smaller reporting company”, as defined in Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will cease to be a smaller reporting company if we have (i) more than $250 million in market value of our shares held by non-affiliates as of the last business day of our most recently completed second fiscal quarter or (ii) more than $100 million of annual revenues in our most recent fiscal year completed before the last business day of our second fiscal quarter and a market value of our shares held by non-affiliates more than $700 million as of the last business day of our second fiscal quarter.
What changed in the latest 10-Q
Risk Factors
Largest changes
As ofsee in full comparisonMarchJune31,30, 2026, we had cash of$180$27,232 and liabilities of$2,563,889.$2,672,914. As of the date of this report,despite raising $125,000 in funding in May 2026,we do not have adequate resources to fund our operations beyond the next few days without considering any future or any future capital raising transactions. We raised $50,000 pursuant to a promissory note in July 2026. We will need to raise additional funding to complete the development of its products and commence the market launch, assuming regulatory approval is obtained. We do not know whether additional financing will be available when needed, whether it will be available on favorable terms, or if it will be available at all. These factors raise substantial doubt about our ability to continue as a going concern. In the event that we are unable to obtain additional financing, we may be unable to continue as a going concern. There is no guarantee that we will be able to secure additional financing. Changes in our operating plans, our existing and anticipated working capital needs, costs related to legal proceedings we might become subject to in the future, the acceleration or modification of our development activities, any near-term or future expansion plans, increased expenses, potential acquisitions or other events may further affect our ability to continue as a going concern. Similarly, the report of our independent registered public accounting firm on our financial statements as of and for the year ended December 31, 2025 includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern. If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in us.
We were incorporated in November 2017 and have a limited operating history, and our business is subject to all of the risks inherent in the establishment of a new business enterprise. Our likelihood of success must be considered in light of the problems, expenses, difficulties,see in full comparisondifficulties,complications and delays frequently encountered in connection with development and expansion of a new business enterprise. Since inception, we have incurred losses and expect to continue to operate at a net loss for at least the next several years. Our net losses for thequarterssix months endedMarchJune31,30, 2026 and year ended December 31, 2025, were$408,626$897,886 and $587,259, respectively, and our accumulated deficit as ofMarchJune31,30, 2026 was$18,267,243.$18,756,503. There can be no assurance that the products under development by us will be cleared for sale in the U.S. or elsewhere. Furthermore, there can be no assurance that if such products are cleared they will be successfully commercialized, and the extent of our future losses and the timing of our profitability are highly uncertain. If we are unable to achieve profitability, we may be unable to continue our operations.
Full comparison: every changed paragraph (4)
We
were incorporated in November 2017 and have a limited operating history, and our business is subject to all of the risks inherent in
the establishment of a new business enterprise. Our likelihood of success must be considered in light of the problems, expenses,
difficulties, difficulties,
complications and delays frequently encountered in connection with development and expansion of a new business
enterprise. Since inception,
we have incurred losses and expect to continue to operate at a net loss for at least the next several
years. Our net losses for the quarters
six months ended MarchJune 31,30, 2026 and year ended December 31, 2025, were $408,626$897,886 and $587,259,
respectively, and our accumulated deficit as of MarchJune 31,30, 2026
was $18,267,243.$18,756,503. There can be no assurance that the products under
development by us will be cleared for sale in the U.S. or elsewhere.
Furthermore, there can be no assurance that if such products
are cleared they will be successfully commercialized, and the extent of
our future losses and the timing of our profitability are
highly uncertain. If we are unable to achieve profitability, we may be unable
to continue our operations.
As
of MarchJune 31,30, 2026, we had cash of $180$27,232 and liabilities of $2,563,889.$2,672,914. As of the date of this report, despite raising $125,000 in funding
in May 2026, we do not have adequate resources
to fund our operations beyond the next few days without considering any future or any
future capital raising transactions. We raised
$50,000 pursuant to a promissory note in July 2026. We will need to raise additional funding to complete the development of its products
and commence
the market launch, assuming regulatory approval is obtained. We do not know whether additional financing will be available
when needed,
whether it will be available on favorable terms, or if it will be available at all. These factors raise substantial doubt
about our ability
to continue as a going concern. In the event that we are unable to obtain additional financing, we may be unable to
continue as a going
concern. There is no guarantee that we will be able to secure additional financing. Changes in our operating plans,
our existing and
anticipated working capital needs, costs related to legal proceedings we might become subject to in the future, the
acceleration or modification
of our development activities, any near-term or future expansion plans, increased expenses, potential acquisitions
or other events may
further affect our ability to continue as a going concern. Similarly, the report of our independent registered public
accounting firm
on our financial statements as of and for the year ended December 31, 2025 includes an explanatory paragraph indicating
that there is
substantial doubt about our ability to continue as a going concern. If we cannot continue as a viable entity, our stockholders
may lose
some or all of their investment in us.
We
are required pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, to maintain internal control over financial reporting
reporting and to assess and report on the effectiveness of those controls. This assessment includes disclosure of any material
weaknesses identified
by our management in our internal control over financial reporting. Although we prepare our financial
statements in accordance with U.S. US
GAAP, our internal accounting controls may not meet all standards applicable to companies with
publicly traded securities. If we fail
to implement any required improvements to our disclosure controls and procedures, we may be
obligated to report control deficiencies,
in which case we could become subject to regulatory sanction or investigation. Further,
such an outcome could damage investor confidence
in the accuracy and reliability of our financial statements.
Our
management has concluded that our internal controls over financial reporting were, and continue to be, ineffective, and as of MarchJune 31,30,
2026 as a result of a material weakness in our internal controls. The material weaknesses are due to the lack of segregation of duties.
While management is working to remediate the material weakness, there is no assurance that such changes, when economically feasible and
sustainable, will remediate the identified material weaknesses or that the controls will prevent or detect future material weaknesses.
If we are not able to maintain effective internal control over financial reporting, our financial statements, including related disclosures,
may be inaccurate, which could have a material adverse effect on our business.
Management's Discussion & Analysis (MD&A)
New heading “Comparison of the six months ended June 30, 2026 and 2025”
New heading “Research and Development Expenses”
New heading “Stock-Based Compensation Expenses”
New heading “General and Administrative Expenses”
Largest changes
“General and administrative expenses decreased by $250,529 or 35%, to $474,403 for the six months ended June 30, 2026 from $724,932 for the six months ended June 30, 2025. Administrative costs consisting of costs related to the services provided by the executive from Sanovas, were allocated based upon the amount of effort spent by such personnel on our business, and was the same as in 2025. …”see in full comparison
Net cash provided by financing activities wassee in full comparison$94,619$258,342 and$184,873$321,073 during thequarterssix months endedMarchJune31,30, 2026 and 2025, respectively. For 2026,2026,the cash flow from financing activities is primarily attributable to the collection of a stock subscription receivable of $125,000, and $200,000 from the sale of common stock, and net repayments of advances from related parties and Sanovas of$30,381$66,658 in thequartersix months ended June 30, 2026. During the six months endedMarchJune31, 2026. For30, 2025, we received approximately $85,000 of advances and invoices paid by affiliates, $86,000 from thecashsaleflowoffrom financingcommonactivitiesstockis primarily attributablepursuant to a private placement and $150,000 pursuant to proceeds from thecollection of astock subscriptionreceivable of $150,000, and net proceeds from advances from related parties and Sanovas of $34,873 in the quarter ended March 31, 2025.receivable.
Full comparison: every changed paragraph (29)
Our first two devices:
We
are actively pursuing our mission to prevent vision loss and blindness due to ocular diseases, including diabetic retinopathy and maculopathy,
in ourfirst two devices:
We
intend to launch RetinalCamTMRetinalCam™ in the fourthsecond quarterhalf of 2026.
In
addition to the above medical device and IRB advancements, we continue to make progress in our planning/and guidanceseek to move forward,
via our contracted clinical resource organization, to conduct pharmaceutical clinical studies for our two products
These
accompanying condensed consolidated financial statements have been prepared in accordance with U.S.US GAAP. The condensed consolidated financial
financial statements include the accounts of the Company and its wholly-owned subsidiary, DNA/GPS, Inc. All significant intercompany
accounts and
transactions have been eliminated in consolidation.
Comparison
of the three months ended MarchJune 31,30, 2026 and 2025
The
following table sets forth key components of our results of operations for the three months ended MarchJune 31,30, 2026 and 2025.
We
did not recognize revenues for the three months ended MarchJune 31,30, 2026 and 2025.
Research
and development expenses increased by $103,850,$51,976, or 786%,360%, to $117,064$66,406 for the three months ended MarchJune 31,30, 2026 from $13,214$14,430 for the three
months ended MarchJune 31,30, 2025. The increase was primarily the result of engaging engineering and technology consultants to work on the RetinalCam
RetinalCam project.
Stock-based
compensation expenses decreased by $21,917$225,407 or 9%,90%, to $210,016$24,782 for the three months ended MarchJune 31,30, 2026 from $231,933$250,189 for the three
months ended MarchJune 31,30, 2025. The decrease was primarily due to the recognition of expense for options issued in the first quarter of
2025 and which had a significant service period in the second quarter of 2025, which had no corresponding service/vested period in
2026. In 2026, the warrants issued in the three months ended June 30, 2026 had only one month of expense recorded since
the issuance date was in June 2026.
General
and administrative expenses decreased by $79,054$171,475 or 23%,45%, to $262,149$212,254 for the three months ended MarchJune 31,30, 2026 from $341,203$383,729 for the
three months ended MarchJune 31,30, 2025. Administrative costs consisting of costs related to the services provided by the executive from Sanovas,
were allocated based upon the amount of effort spent by such personnel on our business, and was the same as in in 2025. Other administrative
expenses, specifically legal and accounting fees, travel and marketing fees were slightly lower because of less travel and marketing
for the fund-raising
activities and listing related expenses.expenses and a decrease in professional fees associated with legal, listing and accounting fees.
Comparison of the six months ended June 30, 2026 and 2025
The following table sets forth key components of our results of operations for the six months ended June 30, 2026 and 2025.
Revenues
We did not recognize revenues for the six months ended June 30, 2026 and 2025.
Research and Development Expenses
Research and development expenses increased by $155,826, or 564%, to $183,470 for the six months ended June 30, 2026 from $27,644 for the six months ended June 30, 2025. The increase was primarily the result of engaging engineering and technology consultants to work on the RetinalCam project.
Stock-Based Compensation Expenses
Stock-based compensation expenses decreased by $247,324 or 51%, to $234,798 for the six months ended June 30, 2026 from $482,122 for the six months ended June 30, 2025. The decrease was primarily due to the recognition of expense for options issued in the first quarter of 2025 and which had a significant service period in the second quarter of 2025, which had no corresponding service/vested period in 2026. In 2026, the warrants issued in the six months ended June 30, 2026 had only one month of expense recorded since the issuance date was in June 2026.
General and Administrative Expenses
General and administrative expenses decreased by $250,529 or 35%, to $474,403 for the six months ended June 30, 2026 from $724,932 for the six months ended June 30, 2025. Administrative costs consisting of costs related to the services provided by the executive from Sanovas, were allocated based upon the amount of effort spent by such personnel on our business, and was the same as in 2025. Other administrative expenses, specifically legal and accounting fees, travel and marketing fees were slightly lower because of less travel and marketing for the fund-raising activities and listing related expenses, as well as decreased professional fees associated with legal, listing and accounting fees.
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 from the sale of common stock, loans and advances
from related parties and by utilizing Sanovas personnel and facilities. During the threesix months ended MarchJune 31,30, 2026, we repaid approximately
$30,000$67,000 of advances and invoices paid by affiliates, and we received $125,000 pursuant to proceeds from a stock subscription receivable.receivable
and $200,000 from the sale of common stock. As of MarchJune 31,30, 2026, we had cash of $180$27,232 and liabilities of $2,563,889.$2,672,914. As of the date
of this report, we do not have adequate resources
to fund our operations beyond June 2026 without considering any future capital raising
transactions. In fact, the cash held on March
31,June 30, 2026 is expected to fund operations only for a few days. Our current private placement is still open, we sold 88,888 shares of common
stock in May 2026, raising $200,000.
We
anticipate that we will need approximately an additional $7,000,000 in operating capital to (i) complete product design and testing for
RetinalGenixTMRetinalGenix™ and RetinalCamTMRetinalCam™ and submit RetinalGenixTMRetinalGenix™ for FDA approval (we anticipate that the RetinalCamTMRetinalCam™ will
will not require FDA approval); (ii) complete the development and expansion of the software tools around the recently acquired DNA/GPS’
genetic mapping technology; and (iii) build the infrastructure for our sustained growth. We do not expect to generate any revenues from
product sales unless and until we successfully complete development of RetinalGenixTMRetinalGenix™ and RetinalCamTMRetinalCam™ and obtain regulatory
regulatory approval for RetinalGenixTM.RetinalGenix™. We will also require additional operating capital as a result of us operating as a
public company, including
for legal, accounting, investor relations, compliance and other expenses.
Cash
Flow Activities for the threesix months ended MarchJune 31,30, 2026 and 2025
Net cash
used in operating activities was $109,213 for the three months ended March 31, 2026. The cash flow used in operating activities in 2026
was driven by the net loss of $590,489 offset in part by non-cash stock-based compensation expense of $210,016 and an increase in accounts
payable and accrued liabilities of $104,757. In addition, Sanovas billed us for allocated costs and expenses paid on behalf of and allocated
to us in the amount of $165,375 during the three months ended March 31, 2026, and we repaid $30,381 of net advances from Sanovas, for
a net change of $155,790 related to Sanovas transactions.
Net
cash used in operating activities was $187,222$245,884 for the threesix months ended MarchJune 31,30, 2025.2026. The cash flow used in operating activities in
in 20252026 was principally driven by the net loss of $587,259$897,886 offset in part by non-cash stock-based compensation expense of $231,933.$234,798 and an increase in
accounts payable and accrued liabilities of $84,198. In
addition, Sanovas billed us for allocated costs and expenses paid on behalf of
and allocated to us in the amount of $165,375$330,750 during the
three six months ended MarchJune 31,30, 2025.2026.
Net cash used in operating activities was $326,294 for the six months ended June 30, 2025. The cash flow used in operating activities in 2025 was principally driven by the net loss of $1,236,677 offset in part by non-cash stock-based compensation expense of $482,122. In addition, Sanovas billed us for allocated costs and expenses paid on behalf of and allocated to us in the amount of $330,750 during the six months ended June 30, 2025.
Net
cash provided by financing activities was $94,619$258,342 and $184,873$321,073 during the quarterssix months ended MarchJune 31,30, 2026 and 2025, respectively. For
2026, 2026,
the cash flow from financing activities is primarily attributable to the collection of a stock subscription receivable of $125,000,
and $200,000 from the sale of common stock, and
net repayments of advances from related parties and Sanovas of $30,381$66,658 in the quartersix months
ended June 30, 2026. During the six months ended MarchJune 31, 2026. For30, 2025, we received approximately $85,000 of advances and invoices paid by affiliates,
$86,000 from the cashsale flowof from
financingcommon activitiesstock is primarily attributablepursuant to a private placement and $150,000 pursuant to proceeds from the collection of a stock subscription receivable of $150,000, and net proceeds from
advances from related parties and Sanovas of $34,873 in the quarter ended March 31, 2025.receivable.
The
preparation of condensed consolidated financial statements in conformity with U.S.US GAAP requires management to make estimates and assumptions
assumptions that affect the reported amounts of assets and liabilities and related disclosures in the condensed consolidated
financial statements
and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to
be reasonable under the
circumstances. The estimation process may yield a range of potentially reasonable estimates of the ultimate
future outcomes and management
must select an amount that falls within that range of reasonable estimates. Estimates are used in
areas including, but not limited to:
research and development expense recognition, valuation of stock options, allowances of
deferred tax assets, accrued expenses and liabilities,
and cash flow assumptions regarding going concern considerations.
RTGN insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding RTGN (13F)
None of the 59 investors we track reported a position in their latest 13F.