04/15/2026 | Press release | Distributed by Public on 04/15/2026 04:11
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
Overview
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) and facilitating the early detection and treatment of multiple systemic diseases through a combination of therapeutic medications and medical device technologies, while empowering patients and their clinicians with secure personal healthcare 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:
| 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 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
| 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 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.
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 RetinalCam; (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 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 sales of the RetinalCam 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.
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 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.
Basis of presentation:
These accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("US GAAP"). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, DNA/GPS, Inc. All intercompany accounts and transactions have been eliminated in consolidation.
Components of Results of Operations
Revenue
We have not generated any revenue since our inception.
Research and Development Expenses
Research and development expenses include personnel costs associated with research and development activities, including third-party contractors to perform research, product and prototype development, and testing of materials. Research and development expenses are charged to operations as incurred.
We accrue for costs incurred by external service providers based on our estimates of services performed and costs incurred. These estimates include the level of services performed by third parties and other indicators of the services completed.
We cannot determine with certainty the duration and costs of future clinical trials and product development or if, when or to what extent we will generate revenue from the commercialization and sale of any product candidate for which we obtain marketing clearance. We may never succeed in obtaining marketing approval for any product candidate. The duration, costs and timing of product development will depend on a variety of factors, including:
| ● | the scope, rate of progress, expense and results of product development, as well as of any future clinical trials of other product candidates and other research and development activities that we may conduct; | |
| ● | the actual probability of success for our product candidates, including their safety and efficacy, early clinical data, competition, manufacturing capability and commercial viability; | |
| ● | significant and changing government regulation and regulatory guidance; | |
| ● | the timing and receipt of any marketing approvals; and | |
| ● | the expense of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights. |
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate.
General and administrative Expenses
General and administrative expenses consist primarily of compensation and consulting related expenses. Administrative expenses also include professional fees and other corporate expenses, including legal fees relating to corporate matters; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses, marketing activities and other operating costs that are not specifically attributable to research activities. We have no full-time employees and have had limited funding; therefore the Company has been required to eliminate or defer as many costs as possible based upon available resources.
We expect that our administrative expenses will increase in the future as we increase our personnel headcount to support our continued research activities and development of our product candidates. We also expect increased expenses associated with being a public company, including costs related to accounting, audit, legal, regulatory and tax-related services associated with compliance with SEC requirements; director and officer insurance costs; and investor and public relations costs.
Interest Expense
Interest expense is principally the coupon interest rate charged on loans from stockholders.
Results of Operations
Comparison of the year ended December 31, 2025 and 2024
The following table sets forth key components of our results of operations for the years ended December 31, 2025 and 2024.
| For the year ended | ||||||||||||||||
| December 31, | ||||||||||||||||
| 2025 | 2024 | Change | % Change | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | ||||||||||
| Expenses | ||||||||||||||||
| General and administrative | 1,300,956 | 1,333,930 | (32,974 | ) | (2 | )% | ||||||||||
| Research and development | 83,040 | 373,271 | (290,231 | ) | (78 | )% | ||||||||||
| Stock-based compensation | 1,040,594 | 2,609,786 | (1,569,192 | ) | (60 | )% | ||||||||||
| Total Expenses | 2,424,590 | 4,316,987 | (1,892,397 | ) | (44 | )% | ||||||||||
| Interest expense, net | 4,005 | 3,840 | 165 | 4 | % | |||||||||||
| Net Loss | $ | (2,428,595 | ) | $ | (4,320,827 | ) | $ | (1,892,232 | ) | (44 | )% | |||||
Revenues
We did not recognize revenues for the years ended December 31, 2025 and 2024.
Research and Development Expenses
| For the year ended | ||||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Direct costs | $ | 83,040 | $ | 348,971 | ||||
| Allocated costs from Sanovas | - | 24,300 | ||||||
| Total Research and Development expenses | $ | 83,040 | $ | 373,271 | ||||
Research and development expenses decreased by $290,231, or 78%, to $83,040 for the year ended December 31, 2025 from $373,271 for the year ended December 31, 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
Stock-based compensation expenses decreased by $1,569,192 or 60%, to $1,040,594 for the year ended December 31, 2025 from $2,609,786 for the year ended December 31, 2024. The decrease 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
| For the year ended | ||||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Direct costs | $ | 639,456 | $ | 703,930 | ||||
| Allocated costs from Sanovas | 661,500 | 630,000 | ||||||
| Total general and administrative expenses | $ | 1,300,956 | $ | 1,333,930 | ||||
General and administrative expenses decreased by $32,974 or 3%, to $1,300,956 for the year ended December 31, 2025 from $1,333,930 for the year ended December 31, 2024. Administrative costs consisting of costs related to the executive from Sanovas, were allocated based upon the amount of effort spent by such personnel on our business, and increased by approximately $31,000 over the 2024 levels. Salaries allocated to the Company from Sanovas increased in 2025 since the majority of time spent by Sanovas' sole employee were on Company activities, and such employee received a contractual salary increase. Other administrative expenses, specifically legal, fund-raising activities and listing related expenses were lower in 2025 as we had more less opportunities at that time, and less funding to procure certain operations.
Liquidity and Capital Resources
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 year ended December 31, 2025, we received $398,000 (net of $125,000 for stock subscribed in 2025 and paid in 2026) from the sale of common 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, 2025, we had cash of $14,774 and liabilities of $2,379,244. As of the date of this report, we do not have adequate resources to fund our operations beyond April 2026 without considering any future capital raising transactions. In fact, the cash held on December 31, 2025 is expected to fund operations only for a few weeks. Although our current private placement is still open, we have not yet sold any securities after December 31, 2025.
We anticipate that we will need approximately an additional $7,000,000 in operating capital to (i) complete product design and testing for RetinalGenixTM and RetinalCamTM and submit RetinalGenixTM for FDA approval (we anticipate that the RetinalCamTM 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 RetinalGenixTM and RetinalCamTM and obtain regulatory approval for RetinalGenixTM. 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.
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.
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.
Cash Flow Activities for the year ended December 31, 2025 and 2024
The following table sets forth a summary of our cash flows for the periods presented:
| For the year ended | ||||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Net cash used in operating activities | $ | (558,350 | ) | $ | (741,936 | ) | ||
| Net cash provided by financing activities | 567,064 | 747,996 | ||||||
| Net increase in cash | 8,714 | 6,060 | ||||||
| Cash at beginning of the period | 6,060 | 0 | ||||||
| Cash at end of the period | $ | 14,774 | $ | 6,060 | ||||
Operating Activities
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.
Net cash used in operating activities was $741,936 for the years ended December 31, 2024. The cash flow used in operating activities in 2024 was principally driven by the net loss of $4,320,827 offset in part by non-cash stock-based compensation expense of $2,609,786, a non-cash charge for stock issued to a vendor for services rendered of $125,000, and an increase in accounts payable and accrued liabilities and accrued interest payable of $191,0033. In addition, Sanovas billed us for allocated costs and expenses paid on behalf of and allocated to us in the amount of $654,300 and we received net advances of $34,908 from related parties including $24,649 of net cash advances from Sanovas during the years ended December 31, 2024.
Financing Activities
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.
Net cash provided by financing activities was $747,996 and $451,623 during the years ended December 31, 2024 and 2023, respectively. For 2024, the cash flow from operations is primarily attributable to sales of common stock of approximately $503,000, proceeds from the exercise of stock options of $210,000 and proceeds from advances from related parties and Sanovas of $34,908 in the years ended December 31, 2024.
Critical Accounting Estimates
The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and related disclosures in the financial statements and accompanying notes. Management bases it estimates on historical experience and on assumptions believed to be reasonable under the circumstances. The estimation process often 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.
Stock-based Compensation
Stock-based compensation represents the cost related to stock-based awards granted to employees. We measure stock-based compensation costs at the grant date, based on the estimated fair value of the award and recognize the cost (net of estimated forfeitures) over the vesting period. Forfeitures are estimated on the date of grant and revised if actual or expected forfeiture activity differs materially from the original estimates. We estimate the fair value of stock options using a Black-Scholes valuation model. The fair value of common stock was determined based upon recent sales of common stock to third parties pursuant to common stock offering, since our common stock trades infrequently in the public markets.
The risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero-coupon issues with a remaining term commensurate with the expected term of the award. Management has estimated expected volatility based on similar comparable industry sector averages. Expected life of the option represents the period of time options are expected to be outstanding. The estimate for dividend yield is 0% because we have not historically paid and does not intend to pay a dividend on its common stock in the foreseeable future.
Allocated costs from Sanovas
A substantial portion of our expenses are costs and expenses paid by Sanovas and costs and expenses allocated to us by Sanovas. We expect that to continue until we have sufficient resources to build our own team and infrastructure to support our operations. The allocations our payroll related expenses are based upon the estimated percentage of effort incurred by each employee on operations. Allocation of non-payroll related expenses are based upon whether the expense related to our operations.
Income taxes
We account for income taxes using the asset-and-liability method in accordance with Accounting Standards Codification 740, Income Taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on the deferred tax assets and liabilities of a change in tax rate is recognized in the period that includes the enactment date. A valuation allowance has been recorded for all of the deferred tax assets.
JOBS Act
We are an "emerging growth company," as defined in Section 2(a) the Securities Act, as modified by the JOBS Act. For as long as we continue to be an emerging growth company, we also intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, exemptions from the requirements of holding a nonbinding advisory stockholder vote on executive compensation and any golden parachute payments not previously approved, exemption from the requirement of auditor attestation in the assessment of our internal control over financial reporting and exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements (auditor discussion and analysis). We will remain an emerging growth company until the earliest of (i) the end of the fiscal year in which the market value of our common stock that is held by non-affiliates exceeds $700 million as of the end of the second fiscal quarter, (ii) the end of the fiscal year in which we have total annual gross revenues of $1.325 billion or more during such fiscal year, (iii) the date on which we issue more than $1 billion in non-convertible debt in a three-year period or (iv) the end of the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement filed under the Securities Act.
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.