RetinalGenix Technologies Inc 10-K for FY2025

RetinalGenix Technologies Inc. (RTGN)

10-K 2026-04-15 For: 2025-12-31

Added on April 15, 2026

About this 10-K

RetinalGenix Technologies Inc filed this 10-K on April 15, 2026, covering the fiscal year ended December 31, 2025 (FY2025).

Headline figures

Fiscal year ended December 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $2.43M; compared with a net loss of $4.32M a year earlier
Diluted EPS: -$0.13; compared with -$0.24 a year earlier

Search and read filings like this one from Claude or ChatGPT with the SEC filings MCP server →

409 Apollo Beach Blvd, Suite 6 Apollo Beach, FL		33572
(Address of principal executive offices)		(Zip code)

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

Part I

Item 1.	Business	6
Item 1A.	Risk Factors	20
Item 1B.	Unresolved Staff Comments	38
Item 1C.	Cybersecurity	38
Item 2.	Properties	38
Item 3.	Legal Proceedings	38
Item 4.	Mine Safety Disclosures	38

Part II

Item 5.	Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	39
Item 6.	Reserved	39
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	40
Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	44
Item 8.	Financial Statements and Supplementary Data	44
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	45
Item 9A.	Controls and Procedures	45
Item 9B.	Other Information	45
Item 9C.	Disclosure Regarding Foreign Jurisdiction that Prevent Inspections	45

Part III

Item 10.	Directors, Executive Officers and Corporate Governance	46
Item 11.	Executive Compensation	50
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	54
Item 13.	Certain Relationships and Related Transactions, and Director Independence	56
Item 14.	Principal Accountant Fees and Services	57

Part IV

Item 15.	Exhibit and Financial Statement Schedules	58
Item 16.	Form 10-K Summary	59

Signatures		60

	●	our business strategies;

	●	the timing of regulatory submissions;

	●	our ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain;

	●	risks relating to the timing and costs of clinical trials and the timing and costs of other expenses;

	●	risks related to market acceptance of products;

	●	intellectual property risks;

	●	risks associated to our reliance on third party organizations;

	●	our competitive position;

	●	our industry environment;

	●	our anticipated financial and operating results, including anticipated sources of revenues;

	●	assumptions regarding the size of the available market, benefits of our products, product pricing and timing of product launches;

	●	management’s expectation with respect to future acquisitions;

	●	statements regarding our goals, intentions, plans and expectations, including the introduction of new products and markets; and

	●	our cash needs and financing plans.

Title of each class		Trading symbol(s)		Name of each exchange on which registered

	●	We have generated no revenue from commercial sales and our future profitability is uncertain.
	●	Failure to obtain the capital necessary to fund our operations, we will be unable to continue our product development and you will likely lose your entire investment.
	●	Raising additional capital may cause dilution to our existing stockholders.
	●	There is substantial doubt about our ability to continue as a going concern.
	●	We have incurred net losses every year and expect to continue to incur increased expenses.
	●	Failure to maintain effective internal control over in accordance with Section 404 of Sarbanes-Oxley could cause our financial reports to be inaccurate.

	●	Our revenues from sales of our products will be dependent upon pricing and reimbursement guidelines.
	●	We will depend upon our suppliers to provide the components we require.
	●	Our commercial and financial success depends on our products being accepted in the market.
	●	We may face substantial competition in the future.
	●	Product liability lawsuits against us could cause us to incur substantial liabilities.
	●	We are dependent on information technology systems.
	●	If the quality or delivery of our products does not meet our customers’ expectations, our reputation could suffer and ultimately our sales and operating earnings could be negatively impacted.
	●	Failure to comply with data privacy and security laws could have a material adverse effect on us
	●	We may not be successful in hiring and retaining key employees, including executive officers.
	●	Our management overlaps substantially with the management and our principal stockholder.
	●	We may acquire other businesses that could negatively affect our operating results and dilute our stockholders’ ownership.
	●	Our failure to accurately forecast demand for our products could result in additional costs.
	●	If our facilities were to experience catastrophic loss, our operations would be seriously harmed.
	●	Changes in general economic conditions and geopolitical and other conditions may adversely impact our business and operating results.
	●	The future of drug negotiation prices under President Trump’s administration is uncertain
	●	We will be dependent upon third parties for the distribution of our products.

	●	Our intellectual property may not be sufficient to protect our products from competition.
	●	We may not be able to enforce our intellectual property rights throughout the world.
	●	Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
	●	We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.

	●	Our failure to obtain and maintain FDA clearances or approvals on a timely basis, or at all, would prevent us from commercializing our products in the U.S., which could severely harm our business.
	●	Our promotional practices will be subject to extensive government scrutiny.
	●	Our product candidates require significant clinical testing before seeking regulatory approval.
	●	Healthcare reform measures could hinder or prevent the commercial success of our product candidates.
	●	Our success depends upon our ability to advance our product candidates.
	●	We do not have experience conducting clinical trials.
	●	A shutdown of the U.S. federal government may adversely affect our business.
	●	Inadequate funding, government shutdowns, workforce reductions or other policy changes affecting government agencies could hinder our business.
	●	Legislative or regulatory reform of the health care system in the U.S. may adversely impact our business.
	●	We are subject to stringent domestic and foreign medical device regulations.
	●	We will also be subject to stringent government regulation in foreign countries.
	●	Failure by us or our distributors to comply with foreign regulations applicable to the products we design, manufacture, install or distribute could expose us to enforcement actions or other adverse consequences.
	●	We will be subject to ongoing requirements and inspections.
	●	We could be subject to substantial fines or damages and possible exclusion from participation in federal or state health care programs if we fail to comply with the laws and regulations applicable to our business.
	●	If we fail to develop and successfully introduce new products our operating results may suffer.

	●	Our stock price may be volatile.
	●	Future sales and issuances of our securities could result in additional dilution.
	●	We have never paid cash dividends and have no plans to pay cash dividends in the future.
	●	The “penny stock” rules of the SEC make transactions in our stock cumbersome.
	●	Certain of our stockholders control a significant number of shares of our common stock.
	●	We have availed ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our common stock less attractive to investors.
	●	Our First Amended and Restated Certificate of Incorporation (“Certificate of Incorporation”) and our Bylaws (the “Bylaws”) and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.
	●	Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming.
	●	Failure to maintain effective internal control over our financial reporting in accordance with Section 404 of Sarbanes-Oxley could cause our financial reports to be inaccurate.
	●	Our Certificate of Incorporation and Bylaws provide that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

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

	2.	RetinalCam^TM, 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 RetinalCam^TM by the end of 2026.

	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.

	1.	Genetic testing: Pharmacogenetic mapping, highlighting key health biomarkers for eye and systemic diseases, through RetinalGenix’s DNA/GPS Inc and partnered organizations.
	2.	Retinal Imaging platform: Retinal camera and operating system for economically capturing high definition optical images for analysis by healthcare providers, using RetinalCam^TM, existing clinical images and RetinalGenix’s Imaging System.
	3.	Patient Informational database: Secure and interoperable database system for genetic information and images controlled by patients for use with their physicians, using RetinalGenix Eye Care Anonymized AI database (RECAD^TM AI system).
	4.	Pharmaceutical Therapies: Developing pharmaceutical products for treating eye and systemic diseases with partnered support, with RTG-2023 (dry age-related macular degeneration) and RTG-2024 (Alzheimer’s syndrome dementia).

	●	RTG-2023 for the treatment of dry age-related macular degeneration (dry AMD); and
	●	RTG-2024 for the treatment of Alzheimer’s syndrome dementia.

	●	6 in 10 adults in the US have a chronic disease^, The leading causes of death and disability and leading drivers of $4.1 trillion in annual health care costs^.
	●	Lack of cost-efficient and easy-to-operate high-resolution screening technology enabling early diagnosis
	●	Inefficient, requiring the patient to access specialty centers and approvals away from home
	●	Sophisticated technicians needed to implement MRI, CT, PET scan, ultrasound, echocardiogram, blood draws at specialty labs, retinal testing, etc.
	●	Results of diagnoses generally are not immediate or confidential
	●	Diagnostic equipment is based at universities, large clinics, and hospitals
	●	Geographic accessibility (Rural even more limited)

	●	Delay in early treatment of eye and systemic diseases
	●	There is expected to be physician workforce shortages throughout the country in 2030
	●	Specialists needed to interpret test results
	●	Inefficient, limited, and costly use of eyecare specialists
	●	Staffing shortages: The healthcare workforce is facing provider and nursing shortages in many geographies
	●	Decreasing medical professional population. The US faces a projected shortage of between 37,800 and 124,000 physicians within 12 years
	●	30+ million people in the US are without health insurance
	●	Worldwide, 4.5 billion people were not fully covered by essential health services

	●	Escalating blindness due to maculopathy, age-related macular degeneration (wet and dry), diabetic retinopathy and other eye diseases
	●	Insufficient number of ophthalmologists and optometrists worldwide <600,000
	●	Lack of early detection of central visual loss or changes due to therapeutic toxicity and various other causes
	●	Drug toxicity from many sources, including therapeutics, metabolic and infectious diseases, auto-immune and vascular disorders

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

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

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

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

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

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

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

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

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

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

	●	cost of treatment;

	●	pricing and availability of alternative products;

	●	the extent of available third-party coverage or reimbursement;

	●	perceived efficacy of our products relative to other products and medical solutions; and

	●	prevalence and severity of adverse side effects associated with treatment.

	●	decreased demand for our products;

	●	injury to our reputation and significant negative media attention;

	●	significant costs to defend the related litigation;

	●	substantial monetary awards;

	●	loss of revenue;

	●	diversion of management and scientific resources from our business operations; and

	●	the inability to commercialize any products that we may develop.

	●	paying monetary damages related to the legal expenses of the third party;

	●	facing additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial condition and the commercial viability of our product; and

	●	restructuring our company or delaying or terminating select business opportunities, including, but not limited to, research and development and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

	●	demonstrate clinically meaningful therapeutic or other medical benefits as compared to a patient receiving no treatment or over existing drugs or other product candidates in development to treat the same patient population;
	●	have the desired therapeutic or medical effects;
	●	be tolerable or free from undesirable or unexpected side effects;
	●	meet applicable regulatory standards;
	●	successfully commercialized by us or our licensees or collaborators.

●	undertaking preclinical development and successfully enroll subjects in clinical trials;

●	participating in regulatory approval processes;

●	formulating and manufacturing products; and

●	conducting sales and marketing activities.

	●	obtain marketing approval for our product candidates require additional funding not budgeted for;
	●	obtain marketing approval at all;
	●	obtain approval for indications or patient populations that are not as broad as intended or desired;
	●	and might be subject to additional post-marketing testing requirements; or
	●	have the product removed from the market after obtaining marketing approval.

●	take a significant, indeterminate amount of time;

●	result in product shortages due to regulatory delays;

●	require the expenditure of substantial resources;

●	involve modifications, repairs or replacements of our products;

●	require design changes of our products;

●	result in limitations on the indicated uses of our products; and

●	result in our never being granted the regulatory approval we seek.

	●	our ability to execute our business plan;

	●	changes in our industry;

	●	competitive pricing pressures;

	●	our ability to obtain working capital financing;

	●	additions or departures of key personnel;

	●	sales of our common stock;

	●	operating results that fall below expectations;

	●	regulatory developments;

	●	economic and other external factors;

	●	period-to-period fluctuations in our financial results;

	●	the public’s response to press releases or other public announcements by us or third parties, including filings with the SEC;

	●	changes in financial estimates or ratings by any securities analysts who follow our common stock, our failure to meet these estimates or failure of those analysts to initiate or maintain coverage of our common stock;

	●	the development and sustainability of an active trading market for our common stock;

	●	any future sales of our common stock by our officers, directors and significant stockholders; and

	●	other events or factors, many of which may be out of our control, including, but not limited to, pandemics such as COVID-19, war, or other acts of God.

	●	delaying, deferring or preventing a change in corporate control;

	●	impeding a merger, consolidation, takeover or other business combination involving us; or

	●	discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

	High		Low
2025
Quarter ended December 31	$	4.01	$	3.20
Quarter ended September 30	$	5.02	$	3.54
Quarter ended June 30	$	5.02	$	2.01
Quarter ended March 31	$	6.36	$	0.01

2024
Quarter ended December 31	$	1.62	$	0.25
Quarter ended September 30	$	1.60	$	1.50
Quarter ended June 30	$	1.50	$	1.00
Quarter ended March 31	$	3.50	$	1.00

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

	2.	RetinalCam^TM, 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.

	●	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.

	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	)%

	Page No.
Consolidated Financial Statements

Report of Independent Registered Public Accounting Firm	F-2

Consolidated Balance Sheets as of December 31, 2025 and 2024	F-3

Consolidated Statements of Operations for the years ended December 31, 2025 and 2024	F-4

Consolidated Statements of Changes in Stockholders’ Deficit for the years ended December 31, 2025 and 2024	F-5

Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024	F-6

Notes to Consolidated Financial Statements	F-7

	December 31, 2025			December 31, 2024
ASSETS
Current Assets
Cash	$	14,774		$	6,060
Total Current Assets		14,774			6,060

Equipment, net of accumulated depreciation of $307 and $251 at December 31, 2025 and 2024, respectively		-			56
Operating lease right-of-use asset		4,272			6,835
Security deposit		1,995			1,995

TOTAL ASSETS	$	21,041		$	14,946
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Liabilities
Current Liabilities
Accounts payable and accrued liabilities	$	1,084,763		$	922,083
Due to Sanovas		674,842			15,709
Due to related parties		489,224			467,793
Shareholders’ notes payable		49,000			49,000
Lease liability – short term portion		2,860			988
Accrued interest payable		19,279			15,439
Total Current Liabilities		2,319,968			1,471,012
Lease liability – long term portion		3,684			6,544
Total liabilities		2,323,652			1,477,556
Commitments and contingencies		-
Stockholders’ Deficit:
Preferred stock, $0.0001 par value; 40,000,000 shares authorized; Series F preferred stock - 3,000,000 shares designated, 0 issued and outstanding at December 31, 2025 and December 31, 2024		-			-
Common stock, $0.0001 par value; 80,000,000 shares authorized; 18,754,739 and 18,522,295 shares issued and outstanding at December 31, 2025 and 2024, respectively		1,875			1,852
Additional paid in capital		15,679,131			14,115,560
Stock subscription receivable		(125,000	)		(150,000	)
Accumulated deficit		(17,858,617	)		(15,430,022	)
Total Stockholders’ Deficit		(2,302,611	)		(1,462,610	)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	21,041		$	14,946

	2025			2024
	For the years ended
	December 31,
	2025			2024

Revenues	$	-		$	-
Operating expenses:
General and administrative		1,300,956			1,333,930
Research and development		83,040			373,271
Stock-based compensation		1,040,594			2,609,786

Total operating expenses		2,424,590			4,316,987

Interest expense, net		4,005			3,840

Net loss	$	(2,428,595	)	$	(4,320,827	)

Net loss per share - basic and diluted	$	(0.13	)	$	(0.24	)

Weighted average number of common shares outstanding during the period- basic and diluted		18,562,592			17,940,639

	Common shares		Amount		Additional Paid in Capital		Stock Subscription Receivable			Accumulated Deficit			Total Stockholder’s Deficit
Balance as at December 31, 2024		18,522,295	$	1,852	$	14,115,560	$	(150,000	)	$	(15,430,022	)	$	(1,462,610	)
Stock-based compensation expense		-		-		1,040,594		-			-			1,040,594

Collection of stock subscription receivable		-		-		-		150,000			-			150,000

Shares sold to investors		176,889		18		397,982		-			-			398,000
Stock subscribed by investors		55,555		5		124,995		(125,000	)
Net loss		-		-		-					(2,428,595	)		(2,428,595	)
Balance as at December 31, 2025		18,754,739	$	1,875	$	15,679,131		(125,000	)	$	(17,858,617	)	$	(2,302,611	)

Balance as at December 31, 2023		17,635,478	$	1,764	$	9,701,774		-		$	(11,109,195	)	$	(1,405,657	)
Balance		17,635,478	$	1,764	$	9,701,774		-		$	(11,109,195	)	$	(1,405,657	)

Exercise of stock options		170,000		17		209,983					-			210,000

Settlement of account payable through issuance of common stock		75,000		7		149,993					-			150,000
Retirement of due to Sanovas through the issuance of shares of common stock to Sanovas Ophthalmology LLC		296,000		30		665,970								666,000
Stock-based compensation expense		-		-		2,609,786					-			2,609,786
Stock issued to vendor		55,555		6		124,994								125,000

Shares sold to investors		223,595		22		503,066					-			503,088
Stock subscribed by investors		66,667		6		149,994		(150,000	)					-
Net loss								-			(4,320,827	)		(4,320,827	)
Balance as at December 31, 2024		18,522,295	$	1,852	$	14,115,560	$	(150,000	)	$	(15,430,022	)	$	(1,462,610	)
Balance		18,522,295	$	1,852	$	14,115,560	$	(150,000	)	$	(15,430,022	)	$	(1,462,610	)

	2025			2024
	Year ended
	December 31,			December 31,
	2025			2024

Balance due to Sanovas – beginning of period	$	15,709		$	2,760

Costs of Sanovas allocated to the Company		661,500			654,300
Retirement of due to Sanovas through the issuance of shares to Sanovas Ophthalmology		-			(666,000	)
Cash advances from Sanovas to the Company, net		(2,367	)		24,649

Balance due to Sanovas - end of period	$	674,842		$	15,709