HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN |
3 Months Ended | ||||||
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Mar. 31, 2026 | |||||||
| Accounting Policies [Abstract] | |||||||
| HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN | NOTE A – HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN
RetinalGenix Technologies Inc. (the “RTGN”), a Delaware corporation, was formed in November 2017 by Sanovas Ophthalmology, LLC (“Sanovas Ophthalmology”), a majority owned subsidiary of Sanovas Inc. (“Sanovas”), a privately held research and development incubator. Since inception, a portion of the operations of RTGN were conducted by Sanovas, who invoices RTGN for costs and expenses paid for on behalf of RTGN and costs and expenses allocated to RTGN for services performed on behalf of the Company.
RTGN was formed to develop technologies to screen, monitor, diagnose and treat ophthalmic and systemic disease. Its 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). RTGN sublicensed certain technology initially developed by Sanovas from Sanovas Ophthalmology – See Note C.
RTGN’s 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). RTGN and its subsidiary, DNA/GPS, Inc. are referred to as the Company.
The Company’s RetinalCam™ device is a portable ophthalmic home screening and monitoring device designed for remote general and home use employing real-time communication and alerting system for physicians available 24/7 and does not require dilation of the consumer’s pupil.
In addition to the above medical device, as announced in October 2023, the Company is engaged with Pearl IRB, a provider of diagnostic testing services for its Institutional Review Board (“IRB”) to conduct a study to personalize medical evaluations for patients receiving direct intraocular injections into their eyes as treatment for wet macular degeneration to help determine whether there is a genetic basis for the success or the failure of the procedure and to help patients evaluate whether the treatment is necessary. The Company has engaged phlebotomists from Seven Springs Surgery Center to facilitate the blood draw process necessary for the Pearl IRB study. The Company anticipates an expansion of the IRB to multistate physicians in the winter of 2026 or early 2027, and the initial analysis shortly thereafter, which will inform its clinical trial plans.
In addition to the above medical device and IRB advancements, the Company continues to make progress in its planning/and guidance to move forward, via its contracted clinical resource organization, to conduct pharmaceutical clinical studies for our two products:
Liquidity and Going Concern
The Company has had net losses since inception and has an accumulated deficit of approximately $18,400,000 at March 31, 2026. As of March 31, 2026, the Company had liabilities of approximately $2,564,000, a significant portion of which is with related parties. The Company has minimal cash at March 31, 2026, and remains dependent on related parties for much of its financing. The Company expects that operating losses and negative cash flows from operations will occur for at least the next several years, and the Company will need to access additional funds to achieve its strategic goals with respect to the sublicensed technology. The Company is in discussions with investment bankers and individual investors with respect to raising additional capital for the Company and potentially up-listing to Nasdaq exchange.
Sanovas has paid a significant portion of the Company’s operating expenses through March 2026, and was owed approximately $831,000 as of March 31, 2026 by the Company. During 2025, the Company sold shares of common stock at $ per share raising gross proceeds of $523,000, including $ of stock subscribed for in 2025 and paid in 2026.
As of the date of this filing, the Company does not have adequate resources to fund its operations through June 2026 without considering any potential future milestone payments that it may receive under any new collaborations that it may enter into in the future or any future capital raising transactions. The Company will need to raise additional funding to complete the development of its products and commence the market launch, assuming regulatory approval is obtained. The Company does 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 the Company’s ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
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