10-Q: Quarterly report pursuant to Section 13 or 15(d)
Published on August 19, 2024
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
For
the quarterly period ended
OR
For the transition period from ________________ to ________________
Commission
File Number:
(Exact Name of Registrant as Specified in its Charter)
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
|
| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code)
Not applicable
(Former name, former address and former fiscal year, if changed since last report
Securities registered pursuant to Section 12(b) of the Act: None
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| ☒ | Smaller reporting company | ||
| Emerging growth company |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The number of shares of the issuer’s common stock, $ par value per share, outstanding at August 16, 2024 was .
PART I — FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS.
RETINALGENIX TECHNOLOGIES INC.
CONSOLIDATED BALANCE SHEETS
| June 30, 2024 (unaudited) | December 31, 2023 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash | $ | $ | ||||||
| Total Current Assets | ||||||||
| Equipment, net of accumulated
depreciation of $ |
||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
| Liabilities | ||||||||
| Current Liabilities | ||||||||
| Accounts payable and accrued liabilities | ||||||||
| Due to Sanovas | ||||||||
| Due to related parties | ||||||||
| Shareholders’ notes payable | ||||||||
| Accrued interest payable | ||||||||
| Total Liabilities | ||||||||
| Stockholders’ Deficit: | ||||||||
| Preferred stock, $ par value; shares authorized; Series F preferred stock - shares designated, issued and outstanding at June 30, 2024 and December 31, 2023 | ||||||||
| Common stock, $ par value; shares authorized; and shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | ||||||||
| Additional paid in capital | ||||||||
| Accumulated deficit | ( |
) | ( |
) | ||||
| Total Stockholders’ Deficit | ( |
) | ( |
) | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | $ | $ | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 2 |
RETINALGENIX TECHNOLOGIES INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
| For The Three Months Ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Revenues | $ | $ | ||||||
| Operating expenses: | ||||||||
| General and administrative expenses | ||||||||
| Research and development | ||||||||
| Stock-based compensation | ||||||||
| Total operating expenses | ||||||||
| Interest expense | ||||||||
| Net loss | $ | ( |
) | $ | ( |
) | ||
| Net loss per share - basic and diluted | $ | ) | $ | ) | ||||
| Weighted average number of common shares outstanding during the period- basic and diluted | ||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 3 |
RETINALGENIX TECHNOLOGIES INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
| For The Six Months Ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Revenues | $ | $ | ||||||
| Operating expenses: | ||||||||
| General and administrative expenses | ||||||||
| Research and development | ||||||||
| Stock-based compensation | ||||||||
| Total operating expenses | ||||||||
| Interest expense | ||||||||
| Net loss | $ | ( |
) | $ | ( |
) | ||
| Net loss per share - basic and diluted | $ | ) | $ | ) | ||||
| Weighted average number of common shares outstanding during the period- basic and diluted | ||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 4 |
RETINALGENIX TECHNOLOGIES INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT (UNAUDITED)
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2024 AND JUNE 30, 2023
| Common shares | Common shares amount | Additional Paid in Capital | Accumulated Deficit | Total Stockholder’s Deficit | ||||||||||||||||
| June 30, 2024 Period | ||||||||||||||||||||
| Balance as at December 31, 2023 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
| Settlement of accounts payable through issuance of shares | ||||||||||||||||||||
| Stock based compensation expense | ||||||||||||||||||||
| Exercise of stock options | ||||||||||||||||||||
| Net loss | ( |
) | ( |
) | ||||||||||||||||
| Balance as at March 31, 2024 | ( |
) | ( |
) | ||||||||||||||||
| Shares sold to investors | ||||||||||||||||||||
| Stock based compensation expense | ||||||||||||||||||||
| Exercise of stock options | ||||||||||||||||||||
| Net loss | ( |
) | ( |
) | ||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
| June 30, 2023 Period | ||||||||||||||||||||
| Balance as at December 31, 2022 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
| Stock-based compensation | ||||||||||||||||||||
| Net loss | ( |
) | ( |
) | ||||||||||||||||
| Balance as at March 31, 2023 | ( |
) | ( |
) | ||||||||||||||||
| Stock-based compensation | ||||||||||||||||||||
| Net loss | ( |
) | ( |
) | ||||||||||||||||
| Balance as at June 30, 2023 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 5 |
RETINALGENIX TECHNOLOGIES INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
| For The Six Months Ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash Flows From (Used In) Operating Activities | ||||||||
| Net loss | $ | ( |
) | $ | ( |
) | ||
| Adjustments to reconcile net loss to net cash (used in) operating activities | ||||||||
| Non-cash items: | ||||||||
| Stock-based compensation expense | ||||||||
| Depreciation expense | ||||||||
| Expenses allocated by Sanovas on behalf of Company | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Increase in accounts payable and accrued liabilities | ||||||||
| Increase in accrued interest | ||||||||
| Total adjustments | ||||||||
| Net cash (used in) operating activities | ( |
) | ( |
) | ||||
| Cash Flows From Financing Activities | ||||||||
| Proceeds from common stock sold | ||||||||
| Proceeds from exercise of stock options and warrants | ||||||||
| Advances from related parties | ||||||||
| Net cash provided by financing activities | ||||||||
| Net increase in cash | ||||||||
| Cash at beginning of period | ||||||||
| Cash at end of period | $ | $ | ||||||
| Supplemental information: | ||||||||
| Interest paid | $ | $ | ||||||
| Income taxes paid | ||||||||
| Vendor liability settled through the issuance of common stock | ||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 6 |
RETINALGENIX TECHNOLOGIES INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE A – HISTORY, BUSINESS PURPOSE, LIQUIDITY AND GOING CONCERN
RetinalGenix Technologies Inc. (the “Company”), 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. During the periods ended June 30, 2024 and 2023, a portion of the operations of the Company were conducted by Sanovas, who invoices the Company for costs and expenses paid for on behalf of the Company and costs and expenses allocated to the Company for services performed on behalf of the Company.
The Company was formed to develop technologies to diagnose and treat ophthalmic disorders. The Company sublicensed certain technology initially developed by Sanovas from Sanovas Ophthalmology – See Note C. The Company is actively pursuing its mission to prevent vision loss and blindness due to ocular diseases, including diabetic retinopathy and maculopathy, in its first two devices:
| 1. | 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 | |
| 2. | Retinal Imaging Screening Device, a portable, retinal imaging system providing a wide field of view without requiring pupil dilation; |
In addition to the above medical device advancements, 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 treatment for wet macular degeneration, which was previously announced on October 30, 2023. The Company and Dr. Perich have engaged phlebotomists from Seven Springs Surgery Center to facilitate the blood draw process necessary for the Pearl IRB study. Blood draws are anticipated to begin in the third quarter 2024. If study proves successful, revenues for this program are anticipated to begin in Q1 2025.
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 their medications:
| 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. |
On
July 5, 2022, the Company entered into an exchange agreement with Dr. Lawrence Perich pursuant to which it acquired all the outstanding
shares of DNA/GPS Inc., a pharmacogenetics company based in Tampa, Florida (“DNA/GPS”), in exchange for the issuance of
shares of the Company’s common stock. The acquisition of DNA/GPS combines DNA/GPS’ genetic mapping capabilities with the
Company’s retinal imaging capabilities. The combined technology is expected to have the ability to screen, monitor and provide
data to profile trends and create diagnostic markers for systemic and retinal disorders in the cardiovascular, Alzheimer’s, Parkinson
disease. The markers and data analysis are rapid and cost effective, thereby eliminating expensive diagnostic equipment such as MRI or
CT scanning. The results are confidential to the patient and anonymous for any third party without permission of the patient. The Company
accounted for this transaction as an asset acquisition in the quarter ended September 30, 2022. The estimated fair value of the transaction
was $
Liquidity and Going Concern
The
Company has had net losses since inception and has an accumulated deficit of approximately $
| 7 |
Sanovas
has paid a significant portion of the Company’s operating expenses through June 2024, and was owed approximately $
As of the date of this report, the Company does not have adequate resources to fund its operations through August 2024 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 consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
NOTE B - SIGNIFICANT ACCOUNTING POLICIES
A summary of significant accounting policies consistently applied in the preparation of the accompanying consolidated financial statements is as follows:
1. Basis of Presentation
The Company’s consolidated financial statements were prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). As of June 30, 2024, there have been no material changes in the Company’s significant accounting policies from those that were disclosed in the Annual Report for the year ended December 31, 2023 (the “2023 Annual Report”).
2. Cash Equivalents
For purpose of the consolidated statements of cash flows, the Company considers all short-term investments purchased with a maturity of three months or less to be cash equivalents.
3. Use of Estimates
In preparing the Company’s consolidated financial statements in conformity with US GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
4. Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis 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 deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 740-10 Income Taxes. ASC Topic 740-10 clarifies the accounting for income taxes by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements. It also provides guidance on the recognition, measurement, and classification of amounts relating to uncertain tax positions, accounting for and disclosure of interest and penalties, accounting in interim periods and disclosures. The application of that guidance did not result in the recognition of any unrecognized tax benefits at June 30, 2024 or December 31, 2023. The Company’s policy is to expense any penalties and interest associated with this topic. At June 30, 2024 and December 31, 2023, there were no amounts accrued for penalties and interest.
| 8 |
The Company computes net income (loss) per share in accordance with ASC 260, Earnings Per Share (“EPS”). Under the provisions of ASC 260, basic net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number of common and common equivalent shares outstanding during the period. However, common shares that are considered anti-dilutive are excluded from the computation of diluted EPS. Since the Company had a loss during the three and six months ended June 30, 2024 and 2023, the basic and diluted net loss per share is the same.
Potentially dilutive securities not included in the computation of loss per share for the three and six months ended June 30, 2024 stock options to purchase shares of common stock, pre-funded warrant to purchase shares of common stock and warrants to purchase shares of common stock. Potentially dilutive securities not included in the computation of loss per share for the three months ended June 30, 2023, include stock options to purchase shares of common stock, pre-funded warrant to purchase shares of common stock, and warrants to purchase shares of common stock.
6. Stock-based compensation:
The Company recognizes expense for stock-based compensation in accordance with ASC Topic 718, Stock-Based Compensation. For stock-based awards, the Company calculates the fair value of the award on the date of grant using the Black Scholes option-pricing model. The expense is recognized over the service period for awards expected to vest. The estimate of stock-based awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative adjustment in the period the estimates are revised. Stock options granted to non-employee consultants are revalued at the end of each reporting period until vested and the changes in their fair value are recorded as adjustments to expense over the related vesting period.
7. Research and Development costs:
Research and development costs are expensed as incurred. Costs incurred in obtaining technology licenses outside of business combinations are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. licensed has not reached technological feasibility and has no alternative future use.
8. Property and Equipment:
Property
and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives (
The Company’s long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount.
9. Recent Accounting Pronouncements:
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 the consolidated financial statements of the Company.
NOTE C - RELATED PARTY TRANSACTIONS
Sanovas
The Company is related to Sanovas through common ownership and management. Sanovas Opthalmology is a majority owned subsidiary of Sanovas and Jerry Katzman, the Company’s Chief Executive Officer, is also a director of Sanovas Ophthalmology and in such capacity has the right to vote and dispose of the securities held by such entity.
Commencing
in 2019, Sanovas began paying expenses on behalf of the Company, and began allocating a portion of expenses and infrastructure costs
to the Company and other entities where Sanovas was performing shared services. Included in such allocated costs is approximately $
| 9 |
The following summarizes the transactions between the Company and Sanovas for the six months ended June 30, 2024 and 2023:
| Six months Ended | ||||||||
| June 30, | June 30, | |||||||
| 2024 | 2023 | |||||||
| Balance due to Sanovas – beginning of year | $ | $ | ||||||
| Costs of Sanovas allocated to the Company | ||||||||
| Proceeds from costs charged by Sanovas to the Company | ||||||||
| Balance due to Sanovas - end of period | $ | $ | ||||||
Sublicense
On June 24, 2021, the Company entered into a sublicense agreement (“Sublicense Agreement”) with Sanovas Ophthalmology pursuant to which Sanovas Ophthalmology granted the Company an exclusive worldwide (“Territory”) license to certain intellectual property licensed to Sanovas Ophthalmology by Sanovas Intellectual Property LLC relating to certain technologies for eye and ocular visualization and monitoring (“Licensed IP”) for uses related to the screening, examination, diagnosis, prevention and/or treatment of any eye disease, medical condition or disorder, or any disease, medical condition or disorder affecting the eye. Pursuant to the Sublicense Agreement, commencing on the date of the first commercial sale of a Licensed Product (as defined in the Sublicense Agreement), in each country in the Territory and continuing on a country by country basis until the expiration or termination of the last Valid Claim (as defined in the Sublicense Agreement) of a licensed patent in such country (the “Royalty End Date”), the Company is obligated to pay Sanovas Ophthalmology a royalty equal to a mid-single digit percentage of any Net Sales (as defined in the Sublicense Agreement) of any Licensed Product. The Sublicense Agreement continues until the Royalty End Date, unless earlier terminated pursuant to its terms. The Sublicense Agreement may be terminated by either party if the other party materially breaches the Sublicense Agreement in a manner that cannot be cured, or materially breaches the Sublicense Agreement in a manner that can be cured and such breach remains uncured for more than 30 days after the receipt by the breaching party of notice specifying the breach. Furthermore, the Company may terminate the Sublicense Agreement at any time upon 90 days written notice to Sanovas Ophthalmology. No royalties have been paid through June 30, 2024 under this Sublicense Agreement.
Due to affiliates
From
time to time, an officer of the Company, a shareholder of the Company and affiliates of Sanovas advanced funds or paid expenses on behalf
of the Company. There is no formal notes or repayment plan for such advances. At June 30, 2024 and December 31, 2023, the Company had
received an aggregate of $
Shareholders’ notes payable – See Note G
NOTE D - COMMON AND PREFERRED STOCK
Pursuant to the Company’s Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”), filed with the Delaware Secretary of State on January 8, 2018, the Company is authorized to issue shares of preferred stock and shares of common stock each with a par value of $ per share. The Company has designated shares of preferred stock as Series F preferred stock.
In November 2020, Sanovas commenced an action in the Court of Chancery of the State of Delaware (the “Delaware Action”) against Lawrence Gerrans and Halo Management LLC (“Halo”), an entity owned by Mr. Gerrans, seeking an order declaring that any rights that Halo and/or Mr. Gerrans may have with respect to any equity securities in Sanovas and each of its affiliated subsidiaries (including, but not limited to, the Company) are void or voidable and may be cancelled.
On November 21, 2021, the Company’s Board of Directors adopted a resolution to rescind the shares of Series F preferred stock purported to be issued to Halo Management Group LLC for lack of contract consideration. The Company recorded this action into its accounts in the fourth quarter of 2021. On April 2, 2024, the Court of Chancery of the State of Delaware issued an order in the Delaware Action voiding and cancelling the shares of Series F Preferred Stock issued to Halo and Gerrans’ rights to any equity securities in the Company.
| 10 |
Common Stock
In
March 2024, the Company issued shares of common stock in settlement of $
In
2024, the Company commenced an offering of its common stock at $ per share. In June 2024, the Company sold shares of common
stock for $
The common stockholders, voting as a separate class, are entitled to elect one member of the Board of Directors.
Preferred Stock
As of June 30, 2024 and December 31, 2023, there were shares of preferred stock designated as Series F preferred stock, of which were outstanding.
The rights and privileges of the Series F preferred stock are summarized as follows:
Voting Privileges and Protective Features:
Redemption:
The Series F preferred stock does not have redemption features.
Dividends:
There
are
Conversion:
The Company has reserved shares of common stock for issuance to employees or consultants from the RetinalGenix Technologies Inc. 2017 Equity Incentive Plan (the “Plan”). The Company may grant stock options, restricted stock or other types of equity incentive instruments under the Plan.
| 11 |
The
Company recognized $
At June 30, 2024, there were shares available to be issued under the Plan. The following table summarizes stock option activity of the Plan through June 30, 2024:
| Options Issued | Weighted-Average Exercise Price | |||||||
| Options outstanding – December 31, 2022 | $ | |||||||
| Granted | ||||||||
| Canceled | ||||||||
| Forfeited | ( |
) | ||||||
| Exercised | ||||||||
| Options outstanding – December 31, 2023 | $ | |||||||
| Granted | ||||||||
| Canceled | ||||||||
| Forfeited | ||||||||
| Exercised | ( |
) | ||||||
| Options outstanding – June 30, 2024 | $ | |||||||
| Exercise Price | Number Outstanding |
Weighted
Average Remaining Contractual Life |
Number June 30, 2024 |
|||||||||
| $ | Years | |||||||||||
| years | ||||||||||||
| Risk-free interest rates | % | |||
| Expected life in years | ||||
| Expected volatility | % | |||
| Expected dividend yield | % | |||
| Fair value common stock | $ |
The fair value of each option grant was estimated on the date of grant to be $ -$ per share using the Black-Scholes option-pricing model with the following assumption weighted-averages in 2023:
| Risk-free interest rates | %- | % | ||
| Expected life in years | ||||
| Expected volatility | % | |||
| Expected dividend yield | % | |||
| Fair value common stock | $ | |||
| 12 |
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 % because the Company has not historically paid, and does not intend to pay a dividend on its common stock in the foreseeable future.
NOTE F - WARRANTS
During
the first quarter of 2024, the Company issued warrants for the issuance of shares of common stock to consultants, board members,
and advisors at an exercise price of $
The following table summarizes warrant activity through June 30, 2024:
| Warrants Issued | Weighted-Average
Exercise Price |
|||||||
| Warrants outstanding – December 31, 2022 | $ | |||||||
| Granted | ||||||||
| Canceled | ||||||||
| Exercised | ||||||||
| Warrants outstanding – December 31, 2023 | ||||||||
| Granted | ||||||||
| Canceled | ||||||||
| Exercised | ||||||||
| Warrants outstanding – June 30, 2024 | $ | |||||||
Additional information regarding the warrants outstanding as of March 31, 2024 is as follows:
| Exercise Price | Number Outstanding |
Weighted
Average Remaining Contractual Life |
Number Exercisable |
|||||||||
| $ | Years | |||||||||||
| $ | Years | |||||||||||
| Risk-free interest rates | % | |||
| Expected life in years | ||||
| Expected volatility | % | |||
| Expected dividend yield | % | |||
| Fair value common stock | $ |
| 13 |
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 % because the Company has not historically paid, and does not intend to pay, a dividend on its common stock in the foreseeable future. The Company recognized stock-based compensation expense of $ and $ in the six months ended June 30, 2024 and 2023, respectively. The Company recognized $ and $ of stock-based compensation expense during the three months ended June 30, 2024 and 2023, respectively, related to stock options which is included in the accompanying consolidated statements of operations. At June 30, 2024, there is approximately $ remaining compensation expense to be recognized. That cost is expected to be recognized over a weighted-average period of approximately years.
Pre-funded Warrant
On
December 27, 2021, the Company entered into an exchange agreement with Sanovas Ophthalmology (the “Exchange Agreement”) pursuant
to which it exchanged shares of common stock (the “Exchange Securities”) held by Sanovas Ophthalmology for a pre-funded
warrant (the “Pre-funded Warrant”) to purchase up to an aggregate of
NOTE G – SHAREHOLDERS’ NOTES PAYABLE
During
2021, the Company borrowed an aggregate of $
NOTE H - SUBSEQUENT EVENTS
Subsequent events were reviewed through August 16, 2024, the date these consolidated financial statements were available for issuance and determined that no subsequent events have occurred that require recognition in the consolidated financial statements.
From
July 1, 2024 through August 19, 2024, the Company sold shares of common stock at $ per share for proceeds of $
| 14 |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Overview
We are an ophthalmic research and development company focused on developing technologies to screen, monitor, diagnose and treat ophthalmic, optical, and sight-threatening disorders. Our mission is to prevent vision loss and blindness due to diabetic retinopathy and maculopathy through two devices: (1) Retinal Imaging Screening Device, a portable, retinal imaging system providing a 200-degree field of view without requiring pupil dilation; and (2) RetinalCamTM, a home monitoring and imaging device offering real-time communication and alerting system for physicians available 24/7.
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 an additional $12,200,000 to (i) complete product design and testing for 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; and (iii) build the infrastructure for our sustained growth. 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 to generate any revenues from product sales unless and until we successfully complete development 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.
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.
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.
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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. As of June 30, 2024, there have been no material changes in the Company’s significant accounting policies from those that were disclosed in the 2023 Annual Report.
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.
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Administrative Expenses
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 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 the coupon interest rate charged on loans from stockholders.
Results of Operations
Comparison of the six months ended June 30, 2024 and 2023
The following table sets forth key components of our results of operations for the six months ended June 30, 2024 and 2023.
| For The Six Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2024 | 2023 | Change | % Change | |||||||||||||
| Revenues | $ | - | $ | - | ||||||||||||
| Expenses | ||||||||||||||||
| General and administrative | 697,723 | 323,339 | 374,384 | 116 | % | |||||||||||
| Research and development | 166,023 | 380,509 | (214,486 | ) | (56 | )% | ||||||||||
| Stock-based compensation | 1,943,843 | 157,018 | 1,786,825 | 1,138 | % | |||||||||||
| Total Expenses | 2,807,589 | 860,866 | 1,946,723 | 226 | % | |||||||||||
| Interest expense | 1,920 | 1,920 | - | - | % | |||||||||||
| Net Loss | $ | (2,809,509 | ) | $ | (862,786 | ) | 1,946,723 | 226 | % | |||||||
Revenues
We did not recognize revenues for the six months ended June 30, 2024 and 2023.
Research and Development Expenses
| For the six months ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Direct costs | $ | 141,723 | $ | 363,849 | ||||
| Allocated costs from Sanovas | 24,300 | 16,660 | ||||||
| Total Research and Development expenses | $ | 166,023 | $ | 380,509 | ||||
Research and development expenses decreased by $214,486, or 56%, to $166,023 for the six months ended June 30, 2024 from $380,509 for the six months ended June 30, 2023. The decrease was primarily the result of a decrease in prototype related expense, engineering and technology consultants, and pilot manufacturing costs.
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Stock Based Compensation Expenses
Stock-based compensation expenses increased by $1,786,825, or 1,138%, to $1,943,843 for the six months ended June 30, 2024 from $157,018 for the six months ended June 30, 2023. The increase was primarily due to the recognition of expense for options issued in the first quarter of 2024, of which a significant portion was vested immediately.
General and Administrative Expenses
| For the six months ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Direct costs | $ | 331,223 | $ | 75,839 | ||||
| Allocated costs from Sanovas | 391,500 | 247,500 | ||||||
| Total General and Administrative expenses | $ | 697,723 | $ | 323,339 | ||||
Administrative expenses increased by $374,384 or 116%, to $697,723 for the six months ended June 30, 2024 from $323,339 for the six months ended June 30, 2023. 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. Administrative costs consisting of costs related to executives from Sanovas, were allocated based upon the amount of effort spent by such personnel on our business, and increased by $144,000 over the 2023 levels. Salaries allocated to the Company from Sanovas increased in 2024 since the majority of time spent by Sanovas employees were on Company activities. The Company also incurred $50,000 in fees as its portion of the legal costs in the Gerrans litigation matter described in Note D. Other administrative expenses, specifically legal and accounting fees, travel and marketing fees were higher because of fund raising and listing related expenses.
Comparison of the quarter ended June 30, 2024 and 2023
The following table sets forth key components of our results of operations for the three months ended June 30, 2024 and 2023.
| For The Three Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2024 | 2023 | Change | % Change | |||||||||||||
| Revenues | $ | - | $ | - | ||||||||||||
| Expenses | ||||||||||||||||
| General and administrative | 368,738 | 120,097 | 248,641 | 207 | % | |||||||||||
| Research and development | 82,926 | 152,577 | (69,651 | ) | (45 | )% | ||||||||||
| Stock-based compensation | 211,009 | 78,509 | 132,500 | 169 | % | |||||||||||
| Total Expenses | 662,673 | 351,183 | 311,490 | 89 | % | |||||||||||
| Interest expense | 960 | 960 | - | - | % | |||||||||||
| Net Loss | $ | (663,633 | ) | $ | (352,143 | ) | 311,490 | 89 | % | |||||||
Revenues
We did not recognize revenues for the three months ended June 30, 2024 and 2023.
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Research and Development Expenses
| For the three months ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Direct costs | $ | 70,776 | $ | 135,917 | ||||
| Allocated costs from Sanovas | 12,150 | 16,660 | ||||||
| Total Research and Development expenses | $ | 82,926 | $ | 152,577 | ||||
Research and development expenses decreased by $69,651, or 45% to $82,926 for the three months ended June 30, 2023 from $152,577 for the three months ended June 30, 2023. The decrease was primarily the result of a decrease in prototype related expense, engineering and technology consultants, and pilot manufacturing costs.
Stock Based Compensation Expenses
Stock-based compensation expenses increased by $132,500, or 169%, to $211,009 for the three months ended June 30, 2023 from $78,509 for the three months ended June 30, 2023. The increase was primarily due to the recognition of expense for options issued in early 2024.
General and Administrative Expenses
| For the three months ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Direct costs | $ | 134,738 | $ | (3,653 | ) | |||
| Allocated costs from Sanovas | 234,000 | 123,750 | ||||||
| Total general and administrative expenses | $ | 368,738 | $ | 120,097 | ||||
Administrative expenses increased by $248,641 or 207%, to $368,738 for the three months ended June 30, 2024 from $120,097 for the three months ended June 30, 2023. We have no full-time employees and have had limited funding, therefore the Company has been required to eliminated or defer as many costs as possible based upon available resources. Administrative costs consisting of costs related to executives from Sanovas, were allocated based upon the amount of effort spent by such personnel on our business, and increased by $110,000 over the 2023 levels. Salaries allocated to the Company from Sanovas increased in 2024 since the majority of time spent by Sanovas employees were on Company activities. The Company also incurred $25,000 in fees as its portion of the legal costs in the Gerrans litigation matter described in Note D. Other administrative expenses, specifically legal and accounting fees, travel and marketing fees were higher because of fund raising and listing related expenses.
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 six months ended June 30, 2024, we received approximately $86,000 of advances and invoices paid by affiliates, $210,000 from the exercise of stock options and $100,000 pursuant to recent private placement of common stock.
We anticipate that we will need $12,200,000 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.
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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 six months ended June 30, 2024 and 2023
The following table sets forth a summary of our cash flows for the periods presented:
| For The Six Months Ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Net cash used in operating activities | $ | (308,614 | ) | $ | (201,385 | ) | ||
| Net cash provided by financing activities | 395,527 | 203,260 | ||||||
| Net increase (decrease) in cash | 86,913 | 1,875 | ||||||
| Cash at beginning of the period | 0 | 38 | ||||||
| Cash at end of the period | $ | 86,913 | $ | 1,913 | ||||
Operating Activities
Net cash used in operating activities was $308,614 for the six months ended June 30, 2024. The cash flow used in operating activities in 2024 was driven by the net loss of $2,809,509 offset in part by non-cash stock-based compensation expense of $1,943,843 and an increase in accounts payable and accrued interest payable of $127,533. In addition, Sanovas billed us for allocated costs and expenses paid on behalf of and allocated to us in the amount of $415,800 and we received $11,749 of net cash advances from Sanovas during the six months ended June 30, 2024.
Net cash used in operating activities was $201,385 for the six months ended June 30, 2023. The increase was driven by higher R&D costs partially offset by a reduction in costs allocated from Sanovas to us and increases in accounts payable due to a lack of funding. The cash flow used in operating activities in 2023 was driven by the net loss of $862,786 offset in part by non-cash expenses of $157,018 and an increase in accounts payable and accrued interest payable of $221,593. In addition, Sanovas billed us for allocated costs and expenses paid on behalf of and allocated to us in the amount of $280,280. and we received $102,423 of net cash payments from Sanovas during the six months ended June 30, 2023.
Financing Activities
Net cash provided by financing activities was $395,527 and $203,260 during the six months ended June 30, 2024 and 2023, respectively, primarily attributable to proceeds from advances from related parties and Sanovas of $203,260 in the six months ended June 30, 2023, and the sale of common stock of $100,000, exercise of stock options of $210,000 and proceeds from advances from related parties of $85,527 in the six months ended June 30, 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.
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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 cost is recorded in the consolidated statements of operations based on the employees’ respective function. The fair value of common stock was determined based upon the sale of common stock to third parties pursuant to the offering which commenced in 2019, which offering continued through January 2022.
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.
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.
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.
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ITEM 3. QUANTATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
The information under this Item is not required to be provided by smaller reporting companies.
ITEM 4. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls
We are required to maintain disclosure controls and procedures (as defined in Rules 13a-15(e)€ and 15d-15(e) of the Exchange Act) that are designed to be effective in providing reasonable assurance that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
In connection with the preparation of this Quarterly Report on Form 10-Q, we carried out an evaluation based on the criteria in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, under the supervision and with the participation of management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based upon that evaluation, due to a material weakness in our internal control over financial reporting relating to a lack of segregation of duties, management concluded that our disclosure controls and procedures were ineffective as of June 30, 2024.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that a reasonable possibility exists that a material misstatement of our financial statements would not be prevented or detected on a timely basis. We are considering various remediation measures, including hiring internal accounting resources or using outside providers to provide additional resources and capabilities as well as implementing a more formal accounting and financial reporting system to mitigate such material weakness, but have not yet adopted or implemented any such measures. When we have sufficient business activity and funding available, we intend to begin to implement remediation measures to address our material weakness and improve our internal control over financial reporting and disclosure controls and procedures. We hope to complete the implementation, remediation and test of the new procedures in the second half of 2024, as resources permit us to spend time and money on building finance infrastructure.
Management is actively engaged in the planning for, and implementation of, remediation efforts to address our material weakness and improve our internal control over financial reporting and disclosure controls and procedures. We are developing procedures for the most critically-needed processes that we hope to have implemented by the end of the year.
Changes in Internal Control Over Financial Reporting
During the quarter ended June 30, 2024, there have been no changes in our internal controls over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
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PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.
ITEM 1A. RISK FACTORS.
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. The following information updates, and should be read in conjunction with, the information disclosed in Part I, Item 1A, “Risk Factors,” contained in our Annual Report on Form 10-K for the year ended December 31, 2023 (the “Annual Report”). Except as described below, our risk factors as of the date of this Quarterly Report on Form 10-Q have not changed materially from those described in “Part I, Item 1A. Risk Factors” of the Annual Report.
Risks Relating to Our Business
We have generated no revenue from commercial sales to date and our future profitability is uncertain.
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, 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 years ended December 31, 2023 and December 31, 2022, were $2,090,889 and $3,913,990, respectively, and our accumulated deficit as of December 31, 2023 and December 31, 2022 was $11,109,195 and $9,018,306, respectively. Our net losses for the six months ended June 30, 2024 and 2023, were $2,809,509 and $862,786, respectively, and our accumulated deficit as of June 30 31, 2024 was $13,918,704. 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.
There is substantial doubt about our ability to continue as a going concern.
As of June 30, 2024, we had cash of $86,913 and liabilities of $1,898,342. As of the date of this report, we do not have adequate resources to fund our operations beyond June 2025 without considering any potential future milestone payments that we may receive under any new collaborations that we may enter into in the future or any future capital raising transactions. 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, 2023 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.
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.
We are required pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, to maintain internal control over financial 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 accounting principles generally accepted in the United States, 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 June 30, 2024 as a result of a material weakness in our internal controls 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.
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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
The foregoing offers, sales and issuances were exempt from registration under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder.
From July 1, 2024 through August 16, 2024, the Company sold 71,111 shares of common stock at $2.25 per share for proceeds of $160,000.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
ITEM 5. OTHER INFORMATION.
On August 18, 2024, Virender Ahluwalia resigned as our Interim Chief Financial Officer and the Board of Directors appointed Jerry Katzman to serve as Interim Chief Financial Officer.
ITEM 6. EXHIBITS.
| * | Filed herewith. |
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.
| RETINALGENIX TECHNOLOGIES INC. | ||
| Date: August 19, 2024 | By: | /s/ Jerry Katzman |
| Jerry Katzman, | ||
| Chief Executive Officer President and Chairman of the Board | ||
| (Principal Executive Officer and Principal Financial Officer and Accounting Officer) | ||
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