| ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES | NOTE
1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES Organization Ritter
Pharmaceuticals, Inc. (the Company’s predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the
name Ritter Natural Sciences, LLC. In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals,
Inc. On May 22, 2020, upon completing a “reverse recapitalization” transaction with Qualigen, Inc., Ritter Pharmaceuticals,
Inc. was renamed Qualigen Therapeutics, Inc. (the “Company”). Qualisys Diagnostics, Inc. was formed as a Minnesota corporation
in 1996, reincorporated to become a Delaware corporation in 1999, and then changed its name to Qualigen, Inc. in 2000. Qualigen, Inc.
was a wholly-owned subsidiary of the Company. On July 20, 2023, the Company sold all of the issued and outstanding shares of common stock
of Qualigen, Inc. to Chembio Diagnostics, Inc. (“Chembio”), a wholly-owned subsidiary of Biosynex, S.A. (“Biosynex”).
Following the consummation of this transaction, Qualigen, Inc. became a wholly-owned subsidiary of Chembio (see Note 5 – Discontinued
Operations). On
May 26, 2022, the Company acquired 2,232,861 350,000 331,464 0.001 These warrants were subsequently exercised on September 13, 2022. 381,786 600,000 52.8 Basis
of Presentation The
accompanying condensed consolidated financial statements of the Company have been prepared in conformity with accounting principles generally
accepted in the United States of America (“U.S. GAAP”), Regulation S-X and rules and regulations of the Securities and Exchange
Commission (“SEC”). Principles
of Consolidation The
accompanying condensed consolidated financial statements include the accounts of the Company and its former wholly-owned and majority
owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to
applicable guidance is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment.
In general, the functional currency of the Company and its subsidiaries is the U.S. dollar. For NanoSynex, the functional currency was
the local currency, New Israeli Shekels (NIS). As such, assets and liabilities for NanoSynex were translated into U.S. dollars with the
effects of foreign currency translation adjustments reflected as a component of accumulated other comprehensive loss within the Company’s
condensed consolidated statements of changes in stockholders’ equity (deficit). As
of July 20, 2023, NanoSynex was deconsolidated from these financial statements as the transactions contemplated by the NanoSynex Amendment
resulted in a loss of control of a subsidiary that constitutes a business under ASC 810. The retained investment in NanoSynex is accounted
for prospectively as an equity method investment. See Note 5 – Discontinued Operations for further information. Discontinued
Operations On
July 20, 2023, the Company completed the sale of Qualigen, Inc. to Chembio Diagnostics, Inc. The sale of Qualigen Inc. constituted a
significant disposition and as such, the Company concluded that the disposition of ownership in Qualigen, Inc. represented a strategic
shift that had a major effect on its operations and financial results. Therefore, Qualigen, Inc. is classified as discontinued operations
for all periods presented herein. On
July 20, 2023, the Company entered into the NanoSynex Amendment, which amended the Master Funding Agreement for the Operational and Technology
Funding of NanoSynex Ltd., dated May 26, 2022, by and between the Company and NanoSynex (the “NanoSynex Funding Agreement”),
a former majority owned subsidiary of the Company, to, among other things, forfeit 281,000 See
Note 5 - Discontinued Operations for further information. Equity
Method Investments Following
deconsolidation of NanoSynex on July 20, 2023, the Company accounts for its retained investment under the equity method of accounting
as it retained the ability to exercise significant influence over the operating and financial policies of the investee. Under the equity
method, the Company recognizes its proportionate share earnings or losses each reporting period with an adjustment to the carrying value
of the investment. As of December 31, 2023, the carrying value of the retained investment was zero, and therefore the Company has suspended
application of the equity method as the Company is not liable for the obligations of the investee nor otherwise committed to provide
financial support. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses
in prior periods. See Note 5 – Discontinued Operations for further information. Accounting
Estimates Management
uses estimates and assumptions in preparing its condensed consolidated financial statements in accordance with U.S. GAAP. Those estimates
and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported
revenues and expenses. The most significant estimates relate to the estimated fair value of derivative financial instruments,
warrant liabilities, and stock-based compensation. Actual results could vary from the estimates that were used. Reverse
Stock Split On
November 23, 2022, the Company effected a 1-for-10 Cash The
Company considers all highly liquid investments purchased with an initial maturity of 90 days or less and money market funds to be cash
equivalents. The
Company maintains the majority of its cash in government money market mutual funds and in accounts at banking institutions in the U.S.
that are of high quality. Cash held in these accounts often exceed the Federal Deposit Insurance Corporation (FDIC) insurance limits.
If such banking institutions were to fail, the Company could lose all or a portion of amounts held in excess of such insurance limitations.
In March 2023, Silicon Valley Bank and Signature Bank, and in May 2023, First Republic Bank, were closed due to liquidity
concerns and taken over by the FDIC. While the Company did not have an account at any of these banks, in the event of failure of any
of the financial institutions where the Company maintains its cash and cash equivalents, there can be no assurance that the Company would
be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely
affect the Company’s business and financial position. Impairment
of Long-Lived Assets The
Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate
that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows
is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between
the net book value of the assets and their estimated fair values. During the three months ended March 31, 2024 and 2023, no Segment
Reporting Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company
has viewed its operations and managed its business as one segment operating primarily within the United States (and in Israel prior to
the NanoSynex deconsolidation). Research
and Development Except
for acquired in process research and development (IPR&D), the Company expenses research and development costs as incurred including
therapeutics license costs. Patent
Costs The
Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting
expenses related to making such applications) and such costs are included in general and administrative expenses in the condensed consolidated
statement of operations. Business
Combinations The
Company accounts for business combinations using the acquisition method pursuant to Financial Accounting Standards Board’s (“FASB”)
ASC Topic 805. This method requires, among other things, that results of operations of acquired companies are included in the Company’s
financial results beginning on the respective acquisition date, and that assets acquired and liabilities assumed are recognized at fair
value as of the acquisition date. Intangible assets acquired in a business combination are recorded at fair value using a discounted
cash flow model. The discounted cash flow model requires assumptions about the timing and amount of future net cash flows, the cost of
capital and terminal values from the perspective of a market participant. Each of these factors can significantly affect the value of
the intangible asset. Any excess of the fair value of consideration transferred (the “purchase price”) over the fair values
of the net assets acquired is recognized as goodwill. The fair value of assets acquired and liabilities assumed in certain cases may
be subject to revision based on the final determination of fair value during a period of time not to exceed 12 months from the acquisition
date. Legal costs, due diligence costs, business valuation costs and all other acquisition-related costs are expensed when incurred. Goodwill Goodwill
represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets acquired,
when accounted for using the purchase method of accounting. Goodwill has an indefinite useful life and is not amortized but is reviewed
for impairment annually and whenever events or changes in circumstances indicate that the carrying value of the goodwill may not be recoverable.
In testing for impairment, the fair value of the reporting unit is compared to the carrying value. If the net assets assigned to the
reporting unit exceed the fair value of the reporting unit, an impairment loss equal to the difference is recorded. Derivative
Financial Instruments and Warrant Liabilities The
Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates
all of its financial instruments, including issued stock purchase warrants, to determine if such instruments are derivatives or contain
features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative
instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported
in the condensed consolidated statements of operations and comprehensive loss. Depending on the features of the derivative financial
instrument, the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments
at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should
be recorded as liabilities or as equity, is re-assessed at the end of each reporting period (See Note 7-Warrant Liabilities and Note
8- Convertible Debt - Related Party). Fair
Value Measurements The
Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established
by accounting guidance and prioritizes the inputs used in measuring fair value. The Company discloses and recognizes the fair value of
its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy
gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level
1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements).
The guidance establishes three levels of the fair value hierarchy as follows:
● Level
1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or
liabilities that the Company has the ability to access at the measurement date;
● Level
2 - Inputs other than quoted prices that are observable for the assets or liability either
directly or indirectly, including inputs in markets that are not considered to be active;
and
● Level
3 - Inputs that are unobservable. Fair
Value of Financial Instruments Cash,
accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates
fair value due to the short-term nature of these instruments. Comprehensive
Loss Comprehensive
loss consists of net income and foreign currency translation adjustments related to the discontinued operations of NanoSynex. Comprehensive
gains (losses) have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements
of stockholders’ equity (deficit) for all periods presented. Stock-Based
Compensation Stock-based
compensation cost for equity awards granted to employees and non-employees is measured at the grant date based on the calculated fair
value of the award using the Black-Scholes option-pricing model, and is recognized as an expense, under the straight-line method, over
the requisite service period (generally the vesting period of the equity grant). If the Company determines that other methods are more
reasonable, or other methods for calculating these assumptions are prescribed by regulators, the fair value calculated for the Company’s
stock options could change significantly. Higher volatility, lower risk-free interest rates, and longer expected lives would result in
an increase to stock-based compensation expense to employees and non-employees determined at the date of grant. Income
Taxes Deferred
income taxes are recognized for temporary differences in the basis of assets and liabilities for financial statement and income tax reporting
that arise due to net operating loss carry forwards, research and development credit carry forwards and from using different methods
and periods to calculate depreciation and amortization, allowance for doubtful accounts, accrued vacation, research and development expenses,
and state taxes. A provision has been made for income taxes due on taxable income and for the deferred taxes on the temporary differences. Deferred
tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all
of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws
and rates on the date of enactment. Realization of the deferred income tax asset is dependent on generating sufficient taxable income
in future years. In
December 2023, the FASB issued Accounting Standards Update 2023-09, Improvements to Income Tax Disclosures, which requires more detailed
income tax disclosures. The guidance requires entities to disclose disaggregated information about their effective tax rate reconciliation
as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis,
with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early
adoption permitted. The Company is evaluating the disclosure requirements related to the new standard. Foreign
Currency Translation The
functional currency for the Company is the U.S. dollar. The functional currency for the discontinued operations of NanoSynex was the
New Israeli Shekel (NIS). The financial statements of NanoSynex were translated into U.S. dollars using exchange rates in effect at each
period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical
exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex was reflected
as a separate component of other comprehensive income (loss) (see Note 5 - Discontinued Operations). Global
Economic Conditions Ongoing
Wars in Ukraine and Israel In
February 2022, Russia invaded Ukraine. While the Company has no direct exposure in Russia and Ukraine, the Company continues to monitor
any broader impact to the global economy, including with respect to inflation, supply chains and fuel prices. The full impact of the
conflict on the Company’s business and financial results remains uncertain and will depend on the severity and duration of the
conflict and its impact on regional and global economic conditions. In
October 2023, Hamas conducted terrorist attacks in Israel resulting in ongoing war. There continue to be hostilities between Israel and
Hezbollah in Lebanon and Hamas in the Gaza Strip, both of which have resulted in rockets being fired into Israel, causing casualties
and disruption of economic activities. In early 2023, there were a number of changes proposed to the political system in Israel by the
current government which, if implemented as planned, could lead to large-scale protests and additional uncertainty, negatively impacting
the operating environment in Israel. Popular uprisings in various countries in the Middle East over the last few years have also affected
the political stability of those countries and have led to a decline in the regional security situation. Such instability may also lead
to deterioration in the political and trade relationships that exist between Israel and these countries. Any armed conflicts, terrorist
activities or political instability involving Israel or other countries in the region could adversely affect the Company’s minority
interest in NanoSynex, its results of operations, financial condition, cash flows and prospects (see Note 5 – Discontinued Operations). Inflation
and Global Economic Conditions During
the year ended 2022 and continuing into the current fiscal year, global commodity and labor markets experienced significant inflationary
pressures attributable to government stimulus and recovery programs, government deficit spending and supply chain issues. The Company
cannot provide assurance that it will be successful in fully offsetting increased costs resulting from inflationary pressure. In addition,
the global economy suffers from slowing growth and rising interest rates, and some economists believe that there may be a global recession
in the near future. If the global economy slows, the Company’s business may be adversely affected. Impact
of COVID-19 Pandemic The
COVID-19 pandemic has had a dramatic impact on businesses globally and on the Company’s business as well. During the height of
the pandemic, sales of diagnostic products decreased significantly and the Company’s net loss increased significantly, as clinics
and small hospitals’ demand for Qualigen, Inc.’s FastPack™ diagnostic test kits was reduced sharply, largely due to
deferral of patients’ non-emergency visits to physician offices. In July 2023 the Company sold Qualigen, Inc., its wholly-owned
subsidiary, to Chembio (see Note 5 - Discontinued Operations). Other
accounting standard updates are either not applicable to the Company or are not expected to have a material impact on the Company’s
condensed consolidated financial statements. |
