| SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES Basis of Presentation The accompanying unaudited condensed consolidated
financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States
of America (U.S. GAAP) for interim unaudited condensed consolidated financial information. Accordingly, they do not include all of the
information and footnotes required by U.S. GAAP for complete consolidated financial statements. The unaudited condensed consolidated
financial statements reflect all adjustments (consisting of normal recurring adjustments) which are, in the opinion of management, necessary
for a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of the results
for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated
financial statements of the Company for the year ended December 31, 2023 and notes thereto contained in the Company’s Annual Report
on Form 10-K. Principles of Consolidation The unaudited condensed consolidated financial
statements include the Company’s accounts and those of the Company’s wholly-owned subsidiary. All significant intercompany
accounts and transactions have been eliminated in consolidation. Liquidity As shown in the accompanying unaudited condensed consolidated financial
statements, the Company incurred negative operating cash flows of $26,299,773 for the six months ended June 30, 2024 and has an accumulated
deficit of $600,498,929 from inception through June 30, 2024. Management believes that the Company’s
existing cash and cash equivalents and short-term investments will enable it to fund operating expenses and capital expenditure requirements
for at least 12 months from the issuance of these unaudited condensed consolidated financial statements. Beyond that point management
will evaluate the size and scope of any subsequent operations and clinical trials that will affect the timing of additional financings
through public or private sales of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing
agreements. Further, additional financing does not affect the Company’s conclusion that based on the cash on hand and the budgeted
cash flow requirements, the Company has sufficient funds to maintain operations for at least 12 months from the issuance of these unaudited
condensed consolidated financial statements. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP
requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of revenues and
expenses for the reporting period. Actual results could differ from those estimates. The significant estimates are stock-based compensation
expenses and recorded amounts related to income taxes. Cash and Cash Equivalents The Company considers cash deposits and all highly
liquid investments with a maturity of three months or less when purchased to be cash equivalents. The Company’s cash deposits are
held at two high-credit-quality financial institutions. The Company’s cash and cash equivalents balance of $2,086,260 at June 30,
2024 at these institutions exceed the federally insured limits. Short-term Investments The Company’s investments consist entirely
of mutual funds. The securities are measured at fair value based on the net asset value (NAV). Substantially all equity investments in
nonconsolidated entities are measured at fair value with recurring changes recognized in earnings, except for those accounted for using
equity method accounting. Changes in fair value of the securities are recorded as part of other income on the condensed consolidated
statements of operations. Short term investment activity is presented in the investing activities section on the condensed consolidated
statements of cash flows. Short-term investments at June 30, 2024 and December
31, 2023, consisted of mutual funds with a fair value of $68,351,069 and $92,232,292, respectively. Patents Costs related to filing and pursuing patent applications
are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain. Leases The Company recognizes its leases with a term
of greater than a year on the balance sheet by recording right-of-use assets and lease liabilities. Leases can be classified as either
operating leases or finance leases. Operating leases will result in straight-line lease expense, while finance leases will result in
front-loaded expense. The Company’s lease consists of an operating lease for office space. The Company does not recognize a lease
liability or right-of-use asset on the balance sheet for short-term leases. Instead, the Company recognizes short-term lease payments
as an expense on a straight-line basis over the lease term. A short-term lease is defined as a lease that, at the commencement date,
has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain
to exercise. Fair Value of Financial Instruments The Company’s financial instruments primarily
include cash, short-term investments, and accounts payable. Due to the short-term nature of cash and accounts payable the carrying amounts
of these assets and liabilities approximate their fair value. Fair value is defined as the price that would
be received to sell an asset, or paid to transfer a liability (an exit price,) in an orderly transaction between market participants
at the reporting date. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices
in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. The fair value hierarchy is as
follows: Level 1 Inputs – Unadjusted quoted
prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 Inputs – Inputs other
than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. These might include
quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets
that are not active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities,
prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other
means. Level 3 Inputs – Prices or valuation
techniques that require inputs that are both significant to the fair value measurement and unobservable (supported by little or no market
activity). As required by Accounting Standard Codification
(ASC) Topic No. 820 – 10 Fair Value Measurement The Company’s short-term investment instruments
of $68,351,069 at June 30, 2024 consist of mutual funds, bank deposits and money market funds and are classified using Level 1 inputs
within the fair value hierarchy because the value is based on quoted prices in active markets. Unrealized gains and losses are recorded
in the condensed consolidated statements of operations under other income. The Company recorded an unrealized loss of $45,465 and a realized
gain of $5,248 included in other income for the three and six months ended June 30, 2024, respectively. The Company recorded an unrealized
loss of $639,634 and an unrealized gain of $651,476 included in other income for the three and six months ended June 30, 2023, respectively. Income Taxes The Company accounts for income taxes using the
asset and liability method. Accordingly, deferred tax assets and liabilities are recognized for the future tax consequences attributable
to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases. 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 the tax rate is
recognized in income or expense in the period that the change is effective. Tax benefits are recognized when it is probable that the
deduction will be sustained. A valuation allowance is established when it is more likely than not that all or a portion of a deferred
tax asset will either expire before the Company is able to realize the benefit, or that future deductibility is uncertain. As of June
30, 2024, and December 31, 2023, the Company had recognized a valuation allowance to the full extent of the Company’s net deferred
tax assets since the likelihood of realization of the benefit does not meet the more likely than not threshold. The Company files a U.S. Federal income tax return
and various state returns. Uncertain tax positions taken on the Company’s tax returns will be accounted for as liabilities for
unrecognized tax benefits. The Company will recognize interest and penalties, if any, related to unrecognized tax benefits in general
and administrative expenses in the statements of operations. There were no liabilities recorded for uncertain tax positions at June 30,
2024 and December 31, 2023. The open tax years, subject to potential examination by the applicable taxing authority, for the Company
are from June 30, 2018 forward. Research and Development Research and development costs primarily consist
of research contracts for the advancement of product development, salaries and benefits, stock-based compensation, and consultants. The
Company expenses all research and development costs in the period incurred. The Company makes an estimate of costs in relation to clinical
study contracts. The Company analyzes the progress of studies, including the progress of clinical studies and phases, invoices received
and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. Stock-Based Compensation The Company measures the cost of employee services
received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over
the period during which an employee is required to provide service in exchange for the award - the requisite service period. The grant-date
fair value of employee share options is estimated using the Black-Scholes option pricing model adjusted for the unique characteristics
of those instruments. Net Loss per Common Share Basic loss per common share attributable to common
stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares
outstanding for the period, without consideration for common stock equivalents. Diluted loss per common share attributable to common
stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common share
equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of
options and warrants to purchase common stock. For all periods presented, there is no difference in the number of shares used to calculate
basic and diluted shares outstanding due to the Company’s net losses in each period. For the six months ended June 30, 2024 and 2023,
the potentially dilutive securities that would be anti-dilutive due to the Company’s net loss are not included in the calculation
of diluted net loss per share attributable to common stockholders. The anti-dilutive securities are as follows (in common stock equivalent
shares):
Six months ended
June 30, June 30,
Stock options 13,052,592 12,483,856
Common stock warrants 1,813,455 3,027,441
Total 14,866,047 15,511,297 Recent Accounting Pronouncements In October 2021, the FASB issued ASU 2021-08,
“Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers”.
The amendments in this ASU require that an entity (acquirer) recognize, and measure contract assets and contract liabilities acquired
in a business combination, including contract assets and contract liabilities arising from revenue contracts with customers, as if it
had originated the contracts as of the acquisition date. The amendments in this ASU were effective for annual and interim periods beginning
after December 15, 2022. The Company adopted this standard effective January 1, 2023 and the standard did not have a significant impact
on our consolidated financial statements. In November 2023, The FASB issued ASU 2023-07,
“Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures” which expands annual and interim disclosures
for reportable segments, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for our
annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. The Company
is currently evaluating the potential effect that the updated standard will have on our financial statement disclosures. In December 2023, the FASB issued ASU 2023-09,
“Income Taxes (Topic 740): Improvements to Income Tax Disclosures” to expand the disclosure requirements for income taxes,
specifically related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective for our annual periods beginning January
1, 2025, with early adoption permitted. The Company is currently evaluating the potential effect that the updated standard will have
on our financial statement disclosures. Subsequent Events The Company’s management reviewed all material events through
the date the unaudited condensed consolidated financial statements were issued for subsequent event disclosure consideration. |
