Indaptus Therapeutics Inc
For the period ended Dec 31, 2024. Filed Mar 13, 2025.
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FY2024 · Filed Mar 13, 2025
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Notes to the Consolidated Financial Statements
Notes to Consolidated Financial Statements
NOTE 1: GENERAL
Indaptus Therapeutics, Inc. and its wholly-owned subsidiaries, Decoy Biosystems, Inc. and Intec Pharma Ltd., collectively (the “Company”), is a biotechnology company dedicated to enhancing and expanding curative cancer immunotherapy for patients with unresectable or metastatic solid tumors and lymphomas, which are responsible for more than 90% of all cancer deaths. The Company is developing a novel, multi-targeted product that activates both innate and adaptive anti-tumor and anti-viral immune responses.
Risks and uncertainties
The Company is subject to a number of risks similar to those of other companies of similar size in its industry, including, but not limited to, the need for successful development of products, the need for additional capital (or financing) to fund operations (see below), competition from substitute products and services from larger companies, protection of proprietary technology, patent litigation, and dependence on key individuals.
Going concern and management’s plans
The Company has incurred net losses and utilized cash in operations since inception. For the year ended December 31, 2024, the Company incurred a net loss of approximately $15.0 million, and as of December 31, 2024, the Company had an accumulated deficit of approximately $60.4 million. In addition, during the year ended December 31, 2024, the Company used approximately $12.3 million of cash in operations and expects to continue to incur significant cash outflows and incur future additional losses as clinical trials and commercialization of the Company’s product candidates will require significant additional financing. The Company believes that, as of the date of the issuance of these consolidated financial statements, it has adequate cash to fund its ongoing activities into the second quarter of 2025 based on its current operating plan. The Company plans to execute its operating plan by obtaining additional capital, principally through entering into collaborations, strategic alliances, or license agreements with third parties and/or additional public or private debt and equity financing, such as through the registered direct offerings and concurrent private placements that the Company completed in August 2024 (the “August 2024 Offering”) and in November 2024 (the “November 2024 Offering”), and through the private placement in January 2025 (the “January 2025 Offering”). Following these offerings, the Company raised a total of approximately $6.3 million, net of placement agent and other offering expenses in the amount of approximately $1.1 million. For more details, see Note 6(c), 6(d) and 6(e). In addition, in February 2025, the Company entered into a Standby Equity Purchase Agreement pursuant to which the Company has the right, but not the obligation, to sell up to $20.0 million of the Company’s common stock during a 36-month period, subject to the restrictions and satisfaction of the conditions in the Standby Equity Purchase Agreement. For more details, see Note 6(f). However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in the amounts required. If the Company is unsuccessful in securing sufficient financing, it may need to delay, reduce, or eliminate its research and development programs, which could adversely affect its business prospects, or cease operations.
As a result of these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company was unable to continue as a going concern.
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES
Basis of presentation
The consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”).
Principles of consolidation
The consolidated financial statements include the accounts of Indaptus and its subsidiaries. Intercompany balances and transactions have been eliminated upon consolidation.
Use of estimates
The preparation of financial statements in accordance with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting periods. The most significant estimates relate to the determination of the fair value of stock-based compensation and the determination of period-end obligations to certain contract research organizations. Management evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and makes adjustments when facts and circumstances dictate. These estimates are based on information available as of the date of the consolidated financial statements; therefore, actual results could differ from those estimates.
Loss per share
Loss per share, basic and diluted, is computed on the basis of the net loss for the period divided by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share is based upon the weighted average number of shares of common stock and of common stock equivalents outstanding when dilutive. Common stock equivalents include outstanding stock options and warrants which are included under the treasury stock method when dilutive.
The following number of stock options and warrants were excluded from the calculation of diluted loss per share because their effect would have been anti-dilutive for the periods presented (share data):
| Weighted average | ||
|---|---|---|
| For the year ended December 31, | ||
| 2024 | 2023 | |
| Outstanding stock options | 2,519,419 | 1,979,196 |
| Warrants | 3,935,282 | 3,090,787 |
Cash and cash equivalents
The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. As of December 31, 2024, and 2023, cash and cash equivalents consist primarily of checking and money market deposits. The Company’s cash balances exceed those that are federally insured; however, the Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash and cash equivalents are held. To date, the Company has not recognized any losses caused by uninsured balances.
Property and equipment
Property and equipment assets are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The Company uses an estimated useful life ofthree years for employee-related computers and other office equipment andfive years for furniture. Leasehold improvements are amortized over the shorter of the lease-term or the estimated useful life of the related asset.
Patents
The Company expenses patent costs, including related legal costs, as incurred and records such costs within general and administrative expense.
Research and development expenses
Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including clinical trials and professional services. All costs associated with research and development are expensed as incurred.
The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which services or materials are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid expense, which will be amortized or expensed as the contracted services are performed.
General and administrative expenses
General and administrative expenses include compensation, employee benefits, and stock-based compensation for executive management, finance, administration and human resources, facility costs (including rent), professional service fees, and other general overhead costs to support the Company’s operations.
Income taxes
Income taxes are accounted for under the asset and liability method. 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 deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded for deferred tax assets if it is more likely than not that some portion or all of the deferred tax assets will not be realized in the foreseeable future. As of December 31, 2024, and 2023, the Company has recorded a full valuation allowance against its deferred tax assets.
The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50% likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest related to unrecognized tax benefits in interest expense and penalties in general and administrative expenses.
Stock-based compensation
The Company measures and records the expense related to stock-based payment awards based on the fair value of those awards as determined using the Black-Scholes-Merton (“Black-Scholes”) model as of the date of grant. The Company recognizes stock-based compensation expense over the requisite service period of the individual grant, generally equal to the vesting period, on a straight-line basis.
The Black-Scholes model requires the use of highly subjective and complex assumptions, which determine the fair value of stock-based payment awards, including the option’s expected term and the price volatility of the underlying stock. The Company estimates the fair value of options granted by using the Black-Scholes model with the following assumptions:
Expected Volatility—The Company estimates volatility for option grants by evaluating the historical volatility of a peer group of companies for the period immediately preceding the option grant for a term that is approximately equal to the options’ expected term.
Expected Term—The expected term of the Company’s options represents the period that the stock-based payment awards are expected to be outstanding. The expected term is estimated using the simplified method for employee stock options since the Company does not have adequate historical exercise data to estimate the expected term.
Risk-Free Interest Rate—The risk-free interest rate is based on the implied yield currently available on U.S. Treasury zero-coupon issues with a term that is equal to the options’ expected term at the grant date.
Dividend Yield—The Company has not declared or paid dividends to date and does not anticipate declaring dividends. As such, the dividend yield has been estimated to be zero.
The Company has elected to recognize forfeitures as they occur.
Fair value measurements
Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company follows the established framework for measuring fair value and providing disclosures about fair value measurements.
The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes:
| Level 1: | Quoted prices in active markets for identical assets or liabilities. |
|---|---|
| Level 2: | Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. |
| Level 3: | Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. |
ASC 820,Fair Value Measurement, requires all entities to disclose the fair value of financial instruments, both assets and liabilities, for which it is practicable to estimate fair value, and defines the fair value of a financial instrument as the amount at which the instrument could be exchanged in a current transaction between willing parties. As of December 31, 2024, and 2023, the recorded values of cash and cash equivalents, prepaid expenses, and accounts payable and other current liabilities approximate their fair values due to the short-term nature of these items.
Recently adopted accounting pronouncements
In November 2023, the FASB issued ASU No. 2023-07, Improvements to Reportable Segment Disclosures. The FASB amended the guidance in ASC 280, Segment Reporting (“ASC 280”), to require a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280. The guidance is applied retrospectively to all periods presented in financial statements unless it is impracticable. This new guidance is effective for public business entities for annual periods beginning after December 15, 2023, and for interim periods beginning after December 15, 2024. The Company adopted this new standard effective December 31, 2024. See Note 9, Segment Information, for disclosures related to the adoption of ASU 2023-07.
Recently issued accounting pronouncements
In November 2024, the FASB issued ASU No. 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures. This ASU will require entities to provide enhanced disclosures, in a tabular format, related to certain expense categories included in the statement of operations. The ASU aims to increase transparency and provide investors with more detailed information about the nature of expenses reported on the face of the income statement. The new ASU is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of this standard on the related disclosures
In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures. This ASU does not change accounting for income taxes but requires new disclosures focusing on two areas, the effective rate reconciliation and taxes paid. This new standard is effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of this standard on the related disclosures.
NOTE 3: PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets are comprised of the following:
| For the year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Prepaid insurance | $506,489 | $554,097 |
| Prepaid research and development | 150,000 | 17,309 |
| Other prepaid expenses | 175,088 | 61,750 |
| Total prepaid expenses and other current assets | $831,577 | $633,156 |
NOTE 4: ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES
Accounts payable and other current liabilities are comprised of the following:
| For the year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Accounts payable | $870,229 | $806,004 |
| Accrued employee costs | 1,371,498 | 1,213,054 |
| Accrued professional fees | 72,054 | 39,165 |
| Accrued research and development | 860,958 | 439,024 |
| Accrued board fees | 117,750 | 117,750 |
| Delaware franchise taxes payable | - | 40,000 |
| Other accrued expenses | 17,228 | 17,330 |
| Total accounts payable and other current liabilities | $3,309,717 | $2,672,327 |
NOTE 5: STOCK-BASED COMPENSATION
The Company has an equity incentive plan for grants to employees, officers, consultants, directors, and other service providers that was approved in 2021 (the “2021 Plan”). The 2021 Plan provides for the grant of non-qualified stock options, incentive stock options, restricted stock awards, restricted stock units, unrestricted stock awards, stock appreciation rights and other forms of stock-based compensation. The 2021 Plan permits the Company’s board to change the type, terms, and conditions of awards as circumstances may change. This flexibility to adjust the type of compensation to be granted is particularly important given current economic and world events.
A summary of the stock option activity during the year ended December 31, 2024, is presented in the table below:
| Weighted average | ||||||
|---|---|---|---|---|---|---|
| Number of options · Exercise price · Remaining contractual life (in years) · Intrinsic value | ||||||
| Outstanding as of January 1, 2024 | 2,050,197 | $10.90 | 7.9 | $36,363 | ||
| Granted | 838,250 | $1.54 | - | $ | - | |
| Forfeited and cancelled | (625) | $ | - | - | $ | - |
| Outstanding as of December 31, 2024 | 2,887,822 | $8.06 | 7.6 | $ | - | |
| Exercisable as of December 31, 2024 | 1,854,764 | $11.54 | 6.8 | $ | - | |
| Vested and expected to vest as of December 31, 2024 | 2,887,822 | $8.06 | 7.6 | $ | - | |
The following table summarizes the total stock-based compensation expense included in the consolidated statements of operations for the periods presented:
| For the year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development | $624,480 | $792,273 |
| General and administrative | 1,681,369 | 2,173,665 |
| Total stock-based compensation expense | $2,305,849 | $2,965,938 |
As of December 31, 2024, total compensation cost not yet recognized related to unvested stock options was approximately $1.0 million, which is expected to be recognized over a weighted-average period of approximately 1.5 years.
The Company estimates the fair value of stock options on the date of grant using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires estimates of highly subjective assumptions, which affect the fair value of each stock option. The weighted average inputs used to measure the value of the options granted during the years ended December 31, 2024 and 2023 are presented in the table below. The weighted average fair value of stock options issued during the years ended December 31, 2024 and 2023 was $1.31 and $1.43 per share, respectively.
| 2024 | 2023 | |
|---|---|---|
| Exercise price | $1.54 | $1.70 |
| Expected term (in years) | 5.8 | 5.8 |
| Volatility | 114.78% | 110.9% |
| Risk free rate | 4.0% | 3.7% |
| Dividend yield | 0.0% | 0.0% |
The following table presents the exercise price of outstanding stock options as of December 31, 2024:
| Exercise price | Options outstanding |
|---|---|
| $0.01 - $8.00 | 1,861,499 |
| $8.01 - $16.00 | 992,250 |
| $16.01 or higher | 34,073 |
| Total | 2,887,822 |
NOTE 6: CAPITALIZATION
| a. | As of December 31, 2024 and December 31, 2023, the Company had 200,000,000 shares of common stock authorized and 12,013,901 and 8,401,047 shares issued and outstanding, respectively. As of December 31, 2024 and December 31, 2023, the Company had 5,000,000 shares of preferred stock authorized. There were no shares of preferred stock issued or outstanding as of December 31, 2024 and 2023. As of December 31, 2024 and December 31, 2023, there were warrants outstanding to purchase an aggregate of 6,675,853 and 3,090,787 shares of common stock, respectively. As of December 31, 2024, these warrants are exercisable at a weighted average price of $6.52 and their weighted average remaining contractual term is 3.5 years. |
| b. | On June 1, 2022, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) which was amended on September 1, 2022 with a sales agent, pursuant to which the Company may offer and sell, from time to time through the sales agent, shares of the Company’s common stock, par value $0.01 per share. The issuance and sale of common stock by the Company under the ATM Agreement is being made pursuant to the Company’s effective “shelf” registration statement on Form S-3 filed with the SEC on September 1, 2022 and declared effective on September 9, 2022. In 2024, the Company sold 152,000 shares of the Company’s common stock for aggregate gross proceeds of approximately $0.4 million. The Company’s ability to issue shares under the shelf registration statement on Form S-3 is limited by General Instruction I.B.6 to Form S-3. On August 6, 2024, the Company filed a prospectus supplement to reduce the amount of shares registered under the prospectus for the ATM to $0.00 and to suspend the ATM program, but the ATM Agreement remains in full force and effect. |
| c. | On August 8, 2024, the Company completed a registered direct offering, pursuant to which the Company sold and issued to certain investors, including an officer of the Company, 1,643,837 shares of the Company’s common stock at a purchase price per share of $1.825. In addition, in a concurrent private placement, the Company also issued to the purchasers in the August 2024 Offering unregistered warrants to purchase 1,643,837 shares of the Company’s common stock (the “August 2024 Warrants”). The August 2024 Warrants are immediately exercisable at an exercise price of $1.70 per share and expire five years from the date of issuance. The total net proceeds were approximately $2.5 million, after deducting placement agent and other offering expenses in the amount of approximately $0.5 million. In September 2024, the Company filed a registration statement to register the resale by the investors of the shares of common stock issuable upon exercise of the August 2024 Warrants. The registration statement was declared effective on September 20, 2024. |
| d. | On November 22, 2024, the Company completed a registered direct offering, pursuant to which the Company sold and issued to certain investors, including an officer of the Company, 1,817,017 shares of the Company’s common stock at a purchase price per share of $1.175. In addition, in a concurrent private placement, the Company also issued to the purchasers in the November 2024 Offering unregistered warrants to purchase 1,817,017 shares of the Company’s common stock (the “November 2024 Warrants”). The November 2024 Warrants are immediately exercisable at an exercise price of $1.05 per share and expire five years from the date of issuance. The total net proceeds were approximately $1.8 million, after deducting placement agent and other offering expenses in the amount of approximately $0.35 million. In December 2024, the Company filed a registration statement to register the resale by the investors of the shares of common stock issuable upon exercise of the November 2024 Warrants. The registration statement was declared effective on December 31, 2024. In addition, in connection with the November 2024 Offering, the Company issued to the placement agent and its designees warrants to purchase an aggregate of 124,212 shares of common stock at an exercise price of $1.3125. The placement agent warrants are exercisable six months from the date of issuance and expire on the fifth anniversary of the issue date. The fair value of a warrant to purchase one share of common stock that was issued to the placement agent was $0.93. |
| e. | On January 16, 2025, the Company completed a private placement offering pursuant to which the Company sold and issued to certain investors an aggregate of 2,109,383 shares of common stock and warrants to purchase 2,109,383 shares of common stock (the “January 2025 Warrants”). The shares and January 2025 Warrants were sold on a combined basis for consideration of $1.065 for one share and one January 2025 Warrant. The January 2025 Warrants are immediately exercisable at an exercise price of $0.94 per share and expire five years from the date of issuance. The total net proceeds were approximately $2.0 million, after deducting placement agent and other offering expenses in the amount of approximately $0.25 million. In February 2025, the Company filed a registration statement to register the resale by the investors of the shares of common stock and shares of common stock issuable upon exercise of the January 2025 Warrants. The registration statement was declared effective on February 11, 2025. In addition, in connection with the January 2025 Offering, the Company issued to the placement agent and its designees warrants to purchase an aggregate of 147,656 shares of common stock at an exercise price of $1.175. The placement agent warrants are exercisable six months from the date of issuance and expire on the fifth anniversary of the issue date. The fair value of a warrant to purchase one share of common stock that was issued to the placement agent was $0.74. |
| f. | On February 12, 2025, the Company entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, LTD., a Cayman Islands exempt limited company (“Yorkville”), which provides that, upon the terms and subject to the restrictions and satisfaction of the conditions in the SEPA, Yorkville is committed to purchase up to an aggregate of $20.0 million of the Company’s shares of common stock over a 36-month period. At the Company’s option, the shares of common stock would be purchased by Yorkville from time to time at a price equal to 97% of the lowest of the three daily VWAPs during a three consecutive trading day period commencing on the date that the Company, subject to certain limitations, delivers a notice to Yorkville that the Company is committing Yorkville to purchase such shares of common stock. The Company may also specify a certain minimum acceptable price per share in each advance. The Company will control the timing and amount of sales of the Company’s shares to Yorkville. As consideration for Yorkville’s irrevocable commitment to purchase shares of the Company’s common stock upon the terms of and subject to restrictions and satisfaction of the conditions set forth in the SEPA, upon execution of the SEPA, the Company issued to Yorkville 305,960 shares of common stock, as commitment shares. Under the applicable Nasdaq Rules and pursuant to the SEPA, in no event may the Company issue or sell to Yorkville more than 2,823,244 shares of common stock (the “Exchange Cap”), which is 19.99% of the shares of common stock outstanding immediately prior to the execution of the SEPA, unless (i) the Company obtains stockholder approval to issue shares of common stock in excess of the Exchange Cap, or (ii) the average price of all applicable sales of common stock under the SEPA equals or exceeds $0.81722 per share (which represents the lower of (i) the Nasdaq Official Closing Price (as reflected on Nasdaq.com) on the trading day immediately preceding the effective date or (ii) the average Nasdaq Official Closing Price of the common stock (as reflected on Nasdaq.com) for the five trading days immediately preceding the effective date). On February 12, 2025, the Company filed a Form S-1 covering the resale of up to 10,000,000 shares of common stock comprised of (i) 305,960 commitment shares, and (ii) up to 9,694,040 shares of common stock reserved for issuance and sale to Yorkville under the SEPA. The Form S-1 was declared effective on February 13, 2025. |
NOTE 7: COMMITMENTS AND CONTINGENCIES
Litigation
From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically, the Company reviews the status of significant matters, if any exist, and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount of such potential loss can be estimated, the Company accrues liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict. Because of such uncertainties, accruals are based on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation.
Leases
On October 1, 2021, the Company entered into a noncancelable two-year operating lease agreement for approximately 2,000 square feet of office space in San Diego, California. The base rent was $7,999 per month with an increase of 3% after the first anniversary of the lease term commencement, which was November 1, 2022.
On April 19, 2023, the Company executed an amendment tothe lease agreement to extend the lease through October 31, 2025. Accordingly, the Company remeasured its operating lease liability under the agreement and recognized an incremental lease liability and right-of-use asset of $236,506. The remeasurement was based on a 9% incremental borrowing rate.
Future minimum annual lease payments and a reconciliation to the Company’s operating lease liability under the Company’s noncancelable operating lease as of December 31, 2024 are as follows:
| Total minimum lease payments in 2025 | $86,862 | |
|---|---|---|
| Less: amount representing interest | (2,698) | |
| Present value of operating lease liability | 84,164 | |
| Less: current portion | (84,164) | |
| Operating lease liability, net of current portion | $ | - |
The Company recognized rent expense of $101,847 and $100,742 during the years ended December 31, 2024 and 2023, respectively. Total cash payments for the operating lease totaled $101,705 and $99,254 during the years ended December 31, 2024 and 2023, respectively.
NOTE 8: INCOME TAXES
As of December 31, 2024, the Company had net operating loss carry forwards that may be available to reduce future years’ taxable income.
The Company’s provision for income taxes consisted of the following:
| For the year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Computed “expected” tax benefit | $(3,154,290) | $(3,238,593) |
| State taxes, net of federal benefit | (11,768) | 1,304 |
| Non-deductible items | 230,890 | 61,842 |
| Change in deferred tax asset valuation allowance | 2,454,200 | 2,509,496 |
| Stock-based compensation | 482,045 | 613,167 |
| Return-to-provision adjustments | 2 | 41,316 |
| Other | 621 | 13,918 |
| Income tax expense | $1,700 | $2,450 |
Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards.
The Company’s net deferred tax assets were comprised of the following as of December 31, 2024 and 2023:
| 2024 · 2023 | ||||
|---|---|---|---|---|
| Deferred tax assets: | ||||
| Net operating losses | $53,447,116 | $51,846,000 | ||
| Capitalized research and development | 2,959,591 | 2,162,872 | ||
| Stock-based compensation | 288,756 | 261,052 | ||
| Accruals | 249,495 | 220,923 | ||
| Operating lease liabilities | 17,760 | 36,761 | ||
| Other | 616 | 559 | ||
| Total gross deferred tax assets | 56,963,334 | 54,528,167 | ||
| Deferred tax liabilities: | ||||
| Right-of-use asset | (17,340) | (36,373) | ||
| Gross deferred tax liabilities | (17,340) | (36,373) | ||
| Less: Deferred tax asset valuation allowance | (56,945,994) | (54,491,794) | ||
| Total net deferred tax assets | $ | - | $ | - |
Deferred income tax assets and liabilities are recorded for differences between the financial statement and tax basis of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized
ASC 740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carryforward period. Because of the Company’s recent history of operating losses, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a full valuation allowance for the years ended December 31, 2024 and 2023. The net change in total valuation allowance for the years ended December 31, 2024 and 2023 was an increase of $2.5 million and increase of $2.5 million respectively.
At December 31, 2024, the Company has United States federal and state net operating loss (NOL) carryforwards of $35.3 million and $7.6 million, respectively. The federal NOL carryforwards generated in pre-2018 tax years of $0.8 million will begin to expire in 2036 while federal NOLs generated after 2017 of $34.4 million will carry forward indefinitely. The state NOL carryforwards of $7.6 million will begin to expire in 2035 unless previously utilized. At December 31, 2024, the Company also had Israel NOL carryforwards of $197.9 million. The Israel NOLs carry forward indefinitely.
The Company’s ability to utilize its net operating losses may be limited under Section 382 and 383 of the Internal Revenue Code. The limitations apply if an ownership change, as defined by Section 382, occurs. Generally, an ownership change occurs when certain shareholders increase their aggregate ownership by more than 50 percentage points over their lowest ownership percentage in a testing period (typically three years). Although the Company has not undergone a Section 382 analysis, it is possible that the utilization of the net operating losses, could be substantially limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be utilized against future taxes. As a result, the Company may not be able to take full advantage of these carryforwards for federal and state tax purposes. Future changes in stock ownership may also trigger an ownership change and, consequently, a Section 382 limitation.
The Company recognizes the benefit of tax positions taken or expected to be taken in its tax returns in the consolidated financial statements when it is more likely than not that the position will be sustained upon examination by authorities. Recognized tax positions are measured at the largest amount of benefit that isgreater than 50% likely of being realized upon settlement. As of December 31, 2024 and 2023 the Company has not recorded any unrecognized tax benefits.
The Company records interest related to unrecognized tax benefits in interest expense and penalties in general and administrative expenses. As of December 31, 2024 and 2023, the Company recordedno accrued interest and penalties related to unrecognized tax benefits. The Company does not expect any significant changes in its tax positions that would warrant recognition of a liability for unrecognized income tax benefits during the next 12 months.
The Company files U.S. federal and various state income tax returns and is subject to the examination for tax years back to 2021 and 2020 for federal and state purposes, respectively, and its NOL’s dating back to inception are subject to adjustment by the taxing authorities if claimed on future tax filings for which the statute remain open to examination. The Company also files Israeli tax returns and is subject to examination for tax years back to 2020. The Company is not currently under audit by the Internal Revenue Service or other similar national, state and local authorities.
NOTE 9: SEGMENT INFORMATION
Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker in deciding how to allocate resources in assessing performance. The Company operates as asingle reporting segment, focusing on the development of a novel and patented systemically administered anti-cancer and anti-viral immunotherapy. The Company’s chief operating decision maker (“CODM”) is the chief executive officer.
The accounting policies of the segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the segment based on operating expenses as reported in the accompanying consolidated statement of operations. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances the development of its product candidates through pre-clinical and clinical trials. In addition, the measure of segment assets is reported on the accompanying consolidated balance sheet as total assets.
As such, the CODM uses cash forecast models in deciding how to invest into the segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used in assessing performance of the segment.
The following table presents reportable segment loss, including significant expenses regularly provided to the CODM, attributable to the Company’s reportable segment for the years ended December 31, 2024 and 2023:
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development: | ||
| External research and development | $4,355,449 | $4,683,828 |
| Internal personnel costs | 2,895,648 | 2,937,879 |
| Total research and development | 7,251,097 | 7,621,707 |
| General and administrative | 8,114,654 | 8,756,767 |
| Other income, net | (343,724) | (955,003) |
| Net loss | $15,022,027 | $15,423,471 |
NOTE 10: SUBSEQUENT EVENTS
The Company evaluated subsequent events from December 31, 2024, the date of these consolidated financial statements, through March 13, 2024, which represents the date the consolidated financial statements were issued, for events requiring recognition or disclosure in the consolidated financial statements for the year ended December 31, 2024. The Company concluded that no events have occurred that would require recognition or disclosure in the consolidated financial statements, except for the January 2025 Offering that was completed on January 16, 2025, as described in Note 6(e) and for the SEPA that was entered with Yorkville on February 12, 2025, as described in Note 6(f).
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.