Indaptus Therapeutics, Inc.
For the period ended Mar 31, 2025. Filed May 14, 2025.
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Mar 31, 2025 · Filed May 14, 2025
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Notes to Unaudited Condensed Consolidated Financial Statements
Notes to the unaudited condensed 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 three-month period ended March 31, 2025, the Company incurred a net loss of approximately $4.5 million, and as of March 31, 2025, the Company had an accumulated deficit of approximately $65.0 million. In addition, during the three-month period ended March 31, 2025, the Company used approximately $5.0 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. As of the date of the issuance of these unaudited condensed consolidated financial statements and based on its current operating plan, the Company will need to obtain additional capital to fund its ongoing activities beyond the second quarter of 2025. 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. 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(c). 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 unaudited condensed 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 unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) and SEC Regulation S-X Article 10 for interim financial statements. Accordingly, they do not contain all the information and notes required by US GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated interim financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of March 31, 2025, and the consolidated results of operations and changes in stockholders’ equity for the three-month periods ended March 31, 2025 and 2024 and cash flows for the three-month periods ended March 31, 2025 and 2024.
These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as filed with the SEC on March 13, 2025. The consolidated balance sheet data as of December 31, 2024, included in these unaudited condensed consolidated financial statements was derived from the audited financial statements for the year ended December 31, 2024, but does not include all disclosures required by US GAAP for annual financial statements.
The results for the three-month period ended March 31, 2025, are not necessarily indicative of the results expected for the year ending December 31, 2025.
Principles of consolidation
The unaudited condensed consolidated financial statements include the accounts of Indaptus Therapeutics, Inc. and its subsidiaries. Intercompany balances and transactions have been eliminated upon consolidation.
Use of estimates
The preparation of the unaudited condensed consolidated 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, including the current economic environment, and adjusts when facts and circumstances dictate. These estimates are based on information available as of the date of the condensed 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 three months ended March 31, | ||
| 2025 | 2024 | |
| Outstanding stock options | 2,887,204 | 2,315,272 |
| Warrants | 8,434,849 | 3,090,787 |
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.
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.
NOTE 3: PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets are comprised of the following:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Prepaid insurance | $295,093 | $506,489 |
| Prepaid research and development | 400,179 | 150,000 |
| Other prepaid expenses | 374,638 | 175,088 |
| Total prepaid expenses and other current assets | $1,069,910 | $831,577 |
NOTE 4: ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES
Accounts payable and other current liabilities are comprised of the following:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Accounts payable | $1,311,095 | $870,229 |
| Accrued employee costs | 83,466 | 1,371,498 |
| Accrued professional fees | 69,959 | 72,054 |
| Accrued research and development | 898,067 | 860,958 |
| Accrued board fees | 117,750 | 117,750 |
| Other accrued expenses | 72,042 | 17,228 |
| Total accounts payable and other current liabilities | $2,552,379 | $3,309,717 |
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 period ended March 31, 2025, 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, 2025 | 2,887,822 | $8.06 | 7.6 | $ | - | |
| Granted | - | $ | - | - | $ | - |
| Forfeited and cancelled | (625) | $ | - | - | $ | - |
| Outstanding as of March 31, 2025 | 2,887,197 | $7.98 | 7.4 | $ | - | |
| Exercisable as of March 31, 2025 | 2,027,405 | $10.62 | 6.7 | $ | - | |
| Vested and expected to vest as of March 31, 2025 | 2,887,197 | $7.98 | 7.4 | $ | - | |
The following table summarizes the total stock-based compensation expense included in the unaudited consolidated statements of operations for the periods presented:
| For the three months ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and development | $69,662 | $217,819 |
| General and administrative | 171,229 | 556,872 |
| Total stock-based compensation expense | $240,891 | $774,691 |
As of March 31, 2025, total compensation cost not yet recognized related to unvested stock options was approximately $0.8 million, which is expected to be recognized over a weighted-average period of approximately 1.4 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. No options were granted during the three months ended March 31, 2025.
The following table presents the exercise price of outstanding stock options as of March 31, 2025:
| Exercise price | Options outstanding |
|---|---|
| $0.01 - $8.00 | 1,861,499 |
| $8.01 - $16.00 | 992,250 |
| $16.01 or higher | 33,448 |
| Total | 2,887,197 |
NOTE 6: CAPITALIZATION
| a. | As of March 31, 2025 and December 31, 2024, the Company had 200,000,000 shares of common stock authorized and 16,034,444 and 12,013,901 shares issued and outstanding, respectively. As of March 31, 2025 and December 31, 2024, the Company had 5,000,000 shares of preferred stock authorized. There were no shares of preferred stock issued or outstanding as of March 31, 2025 and December 31, 2024. As of March 31, 2025 and December 31, 2024, there were warrants outstanding to purchase an aggregate of 8,745,923 and 6,675,853 shares of common stock, respectively. As of March 31, 2025, these warrants are exercisable at a weighted average price of $4.54 and their weighted average remaining contractual term is 3.7 years. |
| b. | 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. |
| c. | 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. During March 2025, the Company sold 1,605,200 shares of common stock under the SEPA for aggregate net proceeds of approximately $1.15 million, after deducting offering expenses in the amount of approximately $0.1 million. |
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
Future minimum annual lease payments and a reconciliation to the Company’s operating lease liability under the Company’s non-cancelable operating lease as of March 31, 2025 are as follows:
| Total minimum lease payments in 2025 | $60,804 | |
|---|---|---|
| Less: amount representing interest | (1,292) | |
| Present value of operating lease liability | 59,512 | |
| Less: current portion | (59,512) | |
| Operating lease liability, net of current portion | $ | - |
The Company recognized rent expense of $25,462 in each of the three months ended March 31, 2025 and 2024. Total cash payments for the operating lease totalled $26,059 and $25,300 during the three months ended March 31, 2025 and 2024, respectively.
NOTE 8: SEGMENT INFORMATION
The Company operates in one business 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 CODM assesses performance for the segment based on operating expenses as reported in the accompanying interim consolidated statements of operations.
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 three months ended March 31, 2025 and 2024:
| Three months ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and development: | ||
| External research and development | $2,285,112 | $780,899 |
| Internal personnel costs | 525,728 | 810,243 |
| Total research and development | 2,810,840 | 1,591,142 |
| General and administrative | 1,761,719 | 2,352,097 |
| Other income, net | (40,129) | (136,562) |
| Net loss | $4,532,430 | $3,806,677 |
NOTE 9: SUBSEQUENT EVENTS
The Company evaluated subsequent events from March 31, 2025, the date of these unaudited condensed consolidated financial statements, through May 14, 2025, which represents the date the condensed consolidated financial statements were issued, for events requiring recognition or disclosure in the condensed consolidated financial statements for the three months ended March 31, 2025. The Company concluded that no events have occurred that would require recognition or disclosure in the condensed consolidated financial statements.
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