SEC Form 10-Q filed by Indaptus Therapeutics Inc.

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2025

 

OR

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE TRANSITION PERIOD FROM TO

 

Commission File Number 001-40652

 

Indaptus Therapeutics, Inc.

(Exact name of Registrant as specified in its Charter)

 

Delaware		86-3158720
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

 

3 Columbus Circle 15th Floor New York, New York		10019
(Address of principal executive offices)		(Zip Code)

 

(Registrant’s telephone number, including area code) +(646) 427-2727

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, par value $0.01 per share		INDP		Nasdaq Capital Market

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☒ NO ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒

 

The number of shares of the Registrant’s common stock outstanding as of May 12, 2025 was 16,034,444.

 

 

 

TABLE OF CONTENTS

 

		Page
PART I. FINANCIAL INFORMATION		F-1
Item 1.	Financial Statements	F-1
	Unaudited Condensed Consolidated Balance Sheets	F-1
	Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss	F-2
	Unaudited Condensed Consolidated Statements of Stockholders’ Equity	F-3
	Unaudited Condensed Consolidated Statements of Cash Flows	F-4
	Notes to Unaudited Condensed Consolidated Financial Statements	F-5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	1
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	7
Item 4.	Controls and Procedures	7
PART II. OTHER INFORMATION		8
Item 1.	Legal Proceedings	8
Item 1A.	Risk Factors	8
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	8
Item 3.	Defaults Upon Senior Securities	8
Item 4.	Mine Safety Disclosures	8
Item 5.	Other Information	8
Item 6.	Exhibits	9

 

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q, or Quarterly Report, contains, and management may make, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, forward-looking statements can be identified by the use of terms such as “believe,” “expect,” “intend,” “plan,” “may,” “should,” “anticipate,” “could,” “might,” “seek,” “target,” “will,” “project,” “forecast,” “continue” or their negatives or variations of these words or other comparable words. These statements include, without limitation, our statements about: our product candidates’ development, including the timing and design of the Phase 1 clinical trial of Decoy20; our expectations regarding the recommended Phase 2 dose for subsequent multi-dosing and combination studies and related timing; the anticipated effects of our product candidates; our plans to develop and commercialize our product candidates; the market potential and treatment potential of our product candidates, including Decoy20; our commercialization, marketing and manufacturing capabilities and strategy; our expectations about the willingness of healthcare professionals to use our product candidates; our general business strategy and the plans and objectives of management for future operations; our research and development activities and costs; our future results of operations and condition; the sufficiency of our cash and cash equivalents to fund our ongoing activities and our ability to continue as a going concern; the impact of current macroeconomic conditions on our operations, ability to access capital, and liquidity.

 

The forward-looking statements in this Quarterly Report are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of known and unknown risks, uncertainties and assumptions, including those described under the sections in this Quarterly Report entitled “Summary Risk Factors,” Part II. Item 1A. “Risk Factors” and Part I. Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report.

 

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.

 

Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. We intend the forward-looking statements contained in this Quarterly Report to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.

 

 

Summary Risk Factors

 

The principal factors and uncertainties that make investing in our common stock risky, include, among others:

 

	●	We are a clinical-stage company with a limited operating history. We are not currently profitable, do not expect to become profitable in the near future and may never become profitable.
	●	We have identified conditions and events that raise substantial doubt regarding our ability to continue as going concern.
	●	Given our lack of current cash flow, we will need to raise additional capital. If we are unable to raise a sufficient amount of capital when needed on acceptable terms or at all, we may be forced to delay, limit or eliminate some or all of our research programs, product development activities and commercialization efforts.
	●	Raising additional capital would cause dilution to our existing shareholders and may restrict our operations or require us to relinquish rights to our technologies or product candidates.
	●	Clinical and preclinical development involves lengthy and expensive processes with uncertain outcomes. Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.
	●	We expect to continue to incur significant research and development expenses and other operating expenses, which may make it difficult for us to attain profitability.
	●	We may expend our limited resources to pursue a limited number of research programs, product candidates and specific indications and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
	●	Our product candidates may cause undesirable side effects that could delay or prevent their regulatory approval or commercialization or have other significant adverse implications on our business, financial condition and results of operations.
	●	The commercial success of our product candidates depends upon their market acceptance among physicians, patients, healthcare payors and the medical community.
	●	We rely on third parties to conduct our preclinical studies and clinical trials and perform other tasks. If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business, financial condition and results of operations could be substantially harmed.
	●	We currently rely on third parties for the manufacture of our product candidates during clinical development, and expect to continue to rely on third parties for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates, or such quantities at an acceptable cost, which could delay, prevent or impair our development or potential commercialization efforts.
	●	The successful commercialization of Decoy20 or any future product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.

 

 

	●	Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize Decoy20 and any future product candidates and may affect the prices we may set.
	●	If our competitors have product candidates that are approved faster, marketed more effectively, are better tolerated, have a more favorable safety profile or are demonstrated to be more effective than our product candidates, our commercial opportunity may be adversely affected.
	●	Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
	●	We may not be able to adequately protect our proprietary or licensed technology in the marketplace.
	●	We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
	●	We are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our results of operations and financial condition.
	●	Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
	●	Our business and operations may suffer in the event of information technology system failures, cyberattacks or deficiencies in our cybersecurity.
	●	Maintaining and improving our financial controls and the requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified board members.
	●	Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
	●	The market price of our common stock is volatile and you may sustain a complete loss of your investment.

 

 

Part I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

INDAPTUS THERAPEUTICS, INC.

 

Unaudited Condensed Consolidated Balance Sheets

 

		March 31, 2025				December 31, 2024
Assets
Current assets:
Cash and cash equivalents		$	3,891,021			$	5,786,753
Prepaid expenses and other current assets			1,069,910				831,577
Total current assets			4,960,931				6,618,330
Non-current assets:
Right-of-use asset			58,119				82,175
Other assets - deposits to third parties			392,572				638,251
Total non-current assets			450,691				720,426
Total assets		$	5,411,622			$	7,338,756
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and other current liabilities		$	2,552,379			$	3,309,717
Operating lease liability, current portion			59,512				84,164
Total current liabilities			2,611,891				3,393,881
Commitments and contingencies (Note 7)			-				-
Stockholders’ equity:
Common stock: $0.01 par value, 200,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 16,034,444 shares issued and outstanding as of March 31, 2025 and 12,013,901 shares issued and outstanding as of December 31, 2024			160,344				120,139
Preferred stock: $0.01 par value, 5,000,000 shares authorized as of March 31, 2025 and December 31, 2024; no shares issued or outstanding			-				-
Additional paid in capital			67,611,000				64,263,919
Accumulated deficit			(64,971,613	)			(60,439,183	)
Total stockholders’ equity			2,799,731				3,944,875
Total liabilities and stockholders’ equity		$	5,411,622			$	7,338,756

 

See accompanying notes to the unaudited condensed consolidated financial statements

 

 

INDAPTUS THERAPEUTICS, INC.

 

Unaudited Condensed Consolidated Statements of Operations

 

		2025				2024
		Three Months Ended March 31,
		2025				2024
Operating expenses:
Research and development		$	2,810,840			$	1,591,142
General and administrative			1,761,719				2,352,097
Total operating expenses			4,572,559				3,943,239
Loss from operations			(4,572,559	)			(3,943,239	)
Other income, net			40,129				136,562
Net loss		$	(4,532,430	)		$	(3,806,677	)
Net loss available to common stockholders per share of common stock, basic and diluted		$	(0.32	)		$	(0.45	)
Weighted average number of shares used in calculating net loss per share, basic and diluted			14,102,378				8,442,364

 

See accompanying notes to the unaudited condensed consolidated financial statements

 

 

INDAPTUS THERAPEUTICS, INC.

 

Unaudited Condensed Consolidated Statements of Stockholders’ Equity

 

		Shares				Amount				Capital				deficit				Total
		Common stock								Additional paid in				Accumulated
		Shares				Amount				Capital				deficit				Total
Balance, January 1, 2024			8,401,047			$	84,011			$	57,409,643			$	(45,417,156	)		$	12,076,498
Stock-based compensation			-				-				774,691				-				774,691
Issuance of shares of common stock, net of issuance costs			137,836				1,378				314,669				-				316,047
Net loss			-				-				-				(3,806,677	)			(3,806,677	)
Balance, March 31, 2024			8,538,883			$	85,389			$	58,499,003			$	(49,223,833	)		$	9,360,559
Balance, January 1, 2025			12,013,901			$	120,139			$	64,263,919			$	(60,439,183	)		$	3,944,875
Balance			12,013,901			$	120,139			$	64,263,919			$	(60,439,183	)		$	3,944,875
Stock-based compensation			-				-				240,891				-				240,891
Issuance of shares of common stock and warrants, net of issuance costs (Note 6b)			2,109,383				21,094				1,965,650				-				1,986,744
Issuance of shares of common stock, net of issuance costs (Note 6c)			1,605,200				16,052				1,143,599				-				1,159,651
Issuance of commitment shares (Note 6c)			305,960				3,059				(3,059	)			-				-
Net loss			-				-				-				(4,532,430	)			(4,532,430	)
Balance, March 31, 2025			16,034,444			$	160,344			$	67,611,000			$	(64,971,613	)		$	2,799,731
Balance			16,034,444			$	160,344			$	67,611,000			$	(64,971,613	)		$	2,799,731

 

See accompanying notes to the unaudited condensed consolidated financial statements

 

 

INDAPTUS THERAPEUTICS, INC.

 

Unaudited Condensed Consolidated Statements of Cash Flows

 

		2025				2024
		For the three months ended March 31,
		2025				2024
Cash flows from operating activities:
Net loss		$	(4,532,430	)		$	(3,806,677	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation			-				735
Stock-based compensation			240,891				774,691
Changes in operating assets and liabilities:
Prepaid expenses and other current and non-current assets			7,346				332,125
Accounts payable and other current liabilities			(762,338	)			(1,237,499	)
Operating lease right-of-use asset and liability, net			(596	)			163
Net cash used in operating activities			(5,047,127	)			(3,936,462	)
Cash flows from financing activities:
Proceeds from issuance of shares of common stock and warrants			3,482,650				336,044
Issuance costs			(331,255	)			(19,997	)
Net cash provided by financing activities			3,151,395				316,047
Net decrease in cash and cash equivalents			(1,895,732	)			(3,620,415	)
Cash and cash equivalents at beginning of period			5,786,753				13,362,053
Cash and cash equivalents at end of period		$	3,891,021			$	9,741,638
Noncash investing and financing activities
Transaction costs in accounts payable and other current liabilities		$	5,000			$	-
Issuance of commitment shares		$	3,059				-

 

See accompanying notes to the unaudited condensed consolidated financial statements

 

 

INDAPTUS THERAPEUTICS, INC.

 

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.

 

F-5

 

 

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):

SCHEDULE OF ANTI-DILUTIVE SECURITIES 

		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.

 

F-6

 

 

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:

SCHEDULE OF PREPAID EXPENSE AND OTHER CURRENT ASSETS 

		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
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:

SCHEDULE OF ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES 

		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.

 

F-7

 

 

A summary of the stock option activity during the period ended March 31, 2025, is presented in the table below:

 SCHEDULE OF STOCK OPTION ACTIVITY 

						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:

 SCHEDULE OF STOCK BASED COMPENSATION EXPENSES 

		2025				2024
		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:

 SCHEDULE OF EXERCISE PRICE OF OUTSTANDING STOCK OPTIONS 

Exercise price		Options outstanding
$0.01 - $8.00			1,861,499
$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.

  

F-8

 

  

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:

 SUMMARY OF MINIMUM LEASE PAYMENTS 

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.

 

F-9

 

 

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:

 SCHEDULE OF REPORTABLE SEGMENT LOSS 

		2025				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.

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Unless the context indicates otherwise, in this Quarterly Report, the terms “Indaptus,” “the Company,” “we,” “us” and “our” refer to Indaptus Therapeutics, Inc. (formerly Intec Parent, Inc., the successor of Intec Pharma Ltd. following the domestication merger) and, where appropriate, its consolidated subsidiaries following the domestication merger and the reverse merger described in our previous periodic reports. References to “Intec Israel” refer to Intec Pharma Ltd., the predecessor of Indaptus prior to the domestication merger, and references to “Decoy” refer to Decoy Biosystems, Inc., the entity acquired by Indaptus in connection with the reverse merger.

 

You should read the following discussion and analysis of our financial condition and results of operations along with our consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report and our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) on March 13, 2025 (the “2024 Annual Report on Form 10-K”). The following discussion contains forward-looking statements that are subject to risks, uncertainties and assumptions. Please also see the “Cautionary Note Regarding Forward-Looking Statements” section in the forepart of this Quarterly Report.

 

Overview

 

We are a clinical biotechnology company developing a novel and patented systemically-administered anti-cancer and anti-viral immunotherapy. We have evolved from more than a century of immunotherapy advances. Our approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system activating signals that can be administered safely intravenously. Our patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria, designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cellular components of innate and adaptive immunity. This approach has led to broad anti-tumor and anti-viral activity in preclinical models, including durable anti-tumor response synergy observed with each of four different classes of existing agents, including NSAIDs, checkpoint therapy, targeted antibody therapy and low-dose chemotherapy. Tumor eradication by our technology was associated with induction of both innate and adaptive immunological memory and, importantly, did not require provision of or targeting a tumor antigen in preclinical models. We have carried out successful current Good Manufacturing Practice (cGMP) manufacturing of our lead clinical candidate, Decoy20.

 

In May 2022, the U.S. Food and Drug Administration, or the FDA, allowed us to proceed under our IND for a Phase 1 clinical trial in participants with advanced solid tumors where currently approved therapies have failed. In December 2022, we initiated an open label, multi-center, dose escalation and expansion, single arm (monotherapy) Phase 1 study conducted in 2 parts. The Phase 1 study began with single dose administration and has now been followed with continuous weekly dosing of Decoy20 in tumor-specific expansion cohorts. The study is enrolling participants with any one of six advanced/metastatic solid tumors, who have exhausted approved treatment options. The study’s objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose, the optimal biologically active and recommended Phase 2 dose, as well as to assess Decoy20 pharmacokinetics (PK), pharmacodynamics and clinical activity. The primary endpoints of the study are incidence, relatedness and severity of adverse events and treatment-emergent adverse events and determining the number of subjects per cohort with dose limiting toxicity-based adverse events. Secondary endpoints include the incidence of anti-drug antibodies and neutralizing antibodies pre- and post-treatment, change in Decoy20 PK parameters over time, objective response rate and duration of response.

 

In August 2023, we evaluated the first four participants who received a single dose of 7 x 10^7 Decoy20 in Part 1 of the Phase 1 clinical trial. All four participants who enrolled were evaluable in the first cohort. These participants experienced generally anticipated transient adverse events including hemodynamic changes such as changes in pulse or blood pressure that resolved within 30 minutes and laboratory abnormalities such as grade 1-3 elevations in transaminases (liver function tests) and grade 4 reductions in lymphocytes that generally resolved within three days. One patient had a dose-limiting toxicity of grade 3 bradycardia (slow heart rate) and grade 2 hypotension (low blood pressure) which resolved within approximately 90 minutes with i.v. fluids. Participants also experienced transient induction of over 50 different biomarkers associated with innate and adaptive anti-tumor immune responses. After the end of infusion, Decoy20 was cleared from the blood within 30 to 120 minutes. Peak cytokine and chemokine induction occurred within ~4 to 24 hours and most cytokine/chemokines returned to the patient’s respective baseline by 24-72 hours. This rapid clearance and associated transient cytokine/chemokine induction are desired to avoid prolonged toxicity, often associated with longer term cytokine exposure.

 

In September 2023, we began the second cohort of the Phase 1 clinical trial after receiving authorization from the Safety Review Committee. The second cohort dose was a reduction from 7 x 10^7 Decoy20 dose to 3 x 10^7 Decoy20. In March 2024, we completed the second cohort of participants who received a single dose of 3 x 10^7 Decoy20 in Part 1 of the clinical trial. Participants on the second (lower dose) cohort experienced adverse events similar in frequency and severity to the higher dose cohort with one dose-limiting toxicity of grade 3 ALT elevation that required one week to resolve. Pharmacodynamic effects included transient induction of multiple biomarkers. Clearance of Decoy20 was similarly rapid. Following authorization from the Safety Review Committee, we advanced into the weekly dosing part of the trial.

 

 

In May and June 2024, we enrolled two additional participants in the first cohort who received a single dose of 7 x 10^7 Decoy20, and in August 2024 we received the authorization from the Safety Review Committee to initiate the weekly dosing with 7 x 10^7 Decoy20.

 

As of October 2024, we completed one month of the weekly dosing part in the first six participants at the 3 x 10^7 Decoy20 dose and following the review of the safety data by the Safety Review Committee we received the authorization to initiate unrestricted enrollment of participants at the 3 x 10^7 Decoy20 dose. As of May 13, 2025, we have enrolled 13 participants on Decoy20 as a single dose and 32 participants in the weekly dosing among the two Decoy20 dose levels and decided to conclude enrollment in the weekly dosing and focus on the combination study of Decoy20 with Tislelizumab, as further described below. We have observed early signs of potential benefits emerging with some participants with stable disease. As expected with the mechanism of action of Decoy20, we have seen adverse events of cytokine release syndrome (CRS) in 4 participants that have resolved within 24 hours.

 

In October 2024, we entered into a clinical supply agreement, or the Supply Agreement, with BeOne Medicines (formerly known as BeiGene Switzerland GmbH), to advance clinical evaluation of Decoy20 in combination with BeOne’s anti-PD-1 antibody, Tislelizumab, or the BeOne Product, for the treatment of participants with advanced solid tumors, or the Combination Study. This Combination Study builds on preclinical results where Decoy20, combined with a PD-1 inhibitor, demonstrated tumor eradication. In March 2025, we announced the initiation of the Phase 1 Combination Study of Decoy20 with Tislelizumab.

 

Under the terms of the Supply Agreement, we will pay for all costs associated with the Combination Study (other than the cost of the BeOne Product), BeOne will supply the BeOne Product to us for the purposes of the study, and we will supply Decoy20 for the purposes of the Combination Study. The Supply Agreement will terminate upon the earlier of (i) the one-year anniversary of the date that we provide BeOne with the Combination Study’s final clinical study report or (ii) the date of termination of the Combination Study, subject to early termination in certain circumstances.

 

Impact of Macroeconomic Conditions on our Operations

 

Economic developments such as inflation, interest rates and tariffs have negatively affected the global financial markets and may reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity. The ultimate impact of current economic conditions is highly uncertain and subject to change. While it is unknown how long these conditions will last and what the complete financial effect will be to us, capital raise efforts and additional development of our technologies may be negatively affected. In addition, our business operations expose us to risks associated with public health crises and epidemics/pandemics.

 

Components of Operating Results

 

Research and Development Expenses

 

Research and development expenses account for a significant portion of our operating expenses. Research and development expenses consist primarily of fees paid to contract research organizations, or CROs, and contract manufacturing organizations, or CMOs, as well as compensation expenses for certain employees involved in the planning, managing, and analyzing the work of the CROs and CMOs and materials used for research and development activities. We expense research and development costs as incurred.

 

We accrue expenses for manufacturing, preclinical studies and clinical trial activities performed by third parties based on estimates of services received and efforts expended pursuant to agreements with CROs, CMOs, and other outside service providers. We determine these estimates 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, we record the payments as a prepaid asset, which will be amortized or expensed as the contracted services are performed. However, actual costs and timing of these activities are highly uncertain, subject to risks and may change depending upon a number of factors, including our clinical development plan.

 

 

We expect our research and development expenses to increase substantially for the foreseeable future as we continue to ramp up our clinical development activities and incur expenses associated with hiring additional personnel to support our research and development efforts. Our expenditures on future nonclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. The duration, costs and timing of preclinical studies and clinical trials and development of product candidates will depend on a variety of factors, including:

 

	●	the timing and receipt of regulatory approvals;
	●	the scope, rate of progress and expenses of preclinical studies and clinical trials and other research and development activities;
	●	potential safety monitoring and other studies requested by regulatory agencies; and
	●	significant and changing government regulation.

 

The process of conducting the necessary clinical research to obtain FDA and other regulatory approval is costly and time consuming and the successful development of product candidates is highly uncertain. As a result of these risks and uncertainties, we are unable to determine with any degree of certainty the duration and completion costs of our research and development projects, or if, when, or to what extent we will generate revenues from the commercialization and sale of any of our product candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates.

 

General and Administrative Expenses

 

General and administrative expenses include compensation, employee benefits, and stock-based compensation, finance administration and human resources, facility costs (including rent), professional service fees, and other general overhead costs to support our operations.

 

We expect our general and administrative expenses to increase for the foreseeable future as we continue to increase our headcount to support our research and development activities and operations generally, the growth of our business and, if any of our product candidates receive marketing approval, commercialization activities. We also expect to continue to incur expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC, additional director and officer insurance expenses, investor relations activities, and other administrative and professional services.

 

Other Income, Net

 

Other income, net, includes interest earned on deposits and investments and other items of income, expense, gain and loss that are incidental to the core operations of the Company.

 

Results of Operations

 

Three months ended March 31, 2025 compared to three months ended March 31, 2024

 

The following table sets forth our results of operations for the three months ended March 31, 2025 and 2024 and the relative dollar change between the two periods.

 

		Three months ended
		March 31,								Change
		2025				2024				$				%
Operating expenses:
Research and development		$	2,810,840			$	1,591,142			$	1,219,698				76.7	%
General and administrative			1,761,719				2,352,097				(590,378	)			(25.1	)%
Total operating expenses			4,572,559				3,943,239				629,320				16.0	%
Loss from operations			(4,572,559	)			(3,943,239	)			(629,320	)			16.0	%
Other income, net			40,129				136,562				(96,433	)			(70.6	)%
Net loss		$	(4,532,430	)		$	(3,806,677	)		$	(725,753	)			19.1	%
Net loss attributable to common stockholders per share, basic and diluted		$	(0.32	)		$	(0.45	)		$	0.13				(28.9	)%
Weighted average number of shares used in calculating net loss per share, basic and diluted			14,102,378				8,442,364

 

 

Research and Development Expenses

 

Our research and development expenses for the three months ended March 31, 2025 amounted to approximately $2.8 million, an increase of approximately $1.2 million, or approximately 76.7%, compared to approximately $1.6 million for the three months ended March 31, 2024. This increase was attributable primarily to an increase of approximately $1.5 million in costs associated with our Phase 1 clinical trial and was offset by a decrease of approximately $0.3 million in payroll and related expenses.

 

General and Administrative Expenses

 

Our general and administrative expenses for the three months ended March 31, 2025 amounted to approximately $1.8 million, a decrease of approximately $0.6 million, or approximately 25.1%, compared to approximately $2.4 million for the three months ended March 31, 2024. This decrease was attributable primarily to a decrease in payroll and related expenses and in legal fees.

 

Other Income, Net

 

During the three months ended March 31, 2025, our other income, net was approximately $0.04 million, which represented a decrease of approximately $0.1 million, or approximately 70.6%, compared to approximately $0.14 million for the three months ended March 31, 2024. The other income generated in the period consists primarily of income earned on our cash and cash equivalent accounts, the balances of which were lower during the three months ended March 31, 2025 compared to the three months ended March 31, 2024.

 

Liquidity and Resources

 

We do not currently have any approved products and have never generated any revenue from product sales. Since our inception, we have funded our operations primarily through public and private offerings of our equity securities.

 

In February 2025, we entered into a SEPA with Yorkville pursuant to which we have the right, but not the obligation, to sell up to $20.0 million of our common stock during a 36-month period, subject to the restrictions and satisfaction of the conditions in the SEPA. Upon execution of the SEPA, we issued to Yorkville 305,960 commitment shares. During March 2025, we sold 1,605,200 shares of our common stock under the SEPA for aggregate SEPA for aggregate net proceeds of approximately $1.15 million, after deducting offering expenses in the amount of approximately $0.1 million.

 

In January 2025, we completed a private placement for the sale and issuance by us of an aggregate of: (i) 2,109,383 shares of our common stock and (ii) warrants to purchase 2,109,383 shares of common stock. The shares and warrants were sold on a combined basis for consideration of $1.065 for one share and a warrant for aggregate gross proceeds of approximately $2.25 million.

 

In November 2024, we completed a registered direct offering, pursuant to which we sold and issued to certain investors 1,817,017 shares of our common stock in a registered direct offering. In addition, in a concurrent private placement, we issued to the investors unregistered warrants to purchase 1,817,017 shares of common. The combined purchase price for one share of common stock and one warrant was $1.175, resulting in gross proceeds of approximately $2.135 million.

 

In August 2024, we completed a registered direct offering, pursuant to which we sold and issued to certain investors, 1,643,837 shares of common stock. In addition, in a concurrent private placement, we issued to the investors unregistered warrants to purchase 1,643,837 shares of common stock. The combined purchase price for one share of common stock and one warrant was $1.825, resulting in gross proceeds of approximately $3.0 million.

 

 

In June 2022, we entered into an At The Market Offering Agreement (the “ATM Agreement”) which was amended on September 1, 2022 with H.C. Wainwright & Co., LLC, as sales agent (“Wainwright”), pursuant to which we may offer and sell, from time to time through Wainwright, shares of our common stock, par value $0.01 per share, for aggregate gross proceeds of up to $3.7 million. The issuance and sale of common stock by us under the ATM Agreement is being made pursuant to our 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, we sold 152,000 shares of our common stock for aggregate gross proceeds of approximately $0.4 million. On August 6, 2024, we 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.

 

As of the date of the issuance of this Quarterly Report and based on our current operating plan, we will need to obtain additional capital to fund our ongoing activities beyond the second quarter of 2025. We will need to increase our capital resources through equity or debt financings, and we may need to do so sooner than we expect. We may also seek to finance our cash needs through collaborations, strategic alliances, or license agreements with third parties. If sources of financing are available, they may result in substantial dilution to our stockholders. We cannot provide any assurance that new financing will be available to us on commercially acceptable terms or in the amounts required, if at all. If we are unable to consummate a financing or other transaction, we may need to delay, reduce, or eliminate our research and development programs, which could adversely affect our business prospects, or cease operations. These conditions raise substantial doubt regarding our ability to continue as a going concern within one year after the date of the filing of this Quarterly Report. For additional information, see Note 1 to our unaudited condensed financial statements included elsewhere in this Quarterly Report. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.

 

We have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years.

 

Cash Flows

 

Operating Activities

 

Net cash used in operating activities was approximately $5.0 million for the three months ended March 31, 2025, compared with net cash used in operating activities of approximately $3.9 million for the three months ended March 31, 2024. The increase in net cash used was primarily attributable to an increase in our research and development activities which were mostly related to our Phase 1 clinical trial.

 

Financing Activities

 

Net cash provided by financing activities for the three months ended March 31, 2025 was approximately $3.2 million, which was provided by the issuance and sale of our common stock and warrants in the January 2025 offering and by the issuance and sale of our common stock under the SEPA. Net cash provided by financing activities for the three months ended March 31, 2024 was approximately $0.3 million, which was provided by the issuance and sale of our common stock under the ATM Agreement.

 

Funding Requirements

 

Our operating expenses are expected to continue to increase in the future in connection with our ongoing activities, particularly as we expect to continue to ramp up our clinical development activities and incur expenses associated with hiring additional personnel to support our research and development efforts. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Furthermore, we expect to continue to incur significant costs associated with operating as a public company.

 

 

As of the date of the issuance of this Quarterly Report and based on our current operating plan, we will need to obtain additional capital to fund our ongoing activities beyond the second quarter of 2025. In May 2025, we began implementing a cost-reduction plan that includes a focus on the Combination Study, the elimination of non-essential expenses and accepted a voluntary temporary reduction of the base salaries of certain officers and temporary elimination of board fees.

 

Our future capital requirements will depend on many factors, including, but not limited to:

 

	●	the scope, progress, results and costs of preclinical studies and clinical trials;
	●	the scope, prioritization and number of our clinical trials and other research and development programs;
	●	the amount of revenues we receive under future licensing, collaboration, development and commercialization arrangements with respect to our product candidates;
	●	the impact of any pandemic, epidemic or other future health crisis on our business and operations;
	●	the costs of the development and expansion of our operational infrastructure;
	●	the costs, timing and outcome of regulatory review of our product candidates;
	●	the ability of us, or our collaborators, to achieve development milestones, marketing approval and other events or developments under our potential future licensing agreements;
	●	the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
	●	the costs and timing of securing manufacturing arrangements for clinical or commercial production;

 

	●	the costs of contracting with third parties to provide sales and marketing capabilities for us or establishing such capabilities ourselves;
	●	the costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or technology;
	●	the magnitude of our general and administrative expenses; and
	●	any cost that we may incur under future in- and out-licensing arrangements relating to one or more of our product candidates.

 

Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of product candidates that we do not expect to be commercially available for the next couple of years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. For example, the trading prices for our and other biopharmaceutical companies’ stock have been highly volatile as a result of current macroeconomic conditions and market volatility. As a result, we may face difficulties raising capital through sales of our common stock on acceptable terms, if at all. If we are unsuccessful in securing sufficient financing, we may need to delay, reduce, or eliminate our research and development programs, which could adversely affect our business prospects, or cease operations. For additional information, see Note 1 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.

 

 

Contractual Obligations

 

Operating lease liabilities represent our commitment for future rent made under a non-cancelable lease for our offices in San Diego, CA. The total future payments for our operating lease obligation on March 31, 2025 were approximately $0.06 million and are due in the next twelve months. For additional details regarding our lease, see Note 7 to our unaudited condensed consolidated financial statements included in this Quarterly Report.

 

We did not have during the periods presented, and we do not currently have any off-balance sheet arrangements, as defined under the SEC rules.

 

 

Critical Accounting Policies

 

This discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates that affect the reported amounts of our assets, liabilities and expenses. Significant accounting policies employed, including the use of estimates, are presented in the notes to our annual financial statements included in our 2024 Annual Report on Form 10-K. We periodically evaluate our estimates, which are based on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Critical accounting policies are those that are most important to the portrayal of our financial condition and results of operations and require our subjective or complex judgments, resulting in the need to make estimates about the effect of matters that are inherently uncertain. If actual performance should differ from historical experience or if the underlying assumptions were to change, our financial condition and results of operations may be materially impacted.

 

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies” in our 2024 Annual Report on Form 10-K. During the three months ended March 31, 2025, there were no material changes to our critical accounting policies from those discussed in our 2024 Annual Report on Form 10-K.

 

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. We are 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.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

We are a smaller reporting company as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and are not required to provide the information otherwise required under this Item 3.

 

Item 4. Controls and Procedures

 

Limitations on Effectiveness of Controls and Procedures

 

In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints, and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officer and principal financial officer, evaluated, as of March 31, 2025, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2025.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

Part II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business.

 

There are currently no pending material legal proceedings, and we are currently not aware of any legal proceedings or claims against us or our property that we believe will have any significant effect on our business, financial position or operating results. None of our officers or directors is a party against us in any legal proceeding.

 

Item 1A. Risk Factors

 

Except as set forth below in this Item 1A and the Risk Factors included in our previous filings made with the SEC, there have been no material changes to our risk factors from those disclosed in “Part I. Item 1A. Risk Factors” in the Form 10-K filed with the SEC on March 13, 2025.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults Upon Senior Securities

 

Not applicable.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

During the three months ended March 31, 2025, no director or “officer” (as defined in Rule 16a-1(f) under the Exchange Act) of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

 

 

Item 6. Exhibits

 

Exhibit No.		Exhibit Description
3.1		Amended and Restated Certificate of Incorporation of Indaptus Therapeutics, Inc., dated as of July 23, 2021 (incorporated herein by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 23, 2021)
3.2		Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Indaptus Therapeutics, Inc. dated August 3, 2021 (incorporated herein by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on August 6, 2021)
3.3		Amended and Restated Bylaws of Indaptus Therapeutics, Inc., dated as of January 22, 2024 (incorporated herein by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 23, 2024)
31.1*		Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a), promulgated under the Securities Exchange Act of 1934, as amended
31.2*		Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a), promulgated under the Securities Exchange Act of 1934, as amended
32.1#		Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2#		Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*		Inline XBRL Instance Document
101.SCH*		Inline XBRL Taxonomy Extension Schema Document
101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*		Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*		Inline XBRL Taxonomy Extension Labels Linkbase Document
101.PRE*		Inline XBRL Taxonomy Extension Presentation Linkbase Document
104		Cover Page Interactive Data File (formatted as Inline XBRL document and included in Exhibit 101)

 

*	Filed herewith
#	Furnished herewith

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	Indaptus Therapeutics, Inc.
Date: May 14, 2025	By:	/s/ Jeffrey A. Meckler
		Jeffrey A. Meckler
		Chief Executive Officer
		(Principal Executive Officer)
Date: May 14, 2025	By:	/s/ Nir Sassi
		Nir Sassi
		Chief Financial Officer
		(Principal Financial and Accounting Officer)