Indaptus Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

Indaptus Therapeutics

Company to present poster at American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2024 highlighting initial results from its Phase 1 clinical trial of Decoy20

NEW YORK, May 08, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update.

Jeffrey Meckler, Chief Executive Officer of Indaptus, commented, “We continue to make steady progress in our clinical development plans and are receiving regular validation for results reported to date, both through a presentation in April at the American Association for Cancer Research (AACR) annual meeting, and the acceptance of further data to be presented in a poster at the American Society of Clinical Oncology (ASCO) annual meeting, which is considered among the top annual oncology conferences. We are encouraged by the results we have reported, along with the early results we are seeing as we advance our trial, and believe they are indicative of the potential for Decoy20, and indeed our platform as a whole. We look forward to reporting more about our progress as it develops.”

Key recent highlights:

• Presenting poster, titled, “Preliminary results of a phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors,” at the American Society of Clinical Oncology annual meeting on June 1, 2024, in Chicago.

• Presented poster outlining mechanism of action of Decoy platform at the American Association for Cancer Research Annual Meeting in April 2024.

• Reported preliminary positive results from second cohort of Phase 1 trial and initiated multi-dose cohort in March 2024.

• Announced granting of key patent that helped to further expand intellectual property portfolio in January 2024.

Financial Highlights for First Quarter ended March 31, 2024

Research and development expenses for the three-month period ended March 31, 2024, were $1.6 million, a decrease of $0.3 million, or 15%, compared with $1.9 million in the three-month period ended March 31, 2023. The decrease was primarily due to the manufacturing processes of Decoy20 that were conducted in the three months period ended March 31, 2023.

General and administrative expenses for the three-month period ended March 31, 2024, were $2.4 million, a decrease of $0.2 million, or 9%, compared with $2.6 million in the three-month period ended March 31, 2023. The decrease was primarily due to decreased legal fees, recruitment costs and directors’ and officers’ insurance expenses, and was offset by an increase in payroll and related expenses and investor relations expenses.

Loss per share for the three-month period ended March 31, 2024 was $0.45, compared with $0.51 for the three-month period ended March 31, 2023.

As of March 31, 2024, the Company had cash and cash equivalents of $9.7 million. As of December 31, 2023, the Company had cash and cash equivalents of $13.4 million. The Company expects that its current cash and cash equivalents will support its ongoing operating activities through the third quarter of 2024. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken. Indaptus continues to assess all financing options that would support its corporate strategy.

Net cash used in operating activities was $3.9 million for the three-month period ended March 31, 2024, compared with net cash used in operating activities of $4.9 million for the three-month period ended March 31, 2023. The $1.0 million decrease in net cash used was primarily attributable to a decrease in our research and development and general and administrative expenses and was also attributable to a settlement fee that was paid in February 2023.

There was no net cash provided by or used in investing activities in the three months ended March 31, 2024. Net cash provided by investing activities was approximately $2.1 million for the three months ended March 31, 2023, which was related to the maturity of $9.0 million in marketable securities, offset by net investment of approximately $6.9 million in marketable securities.

Net cash provided by financing activities for the three months ended March 31, 2024 was approximately $0.3 million, which was provided by issuance and sale of our common stock under the At The Market Offering Agreement. There was no net cash provided by or used in financing activities in the three months ended March 31, 2023.

About Indaptus Therapeutics

Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways 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 (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product. Indaptus’ Decoy product candidates have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things: our expectations and plans regarding our Phase 1 clinical trial of Decoy20, including the timing and design thereof; the anticipated effects of our product candidates, including Decoy20; the plans and objectives of management for future operations; our research and development activities and costs; the sufficiency of our cash and cash equivalents to fund our ongoing activities and our cash management strategy; and our assessment of financing options to support our corporate strategy. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to the following: our limited operating history; conditions and events that raise substantial doubt regarding our ability to continue as going concern; the need for, and our ability to raise, additional capital given our lack of current cash flow; our clinical and preclinical development, which involves a lengthy and expensive process with an uncertain outcome; our incurrence of significant research and development expenses and other operating expenses, which may make it difficult for us to attain profitability; our pursuit of a limited number of research programs, product candidates and specific indications and failure to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success; our ability to obtain and maintain regulatory approval of any product candidate; the market acceptance of our product candidates; our reliance on third parties to conduct our preclinical studies and clinical trials and perform other tasks; our reliance on third parties for the manufacture of our product candidates during clinical development; our ability to successfully commercialize Decoy20 or any future product candidates; our ability to obtain or maintain coverage and adequate reimbursement for our products; the impact of legislation and healthcare reform measures on our ability to obtain marketing approval for and commercialize Decoy20 and any future product candidates; product candidates of our competitors that may be approved faster, marketed more effectively, and better tolerated than our product candidates; our ability to adequately protect our proprietary or licensed technology in the marketplace; the impact of, and costs of complying with healthcare laws and regulations, and our failure to comply with such laws and regulations; information technology system failures, cyberattacks or deficiencies in our cybersecurity; and unfavorable global economic conditions. These and other important factors discussed under the caption “Risk Factors” included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 to be filed with the SEC, our most recent Annual Report on Form 10-K filed with the SEC on March 13, 2024, and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by the cautionary statements included in this press release. We undertake no obligation to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law.

Contact: investors@indaptusrx.com

Investor Relations Contact:
CORE IR
Louie Toma
louie@coreir.com

Media Contact:
CORE IR
Jules Abraham
julesa@coreir.com

INDAPTUS THERAPEUTICS, INC. Unaudited Condensed Consolidated Balance Sheets
	March 31, 2024				December 31, 2023
Assets
Current assets:
Cash and cash equivalents	$	9,741,638			$	13,362,053
Prepaid expenses and other current assets		551,031				633,156
Total current assets		10,292,669				13,995,209
Non-current assets:
Property and equipment, net		-				735
Right-of-use asset		151,118				173,206
Other assets		504,728				754,728
Total non-current assets		655,846				928,669
Total assets	$	10,948,515			$	14,923,878
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and other current liabilities	$	1,434,828			$	2,672,327
Operating lease liability, current portion		102,464				101,705
Total current liabilities		1,537,292				2,774,032
Non-current liabilities:
Operating lease liability, net of current portion		50,664				73,348
Total non-current liabilities		50,664				73,348
Total liabilities		1,587,956				2,847,380
Commitments and contingencies
Stockholders’ equity:
Common stock: $0.01 par value, 200,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 8,538,883 shares issued and outstanding as of March 31, 2024 and 8,401,047 shares issued and outstanding as of December 31, 2023		85,389				84,011
Additional paid in capital		58,499,003				57,409,643
Accumulated deficit		(49,223,833	)			(45,417,156	)
Total stockholders’ equity		9,360,559				12,076,498
Total liabilities and stockholders’ equity	$	10,948,515			$	14,923,878

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
	Three Months Ended March 31,
	2024				2023
Operating expenses:
Research and development	$	1,591,142			$	1,879,900
General and administrative		2,352,097				2,575,266
Total operating expenses		3,943,239				4,455,166
Loss from operations		(3,943,239	)			(4,455,166	)
Other income, net		136,562				201,928
Net loss	$	(3,806,677	)		$	(4,253,238	)
Net loss available to common stockholders per share of common stock, basic and diluted	$	(0.45	)		$	(0.51	)
Weighted average number of shares used in calculating net loss per share, basic and diluted		8,442,364				8,401,047
Net loss	$	(3,806,677	)		$	(4,253,238	)
Other comprehensive income:
Reclassification adjustment for interest earned on marketable securities included in net loss		-				(129,229	)
Change in unrealized gain on marketable securities		-				210,252
Comprehensive loss	$	(3,806,677	)		$	(4,172,215	)

Unaudited Condensed Consolidated Statements of Cash Flows
	For the three months
	ended March 31,
	2024				2023
Cash flows from operating activities:
Net loss	$	(3,806,677	)		$	(4,253,238	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		735				321
Stock-based compensation		774,691				727,144
Interest earned on marketable securities		-				(129,229	)
Changes in operating assets and liabilities:
Prepaid expenses and other assets		332,125				324,205
Accounts payable and other current liabilities		(1,237,499	)			(1,630,225	)
Operating lease right-of-use asset and liability, net		163				(1,200	)
Net cash used in operating activities		(3,936,462	)			(4,962,222	)
Cash flows from investing activities:
Maturity of marketable securities		-				9,000,000
Purchase of marketable securities		-				(6,859,432	)
Net cash provided by investing activities		-				2,140,568
Cash flows from financing activities:						-
Issuance of shares of common stock		336,044
Issuance costs		(19,997	)			-
Net cash provided by financing activities		316,047				-
Net decrease in cash and cash equivalents		(3,620,415	)			(2,821,654	)
Cash and cash equivalents at beginning of period		13,362,053				9,626,800
Cash and cash equivalents at end of period	$	9,741,638			$	6,805,146
Noncash investing and financing activities
Change in accumulated other comprehensive income	$	-			$	81,023
ASC 842 lease renewal option exercise	$	-			$	236,506
Reclassification of security deposit	$	-			$	16,477