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Financial Highlights for Fourth Quarter and Fiscal Year Ended December 31, 2024

Research and development expenses for the three months ended December 31, 2024, were $2.5 million, which compares with $2.0 million in the three months ended December 31, 2023. The change was primarily due to an increase of $0.7 million expenses in our Phase 1 clinical trial and was offset by a decrease of $0.2 million in payroll and related expenses. Research and development expenses for the twelve-month period ended December 31, 2024, were $7.2 million, which compares with $7.6 million in the twelve-month period ended December 31, 2023. The decrease for the twelve-month period was primarily due to a decrease of approximately $1.3 million in the development of our manufacturing processes of Decoy20 that were conducted in 2023. This was offset by an increase of $0.9 million in costs associated with our Phase 1 clinical trial.

General and administrative expenses for the three months ended December 31, 2024, were $1.7 million, which compares with $2.2 million in the three months ended December 31, 2023. The change was primarily due to stock-based compensation, legal fees, and franchise tax expenses. General and administrative expenses for the twelve-month period ended December 31, 2024, were $8.1 million, which compares with $8.8 million in the twelve-month period ended December 31, 2023. The improvement for the twelve-month period was primarily due to a decrease of $1.3 million in legal fees, recruitment costs, payroll and related expenses, franchise tax, and directors’ and officers’ insurance expenses. This was offset by an increase of $0.6 million in investor relations and business development expenses.

Loss per share for the twelve-month period ended December 31, 2024 was $1.61, compared with $1.83 for the twelve-month period ended December 31, 2023.

As of December 31, 2024, the Company had cash and cash equivalents of $5.8 million. During January 2025, the Company conducted a private placement resulting in net proceeds of $2.0 million. During February 2025, the Company established a $20 million equity line of credit with Yorkville. 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 into the second quarter of 2025. 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 $12.3 million for the twelve-month period ended December 31, 2024, compared with net cash used in operating activities of $13.4 million for the twelve-month period ended December 31, 2023. The variance resulted primarily from net changes in operating asset and liability items.

There was no net cash provided by or used in investing activities in the twelve-month period ended December 31, 2024. Net cash provided by investing activities was $17.1 million for the twelve-month period ended December 31, 2023, which was related to the maturity of $24.0 million in marketable securities, offset by net investment of $6.9 million in marketable securities.

Net cash provided by financing activities for the twelve-month period ended December 31, 2024, was $4.7 million, which was provided by the issuance and sale of the Company’s common stock under its ATM program and the issuance and sale of our common stock and warrants in financings conducted in August and November 2024. There was no net cash provided by or used in financing activities in the twelve-month period ended December 31, 2023.

2025 Outlook

• The Company plans to dose the first patients in its combination study to evaluate potential synergy with BeiGene’s Tislelizumab.

• The Company is working to increase the number of trial sites to accelerate patient enrollment and data collection.

• The Company expects to provide further clinical updates throughout 2025, including data from weekly-dosing cohorts.

• The Company plans to provide new data on expansion of the Decoy platform and nominate a new candidate for IND enabling studies.

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 and our anticipated combination study, 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 most recent Annual Report on Form 10-K filed with the SEC on March 13, 2025, 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
917-885-7378