NEW YORK, April 11, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (NASDAQ:INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, was proud to unveil its poster at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) in San Diego on Wednesday, April 10th. The poster details mechanism of action data that demonstrates the Company's Decoy platform successfully induces, matures or activates multiple immune cell type ...

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) For the fiscal year ended December 31, 2023 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 | | --- | --- | | (S ...

Exhibit 99.1 Indaptus Therapeutics Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update NEW YORK (March 13, 2024) - Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the "Company") today announced financial results for the fourth quarter and fiscal year ended December 31, 2023 and provided a corporate update. Jeffrey Meckler, Chief Executive Officer of Indaptus, commented, "We are thrilled with the progress we made in 2023, which was capped off in November when we ...

Financial Performance - The net loss for the three months ended September 30, 2023, was $3,922,388, compared to a net loss of $3,466,365 for the same period in 2022, reflecting an increase in loss of about 13.1%[20] - The company reported a comprehensive loss of $4,056,543 for the three months ended September 30, 2023, compared to $3,424,297 in 2022, an increase of approximately 18.5%[20] - For the nine months ended September 30, 2023, the Company incurred a net loss of approximately $11.4 million, with an accumulated deficit of approximately $41.4 million[29] - Net loss for the nine months ended September 30, 2023, was approximately $11.4 million, an increase of approximately $754,670 or 7% compared to a net loss of $10.7 million for the same period in 2022[75] Cash Flow and Liquidity - As of September 30, 2023, cash and cash equivalents increased to $15,963,998 from $9,626,800 as of December 31, 2022, representing a growth of approximately 66.5%[18] - Cash flows from operating activities resulted in a net cash used of $10,803,370 for the nine months ended September 30, 2023, compared to $10,867,434 in 2022[24] - The company had a net cash provided by investing activities of $17,140,568 for the nine months ended September 30, 2023, contrasting with a net cash used of $21,546,518 in 2022[24] - As of September 30, 2023, the company had approximately $16.0 million in cash and cash equivalents, expected to fund operations into the second quarter of 2024[85] Operating Expenses - Research and development expenses for the three months ended September 30, 2023, were $2,226,688, up from $1,609,554 in 2022, indicating a rise of approximately 38.4%[20] - Total operating expenses for the nine months ended September 30, 2023, were $12,198,840, compared to $10,823,883 in 2022, an increase of about 12.7%[20] - General and administrative expenses for Q3 2023 were approximately $2.0 million, reflecting a 4% increase from $1.9 million in Q3 2022[72] - Total operating expenses for Q3 2023 amounted to $4.2 million, a 20% increase compared to $3.6 million in Q3 2022[70] Research and Development - The company expects research and development expenses to continue increasing as clinical development activities ramp up[64] - Research and development expenses for the nine months ended September 30, 2023, were approximately $5.6 million, an increase of approximately $1.2 million or 27% compared to $4.4 million for the same period in 2022[76] - Research and development expenses for Q3 2023 were approximately $2.2 million, an increase of 38% from $1.6 million in Q3 2022, primarily due to the Phase 1 clinical trial and pipeline expansion activities[71] Capital and Financing - The Company plans to secure additional capital through collaborations, strategic alliances, or public/private financing to fund ongoing activities beyond the second quarter of 2024[29] - The company has entered into agreements to raise capital, including an at-the-market offering agreement for up to $3.7 million and a commitment from Lincoln Park to purchase up to $20.0 million of its common stock over a 36-month period[119] - The company expects to continue incurring significant losses as it expands development activities and seeks regulatory approvals for its product candidates[109] Regulatory and Market Risks - The company has substantial doubt about its ability to continue as a going concern within one year after the filing of this Quarterly Report due to insufficient cash and ongoing losses[110] - The company does not anticipate that any of its current product candidates will receive regulatory approval for several years, if at all[122] - The company may face significant delays in clinical trials due to difficulties in patient recruitment and retention[145] - Regulatory approval processes by the FDA and EMA are lengthy and inherently unpredictable, which could substantially harm the company's business if approvals are not obtained[150] Product Development Challenges - The company is dependent on the success of its lead product candidate, Decoy20, which is still in the early stages of development and has not yet completed any clinical trials[120] - The clinical development process is expensive, time-consuming, and unpredictable, with no guarantee of success for new product candidates[149] - The successful commercialization of products depends on obtaining adequate coverage and reimbursement from governmental and private payors, which is essential for patient affordability[182] Intellectual Property and Compliance - The company may face challenges in adequately protecting its proprietary technology and products, which could adversely affect its business and financial condition[209] - Non-compliance with patent protection requirements could lead to the abandonment or lapse of patents, resulting in a loss of patent rights and allowing competitors to use the company's technologies[215]

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 June 30, 2023 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 juri ...

(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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q 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 jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 | | --- | --- | -- ...

Financial Performance - The net loss for Q3 2022 was $3.47 million, compared to a net loss of $3.37 million in Q3 2021, representing an increase of $99,201[96]. - The net loss attributable to common stockholders per share for Q3 2022 was $0.42, an improvement from $0.81 in Q3 2021[96]. - Net loss for the nine months ended September 30, 2022, was approximately $10.7 million, compared to a net loss of approximately $4.5 million for the same period in 2021, representing an increase of approximately $6.2 million (approximately 138%) in net loss[101]. Expenses - Research and development expenses for Q3 2022 were approximately $1.6 million, an increase of about $900,000 from $700,000 in Q3 2021[97]. - General and administrative expenses for Q3 2022 amounted to approximately $2 million, a decrease of about $700,000 from $2.7 million in Q3 2021[98]. - Total operating expenses for Q3 2022 were $3.55 million, compared to $3.37 million in Q3 2021, reflecting an increase of $184,558[96]. - Research and development expenses for the nine months ended September 30, 2022, were approximately $4.4 million, an increase of approximately $2.8 million (approximately 175%) compared to $1.6 million for the same period in 2021[102]. - General and administrative expenses for the nine months ended September 30, 2022, amounted to approximately $6.4 million, an increase of approximately $3.5 million (approximately 120%) compared to $2.9 million for the same period in 2021[104]. Cash Flow - Net cash used in operating activities was approximately $10.9 million for the nine months ended September 30, 2022, compared to approximately $7.8 million for the same period in 2021, indicating an increase of approximately $3.1 million (approximately 40%) in cash used[108]. - Net cash used in investing activities was approximately $21.5 million for the nine months ended September 30, 2022, primarily due to the purchase of marketable securities investments[109]. - As of September 30, 2022, the company had cash and cash equivalents and marketable securities of approximately $28.5 million, down from approximately $39.1 million as of December 31, 2021[106]. Future Plans - The company plans to commence a Phase 1 clinical trial targeting solid tumors before the end of 2022[80]. - The company expects substantial increases in research and development expenses as it ramps up clinical development activities[91]. - The company plans to commence the Phase 1 clinical trial, expecting a substantial increase in research and development expenses for the remainder of the year[102]. - The company anticipates needing significant additional financing in the future to fund operations, including progressing into additional clinical trials and obtaining regulatory approvals[113]. Mergers and Acquisitions - The company completed a merger with Decoy on August 3, 2021, which resulted in the business of Decoy becoming the business of the combined company[81]. Market Conditions - The company is closely monitoring the impact of the COVID-19 pandemic, which may negatively affect capital raise efforts and technology development[112].

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 June 30, 2022 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 juri ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☐ 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) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For t ...