Latest data from first and second cohorts support Company's 'pulse-prime' approach, demonstrating rapid clearance, broad immune activation, and encouraging safety profile Poster Presented at American Society of Clinical Oncology Annual Meeting NEW YORK, June 03, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (NASDAQ:INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced updated data from its ongoing Phase 1 clinical trial ...

NEW YORK, May 30, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (NASDAQ:INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, announces today that Jeffrey Meckler, Chief Executive Officer, and Roger Waltzman, M.D., M.B.A., Chief Medical Officer, will present a corporate overview at the Jefferies Global Healthcare Conference. The conference is being held on June 5 – 6, 2024 at the Marriott Marquis in New York City. Presentation Date: We ...

NEW YORK, May 29, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (NASDAQ:INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announces data from a poster being presented at the American Society of Clinical Oncology Annual Meeting 2024 on June 1. The conference will be held in Chicago at McCormick Place from May 31-June 4, 2024 where full data will be presented. In the abstract, titled, "Preliminary results of a Phase 1 study of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Commission File Number 001-40652 INDAPTUS THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) 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, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO | Title of each class | Trading Symbol( ...

Exhibit 99.1 Indaptus Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update 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 8, 2024) - Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the "Company"), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announc ...

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 ...

[Corporate Overview and Recent Developments](index=1&type=section&id=Corporate%20Overview%20and%20Recent%20Developments) The company reports positive clinical trial results for its lead candidate and secures a key European patent for its platform technology [Recent Corporate and Clinical Highlights](index=1&type=section&id=Recent%20Corporate%20and%20Clinical%20Highlights) The company reports positive Phase 1 results for Decoy20, initiates a multi-dose cohort, and secures a key European patent - Decoy20 Phase 1 trial demonstrated a **broad immune response** in patients following a single dose in the first cohort and continued to show positive results in the second cohort[2](index=2&type=chunk)[9](index=9&type=chunk) - The company is initiating a **multi-dose cohort** in the Phase 1 trial to determine the safety of multiple doses and potentially enhance anti-tumor activity[2](index=2&type=chunk)[8](index=8&type=chunk)[9](index=9&type=chunk) - In January 2024, a key patent for the company's platform technology was **approved by the European Patent Office**[9](index=9&type=chunk) [Financial Performance Summary](index=1&type=section&id=Financial%20Performance%20Summary) The company's financial performance reflects increased operating expenses and a higher net loss, alongside a significant decrease in cash reserves [Operating Expenses](index=1&type=section&id=Operating%20Expenses) Operating expenses rose due to increased R&D for clinical trials and a modest rise in general and administrative costs Research and Development Expenses (YoY Change) | Period | 2023 (Millions) | 2022 (Millions) | Change (Millions) | Change (%) | | :-------------------------------- | :-------------- | :-------------- | :---------------- | :--------- | | Three-month period ended Dec 31 | $2.0 | $1.9 | $0.1 | 7% | | Twelve-month period ended Dec 31 | $7.6 | $6.3 | $1.3 | 21% | General and Administrative Expenses (YoY Change) | Period | 2023 (Millions) | 2022 (Millions) | Change (Millions) | Change (%) | | :-------------------------------- | :-------------- | :-------------- | :---------------- | :--------- | | Three-month period ended Dec 31 | $2.2 | $2.2 | $0.0 | 0% | | Twelve-month period ended Dec 31 | $8.8 | $8.6 | $0.2 | 2% | [Net Loss and EPS](index=1&type=section&id=Net%20Loss%20and%20EPS) The company's net loss per share increased in fiscal year 2023 compared to the prior year, reflecting higher operating expenses Loss Per Share (Twelve-Month Period) | Period | 2023 | 2022 | | :-------------------------------- | :--- | :--- | | Loss per share (basic and diluted) | $1.83 | $1.73 | [Liquidity and Cash Position](index=1&type=section&id=Liquidity%20and%20Cash%20Position) The company's cash position decreased significantly, with current reserves projected to fund operations through Q3 2024 Cash and Cash Equivalents | As of December 31 | 2023 (Millions) | 2022 (Millions) | | :---------------- | :-------------- | :-------------- | | Cash and cash equivalents | $13.4 | $26.4 | - The company expects its current cash and cash equivalents to support ongoing operating activities **through the third quarter of 2024**[7](index=7&type=chunk) Net Cash Used in Operating Activities (Twelve-Month Period) | Period | 2023 (Millions) | 2022 (Millions) | Change (Millions) | | :-------------------------------- | :-------------- | :-------------- | :---------------- | | Net cash used in operating activities | $13.4 | $13.1 | $0.3 | Net Cash Provided by (Used in) Investing Activities (Twelve-Month Period) | Period | 2023 (Millions) | 2022 (Millions) | | :-------------------------------- | :-------------- | :-------------- | | Net cash provided by (used in) investing activities | $17.1 | ($16.4) | [Company Profile and Technology](index=3&type=section&id=Company%20Profile%20and%20Technology) The company is developing a novel Decoy immunotherapy platform using attenuated bacteria to activate broad immune responses against cancers and viral infections - Indaptus' novel approach is based on activating **both innate and adaptive immune cells** and pathways using a multi-targeted package of immune system-activating signals[13](index=13&type=chunk) - The patented Decoy platform utilizes single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria, acting as **multiple TLR, NLR, and STING agonists**[13](index=13&type=chunk) - Pre-clinical studies demonstrated **single-agent and combination-mediated activity** against metastatic pancreatic, colorectal, breast, and hepatocellular carcinomas, as well as non-Hodgkin's lymphomas[13](index=13&type=chunk) - 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[13](index=13&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements detail the company's balance sheet, operations, and cash flows for the fiscal year ended December 31, 2023 [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) Total assets and stockholders' equity decreased significantly in 2023, driven by a reduction in cash and marketable securities Consolidated Balance Sheet Highlights | Item | December 31, 2023 | December 31, 2022 | | :-------------------------------- | :------------------ | :------------------ | | Cash and cash equivalents | $13,362,053 | $9,626,800 | | Marketable securities | - | $16,806,009 | | Total current assets | $13,995,209 | $27,244,242 | | Total assets | $14,923,878 | $28,063,806 | | Total current liabilities | $2,774,032 | $3,433,341 | | Total liabilities | $2,847,380 | $3,433,341 | | Total stockholders' equity | $12,076,498 | $24,630,465 | [Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's net loss widened in 2023 due to higher research and development expenses, resulting in an increased loss per share Consolidated Statements of Operations Highlights | Item | For the year ended December 31, 2023 | For the year ended December 31, 2022 | | :------------------------------------------ | :----------------------------------- | :----------------------------------- | | Research and development | $7,621,707 | $6,324,657 | | General and administrative | $8,756,767 | $8,586,249 | | Total operating expenses | $16,378,474 | $14,910,906 | | Loss from operations | ($16,378,474) | ($14,910,906) | | Net loss | ($15,423,471) | ($14,322,798) | | Net loss per share, basic and diluted | ($1.83) | ($1.73) | | Comprehensive loss | ($15,519,905) | ($14,226,364) | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Cash used in operations increased slightly, while investing activities shifted to a net cash provider due to the maturity of marketable securities Consolidated Statements of Cash Flows Highlights | Item | For the year ended December 31, 2023 | For the year ended December 31, 2022 | | :------------------------------------------ | :----------------------------------- | :----------------------------------- | | Net loss | ($15,423,471) | ($14,322,798) | | Stock-based compensation | $2,965,938 | $2,957,249 | | Net cash used in operating activities | ($13,405,315) | ($13,078,347) | | Purchase of marketable securities | ($6,859,432) | ($29,599,573) | | Maturity of marketable securities | $24,000,000 | $13,000,000 | | Net cash provided by (used in) investing activities | $17,140,568 | ($16,427,018) | | Net increase (decrease) in cash and cash equivalents | $3,735,253 | ($29,505,365) | | Cash and cash equivalents at end of year | $13,362,053 | $9,626,800 | [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines future expectations regarding clinical trials and financial needs while highlighting material risks that could affect actual results - Forward-looking statements cover expectations and plans for the **Phase 1 clinical trial of Decoy20**, anticipated effects of product candidates, and future financing needs[14](index=14&type=chunk) - Actual results may differ materially due to risks including the company's **limited operating history**, the need for additional capital, and lengthy clinical development processes[14](index=14&type=chunk) [Contact Information](index=3&type=section&id=Contact%20Information) This section provides contact details for investor relations and media inquiries - Investor Relations Contact: Louie Toma, CORE IR, louie@coreir.com[15](index=15&type=chunk)[16](index=16&type=chunk) - Media Contact: Jules Abraham, CORE IR, julesa@coreir.com, 917-885-7378[16](index=16&type=chunk)

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]

PART I. FINANCIAL INFORMATION [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) Unaudited financials show total assets decreased to **$20.8M**, net loss increased to **$7.5M**, with significant going concern uncertainty Condensed Consolidated Balance Sheet Data (Unaudited) | Balance Sheet Items | June 30, 2023 ($) | December 31, 2022 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | 12,698,387 | 9,626,800 | | Marketable securities | 6,993,588 | 16,806,009 | | Total current assets | 19,872,759 | 27,244,242 | | Total assets | 20,844,709 | 28,063,806 | | Total current liabilities | 2,103,046 | 3,433,341 | | Total liabilities | 2,219,216 | 3,433,341 | | Total stockholders' equity | 18,625,493 | 24,630,465 | Condensed Consolidated Statements of Operations (Unaudited) | Statement of Operations | Three Months Ended June 30, 2023 ($) | Three Months Ended June 30, 2022 ($) | Six Months Ended June 30, 2023 ($) | Six Months Ended June 30, 2022 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | 1,480,485 | 1,506,165 | 3,360,385 | 2,803,263 | | General and administrative | 2,014,777 | 2,363,095 | 4,590,043 | 4,468,070 | | Loss from operations | (3,495,262) | (3,869,260) | (7,950,428) | (7,271,333) | | Net loss | (3,245,065) | (3,835,502) | (7,498,303) | (7,200,656) | | Net loss per share, basic and diluted | (0.39) | (0.46) | (0.89) | (0.87) | Condensed Consolidated Statements of Cash Flows (Unaudited, Six Months Ended June 30) | Cash Flow Items | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (7,068,981) | (6,265,890) | | Net cash provided by (used in) investing activities | 10,140,568 | (18,607,463) | | Net increase (decrease) in cash | 3,071,587 | (24,873,353) | | Cash and cash equivalents at end of period | 12,698,387 | 14,258,812 | - The company has identified substantial doubt about its ability to continue as a going concern, as it does not have adequate cash to fund ongoing activities beyond the **second quarter of 2024** without obtaining additional financing[29](index=29&type=chunk)[30](index=30&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Decoy20's Phase 1 trial, increased operating expenses, and liquidity concerns, raising going concern doubts - The company is a clinical-stage biotechnology firm developing Decoy20, a systemically-administered anti-cancer and anti-viral immunotherapy, with a Phase 1 clinical trial initiated in **December 2022** and the first patient cohort completed in **August 2023**[57](index=57&type=chunk)[58](index=58&type=chunk) Comparison of Operating Expenses (Six Months Ended June 30) | Expense Category | 2023 ($) | 2022 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | 3,360,385 | 2,803,263 | 557,122 | 20% | | General and administrative | 4,590,043 | 4,468,070 | 121,973 | 3% | | **Total operating expenses** | **7,950,428** | **7,271,333** | **679,095** | **9%** | - The increase in R&D expenses for the first six months of 2023 was primarily driven by a **$350,000** increase for the Phase 1 clinical trial and a **$250,000** increase in payroll and related expenses[74](index=74&type=chunk) - As of June 30, 2023, the company had approximately **$19.7 million** in cash, cash equivalents, and marketable securities, sufficient to fund operations only into the **second quarter of 2024**, raising substantial doubt about its ability to continue as a going concern[82](index=82&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, the company is exempt from providing market risk disclosures - As a smaller reporting company, Indaptus Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk[94](index=94&type=chunk) [Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2023, with no material changes in internal controls - Based on an evaluation as of **June 30, 2023**, the company's principal executive officer and principal financial officer concluded that disclosure controls and procedures were effective at a reasonable assurance level[96](index=96&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended **June 30, 2023**, that have materially affected, or are reasonably likely to materially affect, internal controls[97](index=97&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) No material legal proceedings are pending; a previous arbitration with LTS Lohmann Therapie Systeme AG was settled - There are currently no pending material legal proceedings against the company[100](index=100&type=chunk) - A dispute with LTS Lohmann Therapie Systeme AG was settled on **February 7, 2023**, with a payment of **Euro 800,000**[49](index=49&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include financial viability, Decoy20 clinical trial uncertainty, third-party reliance, competition, and regulatory hurdles - **Financial Risk:** The company has a history of net losses (**$7.5 million** for the six months ended June 30, 2023) and an accumulated deficit of **$37.5 million**, with conditions raising substantial doubt about its ability to continue as a going concern[103](index=103&type=chunk)[105](index=105&type=chunk) - **Development Risk:** The company is highly dependent on the success of its lead product candidate, Decoy20, where clinical development is a lengthy, expensive, and uncertain process, and positive early results do not guarantee later success[113](index=113&type=chunk)[116](index=116&type=chunk) - **Third-Party Reliance Risk:** The company relies on third-party CROs to conduct clinical trials and CMOs for manufacturing, increasing risks related to quality control, meeting deadlines, and regulatory compliance (cGMP, GCP)[157](index=157&type=chunk)[161](index=161&type=chunk) - **Commercialization Risk:** The success of any approved product depends on market acceptance and obtaining adequate reimbursement from government and private payors, which remains uncertain[154](index=154&type=chunk)[170](index=170&type=chunk) [Other Items (Unregistered Sales, Defaults, Mine Safety, Other Info, Exhibits)](index=60&type=section&id=Item%202-6) This section covers no unregistered equity sales, no defaults, no mine safety issues, and no Rule 10b5-1 trading changes - There were no unregistered sales of equity securities during the period[259](index=259&type=chunk) - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the three months ended **June 30, 2023**[262](index=262&type=chunk)