☒ 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)

(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 ...

Part I [Business Overview](index=7&type=section&id=Item%201.%20Business) Indaptus Therapeutics is a clinical-stage biotechnology company developing a novel, patented systemic anti-cancer and antiviral immunotherapy based on attenuated and inactivated Gram-negative bacteria, with its lead candidate Decoy20 initiating Phase I clinical trials in December 2022 - The company focuses on developing a novel, patented systemic anti-cancer and antiviral immunotherapy based on attenuated and inactivated Gram-negative bacteria[22](index=22&type=chunk)[27](index=27&type=chunk) - The technology has demonstrated broad anti-tumor and antiviral activity in preclinical models, including synergistic effects with five different existing drugs such as checkpoint therapies, targeted antibody therapies, and low-dose chemotherapy[22](index=22&type=chunk)[33](index=33&type=chunk) - In May 2022, the U.S. FDA approved the IND application for its lead clinical candidate Decoy20's Phase I clinical trial, which commenced in December 2022 for patients with advanced solid tumors[23](index=23&type=chunk)[38](index=38&type=chunk) - The company holds an extensive patent portfolio with **34 granted patents** and **16 pending applications** as of March 1, 2023, with patent terms expected between 2033 and 2039[24](index=24&type=chunk)[85](index=85&type=chunk) Overview Background Our Approach Results Business Strategy Competitive Advantages Governmental Regulation U.S. Regulation of Drugs and Biologics Expedited Development and Review Programs Post-Approval Requirements Drug Product Marketing Exclusivity Biosimilars and Reference Product Exclusivity Other Healthcare Laws Coverage and Reimbursement Healthcare Reform Data Privacy and Security Laws Competition Intellectual Property Patents Trade Secrets and Confidential Information Environmental Matters Human Capital Management Historical Background and Corporate Structure Available Information [Risk Factors](index=25&type=page&id=Item%201A.%20Risk%20Factors) The company faces significant risks including lack of profitability, substantial future funding needs, uncertain clinical trial outcomes, potential adverse side effects, reliance on third parties, market acceptance challenges, intellectual property protection, and regulatory compliance - The company is a clinical-stage entity, not yet profitable, and anticipates continued losses, with accumulated deficit of approximately **$30 million** as of December 31, 2022[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) - The company lacks cash flow and requires additional capital, otherwise it may be forced to delay, limit, or cancel some or all of its research, development, and commercialization efforts[107](index=107&type=chunk)[108](index=108&type=chunk) - The clinical and preclinical development process is lengthy, expensive, and uncertain, where any difficulties or delays could increase costs and impact revenue generation capabilities[115](index=115&type=chunk)[117](index=117&type=chunk) - Product candidates may cause adverse side effects, which could delay or prevent regulatory approval or commercialization, or otherwise have a significant adverse impact on the business[128](index=128&type=chunk)[130](index=130&type=chunk) - The company relies on third parties for preclinical studies, clinical trials, and product manufacturing, and failure of these third parties to perform their duties could hinder regulatory approval or commercialization[157](index=157&type=chunk)[162](index=162&type=chunk) - The commercial success of Decoy20 or any future product candidates depends on their market acceptance among physicians, patients, healthcare payers, and the medical community[154](index=154&type=chunk) - The company faces intense competition from rivals with greater financial resources and expertise, which could harm its product commercialization opportunities[190](index=190&type=chunk)[191](index=191&type=chunk) - The company relies on intellectual property protection, such as patents and trade secrets, for its proprietary technology, but may not be able to adequately protect it or may face risks of infringing on others' intellectual property[199](index=199&type=chunk)[200](index=200&type=chunk)[208](index=208&type=chunk) - The company is subject to U.S. federal, state, and foreign healthcare laws and regulations, and non-compliance could lead to increased compliance costs and harm operating results and financial condition[225](index=225&type=chunk)[226](index=226&type=chunk) - The COVID-19 pandemic and unfavorable global economic conditions may significantly adversely affect the company's business and operations, including supply chain disruptions, clinical trial delays, and limited financing capabilities[232](index=232&type=chunk)[257](index=257&type=chunk) - The market price of the company's common stock is highly volatile, and investors may suffer a complete loss of their investment[240](index=240&type=chunk)[241](index=241&type=chunk) Risks Related to Our Financial Position and Capital Requirements Risks Related to the Discovery and Development of Our Product Candidates Risks Related to Our Dependence on Third Parties Risks Related to Commercialization Risks Related to Competition, Retaining Key Employees and Managing Growth Risks Related to Our Intellectual Property Risks Related to Healthcare Laws and Other Legal Compliance Matters Other Risks Related to Our Business Risks Related to Our Common Stock General Risk Factors [Unresolved Staff Comments](index=61&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments.) The company has not received any unresolved comments from the U.S. Securities and Exchange Commission staff - The company has not received any unresolved comments from the SEC staff[260](index=260&type=chunk) [Properties](index=61&type=section&id=Item%202.%20Properties.) The company maintains its principal executive offices in New York City and leases approximately 2,000 square feet of office space in San Diego, deemed sufficient for current needs - The company's principal executive offices are located at 3 Columbus Circle, New York, New York, and it leases approximately 2,000 square feet of office space in San Diego, California, with a lease term until October 31, 2023[261](index=261&type=chunk) [Legal Proceedings](index=61&type=section&id=Item%203.%20Legal%20Proceedings.) The company resolved an arbitration claim from LTS Lohmann Therapie Systeme AG for 2 million Euros related to the former Accordion Pill business, settling for 800,000 Euros (approximately $860,000) in February 2023, with no other material legal proceedings pending - In July 2022, LTS Lohmann Therapie Systeme AG initiated arbitration against the company's subsidiary Intec Israel, demanding payment of **2 million Euros**[263](index=263&type=chunk) - Intec Israel has paid approximately **1 million Euros** and settled the dispute with LTS on February 7, 2023, for **800,000 Euros (approximately $860,000)**[263](index=263&type=chunk)[382](index=382&type=chunk) - As of March 17, 2023, the company has no other material pending legal proceedings or claims[264](index=264&type=chunk) [Mine Safety Disclosures](index=61&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable - This item is not applicable[265](index=265&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=62&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) The company's common stock began trading on Nasdaq Capital Market under 'INDP' on August 4, 2021, with 7 registered holders as of March 17, 2023, and no cash dividends have been declared or paid - The company's common stock was listed on the Nasdaq Capital Market on August 4, 2021, under the ticker symbol **'INDP'**[268](index=268&type=chunk) - As of March 17, 2023, the company had **7 registered holders** of common stock[269](index=269&type=chunk) - The company has never declared or paid cash dividends and plans to reinvest future earnings into business development[270](index=270&type=chunk) - The company did not repurchase any equity securities in 2022[273](index=273&type=chunk) Market Information Holders Dividend Policy Securities Authorized for Issuance under Equity Compensation Plans Recent Sales of Unregistered Securities Purchases of Equity Securities by the Issuer and Affiliated Purchasers [Reserved](index=62&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=62&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) As a clinical-stage biotech, the company saw increased operating and net losses in 2022 driven by R&D and G&A expenses, holding $26.4 million in cash and marketable securities by year-end, projected to fund operations until Q2 2024, while facing ongoing financing needs and macroeconomic uncertainties - The company is a clinical-stage biotechnology company focused on developing novel anti-cancer and antiviral immunotherapies[276](index=276&type=chunk) - The COVID-19 pandemic and macroeconomic conditions, such as supply chain constraints, inflation, and rising interest rates, may adversely affect the company's operations, financing capabilities, and clinical trial progress[277](index=277&type=chunk) - On August 3, 2021, the company completed its merger with Decoy Biosystems, Inc., and was renamed Indaptus Therapeutics, Inc., with its common stock listed on the Nasdaq Capital Market[278](index=278&type=chunk)[280](index=280&type=chunk) - In December 2022, the company entered into an equity purchase agreement with Lincoln Park Capital Fund, LLC, granting it the right to sell up to **$20 million** of its common stock over 36 months[281](index=281&type=chunk) Comparison of Operating Results for 2022 and 2021 | Metric | Year Ended December 31, 2022 ($) | Year Ended December 31, 2021 ($) | Change ($) | Change (%) | | :----------------------------------- | :------------------- | :------------------- | :---------- | :------- | | Research and development expenses | $6,324,657 | $2,523,153 | $3,801,504 | 150% | | General and administrative expenses | $8,586,249 | $5,205,955 | $3,380,294 | 65% | | Total operating expenses | $14,910,906 | $7,729,108 | $7,181,798 | 93% | | Operating loss | $(14,910,906) | $(7,729,108) | $(7,181,798) | 93% | | Other income, net | $588,108 | $17,722 | $570,386 | 3,218% | | Net loss | $(14,322,798) | $(7,711,386) | $(6,611,412) | 86% | | Net loss per share, basic and diluted ($) | $(1.73) | $(1.89) | $0.16 | (8.5)% | | Weighted average shares outstanding | 8,262,119 | 4,090,599 | | | - Research and development expenses increased by **150%** to approximately **$6.3 million** in 2022, primarily due to increased costs for Phase I clinical trials and manufacturing processes, as well as higher salaries and related expenses[292](index=292&type=chunk) - General and administrative expenses increased by **65%** to approximately **$8.6 million** in 2022, mainly due to higher salaries and related expenses from increased executive team personnel, and increased insurance and professional service fees incurred as a public company[294](index=294&type=chunk) - As of December 31, 2022, the company held approximately **$26.4 million** in cash, cash equivalents, and marketable securities, projected to support operations until the second quarter of 2024[300](index=300&type=chunk)[305](index=305&type=chunk) Comparison of Cash Flows for 2022 and 2021 | Cash Flow Category | 2022 ($) | 2021 ($) | | :------------- | :------------------- | :------------------- | | Net cash used in operating activities | $(13,078,347) | $(11,290,535) | | Net cash (used in) provided by investing activities | $(16,427,018) | $447,746 | | Net cash provided by financing activities | $0 | $48,337,455 | | Net (decrease) increase in cash and cash equivalents | $(29,505,365) | $37,494,666 | | Cash and cash equivalents at end of period | $9,626,800 | $39,132,165 | Overview Impact of the COVID-19 Pandemic and Macroeconomic Conditions on our Operations Decoy Merger Recent Events Lincoln Park Committed Equity Facility Components of Operating Results Research and Development Expenses General and Administrative Expenses Other Income, Net Results of Operations Year Ended December 31, 2022 compared to Year Ended December 31, 2021 Liquidity and Resources Cash Flows Operating Activities Investing Activities Financing Activities Funding Requirements Contractual Obligations Critical Accounting Policies Accounting for Research and Development Costs Stock-Based Compensation Recently Issued Accounting Pronouncements [Quantitative and Qualitative Disclosures About Market Risk](index=69&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, the company is exempt from providing the information required by this item under SEC rules - As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk[316](index=316&type=chunk) [Financial Statements and Supplementary Data](index=70&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data.) This section presents the company's audited consolidated financial statements for the years ended December 31, 2022 and 2021, including balance sheets, statements of operations, stockholders' equity, and cash flows, with an unqualified opinion from Haskell & White LLP - Independent registered public accounting firm Haskell & White LLP issued an unqualified opinion on the company's consolidated financial statements for the years ended December 31, 2022 and 2021[320](index=320&type=chunk) Consolidated Balance Sheet Summary (As of December 31) | Metric | 2022 ($) | 2021 ($) | | :----------------------- | :---------- | :---------- | | **Assets** | | | | Cash and cash equivalents | $9,626,800 | $39,132,165 | | Marketable securities | $16,806,009 | - | | Total assets | $28,063,806 | $40,576,583 | | **Liabilities and Stockholders' Equity** | | | | Total liabilities | $3,433,341 | $4,677,003 | | Total stockholders' equity | $24,630,465 | $35,899,580 | | Accumulated deficit | $(29,993,685) | $(15,670,887) | Consolidated Statements of Operations and Comprehensive Loss Summary (As of December 31) | Metric | 2022 ($) | 2021 ($) | | :----------------------- | :---------- | :---------- | | Research and development expenses | $6,324,657 | $2,523,153 | | General and administrative expenses | $8,586,249 | $5,205,955 | | Operating loss | $(14,910,906) | $(7,729,108) | | Net loss | $(14,322,798) | $(7,711,386) | | Net loss per share, basic and diluted ($) | $(1.73) | $(1.89) | | Comprehensive loss | $(14,226,364) | $(7,711,386) | Consolidated Cash Flow Statement Summary (As of December 31) | Cash Flow Category | 2022 ($) | 2021 ($) | | :------------- | :---------- | :---------- | | Net cash used in operating activities | $(13,078,347) | $(11,290,535) | | Net cash (used in) provided by investing activities | $(16,427,018) | $447,746 | | Net cash provided by financing activities | $0 | $48,337,455 | | Cash and cash equivalents at end of period | $9,626,800 | $39,132,165 | - The company's accumulated deficit was approximately **$30 million** as of December 31, 2022, with anticipated future losses requiring additional financing[338](index=338&type=chunk) - As of December 31, 2022, the company had U.S. federal and state net operating loss (NOL) carryforwards of **$19.9 million** and **$7.5 million**, respectively, and an Israeli NOL carryforward of **$198 million**[392](index=392&type=chunk) Report of Independent Registered Public Accounting Firm Consolidated Financial Statements Consolidated Balance Sheets Consolidated Statements of Operations and Comprehensive Loss Consolidated Statements of Stockholders' Equity Consolidated Statements of Cash Flows Notes to the Consolidated Financial Statements NOTE 1: GENERAL NOTE 2: SIGNIFICANT ACCOUNTING POLICIES NOTE 3: MARKETABLE SECURITIES NOTE 4: PREPAID EXPENSES AND OTHER CURRENT ASSETS NOTE 5: ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES NOTE 6: STOCK-BASED COMPENSATION NOTE 7: CAPITALIZATION NOTE 8: COMMITMENTS AND CONTINGENCIES NOTE 9: INCOME TAXES NOTE 10: SUBSEQUENT EVENTS [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=87&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure.) The company states there have been no changes in accountants or disagreements with accountants on accounting and financial disclosure - The company states there have been no changes in accountants or disagreements with accountants on accounting or financial disclosure[398](index=398&type=chunk) [Controls and Procedures](index=87&type=section&id=Item%209A.%20Controls%20and%20Procedures.) Management assessed disclosure controls and internal control over financial reporting as effective at a reasonable assurance level as of December 31, 2022, with no independent auditor attestation report included due to the company's smaller reporting company status - As of December 31, 2022, the company's management assessed and determined its disclosure controls and procedures were effective at a reasonable assurance level[400](index=400&type=chunk) - Management also concluded that the company's internal control over financial reporting was effective as of December 31, 2022[402](index=402&type=chunk) - This annual report does not include an attestation report from the independent registered public accounting firm regarding the effectiveness of internal control, as the company qualifies for the smaller reporting company exemption[403](index=403&type=chunk) - No significant changes in internal control occurred during the quarter ended December 31, 2022[404](index=404&type=chunk) [Other Information](index=87&type=section&id=Item%209B.%20Other%20Information.) No other information is disclosed under this item - No other information is disclosed under this item[405](index=405&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=87&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections.) This item is not applicable - This item is not applicable[406](index=406&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=88&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance.) This section provides information on the company's executive officers and directors as of March 17, 2023, including key leadership roles and the board composition, alongside the established Code of Business Conduct and Ethics applicable to all personnel Executive Officers and Directors (As of March 17, 2023) | Name | Age | Position | | :---------------------- | :--- | :-------------------------------- | | **Executive Officers** | | | | Jeffrey A. Meckler | 56 | Chief Executive Officer and Director | | Michael J. Newman, Ph.D. | 67 | Chief Scientific Officer and Director | | Nir Sassi | 47 | Chief Financial Officer | | Walt A. Linscott, Esq. | 62 | Chief Business Officer | | **Non-Executive Directors** | | | | Dr. Roger J. Pomerantz | 66 | Chairman of the Board | | Hila Karah | 54 | Director | | Anthony J. Maddaluna | 70 | Director | | William B. Hayes | 57 | Director | | Mark J. Gilbert, M.D. | 62 | Director | | Brian O'Callaghan | 63 | Director | | Robert E. Martell, M.D., Ph.D. | 60 | Director | - The company has adopted a Code of Business Conduct and Ethics applicable to all directors, executive officers, and employees, which is publicly available on its website[423](index=423&type=chunk) Executive Officers Non-Employee Directors Code of Business Conduct and Ethics [Executive Compensation](index=92&type=section&id=Item%2011.%20Executive%20Compensation.) The information required by this item will be included by reference in the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Executive compensation information will be included in the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders[425](index=425&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=92&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters.) As of December 31, 2022, the company had 1,672,873 options, warrants, and rights exercisable under the 2021 Equity Incentive Plan with a weighted-average exercise price of $13.01, which includes an evergreen provision for annual share increases Securities Authorized for Issuance under Equity Compensation Plans (As of December 31, 2022) | Plan Category | Number of Securities Underlying Outstanding Options, Warrants and Rights | Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights ($) | Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans | | :--------------------------------- | :--------------------------------- | :--------------------------------- | :--------------------------------- | | Equity compensation plans approved by security holders | 1,672,873 | $13.01 | 314,494 | | Equity compensation plans not approved by security holders | — | — | — | | Total | 1,672,873 | $13.01 | 314,494 | - The 2021 Plan includes an evergreen provision allowing for an annual increase in the number of shares available for issuance, equal to **3%** of the total common stock outstanding at the end of the prior fiscal year or a lesser amount determined by the Board[426](index=426&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=92&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence.) The information required by this item will be included by reference in the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information on certain relationships and related transactions, and director independence will be included in the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders[428](index=428&type=chunk) [Principal Accountant Fees and Services](index=92&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services.) The information required by this item will be included by reference in the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information on principal accountant fees and services will be included in the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders[429](index=429&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=93&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules.) This section lists the financial statements and exhibits included in this annual report, with financial statements detailed in Item 8 and schedules omitted due to inapplicability or prior presentation, and an exhibit list detailing corporate documents - Financial statements are presented in 'Item 8. Financial Statements and Supplementary Data'[430](index=430&type=chunk) - Financial statement schedules are omitted as they are not applicable or the required information is presented in the financial statements[431](index=431&type=chunk) - The exhibit list includes important documents such as the company's certificate of incorporation, merger agreement, equity incentive plans, employment agreements, and securities purchase agreements[432](index=432&type=chunk)[435](index=435&type=chunk) Financial Statements Financial Statement Schedules Exhibits [Form 10-K Summary](index=95&type=section&id=Item%2016.%20Form%2010-K%20Summary) This annual report does not include a Form 10-K summary - This annual report does not include a Form 10-K summary[436](index=436&type=chunk)

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].

[PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Indaptus Therapeutics, Inc., including the balance sheets, statements of operations and other comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's financial position, performance, and accounting policies for the periods ended June 30, 2022 and 2021 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) **Condensed Consolidated Balance Sheets (June 30, 2022 vs. December 31, 2021):** | Item | June 30, 2022 | December 31, 2021 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $14,258,812 | $39,132,165 | | Marketable securities | $18,753,081 | - | | Total current assets | $33,272,777 | $40,387,218 | | Total assets | $34,059,411 | $40,576,583 | | Total current liabilities | $3,623,939 | $4,604,141 | | Total liabilities | $3,651,846 | $4,677,003 | | Total stockholders' equity | $30,407,565 | $35,899,580 | [Condensed Consolidated Statements of Operations and Other Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Other%20Comprehensive%20Loss) **Condensed Consolidated Statements of Operations (Three Months Ended June 30):** | Item | 2022 | 2021 | | :----------------------------------- | :----------- | :---------- | | Research and development | $1,506,165 | $391,118 | | General and administrative | $2,363,095 | $137,527 | | Total operating expenses | $3,869,260 | $528,645 | | Net loss | $(3,835,502) | $(515,479) | | Net loss per share (basic and diluted) | $(0.46) | $(0.27) | **Condensed Consolidated Statements of Operations (Six Months Ended June 30):** | Item | 2022 | 2021 | | :----------------------------------- | :----------- | :---------- | | Research and development | $2,803,263 | $880,839 | | General and administrative | $4,468,070 | $261,782 | | Total operating expenses | $7,271,333 | $1,142,621 | | Net loss | $(7,200,656) | $(1,127,900) | | Net loss per share (basic and diluted) | $(0.87) | $(0.58) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) **Changes in Stockholders' Equity (January 1, 2022 to June 30, 2022):** | Item | Amount | | :-------------------------- | :------------- | | Balance, January 1, 2022 | $35,899,580 | | Stock-based compensation | $1,735,578 | | Other comprehensive loss | $(26,937) | | Net loss | $(7,200,656) | | Balance, June 30, 2022 | $30,407,565 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) **Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30):** | Activity | 2022 | 2021 | | :-------------------------------- | :------------- | :----------- | | Net cash used in operating activities | $(6,265,890) | $(2,120,321) | | Net cash used in investing activities | $(18,607,463) | $(2,200) | | Net cash provided by financing activities | - | $5,450,000 | | Net (decrease) increase in cash | $(24,873,353) | $3,327,479 | | Cash and cash equivalents at end of period | $14,258,812 | $4,964,978 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [NOTE 1: GENERAL](index=8&type=section&id=NOTE%201%3A%20GENERAL) - Indaptus Therapeutics, Inc. is a biotechnology company focused on developing a novel, multi-targeted product for enhancing cancer immunotherapy for unresectable or metastatic solid tumors and lymphomas[21](index=21&type=chunk) - The company completed a merger with Decoy Biosystems, Inc. on August 3, 2021, and subsequently changed its name to Indaptus Therapeutics, Inc., with shares commencing trading on Nasdaq Capital Market under 'INDP' on August 4, 2021[21](index=21&type=chunk) - In connection with the merger, Indaptus raised approximately **$27.3 million** in net proceeds from a private placement of pre-funded warrants and warrants in July 2021[21](index=21&type=chunk) - The company has an accumulated deficit of **$22.9 million** as of June 30, 2022, and expects to incur additional losses, requiring future financing. Management believes it has adequate cash for at least one year but plans to raise additional capital[25](index=25&type=chunk)[26](index=26&type=chunk) [NOTE 2: SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=NOTE%202%3A%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - The financial statements are prepared in accordance with US GAAP and S-X Article 10 for interim financial statements, reflecting all necessary adjustments for a fair statement[28](index=28&type=chunk) - The company uses estimates and assumptions, particularly for stock-based compensation fair value and period-end obligations to contract research organizations[32](index=32&type=chunk) **Anti-Dilutive Securities Excluded from EPS Calculation (June 30):** | Item | 2022 | 2021 | | :---------------------- | :--------- | :------- | | Outstanding stock options | 1,605,623 | 206,079 | | Warrants | 3,090,787 | - | [NOTE 3: MARKETABLE SECURITIES](index=12&type=section&id=NOTE%203%3A%20MARKETABLE%20SECURITIES) - The company's marketable securities consist of U.S. treasury bonds classified as available-for-sale, recorded at fair value with unrealized gains/losses in AOCI[36](index=36&type=chunk)[52](index=52&type=chunk) **Marketable Securities Data:** | Item | June 30, 2022 | December 31, 2021 | | :-------------------------- | :------------ | :---------------- | | Fair value | $18,753,081 | - | | Unrealized loss (3 months) | $(17,716) | - | | Unrealized loss (6 months) | $(26,937) | - | [NOTE 4: PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=13&type=section&id=NOTE%204%3A%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) **Prepaid Expenses and Other Current Assets:** | Item | June 30, 2022 | December 31, 2021 | | :-------------------------------- | :------------ | :---------------- | | Prepaid insurance | $142,588 | $945,023 | | Prepaid research and development | $69,226 | $127,643 | | Other receivables | - | $21,056 | | Other prepaid expenses | $49,070 | $12,931 | | Total | $260,884 | $1,106,653 | [NOTE 5: ACCOUNTS PAYABLE AND OTHER CURRENT LIABILITIES](index=13&type=section&id=NOTE%205%3A%20ACCOUNTS%20PAYABLE%20AND%20OTHER%20CURRENT%20LIABILITIES) **Accounts Payable and Other Current Liabilities:** | Item | June 30, 2022 | December 31, 2021 | | :-------------------------------- | :------------ | :---------------- | | Accounts payable | $2,432,739 | $2,637,806 | | Accrued employee costs | $505,973 | $1,371,136 | | Accrued professional fees | $200,128 | $139,871 | | Accrued research and development | $169,308 | $135,751 | | Accrued board fees | $116,000 | $125,333 | | Delaware franchise taxes payable | $64,465 | - | | Other accrued expenses | $37,421 | $97,779 | | Total | $3,526,034 | $4,507,676 | [NOTE 6: STOCK-BASED COMPENSATION](index=13&type=section&id=NOTE%206%3A%20STOCK-BASED%20COMPENSATION) - The Indaptus 2021 Stock Incentive Plan, approved in June 2021, provides for up to **1,864,963 shares** of common stock for various equity awards[56](index=56&type=chunk) **Stock Option Activity (Six Months Ended June 30, 2022):** | Item | Number of options | Weighted average exercise price | | :-------------------------- | :---------------- | :---------------------------- | | Outstanding as of Jan 1, 2022 | 1,174,660 | $17.10 | | Granted | 464,200 | $4.67 | | Forfeited and cancelled | (33,237) | $11.46 | | Outstanding as of Jun 30, 2022 | 1,605,623 | $13.62 | | Exercisable as of Jun 30, 2022 | 137,797 | $77.01 | **Total Stock-Based Compensation Expense:** | Item | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $214,254 | $8,280 | $384,690 | $16,470 | | General and administrative | $690,141 | $12,393 | $1,350,888 | $24,648 | | Total | $904,395 | $20,673 | $1,735,578 | $41,118 | As of June 30, 2022, unrecognized compensation cost for unvested options was approximately $5.9 million, to be recognized over 2.0 years [NOTE 7: CAPITALIZATION](index=15&type=section&id=NOTE%207%3A%20CAPITALIZATION) - As of June 30, 2022, and December 31, 2021, the company had **200,000,000 shares** of common stock authorized and **8,258,597 shares** issued and outstanding[68](index=68&type=chunk) - There were warrants outstanding to purchase **3,090,787 shares** of common stock as of June 30, 2022, with a weighted average exercise price of **$12.50** and a remaining contractual term of **4.5 years**[68](index=68&type=chunk) [NOTE 8: COMMITMENTS AND CONTINGENCIES](index=15&type=section&id=NOTE%208%3A%20COMMITMENTS%20AND%20CONTINGENCIES) - LTS Lohmann Therapie-System AG filed a Request for Arbitration on July 13, 2022, seeking **€2 million** (approximately **$2.1 million**) from the company's subsidiary Intec Israel for reimbursement related to the discontinuation of the Accordion Pill business. The company accrued this amount as of June 30, 2022[65](index=65&type=chunk) **Future Minimum Annual Lease Payments (as of June 30, 2022):** | Year | Amount | | :--- | :------- | | 2022 | $48,472 | | 2023 | $82,388 | | Total | $130,860 | | Present value of operating lease liability | $125,812 | [NOTE 9: SUBSEQUENT EVENTS](index=15&type=section&id=NOTE%209%3A%20SUBSEQUENT%20EVENTS) - The company evaluated subsequent events through August 8, 2022, and concluded that no events requiring recognition or disclosure occurred, except for the LTS arbitration disclosed in Note 8[68](index=68&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, including an overview of its business, a detailed analysis of operating expenses and net loss for the three and six months ended June 30, 2022, and a discussion of liquidity, capital resources, and critical accounting estimates [Overview](index=16&type=section&id=Overview) - Indaptus Therapeutics is a pre-clinical biotechnology company developing a novel, patented systemically-administered anti-cancer and anti-viral immunotherapy based on attenuated and killed Gram-negative bacteria[72](index=72&type=chunk) - The company's lead clinical candidate, Decoy20, has completed GMP manufacturing and IND-enabling studies. In May 2022, the U.S. FDA cleared its IND application for a Phase 1 clinical trial in advanced solid tumors, planned for the second half of 2022[72](index=72&type=chunk)[73](index=73&type=chunk) - The company completed a merger with Decoy Biosystems, Inc. on August 3, 2021, and subsequently wound down the Accordion Pill business of Intec Israel[74](index=74&type=chunk)[77](index=77&type=chunk) - A private placement in July 2021 generated approximately **$27.3 million** in net proceeds from the sale of pre-funded warrants and warrants[79](index=79&type=chunk)[99](index=99&type=chunk) [Components of Operating Results](index=18&type=section&id=Components%20of%20Operating%20Results) - Research and development expenses, primarily fees to CROs and CMOs and compensation, are expected to increase substantially due to ramp-up in clinical development activities[82](index=82&type=chunk)[83](index=83&type=chunk) - General and administrative expenses, including compensation, benefits, facility costs, and professional fees, are also expected to increase significantly due to headcount growth, public company operating costs, and potential commercialization activities[84](index=84&type=chunk)[85](index=85&type=chunk) - Other income, net, includes interest earned on deposits and other incidental income/expense items[86](index=86&type=chunk) [Results of Operations - Three Months Ended June 30, 2022 compared to Three Months Ended June 30, 2021](index=19&type=section&id=Results%20of%20Operations%20-%20Three%20Months%20Ended%20June%2030%2C%202022%20compared%20to%20Three%20Months%20Ended%20June%2030%2C%202021) **Operating Results (Three Months Ended June 30, 2022 vs. 2021):** | Item | 2022 | 2021 | Change ($) | | :------------------------- | :----------- | :---------- | :----------- | | Research and development | $1,506,165 | $391,118 | $1,115,047 | | General and administrative | $2,363,095 | $137,527 | $2,225,568 | | Total operating expenses | $3,869,260 | $528,645 | $3,340,615 | | Net loss | $(3,835,502) | $(515,479) | $(3,320,023) | | Net loss per share | $(0.46) | $(0.27) | $(0.19) | - The increase in R&D expenses was primarily due to a **$520,000** increase in payroll and related expenses (including **$210,000** stock-based compensation) and a **$570,000** increase for Phase 1 clinical trial preparation and IND submission[90](index=90&type=chunk) - The increase in G&A expenses was mainly driven by a **$1.2 million** increase in payroll and related expenses (including **$700,000** stock-based compensation) due to increased executive headcount post-Merger, and a **$900,000** increase in D&O insurance and professional fees as a public company[91](index=91&type=chunk) [Results of Operations - Six Months Ended June 30, 2022 compared to Six Months Ended June 30, 2021](index=20&type=section&id=Results%20of%20Operations%20-%20Six%20Months%20Ended%20June%2030%2C%202022%20compared%20to%20Six%20Months%20Ended%20June%2030%2C%202021) **Operating Results (Six Months Ended June 30, 2022 vs. 2021):** | Item | 2022 | 2021 | Change ($) | | :------------------------- | :----------- | :---------- | :----------- | | Research and development | $2,803,263 | $880,839 | $1,922,424 | | General and administrative | $4,468,070 | $261,782 | $4,206,288 | | Total operating expenses | $7,271,333 | $1,142,621 | $6,128,712 | | Net loss | $(7,200,656) | $(1,127,900) | $(6,072,756) | | Net loss per share | $(0.87) | $(0.58) | $(0.29) | - The increase in R&D expenses was primarily due to a **$1 million** increase in payroll and related expenses (including **$370,000** stock-based compensation) and a **$900,000** increase for Phase 1 clinical trial preparation and IND submission[95](index=95&type=chunk) - The increase in G&A expenses was mainly due to a **$2.3 million** increase in payroll and related expenses (including **$1.3 million** stock-based compensation) from increased executive headcount post-Merger, and a **$1.7 million** increase in D&O insurance and professional fees as a public company[96](index=96&type=chunk) [Liquidity and Resources](index=20&type=section&id=Liquidity%20and%20Resources) **Cash and Cash Equivalents & Marketable Securities:** | Item | June 30, 2022 | December 31, 2021 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $14,258,812 | $39,132,165 | | Marketable securities | $18,753,081 | - | | Total | $33,011,893 | $39,132,165 | **Net Cash Flow Activities (Six Months Ended June 30):** | Activity | 2022 | 2021 | | :-------------------------------- | :------------- | :----------- | | Net cash used in operating activities | $(6,265,890) | $(2,120,321) | | Net cash used in investing activities | $(18,607,463) | $(2,200) | | Net cash provided by financing activities | - | $5,450,000 | [Current Outlook](index=21&type=section&id=Current%20Outlook) - The company believes it has adequate cash to fund operations for more than one year from the report date, following the August 2021 private placement[103](index=103&type=chunk) - Developing drugs and conducting clinical trials are expensive, and significant additional financing will be required to fund future operations, including clinical trials, regulatory approvals, and commercialization[105](index=105&type=chunk) - Future capital requirements depend on factors like clinical trial progress, regulatory approvals, manufacturing costs, and intellectual property protection. The COVID-19 pandemic and global economic conditions may adversely impact the ability to raise capital[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) [Critical Accounting Estimates](index=22&type=section&id=Critical%20Accounting%20Estimates) - Accounting for Research and Development Costs: Management makes estimates for services received and efforts expended from CROs and CMOs, which can impact reported R&D expenses and related accruals/prepayments[111](index=111&type=chunk) - Stock-Based Compensation: Fair value of awards is determined using the Black-Scholes-Merton model, requiring subjective estimates for expected stock price volatility, expected term, risk-free interest rate, and dividend yield[113](index=113&type=chunk) [Recently Issued Accounting Pronouncements](index=23&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) - There are no recently issued accounting pronouncements that have a material impact on the company[114](index=114&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not required for smaller reporting companies - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[115](index=115&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2022, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting were identified during the quarter - As of June 30, 2022, the company's disclosure controls and procedures were evaluated and deemed effective at the reasonable assurance level by the principal executive officer and principal financial officer[117](index=117&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2022, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[118](index=118&type=chunk) [PART II — OTHER INFORMATION](index=23&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in an arbitration request filed by LTS Lohmann Therapie-System AG seeking €2 million from its subsidiary Intec Israel related to the discontinuation of the Accordion Pill business. This amount has been accrued as of June 30, 2022 - LTS Lohmann Therapie-System AG filed a Request for Arbitration on July 13, 2022, against Intec Israel, alleging entitlement to **€2 million** for reimbursement following the discontinuation of the Accordion Pill business[121](index=121&type=chunk) - As of June 30, 2022, the company accrued **€2 million** (approximately **$2.1 million**) for this potential obligation[121](index=121&type=chunk) [Item 1A. Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) This item is not required for a smaller reporting company - As a smaller reporting company, Indaptus Therapeutics, Inc. is not required to provide a separate section for Risk Factors in this Form 10-Q[122](index=122&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - The company reported no unregistered sales of equity securities or use of proceeds for the period[123](index=123&type=chunk) [Item 3. Defaults upon Senior Securities](index=24&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - The company reported no defaults upon senior securities for the period[124](index=124&type=chunk) [Item 4. Mine Safety Disclosures](index=24&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company's operations[124](index=124&type=chunk) [Item 5. Other Information](index=24&type=section&id=Item%205.%20Other%20Information) No other information is required to be disclosed in this section - There is no other information to report under this item[125](index=125&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including corporate governance documents, certifications from executive officers, and XBRL-related documents - The exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, certifications from the Principal Executive Officer and Principal Financial Officer (31.1, 31.2, 32.1, 32.2), and various Inline XBRL documents (101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104)[126](index=126&type=chunk)

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 ...

Product Development and Clinical Trials - The company has developed a patented systemically-administered anti-cancer and anti-viral immunotherapy, demonstrating broad anti-tumor and anti-viral activity in pre-clinical models [19]. - The company plans to file an IND in the first half of 2022 and initiate a Phase 1 clinical trial targeting tumors with low durable response rates to current immunotherapy [20]. - The target indications for the clinical trial include colorectal, hepatocellular, bladder, cervical, and pancreatic carcinoma, which account for 23% of yearly cancer cases and over 28% of yearly cancer deaths worldwide according to GLOBOCAN 2020 [20]. - The lead clinical candidate, Decoy20, has successfully completed GMP manufacturing and IND-enabling studies, with plans for a Phase 1 clinical trial in 2022 [36]. - The technology has shown significant single-agent anti-tumor activity and durable responses in pre-clinical models for non-Hodgkin's lymphoma, colorectal, hepatocellular, and pancreatic carcinoma [34]. - The company aims to enhance curative cancer immunotherapy for patients with unresectable or metastatic solid tumors and lymphomas, which are responsible for approximately 90% of all cancer deaths [41]. - The commencement of a Phase 1 clinical trial for Decoy20 is contingent upon the successful filing of an Investigational New Drug (IND) application with the FDA in the first half of 2022 [104]. - No clinical trials have been completed to prove the efficacy or safety of any product candidates, which may lead to significant delays or abandonment of development [105]. - The company does not expect any product candidates to receive regulatory approval for commercialization for several years, if at all [106]. - The development process is costly and uncertain, with potential delays due to various unforeseen events [107]. - The company may seek collaborative agreements to assist in the development and commercialization of its product candidates due to limited resources [110]. Financial Performance and Capital Needs - For the years ended December 31, 2021, and 2020, the company reported net losses of approximately $7.7 million and $3.6 million, respectively, with an accumulated deficit of approximately $15.7 million as of December 31, 2021 [97]. - The company does not expect to become profitable in the near future and may never achieve profitability [90]. - The company anticipates significant research and development expenses, which may hinder its ability to attain profitability [90]. - The company will need to raise additional capital due to a lack of current cash flow, which may not be available or could cause dilution [99]. - The company has incurred significant operating losses in every reporting period since its inception [97]. - The company may be required to delay, limit, or eliminate the development of business opportunities if additional financing is not available on satisfactory terms [102]. - The potential market opportunity for the company's product candidates is difficult to estimate and may be smaller than anticipated, impacting revenue and profitability [138]. - The healthcare industry is facing increased limitations on reimbursement and pricing controls, which could adversely affect the company's products [141]. - The company does not anticipate paying any cash dividends in the foreseeable future, focusing instead on retaining funds for business development [205]. - The company may seek additional capital through various means, which could dilute existing shareholders' ownership interests [216]. Regulatory Environment and Compliance - The company operates in a highly regulated industry, subject to significant federal, state, local, and foreign regulations, impacting product development and approval processes [43]. - The company must comply with stringent FDA regulations throughout the drug development process, including preclinical and clinical testing [46]. - The FDA has a 60-day period to determine if an NDA or BLA is accepted for filing, with most applications reviewed within ten months [55]. - Post-approval, the FDA requires adverse event reporting and may mandate Phase IV testing to monitor product effects [62]. - Regulatory approval is not guaranteed, and delays or denials can occur for various reasons, including safety and efficacy concerns [126]. - The company may face significant restrictions on product marketing and ongoing requirements for costly post-approval studies even after receiving regulatory approval [129]. - The company is subject to extensive regulation under the FDA and comparable foreign authorities, which can be costly and time-consuming [90]. - Changes in government funding for the FDA could hinder the company's ability to develop and commercialize product candidates [146]. Intellectual Property and Competition - The company has a broad patent portfolio with 33 granted patents and 16 pending patent applications, supporting its innovative technology [21]. - The company owns 33 granted patents and 16 pending patent applications related to cancer and infectious diseases, with expiration dates between 2033 and 2039 [67]. - The company depends on its ability to protect proprietary technology through patents and other means, and failure to do so could adversely affect its business [173]. - The company may face significant costs related to patent enforcement and protection, which could materially impact its financial condition and results of operations [175]. - The complexity and uncertainty of patent positions may diminish the value of the company's intellectual property, affecting competitive advantage [181]. - Competitors may circumvent patents by developing similar technologies, which could limit the effectiveness of the company's patent protections [182]. - The company faces competition from larger biopharmaceutical companies with greater resources, particularly in cancer immunotherapies [63]. - The company is heavily reliant on the success of its lead product candidate, Decoy20, with significant investments in its development [104]. Management and Operational Risks - The company has five full-time employees and competes for talent with other biotechnology and pharmaceutical firms [73]. - The company is highly dependent on its current senior management, including CEO Jeffrey A. Meckler, CSO Michael J. Newman, and CMO Boyan Litchev, which poses a risk to its ability to develop or commercialize product candidates if key personnel are lost [154]. - The company faces significant competition for qualified personnel, and failure to attract or retain key employees could materially affect its business and operational goals [155]. - The company is a pre-clinical-stage biotechnology firm and will need to expand its organization and improve management systems to support future growth, which may significantly increase expenses [157]. - The company relies on third parties for conducting preclinical studies and clinical trials, and any failure on their part could substantially harm the company's business [93]. - The company does not have internal manufacturing capabilities and relies on third-party manufacturers, which could lead to delays in clinical trials if there are disruptions in supply [168]. - The company may encounter difficulties in enforcing intellectual property rights in foreign jurisdictions, impacting global competitiveness [196]. Market and Economic Factors - The ongoing military conflict between Russia and Ukraine has created economic uncertainty and market volatility, impacting the company's ability to secure additional funding [199]. - The market price of the company's common stock has been volatile, influenced by various factors including clinical trial approvals and regulatory announcements [200]. - The company is subject to risks related to the volatility of the biotechnology market, which may not correlate with its actual operating performance [203]. - The company may face increased legal and financial compliance costs due to public company regulations, which could affect net income [212]. - Sales of a substantial number of shares by existing shareholders could depress the market price of the company's securities [215]. - Intec Israel is classified as a smaller reporting company with a public float market value of less than $250 million, which may make its shares less attractive to investors [218].