
Corporate Overview and Recent Developments 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 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 cohort29 - 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 activity289 - In January 2024, a key patent for the company's platform technology was approved by the European Patent Office9 Financial Performance Summary The company's financial performance reflects increased operating expenses and a higher net loss, alongside a significant decrease in cash reserves Operating Expenses 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 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 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 20247 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 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 signals13 - The patented Decoy platform utilizes single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria, acting as multiple TLR, NLR, and STING agonists13 - Pre-clinical studies demonstrated single-agent and combination-mediated activity against metastatic pancreatic, colorectal, breast, and hepatocellular carcinomas, as well as non-Hodgkin's lymphomas13 - 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 models13 Consolidated Financial Statements 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 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 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 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 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 needs14 - Actual results may differ materially due to risks including the company's limited operating history, the need for additional capital, and lengthy clinical development processes14 Contact Information This section provides contact details for investor relations and media inquiries - Investor Relations Contact: Louie Toma, CORE IR, louie@coreir.com1516 - Media Contact: Jules Abraham, CORE IR, julesa@coreir.com, 917-885-737816