Company Overview and Highlights Introduction and CEO Statement IO Biotech reported Q4 and FY2023 results, highlighting completed Phase 3 enrollment for IO102-IO103 in melanoma and upcoming milestones - Completed enrollment in pivotal Phase 3 trial evaluating lead therapeutic cancer vaccine, IO102-IO103, in combination with KEYTRUDA for advanced melanoma in mid-November 20233 - Interim analysis for overall response rate (ORR) from the pivotal Phase 3 trial is expected in the third quarter of 20243 - Primary endpoint of progression-free survival (PFS) for the pivotal Phase 3 trial is estimated to occur in the second half of 20253 Fourth Quarter 2023 and Recent Operational Highlights The company achieved key Q4 2023 operational and clinical milestones, including Phase 3 trial enrollment completion and Phase 2 trial initiation - Completed enrollment of 380 patients in the pivotal Phase 3 trial (IOB-013/KN-D18) of IO102-IO103 in combination with KEYTRUDA in advanced melanoma in November 20236 - First patient dosed in the Phase 2 solid tumor basket trial (IOB-032/PN-E40) studying IO102-IO103 in combination with pembrolizumab as neo-adjuvant and adjuvant treatment for resectable melanoma or SCCHN in December 20236 - Encouraging preliminary data supporting IO102-IO103 in combination with pembrolizumab as first-line treatment in NSCLC and SCCHN were presented at WCLC (September 2023) and ESMO (October 2023)8 - Expanded its Board of Directors with the appointment of Helen Collins, MD in November 20238 Financial Results Fourth Quarter 2023 Financial Performance IO Biotech's Q4 2023 net loss increased due to higher research and development expenses for clinical trial activities Fourth Quarter 2023 Financial Metrics | Metric | Q4 2023 (thousands) | Q4 2022 (thousands) | Change (YoY) | | :-------------------------------- | :------------------ | :------------------ | :----------- | | Net loss | $ (26,182) | $ (20,072) | (30.4%) | | Research and development expenses | $ 21,770 | $ 14,433 | 50.8% | | General and administrative expenses | $ 6,413 | $ 5,955 | 7.7% | | Net loss per common share, basic and diluted | $ (0.40) | $ (0.70) | 42.9% | - The increase in research and development expenses was primarily related to clinical trial-related activities for the company's IO102-IO103 therapeutic cancer vaccine candidate, including the continued execution of the Phase 3 clinical trial8 - The increase in general and administrative expenses was primarily related to personnel costs due to an increase in head count, offset by a decrease in professional services, consultant and other costs8 Full Year 2023 Financial Performance Full year 2023 net loss widened to $86.1 million, driven by increased research and development expenses Full Year 2023 Financial Metrics | Metric | FY 2023 (thousands) | FY 2022 (thousands) | Change (YoY) | | :-------------------------------- | :------------------ | :------------------ | :----------- | | Net loss | $ (86,083) | $ (71,458) | (20.5%) | | Research and development expenses | $ 67,829 | $ 46,986 | 44.3% | | General and administrative expenses | $ 23,614 | $ 24,438 | (3.4%) | | Net loss per common share, basic and diluted | $ (1.98) | $ (2.48) | 20.2% | Financial Position (Balance Sheet) As of December 31, 2023, cash and cash equivalents were $143.2 million, providing an operational runway into Q4 2025 Balance Sheet Highlights | Metric | 2023 (thousands) | 2022 (thousands) | Change | | :-------------------------------- | :----------------- | :----------------- | :------- | | Cash and cash equivalents | $ 143,193 | $ 142,590 | 0.4% | | Total assets | $ 150,718 | $ 151,805 | (0.7%) | | Total liabilities | $ 17,556 | $ 12,951 | 35.5% | | Total stockholders' equity | $ 133,162 | $ 138,854 | (4.1%) | - Ended 2023 with cash and cash equivalents of approximately $143.2 million, providing an expected operational runway into the fourth quarter of 202558 - During the three months ended December 31, 2023, the company used cash, cash equivalents and restricted cash of $22.9 million from operating and investing activities8 Product and Clinical Program Details About IO102-IO103 (Lead Product Candidate) IO102-IO103 is an investigational, off-the-shelf therapeutic cancer vaccine targeting tumor and immune-suppressive cells - IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine9 - Designed to kill tumor cells and immune-suppressive cells in the tumor microenvironment by stimulating T cells against indoleamine 2,3-dioxygenase (IDO) and/or programmed death-ligand 1 (PD-L1) cells9 - Currently being investigated in a pivotal Phase 3 trial for advanced melanoma and two Phase 2 basket trials for solid tumors9 - Clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which supplies pembrolizumab; IO Biotech maintains global commercial rights to IO102-IO10310 Pivotal Phase 3 Clinical Trial (IOB-013/KN-D18) The IOB-013/KN-D18 trial is a Phase 3 study of IO102-IO103 in advanced melanoma, with PFS as the primary endpoint - IOB-013/KN-D18 is an open label, randomized Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma12 - The primary endpoint of the study is progression-free survival (PFS), which is event-driven and expected in the second half of 202513 - A planned per-protocol interim analysis of overall response rate (ORR) is expected in the third quarter of 2024, with a high statistical bar (p≤0.005) set to preserve alpha for the primary PFS endpoint13 About IO Biotech Company Profile and Platform IO Biotech is a clinical-stage biopharmaceutical company developing cancer vaccines using its T-win® platform, with lead candidate IO102-IO103 - IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform14 - The T-win platform activates T cells to target immunosuppressive cells in the tumor microenvironment14 - Its lead cancer vaccine candidate, IO102-IO103, has been granted breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration14 - IO Biotech is headquartered in Copenhagen, Denmark, and has US headquarters in New York, New York14 Forward-Looking Statements and Contact Information Forward-Looking Statement Disclaimer This section provides a standard disclaimer for forward-looking statements, highlighting inherent risks and no obligation to update - The press release contains forward-looking statements regarding clinical trials, their progress, enrollment or results, or the company's financial position or cash runway16 - Forward-looking statements are inherently subject to risks and uncertainties, and actual results and other events may differ materially from those expressed or implied17 - IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise, except to the extent required by law17 Contact Information This section provides contact details for investor relations inquiries - Contact for investor relations: Maryann Cimino, Director of Investor Relations, IO Biotech, Inc18
IO Biotech(IOBT) - 2023 Q4 - Annual Results