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IO Biotech(IOBT) - 2024 Q1 - Quarterly Results
IO BiotechIO Biotech(US:IOBT)2024-05-14 12:30

Executive Summary & Q1 2024 Business Highlights IO Biotech reported Q1 2024 financial results, updated clinical trial timelines, and strengthened its executive team Company Overview & Q1 2024 Summary IO Biotech, a clinical-stage biopharmaceutical company, updated on its pivotal Phase 3 study, advanced Phase 2 trials, and reported $118.0 million in cash - Pivotal Phase 3 study (IOB-013/KN-D18) interim analysis for overall response rate (ORR) still expected in Q3 2024; primary endpoint of progression-free survival (PFS) now projected to occur in first half of 202534 - Completed enrollment in Phase 2 basket trial IOB-022/KN-D38 and in first cohort of Phase 2 neoadjuvant/adjuvant basket trial IOB-032/PN-E40, which has been expanded to include a randomized melanoma cohort34 - Strengthened executive team with key hires to business and commercial development positions34 Cash and Cash Equivalents | Metric | Amount (USD) | | :----- | :----------- | | Cash and cash equivalents as of March 31, 2024 | $118.0 million | | Expected cash runway | into Q4 2025 | Recent Business Highlights IO Biotech completed Phase 3 enrollment, revised endpoint timelines, expanded Phase 2 trials, and presented new non-clinical data - Completed enrollment of 407 patients in its pivotal Phase 3 trial (IOB-013/KN-D18) of IO102-IO103 in combination with pembrolizumab in advanced melanoma6 - PFS analysis for Phase 3 trial now projected for H1 2025; interim ORR analysis expected in Q3 2024, potentially allowing for BLA submission for accelerated approval6 - Independent Data Monitoring Committee (IDMC) for the Phase 3 trial recommended continuation without modifications in March 20246 - Phase 2 basket trial (IOB-022/KN-D38) completed enrollment; updates to be submitted to medical meetings in Fall 20246 - Phase 2 solid tumor basket trial (IOB-032/PN-E40) expanded to include a randomized melanoma cohort (Cohort C), comparing IO102-IO103 + pembrolizumab vs. pembrolizumab alone6 - Presented new non-clinical data at AACR Annual Meeting 2024 further supporting the dual mechanism of action of IO102-IO1036 - Strengthened executive team with the appointments of Faiçal Miyara, Ph.D., as Chief Business Officer, and Marjan Shamsaei, Pharm.D., as Senior Vice President, Commercial and Portfolio Lead6 Product Pipeline & Clinical Development This section details IO Biotech's lead cancer vaccine candidate, IO102-IO103, and its ongoing clinical trials About IO102-IO103 IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine targeting IDO+ and PD-L1+ cells in the tumor microenvironment - IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to activate T cells against IDO+ and PD-L1+ cells, targeting tumor cells and immune-suppressive cells in the tumor microenvironment8 - Currently being investigated in a pivotal Phase 3 trial (advanced melanoma) and two Phase 2 basket trials (solid tumors, neo-adjuvant/adjuvant solid tumors)8 - Clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which supplies pembrolizumab; IO Biotech maintains global commercial rights to IO102-IO1039 About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial The IOB-013/KN-D18 trial is a randomized Phase 3 study of IO102-IO103 plus pembrolizumab for advanced melanoma, with PFS as the primary endpoint - IOB-013/KN-D18 (NCT05155254) is an open-label, randomized Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in advanced melanoma11 - Patients have been enrolled from centers across the United States, Europe, Australia, Turkey, Israel, and South Africa11 - The primary endpoint of the study is progression-free survival (PFS); biomarker analyses will also be conducted11 - IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab; IO Biotech maintains global commercial rights to IO102-IO10311 Trial Design & Endpoints The IOB-013/KN-D18 trial's primary PFS endpoint is event-driven for H1 2025, with an interim ORR analysis expected in Q3 2024 - The primary endpoint, PFS, is event-driven and will be conducted when 226 events have occurred, estimated for the first half of 202512 - A planned per-protocol interim analysis of overall response rate (ORR) for the first 225 randomized patients is expected in the third quarter of 202412 - A high statistical bar (p≤0.005) was set for the interim analysis to preserve most of the alpha for the primary PFS endpoint12 - The trial is designed to continue to the primary PFS endpoint regardless of the outcome of the interim analysis12 About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial The IOB-022/KN-D38 is a non-comparative Phase 2 trial evaluating IO102-IO103 plus pembrolizumab for first-line advanced NSCLC and SCCHN - IOB-022/KN-D38 (NCT05077709) is a non-comparative, open-label Phase 2 trial13 - Investigates safety and efficacy of IO102-IO103 in combination with pembrolizumab in first-line advanced NSCLC and SCCHN13 - IO Biotech sponsors the trial and maintains global commercial rights; Merck supplies pembrolizumab13 About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial The IOB-032/PN-E40 is a Phase 2 basket trial for resectable melanoma and SCCHN, including a randomized melanoma cohort - IOB-032/PN-E40 (NCT05280314) is a Phase 2 basket trial investigating IO102-IO103 + pembrolizumab as neo-adjuvant/adjuvant treatment for resectable melanoma and SCCHN14 - Cohorts A (melanoma) and B (SCCHN) are single-arm cohorts receiving the combination treatment14 - Cohort C (melanoma) is a randomized 1:1 cohort comparing IO102-IO103 + pembrolizumab to pembrolizumab alone for neo-adjuvant treatment14 - Patients with poor pathological response to pembrolizumab alone in Cohort C may cross over to combination treatment post-surgery15 - The primary endpoint is major pathological response at surgery (≤10% residual viable tumor; central assessment)15 Financial Results This section presents IO Biotech's Q1 2024 financial performance, including net loss, expenses, and balance sheet items First Quarter 2024 Financial Performance IO Biotech reported a net loss of $19.5 million in Q1 2024, driven by increased R&D expenses, with $118.0 million cash on hand Key Financials Q1 2024 vs Q1 2023 | Metric | Q1 2024 (USD) | Q1 2023 (USD) | Change (YoY) | | :-------------------------------- | :------------ | :------------ | :----------- | | Net loss | $(19.5) million | $(17.0) million | $(2.5) million increase | | Research and development expenses | $14.3 million | $11.9 million | $2.4 million increase | | General and administrative expenses | $5.9 million | $6.0 million | $(0.1) million decrease | | Cash and cash equivalents (as of period end) | $118.0 million | N/A (vs. $143.2 million Dec 31, 2023) | $(25.2) million decrease (QoQ) | - The increase in R&D expenses was primarily related to clinical trial-related activities for the IO102-IO103 therapeutic cancer vaccine candidate, including the continued execution of the pivotal Phase 3 clinical trial9 - Cash use of $24.9 million during Q1 2024 was primarily driven by milestone payments and payment of other accrued expenses associated with clinical trials, as well as year-end bonuses9 - The company continues to expect that it will have sufficient cash to run the company into the fourth quarter of 20259 Consolidated Statements of Operations and Comprehensive Loss The company reported a net loss of $19.457 million for Q1 2024, an increase from $17.044 million in Q1 2023, primarily due to higher R&D expenses Consolidated Statements of Operations (Unaudited, in thousands USD) | Metric | Three Months Ended March 31, 2024 (USD) | Three Months Ended March 31, 2023 (USD) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Research and development | $14,311 thousand | $11,900 thousand | | General and administrative | $5,886 thousand | $6,024 thousand | | Total operating expenses | $20,197 thousand | $17,924 thousand | | Loss from operations | $(20,197) thousand | $(17,924) thousand | | Currency exchange (loss) gain, net | $(462) thousand | $258 thousand | | Interest income | $1,617 thousand | $1,028 thousand | | Total other income (expense) | $1,155 thousand | $1,286 thousand | | Net loss | $(19,457) thousand | $(17,044) thousand | | Net loss per common share, basic and diluted | $(0.30) | $(0.59) | | Weighted-average number of shares used in computing net loss per common share, basic and diluted | 65,880,914 | 28,815,267 | Consolidated Balance Sheets Total assets decreased to $128.159 million as of March 31, 2024, from $150.718 million at December 31, 2023, mainly due to reduced cash Consolidated Balance Sheets (Unaudited, in thousands USD) | Metric | March 31, 2024 (USD) | December 31, 2023 (USD) | | :------------------------------------ | :------------- | :---------------- | | Cash and cash equivalents | $117,982 thousand | $143,193 thousand | | Prepaid expenses and other current assets | $6,146 thousand | $4,062 thousand | | Total current assets | $124,128 thousand | $147,255 thousand | | Total assets | $128,159 thousand | $150,718 thousand | | Accounts payable | $3,840 thousand | $3,878 thousand | | Accrued expenses and other current liabilities | $6,537 thousand | $11,184 thousand | | Total current liabilities | $11,043 thousand | $15,717 thousand | | Total liabilities | $12,693 thousand | $17,556 thousand | | Total stockholders' equity | $115,466 thousand | $133,162 thousand | Corporate Information & Disclosures This section provides an overview of IO Biotech, its T-win® platform, lead candidate, and standard forward-looking statements About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing immune-modulating cancer vaccines based on its T-win® platform - IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform16 - The T-win platform activates T cells to target immunosuppressive cells in the tumor microenvironment16 - Lead cancer vaccine candidate, IO102-IO103, has been granted breakthrough therapy designation for advanced melanoma by the US FDA16 - Headquartered in Copenhagen, Denmark, with US headquarters in New York, New York16 Forward-Looking Statement This section outlines standard forward-looking statements regarding future events, clinical trials, and financial position, subject to inherent risks - Press release contains forward-looking statements regarding timing of analyses, clinical trials, their progress, enrollment or results, or the company's financial position or cash runway18 - Forward-looking statements are based on current assumptions and expectations, inherently subject to risks and uncertainties, some of which cannot be predicted or quantified18 - Actual results and other events may differ materially from those expressed or implied18 - 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 law18 Contact Information This section provides contact details for investor relations inquiries for IO Biotech - Contact for Investor Relations: Maryann Cimino, Director of Investor Relations, IO Biotech, Inc20 - Email: mci@iobiotech.com, Phone: 617-710-730520