"This completed cohort data marks a significant step forward in our efforts to explore the potential of IO102- IO103 as a therapeutic cancer vaccine across a range of solid tumors where there is a high need for new, accessible treatments," said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. "We look forward to the presentation of this data at the upcoming ESMO Congress and the continued development of our novel immune-modulating cancer vaccine that could potentially improve outcomes for people liv ...

Core Insights - IO Biotech announced that an abstract related to its lead investigational therapeutic cancer vaccine candidate, IO102-IO103, has been accepted for poster presentation at the ESMO Congress 2024 [1][3] - The presentation will include data from a Phase 2 basket trial of IO102-IO103 in combination with pembrolizumab for treating advanced squamous cell carcinoma of the head and neck [1][3] - The ESMO Congress will take place in Barcelona from September 13-17, 2024, with the specific presentation scheduled for September 14, 2024 [3] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulating therapeutic cancer vaccines using its Twin® platform [1][7] - The company is advancing IO102-IO103 through clinical trials and has received breakthrough therapy designation from the FDA for treating advanced melanoma [7][8] - IO102-IO103 is designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment by activating T cells [11] Clinical Trials - The ongoing clinical trials include a pivotal Phase 3 trial investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma [11] - A Phase 2 basket trial is also being conducted to evaluate IO102-IO103 in combination with pembrolizumab as a first-line treatment for solid tumors [13] - The trials are sponsored by IO Biotech in collaboration with Merck, which supplies pembrolizumab [12][13]

[Executive Summary & Q1 2024 Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Q1%202024%20Business%20Highlights) IO Biotech reported Q1 2024 financial results, updated clinical trial timelines, and strengthened its executive team [Company Overview & Q1 2024 Summary](index=1&type=section&id=Company%20Overview%20%26%20Q1%202024%20Summary) 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 2025**[3](index=3&type=chunk)[4](index=4&type=chunk) - 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 cohort[3](index=3&type=chunk)[4](index=4&type=chunk) - Strengthened executive team with key hires to business and commercial development positions[3](index=3&type=chunk)[4](index=4&type=chunk) 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](index=2&type=section&id=Recent%20Business%20Highlights) 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 melanoma[6](index=6&type=chunk) - **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 approval[6](index=6&type=chunk) - Independent Data Monitoring Committee (IDMC) for the Phase 3 trial recommended continuation without modifications in **March 2024**[6](index=6&type=chunk) - Phase 2 basket trial (IOB-022/KN-D38) completed enrollment; updates to be submitted to medical meetings in **Fall 2024**[6](index=6&type=chunk) - 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 alone[6](index=6&type=chunk) - Presented new non-clinical data at **AACR Annual Meeting 2024** further supporting the dual mechanism of action of IO102-IO103[6](index=6&type=chunk) - 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 Lead[6](index=6&type=chunk) [Product Pipeline & Clinical Development](index=3&type=section&id=Product%20Pipeline%20%26%20Clinical%20Development) This section details IO Biotech's lead cancer vaccine candidate, IO102-IO103, and its ongoing clinical trials [About IO102-IO103](index=3&type=section&id=About%20IO102-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 microenvironment[8](index=8&type=chunk) - 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](index=8&type=chunk) - Clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which supplies pembrolizumab; IO Biotech maintains global commercial rights to IO102-IO103[9](index=9&type=chunk) [About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial](index=4&type=section&id=About%20the%20IOB-013%2FKN-D18%20Pivotal%20Phase%203%20Clinical%20Trial) 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 melanoma[11](index=11&type=chunk) - Patients have been enrolled from centers across the United States, Europe, Australia, Turkey, Israel, and South Africa[11](index=11&type=chunk) - The primary endpoint of the study is **progression-free survival (PFS)**; biomarker analyses will also be conducted[11](index=11&type=chunk) - IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab; IO Biotech maintains global commercial rights to IO102-IO103[11](index=11&type=chunk) [Trial Design & Endpoints](index=4&type=section&id=About%20the%20IOB-013%2FKN-D18%20Clinical%20Trial%20Endpoints) 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 2025**[12](index=12&type=chunk) - A planned per-protocol interim analysis of **overall response rate (ORR)** for the first **225 randomized patients** is expected in the **third quarter of 2024**[12](index=12&type=chunk) - A high statistical bar (**p≤0.005**) was set for the interim analysis to preserve most of the alpha for the primary PFS endpoint[12](index=12&type=chunk) - The trial is designed to continue to the primary PFS endpoint regardless of the outcome of the interim analysis[12](index=12&type=chunk) [About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial](index=4&type=section&id=About%20IOB-022%2FKN-D38%20Phase%202%20Solid%20Tumor%20Basket%20Trial) 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 trial**[13](index=13&type=chunk) - Investigates safety and efficacy of IO102-IO103 in combination with pembrolizumab in first-line advanced **NSCLC** and **SCCHN**[13](index=13&type=chunk) - IO Biotech sponsors the trial and maintains global commercial rights; Merck supplies pembrolizumab[13](index=13&type=chunk) [About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial](index=4&type=section&id=About%20IOB-032%2FPN-E40%20Phase%202%20Solid%20Tumor%20Basket%20Trial) 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 SCCHN[14](index=14&type=chunk) - Cohorts A (melanoma) and B (SCCHN) are single-arm cohorts receiving the combination treatment[14](index=14&type=chunk) - Cohort C (melanoma) is a randomized **1:1 cohort** comparing IO102-IO103 + pembrolizumab to pembrolizumab alone for neo-adjuvant treatment[14](index=14&type=chunk) - Patients with poor pathological response to pembrolizumab alone in Cohort C may cross over to combination treatment post-surgery[15](index=15&type=chunk) - The primary endpoint is **major pathological response** at surgery (**≤10% residual viable tumor**; central assessment)[15](index=15&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) This section presents IO Biotech's Q1 2024 financial performance, including net loss, expenses, and balance sheet items [First Quarter 2024 Financial Performance](index=3&type=section&id=First%20Quarter%202024%20Financial%20Results) 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 trial[9](index=9&type=chunk) - 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 bonuses[9](index=9&type=chunk) - The company continues to expect that it will have sufficient cash to run the company into the **fourth quarter of 2025**[9](index=9&type=chunk) [Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=8&type=section&id=Consolidated%20Balance%20Sheets) 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](index=5&type=section&id=Corporate%20Information%20%26%20Disclosures) This section provides an overview of IO Biotech, its T-win® platform, lead candidate, and standard forward-looking statements [About IO Biotech](index=5&type=section&id=About%20IO%20Biotech) 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® platform**[16](index=16&type=chunk) - The T-win platform activates T cells to target immunosuppressive cells in the tumor microenvironment[16](index=16&type=chunk) - Lead cancer vaccine candidate, **IO102-IO103**, has been granted **breakthrough therapy designation** for advanced melanoma by the US FDA[16](index=16&type=chunk) - Headquartered in Copenhagen, Denmark, with US headquarters in New York, New York[16](index=16&type=chunk) [Forward-Looking Statement](index=5&type=section&id=Forward-Looking%20Statement) 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 runway[18](index=18&type=chunk) - Forward-looking statements are based on current assumptions and expectations, inherently subject to risks and uncertainties, some of which cannot be predicted or quantified[18](index=18&type=chunk) - Actual results and other events may differ materially from those expressed or implied[18](index=18&type=chunk) - 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 law[18](index=18&type=chunk) [Contact Information](index=6&type=section&id=Contact) This section provides contact details for investor relations inquiries for IO Biotech - Contact for Investor Relations: Maryann Cimino, Director of Investor Relations, IO Biotech, Inc[20](index=20&type=chunk) - Email: **mci@iobiotech.com**, Phone: **617-710-7305**[20](index=20&type=chunk)

PART I. FINANCIAL INFORMATION This section presents the company's unaudited interim financial statements and related disclosures [Item 1. Interim Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Interim%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited consolidated financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, statements of cash flows, and accompanying notes, providing a snapshot of the company's financial position and performance for the three months ended March 31, 2024 [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time | Metric | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $117,982 | $143,193 | | Total current assets | $124,128 | $147,255 | | Total assets | $128,159 | $150,718 | | Total current liabilities | $11,043 | $15,717 | | Total liabilities | $12,693 | $17,556 | | Total stockholders' equity | $115,466 | $133,162 | [Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance over a period, including revenues, expenses, and net loss | Metric | Three Months Ended March 31, 2024 (in thousands) | Three Months Ended March 31, 2023 (in thousands) | Change (Amount) (in thousands) | Change (Percent) | | :-------------------------- | :----------------------------------------------- | :----------------------------------------------- | :----------------------------- | :--------------- | | Research and development | $14,311 | $11,900 | $2,411 | 20.3% | | General and administrative | $5,886 | $6,024 | $(138) | (2.3)% | | Total operating expenses | $20,197 | $17,924 | $2,273 | 12.7% | | Loss from operations | $(20,197) | $(17,924) | $(2,273) | 12.7% | | Total other income (expense), net | $1,155 | $1,286 | $(131) | (10.2)% | | Net loss | $(19,457) | $(17,044) | $(2,413) | 14.2% | | Net loss per common share, basic and diluted | $(0.30) | $(0.59) | | | [Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Consolidated%20Statements%20of%20Stockholders%27%20Equity) This section outlines changes in the company's equity accounts, reflecting transactions with owners and comprehensive income or loss | Metric | Balance, January 1, 2024 (in thousands) | Balance, March 31, 2024 (in thousands) | | :------------------------- | :-------------------------------------- | :------------------------------------- | | Additional Paid-In Capital | $406,587 | $408,154 | | Accumulated Deficit | $(263,822) | $(283,279) | | Total Stockholders' Equity | $133,162 | $115,466 | - Equity-based compensation for the three months ended March 31, 2024, was **$1,567 thousand**, contributing to the change in additional paid-in capital[23](index=23&type=chunk) [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities over a period | Metric | Three Months Ended March 31, 2024 (in thousands) | Three Months Ended March 31, 2023 (in thousands) | | :---------------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Net cash used in operating activities | $(24,932) | $(14,690) | | Net cash used in investing activities | $(11) | $(148) | | Net cash provided by financing activities | $— | $— | | Net decrease in cash, cash equivalents and restricted cash | $(24,943) | $(14,838) | | Cash, cash equivalents and restricted cash, end of period | $118,250 | $128,795 | [Notes to Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the figures presented in the consolidated financial statements - IO Biotech, Inc. is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform[29](index=29&type=chunk) - The company completed an IPO in November 2021, raising **$103.3 million** in net proceeds, and a private placement in August 2023, raising **$71.9 million** in net proceeds[32](index=32&type=chunk)[34](index=34&type=chunk) - As of March 31, 2024, the company had an accumulated deficit of **$283.3 million** and expects its **$118.0 million** in cash and cash equivalents to fund operations for at least **12 months** from the financial statements' issuance date[40](index=40&type=chunk) - The company has multiple clinical collaborations with MSD International GmbH (MSDIG) and MSD International Business GmbH (MSDIB) to evaluate IO102-IO103 in combination with KEYTRUDA® for various cancer types, including metastatic non-small cell lung cancer, squamous cell carcinoma of the head and neck, urothelial bladder cancer, and metastatic melanoma[50](index=50&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) | Expense Category | Three Months Ended March 31, 2024 (in thousands) | Three Months Ended March 31, 2023 (in thousands) | | :------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Research and development | $613 | $704 | | General and administrative | $954 | $1,184 | | Total equity-based compensation | $1,567 | $1,888 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of the company's financial condition and operational results, highlighting its clinical-stage development, progress of its lead product candidate IO102-IO103, and future funding requirements. The company anticipates reaching the primary endpoint for its Phase 3 trial in **1H 2025** and expects an interim analysis outcome in **Q3 2024** - The company's lead therapeutic cancer vaccine candidate, IO102-IO103, is designed to target immunosuppressive mechanisms mediated by indoleamine 2,3-dioxygenase (IDO) and programmed death ligand 1 (PD-L1)[84](index=84&type=chunk) - The Phase 3 pivotal trial for IO102-IO103 in combination with pembrolizumab for first-line advanced melanoma completed target enrollment of **407 patients** in November 2023, ahead of schedule[85](index=85&type=chunk) - The primary endpoint of Progression Free Survival (PFS) for the Phase 3 trial is now anticipated in **1H 2025**, accelerated from the previously projected **2H 2025**. An interim analysis of Overall Response Rate (ORR) is expected in **Q3 2024**[86](index=86&type=chunk)[87](index=87&type=chunk) - The company is also evaluating IO102-IO103 in a Phase 2 basket trial (IOB-022/KN-D38) for first-line metastatic non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN), with **58 patients** enrolled as of March 31, 2024[96](index=96&type=chunk) - A Phase 2 neo-adjuvant/adjuvant trial (IOB-032/PN-E40) for resectable melanoma and SCCHN is ongoing, with **15 patients** enrolled in melanoma cohort A and **7** in SCCHN cohort B, and plans to enroll an additional **30 patients** in cohort C[97](index=97&type=chunk) - Preclinical development continues for IO112 (targeting Arginase 1), with an IND filing expected in **2025**, and for IO170 (targeting TGFβ1) in **2024**[99](index=99&type=chunk)[101](index=101&type=chunk) | Financial Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (Amount) | Change (Percent) | | :------------------------------ | :-------------------------------- | :-------------------------------- | :-------------- | :--------------- | | Net Loss | $(19,457) | $(17,044) | $(2,413) | 14.2% | | Research and Development | $14,311 | $11,900 | $2,411 | 20.3% | | General and Administrative | $5,886 | $6,024 | $(138) | (2.3)% | | Other Income (Expense), Net | $1,155 | $1,286 | $(131) | (10.2)% | - Research and development expenses increased by **$2.4 million** (**20.3%**) primarily due to increased preclinical studies and clinical trial-related activities for IO102-IO103, including the pivotal Phase 3 trial, and higher personnel costs, partially offset by a decrease in chemistry, manufacturing, and control activities[120](index=120&type=chunk) - As of March 31, 2024, cash and cash equivalents were **$118.0 million**, which is expected to fund operating expenses and capital requirements into the **fourth quarter of 2025**[127](index=127&type=chunk) | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(24,932) | $(14,690) | | Net cash used in investing activities | $(11) | $(148) | | Net cash provided by financing activities | $— | $— | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company as defined by Item 10 of Regulation S-K and is therefore not required to provide quantitative and qualitative disclosures about market risk[161](index=161&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with the participation of the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of March 31, 2024, and concluded they were effective. There were no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2024[164](index=164&type=chunk) - There has been no change in the company's internal control over financial reporting during the most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, its internal control over financial reporting[166](index=166&type=chunk) PART II. OTHER INFORMATION This section covers various non-financial disclosures, including legal proceedings, risk factors, and equity security information [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings and believes that any litigation arising in the ordinary course of business will not have a material adverse effect - The company is not currently a party to any material legal proceedings[169](index=169&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) This section outlines numerous risks critical to the company's business, including its limited operating history, substantial funding needs, inherent uncertainties in product development and regulatory approval, manufacturing complexities, intense market competition, and challenges in protecting intellectual property. It also covers operational, compliance, and market-related risks - The company has a limited operating history, has incurred net losses since inception (**$19.5 million** for **Q1 2024**), and anticipates continued significant losses, requiring substantial additional funding beyond **Q4 2025**[175](index=175&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) - All product candidates are in clinical or preclinical development, and there is no assurance of successful advancement through clinical trials, regulatory approval, or commercialization, with potential for significant delays or failures[185](index=185&type=chunk)[188](index=188&type=chunk) - The company relies on third-party Contract Manufacturing Organizations (CMOs) for product candidate manufacturing, which is complex and carries risks of production difficulties, quality control issues, and supply interruptions that could delay clinical trials or commercialization[244](index=244&type=chunk)[245](index=245&type=chunk)[277](index=277&type=chunk) - The company faces substantial competition in the oncology market from large pharmaceutical and biotechnology companies with significantly greater financial resources and expertise, which could impact its ability to commercialize products successfully[312](index=312&type=chunk)[314](index=314&type=chunk)[316](index=316&type=chunk) - Maintaining sufficient intellectual property protection for its T-win® platform and product candidates is critical, but the company faces risks from challenges to patent validity, infringement claims by third parties, and difficulties in enforcing trade secrets[347](index=347&type=chunk)[362](index=362&type=chunk)[380](index=380&type=chunk) - The company is subject to various privacy and data security laws (e.g., EU GDPR, UK GDPR, CCPA) and faces risks of security breaches, data loss, or non-compliance, which could result in regulatory investigations, reputational damage, and significant liabilities[339](index=339&type=chunk)[340](index=340&type=chunk)[417](index=417&type=chunk)[418](index=418&type=chunk) - The stock price of the common stock is highly volatile and can be affected by clinical trial results, regulatory developments, competition, and broader market conditions, potentially leading to loss of investment[387](index=387&type=chunk)[388](index=388&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=114&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the use of proceeds from the company's November 2021 IPO, confirming that **$103.3 million** in net proceeds were raised and there has been no material change in their intended use - The company raised **$103.3 million** in net proceeds from its IPO in November 2021, after deducting underwriting discounts and commissions and other offering expenses[432](index=432&type=chunk) - There has been no material change in the use of proceeds from the IPO as described in the prospectus[433](index=433&type=chunk) [Item 3. Defaults Upon Senior Securities](index=114&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[434](index=434&type=chunk) [Item 4. Mine Safety Disclosures](index=114&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures - There are no mine safety disclosures[435](index=435&type=chunk) [Item 5. Other Information](index=114&type=section&id=Item%205.%20Other%20Information) The company reported no other information under this item - No other information is reported under this item[436](index=436&type=chunk) [Item 6. Exhibits](index=115&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including various certifications and XBRL documents - The exhibits include certifications from the Principal Executive Officer and Principal Financial Officer (**31.1**, **31.2**, **32.1**, **32.2**) and Inline XBRL documents (**101.INS**, **101.SCH**, **104**)[438](index=438&type=chunk) [Signatures](index=116&type=section&id=Signatures) The report is duly signed on behalf of IO Biotech, Inc. by its Chief Executive Officer and Chief Financial Officer - The report was signed by Mai-Britt Zocca, Ph.D., Chief Executive Officer and Director, and Amy Sullivan, Chief Financial Officer, on May 14, 2024[440](index=440&type=chunk)

NEW YORK, April 24, 2024 (GLOBE NEWSWIRE) -- IO Biotech (NASDAQ:IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced the acceptance of an abstract related to IO102-IO103, the company's lead investigational therapeutic cancer vaccine candidate, for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago May 31-June 4, 2024. A trial-in-progress poster from ...

NEW YORK, April 15, 2024 (GLOBE NEWSWIRE) -- IO Biotech (NASDAQ:IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced that Marjan Shamsaei, PharmD, joined the company as SVP, Commercial Development and Portfolio Lead for IO102-IO103, the company's lead cancer vaccine candidate currently in a pivotal Phase 3 trial. Ms. Shamsaei joins the company's executive team, reporting to IO Biotech CEO Mai-Britt Zoc ...

NEW YORK, April 09, 2024 (GLOBE NEWSWIRE) -- IO Biotech (NASDAQ:IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today shared new data related to the company's lead therapeutic cancer vaccine candidate, IO102-IO103, at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place April 5-10, 2024, in San Diego, California. "These data build on earlier studies that demonstrated the mechanism ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 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 001-41008 IO BIOTECH, INC. (Exact name of Registrant as specified in its Charter) Delaware 87-0909276 (State or other jurisdiction of inc ...

Company Overview and Highlights [Introduction and CEO Statement](index=1&type=section&id=Introduction%20and%20CEO%20Statement) 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 2023[3](index=3&type=chunk) - Interim analysis for overall response rate (ORR) from the pivotal Phase 3 trial is expected in the **third quarter of 2024**[3](index=3&type=chunk) - Primary endpoint of progression-free survival (PFS) for the pivotal Phase 3 trial is estimated to occur in the **second half of 2025**[3](index=3&type=chunk) [Fourth Quarter 2023 and Recent Operational Highlights](index=1&type=section&id=Fourth%20Quarter%202023%20and%20Recent%20Operational%20Highlights) 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 2023[6](index=6&type=chunk) - 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 2023[6](index=6&type=chunk) - 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](index=8&type=chunk) - Expanded its Board of Directors with the appointment of Helen Collins, MD in November 2023[8](index=8&type=chunk) Financial Results [Fourth Quarter 2023 Financial Performance](index=2&type=section&id=Fourth%20Quarter%202023%20Financial%20Performance) 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 trial[8](index=8&type=chunk) - 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 costs[8](index=8&type=chunk) [Full Year 2023 Financial Performance](index=5&type=section&id=Full%20Year%202023%20Financial%20Performance) 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)](index=2&type=section&id=Financial%20Position%20(Balance%20Sheet)) 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 2025**[5](index=5&type=chunk)[8](index=8&type=chunk) - 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 activities[8](index=8&type=chunk) Product and Clinical Program Details [About IO102-IO103 (Lead Product Candidate)](index=3&type=section&id=About%20IO102-IO103%20(Lead%20Product%20Candidate)) 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 vaccine[9](index=9&type=chunk) - 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) cells[9](index=9&type=chunk) - Currently being investigated in a pivotal Phase 3 trial for advanced melanoma and two Phase 2 basket trials for solid tumors[9](index=9&type=chunk) - Clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which supplies pembrolizumab; IO Biotech maintains global commercial rights to IO102-IO103[10](index=10&type=chunk) [Pivotal Phase 3 Clinical Trial (IOB-013/KN-D18)](index=3&type=section&id=Pivotal%20Phase%203%20Clinical%20Trial%20(IOB-013%2FKN-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) melanoma[12](index=12&type=chunk) - The primary endpoint of the study is progression-free survival (PFS), which is event-driven and expected in the **second half of 2025**[13](index=13&type=chunk) - 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 endpoint[13](index=13&type=chunk) About IO Biotech [Company Profile and Platform](index=3&type=section&id=Company%20Profile%20and%20Platform) 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® platform[14](index=14&type=chunk) - The T-win platform activates T cells to target immunosuppressive cells in the tumor microenvironment[14](index=14&type=chunk) - 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 Administration[14](index=14&type=chunk) - IO Biotech is headquartered in Copenhagen, Denmark, and has US headquarters in New York, New York[14](index=14&type=chunk) Forward-Looking Statements and Contact Information [Forward-Looking Statement Disclaimer](index=3&type=section&id=Forward-Looking%20Statement%20Disclaimer) 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 runway[16](index=16&type=chunk) - Forward-looking statements are inherently subject to risks and uncertainties, and actual results and other events may differ materially from those expressed or implied[17](index=17&type=chunk) - 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 law[17](index=17&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) This section provides contact details for investor relations inquiries - Contact for investor relations: Maryann Cimino, Director of Investor Relations, IO Biotech, Inc[18](index=18&type=chunk)

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited interim financial statements and management's discussion and analysis [Item 1. Interim Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Interim%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements and notes, detailing financial position, performance, and cash flows [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [1. Description of Business, Organization and Liquidity](index=9&type=section&id=1.%20Description%20of%20Business,%20Organization%20and%20Liquidity) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) [3. Fair Value Measurements](index=12&type=section&id=3.%20Fair%20Value%20Measurements) [4. License and Collaboration Agreements](index=12&type=section&id=4.%20License%20and%20Collaboration%20Agreements) [5. Prepaid Expenses and Other Current Assets](index=13&type=section&id=5.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) [6. Property and Equipment, Net](index=13&type=section&id=6.%20Property%20and%20Equipment,%20Net) [7. Accrued Expenses and Other Current Liabilities](index=13&type=section&id=7.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) [8. Leases](index=13&type=section&id=8.%20Leases) [9. Commitments and Contingencies](index=14&type=section&id=9.%20Commitments%20and%20Contingencies) [10. Stockholders' Equity](index=15&type=section&id=10.%20Stockholders'%20Equity) [11. Equity-Based Compensation](index=16&type=section&id=11.%20Equity-Based%20Compensation) [12. Income Taxes](index=17&type=section&id=12.%20Income%20Taxes) [13. Net Loss Per Share](index=17&type=section&id=13.%20Net%20Loss%20Per%20Share) [14. Subsequent Events](index=18&type=section&id=14.%20Subsequent%20Events) Condensed Consolidated Balance Sheets (September 30, 2023 vs. December 31, 2022) | Metric | Sep 30, 2023 (in thousands) | Dec 31, 2022 (in thousands) | Change (in thousands) | % Change | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | :------- | | Cash and cash equivalents | $165,501 | $142,590 | $22,911 | 16.1% | | Total current assets | $168,254 | $148,219 | $20,035 | 13.5% | | Total assets | $172,553 | $151,805 | $20,748 | 13.7% | | Total current liabilities | $12,985 | $10,676 | $2,309 | 21.6% | | Total liabilities | $14,961 | $12,951 | $2,010 | 15.5% | | Total stockholders' equity | $157,592 | $138,854 | $18,738 | 13.5% | | Accumulated deficit | $(237,640) | $(177,739) | $(59,901) | 33.7% | Condensed Consolidated Statements of Operations and Comprehensive Loss (Three Months Ended Sep 30, 2023 vs. 2022) | Metric | Sep 30, 2023 (in thousands) | Sep 30, 2022 (in thousands) | Change (in thousands) | % Change | | :----------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | :------- | | Research and development expenses | $17,655 | $10,022 | $7,633 | 76.2% | | General and administrative expenses | $5,829 | $5,843 | $(14) | (0.2)% | | Total operating expenses | $23,484 | $15,865 | $7,619 | 48.0% | | Loss from operations | $(23,484) | $(15,865) | $(7,619) | 48.0% | | Total other income (expense), net | $1,366 | $292 | $1,074 | 367.8% | | Net loss | $(21,679) | $(15,688) | $(5,991) | 38.2% | | Net loss per common share, basic and diluted | $(0.43) | $(0.54) | $0.11 | (20.4)% | Condensed Consolidated Statements of Operations and Comprehensive Loss (Nine Months Ended Sep 30, 2023 vs. 2022) | Metric | Sep 30, 2023 (in thousands) | Sep 30, 2022 (in thousands) | Change (in thousands) | % Change | | :----------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | :------- | | Research and development expenses | $46,059 | $32,553 | $13,506 | 41.5% | | General and administrative expenses | $17,201 | $18,482 | $(1,281) | (6.9)% | | Total operating expenses | $63,260 | $51,035 | $12,225 | 24.0% | | Loss from operations | $(63,260) | $(51,035) | $(12,225) | 24.0% | | Total other income (expense), net | $3,858 | $(66) | $3,924 | (5945.5)% | | Net loss | $(59,901) | $(51,387) | $(8,514) | 16.6% | | Net loss per common share, basic and diluted | $(1.66) | $(1.78) | $0.12 | (6.7)% | Condensed Consolidated Statements of Cash Flows (Nine Months Ended Sep 30, 2023 vs. 2022) | Metric | Sep 30, 2023 (in thousands) | Sep 30, 2022 (in thousands) | Change (in thousands) | | :----------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Net cash used in operating activities | $(48,942) | $(47,203) | $(1,739) | | Net cash used in investing activities | $(211) | $(341) | $130 | | Net cash provided by financing activities | $71,870 | $0 | $71,870 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $22,717 | $(47,544) | $70,261 | - The Company completed a private placement on August 9, 2023, selling **37,065,647 shares** of common stock and an equal number of warrants at **$2.025 per share** and warrant, generating net proceeds of **$71.9 million** for general corporate purposes[35](index=35&type=chunk)[71](index=71&type=chunk)[106](index=106&type=chunk)[136](index=136&type=chunk) - As of September 30, 2023, the Company had an accumulated deficit of **$237.6 million** and cash and cash equivalents of **$165.5 million**, which are expected to fund operations into the fourth quarter of 2025. Additional funding will be necessary for future clinical and preclinical activities[41](index=41&type=chunk)[107](index=107&type=chunk)[110](index=110&type=chunk)[135](index=135&type=chunk)[146](index=146&type=chunk)[153](index=153&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial condition, operations, clinical developments, and liquidity [Overview](index=19&type=section&id=Overview) [Components of Operating Results](index=23&type=section&id=Components%20of%20Operating%20Results) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) [Critical Accounting Policies and Significant Judgments and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) [Off-Balance Sheet Arrangements](index=33&type=section&id=Off-Balance%20Sheet%20Arrangements) [Emerging Growth Company ("EGC") Status](index=33&type=section&id=Emerging%20Growth%20Company%20(%22EGC%22)%20Status) - IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win technology platform. The lead candidate, IO102-IO103, targets IDO and PD-L1, designed to kill tumor cells and immune-suppressive cells, and modulate the tumor microenvironment[31](index=31&type=chunk)[89](index=89&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk) - IO102-IO103 was granted Breakthrough Therapy Designation (BTD) by the FDA for unresectable/metastatic melanoma. The Phase 1/2 MM1636 trial demonstrated a confirmed overall response rate (ORR) of **73%** and a complete response rate (CRR) of **50%** in metastatic melanoma patients, with a median PFS of **25.5 months**[89](index=89&type=chunk)[95](index=95&type=chunk) - The Phase 3 IOB-013/KN-D18 trial for advanced melanoma was fully enrolled in November 2023, with an increased target of **380 patients**. An interim analysis for ORR is expected mid-2024, with results in 3Q24, potentially supporting accelerated approval. Phase 2 basket trials (IOB-022 for NSCLC/SCCHN and IOB-032 for neo-adjuvant/adjuvant solid tumors) are also underway, showing encouraging early efficacy signals[90](index=90&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk) - The pipeline includes IO112, targeting Arginase 1, currently in a Phase 1 trial, and IO170, targeting TGFβ1, in preclinical studies[101](index=101&type=chunk)[103](index=103&type=chunk) Operating Expenses (Three Months Ended Sep 30, 2023 vs. 2022) | Expense Category | Sep 30, 2023 (in thousands) | Sep 30, 2022 (in thousands) | Change (in thousands) | % Change | | :----------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | :------- | | Research and development | $17,655 | $10,022 | $7,633 | 76.2% | | General and administrative | $5,829 | $5,843 | $(14) | (0.2)% | Operating Expenses (Nine Months Ended Sep 30, 2023 vs. 2022) | Expense Category | Sep 30, 2023 (in thousands) | Sep 30, 2022 (in thousands) | Change (in thousands) | % Change | | :----------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | :------- | | Research and development | $46,059 | $32,553 | $13,506 | 41.5% | | General and administrative | $17,201 | $18,482 | $(1,281) | (6.9)% | - Cash and cash equivalents were **$165.5 million** as of September 30, 2023. The company expects current cash to fund operations into Q4 2025, but additional financing will be required for future clinical and preclinical activities[110](index=110&type=chunk)[138](index=138&type=chunk)[146](index=146&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company, as a smaller reporting company, is not required to provide detailed quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is exempt from providing detailed market risk disclosures[174](index=174&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective, remediating a prior material weakness with no new material changes - Management concluded that disclosure controls and procedures were effective as of September 30, 2023[175](index=175&type=chunk)[176](index=176&type=chunk) - A material weakness in internal control over financial reporting, previously disclosed as of December 31, 2021, was remediated by December 31, 2022[178](index=178&type=chunk)[179](index=179&type=chunk) - No material changes in internal control over financial reporting occurred during the most recently completed fiscal quarter[180](index=180&type=chunk) [PART II. OTHER INFORMATION](index=35&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides other required information, including legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings and does not believe that ordinary course litigation will have a material adverse effect on its business - The company is not currently involved in any material legal proceedings[182](index=182&type=chunk) - Litigation, even if not material, can adversely impact the company due to defense costs, settlement costs, and diversion of management resources[182](index=182&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company's business faces various risks, with global instability posing a new potential adverse impact - Global economic and political instability and conflicts (e.g., Russia/Ukraine, Middle East) could adversely affect business, financial condition, or results of operations[184](index=184&type=chunk) - Conflicts in the Middle East may delay or hinder clinical trials, affecting patient enrollment and retention, and increasing costs[184](index=184&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the August 2023 private placement, raising **$71.9 million**, and confirms no change in IPO proceeds use - In August 2023, the company completed a private placement, issuing **37,065,647 shares** of common stock and an equal number of warrants, generating **$71.9 million** in net proceeds for general corporate purposes[186](index=186&type=chunk)[187](index=187&type=chunk) - The November 2021 IPO raised **$103.3 million** in net proceeds from the sale of **8,222,500 common shares**, with no material change in the planned use of these proceeds[188](index=188&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk) [Item 3. Defaults Upon Senior Securities](index=36&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - No defaults upon senior securities were reported[191](index=191&type=chunk) [Item 4. Mine Safety Disclosures](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures - No mine safety disclosures were reported[192](index=192&type=chunk) [Item 5. Other Information](index=36&type=section&id=Item%205.%20Other%20Information) The company reported no other information - No other information was disclosed[193](index=193&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including agreements, certifications, and XBRL documents - Key exhibits filed include the Securities Purchase Agreement, Registration Rights Agreement, a severance agreement with Eva Ehrnrooth, certifications of principal executive and financial officers, and Inline XBRL documents[194](index=194&type=chunk) [Signatures](index=38&type=section&id=Signatures) This section contains the required signatures for the quarterly report on Form 10-Q