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

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) For the quarterly period ended June 30, 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) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 87-09 ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) 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 incorporation or organization) Ole Maaløes Vej 3 DK-2200 Copenhagen N Denmark NA (Address of principal executive offices) (Zip ...

Part I [Item 1. Business](index=5&type=section&id=Item%201.%20Business) IO Biotech is a clinical-stage biopharmaceutical company developing novel immune-modulating cancer vaccines, with lead candidate IO102-IO103 in Phase 3 for advanced melanoma - IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its **T-win technology platform**[17](index=17&type=chunk) - The lead product candidate, IO102-IO103, targets immunosuppressive mechanisms mediated by **IDO and PD-L1**, demonstrating meaningful tumor regression and durable antitumor response in a Phase 1/2 trial for metastatic melanoma[17](index=17&type=chunk) - IO102-IO103, in combination with pembrolizumab, was granted **Breakthrough Therapy Designation (BTD)** by the FDA for unresectable/metastatic melanoma[17](index=17&type=chunk)[23](index=23&type=chunk) - A potentially registrational **Phase 3 trial (IOB-013/KN-D18)** for IO102-IO103 in combination with pembrolizumab for first-line advanced melanoma began in May 2022, with **75% patient enrollment expected by mid-2023** and completion by year-end 2023[18](index=18&type=chunk) [Overview](index=7&type=section&id=Overview) The T-win platform activates T cells against immunosuppressive mechanisms, with a dual action of direct killing and tumor microenvironment modulation, featuring IO102-IO103 and IO112 in its pipeline - The **T-win platform** activates pre-existing T cells to target immunosuppressive mechanisms, with a dual mechanism of action: **direct killing of immunosuppressive cells** (tumor and TME cells expressing IDO/PD-L1) and **modulation of the TME into a pro-inflammatory environment**[19](index=19&type=chunk)[44](index=44&type=chunk) - The lead candidate, **IO102-IO103**, combines IO102 (targeting IDO+) and IO103 (targeting PD-L1+) for a synergistic therapeutic effect[22](index=22&type=chunk) - **IO112**, a novel product candidate, targets **Arginase 1**, an immunoregulatory enzyme overexpressed in difficult-to-treat tumors, and is currently in a **Phase 1 trial** with an IND filing planned for 2023[28](index=28&type=chunk)[32](index=32&type=chunk) [Our Strategy](index=10&type=section&id=Our%20Strategy) IO Biotech's strategy focuses on advancing IO102-IO103 towards approval in advanced melanoma, expanding its clinical development into other solid tumors, and leveraging the T-win platform for new vaccine candidates - Advance IO102-IO103 towards approval in combination with anti-PD-1 therapy for first-line advanced melanoma, aiming for **accelerated approval based on interim ORR analysis** and MAA filing with EMA based on PFS[32](index=32&type=chunk) - Broaden IO102-IO103 clinical development into other solid tumor settings (NSCLC, SCCHN, UBC) through **Phase 2 basket trials** (IOB-022 for metastatic, IOB-032 for neo-adjuvant/adjuvant)[32](index=32&type=chunk) - Leverage the **T-win platform** to design and advance a portfolio of novel immune-modulating cancer vaccine candidates, including **IO112** (targeting Arginase 1) and other preclinical compounds like TGFB[32](index=32&type=chunk)[33](index=33&type=chunk) - Strengthen position through continuous innovation, **intellectual property expansion (17 patent families)**, and selective strategic collaborations (e.g., with Merck for Keytruda supply)[36](index=36&type=chunk) [Our Approach to Therapeutic Cancer Vaccines](index=11&type=section&id=Our%20Approach%20to%20Therapeutic%20Cancer%20Vaccines) The T-win platform is a novel cancer vaccine approach activating T cells against immunosuppressive mechanisms, aiming for dual action, durable responses, and broad applicability - The **T-win platform** activates naturally occurring T cells to target immunosuppressive mechanisms, employing a dual mechanism: **direct killing of immunosuppressive cells** (IDO+, PD-L1+ tumor and TME cells) and **modulation of the TME into a pro-inflammatory, anti-tumor environment**[44](index=44&type=chunk)[48](index=48&type=chunk) - Key advantages of the T-win platform include **durability of response** (targeting genetically stable immunosuppressive cells), dual/multi-epitope design for broader patient reach, favorable tolerability (subcutaneously injected peptides), versatility in combination therapies, well-understood manufacturing, and ease of administration[52](index=52&type=chunk) - The platform is built on the discovery of naturally occurring, pro-inflammatory T cells against immunosuppressive proteins like **IDO and PD-L1** in cancer patients[45](index=45&type=chunk) [Current Trials](index=16&type=section&id=Current%20Trials) IO Biotech is conducting a Phase 3 registrational trial for IO102-IO103 in advanced melanoma and a Phase 2 basket trial for other solid tumors, showing encouraging initial data - The **IOB-013/KN-D18 Phase 3 trial** for IO102-IO103 + pembrolizumab in first-line advanced melanoma aims for **300 patients**, with an interim ORR analysis one year after 75% randomization and PFS as the primary endpoint[53](index=53&type=chunk) - The **IOB-022 Phase 2 basket trial** is investigating IO102-IO103 + pembrolizumab in first-line metastatic NSCLC (PD-L1 ≥50%), SCCHN (CPS ≥20), and UBC (CPS ≥10)[54](index=54&type=chunk)[55](index=55&type=chunk)[56](index=56&type=chunk) - Initial data from **10 NSCLC patients** in IOB-022 showed **4 partial responses and 4 stable diseases** among 9 evaluable patients, with a safety profile consistent with prior experience[58](index=58&type=chunk) [Our Product Candidates](index=18&type=section&id=Our%20Product%20Candidates) IO Biotech's pipeline features lead candidate IO102-IO103 in Phase 3 for melanoma and Phase 2 for other solid tumors, with IO112 targeting Arginase 1 and preclinical compounds exploring other immunosuppressive molecules - IO102-IO103, combining IDO-derived peptide IO102 and PD-L1-derived peptide IO103, is designed for synergistic anti-tumor effects by directly killing immunosuppressive cells and reducing TME immunosuppression[61](index=61&type=chunk)[62](index=62&type=chunk) MM1636 Phase 1/2 Trial Results (Metastatic Melanoma, as of Jan 5, 2023) | Metric | Value | | :--- | :--- | | Median Follow-up | 49.8 months | | Evaluable Patients | 30 | | Confirmed ORR | 73.3% (95% CI: 54.1% to 87.7%) | | Complete Response Rate (CRR) | 50.0% (95% CI: 31.3% to 68.7%) | | Partial Response Rate | 23.3% (95% CI: 9.9% to 42.3%) | | Median PFS | 25.5 months | | Median OS | Not reached | | Treatment-related AE discontinuation rate | 17% | | Grade 3-5 AEs | 17% (5 patients) | - IO112, targeting Arginase 1, is in a **first-in-human Phase 1 trial** for arginase-positive solid tumors, with preclinical data showing enhanced anti-tumor effect in combination with anti-PD-1 antibody[169](index=169&type=chunk)[172](index=172&type=chunk)[174](index=174&type=chunk) - Preclinical development includes evaluating additional targets like **TGF-ß (IO170)** to modulate the TME for therapeutic benefit across various cancers[176](index=176&type=chunk) [Collaborations](index=45&type=section&id=Collaborations) IO Biotech maintains strategic collaborations with Herlev University Hospital for intellectual property and research, and with MSD International GmbH (Merck) for clinical trials, retaining global commercial rights to its compounds - Agreements with Herlev University Hospital grant IO Biotech options to acquire intellectual property rights related to T-cell activating inventions and non-exclusive licenses for clinical data[178](index=178&type=chunk)[181](index=181&type=chunk) - IO Biotech has multiple Clinical Trial Collaboration and Supply Agreements with MSD (Merck) to evaluate IO102-IO103 in combination with **KEYTRUDA® (pembrolizumab)** for advanced melanoma (Phase 3), metastatic NSCLC, SCCHN, UBC (Phase 2), and neo-adjuvant/adjuvant melanoma and SCCHN (Phase 2)[188](index=188&type=chunk)[189](index=189&type=chunk)[191](index=191&type=chunk) - Under MSD collaborations, IO Biotech sponsors the trials, MSD provides KEYTRUDA® free of charge, data rights are shared, and IO Biotech maintains **global commercial rights** to its compounds[188](index=188&type=chunk)[191](index=191&type=chunk) - A Clinical Trial Research Agreement with Cliniques Universitaires Saint-Luc supports an investigator-initiated study of peptide-based immunotherapy in SCCHN, with Saint-Luc owning data but granting IO Biotech an exclusive license and patent rights[201](index=201&type=chunk)[202](index=202&type=chunk) [Competition](index=48&type=section&id=Competition) The biopharmaceutical industry, particularly immuno-oncology, is highly competitive, with IO Biotech facing established players possessing greater resources and market positions - The biopharmaceutical industry is intensely competitive, with major pharmaceutical and biotechnology companies, academic institutions, and government agencies conducting research and development in cancer immunotherapies[204](index=204&type=chunk) - Key competitors in immuno-oncology include Amgen, AstraZeneca, BMS, Merck, Novartis, Pfizer, and Roche[206](index=206&type=chunk)[497](index=497&type=chunk) - In melanoma, dominant market players are **BMS (nivolumab, nivolumab & ipilimumab)** and **Merck (pembrolizumab)**[207](index=207&type=chunk)[497](index=497&type=chunk) - Many competitors have significantly greater financial, technical, and human resources, potentially leading to faster product development, regulatory approval, and market commercialization[209](index=209&type=chunk)[498](index=498&type=chunk) [Manufacturing and Supply](index=49&type=section&id=Manufacturing%20and%20Supply) IO Biotech relies entirely on third-party CDMOs for manufacturing its peptide-based product candidates, leveraging well-understood synthetic chemistry for high-quality, low-cost, and easily administered products - IO Biotech's compounds are linear peptides manufactured through a **well-understood solid-state peptide synthesis process**, designed for long shelf-life and easy subcutaneous administration[214](index=214&type=chunk) - The company does not own or operate manufacturing facilities and relies on **third-party CDMOs** for all preclinical, clinical, and future commercial supply, ensuring compliance with regulatory requirements[215](index=215&type=chunk)[217](index=217&type=chunk) - This outsourcing strategy allows the company to maintain an efficient infrastructure and focus internal expertise and resources on product candidate development and third-party management[216](index=216&type=chunk) [Commercialization](index=49&type=section&id=Commercialization) IO Biotech holds worldwide commercial rights to its immuno-oncology programs and plans to build a focused sales and marketing organization, potentially pursuing third-party distribution arrangements - IO Biotech holds **worldwide development and commercial rights** to its pipeline and intends to commercialize approved product candidates in key geographies[219](index=219&type=chunk) - The company currently lacks internal marketing, sales, or distribution capabilities[219](index=219&type=chunk) - Plans include building a focused sales and marketing organization to target oncologists and potentially entering into distribution and marketing arrangements with third parties[220](index=220&type=chunk)[221](index=221&type=chunk) [Intellectual Property](index=50&type=section&id=Intellectual%20Property) IO Biotech protects its T-win platform and product candidates through 17 patent families covering various targets, trade secrets, and confidentiality agreements, with patents generally having a 20-year term - IO Biotech's intellectual property strategy involves seeking, maintaining, and defending patent rights, relying on trade secrets and know-how, and leveraging data exclusivity and market exclusivity[223](index=223&type=chunk) - The patent portfolio comprises **17 separate patent families**, covering IO102 (IDO), IO103 (PD-L1), IO112 (Arginase 1), and other targets like TDO, PD-L2, CCL22, Arginase 2, and TGFbeta[224](index=224&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk)[227](index=227&type=chunk) - Patents generally have a **20-year term** from their application filing date, with some U.S. patents having term adjustments[225](index=225&type=chunk) - The company holds the **'T-win' trademark** in the EU, US, China, Japan, and UK, registered for pharmaceuticals and scientific/medical research services[228](index=228&type=chunk) [Government Regulation](index=52&type=section&id=Government%20Regulation) The development and commercialization of IO Biotech's biological products are extensively regulated by authorities like the FDA and EMA, involving rigorous trials, complex approval processes, and ongoing post-approval obligations - Biological products are extensively regulated by the FDA in the U.S. and comparable authorities globally, covering research, development, testing, manufacturing, approval, marketing, and post-approval monitoring[229](index=229&type=chunk)[230](index=230&type=chunk) - The U.S. approval process involves nonclinical testing (GLP), IND submission, clinical trials (Phases 1-3 under GCP), BLA submission, FDA review, manufacturing facility inspections (cGMP), and potential advisory committee review[231](index=231&type=chunk)[232](index=232&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk) - Expedited programs like Fast Track, **Breakthrough Therapy Designation (BTD)**, Priority Review, and Accelerated Approval are available for serious conditions with unmet needs, but do not guarantee faster or ultimate approval[258](index=258&type=chunk)[264](index=264&type=chunk) - Post-approval, products are subject to ongoing requirements including recordkeeping, adverse event reporting, compliance with promotion/advertising rules, and potential post-market studies or Risk Evaluation and Mitigation Strategies (REMS)[265](index=265&type=chunk)[266](index=266&type=chunk)[267](index=267&type=chunk) - In the EU, a **centralized procedure for MA** is mandatory for biotechnology-derived products, involving EMA evaluation (210 days, excluding clock stops) and European Commission approval; Orphan drug designation grants **10 years of market exclusivity**[313](index=313&type=chunk)[316](index=316&type=chunk)[324](index=324&type=chunk) - The company's operations are subject to various healthcare laws (Anti-Kickback Statute, False Claims Act, HIPAA, Physician Payments Sunshine Act) and regulations concerning pricing and reimbursement, which vary significantly by country and can impact market access and profitability[275](index=275&type=chunk)[280](index=280&type=chunk)[289](index=289&type=chunk)[333](index=333&type=chunk) [Item 1A. Risk Factors](index=71&type=section&id=Item%201A.%20Risk%20Factors) IO Biotech faces numerous significant risks, including a limited operating history with consistent net losses, the need for substantial additional funding, unpredictable clinical trial outcomes, and intense competition - IO Biotech has a limited operating history, has incurred net losses since inception (**$71.5 million in 2022, $67.9 million in 2021**), and anticipates continued significant losses, with no guarantee of profitability or revenue generation from product sales[346](index=346&type=chunk)[646](index=646&type=chunk) - The company will need substantial additional funding beyond its current **$142.6 million cash and cash equivalents** (sufficient through Q3 2024) to complete development and commercialization of product candidates, with potential for dilution or relinquishing rights if capital is raised through equity, debt, or collaborations[348](index=348&type=chunk)[349](index=349&type=chunk)[352](index=352&type=chunk)[648](index=648&type=chunk) - All product candidates are in early clinical or preclinical development, and success is uncertain due to the **high risk of clinical trial failure**, the novel nature of T-win technology, and potential delays in site activation or patient enrollment[354](index=354&type=chunk)[355](index=355&type=chunk)[358](index=358&type=chunk)[359](index=359&type=chunk)[364](index=364&type=chunk)[365](index=365&type=chunk) - The company relies on third parties for clinical trials and manufacturing, exposing it to risks of delays, increased costs, quality issues, and regulatory non-compliance[447](index=447&type=chunk)[451](index=451&type=chunk)[452](index=452&type=chunk) - The biopharmaceutical industry is highly competitive, with larger companies possessing greater resources, and the company's intellectual property protection (patents, trade secrets) faces challenges from infringement, invalidation, and evolving patent laws[495](index=495&type=chunk)[498](index=498&type=chunk)[529](index=529&type=chunk)[530](index=530&type=chunk)[535](index=535&type=chunk)[537](index=537&type=chunk) - Operating as a public company incurs increased costs and management time for compliance (Sarbanes-Oxley Act, SEC, Nasdaq), and the stock price is subject to high volatility[598](index=598&type=chunk)[577](index=577&type=chunk) [Item 1B. Unresolved Staff Comments](index=124&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments from the SEC - No unresolved staff comments were reported[628](index=628&type=chunk) [Item 2. Properties](index=124&type=section&id=Item%202.%20Properties) IO Biotech leases office and lab facilities in Copenhagen, New York, and Maryland, with leases expiring between 2027 and 2027, and believes its current facilities are adequate - IO Biotech leases approximately **622 square meters** of office space and lab space in Copenhagen, Denmark, with leases expiring on December 31, 2027[629](index=629&type=chunk) - In the United States, the company leases office space in New York (lease expires February 28, 2027) and lab space in Maryland (lease expires March 31, 2027)[630](index=630&type=chunk) - A UK office facility lease in Monmouthshire is terminable at the company's convenience[630](index=630&type=chunk) - The company believes its current facilities are adequate and that suitable additional or substitute space will be available commercially as needed[631](index=631&type=chunk) [Item 3. Legal Proceedings](index=124&type=section&id=Item%203.%20Legal%20Proceedings) IO Biotech is not currently a party to any material legal proceedings, believing incidental litigation will not materially adversely affect its business, though litigation can still incur costs and divert resources - IO Biotech is not currently a party to any material legal proceedings[632](index=632&type=chunk) - The company believes that the final outcome of ordinary course litigation and claims will not have a material adverse effect on its business[632](index=632&type=chunk) - Litigation, regardless of outcome, can adversely impact the company due to defense and settlement costs and diversion of management resources[632](index=632&type=chunk) [Item 4. Mine Safety Disclosures](index=124&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to IO Biotech, Inc - Mine Safety Disclosures are not applicable to the Registrant[633](index=633&type=chunk) Part II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=125&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) IO Biotech's common stock is listed on Nasdaq under "IOBT," with no dividends paid or anticipated, and the company completed its IPO in November 2021, raising $103.3 million in net proceeds - IO Biotech's common stock is listed on the Nasdaq Global Select Market under the symbol **"IOBT"**[635](index=635&type=chunk) - The company has never declared or paid dividends on its common stock and anticipates retaining future earnings for business development[635](index=635&type=chunk)[812](index=812&type=chunk) Common Stock and Equity Compensation Data (as of March 9, 2023 / Dec 31, 2022) | Metric | Value | | :--- | :--- | | Common Stock Outstanding (March 9, 2023) | 28,815,267 shares | | Holders of Record (March 9, 2023) | 12 | | Securities to be Issued Upon Exercise of Outstanding Options and Warrants (Dec 31, 2022) | 3,920,000 (approx) | | Weighted Average Exercise Price of Outstanding Options and Warrants (Dec 31, 2022) | $10.77 | | Remaining Available for Issuance Under Equity Compensation Plans (Dec 31, 2022) | 1,389,000 (approx) | - The company completed its IPO on November 9, 2021, issuing **8,222,500 shares** of common stock and raising approximately **$103.3 million in net proceeds**[638](index=638&type=chunk)[639](index=639&type=chunk) - There has been no material change in the planned use of IPO proceeds, and no equity securities were purchased by the issuer or affiliated parties[640](index=640&type=chunk)[641](index=641&type=chunk) [Item 6. (Reserved)](index=126&type=section&id=Item%206.%20(Reserved)) This item is reserved and contains no information [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=127&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) IO Biotech, a clinical-stage biopharmaceutical company, has incurred significant operating losses, with net losses of $71.5 million in 2022 and $67.9 million in 2021, and anticipates needing additional funding beyond Q3 2024 - IO Biotech is a clinical-stage biopharmaceutical company focused on developing novel, immune-modulating cancer vaccines, with its lead candidate IO102-IO103 in a potentially registrational Phase 3 trial for advanced melanoma[644](index=644&type=chunk)[645](index=645&type=chunk) Key Financial Highlights (Years Ended December 31) | Metric | 2022 (in thousands) | 2021 (in thousands) | Change (Amount) | Change (Percent) | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $46,986 | $30,152 | $16,834 | 55.8% | | General and administrative expenses | $24,438 | $11,082 | $13,356 | 120.5% | | Total operating expenses | $71,424 | $41,234 | $30,190 | 73.2% | | Loss from operations | $(71,424) | $(41,234) | $(30,190) | 73.2% | | Other income (expense), net | $1,239 | $(26,577) | $27,816 | (104.7)% | | Net loss before income tax expense | $(70,185) | $(67,811) | $(2,374) | 3.5% | | Net loss | $(71,458) | $(67,879) | $(3,579) | 5.3% | | Cash and cash equivalents (as of Dec 31) | $142,590 | $211,531 | $(68,941) | (32.6)% | | Accumulated deficit (as of Dec 31) | $177,739 | $106,281 | $71,458 | 67.2% | - The increase in R&D expenses in 2022 was primarily driven by increased preclinical studies and clinical trial activities for IO102-IO103, including the Phase 3 trial, and higher personnel costs[668](index=668&type=chunk) - General and administrative expenses increased significantly in 2022 due to higher personnel costs (headcount and recruiting), insurance premiums, consulting, and travel costs[669](index=669&type=chunk)[670](index=670&type=chunk) - The company's existing cash and cash equivalents (**$142.6 million** as of December 31, 2022) are expected to fund operations through the **third quarter of 2024**, but additional funding will be necessary thereafter[648](index=648&type=chunk)[673](index=673&type=chunk)[680](index=680&type=chunk) [Overview](index=129&type=section&id=Overview) IO Biotech is a clinical-stage biopharmaceutical company developing immune-modulating cancer vaccines, with its lead candidate IO102-IO103 in a Phase 3 trial for advanced melanoma, incurring significant net losses and requiring future capital raises - IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win technology platform[644](index=644&type=chunk) - The lead product candidate, IO102-IO103, has Breakthrough Therapy Designation for unresectable/metastatic melanoma and is in a potentially registrational Phase 3 trial[644](index=644&type=chunk)[645](index=645&type=chunk) Net Loss and Cash Position (Years Ended December 31) | Metric | 2022 (in millions) | 2021 (in millions) | | :--- | :--- | :--- | | Net Loss | $(71.5) | $(67.9) | | Accumulated Deficit | $(177.7) | $(106.2) | | Cash and Cash Equivalents | $142.6 | $211.5 | - Current cash and cash equivalents (**$142.6 million** as of Dec 31, 2022) are estimated to fund operations through **Q3 2024**, with additional funding required thereafter[648](index=648&type=chunk) [Components of Operating Results](index=130&type=section&id=Components%20of%20Operating%20Results) Operating expenses primarily comprise research and development (R&D) and general and administrative (G&A) costs, with R&D expenses reduced by grant income and tax credits, and other income/expense reflecting foreign exchange and interest - Research and development expenses include personnel, consultants, CROs, CMOs, lab expenses, and patent-related costs, all expensed as incurred[652](index=652&type=chunk) - R&D expenses are reduced by grant income (e.g., **$0.03 million in 2022, $0.1 million in 2021**) and Danish tax credits (**$0.8 million in both 2022 and 2021**)[654](index=654&type=chunk)[655](index=655&type=chunk)[754](index=754&type=chunk)[755](index=755&type=chunk) - General and administrative expenses primarily cover personnel, professional services (legal, audit, accounting), and facility-related fees[663](index=663&type=chunk) - Other income (expense), net, is composed of foreign exchange gains/losses, interest income/expense, and, in 2021, fair value adjustments on convertible notes[665](index=665&type=chunk) [Results of Operations](index=133&type=section&id=Results%20of%20Operations) In 2022, total operating expenses increased by 73.2% to $71.4 million, driven by significant increases in R&D and G&A expenses, while other income (expense), net, shifted to a net income due to the absence of preferred stock tranche adjustments Operating Expenses and Other Income (Years Ended December 31) | Metric | 2022 (in thousands) | 2021 (in thousands) | Change (Amount) | Change (Percent) | | :--- | :--- | :--- | :--- | :--- | | Research and Development Expenses | $46,986 | $30,152 | $16,834 | 55.8% | | General and Administrative Expenses | $24,438 | $11,082 | $13,356 | 120.5% | | Other Income (Expense), Net | $1,239 | $(26,577) | $27,816 | (104.7)% | - The **$16.8 million increase in R&D expenses** was primarily due to a **$5.3 million increase** in preclinical studies and clinical trial-related activities for IO102-IO103 (including Phase 3), a **$7.7 million increase** in personnel costs, and a **$2.9 million increase** in chemistry, manufacturing, and control activities[668](index=668&type=chunk) - The **$13.4 million increase in G&A expenses** was mainly driven by a **$4.3 million increase** in personnel costs (headcount and recruiting) and a **$7.9 million increase** in consultants and other costs (including **$2.9 million insurance, $2.3 million consulting, $0.8 million travel**)[669](index=669&type=chunk)[670](index=670&type=chunk) - The shift in Other income (expense), net, from a net expense to a net income was primarily due to the decrease in fair value adjustments on the company's preferred stock tranche obligations, which were settled in 2021[671](index=671&type=chunk) [Liquidity and Capital Resources](index=134&type=section&id=Liquidity%20and%20Capital%20Resources) IO Biotech's operations are financed by past equity issuances, including a 2021 IPO, with $142.6 million in cash as of December 31, 2022, projected to fund operations through Q3 2024, necessitating additional future financing - Operations have been financed by **$288.7 million in net proceeds** from convertible preference shares, convertible notes, ordinary shares, and a 2021 IPO (**$103.3 million net proceeds**)[646](index=646&type=chunk)[672](index=672&type=chunk) Cash Flow Summary (Years Ended December 31) | Cash Flow Activity | 2022 (in thousands) | 2021 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(59,729) | $(40,646) | | Net cash used in investing activities | $(690) | $(153) | | Net cash provided by financing activities | $0 | $252,951 | - Cash used in operating activities increased from **$40.6 million in 2021 to $59.7 million in 2022**, primarily due to higher net losses and changes in working capital[675](index=675&type=chunk)[676](index=676&type=chunk) - The company's **$142.6 million in cash and cash equivalents** (as of Dec 31, 2022) is expected to fund operations through **Q3 2024**, but additional financing will be required for future clinical and preclinical activities[673](index=673&type=chunk)[680](index=680&type=chunk) [Contractual Obligations and Commitments](index=136&type=section&id=Contractual%20Obligations%20and%20Commitments) IO Biotech has lease obligations for its office and lab spaces extending to 2027 and enters into various third-party service contracts, which are generally terminable with short notice, with non-cancelable obligations not considered material - IO Biotech has lease agreements for office space in Copenhagen, Denmark (expires Dec 2027), Rockville, Maryland (expires April 2027), and New York, NY (expires Jan 2027)[683](index=683&type=chunk) - The company enters into contracts with third-party service providers for clinical trials, preclinical research, manufacturing, and other services, which typically include termination clauses of **30 to 90 days**[684](index=684&type=chunk) - Non-cancelable obligations under these service agreements are not considered material, but financial obligations for active clinical trial patients may extend beyond contractual termination notice periods[684](index=684&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=136&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) IO Biotech's financial statements require significant estimates for R&D accruals, equity-based compensation, and income taxes, with a full valuation allowance against deferred tax assets due to historical losses - Key areas requiring significant estimates and assumptions include contract research organization (CRO) accruals, fair value of stock-based compensation awards, and valuation of deferred tax assets[686](index=686&type=chunk)[689](index=689&type=chunk) - The company's going concern evaluation projects existing cash and cash equivalents (**$142.6 million** as of Dec 31, 2022) to fund operations through **Q3 2024**[688](index=688&type=chunk) - Research and development costs, particularly those from third-party service providers, are estimated based on work progress, contract milestones, patient enrollment, and study duration[689](index=689&type=chunk)[691](index=691&type=chunk) - Equity-based compensation is measured at fair value using a **Black-Scholes option pricing model**, incorporating assumptions for volatility, expected term, risk-free interest rate, and dividend yield[694](index=694&type=chunk) - Deferred tax assets are recognized for temporary differences and loss carryforwards, but a **full valuation allowance** is recorded against net deferred tax assets in Denmark and the U.S. due to the unlikelihood of realization given historical operating losses[697](index=697&type=chunk)[699](index=699&type=chunk)[826](index=826&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=138&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, IO Biotech is not required to provide quantitative and qualitative disclosures about market risk - IO Biotech is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[705](index=705&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=139&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents IO Biotech's audited consolidated financial statements for 2022 and 2021, prepared under U.S. GAAP, highlighting continued net losses and increased operating expenses - The consolidated financial statements for the years ended December 31, 2022 and 2021 were audited by EY Godkendt Revisionspartnerselskab and present fairly the financial position and results of operations in conformity with U.S. GAAP[709](index=709&type=chunk) Consolidated Balance Sheet Highlights (as of December 31, in thousands) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $142,590 | $211,531 | | Total current assets | $148,219 | $221,738 | | Total assets | $151,805 | $222,288 | | Total liabilities | $12,951 | $10,364 | | Total stockholders' equity | $138,854 | $211,924 | | Accumulated deficit | $(177,739) | $(106,281) | Consolidated Statements of Operations and Comprehensive Loss Highlights (Years Ended December 31, in thousands) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Research and development | $46,986 | $30,152 | | General and administrative | $24,438 | $11,082 | | Total operating expenses | $71,424 | $41,234 | | Net loss | $(71,458) | $(67,879) | | Net loss per common share, basic and diluted | $(2.48) | $(17.30) | Consolidated Statements of Cash Flows Highlights (Years Ended December 31, in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(59,729) | $(40,646) | | Net cash used in investing activities | $(690) | $(153) | | Net cash provided by financing activities | $0 | $252,951 | [Notes to the Consolidated Financial Statements](index=147&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) The notes detail IO Biotech's corporate reorganization, IPO, significant accounting policies, fair value measurements, collaboration agreements, and tax provisions, highlighting ongoing losses and future funding needs - IO Biotech completed a corporate reorganization in November 2021, making IO Biotech ApS a wholly-owned subsidiary, and subsequently completed an IPO, raising **$103.3 million in net proceeds**[728](index=728&type=chunk)[729](index=729&type=chunk) - The company's financial statements are prepared in conformity with U.S. GAAP, with the Euro as the functional currency for its Danish and UK subsidiaries, and the U.S. dollar as the reporting currency[739](index=739&type=chunk)[744](index=744&type=chunk) - As of December 31, 2022, cash and cash equivalents were **$142.6 million**, with an accumulated deficit of **$177.7 million**, and current cash is expected to fund operations through **Q3 2024**[736](index=736&type=chunk) - Key accounting estimates include contract research organization accruals, fair value of stock-based compensation (using Black-Scholes model), and valuation of deferred tax assets, for which a **full valuation allowance** is recorded[743](index=743&type=chunk)[762](index=762&type=chunk)[764](index=764&type=chunk)[769](index=769&type=chunk)[826](index=826&type=chunk) - The company has significant collaborations with MSD International GmbH for clinical trials of IO102-IO103 in combination with KEYTRUDA®, and with Herlev University Hospital for scientific support and intellectual property[787](index=787&type=chunk)[789](index=789&type=chunk)[790](index=790&type=chunk)[791](index=791&type=chunk)[792](index=792&type=chunk) - As of December 31, 2022, the company had net operating loss (NOL) carryforwards of approximately **$140.5 million in Denmark**, which can be carried forward indefinitely[827](index=827&type=chunk) [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=161&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) IO Biotech reported no changes in or disagreements with its accountants on accounting and financial disclosure - No changes in or disagreements with accountants on accounting and financial disclosure were reported[835](index=835&type=chunk) [Item 9A. Controls and Procedures](index=161&type=section&id=Item%209A.%20Controls%20and%20Procedures) IO Biotech's management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2022, having remediated a previously identified material weakness - Management concluded that IO Biotech's disclosure controls and procedures were effective as of December 31, 2022[838](index=838&type=chunk) - A previously disclosed material weakness in internal control over financial reporting (related to financial statement close process and lack of finance capacity/expertise) was remediated during 2022[840](index=840&type=chunk)[841](index=841&type=chunk) - Remediation efforts included hiring a Chief Financial Officer and Chief Accounting Officer, four additional accounting/financial reporting personnel, and enhancing financial close processes with additional independent reviews and improved precision[841](index=841&type=chunk)[842](index=842&type=chunk) - Management assessed and concluded that the company's internal control over financial reporting was effective as of December 31, 2022[846](index=846&type=chunk) - As an emerging growth company, IO Biotech is exempt from the requirement to include an attestation report of its independent registered public accounting firm on internal control over financial reporting[847](index=847&type=chunk) [Item 9B. Other Information](index=162&type=section&id=Item%209B.%20Other%20Information) This item reports that there is no other information required to be disclosed - No other information is required to be disclosed under this item[848](index=848&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=162&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item reports that there are no disclosures regarding foreign jurisdictions that prevent inspections - No disclosures regarding foreign jurisdictions that prevent inspections were reported[849](index=849&type=chunk) Part III [Item 10. Directors, Executive Officers and Corporate Governance](index=163&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) The information required for this item is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information regarding Directors, Executive Officers and Corporate Governance is incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting of Stockholders[852](index=852&type=chunk) [Item 11. Executive Compensation](index=163&type=section&id=Item%2011.%20Executive%20Compensation) The information required for this item is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information regarding Executive Compensation is incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting of Stockholders[853](index=853&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=163&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) The information required for this item is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information regarding Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters is incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting of Stockholders[854](index=854&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=163&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) The information required for this item is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information regarding Certain Relationships and Related Transactions, and Director Independence is incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting of Stockholders[855](index=855&type=chunk) [Item 14. Principal Accounting Fees and Services](index=163&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) The information required for this item is incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information regarding Principal Accounting Fees and Services is incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting of Stockholders[856](index=856&type=chunk) Part IV [Item 15. Exhibits, Financial Statement Schedules](index=164&type=section&id=Item%2015.%20Exhibits,%20Financial%20Statement%20Schedules) This section lists all exhibits and financial statement schedules filed as part of the Form 10-K, including corporate documents and key collaboration agreements, with schedules omitted as information is in the financial statements - This item lists exhibits, including Amended and Restated Certificate of Incorporation and Bylaws, Indemnification Agreements, 2021 Equity and Incentive Plan, and 2021 Employee Stock Purchase Plan[858](index=858&type=chunk) - Key agreements listed include Option Assignment Agreements and a Framework Assignment Agreement with Herlev Hospital, and Clinical Trial Collaboration and Supply Agreements with MSD International GmbH[858](index=858&type=chunk)[859](index=859&type=chunk) - Financial statement schedules have been omitted because they are either not required or the information is included in the consolidated financial statements or their notes[858](index=858&type=chunk) [Item 16. Form 10-K Summary](index=165&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item indicates that no Form 10-K Summary is provided - No Form 10-K Summary is provided[861](index=861&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ WASHINGTON, DC 20549 Commission File Number: 001-41008 IO Biotech, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 Delaware 87-0909276 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Ole Maaløes Vej 3 DK-2200 Copenhagen N Denmark NA (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: +45 7070 298 ...

For the transition period from __________________ to __________________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-41008 IO Biotech, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 87-0 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) (Address of principal executive offices) (Zip Code) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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) Del ...