Part I [Business](index=10&type=section&id=Item%201.%20Business) Immunome, Inc. develops antibody therapeutics for oncology and infectious diseases using its proprietary human memory B cell platform - The company utilizes a proprietary human memory B cell platform to discover first-in-class antibody therapeutics[24](index=24&type=chunk) - Primary focus areas are oncology and infectious diseases, with two lead programs: IMM-BCP-01 (COVID-19) and IMM-ONC-01 (Oncology)[25](index=25&type=chunk) - The company's discovery engine has identified over **70 potential novel cancer targets** from screening a fraction of its antibody hits[26](index=26&type=chunk) - The company relies on third-party manufacturers for preclinical, clinical, and future commercial production and does not plan to develop its own manufacturing facilities[100](index=100&type=chunk) [Our Lead Discovery Programs](index=12&type=section&id=Item%201.%20Business-Our%20Lead%20Discovery%20Programs) - **Oncology (IMM-ONC-01):** This program targets IL-38, a novel immune checkpoint, with preclinical data suggesting blocking IL-38 increases anti-tumor immune response, and an IND application to the FDA is planned for the second half of 2022[31](index=31&type=chunk)[33](index=33&type=chunk) - **SARS-CoV-2 (IMM-BCP-01):** This three-antibody cocktail, developed from COVID-19 "super-responders" and targeting non-overlapping regions of the Spike protein, had an IND submitted in November 2021, with FDA clearance for clinical study initiation in March 2022[34](index=34&type=chunk) [Strategic Collaborations and License Agreements](index=31&type=section&id=Item%201.%20Business-Strategic%20Collaborations%20and%20License%20Agreements) - Entered into an Other Transaction Authority (OTA) Agreement with the U.S. Department of Defense (DoD) for the development of a COVID-19 antibody cocktail, with total funding increased to **$17.6 million** in May 2021[88](index=88&type=chunk) - Has an exclusive license agreement with Arrayjet Limited for screening human-derived hybridomas against cell lysate libraries, requiring annual license payments in the **low six figures**[94](index=94&type=chunk) - Holds exclusive license agreements with Whitehead Institute/MIT and Thomas Jefferson University (TJU) for patent rights related to its antibody screening platform, involving milestone and royalty payment obligations[96](index=96&type=chunk)[98](index=98&type=chunk) [Intellectual Property](index=37&type=section&id=Item%201.%20Business-Intellectual%20Property) - As of March 1, 2022, the company owned **65 pending national phase patent applications**, **two pending PCT applications**, and **7 pending U.S. provisional applications**[106](index=106&type=chunk) - The IP strategy relies on a multi-layered approach including patents for compositions of matter and methods of use, as well as trade secrets and know-how[104](index=104&type=chunk)[105](index=105&type=chunk)[113](index=113&type=chunk) - The patent term in the U.S. is generally **20 years** from filing, with potential for patent term extensions under the Hatch-Waxman Act for FDA-approved drugs[107](index=107&type=chunk) [Government Regulation](index=41&type=section&id=Item%201.%20Business-Government%20Regulation) - The company's products are subject to extensive regulation by the FDA under the FDCA and PHSA, covering research, development, testing, manufacturing, and marketing[117](index=117&type=chunk)[118](index=118&type=chunk) - The approval process for a Biologics License Application (BLA) involves preclinical studies and three phases of clinical trials (Phase 1, 2, 3) to establish safety and efficacy[119](index=119&type=chunk)[123](index=123&type=chunk)[125](index=125&type=chunk) - The company may utilize FDA's expedited programs such as Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval to speed up development and review[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk) - Operations are also subject to other healthcare laws, including the federal Anti-Kickback Statute, False Claims Act (FCA), and HIPAA, which regulate interactions with healthcare professionals and protect patient data[150](index=150&type=chunk)[151](index=151&type=chunk)[154](index=154&type=chunk) [Risk Factors](index=62&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including financial losses, funding needs, early-stage program failures, third-party reliance, intellectual property challenges, and regulatory hurdles [Risks Related to Our Business](index=62&type=section&id=Item%201A.%20Risk%20Factors-Risks%20Related%20to%20Our%20Business) - The company is a preclinical stage biopharmaceutical company with a history of losses, an accumulated deficit of **$79.1 million** as of December 31, 2021, and expects to incur significant losses for the foreseeable future[188](index=188&type=chunk) - Substantial additional funding is required to advance product candidates, with existing cash of **$49.2 million** (as of Dec 31, 2021) expected to fund operations for at least **12 months** from the filing date, but future capital needs are uncertain[190](index=190&type=chunk)[192](index=192&type=chunk) - The company's novel discovery engine approach may not result in marketable products, and its lead programs (IMM-BCP-01 and IMM-ONC-01) are in early stages with high risk of failure[195](index=195&type=chunk)[200](index=200&type=chunk)[204](index=204&type=chunk) - The company is dependent on a DoD award for its IMM-BCP-01 program, which could be eliminated, reduced, or delayed, and faces competition from numerous vaccines and treatments for COVID-19[212](index=212&type=chunk)[213](index=213&type=chunk) - Reliance on third parties for conducting clinical trials and manufacturing poses risks related to performance, quality, and supply continuity[261](index=261&type=chunk)[263](index=263&type=chunk) [Risks Related to Our Intellectual Property](index=96&type=section&id=Item%201A.%20Risk%20Factors-Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's success depends on its ability to obtain and maintain patent protection for its technology and product candidates, but there is no guarantee that pending applications will issue or that issued patents will provide adequate protection[283](index=283&type=chunk)[284](index=284&type=chunk)[285](index=285&type=chunk) - Failure to comply with obligations under license agreements (e.g., with Whitehead, TJU, Arrayjet) could result in loss of necessary IP rights[299](index=299&type=chunk)[300](index=300&type=chunk) - Third parties may challenge the company's patent rights or assert their own patents, which could lead to costly litigation and prevent the commercialization of products[309](index=309&type=chunk)[317](index=317&type=chunk) - Protecting intellectual property rights globally is prohibitively expensive, and the laws of some foreign jurisdictions may not protect these rights as effectively as U.S. law[312](index=312&type=chunk)[313](index=313&type=chunk) [Risks Related to Government Regulation](index=114&type=section&id=Item%201A.%20Risk%20Factors-Risks%20Related%20to%20Government%20Regulation) - Failure to comply with complex federal, state, and foreign data protection laws (e.g., HIPAA, GDPR, CCPA) could lead to significant penalties and harm the business[332](index=332&type=chunk)[333](index=333&type=chunk) - Healthcare legislative reforms may adversely affect the business by containing costs, which could reduce demand or pricing for product candidates[338](index=338&type=chunk)[340](index=340&type=chunk) - Future biologic products may face competition from biosimilars sooner than anticipated due to the BPCIA, which provides a **12-year exclusivity period** that could be shortened or challenged[344](index=344&type=chunk)[345](index=345&type=chunk) - Disruptions at the FDA and other government agencies due to funding shortages or health crises like COVID-19 could delay product approvals and hinder business operations[347](index=347&type=chunk)[349](index=349&type=chunk) [Risks Related to Our Common Stock](index=123&type=section&id=Item%201A.%20Risk%20Factors-Risks%20Related%20to%20Our%20Common%20Stock) - The company's stock price has been and may continue to be volatile, and broad market fluctuations could adversely affect the stock price regardless of operating performance[359](index=359&type=chunk) - As of December 31, 2021, executive officers, directors, and 5%+ stockholders beneficially owned approximately **35.7%** of the common stock, giving them significant influence over corporate actions[360](index=360&type=chunk) - Future sales of common stock to raise capital, including through an effective S-3 shelf registration for up to **$200 million**, could result in significant dilution to existing stockholders[365](index=365&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards (**$68.8 million federal**, **$69.2 million state** as of Dec 31, 2021) may be limited by ownership changes under Section 382 of the Code[371](index=371&type=chunk)[372](index=372&type=chunk)[373](index=373&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=133&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Immunome's common stock trades on Nasdaq, has approximately **68 record holders**, has never paid dividends, and recently raised **$27.0 million** through a private placement - The company's common stock has been publicly traded on the Nasdaq Global Market under the symbol "IMNM" since October 2, 2020[394](index=394&type=chunk) - The company has not declared or paid any dividends since inception and does not expect to in the foreseeable future[396](index=396&type=chunk) - On April 26, 2021, the company issued **1,000,000 shares** of common stock and warrants to purchase **500,000 shares** in a private placement, generating gross proceeds of **$27.0 million**[399](index=399&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=136&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Immunome, a development-stage company, reported a **$24.7 million** net loss in 2021 due to increased R&D and G&A expenses, requiring substantial future financing beyond its current **$49.2 million** cash [Results of Operations](index=143&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Results%20of%20operations) Comparison of the years ended December 31, 2021 and 2020 | | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | **(in thousands)** | | | | | **Operating expenses:** | | | | | Research and development | $14,110 | $7,486 | $6,624 | | General and administrative | $11,094 | $4,775 | $6,319 | | **Total operating expenses** | **$25,204** | **$12,261** | **$12,943** | | **Loss from operations** | **($25,204)** | **($12,261)** | **($12,943)** | | **Other income (expenses):** | | | | | Other income | $503 | $— | $503 | | Change in fair value of warrant liability | $— | ($5,538) | $5,538 | | Interest expense, net | ($10) | ($38) | $28 | | **Net loss** | **($24,711)** | **($17,837)** | **($6,874)** | - Net R&D expenses increased by **$6.6 million** in 2021, driven by a **$17.0 million** increase in supplies and outsourced services and a **$3.0 million** increase in personnel costs, partially offset by a **$13.5 million** increase in DoD reimbursement (contra-R&D expense)[436](index=436&type=chunk)[437](index=437&type=chunk) - General and administrative expenses increased by **$6.3 million** in 2021, primarily due to a **$3.2 million** increase in personnel-related costs and a **$3.0 million** increase in professional fees and other costs to support public company operations[439](index=439&type=chunk) [Liquidity and Capital Resources](index=145&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Liquidity%20and%20capital%20resources) - As of December 31, 2021, the company had **$49.2 million** in cash[443](index=443&type=chunk) - The company expects existing cash will fund operations for at least **12 months** from the filing date of the report, but will need to raise additional capital to continue its research and development plans[444](index=444&type=chunk)[456](index=456&type=chunk) Cash Flow Summary (Years ended December 31) | | 2021 | 2020 | | :--- | :--- | :--- | | **(in thousands)** | | | | Net cash used in operating activities | ($18,226) | ($12,134) | | Net cash used in investing activities | ($79) | ($586) | | Net cash provided by financing activities | $27,768 | $49,943 | - Financing activities in 2021 included **$26.7 million** net proceeds from a PIPE funding and **$1.4 million** from warrant and option exercises, while 2020 activities were dominated by **$38.9 million** net proceeds from the IPO[451](index=451&type=chunk)[452](index=452&type=chunk) [Controls and Procedures](index=157&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2021, having remediated prior material weaknesses through staffing and process improvements - Management concluded that disclosure controls and procedures were effective as of December 31, 2021[482](index=482&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2021[484](index=484&type=chunk) - Material weaknesses identified as of December 31, 2020, related to review processes and staffing, were remediated during 2021[488](index=488&type=chunk)[491](index=491&type=chunk) - Remediation efforts included hiring a CFO, Corporate Controller, and Finance Manager, and implementing a formal monthly financial close process and a disclosure committee[490](index=490&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=88&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The information required for this item, covering directors, executive officers, and corporate governance, is incorporated by reference from the company's definitive proxy statement for its 2022 annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the 2022 annual meeting of stockholders[494](index=494&type=chunk) [Executive Compensation](index=89&type=section&id=Item%2011.%20Executive%20Compensation) The information required for this item, covering executive compensation, is incorporated by reference from the company's definitive proxy statement for its 2022 annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the 2022 annual meeting of stockholders[495](index=495&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=89&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) The information required for this item, covering security ownership, is incorporated by reference from the company's definitive proxy statement for its 2022 annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the 2022 annual meeting of stockholders[496](index=496&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=89&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The information required for this item, covering related party transactions and director independence, is incorporated by reference from the company's definitive proxy statement for its 2022 annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the 2022 annual meeting of stockholders[497](index=497&type=chunk) [Principal Accounting Fees and Services](index=89&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) The information required for this item, covering principal accountant fees and services, is incorporated by reference from the company's definitive proxy statement for its 2022 annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the 2022 annual meeting of stockholders[498](index=498&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=89&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section includes the company's financial statements starting on page 90 and a comprehensive index of all exhibits filed with the 10-K report, with no separate financial statement schedules - The company's financial statements are included in the report, starting on page 90[499](index=499&type=chunk) - No financial statement schedules are provided, as all required information is included in the Notes to the Financial Statements[500](index=500&type=chunk) - A detailed list of exhibits, including charter documents, material contracts, and certifications, is provided in the Exhibit Index[501](index=501&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from to Commission File Number: 001-39580 Immunome, Inc. (Exact name of registrant as specified in its charter) 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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 77-0694340 (State or ...

[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section details the company's unaudited financial statements and management's analysis of its financial condition [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Unaudited condensed financial statements show increased cash and assets from financing, with continued net losses and rising operating expenses [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Highlights from the condensed balance sheets show significant increases in cash and total assets Balance Sheet Highlights (In thousands) | Balance Sheet Highlights (In thousands) | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $59,829 | $39,766 | | Total current assets | $62,815 | $42,894 | | Total assets | $64,141 | $44,525 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $3,521 | $3,038 | | Total liabilities | $3,524 | $3,180 | | Total stockholders' equity | $60,617 | $41,345 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) The condensed statements of operations reflect increased operating expenses and net losses for both three and six-month periods Statement of Operations (In thousands) | Statement of Operations (In thousands) | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,233 | $1,892 | $5,212 | $4,007 | | General and administrative | $2,507 | $823 | $4,425 | $1,363 | | **Total operating expenses** | **$5,740** | **$2,715** | **$9,637** | **$5,370** | | Loss from operations | ($5,740) | ($2,715) | ($9,637) | ($5,370) | | **Net loss** | **($5,241)** | **($2,710)** | **($9,139)** | **($5,387)** | | Net loss per share, basic and diluted | ($0.46) | ($2.45) | ($0.83) | ($4.89) | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash flow statements indicate a significant net increase in cash, primarily driven by financing activities Cash Flow Summary (In thousands) | Cash Flow Summary (In thousands) | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($7,276) | ($3,544) | | Net cash used in investing activities | ($39) | ($416) | | Net cash provided by financing activities | $27,378 | $11,206 | | **Net increase in cash and restricted cash** | **$20,063** | **$7,246** | | Cash and restricted cash at end of period | $59,929 | $9,889 | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail the company's biopharmaceutical focus, financial condition, and key events including recent financing and contract amendments - The company is a biopharmaceutical firm focusing on oncology and infectious diseases, including COVID-19, utilizing a proprietary human memory B cell platform[23](index=23&type=chunk) - As of June 30, 2021, the company had an accumulated deficit of **$63.5 million** and expects its cash of **$59.8 million** to fund operations and capital expenditures for at least the next twelve months[25](index=25&type=chunk)[27](index=27&type=chunk) - In July 2020, the company entered into an agreement with the U.S. Department of Defense (DoD) for COVID-19 therapeutic development, which was later amended in May 2021, increasing the total award from **$13.3 million** to **$17.6 million**[51](index=51&type=chunk)[53](index=53&type=chunk) - The company's **$0.5 million** Paycheck Protection Program (PPP) loan, received in April 2020, was fully forgiven on May 21, 2021, and recognized as other income[56](index=56&type=chunk) - On April 28, 2021, the company raised net proceeds of **$26.4 million** through a private placement of **1,000,000 units** at **$27.00 per unit**[26](index=26&type=chunk)[65](index=65&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses increased operating losses from higher R&D and G&A expenses, with liquidity boosted by recent financing [Overview](index=27&type=section&id=Overview) The company, a development-stage biopharmaceutical firm, has primarily financed operations through equity sales, incurring significant net losses - The company received net proceeds of **$41.7 million** from its IPO in October 2020 and **$26.4 million** from a private placement in April 2021[91](index=91&type=chunk) - Net losses were **$5.2 million** for Q2 2021 and **$9.1 million** for the six months ended June 30, 2021[92](index=92&type=chunk) - As of June 30, 2021, the company had a cash balance of **$59.8 million**, which is expected to fund operations through fiscal year 2022[93](index=93&type=chunk)[97](index=97&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20operations) Operating expenses significantly increased due to higher R&D and G&A costs, partially offset by DoD contract reimbursement Operating Results (In thousands) | Operating Results (In thousands) | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | Change | | :--- | :--- | :--- | :--- | | Research and development | $5,212 | $4,007 | $1,205 | | General and administrative | $4,425 | $1,363 | $3,062 | | **Total operating expenses** | **$9,637** | **$5,370** | **$4,267** | | **Net loss** | **($9,139)** | **($5,387)** | **($3,752)** | - For the six months ended June 30, 2021, R&D expenses increased by **$1.2 million**, reflecting a **$9.3 million** increase in non-DoD related activities, partially offset by **$8.0 million** in contra-R&D expenses from the DoD agreement[121](index=121&type=chunk) - G&A expenses for the six months ended June 30, 2021, increased by **$3.1 million**, primarily due to a **$1.0 million** increase in personnel costs and a **$1.7 million** increase in professional fees and other expenses related to operating as a public company[123](index=123&type=chunk) - The company recognized **$0.5 million** in other income during the first half of 2021 due to the forgiveness of its PPP Loan[125](index=125&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20capital%20resources) The company's liquidity was significantly boosted by recent financing, with existing cash expected to fund operations through fiscal year 2022 - As of June 30, 2021, the company had **$59.8 million** in cash and has raised an aggregate of **$122.9 million** in gross proceeds since inception[127](index=127&type=chunk) Cash Flow Summary (In thousands) | Cash Flow Summary (In thousands) | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Cash used in operating activities | ($7,276) | ($3,544) | | Cash used in investing activities | ($39) | ($416) | | Cash provided by financing activities | $27,378 | $11,206 | - Financing activities in the first six months of 2021 provided **$27.3 million**, mainly from the sale of common stock and warrants and the exercise of existing warrants and options[132](index=132&type=chunk) - Existing cash as of June 30, 2021, is expected to fund operating expenses and capital expenditures through fiscal year 2022[135](index=135&type=chunk) [Critical Accounting Policies and Use of Estimates](index=41&type=section&id=Critical%20accounting%20policies%20and%20use%20of%20estimates) Share-based compensation is identified as a critical accounting policy requiring significant estimates, particularly in valuing common stock - Share-based compensation is a critical accounting policy, with fair value estimated using the Black-Scholes model, which requires subjective assumptions[144](index=144&type=chunk) - Prior to May 2020, the company valued its common stock using a net asset approach and the Option Pricing Method (OPM); it switched to the probability-weighted expected return method (PWERM) in May 2020[146](index=146&type=chunk)[149](index=149&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk.) As a smaller reporting company, the company is not required to provide market risk disclosures - The company is a smaller reporting company and is not required to provide information for this item[157](index=157&type=chunk) [Controls and Procedures](index=47&type=section&id=Item%204.%20Controls%20and%20Procedures.) Disclosure controls and procedures were ineffective due to material weaknesses in internal control, with remediation efforts underway - Management concluded that as of June 30, 2021, the company's disclosure controls and procedures were not effective[158](index=158&type=chunk) - Material weaknesses were identified related to: lack of review of journal entries, lack of timely and effective review of financial statement account balances, and lack of sufficient accounting personnel[160](index=160&type=chunk) - Remediation activities are in progress, including implementing a formal monthly financial close process, creating a disclosure committee, and hiring a full-time CFO, Controller, and other accounting staff[161](index=161&type=chunk) [PART II – OTHER INFORMATION](index=50&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, and a list of exhibits filed with the report [Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not currently a party to any material legal proceedings - As of the reporting date, the company is not involved in any material legal proceedings[167](index=167&type=chunk) [Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors.) As a smaller reporting company, the company is not required to provide risk factor information - The company is a smaller reporting company and is not required to provide information for this item[168](index=168&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=50&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) Details on unregistered equity sales and use of proceeds are referenced in the April 2021 Form 8-K filing - Details regarding the unregistered sale of common stock are available in the Form 8-K filed on April 20, 2021[169](index=169&type=chunk) [Exhibits](index=51&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed, including corporate governance documents, material contracts, and certifications - The exhibits include key agreements such as the Securities Purchase Agreement from April 2021 and a modification to the Department of Defense contract from May 2021[175](index=175&type=chunk) - Certifications by the Chief Executive Officer and Chief Financial Officer pursuant to the Sarbanes-Oxley Act of 2002 are included as exhibits[175](index=175&type=chunk)

PART I – FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) For the three months ended March 31, 2021, Immunome, Inc. reported a net loss of $3.9 million, an increase from a $2.7 million loss in the same period of 2020. Total assets decreased to $42.6 million from $44.5 million at year-end 2020, primarily due to a decrease in cash. The company's operations used $3.5 million in cash, driven by the net loss and investments in prepaid expenses [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2021, the company's total assets were $42.6 million, a slight decrease from $44.5 million at December 31, 2020. The decrease was primarily driven by a reduction in cash from $39.8 million to $36.3 million. Total liabilities increased to $4.7 million from $3.2 million, mainly due to a rise in accounts payable Condensed Balance Sheet Summary (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $36,276 | $39,766 | | Total current assets | $41,107 | $42,894 | | Total assets | $42,593 | $44,525 | | **Liabilities & Stockholders' Equity** | | | | Accounts payable | $2,958 | $1,187 | | Total current liabilities | $4,571 | $3,038 | | Total liabilities | $4,710 | $3,180 | | Total stockholders' equity | $37,883 | $41,345 | | Total liabilities and stockholders' equity | $42,593 | $44,525 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) For the three months ended March 31, 2021, the company reported a net loss of $3.9 million, or ($0.37) per share, compared to a net loss of $2.7 million, or ($2.44) per share, for the same period in 2020. The increased loss was driven by a significant rise in general and administrative expenses, which grew to $1.9 million from $0.5 million year-over-year Condensed Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Research and development | $1,979 | $2,115 | | General and administrative | $1,918 | $540 | | Total operating expenses | $3,897 | $2,655 | | Loss from operations | ($3,897) | ($2,655) | | Net loss | ($3,898) | ($2,677) | | Net loss per share, basic and diluted | ($0.37) | ($2.44) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the first quarter of 2021, net cash used in operating activities was $3.5 million, an increase from $2.1 million in the prior year period, primarily due to a higher net loss and changes in working capital. Financing activities provided a net cash inflow of $76,000, a significant decrease from $844,000 in Q1 2020 which included proceeds from preferred stock sales. The company's cash and restricted cash balance decreased by $3.5 million during the quarter Condensed Statements of Cash Flows Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,535) | ($2,064) | | Net cash used in investing activities | ($31) | ($55) | | Net cash provided by financing activities | $76 | $844 | | Net decrease in cash and restricted cash | ($3,490) | ($1,275) | | Cash and restricted cash at end of period | $36,376 | $1,368 | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail the company's business as a biopharmaceutical firm focused on oncology and infectious diseases, its history of net losses, and its reliance on capital raises, including a recent IPO and private placement. Key accounting policies are outlined, including the treatment of a $13.3 million DoD expense reimbursement contract which resulted in a $4.0 million contra-R&D expense in Q1 2021. The notes also cover debt obligations, including a $0.5 million PPP loan awaiting a forgiveness decision, share-based compensation expenses of $325,000 for the quarter, and a subsequent event in April 2021 where the company raised $27.0 million through a private placement - The company is a biopharmaceutical company focused on discovering and developing antibody therapeutics for oncology and infectious diseases, including COVID-19[24](index=24&type=chunk) - The company has a history of net losses, with a **net loss of $3.9 million** for Q1 2021 and an **accumulated deficit of $58.3 million** as of March 31, 2021[26](index=26&type=chunk) - In July 2020, the company entered into a **$13.3 million expense reimbursement contract** with the U.S. Department of Defense (DoD) to develop a treatment for COVID-19. This resulted in a **$4.0 million contra-research and development expense** for Q1 2021[51](index=51&type=chunk) - In April 2021, the company raised **gross proceeds of $27.0 million** by selling **1,000,000 shares** of common stock in a private placement[86](index=86&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses the company's financial performance for Q1 2021, highlighting a net loss of $3.9 million compared to $2.7 million in Q1 2020. The increase was driven by a $1.4 million rise in G&A expenses due to costs associated with being a public company. R&D expenses were $2.0 million, reflecting a $4.0 million contra-R&D expense from a DoD contract that offset program costs. The company ended the quarter with $36.3 million in cash and subsequently raised an additional $27.0 million in April 2021, which is expected to fund operations through fiscal year 2022. Management also notes the ongoing risks of the COVID-19 pandemic and details critical accounting policies, particularly regarding share-based compensation [Overview](index=27&type=section&id=Overview) The company is a development-stage biopharmaceutical firm that has historically funded its operations through sales of equity and convertible notes. Key financing events include an IPO in October 2020, which raised net proceeds of $41.7 million, and a private placement in April 2021 that raised $27.0 million. The company has incurred significant operating losses since inception, with a net loss of $3.9 million in Q1 2021, and expects losses to continue as it advances its preclinical programs - The company closed its IPO on October 6, 2020, receiving **net proceeds of $41.7 million**[93](index=93&type=chunk) - As of March 31, 2021, the company had a **cash balance of $36.3 million** and subsequently raised an additional **$27.0 million** in a private placement in April 2021[95](index=95&type=chunk) - The company expects to continue incurring significant expenses and operating losses as it advances its portfolio of preclinical programs[95](index=95&type=chunk)[96](index=96&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20operations) For the three months ended March 31, 2021, the net loss increased to $3.9 million from $2.7 million in the prior-year period. General and administrative expenses rose by $1.4 million to $1.9 million, primarily due to increased personnel costs and professional fees associated with operating as a public company. Research and development expenses were $2.0 million, reflecting a $4.0 million contra-R&D expense from the DoD Agreement which offset increased program spending Comparison of Operations (in thousands) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change | | :--- | :--- | :--- | :--- | | Research and development | $1,979 | $2,115 | ($136) | | General and administrative | $1,918 | $540 | $1,378 | | Total operating expenses | $3,897 | $2,655 | $1,242 | | Net loss | ($3,898) | ($2,677) | ($1,221) | - R&D expenses for Q1 2021 included a **$4.0 million contra-R&D expense** related to the DoD Agreement, which offset underlying costs[117](index=117&type=chunk) - The **$1.4 million increase** in G&A expenses was primarily driven by a **$0.3 million increase** in personnel-related costs and a **$1.1 million increase** in professional, consulting, and legal fees to support public company operations[119](index=119&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20capital%20resources) As of March 31, 2021, the company had $36.3 million in cash. In April 2021, it raised an additional $27.0 million in gross proceeds from a common stock sale. Management expects this combined capital to fund operations and capital expenditures through fiscal year 2022. Net cash used in operating activities was $3.5 million for Q1 2021. The company anticipates needing substantial additional financing in the future to advance its programs and will seek funds through equity/debt financings or collaborations - The company had **$36.3 million in cash** as of March 31, 2021, and raised an additional **$27.0 million in gross proceeds** in April 2021[121](index=121&type=chunk) - Existing cash plus proceeds from the April 2021 financing are expected to fund operations through fiscal year 2022[129](index=129&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Cash used in operating activities | ($3,535) | ($2,064) | | Cash used in investing activities | ($31) | ($55) | | Cash provided by financing activities | $76 | $844 | [Critical Accounting Policies and Use of Estimates](index=39&type=section&id=Critical%20accounting%20policies%20and%20use%20of%20estimates) The company's most critical accounting policy involves share-based compensation. The fair value of stock options is determined using the Black-Scholes model, which requires significant management judgment for inputs like expected volatility and the fair value of common stock. Prior to its IPO, the company used methods like the net asset approach and the probability-weighted expected return method (PWERM) to estimate its common stock fair value - Share-based compensation is a critical accounting policy, with fair value estimated using the Black-Scholes option pricing model[139](index=139&type=chunk) - Prior to the IPO, the company used the Option Pricing Method (OPM) and, beginning in May 2020, the probability-weighted expected return method (PWERM) to determine the fair value of its common stock[141](index=141&type=chunk)[142](index=142&type=chunk)[143](index=143&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk.) The company states that this information is not required to be provided by smaller reporting companies - As a smaller reporting company, Immunome, Inc. is not required to provide quantitative and qualitative disclosures about market risk[151](index=151&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that as of March 31, 2021, the company's disclosure controls and procedures were not effective due to identified material weaknesses in internal control over financial reporting. These weaknesses relate to a lack of journal entry review, ineffective review of financial statement account balances, and insufficient accounting personnel. The company is actively undertaking remediation efforts, including implementing a formal monthly close process, creating a disclosure committee, and hiring a full-time CFO and other qualified personnel - Management concluded that disclosure controls and procedures were not effective as of March 31, 2021, due to material weaknesses[152](index=152&type=chunk) - Identified material weaknesses include: lack of review of journal entries, lack of timely and effective review of financial statement account balances, and lack of sufficient accounting and reporting personnel[154](index=154&type=chunk) - Remediation activities include implementing a formal monthly close process, creating a disclosure committee, and hiring additional qualified financial personnel, including a full-time CFO[155](index=155&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings.) The company reports that it is not currently a party to any material legal proceedings - The company is not currently involved in any material legal proceedings[161](index=161&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors.) As a smaller reporting company, Immunome, Inc. is not required to provide this information in its Form 10-Q - Disclosure of risk factors is not required for smaller reporting companies in this filing[162](index=162&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) During the first quarter of 2021, the company issued 14,270 shares of common stock from the exercise of stock options for approximately $5,624 and 11,666 shares from the exercise of warrants for approximately $104,994. These issuances were exempt from registration under Rule 701 or Section 4(a)(2) of the Securities Act - In Q1 2021, the company issued **14,270 shares of common stock** upon exercise of stock options for aggregate consideration of **$5,624**[163](index=163&type=chunk) - In Q1 2021, the company issued **11,666 shares of common stock** upon exercise of warrants for aggregate consideration of **$104,994**[163](index=163&type=chunk) [Defaults Upon Senior Securities](index=48&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) The company reported no defaults upon senior securities - None[165](index=165&type=chunk) [Mine Safety Disclosures](index=48&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - Not applicable[166](index=166&type=chunk) [Other Information](index=48&type=section&id=Item%205.%20Other%20Information.) The company reported no other information for this item - None[167](index=167&type=chunk) [Exhibits](index=49&type=section&id=Item%206.%20Exhibits.) This section lists the exhibits filed with the Form 10-Q, including the company's certificate of incorporation, bylaws, recent securities purchase agreements, and officer certifications required by the Sarbanes-Oxley Act - The exhibit index lists key corporate documents and agreements, including the Amended and Restated Certificate of Incorporation, a Securities Purchase Agreement dated April 26, 2021, and certifications by the CEO and CFO[170](index=170&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K IMMUNOME, INC. (Exact name of registrant as specified in its charter) (State of Other Jurisdiction of incorporation or Organization) (I.R.S. Employer Identification No.) Delaware 77-0694340 665 Stockton Drive, Suite 300, Exton, PA 19341 (Address of principal executive offices) (Zip code) Registrant's telephone number, including area code: (610) 321-3700 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE S ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 September 30, 2020 For the transition period from to Commission File Number: 001-39580 Immunome, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 77-0694340 (I.R.S. Employer Identification No.) 665 ...