PART I [Business](index=5&type=section&id=Item%201.%20Business) Immunome, Inc. is a preclinical-stage biopharmaceutical company focused on discovering and developing first-in-class antibody therapeutics for oncology and infectious diseases, leveraging its proprietary human memory B cell platform - Immunome is a biopharmaceutical company utilizing a proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics for oncology and infectious diseases[20](index=20&type=chunk) - The lead oncology program, IMM-ONC-01, targets IL-38, a novel immune checkpoint inhibitor, and is expected to file an IND application in the **second half of 2021**[22](index=22&type=chunk)[25](index=25&type=chunk)[28](index=28&type=chunk)[32](index=32&type=chunk) - The lead infectious disease program, IMM-BCP-01, is developing an antibody cocktail against SARS-CoV-2 from 'super-responders' and aims for an IND filing in **late Q2 or early Q3 2021**[24](index=24&type=chunk)[29](index=29&type=chunk)[34](index=34&type=chunk) - The company's discovery engine is characterized by an unbiased, broad, deep, and efficient approach to identifying novel antibody-target pairs[25](index=25&type=chunk)[26](index=26&type=chunk)[36](index=36&type=chunk) Overview Immunome leverages human memory B cells from patients who have successfully fought off diseases to discover novel therapeutic antibodies and their targets[20](index=20&type=chunk) - The company has processed over **150 cancer patient samples**, generated **300,000+ hybridomas**, and identified **~1,300 'hit' antibodies**, leading to over **50 potentially novel cancer targets**[22](index=22&type=chunk) - The IMM-BCP-01 program, in collaboration with the DoD, focuses on identifying a cocktail of anti-viral antibodies from COVID-19 'super-responders' to combat SARS-CoV-2 and its variants[24](index=24&type=chunk) Key Attributes of Our Discovery Engine - The discovery engine captures and expands patient-derived memory B cells, converts them into stable human hybridomas, and interrogates produced antibodies against disease-related antigens using high-throughput screening[26](index=26&type=chunk) - It simultaneously identifies relevant, potentially novel target antigens and high-affinity antibodies, aiming to advance **one to two antibodies** into IND-enabling development studies per year[26](index=26&type=chunk) Our Lead Discovery Programs - IMM-ONC-01 targets IL-38, a novel tumor-derived immune checkpoint, with preclinical data showing restoration of immune response and anti-tumor activity in animal models, with an IND filing planned for **H2 2021**[25](index=25&type=chunk)[28](index=28&type=chunk) - IMM-BCP-01 is developing an antibody cocktail from COVID-19 'super-responders' to target multiple viral antigens, including against emerging SARS-CoV-2 variants, with an IND filing planned for **late Q2 or early Q3 2021**[29](index=29&type=chunk) Management - The management team possesses broad expertise in therapeutic discovery and development, including world-class immunologists and biologists[30](index=30&type=chunk) Sources of Capital - Since 2015, Immunome has raised over **$95.8 million** through private financings and its IPO (October 6, 2020)[31](index=31&type=chunk) - In 2020, the company was awarded a contract for up to **$13.3 million** in expense reimbursement from the DoD for its IMM-BCP-01 program[31](index=31&type=chunk) Our Strategy - Immunome's strategy includes advancing IMM-ONC-01 and IMM-BCP-01 into clinical development, investing in its discovery engine to expand the pipeline, forming strategic partnerships, and expanding its intellectual property estate[32](index=32&type=chunk)[34](index=34&type=chunk)[36](index=36&type=chunk) - The company aims to advance **one to two programs** into IND-enabling studies per year[36](index=36&type=chunk) Our Strengths - The company's discovery engine is unbiased, broad, deep, and efficient, enabling the discovery of novel antibody-antigen pairs[36](index=36&type=chunk) The Challenges Faced by Existing Antibody Therapies for Cancer - Existing cancer therapeutics, including biologics, have limited success in advanced malignancies (e.g., **<10% five-year survival rate** for certain organs), partly due to a limited understanding of tumor diversity and complexity[35](index=35&type=chunk)[38](index=38&type=chunk) Our Solution: Immunome's Discovery Engine - The discovery process involves patient sampling (lymph node, tumor, or blood), fusing and immortalizing memory B cells into hybridomas, and high-throughput antibody screening against disease-related antigens[40](index=40&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk) - Antibody validation identifies specific antigens using protein microarrays or immunoprecipitation/mass spectrometry, followed by functional assays to assess therapeutic potential[44](index=44&type=chunk) - The engine has screened over **300,000 hybridomas**, identified **1,300 'hit' antibodies**, and over **50 cancer targets**, with a focus on unmodified antibodies for simpler development[45](index=45&type=chunk)[46](index=46&type=chunk) - A key output is 'functional clustering' of targets, providing insights into cancer biology and guiding future pipeline development[47](index=47&type=chunk)[48](index=48&type=chunk) Our Multiple Product Development Opportunities in Cancer - Immunome's platform supports various therapeutic modalities: unmodified immunoglobulins for direct anti-tumor effects or immune activation, Antibody-Drug Conjugates (ADCs) for targets with dense cell surface expression and rapid internalization, and Engineered Patient Derived Immunoglobulins to enhance T cell effector activities[50](index=50&type=chunk)[52](index=52&type=chunk) Our Lead Oncology Discovery Program (IMM-ONC-01) - IMM-ONC-01 targets IL-38, an IL-1 family cytokine, which appears to promote immune evasion in tumors, with TCGA data showing an inverse relationship between high IL-38 expression and immune effector cell presence in multiple tumors[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) - Preclinical testing with anti-IL-38 antibody CD1-M3 demonstrated high specificity for IL-38, blocked its activity in vitro, and restored innate and adaptive anti-tumor immune responses in mouse models, leading to anti-tumor efficacy comparable to existing immune-oncology agents[58](index=58&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk) - An IND filing for IMM-ONC-01 is expected in the **second half of 2021**[28](index=28&type=chunk)[32](index=32&type=chunk)[66](index=66&type=chunk) Our Lead Infectious Disease Discovery Program (IMM-BCP-01) - IMM-BCP-01 aims to develop an antibody cocktail from COVID-19 'super-responders' targeting multiple SARS-CoV-2 viral antigens (spike, nucleocapsid, membrane, ORF proteins) to achieve broad anti-viral activity and address emerging variants[68](index=68&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk)[72](index=72&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk) - Research identified over **400 antibodies**, with **more than half** directed at non-spike proteins, and antibodies targeting conserved spike epitopes showed neutralization against B.1.351 (South African) and B.1.1.7 (UK) variants[70](index=70&type=chunk)[75](index=75&type=chunk) - An IND application for IMM-BCP-01 is expected in **late Q2 or early Q3 2021** for testing in COVID-19 patients[29](index=29&type=chunk)[75](index=75&type=chunk) Strategic Collaborations and License Agreements - Immunome collaborates with the U.S. Department of Defense (DoD) for the IMM-BCP-01 program, receiving up to **$13.3 million** in expense reimbursement for SARS-CoV-2 antibody cocktail development[78](index=78&type=chunk)[81](index=81&type=chunk) - The company holds exclusive license agreements with Arrayjet Limited (for screening technology), Whitehead Institute for Biomedical Research and MIT (for antibody screening platform), and Thomas Jefferson University (for patent rights, know-how, and materials related to its platform)[83](index=83&type=chunk)[87](index=87&type=chunk)[94](index=94&type=chunk) - A collaboration with pH Pharma for Antibody-Drug Conjugates (ADCs) in oncology expired in **January 2021** without developed ADCs[99](index=99&type=chunk) Manufacturing - Immunome relies on third-party manufacturers, such as Abzena, for preclinical and future clinical trial product materials, as it does not possess internal cGMP manufacturing capabilities[100](index=100&type=chunk) Competition - Immunome faces competition in oncology from companies like AbCellera, Adaptive Biotechnologies, and large pharmaceutical companies (e.g., AstraZeneca, Merck)[101](index=101&type=chunk)[102](index=102&type=chunk)[103](index=103&type=chunk) - In infectious diseases (COVID-19), competitors include Regeneron, GlaxoSmithKline, Vir Biotechnology, Eli Lilly, and vaccine developers like Moderna and Pfizer[104](index=104&type=chunk) Intellectual Property - Immunome protects its technology through patents (compositions of matter, methods of use, diagnostics) and trade secrets, with national phase patent applications in **11 countries** and pending PCT/US provisional applications[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk)[117](index=117&type=chunk) - Patent applications for lead antibodies (IMM-ONC-01, IMM-BCP-01) and identified antigens are expected to expire between **2039 and 2042** if issued[107](index=107&type=chunk) - The company also relies on regulatory protections like orphan drug designations and patent term extensions[105](index=105&type=chunk)[110](index=110&type=chunk) Government Regulation - Biologics development is extensively regulated by the FDA under the FDCA and PHSA, involving preclinical studies (GLP), IND submission, and multi-phase clinical trials (GCP)[119](index=119&type=chunk)[120](index=120&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk)[127](index=127&type=chunk) - BLA submission and review require demonstrating safety, purity, and potency, compliance with cGMP, and may involve advisory committee review and facility inspections[130](index=130&type=chunk)[131](index=131&type=chunk)[133](index=133&type=chunk) - Expedited programs (Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval) are available for qualifying product candidates, but do not change approval standards[136](index=136&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[142](index=142&type=chunk) - Post-approval, products are subject to continuous regulation, including adverse event reporting, periodic reporting, and cGMP compliance, with potential for withdrawal of approval or REMS imposition[148](index=148&type=chunk)[149](index=149&type=chunk)[152](index=152&type=chunk) - The BPCIA provides an abbreviated approval pathway for biosimilars, granting **12 years of exclusivity** to reference biological products, but its ultimate impact is uncertain[153](index=153&type=chunk)[155](index=155&type=chunk)[159](index=159&type=chunk) - The company's operations are subject to various U.S. healthcare laws (Anti-Kickback Statute, False Claims Act, HIPAA, Sunshine Act) and foreign anti-corruption laws (FCPA), with non-compliance leading to significant penalties[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk)[167](index=167&type=chunk)[169](index=169&type=chunk)[172](index=172&type=chunk)[194](index=194&type=chunk) - Coverage and adequate reimbursement from third-party payors (government, private insurers) are crucial for product commercialization, but are uncertain and subject to cost-containment pressures and varying policies[174](index=174&type=chunk)[175](index=175&type=chunk)[179](index=179&type=chunk)[180](index=180&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk) - Healthcare reform measures, including the ACA and subsequent legislative changes, aim to control costs and impact drug pricing, potentially affecting future product revenues[184](index=184&type=chunk)[185](index=185&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk)[192](index=192&type=chunk)[193](index=193&type=chunk) Employees and Human Capital Resources - As of **December 31, 2020**, Immunome had **23 full-time employees**, with **19 in R&D** and **4 in G&A**, and offers competitive compensation, annual bonuses, and equity incentive plans[197](index=197&type=chunk)[199](index=199&type=chunk) Facilities - The company leases **11,000 square feet** of office and laboratory space in Exton, Pennsylvania, with the lease expiring on **August 31, 2022**[200](index=200&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) Immunome faces significant risks as a preclinical-stage biopharmaceutical company, including a history of losses and the need for substantial additional funding - Immunome is a preclinical-stage company with an accumulated deficit of **$54.4 million** as of **December 31, 2020**, and expects to incur significant losses for the foreseeable future[202](index=202&type=chunk) - The company's lead programs, IMM-BCP-01 and IMM-ONC-01, are in preclinical development and have never been tested in humans, carrying high risks of failure in clinical development and regulatory approval[215](index=215&type=chunk)[217](index=217&type=chunk) - The COVID-19 pandemic has impacted operations, including decreased laboratory productivity and potential delays in clinical trials, and could negatively affect the IMM-BCP-01 program's development and market potential[227](index=227&type=chunk)[230](index=230&type=chunk)[231](index=231&type=chunk)[233](index=233&type=chunk)[235](index=235&type=chunk)[237](index=237&type=chunk)[243](index=243&type=chunk) - The company's success depends on obtaining and maintaining intellectual property protection, which is uncertain due to the complex and evolving nature of patent law in biotechnology[340](index=340&type=chunk)[349](index=349&type=chunk)[350](index=350&type=chunk) Risks Related to Our Business - Immunome has a history of financial losses, with a **net loss of $17.8 million in 2020**, and expects continued significant losses, requiring substantial additional funds beyond its current **cash of $39.9 million** (as of Dec 31, 2020) to fund operations through **Q2 2022**[202](index=202&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk) - The company's preclinical-stage product candidates (IMM-BCP-01, IMM-ONC-01) have not been tested in humans, and there's no guarantee of successful clinical development, regulatory approval, or commercialization[215](index=215&type=chunk)[217](index=217&type=chunk) - The novel and unproven nature of Immunome's discovery engine means it may not successfully build a pipeline of marketable product candidates[224](index=224&type=chunk)[225](index=225&type=chunk) - The COVID-19 pandemic has caused decreased laboratory productivity, potential delays in IND filings and clinical trials, and increased competition for COVID-19 treatments, potentially impacting the IMM-BCP-01 program[227](index=227&type=chunk)[230](index=230&type=chunk)[231](index=231&type=chunk)[233](index=233&type=chunk)[237](index=237&type=chunk)[242](index=242&type=chunk)[243](index=243&type=chunk) - Reliance on third-party CROs and manufacturers for preclinical and clinical studies, and manufacturing, poses risks of delays, quality issues, and supply interruptions[305](index=305&type=chunk)[308](index=308&type=chunk)[309](index=309&type=chunk)[310](index=310&type=chunk)[311](index=311&type=chunk)[313](index=313&type=chunk) - The company's success is highly dependent on attracting and retaining key management and technical personnel, and difficulties in managing growth could impair operations[315](index=315&type=chunk)[319](index=319&type=chunk)[320](index=320&type=chunk)[321](index=321&type=chunk) Risks Related to Our Intellectual Property - Immunome's success depends on obtaining and maintaining patent protection for its technology and product candidates, but there's no guarantee that pending applications will issue or provide adequate protection[340](index=340&type=chunk)[341](index=341&type=chunk)[342](index=342&type=chunk)[344](index=344&type=chunk)[346](index=346&type=chunk)[347](index=347&type=chunk) - In-licensed patent rights from academic institutions may be subject to government 'march-in rights' or non-exclusive licenses, potentially harming competitive position[354](index=354&type=chunk) - Failure to comply with license obligations could lead to loss of intellectual property rights or increased financial burdens[355](index=355&type=chunk)[356](index=356&type=chunk)[358](index=358&type=chunk)[359](index=359&type=chunk)[361](index=361&type=chunk) - Patent terms may not adequately protect competitive position due to the lengthy development process and potential limitations on extensions[362](index=362&type=chunk)[363](index=363&type=chunk)[364](index=364&type=chunk)[365](index=365&type=chunk) - Changes in U.S. or foreign patent law (e.g., Leahy-Smith Act) or their interpretation could diminish patent value and increase prosecution/enforcement costs[366](index=366&type=chunk)[367](index=367&type=chunk) - Third parties may challenge Immunome's patent rights or assert their own, potentially leading to costly litigation, licensing requirements, or inability to commercialize products[368](index=368&type=chunk)[371](index=371&type=chunk)[372](index=372&type=chunk)[377](index=377&type=chunk)[378](index=378&type=chunk)[379](index=379&type=chunk)[380](index=380&type=chunk)[383](index=383&type=chunk)[384](index=384&type=chunk)[385](index=385&type=chunk) - Inability to protect trade secrets or claims of wrongful use of former employers' proprietary information could harm business and competitive position[388](index=388&type=chunk)[389](index=389&type=chunk) Risks Related to Government Regulation - Healthcare legislative reforms (e.g., ACA, Tax Act, BBA) aim to contain costs and impact drug pricing, potentially reducing demand or increasing pricing pressures for Immunome's future products[396](index=396&type=chunk)[397](index=397&type=chunk)[398](index=398&type=chunk)[400](index=400&type=chunk)[401](index=401&type=chunk)[403](index=403&type=chunk)[404](index=404&type=chunk) - Non-compliance with healthcare fraud and abuse laws (Anti-Kickback Statute, False Claims Act, HIPAA) can lead to severe penalties, including fines, imprisonment, and exclusion from government programs[405](index=405&type=chunk)[406](index=406&type=chunk)[407](index=407&type=chunk)[408](index=408&type=chunk)[409](index=409&type=chunk)[410](index=410&type=chunk) - Future biologic products may face earlier competition from biosimilars due to the BPCIA, potentially shortening exclusivity periods and impacting commercial prospects[411](index=411&type=chunk)[412](index=412&type=chunk)[413](index=413&type=chunk) - Disruptions at regulatory agencies (FDA, SEC) due to funding shortages or global health concerns (e.g., COVID-19) could delay product development, approval, and commercialization[415](index=415&type=chunk)[416](index=416&type=chunk)[417](index=417&type=chunk)[418](index=418&type=chunk) - Post-approval, products remain subject to continuous regulatory requirements, and non-compliance can lead to fines, withdrawal of approval, or market restrictions[419](index=419&type=chunk)[420](index=420&type=chunk)[421](index=421&type=chunk) - Unfavorable pricing regulations or inadequate third-party coverage and reimbursement policies could significantly harm the commercial viability of approved products[422](index=422&type=chunk)[423](index=423&type=chunk)[424](index=424&type=chunk)[425](index=425&type=chunk)[427](index=427&type=chunk) - Non-compliance with U.S. and foreign anti-corruption and anti-money laundering laws (e.g., FCPA) can result in criminal or civil liability and reputational damage[428](index=428&type=chunk)[429](index=429&type=chunk)[431](index=431&type=chunk)[432](index=432&type=chunk) Risks Related to Our Common Stock - The trading price of Immunome's common stock has been volatile since its IPO and may continue to fluctuate due to various factors, including preclinical/clinical trial results, regulatory developments, competition, and market conditions[433](index=433&type=chunk)[434](index=434&type=chunk)[436](index=436&type=chunk) - Principal stockholders and management beneficially owned approximately **34.7% of common stock** as of **December 31, 2020**, allowing them to exert significant control over corporate actions[438](index=438&type=chunk)[439](index=439&type=chunk)[440](index=440&type=chunk) - Future sales of common stock by existing stockholders after lock-up periods, or issuances of new equity, could cause stock price dilution and decline[441](index=441&type=chunk)[442](index=442&type=chunk)[443](index=443&type=chunk)[444](index=444&type=chunk) - As an 'emerging growth company,' Immunome benefits from reduced reporting requirements, which may make its stock less attractive to some investors and increase volatility[445](index=445&type=chunk)[446](index=446&type=chunk)[447](index=447&type=chunk)[448](index=448&type=chunk) - Operating as a public company incurs increased costs and management time for compliance, and identified material weaknesses in internal control over financial reporting could adversely affect investor confidence and stock value[449](index=449&type=chunk)[453](index=453&type=chunk)[457](index=457&type=chunk)[458](index=458&type=chunk)[460](index=460&type=chunk) - Anti-takeover provisions in charter documents and Delaware law could make acquisitions more difficult and prevent changes in management[462](index=462&type=chunk)[463](index=463&type=chunk) [Unresolved Staff Comments](index=89&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company has no unresolved staff comments from the SEC - There are no unresolved staff comments[468](index=468&type=chunk) [Properties](index=89&type=section&id=Item%202.%20Properties) Immunome leases 11,000 square feet of office and laboratory space in Exton, Pennsylvania, under a lease expiring on August 31, 2022, which is considered sufficient for immediate needs - Immunome leases **11,000 square feet** of office and laboratory space in Exton, Pennsylvania[469](index=469&type=chunk) - The current lease expires on **August 31, 2022**, and the space is deemed sufficient for immediate facility needs[469](index=469&type=chunk) [Legal Proceedings](index=89&type=section&id=Item%203.%20Legal%20Proceedings) Immunome is not currently involved in any material legal proceedings, though it may encounter litigation in the ordinary course of business, which could adversely impact the company - Immunome is not currently a party to any material legal proceedings[470](index=470&type=chunk) - Litigation, regardless of outcome, can have an adverse impact due to defense costs, diversion of management resources, and reputational harm[470](index=470&type=chunk) [Mine Safety Disclosures](index=89&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Immunome, Inc. - Not applicable[471](index=471&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=89&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 began trading on the Nasdaq Global Market under 'IMNM' on October 2, 2020, with approximately 10,659,626 outstanding shares as of March 22, 2021, and no dividends paid - Immunome's common stock has been publicly traded on the Nasdaq Global Market under the symbol **'IMNM'** since **October 2, 2020**[472](index=472&type=chunk) - As of **March 22, 2021**, there were **10,659,626 shares** of common stock outstanding[7](index=7&type=chunk)[473](index=473&type=chunk) - The company has not declared or paid any dividends since its inception and does not expect to in the foreseeable future[474](index=474&type=chunk)[461](index=461&type=chunk) - In 2020, the company issued **1,226,925 shares of Series A convertible preferred stock** to **51 investors for $11 million**, **127,291 shares of common stock** upon option exercise for **$20,849**, granted **1,168,618 stock options**, and issued **1,035,196 warrants** to purchase Series A preferred stock[477](index=477&type=chunk)[478](index=478&type=chunk)[479](index=479&type=chunk)[480](index=480&type=chunk) - The IPO, completed in **October 2020**, involved the sale of **3,737,500 shares of common stock at $12.00 per share**, generating net proceeds of approximately **$38.7 million** after deducting underwriting discounts and offering costs[482](index=482&type=chunk)[484](index=484&type=chunk)[485](index=485&type=chunk) [Selected Financial Data](index=91&type=section&id=Item%206.%20Selected%20Financial%20Data) This item is not required for Immunome, Inc. as an emerging growth company - Selected Financial Data is not required[488](index=488&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=92&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Immunome, Inc. is a development-stage company with all programs in preclinical stages, having incurred significant operating losses since inception, with IPO proceeds funding operations through Q2 2022, requiring future capital - Immunome is a development-stage company with all programs in preclinical stages, having incurred significant operating losses since inception[493](index=493&type=chunk) Net Loss (in millions) | Year Ended December 31, | Net Loss | | :---------------------- | :------- | | 2020 | $(17.8) | | 2019 | $(10.4) | - The company closed its IPO in **October 2020**, receiving net proceeds of **$41.7 million**[492](index=492&type=chunk) - As of **December 31, 2020**, Immunome had a cash balance of **$39.8 million**, expected to fund operations through the **second fiscal quarter of 2022**[494](index=494&type=chunk)[500](index=500&type=chunk) - Future funding will be required to support increasing R&D expenses, preclinical and clinical development, intellectual property protection, and public company operating costs[494](index=494&type=chunk)[495](index=495&type=chunk)[497](index=497&type=chunk)[499](index=499&type=chunk)[529](index=529&type=chunk)[530](index=530&type=chunk)[531](index=531&type=chunk) - The COVID-19 pandemic has caused significant disruptions, including work-from-home policies and potential delays in development timelines, with uncertain future economic impact[501](index=501&type=chunk)[504](index=504&type=chunk)[505](index=505&type=chunk)[506](index=506&type=chunk)[507](index=507&type=chunk)[515](index=515&type=chunk) Overview - Since inception in **2006**, Immunome has focused resources on R&D, capital raising, team building, and IP portfolio development, financing operations primarily through equity sales and convertible notes[491](index=491&type=chunk) - The company received **$0.5 million** from the Paycheck Protection Program (PPP) in **April 2020**[491](index=491&type=chunk) - Immunome expects to incur significant expenses and increasing operating losses as it advances preclinical and clinical development, expands R&D, protects IP, and hires personnel[494](index=494&type=chunk)[495](index=495&type=chunk)[497](index=497&type=chunk) COVID-19 Pandemic - Immunome implemented work-from-home policies and stringent safety measures for laboratory staff to mitigate COVID-19 risks, which has resulted in decreased productivity[505](index=505&type=chunk) - The pandemic's impact on development timelines, preclinical R&D, global financial markets, and liquidity remains uncertain[505](index=505&type=chunk)[506](index=506&type=chunk)[507](index=507&type=chunk) Components of our results of operations - Research and development expenses include personnel, discovery/preclinical costs, manufacturing process development, lab supplies, and facilities expenses, expensed as incurred[508](index=508&type=chunk) - Expense reimbursements from the DoD Agreement are recorded as contra-research and development expenses[510](index=510&type=chunk) - General and administrative expenses cover executive, IP, business development, and administrative personnel costs, legal fees, professional fees, and public company operating costs[511](index=511&type=chunk)[512](index=512&type=chunk) - Change in fair value of warrant liability reflects non-cash charges from remeasuring preferred stock warrants, which were reclassified to equity upon IPO[513](index=513&type=chunk) - Interest expense, net, includes interest on capital leases and equipment loans, offset by interest income on cash[514](index=514&type=chunk) Results of operations Comparison of Operating Results (in thousands) | Operating Expenses (in thousands) | 2020 | 2019 | Change | | :-------------------------------- | :--- | :--- | :----- | | Research and development | $7,486 | $8,823 | $(1,337) | | General and administrative | $4,775 | $1,525 | $3,250 | | Total operating expenses | $12,261 | $10,348 | $1,913 | | Loss from operations | $(12,261) | $(10,348) | $(1,913) | | Other expenses: | | | | | Change in fair value of warrant liability | $(5,538) | $— | $(5,538) | | Interest expense, net | $(38) | $(96) | $58 | | Total other expenses | $(5,576) | $(96) | $(5,480) | | Net loss | $(17,837) | $(10,444) | $(7,393) | - Research and development expenses decreased by **$1.3 million** in 2020, primarily due to **$1.7 million** in DoD expense reimbursements, offset by increases in personnel and facility costs[517](index=517&type=chunk) - General and administrative expenses increased by **$3.3 million** in 2020, driven by higher personnel costs (including share-based compensation) and professional fees related to public company operations[519](index=519&type=chunk) - A non-cash charge of **$5.5 million** was recognized in 2020 for the change in fair value of convertible preferred stock warrant liability, which increased due to the rise in Series A preferred stock fair value[520](index=520&type=chunk) Liquidity and capital resources - Immunome had **$39.8 million in cash** as of **December 31, 2020**, following **$95.3 million** in gross proceeds from equity sales and convertible notes since inception, and **$0.5 million** from the PPP loan[522](index=522&type=chunk) - Existing cash is expected to fund operations through **Q2 2022**, but substantial additional financing will be required thereafter for R&D, clinical trials, and growth[522](index=522&type=chunk)[530](index=530&type=chunk) Cash Flows (in thousands) | Cash Flow Activity (in thousands) | 2020 | 2019 | | :-------------------------------- | :--- | :--- | | Cash used in operating activities | $(12,134) | $(9,600) | | Cash used in investing activities | $(586) | $(233) | | Cash provided by financing activities | $49,943 | $10,774 | | Net increase in cash and restricted cash | $37,223 | $941 | - Net cash used in operating activities was **$12.1 million** in 2020, primarily due to net loss, offset by noncash charges and increases in payables[524](index=524&type=chunk) - Net cash provided by financing activities was **$49.9 million** in 2020, mainly from IPO proceeds (**$38.9 million net**), Series A preferred stock issuance (**$11.0 million net**), and the PPP loan (**$0.5 million**)[527](index=527&type=chunk) Critical accounting policies and significant judgements - Critical accounting policies include share-based compensation and warrant liability, requiring significant management estimates and judgments[536](index=536&type=chunk)[537](index=537&type=chunk) - Share-based compensation fair value is estimated using the Black-Scholes model, with key assumptions including common stock fair value (IPO price post-October 2020, prior valuations based on net asset/PWERM), expected volatility, term, and risk-free rate[538](index=538&type=chunk)[539](index=539&type=chunk)[540](index=540&type=chunk)[541](index=541&type=chunk)[542](index=542&type=chunk)[543](index=543&type=chunk) - Warrants to purchase Series A preferred stock were classified as a liability and remeasured at fair value until the IPO, when they converted to common stock warrants and were reclassified to additional paid-in capital[545](index=545&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=102&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not required for Immunome, Inc. - Not required[547](index=547&type=chunk) [Financial Statements and Supplementary Data](index=102&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The required financial statements and supplementary data are presented on pages 105 through 128 of this Annual Report - The information required by this Item is set forth on **pages 105 through 128**[548](index=548&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=102&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There have been no changes in or disagreements with accountants on accounting and financial disclosure - None[549](index=549&type=chunk) [Controls and Procedures](index=102&type=section&id=Item%209A.%20Controls%20and%20Procedures) Immunome's management concluded that its disclosure controls and procedures were not effective as of December 31, 2020, due to identified material weaknesses, with remediation efforts underway but not yet fully effective - As of **December 31, 2020**, Immunome's disclosure controls and procedures were not designed at a reasonable assurance level and were not effective[550](index=550&type=chunk) - Material weaknesses identified include lack of review of journal entries, insufficient review of financial statement account balances, and inadequate accounting and financial reporting personnel[552](index=552&type=chunk)[553](index=553&type=chunk) - Remediation activities include implementing a monthly financial statement close process with formal reviews, creating a disclosure committee, and actively recruiting qualified accounting personnel[554](index=554&type=chunk) - The material weaknesses are not yet considered remediated as the remedial controls are still being implemented, documented, and tested[556](index=556&type=chunk) [Other Information](index=103&type=section&id=Item%209B.%20Other%20Information) There is no other information to report under this item - None[559](index=559&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=103&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's definitive proxy statement for the 2021 annual meeting of stockholders - Information is incorporated by reference to the definitive proxy statement for the **2021 annual meeting of stockholders**[560](index=560&type=chunk) [Executive Compensation](index=103&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's definitive proxy statement for the 2021 annual meeting of stockholders - Information is incorporated by reference to the definitive proxy statement for the **2021 annual meeting of stockholders**[561](index=561&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=103&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) 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 2021 annual meeting of stockholders - Information is incorporated by reference to the definitive proxy statement for the **2021 annual meeting of stockholders**[562](index=562&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=103&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's definitive proxy statement for the 2021 annual meeting of stockholders - Information is incorporated by reference to the definitive proxy statement for the **2021 annual meeting of stockholders**[563](index=563&type=chunk) [Principal Accounting Fees and Services](index=103&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the company's definitive proxy statement for the 2021 annual meeting of stockholders - Information is incorporated by reference to the definitive proxy statement for the **2021 annual meeting of stockholders**[564](index=564&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=103&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements, financial statement schedules, and exhibits filed as part of this Annual Report on Form 10-K - This section includes the Index to Consolidated Financial Statements on **page 105**[565](index=565&type=chunk) - No separate financial statement schedules are provided as all required information is in the Notes to the Consolidated Financial Statements[566](index=566&type=chunk) - A comprehensive exhibit index is provided, detailing various agreements, plans, and certifications[567](index=567&type=chunk)[698](index=698&type=chunk)[700](index=700&type=chunk)[702](index=702&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=106&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Deloitte & Touche LLP, as the independent registered public accounting firm, audited Immunome, Inc.'s financial statements for the years ended December 31, 2020 and 2019, and issued an unqualified opinion, stating that the financial statements present fairly, in all material respects, the company's financial position, results of operations, and cash flows in conformity with GAAP - Deloitte & Touche LLP audited Immunome, Inc.'s financial statements for **2020 and 2019**[572](index=572&type=chunk) - The firm issued an **unqualified opinion**, stating the financial statements present fairly the company's financial position, results of operations, and cash flows in conformity with GAAP[572](index=572&type=chunk) - The audit did not include an opinion on the effectiveness of the company's internal control over financial reporting[574](index=574&type=chunk) [Balance Sheets as of December 31, 2020 and 2019](index=107&type=section&id=Balance%20Sheets%20as%20of%20December%2031%2C%202020%20and%202019) The balance sheets show a significant increase in total assets and stockholders' equity from 2019 to 2020, primarily driven by the IPO proceeds, with cash increasing substantially and convertible preferred stock eliminated due to conversion into common stock Balance Sheet Summary (in thousands) | Item | December 31, 2020 | December 31, 2019 | | :---------------------------------------- | :---------------- | :---------------- | | **Assets** | | | | Cash | $39,766 | $2,543 | | Total current assets | $42,894 | $3,122 | | Property and equipment, net | $1,531 | $1,700 | | Total assets | $44,525 | $5,060 | | **Liabilities** | | | | Total current liabilities | $3,038 | $1,665 | | Total liabilities | $3,180 | $1,796 | | **Equity** | | | | Series A convertible preferred stock | $— | $38,894 | | Common stock | $1 | $— | | Additional paid-in capital | $95,738 | $927 | | Accumulated deficit | $(54,394) | $(36,557) | | Total stockholders' equity (deficit) | $41,345 | $(35,630) | - Cash increased significantly from **$2.5 million in 2019 to $39.8 million in 2020**, primarily due to IPO proceeds[578](index=578&type=chunk) - Series A convertible preferred stock was eliminated in 2020, converting to common stock upon the IPO, leading to a substantial increase in additional paid-in capital and a shift from stockholders' deficit to equity[578](index=578&type=chunk) [Statements of Operations for the years ended December 31, 2020 and 2019](index=108&type=section&id=Statements%20of%20Operations%20for%20the%20years%20ended%20December%2031%2C%202020%20and%202019) Immunome reported a net loss of $17.8 million in 2020, an increase from $10.4 million in 2019, primarily driven by a significant non-cash charge for the change in fair value of warrant liability and increased general and administrative expenses, partially offset by a decrease in R&D expenses due to DoD reimbursements Statements of Operations Summary (in thousands, except per share amounts) | Item | Year ended December 31, 2020 | Year ended December 31, 2019 | | :---------------------------------------- | :--------------------------- | :--------------------------- | | Research and development | $7,486 | $8,823 | | General and administrative | $4,775 | $1,525 | | Total operating expenses | $12,261 | $10,348 | | Loss from operations | $(12,261) | $(10,348) | | Change in fair value of warrant liability | $(5,538) | $— | | Interest expense, net | $(38) | $(96) | | Net loss | $(17,837) | $(10,444) | | Net loss per share, basic and diluted | $(5.26) | $(9.55) | | Weighted-average common shares outstanding | 3,389,592 | 1,093,959 | - Net loss increased by **$7.4 million** from 2019 to 2020, primarily due to a **$5.5 million non-cash charge** for warrant liability and a **$3.3 million increase** in G&A expenses[516](index=516&type=chunk)[519](index=519&type=chunk)[520](index=520&type=chunk) - Research and development expenses decreased by **$1.3 million** in 2020, largely due to **$1.7 million** in DoD expense reimbursements[517](index=517&type=chunk) [Statements of Changes in Convertible Preferred Stock and Stockholders' Equity (Deficit) for the years ended December 31, 2020 and 2019](index=109&type=section&id=Statements%20of%20Changes%20in%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity%20%28Deficit%29%20for%20the%20years%20ended%20December%2031%2C%202020%20and%202019) The statements reflect a significant transformation in Immunome's equity structure in 2020, moving from a substantial accumulated deficit to positive stockholders' equity, primarily driven by the conversion of all Series A convertible preferred stock into common stock and the reclassification of liability-classified warrants to additional paid-in capital upon the IPO, alongside the proceeds from the common stock offering Changes in Equity (in thousands, except share amounts) | Item | Balance at Jan 1, 2019 | 2019 Activity | Balance at Dec 31, 2019 | 2020 Activity | Balance at Dec 31, 2020 | | :---------------------------------------- | :--------------------- | :------------ | :---------------------- | :------------ | :---------------------- | | Series A convertible preferred stock (shares) | 3,108,776 | 1,334,483 | 4,443,259 | (5,670,184) | — | | Series A convertible preferred stock (amount) | $27,513 | $11,381 | $38,894 | $(48,369) | $— | | Common stock (shares) | 1,087,821 | 11,449 | 1,099,270 | 9,534,975 | 10,634,245 | | Common stock (amount) | $— | $— | $— | $1 | $1 | | Additional paid-in capital | $908 | $19 | $927 | $94,811 | $95,738 | | Accumulated deficit | $(26,113) | $(10,444) | $(36,557) | $(17,837) | $(54,394) | | Total stockholders' equity (deficit) | $(25,205) | $(10,430) | $(35,630) | $76,975 | $41,345 | - In 2020, **5,670,184 shares of Series A convertible preferred stock** were converted into common stock upon the IPO, and **1,035,196 liability-classified warrants** were converted to common stock warrants and reclassified to additional paid-in capital (**$7.06 million**)[582](index=582&type=chunk)[676](index=676&type=chunk)[677](index=677&type=chunk) - The sale of **3,737,500 common stock shares** in connection with the IPO contributed **$38.7 million** to additional paid-in capital[582](index=582&type=chunk) - Accumulated deficit increased by **$17.8 million** in 2020, reflecting the net loss for the year[582](index=582&type=chunk) [Statements of Cash Flows for the years ended December 31, 2020 and 2019](index=110&type=section&id=Statements%20of%20Cash%20Flows%20for%20the%20years%20ended%20December%2031%2C%202020%20and%202019) Immunome's cash and restricted cash significantly increased in 2020, primarily driven by substantial cash provided by financing activities, including IPO proceeds and Series A preferred stock sales, despite continued cash usage in operating and investing activities Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | Year ended December 31, 2020 | Year ended December 31, 2019 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(12,134) | $(9,600) | | Net cash used in investing activities | $(586) | $(233) | | Net cash provided by financing activities | $49,943 | $10,774 | | Net increase in cash and restricted cash | $37,223 | $941 | | Cash and restricted cash at end of year | $39,866 | $2,643 | - Operating activities used **$12.1 million** in 2020, primarily due to the net loss, partially offset by noncash adjustments like depreciation, share-based compensation, and warrant liability changes[524](index=524&type=chunk)[585](index=585&type=chunk) - Investing activities used **$0.6 million** in 2020 for property and equipment purchases[526](index=526&type=chunk)[585](index=585&type=chunk) - Financing activities provided **$49.9 million** in 2020, mainly from **$38.9 million net IPO proceeds**, **$11.0 million** from Series A preferred stock, and **$0.5 million** from the PPP loan[527](index=527&type=chunk)[585](index=585&type=chunk) [Notes to Financial Statements](index=111&type=section&id=Notes%20to%20Financial%20Statements) The notes provide detailed information on Immunome's business, significant accounting policies, and financial instruments, covering the company's early-stage nature, ongoing operating losses, reliance on external funding, and the impact of the IPO on equity - Immunome is an early-stage biotechnology company with a history of net losses, expecting continued losses due to R&D costs for preclinical and clinical development[587](index=587&type=chunk)[588](index=588&type=chunk) - The company's IPO in **October 2020** generated **$41.7 million in net proceeds**, and its cash balance of **$39.8 million** (as of Dec 31, 2020) is expected to fund operations through **Q2 2022**, necessitating additional future financing[589](index=589&type=chunk)[590](index=590&type=chunk)[591](index=591&type=chunk) - Significant accounting policies include expensing R&D costs as incurred, recognizing DoD expense reimbursements as contra-R&D, classifying preferred stock as temporary equity (converted to common stock upon IPO), and valuing warrants as liabilities (reclassified to equity upon IPO)[595](index=595&type=chunk)[604](index=604&type=chunk)[605](index=605&type=chunk)[606](index=606&type=chunk)[608](index=608&type=chunk)[610](index=610&type=chunk) - Share-based compensation is recognized at fair value using the Black-Scholes model, with the fair value of common stock estimated based on various factors prior to the IPO and market price thereafter[612](index=612&type=chunk)[614](index=614&type=chunk)[615](index=615&type=chunk)[618](index=618&type=chunk) - The company has various commitments, including operating leases for facilities and equipment, employment agreements, and a 401(k) plan, and is not currently party to any material legal proceedings[648](index=648&type=chunk)[649](index=649&type=chunk)[650](index=650&type=chunk)[652](index=652&type=chunk)[653](index=653&type=chunk)[654](index=654&type=chunk) - Immunome holds multiple licensing agreements (**2009, 2012, 2019**) for its base editing, patent rights, know-how, and screening technologies, involving annual fees, milestone payments, and low single-digit royalties on net sales[655](index=655&type=chunk)[656](index=656&type=chunk)[659](index=659&type=chunk)[662](index=662&type=chunk)[665](index=665&type=chunk)[666](index=666&type=chunk) - As of **December 31, 2020**, the company had **$47.3 million** in federal and **$47.7 million** in state net operating loss carryforwards, subject to potential limitations under Sections 382 and 383 of the Internal Revenue Code[689](index=689&type=chunk) 1. Nature of the business and basis of presentation - Immunome, Inc. was incorporated in **2006** (Delaware in **2015**) and is a biotechnology company focused on novel cancer immunotherapies using a patented human B cell process[586](index=586&type=chunk) - The company has incurred net losses since inception (**$17.8M in 2020, $10.4M in 2019**) and expects future losses due to R&D costs for preclinical and clinical development[588](index=588&type=chunk) - The IPO in **October 2020** generated **$41.7 million in net proceeds**, with **$39.8 million cash** as of Dec 31, 2020, expected to fund operations through **Q2 2022**, requiring additional financing thereafter[589](index=589&type=chunk)[590](index=590&type=chunk) 2. Summary of significant accounting policies - Financial statements are prepared in accordance with GAAP, and the company uses estimates and assumptions for fair value measurements (e.g., common stock, warrant liability)[595](index=595&type=chunk)[597](index=597&type=chunk) - A **one-for-six reverse stock split** was legally effective on **September 22, 2020**, retroactively adjusting all share and per-share amounts[596](index=596&type=chunk) - Cash includes standard checking and money market accounts; restricted cash (**$100k**) serves as collateral for a lease security deposit[598](index=598&type=chunk)[599](index=599&type=chunk) - Property and equipment are depreciated straight-line over estimated useful lives (**3-5 years**); long-lived assets are evaluated for impairment[601](index=601&type=chunk)[602](index=602&type=chunk) - IPO costs were capitalized and then recorded as a reduction of additional paid-in capital upon IPO consummation[603](index=603&type=chunk) - Series A Preferred stock was classified as temporary equity due to contingent redeemability and converted to common stock upon IPO[604](index=604&type=chunk) - DoD expense reimbursements are recorded as contra-research and development expenses[605](index=605&type=chunk) - Warrants to purchase Series A preferred stock were liability-classified and remeasured at fair value until IPO, then reclassified to additional paid-in capital[606](index=606&type=chunk)[608](index=608&type=chunk)[609](index=609&type=chunk) - R&D costs are expensed as incurred; share-based compensation is recognized at fair value using the Black-Scholes model over the vesting period[610](index=610&type=chunk)[612](index=612&type=chunk)[613](index=613&type=chunk)[614](index=614&type=chunk)[615](index=615&type=chunk)[616](index=616&type=chunk)[617](index=617&type=chunk)[618](index=618&type=chunk) - The company uses the two-class method for net loss per share calculation, excluding dilutive securities when anti-dilutive[626](index=626&type=chunk)[627](index=627&type=chunk)[628](index=628&type=chunk)[629](index=629&type=chunk) - As an emerging growth company, Immunome elected the extended transition period for new accounting standards, with ASC 842 (Leases) effective **January 1, 2022**[633](index=633&type=chunk)[634](index=634&type=chunk) 3. Fair value measurement Change in Fair Value of Warrant Liability (in thousands) | Item | Amount | | :---------------------------------------------- | :----- | | Balance, December 31, 2019 | $— | | Issuance of warrants on June 2, 2020 | $1,522 | | Change in fair value of warrant liability | $5,538 | | Reclass of warrant liability to additional paid-in capital upon IPO | $(7,060) | | Warrant liability, December 31, 2020 | $— | - The warrant liability was valued using **Level 3 unobservable inputs** in a Black-Scholes model, reflecting changes in the fair value of Series A preferred stock[636](index=636&type=chunk) 4. Property and equipment, net Property and Equipment, Net (in thousands) | Asset Category | December 31, 2020 | December 31, 2019 | | :---------------------------------- | :---------------- | :---------------- | | Lab equipment | $3,506 | $2,942 | | Leasehold improvements | $185 | $184 | | Computer equipment | $96 | $76 | | Office equipment and furniture and fixtures | $18 | $17 | | Total gross property and equipment | $3,805 | $3,219 | | Less accumulated depreciation and amortization | $(2,274) | $(1,519) | | Property and equipment, net | $1,531 | $1,700 | - Depreciation and amortization expense was **$0.8 million in 2020** and **$0.6 million in 2019**[638](index=638&type=chunk) 5. Department of Defense (DoD) expense reimbursement contract - In **July 2020**, Immunome entered a DoD Agreement for up to **$13.3 million** to develop Biosynthetic Convalescent Plasma (BCP) for COVID-19[639](index=639&type=chunk) - The company recorded **$1.7 million** as contra-research and development expense in 2020[639](index=639&type=chunk) - As of **December 31, 2020**, a **$0.9 million** expense reimbursement receivable was due from the DoD[639](index=639&type=chunk) 6. Accrued expenses Accrued Expenses (in thousands) | Item | December 31, 2020 | December 31, 2019 | | :---------------------------------- | :---------------- | :---------------- | | Compensation and related benefits | $845 | $426 | | Professional fees, contractors and other | $527 | $240 | | Total accrued expenses | $1,372 | $666 | 7. Convertible promissory notes - In 2019, Immunome issued **$6.8 million** in non-interest bearing convertible promissory notes, which automatically converted into **821,657 shares of Series A Preferred stock** in **November 2019**[641](index=641&type=chunk)[642](index=642&type=chunk) 8. Equipment loan payables - Immunome has equipment financing agreements with interest rates ranging from **9.03% to 12.08%**[644](index=644&type=chunk) Future Equipment Loan Payments (in thousands) | Year ending December 31, | Amount | | :----------------------- | :----- | | 2021 | $117 | | Less amounts representing interest | $(4) | | Total equipment loan payable | $113 | 9. Long-term debt - On **April 30, 2020**, Immunome received a **$0.5 million PPP loan** from Silicon Valley Bank, bearing **1% interest**, with potential for forgiveness based on qualifying expenses[646](index=646&type=chunk) - The company applied for loan forgiveness in **January 2021** and is awaiting a decision[646](index=646&type=chunk) Long-Term Debt Payments (in thousands) | Years ending December 31, | Amount | | :------------------------ | :----- | | 2021 | $366 | | 2022 | $134 | | Total | $500 | | Less current portion of long-term debt | $(366) | | Long-term debt, net of current portion | $134 | 10. Commitments and contingencies - Immunome leases office and laboratory space in Exton, PA, with a lease term of **62 months** commencing **July 1, 2017**, and an option for **two additional five-year terms**[648](index=648&type=chunk) Future Minimum Operating Lease Payments (in thousands) | Years ending December 31, | Amount | | :------------------------ | :----- | | 2021 | $349 | | 2022 | $153 | | Total | $502 | - Rent expense was **$0.4 million in 2020** and **$0.3 million in 2019**[650](index=650&type=chunk) - All capital leases for laboratory equipment expired during 2020, with interest expense of **$7,000 in 2020**[651](index=651&type=chunk) - The company maintains a 401(k) Plan, making matching contributions of **$74,000 in 2020** and **$61,000 in 2019**[653](index=653&type=chunk) 11. Licensing arrangements - Immunome has a **2009 exclusive, royalty-bearing license agreement** with two research institutions for base editing technology, requiring annual maintenance fees and potential milestone/royalty payments[655](index=655&type=chunk)[656](index=656&type=chunk) - A **2012 exclusive, royalty-bearing license agreement** with a medical institution covers patent rights, know-how, and materials, with potential aggregate milestone payments of **$1.0 million**[659](index=659&type=chunk)[662](index=662&type=chunk) - A **2019 exclusive, royalty-bearing license agreement** with Arrayjet Limited covers substrate handling and printing technology, requiring an annual exclusivity fee (expensed as R&D) and potential royalties[665](index=665&type=chunk)[666](index=666&type=chunk)[668](index=668&type=chunk) - All licensing rights were accounted for as asset acquisitions, with cash/share-based payment obligations recorded as R&D expense, as assets had not reached technological feasibility[657](index=657&type=chunk)[663](index=663&type=chunk)[667](index=667&type=chunk) 12. Common stock and convertible preferred stock - Upon IPO in **October 2020**, Immunome issued **3,757,500 common shares at $12.00/share**, generating **$41.7 million net proceeds**, and increased authorized common stock to **200,000,000 shares**[671](index=671&type=chunk) - All Series A Preferred stock (**5,670,184 shares**) converted into common stock upon the IPO[676](index=676&type=chunk) - In 2020, **1,226,925 Series A Preferred shares** were sold for **$11.0 million**, and **1,035,196 warrants** to purchase Series A Preferred (fair value **$1.5 million**) were issued[673](index=673&type=chunk) - Outstanding warrants (**1,035,196**) to acquire common stock were reclassified from liability to additional paid-in capital (**$7.1 million**) upon IPO[677](index=677&type=chunk) Warrant Fair Value Inputs (Black-Scholes Model) | Input | June 2, 2020 | October 6, 2020 | | :------------------------ | :----------- | :-------------- | | Volatility rate | 79.0% | 82.0% | | Risk-free interest rate | 0.2% | 0.2% | | Expected term (in years) | 3.0 | 2.7 | | Strike price (per share) | $9.00 | $9.00 | | Fair value of Series A convertible preferred stock | $4.44 | $12.00 | 13. Share-based compensation - Immunome replaced its **2008 and 2018 Equity Incentive Plans** with the **2020 Equity Incentive Plan** and adopted the **2020 Employee Stock Purchase Plan (ESPP)** in **September 2020**[679](index=679&type=chunk)[680](index=680&type=chunk) Share-Based Compensation Expense (in thousands) | Expense Category | Year Ended December 31, 2020 | Year Ended December 31, 2019 | | :------------------------- | :--------------------------- | :--------------------------- | | General and administrative | $441 | $5 | | Research and development | $180 | $9 | | Total | $621 | $14 | - Unrecognized compensation cost for unvested options was **$3.6 million** as of **December 31, 2020**, to be recognized over **3.88 years**[682](index=682&type=chunk) Stock Option Activity Summary (2020) | Item | Number of shares | Weighted average exercise price per share | | :------------------------------------ | :--------------- | :---------------------------------------- | | Outstanding at January 1, 2020 | 583,622 | $0.47 | | Granted | 1,168,618 | $4.90 | | Forfeited | (152,109) | $8.90 | | Exercised | (127,291) | $0.16 | | Outstanding at December 31, 2020 | 1,472,840 | $3.14 | | Exercisable at December 31, 2020 | 632,524 | $0.89 | - The weighted-average grant date fair value of stock options granted was **$3.71 in 2020** and **$0.24 in 2019**[683](index=683&type=chunk) 14. Income taxes Deferred Tax Assets and Liabilities (in thousands) | Item | December 31, 2020 | December 31, 2019 | | :---------------------------------- | :---------------- | :---------------- | | Net operating loss carryforwards | $13,693 | $10,202 | | Research and development credits | $1,560 | $1,355 | | Gross deferred tax assets | $15,538 | $11,874 | | Less: valuation allowance | $(15,435) | $(11,711) | | Net deferred tax asset | $103 | $163 | | Deferred tax liability (Depreciation) | $(103) | $(163) | | Total deferred tax liabilities | $— | $— | - Immunome had no income tax expense in **2020 and 2019** due to operating losses and recorded a full valuation allowance against net deferred tax assets[685](index=685&type=chunk) - As of **December 31, 2020**, the company had **$47.3 million federal** and **$47.7 million state NOL carryforwards**, and **$1.4 million federal R&D tax credits**, with various expiration dates through **2039**[689](index=689&type=chunk) - NOLs generated in **2018 and 2019** (**$18.3 million**) do not expire, but federal NOLs from **2020 and 2019** are limited to offsetting **80% of taxable income** after **December 31, 2020**[689](index=689&type=chunk) 15. Interest expense, net Interest Expense, Net (in thousands) | Item | Year Ended December 31, 2020 | Year Ended December 31, 2019 | | :------------------------------------ | :--------------------------- | :--------------------------- | | Capital lease obligations interest expense | $(18) | $(60) | | Equipment loan payable interest expense | $(21) | $(46) | | Interest income | $1 | $10 | | Total interest expense, net | $(38) | $(96) | 16. Related party transactions - Immunome has license agreements with shareholders, incurring approximately **$0.1 million in expenses in 2020** and **$0.2 million in 2019**[693](index=693&type=chunk) - In 2019, **$3.8 million of convertible promissory notes** were issued to existing preferred stock investors, which later converted to Series A Preferred shares[694](index=694&type=chunk) - The company has a Master Services Agreement with Broadband Advisory for corporate finance, strategic planning, and management recruiting services, incurring **$0.2 million annually in 2020 and 2019**[696](index=696&type=chunk)

[General Information](index=1&type=section&id=General%20Information) [Form 10-Q Details](index=1&type=section&id=Form%2010-Q%20Details) This document is a Quarterly Report on Form 10-Q for Immunome, Inc. for the period ended September 30, 2020, detailing its corporate status and stock information - The report is a Quarterly Report on Form 10-Q for the period ended September 30, 2020[2](index=2&type=chunk) Registrant Information | Detail | Value | | :-------------------------------- | :----------- | | Registrant Name | Immunome, Inc. | | State of Incorporation | Delaware | | Trading Symbol | IMNM | | Market | The Nasdaq Capital Market | | Filer Status | Non-accelerated filer, Smaller reporting company, Emerging growth company | - As of October 31, 2020, there were **10,541,629 shares** of common stock outstanding[5](index=5&type=chunk) [PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements.](index=3&type=section&id=Item%201.%20Financial%20Statements.) This section presents Immunome, Inc.'s unaudited condensed financial statements, including balance sheets, statements of operations, changes in equity, and cash flows, along with comprehensive explanatory notes [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) The condensed balance sheets show a significant increase in total assets and liabilities from December 31, 2019, to September 30, 2020, primarily driven by an increase in cash and the recognition of a warrant liability Condensed Balance Sheet Highlights (in thousands) | Metric | Sep 30, 2020 | Dec 31, 2019 | | :-------------------------------- | :----------- | :----------- | | Cash | $6,744 | $2,543 | | Total current assets | $7,483 | $3,122 | | Total assets | $11,983 | $5,060 | | Total current liabilities | $5,406 | $1,665 | | Warrant liability | $7,071 | $— | | Total liabilities | $12,699 | $1,796 | | Total stockholders' deficit | $(49,085) | $(35,630) | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) The company reported increased net losses for both the three and nine months ended September 30, 2020, compared to the prior year, largely due to a significant non-cash charge from the change in fair value of warrant liability Condensed Statements of Operations Highlights (in thousands) | Metric | 3 Months Ended Sep 30, 2020 | 3 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2020 | 9 Months Ended Sep 30, 2019 | | :---------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $1,644 | $2,234 | $5,651 | $6,391 | | General and administrative | $1,174 | $486 | $2,537 | $1,069 | | Total operating expenses | $2,818 | $2,720 | $8,188 | $7,460 | | Loss from operations | $(2,818) | $(2,720) | $(8,188) | $(7,460) | | Change in fair value of warrant liability | $(5,549) | $— | $(5,549) | $— | | Net loss | $(8,377) | $(2,737) | $(13,764) | $(7,522) | | Net loss per share (basic and diluted) | $(7.52) | $(2.50) | $(12.44) | $(6.88) | [Condensed Statements of Changes in Convertible Preferred Stock and Stockholders' Deficit](index=6&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Deficit) The statements detail changes in convertible preferred stock and stockholders' deficit, reflecting the issuance of Series A convertible preferred stock, share-based compensation, exercise of stock options, and net losses for the periods presented Changes in Convertible Preferred Stock and Stockholders' Deficit (9 Months Ended Sep 30, 2020, in thousands) | Item | Series A Amount | Additional Paid-in Capital | Accumulated Deficit | Total Stockholders' Deficit | | :-------------------------------------------------------------------------------- | :---------------- | :------------------------- | :------------------ | :-------------------------- | | Balance at Dec 31, 2019 | $38,894 | $927 | $(36,557) | $(35,630) | | Sale of Series A convertible preferred stock and warrants (net) | $9,475 | $— | $— | $— | | Share-based compensation expense | $— | $302 | $— | $302 | | Exercise of stock options | $— | $7 | $— | $7 | | Net loss | $— | $— | $(13,764) | $(13,764) | | Balance at Sep 30, 2020 | $48,369 | $1,236 | $(50,321) | $(49,085) | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash flows from operating activities remained negative, while financing activities provided significant cash, primarily from the sale of convertible preferred stock and a PPP loan, leading to a net increase in cash and restricted cash for the nine months ended September 30, 2020 Condensed Statements of Cash Flows Highlights (9 Months Ended Sep 30, in thousands) | Cash Flow Activity | 2020 | 2019 | | :-------------------------------- | :----- | :----- | | Net cash used in operating activities | $(6,072) | $(7,021) | | Net cash used in investing activities | $(540) | $(166) | | Net cash provided by financing activities | $10,813 | $6,345 | | Net increase (decrease) in cash and restricted cash | $4,201 | $(842) | | Cash and restricted cash at end of period | $6,844 | $860 | - Non-cash financing activities for 2020 included **$1.522 million** fair value of liability-classified warrants issued and **$2.221 million** IPO costs included in accounts payable[21](index=21&type=chunk) [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) These notes provide detailed explanations of the company's business, significant accounting policies, financial instrument valuations, debt, equity transactions, and other commitments, offering crucial context for the financial statements [Note 1. Nature of the business and basis of presentation](index=9&type=section&id=Note%201.%20Nature%20of%20the%20business%20and%20basis%20of%20presentation) Immunome, Inc. is a biotechnology company focused on immunotherapies, operating as an early-stage company with a history of net losses, whose recent IPO significantly improved its liquidity, alleviating prior going concern concerns - Immunome, Inc. is a biotechnology company focused on identifying novel cancer and infectious disease immunotherapies using a patented B cell immortalization process[23](index=23&type=chunk) - The company has incurred net losses since inception, with a net loss of **$13.8 million** for the nine months ended September 30, 2020, and an accumulated deficit of **$50.3 million**[26](index=26&type=chunk) - On October 6, 2020, the company closed its IPO, issuing **3,250,000 shares** at **$12.00/share**, generating net proceeds of **$41.7 million**, which, combined with existing cash, is expected to fund operations into Q1 2022, alleviating prior going concern doubts[25](index=25&type=chunk)[27](index=27&type=chunk) [Note 2. Summary of significant accounting policies](index=11&type=section&id=Note%202.%20Summary%20of%20significant%20accounting%20policies) This note outlines the accounting principles used, including GAAP compliance, unaudited interim results, the impact of a reverse stock split, use of estimates, fair value measurements, government contract funding as contra-R&D expense, warrant liability classification and valuation, research and development cost expensing, and net loss per share calculation using the two-class method - The financial statements are prepared in accordance with GAAP and include unaudited interim results[33](index=33&type=chunk)[34](index=34&type=chunk) - A one-for-six reverse stock split was legally effective on September 22, 2020, retroactively adjusting all share and per share amounts[36](index=36&type=chunk) - Warrants to purchase Series A convertible preferred stock are classified as a liability and remeasured to fair value at each balance sheet date, with changes recognized in the statements of operations, and fair value is estimated using the Black-Scholes option pricing model[42](index=42&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) - Research and development costs are expensed as incurred, and amounts received under the U.S. Department of Defense expense reimbursement contract are accounted for as contra-research and development expenses[41](index=41&type=chunk)[46](index=46&type=chunk) - Net loss per share is computed using the two-class method, excluding potentially dilutive securities when their effect is anti-dilutive[47](index=47&type=chunk)[50](index=50&type=chunk) [Note 3. Fair value measurements](index=16&type=section&id=Note%203.%20Fair%20value%20measurements) This note details the fair value measurements, specifically for the warrant liability, which is categorized as Level 3 due to the use of unobservable inputs, and which increased significantly during the nine months ended September 30, 2020 Fair Value Measurements (September 30, 2020, in thousands) | Liabilities | Total | Level 1 | Level 2 | Level 3 | | :-------------------------------- | :---- | :------ | :------ | :------ | | Warrant liability | $7,071 | $— | $— | $7,071 | | Total liabilities measured and recorded at fair value | $7,071 | $— | $— | $7,071 | Reconciliation of Change in Fair Value of Warrant Liability (9 Months Ended Sep 30, 2020, in thousands) | Item | Fair Value Measurements Using Significant Unobservable Inputs (Level 3) | | :-------------------------------- | :-------------------------------------------------------- | | Balance, December 31, 2019 | $— | | Issuance of warrants on June 2, 2020 | $1,522 | | Change in fair value of warrant liability | $5,549 | | Warrant liability, September 30, 2020 | $7,071 | [Note 4. U.S. Department of Defense ("DoD") expense reimbursement contract](index=17&type=section&id=Note%204.%20U.S.%20Department%20of%20Defense%20(%22DoD%22)%20expense%20reimbursement%20contract) In July 2020, the company entered into an OTA Agreement with the DoD for **$13.3 million** to develop Biosynthetic Convalescent Plasma (BCP) for COVID-19 treatment, recording **$0.6 million** as contra-research and development expense for the three and nine months ended September 30, 2020 - The company secured a **$13.3 million** OTA Agreement with the DoD in July 2020 to develop Biosynthetic Convalescent Plasma (BCP) for COVID-19[55](index=55&type=chunk) - Contra-research and development expense of **$0.6 million** was recorded for both the three and nine months ended September 30, 2020, related to this agreement[55](index=55&type=chunk) [Note 5. Accrued expenses](index=17&type=section&id=Note%205.%20Accrued%20expenses) Accrued expenses significantly increased from December 31, 2019, to September 30, 2020, primarily due to IPO costs and higher compensation and related benefits Accrued Expenses (in thousands) | Category | Sep 30, 2020 | Dec 31, 2019 | | :-------------------------- | :----------- | :----------- | | IPO costs | $1,165 | $— | | Compensation and related benefits | $831 | $426 | | Research and development, and other | $334 | $240 | | Total | $2,330 | $666 | [Note 6. Convertible promissory notes](index=17&type=section&id=Note%206.%20Convertible%20promissory%20notes) In 2019, the company issued **$6.8 million** in non-interest bearing convertible promissory notes, which automatically converted into **821,657 shares** of Series A Preferred stock in November 2019 upon the completion of a Series A Preferred sale - From January to July 2019, the company issued **$6.8 million** in non-interest bearing convertible promissory notes[57](index=57&type=chunk) - These notes automatically converted into **821,657 shares** of Series A Preferred stock in November 2019[58](index=58&type=chunk) [Note 7. Equipment loan payables](index=19&type=section&id=Note%207.%20Equipment%20loan%20payables) The company has equipment financing agreements with interest rates ranging from **9.03% to 12.08%**, with future payments totaling **$168,000** as of September 30, 2020, primarily due in 2021 - Equipment financing agreements have interest rates between **9.03% and 12.08%**[60](index=60&type=chunk) Future Equipment Loan Payments (as of Sep 30, 2020, in thousands) | Years ending December 31, | Amount | | :-------------------------- | :----- | | 2020 (remaining 3 months) | $51 | | 2021 | $117 | | Total | $168 | | Less amounts representing interest | $(8) | | Total equipment loan payable | $160 | [Note 8. Long-term debt](index=19&type=section&id=Note%208.%20Long-term%20debt) In April 2020, the company secured a **$0.5 million** PPP loan under the CARES Act, bearing **1% interest**, with payments deferred until October 2020, and the company intends to apply for loan forgiveness - On April 30, 2020, the company entered into a **$0.5 million** PPP loan agreement with Silicon Valley Bank under the CARES Act[62](index=62&type=chunk) - The loan matures in two years, bears **1% interest**, and payments were deferred until October 30, 2020, with the company planning to apply for forgiveness[62](index=62&type=chunk) Future Principal Payments for Long-Term Debt (as of Sep 30, 2020, in thousands) | Years ending December 31, | Amount | | :-------------------------- | :----- | | 2020 (remaining 3 months) | $55 | | 2021 | $333 | | 2022 | $112 | | Total | $500 | | Less current portion of long-term debt | $(305) | | Long-term debt, net of current portion | $195 | [Note 9. Commitments and contingencies](index=21&type=section&id=Note%209.%20Commitments%20and%20contingencies) The company has commitments related to an operating lease for office and laboratory space, with future minimum payments totaling **$434,000** as of September 30, 2020, while capital leases for equipment ended in July 2020, and the company also has employment agreements and a 401(k) plan - The company leases office and laboratory space under a 62-month operating lease, with future minimum payments of **$434,000** as of September 30, 2020[64](index=64&type=chunk)[65](index=65&type=chunk) - Capital leases for laboratory equipment, with interest rates from **9.43% to 11.35%**, concluded in July 2020[66](index=66&type=chunk) - The company maintains employment agreements with key personnel and a defined-contribution 401(k) plan for employees[67](index=67&type=chunk)[68](index=68&type=chunk) [Note 10. Convertible preferred stock and stockholders' deficit](index=21&type=section&id=Note%2010.%20Convertible%20preferred%20stock%20and%20stockholders'%20deficit) This note details the terms of Series A convertible preferred stock, including dividend, voting, liquidation, and conversion rights, and its classification as temporary equity, also describing common stock rights and the conversion of all preferred stock into common stock upon the IPO - In June 2020, the company sold **1,226,925 shares** of Series A Preferred stock for **$11.0 million** gross proceeds and issued warrants to purchase **1,035,196 shares** of Series A Preferred[70](index=70&type=chunk)[71](index=71&type=chunk) - Series A Preferred stockholders have dividend participation rights (though none declared), voting rights on an as-converted basis, and liquidation preferences[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) - The Series A Preferred is convertible into common stock at **$9.00 per share**, with automatic conversion upon a public offering meeting specific criteria, and is classified as temporary equity due to contingent redemption events outside the company's control[75](index=75&type=chunk)[76](index=76&type=chunk) - Upon the IPO closing on October 6, 2020, all outstanding Series A Preferred stock converted into **5,670,184 shares** of common stock[25](index=25&type=chunk)[80](index=80&type=chunk) [Note 11. Warrants to acquire shares of Series A convertible preferred stock](index=25&type=section&id=Note%2011.%20Warrants%20to%20acquire%20shares%20of%20Series%20A%20convertible%20preferred%20stock) The company issued **1,035,196** liability-classified warrants to acquire Series A convertible preferred stock in June 2020, which are valued using a Black-Scholes model and will convert to common stock warrants upon IPO completion - **1,035,196** liability-classified warrants to acquire Series A convertible preferred stock were issued in June 2020[83](index=83&type=chunk) - The fair value of these warrants is estimated using a Black-Scholes pricing model, incorporating inputs like volatility rate (**79.0%** on June 2, 2020; **81.9%** on Sep 30, 2020), risk-free interest rate (**0.2%**), expected term (**3.0 years**), strike price (**$9.00**), and fair value of Series A preferred stock (**$4.44** on June 2, 2020; **$12.00** on Sep 30, 2020)[84](index=84&type=chunk) [Note 12. Share-based compensation](index=25&type=section&id=Note%2012.%20Share-based%20compensation) The company has various equity incentive plans (2008, 2018, 2020 Plans, and ESPP Plan) for granting stock options and other awards, with share-based compensation expense increasing significantly in 2020, and unrecognized compensation cost for unvested options totaling **$1.5 million** as of September 30, 2020 - The company operates under the 2008, 2018, and 2020 Equity Incentive Plans, and adopted the 2020 Employee Stock Purchase Plan (ESPP Plan)[85](index=85&type=chunk)[86](index=86&type=chunk) Share-Based Compensation Expense (in thousands) | Category | 3 Months Ended Sep 30, 2020 | 3 Months Ended Sep 30, 2019 | 9 Months Ended Sep 30, 2020 | 9 Months Ended Sep 30, 2019 | | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | General and administrative | $78 | $1 | $208 | $5 | | Research and development | $39 | $— | $94 | $6 | | Total | $117 | $1 | $302 | $11 | - Unrecognized compensation cost for unvested options was **$1.5 million** as of September 30, 2020, to be recognized over an estimated **2.82 years**[90](index=90&type=chunk) - Stock options outstanding at September 30, 2020, totaled **1,316,267 shares** with a weighted-average exercise price of **$0.97** and an aggregate intrinsic value of **$14.5 million**[91](index=91&type=chunk)[93](index=93&type=chunk) [Note 13. Related party transactions](index=29&type=section&id=Note%2013.%20Related%20party%20transactions) Related party transactions include license agreements, convertible promissory notes from existing investors, and a master services agreement with Broadband for advisory services, resulting in **$0.1 million** in general and administrative expenses for the three and nine months ended September 30, 2020 - Expenses with related parties from license agreements were de minimis for the three and nine months ended September 30, 2020[95](index=95&type=chunk) - In 2019, **$3.8 million** of convertible promissory notes were issued to existing preferred stock investors, which later converted to Series A Preferred shares[96](index=96&type=chunk) - The company pays Broadband Capital Partners LLC **$20,000 per month** for advisory services, totaling **$0.1 million** in general and administrative expenses for both the three and nine months ended September 30, 2020[97](index=97&type=chunk) [Note 14. Subsequent events](index=29&type=section&id=Note%2014.%20Subsequent%20events) Subsequent to the reporting period, the company completed its IPO on October 6, 2020, raising **$41.7 million** net proceeds, with all outstanding convertible preferred stock and warrants converting into common stock, and the authorized common stock being increased - On October 6, 2020, the company closed its IPO, selling **3,250,000 shares** at **$12.00 per share**, with underwriters exercising an option for an additional **487,500 shares**, resulting in **$41.7 million** net proceeds[98](index=98&type=chunk) - Upon IPO closing, all outstanding convertible preferred stock converted into **5,670,184 shares** of common stock, and warrants to purchase preferred stock converted into warrants to purchase common stock[98](index=98&type=chunk) - The company's authorized common stock was increased to **200,000,000 shares**, and **10,000,000 shares** of 'blank check' preferred stock were authorized[98](index=98&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, highlighting its development stage, recent IPO, and the impact of the COVID-19 pandemic, detailing operating expenses, analyzing financial performance, discussing liquidity, funding requirements, critical accounting policies, and the implications of the JOBS Act [Overview](index=31&type=section&id=Overview) Immunome, Inc. is a development-stage biotechnology company with no product sales revenue to date, primarily funding operations through preferred stock sales, warrants, convertible notes, and a recent IPO, and continues to incur significant operating losses, requiring substantial additional financing for its preclinical and future clinical development - Immunome is a development-stage company with all programs at a preclinical stage, having generated no revenue from product sales to date[105](index=105&type=chunk) - The company has financed operations through **$50.4 million** from preferred stock/warrants and convertible notes, a **$0.5 million** PPP loan, and **$41.7 million** net proceeds from its October 2020 IPO[102](index=102&type=chunk)[103](index=103&type=chunk) - Net losses were **$8.4 million** for the three months and **$13.8 million** for the nine months ended September 30, 2020, and the company expects continued significant operating losses and will need substantial additional financing beyond Q1 2022[105](index=105&type=chunk)[106](index=106&type=chunk)[112](index=112&type=chunk) [COVID-19 Pandemic](index=35&type=section&id=COVID-19%20Pandemic) The COVID-19 pandemic has caused significant disruptions, leading Immunome to implement work-from-home policies and stringent safety measures for essential staff, and while no significant impact on operations or financial statements has been observed to date, future effects on development timelines, liquidity, and stock value remain uncertain - The COVID-19 pandemic has led to severe travel restrictions, social distancing, and stay-at-home orders, causing significant disruptions to economies and financial markets[113](index=113&type=chunk) - Immunome implemented a work-from-home policy for most employees and stringent safety measures for business-critical staff to maintain business continuity[114](index=114&type=chunk) - To date, there has not been a significant impact on the company's operations or financial statements, but future effects on development timelines, access to capital, and stock value are uncertain[32](index=32&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) [Components of our results of operations](index=36&type=section&id=Components%20of%20our%20results%20of%20operations) This section defines the key components of the company's operating results: research and development expenses (expensed as incurred, including personnel, preclinical, manufacturing, and supplies, offset by DoD funding), general and administrative expenses (salaries, legal, professional fees), change in fair value of warrant liability (non-cash charge from remeasurement), and interest expense, net - Research and development expenses are expensed as incurred, covering personnel, preclinical development, manufacturing, and supplies, with DoD funding recognized as contra-R&D expense[117](index=117&type=chunk)[120](index=120&type=chunk) - General and administrative expenses include salaries, legal fees, professional fees, and other operating costs, expected to increase with public company operations[121](index=121&type=chunk)[122](index=122&type=chunk) - Change in fair value of warrant liability is a non-cash charge reflecting remeasurement of preferred stock warrants, which converted to common stock warrants post-IPO[123](index=123&type=chunk)[125](index=125&type=chunk) [Results of operations](index=38&type=section&id=Results%20of%20operations) The company's results of operations show a significant increase in net loss for both the three and nine months ended September 30, 2020, primarily driven by a **$5.5 million** non-cash charge from the change in fair value of warrant liability, with research and development expenses decreasing for the nine-month period due to reduced outsourced services, while general and administrative expenses increased due to higher personnel and professional fees Operating Results (3 Months Ended Sep 30, in thousands) | Metric | 2020 | 2019 | Change | | :-------------------------------- | :----- | :----- | :----- | | Research and development | $1,644 | $2,234 | $(590) | | General and administrative | $1,174 | $486 | $688 | | Total operating expenses | $2,818 | $2,720 | $98 | | Loss from operations | $(2,818) | $(2,720) | $(98) | | Change in fair value of warrant liability | $(5,549) | $— | $(5,549) | | Net loss | $(8,377) | $(2,737) | $(5,640) | Operating Results (9 Months Ended Sep 30, in thousands) | Metric | 2020 | 2019 | Change | | :-------------------------------- | :----- | :----- | :----- | | Research and development | $5,651 | $6,391 | $(740) | | General and administrative | $2,537 | $1,069 | $1,468 | | Total operating expenses | $8,188 | $7,460 | $728 | | Loss from operations | $(8,188) | $(7,460) | $(728) | | Change in fair value of warrant liability | $(5,549) | $— | $(5,549) | | Net loss | $(13,764) | $(7,522) | $(6,242) | - Research and development expenses for the three months ended September 30, 2020, decreased by **$0.6 million** due to DoD contra-R&D expense, but increased slightly excluding this effect due to higher personnel and facility costs, offset by reduced outsourced services[128](index=128&type=chunk) - General and administrative expenses increased by **$0.7 million** for the three months and **$1.5 million** for the nine months ended September 30, 2020, primarily due to increased personnel-related costs and professional fees[130](index=130&type=chunk)[136](index=136&type=chunk) [Liquidity and capital resources](index=42&type=section&id=Liquidity%20and%20capital%20resources) The company has historically incurred significant operating losses and expects this trend to continue, and while the recent IPO provided substantial cash, additional financing will be required to fund ongoing research and development and growth strategies beyond Q1 2022, with cash flows reflecting significant cash used in operations and investing, offset by cash provided by financing activities - The company has incurred significant operating losses since inception and expects to continue doing so, requiring substantial additional financing for preclinical and clinical development[141](index=141&type=chunk)[150](index=150&type=chunk) - As of September 30, 2020, cash was **$6.7 million**, supplemented by **$41.7 million** net IPO proceeds in October 2020, expected to fund operations into Q1 2022[142](index=142&type=chunk)[151](index=151&type=chunk) Cash Flow Summary (9 Months Ended Sep 30, in thousands) | Cash Flow Activity | 2020 | 2019 | | :-------------------------------- | :----- | :----- | | Cash used in operating activities | $(6,072) | $(7,021) | | Cash used in investing activities | $(540) | $(166) | | Cash provided by financing activities | $10,813 | $6,345 | | Net increase (decrease) in cash and restricted cash | $4,201 | $(842) | - Future funding requirements depend on factors like the costs of developing the Immunome Discovery Engine, preclinical/clinical trials, intellectual property, regulatory approvals, and operating as a public company[152](index=152&type=chunk)[153](index=153&type=chunk) [Critical accounting policies and use of estimates](index=46&type=section&id=Critical%20accounting%20policies%20and%20use%20of%20estimates) This section outlines critical accounting policies requiring significant management judgment and estimates, including government contract funding, share-based compensation (using Black-Scholes and probability-weighted expected return methods), and warrant liability valuation (using Black-Scholes), noting that the IPO eliminates the need for estimates in valuing common stock and warrants - Government contract funding is accounted for as contra-research and development expenses[159](index=159&type=chunk) - Share-based compensation expense is recognized over the vesting period, with fair value estimated using the Black-Scholes model, relying on inputs like common stock fair value, volatility, and expected term[160](index=160&type=chunk)[161](index=161&type=chunk) - Prior to May 2020, common and preferred stock were valued using a net asset approach and Option Pricing Method (OPM); from May to September 2020, the probability-weighted expected return method was used[162](index=162&type=chunk)[164](index=164&type=chunk) - Warrant liability is valued using the Black-Scholes option pricing model, incorporating assumptions about the underlying Series A convertible preferred stock's fair value, contractual term, risk-free interest rate, and volatility[169](index=169&type=chunk)[170](index=170&type=chunk) [Recently issued accounting standards](index=50&type=section&id=Recently%20issued%20accounting%20standards) Management does not expect any recently issued accounting standards to significantly impact the company's financial position, operations, or cash flows - No recently issued accounting standards are expected to impact the company's financial position, operations, or cash flows[171](index=171&type=chunk) [JOBS Act](index=50&type=section&id=JOBS%20Act) As an emerging growth company under the JOBS Act, Immunome is eligible for reduced disclosure requirements and has elected to use the extended transition period for complying with new or revised accounting standards, meaning it will adopt new standards at the same time as private companies - Immunome qualifies as an 'emerging growth company' under the JOBS Act, allowing for reduced disclosure requirements[172](index=172&type=chunk) - The company has elected to use the extended transition period for complying with new or revised accounting standards, adopting them at the same time as private companies[176](index=176&type=chunk) [Off-balance sheet arrangements](index=52&type=section&id=Off-balance%20sheet%20arrangements) The company has no off-balance sheet arrangements as defined by SEC rules and regulations - The company does not have any off-balance sheet arrangements[177](index=177&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Immunome, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company, as a smaller reporting company, is not required to provide disclosures about market risk[178](index=178&type=chunk) [Item 4. Controls and Procedures](index=52&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were ineffective as of September 30, 2020, due to previously identified material weaknesses related to review processes and insufficient accounting personnel, and the company is actively remediating these weaknesses by implementing new controls and hiring experienced financial personnel - Management, including the CEO and CFO, concluded that disclosure controls and procedures were ineffective as of September 30, 2020[179](index=179&type=chunk) - Three material weaknesses were identified: lack of review of journal entries, lack of timely and effective review of financial statement account reconciliations, and insufficient accounting personnel[181](index=181&type=chunk)[183](index=183&type=chunk) - Remediation efforts include implementing controls for journal entry and reconciliation reviews, hiring a full-time CFO and Corporate Controller, and engaging consultants[184](index=184&type=chunk) - The company acknowledges inherent limitations in control systems, providing reasonable, not absolute, assurance of effectiveness[185](index=185&type=chunk) [PART II – OTHER INFORMATION](index=56&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=56&type=section&id=Item%201.%20Legal%20Proceedings) Immunome, Inc. is not currently involved in any material legal proceedings, though it may encounter ordinary course legal matters from time to time - The company is not currently a party to any material legal proceedings[188](index=188&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's IPO prospectus filed on October 5, 2020 - No material changes to the risk factors described in the IPO prospectus filed on October 5, 2020[189](index=189&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=56&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter ended September 30, 2020, Immunome granted stock options and issued common stock upon option exercises, relying on Rule 701 and Section 4(a)(2) exemptions, and the company also detailed the use of proceeds from its October 2020 IPO, which generated **$33.8 million** net of other offering expenses - During Q3 2020, the company granted options to purchase **301,647 common shares** to employees and **23,332 shares** to consultants[190](index=190&type=chunk) - **12,224 common shares** were issued upon option exercise for **$7,558** aggregate consideration, relying on Rule 701 and Section 4(a)(2) exemptions[191](index=191&type=chunk)[192](index=192&type=chunk) - The IPO, effective October 1, 2020, generated **$39.0 million** gross proceeds from **3,250,000 common shares** at **$12.00/share**[193](index=193&type=chunk) - Net proceeds from the IPO were **$36.3 million** after underwriting discounts, with **$33.8 million** remaining after other offering expenses, to be used as described in the IPO prospectus[194](index=194&type=chunk) [Item 3. Defaults Upon Senior Securities](index=56&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - There were no defaults upon senior securities[196](index=196&type=chunk) [Item 4. Mine Safety Disclosures](index=58&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Immunome, Inc - Mine Safety Disclosures are not applicable to the company[198](index=198&type=chunk) [Item 5. Other Information](index=58&type=section&id=Item%205.%20Other%20Information) The company reported no other information required under this item - No other information is reported under this item[199](index=199&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including organizational documents, equity-related agreements, indemnity agreements, incentive plans, employment agreements, consulting agreements, license agreements, and certifications - The exhibit index includes organizational documents (Amended and Restated Certificate of Incorporation, Bylaws), common stock certificates, and investor rights agreements[202](index=202&type=chunk) - Equity-related exhibits cover preferred stock warrants, various equity incentive plans (2008, 2018, 2020 Plans, ESPP Plan), and forms of stock option grant notices[202](index=202&type=chunk) - Other exhibits include indemnity agreements, employment and consulting agreements, several license agreements (e.g., with Arrayjet Limited, MIT, Thomas Jefferson University, PH Pharma Co Ltd), and the DoD OTA Agreement[202](index=202&type=chunk)[204](index=204&type=chunk)[206](index=206&type=chunk) - Certifications from the Chief Executive Officer and Chief Financial Officer pursuant to Sarbanes-Oxley Act sections 302 and 906 are also included[206](index=206&type=chunk)