[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents Immunome, Inc.'s unaudited financial statements, management's discussion, market risk disclosures, and controls and procedures. [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Immunome, Inc.'s unaudited condensed financial statements for the periods ended June 30, 2023, and December 31, 2022, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows. The company reported a significant increase in cash and cash equivalents, primarily driven by deferred revenue from a collaboration agreement with AbbVie, while continuing to incur net losses. [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets%20as%20of%20June%2030,%202023%20and%20December%2031,%202022) This section provides Immunome's financial position, showing significant increases in cash and liabilities due to the AbbVie collaboration. | Metric | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | Change (in thousands) | % Change | | :-------------------------------- | :----------------------------- | :------------------------------- | :-------------------- | :------- | | Cash and cash equivalents | $38,416 | $20,323 | $18,093 | 89.0% | | Total current assets | $39,526 | $22,649 | $16,877 | 74.5% | | Total assets | $41,435 | $24,046 | $17,389 | 72.3% | | Total current liabilities | $26,392 | $7,331 | $19,061 | 260.0% | | Total liabilities | $32,097 | $7,393 | $24,704 | 334.1% | | Total stockholders' equity | $9,338 | $16,653 | $(7,315) | -43.9% | | Accumulated deficit | $(125,828) | $(116,001) | $(9,827) | 8.5% | - The significant increase in total liabilities is primarily due to a new deferred revenue of **$17.668 million** from the AbbVie collaboration, which was zero at December 31, 2022[11](index=11&type=chunk) [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202023%20and%202022) This section details Immunome's revenue and expenses, showing a reduced net loss driven by collaboration revenue and lower R&D costs. | Metric (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Change (3M) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change (6M) | | :-------------------- | :------------------------------- | :------------------------------- | :---------- | :----------------------------- | :----------------------------- | :---------- | | Collaboration revenue | $4,263 | $0 | $4,263 | $6,627 | $0 | $6,627 | | R&D expenses | $5,716 | $5,717 | $(1) | $9,629 | $13,795 | $(4,166) | | G&A expenses | $4,320 | $3,209 | $1,111 | $7,242 | $6,785 | $457 | | Total operating expenses | $10,036 | $8,926 | $1,110 | $16,871 | $20,580 | $(3,709) | | Loss from operations | $(5,773) | $(8,926) | $3,153 | $(10,244) | $(20,580) | $10,336 | | Interest income | $216 | $2 | $214 | $417 | $3 | $414 | | Net loss | $(5,557) | $(8,924) | $3,367 | $(9,827) | $(20,577) | $10,750 | | Net loss per share (basic & diluted) | $(0.46) | $(0.74) | $0.28 | $(0.81) | $(1.70) | $0.89 | - Collaboration revenue of **$4.263 million** (Q2 2023) and **$6.627 million** (YTD Q2 2023) was recognized from the AbbVie agreement, which was non-existent in the prior year periods[13](index=13&type=chunk) - Net loss significantly decreased by **$3.367 million** for the three months ended June 30, 2023, and by **$10.750 million** for the six months ended June 30, 2023, primarily due to collaboration revenue and reduced R&D expenses[13](index=13&type=chunk) [Condensed Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202023%20and%202022) This section tracks changes in stockholders' equity, primarily impacted by net loss and share-based compensation. - Stockholders' equity decreased from **$16.653 million** at January 1, 2023, to **$9.338 million** at June 30, 2023, primarily due to a net loss of **$9.827 million**, partially offset by share-based compensation expense of **$2.198 million** and common stock issuances[16](index=16&type=chunk) - For the six months ended June 30, 2023, the company issued **5,925 shares** of common stock under an ATM agreement for **$34,000** net proceeds and **55,250 shares** to non-employee directors for **$221,000** in lieu of compensation[16](index=16&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030,%202023%20and%202022) This section summarizes cash inflows and outflows, showing significant cash generation from operating activities due to deferred revenue. | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :----- | | Net cash provided by (used in) operating activities | $18,505 | $(14,436) | $32,941 | | Net cash used in investing activities | $(446) | $(176) | $(270) | | Net cash provided by financing activities | $34 | $32 | $2 | | Net increase (decrease) in cash and cash equivalents and restricted cash | $18,093 | $(14,580) | $32,673 | | Cash and cash equivalents and restricted cash at end of period | $38,516 | $34,749 | $3,767 | - Operating activities generated **$18.505 million** in cash for the six months ended June 30, 2023, a significant improvement from a **$14.436 million** cash usage in the prior year, primarily driven by a **$23.373 million** increase in deferred revenue from the AbbVie collaboration[19](index=19&type=chunk) [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed financial statements. [1. Nature of the business](index=8&type=section&id=1.%20Nature%20of%20the%20business) Immunome's biopharmaceutical focus, financial performance, pending merger with Morphimmune, and AbbVie collaboration are detailed. - Immunome, Inc. is a biopharmaceutical company focused on oncology, developing antibody therapeutics using a proprietary human memory B cell platform[22](index=22&type=chunk) - The company has incurred net losses of **$9.8 million** (six months ended June 30, 2023) and **$20.6 million** (six months ended June 30, 2022), with an accumulated deficit of **$125.8 million** as of June 30, 2023[25](index=25&type=chunk) - On June 29, 2023, Immunome entered into a Merger Agreement with Morphimmune Inc., a biotechnology company focused on targeted oncology therapeutics. The merger is expected to close by the end of 2023 and will be treated as an asset acquisition by Immunome[24](index=24&type=chunk)[33](index=33&type=chunk)[37](index=37&type=chunk) - Immunome received a **$30.0 million** non-refundable upfront payment from AbbVie in January 2023 under a collaboration agreement and is potentially eligible for up to **$2.8 billion** in additional payments[26](index=26&type=chunk)[27](index=27&type=chunk) - In connection with the merger, Immunome entered into subscription agreements for a PIPE financing of approximately **$125.0 million** through the issuance of **21,690,871 shares** of common stock at **$5.75 per share** (or **$5.91** for affiliates)[40](index=40&type=chunk) - As of June 30, 2023, the company had **$38.4 million** in cash and cash equivalents and expects this, excluding PIPE proceeds, to fund operations for at least 12 months[30](index=30&type=chunk) [2. Summary of significant accounting policies](index=12&type=section&id=2.%20Summary%20of%20significant%20accounting%20policies) This section outlines Immunome's key accounting principles, including revenue recognition, R&D, and share-based compensation. - The company operates as one segment exclusively in the United States[45](index=45&type=chunk) - Restricted cash of **$0.1 million** at June 30, 2023, serves as collateral for a lease security deposit[51](index=51&type=chunk) - Deferred offering costs of **$0.4 million** (June 30, 2023) are capitalized for the ATM Agreement and PIPE transaction, to be offset against gross proceeds upon consummation[53](index=53&type=chunk)[54](index=54&type=chunk) - Government assistance from the DoD and CARES Act employee retention credit are recorded as contra-research and development or contra-general and administrative expenses[55](index=55&type=chunk) - Collaboration revenue is recognized over the estimated performance period of R&D services using the cost-to-cost input method, following the five-step model of ASC 606[60](index=60&type=chunk)[83](index=83&type=chunk) - Share-based compensation is expensed over the vesting period, with stock option fair values estimated using the Black-Scholes model[65](index=65&type=chunk)[66](index=66&type=chunk) - The company adopted ASU No. 2016-13 (Measurement of Credit Losses on Financial Instruments) on January 1, 2023, with no impact on its condensed financial statements[76](index=76&type=chunk) [3. Collaboration Agreement with AbbVie](index=22&type=section&id=3.%20Collaboration%20Agreement%20with%20AbbVie) This section details the strategic collaboration with AbbVie for oncology target discovery, including upfront and potential milestone payments. - Immunome entered a Collaboration Agreement with AbbVie in January 2023 to discover up to **10 novel target-antibody pairs** for oncology[77](index=77&type=chunk) - AbbVie paid a nonrefundable upfront payment of **$30.0 million** and may pay up to **$70.0 million** in platform access payments, low single-digit million option exercise fees per target, and up to **$120.0 million** in development/commercial sale milestones per target, plus tiered low single-digit royalties[78](index=78&type=chunk) - The total potential value of the agreement is approximately **$2.8 billion**[27](index=27&type=chunk)[78](index=78&type=chunk) - Immunome recognized **$4.3 million** and **$6.6 million** in collaboration revenue for the three and six months ended June 30, 2023, respectively, from the upfront payment, which is being recognized over an estimated 1.5-year R&D period[83](index=83&type=chunk)[84](index=84&type=chunk) [4. Government assistance programs](index=24&type=section&id=4.%20Government%20assistance%20programs) This section describes government funding received from the DoD and CARES Act employee retention credit. - Immunome received the maximum **$17.6 million** in expense reimbursement from the DoD under the OTA Agreement for COVID-19 antibody development from inception through 2022[26](index=26&type=chunk)[86](index=86&type=chunk) - No contra-research and development expense related to the DoD agreement was recorded for the three and six months ended June 30, 2023[87](index=87&type=chunk) - The company was eligible for an **$0.8 million** refundable employee retention credit under the CARES Act, with **$0.2 million** remaining as a receivable as of June 30, 2023[88](index=88&type=chunk)[90](index=90&type=chunk) [5. Prepaid expenses and other assets](index=26&type=section&id=5.%20Prepaid%20expenses%20and%20other%20assets) This section provides a breakdown of prepaid expenses and other current assets, showing changes in receivables and advance payments. | (in thousands) | June 30, 2023 | December 31, 2022 | | :-------------------------------- | :------------ | :---------------- | | Prepaid subscriptions and service contracts | $497 | $876 | | Prepaid insurance | $271 | $158 | | CARES Act employee retention credit receivable | $208 | $847 | | Research and development advance payments | $134 | $445 | | Total | $1,110 | $2,326 | [6. Accrued expenses and other liabilities](index=26&type=section&id=6.%20Accrued%20expenses%20and%20other%20liabilities) This section details accrued expenses and other current liabilities, highlighting changes in professional fees and R&D accruals. | (in thousands) | June 30, 2023 | December 31, 2022 | | :-------------------------------- | :------------ | :---------------- | | Research and development | $1,980 | $2,261 | | Professional fees | $1,649 | $481 | | Compensation and related benefits | $907 | $1,874 | | Short-term operating lease liability and other liabilities | $489 | $293 | | Deferred research obligations | $0 | $22 | | Total | $5,025 | $4,931 | [7. Commitments and contingencies](index=26&type=section&id=7.%20Commitments%20and%20contingencies) This section discusses employment agreements, 401(k) plan, legal proceedings, and potential milestone payments under license agreements. - The company is not a party to any material litigation[95](index=95&type=chunk) - Immunome may need to pay developmental and regulatory milestone payments of up to approximately **$2.6 million** and commercial milestone payments of up to **$1.5 million** under various license agreements[96](index=96&type=chunk) - No development, regulatory, or commercial milestone payments were recorded during the three and six months ended June 30, 2023[97](index=97&type=chunk) - A Letter Agreement with Whitehead Institute, effective January 4, 2023, clarifies exclusions from payment obligations for certain collaborator payments and outlines new payment terms for net sales and milestones[98](index=98&type=chunk) [8. Leases](index=28&type=section&id=8.%20Leases) This section provides information on Immunome's office and laboratory lease, including right-of-use assets, liabilities, and lease expenses. - Immunome leases approximately **11,000 square feet** of office and laboratory space in Exton, Pennsylvania, with the current lease extending until March 2024 and options for two additional five-year terms[99](index=99&type=chunk) | (in thousands) | June 30, 2023 | December 31, 2022 | | :-------------------------- | :------------ | :---------------- | | Operating lease right-of-use assets | $174 | $284 | | Operating lease liability | $180 | $229 | | Total operating lease liability | $180 | $291 | | Lease Expense (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative | $18 | $19 | $38 | $37 | | Research and development | $42 | $41 | $83 | $84 | | Total lease expense | $60 | $60 | $121 | $121 | - As of June 30, 2023, the weighted-average remaining lease term is **0.8 years**, and the weighted-average discount rate is **9.0%**[103](index=103&type=chunk) [9. Common stock](index=30&type=section&id=9.%20Common%20stock) This section details common stock outstanding, ATM sales, director issuances, and warrant activity. - As of June 30, 2023, **12,200,433 shares** of common stock were issued and outstanding[11](index=11&type=chunk) - In January 2023, Immunome sold **5,925 shares** of common stock under the ATM Agreement, generating approximately **$34,000** in net proceeds[105](index=105&type=chunk) - On January 15, 2023, **55,250 shares** of common stock were issued to non-employee directors in lieu of accrued compensation for 2022[105](index=105&type=chunk) | Warrants | Number of Warrants Outstanding | Exercise Price per Share | Expiration Date | | :------- | :----------------------------- | :----------------------- | :-------------- | | Series B | 500,000 | $10.00 | April 28, 2024 | - On June 2, 2023, **803,112 Series A warrants** with an exercise price of **$9.00** expired[106](index=106&type=chunk) [10. Share-based compensation](index=32&type=section&id=10.%20Share-based%20compensation) This section provides an overview of equity incentive plans, share-based compensation expense, and stock option activity. - The 2020 Equity Incentive Plan and ESPP automatically increase shares reserved annually; as of June 30, 2023, **1,236,420 shares** were available under the 2020 Plan and **473,733** under the ESPP[107](index=107&type=chunk)[108](index=108&type=chunk) | Share-based Compensation Expense (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $427 | $462 | $857 | $907 | | General and administrative | $606 | $865 | $1,400 | $1,730 | | Total | $1,033 | $1,327 | $2,257 | $2,637 | - Unrecognized compensation cost related to unvested options and restricted stock awards was **$8.4 million** as of June 30, 2023, to be recognized over an estimated weighted average period of **3.1 years**[110](index=110&type=chunk) | Stock Option Activity (Six Months Ended June 30, 2023) | Number of shares | Weighted average exercise price per share | | :------------------------------------- | :--------------- | :---------------------------------------- | | Outstanding at January 1, 2023 | 2,519,405 | $9.60 | | Granted | 658,900 | $4.87 | | Forfeited | (98,216) | $11.56 | | Expired | (42,009) | $16.25 | | Outstanding at June 30, 2023 | 3,038,080 | $8.42 | | Exercisable at June 30, 2023 | 1,563,646 | $8.66 | - The weighted-average grant date fair value of stock options granted was **$3.67 per share** for the six months ended June 30, 2023, up from **$2.65** in the prior year[114](index=114&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section provides management's perspective on Immunome's financial condition and operational results, highlighting the company's focus on R&D, significant operating losses, and the need for future funding. Key discussions include the pending merger with Morphimmune, the strategic collaboration with AbbVie, and the performance of its oncology and SARS-CoV-2 programs. The company's liquidity is supported by existing cash and potential proceeds from the merger and PIPE financing, but substantial additional capital will be required to advance its pipeline and growth strategy. [Overview](index=35&type=section&id=Overview) This section covers Immunome's financial position, ongoing operating losses, future funding needs, and reliance on collaborations. - Immunome has incurred significant operating losses since inception, with net losses of **$5.6 million** and **$8.9 million** for the three months ended June 30, 2023 and 2022, respectively, and **$9.8 million** and **$20.6 million** for the six months ended June 30, 2023 and 2022, respectively[121](index=121&type=chunk) - As of June 30, 2023, the company had **$38.4 million** in cash and cash equivalents[122](index=122&type=chunk) - The company expects to continue incurring significant expenses for R&D, regulatory approvals, IP protection, and personnel, requiring substantial additional financing[123](index=123&type=chunk) - Future funding is expected to come from equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements[123](index=123&type=chunk) [Merger Agreement](index=39&type=section&id=Merger%20Agreement) This section details the pending merger with Morphimmune, ownership structure, accounting treatment, and concurrent PIPE financing. - Immunome entered a Merger Agreement with Morphimmune Inc. on June 29, 2023, with Morphimmune becoming a wholly-owned subsidiary, expected to close by end of 2023[128](index=128&type=chunk) - Pre-Merger Immunome equityholders are expected to own approximately **55%** and Morphimmune equityholders **45%** of the combined company on a fully diluted basis[130](index=130&type=chunk) - The merger will be treated as an asset acquisition by Immunome, with the fair value of acquired in-process R&D (IPR&D) assets (Mi-1001 and 177Lu-FAP) expensed as R&D on the acquisition date[132](index=132&type=chunk)[134](index=134&type=chunk) - A concurrent PIPE financing of approximately **$125.0 million**, involving the issuance of **21,690,871 shares** of common stock, is expected to close immediately following the merger[135](index=135&type=chunk) [Our current programs and strategic collaboration](index=41&type=section&id=Our%20current%20programs%20and%20strategic%20collaboration) This section provides updates on Immunome's oncology and SARS-CoV-2 programs, discovery engine investments, and the AbbVie collaboration. - Immunome's lead oncology program, IMM-ONC-01, targets IL-38, a negative regulator of inflammation, with an IND application planned for Q1 2024[136](index=136&type=chunk)[137](index=137&type=chunk) - The SARS-CoV-2 program, IMM-BCP-01, completed dosing of the first cohort in a Phase 1b study in January 2023, and the company is now seeking a partner for continued development[138](index=138&type=chunk) - The company plans to continue investing in its proprietary discovery engine to expand its pipeline, evaluate novel antibody-target pairs, and develop antibody therapeutics, including ADCs[139](index=139&type=chunk) - The Collaboration Agreement with AbbVie, signed in January 2023, involves discovering up to **10 novel target-antibody pairs** for oncology, with potential payments up to approximately **$2.8 billion**[142](index=142&type=chunk)[144](index=144&type=chunk) [Components of our results of operations](index=45&type=section&id=Components%20of%20our%20results%20of%20operations) This section explains the sources of revenue and the nature of research and development, general and administrative expenses. - Collaboration revenue is currently the sole source of revenue, derived from the AbbVie agreement, with no product sales expected in the foreseeable future[146](index=146&type=chunk) - Research and development expenses are charged as incurred and include personnel, external program costs, clinical trials, manufacturing, and laboratory supplies, with DoD reimbursements and CARES Act employee retention credits recorded as contra-expenses[147](index=147&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) - General and administrative expenses include personnel, legal, professional fees, insurance, and facility costs, also offset by CARES Act employee retention credits[153](index=153&type=chunk)[154](index=154&type=chunk) [Results of operations](index=47&type=section&id=Results%20of%20operations) This section provides an analysis of Immunome's financial performance for the three and six months ended June 30, 2023 and 2022. [Three months ended June 30, 2023 and 2022](index=48&type=section&id=Three%20months%20ended%20June%2030,%202023%20and%202022) This section details quarterly financial performance, highlighting collaboration revenue, R&D, G&A expenses, and net loss changes. | Metric (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Change | | :-------------------- | :------------------------------- | :------------------------------- | :----- | | Collaboration revenue | $4,263 | $0 | $4,263 | | R&D expenses | $5,716 | $5,717 | $(1) | | General and administrative | $4,320 | $3,209 | $1,111 | | Interest income | $216 | $2 | $214 | | Net loss | $(5,557) | $(8,924) | $3,367 | - R&D expenses were flat, with a **$1.2 million** decrease in ONC-01 external program expenses and a **$1.0 million** decrease in BCP-01 external program expenses (net of contra expense), offset by a **$1.3 million** increase in outsourced research for the AbbVie collaboration and a **$0.9 million** increase in personnel-related costs[161](index=161&type=chunk) - General and administrative expenses increased by **$1.1 million**, primarily due to a **$1.6 million** increase in professional fees related to the Morphimmune merger, partially offset by a **$0.4 million** decrease in general expenses and a **$0.1 million** decrease in personnel-related costs[163](index=163&type=chunk) [Six months ended June 30, 2023 and 2022](index=50&type=section&id=Six%20months%20ended%20June%2030,%202023%20and%202022) This section details half-year financial performance, highlighting collaboration revenue, R&D, G&A expenses, and net loss changes. | Metric (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change | | :-------------------- | :----------------------------- | :----------------------------- | :----- | | Collaboration revenue | $6,627 | $0 | $6,627 | | R&D expenses | $9,629 | $13,795 | $(4,166) | | General and administrative | $7,242 | $6,785 | $457 | | Interest income | $417 | $3 | $414 | | Net loss | $(9,827) | $(20,577) | $10,750 | - R&D expenses decreased by **$4.2 million**, with ONC-01 external program expenses down **$3.4 million** and BCP-01 external program expenses down **$3.2 million** (net of contra expense), partially offset by a **$1.7 million** increase in outsourced research for the AbbVie collaboration and a **$0.7 million** increase in personnel-related costs[167](index=167&type=chunk) - General and administrative expenses increased by **$0.4 million**, primarily due to a **$1.2 million** increase in professional fees related to the merger, offset by an **$0.8 million** decrease in general expenses[168](index=168&type=chunk) [Liquidity and capital resources](index=50&type=section&id=Liquidity%20and%20capital%20resources) This section discusses Immunome's funding history, current liquidity, future capital requirements, and financing strategies. - Through June 30, 2023, Immunome raised an aggregate of **$155.2 million** in gross proceeds from various sources, including common stock sales, preferred stock, warrants, and strategic partnerships[170](index=170&type=chunk) - The company received a **$30.0 million** upfront payment from AbbVie in January 2023 and **$17.6 million** in expense reimbursement from the DoD through 2022[170](index=170&type=chunk) - Immunome has an Open Market Sale Agreement (ATM Agreement) allowing for the sale of up to **$75.0 million** in common stock, with **$34,000** net proceeds from sales through June 30, 2023[171](index=171&type=chunk)[173](index=173&type=chunk) - A **$125.0 million** PIPE financing is expected to close concurrently with the Morphimmune merger[175](index=175&type=chunk) - Cash provided by operating activities was **$18.5 million** for the six months ended June 30, 2023, a significant increase from **$14.4 million** used in the prior year, primarily due to deferred revenue from the AbbVie collaboration[177](index=177&type=chunk)[178](index=178&type=chunk) - The company expects its existing cash (excluding PIPE proceeds) to fund operations for at least 12 months but will require additional financing for its growth strategy[184](index=184&type=chunk) [Critical accounting policies and use of estimates](index=58&type=section&id=Critical%20accounting%20policies%20and%20use%20of%20estimates) This section explains key accounting policies requiring significant judgment, such as revenue recognition and share-based compensation. - Collaboration revenue recognition under ASC 606 requires significant judgment in identifying distinct performance obligations, allocating transaction price, and assessing variable consideration[196](index=196&type=chunk)[197](index=197&type=chunk) - Share-based compensation fair value is estimated using the Black-Scholes option pricing model, which relies on subjective assumptions such as expected volatility, expected term, and risk-free interest rate[198](index=198&type=chunk)[199](index=199&type=chunk) - Accrued research and development expenses are estimated based on open contracts, purchase orders, and communication with personnel to determine services performed and associated costs[202](index=202&type=chunk) - Immunome qualifies as an 'emerging growth company' under the JOBS Act and has elected to use the extended transition period for complying with new or revised financial accounting standards[204](index=204&type=chunk)[205](index=205&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=60&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk.) This section is not required to be provided by smaller reporting companies, and therefore, no specific disclosures about market risk are included in this report. - The information under this item is not required to be provided by smaller reporting companies[207](index=207&type=chunk) [Item 4. Controls and Procedures](index=62&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management, with the participation of the CEO and CFO, evaluated the effectiveness of Immunome's disclosure controls and procedures as of June 30, 2023, and concluded they were effective. No changes in internal control over financial reporting occurred during the quarter that materially affected or are reasonably likely to materially affect these controls. - As of June 30, 2023, Immunome's disclosure controls and procedures were evaluated and deemed effective by management, including the CEO and CFO[208](index=208&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2023[209](index=209&type=chunk) [PART II – OTHER INFORMATION](index=62&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section includes other information such as legal proceedings, risk factors, unregistered sales of equity securities, defaults, mine safety disclosures, and a list of exhibits. [Item 1. Legal Proceedings](index=62&type=section&id=Item%201.%20Legal%20Proceedings.) Immunome is not currently a party to any material legal proceedings. - Immunome is not currently a party to any material legal proceedings[211](index=211&type=chunk) [Item 1A. Risk Factors](index=62&type=section&id=Item%201A.%20Risk%20Factors.) This section is not required to be provided by smaller reporting companies. - The information under this item is not required to be provided by smaller reporting companies[212](index=212&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=62&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) There were no unregistered sales of equity securities or use of proceeds to report for the period. - None[213](index=213&type=chunk) [Item 3. Defaults Upon Senior Securities](index=62&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) There were no defaults upon senior securities to report for the period. - None[214](index=214&type=chunk) [Item 4. Mine Safety Disclosures](index=62&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to Immunome, Inc. - Not applicable[215](index=215&type=chunk) [Item 5. Other Information](index=62&type=section&id=Item%205.%20Other%20Information.) There is no other information to report for the period. - None[216](index=216&type=chunk) [Item 6. Exhibits](index=63&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed as part of the Form 10-Q, including the Merger Agreement, organizational documents, stockholder support agreements, lock-up agreements, subscription agreements for the PIPE financing, employment agreements, and certifications. - Key exhibits include the Agreement and Plan of Merger and Reorganization, forms of Stockholder Support Agreements, Lock-Up Agreement, Subscription Agreement for PIPE financing, and the Employment Agreement for the new CEO[218](index=218&type=chunk)

Table of Contents For the transition period from to Commission File Number: 001-39580 Immunome, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Delaware 77-0694340 (State or oth ...

Oncology and Therapeutics Development - The company has identified over 1,000 individual antibodies, referred to as "hits," with high-affinity binding to cancer cells or tumor extracts, leading to the identification of over 70 potentially novel cancer targets[23]. - The lead oncology program, IMM-ONC-01, targets IL-38, with plans to submit an IND application to the FDA by mid-2023[39]. - The company aims to leverage insights from over 70 identified cancer targets to guide future oncology pipeline assets and strategic collaborations[24]. - The company is focused on developing antibody therapeutics for oncology and infectious diseases, utilizing a proprietary human memory B cell platform[22]. - The company plans to submit an IND for the IMM-ONC-01 program by mid-2023, but there are no assurances that this will occur as anticipated[195]. - The company has decided to seek a partner for the IMM-BCP-01 program to continue its Phase 1b trial and further development activities[203]. Clinical Trials and Regulatory Compliance - The Phase 1b study of IMM-BCP-01 successfully completed dosing of the first cohort of patients with no significant treatment-related adverse events as of January 6, 2023[40]. - Clinical trials must be conducted under protocols detailing study objectives, safety monitoring parameters, and effectiveness criteria[91]. - The FDA requires sponsors of Phase 3 clinical trials to submit a diversity action plan, including enrollment goals and rationale[100]. - The FDA may require additional Phase 4 studies post-approval to gather more information about a product[96]. - The company must submit results of preclinical studies, manufacturing information, and proposed clinical protocols to the FDA as part of the IND application[89]. - The company may face significant delays in advancing its programs and development candidates through clinical development and obtaining regulatory approval[192]. Financial Performance and Funding - As of December 31, 2022, the company had an accumulated deficit of $116.0 million and reported a net loss of $36.9 million for the year ended December 31, 2022[183]. - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future[185]. - The company expects net losses to increase substantially as operations continue, with future losses being uncertain[186]. - The research and development of biopharmaceutical products is capital-intensive, and the company will need substantial additional funds to expand its capabilities[187]. - The company has used substantial funds to develop its discovery engine and will require significant funds for further research and development[187]. Intellectual Property and Licensing - The company plans to expand its intellectual property estate and may pursue both therapeutic and diagnostic applications of its antibodies[44]. - The company owns 68 pending national phase patent applications in the U.S. and abroad, three pending PCT applications, and seven pending U.S. provisional patent applications, covering a total of 12 patent families[74]. - The company has a layered patent estate that it believes provides substantial intellectual property protection, including methods of treatment for diseases expressing novel targets[73]. - The company is required to navigate various preclinical, clinical, and commercial approval requirements set by regulatory agencies for its programs and development candidates[86]. Collaborations and Partnerships - The Company entered into a collaboration agreement with AbbVie, which includes an upfront payment of $30 million and potential total payments of up to $2.8 billion based on various milestones and royalties[48][50]. - AbbVie will pay additional platform access payments of up to $70 million based on the Company's use of its discovery engine and delivery of validated target pairs (VTPs)[48]. - The Company is exploring strategic collaborations and licensing agreements to maximize the value of its platform and programs[46]. Challenges and Risks - The five-year survival rate for patients with advanced malignancies remains below 10%, highlighting the need for innovative cancer therapeutics[28]. - The company may face challenges in obtaining reimbursement for its products due to higher prices associated with branded drugs and the need for extensive pharmacoeconomic studies[161]. - Delays in clinical trials may arise from various factors, including regulatory approvals, participant recruitment challenges, and manufacturing process issues[209][210]. - The company anticipates that competition for clinical trial participants may reduce the number available for its trials, impacting enrollment[211]. Government Regulations and Market Access - Coverage and adequate reimbursement from governmental health care programs are critical to new product acceptance[158]. - The company is subject to various pricing and reimbursement regulations, which may impact the marketability of its products[165]. - The Inflation Reduction Act of 2022 requires manufacturers to pay rebates if drug prices increase faster than inflation, starting in 2023[172]. - The FDA closely regulates marketing and promotion of biologics, allowing only claims that are approved and in accordance with the product's labeling[135].

PART I – FINANCIAL INFORMATION Presents unaudited financial statements, management's discussion, market risk, and controls for the period [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Presents unaudited condensed financial statements for Immunome, Inc., detailing financial position, operations, and cash flows [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Details assets, liabilities, and equity, showing decreased cash and total assets, and increased accumulated deficit due to ongoing net losses Condensed Balance Sheets | Account | Sep 30, 2022 ($ thousands) | Dec 31, 2021 ($ thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 27,078 | 49,229 | | Total current assets | 29,239 | 56,638 | | Total assets | 30,546 | 57,925 | | **Liabilities & Equity** | | | | Total liabilities | 7,462 | 9,740 | | Accumulated deficit | (108,215) | (79,105) | | Total stockholders' equity | 23,084 | 48,185 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Reports a significant increase in net loss to **$29.1 million**, primarily due to higher research and development expenses Condensed Statements of Operations | Metric | Nine Months Ended Sep 30, 2022 ($ thousands) | Nine Months Ended Sep 30, 2021 ($ thousands) | | :--- | :--- | :--- | | Research and development | 19,020 | 9,725 | | General and administrative | 10,094 | 7,635 | | Total operating expenses | 29,114 | 17,360 | | Loss from operations | (29,114) | (17,360) | | Net loss | (29,110) | (16,859) | | Net loss per share | (2.45) | (1.49) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Shows a near doubling of cash used in operations and a significant decrease in cash from financing activities, resulting in a net cash decrease Condensed Statements of Cash Flows | Cash Flow Activity | Nine Months Ended Sep 30, 2022 ($ thousands) | Nine Months Ended Sep 30, 2021 ($ thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (22,007) | (11,421) | | Net cash used in investing activities | (176) | (65) | | Net cash provided by financing activities | 32 | 27,963 | | Net (decrease) increase in cash | (22,151) | 16,477 | | Cash at end of period | 27,178 | 56,343 | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Provides detailed context on the company's financial position, operations, capital raising, and significant transactions like warrant modification - The company is a clinical-stage biopharmaceutical firm focusing on oncology and infectious diseases, including COVID-19, and has incurred net losses since inception, expecting them to continue[21](index=21&type=chunk)[23](index=23&type=chunk) - As of September 30, 2022, the company had **$27.1 million** in cash and cash equivalents, believed to be sufficient to fund operations for at least 12 months from the report's filing date[25](index=25&type=chunk) - In July 2020, the company entered into a U.S. Department of Defense (DoD) agreement for up to **$17.6 million** in funding for its COVID-19 antibody therapeutic development, with **$17.4 million** received as of September 30, 2022[59](index=59&type=chunk)[62](index=62&type=chunk) - On September 2, 2022, the company modified its Series B Warrants, reducing the exercise price from **$45.00 to $10.00** per share, resulting in a non-cash deemed dividend of **$0.6 million**[83](index=83&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses financial performance, liquidity, and operational progress, highlighting increased net loss, program advancements, and future funding needs - The company's lead COVID-19 program, IMM-BCP-01, initiated a Phase 1b study in June 2022, with topline safety and PK data expected by the end of 2022[108](index=108&type=chunk)[109](index=109&type=chunk) - The lead oncology program, IMM-ONC-01, targeting IL-38, is advancing towards clinical trials, with plans to submit an IND application by mid-2023[110](index=110&type=chunk) Expense Category Changes | Expense Category | Nine Months Ended Sep 30, 2022 ($M) | Nine Months Ended Sep 30, 2021 ($M) | Change ($M) | Primary Driver of Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | 19.0 | 9.7 | +9.3 | $12.7M reduction in contra-R&D expense from DoD contract, partially offset by lower outsourced research costs | | General & Administrative | 10.1 | 7.6 | +2.5 | $2.5M increase in personnel-related costs due to higher headcount and stock-based compensation | - The company expects its cash of **$27.1 million** as of September 30, 2022, will be sufficient to fund operations for at least 12 months from the filing date, but substantial additional financing will be required for long-term strategy[107](index=107&type=chunk)[142](index=142&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=50&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 market risk disclosures - The company is not required to provide quantitative and qualitative disclosures about market risk because it qualifies as a smaller reporting company[172](index=172&type=chunk) [Controls and Procedures](index=50&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded disclosure controls were effective, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of September 30, 2022, the company's disclosure controls and procedures were effective[175](index=175&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended September 30, 2022[176](index=176&type=chunk) PART II – OTHER INFORMATION Covers legal proceedings, risk factors, equity sales, and required exhibits for the reporting period [Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings.) The company reports it is not currently a party to any material legal proceedings - The company is not currently involved in any material legal proceedings[178](index=178&type=chunk) [Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors.) As a smaller reporting company, Immunome, Inc. is not required to provide risk factor disclosures - The company is not required to provide risk factor disclosures in its Form 10-Q as it is a smaller reporting company[179](index=179&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company reported no unregistered sales of equity securities or use of proceeds during the period - There were no unregistered sales of equity securities or use of proceeds to report for the period[180](index=180&type=chunk) [Exhibits](index=53&type=section&id=Item%206.%20Exhibits.) Lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and interactive data files - Exhibits filed with the report include certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[186](index=186&type=chunk)

PART I – FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Immunome, Inc.'s unaudited condensed financial statements as of June 30, 2022, reflect a **$20.6 million** net loss and **$34.6 million** cash position [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to **$39.0 million** by June 30, 2022, driven by reduced cash, while stockholders' equity declined to **$30.3 million** Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $34,649 | $49,229 | | Total current assets | $37,598 | $56,638 | | Total assets | $39,019 | $57,925 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $8,618 | $9,728 | | Total liabilities | $8,742 | $9,740 | | Accumulated deficit | $(99,682) | $(79,105) | | Total stockholders' equity | $30,277 | $48,185 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Net loss for the six months ended June 30, 2022, more than doubled to **$20.6 million**, primarily due to increased R&D expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $5,717 | $3,233 | $13,795 | $5,212 | | General and administrative | $3,209 | $2,507 | $6,785 | $4,425 | | **Loss from operations** | **$(8,926)** | **$(5,740)** | **$(20,580)** | **$(9,637)** | | **Net loss** | **$(8,924)** | **$(5,241)** | **$(20,577)** | **$(9,139)** | | Net loss per share | $(0.74) | $(0.46) | $(1.70) | $(0.83) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to **$14.4 million** for the six months ended June 30, 2022, reflecting higher net loss Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,436) | $(7,276) | | Net cash used in investing activities | $(176) | $(39) | | Net cash provided by financing activities | $32 | $27,378 | | **Net (decrease) increase in cash** | **$(14,580)** | **$20,063** | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail the company's biopharmaceutical focus, liquidity challenges, **$99.7 million** accumulated deficit, and DoD contract funding - The company is a biopharmaceutical firm focused on discovering and developing antibody therapeutics for oncology and infectious diseases, including COVID-19[21](index=21&type=chunk) - As of June 30, 2022, the company had an accumulated deficit of **$99.7 million** and expects to generate losses for the foreseeable future[23](index=23&type=chunk)[25](index=25&type=chunk) - Its cash and cash equivalents of **$34.6 million** are expected to fund operations for at least 12 months from the filing date[23](index=23&type=chunk)[25](index=25&type=chunk) - The company has a contract with the Department of Defense (DoD) for its COVID-19 antibody therapeutic, with total funding of **$17.6 million**[58](index=58&type=chunk)[62](index=62&type=chunk) - As of June 30, 2022, **$17.4 million** had been received from the DoD contract[58](index=58&type=chunk)[62](index=62&type=chunk) - The company adopted the new lease accounting standard, ASC 842, on January 1, 2022, resulting in the recognition of a right-of-use asset and lease liability of **$0.2 million**[56](index=56&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses the company's clinical transition, increased operating losses from higher R&D, and liquidity needs for pipeline advancement [Overview and Lead Programs](index=27&type=section&id=Overview%20and%20Lead%20Programs) The company is a clinical-stage biopharmaceutical firm with lead programs IMM-BCP-01 (COVID-19) and IMM-ONC-01 (oncology) - The company's Phase 1b study of IMM-BCP-01 for patients with SARS-CoV-2 is underway, with topline data anticipated in the second half of 2022[105](index=105&type=chunk) - For the lead oncology program, IMM-ONC-01, the company plans to submit an IND application in the second half of 2022[107](index=107&type=chunk) - The company's discovery engine is expected to advance one to two programs into IND-enabling studies per year[108](index=108&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Operating expenses significantly increased, driven by an **$8.6 million** rise in net R&D and **$2.4 million** in G&A expenses Comparison of Operating Results (in thousands) | Expense Category | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $13,795 | $5,212 | $8,583 | | General and administrative | $6,785 | $4,425 | $2,360 | | **Total operating expenses** | **$20,580** | **$9,637** | **$10,943** | - The increase in R&D expenses for the first six months of 2022 was primarily due to a **$7.4 million** reduction in contra-R&D expense related to the DoD agreement and a **$1.2 million** increase in personnel costs[136](index=136&type=chunk) - The increase in G&A expenses for the first six months of 2022 was mainly driven by a **$2.3 million** rise in personnel-related costs from increased headcount and stock-based compensation[138](index=138&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$34.6 million** cash as of June 30, 2022, sufficient for 12 months, but requires additional capital for R&D - The company had **$34.6 million** in cash as of June 30, 2022, which is expected to fund operations for at least 12 months from the filing date[142](index=142&type=chunk)[152](index=152&type=chunk) Summary of Cash Flows (in thousands) | Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Cash used in operating activities | $(14,436) | $(7,276) | | Cash used in investing activities | $(176) | $(39) | | Cash provided by financing activities | $32 | $27,378 | - The company has an Open Market Sale Agreement (ATM) in place, allowing it to sell up to **$75.0 million** in common shares, but has not yet sold any shares under this agreement[142](index=142&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk.) As a smaller reporting company, Immunome, Inc. is not required to provide market risk disclosures - As a smaller reporting company, Immunome, Inc. is not required to provide quantitative and qualitative disclosures about market risk[169](index=169&type=chunk) [Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded disclosure controls and procedures were effective as of June 30, 2022, with no material changes - Management concluded that as of June 30, 2022, the company's disclosure controls and procedures were effective[171](index=171&type=chunk) - No material changes were made to the internal control over financial reporting during the quarter ended June 30, 2022[172](index=172&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=51&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not currently involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[174](index=174&type=chunk) [Risk Factors](index=51&type=section&id=Item%201A.%20Risk%20Factors.) As a smaller reporting company, Immunome, Inc. is not required to provide risk factor information - As a smaller reporting company, Immunome, Inc. is not required to provide this information[175](index=175&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) No unregistered sales of equity securities or use of proceeds were reported for the period - There were no unregistered sales of equity securities or use of proceeds to report for the period[176](index=176&type=chunk) [Exhibits](index=52&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with the Form 10-Q, including corporate governance documents and certifications - Exhibits filed include corporate governance documents, a director compensation policy, and required Sarbanes-Oxley certifications[181](index=181&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39580 Immunome, Inc. (Exact name of registrant as specified in its charter) Delaware 77-0694340 (State or oth ...

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

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from to Commission File Number: 001-39580 Immunome, Inc. (Exact name of registrant as specified in its charter) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 77-0694340 (State or ...

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

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