Immunome, Inc. (IMNM) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock ma ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39580 IMMUNOME, INC. (Exact name of registrant as specified in its charter) Delaware 77-0694340 (State of Other Jurisdiction of incorporation or Organization) ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39580 Immunome, Inc. (Exact name of registrant as specified in its charter) Delaware 77-0694340 (State or ...

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 June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39580 Immunome, Inc. (Exact name of registrant as specified in its charter) Delaware 77-0694340 (State or othe ...

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].

(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q 665 Stockton Drive, Suite 300 Exton, PA 19341 (Address of principal executive offices) (Zip Code) For the transition period from to Commission File Number: 001-39580 (610) 321-3700 Immunome, Inc. For the quarterly period ended September 30, 2022 (Exact name of registrant as specified in its charter) OR Delawar ...

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 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 other jurisdiction of incorporation or organizati ...

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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39580 IMMUNOME, INC. (Exact name of registrant as specified in its charter) Delaware 77-0694340 (State of Other Jurisdiction of incorporation or Organization) ...