Varegacestat

BOTHELL, Wash.--(BUSINESS WIRE)-- Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced the appointment of Sandra M. Swain, M.D., to its Board of Directors. Dr. Swain has over 30 years of oncology clinical research experience and has served on both public company and non-profit boards. “Immunome is pleased to welcome Sandra to the Board of Directors, especially given her extensive experience as a successful clinical researcher,” stated Clay Siegall, PhD, President and Chief Executive Officer of Immunome. “Her deep understanding of oncology and patient care will add a valuable perspective as we advance AL102 through Phase 3 and prepare Investigational New Drug (IND) filings for IM-1021 and IM-3050.” “I am drawn to Immunome’s commitment to developing transformative therapies that meaningfully improve patients’ lives,” remarked Dr. Swain. “Immunome’s promising pipeline, talented team, and focus on patients offers a tremendous opportunity to address unmet medical need. I look forward to serving as a Board member and supporting Immunome’s important mission.” Dr. Swain has served as Associate Dean for Research Development at Georgetown University Medical Center since 2016, and as Professor of Medicine at Georgetown University Medical Center since 2007. She has also served as Vice President of Genetic Medicine at MedStar Health, a not-for-profit healthcare system, since 2018. Dr. Swain served on the board of directors of the American Society of Clinical Oncology (ASCO) from 2008-2013 and was ASCO President 2012-13. Since 2007, Dr. Swain has served on the board of directors for Conquer Cancer, the ASCO Foundation, including as treasurer of the Executive Committee from 2016 to 2019 and on the Joint Investment Committee from 2016 to 2018. Dr. Swain previously served on the board of directors of Seagen Inc. from November 2022 until its acquisition by Pfizer Inc. in December 2023. Dr. Swain holds an M.D. from the University of Florida and a B.A. in Chemistry from the University of North Carolina at Chapel Hill. Dr. Swain completed a residency in Internal Medicine at Vanderbilt University and a fellowship in Medical Oncology at the National Cancer Institute, National Institutes of Health. About Immunome, Inc. Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, RLTs and immunotherapies. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets. For more information, visit or follow us on X/Twitter and LinkedIn. Cautionary Statement Regarding Forward-Looking Statements Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). We use words such as “advance,” “promising,” “opportunity,” “look forward,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. These forward-looking statements include, but are not limited to, statements regarding Immunome’s expectations regarding its ongoing clinical trial for AL102 and preparation of IND filings for IM-1021 and IM-3050; the advancement of Immunome’s pipeline; the ability to execute on Immunome’s mission; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Such forward-looking statements are based on Immunome’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors. These factors include, but are not limited to, the risk that Immunome will not be able to realize the benefits of its strategic transactions, Immunome’s ability to grow and successfully execute on its business plan, including the development and commercialization of its pipeline; changes in the applicable laws or regulations; the possibility that Immunome may be adversely affected by other economic, market, business, and/or competitive factors; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that interim results of a clinical trial do not necessarily predict final results; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the risk that our product and development candidates fail to achieve their intended endpoints; the complexity of numerous regulatory and legal requirements that Immunome needs to comply with to operate its business; the reliance on Immunome’s management; the prior experience and successes of the Immunome’s management team not being indicative of any future success; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; the failure to obtain, adequately protect, maintain or enforce Immunome’s intellectual property rights; and other risks and uncertainties indicated from time to time described in exhibit 99.2 filed with Immunome’s Current Report on Form 8-K with Securities and Exchange Commission (“SEC”) on February 13, 2024, and in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 28, 2024, and in Immunome’s other filings with the SEC. Immunome cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Moreover, Immunome operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required by law, Immunome does not undertake any obligation to update publicly any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in their expectations. View source version on businesswire.com: Contacts Max Rosett Interim Chief Financial Officer investors@immunome.com Source: Immunome View this news release online at:

Topline data for Phase 3 RINGSIDE trial of AL102 expected in first quarter of 2025 IM-1021 and IM-3050 IND filings expected in first quarter of 2025 Current cash expected to fund activities into 2026 BOTHELL, Wash.--(BUSINESS WIRE)-- Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the full year ended December 31, 2023, and provided an overview of recent developments. “2023 was a transformative year for Immunome as we closed the merger with Morphimmune, advanced our pipeline and expanded the company’s leadership team,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer. “These accomplishments laid the groundwork for a productive start to 2024, including the acquisition of two promising assets and a successful financing.” Dr. Siegall continued, “We are focused on efficiently developing our four existing assets and expanding our pipeline. We expect to add novel antibody-drug conjugates (ADCs) and radioligand therapies (RLTs) to the pipeline through internal discovery efforts while continuing to evaluate opportunities to acquire high-quality assets on favorable financial terms. We are well-positioned to develop best-in-class or first-in-class therapies to improve the lives of cancer patients.” Pipeline Highlights The purchase of AL102 from Ayala Pharmaceuticals closed on March 25, 2024. Immunome expects to report topline data for the ongoing Phase 3 RINGSIDE Part B trial of AL102 in the first quarter of 2025. Ayala previously announced the full enrollment of RINGSIDE in February 2024. In parallel, Immunome is evaluating and performing additional manufacturing and pharmacology work required to support an NDA submission of AL102. Immunome’s preclinical pipeline includes IM-1021, a ROR1 ADC; IM-3050, a FAP-targeted RLT; and IM-4320, an anti-IL-38 immunotherapy candidate. Immunome anticipates submitting investigational new drug applications (INDs) for IM-3050 and IM-1021 in the first quarter of 2025. Anticipated timing for an IND for IM-4320 will be shared at a later date. Highlights from 2023 and early 2024 Successfully completed an underwritten offering of 11.5M shares priced at $20 per share for gross proceeds of $230.0M in February 2024, providing capital that is expected to support completion of the RINGSIDE trial and advancement of IM-1021, IM-3050 and IM-4320 into clinic. Immunome’s current cash runway is expected to extend into 2026. Acquired AL102, a Phase 3 gamma secretase inhibitor with best-in-class potential, from Ayala Pharmaceuticals in March 2024. Exclusively licensed IM-1021 (formerly known as ZPC-21), a preclinical ROR1 ADC with first-in-class potential, as well as the underlying ADC linker-payload technology, from Zentalis in January 2024. Nominated IM-3050 as a FAP RLT candidate with first-in-class potential in December 2023. Completed the acquisition of Morphimmune, Inc, a concurrent PIPE of $125 million, and the transition to Clay Siegall, Ph.D. as President and CEO in October 2023. Filled leadership positions post-merger, including key members of the Executive Committee and five VP/SVP roles. Full-year 2023 Financial Results As of December 31, 2023, cash, cash equivalents and marketable securities totaled $138.1 million, which does not include gross proceeds of $230 million from the February financing. Research and development expenses for the year ended December 31, 2023 were $23.1 million. In-process research and development expenses for the year ended December 31, 2023 were $80.8 million. General and administrative expenses for the year ended December 31, 2023 were $19.7 million. Immunome reported a net loss of $106.8 million, or basic and diluted net loss per share attributable to common stockholders of $5.38, for the year ended December 31, 2023. About Immunome, Inc. Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, RLTs and immunotherapies. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets. For more information, visit or follow us on Twitter and LinkedIn. Cautionary Statement Regarding Forward-Looking Statements Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). We use words such as “may,” “could,” “potential,” “will,” “plan,” “believe,” “goal,” “optimistic,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. These forward-looking statements include, but are not limited to, statements regarding immunome’s expectation to add novel ADCs and RLTs to its pipeline; Immunome’s expectation to report topline data for the ongoing Phase 3 RINGSIDE Part B trial of AL102 in the first quarter of 2025; Immunome’s expected timeline for filing INDs for IM-3050 and IM-1021 in the first quarter of 2025; Immunome’s expectation that it will share a date for filing an IND for IM-4320; Immunome’s expectation that the funds from the February financing will support completion of the RINGSIDE trial and advancement of IM-1021, IM-3050 and IM-4320 into clinic; Immunome’s expected cash runway; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Such forward-looking statements are based on Immunome’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, the risk that Immunome will not be able to realize the benefits of its strategic transactions, Immunome’s ability to grow and successfully execute on its business plan, including the development and commercialization of its pipeline; changes in the applicable laws or regulations; the possibility that Immunome may be adversely affected by other economic, business, and/or competitive factors; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that interim results of a clinical trial do not necessarily predict final results; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the risk that our product and development candidates fail to achieve their intended endpoints; the complexity of numerous regulatory and legal requirements that Immunome needs to comply with to operate its business; the reliance on Immunome’s management; the prior experience and successes of the Immunome’s management team not being indicative of any future success; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; the failure to obtain, adequately protect, maintain or enforce Immunome’s intellectual property rights; and other risks and uncertainties indicated from time to time described in exhibit 99.2 filed with Immunome’s Current Report on Form 8-K with Securities and Exchange Commission (“SEC”) on February 13, 2024, and in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2023, being filed with the SEC later today, and in Immunome’s other filings with the SEC. Immunome cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Moreover, Immunome operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required by law, Immunome does not undertake any obligation to update publicly any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in their expectations. Immunome, Inc. Consolidated Balance Sheets (in thousands, except share and per share amounts) December 31, 2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $ 98,679 $ 20,323 Marketable securities 39,463 — Prepaid expenses and other current assets 6,561 2,326 Total current assets 144,703 22,649 Property and equipment, net 2,073 681 Operating right-of-use asset, net 1,564 284 Restricted cash 100 100 Deferred offering costs — 332 Other long-term assets 100 — Total assets $ 148,540 $ 24,046 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 3,311 $ 2,400 Accrued expenses and other current liabilities 8,025 4,931 Deferred revenue, current 10,493 — Total current liabilities 21,829 7,331 Deferred revenue, non-current 5,489 — Other long-term liabilities 1,340 62 Total liabilities 28,658 7,393 Commitments and contingencies (Note 8) Stockholders’ equity: Preferred stock — — Common stock 4 1 Additional paid-in capital 342,663 132,653 Accumulated other comprehensive income 22 — Accumulated deficit (222,807 ) (116,001 ) Total stockholders’ equity 119,882 16,653 Total liabilities and stockholders’ equity $ 148,540 $ 24,046 Immunome, Inc. Consolidated Statements of Operations (in thousands, except share and per share amounts) Year Ended December 31, 2023 2022 Collaboration revenue $ 14,018 $ — Operating expenses: In-process research and development 80,802 — Research and development 23,089 23,272 General and administrative 19,657 13,629 Total operating expenses 123,548 36,901 Loss from operations (109,530 ) (36,901 ) Other income: Interest income, net 2,724 5 Total other income 2,724 5 Net loss $ (106,806 ) $ (36,896 ) Deemed dividend arising from warrant modification — (622 ) Net loss attributable to common stockholders $ (106,806 ) $ (37,518 ) Per share information: Net loss per common share, basic and diluted $ (5.38 ) $ (3.09 ) Weighted-average common shares outstanding, basic and diluted 19,843,651 12,126,573 Comprehensive loss Net loss $ (106,806 ) $ (37,518 ) Unrealized gain on marketable securities 22 — Comprehensive loss $ (106,784 ) $ (37,518 )