LCB-71

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 quarter ended March 31, 2025 and provided a business update. “Immunome continued to build momentum in the first quarter of 2025,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer. “We remain on track to share topline data for the RINGSIDE trial of varegacestat in the second half of 2025, and we are optimistic that varegacestat will demonstrate differentiated efficacy across multiple endpoints. “Varegacestat is complemented by a robust pipeline of differentiated programs with first-in-class or best-in-class potential. The dose escalation portion of the Phase 1 clinical trial of IM-1021, our ROR1 ADC, is ongoing in solid tumors and lymphoma. Following the recent clearance of the IND for IM-3050, our FAP radiotherapy, we expect to start a clinical trial for that program in the second half of this year. We are making progress on IND-enabling manufacturing for IM-1617, IM-1335 and IM-1340, each of which incorporate our differentiated TOP1 inhibitor, HC74.” Pipeline Highlights Varegacestat: Full enrollment for the Phase 3 RINGSIDE Part B study of varegacestat for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing the manufacturing and pharmacology work required to support a new drug application filing for varegacestat. IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with the first patient dosed in February 2025. The trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors. IM-3050: Immunome received IND clearance for IM-3050 in April 2025 and expects to initiate a Phase 1 clinical trial in the second half of 2025. Preclinical Pipeline: Immunome’s three preclinical ADCs against solid tumor targets, IM-1617, IM-1340 and IM-1335, each of which incorporates HC74, are currently undergoing IND-enabling work. Additional undisclosed ADCs are in discovery and lead optimization. First Quarter 2025 Financial Results As of March 31, 2025, cash, cash equivalents and marketable securities totaled $317.3 million. This total includes net proceeds of $161.7 million from the January 2025 financing and reflects approximately $11 million in payments during the quarter related to non-recurring IM-1021 milestones and 2024 annual performance bonuses. Immunome expects its current cash position to fund operations into 2027. Research and development expenses for the quarter ended March 31, 2025 were $36.9 million, including stock-based compensation costs of $2.4 million. General and administrative expenses for the quarter ended March 31, 2025 were $10.7 million, including stock-based compensation expense of $3.3 million. Immunome reported a net loss of $41.6 million for the quarter ended March 31, 2025. About Immunome, Inc. Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. For more information, visit www.immunome.com. Cautionary Statement Regarding Forward-Looking Statements Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “focused,” “on track,” “optimistic,” “will,” “potential,” “expect,” and similar expressions to identify these forward-looking statements. These forward-looking statements include Immunome’s expected timing for providing topline data for the Phase 3 RINGSIDE Part B trial; Immunome’s expected cash runway and ability to achieve clinical milestones; Immunome’s expectation that it will enroll patients in its Phase 1 clinical trial for IM-1021 and will report resulting clinical trial data, and that it will initiate a Phase 1 clinical trial for IM-3050; Immunome’s expectations regarding regulatory filings; the ability of Immunome to advance its pipeline; the potential of Immunome’s ADC programs to provide first-in-class or best-in-class status; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including the risk that Immunome will not be able to realize the benefits of its strategic transactions; 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 Immunome’s programs and product candidates fail to achieve their intended endpoints; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; Immunome’s ability to grow and advance its pipeline and successfully execute on its business plan; and other risks and uncertainties included under the caption “Risk Factors” in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 19, 2025 and in Immunome’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, to be filed with the SEC later today. These documents can also be accessed on Immunome’s website at www.immunome.com by clicking on the link “Financials” under the “Investors” tab. The forward-looking statements included in this press release are made only as of the date hereof. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release. 257,613 143,351 59,710 73,952 5,807 4,036 323,130 221,339 10,953 10,113 4,163 4,278 100 100 4,347 4,411 342,693 240,241 9,126 14,189 17,656 33,177 4,015 6,941 30,797 54,307 4,770 4,769 35,567 59,076 — — 9 6 864,530 696,872 (3 ) 57 (557,410 ) (515,770 ) 307,126 181,165 342,693 240,241 Three Months Ended March 31, 2025 2024 ) ) ) ) ) ) ) ) ) ) ) )

BFC Group简介BFC Group是一家立足于中国的精品投行，专注于医疗健康领域的并购、专利许可、融资。我们的业务板块涉及中国、美国和欧洲，曾与国内外众多领先的医疗健康公司有过合作并保持着良好的关系。随着在美国和中国一线运营经验的不断积累，我们对客户在本土之外建立公司或扩展业务所面临的挑战有着深刻的理解。立于塔顶，高瞻之见。使命愿景紧跟医疗健康领域趋势，通过合作推动科学突破与创新。依客户需求制定战略拓展计划，并在目标市场全方位落实与执行。成为专注医疗健康行业最优秀的投资银行。No.1香港资本市场香港股市总体概览美国征收“对等关税”引发贸易冲突升级和经济衰退危机继续冲击市场。恒生指数周一下跌13.22%，即1997年亚洲金融危机后港股最大单日跌幅，后受一系列政策面利好举措刺激，港股亦小幅回暖，截止上周五，累计下跌8.5%。2025年至今，恒生指数累计上涨4.3%。上周，恒生医疗保健指数(HSHCI)累计下跌9.3%。成分股中，仅一脉阳光、乐普生物-B、东阳光长江药业、京东健康、微创机器人-B和锦欣生殖录得涨幅。消息面上，当地时间4月8日，美国总统特朗普发表讲话称，美国将对药品征收关税。此外，4月11日，据外媒FoxBusiness资深记者Charles Gasparino报道，特朗普政府正考虑将中国上市公司股票从美国交易所摘牌。即将上任的美国证券交易委员会(SEC)主席Paul Atkins可能在正式就职后处理摘牌事宜。对此，再鼎医药已第一时间发布声明，表示公司符合美国《外国公司问责法案》(HFCAA)，不受退市影响，然港个股仍受恐慌情绪影响，周累计下跌23%。2025年至今，医药板块领先大盘，恒生医疗保健指数累计上涨15.7%，高于恒生指数11.4个百分点。香港股市医疗健康板块概览2025年3月恒生医疗保健指数上涨7.4%。上周市值前20个股大多下跌。4月8日，中国国家药监局（NMPA）官网最新公示，由翰森制药申报的枸橼酸艾瑞芬净片的新药上市申请已获得批准。根据翰森制药早先新闻稿，艾瑞芬净是一款全新三萜类结构的糖原合成酶抑制剂，同时具有口服和静脉制剂的治疗优势，本次获批用于成年和初潮后女性外阴阴道念珠菌病（VVC）的治疗。艾瑞芬净最初由SCYNEXIS公司开发。2021年2月，翰森制药与SCYNEXIS签订授权协议，负责艾瑞芬净在中国的开发、监管批准及商业化。香港股市医疗健康板块证券发行2024年共计有12家企业上市(其中3家为依照18A新规上市的未盈利生物医药公司)，共募集金额54.0亿港元。2025年截至目前，共有2家企业上市(其中1家为依照18A新规上市的未盈利生物医药公司)，数量与去年同期持平，金额总数上领先去年同期70.5%。上周无新增IPO。2024年共计19家企业完成定增，共募资金额80.9亿港元。2025年至今，共有8家企业完成定增，目前数量领先去年同期60%，金额总数上领先去年同期242.8%。4月10日，基石药业-B完成配售合共8000万股，配售价为每股2.933港元，筹资总额约为2.35亿港元。配售所得款项净额预期将用于以下用途：(i)90%用于与本集团「管缐2.0」中的资产，尤其是CS5001（一款处于临床阶段的ROR1ADC（潜在同类最佳ROR1ADC）），以及CS2009（一款靶向PD-1、VEGFA及CTLA-4的三特异性分子，潜在同类首创/同类最优的下一代肿瘤免疫骨架）有关的进一步研发；及(ii)余下所得款项净额于适当时用于其他一般公司用途。4月8日，和铂医药-B公告完成认购事项。合共7627.18万股认购股份已成功配发及发行予Astra Zeneca Holdings，认购价为每股1.38美元(相当于每股约10.74港元)，较股份认购协议日期前最后5个连续交易日(不包括该日)于联交所所报每股平均收市价约8.44港元溢价约27.3%。所得总额1.05亿美元(约8.19亿港元)，将用作研发、营运及一般营运资金需求。完成后，Astra Zeneca将持有公司股本9.15%。香港股市医疗健康板块IPO动态港股医疗板块拟上市企业No.2沪深资本市场沪深股市总体股市概览受海外关税冲击影响，周一A股迎来调整，上证指数收跌7.34%。临近收盘之时，中央汇金发布公告称已再次增持了交易型开放式指数基金（ETF），4月7日和8日两天，ETF产品合计净流入资金超过1900亿元。截至周五，A股连续4日反弹，本周上证指数跌3.11%，深成指跌5.13%，创业板指跌6.73%。截至目前，2024年上证综指下跌3.4%，沪深300下跌4.7%。4月9日，针对美国继续加征关税，中国宣布多项反制措施，包括将对原产于美国的进口商品加征关税税率从34%提高至84%。4月9日，特朗普决定再次加码，继续对中国产品加税到125%，并且即日生效。4月12日，国务院关税税则委员会公告称，自4月12日起，对原产于美国的加征关税税率，由84%提高至125%。上周，上证医药下跌4.5%，医药中信指数下跌5.4%。2025年，A股医药板块回暖。上证医药上涨1.8%，领先上证综指5.2个百分点。医药中信指数下跌1.0%，领先沪深300指数3.7个百分点。沪深股市医疗健康板块概览2023年医药中信指数下跌6.77%。继2025年2月回升5.0%后，3月延续涨势，上涨1.3%。上周市值前20个股多数下跌。4月8日，NMPA官网公示恒瑞医药递交艾玛昔替尼的新适应症上市申请已获得批准，本次获批针对的适应症为：用于对局部外用治疗或其他系统性治疗应答不充分或不耐受的成人和12岁及以上青少年中度至重度特应性皮炎患者。艾玛昔替尼是一种高选择性的JAK1抑制剂，对JAK1的选择性是对JAK2的16倍。2024年3月，恒瑞医药宣布在第82届美国皮肤病学会年会（AAD）介绍了艾玛昔替尼治疗中重度特应性皮炎（AD）的3期研究结果。结果显示，16周时，艾玛昔替尼4mg组、8mg组与安慰剂组的IGA应答率分别为36.3％、42.0％、9.0％，表明该药物能有效改善中重度AD的疾病活动度。沪深股市医疗健康板块概览上周，创新药指数下跌7.0%，医疗器械指数下跌6.0%。4月9日，荣昌生物逆势上涨8.7%。消息面上，公司宣布其自主研发的BLyS/APRIL双靶点融合蛋白创新药泰它西普（telitacicept，RC18）用于治疗全身型重症肌无力（gMG）3期研究结果，以“最新突破性研究”口头报告亮相美国神经病学学会（AAN）年会。数据显示，泰它西普治疗24周后，MG-ADL评分较基线降低5.74分，安慰剂组降低0.91分；98.1%的患者重症肌无力日常活动评分（MG-ADL）改善≥3分，87%的患者定量重症肌无力评分（QMG）改善≥5分，具有显著的临床意义。沪深股市医疗健康板块新股发行2024年，共4家企业申报IPO。总体数量同比减少71.4%。共募集资金2.47亿元人民币，总体金额同比减少87.7%。上周无新增IPO。2024年，有7家企业发行定增，总体数量同比减少65%。累计定增金额4.95亿元人民币，总体金额同比减少67.6%。上周无新增定增。沪深股市医疗健康板块IPO动态沪深股市医疗板块IPO排队企业情况No.3NASDAQ美国股市总体股市概览美国“对等关税”政策冲击引发全球股市巨震，周三的“对等关税”暂停令引发美股历史性反弹，周四，随着“关税暂停令”的安抚作用消退，美股重回跌势。上周美股三大指数大幅收涨跌，道琼斯工业指数累涨4.95%，标普500指数累涨5.7%，纳斯达克指数累涨7.29%。2025年截至目前，纳指累计下跌13.4%。上周纳斯达克生物技术指数 (NBI）落后于大盘的猛涨之势，微涨0.1%。4月10日，诺华宣布未来5年将在美国投资230亿美元扩建本土制药产能，计划新建7座工厂并保留10个现有生产基地，创造约5000个就业岗位。该投资将覆盖原料药、生物制剂生产及药品包装，确保美国市场关键药物的本土化供应。2024年截至目前，NBI累跌9.3%，跌幅相比纳指缓和4.1个百分点。美国股市医疗健康板块概览2025年开年至今，纳斯达克生物技术指数 (NBI)表现稳定，3月总体震荡6.1%。上周NBI指数速降，指数成分公司股价涨跌互现。2025年4月10日，FDA宣布将逐步终止实施近40年的动物实验（GLP）要求，并启动试点计划，允许部分单抗类药物采用非动物测试策略。此消息导致传统CRO公司查尔斯河股价大跌28.13%，而AI医药概念股（如Certara、Schrodinger）盘后暴涨15%-25%。美国股市医疗健康板块新股发行2024年全年NGS&NGM医疗健康板块累计有30支新股发行，累计募资超55.13亿美金。2025年截至目前，NGS&NGM医疗健康板块共有11支新股发行，累计募资10.276亿美元，相较去年同期数量上落后8.3%，金额下降67.7%。上周Nasdaq无新增IPO。2024年共有322家企业完成定增，累计募集资金约293.8亿美元.2025年截至目前共有92家企业完成定增，总体数量上比去年同期下降32.4%，金额较去年同期下降76.0%。上周共有4起新增定增。其中募资金额最高的是IMMUNITYBIO- Anktiva是其核心产品，也是唯一一款商业化产品，2024年4月22日获得FDA批准上市，联合卡介苗（BCG）用于治疗卡介苗不响应的非肌层浸润性膀胱癌 （NMIBC） 伴原位癌 （CIS），伴或不伴状瘤患者。公司此次以2.58美元每股的价格募集了7500万美元。医疗健康板块IPO动态No.4近期融资事件