PLA2R

-- First clinical data with povetacicept presented at American Society of Nephrology Kidney Week support best-in-class potential and broad pipeline opportunity – -- Company closed an oversubscribed $150 million equity offering to accelerate multiple development activities – -- Multiple catalysts with povetacicept targeted in 2024 including initiation of pivotal IgAN and phase 2 lupus clinical trials -- SEATTLE--(BUSINESS WIRE)-- Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results and company highlights for the third quarter ended September 30, 2023. “The first presentation of clinical data in patients for povetacicept during a late-breaking session at the American Society of Nephrology (ASN) Kidney Week Meeting marked an important milestone in Alpine’s history. Based on continued strong support from investigators and key opinion leaders, we plan to advance povetacicept into a pivotal study in IgA nephropathy (IgAN) and a phase 2 study in systemic lupus erythematosus (SLE) in the second half of 2024,” said Mitchell Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. “Following our data presentation, we executed a follow-on equity offering of $150 million to bolster our balance sheet. The additional capital enables us to further accelerate development activities, including povetacicept, across multiple autoantibody-related diseases.” Dr. Gold continued, “These initial data and the subsequent follow-on offering set the stage for an active, catalyst-heavy 2024, with additional data expected in IgAN that will include longer term follow-up from our low-dose cohort and initial data from our high-dose cohort. In addition, we look forward to sharing initial data from povetacicept in autoimmune cytopenias. We believe povetacicept, which is a wholly-owned program, represents a unique, potentially best-in-class molecule and look forward to using our strong balance sheet to support a broad development plan across multiple indications.” Third Quarter 2023 Highlights & Recent Updates Highlights From Data Presented at the American Society of Nephrology (ASN) Kidney Week In IgAN, treatment with low-dose povetacicept, 80 mg subcutaneously (SC) every four weeks was associated with clinically meaningful improvements in proteinuria, with a 53.5% reduction from baseline in urine protein to creatinine ratio (UPCR; n=5) at 24 weeks. In addition, at 24 weeks, 4/5 (80%) had achieved remission, as defined as UPCR < 0.5 g/g and ≥ 50% reduction in UPCR from baseline with stable renal function (£ 25% reduction in eGFR from baseline). In IgAN, treatment with low-dose povetacicept was also associated with a >60% reduction in the key disease-related biomarker galactose-deficient IgA1 (Gd-IgA1), as well as stable renal function as assessed by estimated glomerular filtration rate (eGFR) (+7.1% from baseline at 24 weeks; n=5). The first participant with primary membranous nephropathy (pMN), also treated with povetacicept 80 mg subcutaneously (SC) every four weeks, achieved an immunological remission, defined as a reduction in the highly disease-relevant biomarker anti-PLA2R1 to an undetectable level, from a baseline of 209 to < 2 RU/mL by 22 weeks. Povetacicept has been well tolerated, with no reported administration-associated reactions, no instances of IgG < 3 g/L, and no severe infections. A higher dose of povetacicept, 240 mg SC every four weeks, continues to enroll, with initial data expected in first half of 2024. Link to the ASN poster: Highlights From Data Presented at the American Association of Neuromuscular & Electrodiagnostic (AANEM) Medicine Meeting In a model of murine experimental autoimmune myasthenia gravis (EAMG), povetacicept improved disease activity, with clinical scores superior to treatment with either the FcRn inhibitor efgartigimod or an anti-CD20 depleting antibody. It also reduced anti-AChR IgG autoantibodies and serum Ig isotypes, including IgM and IgA, superior to both comparator treatments. Link to the AANEM poster: Highlights From Data Presented at the American College of Rheumatology (ACR) Meeting In SLE patients, BAFF- and APRIL-related genes (i.e., BAFF, APRIL, TACI, and BCMA) were increased in myeloid lineage cells and B cells compared to healthy adults. Povetacicept, as compared to single BAFF or APRIL pathway inhibitors, more potently downregulated genes associated with activation in B cells. Povetacicept significantly reduced multiple disease parameters in a mouse model of lupus, more effectively than wild-type TACI-Fc or conventional B cell depletion. Link to povetacicept poster: Third Quarter 2023 Financial Results Cash Position and Runway: As of September 30, 2023, Alpine’s cash and investments totaled $227.2 million compared to $273.4 million as of December 31, 2022. The Company anticipates its current cash and investments, together with the $140.5 million in net proceeds after deducting discounts, commissions and estimated costs from the subsequently completed stock offering, are sufficient to fund planned operations into 2026. Collaboration Revenue: For the three and nine months ended September 30, 2023, collaboration revenue was $10.0 million and $28.0 million, respectively, compared to $8.4 million and $27.3 million for the same periods in 2022. The increase in collaboration revenue over the three-month period relates primarily to increases of $3.5 million in Horizon revenue, largely as the result of our two ongoing Research Programs nearing completion during the 2023 period, whereas the lower revenue during the 2022 period resulted from services rendered in connection with only the first Research Program. These increases were offset by decreases in AbbVie revenue of $1.4 million primarily due to lower contributed employee hours. The increase in collaboration revenue for the nine months ended September 30, 2023, as compared to the prior year, primarily relates to increases in AbbVie revenue as the related clinical trial continues patient enrollment, and Horizon revenue for services rendered in connection with our two ongoing Research programs, whereas the lower Horizon revenue in the 2022 period was primarily the result of the completion of the Existing Program, followed by the commencement of the first additional research program. Research and Development Expenses: For the three and nine months ended September 30, 2023, research and development expenses, inclusive of non-cash expenses, were $19.2 million and $58.0 million, respectively, compared to $17.6 million and $51.5 million for the same periods in 2022. The respective increases of $1.6 million and $6.5 million were primarily attributable to process development, manufacturing, higher clinical trial costs, as well as increases in personnel costs. General and Administrative Expenses: For the three and nine months ended September 30, 2023, general and administrative expenses, inclusive of non-cash expenses, were $5.4 million and $15.8 million, respectively, compared to $4.6 million and $13.6 million for the same periods in 2022. The respective increases of $0.8 million and $2.3 million were primarily attributable to increases in personnel and legal costs. Net Loss: Net loss for the three and nine months ended September 30, 2023, was $11.7 million and $38.1 million, respectively, compared to net losses of $13.3 million and $38.9 million for the same periods in 2022. Alpine Immune Sciences, Inc. Selected Condensed Consolidated Balance Sheet Data (In thousands) September 30, 2023 December 31, 2022 (unaudited) Cash and cash equivalents $ 18,981 $ 13,376 Short-term investments 174,472 224,265 Total current assets 197,415 240,993 Long-term investments 33,502 35,481 Total assets 240,547 286,686 Total current liabilities 51,818 57,996 Total stockholders’ equity 161,631 179,420 Total liabilities and stockholders’ equity 240,547 286,686 Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) Data (In thousands, except share and per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) Collaboration revenue $ 10,043 $ 8,367 $ 28,023 $ 27,288 Operating expenses: Research and development 19,150 17,589 57,972 51,487 General and administrative 5,443 4,610 15,848 13,579 Total operating expenses 24,593 22,199 73,820 65,066 Loss from operations (14,550 ) (13,832 ) (45,797 ) (37,778 ) Other income (expense): Interest income 2,891 664 7,837 1,123 Interest expense — (105 ) (98 ) (389 ) Other, net (63 ) — (86 ) (72 ) Loss before taxes (11,722 ) (13,273 ) (38,144 ) (37,116 ) Income tax expense — — — (1,782 ) Net loss $ (11,722 ) $ (13,273 ) $ (38,144 ) $ (38,898 ) Comprehensive income (loss): Unrealized gain (loss) on investments 170 (307 ) 677 (1,385 ) Unrealized (loss) gain on foreign currency translation (60 ) 7 (96 ) (11 ) Comprehensive loss $ (11,612 ) $ (13,573 ) $ (37,563 ) $ (40,294 ) Weighted-average shares used to compute basic and diluted net loss per share 49,222,344 31,574,358 48,286,203 31,559,886 Basic and diluted net loss per share $ (0.24 ) $ (0.42 ) $ (0.79 ) $ (1.23 ) About Povetacicept (ALPN-303) Povetacicept (ALPN-303) is a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation and/or survival of B cells, particularly antibody-secreting cells, as well as T cells and innate immune cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept has exhibited greater potency in preclinical studies versus other inhibitors of BAFF and/or APRIL alone and B cell depletion. Povetacicept is in development for multiple autoimmune diseases, including IgA nephropathy and other autoimmune kidney diseases, systemic lupus erythematosus, and autoimmune cytopenias. About RUBY-3 RUBY-3 (NCT05732402) is a multiple ascending dose, multi-cohort, open label, phase 1b/2a study of povetacicept in autoimmune glomerulonephritis, where povetacicept is being administered subcutaneously for up to 48 weeks. Key endpoints include proteinuria, eGFR, renal response, and disease-related autoantibodies. About RUBY-4 RUBY-4 (NCT05757570) is a multi-cohort, open label, phase 1b study of povetacicept in immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease, where povetacicept is being administered subcutaneously for up to 48 weeks. Key endpoints include respective blood cell counts, including durable responses, as well as disease-related autoantibodies. About Alpine Immune Sciences Alpine Immune Sciences is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit . Follow @AlpineImmuneSci on X and LinkedIn. Forward-Looking Statements This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies; the timing of and results from clinical trials and preclinical development activities; clinical and regulatory objectives and the timing thereof; expectations regarding the sufficiency of cash, cash equivalents, restricted cash, and investments, along with proceeds from our November 2023 follow-on equity offering, to fund our planned operations into 2026; our ability to achieve additional milestones in our collaborations and proprietary programs; the progress and potential of our development programs; future development plans and clinical and regulatory milestones and objectives, including the timing and achievement thereof; the efficacy of our clinical trial designs; anticipated enrollment in our clinical trials and the timing thereof; expectations regarding the anticipated reporting of data from our ongoing and planned clinical trials and potential publication of future clinical data; our ability to potentially advance povetacicept directly into a pivotal trial in 2024 as well as a phase 2 study in systemic lupus erythematosus, pending engagement with and approval of the Food and Drug Administration; and the potential efficacy, safety profile, addressable market, regulatory success and commercial or therapeutic potential of our product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and preclinical efforts may not yield additional product candidates; our discovery stage and preclinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; we may be unable to advance povetacicept directly into a pivotal trial or a phase 2 study in systemic lupus erythematosus in 2024; the impact of pandemics, or other related health crises on our business, research and clinical development plans and timelines and results of operations, including the impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. The RUBY and Alpine logos are registered trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

- 美国 FDA 基于天境生物合作伙伴 HI-Bio 主导的 M-PLACE 2 期临床研究的积极成果，授予菲泽妥单抗治疗原发性膜性肾病突破性疗法认定 - 天境生物拥有菲泽妥单抗在大中华地区所有适应症的独家开发和商业化权益；菲泽妥单抗二线治疗多发性骨髓瘤的 3 期临床数据预计于 2024 年公布，后续将根据计划递交 BLA 申请 美国马里兰州罗克维尔和中国上海 2023年11月2日 /美通社/ -- 天境生物（"公司"）（纳斯达克股票代码：IMAB）是一家国际生物科技公司，致力于通过创新免疫疗法和生物药的药物发现、临床开发和产品商业化，为全球患者提供高度差异化的治疗手段。公司今天与合作伙伴HI-Bio（一家专注于为免疫介导性疾病领域开发免疫疗法的临床阶段生物科技公司）共同宣布，美国食品药品监督管理局（FDA）已授予差异化CD38抗体菲泽妥单抗用于治疗原发性膜性肾病（PMN）的突破性疗法认定（Breakthrough Therapy Designation, BTD）。 此次FDA突破性疗法认定，基于包括M-PLACE研究（一项菲泽妥单抗治疗原发性膜性肾病的1b/2a期概念验证、开放标签研究）在内的多项的积极临床结果。M-PLACE研究的最终结果将由俄亥俄州立大学肾脏病学部主任Brand Rovin博士，于2023年11月1日至5日举行的美国肾脏病学会肾脏周（ASN Kidney Week 2023）上以口头报告形式公布。 天境生物总裁朱秀轩博士表示："很高兴菲泽妥单抗继今年5月获得FDA授予的孤儿药资格认定后，又获得了突破性疗法认定。对于天境生物、我们的合作伙伴HI-Bio、以及饱受疾病困扰的PMN患者而言，此次认定不仅是菲泽妥单抗研发道路上的重要里程碑，也进一步坚定了我们探索这一创新免疫疗法在癌症及自身免疫性疾病领域治疗潜力的信心。" HI-Bio首席医疗官Uptal Patel博士表示："FDA授予菲泽妥单抗突破性疗法认定，是对菲泽妥单抗治疗PMN的潜力的充分认可。积极的临床数据让我们坚信，菲泽妥单抗精准靶向清除CD38+浆细胞的设计策略，同样适用于更多由CD38+浆细胞驱动产生的抗体引发的免疫介导性疾病，包括PMN、IgA肾病、抗体介导性排斥反应、及狼疮性肾炎等。" 天境生物拥有菲泽妥单抗在大中华地区（包括中国大陆、香港、澳门和台湾）所有适应症的独家开发和商业化权益。目前，公司正在开展菲泽妥单抗治疗癌症及自身免疫性疾病的研究；其中，以无进展生存期（PFS）为主要研究终点的菲泽妥单抗联合来那度胺和地塞米松二线治疗多发性骨髓瘤（MM）的3期注册性临床试验正在稳步推进中。公司预计将于2024年公布该项研究的成果，后续将根据计划递交生物制品上市许可申请（BLA）。 突破性疗法认定源于《美国食品和药物管理局安全及创新法案》（FDASIA）的规定，适用于治疗严重或危及生命的疾病且初步临床证据显示出显著优于现有疗法的药品，旨在加速该药品的开发和审评程序，是继快速通道、加速审批、优先审评之后，FDA又一重要的新药评审通道。根据规定，获得突破性疗法认定的药物开发过程将获得包括FDA资深评审员在内的更加密切的指导及多种形式的支持，保障在更短时间内为患者提供新的治疗选择。 关于原发性膜性肾病（ PMN ） PMN是一种罕见的自身抗体介导的自身免疫性肾脏疾病，是全球成人肾病综合征的主要原因。该病的发病及诊断通常在40-50岁之间，80%的患者表现为肾病综合征，即水肿、蛋白尿少于3.5g/天、低白蛋白血症。 PMN的特点是免疫复合物在足细胞和肾小球内皮之间的空间形成沉积，从而造成肾小球基底膜增厚。大约80%的原发性膜性肾病病例是由于识别足细胞上表达的PLA2R抗原的自身抗体引起的。aPLA2R抗体是诊断和预后的生物标志物。CD38+浆细胞驱动产生致病性的aPLA2R抗体，从而损害肾小球功能。 目前，全球尚无获批的PMN治疗方法，存在巨大未被满足的临床需求。当前的护理标准包括标签外使用的支持性护理措施（如血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂、他汀类药物和利尿剂）、常规免疫抑制治疗（如环磷酰胺联合类固醇和钙调磷酸酶抑制剂），或B细胞消耗剂（如CD20抗体）。然而，以上治疗方法并非对所有患者均有疗效，有相当比例的患者没有获得缓解。此外，传统的免疫抑制治疗具有较高的毒性风险。 关于菲泽妥单抗 菲泽妥单抗是一款靶向CD38（一种在成熟浆细胞上表达的蛋白质）的在研人源单克隆抗体。该抗体所针对的多发性骨髓瘤表面CD38抗原，属于恶性浆细胞表面表达最强烈、且均一的肿瘤抗原。该抗体的作用机制是通过抗体依赖性细胞毒性和抗体依赖性细胞吞噬作用杀伤表达CD38的肿瘤细胞。但并没有涉及补体依赖的细胞毒性作用（CDC）。 研究表明， CD3 8抗体还具有在其他癌症及自身免疫性疾病的治疗潜力。依据天境生物与MorphoSys于2017年11月签订的许可协议，天境生物拥有菲泽妥单抗在大中华地区（包括中国大陆、台湾、香港和澳门）所有适应症的独家开发和商业化权益。2022年6月， HI-Bio与MorphoSys达成参股与授权许可协议， HI-Bio 获得菲泽妥单抗在大中华区以外的全球其它地区所有适应症的开发和商业化权益。 关于天境生物 天境生物（纳斯达克股票代码：IMAB）是一家国际生物科技公司，致力于通过创新免疫疗法和生物药的药物发现、临床开发和产品商业化，为全球患者提供高度差异化的治疗手段。公司在"快速产品上市"和"快速概念验证"的双轮策略驱动下，通过自主研发、全球授权合作和商业化合作等多元化模式，建立起了多个具有全球竞争力的创新药研发管线。更多信息请访问 https://www.i-mabbiopharma.com/ 并关注天境生物 领英 、 推特 及 微信 官方账号。 天境生物前瞻性声明 本新闻稿包含根据《1995 年私人证券诉讼改革法案》以及其他联邦证券法律下定义的前瞻性声明，包括有关菲泽妥单抗的临床试验结果，临床试验数据对患者产生的潜在影响，天境生物有关菲泽妥单抗进展及预期的临床开发计划、药政里程碑及商业化。由于各种重要因素的影响，实际结果可能与前瞻性声明有重大差异。这些因素包括但不限于以下事项的风险：天境生物证明其候选药物安全性和疗效的能力；候选药物的临床结果可能不支持进一步开发或新药上市审批；相关监管机构就天境生物候选药物的监管审批作出决定的内容和时间；天境生物的候选药物（如能获批）获得商业成功的能力；天境生物对其技术和药物知识产权保护获得和维护的能力；天境生物依赖第三方进行药物开发、生产和其他服务的情况；天境生物有限的运营历史和获得进一步的运营资金以完成候选药物开发和商业化的能力；新冠病毒对公司临床开发、商业以及其他业务运营带来的影响；以及天境生物在最近年度报告20-F表格中"风险因素"章节里更全面讨论的各类风险；以及天境生物向美国证券交易委员会期后呈报中关于潜在风险、不确定性以及其他重要因素的讨论。所有前瞻性声明基于天境生物目前掌握的信息，除非法律另有要求，天境生物没有因新信息、日后事件或其他原因而公开更新或修订任何前瞻性声明的义务。 天境生物联系人 Tyler Ehler ，投资者关系高级总监 IR@i-mabbiopharma.com 冯琦，首席传播官 PR@i-mabbiopharma.com

FDA granted Breakthrough Therapy Designation for felzartamab in PMN upon positive clinical data from M-PLACE, a Phase 2 study led by I-Mab partner HI-Bio I-Mab has full development and commercialization rights of felzartamab in Greater China for all indications, with Phase 3 multiple myeloma data expected in 2024, followed by a planned BLA submission ROCKVILLE, Md. and SHANGHAI, Nov. 2, 2023 /PRNewswire/ -- I-Mab (Nasdaq: IMAB) (the "Company"), a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics, and HI-Bio, a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for felzartamab, an investigational CD38 antibody, for the treatment of primary membranous nephropathy (PMN). "The FDA's decision to grant felzartamab Breakthrough Therapy designation is recognition of the promising data we have collected to date, as well as an acknowledgement of the need for major advances over available therapies in the treatment of patients with PMN," said Dr. Uptal Patel, Chief Medical Officer of HI-Bio. "We believe that the cellular depletion strategy with felzartamab in PMN is applicable to many more immune-mediated diseases driven by antibodies produced in CD38+ plasma cells. For that reason, we are currently developing felzartamab in multiple diseases including PMN, IgA nephropathy, antibody-mediated rejection and lupus nephritis." The FDA selectively grants Breakthrough Therapy Designation to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition, and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). The designation for felzartamab was based on clinical data submitted to the FDA, including results from M-PLACE, a Phase 1b/2a proof-of-concept, open-label study. The final analysis of the M-PLACE study has been accepted as an oral presentation at the American Society of Nephrology (ASN) Kidney Week 2023 Annual Meeting (Abstract TH-OR27), taking place November 1–5, 2023, by Brad Rovin, M.D., Director of the Division of Nephrology at Ohio State University. I-Mab has the full rights to develop and commercialize felzartamab for all indications in Greater China which encompasses Mainland China, Hong Kong, Macau, and Taiwan. I-Mab is evaluating felzartamab in oncology and autoimmune diseases. I-Mab is currently conducting a Phase 3 registrational study of felzartamab in combination with lenalidomide and dexamethasone as a second-line treatment for multiple myeloma (MM) in China with progression-free survival (PFS) as the primary endpoint, with a projected read-out in 2024, followed by a planned BLA submission. "We are excited about the potential therapeutic benefit of felzartamab through this Breakthrough Therapy Designation by the FDA, following the Orphan Drug Designation received in May," said Dr. Andrew Zhu, President of I-Mab. "This designation represents an important milestone for I-Mab, our partner HI-Bio, and the PMN community as we continue to evaluate felzartamab as an innovative immunotherapy for multiple indications, including cancers and autoimmune diseases." About Primary Membranous Nephropathy (PMN) PMN is a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome (NS) in adults worldwide. Disease onset and diagnosis typically occurs between 40 and 50 years of age, with 80% of patients presenting with nephrotic syndrome (i.e., edema, >3.5 g/day proteinuria, hypoalbuminemia). PMN is characterized by a thickening of the glomerular basement membrane (GBM) due to the formation and deposition of immune complexes in this space between podocytes and the glomerular endothelium of the kidney. Approximately 80% of PMN cases arise due to autoantibodies that recognize the phospholipase A2 receptor (PLA2R) antigen expressed on podocytes. Anti-PLA2R is both a diagnostic and prognostic biomarker, and total aPLA2R antibody level has been shown to be a biomarker for prognosis of outcome in patients with PMN. Other autoantibodies have been identified in patients with PMN including anti-THSD7A, NELL-1 and Sema3B, further supporting the role of antibody-secreting plasma cells in the pathophysiology of PMN. CD38+ long-lived plasma cells and plasmablasts are a main source of autoantibodies. There are no approved therapies for PMN. The current standard of care comprises off-label use of supportive care measures (e.g., angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, statins, and diuretics), conventional immunosuppressive treatments (ISTs) (e.g. cyclophosphamide combined with steroids and calcineurin inhibitors) or B-cell depleting agents (e.g. anti-CD20 antibodies). However, these treatments are not effective in all patients, with a significant proportion of patients not achieving remission or relapsing. In addition, conventional immunosuppressive treatments are associated with a high risk of toxicity. About Felzartamab Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. The antibody is directed against CD38 on the surface of multiple myeloma cells, which has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. According to its suggested mode of action, the antibody recruits cells of the body's immune system to kill the tumor through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The antibody does not involve complement dependent cytotoxicity, or CDC, an additional immune mechanism involved in tumor cell killing. Scientific research suggests that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on a licensing agreement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the exclusive rights for development and commercialization of felzartamab for all indications in Greater China, which encompasses Mainland China, Hong Kong, Macao, and Taiwan. HI-Bio in-licensed felzartamab from MorphoSys in June 2022, and holds exclusive worldwide rights for felzartamab with the exception of Greater China. About I-Mab I-Mab (Nasdaq: IMAB) is a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics. I-Mab's innovative pipeline is driven by internal R&D's Fast-to-Proof-of-Concept, Fast-to-Market development strategies, and through global partnerships. For more information, please visit and follow us on LinkedIn, Twitter, and WeChat. I-Mab Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from clinical studies of felzartamab, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones, and commercialization of felzartmab. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the US Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. I-Mab Contacts View original content to download multimedia: SOURCE I-Mab Company Codes: NASDAQ-NMS:IMAB