Obexelimab

- Advancing Phase 2 and Phase 3 trials of obexelimab, a unique CD-19 x FcγRIIb inhibitor of B cell function- -Topline results from Phase 2 Trial in Relapsing Multiple Sclerosis (MoonStone) expected in third quarter 2025- -Topline results from pivotal Phase 3 Trial in Immunoglobulin G4-Related Disease (INDIGO) expected year-end 2025- - Enrollment of Phase 2 Trial in Systemic Lupus Erythematosus (SunStone) expected to be completed in 2025- - Out-licensed greater-China anti-IGF-1R Thyroid Eye Disease programs to Zai Lab - Feb. 05, 2025 -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of therapies for autoimmune diseases, today announced its 2024 accomplishments, outlined its key business objectives for 2025 and announced preliminary unaudited cash balance as of year-end 2024. “Based upon the progress achieved across all of our corporate goals and objectives during 2024, we enter 2025 with an opportunity to achieve major value-driving milestones with the anticipated results from our ongoing obexelimab Phase 2 and Phase 3 clinical trials,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “We are extremely proud of the accomplishments of our dedicated team as we enter the year well-financed and able to focus on execution, and achievement of our key objectives for the year.” The Company enters 2025 well-capitalized to deliver its key milestones with approximately $350 million in cash, cash equivalents, and short-term investments as of December 31, 2024, 1 which is expected to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026. During 2024, the Company achieved the following objectives and announced a recent business development transaction: Completed enrollment of the Phase 3 INDIGO trial, a global Phase 3 registration-directed, randomized, double-blind placebo-controlled trial of obexelimab in patients with Immunoglobulin-G4 Related Disease (IgG4-RD), the largest clinical trial ever conducted in this patient population. Initiated the Phase 2 MoonStone trial, a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with Relapsing Multiple Sclerosis (RMS). Initiated the Phase 2 SunStone trial, a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab to reduce disease activity in patients with Systemic Lupus Erythematosus (SLE). Provided initial data from the Phase 2 SApHiAre trial, a global, multicenter, open-label safety and dose confirmation run-in period (SRP) to evaluate the safety and activity of obexelimab in patients with warm Autoimmune Hemolytic Anemia (wAIHA). Obexelimab achieved clinical proof-of-mechanism by increasing hemoglobin levels and red blood cells, and decreasing LDH and total bilirubin levels. Obexelimab was well tolerated in the SRP. Completed an upsized Series C and initial public offering, raising approximately $458.7 million in aggregate gross proceeds to fund its planned activities for obexelimab and the Company’s growth strategy. Bolstered its leadership team with the appointments of Chief Commercial Officer, Orlando Oliveira, and Chief Legal Officer, Jeff Held. Out-licensed ZB005, a human IgG4 monoclonal antibody designed to bind only to the active form of C1s, for which Zenas held the development and commercialization rights in China, Hong Kong, Macau and Taiwan (Greater China) through an exclusive license with Dianthus. The Company recently out-licensed regional rights to its thyroid eye disease programs, including ZB001, an insulin-like growth factor-1 receptor (anti-IGF-1R) monoclonal antibody, to Zai Lab (Zai). Zenas received an upfront fee and is eligible to receive milestone payments and royalties in the future, as consideration for an exclusive sublicense to Zai to develop and commercialize ZB001 and related programs in Greater China. Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered, subcutaneous once-weekly injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Obexelimab has been evaluated in five completed clinical trials in a total of 198 patients who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well tolerated and demonstrated clinical activity across these five clinical trials, providing the Company an initial clinical proof of concept for obexelimab as a potent B cell inhibitor for the treatment of patients living with certain autoimmune diseases. During 2025, the Company expects to achieve the following key clinical milestones: Report the 12-week primary endpoint results in the third quarter of 2025 from the Phase 2 MoonStone trial in patients with RMS. The role of B cells in the pathogenesis of multiple sclerosis including RMS has been demonstrated through the successful clinical development, approval and clinical use of anti-CD20 B cell targeting therapies of other companies, including OCREVUS® (ocrelizumab) and KESIMPTA® (ofatumumab), which selectively deplete CD20-expressing B cells. The Company believes obexelimab’s unique mechanism of action to potently inhibit but not deplete a broader B cell lineage than CD20, nonclinical data, and a subcutaneous injection regimen, supports its potential for the treatment of RMS. Following an initial screening period, patients in the MoonStone trial are being randomized 2:1 to 250 mg of obexelimab or placebo administered as a subcutaneous injection every seven days for a 12-week treatment period. The primary objective of this double-blinded portion of the trial will be to assess the change from baseline in the cumulative number of gadolinium (Gd) enhancing lesions identified on T1-weighted magnetic resonance imaging (MRI). Upon completion of the 12-week period, patients will enter an open-label period where patients on placebo will receive obexelimab treatment for at least three months, and patients initially randomized to obexelimab will continue treatment. Important secondary endpoints during this open-label period include using standardized assessments, novel 3D imaging and biomarkers, including serum neurofilament light chain (NfL), to evaluate the impact of obexelimab on disease progression. More information on the Phase 2 MoonStone trial (NCT06564311) is available at clinicaltrials.gov Report topline results year-end 2025 from the Phase 3 INDIGO trial in patients with IgG4-RD. IgG4-RD is a chronic fibro-inflammatory disease that can affect virtually all organ systems, including the pancreas, biliary tract, salivary and lacrimal glands, lungs, and kidneys. Patients with IgG4-RD may present with a single organ involved but more frequently present with multiple organ involvement. As the disease progresses and patients experience new or worsening symptoms (i.e., flares), lesions develop in additional organs and the cellular inflammation characterizing early disease moves toward a more fibrotic stage, which can lead to major irreversible tissue damage and ultimately organ failure. We estimate that the currently diagnosed population of IgG4-RD patients in the U.S. is approximately 20,000, with comparable prevalence rates globally. Despite the growing recognition of IgG4-RD and advances in the understanding of its pathophysiology, there are no approved therapies for the treatment of this disease and there remains high unmet medical need. The current standard of care is treatment with glucocorticoids (GCs). Although GCs are initially effective, treatment with GCs can often result in various complications and co-morbidities. Most patients can relapse within 12 months of discontinuing GC treatment, and maintenance therapy with GCs has not been shown to prevent recurrence of disease. The pathogenesis of IgG4-RD suggests that B cell-targeted therapies may provide therapeutic benefit. Although not approved by any regulatory authorities to treat IgG4-RD, certain B cell depleting agents (e.g., rituximab) are occasionally administered to patients with IgG4-RD. However, B cell depleting agents are often associated with infections, including serious opportunistic infections, and can compromise a patient’s ability to mount a response to vaccinations. The reported evidence for the role of B cells in the pathogenesis of IgG4-RD, the observed effects of B cell targeting agents in previous trials in IgG4-RD, the data from our Phase 2 IgG4-RD trials with obexelimab, and its unique, non-depleting mechanism and once-weekly, subcutaneous injection regimen support its development in patients with IgG4-RD. INDIGO is the largest clinical trial conducted in patients living with IgG4-RD and is designed to evaluate the safety and efficacy of obexelimab in approximately 190 patients with active IgG4-RD and being conducted at approximately 100 sites in 20 countries. Following an initial screening period, patients were randomized 1:1 to 250 mg of obexelimab or placebo administered as a subcutaneous injection every seven days for 52 weeks, followed by an opportunity for eligible patients to continue in an open-label extension period where all patients will receive treatment with obexelimab. The primary efficacy endpoint of INDIGO is the time to first IgG4-RD flare, as determined per protocol by the investigator and the adjudication committee. Secondary endpoints include annualized flare rate, the proportion of patients achieving complete remission, and use and quantity of rescue medication, including GCs. More information on the Phase 3 INDIGO trial (NCT05662241) is available at clinicaltrials.gov Complete enrollment in 2025 in the Phase 2 SunStone trial in patients with SLE and report topline results in the first half of 2026. The crucial role of B cells in SLE pathogenesis is well recognized, from producing autoantibodies to abnormal regulation of immune responses. Moreover, SLE is an autoimmune disease characterized by B cell dysfunction, the production of autoantibodies toward cellular and nuclear components, and multiorgan damage caused by immune complex deposition and inflammation within affected tissues. Current treatments are limited in number and modestly effective. Obexelimab has demonstrated clinical activity in a prior Phase 2 double-blind, randomized trial demonstrating proof-of-concept in the overall trial population and increased response in patients who maintained higher systemic exposure to obexelimab, and also in biomarker-defined subpopulations. Coupled with the safety data obtained to date, we believe these data provide support for the development of obexelimab in patients with SLE. Patients with active SLE determined at screening by the investigator and adjudication committee are randomized 1:1 to obexelimab 250 mg or placebo administered as a subcutaneous injection every seven days for 24 weeks. The 250 mg once-weekly subcutaneous injection dose has been selected to maximize the potential for clinical activity as higher systemic exposure (Ctrough) correlated with greater clinical activity in the prior Phase 2 trial in SLE. The primary endpoint is the percentage of responders, defined by BILAG-based Composite Lupus Assessment, with a reduction of SLE disease activity at week 24. Biomarker analysis is planned to be conducted in all patients, including baseline RNA expression profiles to immunophenotype patients and evaluation of their differential responses to treatment. More information on the Phase 2 SunStone trial (NCT06559163) is available at clinicaltrials.gov Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on LinkedIn. 1 This amount is preliminary and unaudited and is subject to completion of the Company’s financial closing procedures. As a result, this amount may differ materially from the amount that will be reflected in the Company’s consolidated financial statements for the year ended December 31, 2024. The content above comes from the network. if any infringement, please contact us to modify.

-推进Obexelimab的2期和3期试验，这是一种独特的 CD-19 x FcγRIIb B细胞功能抑制剂 -预计将于2025年第三季度公布复发性多发性硬化症(MoonStone)2期临床试验的顶线结果 -预计将于2025年底公布IgG4相关疾病(INDIGO)3期试验的顶线结果 -预计将于2025年完成系统性红斑狼疮(SunStone)2期临床试验的入组 -将大中华区抗IGF-1R甲状腺眼病项目转让给Zai Lab 美国马萨诸塞州沃尔瑟姆，2025年2月5日(GLOBE NEWSWIRE)--Zenas BioPharma, Inc.(以下简称"Zenas"或"公司")(纳斯达克股票代码:ZBIO)是一家处于临床阶段的全球性生物制药公司，致力于成为自身免疫性疾病疗法开发和商业化领域的领导者，今天宣布了其 2024年的主要成就，概述了公司2025年的主要业务目标，并公布了截至 2024 年年底的初步未经审计的现金余额。 Zenas BioPharma创始人兼首席执行官Lonnie Moulder说:"基于我们在2024年期间在所有公司目标方面取得的进展，2025年我们将有机会通过正在进行的obexelimab 2期和3期临床试验的预期结果达成重大的里程碑，对于我们团队所取得的成就我们感到非常自豪，因为我们今年资金充足，能够专注于执行和实现公司当年的主要目标。" 截至2024年12月31日，公司拥有约3.5亿美元的现金、现金等价物和短期投资，预计这些资金可满足公司至2026年第四季度的运营支出和资本支出需求*，因此公司有充足的资本实现2025年的主要里程碑。 *这一数额是初步的，未经审计，有待公司完成财务结算程序。因此，该金额可能与公司截至2024年12月31日的年度合并财务报表中反映的金额存在差异。 2024年成就和近期成果 2024年期间，公司实现了以下目标以及最近的一项业务发展交易： 完成了INDIGO 3期实验，这是一项针对IgG4相关疾病的全球性、基于注册目的、随机、双盲、安慰剂对照试验，也是迄今为止在该患者群体中开展的规模最大的临床试验。 启动MoonStone 2期试验，这是一项多中心、随机、双盲、安慰剂对照的2期试验，旨在评估obexelimab对复发性多发性硬化症(RMS)患者的疗效和安全性。 启动SunStone 2期试验，这是一项2期、多中心、随机、双盲、安慰剂对照试验，旨在评估Obexelimab减轻系统性红斑狼疮患者疾病活动的疗效和安全性。 提供了SApHiAre 2期试验的初步数据，该试验是一项全球性、多中心、开放标签的安全性和剂量确认导入期(SRP)试验，目的是评估Obexelimab在温抗体型自身免疫性溶血性贫血(wAIHA)患者中的安全性和活性。Obexelimab提高了血红蛋白和红细胞水平，降低了LDH和总胆红素水平，从而获得了临床机制验证。Obexelimab在SRP中的耐受性良好。 完成C轮增发和首次公开募股，募集资金总额约4.587亿美元，用于支持Obexelimab的临床试验和公司的发展战略。 任命首席商务官Orlando Oliveira和首席法务官Jeff Held，加强了领导团队。 转让ZB005大中华区的权益，ZB005是一种人IgG4单克隆抗体，用于仅与活性形式的C1s 结合，Zenas通过与Dianthus公司的独家许可，拥有该抗体在中国大陆、香港、澳门和台湾(大中华区)的开发和商业化权利。 公司近期将其甲状腺眼病项目ZB001胰岛素样生长因子-1受体(抗IGF-1R)单克隆抗体的大中华区权益授权给了Zai Lab，Zenas收到了一笔预付费以及未来有权获得里程碑付款和特许权使用费，作为对Zai Lab在大中华区开发和商业化ZB001及相关项目的独家转授权的对价。 Obexelimab 2025临床里程碑 Obexelimab是一种双功能单克隆抗体，可同时结合CD19和FcγRIIb(广泛存在于B细胞系中)，从而抑制与许多自身免疫性疾病有关的细胞的活性，而不会耗竭它们。这种独特的作用机制和每周一次的皮下注射方案可广泛而有效地解决B细胞系在慢性自身免疫性疾病中的致病作用。Obexelimab已在五项已完成的临床试验中进行了评估，共有198名患者通过静脉输注或皮下注射接受了Obexelimab治疗。在这五项临床试验中，Obexelimab的耐受性和临床活性均表现良好，为公司提供了一个初步的临床概念验证，即Obexelimab是一种有效的B细胞抑制剂，可用于治疗某些自身免疫性疾病。 2025年，公司预计将实现以下重要临床里程碑： 在2025年第三季度获得针对RMS患者的MoonStone 2期试验的12周主要终点结果。 其他公司的抗CD20 B细胞靶向疗法，包括OCREVUS®(ocrelizumab)和KESIMPTA®(ofatumumab)的成功临床开发、批准和临床应用证明了B细胞在包括RMS在内的多发性硬化症发病机制中的作用，这些疗法可选择性地清除CD20表达的B细胞。公司认为，obexelimab具有独特的作用机制，能有效抑制CD20更广泛的B细胞系但不消耗B细胞，其非临床数据和皮下注射方案都支持其治疗RMS的潜力。 o 经过初步筛选后，MoonStone试验的患者将按2:1的比例随机分配到250毫克的Obexelimab或安慰剂中，每七天皮下注射一次，治疗期为12周。 o 该试验双盲部分的主要目标是评估T1加权磁共振成像(MRI)中发现的钆(Gd)增强病灶的累积数量与基线相比的变化。 o 12周疗程结束后，患者将进入开放标签期，在此期间，服用安慰剂的患者将接受至少3个月的Obexelimab治疗，而最初随机接受Obexelimab治疗的患者将继续接受治疗。 o 开放标签期的重要次要终点包括使用标准化评估、新型三维成像和生物标志物(包括血清神经丝轻链(NfL))来评估Obexelimab对疾病进展的影响。 有关MoonStone 2期试验(NCT06564311)的更多信息，请访问clinicaltrials.gov 2025年年末公布针对IgG4-RD患者的INDIGO 3期试验的初步结果 IgG4-RD是一种慢性免疫介导纤维炎性疾病，几乎可影响所有器官系统，包括胰腺、胆道、唾液腺和泪腺、肺和肾。IgG4-RD患者可能表现为单一器官症状，但更常见的是多器官受影响。随着病情的发展，患者会出现新的或恶化的症状(即复发)，病变会在更多器官中发展，早期疾病的细胞炎症会向纤维化阶段发展，这可能会导致严重的不可逆转的组织损伤，最终导致器官衰竭。我们估计，目前美国确诊的IgG4-RD患者约有20,000人，全球发病率相当。 尽管人们对IgG4-RD的认识在不断提高，对其病理生理学的理解也在不断进步，但治疗这种疾病尚未有合适疗法，仍有大量治疗需求未得到满足。目前的标准疗法是使用糖皮质激素(GCs)治疗。尽管糖皮质激素最初是有效的，但使用糖皮质激素治疗往往会导致各种并发症和合并症。大多数患者会在停止GCs治疗后的12个月内复发，而GCs的维持治疗尚未证明能防止疾病复发。 IgG4-RD的发病机制表明，B细胞靶向疗法可能会带来治疗效果。虽然还未有得到批准的产品用于治疗IgG4-RD，但某些B细胞耗竭剂(如rituximab)偶尔也会用于IgG4-RD患者。然而，B细胞耗竭剂药物通常与感染有关，包括严重机会性感染，而且会损害患者对疫苗接种产生反应的能力。 有证据表明B细胞在IgG4-RD发病机制中的作用，B细胞靶向药物在既往的 IgG4-RD试验中观察到的效果，我们用Obexelimab进行的IgG4-RD 2期试验的数据，以及它独特的非耗竭机制和每周一次的皮下注射方案，都支持在IgG4-RD患者中开发这种药物。 o INDIGO是针对IgG4-RD患者开展的规模最大的临床试验，旨在评估Obexelimab在约190名活动性IgG4-RD患者中的安全性和有效性，目前正在20个国家的约100个研究中心进行。 o 经过初步筛选后，患者按1:1随机分配到250毫克的Obexelimab或安慰剂，每七天皮下注射一次，持续 52 周，随后符合条件的患者有机会继续接受开放标签延长期治疗，所有患者都将接受Obexelimab治疗。 o INDIGO的主要疗效终点是首次IgG4-RD复发的时间，由研究者和裁定委员会根据方案确定。 o 次要终点包括年复发率、获得完全缓解的患者比例以及补救药物(包括 GCs)的使用情况和数量。 有关INDIGO 3期试验(NCT05662241)的更多信息，请访问clinicaltrials.gov 于2025年完成系统性红斑狼疮患者SunStone 2期试验的入组工作，并于2026年上半年报告初步结果 从产生自身抗体到异常调节免疫反应，B细胞在系统性红斑狼疮发病机制中的关键作用已得到认证。此外，系统性红斑狼疮是一种自身免疫性疾病，其特点是B细胞功能障碍、产生针对细胞和核成分的自身抗体，以及受影响组织内免疫复合物沉积和炎症引起的多器官损伤。目前的治疗方法数量有限，疗效一般。Obexelimab在之前的一项2期双盲随机试验中显示出了临床活性，在整个试验人群中证明了概念，并在保持较高的Obexelimab全身暴露量的患者和生物标志物定义的亚人群中增加了反应。加上迄今为止获得的安全性数据，我们相信这些数据为在系统性红斑狼疮患者中开发Obexelimab 提供了支持。 o 经研究者和裁定委员会筛选确定为活动性系统性红斑狼疮患者，按1:1随机分配到Obexelimab 250毫克或安慰剂，每七天皮下注射一次，共注射24周。 o在之前的系统性红斑狼疮2期试验中，较高的全身暴露量(Ctrough)与较高的临床活性相关，因此选择了每周一次的250毫克皮下注射剂量，以最大限度地提高临床活性。 o 主要终点是在第24周时系统性红斑狼疮疾病活动减少的应答者百分比，该百分比由基于BILAG的狼疮综合评估确定。 o 计划对所有患者进行生物标志物分析，包括基线RNA表达谱，以对患者进行免疫分型，并评估他们对治疗的不同反应。 有关SunStone 2 期实验(NCT06559163)的更多信息，请访问 clinicaltrials.gov 关于Zenas BioPharma Zenas BioPharma是一家全球生物制药公司，致力于成为为世界各地患者开发和商业化免疫学疗法的领导者。我们的核心业务战略是将经验丰富的领导团队与严谨的候选产品组合相结合，在全球范围内发现、收购和开发我们认为能为自身免疫疾病患者带来卓越临床疗效的候选产品。Zenas的主要候选产品Obexelimab是一种双功能单克隆抗体，能同时结合CD19和FcγRIIb(广泛存在于 B 细胞系中)，从而抑制与许多自身免疫性疾病有关的细胞的活性，而不会消耗这些细胞。我们相信，Obexelimab的作用机制和慢性给药方案可以广泛而有效地解决B细胞系在慢性自身免疫性疾病中的致病作用。欲了解有关Zenas BioPharma的更多信息，请访问网站：www.zenasbio.com，LinkedIn及微信公众号上关注我们。 前瞻性说明 本新闻稿包含 “前瞻性声明”，其中涉及风险、不确定性和突发事件，许多风险、不确定性和突发事件超出了公司的控制范围，可能导致实际结果、业绩或成果与预期结果、业绩或成果存在实质性差异。本新闻稿中除历史事实陈述外的所有陈述均为前瞻性陈述。在某些情况下，您可以通过 “可能”、“将要”、“应该”、“期望”、“计划”、“预期”、“也许”、“打算”、“目标”、“项目”、“考虑”、“相信”、“估计”、“预测”、“潜在”或 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日公司未经审计的初步现金、现金等价物和短期投资；以及现金流指导。本新闻稿中的前瞻性表述仅涉及截至本新闻稿发布之日的情况，受许多已知和未知风险、不确定性和假设的影响，可能导致公司的实际结果与前瞻性表述中的预期结果存在实质性差异，这些风险、不确定性和假设包括但不限于公司的经营历史较短，自公司成立以来的亏损，以及预计在可预见的未来将发生不断增加的亏损；公司需要大量额外融资以实现公司目标；临床开发的不确定性，临床开发耗时长、成本高、结果不确定，以及在完成或未能完成公司现有候选产品或任何未来候选产品的开发和商业化过程中与额外成本或延迟相关的风险；临床试验中患者入组和用药的延迟或困难；公司候选产品引起的任何重大不良事件或不良副作用的影响；潜在的竞争，包括来自大型和专业制药及生物技术公司的竞争，其中许多公司已经在公司目前的适应症方面拥有获得批准的疗法；公司从目前或未来的合作或授权协议中获益的能力，以及成功完成未来合作的能力；公司在美国或任何其他司法管辖区获得任何候选产品商业化的监管批准的能力，以及任何此类批准的适应症可能比公司寻求的更狭窄的风险；公司对公司高级管理人员及其他临床和科研人员服务的依赖性，以及公司留住这些人员或招聘更多管理人员或临床和科研人员的能力；公司发展组织、管理公司发展和扩大公司业务的能力；与公司候选产品生产相关的风险(生产过程非常复杂)，以及公司的第三方生产商在生产过程中可能遇到困难的风险；公司为候选产品或公司未来可能开发的候选产品获得并保持足够的知识产权保护的能力；公司依赖第三方开展临床前研究和临床试验的情况；公司履行其他方授予公司的候选产品开发和商业化权利许可下的义务的情况；与公司供应商运营相关的风险，其中许多供应商位于美国境外，包括公司目前唯一的药物物质和药物产品合同生产机构，位于中国的药明康德生物制品(香港)有限公司；以及公司截至2024年9月30日的10-Q季报中 “风险因素 ”一节所述的其他风险和不确定性，以及我们向美国证券交易委员会提交的其他信息。本新闻稿中的前瞻性表述本身具有不确定性，并非对未来事件的保证。由于前瞻性表述本身存在风险和不确定性，其中有些风险和不确定性无法预测或量化，有些风险和不确定性超出了公司的控制范围，因此您不应过分依赖这些前瞻性表述。前瞻性表述中反映的事件和情况可能无法实现或不会发生，未来的实际结果、业绩以及事件和情况可能与前瞻性表述大相径庭。此外，公司在不断变化的环境中运营，新的风险和不确定因素可能不时出现，管理层无法预测所有风险和不确定因素。除非适用法律另有规定，否则公司不承诺公开更新或修订此处包含的任何前瞻性表述，无论是否因任何新信息、未来事件、环境变化或其他原因所致。 Zenas BioPharma文字商标和Logo是Zenas BioPharma公司或其关联公司的商标。 投资者联系： Matthew Osborne   投资者关系与企业沟通  Matt.osborne@zenasbio.com   媒体联系：  Argot Partners Zenas@argotpartners.com 关注我们 获得更多相关信息