VTX3232 was well-tolerated in the Phase 1 trial with robust target coverage achieved in both plasma and CSF; Ventyx is planning to initiate Phase 2a trials in Parkinson’s disease and obesity in H2 2024

VTX3232在1期试验中耐受性良好，在血浆和脑脊液中均实现了强大的目标覆盖率；Ventyx计划于2024年下半年启动帕金森病和肥胖症的2a期试验

Topline Phase 2 data for VTX2735 in CAPS patients establish clinical proof of concept; Ventyx is planning to evaluate VTX2735 in cardiovascular diseases

CAPS患者VTX2735的Topline 2期数据建立了临床概念证明；Ventyx计划评估VTX2735在心血管疾病中的作用

Early Phase 2 open-label extension data continue to support the clinical profile of VTX002 in ulcerative colitis; Ventyx is planning to seek a partner or other nondilutive financing for pivotal Phase 3 trial

早期2期开放标签扩展数据继续支持VTX002在溃疡性结肠炎中的临床表现；Ventyx计划为关键的3期试验寻求合作伙伴或其他非稀释性融资

Based on pipeline reprioritization and recent PIPE financing, Ventyx expects its current cash, cash equivalents and marketable securities to fund planned operations into at least H2 2026

根据管道重新优先化和最近的管道融资，Ventyx预计其目前的现金、现金等价物和有价证券将至少为2026年下半年的计划运营提供资金

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, will provide clinical and pipeline updates today during its virtual investor event..

圣迭戈，2024年3月11日（环球通讯社）--Ventyx Biosciences，Inc.（纳斯达克：VTYX）（“Ventyx”），一家临床阶段的生物制药公司，专注于推进新型口服疗法，以解决广泛的炎症性疾病和严重未满足的医疗需求，今天将在其虚拟投资者活动期间提供临床和管道更新。。

“We are excited to announce clinical updates from our novel NLRP3 inhibitor portfolio, including topline results from the Phase 1 trial of VTX3232 in healthy volunteers and topline results from the Phase 2 trial of VTX2735 in CAPS patients,” said Raju Mohan, Chief Executive Officer. “With these compelling clinical results and support from our recent PIPE financing, we are announcing a pipeline reprioritization, with internal resources to be focused on advancing our portfolio of potential best-in-class NLRP3 inhibitors in high value indications with substantial unmet medical need.”.

首席执行官Raju Mohan说：“我们很高兴宣布我们新型NLRP3抑制剂组合的临床更新，包括健康志愿者VTX3232第一阶段试验的结果以及CAPS患者VTX2735第二阶段试验的结果。”。“凭借这些令人信服的临床结果和我们最近的PIPE融资的支持，我们宣布进行管道重新优先化，内部资源将集中在推进我们潜在的同类最佳NLRP3抑制剂组合，以满足大量未满足的医疗需求。”。

Pipeline Updates

管道更新

VTX3232 (CNS-penetrant NLRP3 Inhibitor): We completed a Phase 1 single- and multiple-ascending dose trial of VTX3232 in adult healthy volunteers to assess the safety, pharmacokinetics and pharmacodynamics of VTX3232. Separate cohorts were included in this trial in which serial cerebrospinal fluid (CSF) sampling was conducted to assess drug exposure and target engagement in the CSF..

VTX3232（中枢神经系统渗透性NLRP3抑制剂）：我们在成年健康志愿者中完成了VTX3232的1期单剂量和多剂量递增试验，以评估VTX3232的安全性，药代动力学和药效学。该试验包括单独的队列，其中进行了连续脑脊液（CSF）采样以评估药物暴露和CSF中的目标参与。。

VTX3232 was well-tolerated with no dose-limiting toxicities identified. All treatment-emergent adverse events were graded mild or moderate. VTX3232 exhibited a dose-dependent and dose-linear pharmacokinetic profile. Repeat doses of 3 mg QD maintained steady-state IL-1β IC50 coverage in both plasma and CSF over 24 hours.

VTX3232耐受性良好，未发现剂量限制性毒性。所有治疗紧急不良事件均为轻度或中度。VTX3232表现出剂量依赖性和剂量线性药代动力学特征。每天一次重复服用3 mg可在24小时内维持血浆和脑脊液中稳态IL-1βIC50的覆盖率。

Repeat doses of 40 mg QD exceeded steady-state IL-1β IC90 coverage in both plasma and CSF over 24 hours. Robust, dose-dependent pharmacodynamic effects were observed in a whole blood ex vivo IL-1β stimulation assay. Additionally, reductions in inflammatory biomarkers were observed in plasma and CSF samples.

在24小时内，每天一次重复服用40毫克的剂量超过了血浆和脑脊液中稳态IL-1βIC90的覆盖率。在全血离体IL-1β刺激测定中观察到强烈的剂量依赖性药效学效应。此外，在血浆和脑脊液样品中观察到炎症生物标志物的减少。

We believe these data support the potential for VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases..

我们相信这些数据支持VTX3232成为治疗神经炎症性疾病的最佳中枢神经系统渗透性NLRP3抑制剂的潜力。。

We expect to initiate a Phase 2a trial of VTX3232 in patients with early Parkinson’s disease during the second half of 2024. We also expect to initiate a Phase 2a trial of VTX3232 in subjects with obesity and certain additional risk factors for cardiovascular disease during the second half of 2024..

我们预计在2024年下半年开始对早期帕金森病患者进行VTX3232的2a期试验。我们还预计在2024年下半年在肥胖和某些其他心血管疾病危险因素的受试者中启动VTX3232的2a期试验。。

VTX2735 (Peripheral NLRP3 Inhibitor): We completed a Phase 2 trial of VTX2735 in patients with cryopyrin-associated periodic syndromes, or CAPS, a group of rare autoinflammatory conditions caused by gain-of-function mutations in the NLRP3 gene. This trial enrolled 7 patients with familial cold autoinflammatory syndrome (FCAS), the most common subset of CAPS.

VTX2735（外周NLRP3抑制剂）：我们在患有cryopyrin相关周期性综合征（CAPS）的患者中完成了VTX2735的2期临床试验，CAPS是由NLRP3基因的功能获得性突变引起的一组罕见的自身炎症。该试验招募了7名家族性感冒自身炎症综合征（FCAS）患者，这是CAPS最常见的子集。

Treatment with VTX2735 demonstrated clinically meaningful improvements in disease activity, including an 85% mean reduction in the Key Symptom Score during Treatment Period 1. Reductions in inflammatory biomarkers were also observed, consistent with improvements in disease activity. VTX2735 was well-tolerated and all drug-related adverse events were graded mild.

VTX2735治疗显示疾病活动有临床意义的改善，包括治疗期间1关键症状评分平均降低85%。还观察到炎症生物标志物的减少，与疾病活动的改善一致。VTX2735耐受性良好，所有与药物相关的不良事件均为轻度。

We believe these data establish compelling clinical proof of concept for our peripheral NLRP3 inhibitor VTX2735..

我们相信这些数据为我们的外周NLRP3抑制剂VTX2735建立了令人信服的临床概念证明。。

We plan to evaluate VTX2735 in cardiovascular diseases with an initial focus on the secondary prevention of major adverse cardiovascular events (MACE) and recurrent pericarditis.

我们计划评估心血管疾病中的VTX2735，最初重点是主要不良心血管事件（MACE）和复发性心包炎的二级预防。

VTX002 (S1P1R Modulator): In October 2023, we announced positive results from the Phase 2 trial of VTX002 in patients with moderately to severely active ulcerative colitis (UC). We believe these results establish VTX002 as a potential best-in-disease oral agent in UC based on its differentiated efficacy profile, including a high rate of complete endoscopic remission, and its potential best-in-class safety profile..

VTX002（S1P1R调节剂）：2023年10月，我们宣布了VTX002在中度至重度活动性溃疡性结肠炎（UC）患者中的2期试验的阳性结果。我们相信，这些结果基于其不同的疗效特征，包括高完全内镜缓解率及其潜在的同类最佳安全性，将VTX002确立为UC中潜在的最佳疾病口服药物。。

At our virtual investor event, we will present data from the ongoing Phase 2 open-label extension. We believe these data continue to support the potentially differentiated profile of VTX002 in ulcerative colitis, with robust rates of clinical remission and endoscopic remission observed among participants completing 52 weeks of treatment with VTX002.

在我们的虚拟投资者活动上，我们将展示正在进行的第二阶段开放标签扩展的数据。我们相信这些数据继续支持VTX002在溃疡性结肠炎中的潜在分化特征，在完成VTX002治疗52周的参与者中观察到了强大的临床缓解率和内镜缓解率。

At least half of the patients in the 60 mg treat-through group achieved clinical remission or endoscopic remission at Week 52. Activities are underway to prepare for a Phase 3 trial. We intend to identify a partner or other source of non-dilutive financing to support the pivotal Phase 3 trial of VTX002 in ulcerative colitis..

60 mg treat-through组中至少有一半患者在第52周达到临床缓解或内镜缓解。正在开展活动，为第三阶段试验做准备。我们打算确定合作伙伴或其他非稀释性融资来源，以支持VTX002在溃疡性结肠炎中的关键3期试验。。

VTX958 (TYK2 Inhibitor): We are evaluating VTX958 in a Phase 2 trial in patients with moderately to severely active Crohn’s disease. We recently implemented a protocol amendment for the ongoing Phase 2 trial to streamline trial design and accelerate the detection of an efficacy signal. As a result of the protocol amendment, target enrollment in the trial was revised from approximately 132 patients to approximately 93 patients.

VTX958（TYK2抑制剂）：我们正在对中度至重度活动性克罗恩病患者的2期试验中评估VTX958。我们最近为正在进行的第二阶段试验实施了一项协议修正案，以简化试验设计并加速功效信号的检测。由于方案修订，试验的目标登记从大约132名患者修订为大约93名患者。

The trial’s sole primary endpoint is now the change from baseline in the mean Crohn’s disease activity index (CDAI) score at Week 12. We anticipate completing randomization of the trial during the first quarter of 2024 and expect to report topline results from the Phase 2 Crohn’s disease trial during the middle of 2024..

该试验唯一的主要终点是第12周克罗恩病平均活动指数（CDAI）评分与基线的变化。我们预计在2024年第一季度完成试验的随机化，并预计在2024年中期报告第二阶段克罗恩病试验的最终结果。。

Cash Runway: We reported cash, cash equivalents and marketable securities of $252.2 million as of December 31, 2023. Combined with gross proceeds of approximately $100 million from our recent PIPE financing, and based on our revised pipeline priorities, we now expect our current cash, cash equivalents and marketable securities to fund planned operations into at least the second half of 2026..

现金跑道：截至2023年12月31日，我们报告的现金、现金等价物和有价证券为2.522亿美元。结合我们最近管道融资产生的约1亿美元总收益，并根据我们修订的管道优先级，我们现在预计我们目前的现金、现金等价物和有价证券将至少为2026年下半年的计划运营提供资金。。

Webcast and Conference Call Information

网络广播和电话会议信息

Ventyx will host a virtual investor event today, Monday, March 11, 2024 from 11:00AM to 12:30PM ET. To participate in the event, please dial (800) 343-4849 (U.S.) or (203) 518-9848 (international) and reference passcode VTYX0311. A live webcast will be available in the Investors section of the Company’s website at www.ventyxbio.com.

Ventyx将于2024年3月11日（星期一）上午11:00至下午12:30举办虚拟投资者活动。要参加活动，请拨打（800）343-4849（美国）或（203）518-9848（国际）并参考密码VTYX0311。在线直播将在公司网站www.ventyxbio.com的投资者部分进行。

A recording of the webcast will be available for thirty days following the call..

通话后30天内将提供网络广播录音。。

About Ventyx Biosciences

关于Ventyx Biosciences

Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical need with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs.

Ventyx是一家临床阶段的生物制药公司，专注于为患有自身免疫性和炎性疾病的患者开发创新的口服药物。我们相信，我们有效发现和开发差异化候选药物的能力将使我们能够通过新型口服疗法解决未满足的重要医疗需求，从而将炎症和免疫学市场从注射药物转向口服药物。

Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. Ventyx is headquartered in San Diego, California. For more information about Ventyx, please visit www.ventyxbio.com..

我们目前的渠道包括针对NLRP3，S1P1R和TYK2的内部发现的临床计划，使我们成为外周和神经炎症性疾病口服免疫疗法开发的领导者。Ventyx总部位于加利福尼亚州圣地亚哥。有关Ventyx的更多信息，请访问www.ventyxbio.com。。

Forward-Looking Statements

前瞻性声明

Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Ventyx’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential of Ventyx’s product candidates, including the potential of VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases, and the potential of VTX002 as a best-in-disease oral agent in UC ; the potentially differentiated profile of VTX002 in UC; the anticipated continued progression of the development pipeline for Ventyx’s product candidates, including the anticipated timing for the initiation of Phase 2a trials of VTX3232 in Parkinson’s disease and obesity in H2 2024, and the plan to evaluate VTX2735 in cardiovascular diseases; management’s plans with respect to a potential pivotal Phase 3 trial for VTX002 in UC, supported by a partner or other source of non-dilutive financing; ; the anticipated timing of updates regarding the VTX958 Phase 2 trial in Crohn’s disease; and the expected timeframe for funding Ventyx’s operating plan with current cash, cash equivalents and marketable securities.

Ventyx提醒您，本新闻稿中关于非历史事实的声明是前瞻性声明。这些陈述是基于Ventyx目前的信念和期望。此类前瞻性声明包括但不限于以下声明：Ventyx候选产品的潜力，包括VTX3232成为治疗神经炎症性疾病的最佳中枢神经系统渗透性NLRP3抑制剂的潜力，以及VTX002作为UC最佳口服药物的潜力；UC中VTX002的潜在差异；Ventyx候选产品开发管道的预期持续进展，包括2024年下半年开始VTX3232帕金森病和肥胖症2a期试验的预期时间，以及评估心血管疾病VTX2735的计划；管理层关于加州大学VTX002潜在关键3期试验的计划，由合伙人或其他非稀释性融资来源支持；关于克罗恩病VTX958 2期试验的预期更新时间；以及用现有现金、现金等价物和有价证券为Ventyx的运营计划提供资金的预期时间表。

The inclusion of forward-looking statements should not be regarded as a representation by Ventyx that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Ventyx’s business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; Ventyx’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disrupt.

纳入前瞻性声明不应被视为Ventyx表示其任何计划都将实现。由于Ventyx业务固有的风险和不确定性，实际结果可能与本新闻稿中的结果有所不同，包括但不限于：临床试验的开始，注册和完成可能会延迟；Ventyx在产品制造、研究以及临床前和临床测试方面对第三方的依赖；打乱。

Investor Relations Contact

投资者关系联系人

Patti Bank

帕蒂银行

Managing Director

总经理

ICR Westwicke

ICR Westwicke

(415) 513-1284

(415) 513-1284

IR@ventyxbio.com

IR@ventyxbio.com