Benvitimod

Financing led by ADAR1 Capital Management and Janus Henderson Investors $30 million up front with the potential to receive an additional $20 million at clinical study initiation Phase 1 clinical study initiation planned mid-2026; data anticipated approximately 6 months thereafter LA JOLLA, Calif.--(BUSINESS WIRE)-- Equillium, Inc. (“Equillium” or the “Company”) (Nasdaq: EQ), a biotechnology innovator developing novel therapies to treat severe autoimmune and inflammatory disorders, today announced it has entered into a definitive securities purchase agreement with leading healthcare investors that will provide up to $50 million in gross proceeds to Equillium. The private placement is comprised of (i) an initial upfront financing of approximately $30 million in gross proceeds in exchange for approximately 52.6 million shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock), representing a purchase price of $0.57 for each share of common stock sold at the initial closing (or $0.5699 for each pre-funded warrant sold in lieu of common stock at the initial closing), and (ii) the potential for up to an additional $20 million in gross proceeds in exchange for up to approximately 35.1 million shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock), subject to achieving specified milestones related to clinical study initiation and share price. The financing is being led by new investors ADAR1 Capital Management and Janus Henderson Investors, and includes participation from additional new investors Adage Capital Partners LP, Coastlands Capital, and Woodline Partners LP. “We’re delighted to have the support of such a strong syndicate of top-tier biotech investors who share our vision for advancing transformative therapies for patients,” said Bruce Steel, Chief Executive Officer of Equillium. “This funding marks a significant milestone for Equillium, enabling us to accelerate the clinical development of EQ504 into a Phase 1 proof-of-mechanism study in mid-2026, with data expected to follow approximately six months thereafter.” The aryl hydrocarbon receptor (AhR) is critical to barrier organ physiology and immunology. Modulating AhR induces IL-10 and IL-22, two cytokines that mitigate excessive inflammation, restore barrier function and promote regeneration of tissues. Modulation of AhR has been clinically validated in the treatment of both skin and gastrointestinal (GI) diseases through tapinarof (VTAMA®) and indigo naturalis, a botanical treatment rich in natural AhR modulators. AhR binds a diverse array of heterocyclic or aromatic compounds, including several approved drugs. Recently, Abivax SA reported Phase 3 data in the treatment of ulcerative colitis with obefazimod. The structure of obefazimod has similarities to other AhR modulators and in pre-clinical models of colitis obefazimod was seen to induce both IL-10 and IL-22, both hallmarks of AhR modulation. “IL-10 and IL-22 are both powerful cytokines that are the basis of many drug development programs,” said Dr. Stephen Connelly, Chief Scientific Officer of Equillium. “In combination, we believe that their induction through AhR modulation affords a differentiated, multi-modal and non-immunosuppressive approach to treating tissue inflammation. We intend to develop EQ504 as a novel oral, colon-targeted treatment that we believe has the potential to make a meaningful impact in the treatment for ulcerative colitis and pouchitis, and we’re excited to advance this program into the clinic.” Equillium intends to use the proceeds from this financing to fund the further development of EQ504, working capital and general corporate purposes. The Company has not initiated its recently announced cryptocurrency treasury reserve strategy and is prioritizing development of EQ504. Equillium expects net proceeds from the initial closing of the financing will extend its cash runway through 2027. Leerink Partners is acting as lead placement agent in connection with the financing, and LifeSci Capital is acting as co-placement agent. The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The investors have been granted customary resale Form S-3 registration rights for the shares of common stock issued to them in the financing. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About EQ504 EQ504 is an investigational potent and selective aryl hydrocarbon receptor (AhR) modulator designed with a multi-modal, non-immunosuppressive mechanism of action to be complementary to other inflammation and immunology agents. AhR is critical to barrier organ tissue physiology and immunology, maintaining barrier function and promoting tissue repair and regeneration, while regulating resident immune cells with anti-inflammatory responses. EQ504’s preclinical properties provide the potential for targeted, local delivery via enteric coating for the treatment of ulcerative colitis and pouchitis or inhaled formulations for the treatment of inflammatory lung diseases. About Equillium Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders. The Company’s pipeline consists of novel immunomodulatory assets and a product platform targeting immuno-inflammatory pathways. For more information, visit www.equilliumbio.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future”, “potential” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements include, but are not limited to, statements regarding the timing, size, pricing and completion of the proposed private placement, including the milestone closing; Equillium’s plans to initiate a phase 1 clinical study for EQ504 by mid-2026 and the anticipated timing for date therefrom; Equillium’s intent to develop EQ504 as an orally delivered, colon-targeted treatment, the potential of EQ504 to treat ulcerative colitis and pouchitis; Equillium’s expectation that the net proceeds from the initial closing will extend its cash runway through 2027; Equillium’s expected use of the net proceeds from the private placement; Equillium’s intent to prioritize development of EQ504; and other statements that are not historical facts. Because such statements are subject to risks and uncertainties, many of which are outside of Equillium’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: risks and uncertainties related to market conditions; volatility in the trading price of Equillium’s common stock; risks inherent in achieving clinical milestones and stock price thresholds; Equillium’s ability to initiate or progress clinical trials on the anticipated timelines, if at all; the potential for results from clinical trials to differ from nonclinical, early clinical, preliminary or expected results; reliance on the clinical results from third-party product candidates and/or approved drugs to support advancement and the potential of Equillium’s product candidates;; implementation of Equillium’s strategic plans for its business and product candidates; the sufficiency of Equillium’s capital resources and need for additional capital to achieve its goals; and other risks and uncertainties described more fully under the heading “Risk Factors” in Equillium’s Quarterly Report on form 10-Q for the quarter ended March 31, 2025 filed with the Securities and Exchange Commission (SEC), as supplemented by the Current Report on Form 8-K filed with the SEC on August 4, 2025, and elsewhere in Equillium’s filings and reports, which may be accessed for free by visiting the SEC’s website and on Equillium’s website under the heading “Investors.” Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Corporate Contact Investor Relations 858-240-1200 ir@equilliumbio.com

国际顶级期刊《自然》旗下《信号转导与靶向治疗》杂志，近日发表了一篇题为“中国创新药发展和监管支持的现状”的综述文章，系统回顾了中国创新药的跨越式发展历程，以及中国药品审评审批制度改革带来的变化。 文章选用了部分中国研发新药案例，而首个被顶刊点名的“中国新药样本”，是一款治疗皮肤病、名为本维莫德的1类新药，成为了中国药审改革最硬的“新药勋章”。 国际顶级期刊《自然》旗下《信号转导与靶向治疗》杂志 文章数据显示，2019-2023年间，中国创新药研发实现跨越式发展。得益于一系列监管制度改革，新药临床试验（IND）与上市申请（NDA）的数量和批准率均显著增长，研发上市周期也明显缩短。同时，研发管线质量持续提升，全球首创First-in-class等高价值创新药物增速已超越“Me-too”类，使中国成为全球第二大创新药研发管线持有国。中国深度参与全球多中心临床试验，创新药出海授权交易激增，国际认可度和影响力也快速提升。 作为拥有自主知识产权的全球首创药物，本维莫德于2019年率先获得国家药监局批准，比美国FDA早了整整三年。“本维莫德的价值不仅在于填补了治疗领域空白，更在于验证中国药物监管体系的效率和成熟度。"清华大学医学院首席研究员孔繁圃表示。 孔繁圃进一步解读表示，首先，本维莫德乳膏作为中国原创1类新药，因其创新结构和临床价值，获得国家药监局（NMPA）优先审评资格，实现了高效审批，彰显中国监管路径的有效性。其次，本维莫德在中国首发获批后，短短三年内再获美国FDA批准，这一里程碑不仅证明该药的临床价值，更标志着国际权威机构对中国创新药的认可。再次，NMPA对本维莫德的快速审评，展现了其对前沿作用机制（如靶向AhR通路）的科学判断力和审评能力，这一成功案例推动中国从“仿制药大国”向“创新药策源地”转型，是全球医药领域获得更高话语权的标志。  “过去是中国人等西方新药，现在是世界等中国新药。”本维莫德发明人、上海泽德曼医药科技有限公司董事长陈庚辉博士指出，“这种转变背后是我国药品监管体系的系统性重构和进步，而这种重构在本维莫德升级产品——泽立美乳膏上得到再一次彰显。2024年11月，全球首创无激素儿童湿疹AhR新药泽立美在中国获批上市，20天之后又获得FDA批准，获批速度再一次领先美国。本维莫德从科研实力和获批速度可谓在国际上打出了‘双响炮’！” 分析人士指出，依靠制度创新、市场需求和科研突破的共振，使得泽立美（本维莫德）所代表的“中国原创、全球共享”模式正在形成示范效应。据不完全统计，2024年我国创新药出海总数达98笔，总交易金额攀升至595.505亿美元，中国正在从全球医药创新的追随者转变为重要贡献和领跑者。 这种创新优势正在转化为患者实惠。孔繁圃表示，“创新药不是遥不可及的科技，而是能让老百姓真正用上的治疗选择。“未来，随着中国创新药研发持续发力，更多“首创新药”不仅能先在中国上市，还有望走向全球，让世界见证“中国好药”的实力。  关于上海泽德曼医药 上海泽德曼医药科技有限公司于2021年6月在上海张江成立，是一家聚焦于“超级靶点”芳香烃受体（AhR）及相关疾病治疗药物商业化阶段的医药公司。 关于泽立美乳膏 作为治疗特应性皮炎的全球首个非激素类外用芳香烃受体（AhR）调节剂，泽立美®克服了传统激素治疗的不足。激素药物治疗特应性皮炎，只能通过抑制炎症起效，却对皮肤细胞有直接损伤，长期使用会导致皮肤变薄，皮肤保护屏障脆弱。而泽立美，由于其全新的作用机制，在消除炎症的同时，更加对皮肤有修复和保护的作用。 泽立美®治疗特应性皮炎的四重治疗机制：抑制炎症反应、修复皮肤屏障、抗氧化应激及平衡皮肤微生态。 临床研究数据充分证明了泽立美®对儿童和成人特应性皮炎的卓越疗效。治疗8周时EASI-75（湿疹面积和严重程度改善75%以上）应答率达54.4%，在2-17岁儿童患者中，EASI-75应答率更是高达69.2%，其中7-11岁患儿组更达到83.9%。