商务合作
动脉网APP
可切换为仅中文
Investors include ARCH Venture Partners, Adage Capital Management LP, Caligan Partners LP, RTW Investments, a leading mutual fund and other new and existing institutional investors.
投资者包括ARCH Venture Partners、Adage Capital Management LP、Caligan Partners LP、RTW Investments、一家领先的共同基金以及其他新的和现有的机构投资者。
Ronde-cel, a next-generation CD19/CD20 CAR T-cell product candidate, is advancing toward pivotal data in mid-2027, with the potential to deliver meaningful and durable clinical benefit for patients with relapsed/refractory large B-cell lymphoma
Ronde-cel 是一种下一代 CD19/CD20 CAR-T 细胞候选产品,正朝着在 2027 年中期获得关键性数据的方向推进,有望为复发/难治性大 B 细胞淋巴瘤患者带来显著且持久的临床获益。
Proceeds expected to extend cash runway into 2028, beyond anticipated BLA submission for ronde-cel in the second half of 2027, as well as updated clinical data from our GCC-targeted LYL273 program for patients with metastatic colorectal cancer
预计所得款项将使现金跑道延长至2028年,超过预计于2027年下半年提交的ronde-cel生物制品许可申请(BLA),以及针对转移性结直肠癌患者的GCC靶向LYL273项目的最新临床数据。
SOUTH SAN FRANCISCO, Calif., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced that it has entered into a securities purchase agreement for a private placement of approximately $80 million of its common stock.
加利福尼亚州南旧金山,2026年11月4日(环球电讯社)——Lyell Immunopharma, Inc.(纳斯达克股票代码:LYEL)是一家处于临床后期阶段的公司,致力于推进用于癌症患者的下一代嵌合抗原受体(CAR)T细胞疗法产品管线。该公司今日宣布,已签订证券购买协议,将以私募方式发行价值约8,000万美元的普通股。
The investors include ARCH Venture Partners, Adage Capital Management LP, Caligan Partners LP, RTW Investments, a leading mutual fund and other new and existing institutional investors..
投资者包括 ARCH Venture Partners、Adage Capital Management LP、Caligan Partners LP、RTW Investments、一家领先的共同基金以及其他新老机构投资者。
The financing is expected to extend Lyell’s cash runway into 2028, providing capital to support key clinical and regulatory milestones for rondecabtagene autoleucel (ronde-cel), its next-generation dual-targeting CD19/CD20 CAR T-cell product candidate being developed for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL).
预计此次融资将把 Lyell 的现金跑道延长至 2028 年,为其下一代双靶点 CD19/CD20 CAR-T 细胞候选产品 rondecabtagene autoleucel(ronde-cel)提供资金,以支持关键的临床和监管里程碑。该产品正在开发中,旨在治疗复发/难治性(R/R)大 B 细胞淋巴瘤(LBCL)患者。
Lyell expects to present additional clinical data from the ongoing pivotal PiNACLE trial in the third-or later-line (3L+) LBCL setting at the 68.
Lyell 预计将在第68届年会上公布正在进行的 PiNACLE 关键性试验在第三线或后线(3L+)LBCL 治疗环境中的更多临床数据。
th
泰国
American Society of Hematology (ASH) Annual Meeting and Exposition in December 2026, with the full pivotal dataset anticipated in mid-2027 and submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) expected to follow in the second half of 2027.
2026年12月举行的美国血液学会(ASH)年会暨博览会,预计于2027年年中公布完整的关键数据集,并随后在2027年下半年向美国食品药品监督管理局(FDA)提交生物制品许可申请(BLA)。
“This financing strengthens our financial position and supports the execution of our strategy as we approach several important clinical and regulatory milestones,” said Smital Shah, Chief Financial and Business Officer of Lyell. “We see a significant clinical and commercial opportunity for ronde-cel, which has the potential to deliver durable responses with a one-time treatment that can be administered in the outpatient setting.
“这笔融资增强了我们的财务实力,并支持我们在接近多个重要临床和监管里程碑之际执行公司战略,”Lyell首席财务兼商务官Smital Shah表示。“我们认为ronde-cel具有重大的临床和商业机会,它有望通过一种可在门诊环境下进行的一次性治疗,带来持久的疗效反应。”
We are pleased to have the strong support of our syndicate of high-quality existing and new investors as we advance toward these important milestones.”.
“在迈向这些重要里程碑的过程中,我们很高兴获得了由优质现有投资者和新投资者组成的银团的有力支持。”
Ronde-cel is currently being evaluated in two pivotal trials: PiNACLE, a single-arm trial in the 3L+ LBCL setting intended to support an initial BLA submission for regular marketing approval, and PiNACLE-H2H, a Phase 3 randomized controlled trial comparing ronde-cel to investigator’s choice of an approved CD19-directed CAR T-cell therapy in the second-line (2L) setting.
Ronde-cel 目前正在两项关键试验中接受评估:PiNACLE 是一项在三线及以上(3L+)弥漫性大 B 细胞淋巴瘤(LBCL)患者中开展的单臂试验,旨在支持首次提交生物制品许可申请(BLA)以获得常规上市批准;PiNACLE-H2H 是一项 III 期随机对照试验,在二线(2L)治疗背景下比较 ronde-cel 与研究者选择的已获批 CD19 靶向 CAR T 细胞疗法。
Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for R/R diffuse LBCL in the 3L+ setting, as well as RMAT designation for LBCL in the 2L setting..
Ronde-cel 已获得美国食品药品监督管理局(FDA)授予的再生医学先进疗法(RMAT)认定和快速通道资格,用于治疗三线及以上(3L+)复发或难治性弥漫性大B细胞淋巴瘤(LBCL),同时也获得了用于二线(2L)LBCL治疗的RMAT认定。
Lyell is also advancing LYL273, its GCC-targeted CAR T-cell product candidate for patients with metastatic colorectal cancer (mCRC). The program is progressing toward selection of a recommended Phase 2 dose and optimization of the safety management plan, with additional clinical data and a planned End-of-Phase 1 meeting with the FDA expected in 2027..
Lyell 也在推进 LYL273,这是其针对转移性结直肠癌(mCRC)患者的以 GCC 为靶点的 CAR T 细胞候选产品。该计划正朝着确定推荐的 II 期剂量和优化安全管理方案的方向进展,预计将在 2027 年获得更多临床数据,并与美国食品药品监督管理局(FDA)召开计划的 I 期结束会议。
Private Placement Details
私募发行详情
Under the terms of the securities purchase agreement, Lyell has agreed to sell 7,428,040 shares of common stock at a purchase price of $10.77 per share, equal to the closing price of Lyell’s common stock on November 3, 2026. The financing is expected to generate gross proceeds of approximately $80 million before deducting placement agent fees and other offering expenses.
根据证券购买协议的条款,Lyell 同意以每股 10.77 美元的价格出售 7,428,040 股普通股,该价格等于 Lyell 普通股在 2026 年 11 月 3 日的收盘价。在扣除配售代理费及其他发行费用之前,此次融资预计将筹集约 8,000 万美元的总收益。
The private placement is expected to close on or about November 4, 2026, subject to customary closing conditions..
本次私募预计将于2026年11月4日或前后完成交割,具体取决于惯例的交割条件。
Goldman Sachs and Leerink Partners acted as placement agents in connection with the financing.
高盛集团和Leerink Partners在此次融资中担任配售代理。
Lyell intends to use the net proceeds from the private placement, together with its existing cash, cash equivalents and marketable securities, to support the continued clinical development of ronde-cel, including its ongoing pivotal trials and planned regulatory submission activities, and the continued development of LYL273, as well as for working capital and other general corporate purposes..
莱尔计划将私募发行的净收益,连同其现有现金、现金等价物及有价证券,用于支持 ronde-cel 的持续临床开发(包括正在进行的的关键性试验和计划中的监管申报活动),以及 LYL273 的持续开发,并用于营运资金和其他一般公司用途。
Following the financing, Lyell expects its cash, cash equivalents and marketable securities to be sufficient to meet working capital and capital expenditure needs into 2028, including through the anticipated pivotal data and BLA submission for ronde-cel, as well as through the expected clinical data and regulatory update from the LYL273 development program in mCRC..
融资完成后,Lyell 预计其现金、现金等价物及有价证券将足以满足直至 2028 年的营运资金和资本支出需求,涵盖 ronde-cel 的预期关键数据读出及生物制品许可申请(BLA)提交,以及 mCRC 适应症中 LYL273 开发项目的预期临床数据和监管更新。
The offer and sale of the securities in the private placement 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 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..
本次私募中证券的发行与销售属于不涉及公开发行的交易,且未根据经修订的《1933年证券法》(以下简称“《证券法》”)或适用的州证券法进行注册。因此,除非依据生效的注册声明或符合《证券法》及适用州证券法规定的注册要求豁免,否则不得在美国重新要约或转售该等证券。
The investors have been granted customary resale Form S-3 registration rights for the shares of common stock issued in the financing.
投资者已获授予就融资中发行的普通股股份进行转售的常规S-3表格注册权。
This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction..
本新闻稿不构成出售要约,也不构成购买要约的征询;在任何州或司法管辖区,若根据该州或司法管辖区的证券法律,在注册或资格认定之前进行此类要约、征询或销售属于违法行为,则不得在该州或司法管辖区销售这些证券。
About Lyell Immunopharma, Inc.
关于 Lyell Immunopharma, Inc.
Lyell is a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to arm CAR T cells with enhancements needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment.
Lyell 是一家处于临床后期阶段的公司,正在推进一系列下一代 CAR T 细胞疗法,用于治疗血液系统恶性肿瘤和实体瘤患者。为实现细胞疗法在癌症治疗中的潜力,Lyell 利用一系列技术为 CAR T 细胞提供必要的增强功能,以驱动持久的肿瘤细胞毒性,并获得一致且长期的临床响应,包括抵抗耗竭、在敌对的肿瘤微环境中维持持久的干性特征和功能。
LyFE has commercial launch capability and is expected to have the capacity to manufacture more than 3,000 CAR T-cell doses per year. To learn more, please visit .
LyFE 具备商业化生产能力,预计每年可生产超过 3,000 剂 CAR T 细胞。如需了解更多信息,请访问 。
www.lyell.com
www.lyell.com
.
。
Forward-Looking Statements
前瞻性陈述
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the timing, size, pricing and completion of the proposed private placement; the expected use of proceeds from the private placement; Lyell’s plans for its existing cash, cash equivalents and marketable securities, and its expectation that its financial position and cash runway will be sufficient to meet working capital and capital expenditure needs into 2028; Lyell’s expectations around the progress of the PiNACLE and PiNACLE-H2H trials, including the expected timing for release of additional and pivotal data from the PiNACLE trial; the use of pivotal data from the PiNACLE trial to support a BLA submission to the FDA in the second half of 2027 and other expectations around regulatory submissions; Lyell’s expectations around the progress of the U.S.
本新闻稿包含经1995年《私人证券诉讼改革法案》界定的前瞻性陈述。本新闻稿中明示或暗示的前瞻性陈述包括但不限于以下方面的陈述:拟议私募发行的时机、规模、定价及完成情况;私募发行所得款项的预期用途;Lyell对其现有现金、现金等价物及有价证券的计划,以及其预期财务状况和现金跑道将足以满足直至2028年的营运资金和资本支出需求;Lyell对PiNACLE和PiNACLE-H2H临床试验进展的预期,包括预计发布PiNACLE试验更多数据及关键性数据的时间;利用PiNACLE试验的关键性数据支持在2027年下半年向美国食品药品监督管理局(FDA)提交生物制品许可申请(BLA),以及其他与监管申报相关的预期;Lyell对美国境内进展的预期。
Phase 1 trial for LYL273, including the expected activities to determine a recommended Phase 2 dose and optimized safety plan and timing for release of additional clinical data from this trial and an End-of-Phase 1 FDA meeting; the anticipated benefits of Orphan Drug, RMAT and Fast Track designations for ronde-cel ; the capability of LyFE to manufacture drug supply through potential commercial launch and its expected manufacturing capacity; the potential clinical benefits and therapeutic potential of Lyell’s product candidates; and other statements that are not historical fact.
LYL273 的 I 期临床试验,包括旨在确定推荐的 II 期剂量和优化安全性方案的预期活动,以及发布该试验额外临床数据的时间安排和与 FDA 举行的 I 期结束会议;ronde-cel 获得孤儿药、再生医学先进疗法(RMAT)和快速通道认定的预期益处;LyFE 通过潜在的商业化上市阶段生产药物供应的能力及其预期的生产能力;Lyell 候选产品的潜在临床益处和治疗潜力;以及其他非历史事实的陈述。
These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertai.
这些陈述基于Lyell当前的计划、目标、估计、预期和意图,并非对未来业绩的保证,且本质上涉及重大风险和不确定性。
Lyell Investor Relations
莱尔投资者关系
IR@lyell.com
IR@lyell.com