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Viridian Therapeutics任命新任首席执行官,推出下一代FcRn抑制剂计划,并宣布1.85亿美元私募融资

Viridian Therapeutics Appoints New Chief Executive Officer, Unveils Next Generation FcRn Inhibitor Programs and Announces $185 Million Private Placement Financing

businesswire 等信源发布 2023-10-30 19:30

可切换为仅中文


WALTHAM, Mass.--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that Stephen Mahoney has been appointed the company’s President and Chief Executive Officer, and a member of the Board of Directors, effective immediately.

马萨诸塞州沃尔瑟姆-(BUSINESS WIRE)-Viridian Therapeutics,Inc。(纳斯达克股票代码:VRDN),一家专注于发现和开发用于严重和罕见疾病的潜在一流药物的生物技术公司,今天宣布Stephen Mahoney已被任命该公司总裁兼首席执行官和董事会成员立即生效。

Viridian also disclosed a preclinical portfolio of FcRn inhibitors designed to deliver next generation treatments for patients suffering from antibody-mediated autoimmune diseases. To advance its expanded strategic priorities, the company also announced that it has entered into an agreement to sell shares of its common and Series B preferred stock to certain institutional investors in a private placement transaction and will receive aggregate gross proceeds of $185 million, before deducting estimated offering expenses..

Viridian还公开了FcRn抑制剂的临床前组合,旨在为患有抗体介导的自身免疫疾病的患者提供下一代治疗。为了推进其扩大的战略重点,本公司还宣布,已签订协议,在私募股权交易中将其普通股和B系列优先股股份出售给某些机构投资者,并将获得1.85亿美元的总收益,然后扣除估计的提供费用。。

New Chief Executive Officer to Drive Expanded Strategic Priorities

新首席执行官推动扩大战略重点

Stephen Mahoney’s appointment as President and Chief Executive Officer combines his leadership and track record of operational execution with the company’s strategy of delivering potentially best-in-class next generation molecules in commercially established disease areas. Viridian’s pipeline is composed of intravenous and subcutaneous IGF-1R inhibitors for patients with TED and, as of today’s announcement, next generation FcRn inhibitors for the treatment of autoimmune diseases.

Stephen Mahoney被任命为总裁兼首席执行官,他的领导和业务执行记录与公司在商业上建立的疾病领域提供潜在一流的下一代分子的战略相结合。Viridian的管道由TED患者的静脉和皮下IGF-1R抑制剂组成,截至今天公布的用于治疗自身免疫性疾病的下一代FcRn抑制剂。

Scott Myers’s departure as President and CEO of the company was effective as of October 29, 2023..

Scott Myers作为公司总裁兼首席执行官的离职自2023年10月29日起生效。。

“We are grateful for Scott’s contributions and the operational progress Viridian was able to achieve during his tenure,” said Tomas Kiselak, Chairman of Viridian’s Board of Directors. “The Board believes that the transition to Steve’s leadership with his strong track record of driving execution and his alignment with our corporate strategy can enable Viridian to build a potentially best-in-class IGF-1R inhibition franchise in TED and advance our efforts to deliver next generation FcRn inhibitors for the treatment of autoimmune diseases.”.

Viridian董事会主席Tomas Kiselak说:“我们感谢Scott的贡献以及Viridian在任职期间取得的运营进展。”。“董事会认为,以其强大的推动执行记录和与我们公司战略的一致性向史蒂夫领导力的转变可以使Viridian在TED中建立潜在的一流IGF-1R抑制特许经营权,并推动我们努力提供下一代FcRn抑制剂用于治疗自身免疫性疾病“。

Mr. Mahoney brings more than two decades of experience in the biopharmaceutical industry where he has held a number of strategic, operational, financial, business development and legal roles with regional and global responsibilities. He most recently served as President, Chief Financial and Operating Officer of Magenta Therapeutics.

Mahoney先生在生物制药行业拥有二十多年的经验,在那里他担任了一系列具有区域和全球责任的战略,运营,财务,业务发展和法律角色。他最近担任Magenta Therapeutics的总裁,首席财务和运营官。

Prior to Magenta, Mr. Mahoney served as President and Chief Operating Officer of Kiniksa Pharmaceuticals. He also served as Chief Commercial Officer, among other executive titles of increasing responsibility, at Synageva Biopharma Corp. and was a business and transactional attorney at Genzyme Corporation.

在洋红色之前,Mahoney先生担任Kiniksa Pharmaceuticals的总裁兼首席运营官。他还在Synageva Biopharma Corp.担任首席商业官,以及其他增加责任的执行职务,并且是Genzyme Corporation的商业和交易律师。

Mr. Mahoney holds an M.B.A. and J.D. from Boston College and a B.A. from Colorado College..

Mahoney先生拥有波士顿学院的M.B.A.和J.D.以及科罗拉多学院的B.A。。

“I am excited to join the Viridian team at this critical time and help deliver on the promise of the company’s broad pipeline,” said Mr. Mahoney. “As we seek to optimize our future commercial position with the TED franchise, we have a dual focus of delivering the results from our two THRIVE Phase 3 clinical trials of VRDN-001 in both active and chronic TED while also prioritizing and accelerating the development of a potentially best-in-class subcutaneous delivery option for patients.

Mahoney先生说:“我很高兴在这个关键时刻加入Viridian团队,帮助实现公司广泛渠道的承诺。”。“当我们寻求通过TED特许经营来优化我们未来的商业地位时,我们双重关注在活动和慢性TED中提供VRDN-001的两个茁壮成长的3期临床试验结果,同时优先考虑和加速发展为患者提供潜在的一流皮下给药选择。

As announced today, we are also thrilled about the potential of our novel portfolio of FcRn inhibitors, and we look forward to moving these programs to the clinic as quickly as possible.”.

正如今天宣布的那样,我们也对我们新型FcRn抑制剂组合的潜力感到兴奋,我们期待着尽快将这些项目推向临床。

Viridian also announced that Thomas Beetham will be joining the company as Chief Operating Officer, and Shan Wu, Ph.D., will be joining as Chief Business Officer, each of whom have worked with Mr. Mahoney in prior companies and will strengthen Viridian’s management team.

Viridian还宣布Thomas Beetham将作为首席运营官加入该公司,Shan Wu博士将加入首席商务官,他们每个人都在之前的公司与Mahoney先生合作,并将加强Viridian的管理团队。

TED Clinical Development Remains On Track with Selection of Subcutaneous Program by Year End 2023 and VRDN-001 THRIVE Topline Results in Active TED Expected in Mid-2024

TED的临床开发仍在继续,到2023年底选择皮下计划,VRDN-001在2024年中期取得积极的TED成果

Viridian continues to advance its differentiated and improved product candidates for TED patients and is simultaneously focused on developing both its subcutaneous and intravenous IGF-1R inhibitor programs. The company has designed the subcutaneous program to be a potentially best-in-class, self-administered, infrequent, and low-volume injection for patients.

Viridian继续推进其针对TED患者的分化和改进的候选产品,同时专注于开发其皮下和静脉内IGF-1R抑制剂计划。该公司已将皮下注射计划设计为可能是一流,自我管理,罕见和低容量的患者注射。

The intravenous VRDN-001 program, which features a shorter infusion time and fewer infusions compared to the currently marketed IGF-1R inhibitor, is on track for its Phase 3 data readouts. The company expects that its intravenous VRDN-001 has the potential to establish a strong foothold in the multi-billion-dollar TED commercial market and will help facilitate the future introduction of its subcutaneous program..

与目前市售的IGF-1R抑制剂相比,静脉注射VRDN-001程序具有更短的输注时间和更少的输注,正在进行3期数据读数。该公司预计其静脉注射VRDN-001有可能在价值数十亿美元的商业市场上建立强有力的立足点,并将有助于促进未来推出其皮下注射计划。。

Viridian is on track to select its lead subcutaneous IGF-1R program by the end of 2023 and expects such program to enter a pivotal Phase 2/3 trial in mid-2024. The company expects topline results from the first THRIVE Phase 3 clinical trial for intravenous VRDN-001 for active TED to be available in mid-2024.

Viridian正在计划在2023年底之前选择其主要的皮下IGF-1R计划,并预计该计划将在2024年中期进入关键的2/3期试验阶段。该公司预计2024年中期将推出用于活性TED的静脉注射VRDN-001的第一个THRIVE 3期临床试验的顶级结果。

The THRIVE-2 clinical trial in chronic TED patients is recruiting patients, and the company expects topline clinical results by year end 2024..

慢性TED患者的THRIVE-2临床试验正在招募患者,该公司预计到2024年底将获得最佳临床结果。。

Next Generation FcRn Inhibitor Portfolio Unveiled; First IND Filing Planned by Year End 2024

新一代FcRn抑制剂组合推出;计划在2024年底提交第一份IND文件

Consistent with Viridian’s vision to develop the next generation of best-in-class products for severe autoimmune and rare diseases, the company disclosed that it is developing a portfolio of engineered FcRn inhibitors, VRDN-006 and VRDN-008. FcRn inhibitors have the potential to treat a broad array of autoimmune diseases, representing a significant commercial market opportunity.

与Viridian开发下一代针对严重自身免疫性和罕见疾病的一流产品的愿景一致,该公司披露该公司正在开发一系列工程化FcRn抑制剂VRDN-006和VRDN-008。FcRn抑制剂具有治疗广泛的自身免疫疾病的潜力,代表了重要的商业市场机会。

Viridian’s multi-pronged engineering approach has resulted in a portfolio of FcRn-targeting molecules that leverage the clinically and commercially validated mechanism of FcRn inhibition while potentially addressing the limitations of current agents such as incomplete IgG suppression and needed improvements in safety..

Viridian的多管齐下的工程方法已经产生了一系列FcRn靶向分子,这些分子利用临床和商业验证的FcRn抑制机制,同时可能解决当前药物的局限性,如不完全的IgG抑制和所需的安全性改进。。

VRDN-006 is a FcRn-targeting Fc fragment, and in non-human primate studies, demonstrated specificity for blocking FcRn-IgG interactions while showing no increases in albumin or low-density lipoprotein (LDL) levels. In head-to-head non-human primate studies, VRDN-006 demonstrated comparable potency and IgG lowering to efgartigimod, the current standard of care in FcRn inhibition, as well as a similar safety profile.

VRDN-006是靶向FcRn的Fc片段,并且在非人灵长类动物研究中,证明了阻断FcRn-IgG相互作用的特异性,同时显示白蛋白或低密度脂蛋白(LDL)水平没有增加。在头对头的非人灵长类动物研究中,VRDN-006表现出与efgartigimod相当的效力和IgG降低,efgartigimod是FcRn抑制的当前护理标准,以及类似的安全性。

Viridian plans to file an IND for VRDN-006 by year end 2024 and expects healthy volunteer data for VRDN-006 in the second half of 2025. VRDN-008 is a novel, first-in-class FcRn inhibitor that aims to pair IgG suppression with extended half-life technology, potentially enabling deeper and more durable suppression than existing anti-FcRn therapies.

Viridian计划在2024年底之前为VRDN-006提交IND,并预计2025年下半年VRDN-006的健康志愿者数据。VRDN-008是一种新型的一流FcRn抑制剂,旨在将IgG抑制与延长的半衰期技术相结合,可能比现有的抗FcRn疗法实现更深,更持久的抑制。

Both molecules are designed to be convenient, self-administered, subcutaneous products. The company plans to share additional details about its FcRn portfolio in 2024..

这两种分子都被设计成方便的自我管理的皮下产品。该公司计划于2024年分享有关其FcRn组合的更多详细信息。。

$185 Million Financing to Fund Expanded Pipeline and Extend Cash Runway

1.85亿美元用于资助扩张管道和延长现金跑道的融资

Viridian announced it has entered into agreements for a private placement financing that is expected to close by November 1, 2023, and result in anticipated gross proceeds of approximately $185 million, before deducting estimated offering expenses. The financing was led by Fairmount Funds with participation from both existing investors, including Braidwell LP, Commodore Capital, Deep Track Capital, Venrock, Paradigm BioCapital and Perceptive Advisors, as well as new investors, including entities managed by RTW Investments, LP and Surveyor Capital (a Citadel company).

Viridian宣布已就预计将于2023年11月1日前结束的私募融资达成协议,并在扣除估计的提供费用之前产生约1.85亿美元的预期总收益。该融资由Fairmount基金领导,现有投资者包括Braidwell LP,Commodore Capital,Deep Track Capital,Venrock,Paradigm BioCapital和Perceptive Advisors,以及新投资者,包括RTW Investments,LP和Surveyor管理的实体资本(一家城堡公司)。

In the private placement, Viridian is selling an aggregate of 8,789,022 shares of its common stock at a price of $12.38 per share and an aggregate of 92,312 shares of its Series B preferred stock at a price of $825.3746 per share, which are convertible into approximately 6,154,441 shares of common stock, subject to beneficial ownership conversion limits.

在私募股权中,Viridian以每股12.38美元的价格出售其普通股8789022股,其B系列优先股合计92312股,价格为每股825.3746美元,可转换为约6154441股普通股,受有益所有权转换限制。

Proceeds will be used to fund pipeline programs, including the FcRn portfolio, and for general corporate purposes and working capital. The company also expects that the proceeds will extend its cash runway to fund its operating plan into 2026..

收益将用于资助管道计划,包括FcRn组合,以及一般公司用途和营运资本。公司还预计所得款项将延长其现金跑道,为其经营计划提供资金至2026年。。

Jefferies, Evercore ISI, and Stifel are acting as lead placement agents for the private placement financing. LifeSci Capital LLC and Wedbush PacGrow are also acting as co-placement agents for the private placement financing.

Jefferies,Evercore ISI和Stifel正担任私人配售融资的牵头代理。LifeSci Capital LLC和Wedbush PacGrow也担任私人配售融资的合作代理商。

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended (the Securities Act), or any states' securities laws, and may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act.

在私人发行中销售的证券尚未根据1933年修订的“证券法”(“证券法”)或任何州的证券法进行注册,并且不得在美国提供或销售,除非根据有效注册声明或对“证券法”注册要求的适用豁免。

Viridian has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares issued in the private placement..

Viridian已同意向证券交易委员会提交注册声明,注册转售私人配售股份。。

This press release shall not constitute an offer to sell, or the 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..

本新闻稿不得构成出售报价或征求购买报价,也不得在任何国家或管辖区销售这些证券,在注册之前此类报价,征求或销售将是非法的或根据任何此类州或管辖区的证券法进行资格认证。。

Notice of Issuance of Inducement Grants

发放诱导补助金的通知

Viridian also announced the grant of an inducement award to Mr. Mahoney, as well as to Mr. Beetham and to two other new employees, including Dr. Wu, in each case as an inducement material to such executive officer or employee’s employment pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. Mr. Mahoney was granted an option to purchase 1,259,400 shares of Viridian’s common stock, Mr.

Viridian还宣布向Mahoney先生以及Beetham先生和其他两名新员工(包括Wu博士)授予诱导奖,在每种情况下均作为诱导材料授予此类执行官或员工的工作。纳斯达克上市规则第5635(c)(4)条。Mahoney先生被授予购买Viridian普通股1259400股的选择权。

Beetham was granted an option to purchase 474,400 shares of Viridian’s common stock, and the other new employees were granted options to purchase an aggregate of 268,200 shares of Viridian’s common stock. In each case, the shares underlying the options vest become exercisable as follows: one quarter of the underlying shares on the first anniversary of October 30, 2023 and then in equal monthly installments thereafter over the following 36 months, subject to the grantee’s continued service to the company.

Beetham被授予购买474400股Viridian普通股的期权,其他新员工被授予购买总共268200股Viridian普通股的期权。在每种情况下,期权背心所依据的股份均可行使如下:2023年10月30日一周年的四分之一基础股份,然后在接下来的36个月内每月平均分摊一次,具体取决于受让人的持续服务公司。

The exercise price of the stock options will equal the closing price of the company's common stock on October 30, 2023, the date of the grant. The inducement awards were granted outside of the company’s Amended and Restated 2016 Equity Incentive Plan but remain subject to the terms and conditions of such plan..

股票期权的行使价将等于本公司普通股于2023年10月30日(授予日期)的闭合价。诱导奖励是在本公司经修订并重述的2016年股权激励计划之外授予的,但仍受本计划的条款和条件的约束。。

About Viridian Therapeutics

关于Viridian疗法

Viridian is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and engineering enables it to develop differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas..

Viridian是一家生物制药公司,致力于为严重和罕见疾病患者设计和开发潜在的一流药物。Viridian在抗体发现和工程方面的专业知识使其能够为商业上确定的疾病领域中先前验证的药物靶标开发不同的治疗候选物。。

Viridian is advancing multiple candidates in the clinic for the treatment of patients with TED. The company is conducting two global Phase 3 studies (THRIVE and THRIVE-2) to evaluate the safety and efficacy of VRDN-001 in patients with active and chronic TED. Simultaneously, the company is developing its subcutaneous program strategy with the goal of providing a potentially more conveniently administered therapy to patients with TED.

Viridian正在临床上推进多名候选人治疗TED患者。该公司正在进行两项全球3期研究(THRIVE和THRIVE-2),以评估VRDN-001在活动性和慢性TED患者中的安全性和有效性。同时,该公司正在制定其皮下计划策略,目的是为TED患者提供更方便的治疗方法。

In addition to its TED portfolio, Viridian is advancing a novel portfolio of FcRn inhibitors with the potential to be developed in multiple autoimmune diseases. Viridian is also developing additional preclinical assets in autoimmune and rare diseases..

除了其TED产品组合外,Viridian正在推进一系列新型FcRn抑制剂,这些抑制剂有可能在多种自身免疫性疾病中开发。Viridian还在自身免疫和罕见疾病方面开发额外的临床前资产。。

Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X.

Viridian总部设在马萨诸塞州沃尔瑟姆。欲了解更多信息,请访问www.viridiantherapeutics.com。按照LinkedIn和X上的Viridian。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' or 'would' or other similar terms or expressions that concern our expectations, plans and intentions.

本新闻稿包含1995年“私人证券诉讼改革法”含义内的前瞻性声明。这些陈述可以通过使用诸如但不限于“预期”,“相信”,“继续”,“可以”,“估计”,“期望”,“意图”,“可能”,“可能”,“计划,“潜力”,“预测”,“项目”,“应该”,“目标”,“将会”或其他与我们的期望,计划和意图有关的类似术语或表达方式。

Forward-looking statements include, without limitation, statements regarding our expectations, strategies, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions.

前瞻性陈述包括但不限于关于我们的期望,策略,计划和意图的陈述。前瞻性陈述既不是历史事实,也不是未来表现的保证。相反,它们基于我们目前的信念,期望和假设。

New risks and uncertainties may emerge from time to time, and it.

新的风险和不确定性可能会不时出现。

is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: the potential efficacy and safety of VRDN-001 for the treatment of TED, the relationship between the results from the positive data from the ongoing Phase 1/2 clinical trial of VRDN-001 in patients with chronic TED and the results of ongoing or future clinical trials; the timing, progress and plans for our ongoing or future research, pre-clinical and clinical development programs; expectations regarding the timing for data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; manufacturing risks; our ability to develop a subcutaneous formulation (SC); our plan regarding a lead SC program candidate; expectations regarding use of proceeds from the private placement financing; expectations regarding our FcRn portfolio; other matters that could affect the sufficiency of existing cash, cash equivalents and short-term investments to fund operations; our financial position and its projected cash runway; our future operating results and financial performance; the clinical utility of our therapeutic candidates and our intellectual property position; the timing of pre-clinical and clinical trial activities and reporting results from same, including those risks set forth under the caption 'Risk Factors' in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC.

无法预测所有风险和不确定性。对于任何此类前瞻性陈述的准确性,不作任何陈述或保证(明示或暗示)。这些前瞻性陈述受到许多重大风险和不确定性的影响,包括但不限于:VRDN-001治疗TED的潜在疗效和安全性,来自正在进行的阶段的阳性数据的结果之间的关系VRDN-001在慢性TED患者中的1/2临床试验以及正在进行或将来的临床试验的结果;我们正在进行或未来的研究,临床前和临床开发计划的时间,进展和计划;对数据时间的期望;与临床药物开发有关的不确定性和潜在延误;监管延误在我们临床计划中的持续时间和影响;获得和维持我们治疗候选人的监管批准的时间和能力;制造风险;我们开发皮下制剂(SC)的能力;我们关于主要SC计划候选人的计划;对使用私募融资收益的期望;对我们的FcRn投资组合的期望;其他可能影响现有现金,现金等价物和短期投资资金运营的充足性的事项;我们的财务状况及其预计的现金跑道;我们未来的运营成果和财务业绩;我们的治疗候选人的临床效用和我们的知识产权立场;临床前和临床试验活动的时间安排和报告结果相同,包括我们在向美国证券交易委员会提交的表格10-Q的季度报告中标题为“风险因素”的风险。