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免疫疗法研发商Aditxt签署最终协议收购生物防御疫苗开发商Appili Therapeutics

Aditxt Signs a Definitive Agreement to Acquire Appili Therapeutics Inc., Developer of a Biodefense Vaccine Funded by the U.S. Department of Defense (DoD)

businesswire 等信源发布 2024-04-02 18:30

可切换为仅中文


MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Aditxt, Inc. (“Aditxt” or the “Company”) (NASDAQ: ADTX), a company dedicated to discovering, developing, and deploying promising health innovations, today announced that it has entered into a definitive arrangement agreement ('Arrangement Agreement') to acquire Appili Therapeutics Inc.

加利福尼亚州山景城讯(商业新闻短讯)--ADIXT,Inc.(“ADIXT”或“公司”)(纳斯达克:ADTX),一家致力于发现、开发和部署有前景的健康创新的公司,今天宣布,它已经签署了一份最终的安排协议(“安排协议”),以收购Appili Therapeutics Inc。

(TSX: APLI; OTCQX: APLIF) (“Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures. Under the Arrangement Agreement, Aditxt’s wholly owned subsidiary, Adivir, Inc. (“Adivir”) agreed to acquire all issued and outstanding Class A common shares of Appili (the “Appili Shares”) through a court-approved plan of arrangement under the Canada Business Corporations Act ('Transaction')..

(TSX:APLI;OTCQX:APLIF)(“Appili”),一家专注于传染病药物开发和医疗对策的生物制药公司。根据安排协议,ADIXT的全资子公司Adivir,Inc.(“Adivir”)同意通过法院批准的《加拿大商业公司法》(“交易”)安排计划收购Appili的所有已发行和流通的A类普通股(“Appili股份”)。

Since its inception in 2015, Appili has developed a diverse portfolio, including the FDA-approved LIKMEZ™ (previously ATI-1501), ATI-1701 biodefense program supported by a USD $14 million non-dilutive award from the U.S DoD., and ATI-1801, a topical formulation targeting cutaneous leishmaniasis, a painful and disfiguring disease..

自2015年成立以来,Appili已开发出多种投资组合,包括FDA批准的LIKMEZ™(以前称为ATI-1501)、ATI-1701生物防御计划,并获得了美国国防部1400万美元的非稀释性奖励。,和ATI-1801,一种针对皮肤利什曼病(一种痛苦且毁容的疾病)的局部制剂。

LIKMEZ, FDA-Approved Taste-Masked Oral Suspension for Bacterial Infections

LIKMEZ,FDA批准用于细菌感染的掩味口服混悬液

Appili developed LIKMEZ, a new formulation of the antibiotic metronidazole, specifically tailored to improve patient experience and adherence, particularly in patients who have difficulty swallowing large tablets. The patent-protected LIKMEZ is a reformulated taste-masking technology containing metronidazole, which makes it easier to swallow and better tasting, increasing patient compliance..

Appili开发了LIKMEZ,这是一种新的抗生素甲硝唑制剂,专门用于改善患者的体验和依从性,特别是对于吞咽大药片有困难的患者。受专利保护的LIKMEZ是一种含有甲硝唑的改良味觉掩蔽技术,它使吞咽更容易,口感更好,提高了患者的依从性。

The U.S. FDA's approval of LIKMEZ highlighted Appili’s capacity to identify and develop significant opportunities within the infectious disease domain. Appili licensed the manufacturing and commercialization rights in the U.S. and other selected territories to Saptalis Pharmaceuticals, LLC (“Saptalis”).

美国食品和药物管理局(FDA)对利克斯(LIKMEZ)的批准突显了Appili在传染病领域识别和开发重大机会的能力。Appili将美国和其他选定地区的制造和商业化权利许可给了Saptalis Pharmaceuticals,LLC(“Saptalis”)。

Appili, in collaboration with Saptalis, continued the product's development, ultimately achieving FDA approval in the United States. With FDA approval, future revenue is expected to be derived from milestone payments and royalties from Saptalis under the license agreement..

Appili与Saptalis合作,继续开发该产品,最终在美国获得FDA批准。经FDA批准,未来的收入预计将来自许可协议下Saptalis的里程碑付款和版税。

Appili is developing ATI-1701 as a live attenuated vaccine to combat Francisella tularensis, which is classified by the U.S. National Institutes of Health (NIH) as a Category A pathogen, an organism that poses the highest risk to national security and public health due to its high rate of infectivity and ability to cause lethal pneumonia and systemic infection.

阿皮利正在开发ATI-1701作为一种减毒活疫苗,用于对抗土拉弗朗西斯菌,该菌被美国国立卫生研究院(NIH)列为a类病原体,由于其高感染率和致命性肺炎和全身感染的能力,对国家安全和公共卫生构成最高风险。

Estimated to be 1,000-fold more infectious than anthrax, experts consider the aerosolized form to have a high potential for use in a bioterrorism attack..

据估计,其传染性比炭疽病高1000倍,专家认为这种雾化形式很有可能用于生物恐怖主义袭击。

Appili's strategic alignment with governmental and public health priorities has secured non-dilutive funding of USD $14 million from the U.S. DoD for its ATI-1701 biodefense program. This funding has been crucial in advancing the development of ATI-1701, including support for manufacturing, non-clinical studies, and regulatory activities through the submission of an Investigational New Drug (IND) application.

Appili与政府和公共卫生优先事项的战略一致性已确保美国国防部为其ATI-1701生物防御计划提供1400万美元的非稀释性资金。这笔资金对于推进ATI-1701的开发至关重要,包括通过提交研究性新药(IND)申请来支持制造、非临床研究和监管活动。

ATI-1701 may be eligible for a Priority Review Voucher (PRV) if the U.S. Government extends the Medical Countermeasures PRV program. A PRV enables its recipient to expedite the review process for future drug applications upon issuance. While no assurance can be provided that ATI-1701 will be deemed eligible for a priority review voucher or, what its ultimate worth will be if approved, and recent secondary market transactions involving PRVs have ranged from USD $80 million to USD $100 million, their strategic value extends beyond the secondary market, offering significant advantages in accelerating the development timeline of new treatments..

如果美国政府延长医疗对策PRV计划,ATI-1701可能有资格获得优先审查凭证(PRV)。PRV使其接收者能够在发布后加快未来药物申请的审查过程。虽然不能保证ATI-1701将被视为有资格获得优先审查凭证,或者如果获得批准,其最终价值将是什么,并且最近涉及PRV的二级市场交易从8000万美元到1亿美元不等,但它们的战略价值超出了二级市场,在加快新疗法的开发时间表方面具有重大优势。

ATI-1801 represents Appili’s innovative approach to combating cutaneous leishmaniasis (CL), a devastating skin infection classified by the World Health Organization (WHO) as a Neglected Tropical Disease (NTD) that impacts hundreds of thousands of individuals globally. This topical product is formulated with paromomycin, a previously approved antibiotic available in oral or injectable form.

ATI-1801代表了Appili对抗皮肤利什曼病(CL)的创新方法,这是一种毁灭性的皮肤感染,被世界卫生组织(WHO)归类为被忽视的热带病(NTD),影响全球数十万人。该外用产品由巴龙霉素配制而成,巴龙霉素是一种先前批准的抗生素,可口服或注射。

The topical formulation allows a more direct and comfortable application for patients who suffer from painful CL lesions..

局部制剂可以为患有疼痛性CL病变的患者提供更直接和舒适的应用。

Having undergone evaluation in a Phase 3 study, ATI-1801 targets CL infections that manifest through skin lesions and ulcers, leading to potential scarring, disfigurement, and societal stigma. Appili is committed to collaborating with stakeholders worldwide to advance the development of ATI-1801 and to obtain regulatory approvals, ensuring global access to this critical treatment.

经过3期研究的评估,ATI-1801针对通过皮肤病变和溃疡表现出来的CL感染,导致潜在的疤痕,毁容和社会耻辱。Appili致力于与世界各地的利益相关者合作,推动ATI-1801的开发并获得监管部门的批准,确保全球获得这种关键治疗。

Additionally, Appili is assessing the potential for ATI-1801 to qualify for a Priority Review Voucher (PRV), a step that could further expedite bringing this essential therapy to those in need..

此外,Appili正在评估ATI-1801是否有资格获得优先审查凭证(PRV),这一步骤可以进一步加快将这种基本疗法带给需要的人。

Synergy with Aditxt’s Programs

与Aditxt的程序协同

This acquisition will enhance Aditxt’s portfolio of subsidiaries and create synergies with its existing programs, particularly precision diagnostics. Integrating Appili’s expertise and product lines would pave the way for a comprehensive approach to population health, from early detection and prevention to treatment.

此次收购将增强ADIXT的子公司投资组合,并与其现有项目(尤其是precision diagnostics)产生协同作用。整合Appili的专业知识和产品线将为从早期发现和预防到治疗的全面人群健康方法铺平道路。

The potential for collaboration within the Aditxt ecosystem can streamline patient care, from early detection through precision diagnostics to developing tailored treatment strategies..

ADIXT生态系统内合作的潜力可以简化患者护理,从早期发现到精确诊断,再到制定量身定制的治疗策略。

Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, elaborated on the significance of this acquisition, stating, “The acquisition of Appili would represent another step in Aditxt’s journey towards advancing promising innovations in health. Our mission is to accelerate some of the most promising health innovations, like those developed by Appili, to reach their full potential and to have a lasting impact.

Aditxt联合创始人、董事长兼首席执行官阿姆罗·阿尔巴纳(Amro Albanna)阐述了此次收购的重要性,他表示:“收购阿皮利将是Aditxt在推进有希望的健康创新方面迈出的又一步。我们的使命是加速一些最有希望的健康创新,如阿皮利开发的创新,以充分发挥其潜力并产生持久的影响。

The urgency for innovative and effective public health solutions is unprecedented. The need to discover and bring new treatments to the market or to enhance existing ones to combat public health challenges has never been more critical. By integrating Appili’s proven expertise and diverse portfolio in the infectious disease and biodefense domain, Aditxt can substantially contribute to advancing public health solutions.”.

创新和有效的公共卫生解决方案的紧迫性是前所未有的。发现新疗法并将其推向市场或改进现有疗法以应对公共卫生挑战的需求从未如此迫切。通过整合Appili在传染病和生物防御领域经验证的专业知识和多样化的投资组合,ADIXT可以为推进公共卫生解决方案做出重大贡献。”

“This transaction with Aditxt aligns with our goals on multiple levels. We see this as an opportunity for growth, innovation, and collaboration. Our shared vision and combined expertise will undoubtedly accelerate our mission to develop innovative treatments and solutions for some of the most challenging health threats facing the world today.

“与ADIXT的这笔交易在多个层面上符合我们的目标。我们认为这是一个增长、创新和合作的机会。我们共同的愿景和综合的专业知识无疑将加速我们的使命,为当今世界面临的一些最具挑战性的健康威胁开发创新的治疗方法和解决方案。

Appili can now leverage Aditxt’s proven research and development, operations, and commercialization expertise to accelerate the development of our three programs. Secondly, as a NASDAQ-listed company, we believe Aditxt can facilitate capital access in this challenging economic environment. We welcome this new chapter, confident that together, we will achieve even greater heights in deploying innovative healthcare solutions,” said Dr.

Appili现在可以利用ADIXT经过验证的研发、运营和商业化专业知识来加速我们三个项目的开发。其次,作为一家在纳斯达克上市的公司,我们相信ADIXT可以在这种充满挑战的经济环境中促进资本进入。我们欢迎这一新篇章,相信共同努力,我们将在部署创新医疗保健解决方案方面取得更大的成就。

Don Cilla, President and CEO of Appili Therapeutics..

Don Cilla,Appili Therapeutics总裁兼首席执行官。

Transaction Details:

交易详细信息:

The Transaction will be effected through a court-approved plan of arrangement under the Canada Business Corporations Act. Under the terms of the Arrangement Agreement, Adivir will acquire all of the issued and outstanding Appili Shares, with each Appili Shareholder receiving (i) 0.002745004 of a share of common stock (each whole share, an “Aditxt Share”) of Aditxt (the “Share Consideration”) and (ii) US$0.0467 for each Appili Share held (the “Cash Consideration” and together with the Share Consideration collectively, the “Transaction Consideration”) representing total consideration per Appili Share of approximately US$0.0561 based on the closing price of Aditxt stock on March 28, 2024 After giving effect to the Transaction, Appili Shareholders will hold approximately 19.99% of the issued and outstanding Aditxt Shares (on a non-diluted basis) based on the currently issued and outstanding Aditxt Shares (calculated on a non-diluted basis).

根据《加拿大商业公司法》,该交易将通过法院批准的安排计划生效。根据安排协议的条款,Adivir将收购所有已发行和流通的Appili股份,每个Appili股东将获得(i)0.002745004股普通股(每股整股,一股“Aditxt股份”)的Aditxt(“股份对价”)和(ii)0.0467美元的每股持有的Appili股份(“现金对价”,加上股份对价统称为“交易对价”),代表每股Appili股份的总对价约为0.0561美元,根据2024年3月28日Aditxt股票的收盘价,交易生效后,Appili股东将持有约19.基于当前已发行和已发行的ADIXT股份(以非稀释为基础计算),占已发行和已发行ADIXT股份的99%(以非稀释为基础)。

In connection with the Transaction, each outstanding option and warrant of Appili will be cashed out based on the implied in-the-money value of the Transaction Consideration..

就交易而言,Appili的每项未偿期权和认股权证将根据交易对价的隐含货币价值予以兑现。

In connection with the Transaction Aditxt will: (i) agree to repay no less than 50% in outstanding senior secured debt at the closing of the Transaction (the “Closing”) and to repay the remaining outstanding senior secured debt by no later than December 31, 2024; (ii) acquire all of Appili’s remaining outstanding liabilities and indebtedness; and (iii) agree to satisfy certain payables of Appili at Closing as further detailed in the Arrangement Agreement..

就交易而言,ADIXT将:(i)同意在交易结束时(以下简称“结束”)偿还不少于50%的未偿优先担保债务,并在2024年12月31日之前偿还剩余的未偿优先担保债务;(ii)收购Appili的所有剩余未偿债务;(iii)同意在交割时清偿Appili的某些应付款项,详见安排协议。

The Transaction is subject to the approval of at least two-thirds of the votes cast at the special meeting of the Appili Shareholders, which is expected to be held before the end of calendar Q2 2024 to approve the Transaction.

该交易需要在阿皮利股东特别会议上获得至少三分之二的投票批准,该会议预计将在2024年第二季度末之前举行,以批准该交易。

Appili's directors, officers, and certain shareholders holding approximately 11.9% of the total voting power of the issued and outstanding Appili Shares have entered into voting support agreements with the Buyer to vote in favor of the Transaction.

Appili的董事、管理人员和持有已发行和流通的Appili股份总投票权约11.9%的某些股东已与买方签订投票支持协议,对交易投赞成票。

The Transaction is conditional upon Aditxt raising at least US$20 million in financing (the “Aditxt Financing”) prior to Closing. In addition, completion of the Transaction is subject to other customary conditions, including the receipt of all necessary court, regulatory and stock exchange approvals.

该交易的条件是ADIXT在交割前至少融资2000万美元(“ADIXT融资”)。此外,交易的完成还取决于其他习惯条件,包括收到所有必要的法院、监管机构和证券交易所的批准。

Subject to receiving all required approvals, Closing is expected to occur not later than early Q3 2024..

在收到所有要求的批准后,预计交割时间不晚于2024年第三季度初。

The Arrangement Agreement contains customary terms and conditions, including non-solicitation provisions, which are subject to Appili's right to consider and accept a superior proposal subject to a matching right in favor of Aditxt. The Arrangement Agreement also provides for paying a termination fee of Cdn$1.25 million in certain circumstances..

安排协议包含习惯性条款和条件,包括非招揽条款,这些条款和条件取决于阿皮利有权考虑和接受优先提案,并有权以ADIXT为受益人进行匹配。安排协议还规定在某些情况下支付125万加元的终止费。

None of the securities to be issued pursuant to the Arrangement Agreement have been or will be registered under the United States Securities Act of 1933, as amended (the 'U.S. Securities Act'), or any state securities laws, and any securities issued in the Transaction are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S.

根据《安排协议》发行的任何证券均未或将不会根据经修订的《1933年美国证券法》(“美国证券法”)或任何州证券法进行登记,交易中发行的任何证券预计将根据《美国证券法》第3(a)(10)节规定的登记要求豁免发行。

Securities Act and applicable exemptions under state securities laws. This news release does not constitute an offer to sell or the solicitation of an offer to buy any securities..

《证券法》和州证券法规定的适用豁免。本新闻稿不构成出售或邀请购买任何证券的要约。

If the Transaction is completed, the Appili Shares will be delisted from the TSX and the OTCQX and Appili will apply to cease to be a reporting issuer.

如果交易完成,Appili股份将从TSX退市,OTCQX和Appili将申请停止作为报告发行人。

Aird & Berlis LLP acted as Canadian legal counsel to Aditxt. Sheppard, Mullin, Richter & Hampton LLP acted as US securities counsel to Aditxt and Nelson Mullins Riley & Scarborough LLP acted as US M&A counsel to Aditxt.

Aird&Berlis LLP担任ADIXT的加拿大法律顾问。Sheppard、Mullin、Richter&Hampton LLP担任ADIXT的美国证券法律顾问,Nelson Mullins Riley&Scarborough LLP担任ADIXT的美国并购法律顾问。

Dentons Canada LLP acted as legal counsel to Appili. Bloom Burton & Co. acted as financial advisor to the Appili Board and BDO Canada LLP acted as independent financial advisor to the Appili Special Committee.

Dentons Canada LLP担任Appili的法律顾问。Bloom Burton&Co.担任Appili董事会的财务顾问,BDO Canada LLP担任Appili特别委员会的独立财务顾问。

Aditxt, Inc.® (“Aditxt”) (NASDAQ: ADTX) is an innovation platform dedicated to discovering, developing, and deploying promising innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges.

Aditxt,Inc.®(“Aditxt”)(纳斯达克:ADTX)是一个创新平台,致力于发现、开发和部署有前途的创新。Aditxt的研究机构、行业合作伙伴和股东生态系统共同推动了他们“共同创造有希望的创新”的使命。创新平台是Aditxt战略的基石,在该战略中,多学科推动了颠覆性增长,并应对了重大的社会挑战。

Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued, and empowers collective progress..

ADIXT采用了一种独特的模式,使创新民主化,确保每个利益相关者的声音都能被听到和重视,并促进集体进步。

Aditxt has a diverse innovation portfolio, including Adimune™, Inc., which is leading the charge in developing a novel class of therapeutics for retraining the immune system to combat organ rejection, autoimmunity, and allergies. Adivir™, Inc. focuses on enhancing national and population health and impacting public health globally.

Aditxt拥有多样化的创新组合,其中包括Adimune™公司,该公司正在开发一类新型疗法,用于重新训练免疫系统以对抗器官排斥,自身免疫和过敏。Adivir™公司专注于增强国家和人口健康,影响全球公共卫生。

Pearsanta™, Inc., delivers rapid, personalized, and high-quality lab testing accessible anytime, anywhere, led by its CLIA-certified and CAP-accredited clinical laboratory based in Richmond, VA..

Pearsanta™公司在其位于弗吉尼亚州里士满的CLIA认证和CAP认证临床实验室的带领下,随时随地提供快速、个性化和高质量的实验室测试。

About Appili Therapeutics

关于Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili aims to strategically develop a pipeline of novel therapies to prevent deaths and improve lives.

Appili Therapeutics是一家传染病生物制药公司,旨在建立,投资组合驱动,专注于实现其解决威胁生命的感染的使命。通过系统地识别未满足需求的紧急感染,Appili旨在战略性地开发一系列新疗法,以预防死亡并改善生活。

The Company is currently advancing a diverse range of anti-infectives, including a vaccine candidate to eliminate a severe biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel easy to use, liquid oral formulation targeting parasitic and anaerobic infections.

该公司目前正在开发多种抗感染药物,包括用于消除严重生物武器威胁的候选疫苗,用于治疗毁容疾病的局部抗寄生虫药,以及针对寄生虫和厌氧感染的新型易于使用的液体口服制剂。

Appili is at the epicenter of the global fight against infection, led by a proven management team..

阿皮利是全球抗击感染斗争的中心,由一支成熟的管理团队领导。

Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company’s ability to close the proposed transaction, including but not limited to, the Company’s ability to raise the necessary capital to close the transaction; the ability of both companies to secure all required regulatory, third-party and shareholder approvals for the proposed transaction; the Company’s expectation that shares of its common stock will remain listed on the Nasdaq Stock Market; the anticipated timing to close the transaction; the anticipated financial performances of the Company and Appili both before and after the proposed transaction; the anticipated benefits of the proposed transaction including synergies to Aditxt’s business following the proposed transaction; Appili’s ability to secure PRV vouchers for one or more of its programs; Aditxt’s ability to leverage Appili for subsequent product acquisitions and license agreements subsequent to the transaction; Appili’s ability to secure and maintain requisite regulatory approvals; costs related to the transaction; and changes to the potential market size and the size of the patient populations utilizing LIKMEZ.

本新闻稿中的某些声明构成联邦证券法所指的“前瞻性声明”。前瞻性陈述包括关于公司完成拟议交易的能力的陈述,包括但不限于公司筹集必要资本以完成交易的能力;两家公司获得拟议交易所需的所有监管、第三方和股东批准的能力;公司预期其普通股股票将继续在纳斯达克股票市场上市;完成交易的预期时间;拟议交易前后公司和Appili的预期财务业绩;拟议交易的预期收益,包括拟议交易后ADIXT业务的协同效应;Appili为其一个或多个项目获得PRV凭证的能力;ADIXT能够利用Appili进行交易后的后续产品收购和许可协议;Appili获得和维持必要监管批准的能力;与交易相关的成本;以及利用LIKMEZ改变潜在市场规模和患者人群规模。

You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the each company’s SEC filings, including Aditxt’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on April .

提醒您不要过度依赖这些前瞻性声明,这些声明仅在本新闻稿发布之日有效。这些前瞻性陈述都涉及风险和不确定性。可能导致实际结果与前瞻性声明中讨论或暗示的结果存在重大差异的重要因素已在每家公司向美国证券交易委员会提交的文件中披露,包括ADIXT于2022年4月31日向美国证券交易委员会提交的10-K表年度报告。