Aditxt Signs Second Amendment to the Arrangement Agreement with Appili Therapeutics, Targeting September 30 Closing of the Acquisition
Aditxt (NASDAQ: ADTX) has signed a second amendment to the arrangement agreement with Appili Therapeutics, targeting a September 30, 2024 closing date for the acquisition. The deal involves Aditxt acquiring all issued and outstanding Class A common shares of Appili through a court-approved plan. Key conditions include Aditxt raising at least US$20 million in financing before closing.
Appili has raised over CAD $100 million since 2015 for developing therapeutics in the global infectious disease and biodefense markets. Their portfolio includes LIKMEZ™, an FDA-approved antibiotic suspension, ATI-1701, a tularemia vaccine, and ATI-1801, a topical antiparasitic product. Two programs are potentially eligible for FDA Priority Review Vouchers, subject to legislation renewal.
Aditxt (NASDAQ: ADTX) ha firmato un secondo emendamento all'accordo con Appili Therapeutics, fissando come data di chiusura per l'acquisizione il 30 settembre 2024. L'accordo prevede che Aditxt acquisisca tutte le azioni comuni di Classe A di Appili emesse e in circolazione tramite un piano approvato dal tribunale. Le condizioni chiave includono la raccolta da parte di Aditxt di almeno 20 milioni di dollari USA in finanziamenti prima della chiusura.
Appili ha raccolto oltre 100 milioni di dollari CAD dal 2015 per lo sviluppo di terapie nei mercati globali delle malattie infettive e della biodefesa. Il loro portafoglio comprende LIKMEZ™, un antibiotico in sospensione approvato dalla FDA, ATI-1701, un vaccino contro la tularemia, e ATI-1801, un prodotto antiparassitario topico. Due programmi potrebbero essere idonei per i Voucher di Revisione Prioritaria della FDA, soggetti a rinnovo legislativo.
Aditxt (NASDAQ: ADTX) ha firmado una segunda enmienda al acuerdo con Appili Therapeutics, fijando como fecha de cierre para la adquisición el 30 de septiembre de 2024. El acuerdo implica que Aditxt adquiere todas las acciones comunes de Clase A emitidas y en circulación de Appili a través de un plan aprobado por el tribunal. Las condiciones clave incluyen que Aditxt recaude al menos 20 millones de dólares estadounidenses en financiamiento antes del cierre.
Appili ha recaudado más de 100 millones de dólares canadienses desde 2015 para desarrollar terapias en los mercados globales de enfermedades infecciosas y biodefensa. Su cartera incluye LIKMEZ™, una suspensión antibiótica aprobada por la FDA, ATI-1701, una vacuna contra la tularemia, y ATI-1801, un producto antiparasitario tópico. Dos programas son potencialmente elegibles para los Vouchers de Revisión Prioritaria de la FDA, sujetos a renovación legislativa.
Aditxt (NASDAQ: ADTX)가 Appili Therapeutics와의 협약에 대한 두 번째 수정안을 체결하였으며, 인수 마감일을 2024년 9월 30일로 설정하였습니다. 이 거래는 Aditxt가 법원 승인 계획을 통해 Appili의 모든 발행된 및 유통되는 A 클래스 보통주를 인수하는 것을 포함합니다. 주요 조건 중 하나는 Aditxt가 마감 전에 최소 2000만 달러의 자금을 모집하는 것입니다.
Appili는 2015년 이래로 전세계 감염병 및 생물 방어 시장을 위한 치료제를 개발하기 위해 1억 캐나다 달러 이상을 모집하였습니다. 그들의 포트폴리오는 FDA 승인 항생제 서스펜션인 LIKMEZ™, 인후염 백신인 ATI-1701, 국소용 항기생충 제품인 ATI-1801을 포함하고 있습니다. 두 가지 프로그램은 법안 갱신에 따라 FDA 우선 심사 바우처를 받을 수 있는 잠재적인 자격이 있을 수 있습니다.
Aditxt (NASDAQ: ADTX) a signé un deuxième amendement à l'accord avec Appili Therapeutics, visant une date de clôture pour l'acquisition le 30 septembre 2024. L'accord implique qu'Aditxt acquiert toutes les actions ordinaires de Classe A émises et en circulation d'Appili par le biais d'un plan approuvé par le tribunal. Les conditions clés incluent qu'Aditxt lève au moins 20 millions de dollars américains en financement avant la clôture.
Appili a levé plus de 100 millions de dollars canadiens depuis 2015 pour le développement de thérapies sur les marchés mondiaux des maladies infectieuses et de la biodéfense. Leur portefeuille comprend LIKMEZ™, une suspension antibiotique approuvée par la FDA, ATI-1701, un vaccin contre la tularemie, et ATI-1801, un produit antiparasitaire topique. Deux programmes pourraient être éligibles pour les bons de révision prioritaire de la FDA, sous réserve de renouvellement législatif.
Aditxt (NASDAQ: ADTX) hat eine zweite Änderung des Arrangementvertrags mit Appili Therapeutics unterzeichnet, die als Abschlussdatum für die Akquisition den 30. September 2024 festlegt. Der Deal umfasst, dass Aditxt alle ausgegebenen und ausstehenden Stammaktien der Klasse A von Appili durch einen vom Gericht genehmigten Plan erwirbt. Zu den wichtigsten Bedingungen gehört, dass Aditxt vor dem Abschluss mindestens 20 Millionen US-Dollar an Finanzierungen aufbringt.
Appili hat seit 2015 über 100 Millionen CAD für die Entwicklung von Therapeutika in den globalen Märkten für Infektionskrankheiten und Biodefense gesammelt. Ihr Portfolio umfasst LIKMEZ™, eine von der FDA genehmigte antibiotische Suspension, ATI-1701, einen Tularemia-Impfstoff, und ATI-1801, ein topisches Antiparasitikum. Zwei Programme könnten potenziell für die FDA Priority Review Vouchers in Frage kommen, vorbehaltlich einer gesetzlichen Erneuerung.
- Acquisition of Appili Therapeutics expands Aditxt's portfolio in the growing infectious disease therapeutics market
- Appili's LIKMEZ™ product is already FDA-approved and generating sales-based milestone payments and royalties
- ATI-1701 vaccine has received US$14 million in U.S. Air Force Academy commitments
- Two of Appili's programs are potentially eligible for FDA Priority Review Vouchers, which have averaged US$100 million in recent transactions
- Global infectious disease therapeutics market is projected to grow from US$115 billion in 2022 to US$164.58 billion by 2032
- Acquisition is conditional on Aditxt raising at least US$20 million in financing before closing
- Transaction is subject to court, regulatory, and stock exchange approvals, with no assurance of completion
- Closing date has been extended from August 30 to September 30, 2024, indicating potential delays
The amendment to the arrangement agreement between Aditxt and Appili Therapeutics is a significant development, albeit with some caveats. The extension of key deadlines, particularly the Outside Date to September 30, 2024 and the Aditxt Financing deadline to September 15, 2024, provides more time for the deal to materialize. However, this also indicates potential challenges in meeting original timelines.
The US$20 million financing condition is crucial. While it demonstrates Aditxt's commitment, it also presents a hurdle in the current market environment. Investors should closely monitor Aditxt's ability to secure this funding, as it's pivotal for the deal's success.
Appili's portfolio, particularly LIKMEZ™, which is already generating revenue, could provide immediate value post-acquisition. The potential for Priority Review Vouchers (PRVs) for ATI-1701 and ATI-1801 is intriguing, given their average market value of
The projected growth of the infectious disease therapeutics market to
The acquisition of Appili Therapeutics by Aditxt represents a strategic move in the infectious disease and biodefense sectors. Appili's diverse portfolio addresses critical areas of unmet medical needs, which could potentially position Aditxt as a significant player in these markets.
LIKMEZ™, an FDA-approved product, provides immediate commercial potential. Its unique formulation addressing dysphagia patients could capture a niche market, particularly beneficial for pediatric and geriatric populations.
ATI-1701, targeting tularemia, is particularly noteworthy. Its classification as a Category A pathogen and potential use in bioterrorism defense aligns with national security interests. The
ATI-1801's focus on cutaneous leishmaniasis addresses a significant global health issue, particularly in developing regions. Its potential for a Priority Review Voucher adds considerable value, although this is dependent on legislative factors.
The acquisition could accelerate Appili's development pipeline, leveraging Aditxt's resources. However, the success of this strategy hinges on Aditxt's ability to effectively integrate and manage these diverse programs post-acquisition.
The Aditxt-Appili deal reflects broader trends in the biotech sector, where larger entities acquire smaller, specialized firms to diversify their portfolios and tap into niche markets. This acquisition could potentially reshape Aditxt's market position, especially in the infectious disease and biodefense segments.
The global infectious disease therapeutics market's projected growth to
The COVID-19 pandemic has heightened awareness and investment in infectious disease research and biodefense. Appili's portfolio, particularly ATI-1701 for tularemia, could attract increased attention and funding in this new landscape.
However, market reception will largely depend on Aditxt's post-acquisition strategy and its ability to effectively commercialize Appili's pipeline. The success of LIKMEZ™ in the U.S. market will be a key indicator of the combined entity's commercial capabilities.
Investors should also consider the potential impact of successful Priority Review Vouchers, which could significantly accelerate future drug approvals and provide substantial financial benefits, either through use or sale.
Appili, with a commercial-stage pipeline, has raised CAD
The transaction is conditional upon Aditxt raising at least
Since Appili’s inception in 2015, over CAD
LIKMEZ™: An FDA-approved, taste-masked oral liquid suspension of the antibiotic metronidazole designed to treat bacterial infection. LIKMEZ is the first and only FDA-approved ready-made suspension of metronidazole for treating antimicrobial infections that addresses the unmet need in patients with dysphagia to avoid risks associated with drug compounding and discontinuation-related anti-microbial resistance. This is particularly beneficial for children and the elderly. With Appili’s partners, Saptalis Pharmaceuticals LLC launched LIKMEZ in November 2023, and commercial sales in
ATI-1701: This live attenuated vaccine targets tularemia, a bacterial infection caused by Francisella tularensis. The development of ATI-1701 is critical, as tularemia poses significant threats to public health and national security. It is classified as a Category A pathogen by the National Institutes of Health for its potential use in bioterrorism, as it is potentially 1,000 times more infectious than anthrax. ATI-1701 has been awarded a total of
ATI-1801: A topical antiparasitic product licensed from the US Army Medical Materiel Development Activity is in advanced clinical trials. This novel topical formulation is developed to combat cutaneous leishmaniasis (CL), a devastating disease causing disfiguring skin lesions and affecting hundreds of thousands of people annually, primarily in tropical and subtropical regions. Recognized by the World Health Organization as a Neglected Tropical Disease, CL presents significant social and economic challenges, particularly in impoverished communities. CL leads to severe physical deformities and social stigma, contributing to isolation and diminished quality of life for those affected. Formulated with paromomycin, an antibiotic approved for other uses, ATI-1801 provides a direct and effective treatment for CL’s painful and disfiguring lesions.
Subject to the renewal of certain legislation, ATI-1701 and ATI-1801 could be eligible for a Priority Review Voucher (PRV). A PRV enables its recipient to expedite the review process for future drug applications upon issuance. While PRVs can be traded, and recent transactions have averaged approximately
Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, commented, "Completing the acquisition of Appili Therapeutics will be another milestone in advancing our mission of making promising innovations possible, together. The strategic importance of Appili’s work in developing treatments and vaccines for infectious diseases and medical countermeasures could impact millions of people around the globe. We believe Appili’s team and their product portfolio can potentially address some of the most urgent public health challenges, including antibiotic-resistant infections and bioterrorism threats.”
Dr. Don Cilla, President and CEO of Appili Therapeutics, stated: "This upcoming transaction with Aditxt aligns with our strategic goals, presenting exciting new opportunities across multiple fronts. Leveraging the Aditxt platform will significantly enhance our ability to combat life-threatening infectious diseases, allowing us to expand our reach and impact. Our shared vision and combined expertise will rapidly advance our mission to develop treatments for some of today's most critical national security risks.”
Aditxt currently operates two programs focused on immune health and precision diagnostics. With the completion of the Appili Therapeutics acquisition and another ongoing transaction, Evofem, Aditxt will establish two additional programs. Following closing, Aditxt will seek to empower these programs to operate autonomously while collectively contributing to their goal of discovering, developing, and deploying impactful health innovations that address some of the most pressing health challenges.
About Aditxt, Inc.
Aditxt, Inc.® 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 operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued and empowers collective progress.
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. 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
For more information, see www.aditxt.com.
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Forward-Looking Statements
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 intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s ability to finance and execute on its strategic M&A initiatives; the Company’s ability obtain the necessary funding and partner to commence clinical trials; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the Company’s ability to raise additional capital; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as market and other conditions and those risks more fully discussed in the section titled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Mary O’ Brien
mobrien@aditxt.com
(516) 753-9933
Source: Aditxt, Inc.
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