Aditxt Signs Second Amendment to the Arrangement Agreement with Appili Therapeutics, Targeting September 30 Closing of the Acquisition

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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

Insights

Financial Analyst

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 $100 million. However, this is contingent on legislation renewal and successful development, adding an element of uncertainty.

The projected growth of the infectious disease therapeutics market to $164.58 billion by 2032 presents a substantial opportunity. However, investors should weigh this potential against the risks associated with drug development and regulatory approvals.

Biotech Industry Analyst

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 $14 million in U.S. Air Force Academy commitments underscores its strategic importance.

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.

Market Research Analyst

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 $164.58 billion by 2032 presents a significant opportunity. Appili's focus on emerging, neglected and resistant infectious diseases aligns well with this trend, potentially giving Aditxt a competitive edge in a rapidly expanding market.

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 $100M towards developing therapeutics for the global infectious disease and biodefense markets. Subject to the renewal of certain legislation, two programs are potentially eligible for FDA Priority Review Vouchers

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- Aditxt, Inc. (“Aditxt”) (NASDAQ: ADTX), a company dedicated to discovering, developing, and deploying promising health innovations, and its wholly-owned subsidiary, Adivir, Inc., have entered into a second Amending Agreement (the “Amending Agreement”) with Appili Therapeutics Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), a biopharmaceutical company developing treatments and vaccines for infectious diseases and medical countermeasures. Under the Amending Agreement, (a) the Outside Date (as defined in the Arrangement Agreement) was changed from August 30, 2024 to September 30, 2024, (b) the deadline to convene Appili’s special shareholders’ meeting was changed from August 30, 2024, to September 30, 2024, and (c) the deadline for Aditxt to complete the Financing (as defined below) was changed from August 30, 2024 to September 15, 2024, or such later date as the parties may agree in writing. Aditxt will acquire all issued and outstanding Class A common shares of Appili through a court-approved plan of arrangement governed by the Canada Business Corporations Act. The transaction is targeted for closure by September 30, 2024.

The transaction is conditional upon Aditxt raising at least US$20 million in financing (the “Aditxt Financing”) before 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. No assurance can be given that all of the conditions to closing will be obtained or satisfied or that the transaction will ultimately close.

Since Appili’s inception in 2015, over CAD $100 million has been raised towards developing antivirals and vaccines to treat emerging, neglected, and resistant infectious diseases. The company's focused efforts on enhancing existing treatments and pioneering new anti-infective classes aim to address a wide range of urgent medical needs in infectious diseases and biodefense. Appili’s portfolio addresses critical health challenges and has the potential to enhance national security, including:

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 the United States are ongoing. Appili receives sales-based milestone payments and royalties from Saptalis tied to the product's sales.

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 US$14 million in U.S. Air Force Academy commitments, facilitating essential activities like manufacturing, non-clinical studies, and regulatory activities for an Investigational New Drug (IND) application, positioning ATI-1701 as a pivotal element in biodefense strategies.

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 US$100 million, their strategic value can extend beyond the secondary market, offering significant advantages in accelerating the development timeline of new treatments. Moreover, the recent pandemic has further emphasized the global demand for innovative infectious disease solutions. Market analysis by Precedence Research forecasts that the global market for infectious disease therapeutics, valued at US$115 billion in 2022, is expected to grow to approximately US$164.58 billion by 2032. This growth trajectory presents a significant opportunity for Appili to contribute to this expanding market while seeking to address some of the most pressing global public health challenges.

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 Richmond, VA.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240725152521/en/

Mary O’ Brien

mobrien@aditxt.com

(516) 753-9933

Source: Aditxt, Inc.

FAQ

What is the target closing date for Aditxt's acquisition of Appili Therapeutics?

The target closing date for Aditxt's acquisition of Appili Therapeutics is September 30, 2024.

How much financing does Aditxt (ADTX) need to raise for the Appili acquisition?

Aditxt (ADTX) needs to raise at least US$20 million in financing before closing the Appili acquisition.

What are the key products in Appili Therapeutics' portfolio?

Appili Therapeutics' key products include LIKMEZ™ (an FDA-approved antibiotic suspension), ATI-1701 (a tularemia vaccine), and ATI-1801 (a topical antiparasitic product).

How much funding has Appili Therapeutics raised since its inception?

Appili Therapeutics has raised over CAD $100 million since its inception in 2015 for developing therapeutics in the infectious disease and biodefense markets.

What is the potential value of FDA Priority Review Vouchers for Appili's programs?

FDA Priority Review Vouchers, which two of Appili's programs may be eligible for, have averaged approximately US$100 million in recent transactions.