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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240725152521/en/
Mary O’ Brien mobrien@aditxt.com (516) 753-9933
Aditxt (NASDAQ:ADTX)
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