Appili has a commercial-stage pipeline, has
raised CAD $100M towards developing therapeutics for the global
infectious disease and biodefense markets, and subject to the
renewal of certain legislation, two programs potentially eligible
for FDA Priority Review Vouchers
Aditxt, Inc. (“Aditxt” or the “Company”) (NASDAQ: ADTX), an
innovation platform dedicated to accelerating promising health
innovations with two existing programs focused on immune health and
precision health, announced that Appili Therapeutics Inc. (TSX:
APLI; OTCPink: APLIF) (“Appili”) has commenced the mailing of its
management information circular in connection with the upcoming
special meeting of their shareholders, which will be held virtually
on November 6, 2024. Appili’s board of directors has recommended
the shareholders’ vote in favor of the proposed acquisition by
Aditxt.
Since its founding in 2015, over CAD $100 million has been
raised towards developing antivirals and vaccines for emerging and
neglected infectious agents to address a wide range of urgent
medical needs in infectious diseases and biodefense. As a result,
Appili’s portfolio includes LIKMEZ™, the first and only
FDA-approved, taste-masked oral liquid suspension form of the
antibiotic, metronidazole. LIKMEZ addresses an unmet need in
patients, such as children and the elderly, who have trouble
swallowing large pills. LIKMEZ was commercially launched by
Saptalis Pharmaceuticals LLC in 2023, and the product is now
available to patients and doctors in the United States. Appili has
the right to receive sales-based milestone payments and royalties
from Saptalis based on sale of the product.
In addition, Appili has two programs, ATI-1701 and 1801, which,
subject to the renewal of certain legislation, are potentially
eligible for FDA Priority Review Vouchers (PRVs). A PRV enables its
recipient to expedite the review process for future drug
applications upon issuance. While PRVs can be traded, and recent
transactions averaged approximately $100 million, their strategic
value can potentially extend beyond the secondary market, offering
significant advantages in accelerating the development timeline of
new treatments.
ATI-1701 is a live attenuated vaccine that targets tularemia.
This bacterial infection caused by Francisella tularensis is
potentially 1,000 times more infectious than anthrax, posing
significant threats to public health and national security and,
thus, classified as a Category A pathogen by the National
Institutes of Health for its potential use in bioterrorism.
ATI-1701 has been awarded a total of $14 million in U.S. Air Force
Academy funding 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 is another
program representing a topical antiparasitic product licensed by
the US Army Medical Materiel Development Activity.
ATI-1801 is in advanced clinical trials. This novel topical
formulation is being 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. This novel topical formulation of
paromomycin provides a more comfortable application of the
anti-infective agent to treat CL’s painful and disfiguring lesions
effectively.
Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt,
commented, “Completing the acquisition of Appili would be another
vehicle to expand Aditxt’s reach in addressing infectious diseases
with commercial or clinical development programs. 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
asset portfolio could 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,
“Appili’s board of directors recommends that shareholders vote in
favor of the proposed acquisition by Aditxt, as this transaction
aligns with our strategic goals and opens new opportunities across
multiple fronts. Appili has received indications of support from
approximately 29% of the total voting power. By leveraging the
Aditxt’s platform, we will significantly enhance our ability to
combat life-threatening infectious diseases, enabling us to expand
our reach and impact. Our combined expertise will rapidly advance
our mission to develop treatments for some of today’s most critical
public health challenges.”
The closing of the transaction with Appili is subject to several
conditions, including but not limited to approval of the
transaction by Appili’s shareholders and Aditxt raising sufficient
capital to fund its obligations at closing. No assurance can be
provided that all of the conditions to closing will be obtained or
satisfied or that the transaction will ultimately close.
About Aditxt, Inc.
Aditxt, Inc.® is an innovation platform dedicated to
accelerating promising health 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 currently operates two programs focused on immune health
and precision health. The Company plans to introduce two additional
programs dedicated to public health and women’s health. For these,
Aditxt has entered into an Arrangement Agreement with Appili
Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which
focuses on infectious diseases, and a Merger Agreement with Evofem
Biosciences, Inc. (OTCQB: EVFM). Each program will be designed to
function autonomously while collectively advancing Aditxt’s mission
of discovering, developing, and deploying innovative health
solutions to tackle some of the most urgent health challenges. The
closing of each of the transactions with Appili and Evofem is
subject to several conditions, including but not limited to
approval of the transactions by the respective target shareholders
and Aditxt raising sufficient capital to fund its obligations at
closing. No assurance can be provided that all of the conditions to
closing will be obtained or satisfied or that either of the
transactions will ultimately close.
For more information, www.aditxt.com.
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https://www.facebook.com/aditxtplatform/
About Appili
Appili 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’s goal is to strategically develop a pipeline of novel
therapies to prevent deaths and improve lives. Appili is currently
advancing a diverse range of anti-infectives, including an FDA
approved ready-made suspension of metronidazole for the treatment
of antimicrobial infections, a vaccine candidate to eliminate a
serious biological weapon threat, and a topical antiparasitic for
the treatment of a disfiguring disease. Led by a proven management
team, Appili is at the epicenter of the global fight against
infection.
For more information about Appili Therapeutics Inc., visit
www.AppiliTherapeutics.com.
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 its strategic M&A
initiatives; the Company’s ability to 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 Aditxt’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/20241010955824/en/
Media Relations Contact: Mary O’ Brien mobrien@aditxt.com
(516) 753-9933
Appili Therapeutics (TSX:APLI)
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