If complete, the transaction would be the first step in
establishing commercial presence in infectious disease therapeutics
and transforming Aditxt into a global biotech company
Aditxt Inc. (Nasdaq: ADTX), a biotech innovation company with a
mission to improve the health of the immune system, has signed a
share exchange agreement to acquire AiPharma Global Holdings LLC, a
wholly-owned subsidiary of AiPharma Group Ltd. (“AiPharma”). The
share exchange agreement contemplates that the transaction would
involve two steps. First, an initial closing is expected to occur
upon the satisfaction of certain conditions no later than January
31, 2022, at which Aditxt will acquire 9.5% of the issued and
outstanding equity interests in AiPharma in exchange for the
issuance of approximately 4.8 million shares of common stock of
Aditxt and a cash payment of $250,000. Second, Aditxt would then
acquire the remaining 90.5% of the issued and outstanding equity
interests in AiPharma in exchange for the issuance of approximately
39.9 million shares of common stock of Aditxt and a cash payment of
$250,000 at a secondary closing, subject to the satisfaction or
waiver of certain conditions to closing, including, but not limited
to, shareholder and Nasdaq approval.
Business Highlights:
- AiPharma holds directly, or through its affiliates worldwide
(excluding Japan), exclusive rights to Avigan and all formulations
of Favipiravir. This broad-spectrum oral antiviral drug targets
COVID-19 and other infectious diseases. Avigan has regulatory
approval to treat COVID-19 and influenza in Mexico, United Arab
Emirates, India, Indonesia, Malaysia, Japan, and Thailand. Other
countries buy the treatment under compassionate patient programs.
In the United States, Phase 3 PRESECO (PREventing Severe COVID-19)
clinical trial evaluating Avigan for the treatment of
mild-to-moderate COVID-19 did not achieve statistical significance
on the primary endpoint of time to sustained clinical recovery.
AiPharma is currently planning to launch a new global clinical
trial involving escalated doses of monotherapy and combination
therapy.
- In September 2021, AiPharma entered into a strategic alliance
with Appili Therapeutics (TSX:APLI) (OTCQX: APLIF) (“Appili”), an
infectious disease biopharmaceutical company, pursuant to which
AiPharma and Appili intend to establish minority positions in each
other’s businesses.
- Appili has a pipeline of five therapeutics and recently
announced positive one year challenge results from its preclinical
study evaluating the efficacy of ATI-1701, a vaccine to protect
against a potential bioterrorism agent, 1,000 times more infectious
than anthrax.
- The senior leadership team, who have a successful track record
in rapid commercialization, will remain in place to support the
acceleration of Aditxt's growth strategy.
- Together, the combined companies would offer an enhanced value
proposition with a suite of monitoring and treatment solutions for
infectious diseases enabling detection, prevention, and treatment,
expanding the offering to AiPharma’s existing global network of
distributors.
Aditxt Co-Founder and CEO Amro Albanna commented, “We are taking
steps that we believe will transform Aditxt into a fully-integrated
commercial-stage global biopharmaceutical business, with focus on
all aspects of immune diagnosis and therapeutics. The proposed
transaction with AiPharma would commercially establish Aditxt in
the infectious disease space complementing our current therapeutic
programs in autoimmunity, dermatology, organ transplantation, and
central nervous system. This transaction mirrors the parallel steps
we are taking in immune diagnosis with the recently announced
intent to acquire a company in the Point-of-Care space which would
technologically and commercially complement AditxtScore™. These
combined transactions would allow us to execute our strategy of
growth, global expansion, and product portfolio diversification,
consistent with our priorities to advance our immune monitoring and
treatment technologies to advance human health globally. We look
forward to working with the AiPharma team to bring valuable
therapeutic options to extend and improve the quality of life of
millions of patients.”
“Since our launch, AiPharma has worked to develop and deliver
transformative solutions to patients around the world. We remain
committed and steadfast in bringing an effective broad spectrum
anti-viral treatment to the market while leveraging our strong
pipeline of opportunities and our commercial network,” stated
Alessandro Gadotti, Chief Executive Officer of AiPharma. “The
acquisition of AiPharma, with our strong commercial portfolio and
robust pipeline, will support Aditxt’s near-term ambition to
develop novel therapies and technologies in areas of immunology
with a high unmet medical need. We are delighted at the prospect of
being acquired by Aditxt at this exciting juncture in their
journey; AiPharma will help fuel strategic growth and deliver
future pipeline and M&A activities so that even more patients
can access critical medicines and technologies now and in the
future.”
The description of the proposed transaction contained herein is
only a high-level summary. Additional information about the
proposed transaction, including a copy of the share exchange
agreement, will be provided in a Current Report on Form 8-K to be
filed by Aditxt with the Securities and Exchange Commission (“SEC”)
and available at the SEC’s website at www.sec.gov. In addition,
Aditxt intends to file a registration statement on Form S-4 with
the SEC, including a proxy statement/prospectus, and will file
other documents regarding the proposed transaction with the
SEC.
The definitive agreement follows Aditxt’s prior announcement on
August 25, 2021, of its intention to acquire AiPharma and Aditxt’s
bridge loan funding to AiPharma, subject to certain closing
conditions. There is no assurance that Aditxt’s acquisition of
AiPharma will be completed.
About Aditxt:
Aditxt is developing technologies focused on improving the
immune system's health through immune monitoring and reprogramming.
Aditxt’s immune monitoring technology is designed to provide a
personalized, comprehensive immune system profile. Aditxt’s immune
reprogramming technology is currently at the pre-clinical stage. It
is designed to retrain the immune system to induce tolerance to
address rejection of transplanted organs, autoimmune diseases, and
allergies.
For more information, please visit: www.aditxt.com.
About AiPharma:
AiPharma is a commercial-stage biopharmaceutical company focused
on developing oral therapies to address the unmet medical needs of
patients with life-threatening viral diseases. Leveraging a deep
understanding of antiviral drug development, nucleotide chemistry,
biology, biochemistry, and virology, AiPharma has built a
nucleotide prodrug platform to develop novel product candidates to
treat single-stranded ribonucleic acid, or ssRNA, viruses, which
are a prevalent cause of severe viral diseases. Currently, AiPharma
is focused on the clinical and commercial development of orally
available, potent, and selective nucleotide prodrugs for
difficult-to-treat, life-threatening viral infections, including
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the
virus that causes COVID-19, dengue virus, hepatitis C virus (HCV)
and respiratory syncytial virus (RSV).
AiPharma holds directly, or through its affiliates worldwide
(excluding Japan), exclusive rights to Avigan (Favipiravir) and all
other formulations of the molecule. This broad-spectrum oral
antiviral drug targets COVID-19 and 11 classes of infectious
diseases. Regulatory approval for the indication of COVID-19 and/or
influenza has been granted in Mexico, Japan, Thailand, Malaysia,
UAE, Morocco, Indonesia, India, and United Arab Emirates. Countries
purchasing on a Compassionate Patient Basis include the United
Kingdom, Hungary, and Saudi Arabia.
For more information, please visit www.aipharmalab.com.
Important Information About the Proposed Transaction and
Where to Find It
This press release relates to a proposed transaction between
Aditxt and AiPharma. This press release does not constitute an
offer to sell or exchange, or the solicitation of an offer to buy
or exchange, any securities, nor shall there be any sale of
securities in any jurisdiction in which such offer, sale, or
exchange would be unlawful prior to registration or qualification
under the securities laws of any such jurisdiction. In connection
with the transaction described herein, Aditxt intends to file
relevant materials with the SEC including a registration statement
on Form S-4, which will include a prospectus with respect to the
combined company’s securities to be issued in connection with the
business combination and a proxy statement with respect to the
stockholder meeting of Aditxt to vote on the business combination.
Promptly after the registration statement is declared effective by
the SEC, Aditxt will mail the definitive proxy statement/prospectus
and a proxy card to each stockholder as record date for the meeting
of Aditxt’s stockholders be established for voting on the proposed
business combination. Aditxt urges its investors, stockholders, and
other interested persons to read, when available, the preliminary
proxy statement/prospectus as well as other documents filed with
the SEC because these documents will contain important information
about Aditxt, AiPharma, and the business combination. Once
available, stockholders will also be able to obtain a copy of the
Form S-4, including the proxy statement/prospectus, and other
documents filed with the SEC without charge, by directing a request
to Aditxt, Attn: Amro Albanna, 737 N. Fifth Street, Suite 200,
Richmond, VA 23219. The preliminary and definitive proxy
statement/prospectus to be included in the registration statement,
once available, can also be obtained, without charge, at the SEC’s
website (www.sec.gov).
Participants in the Solicitation
Aditxt and its directors and executive officers may be deemed
participants in the solicitation of proxies from Aditxt’s
stockholders concerning the business combination. Information about
Aditxt’s directors and executive officers and a description of
their interests in Aditxt will be included in the proxy
statement/prospectus for the proposed transaction and be available
at the SEC’s website (www.sec.gov).
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 Aditxt’s (the “Company”) 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 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 industry in which the Company
operates; and the trends that may affect the industry or the
Company. These forward-looking statements are subject to a number
of risks including, but not limited to, the following risks
relating to the proposed transaction: (1) the risk that the
proposed transaction may not be completed in a timely manner or at
all, which may adversely affect the price of Aditxt’s securities;
(2) the failure to satisfy the conditions to closing the proposed
transaction, including the approval by the stockholders of Aditxt
and AiPharma; (3) the outcome of any legal proceedings that may be
instituted related to the proposed transaction; (4) the ability to
realize the anticipated benefits of the proposed transaction; (5)
the risk that the product candidates that AiPharma is developing
may not progress through clinical development or receive regulatory
approvals within expected timelines or at all; (6) the risk that
AiPharma’s clinical trials may not confirm any safety, efficacy or
other product characteristics that would enable subsequent clinical
trials; (7) the risk that AiPharma will be unable to successfully
market or gain market acceptance of its product candidates, if
approved; (8) the risk that AiPharma’s product candidates may not
be beneficial to patients or successfully commercialized, if
approved; (9) the risk that AiPharma has overestimated the size of
the target patient population, their willingness to try new
therapies and the willingness of physicians to prescribe these
therapies; (10) the effects of competition on AiPharma’s business;
(11) the risk that third parties on which AiPharma depends for
clinical trials and other critical services will fail to perform
satisfactorily; (12) the risk that AiPharma may not be able to
recruit and retain qualified personnel; (13) the risk that
AiPharma’s business, operations, clinical development plans and
timelines, and supply chain could be adversely affected by the
effects of health epidemics, including the ongoing COVID-19
pandemic; (14) the risk that AiPharma will be unable to obtain and
maintain sufficient intellectual property protection for its drug
products or will infringe the intellectual property protection of
others; (15) the risk the combined company will fail to realize the
anticipated benefits of the proposed transaction; and (16) other
risks and uncertainties indicated from time to time in AiPharma’s
public filings with the SEC. If any of these risks materialize or
Aditxt’s and AiPharma’s assumptions prove incorrect, actual results
could differ materially from the results implied by these
forward-looking statements. There may be additional risks that
neither Aditxt nor AiPharma presently knows, or that Aditxt or
AiPharma currently believe are immaterial. That could also cause
actual results to differ from those contained in the
forward-looking statements. In addition, forward-looking statements
reflect Aditxt’s and AiPharma’s expectations, plans, or forecasts
of future events and views as of the date of this press release.
Aditxt and AiPharma anticipate that subsequent events and
developments will cause Aditxt’s and AiPharma’s assessments.
However, while Aditxt and AiPharma may elect to update these
forward-looking statements at some point in the future, Aditxt and
AiPharma specifically disclaim any obligation to do so, except as
otherwise required by law. These forward-looking statements should
not be relied upon as representing Aditxt’s and AiPharma’s
assessments of any date after the date of this press release.
Accordingly, undue reliance should not be placed upon the
forward-looking statements. 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 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 essential
factors in the Company’s other filings with the Securities and
Exchange Commission. All such statements speak only as of the date
made. 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.
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Media and Investor Relations Contact: Aditxt Investor
Communications ir@aditxt.com
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