Strategic alliance for the global development
of oral antiviral medicine Avigan®/ReeqonusTM (favipiravir) for the
treatment of COVID-19 and other infectious disease programs
New agreement with existing consortium partner
AiPharma enhances complementary skills and creates global reach
with expanded resources
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases, and AiPharma Global Holdings
LLC (“AiPharma”), a private pharmaceutical research, development
and commercialization company, today announced a strategic alliance
to advance the global development of Avigan®/Reeqonus™
(favipiravir), a broad-spectrum oral antiviral currently being
evaluated by Appili and its global consortium of partners for the
potential treatment and prevention of COVID-19, including in
Appili’s Phase 3 COVID-19 treatment trial PRESECO (PREventing
SEvere COVID-19) which completed enrollment last week. Appili and
AiPharma entered into a strategic equity transaction (the
“Definitive Agreement”) to establish minority positions in each
other’s businesses, further align their goals and participate in
each other’s respective economic interests.
Selected highlights of the strategic alliance include:
- Accelerated and strengthened development of Avigan/Reeqonus
(favipiravir) on a coordinated and worldwide basis
- AiPharma expects access to cash flows tied to the growing
worldwide sales of Avigan/Reegonus via its 50% equity stake in
consortium member Global Response Aid (“GRA”)
- The establishment of a joint scientific steering committee to
coordinate the rapid development of Avigan/Reeqonus
- Equity transaction: Appili exchanges shares with AiPharma for
strong alignment and mutual economic participation in each other’s
respective businesses
- Plans to bring on additional programs, assets and partners to
further the goal of becoming a global, integrated and infectious
disease specialized healthcare company
“COVID-19 continues to be an immense health threat with little
relief in sight. The world needs safe and effective oral antivirals
that can help alleviate the threat of COVID-19, and I believe
Avigan/Reeqonus has the potential to change the trajectory of this
pandemic,” said Armand Balboni, M.D., Ph.D., Chief Executive
Officer of Appili Therapeutics. “This partnership will help us
further streamline activities and move quickly following the
PRESECO readout to key clinical, regulatory and commercial
milestones.”
Alessandro Gadotti, Chief Executive Officer at AiPharma, added,
“This is an exciting and important partnership for us. Our work
with Appili will have real impact for people and communities around
the world. The strength of oral antiviral treatments, such as
Avigan/Reeqonus, in real terms is that they fight COVID-19 in the
community and not in hospitals - which can majorly reduce pressures
on healthcare systems. Our joint product portfolio puts us on the
front line in the fight against COVID-19 and future pandemic
preparedness. Our company was established by a team of drug
development, infectious disease, data scientists and
commercialization experts. We believe that this expertise, paired
with Appili’s promising pipeline of specialty therapeutics, will
allow us to evolve into a global integrated infectious disease
healthcare company.”
One of AiPharma’s portfolio companies is GRA, a 50-50 joint
venture with Agility (KSE/DFM: AGLTY) and a member of the
consortium focused on the global development, commercialization and
distribution of Avigan/Reeqonus. The consortium, which also
includes the original Avigan/Reeqonus developer, FUJIFILM Toyama
Chemical Co. Ltd., has made Avigan/Reeqonus available in
jurisdictions where it is authorized as it completes its Phase 3
clinical program and has realized significant and rapidly growing
global product revenues since the start of the pandemic. Through
its participation in the consortium advancing Avigan/Reeqonus
worldwide, GRA is entitled to 50% of the net profits from the
worldwide sales of Avigan/Reeqonus (outside of Japan, China and
Russia; net of any profit shares paid to Appili).
The partnership between Appili and AiPharma will include the
formation of a joint scientific steering committee to further
coordinate global clinical and regulatory activities for
Avigan/Reeqonus around the world. The steering committee will
include the following members:
- Dr. Armand Balboni, Chief Executive Officer, Appili
- Dr. Yoav Golan, Chief Medical Officer, Appili
- Dr. Alessandro Gadotti, Chief Executive Officer, AiPharma
- Dr. Richard Kaszynski, Chief Medical Officer, AiPharma
Under the terms of the equity transaction, AiPharma will receive
that number of Class A common shares of Appili (“Appili Shares”) as
is equal to 24% of the issued and outstanding Appili Shares
immediately prior to the Definitive Agreement (calculated on a
non-diluted basis). AiPharma has also been granted certain investor
rights, including pre-emptive rights, certain consent rights and
registration rights (which rights will be extinguished if the
AiPharma holdings fall below 10% of the issued and outstanding
Appili Shares). Assuming no further equity issuances, it is
expected that AiPharma will hold approximately 19.4% of the issued
and outstanding Appili Shares immediately following closing.
In exchange, Appili will receive approximately 6% of the issued
and outstanding AiPharma shares (calculated on a non-diluted
basis).
The Toronto Stock Exchange (“TSX”) has conditionally approved
the transactions described herein (the “Transaction”). Closing of
the Transaction is conditional upon obtaining certain third party
consents and receipt of final TSX approval, which is subject to
satisfaction of customary listing conditions (including clearance
of requisite personal information forms on behalf of AiPharma).
The Transaction is expected to be completed in Q4 2021.
Additional Early Warning Disclosures of AiPharma
Pursuant to the terms of the Definitive Agreement, AiPharma has
agreed to subscribe for and purchase (the “Investment”) 15,079,709
Appili Shares, in consideration for the issuance of 66,721 shares
of AiPharma, representing approximately a 6% interest in AiPharma
as at September 28, 2021, with a value, based on the closing price
of Appili’s shares on the Toronto Stock Exchange on September 28,
2021, of approximately C$15.4 million.
Immediately prior to the Investment, AiPharma, its affiliates
and joint actors owned no voting or equity securities in the
capital of Appili. Upon closing of the Investment, AiPharma and its
affiliates will own 15,079,709 Appili Shares, representing
approximately 19.4% of the currently outstanding Appili Shares, on
a non-diluted basis. When acquired, the Appili Shares will be held
by AiPharma for investment purposes and in furtherance of the
strategic alliance of Appili and AiPharma on the potential joint
development and commercialization of favipiravir and all other
molecules of Appili’s portfolio, as is further provided for in the
Definitive Agreement. Depending on market conditions and other
factors, including AiPharma’s business and financial condition,
AiPharma or its affiliates may acquire additional securities of
Appili or dispose of some or all of the securities of Appili that
it owns at such time.
AiPharma is a limited liability company organized under the laws
of the State of Delaware. The principal business of AiPharma is
pharmaceutical research, development and commercialization.
AiPharma’s address is One JLT (14th Floor), Jumeriah Lakes Towers,
Dubai, United Arab Emirates, PO Box 103805.
An early warning report with additional information in respect
of the foregoing matters will be filed and made available on the
System for Electronic Document Analysis and Review (SEDAR) at
www.sedar.com under Appili’s profile. To obtain a copy of this
report, you may also contact John White (General Counsel, AiPharma)
at +971 58 554 8666.
About Appili Therapeutics
Appili Therapeutics 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. As part of
a global consortium, Appili is sponsoring late-stage clinical
trials evaluating the antiviral Avigan/Reeqonus for the worldwide
treatment and prevention of COVID-19. The Company is also advancing
a diverse range of anti-infectives, including a broad-spectrum
antifungal, a vaccine candidate to eliminate a serious biological
weapon threat, and two novel antibiotic programs. Led by a proven
management team, Appili is at the epicenter of the global fight
against infection. For more information, visit
www.AppiliTherapeutics.com.
About AiPharma
AiPharma is a biopharmaceutical company focused on discovering,
developing, and commercializing oral therapies to address the unmet
medical needs of patients with life-threatening viral diseases.
Leveraging the Company’s 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 also holds exclusive
commercial rights for Avigan in Russia and China. For more
information, please visit www.aipharmalab.com.
About Global Response Aid (GRA)
Agility (KSE/DFM: AGLTY), one of the world's leading logistics
companies and AiPharma, an innovative pharma research, development
and commercialization company based in Dubai, established Global
Response Aid (GRA) to address the market challenges created by the
COVID-19 pandemic and other threats to public health. GRA delivers
innovative, effective healthcare solutions through a range of
pharmaceutical products and technology platforms. It works closely
with governments, regulatory authorities, hospitals, clinics,
healthcare providers, life sciences companies, NGOs and public
institutions to develop strategies that allow them to tackle public
health challenges.
Forward looking statements
This news release contains “forward-looking statements,” which
reflect the current expectations of the Company’s management for
future growth, results of operations, performance and business
prospects and opportunities, including statements with respect to:
the anticipated closing date of the Transaction, the potential
benefits of the Transaction, AiPharma’s expectations regarding its
ability to access potential cash flows from the consortium sales of
favipiravir, the potential use of favipiravir for the treatment of
COVID-19 (including as an early treatment of COVID-19 to control
disease progression and limit virus spread); and the development,
manufacturing and commercialization plans of the parties with
respect to favipiravir. Wherever possible, words such as “may,”
“would,” “could,” “should,” “will,” “anticipate,” “believe,”
“plan,” “expect,” “intend,” “estimate,” “potential for” and similar
expressions have been used to identify these forward-looking
statements. Forward looking statements contained in this press
release are provided in reliance on certain assumptions, including
with respect to: securing final TSX approval for the Transaction in
a timely manner; AiPharma’s ability to execute on its business
strategy and enforce its contractual entitlements, including with
respect to its ability access potential cash flows from the
consortium sales of favipiravir, the timing of clinical results;
securing all requisite required approvals and funding to complete
all requisite clinical trials; other expectations and assumptions
concerning the ongoing clinical trials (including with respect to
the continuation and/or the timely completion of such trials and
their potential outcomes and benefits); and the ability of the
parties to successfully develop, manufacture and commercialize
favipiravir for the treatment of COVID-19 following successful
completion of the requisite clinical trials and receipt of all
requisite regulatory and other approvals. Although the Company
believes that the expectations reflected in these forward-looking
statements are reasonable, the Company cannot give assurance that
these expectations will prove to have been correct.
Forward-looking statements involve significant known and unknown
risks, uncertainties and assumptions, including, without
limitation, economic, competitive, political and social
uncertainties; known and unknown risks and liabilities relating to
the ongoing COVID-19 pandemic; the risk that the requisite
conditions for final TSX approval for the Transaction cannot be
satisfied on terms satisfactory to the parties or at all; risks
relating to the failure of the parties to realize the anticipated
benefits of this Transaction; risks relating to the volume of sales
of favipiravir worldwide; risks relating to AiPharma’s ability to
execute on its business strategy as currently contemplated and
enforce its contractual entitlements, including with respect to the
ability of AiPharma to access cash flows in connection with the
sales of favipiravir by the consortium partners; risks relating to
the inability of Appili to complete all requisite clinical trials
(including risks relating to the outcome thereof) and to secure all
required funding and approvals relating thereto; risks relating to
the development, manufacturing and commercialization of favipiravir
in Canada, the U.S and other jurisdictions; unforeseen events,
developments, or factors causing any of the aforesaid expectations
and assumptions not to be correct; and the other risk factors
listed in the annual information form of the Company dated June 23,
2021 and the other filings made by the Company with the Canadian
securities’ regulatory authorities (which may be viewed under the
Company’s profile on SEDAR at www.sedar.com). Should one or more of
these risks or uncertainties materialize or should assumptions
underlying the forward-looking statements prove incorrect, actual
results, performance or achievements may vary materially from those
expressed or implied by the forward-looking statements contained in
this news release. These factors should be considered carefully,
and prospective investors should not place undue reliance on the
forward-looking statements. The Company disclaims any intention or
obligation to revise forward-looking statements whether as a result
of new information, future developments or otherwise, except as
required by law.
The Company is not making any express or implied claims that it
has the ability to eliminate, cure or contain the COVID-19 (or
SARS-2 Coronavirus) at this time.
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version on businesswire.com: https://www.businesswire.com/news/home/20210929005499/en/
Media Contacts Danielle Raabe APCO Worldwide T:
1-646-717-9915 Email: DRaabe@apcoworldwide.com Investor
Relations Contacts Stéphane Paquette; Senior Director,
Corporate Development Appili Therapeutics E:
Info@AppiliTherapeutics.com
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