Dr. Armand Balboni appointed as Chair of the Board and moves to
the U.S. Air Force Academy to take over as Principal Investigator
for the ATI-1701 program; and Dr. Don Cilla promoted to President
and Chief Executive Officer of Appili
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases and biodefense, today announced
that the U.S. Department of Defense (“DOD”), via the Joint Science
and Technology Office of the Defense Threat Reduction Agency
(“DTRA”) in partnership with the U.S. Air Force Academy (“USAFA”),
will provide at least US$14 million in funding over two years to
fund the development of ATI-1701. ATI-1701 is a potential
first-in-class vaccine candidate for the prevention of infection
with aerosolized Francisella tularensis, a top-priority
biothreat.
Appili is expected to partner with USAFA to advance the program.
This revised funding represents a 40% increase over the originally
anticipated DTRA funding for this program, as announced in February
2022. With DTRA’s additional support, work on ATI-1701 is expected
to include nonclinical, manufacturing, and regulatory activities to
prepare for an Investigational New Drug (“IND”) application to the
United States Food and Drug Administration (“FDA”). If approved by
the FDA, ATI-1701 may be eligible for a Priority Review
Voucher.
“We are excited to announce the funding from DTRA in partnership
with USAFA for Appili’s ATI-1701 as it will help in addressing an
urgent risk to public health. This funding is expected to
strengthen Appili’s foundation in infectious disease and
biodefense,” said Dr. Don Cilla, Pharm.D., M.B.A., Appili’s
President and CEO.
About ATI-1701 and DTRA Contract
Appili owns the commercial rights to, and is developing,
ATI-1701 as a vaccine to prevent Francisella tularensis, which has
been classified as a Category A pathogen by the U.S. National
Institutes of Health due to its high rates of infectiousness and
ability to cause lethal pneumonia and systemic infection. As the
transmission of Francisella tularensis in the aerosolized form can
be more infectious than anthrax, it is considered to be a high
bioterrorism threat.
Earlier this year, Appili announced positive one-year results
from its preclinical study evaluating the efficacy of biodefense
vaccine candidate ATI-1701 in a lethal animal model of tularemia. A
one-year survival rate of 29% (n = 2/7) was reported in the
ATI-1701 vaccinated cohort, compared to 0% (n = 0/5) in mock
vaccinated controls. The positive data built on previously reported
efficacy results observed at 28- and 90-day challenge timepoints
where there was 100% survival of ATI-1701 vaccinated animals at the
90-day challenge timepoint. These data position ATI-1701 to
potentially become the first approved vaccine for the prevention of
tularemia. The study was funded by DTRA and conducted by
MRIGlobal.
The DTRA funding will initially be advanced to USAFA, as the
prime contractor under the supervision of Dr. Balboni as principal
investigator. As noted above, Appili is expected to partner with
USAFA, subject to negotiating definitive documentation governing
the terms of such engagement.
The expected total program funding amount is ~US$14 million,
with a portion of the funding subject to future U.S. federal budget
approval. This funding is expected to advance the ATI-1701 program
to an IND submission to the FDA in 2024.
Appili Leadership Transition
As part of today’s announcement, Dr. Armand Balboni has been
appointed as Chair of the Board of Directors of Appili and will
continue providing oversight and guidance to Appili’s overall
portfolio, with a specific focus on the ATI-1701 Program for which
he will serve as Principal Investigator. Dr. Balboni will be
returning to the Department of Defense as a LT. Colonel, faculty
member and Director of the Life Sciences Research Center at
USAFA.
Don Cilla, Pharm.D., M.B.A., who has served as Appili’s Chief
Development Officer for two years, has been promoted to the
position of President and Chief Executive Officer of Appili. Dr.
Cilla has over 35 years of experience in the pharmaceutical
industry, serving in key leadership roles across research and
development in pharmaceutical, biotech and generic drug companies.
In prior roles, Dr. Cilla led and participated in the global
development of more than 40 products, of which six products are
clinically and commercially successful.
“I am delighted to be chosen for this tremendous opportunity to
build on Appili’s foundation and to renew our focus in infectious
disease and biodefense treatments. We’re grateful for this funding,
which will advance ATI-1701 to the next stage of development” said
Dr. Cilla.
In his new role as President and Chief Executive Officer, Dr.
Cilla will also join Appili’s Board of Directors. Additional Board
changes include Ian Mortimer stepping down as Chair of the Board
and Director and Dr. Theresa Matkovits being appointed as Lead
Independent Director.
“I have forged a strong relationship with Don as the Chief
Development Officer at Appili and I’m excited for Don to move into
the Chief Executive Officer role given his tremendous track record
in drug development,” said Dr. Balboni. “I also want to extend my
gratitude to Ian Mortimer for his years of service on our Board and
as Board Chair, where we have benefited greatly from his leadership
and guidance.”
About ATI-1701
Appili is developing ATI-1701 as a vaccine to combat Francisella
tularensis, which is classified by the U.S. National Institutes of
Health (NIH) as a Category A pathogen, an organism that poses the
highest risk to national security and public health. Estimated to
be 1,000-fold more infectious than anthrax, experts consider the
aerosolized form to have a high potential for use in a bioterrorism
attack.
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. The Company
is currently advancing a diverse range of anti-infectives,
including a vaccine candidate to eliminate a serious biological
weapon threat, a topical antiparasitic for the treatment of a
disfiguring disease, and a novel easy to use, liquid oral
formulation targeting parasitic and anaerobic infections. Led by a
proven management team, Appili is at the epicenter of the global
fight against infection. For more information, visit
www.AppiliTherapeutics.com.
Forward-Looking Statements
This news release contains “forward-looking statements”,
including with respect to the anticipated funding amount, the
anticipated timing of such funding, the Company’s ongoing
development plans and timeline with respect to ATI-1701 and the
Company’s expected cash runway. 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 the satisfaction of all conditions precedent to the advancement
of the full anticipated funding (including receipt by DTRA of any
requisite U.S. federal budget approvals, general development plans
with respect to ATI-1701, general access to data required to
support regulatory submissions, expected PRV eligibility for
ATI-1701, and the nature and scope of the services to be provided
by Appili to USAFA with respect to advancing the ATI-1701 program).
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, the risk that the final conditions governing the
funding and the relationship of between Appili and USAFA may not be
satisfactory to the Company , the final funding amount may be
different than that communicated herein (including as a result of
the failure to secure the requisite US government budget
approvals), receipt of funding may be delayed in the event that any
remaining conditions are not satisfied in a timely manner, ATI-1701
may ultimately be determined not to be PRV eligible, other standard
risks associated with governmental grants of this nature and the
other risk factors listed in the annual information form of the
Company dated June 23, 2022 and the other filings made by the
Company with the Canadian securities regulatory authorities (which
may be viewed 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221113005149/en/
Media Contact: Danielle Raabe/APCO Worldwide T:
1-646-717-9915 E: DRaabe@apcoworldwide.com
Investor Relations Contact: Jenna McNeil; Corporate
Affairs and Communications Manager Appili Therapeutics E:
Info@AppiliTherapeutics.com
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