Appili completes strategic reprioritization of programs to focus
on ATI-1701, a biodefense tularemia vaccine candidate, ATI-1801, a
topical antiparasitic product for the treatment of a disfiguring
disease, and ATI-1501, a liquid oral formulation of the antibiotic
metronidazole.
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
its financial and operational results for the second quarter of its
fiscal year 2023, which ended on September 30, 2022.
“We continue to move significantly closer to being able to
provide a safe and effective vaccine for the bacteria Francisella
tularensis, which poses a great threat to public health and is
considered by many governments to be a top-priority biothreat,”
said Don Cilla, Pharm.D., M.B.A., Chief Development Officer of
Appili Therapeutics. “As both biothreats and threats from
infectious diseases continue to pose great challenges to
communities around the world, we’re grateful for the anticipated
commitment of over $US10 million in new funding from the Department
of Defense’s Defense Threat Reduction Agency (DTRA).”
Second quarter and recent operational highlights include:
- Announced a commitment of over US$10 million in funding from
DTRA to advance our biodefense tularemia vaccine candidate ATI-1701
to help combat the bacteria Francisella tularensis, the causative
agent of tularemia and a top-priority biothreat. Appili expects
this program may be eligible for a Priority Review Voucher (“PRV”)
if approved by the United States Food and Drug Administration
(“FDA”).
- Remain on track to seek FDA approval by the end of 2023 for
ATI-1501, our liquid oral formulation of the antibiotic
metronidazole which was designed to help patients burdened by
difficult-to-treat bacterial infections.
- Presented an update, including Phase 3 efficacy data, on our
cutaneous leishmaniasis product, topical paromomycin, ATI-1801 at
the WorldLeish7 Conference in Cartagena, Colombia. ATI-1801 may be
eligible for a valuable Priority Review Voucher if approved by the
FDA.
Financial Results
The Company prepares its financial statements in accordance with
IFRS as issued by the International Accounting Standard Board and
Part I of Chartered Professional Accountants of Canada
Handbook–Accounting. All figures are stated in Canadian dollars
unless otherwise stated.
The net loss and comprehensive loss of $4 million or $0.04 loss
per share for the six months ended September 30, 2022 was $14.5
million lower than the net loss and comprehensive loss of $18.5
million, or $0.30 loss per share, during the six months ended
September 30, 2021. This relates mainly to a decrease in research
and development expenses by $14.9 million, a decrease in general
and administrative expenses by $0.3 million, and a decrease in
business development by $0.5 million. These decreases were offset
by an increase in financing costs by $0.2 million, an increase in
foreign exchange loss by $0.4 million, and a decrease in government
assistance by $0.5 million.
As of September 30, 2022, the Company had cash of $2.4 million,
compared to $6.7 million on March 31, 2022. As of November 9, 2022,
the Company had 121,226,120 issued and outstanding Common Shares,
8,293,040 stock options, and 49,817,879 warrants outstanding.
This press release should be read in conjunction with the
Company’s unaudited interim condensed financial statements for the
second quarter of the 2023 fiscal year and the related management
discussion and analysis (MD&A), copies of which are available
on SEDAR at www.sedar.com.
Appili Portfolio Reprioritization
Appili also announced plans to focus its resources on advancing
its portfolio of infectious disease and biodefense assets,
including ATI-1701, ATI-1801, and ATI-1501. The Company will
discontinue development of its remaining portfolio programs
ATI-2307, a broad-spectrum anti-fungal, and ATI-1503, a
broad-spectrum antibiotic targeting multi-drug resistant
Gram-negative bacteria.
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 Company’s development of its products
and expected funding arrangements. 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. These forward-looking statements reflect the current
expectations of the Company’s management for future growth, results
of operations, performance and business prospects and opportunities
and involve significant known and unknown risks, uncertainties and
assumptions, including, without limitation, risks and assumptions
related to securing the full anticipated funding from DTRA and
those risks, uncertainties and assumptions 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/20221109006155/en/
Media Contact: Danielle Raabe/APCO Worldwide T:
1-646-717-9915 E: DRaabe@apcoworldwide.com
Investor Relations Contact: Jenna McNeil, Communications
Manager Appili Therapeutics E: Info@AppiliTherapeutics.com
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