Appili Therapeutics Inc. (TSX: APLI, OTCQB: 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 third quarter of its
fiscal year 2023, which ended on December 31, 2022.
“Over the past couple of months, it has been an immense honor to
serve as the company’s CEO and I’m incredibly proud of all that we
have accomplished to enhance and accelerate our diversified
portfolio,” said Don Cilla, Pharm.D., M.B.A., President and Chief
Executive Officer of Appili Therapeutics. “Recently we announced
that the U.S. Department of Defense (“DoD”) has approved ~US$14
million in funding for ATI-1701 to develop this top-priority
biothreat vaccine for tularemia through IND submission. Subject to
contract finalization, this is expected to further position Appili
as a leader in the infectious disease and biodefense market with
two biodefense programs that we believe may be eligible for
Priority Review Vouchers (“PRV”) upon U.S. Food and Drug
Administration (“FDA”) approval.”
“This next quarter will be an important one for Appili on
multiple fronts; with ATI-1501, the FDA has accepted the New Drug
Application (“NDA”) and assigned the NDA submission a PDUFA date of
September 23, 2023. We are working diligently with our partner,
Saptalis, and the FDA on receiving NDA approval and preparing for
market launch. On our biodefense programs, we are in the process of
finalizing definitive contracts with the DoD and preparing to
initiate IND-enabling toxicology studies for ATI-1701, selecting a
Contract Drug Manufacturing Organization (“CDMO”), and engaging
regulatory authorities to align on development plans for ATI-1801,
an urgently needed treatment for those suffering from cutaneous
leishmaniasis.”
Program highlights along with recent developments include:
ATI-1701, Biodefense Vaccine Candidate with ~US$14 Million in
Funding from U.S. Department of Defense
ATI-1701 is a novel, live-attenuated vaccine for F. tularensis,
which causes tularemia, is a Category A pathogen which can be
aerosolized, and is over 1,000 times more infectious than anthrax.
Since it is a highly infectious pathogen capable of causing severe
illness, medical counter measures for F. tularensis are a top
biodefense priority for the United States and governments around
the world. There is currently no approved vaccine for the
prevention of tularemia in the United States or other major global
markets.
Drug manufacturing activities have been initiated and additional
animal work commenced in 2019. Preliminary data from a recently
completed non-human primate study showed a protective effect from
ATI-1701 when animals were challenged with a lethal dose of F.
tularensis 28 days after vaccination, and complete (100% survival)
protection from lethal challenge 90 days after vaccination. At 365
days after vaccination, mice (100% survival) and non-human primates
(29% survival) still showed evidence of protection.
In February 2022, the United States Defense Threat Reduction
Agency selected the Company’s proposal for additional funding to
advance ATI-1701. The U.S. Airforce Academy will serve as the prime
contractor for this program, while the Company is preparing to
serve as a top tier contractor overseeing the comprehensive
development activities for ATI-1701. The expected total funding
amount of approximately US$14 million should fund this scope of
work through IND submission. If approved by the FDA, Appili may be
well placed to receive stockpiling contracts and the program may be
eligible for a valuable PRV.
ATI-1801, Robust data and Potential PRV
ATI-1801 is a novel topical formulation of paromomycin (15% w/w)
under advanced clinical development for the treatment of cutaneous
leishmaniasis, a disfiguring infection of the skin that affects
hundreds of thousands of people around the world annually. The
disease is a serious impediment to socioeconomic development and a
priority for governments and non-governmental organizations around
the world.
Appili licensed the full clinical dossier for ATI-1801 from the
US Army Medical Materiel Development Activity, including the
results of a randomized, vehicle-controlled Phase 3 study which
evaluated the safety and efficacy of ATI-1801 for the treatment of
cutaneous leishmaniasis in Tunisia. The study met its primary
endpoint, with ATI-1801 administered topically once daily for 20
days demonstrating a significant improvement in the rate of
clinical cure.
Appili plans to select a Contract Drug Manufacturing
Organization to produce the topical cream and then meet with the
FDA later this year to discuss the previously generated Phase 3
data, the topical cream formulation, and agree on the necessary
registration package to support an NDA submission.
ATI-1801 has received an orphan drug designation from the FDA
for the treatment of certain forms of cutaneous leishmaniasis. This
program may be eligible for a tropical disease PRV, if approved by
the FDA.
ATI- 1501, Partnered, Moving Towards FDA Approval and
Commercial Launch
ATI-1501 is a taste-masked liquid oral suspension formulation of
an antibiotic, metronidazole. Metronidazole is a front-line
antibiotic for the treatment of anaerobic bacterial and parasitic
infections. Metronidazole has a strong bitter and metallic taste
that is exacerbated by crushing and can reduce patient adherence to
treatment. ATI-1501 is aimed at making it easier for patients with
difficulties swallowing and sensitivity to taste to take
metronidazole, improving compliance and supporting clinical
outcomes.
In December 2019, Appili entered into a development and
commercialization agreement with Saptalis for the manufacturing,
development, and commercialization of ATI-1501. Appili is eligible
to receive multiple milestone and royalty payments on the
development and sale of ATI-1501 in the United States. It is
expected that the FDA review will be complete in Q3 2024, and
commercialization would commence shortly after approval. The
Company expects to receive milestone payments in Q3 2024 and Q4
2024 based on Saptalis’ proposed NDA submission timeline and
commercialization plans.
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 $6.6 million or $0.06
loss per share for the nine months ended December 31, 2022 was
$15.2 million lower than the net loss and comprehensive loss of
$21.8 million or $0.33 loss per share during the nine months ended
December 31, 2021. This relates mainly to a decrease in research
and development costs by $17.3 million, a decrease in business
development by $0.6 million and a decrease in general
administrative expenses by $0.1 million. These decreases were
offset by an increase in financing costs by $0.3 million, an
increase in foreign exchange loss by $0.4 million, a decrease in
government assistance by $0.7 million and a decrease in revenue and
interest income by $1.4 million.
As of December 31, 2022, the Company had cash of $1.4 million,
compared to $6.7 million on March 31, 2022. As of February 13,
2023, the Company had 121,226,120 issued and outstanding Common
Shares, 8,081,772 stock options, and 51,317,879 warrants
outstanding.
This press release should be read in conjunction with the
Company’s unaudited interim condensed financial statements for the
three and nine month period ended December 31, 2022 and the related
management discussion and analysis (MD&A), copies of which are
available on SEDAR at www.sedar.com.
+++
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 partnering with the DoD, the anticipated
funding amount under the partnership with the DoD, PRV eligibility
for ATI-1701 and ATI-1801, the regulatory approval and
commercialization timeline for ATI-1501 and other statements
relating to the Company’s ongoing development plans and timeline
with respect to its various products. 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 in a timely manner (including
receipt by the DoD of any requisite U.S. federal budget approvals),
general development plans with respect to the Company’s products
(including ATI-1701, ATI-1501 and ATI-1801), general access to data
required to support regulatory submissions, expected PRV
eligibility for ATI-1701 and ATI-1801, the nature and scope of the
services to be provided by Appili to the DoD with respect to
advancing the ATI-1701 program and expected commercialization
approval for ATI-1501. 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 the DoD may not
be satisfactory to the Company, the final funding amount for
ATI-1701 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 (including finalization of definitive
agreements with the DoD) are not satisfied in a timely manner,
either ATI-1701 or ATI-1801 may ultimately be determined not to be
PRV eligible, other standard risks associated with governmental
funding, ATI-1501 may not be approved for commercialization on the
expected timeline or at all, and the other risk factors listed in
the annual information form of the Company dated June 29, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230213005679/en/
Investor Relations: Don Cilla, Pharm.D., M.B.A.,
President and CEO Appili Therapeutics E:
Info@AppiliTherapeutics.com
Media: Jenna McNeil, Communications Manager Appili
Therapeutics E: JMcNeil@AppiliTherapeutics.com
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