Executed US$7.3M initial contract with U.S. Air Force Academy
for ATI-1701
Upcoming PDUFA date of September 23, 2023 for ATI-1501
Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company”
or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases and biodefense products, today
announced its financial and operational results for the fiscal year
ended March 31, 2023, and provided an update on the Company’s
strategy for fiscal 2024. All figures are stated in Canadian
dollars unless otherwise stated.
“During this fiscal year, the Defense Threat Reduction Agency
(“DTRA”) in partnership with the U.S. Air Force Academy (“USAFA”)
approved approximately US$14 million in funding over two years for
the advancement of ATI-1701, our vaccine against Tularemia, a
top-priority biothreat. Recently, we executed an agreement with
USAFA for an initial amount of this funding. With this funding and
the additional strength added to our senior leadership team, we
have the resources in place to continue the advancement of this
program and to execute our strategy in advancing our infectious
disease assets forward,” said Don Cilla, Pharm.D., M.B.A.,
President and Chief Executive Officer of Appili Therapeutics. “In
addition, we recently received patent coverage providing
exclusivity through at least 2039 for ATI-1501, our taste-masked
liquid oral suspension formulation of Metronidazole. This is a key
achievement prior to the upcoming FDA PDUFA date of September 23,
2023.”
ATI-1701, Biodefense Vaccine Candidate with Secured Funding
from U.S. Air Force Academy
ATI-1701 is a novel, live-attenuated vaccine for F. tularensis,
which causes tularemia, 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.
In May 2023, Appili executed the initial contract with USAFA
(the “USAFA Cooperative Agreement”) for the previously announced
funding of the ATI-1701 program. This contract represents the first
stage of funding from the previously announced award from the U.S.
Department of Defense (“DOD”). This initial funding, in the amount
of US$7.3 million, will be used to kick-off ATI-1701 early-stage
development and regulatory activities. As the initial activities
progress, Appili will be engaging USAFA for additional tranches of
funding to continue development through IND. Under the terms of its
agreement with USAFA, Appili will be reimbursed for direct costs
and labour associated with budgeted program activities, plus will
recover a portion of its overhead costs. Appili has submitted its
first invoice for such costs and anticipates receiving payment by
the end of June 2023.
If approved by the FDA, Appili may be well placed to receive
stockpiling contracts and if ATI-1701 is approved by the FDA as a
countermeasure for the prevention of tularemia, it is the Company’s
expectation that the program may be eligible for a priority review
voucher (“PRV”).
ATI-1801, demonstrated safe and effective across Phase 3
studies.
ATI-1801 is Appili’s topical paromomycin product with
demonstrated Phase 3 efficacy used to treat cutaneous
leishmaniasis, a disfiguring infection of the skin that affects
hundreds of thousands of people around the world annually. It is an
infection characterized by the formation of lesions and ulcers
often leading to scarring, disfigurement, and stigmatization for
those infected.
Appili selected a Contract Drug Manufacturing Organization to
produce the topical cream which will allow them to meet with the
FDA to discuss the previously generated Phase 3 data, the topical
cream formulation, and agree on the necessary registration package
to support an NDA submission. The development timelines for
ATI-1801 will be driven by the FDAs feedback on the required
bridging study design. Appili expects to pursue non-dilutive
funding and partnership opportunities with NGOs and government
agencies which share the Company’s focus on tropical diseases to
help complete the remaining development work.
ATI-1801 has received an Orphan Drug Designation from the FDA
for the treatment of certain forms of cutaneous leishmaniasis. The
Company is actively evaluating the eligibility of ATI-1801 for a
PRV which, if confirmed, would make ATI-1801 the second PRV
eligible program at Appili, joining ATI-1701.
ATI- 1501, with Patent Coverage through 2039
ATI-1501 is a taste-masked liquid oral suspension formulation of
an antibiotic, metronidazole. Metronidazole is a front-line
antibiotic currently only available in a large tablet dosage form
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.
Appili recently received US$250,000 in milestone payments from
Saptalis in 2023 and expects to receive additional milestone
payments in Q3 2024 and Q4 2024 based on Saptalis’ NDA submission
and commercialization plans.
In May 2023, the United States Patent and Trademark Office
published patent claims for ATI-1501 under the U.S. Application No.
18/072,154 filed on November 30, 2022, and titled "Oral
Formulations of Metronidazole and Methods of Treating an Infection
Using Same". The patent covers the composition and preparation
methods for the drug through 2039.
Annual 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.
The net loss and comprehensive loss of $9.2 million or $0.08
loss per share for the year ended March 31, 2023, was $15.9 million
lower than the net loss and comprehensive loss of $25.1 million or
$0.38 loss per share during the year ended March 31, 2022. This
relates mainly to a $17 million decrease in research and
development (R&D) expenses, $0.2 million decrease in general
and administrative expenses, $0.5 million decrease in business
development expenses and $0.5 million decrease in financing costs,
offset by $0.4 million increase in exchange loss and a $1 million
decrease in government assistance and $1.1 million decrease in
revenue.
On March 31, 2023, the Company had cash of $2.5 million compared
to $6.7 million on March 31, 2022. The Company has included a going
concern note in its financial statements for the fiscal year ended
March 31, 2023. In particular, the Company is dependent in large
part on receiving all DOD funding in a timely manner. Delays in
reimbursement for previously submitted expenses in the near term
may, in the absence of alternative funding arrangements, result in
the Company not being able to maintain a minimum cash balance as
required in its long term debt arrangements with Long Zone
Holdings. For further details, please refer to the Company’s going
concern note in the Company’s management’s discussion and analysis
(the “MD&A”) for the fiscal year ended March 31, 2023.
As of June 22, 2023, the Company had 121,266,120 issued and
outstanding Common Shares, 7,842,000 stock options and 58,247,879
warrants outstanding.
This press release should be read in conjunction with the
Company’s audited annual consolidated financial statements for the
fiscal year ended March 31, 2023, and the related MD&A, copies
of which are available under the Company’s profile 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 the funding
commitment from USAFA, further anticipated milestones and the
timing thereof, the Company’s development plans with respect to
ATI-1501, ATI-1701 and ATI-1801, the timing of any milestone and/or
royalty payments in respect of ATI-1501, potential Priority Review
Voucher eligibility for ATI-1701 and ATI-1801 and the Company’s
expectations with respect to its ability to operate as a going
concern and satisfy its ongoing working capital requirements.
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, those listed in the annual information form of
the Company dated June 22, 2023, 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/20230622885165/en/
Media: Jenna McNeil, Communications Manager Appili
Therapeutics JMcNeil@AppiliTherapeutics.com
Investor Relations: Don Cilla, President and CEO Appili
Therapeutics Info@AppiliTherapeutics.com
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