FDA established a PDUFA action date for ATI-1501 of September
23, 2023
Government funding committed to enable Appili to advance its
biodefense vaccine candidate ATI-1701 towards an IND
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 first
quarter of its fiscal year 2024, which ended on June 30, 2023. All
figures are stated in Canadian dollars unless otherwise stated.
"During this quarter, we executed an agreement with United
States Air Force Academy (“USAFA”) for an initial amount of
US$7.3million in funding from the Defense Threat Reduction Agency
and USAFA for our ATI-1701 vaccine, a crucial defense against
Tularemia, which is a top-priority biothreat. Our partnership with
USAFA and the recent agreement execution will enable us to advance
this program towards an Investigational New Drug (“IND”),” said Don
Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of
Appili Therapeutics. "Additionally, securing US patent coverage
through at least 2039 for ATI-1501, our Metronidazole formulation,
is a significant milestone leading up to the anticipated FDA
Prescription Drug User Fee (“PDUFA”) date on September 23, 2023. We
look forward to receiving milestone payments and royalties from our
partner, Saptalis Pharmaceuticals LLC ("Saptalis”), in the coming
quarters based on their submission and commercialization plans.
These achievements are expected to position us with the required
resources to continue to make progress in advancing our infectious
disease assets."
Operational Highlights
On May 5, 2023, Appili executed an initial cooperative agreement
with USAFA the previously announced funding of the ATI-1701
program. This agreement provides the first stage of funding from
the previously announced US$14 million 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 submit proposals to USAFA for additional
tranches of funding to continue development through IND submission.
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.
On May 24, 2023, the United States Patent and Trademark Office
published patent claims for ATI-1501, Appili’s liquid oral
reformulation of the antibiotic metronidazole, under the U.S.
Application No. 18/072,154, covering the composition and
preparation methods. The patent extends protection for this
formulation through 2039.
Appili completed the technology transfer of ATI-1801, a
treatment for cutaneous leishmaniasis, to the Company’s contract
manufacturing organization. Appili plans to request a meeting with
the U.S. Food and Drug Administration (“FDA”) later this year to
discuss the previously generated Phase 3 data and agree on the
necessary registration package to support a New Drug Application
(“NDA”) submission, which the Company expects will include
available nonclinical, manufacturing, and clinical data generated
to date. To complete the remaining development work, Appili expects
to pursue non-dilutive funding and partnership opportunities with
NGOs and government agencies which share the Company’s focus on
tropical diseases.
Appili is actively evaluating the eligibility of ATI-1801 for a
priority review voucher (“PRV”) which, if confirmed, would make
ATI-1801 the second program at Appili that is potentially PRV
eligible, joining ATI-1701.
Upcoming Milestones
- The FDA established a PDUFA action date for ATI-1501 of
September 23, 2023.
- Appili expects to receive milestone payments for ATI-1501 in
calendar Q3 2023 and Q4 2023 based on Saptalis’ NDA submission and
commercialization plans.
- Appili expects to receive first payments from USAFA for
ATI-1701 in the coming weeks
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. All figures are stated in Canadian dollars
unless otherwise stated.
The net loss and comprehensive loss of $1.5 million or $0.01
loss per share for the three months ended June 30, 2023, was $0.8
million lower than the net loss and comprehensive loss of $2.3
million or $0.03 loss per share during the three months ended June
30, 2022. This relates mainly to an increase in government
assistance of $0.8 million, an increase of $0.3 million in foreign
exchange gains and a decrease in general and administrative
expenses by $0.2 million. These decreases were offset by an
increase in research and development expenses of $0.2 million, an
increase in financing costs of $0.2 million and an increase in
business development of $0.1 million.
As of June 30, 2023, the Company had cash of $0.5 million,
compared to $2.5 million on March 31, 2023. In addition, the
Company is dependent in large part on receiving the US$14 million
DOD funding for the development of ATI-1701 in a timely manner. Due
to delays in reimbursement for previously submitted invoices in the
near term, Appili entered into a definitive agreement with respect
to an unsecured $300,000 bridge loan from Bloom Burton & Co.
Inc. For further details, please refer to the Company’s
management’s discussion and analysis (the “MD&A”) for the first
quarter of the 2024 fiscal year.
As of August 11, 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 unaudited interim condensed financial statements for the
first quarter of the 2024 fiscal year and the related MD&A,
copies of which are available under the Company’s profile on SEDAR+
at www.sedarplus.ca.
About Appili Therapeutics
Appili Therapeutics is a biopharmaceutical company that is
purposefully built, portfolio-driven, and people-focused to fulfill
its mission of solving life-threatening infectious diseases. 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 and
expected timing of invoice payment, further anticipated milestones
and the timing thereof, the Company’s development plans with
respect to ATI-1501, ATI-1701 and ATI-1801, the anticipated PDUFA
timing for ATI-1501, the timing of any milestone and/or royalty
payments in respect of ATI-1501, potential PRV 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.sedarplus.ca). 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/20230811690167/en/
Media: Jenna McNeil, Communications Manager Appili
Therapeutics E: Info@AppiliTherapeutics.com
Investor Relations: Don Cilla, President and CEO Appili
Therapeutics E: Info@AppiliTherapeutics.com
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