FDA approves ATI-1501 for Metronidazole Oral Suspension
500mg/5mL and its brand name LIKMEZ™
Appili received an additional funding commitment from the U.S.
Air Force Academy for ATI-1701, bringing the total program funding
awarded to US$14 million
Appili Therapeutics Appoints Seasoned Biopharma Executive Mr.
Prakash Gowd to its Board of Directors
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 second
quarter of its fiscal year 2024, which ended on September 30, 2023.
All figures are stated in Canadian dollars unless otherwise
stated.
"Notably, the Company’s most advanced asset ATI-1501, received
U.S. Food and Drug Administration (“FDA”) approval on September 22,
2023, along with its brand name LIKMEZ. The approval of LIKMEZ,
shortly after securing patent coverage through 2039, is an
important milestone that demonstrates Appili’s ability to identify
promising opportunities, accelerate their development, and unlock
value for the benefit of both patients and shareholders, ” said Don
Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of
Appili Therapeutics, "Importantly, ATI-1701 recently received an
additional funding commitment from USAFA, bringing the total
program funding awarded to US$14 million. At Appili, we are proud
of our strong government partnerships which enable us to advance
this biodefense program towards an Investigational New Drug
(“IND”).”
Operational Highlights
The Company has made significant operational progress during
this quarter. The Company received FDA approval for LIKMEZ
(ATI-1501) for the treatment of anaerobic bacterial infections on
September 22, 2023. Appili expects to receive additional milestone
payments and royalties from its partner, Saptalis Pharmaceuticals
(“Saptalis”) based on this FDA approval and Saptalis’
commercialization. Saptalis is preparing for commercial launch in
late 2023. On October 13, 2023, the Company’s recently issued U.S.
patent related to LIKMEZ with coverage through 2039, U.S.
Application No. 18/072,154 was listed in the FDA publication,
“Approved Drug Products with Therapeutic Equivalence Evaluations”,
commonly known as the “Orange Book”.
Appili’s development program ATI-1701, for the prevention of F.
Tularensis, has received awards totalling US$14 million from the
U.S. Air Force Academy (“USAFA”). Under the terms of the recently
modified agreement with USAFA governing such awards, Appili will be
reimbursed for subcontractor and vendor costs necessary to carry
out the technical tasks. Additionally, Appili will be reimbursed
for direct labour costs associated with budgeted program
activities, including a portion of its overhead costs. During our
second fiscal quarter, Appili progressed early-stage development
activities and regulatory activities. In addition, Appili
successfully completed a knowledge transfer and executed a
technology transfer for the ATI-1701 drug substance manufacturing
process to the Phase 1 Contract Manufacturing Organization
(“CMO”).
With respect to Appili’s ATI-1801 program, for the treatment of
cutaneous leishmaniasis, the Company plans to request a meeting
with the FDA later this year to discuss the previously generated
Phase 3 data and agree on the registration package necessary to
support a New Drug Application (“NDA”) submission, which the
Company expects will include available nonclinical, manufacturing,
and clinical data generated to date. 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 remaining development work.
Upcoming Milestones
- Appili anticipates receiving royalty and milestone payments
from its partner Saptalis, based on LIKMEZ NDA approval and
commercialization.
- Appili plans to hold a pre-IND meeting with the FDA to discuss
ATI-1701’s regulatory, CMC, toxicology, and Phase 1
strategies.
- Appili expects the ATI-1701 CMO to successfully produce
engineering batches.
- Appili plans to request a meeting with the FDA later this year
to discuss the previously generated ATI-1801 Phase 3 data and agree
on the necessary registration package to support an NDA
submission.
Corporate Update
Today the company announced that it has appointed Prakash Gowd,
MBA, BSc. Pharm, C.Dir., to its Board of Directors. Mr. Gowd’s
career covers a broad range of commercial successes involving
corporate development, fundraising, and marketing across multiple
business models and therapeutic areas.
“We are very pleased to welcome Prakash to Appili’s Board. His
background in corporate finance, product development and strategic
planning will be very valuable as we advance our programs through
multiple milestones, from ATI-1701’s IND submission, to the FDA
interactions for our ATI-1801 asset,” said Dr. Armand Balboni,
Chair of the Appili Board. “We are thrilled to have Prakash as a
Board member and look forward to his leadership experience as we
progress our candidates through these next crucial stages.”
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 $1.0 million or $0.01
loss per share for the three months ended September 30, 2023, was
$0.6 million lower than the net loss and comprehensive loss of $1.6
million or $0.02 loss per share during the three months ended
September 30, 2022. This relates mainly to an increase in milestone
revenue of $0.3 million, an increase in government assistance of
$1.0 million, a decrease in foreign exchange losses of $0.2 million
and a decrease in general and administrative expenses of $0.1
million. These decreases were offset by an increase in research and
development expenses of $0.8 million and an increase in financing
costs of $0.2 million.
As of September 30, 2023, the Company had cash of $0.4 million,
compared to $2.5 million on March 31, 2023.
As of November 13, 2023, the Company had 121,266,120 issued and
outstanding Common Shares, 7,842,000 stock options, and 44,856,874
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 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
an FDA approved ready made suspension of metronidazole for the
treatment of antimicrobial infections, a vaccine candidate to
eliminate a serious biological weapon threat, and a topical
antiparasitic for the treatment of a disfiguring disease. 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 and
timelines with respect to ATI-1501, ATI-1701 and ATI-1801, , the
timing of any milestone and/or royalty payments in respect of
ATI-1501, 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/20231113109537/en/
Media Contact: Jenna McNeil, Communications Manager
Appili Therapeutics E: JMcNeil@AppiliTherapeutics.com Investor
Relations Contact: Don Cilla, President and CEO Appili
Therapeutics E: Info@AppiliTherapeutics.com
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