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
the results from its annual meeting of shareholders held earlier
today.
Results of Annual Meeting
Based on the proxies received and the vote conducted at the
meeting, all tabled resolutions were approved by the shareholders
of the Company, including the election of the following directors
for the ensuing year: Don Cilla, Brian Bloom, Theresa Matkovits,
Juergen Froehlich, Armand Balboni and Rochelle Stenzler.
Voting results for each director are summarized below:
Name of
Nominee
Percentage of
Votes For
Percentage of
Votes Against
Don Cilla
15,441,269 (86.24%)
2,463,125 (13.76%)
Brian Bloom
15,444,109 (86.26%)
2,460,285 (13.74%)
Theresa Matkovits
17,601,894 (98.31%)
302,500 (1.69%)
Juergen Froehlich
17,602,394 (98.31%)
302,000 (1.69%)
Armand Balboni
15,431,769 (86.19%)
2,472,625 (13.81%)
Rochelle Stenzler
17,599,053 (98.29%)
305,340 (1.71%)
Shareholders also approved the re-appointment of
PricewaterhouseCoopers, LLP, Chartered Accountants, as the
independent auditor of the Company for the ensuing year and
authorized the directors of the Company to fix their
remuneration.
The Company has filed a report of the voting results on all
resolutions voted on the Meeting on the Company’s SEDAR+ profile at
www.sedarplus.ca.
Corporate Update
Since Appili’s last annual meeting, the Company has made
significant progress. Most recently, the Company’s ATI-1501 program
for the treatment of anaerobic bacterial infections, received U.S.
Food and Drug Administration (“FDA”) approval on September 22,
2023. The approval of this product, with the brand name of
LIKMEZTM, entitles Appili to receive royalties and milestone
payments from its partner Saptalis Pharmaceuticals LLC.
Appili’s developmental program ATI-1701 for the prevention of F.
Tularensis, has received an award of approximately US$7.3 million
from the U.S. Air Force Academy (“USAFA”). The initial funding
commitment of US$7.3 million was used to kick-off ATI-1701
early-stage development and regulatory activities, which are
currently ongoing. Under the terms of the agreement with USAFA,
Appili will be reimbursed for the subcontractor and vendor costs
necessary to carry out the technical tasks. These committed funds,
and other tranches of planned funding, are expected to advance the
ATI-1701 program to an IND submission to the FDA. Additionally,
Appili will be reimbursed for direct labour costs associated with
budgeted program activities, including a portion of its overhead
costs. Appili has also entered into an agreement with its lender
whereby, if needed, Appili may obtain temporary waivers of a
minimum cash balance requirement. Such waivers may from time to
time be necessary depending on the timing of reimbursements for
expenses submitted to USAFA.
With respect to Appili’s ATI-1801 program, for the treatment of
cutaneous leishmaniasis, the Company has selected a new CDMO and is
planning to meet with the FDA to align on the requirements to
bridge to the prior Phase 3 efficacy data to support a New Drug
Application.
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 commercialization plans and timeline with
respect to its programs. 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 funding commitment from USAFA
(including receipt by USAFA of any requisite U.S. federal budget
approvals, general development plans with respect to ATI-1701,
general access to data required to support regulatory submissions,
the nature and scope of the services to be provided by Appili to
USAFA with respect to advancing the ATI-1701 program and the
timing, scope and budget of additional contracts with USAFA and the
ability of the Company to receive timely expense reimbursements
from USAFA (including expense reimbursement for costs incurred
prior to USAFA’s initial commitment of funds) and the
commercialization plans for LIKMEZ. . 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 between Appili and USAFA may not be satisfactory to
the Company, the final funding amount may be different than that
communicated herein (including as a result of the failure to secure
the requisite U.S. government budget approvals, the inability of
the Company to access committed funding under the terms and
conditions of the existing contractual arrangements with USAFA in a
timely manner or at all or any changes in funding arrangements
between USAFA and the US Defense Threat Reduction Agency, as the
ultimate funding agency), receipt of funding may be delayed as a
result of any U.S. government shutdown or if any remaining
conditions are not satisfied in a timely manner, other standard
risks associated with government grants and contracting of this
nature and the other risk factors 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.com). In particular, any
delays in the reimbursement by USAFA of previously submitted
expenses in the near term may, in the absence of the Company
securing satisfactory alternative funding arrangements or a waiver,
result in the Company not being able to satisfy its covenants to
maintain a minimum cash balance pursuant to the loan agreement with
Long Zone Holdings Inc. (“LZH”). Absent a waiver, such default may
result in the acceleration of all obligations owing to LZH under
such agreement. Delays in future expense reimbursements by USAFA in
the near term may also materially and adversely impact the
Company’s working capital requirements in the absence of securing
satisfactory alternative funding arrangements. For further details,
please refer to the Company’s going concern note in the Company’s
management’s discussion and analysis for the fiscal year ended
March 31, 2023. 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/20230927413073/en/
Media Contact: Jenna McNeil, Corporate Affairs and
Communications Manager Appili Therapeutics E:
JMcNeil@AppiliTherapeutics.com
Investor Relations Contact: Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics E: Info@AppiliTherapeutics.com
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