Additional US$6.6 million funding commitment for ATI-1701 brings
the total program funding awarded to approximately US$14
million
These funds along with other potential funding sources, are
anticipated to continue to advance the ATI-1701 program toward an
IND submission to the FDA in 2024
The company also announces a change to it’s 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, today announced
that the company secured a commitment for the second stage of
funding for ATI-1701 from the U.S. Air Force Academy (“USAFA”), who
is working in partnership with the Defense Threat Reduction Agency
(“DTRA”), the funding agency. ATI-1701 is the Company’s potential
first-in-class vaccine candidate for the prevention of infection
with Francisella tularensis, the causative agent of tularemia and a
top-priority biothreat.
With this additional 6.6 million award, Appili’s ATI-1701
program has been awarded the total US$14 million in USAFA funding
commitments announced on May 8, 2023.
“Being awarded this additional funding commitment from USAFA, in
partnership with DTRA further strengthens Appili’s foundation in
biodefense and enables us to scale-up our efforts to develop an
urgently needed vaccine for this serious bioterrorism threat,” said
Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer
of Appili. “This level of funding commitment should further support
nonclinical, manufacturing, and regulatory activities for ATI-1701,
and should enable us to continue to advance this program towards an
Investigational New Drug (“IND”).”
Appili will continue to oversee a comprehensive development
program for ATI-1701, which includes nonclinical studies,
manufacturing, and regulatory activities to support an IND
submission. In May 2023, Appili was awarded the first stage of
funding commitment from USAFA of US$7.3 million. The initial
commitment 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. 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 has obtained
temporary waivers of a minimum cash balance requirement. Further
waivers may be necessary from time to time depending on the timing
of reimbursements for expenses submitted to USAFA.
Corporate Update
It is with great sadness that the Company must announce that one
of its Directors, Rochelle Stenzler, has passed away. The Company
plans on seeking a new independent Director to join its Board in
the coming months.
About ATI-1701
Appili is developing ATI-1701 as a vaccine to combat Francisella
tularensis, which is classified by the U.S. National Institutes of
Health (NIH) as a Category A pathogen, an organism that poses the
highest risk to national security and public health. Estimated to
be 1,000-fold more infectious than anthrax, experts consider the
aerosolized form to have a high potential for use in a bioterrorism
attack.
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,
anticipated funding amount, the anticipated timing of such funding,
the Company’s ongoing development plans and timeline with respect
to ATI-1701. 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). 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 DTRA, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231025902792/en/
Media: Jenna McNeil, Communications Manager Appili
Therapeutics E: JMcNeil@AppiliTherapeutics.com
Investor Relations: Don Cilla, President and CEO Appili
Therapeutics E: Info@AppiliTherapeutics.com
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