Appili Therapeutics Reports Financial and Operational Results for First Quarter of Fiscal Year 2022
13 August 2021 - 1:17PM
Business Wire
Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company”
or “Appili”), a biopharmaceutical company developing anti-infective
drug candidates, today announced its financial and operational
results for the first quarter of its fiscal year 2022, which ended
on June 30, 2021.
“As COVID-19 cases surge in many parts of the world, the need
for safe and effective oral antivirals to contain outbreaks and
stay ahead of variants has never been more clear,” said Armand
Balboni, M.D., Ph.D., Chief Executive Officer of Appili
Therapeutics. “With our PRESECO Phase 3 trial rapidly approaching a
top-line read-out and our clinical stage antifungal on track for
Phase 2 initiation next year, we are well-positioned to deliver
urgently needed medicines for COVID-19 and other life-threatening
infections.”
First quarter and recent operational highlights include:
- Completing an interim analysis of Appili’s ongoing Phase 3
PRESECO (PREventing SEvere COVID-19)
trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential
oral therapy for patients with mild-to-moderate COVID-19 and
receiving a unanimous recommendation from an independent Data
Safety and Monitoring Board (“DSMB”) to continue the study without
modifications
- Expanding the PRESECO Phase 3 trial to Latin America in June
with the addition of several clinical research sites in Mexico and
Brazil
- Entering into an agreement in August with the Lind Partners for
$3.5 million in funding to support PRESECO and the broader Appili
pipeline
- Building out our preclinical data package and working with
leading investigators/advisors to set our Phase 2 protocols for our
lead anti-fungal clinical trial, scheduled to begin early next
year
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 $7.4 million or $0.12
loss per share for the three months ended June 30, 2021, was $4.8
million higher than the net loss and comprehensive loss of $2.6
million or $0.05 loss per share during the three months ended June
30, 2020. This relates mainly to an increase in research and
development expenses by $4.5 million, an increase in business
development of $0.23 million, an increase in general and
administration expenses by $0.09 million, an increase in accreted
interest of $0.02 million, and an increase in income tax expense of
$0.02 million. These increases were offset by an increase of
government assistance of $0.14 million.
As of June 30, 2021, the Company had cash and short-term
investments of $9.33 million, compared to $16.1 million on March
31, 2021. As of August 13, 2021, the Company had 62,832,120 issued
and outstanding Common Shares, 6,793,536 stock options, and
14,326,276 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 2022 fiscal year and the related management
discussion and analysis (MD&A), copies of which are available
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. As part of
a global consortium, Appili is sponsoring late-stage clinical
trials evaluating the antiviral Avigan® / REEQONUS™(favipiravir)
for the worldwide treatment and prevention of COVID-19. The Company
is also advancing a diverse range of anti-infectives, including a
broad-spectrum antifungal, a vaccine candidate to eliminate a
serious biological weapon threat, and two novel antibiotic
programs. Led by a proven management team, Appili is at the
epicenter of the global fight against infection. For more
information, visit www.AppiliTherapeutics.com.
This news release contains “forward-looking statements”,
including with respect to the expected interim data read-out
timetable for the PRESECO study, which reflect the current
expectations of the Company’s management future growth, results of
operations, performance and business prospects and opportunities.
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 involve significant known and unknown risks,
uncertainties and assumptions, including, without limitation, those
listed in the annual information form of the Company dated June 23,
2021 and the other filings made by the Company with the Canadian
securities regulatory authorities (which may be viewed at ). 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.
The Company is not making any express or implied claims that its
product has the ability to eliminate, cure or contain the COVID-19
(or SARS-2 coronavirus) at this time.
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version on businesswire.com: https://www.businesswire.com/news/home/20210813005185/en/
Media Contact: Mackenzie Mittleman/APCO Worldwide T:
(760) 578-5079 Email: Mmittleman@apcoworldwide.com Investor
Relations Contact: Kimberly Stephens, CFO Appili Therapeutics
TSX: APLI E: kstephens@appilitherapeutics.com
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