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 fiscal year ended March 31, 2021, and
provided an update on the Company’s strategy for fiscal 2022. All
figures are stated in Canadian dollars unless otherwise stated.
“As we enter our next fiscal year as a public company, we are
excited about the pace of progress related to several of our
therapies, as well as our planned future business development
strategy. Our goal is to use a scientifically rigorous, and
financially sound approach to identify and develop novel therapies
that meet the greatest patient needs. We believe this will create
enduring value for shareholders,” said Armand Balboni, MD, PhD,
Chief Executive Officer of Appili Therapeutics.
“We are encouraged that an independent Data and Safety
Monitoring Board has recommended continuation without modification
of Appili’s ongoing Phase 3 PRESECO (PREventing SEvere
COVID-19) trial evaluating
Avigan®/Reeqonus™ (favipiravir). We look forward to the completion
of the PRESECO trial and are hopeful that Avigan/Reeqonus will
emerge as one of the first prescription oral medicine for newly
diagnosed patients with COVID-19,” continued Dr. Balboni.
2021 and recent highlights include:
Financial
- Graduated to the main board of the Toronto Stock Exchange (TSX)
and received DTC eligibility in the U.S.
- Completed equity financing of $15,525,000 and concurrent
private placement of $1,440,000.
Leadership
- Appointed veteran healthcare executive Rochelle Stenzler to its
Board of Directors.
- Appointed both Dr. Yoav Golan as the Company’s first Chief
Medical Officer and senior drug development executive Don Cilla as
Chief Development Officer.
Development Programs
- Signed a collaboration, development, and supply agreement to
create a global consortium with Dr. Reddy’s Laboratories Ltd.
(“DRL”) and Global Response Aid (“GRA”) for oral COVID-19 antiviral
candidate favipiravir.
- Received recommendation from an independent Data and Safety
Monitoring Board (“DSMB”) to continue without modification 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.
- Conducted a meeting with Key Opinion Leaders to determine
clinical path for the ATI-2307 program targeting resistant fungal
infections. The Company expects to engage regulatory authorities in
2021 and submit regulatory filings with the U.S. Food and Drug
Administration and other health authorities and start Phase 2
clinical trials in 2022.
- Secured an additional USD$6.3 million from the Defense Threat
and Reduction Agency (“DTRA”) to fund the regulatory, manufacturing
and pre-IND studies for the Company’s ATI-1701 vaccine
program.
Appili continues to work on advancing its other anti-infective
programs through development. The COVID-19 pandemic, and the recent
global rise of black fungal infections, has demonstrated that there
are a substantial number of infectious pathogens that present
serious threats to human health. “We are committed to advancing
novel therapies that address unmet needs in infectious disease, and
our anti-fungal ATI-2307 program is an important part of our
pipeline,” said Dr. Balboni. “We are continuing our cutting-edge
work to advance the program, with the goal of filing a Phase 2
protocol with regulatory agencies by the end of this year.”
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.
The net loss and comprehensive loss of $14.3M million or $0.24
loss per share for the year ended March 31, 2021 was $8.9 million
higher than the net loss and comprehensive loss of $5.4 million or
$0.16 loss per share during the year ended March 31, 2020. This
relates mainly to a $8.1 million increase in research and
development (R&D) expenses, $1.5 million increase in general
and administrative expenses and a $0.06 million increase in
accreted interest, offset by a $0.6 million increase in government
assistance and a $0.3 million decrease in business development.
At March 31, 2021, the Company had cash and short-term
investments of $16.1 million and working capital of $13.6 million,
compared to $10.5 million and $9.7 million, respectively at March
31, 2020.
As of June 23, 2021, the Company had the Company had 62,832,120
issued and outstanding Common Shares, 6,796,869 stock options and
14,625,993 warrants outstanding.
This press release should be read in conjunction with the
Company’s audited annual consolidated financial statements for the
fiscal year ended March 31, 2021 and the related management
discussion and analysis (MD&A), copies of which are available
under the Company’s profile 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® / REEQONUSTM (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 infectious
disease. For more information, visit
www.AppiliTherapeutics.com.
Forward looking statements This news release contains
“forward-looking statements” 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 www.sedar.com).
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
investigational product favipiravir has the ability to eliminate,
cure or contain the COVID-19 (or SARS-2 coronavirus) at this
time.
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Investor Relations Contacts
Kimberly Stephens, CFO Appili Therapeutics E:
Info@AppiliTherapeutics.com
Laura Kiernan, IRC, CPA High Touch Investor Relations T:
914-598-7733 E: AppiliTherapeutics@htir.net
Media Contacts Mackenzie
Mittleman/APCO Worldwide T: (760) 578-5079 Email:
Mmittleman@apcoworldwide.com
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