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Appili Therapeutics Announces FY 2020 Annual and Financial Results

T.APLI

HALIFAX, Nova Scotia

Company well-capitalized, reporting record level of capital support with over $27M CAN in equity financings

Pipeline portfolio strengthened with initiation of unique COVID-19 clinical study focused on preventing disease outbreaks in long-term care settings, acquisition of Phase 2-ready novel anti-fungal program, and commercialization deal for later-stage antibiotic

Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today reported its financial and operational results for the year ended March 31, 2020.

“2020 proved to be a transformative year for Appili,” said Armand Balboni, MD, PhD, Chief Executive Officer of Appili Therapeutics. “Appili emerged fully onto the global biotech stage this year, transitioning to a publicly traded company, adding novel anti-fungal and anti-viral programs to our development portfolio, including our recently announced trial assessing favipiravir, which we believe has the potential to address a critical global unmet need as a preventative agent for COVID-19. We look forward to making continued, purposeful progress over the course of the next year as Company advances its mission to identify and address significant unmet needs in the infectious disease sector, and beyond.”

2020 and recent highlights included:

  • Financial
    • Debuted as a public company on the TSXV exchange and subsequently began trading on the OTCQX trading platform
    • Completed successful equity financings for $10.25M CAD in February 2020 and $16.9M CAD in June 2020
    • Increased its non-dilutive funding, including a $3M USD grant from the U.S. Department of Defense and a $476,000 CAD repayable contribution through Atlantic Canada Opportunities Agency
  • Leadership
    • Named Dr. Armand Balboni as new Chief Executive Officer
    • Expanded the Board of Directors with the addition of veteran biotech executive Dr. Juergen Froehlich
    • Named infectious disease specialist Dr. Yoav Golan as Appili’s Chief Medical Officer
  • Development Programs
    • Received Health Canada approval to initiate Phase 2 trial evaluating FujiFilm Toyama Chemical’s (“FFTC”) favipiravir as a prophylaxis against COVID-19 outbreaks in long-term care homes (May 2020)
    • Entered into a commercialization agreement with Saptalis Pharmaceuticals for Appili’s reformulation of the antibiotic metronidazole (December 2019)
    • Acquired ATI-2307, a novel broad spectrum anti-fungal drug candidate from FFTC to target resistant fungal infections, including Cryptococcus and Candida (November 2019)

“Appili has laid the groundwork for continued progress and impact in our industry,” said Kimberly Stephens, CPA, CA, Chief Financial Officer at Appili. “With continued support from the investor community – including two successful fundraises – and our listing on TSXV and the OTCQX trading platform, we remain well capitalized and well positioned to advance our pipeline through milestones that create value for our shareholders and solutions for patients.”

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.

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 dollar figures are $CAN unless otherwise noted.

The net loss and comprehensive loss of $5,416,496 or $0.16 loss per share for the year ended March 31, 2020 was $1,085,512 higher than the net loss and comprehensive loss of $4,330,984 or $0.14 loss per share during the year ended March 31, 2019. This relates mainly to a $909,918 increase in general and administrative expenses, a $1,483,478 decrease in government assistance and a $80,949 increase in business development, offset by a $1,242,315 decrease in research and development (R&D) expenses and a $53,588 increase in accreted interest.

At March 31, 2020, the Company had cash and short-term investments of $10,540,165 and working capital of $9,732,658, compared to $5,451,578 and $5,405,447, respectively at March 31, 2019. Subsequent to the year ended March 31, 2020, the Company completed a public offering for aggregate gross proceeds of $15,525,000 and a concurrent private placement for aggregate gross proceeds of $1,440,000 on June 10, 2020.

As of June 24, 2020, the Company had 61,604,011 Class A common shares issued and outstanding, 4,021,757 stock options and 7,359,354 and warrants.

This press release should be read in conjunction with the Company’s audited annual consolidated financial statements for the fiscal year ended March 31, 2020 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 Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FFTC.’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

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 24, 2020 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.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

Media Relations:
Andrea Cohen, Sam Brown Inc.
T: 917-209-7163
E: andreacohen@sambrown.com

Investor Relations:
Kimberly Stephens, CFO
Appili Therapeutics
E: Info@AppiliTherapeutics.com



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