Appili Prepares Canadian Long-Term Care Facilities to Enroll Participants in a Clinical Trial Evaluating Favipiravir as an Ou...

Site screening is required in advance of potential outbreaks in Ontario long-term care centers

Only trial in the world investigating use of favipiravir as preventative measure against COVID-19 outbreaks

Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that the Company has initiated site screening of long term care (LTC) facilities in Ontario for its Phase 2 study evaluating favipiravir as a post-exposure outbreak control measure against COVID-19. Residents at screened sites will be eligible for enrollment and randomization into the trial upon confirmation of a COVID-19 outbreak. The trial is expected to ultimately enroll approximately 760 participants at 16 LTC facilities. Appili may increase the number of LTC facilities screened depending on the trajectory of the COVID-19 pandemic.

“As expected, as physical distancing restrictions are eased, COVID-19 cases are increasing in Ontario and across Canada” said Primary Investigator Dr. Allison McGeer, senior clinician scientist at the Lunenfeld-Tanenbaum Research Institute at Sinai Health. “We have made significant progress in screening potential trial sites, which is a necessary precursor to dosing trial participants. When COVID-19 inevitably is introduced into these facilities, our team will be ready to treat participants and gather the necessary data to understand the utility of favipiravir for outbreak control.”

Favipiravir is a broad-spectrum antiviral available in oral tablet form. Appili is conducting this partially blinded, placebo-controlled cluster-randomized trial (RCT) to evaluate the safety and efficacy of favipiravir in controlling outbreaks of COVID-19 in long term care facilities. Residents of long-term care comprise the vast majority of Canadian COVID-19 deaths.

Favipiravir was originally developed and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza outbreak under the name AVIGAN. Following promising clinical studies, Russia and India recently approved favipiravir-based antiviral medications for the emergency treatment of COVID-19.i ii Researchers are conducting additional trials evaluating favipiravir as a treatment for COVID-19 in countries including the United States, Japan, China, and the United Kingdom.

“We believe that we will ultimately need a multi-faceted approach to defeat the COVID-19 global pandemic, and that favipiravir will be an important part of the arsenal that helps defeats the biggest public health threat of our lifetime,” said Armand Balboni, MD, Chief Executive Officer at Appili Therapeutics. “In addition to the growing body of scientific data indicating antiviral activity against this corona virus, favipiravir has the added benefit of being an oral treatment, not an intravenous drug, which is of particular utility in the LTC setting. Furthermore, it may provide an additional avenue of prophylaxis for this highly vulnerable patient population, as vaccines are less likely to work in elderly or immunocompromised patients.”

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 FUJIFILM Toyama Chemical Inc.’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.

Forward looking statements

This news release contains “forward-looking statements,” which reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities, including statements with respect to: the scope and parameters of the proposed clinical trial and the likelihood that the clinical trial will be consummated on the terms and timeline provided herein or at all; and the potential use of favipiravir as a prophylactic agent for the treatment of COVID-19. 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: securing all requisite required approvals and funding for the clinical trial; site availability and patient enrolment; and other expectations and assumptions concerning the proposed clinical trial (including with respect to potential outcomes and benefits). 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, economic, competitive, political and social uncertainties; known and unknown risks and liabilities relating to the ongoing COVID-19 pandemic; risks relating to the inability of Appili to secure any requisite rights to manufacture and commercialize favipiravir in Canada on favourable terms or at all; unforeseen events, developments, or factors causing any of the aforesaid expectations and assumptions not to be correct; and the other risk factors 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.

The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

i RDIF and ChemRar announce first interim results of clinical trials of Favipiravir drug’s effectiveness in coronavirus therapy

ii Glenmark Becomes the First Pharmaceutical Company in India to Receive Regulatory Approval for Oral Antiviral Favipiravir, for the Treatment of Mild to Moderate COVID-19

View source version on businesswire.com: https://www.businesswire.com/news/home/20200730005470/en/

Media Relations Contacts: Canadian Media: Chantal Allan Sam Brown Inc. T: 613-319-4384 (CAN) T: 805-242-3080 (U.S.) E: [e-mail]

US/Trade Media: Andrea Cohen Sam Brown Inc. T: 917-209-7163 E: [e-mail]

Investor Relations Contact: Kimberly Stephens, CFO Appili Therapeutics Inc. TSXV: APLI E: [e-mail]