Category: Archives 2020

HYDERABAD, India & MISSISSAUGA, Ontario & HALIFAX, Nova Scotia–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”), Appili Therapeutics (TSX: APLI, OTCQX: APLIF) and Global Response Aid FZCO(GRA) today announced that Dr. Reddy’s Canada has filed an application on behalf of the consortium for REEQONUS™ (favipiravir) Tablets for the acute treatment of mild to moderate COVID-19 adult patients under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. REEQONUS™ is also known as Avigan® (favipiravir) Tablets, developed by FUJIFILM Toyama Chemical Co., Ltd.

“We are pleased to work with our partners at GRA and Appili to be the first in Canada to file an application for oral solid tablets for COVID-19 treatment under Health Canada’s Interim Order,” says Vinod Ramachandran, Ph.D., Vice President and General Manager, Dr. Reddy’s Laboratories Canada Inc. “Dr. Reddy’s is working closely with Health Canada for an expedited review of the drug application, as speed to market is essential in these unprecedented times. If approved, we look forward to launching this important product soon to benefit the lives and health of COVID-19 patients in Canada.

“Reaching patients early in the infection to prevent possible progression into more serious forms of this disease remains a critical unmet need in the COVID-19 treatment landscape,” says Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Our role remains to design rigorous trials to obtain the data that identify COVID-19 patients that may benefit from REEQONUS™. We look forward to working with our partners in providing information to Health Canada with the goal of advancing this important innovation for patients.”

“Our outreach to Canada is a part of our global efforts to play an active role in addressing the COVID-19 situation. The filing is a testimony to our commitment of bringing a potential solution to COVID-19 for the Canadian population,” says Mitch Wilson, Chief Executive Officer of GRA.

In September, the Interim Order Respecting the Importation, Sale and Advertising of Drugs for use in Relation to COVID-19 was signed by the Minister of Health in Canada to create a new authorization pathway that will help expedite the authorization of drugs and vaccines for COVID-19. According to Health Canada, REEQONUS™ (favipiravir) Tablets are the first oral solid dosage form submitted under the Interim Order.

Avigan® is a trademark of FUJIFILM Toyama Chemical Co., Ltd.

About Dr. Reddy’s:Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services, including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to:www.drreddys.com.

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the “Risk Factors” and “Forward-Looking Statements” sections of our Annual Report on Form 20-F for the year ended March 31, 2019. The company assumes no obligation to update any information contained herein.”

 

About FUJIFILM Corporation: FUJIFILM Corporation, Tokyo, Japan, is one of the major operating companies of FUJIFILM Holdings Corporation. The company brings cutting-edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to various fields, including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: holdings.fujifilm.com.

 

About Global Response Aid (GRA): Agility (KSE/DFM: AGLTY), one of the world’s leading logistics companies, and AiPharma, an innovative pharma research, development and commercialization company based in Dubai, established Global Response Aid (GRA) to address the market challenges created by the COVID-19 pandemic and other threats to public health. GRA delivers innovative, effective healthcare solutions through a range of pharmaceutical products and technology platforms. It works closely with governments, regulatory authorities, hospitals, clinics, healthcare providers, life sciences companies, NGOs and public institutions to develop strategies that allow them to tackle public health challenges. For more information: www.globalresponseaid.com, www.agility.com.

About AiPharma: AiPharma is an early-stage biotechnology company with regional offices in Dubai and Tokyo. We take a highly interdisciplinary approach to science, with our services building upon work from leading academic labs in biophysics and algorithmic design that enables the acceleration of life science research and development in the pursuit of improved human health. For more information: www.aipharmalab.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® (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.

 

Appili 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 design, scope and parameters of the proposed REEQONUS™ (favipiravir) clinical trials and the likelihood that such clinical trials will be initiated or consummated on the terms and timeline provided herein or at all; the anticipated timing for the release of study data; the potential use of REEQONUS™ (favipiravir) for the treatment of COVID-19 (including as an early treatment of COVID-19 to control disease progression and limit virus spread); and the development, manufacturing and commercialization plans of the parties with respect to REEQONUS™ (favipiravir). 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 applicable clinical trials; finalizing mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to the applicable clinical trials; site and patient enrolment; other expectations and assumptions concerning the proposed clinical trials (including with respect to timely completion of such trials and their potential outcomes and benefits); and the ability of the parties to successfully develop, manufacture and commercialize favipiravir for the treatment of COVID-19 following successful completion of the requisite clinical trials and receipt of all requisite regulatory and other approvals. 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 initiate or complete all requisite clinical trials (including risks relating to the outcome thereof) and to secure all required funding and approvals relating thereto; risks relating to the development, manufacturing and commercialization of REEQONUS™ (favipiravir) in Canada, the U.S and other jurisdictions; 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 ann

HALIFAX, Nova Scotia, December 2, 2020 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that investigators have dosed the first participant in its Phase 3 trial (referred to as the “PRESECO” clinical trial) evaluating oral Avigan® tablets (favipiravir) for the treatment of COVID-19. Appili has  engaged PRA Health Sciences as a clinical research organization (CRO) to administer the trial at 47 outpatient sites. The randomized, double-blind, placebo-controlled study will enroll approximately 826 participants. This study is the second Appili-sponsored COVID-19 clinical trial that has initiated dosing this quarter. Appili expects to report early data from the PRESECO study in the first half of 2021. Appili is initially focusing the trial in the United States but may expand the program to other areas of the world affected by COVID-19.

“Dosing the first participants in our first Phase 3 trial is a significant milestone as we work to stem the tide of this coronavirus,” said Dr. Yoav Golan, Chief Medical Officer, Appili Therapeutics. “Early intervention with patients before they develop severe COVID-19 and require hospitalization remains a significant unmet need in the COVID-19 treatment landscape. As is the case with influenza, we believe that even with effective vaccines, oral antivirals will play a critical role in treating COVID-19 and preventing its progression. Avigan’s pill format and shelf-life stability make it particularly well-suited for this endeavor and we look forward to gathering the necessary data to determine Avigan’s utility for these patients.”

 

Appili’s COVID-19 Clinical Program

Appili is sponsoring three randomized, double-blind, placebo-controlled clinical studies to determine the safety and effectiveness of Avigan tablets in outpatients in multiple COVID-19 indications:

• The Phase 3 PRESECO (Preventing Severe COVID Disease) study aims to determine the efficacy of Avigan as a treatment for COVID-19 in patients with a positive COVID-19 test and mild-to-moderate symptoms, with the goal of alleviating symptoms and preventing disease progression before the infection requires hospitalizations or other intensive interventions;
• The Phase 3 PEPCO (Post Exposure Prophylaxis for COVID-19) study is evaluating Avigan in preventing the development of COVID-19 when given to asymptomatic individuals who have had direct exposure (within 72 hours) to an infected person; and
• The Phase 2 CONTROL study is evaluating the use of Avigan to control outbreaks of COVID-19 in Canadian long-term care facilities, where the burden of severe disease and death is unusually high.

“We are fully committed to obtaining robust clinical data that demonstrates how Avigan may best fit into the full spectrum of a global pandemic response by addressing significant unmet needs,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Providing early access to antiviral therapy is the cornerstone of our clinical strategy. Working with regulatory agencies and our partners, we have chosen to pursue a multi-pronged clinical trial approach, with triggers for treatment that include either a positive COVID diagnosis or known recent exposure to a COVID-19 case. Our target patient population includes those in the outpatient setting most vulnerable to the devastating effects of advanced COVID-19 infections, including those over 50, with significant co-morbidities, and front-line workers.”

 

About Avigan (Favipiravir)

Avigan is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Following promising clinical studies, Russia and India recently approved favipiravir-based antiviral medications for the emergency treatment of COVID-19.[i] [ii]FFTC recently announced positive Phase 3 data in the use of Avigan in hospitalized COVID-19 patients.

Unlike most other interventions that researchers are evaluating in COVID-19, Avigan has already been thoroughly studied in human trials and has a well-known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Avigan’s oral tablet form is shelf-stable and has an established commercial manufacturing process, which may provide advantages over other COVID-19 interventions, which often require temperature-controlled storage and/or injection or intravenous administration.

Appili has joined a consortium of companies, including Dr. Reddy’s Labs, Global Response Aid, and FFTC, for the worldwide development and distribution of Avigan tablets for the potential treatment and prevention of COVID-19 (excluding Japan, China, and Russia.) This consortium is designed to ensure that Avigan is thoroughly evaluated in rigorous clinical studies and, if it receives the proper regulatory approvals, has the infrastructure in place to support worldwide distribution.

 

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® (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.

 

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 design, scope and parameters of the proposed Avigan® (favipiravir) clinical trials and the likelihood that such clinical trials will be initiated or consummated on the terms and timeline provided herein or at all; the anticipated timing for the release of study data; the potential use of Avigan® (favipiravir) for the treatment of COVID-19 (including as an early treatment of COVID-19 to control disease progression and limit virus spread); and the development, manufacturing and commercialization plans of the parties with respect to Avigan® (favipiravir). 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 applicable clinical trials; finalizing mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to the applicable clinical trials; site and patient enrolment; other expectations and assumptions concerning the proposed clinical trials (including with respect to timely completion of such trials and their potential outcomes and benefits); and the ability of the parties to successfully develop, manufacture and commercialize favipiravir for the treatment of COVID-19 following successful completion of the requisite clinical trials and receipt of all requisite regulatory and other approvals. 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 initiate or complete all requisite clinical trials (including risks relating to the outcome thereof) and to secure all required funding and approvals relating thereto; risks relating to the development, manufacturing and commercialization of Avigan® (favipiravir) in Canada, the U.S and other jurisdictions; 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.

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.

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

 

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

 

Investor Relations Contact
Kimberly Stephens, CFO
Appili Therapeutics Inc.
TSX: APLI
E: [email protected]

________________________________

[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

HALIFAX, Nova Scotia, November 24, 2020 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced initiation of its Phase 3 Post Exposure Prophylaxis for COVID-19 (PEPCO) study to evaluate Avigan® tablets (favipiravir) in the prevention of COVID-19. Health Canada has provided a ‘No Objection Letter (NOL)’ for Appili’s proposed study; the U.S. FDA accepted a submission of a protocol amendment to conduct the trial in the United States.

“Addressing infections and spread early in the community setting remains a particular unmet need for COVID-19, and that is the cornerstone of our clinical strategy,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Since Avigan comes in a pill form, it allows for easier administration than other approaches, which usually require injections or intravenous administration, and also enables patients to receive it early after exposure.”

The primary objective of the PEPCO study is to determine if the use of Avigan is safe and effective in preventing COVID 19 among vulnerable individuals who have had recent direct exposure to a confirmed COVID-19-infected person. Appili has contracted with CATO Research LLC, a third-party clinical research organization, to administer the trial in Canada and the United States. Appili expects to initiate enrollment and dosing before the end of 2021.

This is the second Phase 3 study Appili has announced to evaluate the utility of Avigan tablets against COVID-19 in the community setting. The other study also known as the PRESECO study, is evaluating Avigan for the treatment of adults with mild-to-moderate symptoms of COVID-19. PRESECO’s objective is to determine if Avigan is safe and effective in shortening the time to clinical recovery, preventing progression to severe disease, and diminishing the period of infectiousness. In addition to the PEPCO and PRESECO studies, Appili is sponsoring a Phase 2 CONTROL study evaluating the use of Avigan to control outbreaks of COVID-19 in Canadian long-term care facilities, where the burden of severe disease and death is unusually high.

“Our clinical strategy focuses on determining when, and who, may benefit most from using Avigan to treat and prevent outbreaks of COVID-19. The PEPCO study aims at providing early intervention to those most vulnerable to severe infections, with the aim of controlling outbreaks in homes and outpatient facilities,” said Dr. Yoav Golan, Chief Medical Officer, Appili Therapeutics. “We look forward to continuing to work with our partners to advance this important study.”

 

About the PEPCO Study

PEPCO is a double-blinded, placebo-controlled, randomized, multinational, Phase 3 clinical trial that will enroll approximately 1,156 participants through 47 medical centers (“sites”). Site investigators will oversee participant enrollment, intervention, and follow-up during the course of the study. Participants will be outpatients residing in assisted living facilities or their own private residences.

Researchers will be evaluating the safety and efficacy of Avigan in preventing the development of COVID-19 when given to asymptomatic individuals who had direct exposure (within 72 hours) to an infected person. Inclusion criteria focuses on vulnerable individuals who are at high risk of developing severe complications of COVID-19, including:

• individuals 60 years of age or older regardless of having underlying comorbidities, or
• individuals who are 18 years of age or older who have at least one significant underlying condition.

The PEPCO (preventative) and PRESECO (treatment) trials are designed to give researchers the option to accelerate enrollment by coordinating with infected individuals and those they may have exposed, wherein those who test positive for COVID-19 are enrolled into the PRESECO trial, and consenting associates with whom they’ve been in contact may be enrolled in the PEPCO study. The PEPCO and PRESECO studies will be part of the dataset for the recently announced consortium to develop and distribute Avigan® tablets globally in COVID-19 indications. As part of that agreement, Appili is focused initially on clinical development in the United States and Canada. Appili may expand these trials into other countries severely affected by COVID, including those in Central and South America and the European Union.

 

About Avigan® (Favipiravir)

Avigan® is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Following promising clinical studies, Russia and India recently approved favipiravir-based antiviral medications for the emergency treatment of COVID-19.[i] [ii]FFTC recently announced positive Phase 3 data in the use of Avigan in hospitalized COVID-19 patients.

Unlike most other interventions that researchers are evaluating in COVID-19, Avigan has already been thoroughly studied in human trials and has a known safety profile, with over 3,000 subjects receiving at least one dose of the drug. There is also an established manufacturing process in place that can be used to ramp up supply, should the drug receive regulatory approvals in additional indications. Avigan’s oral tablet form is shelf-stable and may provide advantages in the community setting over other COVID-19 interventions, which often require temperature-controlled storage and/or injection or intravenous administration.

Appili has joined a consortium of companies, including Dr. Reddy’s Labs, Global Response Aid, and FFTC, for the worldwide development and distribution of Avigan tablets for the potential treatment and prevention of COVID-19 (excluding Japan, China, and Russia.) The purpose of this consortium is to ensure that Avigan is thoroughly evaluated in rigorous clinical studies and, if it receives the proper regulatory approvals, has the infrastructure in place to support worldwide distribution.

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused in fulfilling 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 (favipiravir) for the worldwide treatment and prevention of COVID-19. In addition, Appili is 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.

 

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 design, scope, parameters and timeline of the proposed Avigan® (favipiravir) clinical trials and the likelihood that such clinical trials will be initiated or consummated on the terms and timeline provided herein or at all; the potential use of Avigan® (favipiravir) for the treatment of COVID-19 (including as an early treatment of COVID-19 to control disease progression and limit virus spread); and the development, manufacturing and commercialization plans with respect to Avigan® (favipiravir). 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 applicable clinical trials; finalizing mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to the applicable clinical trials; site and patient enrolment; other expectations and assumptions concerning the proposed clinical trials (including with respect to potential outcomes and benefits); and the ability of the parties to successfully develop, manufacture and commercialize favipiravir for the treatment of COVID-19 following successful completion of the requisite clinical trials and receipt of all requisite regulatory and other approvals. 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 initiate or complete all requisite clinical trials (including risks relating to the outcome thereof) and to secure all required funding and approvals relating thereto; risks relating to the development, manufacturing and commercialization of Avigan® (favipiravir) in Canada, the U.S and other jurisdictions; 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.

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.

###

Media Contacts

 

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

 

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

 

Investor Relations Contact
Kimberly Stephens, CFO
Appili Therapeutics Inc.
TSX: APLI
E: [email protected]

______________________________________________________

[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

HALIFAX, Nova Scotia, November 13, 2020 – 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 second quarter of its fiscal year 2021, which ended September 30, 2020.

​Second quarter and recent operational highlights include:

• Entering into a global partnership agreement with Dr. Reddy’s Laboratories Ltd., Global Response Aid, and FUJIFILM Toyama Chemical Co. for the worldwide development and distribution of Avigan® tablets (favipiravir) for the potential prevention and treatment of COVID-19 (excluding Japan, China, and Russia)
• Filing a protocol with the U.S. Food and Drug Administration (FDA) for the Company’s Phase 3 trial evaluating Avigan® as a potential treatment for COVID-19 in the U.S.
• Enrolling and dosing the first cluster of participants in our CONTROL Phase 2 trial evaluating Avigan® for outbreak control against COVID-19 in Canadian long-term care facilities
• Appointing senior drug development executive Don Cilla to serve as Appili’s Chief Development Officer
• Graduating to the main board of the Toronto Stock Exchange (TSX) and earning DTC eligibility in the U.S.

 

“As the world enters the next wave of COVID-19 infections, our antiviral programs are steadily advancing. We were very pleased to sign a global deal with world-class partners to develop Avigan® for the potential treatment and prevention of COVID-19, to dose the first participants in our CONTROL trial, and to file a protocol with the U.S. FDA for Appili’s first Phase 3 study, which is investigating Avigan® for the treatment of early-to-moderate COVID-19 infections,” said Kimberly Stephens, Chief Financial Officer of Appili Therapeutics. “We’ve also staffed key positions, including the appointment of Don Cilla as Chief Development Officer, and graduated to the TSX exchange within 18 months of originally listing on the TSX Venture Exchange. We continue to work diligently to progress our clinical programs, bolster our financial position, expand our team, and drive value for our pipeline portfolio.”

 

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 $5.1 million or $0.09 loss per share for the six months ended September 30, 2020 was $2.1 million higher than the net loss and comprehensive loss of $2.9 million or $0.09 loss per share during the six months ended September 30, 2019. This relates mainly to a $1.6 million increase in research and development (R&D) expenses, a $0.8 million increase in general and administrative expenses, offset by a $0.3 million decrease in business development expenses.

As of September 30, 2020, the Company had cash and short-term investments of $22.9 million, compared to $10.5 million on March 31, 2020. As of November 12, 2020, the Company 62,284,216 issued and outstanding Common Shares, 4,548,949 stock options and 15,011,610 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for September 30, 2020 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 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. Appili’s diverse pipeline aims to address some of the most urgent threats in global public health, including Avigan® tablets, which Appili is evaluating, as part of a consortium with Dr. Reddys Labs, Global Response Aid, and FujiFilm Toyama Chemical for the global treatment and prevention of COVID-19. Appili is also evaluating 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, 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.

###

Media Contact:
Andrea Cohen
Sam Brown Inc.
T: 917-209-7163
E: [email protected]

 

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
TSX: APLI
E: [email protected]

HALIFAX, Nova Scotia, October 30, 2020 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that it has signed a collaboration, development and supply agreement with Dr. Reddy’s Laboratories Ltd. (BSE:500124, NSE:DRREDDY, NYSE:RDY, “Dr. Reddy’s”) and Global Response Aid (“GRA”). This agreement follows on and is harmonized with the previously announced global licensing transaction (excluding Japan, Russia, and China) between DRL, GRA and FUJIFILM Toyama Chemical Co., Ltd. (“FFTC”), the originator of Avigan® tablets. The agreements work together to coordinate and accelerate the worldwide development, commercialization, and distribution of Avigan® tablets (favipiravir) for the potential treatment and prevention of COVID-19.

In joining the global consortium to advance Avigan®, Appili will assume key responsibilities for the design and implementation of the consortium’s global clinical programs and related work, including, but not limited to, the design and implementation of multiple pivotal Phase 3 trials to enable regulatory submission, review, and, if supported by data, approvals for the use of Avigan® tablets in the treatment or prevention of COVID-19 in the US, Canada and internationally. The clinical development strategy will focus on evaluating Avigan® tablets for early treatment and post-exposure prophylaxis in the community setting.

Dr. Reddy’s and GRA  will continue to be responsible for the research and development, manufacturing, commercialization, and distribution of Avigan®. FFTC is the innovator that originally developed Avigan® for use in pandemic influenza and is supplying its knowledge base, including clinical data and intellectual property, in support of the consortium’s operations. In collaboration with its partners, Appili will design and oversee Phase 3 clinical trials to support regulatory submissions worldwide. Appili will be responsible for the US and Canadian clinical trials conducted on behalf of the consortium and will receive a profit share on all US and Canadian sales for a specified term. Appili is also eligible to receive royalties on sales in Europe and Latin America for a specified term.

“To address the ongoing threat of COVID-19 we must not only identify effective agents through rigorous clinical evaluation, we must also ensure they are widely available, which is a particular challenge in COVID-19, where billions of people from every corner of the globe are at risk from this threat,” said Dr. Armand Balboni, Chief Executive Officer at Appili Therapeutics. “This consortium is designed to do just that, with world-class expertise not only in drug development but also in manufacturing and commercialization to support access. We are thrilled to join this group of industry leaders in their global effort, contributing our drug development expertise and extensive experience with Avigan® to accelerate its development on a globally coordinated basis. We look forward to the timely outcomes of our ongoing and soon-to-be initiated late-stage clinical trials to evaluate Avigan® as the first orally available anti-viral treatment option for COVID-19.”

Appili has previously announced a Phase 2 trial evaluating the use of favipiravir to control outbreaks of COVID-19 in long-term care facilities and a Phase 3 trial in the United States evaluating the use of Avigan® for the early treatment of patients with mild-to-moderate COVID-19 symptoms. Working with the consortium, Appili expects to expand its favipiravir clinical programs internationally.

 

About Avigan® (favipiravir)

Avigan® (favipiravir) is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza 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] FFTC recently announced positive Phase 3 data in the use of AVIGAN in hospitalized COVID-19 patients. In a previously announced agreement, Dr. Reddy’s and GRA received a license from FFTC for the manufacturing, development, and commercial rights to favipiravir outside of Japan, China, and Russia.

Additional clinical trials for favipiravir in COVID-19 are ongoing in the United States, China, India, and the United Kingdom. Unlike most other interventions that researchers are evaluating in the COVID-19 indication, favipiravir has already been thoroughly studied in human trials outside of North America and has a known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Favipiravir’s oral tablet form may also provide advantages in the community setting over other COVID-19 interventions, which often require injection or intravenous administration.

 

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 Avigan® for the potential treatment and prevention of COVID-19. 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.

 

About Dr. Reddy’s

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr. Reddy’s major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Its major markets include the USA, India, Russia & CIS countries, and Europe.

 

About Global Response Aid
Global Response Aid, based in Dubai, provides solutions to public health challenges. GRA was established by global logistics leader Agility to procure and develop certified diagnostic, testing and protective products and services used in the detection, treatment and prevention of COVID-19 and other public health threats. GRA works with trusted manufacturers to source safe, effective products for governments, health authorities and public institutions; frontline medical facilities; NGOs; and companies looking to safeguard workers and workplaces. GRA-sourced products include ventilators, thermal detection equipment, thermometers, masks, goggles, protective suits, nitrile gloves, cleaning and sanitation supplies, and point-of-care test kits. GRA’s mobile phone app helps stop the spread of viruses through the use of community-driven contact tracing and alerts. GRA also deploys Mobile Diagnostic Testing Vehicles and trained teams that perform COVID-19 testing at schools and workplaces.

 

About FUJIFILM Toyama Chemical Co.

FFTC, Tokyo, Japan is one of the major operating companies of FUJIFILM Holdings Corporation. The company brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship.

 

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 design, scope and parameters of the proposed Avigan® (favipiravir) clinical trials and the likelihood that such clinical trials will be initiated or consummated on the terms and timeline provided herein or at all; the potential use of Avigan® (favipiravir) for the treatment of COVID-19 (including as an early treatment of COVID-19 to control disease progression and limit virus spread); and the development, manufacturing and commercialization plans of the parties with respect to Avigan® (favipiravir). 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 applicable clinical trials; finalizing mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to the applicable clinical trials; site and patient enrolment; other expectations and assumptions concerning the proposed clinical trials (including with respect to potential outcomes and benefits); and the ability of the parties to successfully develop, manufacture and commercialize favipiravir for the treatment of COVID-19 following successful completion of the requisite clinical trials and receipt of all requisite regulatory and other approvals. 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 initiate or complete all requisite clinical trials (including risks relating to the outcome thereof) and to secure all required funding and approvals relating thereto; risks relating to the development, manufacturing and commercialization of Avigan® (favipiravir) in Canada, the U.S and other jurisdictions; 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.

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.

###

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

 

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

 

Investor Relations Contact
Kimberly Stephens, CFO
Appili Therapeutics Inc.
TSX: APLI
E: [email protected]

________________________________

[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

HALIFAX, Nova Scotia, October 29, 2020 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company developing anti-infective drug candidates, today announced that it has recruited Don Cilla, PharmD, MBA, to serve as the Company’s new Chief Development Officer (CDO), effective November 1, 2020. In this role, Dr. Cilla will oversee the strategy and execution of the preclinical and clinical programs for Appili’s anti-infective pipeline. He will be responsible for advancing programs through clinical development, regulatory submission, and commercialization milestones. He brings to this role more than 30 years of experience in the drug development industry spanning large, midsize, and start-up companies, with extensive global clinical development and regulatory expertise.

“Our clinical programs have reached inflection points crucial to asset development and value creation, and Don’s vast clinical and regulatory experience is a strong fit with the needs of our novel pipeline, each of which has its own unique pathway and value drivers,”  said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “His well-established track record developing a broad range of drug products in early and later phase development will be a tremendous asset to the Appili team. We welcome his insights and expertise as we work to drive our programs forward in order to address significant and severe unmet needs for patients facing life-threatening infections.”

Dr. Cilla’s career includes positions of increasing responsibility in drug product team leadership, program management, clinical pharmacology, clinical development, and administration in large pharmaceutical, biotechnology, and generic drug companies. He has held a broad range of development positions in a variety of companies, including Shire Pharmaceuticals (Takeda), MedImmune (AstraZeneca), and Otsuka America Pharmaceuticals. He also has served in multiple consulting roles, outsourcing his expertise to build and lead teams for biotechnology companies in need of deep drug development and functional area capabilities.

Dr. Cilla’s extensive experience includes eight marketing authorization applications for new products or line extensions, serving as a key team member for multiple U.S. Food and Drug Administration (FDA) advisory committee meetings, and contributing to 16 Investigational New Drug (IND) applications. He has been involved in more than 40 drug development programs across a wide range of therapeutic areas, including anti-infectives, of which 20 products were ultimately approved for commercialization. Dr. Cilla earned his Doctor of Pharmacy degree from the University of Michigan and an MBA from the University of Phoenix.

“There is a clear and urgent need for highly effective and novel infectious disease products to address the unmet medical needs resulting from more resistant and virulent infectious agents that society faces today. Appili has a unique approach to building out its pipeline into an exciting portfolio of programs. This includes a timely and highly focused COVID-19 program, which certainly has global implications, as well as its other assets – including the novel anti-fungal, next-generation antibiotic program, and a biodefense vaccine,” said Don Cilla, PharmD, MBA, Chief Development Officer of Appili Therapeutics. “The current pipeline is comprised of broad and exciting programs that truly reflect patient-focused needs, which will give Appili the opportunity to collaborate with key industry players in bringing these products to market. This approach is a strong fit with my experience in the biopharma industry, and I am thrilled to be a part of this team at such an exciting time for the Company.”

 

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.

 

Forward-Looking Statements

This news release contains “forward-looking statements”, including with respect to the effective date of the TSX listing and the TSXV delisting, 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.

###

Media Contact:
Andrea Cohen
Sam Brown Inc.
T: 917-209-7163
E: [email protected]

 

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
TSX: APLI
E: [email protected]

HALIFAX, Nova Scotia, October 27, 2020– Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that Appili’s CEO Dr. Armand Balboni will be presenting at the first-ever Life Science Investor Day Virtual Conference hosted by TSX. The event will be held online on October 29, 2020.

Presentation details are as follows:

• Presenter: Appili’s CEO Dr. Armand Balboni
• Date: Thursday, October 29, 2020
• 11:00 a.m. – 12:30 p.m. ET
• Panel Topic: In the Global Fight Against Infection
• Those interested in the presentation can click this hyperlink to register and access the webcast.

Dr. Balboni will be covering briefly in his presentation details about the drug development initiatives that Appili Therapeutics Inc. is working on, including the clinical program to evaluate favipiravir for the treatment and prevention of COVID-19.

 

About the Conference

The Toronto Stock Exchange is hosting its first-ever Virtual TSX Life Sciences Investor Day conference. The conference consists of six companies that are at various stages of development, from early stage to near commercialization. The participants represent the next wave of innovation in the life science sector and will be showcasing the innovation and growth opportunities in Canada’s Life Sciences sector.

 

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.

###

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
TSX: APLI
E: [email protected]

HALIFAX, Nova Scotia, October 27, 2020 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the Company or Appili), a biopharmaceutical company developing anti-infective drug candidates, today announced updates for the continued development of its ATI-1701 biodefense vaccine program. Appili has entered into an agreement with Ology Biosciences, a biologics contract development and manufacturing organization (CDMO), under which Ology will manufacture ATI-1701, a novel live attenuated tularemia vaccine candidate. The U.S. Department of Defense (DOD), through the Joint Science and Technology Office of the Defense Threat Reduction Agency (DTRA), awarded Ology Bioservices $6.3MM USD for ATI-1701 manufacturing and development work under contract # MCDC18-04-13-006. DTRA-funded manufacturing work will be used to provide vaccine supply for future development of Appili’s ATI-1701 program.

“Tularemia is a potentially deadly biological weapon for which there is no approved vaccine. ATI-1701 has the potential to address this critical biodefense gap and we are eager to start the next stage of its development,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “We are grateful for the work of our partners Ology Bioservices an MRI-Global, along with the continued support from DTRA, to address this urgent need.”

Appili is developing ATI-1701 as a vaccine to combat F. tularensis, which the U.S. National Institutes of Health (NIH) defines as a Category A pathogen (an organism that poses the highest risk to national security and public health). As it is 1,000 times more infectious than anthrax, experts consider the aerosolized form to have a high potential use in a bioterrorist attack.[i]  Several countries may already have operational weapons programs leveraging this pathogen, making the need for a vaccine to counter this biological weapons threat exceedingly important.[ii]Appili is developing ATI-1701 under the ‘Animal Rule’ regulatory pathway.

 

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.

Efforts sponsored by the U.S. Government under Other Transaction Number W15QKN-16-9-1002 between the MCDC, and the Government. The U.S. Government is authorized to reproduce and distribute reprints for governmental purposes notwithstanding any copyright notation thereon.

###

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
TSX: APLI
E: [email protected]

______________________________________________________

[i] PHAC PSDS (2011) Anthrax; PHAC PSDS (2011) Tularemia

[ii] Oyston P (2004) Nat Rev Microbiol 2: 967-979

HALIFAX, Nova Scotia, October 20, 2020 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that investigators enrolled and dosed the first cluster of participants in Appili’s CONTROL COVID-19 clinical trial. Appili is sponsoring the Phase 2 cluster-randomized placebo-controlled trial (cluster-RCT) evaluating the effectiveness of favipiravir as a preventative measure against COVID-19 outbreaks in long-term care (LTC) facilities. This Phase 2 trial is an integral part of Appili’s broader clinical program aimed at evaluating early administration of favipiravir to limit the spread and severity of COVID-19 in high-risk patients, including the elderly.

Under the trial protocol, once an outbreak is confirmed via a PCR (nasal swab) test in an LTC facility unit, all consenting residents in that unit (cluster) will receive either favipiravir or a placebo. Dr. Allison McGeer, senior clinician scientist at Sinai Health’s Lunenfeld-Tanenbaum Research Institute (LTRI) in Toronto, is the study’s primary investigator. Researchers plan to conduct the trial at 16 LTC centers throughout the course of the study. The study population will include elderly subjects with co-morbidities and front-line healthcare workers with recent COVID-19 exposure or confirmed infection. Appili expects to report topline data from the study in 2021. The primary outcome will be control of the outbreak, defined as no new microbiologically confirmed cases of COVID-19 for at least 24 consecutive days.

“Providing early access for vulnerable patients to antiviral therapy, particularly in a community setting, is a cornerstone of Appili’s COVID-19 clinical strategy. We believe favipiravir’s mechanism of action and oral tablet formulation will best serve patients in these conditions,” said Yoav Golan, MD, Chief Medical Officer at Appili Therapeutics. “Dosing the first cluster of participants in our COVID-19 trial is an important milestone for Appili’s program. Our clinical strategy has a strong potential to show a benefit in this population and truly differentiates Appili’s program from other approaches.”

Favipiravir is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza 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] FFTC recently announced positive Phase 3 data in the use of AVIGAN in hospitalized COVID-19 patients[iii]. Researchers are conducting additional trials evaluating favipiravir as a treatment for COVID-19 in several countries, including the United States, China, India, and the United Kingdom. Unlike most other interventions that researchers are evaluating in the COVID-19 indication, favipiravir has already been thoroughly studied in human trials and has a known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Favipiravir’s oral tablet form may also provide advantages in the community setting over other approaches to addressing COVID-19, which often require injection or intravenous administration.

“Appili was built to solve infectious disease problems, and we believe that favipiravir has the potential to be an important part of the arsenal that ultimately addresses this coronavirus pandemic,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics.“Beginning the rigorous evaluation of favipiravir in patients for COVID-19 indications is an important step for the program, and we are proud to work with our partners, including those at Sinai Health, to continue advancing our COVID-19 clinical program.”

 

Update on APLI Shares in Escrow

As previously announced, on September 16, 2020, the Class A common shares of the Company (the “Common Shares”) ceased trading on the facilities of the TSX Venture Exchange and commenced trading on the Toronto Stock Exchange (the “Graduation.”) As a result of the Graduation and pursuant to the terms of the escrow release agreement between the Company, Computershare Investor Services Inc., and certain security holders of the Company dated June 12, 2019, the release from escrow of certain Common Shares and options to purchase Common Shares (the “Options”) will be accelerated. As such an aggregate of 5,317,834 Common Shares and 835,688 Options currently held in escrow will be released on or about October 30, 2020; and the final 3,798,451 Common Shares and 328,715 Options will be released from escrow on or about December 29, 2020. The number of outstanding Common Shares will not change as a result of the escrow release.

 

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; the timeline for reporting topline data; and the potential use of favipiravir as a prophylactic or early treatment 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 approvals and funding for the clinical trial; finalizing a mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to this clinical trial; site 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 that may prevent the Company from completing the proposed clinical trial on the terms and timeline provided herein or all or that would cause 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.

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.

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Media Relations Contacts:

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

 

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

 

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics Inc.
TSXV: APLI
E: [email protected]

_______________________________________________________

[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

[iii] Anti-influenza drug Avigan® Tablet Meets Primary Endpoint in Phase III Clinical Trial in Japan for COVID-19 patients

HALIFAX, Nova Scotia, September 14, 2020 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the Company or Appili), a biopharmaceutical company developing anti-infective drug candidates, today announced that its common shares will commence trading on the Toronto Stock Exchange (TSX) as of the opening of trading on Wednesday, September 16, 2020 under the Company’s current trading symbol, “APLI.”

“Graduating to the premier exchange for Canadian equities is a validation of our efforts to expand awareness of Appili in the capital markets and the value of our pipeline portfolio,” said  Kimberly Stephens, Chief Financial Officer of Appili Therapeutics. “This milestone enables access to another echelon of North American investors, and we look forward to continuing to drive value to our shareholders in our mission to develop therapies to help patients address serious unmet needs in infectious disease.”

Appili’s common shares are expected to trade on the TSX under the existing CUSIP #03783R107 and ISIN #CA03783R1073. In connection with the Company’s graduation to the TSX, the common shares will be delisted from the TSX Venture Exchange (TSXV) immediately following the close of trading on September 15, 2020.

 

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”, including with respect to the effective date of the TSX listing and the TSXV delisting, 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.

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Media Contact:
Andrea Cohen
Sam Brown Inc.
T: 917-209-7163
E: [email protected]

 

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
TSX: APLI
E: [email protected]