Author: rajarshi

HALIFAX, Nova Scotia, August 13, 2021 – Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company developing anti-infective drug candidates, today announced its financial and operational results for the first quarter of its fiscal year 2022, which ended on June 30, 2021.

“As COVID-19 cases surge in many parts of the world, the need for safe and effective oral antivirals to contain outbreaks and stay ahead of variants has never been more clear,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer of Appili Therapeutics. “With our PRESECO Phase 3 trial rapidly approaching a top-line read-out and our clinical stage antifungal on track for Phase 2 initiation next year, we are well-positioned to deliver urgently needed medicines for COVID-19 and other life-threatening infections.”

First quarter and recent operational highlights include:

• Completing an interim analysis of Appili’s ongoing Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19 and receiving a unanimous recommendation from the independent Data Safety and Monitoring Board (“DSMB”)to continue the study without modifications
• Expanding the PRESECO Phase 3 trial to Latin America in June with the addition of several clinical research sites in Mexico and Brazil
• Entering into an agreement in August with the Lind Partners for $3.5 million in funding to support PRESECO and the broader Appili pipeline
• Building out our preclinical data package and working with leading investigators/advisors to set our Phase 2 protocols for our lead anti-fungal clinical trial, scheduled to begin early next year

 

Financial Results

The Company prepares its financial statements in accordance with IFRS as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are stated in Canadian dollars unless otherwise stated.

The net loss and comprehensive loss of $7.4 million or $0.12 loss per share for the three months ended June 30, 2021, was $4.8 million higher than the net loss and comprehensive loss of $2.6 million or $0.05 loss per share during the three months ended June 30, 2020. This relates mainly to an increase in research and development expenses by $4.5 million, an increase in business development of $0.23 million, an increase in general and administration expenses by $0.09 million, an increase in accreted interest of $0.02 million, and an increase in income tax expense of $0.02 million. These increases were offset by an increase of government assistance of $0.14 million.

As of June 30, 2021, the Company had cash and short-term investments of $9.33 million, compared to $16.1 million on March 31, 2021. As of August 13, 2021, the Company had 62,832,120 issued and outstanding Common Shares, 6,793,536 stock options, and 14,326,276 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for the first quarter of the 2022 fiscal year and the related management discussion and analysis (MD&A), copies of which are available on SEDAR at www.sedar.com.

+++

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan® / REEQONUS™(favipiravir) for the worldwide treatment and prevention of COVID-19. The Company is also advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

This news release contains “forward-looking statements”, including with respect to the expected interim data read-out timetable for the PRESECO study, which reflect the current expectations of the Company’s management future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for,” and similar expressions have been used to identify these forward-looking statements. Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 23, 2021 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at ). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

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

###

Media Contact
Mackenzie Mittleman/APCO Worldwide
T: (760) 578-5079
E: [email protected]

 

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

HALIFAX, Nova Scotia, August 9, 2021 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced that it has entered into a $3.5 million convertible security funding agreement (the “Agreement”) with Lind Global Fund II, LP, an investment entity managed by The Lind Partners, a New York based institutional fund manager (together “Lind”).

Appili Therapeutics intends to use the funding to support the operations of the Company as it prepares for top-line data from its PRESECO Phase 3 trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19. The funding will also be used to advance the broader Appili pipeline, including ATI-2307, a novel clinical stage antifungal expected to enter Phase 2 study in 2022.

“Appili is working to develop medicines for some of the most urgent health challenges facing the world today, including the COVID-19 pandemic and the growing threat of Candida auris, a highly drug-resistant fungus that is spreading within hospital settings,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “This funding from Lind will help us move our pipeline forward to address these important public health threats, as well as provide Appili greater operational flexibility.”

Under the terms of the Agreement, Lind will make an investment of $3.5 million in exchange for a secured convertible security with a principal amount of $4.095 million (“Face Value”) and a 24-month maturity date. Appili will receive net proceeds of $3.395 million from the funding (after deducting a commitment fee of $105,000). Lind will be entitled to convert up to 1/20thof the Face Value per month into Class A common shares of Appili (“Shares”) at a price equal to 85% of the five-day volume weighted average share price (“VWAP”) immediately prior to conversion (the “Conversion Price”). Shares underlying the convertible security will be subject to resale restrictions for a period of four months and one day following the closing date.

The Agreement also includes provisions entitling Lind to accelerated conversion rates based on Appili’s trading price. Appili has the right to buy-back outstanding Face Value at any time with no penalty. If Appili elects to exercise its buy-back rights, Lind will have the option to convert up to 25% of the Face Value. In addition, if such buy-back right is exercised within 180 days, the Face Value will be reduced to $3,794,000.

As part of the Agreement, Lind will be issued 2,209,874 cash-exercise warrants, exercisable for 48 months, subject to acceleration, with a warrant exercise price of $0.9517, representing a 30% premium to the 20-day VWAP immediately prior to execution of the Agreement.

The convertible security will be secured against all of the assets and property of the Company pursuant to a general security agreement.

The transaction contemplated under the Agreement has been conditionally approved by the Toronto Stock Exchange. Funding under the Agreement is expected to be completed on or before August 20, 2021.

“Lind is excited to invest in Appili Therapeutics at such a critical moment for the company,” said Phillip Valliere, Managing Director from The Lind Partners. “We look forward to helping Appili further accelerate their pipeline and supporting them in their upcoming trials.”

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities described herein. The securities offered have not been registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as both such terms are defined in Regulation S promulgated under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

+++

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan/Reeqonus 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.

 

About The Lind Partners

The Lind Partners is an institutional fund manager and leading provider of growth capital to small- and mid-cap companies publicly traded in the US, Canada, Australia and the UK. Lind makes direct investments ranging from US$1 to US$30 million, invests in syndicated equity offerings and selectively buys on market. Lind has completed more than 100 direct investments totaling over US$1 billion in value and has been a flexible and supportive capital partner to investee companies since 2011. For more information, please visit www.thelindpartners.com.

 

Forward looking statements

This news release contains “forward-looking statements”, including with respect to the proposed use of proceeds and the funding timeline. 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. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 23, 2021 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

###

Media Contacts
Danielle Raabe/APCO Worldwide
T: (646) 717 9915
Email: [email protected]

 

Investor Relations Contacts
Kimberly Stephens, CFO
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, June 24, 2021 – Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company developing anti-infective drug candidates, today announced its financial and operational results for the fiscal year ended March 31, 2021, and provided an update on the Company’s strategy for fiscal 2022.  All figures are stated in Canadian dollars unless otherwise stated.

“As we enter our next fiscal year as a public company, we are excited about the pace of progress related to several of our therapies, as well as our planned future business development strategy. Our goal is to use a scientifically rigorous, and financially sound approach to identify and develop novel therapies that meet the greatest patient needs. We believe this will create enduring value for shareholders,” said Armand Balboni, MD, PhD, Chief Executive Officer of Appili Therapeutics.

“We are encouraged that an independent Data and Safety Monitoring Board has recommended continuation without modification of Appili’s ongoing Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™ (favipiravir).  We look forward to the completion of the PRESECOtrial and are hopeful that Avigan/Reeqonus will emerge as one of the first prescription oral medicine for newly diagnosed patients with COVID-19,” continued Dr. Balboni.

 

2021 and recent highlights include:

Financial

• Graduated to the main board of the Toronto Stock Exchange (TSX) and received DTC eligibility in the U.S.
• Completed equity financing of $15,525,000 and concurrent private placement of $1,440,000.

Leadership

• Appointed veteran healthcare executive Rochelle Stenzler to its Board of Directors.
• Appointed both Dr. Yoav Golan as the Company’s first Chief Medical Officer and senior drug development executive Don Cilla as Chief Development Officer.

Development Programs

• Signed a collaboration, development, and supply agrement to create a global consortium with Dr. Reddy’s Laboratories Ltd. (“DRL”) and Global Response Aid (“GRA”) for oral COVID-19 antiviral candidate favipiravir.
• Received recommendation from an independent Data and Safety Monitoring Board (“DSMB”) to continue without modification of Appili’s ongoing Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19.
• Conducted a meeting with Key Opinion Leaders to determine clinical path for the ATI-2307 program targeting resistant fungal infections. The Company expects to engage regulatory authorities in 2021 and submit regulatory filings with the U.S. Food and Drug Administration and other health authorities and start Phase 2 clinical trials in 2022.
• Secured an additional USD$6.3 million from the Defense Threat and Reduction Agency (“DTRA”) to fund the regulatory, manufacturing and pre-IND studies for the Company’s ATI-1701 vaccine program.
• Appili continues to work on advancing its other anti-infective programs through development. The COVID-19 pandemic, and the recent global rise of black fungal infections, has demonstrated that there are a substantial number of infectious pathogens that present serious threats to human health.  “We are committed to advancing novel therapies that address unmet needs in infectious disease, and our anti-fungal ATI-2307 program is an important part of our pipeline,” said Dr. Balboni. “We are continuing our cutting-edge work to advance the program, with the goal of filing a Phase 2 protocol with regulatory agencies by the end of this year.”

 

Annual Financial Results

The Company prepares its financial statements in accordance with IFRS as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook – Accounting.

The net loss and comprehensive loss of $14.3M million or $0.24 loss per share for the year ended March 31, 2021 was $8.9 million higher than the net loss and comprehensive loss of $5.4 million or $0.16 loss per share during the year ended March 31, 2020. This relates mainly to a $8.1 million increase in research and development (R&D) expenses, $1.5 million increase in general and administrative expenses and a $0.06 million increase in accreted interest, offset by a $0.6 million increase in government assistance and a $0.3 million decrease in business development.

At March 31, 2021, the Company had cash and short-term investments of $16.1 million and working capital of $13.6 million, compared to $10.5 million and $9.7 million, respectively at March 31, 2020.

As of June 23, 2021, the Company had the Company had 62,832,120issued and outstanding Common Shares, 6,796,869 stock options and 14,625,993 warrants outstanding.

This press release should be read in conjunction with the Company’s audited annual consolidated financial statements for the fiscal year ended March 31, 2021 and the related management discussion and analysis (MD&A), copies of which are available under the Company’s profile on SEDAR at www.sedar.com

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. As part of  a  global  consortium,  Appili  is  sponsoring late-stage clinical trials evaluating the antiviral Avigan® / REEQONUSTM  (favipiravir) for the worldwide treatment and prevention of COVID-19. The Company is also advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two  novel  antibiotic  programs. Led  by  a proven management team, Appili is at the epicenter of the global fight against against infectious disease. For more information, visit www.AppiliTherapeutics.com.

 

Forward looking statements

This news release contains “forward-looking statements” which reflect the current expectations of the Company’s management future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for,” and similar expressions have been used to identify these forward-looking statements. Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 23, 2021 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

The Company is not making any express or implied claims that its investigational product favipiravir has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 coronavirus) at this time.

###

Investor Relations Contacts
Kimberly Stephens, CFO
Appili Therapeutics
E: [email protected]

 

Laura Kiernan, IRC, CPA
High Touch Investor Relations
T: (914) 598-7733
E: [email protected]

 

Media Contacts
Mackenzie Mittleman/APCO Worldwide
T: (760) 578-5079
E: [email protected]

HALIFAX, Nova Scotia, June 17, 2021 – Appili Therapeutics Inc. (TSX: APLI, OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, has added several clinical research sites in Mexico and Brazil to its Phase 3 clinical trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19. The expansion into Mexico and Brazil will ensure a timely completion of this pivotal trial and reaffirm favipiravir as one of the most advanced oral COVID-19 antiviral candidates in development with top-line data expected in Q3 2021.

Appili’s PRESECO (PREventing SEvere COVID-19) study is evaluating the safety and efficacy of Avigan/Reeqonus, an oral antiviral that selectively inhibits viral RNA-dependent RNA polymerase (RdRP), as a potential home-based treatment for patients with mild-to-moderate COVID-19. The primary goal of the study is to demonstrate a significant shortening of the time to sustained recovery for study patients receiving the experimental medicine compared to a placebo.

There are more than 730 U.S. patients currently enrolled in the PRESECO study. Site activation is underway in Mexico and the first sites are active and enrolling patients. Site activation in Brazil is expected to start in the coming weeks. With the addition of the new sites, Appili expects to complete enrollment and report top-line results by the end of September.

“While the situation is improving in the U.S., COVID-19 remains an international crisis. Here and abroad, physicians and government leaders have been calling for effective oral antiviral medicines to treat these patients. With cases decreasing in the U.S. our clinical expansion into Brazil and Mexico will help us meet our enrollment goal. With this expansion of our trial, we will be able to move quicker towards our goal of determining whether Avigan/Reeqonus is effective in helping people who suffer from mild-to-moderate COVID-19 to recover faster and avoid hospitalization and death,” said Yoav Golan, M.D., Chief Medical Officer, Appili Therapeutics.

Recently, an independent Data and Safety Monitoring Board (DSMB) recommended continuation of PRESECO without modification. This expansion is a key component of continuing the trial completion.

As part of the expansion and prioritization of the PRESECO treatment study, Appili has ended its CONTROL trial. CONTROL was a Phase 2 trial designed to determine whether Avigan/Reeqonus  could  prevent   an  outbreak  of  COVID-19 in long-term care settings and originally developed in collaboration with researchers at Sinai Health as part of the early response to the COVID-19 pandemic.

Appili  has  also  planned a  Phase 3  study PEPCO (Post Exposure   Prophylaxis   for   COVID-19),   designed   to   evaluate

Avigan/Reeqonus  for  the prevention  of COVID-19  when  given to   asymptomatic   individuals  who  have   had  direct   exposure (within 72 hours) to an infected person. Appili expects to initiate enrollment  in  the  second   half   of   2021   following   successful completion  of  the PRESECO study.

“We are prioritizing and expanding PRESECO to meet the acute need for effective oral COVID-19 therapies and are looking forward to our top-line data readout next quarter,” said Armand Balboni, Chief Executive Officer, Appili Therapeutics. “However, we also recognize that the value of oral antivirals goes beyond treatment and expect our post-exposure prophylaxis study PEPCO to rapidly follow our PRESECO readout. This Phase 3 study, already filed with the FDA, has the potential to significantly expand the value of Avigan/Reeqonus and protect vulnerable patients.”

 

About the PRESECO Clinical Trial

The Phase 3 PRESECO (Preventing Severe COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center superiority trial investigating the safety and efficacy of Avigan/Reeqonus in the early treatment outpatient setting for adults infected with COVID-19 and showing mild-to-moderate symptoms. Investigators are enrolling participants at multiple clinical trial sites in the United States. Participants are expected to be outpatients who do not require hospitalization and who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administer the drug regimen in their homes, with clinical investigators monitoring them remotely.

 

About Avigan/Reeqonus

Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet form. It is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded  RNA  viruses, including  coronaviruses.  Developed by FUJIFILM  Toyama  Chemical  Co.,  Ltd.  (FFTC) and approved  in

Japan as a treatment and stockpile countermeasure for pandemic influenza. Unlike most other interventions that researchers are evaluating in COVID-19, Avigan/Reeqonus 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/Reeqonus’ 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 Laboratories, Global Response Aid, and FFTC, for the worldwide development and distribution of Avigan/Reeqonus tablets for the potential treatment and prevention of COVID-19 (excluding Japan, China, and Russia.) This consortium is designed to ensure that Avigan/Reeqonus is thoroughly evaluated in rigorous clinical studies and, if it receives the proper regulatory approvals, has the infrastructure in place to support worldwide manufacturing and 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/Reeqonus 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, parameters and location of the proposed Avigan® /Reeqonus (generic name: favipiravir) clinical trials and the likelihood that such clinical trials will be consummated on the terms and timeline provided herein or at all; the anticipated timing for completion of the study and the release of study data; the potential use of 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 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: timing of clinical results; 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 the continuation and/or expansion of the clinical trials, the 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 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 under the Company’s profile on SEDAR 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
Mackenzie Mittleman/APCO Worldwide
T: (760) 578-5079
Email: [email protected]

 

Investor Relations Contacts
Kimberly Stephens, CFO
Appili Therapeutics
E: [email protected]

 

Laura Kiernan, IRC, CPA
High Touch Investor Relations
T: (914) 598-7733
E: [email protected]

HALIFAX, Nova Scotia, May 17, 2021 – Appili Therapeutics Inc. (TSX: APLI, OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced that an independent Data and Safety Monitoring Board (DSMB) has recommended continuation without modification of Appili’s ongoing Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19.

“Even with effective vaccines available, COVID-19 is here to stay for the foreseeable future. A safe and effective oral anti-viral medicine is what government leaders and physicians around the world have been asking for since the start of the pandemic. We remain hopeful that once PRESECO is completed, Avigan/Reeqonus will emerge as the first prescription oral medicine for newly diagnosed patients with COVID-19,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics.

The PRESECO study is evaluating the safety and efficacy of Avigan/Reeqonus, an oral antiviral that selectively inhibits viral RNA-dependent RNA polymerase (RdRP), as a potential treatment for patients with mild-to-moderate COVID-19. The primary goal of the study is to demonstrate a significant shortening of the time to sustained recovery for study patients receiving the experimental medicine compared to a placebo. The DSMB reported no safety issues that would have required the study to be terminated. It also did not recommend stopping the study for futility. As a result, Appili will continue the study without modification.

The interim analysis is based on data from approximately 600 subjects. Appili Therapeutics will continue recruiting patients at the 27 study sites across the United States and expects to report top-line results in Q3 2021, which will inform subsequent interactions with regulators, including the possibility Appili will pursue an Emergency Use Authorization from the U.S. Food and Drug Administration.

“COVID-19 is surging again in various parts of the world, including Asia and South America. As a practicing infectious diseases physician, I understand the importance of discovering and delivering new medicines to treat COVID-19 here and around the world,” said Yoav Golan, Chief Medical Officer, Appili.

 

About the PRESECO Clinical Trial

The Phase 3 PRESECO (Preventing Severe COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center superiority trial investigating the safety and efficacy of Avigan/Reeqonus in the early treatment outpatient setting for adults infected with COVID-19 and showing mild-to-moderate symptoms. Investigators are enrolling participants at multiple clinical trial sites in the United States. Participants are expected to be outpatients who do not require hospitalization and who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administer the drug regimen in their homes, with clinical investigators monitoring them remotely.

 

About Avigan/Reeqonus

Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet form. It is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. Developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Unlike most other interventions that researchers are evaluating in COVID-19, Avigan/Reeqonus 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/Reeqonus’ 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 Laboratories, Global Response Aid, and FFTC, for the worldwide development and distribution of Avigan/Reeqonus tablets for the potential treatment and prevention of COVID-19 (excluding Japan, China, and Russia.) This consortium is designed to ensure that Avigan/Reeqonus is thoroughly evaluated in rigorous clinical studies and, if it receives the proper regulatory approvals, has the infrastructure in place to support worldwide manufacturing and 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/Reeqonus 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, parameters and location of the proposed Avigan® /Reeqonus (generic name: favipiravir) clinical trials and the likelihood that such clinical trials will be consummated on the terms and timeline provided herein or at all; the anticipated timing for completion of the study and the release of study data; the potential use of 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 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: timing of clinical results; 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 the continuation and/or expansion of the clinical trials, the 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 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 under the Company’s profile on SEDAR 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
Mackenzie Mittleman/APCO Worldwide
T: (760) 578-5079
E: [email protected]

 

Investor Relations Contacts
Kimberly Stephens, CFO
Appili Therapeutics
E: [email protected]

 

Laura Kiernan, IRC, CPA
High Touch Investor Relations
T: 914-598-7733
E: [email protected]

HALIFAX, Nova Scotia, April 19, 2021 – Appili Therapeutics Inc. (TSX:APLI; OTCQX:APLIF) (the Company or Appili), a biopharmaceutical company developing anti-infective drug candidates, today announced that the Company’s Chief Executive Officer, Dr. Armand Balboni will present at the fully virtual Bloom Burton & Co. Healthcare Investor Conference taking place on April 20 and 21, 2021.

Appili management will be conducting one-to-one meetings throughout the conference and is scheduled to present as follows:

Date: Wednesday, April 21st
Time: 10:00 AM ET

A live webcast of Appili’s presentation can be accessed on the Company’s website on the Events and Presentations page. A replay of the presentation will also be made available following the live presentation.

To request virtual one-to-one meetings, please register for the conference HERE.

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan® / REEQONUSTM (favipiravir) for the worldwide treatment and prevention of COVID-19. The Company is also advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

ABOUT BLOOM BURTON & CO

Bloom Burton hosts its annual Healthcare Investor Conference in

Bloom Burton & Co. (Bloom Burton Securities Inc.) is a firm dedicated to accelerating returns in the healthcare sector for both investors and companies. Bloom Burton has an experienced team of medical, scientific, pharmaceutical, legal and capital markets professionals who perform a deep level of diligence, which combined with our creative and entrepreneurial approach, assists our clients in achieving the right monetization events. Bloom Burton and its affiliates provide capital raising, M&A advisory, equity research, business strategy and scientific consulting, advisory on direct investing and company creation and incubation services. Bloom Burton Securities Inc. is a member of the Investment Industry Regulatory Organization of Canada (IIROC) and is also a member of the Canadian Investor Protection Fund (CIPF).

For more information, visit https://www.bloomburton.com

###

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

 

Laura Kiernan, IRC, CPA
High Touch Investor Relations
T:   914-598-7733
E: [email protected]

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.

###

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]