Category: Archives 2021

HALIFAX, Nova Scotia, September 20, 2021 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced it entered into an agreement with FUJIFILM Toyama Chemical Co., Ltd. (“FFTC”), that will provide funding support for its Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial. The new funding of $1,000,000 USD was secured from FFTC, one of the Company’s partners in a global consortium focused on the worldwide development, commercialization, and distribution of Avigan®/Reeqonus™ (favipiravir) tablets for the potential treatment and prevention of COVID-19.

The new funding will support various components of the recently expanded PRESECO trial, including study close-out activities as the Company prepares for database lock and top-line results. Enrollment targets for PRESECO and the viral shedding sub-study were recently increased to enable additional enrollment of COVID-19 variant cases and maximize the number of patients in the final analysis. As part of the agreement, FFTC will receive direct access to PRESECO data in support of local regulatory submissions in Japan. PRESECO is investigating the safety and efficacy of Avigan/Reeqonus in the early treatment outpatient setting for adults infected with COVID-19.

“FFTC recognizes the unmet need of this pandemic, which is the lack of safe, effective oral antiviral medicines to treat mild-to-moderate COVID-19 patients. With FFTC’s support, we are one step closer to determining if Avigan/Reeqonus will meet this need,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics.

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 FFTC and originally approved in Japan as a treatment for pandemic influenza, this product is one of the few oral antiviral candidates in Phase 3 clinical development to treat newly diagnosed COVID-19 patients.

“We share the sense of urgency that so many physicians and nurses have expressed globally for the need of new treatments developed that will help bring this pandemic to an end. We remain confident Avigan/Reeqonus will play an important role in North America, Japan, and around the world in the treatment of COVID-19 now, and in the near future,” said Junji Okada, President, FUJIFILM Toyama Co., Ltd.

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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 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, Brazil and Mexico. Participants are outpatients with mild-to-moderate symptoms 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 patients 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.

 

About FUJIFILM Toyama Chemical Co., Ltd. (FFTC)

FFTC is an operating company of FUJIFILM Holdings Corporation, Tokyo, Japan. FUJIFILM Holdings Corporation 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, highly functional materials, document solutions and imaging 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, 2021, the company had global revenues of $21 billion, at an exchange rate of 106 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.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 each 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 23, 2021 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.

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Media Contact
Danielle Raabe/APCO Worldwide
T: 1-646-717-9915
E: [email protected]

 

Investor Relations Contact
Stéphane Paquette; Senior Director, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, September 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 it has completed patient enrollment in the viral shedding sub-study portion of its Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral antiviral COVID-19 treatment in the United States.

The viral shedding sub-study is designed to identify COVID-19 variants in study patients and evaluate the direct antiviral effect of favipiravir against the SARS-CoV-2 virus, including recent and emerging variants. Saliva samples are being collected daily from sub-study participants for viral load assessments and whole genome sequencing. Antiviral efficacy endpoints in study participants with detectable SARS-CoV-2 virus in saliva (defined as >100 RNA copies, using an RT-PCR assay) will be assessed from study day 3 onward and include time (number of days) to negative conversion (defined as <100 RNA copies) to study day 10.

PRESECO and sub-study enrollment targets were recently increased to maximize the number of cases included in the analysis and to ensure that there is an adequate representation of variants, including Delta, which is now dominant worldwide. The sub-study is now fully enrolled with over 550 patients and full enrollment for the overall study is imminent.

“The need for an oral, safe and effective antiviral that can be taken at home early in the course of COVID-19, such as Avigan/Reeqonus, has never been greater and will continue to grow as this virus evolves and mutates in response to a changing environment,” said Yoav Golan, M.D., Chief Medical Officer, Appili Therapeutics. “This sub-study, which includes patients recently enrolled from regions with high COVID-19 variant case loads, will provide critical data to assess Avigan/Reeqonus’ antiviral efficacy against today’s most relevant variants.”

Viral shedding sub-study results are expected concurrently with PRESECO top-line results.

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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 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, Brazil and Mexico. Participants are outpatients with mild-to-moderate symptoms 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 patients 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 each 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 23, 2021 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.

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Media Contacts
Danielle Raabe/APCO Worldwide
T: 1-646-717-9915
E: [email protected]

 

Investor Relations Contacts
Stéphane Paquette; Senior Director, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, September 8, 2021 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced the results from its annual general meeting of shareholders held on Tuesday, September 7, 2021. The Company also announced the addition of Josef Vejvoda to its Board of Directors (the “Board”).

Based on the proxies received and the vote conducted at the meeting, all tabled resolutions were approved by the shareholders of the Company, including the election of the following directors for the ensuing year: Ian Mortimer, Brian Bloom, Juergen Froehlich, Theresa Matkovits, Rochelle Stenzler, Armand Balboni, and newly elected Josef Vejvoda.

Voting results for each director are summarized below:

Ian Mortimer
99.85% of Votes For
0.15% of Votes Withheld

Brian Bloom
100% of Votes For
0% of Votes Withheld

Juergen Froehlich
99.85% of Votes For
0.15% of Votes Withheld

Theresa Matkovits
99.85% of Votes For
0.15% of Votes Withheld

Rochelle Stenzler
100% of Votes For
0% of Votes Withheld

Armand Balboni
100% of Votes For
0%  of Votes Withheld

Josef Vejvoda
100% of Votes For
0% of Votes Withheld

 

Josef Vejvoda brings to Appili’s Board over 25 years of capital markets experience. Mr. Vejvoda currently acts as special advisor to K2 & Associates Investment Management Inc. (“K2”), a multi-strategy investment fund, and previously held senior operating executive positions at K2 as Chief Compliance Officer and Chief Executive Officer. Mr. Vejvoda has also held senior management roles at a number of the country’s largest financial institutions, including Merrill Lynch Canada, National Bank Financial and TD Securities, as well as serving on numerous public company boards.

Mr. Vejvoda graduated from Queen’s University with a BSc in Computer Science. Mr. Vejvoda has also earned the Chartered Investment Manager (CIM®) designation from the Canadian Securities Institute and is a graduate of the Institute of Corporate Directors having achieved the ICD.D designation.

Shareholders also approved the re-appointment of PricewaterhouseCoopers, LLP, Chartered Accountants, as independent auditor of the Company for the ensuing year and authorized the directors of the Company to fix their remuneration.

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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.

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

 

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

HALIFAX, Nova Scotia, August 18, 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 closed its $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. Details of the Agreement were previously disclosed in the Company’s news release on August 9, 2021. Appili has received net proceeds of $3.395 million from the funding.

 

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.

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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”. 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.

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

 

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

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.

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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]