Category: Archives 2021

HALIFAX, Nova Scotia, December 23, 2021 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”) announced today a correction to its press release entitled “Appili Therapeutics Announces Update to Funding Agreement with The Lind Partners” which was issued on December 22, 2021 (the “Initial Press Release”).

The Initial Press Release incorrectly stated that Lind had agreed to a standstill period expiring on March 18, 2021. The correct expiry date for the standstill period is March 18, 2022. This correction does not change any other information reported in the Initial Press Release.

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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. The Company 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.

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

 

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

HALIFAX, Nova Scotia, December 22, 2021 – Appili Therapeutics Inc. (TSX:APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, announced today that the Company and Lind Global Fund II, LP, an investment entity managed by The Lind Partners, a New York based institutional fund manager (together “Lind”), have agreed to amend certain terms of the previously announced senior convertible funding agreement (the “Funding Agreement”).

Under the previously disclosed Funding Agreement, Appili issued to Lind a secured convertible security with a face value of $4.095 million and a 24-month maturity date. Under the revised terms, Appili has agreed to make a voluntary prepayment of $1 million towards the principal amount outstanding under the Funding Agreement. In exchange, Lind has agreed to a standstill period expiring on March 18, 2021 during which Lind shall not be entitled to convert any of the remaining principal amount outstanding into Appili shares, which is now approximately $3 million.

“Today’s agreement is an important part of Appili’s near-term strategy to maximize balance sheet flexibility and ultimately grow shareholder value” said Dr. Armand Balboni, CEO of Appili Therapeutics. “We are grateful for the continued support from our partners at Lind as we look to expand and advance our diversified anti-infective pipeline of four potential products through key development milestones in 2022, including a Phase 2 start for our novel antifungal ATI-2307. In addition, we believe that two of our programs come with the additional potential for obtaining priority review vouchers, which could add significant, non-dilutive value to our shareholders in the event these programs are successful.”

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. The Company 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.

 

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. Such forward looking statements include statements with respect to the Company’s development plans with respect to its product portfolio and expectations with respect to priority review voucher eligibility. 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, (i) risks relating to unforeseen events that may delay or impede the Company’s development plans with respect to its product portfolio, (ii) the risk that a product may ultimately not be priority review voucher eligible and (iii) the risks and assumptions 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 Contact:
Danielle Raabe/APCO Worldwide
T: 1-646-717-9915
E: [email protected]

 

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

HALIFAX, Nova Scotia, November 19, 2021 – Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced positive one year challenge results from its preclinical study evaluating the efficacy of biodefense vaccine candidate ATI-1701 in a lethal model of tularemia.  A survival rate of 29% (n = 2/7) was reported in the ATI-1701 vaccinated cohort, compared to 0% (n = 0/5) in mock vaccinated controls.

The results reported today are from the final challenge timepoint in a preclinical study evaluating the efficacy of ATI-1701 28 days, 90 days, and one year after vaccination. At each challenge timepoint, cohorts of vaccinated and unvaccinated animals received a lethal exposure of aerosolized Francisella tularensis, the causative agent of tularemia. In January 2020, Appili had reported 90-day efficacy results, with 100% of ATI-1701 vaccinated animals surviving exposure compared to 0% of the controls. Both 28- and 90-day efficacy data have also been presented previously by Appili’s partners MRIGlobal at biodefense conferences in the U.S. The study was funded by the U.S Defense Threat Reduction Agency (“DTRA”) and conducted by MRIGlobal.

“We are excited to see signals of protection and survival benefit as far out as one year post vaccination. Efficacy under these stringent conditions is a compelling differentiator and positions ATI-1701 as a leading candidate to be the first approved vaccine for the prevention of tularemia,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “We are grateful for the support of DTRA and our partners to achieve this significant milestone and look forward to making continued progress on manufacturing and IND-enabling activities to advance ATI-1701 into the clinic.”

The Company also announced today that Josef Vejvoda has resigned from the Company’s Board of Directors to pursue other endeavours.

 

About ATI-1701

Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which is classified by the U.S. National Institutes of Health (NIH) as a Category A pathogen, an organism that poses the highest risk to national security and public health. Estimated to be 1,000 times more infectious than anthrax, experts consider the aerosolized form to have a high potential use in a bioterrorist attack. Several countries may already have operational weapons programs leveraging this pathogen, making the need for a vaccine to counter this biological weapons threat exceedingly important.

 

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 recently sponsored a late-stage clinical trial evaluating the antiviral Avigan/Reeqonus for the treatment 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”, including with respect to the proposed use of proceeds. 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. Such forward looking statements include statements with respect to the Company’s development plans relating to ATI-1701. 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, the risks 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 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, November 12, 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 second quarter of its fiscal year 2022, which ended on September 30, 2021.

“Although the top-line results of our Phase 3 PRESECO trial were not what we had hoped for, I am incredibly proud of all that our team accomplished this quarter which continues to demonstrate Appili’s ability to rapidly execute and achieve key development milestones,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer of Appili Therapeutics. “I am excited to deploy our expanded drug development infrastructure to tackle the many other infectious disease threats in front of us and advance our broader anti-infective pipeline including our novel, clinical-stage antifungal ATI-2307 slated to enter Phase 2 next year, and our first-in-class biodefense vaccine candidate ATI-1701.”

Second quarter and recent operational highlights include:

• In September, announcing last patient enrolled in the Phase 3 PRESECO clinical trial evaluating Avigan®/Reeqonus™ for mild-to-moderate COVID-19 and its viral shedding sub-study, and subsequently reporting top-line results for the study.
• Announcing a closing of public offering of $7,000,220 and entering into an agreement with the Lind Partners for $3.5 million in funding to further strengthen the Company’s momentum as a fully integrated, infectious disease specialized company.
• Entering into a data transfer agreement with FUJIFILM Toyama Chemical Co., Ltd., that will provide funding support of $1,000,000 USD for the Phase 3 PRESECO trial.
• Entering into a strategic alliance and equity transaction with existing consortium partner AiPharma to enhance complementary skills and create global reach with expanded resources.
• Preparing for ATI-2307 clinical trial drug product GMP manufacturing runs to be initiated in December 2021.

Kimberly Stephens, CPA, CA, who has been the Company’s Chief Financial Officer since 2016, has chosen to leave Appili for personal reasons effective November 16, 2021. Kenneth G. Howling, who has over 25 years of experience in senior financial positions across several healthcare and pharmaceutical companies, will be joining Appili Therapeutics as Acting Chief Financial Officer this fall.

“On behalf of our entire team, I would like to thank Kimberly for her commitment and contribution to Appili Therapeutics,” continued Armand Balboni, CEO of Appili Therapeutics. “Since joining Appili in 2016, Kimberly has been an integral part of our executive team leading Appili through many of our biggest milestones, including taking the company public and up-listing to the Toronto Stock Exchange. We wish her well in her future endeavors.”

 

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 $18.5 million or $0.30 loss per share for the six months ended September 30, 2021 was $13.5 million higher than the net loss and comprehensive loss of $5.1 million or $0.09 loss per share during the six months ended September 30, 2020. This relates mainly to an increase in research and development expenses by $13.4 million, an increase in business development of $0.2 million and an increase in accreted interest of $0.2 million. These increases were offset by a decrease in general and administration expenses by $0.2 million increase of government assistance of $0.3 million.

As of September 30, 2021, the Company had cash and short-term investments of $10.0 million, compared to $16.1 million on March 31, 2021. As of November 12, 2021, the Company had 71,266,120 issued and outstanding Common Shares, 6,621,489 stock options, and 21,343,530 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for the second 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 recently sponsored a late-stage clinical trial evaluating the antiviral Avigan/Reeqonus for the treatment 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”, including with respect to the proposed use of proceeds. 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, the risk that the Company may not be able to continue as a going concern and those risks 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 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, November 12, 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 the Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial evaluating oral antiviral Avigan®/Reeqonus™(favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery. Additional analyses of the trial data are ongoing. The clinical trial enrolled 1,231 patients with mild-to-moderate COVID-19 from 38 study sites across the United States, Mexico, and Brazil.

“While we are disappointed by the topline results of the PRESECO trial, we remain steadfast in our belief that safe and effective oral antivirals are urgently needed for patients who are still struggling to overcome COVID-19. We wish to thank all the patients who participated, and hope that information obtained from our trial can help guide research and development around more potential treatment options for COVID-19,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Appili remains committed to addressing the challenges posed by infectious diseases and we will continue developing our pipeline to improve patient lives around the world.”

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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, global superiority trial investigating the safety and efficacy of oral Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms. Participants were enrolled at multiple clinical trial sites in the United States, Brazil and Mexico. Participants were outpatients with mild-to-moderate symptoms who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administered 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.

 

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. 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 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 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
Email: [email protected]

 

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

HALIFAX, Nova Scotia, October 14, 2021 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”) announced the closing of its previously announced public offering (the “Offering”) of units (the “Units”). The Offering was made pursuant to an agency agreement entered into with a syndicate of agents led by Bloom Burton Securities Inc. (the “Lead Agent”) and including iA Private Wealth Inc., Leede Jones Gable Inc., Research Capital Corporation, and Richardson Wealth Limited (collectively with the Lead Agent, the “Agents”) and the Company.

Pursuant to the Offering, the Company issued a total of 8,434,000 Units at a price of $0.83 per Unit for aggregate gross proceeds of $7,000,220. Each Unit is comprised of one Class A common share of the Company (a “Common Share”) and one-half of one Common Share purchase warrant of the Company (each whole Common Share purchase warrant, a “Warrant”). Each Warrant entitles the holder thereof to acquire one Common Share (a “Warrant Share”) at an exercise price of $1.10 per Warrant Share until October 14, 2024.

“This funding will play a critical role in continuing our momentum as we work to improve patient lives, expand our global reach, and build out a fully integrated, infectious disease specialized company,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “With the COVID-19 pandemic continuing to evolve, the need for at-home oral antivirals remains urgent. As Appili rapidly approaches the top-line readout from our Phase 3 PRESECO trial, which is evaluating the oral antiviral Avigan®/Reeqonus™ (favipiravir) for the treatment of mild-to-moderate COVID-19, this funding will support us as we move aggressively to deliver this critically needed medicine and hopefully change the trajectory of this pandemic.”

The Units were qualified for sale by way of a prospectus supplement dated October 8, 2021 to the short base shelf prospectus of the Company dated September 19, 2019 (collectively, the “Prospectus”). A copy of the Prospectus is available under the Company’s profile at www.sedar.com.

In connection with the Offering, the Company has paid the Agents an aggregate cash consideration of $490,015.40. As additional consideration, the Agents have received 590,380 broker warrants (“Broker Warrants”). Each Broker Warrant is exercisable for one Common Share (a “Broker Warrant Share”) at a price of $0.83 per Broker Warrant Share until October 14, 2023.

The net proceeds of the Offering will be used primarily towards funding research and development activities for oral COVID-19 antiviral candidate Avigan®/ReeqonusTM (favipiravir), including costs associated Appili’s global Phase 3 trial evaluating Avigan/Reeqonus for the treatment of mild-to-moderate COVID-19 (PREventing SEvere COVID-19; PRESECO). Net proceeds of the Offering will also be used to support business development initiatives to expand the Company’s portfolio of programs, as well as fund development costs for the Company’s other product candidates, including the ATI-2307 antifungal program, and for working capital and general corporate purposes. Details as to the specific allocation of the proceeds were disclosed in the Prospectus Supplement.

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and accordingly, may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as each such term is defined in Regulation S under the U.S. Securities Act), except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions therefrom. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Corporation’s securities to, or for the account or benefit of, persons in the United States or U.S. Persons.

As partial consideration for its services in connection with the Offering, the Lead Agent received 128,674 Broker Warrants. Prior to the closing of the Offering, the Lead Agent together with Bloom Burton & Co. Inc. and Bloom Burton Development Corporation (collectively, “Bloom Burton”), each an affiliate of the Lead Agent, beneficially owned, directly and indirectly, an aggregate of 14,358,611 Common Shares, 256,545 share purchase warrants (the “First Previously Held Broker Warrants”) exercisable into 256,545 Common Shares at a price of $0.80 per Common Share until February 20, 2022, and 280,777 share purchase warrants (the ”Second Previously Held Broker Warrants”) exercisable into 280,777 Common Shares at a price of $1.20 per Common Share until June 10, 2022, representing approximately 22.85% of the then issued and outstanding Common Shares on a non-diluted basis, and 23.51% of the then issued and outstanding Common Shares on a partially-diluted basis, assuming the exercise of the First and Second Previously Held Broker Warrants held by Bloom Burton and its affiliates only.

Immediately following closing of the Offering, Bloom Burton beneficially owns, directly or indirectly, 14,358,611 Common Shares, 256,545 First Previously Held Broker Warrants, 280,777 Second Previously Held Broker Warrants and 128,674 Broker Warrants, representing 20.15% of the Common Shares issued and outstanding on a non-diluted basis and 20.89% of the Common Shares issued and outstanding on a partially-diluted basis, assuming the exercise of the First Previously Held Broker Warrants, Second Previously Held Broker Warrants and the Broker Warrants held by Bloom Burton only.

The Lead Agent received the Broker Warrants in the normal course of its business as a registered investment dealer. The Broker Warrants and the other securities of the Company beneficially owned, directly or indirectly, by Bloom Burton, are held for investment purposes. Bloom Burton has a long-term view of the investment and may acquire additional securities including either in the open market or through private acquisitions or sell the securities including either on the open market or through private dispositions in the future depending on market conditions, reformulation of plans and/or other relevant factors.

An early warning report relating to this transaction will be filed on SEDAR under the Company’s profile at www.sedar.com. To obtain a copy of such report, please contact Sonia Yung at (416) 640-7575 or at [email protected]. Bloom Burton is a company existing under the laws of Ontario specializing in the healthcare investment industry with its head office at 65 Front Street East, Suite 300, Toronto, Ontario, M5E 1B5.

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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.

 

Forward looking statements

This news release contains “forward-looking statements”, including with respect to the proposed use of proceeds. 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 Prospectus 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
Stéphane Paquette; Senior Director, Corporate Development
Appili Therapeutics
E: [email protected]

HALIFAX, Nova Scotia, October 7, 2021 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”) is pleased to announce today that it has priced its previously announced overnight marketed offering of equity securities (the “Offering”). Pursuant to the Offering, Appili will issue 8,434,000 units of the Company (“Units”) at a price of C$0.83 per Unit (the “Offering Price”) for gross proceeds of C$7,000,220. Each Unit is comprised of one Class A common share of the Company (a “Common Share”) and one-half of one Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant is exercisable at a price of C$1.10 and entitles the holder thereof to acquire one Common Share for a period of 3 years following the date of the closing of the Offering (the “Closing Date”).

The Offering will be conducted on a best efforts agency basis pursuant to the terms and conditions of an agency agreement to be entered into between the Company and a syndicate of agents lead by Bloom Burton Securities Inc. (the “Lead Agent”) and including iA Private Wealth Inc., Leede Jones Gable Inc., Research Capital Corporation, and Richardson Wealth Limited (collectively with the Lead Agent, the “Agents”). In connection with the Offering, the Agents will be paid a cash commission equal to 7.0% of the gross proceeds of the Offering and will be issued that number of non-transferable broker warrants (“Broker Warrants”) equal to 7.0% of the number of Units sold in the Offering). Each Broker Warrant will be exercisable to acquire one Common Share at the Offering Price for a period of 24 months from the Closing Date.

The Company expects the Closing Date to occur on or about October 14, 2021. The Offering is subject to the satisfaction of certain customary closing conditions, including, but not limited to, the receipt of all necessary regulatory and stock exchange approvals (including, for certainty, the approval of the Toronto Stock Exchange).

The Offering is to be effected by way of a prospectus supplement to Appili’s base shelf prospectus dated September 19, 2019 (collectively, the “Prospectus Supplement”). The Prospectus Supplement will be filed in each Province of Canada (other than Quebec) and a copy of the Prospectus Supplement will be available under the Company’s profile at www.sedar.com. This news release does not provide full disclosure of all material facts relating to the Units. Investors should read the Prospectus Supplement for disclosure of those facts, especially risk factors relating to the Offering, before making an investment decision.

The net proceeds of the Offering will be used primarily towards funding research and development activities for oral COVID-19 antiviral candidate Avigan®/ReeqonusTM (favipiravir), including costs associated Appili’s global Phase 3 trial evaluating Avigan/Reeqonus for the treatment of mild-to-moderate COVID-19 (PREventing SEvere COVID-19; PRESECO). Net proceeds of the Offering will also be used to support business development initiatives to expand the Company’s portfolio of programs, as well as fund development costs for the Company’s other product candidates, including the ATI-2307 antifungal program, and for working capital and general corporate purposes. Details as to the specific allocation of the proceeds will be disclosed in the Prospectus Supplement.

 

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and accordingly, may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as each such term is defined in Regulation S under the U.S. Securities Act), except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions therefrom. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Corporation’s securities to, or for the account or benefit of, persons in the United States or U.S. Persons.

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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.

 

Forward looking statements

This news release contains “forward-looking statements”, including with respect to the proposed terms of the Offering, the anticipated closing date and the proposed use of proceeds. 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
E: [email protected]

 

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

HALIFAX, Nova Scotia, October 6, 2021 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, has announced today that it will undertake an overnight marketed public offering (the “Offering”) of units (the “Units”), comprised of Class A common shares and Class A common share purchase warrants (“Warrants”). The Offering is to be effected on a best efforts agency basis in each Province of Canada (other than Quebec) by way of a prospectus supplement (the “Prospectus Supplement”) to the Company’s base shelf prospectus dated September 19, 2019 (together with the Prospectus Supplement, the “Prospectus”). The number of Units to be distributed, the price and composition of each Unit, and the exercise price of each Warrant will be determined in the context of the market with final terms to be determined at the time of pricing. It is expected that the Offering will be conducted through a syndicate of agents led by Bloom Burton Securities Inc., and including iA Private Wealth Inc., Leede Jones Gable Inc., Research Capital Corporation, and Richardson Wealth Ltd.

The Offering is subject to a number of conditions, including, without limitation, receipt of all regulatory approvals. The net proceeds of the Offering will be used primarily towards funding research and development activities for oral COVID-19 antiviral candidate Avigan®/ReeqonusTM(favipiravir), including costs associated Appili’s global Phase 3 trial evaluating Avigan/Reeqonus for the treatment of mild-to-moderate COVID-19 (PREventing SEvere COVID-19; PRESECO). Net proceeds of the Offering will also be used to support business development initiatives to expand the Company’s portfolio of programs, as well as to fund development costs for the Company’s other product candidates, including the ATI-2307 antifungal program, and for working capital and general corporate purposes. Details as to the specific allocation of the proceeds will be disclosed in the Prospectus Supplement.

 

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and accordingly, may not be offered or sold in the United States (as such term is defined in Regulation S under the U.S. Securities Act), except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions therefrom. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Corporation’s securities in the United States.

+++

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”, including with respect to the proposed terms of the Offering and the proposed use of proceeds. 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
E: [email protected]

 

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

HALIFAX, Nova Scotia, September 29, 2021 – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, and AiPharma Global Holdings LLC (“AiPharma”), a private pharmaceutical research, development and commercialization company, today announced a strategic alliance to advance the global development of Avigan®/Reeqonus™ (favipiravir), a broad-spectrum oral antiviral currently being evaluated by Appili and its global consortium of partners for the potential treatment and prevention of COVID-19, including in Appili’s Phase 3 COVID-19 treatment trial PRESECO (PREventing SEvere COVID-19) which completed enrollment last week. Appili and AiPharma entered into a strategic equity transaction (the “Definitive Agreement”) to establish minority positions in each other’s businesses, further align their goals and participate in each other’s respective economic interests.

Selected highlights of the strategic alliance include:

• Accelerated and strengthened development of Avigan/Reeqonus (favipiravir) on a coordinated and worldwide basis
• AiPharma expects access to cash flows tied to the growing worldwide sales of Avigan/Reegonus via its 50% equity stake in consortium member Global Response Aid (“GRA”)
• The establishment of a joint scientific steering committee to coordinate the rapid development of Avigan/Reeqonus
• Equity transaction: Appili exchanges shares with AiPharma for strong alignment and mutual economic participation in each other’s respective businesses
• Plans to bring on additional programs, assets and partners to further the goal of becoming a global, integrated and infectious disease specialized healthcare company

“COVID-19 continues to be an immense health threat with little relief in sight. The world needs safe and effective oral antivirals that can help alleviate the threat of COVID-19, and I believe Avigan/Reeqonus has the potential to change the trajectory of this pandemic,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer of Appili Therapeutics. “This partnership will help us further streamline activities and move quickly following the PRESECO readout to key clinical, regulatory and commercial milestones.”

Alessandro Gadotti, Chief Executive Officer at AiPharma, added, “This is an exciting and important partnership for us. Our work with Appili will have real impact for people and communities around the world. The strength of oral antiviral treatments, such as Avigan/Reeqonus, in real terms is that they fight COVID-19 in the community and not in hospitals – which can majorly reduce pressures on healthcare systems. Our joint product portfolio puts us on the front line in the fight against COVID-19 and future pandemic preparedness. Our company was established by a team of drug development, infectious disease, data scientists and commercialization experts. We believe that this expertise, paired with Appili’s promising pipeline of specialty therapeutics, will allow us to evolve into a global integrated infectious disease healthcare company.”

One of AiPharma’s portfolio companies is GRA, a 50-50 joint venture with Agility (KSE/DFM: AGLTY) and a member of the consortium focused on the global development, commercialization and distribution of Avigan/Reeqonus. The consortium, which also includes the original Avigan/Reeqonus developer, FUJIFILM Toyama Chemical Co. Ltd., has made Avigan/Reeqonus available in jurisdictions where it is authorized as it completes its Phase 3 clinical program and has realized significant and rapidly growing global product revenues since the start of the pandemic. Through its participation in the consortium advancing Avigan/Reeqonus worldwide, GRA is entitled to 50% of the net profits from the worldwide sales of Avigan/Reeqonus (outside of Japan, China and Russia; net of any profit shares paid to Appili).

The partnership between Appili and AiPharma will include the formation of a joint scientific steering committee to further coordinate global clinical and regulatory activities for Avigan/Reeqonus around the world. The steering committee will include the following members:

• Dr. Armand Balboni, Chief Executive Officer, Appili
• Dr. Yoav Golan, Chief Medical Officer, Appili
• Dr. Alessandro Gadotti, Chief Executive Officer, AiPharma
• Dr. Richard Kaszynski, Chief Medical Officer, AiPharma

Under the terms of the equity transaction, AiPharma will receive that number of Class A common shares of Appili (“Appili Shares”) as is equal to 24% of the issued and outstanding Appili Shares immediately prior to the Definitive Agreement (calculated on a non-diluted basis). AiPharma has also been granted certain investor rights, including pre-emptive rights, certain consent rights and registration rights (which rights will be extinguished if the AiPharma holdings fall below 10% of the issued and outstanding Appili Shares). Assuming no further equity issuances, it is expected that AiPharma will hold approximately 19.4% of the issued and outstanding Appili Shares immediately following closing.

In exchange, Appili will receive approximately 6% of the issued and outstanding AiPharma shares (calculated on a non-diluted basis).

The Toronto Stock Exchange (“TSX”) has conditionally approved the transactions described herein (the “Transaction”). Closing of the Transaction is conditional upon obtaining certain third party consents and receipt of final TSX approval, which is subject to satisfaction of customary listing conditions (including clearance of requisite personal information forms on behalf of AiPharma).

The Transaction is expected to be completed in Q4 2021.

+++

Additional Early Warning Disclosures of AiPharma

Pursuant to the terms of the Definitive Agreement, AiPharma has agreed to subscribe for and purchase (the “Investment”) 15,079,709 Appili Shares, in consideration for the issuance of 66,721 shares of AiPharma, representing approximately a 6% interest in AiPharma as at September 28, 2021, with a value, based on the closing price of Appili’s shares on the Toronto Stock Exchange on September 28, 2021, of approximately C$15.4 million.

Immediately prior to the Investment, AiPharma, its affiliates and joint actors owned no voting or equity securities in the capital of Appili. Upon closing of the Investment, AiPharma and its affiliates will own 15,079,709 Appili Shares, representing approximately 19.4% of the currently outstanding Appili Shares, on a non-diluted basis. When acquired, the Appili Shares will be held by AiPharma for investment purposes and in furtherance of the strategic alliance of Appili and AiPharma on the potential joint development and commercialization of favipiravir and all other molecules of Appili’s portfolio, as is further provided for in the Definitive Agreement. Depending on market conditions and other factors, including AiPharma’s business and financial condition, AiPharma or its affiliates may acquire additional securities of Appili or dispose of some or all of the securities of Appili that it owns at such time.

AiPharma is a limited liability company organized under the laws of the State of Delaware. The principal business of AiPharma is pharmaceutical research, development and commercialization. AiPharma’s address is One JLT (14th Floor), Jumeriah Lakes Towers, Dubai, United Arab Emirates, PO Box 103805.

An early warning report with additional information in respect of the foregoing matters will be filed and made available on the System for Electronic Document Analysis and Review (SEDAR) at www.sedar.com under Appili’s profile. To obtain a copy of this report, you may also contact John White (General Counsel, AiPharma) at +971 58 554 8666.

 

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 AiPharma

AiPharma is a biopharmaceutical company focused on discovering, developing, and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company’s deep understanding of antiviral drug development, nucleotide chemistry, biology, biochemistry, and virology, AiPharma has built a nucleotide prodrug platform to develop novel product candidates to treat single-stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, AiPharma is focused on the clinical and commercial development of orally available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). AiPharma also holds exclusive commercial rights for Avigan in Russia and China. For more information, please visit www.aipharmalab.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.

 

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 anticipated closing date of the Transaction, the potential benefits of the Transaction, AiPharma’s expectations regarding its ability to access potential cash flows from the consortium sales of favipiravir, 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: securing final TSX approval for the Transaction in a timely manner; AiPharma’s ability to execute on its business strategy and enforce its contractual entitlements, including with respect to its ability access potential cash flows from the consortium sales of favipiravir, the timing of clinical results; securing all requisite required approvals and funding to complete all requisite clinical trials; other expectations and assumptions concerning the ongoing clinical trials (including with respect to the continuation and/or 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; the risk that the requisite conditions for final TSX approval for the Transaction cannot be satisfied on terms satisfactory to the parties or at all; risks relating to the failure of the parties to realize the anticipated benefits of this Transaction; risks relating to the volume of sales of favipiravir worldwide; risks relating to AiPharma’s ability to execute on its business strategy as currently contemplated and enforce its contractual entitlements, including with respect to the ability of AiPharma to access cash flows in connection with the sales of favipiravir by the consortium partners; risks relating to the inability of Appili to 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.

###

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 23, 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 enrollment in its global Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating oral Avigan®/Reeqonus™(favipiravir) as a potential COVID-19 treatment. Appili expects to report top-line data from this trial in approximately 60 days.

Appili launched the PRESECO clinical trial in November 2020 to evaluate oral Avigan/Reeqonus as a potential at-home therapy for patients with mild-to-moderate COVID-19. Enrollment targets were subsequently increased to maximize the number of patients and COVID-19 variant cases, including Delta, in the trial. With today’s announcement, the double-blind, placebo-controlled, randomized, global, multi-center trial has enrolled 1,231 patients from 38 study sites across the United States, Mexico, and Brazil.

“Completing enrollment in this large Phase 3 pivotal trial in just ten months is a tremendous accomplishment for Appili. With this major milestone now achieved, we have a clear path to completing the PRESECO data analysis in the coming weeks and determining if Avigan/Reeqonus has the potential to meet the urgent global clinical need for a safe and effective oral treatment for this deadly disease,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer, Appili Therapeutics.

The primary goal of PRESECO is to evaluate the impact of oral Avigan/Reeqonus on time to COVID-19 symptom resolution. The study also aims to evaluate the effect of oral treatment on progression to more severe COVID-19 disease. Finally, this Phase 3 clinical trial includes a viral shedding sub-study, which is evaluating impact of the treatment on time to viral clearance. Viral isolates will also be sequenced for identification of COVID-19 variants.

“As we have seen over the past 18 months, this virus continues to mutate, enhancing its ability to infect and cause significant symptoms, especially in those who have not been vaccinated. My hope is that Avigan/Reeqonus will emerge as a standard of care treatment for mild to moderate COVID-19 patients, resolve patient’s symptoms more rapidly, and limit progression to more severe disease” said Yoav Golan, M.D., Chief Medical Officer, Appili Therapeutics.

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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, global superiority trial investigating the safety and efficacy of oral Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms. Participants were enrolled 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 the ongoing Avigan® /Reeqonus (generic name: favipiravir) clinical trial and the likelihood that such clinical trial 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 clinical trial;; other expectations and assumptions concerning the clinical trial (including with respect to 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.

###

Media Contact
Mackenzie Mittleman
APCO Worldwide
T: 1-760-578-5079
E: [email protected]

 

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