Categories
Archives Archives 2020

Appili Therapeutics Receives Eligibility for DTC Trading in the U.S

HALIFAX, Nova Scotia, August 11, 2020 – Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the Company or Appili), a biopharmaceutical company developing anti-infective drug candidates, today announced that its listed in the common shares United States, under the symbol APLIF, are Depository Trust Company (DTC) eligible. DTC is a subsidiary of the Depository Trust & Clearing Corporation, a U.S. company that manages the electronic clearing and settlement of publicly traded companies. DTC services provide simplification, convenience, and cost benefits for investors and brokers trading Canadian securities in the United States.

“Our programs have implications worldwide, including our recently announced U.S. expansion of the Phase 2 trial evaluating favipiravir as a prophylaxis against COVID-19,” said  Kimberly Stephens, Chief Financial Officer of Appili Therapeutics. “DTC eligibility provides access to a broader base of investors in North America and bolsters the visibility of Appili in the capital markets, thereby further solidifying our ability to improve our share liquidity and advance our programs.”

Appili’s common shares will continue to trade under Cusip #03783R107 and ISIN # CA03783R1073.

 

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FFTC’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

This news release contains “forward-looking statements” which reflect the current expectations of the Company’s management future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for,” and similar expressions have been used to identify these forward-looking statements. Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 24, 2020 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

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

 

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

Categories
Archives Archives 2020

FDA Clears Appili Therapeutics to Expand its Phase 2 Clinical Trial of Favipiravir for the Potential Prevention of COVID-19 at U.S. Long-Term Care Facilities

U.S. expansion of antiviral outbreak control trial in long-term care facilities

Favipiravir already approved in India and Russia for emergency use against COVID-19 and as a pandemic influenza antiviral medication in Japan

First oral antiviral that may provide protection for elderly and vulnerable populations without need for intravenous administration or injections

Over 40% of deaths in the United States involve nursing home residents and staff [i]

HALIFAX, Nova Scotia, August 10, 2020 – Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to proceed after Appili’s filing of an investigational new drug (IND) application for broad-spectrum antiviral favipiravir. Appili is expanding its Phase 2 clinical trial into the U.S. to evaluate the safety and efficacy of favipiravir tablets in controlling outbreaks following exposure to COVID-19 in long-term care (LTC) facilities. Appili’s Phase 2 clinical trial is leveraging the versatility of favipiravir as an oral tablet suitable for administration across a wide variety of care settings, including long-term care.Appili intends to enroll up to 760 participants in this Phase 2 clinical trial across both the U.S. and in Canada. Health Canada provided regulatory clearance on May 21, 2020 for Appili’s Phase 2 study evaluating FUJIFILM Toyama Chemical’s (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks.

“The burden of illness in long-term care centers continues to be a significant problem, and finding ways to offer LTC residents and staff protection against COVID-19 with an oral treatment would be a significant advance in our fight to control the devastating effects of this pandemic,” said Dr. Armand Balboni, Chief Executive Officer at Appili Therapeutics. “The limited response to vaccines often seen in the elderly further supports expanding this trial into the U.S. Favipiravir is an antiviral that can be administered orally as a tablet, without the need to be given intravenously or as injections, and may be an important option to avoid and/or control outbreaks in elderly residents living in LTC facilities.”

“The elderly are at the highest risk for contracting the disease and the rising rates of COVID-19 infection currently seen in much of the U.S. will likely continue to be a major threat to those living and working in long-term care facilities,” said Primary Investigator Dr. Allison McGeer, senior clinician scientist at the Lunenfeld-Tanenbaum Research Institute at Sinai Health. “Through the means of a randomized control clinical trial, our team is looking forward to working with clinical partners in the U.S. to understand if favipiravir could be an option for outbreak control in this setting.”

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

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.

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FUJIFILM Toyama Chemical Inc.’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

 

Forward looking statements

This news release contains “forward-looking statements,” which reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities, including statements with respect to: the scope and parameters of the proposed clinical trial in Canada and the U.S. and the likelihood that such clinical trial will be consummated on the terms and timeline provided herein or at all; and the potential use of favipiravir for the treatment of COVID-19 (including as a method of outbreak control in long-term care facilities). Wherever possible, words such as “may,” “would,” “could, “ “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to: securing all requisite required approvals and funding for the clinical trial in Canada and the U.S.; finalizing a mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to this clinical trial; patient enrolment; and other expectations and assumptions concerning the proposed clinical trial in Canada and the U.S. (including with respect to potential outcomes and benefits). Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.

Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, economic, competitive, political and social uncertainties; known and unknown risks and liabilities relating to the ongoing COVID-19 pandemic; risks relating to the inability of Appili to secure any requisite rights to manufacture and commercialize favipiravir in Canada, the U.S and other jurisdictions on favourable terms or at all; unforeseen events, developments, or factors causing any of the aforesaid expectations and assumptions not to be correct; and the other risk factors listed in the annual information form of the Company dated June 24, 2020 and the other filings made by the Company with the Canadian securities’ regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

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

 

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

 

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

 

[i] The New York Times: More Than 40% of U.S. Coronavirus Deaths Are Linked to Nursing Homes

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

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

Categories
Archives Archives 2020

Appili Prepares Canadian Long-Term Care Facilities to Enroll Participants in a Clinical Trial Evaluating Favipiravir as an Outbreak Control Agent Against COVID-19

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

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

HALIFAX, Nova Scotia, July 30, 2020 – Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that the Company has initiated site screening of long term care (LTC) facilities in Ontario for its Phase 2 study evaluating favipiravir as a post-exposure outbreak control measure against COVID-19. Residents at screened sites will be eligible for enrollment and randomization into the trial upon confirmation of a COVID-19 outbreak. The trial is expected to ultimately enroll approximately 760 participants at 16 LTC facilities. Appili may increase the number of LTC facilities screened depending on the trajectory of the COVID-19 pandemic.

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

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

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

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

 

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FUJIFILM Toyama Chemical Inc.’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

 

Forward looking statements

This news release contains “forward-looking statements,” which reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities, including statements with respect to: the scope and parameters of the proposed clinical trial and the likelihood that the clinical trial will be consummated on the terms and timeline provided herein or at all; and the potential use of favipiravir as a prophylactic agent for the treatment of COVID-19. Wherever possible, words such as “may,” “would,” “could, “ “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements.  Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to: securing all requisite required approvals and funding for the clinical trial;  site availability and patient enrolment; and other expectations and assumptions concerning the proposed clinical trial (including with respect to potential outcomes and benefits). Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.

Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, economic, competitive, political and social uncertainties; known and unknown risks and liabilities relating to the ongoing COVID-19 pandemic; risks relating to the inability of Appili to secure any requisite rights to manufacture and commercialize favipiravir in Canada on favourable terms or at all; unforeseen events, developments, or factors causing any of the aforesaid expectations and assumptions not to be correct; and the other risk factors listed in the annual information form of the Company dated June 24, 2020 and the other filings made by the Company with the Canadian securities’ regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

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

###

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

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

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

 

TSXV: APLI

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

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

Categories
Archives Archives 2020

Appili Therapeutics Announces FY 2020 Annual and Financial Results

Company well-capitalized, reporting record level of capital support with over $27M CAN in equity financings

Pipeline portfolio strengthened with initiation of unique COVID-19 clinical study focused on preventing disease outbreaks in long-term care settings, acquisition of Phase 2-ready novel anti-fungal program, and commercialization deal for later-stage antibiotic

HALIFAX, Nova Scotia, June 24, 2020 – Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today reported its financial and operational results for the year ended March 31, 2020.

“2020 proved to be a transformative year for Appili,” said Armand Balboni, MD, PhD, Chief Executive Officer of Appili Therapeutics. “Appili emerged fully onto the global biotech stage this year, transitioning to a publicly traded company, adding novel anti-fungal and anti-viral programs to our development portfolio, including our recently announced trial assessing favipiravir, which we believe has the potential to address a critical global unmet need as a preventative agent for COVID-19. We look forward to making continued, purposeful progress over the course of the next year as Company advances its mission to identify and address significant unmet needs in the infectious disease sector, and beyond.”

2020 and recent highlights included:

– Financial

  • Debuted as a public company on the TSXV exchange and subsequently began trading on the OTCQX trading platform
  • Completed successful equity financings for $10.25M CAD in February 2020 and $16.9M CAD in June 2020
  • Increased its non-dilutive funding, including a $3M USD grant from the U.S. Department of Defense and a $476,000 CAD repayable contribution through Atlantic Canada Opportunities Agency

– Leadership

  • Named Dr. Armand Balboni as new Chief Executive Officer
  • Expanded the Board of Directors with the addition of veteran biotech executive Dr. Juergen Froehlich
  • Named infectious disease specialist Dr. Yoav Golan as Appili’s Chief Medical Officer

– Development Programs

  • Received Health Canada approval to initiate Phase 2 trial evaluating FujiFilm Toyama Chemical’s (“FFTC”) favipiravir as a prophylaxis against COVID-19 outbreaks in long-term care homes (May 2020)
  • Entered into a commercialization agreement with Saptalis Pharmaceuticals for Appili’s reformulation of the antibiotic metronidazole (December 2019)
  • Acquired ATI-2307, a novel broad spectrum anti-fungal drug candidate from FFTC to target resistant fungal infections, including Cryptococcus and Candida (November 2019)

“Appili has laid the groundwork for continued progress and impact in our industry,” said Kimberly Stephens, CPA, CA, Chief Financial Officer at Appili. “With continued support from the investor community – including two successful fundraises – and our listing on TSXV and the OTCQX trading platform, we remain well capitalized and well positioned to advance our pipeline through milestones that create value for our shareholders and solutions for patients.”

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.

 

Financial Results

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

The net loss and comprehensive loss of $5,416,496 or $0.16 loss per share for the year ended March 31, 2020 was $1,085,512 higher than the net loss and comprehensive loss of $4,330,984 or $0.14 loss per share during the year ended March 31, 2019. This relates mainly to a $909,918 increase in general and administrative expenses, a $1,483,478 decrease in government assistance and a $80,949 increase in business development, offset by a $1,242,315 decrease in research and development (R&D) expenses and a $53,588 increase in accreted interest.

At March 31, 2020, the Company had cash and short-term investments of $10,540,165 and working capital of $9,732,658, compared to $5,451,578 and $5,405,447, respectively at March 31, 2019. Subsequent to the year ended March 31, 2020, the Company completed a public offering for aggregate gross proceeds of $15,525,000 and a concurrent private placement for aggregate gross proceeds of $1,440,000 on June 10, 2020.

As of June 24, 2020, the Company had 61,604,011 Class A common shares issued and outstanding, 4,021,757 stock options and 7,359,354 and warrants.

This press release should be read in conjunction with the Company’s audited annual consolidated financial statements for the fiscal year ended March 31, 2020 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 Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FFTC.’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

This news release contains “forward-looking statements” which reflect the current expectations of the Company’s management future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may “, “would “, “could “, “should”, “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 24, 2020 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

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

 

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

Categories
Archives Archives 2020

Appili Therapeutics Commences Trading on the OTCQX Marketplace

HALIFAX, Nova Scotia, June 15, 2020 – Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the “Company” or “Appili”) is pleased to announce today that its common shares began trading on the OTCQX Best Market®.  The OTCQX Market offers companies efficient, cost-effective access to the U.S. capital markets. Appili’s shares are trading under the ticker symbol “APLIF.”

“The OTCQX qualification provides trading access for our securities to US-based investors, which is an important milestone as we advance our anti-infective programs and build our visibility in the global marketplace,” said Kimberly Stephens, CP, CFA, Chief Financial Officer, Appili Therapeutics. “Our pipeline programs, including our recently announced trial that is investigating the use of favipiravir in COVID-19, have implications worldwide. This milestone provides transparency to our current and future shareholders on a recognized U.S. securities trading platform.”

The OTCQX® Best Market is for established, investor-focused U.S. and international companies. To qualify for the OTCQX market, companies must meet high financial standards, follow best practice corporate governance, demonstrate compliance with U.S. securities laws, be current in their disclosure, and have a professional third-party sponsor introduction.

 

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FUJIFILM Toyama Chemical Inc.’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

 

Forward looking statements

This news release contains “forward-looking statements” which reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities. 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 July 3, 2019 and the other filings made by the Company with the Canadian securities’ regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

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

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

Categories
Archives Archives 2020

Appili Therapeutics Announces Closing of Public Offering of $15,525,000 and Concurrent Private Placement of $1,440,000

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

HALIFAX, Nova Scotia, June 10, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”) announced the closing of its previously announced public offering (the “Public Offering”) of units (the “Units”). The Public 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 Mackie Research Capital Corporation, Industrial Alliance Securities Inc., Haywood Securities Inc., and Richardson GMP Limited (collectively with the Lead Agent, the “Agents”) and the Company.

Pursuant to the Public Offering, the Company issued a total of 12,937,500 Units at a price of $1.20 per Unit for aggregate gross proceeds of $15,525,000, which includes the exercise in full by the Agents of their over-allotment option to purchase 1,687,500 additional Units for additional gross proceeds of $2,025,000. 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 $1.50 per Warrant Share until June 10, 2023.

“Appili has entered the global effort to solve the COVID-19 pandemic, and our team, along with our partners, including Fujifilm Toyama Chemical and Sinai Health, are working diligently to advance this randomized controlled trial as quickly and as thoroughly as possible,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Appili was built to solve infectious disease problems, and we believe that favipiravir will be an important part of the arsenal that ultimately addresses this coronavirus pandemic. With the continued support from the investment community, the results of this fundraise bolsters our capacity to push forward our Phase 2 program, which is designed to address a critical unmet need for the most vulnerable COVID-19 patients.”

The Units were qualified for sale by way of a prospectus supplement dated June 5, 2020 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 Public Offering, the Company has paid the Agents an aggregate cash consideration of $1,083,390. As additional consideration, the Agents have received 902,825 broker warrants (“Broker Warrants”). Each Broker Warrant is exercisable for one Common Share (a “Broker Warrant Share”) at a price of $1.20 per Broker Warrant Share until June 10, 2022.

The Company also currently closed a non-brokered private placement of 1,200,000 Units, at the Offering Price for gross proceeds of $1,440,000 (the “Concurrent Private Placement” and with the Public Offering, the “Offerings”). No fees or commissions are payable to the Agents in connection with the Concurrent Private Placement. All securities issued pursuant to the Concurrent Private Placement are subject to a hold period of four months.

The net proceeds of the Public Offering will be used primarily towards funding planned research and development activities for the clinical trial sponsored by the Company evaluating FUJIFILM Toyama Chemical Inc.’s (“FFTC”) drug favipiravir in long-term care facilities as a potential preventative measure against COVID-19. Net proceeds of the Public Offering will also be used to fund development costs for the Company’s other product candidates, including the ATI-2307 antifungal program, the ATI-1701 tularemia vaccine program, and the antibiotic ATI-1503 program, as well as for working capital and general corporate purposes. Details as to the specific allocation of the proceeds are disclosed in the Prospectus.

The net proceeds of the Concurrent Private Placement are expected to be used to fund other research and development activities, business development activities, general and administrative expenses, and for general working capital purposes.

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.

As partial consideration for its services in connection with the Public Offering, the Lead Agent received 280,777 Broker Warrants. Prior to the closing of the Offerings, 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 14,350,120 Common Shares, 256,545 share purchase warrants (the “Previously Held Broker Warrants”) exercisble into 256,545 Common Shares at a price of $0.80 per Common Share until February 20, 2023, and 2,200 share purchase warrants (the ”IPO Broker Warrants”) exercisable into 8,491 Common Shares at a price of $1.10 per Common Share until November 21, 2020, representing approximately 30.24% of the then issued and outstanding Common Shares on a non-diluted basis, and 30.62% of the then issued and outstanding Common Shares on a partially-diluted basis, assuming the exercise of the IPO Broker Warrants and Previously Held Broker Warrants held by Bloom Burton and its affiliates only.

Immediately following closing of the Offerings, Bloom Burton beneficially owns, directly or indirectly, 14,350,120 Common Shares, 2,200 IPO Broker Warrants, 256,545 Previously Held Broker Warrants and 280,777 Broker Warrants, representing 23.30% of the Common Shares issued and outstanding on a non-diluted basis and 23.97% of the Common Shares issued and outstanding on a partially-diluted basis, assuming the exercise of the IPO Broker Warrants, 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, to the extent permitted under the escrow agreement dated as of June 12, 2019 to which Bloom Burton is party.

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.

 

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FFTC’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

 

Forward looking statements

This news release contains “forward-looking statements”, including with respect to the 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.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

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

 

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

Categories
Archives Archives 2020

Appili Therapeutics Announces Filing of Prospectus Supplement and Proposed Concurrent Private Placement

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

HALIFAX, Nova Scotia, June 5, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”) announced today that it has filed a prospectus supplement to its base shelf prospectus dated September 19, 2019 (collectively, the “Prospectus Supplement”) in connection with its previously announced overnight marketed offering of equity securities (the “Public Offering”). The Prospectus Supplement was 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.

Concurrently with the filing of the Prospectus Supplement, the Company has entered into an agency agreement with a syndicate of agents led by Bloom Burton Securities Inc. (the “Lead Agent”) and including Mackie Research Capital Corporation, Industrial Alliance Securities Inc., Haywood Securities Inc. and Richardson GMP Limited (collectively with the Lead Agent, the “Agents”) governing the issuance, on a best efforts agency basis, of 11,250,000 units of the Company (“Units”) at a price of C$1.20 per Unit (the “Offering Price”) for gross proceeds of C$13,500,000.  Each Unit is comprised of one Class A common share of the Company (a “Common Share”) and one-half (1/2) of one Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant is exercisable at a price of C$1.50 and entitles the holder thereof to acquire one Common Share for a period of 3 years following the date of the closing of the Public Offering (the “Closing Date”). The Company has also granted the Agents an over-allotment option to offer for sale that number of additional Units equal to 15% of the Units sold under the Public Offering and/or additional Warrants equal to 15% of the number of Warrants sold under the Public Offering (in each case excluding the over-allotment option), exercisable at any time up to 30 days after the Closing Date.

In connection with the Public Offering, the Agents will be paid a cash commission equal to 7.0% of the gross proceeds of the Public Offering (including any Units sold pursuant to the exercise of the over-allotment option, but not including any Units sold to purchasers on a president’s list to be agreed to by the Company and the Lead Agent (the “Purchaser’s List”)) 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 Public Offering (including any Units sold pursuant to the exercise of the over-allotment option, but excluding Units sold to President’s List purchasers).  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 also announced the proposed issuance of an aggregate of approximately 1,200,000 Units, on a non-brokered private placement basis, at the Offering Price for gross proceeds of approximately $1,440,000 (the “Concurrent Private Placement”). No fees or commissions will be payable to the Agents in connection with the Concurrent Private Placement.

The net proceeds of the Public Offering will be used primarily towards funding planned research and development activities for the clinical trial sponsored by the Company evaluating FUJIFILM Toyama Chemical Inc.’s (FFTC) drug favipiravir in long-term care facilities as a potential preventative measure against COVID-19. Net proceeds of the Public Offering will also be used to fund development costs for the Company’s other product candidates, including the ATI-2307 antifungal program, the ATI-1701 tularemia vaccine program and the antibiotic ATI-1503 program, as well as for working capital and general corporate purposes. Details as to the specific allocation of the proceeds are disclosed in the Prospectus Supplement.

The net proceeds of the Concurrent Private Placement are expected to be used to fund other research and development activities, business development activities, general and administrative expenses and for general working capital purposes.

The Company expects to close the Public Offering and the Concurrent Private Placement on or about June 10, 2020. The Public Offering and the Concurrent Private Placement are 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 TSX Venture Exchange.

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, including applicable risk factors, before making an investment decision.

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 Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FUJIFILM Toyama Chemical Inc.’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

 

Forward looking statements

This news release contains “forward-looking statements”, including with respect to expected closing of the Public Offering, the Concurrent Private Placement 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 Prospectus Supplement and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

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

 

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

Categories
Archives Archives 2020

Appili Therapeutics Announces Pricing of Overnight Marketed Equity Offering in June 2020

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

HALIFAX, Nova Scotia, June 4, 2020 – Appili Therapeutics Inc. (TSXV: 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 11,250,000 units of the Company (“Units”) at a price of C$1.20 per Unit (the “Offering Price”) for gross proceeds of C$13,500,000. Each Unit is comprised of one Class A common share of the Company (a “Common Share”) and one-half (1/2) of one Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant is exercisable at a price of C$1.50 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 Mackie Research Capital Corporation, Industrial Alliance Securities Inc., Haywood Securities Inc. and Richardson GMP 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 (including any Units sold pursuant to the exercise of the over-allotment option, but not including any Units sold to purchasers on a president’s list to be agreed to by the Company and the Lead Agent (the “Purchaser’s List”)) 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 (including any Units sold pursuant to the exercise of the over-allotment option, but excluding Units sold to President’s List purchasers).  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 will also grant the Agents an over-allotment option to offer for sale that number of additional Units equal to 15% of the Units sold under the Offering and/or additional Warrants equal to 15% of the number of Warrants sold under the Offering (in each case excluding the over-allotment option), exercisable at any time up to 30 days after the Closing Date.

The Company expects the Closing Date to occur on or about June 10, 2020. 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 TSX Venture Exchange (the “TSXV”)).

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 planned research and development activities for the clinical trial sponsored by the Company evaluating FUJIFILM Toyama Chemical Inc.’s (FFTC) drug favipiravir in long-term care facilities as a potential preventative measure against COVID-19. Net proceeds of the Offering will also be used to fund development costs for the Company’s other product candidates, including the ATI-2307 antifungal program, the ATI-1701 tularemia vaccine program and the antibiotic ATI-1503 program, as well as for working capital and general corporate purposes. Details as to the specific allocation of the proceeds will be disclosed in the Prospectus Supplement.

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 Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FUJIFILM Toyama Chemical Inc.’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

 

Forward looking statements

This news release contains “forward-looking statements”, including with respect to expected closing 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 July 3, 2019 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

###

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

 

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

Categories
Archives Archives 2020

Appili Therapeutics Announces Overnight Marketed Equity Offering

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

HALIFAX, Nova Scotia, May 17, 2022 – Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced 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 May 16, 2022 (the “Base Shelf 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 Leede Jones Gable Inc.

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 for working capital purposes and to fund the development of certain product candidates of the Company. 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. The Company is currently advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic product for the treatment of a disfiguring disease, 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, the Base Shelf 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.

###

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]

Categories
Archives Archives 2020

Health Canada Clears Appili Therapeutics’ Phase 2 Clinical Trial Evaluating Favipiravir as a Prophylactic Agent Against COVID-19 Outbreaks

Appili program designed to address the most urgent aspects of the COVID-19 public health threat

First clinical study to examine the use of favipiravir for COVID-19 outbreak control; National Institute on Ageing estimates over 80 per cent of COVID-19 deaths in Canada are occurring at long-term care facilities

With drug donated by FUJIFILM Toyama Chemical, Appili will conduct the trial with infectious disease specialists at Sinai Health in Toronto, the University of Toronto, Sunnybrook Health Sciences Centre, and Unity Health Toronto

HALIFAX, Nova Scotia, May 21, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that Health Canada provided regulatory clearance for Appili’s Phase 2 study evaluating FUJIFILM Toyama Chemical’s (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks. Dr. Allison McGeer, senior clinician scientist at Sinai Health’s Lunenfeld-Tanenbaum Research Institute in Toronto, Ontario is the study’s primary investigator. Appili expects trial recruitment to begin imminently. Researchers will enroll approximately 760 subjects, both residents and staff, at 16 long-term care homes (LTCHs) in Ontario. The National Institute on Ageing has estimated that as of May 6, 2020, 82 percent of deaths related to COVID-19 in Canada were associated with long-term care facilities.[i]

“Given the severity of COVID-19 amongst the elderly, and the evidence of ongoing transmission with severe outcomes in LTCHs, it is critical to develop interventions that minimize the spread of disease in this setting. As vaccines and treatment for COVID-19 remain unavailable, we must explore all possible solutions,” said Dr. McGeer. “We look forward to working with Appili on this study, as the pandemic continues to present devastating consequences for LTCH residents and their families.”

 

The Trial

The partially blinded, cluster randomized placebo-controlled trial (cluster-RCT) will recruit approximately 760 participants across 16 LTCHs in Ontario. Investigators from the University of Toronto, Sunnybrook Health Sciences Centre, and Unity Health Toronto are also participating in the study. The primary objective of the Phase 2 trial is to evaluate the efficacy of favipiravir or 25 days compared with placebo as a prophylaxis to prevent COVID-19 outbreaks in LTCHs. The primary endpoint will be outbreak control, defined as no new cases of COVID-19 in residents for 24 consecutive days up to Day 40 after the start of prophylaxis. Secondary objectives include measures of safety, rates of infection, disease progression, and fatality rates.

“With the strikingly high fatality rate from COVID-19 in long- term care facilities, there is a particularly urgent need to protect our most vulnerable members of society. Preventing and controlling COVID-19 outbreaks in long-term care facilities is therefore of extreme importance,” said Yoav Golan, MD, Chief Medical Officer at Appili Therapeutics. “Industry and academia are coming together in unprecedented ways to mitigate this crisis, and Appili is proud to be part of this unique collaboration. Dr. McGeer and her team at Mount Sinai, along with our other medical partners from some of the premier institutions in Toronto, have extensive experience in working to mitigate respiratory infections in long term care settings. Together with the support from FFTC, we are in a unique position to evaluate the utility of favipiravir as a COVID-19 prophylaxis to control further outbreaks in these facilities, which could be a significant advance for Canadian patients, with implications for global application in similar high-risk outbreak settings.”

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

 

Favipiravir

Favipiravir is a broad-spectrum antiviral approved in Japan under the brand name Avigan. Japanese health authorities provided approval to FFTC in 2014 to use Avigan as a treatment and stockpile countermeasure for pandemic influenza outbreak. Recent studies suggest favipiravir may have potential utility for the treatment of COVID-19.[ii] [iii] Researchers in Wuhan, China, reported in early February that favipiravir demonstrated anti-viral activity in vitro against SARS-CoV-2. Small-scale clinical trials conducted in China have also indicated that favipiravir may provide clinical benefit in patients with COVID-19.

 

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments, and government agencies. For more information, visit www.AppiliTherapeutics.com.

 

Forward looking statements

This news release contains “forward-looking statements,” which reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities, including statements with respect to: the scope and parameters of the proposed clinical trial and the likelihood that the clinical trial will be consummated on the terms and timeline provided herein or at all; and the potential use of favipiravir as a prophylactic agent for the treatment of COVID-19. Wherever possible, words such as “may,” “would,” “could, “ “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements.  Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to: securing all requisite required approvals and funding for the clinical trial; finalizing a mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to this clinical trial;  patient enrolment; and other expectations and assumptions concerning the proposed clinical trial (including with respect to potential outcomes and benefits). Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.

Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, economic, competitive, political and social uncertainties; known and unknown risks and liabilities relating to the ongoing COVID-19 pandemic; risks relating to the inability of Appili to secure any requisite rights to manufacture and commercialize favipiravir in Canada on favourable terms or at all; unforeseen events, developments, or factors causing any of the aforesaid expectations and assumptions not to be correct; and the other risk factors listed in the annual information form of the Company dated July 3, 2019 and the other filings made by the Company with the Canadian securities’ regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

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[i] MacCharles, Tonda. 82% of Canada’s COVID-19 deaths have been in long-term care, new data reveals. The Star Accessed online May 7, 2020.

[ii] Cai et al (2020) Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study. Engineering. https://doi.org/10.1016/j.eng.2020.03.007

[iii] Chen et al (2020) Favipiravir versus arbidol for COVID-19: A Randomized Clinical Trial. medRxiv preprint doi: https://doi.org/10.1101/2020.03.17.20037432

Media Relations Contact:
Canadian Media:
Chantal Allan
Sam Brown Inc.
T: 805-242-3080
E: [email protected]

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

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