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.

###

[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]

Categories
Archives Archives 2020

Appili Therapeutics Submits CTA with Health Canada to Sponsor Prophylactic Phase 2 Clinical Trial Evaluating FUJIFILM Toyama Chemical’s Favipiravir as a Preventative Measure Against COVID-19 in Canadian Long-Term Care Facilities

First clinical program in the world designed to assess the use of favipiravir for COVID-19 as prophylaxis for outbreak control; antiviral drug has shown early efficacy against COVID-19

HALIFAX, Nova Scotia, May 11, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that it will sponsor the first clinical trial evaluating FUJIFILM Toyama Chemical’s (FFTC) drug favipiravir for the prevention of COVID-19, a respiratory infection caused by the novel SARS-CoV-2 coronavirus. Favipiravir is approved in Japan as the anti-influenza drug Avigan. With FFTC providing support through donated drug product, the phase 2 study will be conducted at long-term care facilities in Ontario. Appili has filed the clinical trial application (CTA) with Health Canada and expects to initiate the trial as soon as possible following receipt of regulatory clearance.

“As the world races to address the COVID-19 pandemic, Appili is proud to support this endeavour that is looking at this problem specifically in Canada’s most vulnerable patients, establishing a world-class clinical program and significant contribution to the global dataset that is needed to help address this crisis,” said Armand Balboni, MD, PhD, Chief Executive Officer, Appili Therapeutics. “Appili was built to tackle the most urgent needs in infectious diseases in innovative ways that no other organization could or would be willing to take on. This program illustrates our commitment to leverage our relationships and expertise to do the right thing for patients and public health.”

Favipiravir is a broad-spectrum antiviral developed by FFTC and approved in Japan under the brand name Avigan. Japanese health authorities provided approval to FFTC in 2014 to use Avigan as a treatment in a pandemic influenza outbreak. Favipiravir was also used in a clinical trial to address the Ebola outbreak in Guinea. FFTC is actively supporting several controlled clinical trials for favipiravir to investigate its use against COVID-19. Recent studies suggest favipiravir may have potential utility for the treatment of COVID-19.     Researchers in Wuhan, China, reported in early February that favipiravir demonstrated anti-viral activity in vitro against SARS-CoV-2. Small-scale trials conducted in China have also indicated that favipiravir may provide clinical benefit in patients with COVID-19.

“We have an ongoing relationship with Appili and are pleased to support the company in its efforts to assess favipiravir for the potential benefit of Canadian patients,” said Junji Okada, President of FFTC. “We are well-aligned with Appili in our commitment to innovative R&D work that may address public health crises by mitigating the threat of deadly infections.”

The cluster randomized placebo-controlled trial (cluster-RCT) will recruit patients at multiple long-term care facilities throughout Ontario. The primary endpoint will be the safety and efficacy of favipiravir in the prevention of further outbreak in long-term care facilities. Secondary endpoints will assess favipiravir’s potential to inhibit disease progression in this subject population. As of May 2020, the majority of deaths in Canada resulting from COVID-19 have occurred in long-term care facilities, making this population especially vulnerable to the pandemic.

 

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 tothe scope,parameters and particulars 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. 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 regulatory approvals (including Health Canada approval) 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; the state of the current market conditions and their anticipated impact on the Company’s business; and other expectations and assumptions concerning the proposed clinical trial.  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.

###

[i] 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

[ii] Chen et al (2020) Favipiravir versus arbidol for COVID-19: A Ranomized 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
E: [email protected]

Categories
Archives Archives 2020

Appili Therapeutics to Present at Maxim Group’s Infectious Disease Virtual Conference

HALIFAX, Nova Scotia, May 4, 2020 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that Appili’s CEO Dr. Armand Balboni will be a panelist at the upcoming “Infectious Disease Virtual Conference” presented by Maxim Group. Dr. Balboni will be discussing Appili’s ATI-2307 program, a novel antifungal for resistant infections that the Company acquired from FUJIFILM Toyama Chemical in 2019. The conference, called, The Renaissance of the Anti-infective Sector, will occur online on Tuesday, May 5, 2020.

Presentation details are as follows:

  • Date: Tuesday, May 5, 2020
  • 12:15 – 1:45 p.m. ET
  • Panel: Antifungals

About the Conference

The conference consists of four panels of companies in various stages of development, from early stage to near commercialization, that represent the next wave of innovation in the infectious disease sector.

While COVID-19 has captured the world’s attention for now, there is another pandemic that has been smoldering beneath the surface; drug resistant bacteria and fungi driving alarming rates of invasive disease, which result in high rates of mortality and a significant burden on the healthcare system. The lag in development of novel anti-infectives is multi-factorial, but moving through 2020 and beyond, there is a renaissance in drug development taking place that has not been observed for some time. This includes novel drugs and new drug classes, changes in regulatory guidelines and incentives for drug developers, changes to clinical trial design and execution, changes in views from payers and the investment community.

 

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.

###

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 Names Infectious Disease Specialist Yoav Golan, MD, as its Chief Medical Officer

Dr. Golan, an infectious disease thought leader at Tufts Medical Center, fills key clinical position to help advance Appili’s infectious disease portfolio

HALIFAX, Nova Scotia, April 21, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that it has appointed Yoav Golan, MD, to serve as the Company’s first Chief Medical Officer (CMO). Dr. Golan has spent his 25+ year-career as an infectious disease (ID) medical specialist, most recently serving as an attending physician in the Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center, and as an associate professor at Tufts University School of Medicine in Boston. In his role as Appili’s CMO, Dr. Golan will be responsible for the clinical development strategy and execution across all of Appili’s pipeline assets, which is comprised of a broad spectrum of antimicrobial candidates. In particular, he will be a leadership resource for applying medical and scientific rigor to Appili’s clinical programs.

“As Appili’s pipeline assets progress toward active clinical trials, and our focus expands to include multiple types of antimicrobial programs, now is the optimal time to add patient-centered medical expertise to our leadership team,” said Armand Balboni, MD, PhD Chief Executive Officer, Appili Therapeutics. “We are thrilled to have an executive with Yoav’s caliber to lead our clinical programs; his lifelong commitment to patients and the breadth and depth of his infectious disease acumen will be invaluable resources for our work.”

Dr. Golan has conducted extensive research in the ID space, publishing several books and over 50 peer-reviewed studies in journals including The New England Journal of Medicine and The Lancet Infectious Diseases. His research focuses on hospital-acquired infections with emphasis on ICU infections, the impact of antibiotic resistance on outcomes, and development of early culture-independent treatment strategies. Dr. Golan’s recent work has focused on C. difficile infections as well as invasive candidiasis. He has been involved in the development of multiple anti-infectives, including, fidaxomicin, ceftaroline and bezlotuximab.

In addition to his work at Tufts, he has served several executive positions at biotechnology companies, including as Chief Scientific Officer of Profility Inc. and as Chief Executive Officer, ExArca Pharmaceuticals. He is on the peer review committee of multiple medical and scientific journals and is a member of numerous medical societies, including the Infectious Disease Society of America and the American Society for Microbiology. Dr. Golan is a graduate of the Hadassah School of Medicine at the Hebrew University in Jerusalem, Israel. He completed a medicine residency and Infectious Diseases fellowship at the Tel Aviv Sourasky Medical Center, followed by a transplant ID fellowship and masters in statistics and modeling at Tufts University School of Medicine.

“Now more than ever, we need strong, creative, and viable solutions to address the increasing threat of emerging infections,” said Dr. Golan. “Appili is doing excellent work to advance critical programs in the infectious disease space, and I look forward to continued work with the Board and the Company’s leadership team to advance research and help the patients who need better anti-infective options.”

Dr. Golan has served Appili in an advisory capacity since the Company’s inception in 2016. He will initially join Appili’s leadership team in a part time role and plans to maintain his work with Tufts Medical Center, also in a part-time capacity.

 

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. 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 Reports Financial and Operational Results for Third Quarter Fiscal Year 2020 Copy

HALIFAX, Nova Scotia, February 27, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today reported its financial and operational results for the third quarter of its fiscal year 2020, ending December 31, 2019.

Third quarter and recent operational highlights included:

  • Acquiring ATI-2307, a novel, antifungal candidate from FUJIFILM Toyama Chemical Co., LTD, thereby adding another clinical-stage asset to the Company’s pipeline;
  • Entering its first commercialization agreement by partnering with Saptalis Pharmaceuticals on ATI-1501, Appili’s taste-masked liquid oral suspension of the antibiotic metronidazole;
  • Naming Dr. Armand Balboni as Appili’s new Chief Executive Officer; and
  • Securing C$10,250,000 in funding via a marketed equity offering.

 

“Our third quarter proved to be a transformative period for Appili and we are pleased to continue executing against our mission: addressing urgent unmet needs in the infectious disease marketplace,” said Kimberly Stephens, Chief Financial Officer of Appili Therapeutics. “In the third quarter alone, we expanded our asset pipeline with the acquisition of ATI-2307—a novel anti-fungal clinical asset, secured an optimal partner for the commercialization of ATI-1501 and transitioned our CEO leadership to industry veteran Dr. Armand Balboni, whose significant late-stage development experience will be instrumental in this period of the Company’s corporate growth.”

Chief Executive Officer Dr. Balboni added, “Our recent funding has provided significant financial support that positions Appili to continue meeting our value-driving milestones. We are very pleased that this offering included many of our long-standing investors, as well as many new participants. Together with the Board of Directors and leadership team, we believe that Appili is well positioned to keep advancing our programs and maintain leadership in the infectious disease marketplace.”

 

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 $4,129,423 or $0.13 loss per share for the nine months ended December 31, 2019 was $1,104,895 higher than the net loss and comprehensive loss of $3,024,528 or $0.10 loss per share during the nine months ended December 31, 2018. This relates mainly to a $1,209,528 decrease in government assistance, a $795,797 increase in general and administrative expenses, a $337,128 increase in business development expenses, and a reduction of accreted interest by $90,193, offset by a $1,128,645 decrease in research and development (R&D) expenses and an increase of revenue by $199,106 attributable to the out-license of ATI-1501.

As of December 31, 2019, the Company had cash and short-term investments of $2,438,599, compared to $5,451,578 at March 31, 2019.

As of February 26, 2020, the Company had 46,401,447 Class A common shares (“Common Shares”) issued and outstanding. In addition, the Company had 4,402,932 stock options and 8,043,243 warrants outstanding as of February 26, 2020.

The Company’s unaudited interim condensed financial statements for December 31, 2019 and the management discussion and analysis (MD&A) are available on SEDAR at www.sedar.com.

 

Investor Relations Consultant

The Company also announced that it has retained Transcend Capital Inc. (“Transcend Capital”) to provide strategic investor relations services.  With offices in Vancouver, British Columbia, Transcend Capital is a full-service investor relations firm that assists small and mid-cap companies with market awareness campaigns and exposes their clients to an extensive network of retail and institutional clients. Mr. Etienne Moshevich is the sole owner of Transcend Capital.

Under the terms of the consulting agreement with Transcend Capital (the “Agreement”), the Company has agreed to pay Transcend Capital CDN $50,000 for a term of 6 months.  The Agreement is subject to the approval of the TSX Venture Exchange.  The Agreement has an initial term of six months but may be extended by the parties. The fees paid by the Company to Transcend Capital are for its services only.  Transcend Capital advises that it currently holds 62,500 common shares and 31,250 common share purchase warrants of the Company.

 

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this challenging disease space. Appili has built a pipeline of assets designed to address a broad range of urgent threats in global public health. ATI-2307, a novel, broad spectrum, clinical stage antifungal, is in development to address severe and difficult-to-treat invasive fungal infections. Via an in-licensing program, Appili is developing ATI-1701, a vaccine for tularemia, to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program developing a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with the antibiotic 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 science 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 July 2, 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 $10,250,000

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

HALIFAX, Nova Scotia, February 20, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”) is pleased to announce 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 between Bloom Burton Securities Inc. (the “Lead Agent”), Mackie Research Capital Corporation, Haywood Securities Inc. and Industrial Alliance Securities Inc. (together with the Lead Agent, the “Agents”) and the Company.

Pursuant to the Offering, the Company issued a total of 12,812,500 Units at a price of $0.80 per Unit for aggregate gross proceeds of $10,250,000. 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 CDN$1.10 per Warrant Share until February 20, 2023.

“Funds from this offering put Appili in a very solid position to keep delivering on the value-driving milestones in our pipeline,” said Dr. Armand Balboni, Chief Executive Officer of Appili. “Preparing our new asset, ATI-2307, for Phase 2 work; selecting a clinical candidate for our negamycin antibiotic program; delivering critical proof-of-concept one-year data on our ATI-1701 biothreat vaccine candidate; and working towards our first commercial product with our partner Saptalis Pharmaceuticals on ATI-1501, we are well-funded and galvanized to progress our assets against these urgent threats in the anti-infective space. We are especially pleased that this round welcomed a myriad of new shareholders to the Appili investor base, alongside the continued support of many of our long-standing shareholders.”

The Units were qualified for sale by way of a prospectus supplement dated February 14, 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 Offering, the Company has paid the Agents an aggregate cash consideration of $717,500. As additional consideration, the Agents have received 896,875 broker warrants (“Broker Warrants”). Each Broker Warrant is exercisable for one Common Share (a “Broker Warrant Share”) at a price of $0.80 per Broker Warrant Share until February 20, 2022.

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 U.S. Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from 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 Offering, the Lead Agent received 256,545 Broker Warrants. Prior to the closing of the Offering, Bloom Burton & Co. Inc. (“Bloom Burton”), an affiliate of the Lead Agent, beneficially owned, directly and indirectly, 14,350,120 Common Shares (13,896,000 of which are held by its wholly-owned subsidiary Bloom Burton Development Corporation) 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 (which are held by the Lead Agent), representing approximately 42.72% of the then issued and outstanding Common Shares on a non-diluted basis, and 42.74% of the then issued and outstanding Common Shares on a partially-diluted basis, assuming the exercise of the IPO Broker Warrants held by Bloom Burton and its affiliates only.

Immediately following closing of the Offering, Bloom Burton beneficially owns, directly or indirectly, 14,350,120 Common Shares, 2,200 IPO Broker Warrants and 256,545 Broker Warrants, representing 30.93% of the Common Shares issued and outstanding on a non-diluted basis and 31.32% of the Common Shares issued and outstanding on a partially-diluted basis, assuming the exercise of the IPO Broker Warrants and the Broker Warrants held by Bloom Burton and its affiliates 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. 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. 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. The head office of the Company is located at #21 – 1344 Summer St., Halifax, Nova Scotia, B3H 0A8.

 

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 Upsizing of Previously Announced Equity Offering in February 2020

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

HALIFAX, Nova Scotia, February 14, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”) is pleased to announce today that it has increased the size of its previously announced offering of equity securities (the “Offering”). Pursuant to the revised terms of the Offering, Appili will issue an aggregate of 12,812,500 Units at a price of C$0.80 per Unit (the “Offering Price”) for aggregate gross proceeds of C$10,250,000. 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$1.10 and entitles the holder thereof to acquire one Common Share for a period of 3 years following the closing of the Offering (the “Closing”).

The Offering is being 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 led by Bloom Burton Securities Inc. and including Mackie Research Capital Corporation, Haywood Securities Inc. and Industrial Alliance Securities Inc. (collectively, 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.  The Offering will no longer be subject to an over-allotment option.

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 Company expects the Closing to occur on or about February 20, 2020.

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 to fund planned research and development activities for the Company’s four product candidates including the newly acquired ATI-2307 antifungal program, the ATI-1701 tularemia vaccine program, the antibiotic ATI-1503 program and the out-licensed ATI-1501 reformulation 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 U.S. Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from 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. 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]