Author: rajarshi

HALIFAX, Nova Scotia, July 3, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced its financial and operational results for the year ended March 31, 2019.

Operational highlights include:

• Announcing results in its completed Phase 1 study for ATI-1501, a pivotal relative bioavailability trial that met its primary objective by demonstrating that ATI-1501 achieved equivalent systemic drug levels as a metronidazole tablet; it was also well tolerated, consistent with the known safety profile of metronidazole
• Securing a $3.6M in funding via a special warrant private placement round enabling the Company to complete a direct listing on the TSX Venture Exchange (“TSXV”)
• Expanding the leadership team to include Armand Balboni, MD, as Chief Development Officer and Myriam Triest, PhD, as Director, Manufacturing and Pharmaceutical Development
• Expanding its Board of Directors with the appointment of Global Infectious Disease Pharmaceutical Executive Dr. Theresa Matkovits

“FY2019 was a great year for Appili Therapeutics as we advanced our pipeline, expanded our team, and laid the groundwork for long term operational and financial success,” said Kevin Sullivan, CEO of Appili Therapeutics. “We achieved a major milestone by listing on the TSXV last month; are well funded to near term milestones; and looking forward to the next stage in our growth. We are energized about the opportunities on our horizon and remain committed to our mission: provide value to patients and shareholders by delivering solutions to address the global threat of infectious diseases.”

 

Annual Financial Results

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

The net loss and comprehensive loss of $4,300,984 or $0.14 loss per share for the year ended March 31, 2019 was $354,869 higher than the net loss and comprehensive loss of $3,976,115 or $0.16 loss per share during the year ended March 31, 2018. This relates mainly to a $751,629 increase in general and administrative expenses, a $621,226 decrease in government assistance and a $126,446 increase in business development, offset by a $894,253 decrease in research and development (R&D) expenses and a $250,179 increase in accreted interest.

At March 31, 2019, the Company had cash and short-term investments of $5,451,578 and working capital of $5,405,447, compared to $5,751,820 and $5,866,482, respectively at March 31, 2018.

As of July 2, 2019, the Company had 33,588,947 Class A common shares (“Common Shares”) issued and outstanding. In addition, the Company had 725,967 stock options and 259,877 and warrants exercisable into 2,737,898 and 1,003,117 Common Shares, respectively.

The Company’s audited annual consolidated financial statements for 2019 and the management discussion and analysis (MD&A), are available on SEDAR at www.sedar.com.

 

About Appili Therapeutics

Appili Therapeutics, Inc. was founded to advance the global fight against infectious disease by matching clearly-defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this challenging 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. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, being developed to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, which are 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 metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, 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. Such statements include, but are not limited to, statements regarding the Company’s proposed development plans and business strategy. 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 statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to adequately fund and implement its development plans and business strategy. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements 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. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these 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. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

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

 

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

Appili’s multi-drug-resistant antibiotic program has the potential to address public health threats for both military and civilian populations worldwide.

NOT FOR DISTRIBUTION IN THE UNITED STATES OR OVER UNITED STATES NEWS WIRE SERVICES

HALIFAX, Nova Scotia, June 13, 2019 – Biopharmaceutical company Appili Therapeutics Inc. (“Appili” or the “Company”) today announces that it has filed and obtained a receipt for its final prospectus (the “Prospectus”) in connection with its $3.6 million special warrant offering (the “Offering”) that closed in multiple tranches during the period commencing on November 21, 2018 and ending on March 19, 2019. The Offering was led by Mackie Research Capital Corporation and included Echelon Wealth Partners Inc. and Bloom Burton Securities Inc.

The Prospectus qualifies the distribution of 3,257,665 Class A common shares of Appili (the “Common Shares”) issuable for no additional consideration upon the exercise or deemed exercise of special warrants of the Company (the “Special Warrants.”)  The Special Warrants were issued under, and are governed by, the terms and conditions of a special warrant indenture dated November 21, 2018, as amended on May 3, 2019, between Computershare Trust Company of Canada and the Company.

As a result of obtaining the receipt for the Prospectus, all unexercised Special Warrants will be deemed to be automatically exercised on June 17, 2019 without any further action on the part of the holders.

A copy of the Prospectus is available on SEDAR at www.sedar.com.

Appili has received conditional approval from the TSX Venture Exchange (the “TSXV”) for the listing of the Common Shares on the TSXV, subject to the completion of customary requirements of the TSXV, including the receipt of all required documentation. Following receipt of final approval from the TSXV, the Common Shares will commence trading on the TSXV under the symbol “APLI”.

No securities regulatory authority has either approved or disapproved the contents of this news release. The Common Shares 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. Accordingly, the Common Shares may not be offered or sold within the United States unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to exemptions from the registration requirements of the U.S. Securities Act and applicable state securities laws. This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any securities of Appili in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

​

About Appili Therapeutics

Appili 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 significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats to global public health. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, being developed to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, which are 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 marketed antibiotic metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments, and government agencies.

​

Certain information in this press release contains forward-looking statements. Such statements include but are not limited to the Company’s intention to list the Common Shares on the TSXV. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict, including the risk that the Company may not be able to secure a listing on the TSXV and certain other risk factors set out under the heading “Risk Factors” in the Prospectus. Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements, unless and until required by securities laws applicable to the Company.

Neither the TSXV, 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 Contacts:
Andrea Cohen, Sam Brown Inc.
T: 917-209-7163
E: [email protected]

 

Chris Brooks
Director, Communications and Outreach
Atlantic Canada Opportunities Agency
902-426-9417 / 902-830-3839 (cell)
E: [email protected]

​

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

HALIFAX, Nova Scotia, April 10, 2019 – Pharmaceutical company Appili Therapeutics Inc. (“Appili” or the “Company”) announced today that it is receiving a $476,000 CAD repayable contribution through the Atlantic Canada Opportunities Agency’s (ACOA) Regional Economic Growth through Innovation (REGI) program. Appili is creating novel antibiotic and anti-infective therapies to help patients suffering from serious infections and to address the need for new treatments due to increasing resistance to currently available antibiotics.

This contribution will help to maintain highly qualified positions in Halifax while supporting world class research and development operations to combat a global crisis that poses a serious threat to human health. The company will use this assistance to procure materials for continued development of its pipeline of novel drug candidates, as well as to further explore the listing of its common shares on the TSX Venture Exchange (the “TSXV”).

“The support from our community – the financial resources, human talent, and federal and local backing – are an integral part of Appili’s growth and innovation,” said Kevin Sullivan, CEO of Appili Therapeutics. “We have had a strong working relationship with ACOA since our inception and are very grateful for its continued support. The urgent medical need for stronger anti-infectives is a global problem, and we are proud to bring solutions developed here in Atlantic Canada to this fight.”

This loan follows Appili’s recently announced private placement financing, which raised proceeds of $3.6 million CAD.

“Seeing high quality research, commercialization and jobs in Atlantic Canada is a top priority,” said Andy Fillmore, Parliamentary Secretary to the Minister of Canadian Heritage and Multiculturalism and Member of Parliament for Halifax, on behalf of the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for ACOA. “Appili’s pipeline of anti-infective medications are already bringing foreign investment and highly skilled workers to the region. Investments such as these build on the government’s plan to deliver meaningful results for the middle-class and those who are working hard to join it.”

​

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 significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats to global public health. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, being developed to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, which are 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 metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, 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.

​Certain information in this press release may contain forward-looking statements. Such statements include, but are not limited to the proposed use of proceeds and the Company’s intention to list its common shares on the TSXV.  This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict, including the risk that the Company may not be able to secure a listing on the TSXV or another stock exchange mutually acceptable to the Company and the Agents and certain other risk factors set out under the heading “Risk Factors” in the preliminary prospectus of the Company dated March 20, 2019, a copy of which is available under the Company’s profile on SEDAR at www.sedar.com.  Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements unless and until required by securities laws applicable to the Company.

​Neither the Toronto 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]

 

Chris Brooks
Director, Communications and Outreach
Atlantic Canada Opportunities Agency
T: 902-426-9417 / 902-830-3839 (cell)
E: [email protected]

 

Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
T: 902-426-9417 / 902-830-3839 (cell)
E: [email protected]

HALIFAX, Nova Scotia, April 8, 2019 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that it will participate in the Bloom Burton & Co. Healthcare Investor Conference 2019. The conference takes place April 30 – May 1, 2019, in Toronto, Canada.

Appili’s Chief Executive Officer Kevin Sullivan will present a corporate overview and update on the Company’s active pipeline and business development programs.

​

Presentation details are as follows:

• Date: Tuesday, April 30, 2019
• Time: 3:30 pm ET
• Location: Metro Toronto Convention Centre, 255 Front St W, Toronto, Ontario

​Investors interested in arranging a meeting with Mr. Sullivan during this conference should contact Bloom Burton & Co.’s conference coordinator.

​

About the Conference

The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly traded and private companies through presentations and private meetings.

​

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 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. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, being developed to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, which are 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 metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, 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.

​

About Bloom Burton & Co.

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

​###

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]

NOT FOR DISSEMINATION OR DISTRIBUTION IN THE UNITED STATES OR THROUGH U.S. NEWSWIRE SERVICES.

HALIFAX, Nova Scotia, March 25, 2019 – Appili Therapeutics Inc. (“Appili” or the “Company”) is pleased to announce the closing of its private placement offering (the “Brokered Offering”) of special warrants (the “Special Warrants”) for aggregate gross proceeds of $1,944,282, and with a concurrent non-brokered private placement offering (the “Non-Brokered Offering” and together with the Brokered Offering, the “Offering”) pursuant to which the Company raised aggregate gross proceeds of $1,642,532, the Company has closed on total gross proceeds of $3,586,813. Mackie Research Capital Corp, as Lead Agent and together with Echelon Wealth Partners Inc. and Bloom Burton Securities Inc. (collectively and together with the Lead Agent, the “Agents”) acted as the agents in connection with the Brokered Offering.

“As we prepare for our next phase of growth, financial strength and careful stewardship of our resources remain incredibly important to Appili,” said Kimberly Stephens, Chief Financial Officer of Appili. “As we pursue additional pipeline assets and continue with the process of taking Appili public on the TSX Venture Exchange (the “TSXV”), we are grateful for the continued support of our investor base and look forward to additional opportunities to drive value to our shareholders and, ultimately, to patients.”

Pursuant to the Offering, the Company issued an aggregate of 843,956 Special Warrants in multiple tranches, at a price of $4.25 per Special Warrant. Each Special Warrant is automatically exercisable, for no additional consideration, for one common share of the Company (the “Underlying Share”) on the date that is two business days following the earlier of: (i) November 21, 2019 and (ii) the date (the “Qualification Date”) that is the later of (A) the date on which the Company obtains receipt from the applicable securities regulatory authorities (the “Securities Commissions”) for a (final) prospectus qualifying distribution of the Underlying Shares, and (B) the date on which the Underlying Shares are approved for listing on the TSXV or another stock exchange mutually agreed upon by the Company and the Agents.

Kevin Sullivan, CEO of Appili Therapeutics, commented, “Our business model allows us to pursue a broad range of infectious disease pipeline assets, which places us in the unique position of being able to maximize the capital efficiency of our drug development programs. We have secured $19.1 million in non-dilutive funding from a range of sources that has further bolstered our disciplined approach to building out our pipeline. The $3.6 million from this round of financing is an important component of our growth plans and we look forward to working with our partners – with the ongoing support of our shareholders – to advance our novel programs toward fruition.”

The net proceeds from the Offering will be used for the research and development of Appili’s current anti-infective pipeline of products, working capital, and general corporate purposes.

The Company is also pleased to announce that, in accordance with the terms of the Offering, the Company has filed a preliminary long form prospectus (the “Preliminary Prospectus”) with the securities commissions in each of the provinces of British Columbia, Alberta, Manitoba, Ontario, Quebec and Nova Scotia qualifying the distribution of the Underlying Shares.  The Preliminary Prospectus contains important information relating to the Company, the Offering and the Underlying Shares and is still subject to completion or amendment. For more information, readers are advised to consult the Preliminary Prospectus, including the risk factors described therein. A copy of the Preliminary Prospectus is available under the Company’s profile on SEDAR at www.sedar.com.

In connection with the Brokered Offering, the Agents received a cash commission equal to 8% of the aggregate gross proceeds of the Brokered Offering and an aggregate of 34,597 compensation warrants (the “Compensation Warrants”). Each Compensation Warrant entitles the holder thereof to acquire one common share of the Company at a price of $4.25 per share until November 21, 2020, subject to adjustment in certain events.

In addition, in connection with the Non-Brokered Offering, the Company paid finder fees of $131,403 and issued an aggregate of 30,918 finder warrants (the “Finder Warrants”) to certain finders in connection with the closing of the Non-Brokered Offering.  Each Finder Warrant entitles the holder thereof to acquire one common share of the Company at a price of $4.25 per share until November 21, 2020, subject to adjustment in certain events.

There will not be any sale or any acceptance of an offer to buy the Special Warrants pursuant to the Preliminary Prospectus. No securities regulatory authority has either approved or disapproved the content of this release.

This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful, including any of the securities in the United States of America. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “1933 Act”) or any state securities laws and may not be offered or sold within the United States or to, or for account or benefit of, U.S. Persons (as defined in Regulation S under the 1933 Act) unless registered under the 1933 Act and applicable state securities laws, or an exemption from such registration requirements is available.

 

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 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. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, being developed to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, which are 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 metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, 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.

Certain information in this press release may contain forward-looking statements. Such statements include, but are not limited to the proposed use of proceeds and the Company’s intention to list its common shares on the TSXV.  This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict including the risk that the Company may not be able to obtain a receipt for a final prospectus qualifying the distribution of the Underlying Shares, the risk that the Company may not be able to secure a listing on the TSXV or another stock exchange mutually acceptable to the Company and the Agents and certain other risk factors set out under the heading “Risk Factors” in the Preliminary Prospectus.  Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements unless and until required by securities laws applicable to the Company.

Neither the Toronto 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.

HALIFAX, Nova Scotia, October 1, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, has named Dr. Armand Balboni as its first Chief Scientific Officer (CSO). In his new role with Appili, Dr. Balboni is responsible for the Company’s clinical and scientific strategy, with a particular emphasis on overseeing the scientific aspects of Appili’s government and industry collaborations and steering the Company’s clinical programs through regulatory and pre-commercialization processes.

“Armand’s medical science, business, and military experience, including his particular focus in infectious disease, is a powerful combination, and having an expert of his caliber on our team is a ‘win’ for this Company and our shareholders,” said Kevin Sullivan, MBA, Chief Executive Officer of Appili Therapeutics. “Our clinical program has grown substantially since our inception, and Armand’s experience with unique regulatory pathways and the role public/private partnerships can play in drug development will be critical to us as we advance our pipeline. We look forward to his continued guidance and support as we move into our next stage of growth.”

Dr. Balboni’s over 20-year healthcare career encompasses medical and drug development experience across a range of civilian and military organizations. He is a partner, senior advisor and member of the Board of Directors of the investment advisory firm Bloom Burton & Co. Dr. Balboni served as the senior advisor on scientific, regulatory, and medical affairs for the companies within Bloom Burton’s ‘incubation’ program, advising some of the most recent promising young Canadian biotech companies.

Earlier in his career, Dr. Balboni completed a period of active duty in the U.S. Army as the Deputy Director, Office of Regulated Activities (ORA) and senior reviewer on the clinical pharmacovigilance team. Dr. Balboni’s tenure in the ORA focused on regulatory filings (Emergency Use Authorizations (EUAs), meetings, pre-sub filings etc.) for military-relevant medical products across all therapeutic areas.

In addition, Dr. Balboni completed a U.S. Department of Defense fellowship at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) in the Division of Anti-infective Products, and in the Office of Counterterrorism and Emerging Threats (OCET). He also served as the Chief, Office of Research and Technology Application (ORTA) at the U.S. Army Research Institute of Infectious Disease (USAMRIID). His office was tasked with oversight of all strategic partnerships between USAMRIID and universities, U.S. and foreign government agencies, and biotechnology and pharmaceutical companies.

“Appili is doing very important work in the infectious disease space, from developing options for some of the most threatening drug-resistant bacteria emerging in our healthcare landscape, to tackling head-on significant bioterrorism threats,” said Dr. Balboni. “I have been impressed with their notable progress in the three years that the Company has been operating, and am eager to continue supporting their efforts as the first Chief Scientific Officer.”

Dr. Balboni has also held various academic teaching positions, including posts at Westfield State University, the University of Maryland University College, and currently as Assistant Professor in Chemistry and Life Sciences at the United States Military Academy at West Point. He completed his doctoral work in the MD/PhD program at the Icahn School of Medicine at Mount Sinai and earned his law degree at Brooklyn Law School.

 

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. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, 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.

###

Media Relations Contact:
Mike Beyer, Sam Brown Inc.
T: 312-961-2502
E: [email protected]

 

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

HALIFAX, Nova Scotia, August 16, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”) announced today the results of the Company’s annual and special meeting of shareholders (the “Meeting”), which was held on August 15, 2018.

At the Meeting, the shareholders re-elected the following individuals to serve on the Board of Directors (the “Board”) until the next annual meeting of shareholders:

• Brian M. Bloom, Chair, Chairman & Chief Executive Officer, Bloom Burton & Co.
• John Holyoake, DPhil, Vice President, Investment Banking, Bloom Burton & Co.
• Lidija Marusic, PhD, Investment Manager, Innovacorp
• Stephen Nicolle, President, Cape Bear Advisors
• Ian Mortimer, President and Chief Financial Officer, Xenon Pharmaceuticals Inc.
• Kevin Sullivan, MBA, CEO, Appili Therapeutics

“Appili has, of late, experienced tremendous progress, and at this year’s AGM, we recognized the achievements our team has made over the past year, including advancing the clinical progress of our lead candidate, ATI-1501, and in-licensing a new asset with our ATI-1701 tularaemia vaccine candidate,” said Mr. Sullivan. “In addition, the shareholders and leadership are looking forward, strengthening the fundamental structural, leadership, and financing pillars of the company to prepare Appili for our next stage of progress.”

The shareholders also voted in favour of the following matters:

1. The re-appointment of PricewaterhouseCoopers LLP, Chartered Accountants, as the Company’s independent auditors;

2. The continuance of the company as a federal corporation under the provisions of the Canada Business Corporations Act (“CBCA”);

3. The adoption of new CBCA compliant bylaws upon the effective date of the continuance; and

4. Certain amendments to the authorized capital of the Company (to be effective upon the effective date of the continuance), including the redesignation of the existing common shares as Class A common shares, and the creation of Class B non-voting common shares and “blank cheque” preferred shares.

Despite receipt of shareholder approval for the continuance, new bylaws and amendments to the authorized capital, the Board may elect not to proceed with such matters if, in the opinion of the Board, such step would not be in the best interest 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. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, 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.

New Antibiotic Formulation Designed to Treat Parasitic and Anaerobic Bacterial Infections; Appili Will Use Study Data as Basis for NDA Filing

HALIFAX, Nova Scotia, July 30, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”) announced today positive top-line results of a pivotal relative bioavailability study evaluating pharmacokinetics, safety, and palatability of ATI-1501 in healthy, normal adults. Data from this study will be used to file a New Drug Application (NDA) with the US Food & Drug Administration (FDA) for ATI-1501 in early 2019. ATI-1501 is a proprietary, taste-masked oral suspension formulation of the antibiotic metronidazole, which is broadly prescribed to treat parasitic and anaerobic bacterial infections that heavily burden the elderly.

The clinical study results announced today showed that a single 500 mg dose of ATI-1501 achieved equivalent systemic drug levels to a 500 mg metronidazole tablet under fasted and fed conditions. ATI-1501 was well tolerated and safety observations for ATI-1501 were consistent with the known safety profile of metronidazole.

“Appili Therapeutics set out to address an unmet medical need – namely to provide an alternative antibiotic solution for patients with difficulty swallowing.  Our clinical data demonstrate that ATI-1501 has an acceptable safety profile while being more palatable than metronidazole tablets for a vulnerable patient population,” said Jamie Doran, MSc, DABT, ERT,Vice President of Drug Development for Appili. “As we move towards a submission to the FDA for market approval, we anticipate that ATI-1501 will soon be available to healthcare providers and caregivers as an excellent alternate treatment option for those with serious infections requiring treatment with metronidazole.”

In many countries, including the US and Canada, oral metronidazole is only available in solid forms. Patients with difficulty swallowing the oral tablet require pharmacists, the patients themselves or caregivers to crush the drug and add it to food prior to patients ingesting it. This process increases risk for dosing error and amplifies the pronounced bitter taste of metronidazole that can negatively impact patients’ ability to comply with their full treatment regimen. The bitter taste of metronidazole is so pronounced that it is listed as an adverse event on the drug label.  ATI-1501 has been designed to offer patients with difficulty swallowing the drug a more palatable, easy-to-take liquid suspension alternative.

 

About the Bioavailability Study

The primary objective of the randomized, open-label, single-dose, two-sequence, cross-over clinical study was to assess the relative bioavailability of ATI-1501 compared to the reference product Flagyl® (solid metronidazole tablets) under fasted and fed conditions. Clinicians performed the study under an Investigational New Drug application (IND) and a Clinical Trial Application (CTA) approved, respectively, by the US Food and Drug Administration and Health Canada in 2017. A total of 44 healthy adults aged 18 to 63 years completed the study.

A planned subset of participants was also asked to evaluate the taste properties and relative preference for ATI-1501 compared to metronidazole crushed in applesauce, which is the current standard of care for elderly and pediatric patients with difficulty swallowing. Palatability measures were assessed using the 9-point hedonic scale, the most widely recognized and used scale to measure taste preference and selection in the food industry. A total of 25 participants participated in this palatability and preference component, ranging from 18 to 63 years of age. ATI-1501 exhibited meaningful and statistically significant improvements across all palatability measures (taste, bitterness, smell, texture) compared to crushed tablets with a corresponding reduction in bitterness scores and a strong preference for ATI-1501 over the current standard of care.

Based on these findings, Appili expects to submit complete study results for publication in a peer-reviewed medical journal.

“We are currently pursuing commercial manufacturing activities to support an NDA filing in the first quarter of 2019,” said Appili CEO Kevin Sullivan, MBA. “In addition, we are actively engaged in commercialization and licensing activities to maximize patient access to ATI-1501 in US and global markets.”

 

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. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, 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.