Author: rajarshi

HALIFAX, Nova Scotia, October 30, 2017 – Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today that both the US Food and Drug Administration (FDA) and Health Canada have cleared its IND and CTA clinical investigation applications, respectively, to conduct a clinical trial of ATI-1501, a taste-masked antibiotic targeting anaerobic bacteria like Clostridium difficile. ATI-1501 has been optimized in an oral liquid suspension to provide patients who have difficulty swallowing with a more convenient alternative to the currently marketed metronidazole tablet.

Appili plans to conduct the ATI-1501 clinical study in Toronto, Ontario and will begin recruiting subjects in November 2017. The company expects to enroll approximately 40 healthy volunteers in this bioavailability study.

“Having both Health Canada and FDA authorization affirms our confidence in our regulatory and development strategy,” said Kevin Sullivan CEO of Appili Therapeutics. “We’re excited to take ATI-1501 into clinical trials because it brings us a step closer to offering physicians a new weapon to fight serious infections and improve patient compliance.”

ATI-1501 fulfills an unmet market need for millions of people with swallowing difficulties who have been prescribed metronidazole. These individuals, primarily children and the elderly, are not completing their full course of metronidazole tablets because of the extreme bitter taste and difficulty swallowing tablets. Poor patient compliance is leading to the spread of infection, recurrent infections, and antibiotic resistance, which makes treatment more complicated and expensive. As the mainstay for treating anaerobic bacterial infections, IMS Health reports that over 9.5 million prescriptions of metronidazole tablets are issued in the US each year.

Appili’s ATI-1501 oral liquid antibiotic candidate has been taste-masked to improve palatability and reduce issues with non-compliance. Once ingested, the well-studied and established antibiotic is designed to kill anaerobic bacteria by interfering with their DNA, which clears up the infection.

“We expect the completion of this clinical trial will set us up to file our new drug application in 2018 and advance our commercialization activities,” said Jamie Doran, Vice President of Drug Development of Appili Therapeutics.

Appili’s regulatory strategy involves registration using a 505(b)(2) pathway in the US, which is an abbreviated FDA pathway that allows the Company to reference safety and efficacy data of the original oral metronidazole tablet.

About the PRMRP Grant

This work is supported by the DOD Congressionally Directed Medical Research Programs through the Peer Reviewed Medical Research Program under Award No. W81XWH-17-1-0180. In conducting this research, the investigators will adhere to the laws of the United States and regulations of the Department of Agriculture, as well as the CDC-NIH Guide for Biosafety in Microbiological and Biomedical Laboratories. For more information, visit http://cdmrp.army.mil.

About Appili Therapeutics

Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections that has been granted orphan drug status by the FDA. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections. These drug-resistant infections have been identified by the US Centers for Disease Control (CDC) and the World Health Organization as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com.

HALIFAX, Nova Scotia, October 23, 2017 – Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today it raised $3,062,000 in a private placement financing, bringing the total equity raised since its seed round in March 2016 to $7,477,000.

This private placement includes investments from new and current investors including Innovacorp, Nova Scotia’s early stage venture capital organization. Proceeds from the financing will be used to fund operations and the continued growth of the company. Specifically, the additional funding will enable Appili to advance its pipeline of anti-infectives and move its lead antibiotic, a taste-masked treatment for anaerobic infections, into the clini

“Appili has assembled a team with the proven ability to bring new antibiotics to market, and has made remarkable progress in building a pipeline that addresses major unmet needs in bacterial infections,” said Dr. Lidija Marušić, life sciences investment manager at Innovacorp and member of Appili’s Board of Directors. Innovacorp has participated in all of Appili’s financing rounds.

“There is a robust market opportunity for antibiotics that really bring value and the successful closing of this financing round reflects that,” said Kimberly Stephens, CFO of Appili Therapeutics.

“We appreciate the confidence investors have in our strategy to build a balanced-risk pipeline of products designed to treat the most serious and drug-resistant infections affecting patients today,” said Kevin Sullivan, CEO of Appili Therapeutics.

About Appili Therapeutics

Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections that has been granted orphan drug status by the FDA. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections. These drug-resistant infections have been identified by the US Centers for Disease Control (CDC) and the World Health Organization as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com.

HALIFAX, Nova Scotia, September 8, 2017 – Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, today announced the results of the Company’s annual general meeting of shareholders (AGM) held on September 7, 2017.

During the AGM, the shareholders re-elected: Brian Bloom, Dr. John Holyoake, Dr. Lidija Marusic, Stephen Nicolle and Kevin Sullivan to serve on the Board of Directors until the next annual meeting of shareholders.

The shareholders approved all motions put forth at the meeting including the appointment of PricewaterhouseCoopers LLP, Chartered Accountants, as the Company’s independent auditors.

About Appili Therapeutics

Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections that has been granted orphan drug status by the FDA. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections. These drug-resistant infections have been identified by the US Centers for Disease Control (CDC) and the World Health Organization as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com.

HALIFAX, Nova Scotia, July 6, 2017 – Appili Therapeutics Inc. (“Appili”), an anti-infective drug development company, announced today that Sean McBride, a 26 year pharmaceutical veteran, has joined the company as Vice President, Business Development. Mr. McBride will lead Appili’s out-licensing, product in-licensing and acquisition opportunities as the company builds its pipeline of infectious disease products.

“We are delighted to have Mr. McBride join our strong leadership team,” said Kevin Sullivan, CEO of Appili Therapeutics. “Sean’s experience in international deal-making, along with his expertise in pharmaceutical sales and marketing will be invaluable as we build our balanced-risk pipeline of near-to-revenue opportunities with higher-risk, transformational drugs that can truly change the way we treat infectious disease.”

“This is an exciting time to be joining the Appili team as it seeks to take advantage of the many incentives aimed at fighting antibiotic resistance and grow its pipeline of anti-infectives,” said Mr. McBride. “There are many players including government, non-profit, and for-profit organizations with an interest in infectious diseases and I look forward to bringing my experience working with these organizations, and contributing to the Company’s future success.”

Mr. McBride brings more than two decades of experience within the Canadian pharmaceutical and biotechnology industry. His expertise lies in licensing, purchasing and divesting assets, in addition to advancing the commercialization of early stage assets and identifying opportunities for growth. Prior to joining Appili, Mr. McBride spent 10 years at GlaxoSmithKline Inc. (GSK) serving in many roles of increasing responsibility. Most recently he served as head of an entrepreneurial business unit where he negotiated global asset transactions and was responsible for the commercial success of over 40 brand assets. Prior to joining GSK, Mr. McBride served as a director for healthcare agencies conducting commercial and strategic assessments in both Canada and the US and also served as director of marketing with Roche Pharmaceuticals. Mr. McBride has a Bachelor of Business Administration from Simon Fraser University.

About Appili Therapeutics

Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections that has been granted orphan drug status by the FDA. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections. These drug-resistant infections have been identified by the US Centers for Disease Control (CDC) and the World Health Organization as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com.

HALIFAX, Nova Scotia, April 19, 2017 – Appili Therapeutics Inc. (“Appili”), an anti-infective drug development company, today announced that it will participate in this year’s Bloom Burton & Co. Healthcare Investor Conference in Toronto, Canada. The event takes place May 1-2, 2017 at the Sheraton Centre Toronto Hotel.

Appili’s Chief Financial Officer, Kimberly Stephens, will present a corporate overview and update on Monday, May 1, 2017 at 1:30 p.m. ET in Hall B, Lower Concourse Level of the Sheraton Centre Toronto Hotel.

Ms. Stephens’ presentation will focus on market potential of Appili’s anti-infective pipeline as the company advances its late-stage and early-stage antibiotic candidates. She will discuss the future clinical path for its lead product, ATI-1501, a taste-masked, oral antibiotic that treats anaerobic infections like Clostridium difficile, as well as the Company’s earlier-stage product, ATI-1503, a novel antibiotic that targets Gram-negative bacteria.

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

About the Conference

Bloom Burton & Co. is hosting its sixth annual Healthcare Investor Conference on May 1 and 2, 2017 at the Sheraton Centre Toronto Hotel, Toronto, Canada. The Company aims to showcase approximately 60 of Canada’s premier healthcare companies to its network of international investors. The conference includes networking sessions, keynote speeches and panel discussions with venture capital, public equity and strategic investors. The event attracts investors who are interested in the latest developments in Canadian healthcare companies. Investors will have the opportunity to obtain corporate updates from presenting companies and participate in 1-on-1 meetings with company management.

About Appili Therapeutics

Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections, including C. difficile. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat drug-resistant Gram-negative infections, including Klebsiella neumoniae, Acinetobactor baumannii, and Pseudomonas aeruginosa. These drug-resistant infections have been identified by the Centers for Disease Control and Prevention as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com.

HALIFAX, Nova Scotia, April 11, 2017 – Appili Therapeutics Inc.(“Appili”), an anti-infective drug development company, announced today that it will be receiving an additional $400,000 from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP), bringing IRAP support for this project to a total of up to $759,000. This funding supports the development of ATI-1503, an antibiotic targeting drug-resistant Gram-negative bacteria, including Klebsiella pneumoniae, Acinetobactor baumannii, and Pseudomonas aeruginosa. These superbugs cause potentially deadly infections, including pneumonia and blood infections.

“Doctors are fast running out of treatment options and IRAP funding is an important part of our financial strategy for helping Appili develop a new antibiotic that can treat these deadly diseases,” said Kimberly Stephens, CFO of Appili Therapeutics.

ATI-1503 is a synthetic version of the naturally-occurring Negamycin antibiotic. Using IRAP funding, Appili’s expert drug development team will employ advanced X-ray crystallography to visualize the exact structure of ATI-1503 binding to the bacterial target. The crystal structure data is then used to systematically and precisely optimize the potency of ATI-1503 against these drug-resistant infections.

Klebsiella pneumoniae, Acinetobactor baumannii, and Pseudomonas aeruginosa are Gram-negative bacteria with two cellular walls, making it hard for antibiotics to penetrate. ATI-1503 holds promise for treating these superbugs because it penetrates the double exterior membranes and attacks the protein generating machinery of Gram-negative bacteria.

Additionally, Klebsiella pneumoniae, Acinetobactor baumannii, and Pseudomonas aeruginosa thrive in hospitals and residential care facilities, infecting already vulnerable patients. Because these bacteria are resistant to most antibiotics, they are among the priority pathogens for the Centers for Disease Control and Prevention and the World Health Organization because they pose the highest threat to human health.

According to the Centers for Disease Control and Prevention, in the United States over two million cases of drug-resistant infections are reported annually and, with limited treatment options, hospitalization costs for these drug-resistant infections exceed $20 billion a year.

About Appili Therapeutics

Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections, including C. difficile. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat drug-resistant Gram-negative infections. For more information visit www.AppiliTherapeutics.com.

HALIFAX, Nova Scotia, February 17, 2017 – Appili Therapeutics Inc.(“Appili”), an anti-infective drug development company, announced today that it will be receiving $2,803,148 from the Atlantic Canada Opportunities Agency (ACOA), under the Atlantic Innovation Fund (AIF). This funding will enable Appili to take its first drug, ATI-1501 – a taste-masked, oral antibiotic that treats anaerobic infections like Clostridium difficile – through clinical trials to be ready for market approval.

“Having ACOA recognize the potential of our antibiotic reformulation to become a new weapon against anaerobic infections is outstanding,” said Kevin Sullivan, CEO of Appili Therapeutics. “This AIF funding supports our strategy to advance ATI-1501 into human clinical trials as soon as possible.”

Appili plans to take the antibiotic into clinical trials this year and is presently manufacturing the clinical batch of ATI-1501 to good manufacturing practices (GMP), the standard required by the Health Canada and the U.S. Food and Drug Administration (FDA).

ATI-1501 is a reformulation of metronidazole, a front-line treatment for anaerobic bacterial infections, including C. difficile. Over 10 million metronidazole prescriptions are issued in the U.S. annually.

The bitter taste of the metronidazole tablets results in poor patient compliance, which leads to the spread of infections and recurrent infections within the patients. In particular, reluctance to complete the prescribed course of antibiotics is highly problematic among children and the elderly with swallowing issues, who must crush and re-suspend tablets to ingest the metronidazole.

ATI-1501 has been optimized to improve palatability, which should significantly reduce issues with non-compliance. Once ingested, ATI-1501 kills anaerobic bacteria by interfering with their DNA, leading to bacterial cell death and clears up the infection.

About Appili Therapeutics

Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections, including C. difficile. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat drug-resistant Gram-negative infections. For more information visit www.AppiliTherapeutics.com.

HALIFAX, Nova Scotia, January 6, 2017 – Appili Therapeutics Inc. (“Appili”), an anti-infective drug development company, announced today that Stephen Nicolle has been appointed to its Board of Directors. A seasoned executive, Mr. Nicolle has led companies to deliver innovative customer value and returned over $100 million to their investors.

“When it comes to leading venture-backed companies, Mr. Nicolle brings unparalleled business expertise and vision that will be instrumental as we grow and develop our pipeline of anti-infective products,” said Kevin Sullivan, CEO of Appili Therapeutics.

“I am attracted by Appili’s strategic approach of acquiring and developing early stage and late stage products which uniquely address the global demand for new antibiotic treatments to combat bacterial resistance,” said Stephen Nicolle, board director of Appili Therapeutics.  “I am honoured to join Appili’s board and look forward to making a contribution to this ambitious and exciting start-up company.”

Mr. Nicolle has 20 years of experience leading companies and growing shareholder value.  He is currently president of Cape Bear Advisors where he consults and holds numerous board positions, including vice chair of the start-up accelerator Propel ICT. Mr. Nicolle is the former CEO of leading healthcare technology company, STI Technologies, where he negotiated agreements with top pharmaceutical companies resulting in an increase in revenue of 500 per cent.  Before STI Technologies Mr. Nicolle spent 10 years leading venture-backed technology companies, including: CEO of Tatara Systems, CEO of Sigma Systems, COO at March Networks, and President of Nortel’s Service Provider eBusiness Solutions Group. He is a graduate of Western University with an honours degree in computer science.

Mr. Sullivan makes this announcement as he heads to San Francisco, where the life science industry’s largest investor conference, the JP Morgan Healthcare conference, is being held.

About Appili Therapeutics

Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501, a taste-masked treatment for anaerobic infections, including Clostridium difficile, has been granted orphan drug status by the FDA. Appili plans to take ATI-1501 into clinical trials in 2017. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections such as Klebsiella pneumoniae. These drug-resistant infections have been identified by the U.S. Center for Disease Control (CDC) as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com.

HALIFAX, Nova Scotia, December 21, 2016 – Appili Therapeutics Inc. (“Appili”), an anti-infective drug development company, announced today it raised $2,151,000 in its over-subscribed private placement financing. Participants in this capital raise included current Appili investors such as Innovacorp, as well as new individual and institutional investors. Proceeds from the financing will be used to advance its lead product candidate, a taste-masked antibiotic designed to treat anaerobic infections like Clostridium difficile, into clinical trials. In addition, the Company will advance the development of a novel class of antibiotics targeting drug-resistant Gram-negative bacteria and evaluate opportunities to add high potential anti-infective programs to its pipeline.

“We appreciate the support and confidence our investors have in our strategy to build a pipeline of products that fit with our balanced-risk portfolio approach,” said Kevin Sullivan, CEO of Appili Therapeutics. “We continue to seek new programs that complement this balanced-risk approach with a mix of near-term revenue programs along with early stage programs that have the potential to fundamentally change how we treat infectious disease.”

“In a very short period of time, Appili has made significant progress with their strategy to identify and develop improved anti-infective therapies, and we look forward to supporting their upcoming clinical trial,” said Dr. Lidija Marušić, life sciences investment manager at Innovacorp, Nova Scotia’s early stage venture capital organization, and member of Appili’s Board of Directors.

“We are thrilled by the strong investor interest in this financing, which validates Appili’s strategy, science and development programs,” said Brian Bloom, president of Bloom Burton & Co., a healthcare-specialized investment bank, and chair of Appili’s Board of Directors.

About Appili Therapeutics

Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501, a taste-masked treatment for anaerobic infections, including Clostridium difficile, has been granted orphan drug status by the FDA. Appili plans to take ATI-1501 into clinical trials in 2017. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections such as Klebsiella pneumoniae. These drug-resistant infections have been identified by the U.S. Center for Disease Control (CDC) as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com

HALIFAX, Nova Scotia, October 3, 2016 – Appili Therapeutics Inc., an anti-infective pharmaceutical development company, announced today that Kimberly Stephens, CPA, has joined the company as Chief Financial Officer. Ms. Stephens will be providing key financial and operational leadership to Appili to help drive its growth.

“We are pleased to welcome Ms. Stephens to the Appili executive management team,” said Kevin Sullivan, CEO of Appili Therapeutics. “Her significant financial expertise and insight into the biopharmaceutical industry will bolster our growing scientific pipeline as we take our first product, a taste-masked treatment for Clostridium difficile infection, into clinical trials.”

“With our first clinical trial on the horizon, it’s an exciting time to be joining Appili and I look forward to being a key contributor to the company’s future growth and acquisition success,” said Ms. Stephens. “I am impressed by Appili’s strategic focus on treating infectious diseases, and it is my privilege to join such a dynamic team of dedicated professionals.”

Ms. Stephens brings over 15 years of financial management experience in senior financial positions with private and public companies. Most recently, she served as CFO of Immunovaccine Inc. (TSX: IMV; OTCQX: IMMVF) from 2011-2016, where she managed the raising of more than $40 million through equity financings and government grants. Prior to joining Immunovaccine Inc., Ms. Stephens served as director of finance for the Canadian subsidiary of Germanischer Lloyd. She has also been the director of finance for SolutionInc, and started her career as an audit manager in the assurance and advisory group at PwC. Ms. Stephens holds a bachelor of commerce degree from Mount Allison University and is a chartered professional accountant (CPA).

Ms. Stephens will continue to serve Immunovaccine as Chief Financial Officer through December 2016 while the company conducts its ongoing process of identifying and transitioning her successor. About Appili Therapeutics Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501, a taste-
masked treatment for Clostridium difficile infection, has been granted orphan drug designation by the FDA. Appili plans to take ATI-1501 into clinical trials in 2017. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections such as Klebsiella pneumoniae.

These drug-resistant infections have been identified by the U.S. Center for Disease Control (CDC) as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com.

About Appili Therapeutics

Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501, a taste-masked treatment for anaerobic infections, including Clostridium difficile, has been granted orphan drug status by the FDA. Appili plans to take ATI-1501 into clinical trials in 2017. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections such as Klebsiella pneumoniae. These drug-resistant infections have been identified by the U.S. Center for Disease Control (CDC) as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com.