Leading Health and Life Sciences in Nova Scotia

ENTREVESTOR: Atlantic Canadian startups eyeing the stock market like never before

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The stock market is looming larger in the Atlantic Canadian startup community than it ever has before, as several leading companies are choosing public markets as the best option to secure long-term financing.

Just in the past week, Metamaterial Technologies Inc. of Dartmouth announced that it will seek a listing on the Canadian Stock Exchange, with a goal of raising more than $10 million. And shares of Halifax-based drug discovery company Appili Therapeutics began trading on the TSX Venture exchange.

In fact, stock markets have been a fruitful source of funding for the region’s high-growth innovation companies for the past 18 months, and the moves by MTI, Appili and others will only add fuel to a growing trend.

Atlantic Canadian companies raised more than $24 million by selling shares and derivatives on the stock markets in calendar 2018. That’s almost as much as the $29.4 million raised from angel investors, which invested at record levels in Atlantic Canada last year.

There are not a lot of transactions by the publicly listed companies, but the recent ones have been noteworthy: Last August, Halifax-based Sona Nanotech listed on the Canadian Securities Exchange, choosing the alternative exchange rather than the TSX Venture exchange. The company raised $2 million during the listing. Kraken Robotics of St. John’s closed a $2.3 million sale of shares and warrants to its customer Ocean Infinity in June last year. The company then raised further capital in December when it sold $6 million worth of shares. In February 2018, Halifax-based IMV announced that it had closed a bought deal to raise $14.4 million. In March 2019, IMV closed another share sale, which raised an additional $26.7 million.

And other companies like BlueDrop Performance Learning of St. John’s and Exeblock, a Halifax blockchain companies, are also listed.

The driving force behind this interest in public listings is the longevity and strength of the current bull market. Eleven years have past since the financial crisis and the stock market seems like a dependable and profitable place to raise capital. Of course, a market crash and/or recession would likely put the brakes on further companies move toward the public markets.

In recent years, Canadian tech shares have performed well and investors are looking for small tech companies the way they used to look for penny stocks in the mining and oil and gas sectors. And IMV, after years of a languishing share price, has finally been resurrected and is leading the way for other Atlantic Canadian stocks to test the markets.

For Appili Therapeutics, which has 30.3 million shares outstanding and a market capitalization as of the close Monday of $24.2 million, the public listing is a crucial step in its mission to find cures for antibiotic-resistant diseases.

“According to both the World Health Organization and the U.S. Centers for Disease Control and Prevention, there remains an increasing need for innovations to combat the mounting threats of infectious diseases,” said CEO Kevin Sullivan in a statement. ”Our public listing marks an important inflection point in our ability to deepen our reach into this market and demonstrate that it is possible to invest in a compelling and attractive social mission and business opportunity in parallel.”

ENTREVESTOR: Appili Starts Trading on TSXV

See full Entrevestor article here

Shares of Halifax drug discovery company Appili Therapeutics Inc. begin trading on the TSX Venture exchange today.

The company, whose long-term goal is to produce drugs that can combat antibiotic-resistant viruses, issued a statement Monday evening saying  the Toronto Stock Exchange had accepted its application for an initial public offering.

Appili is not raising new funds in the listing as it meets the TSX Venture requirements for capital, with enough money in the bank to last until mid-2020. The company raised $3.6 million earlier in the year via a sale of warrants. Since inception, the company has raised a total of $15.4 million in equity funding and $19 million in non-dilutive funds, and decided last autumn that its best long-term route to capital would be found in public markets.

“This public listing is an important part of our evolution as we look to continue to build our pipeline of products that treat the most serious threats to human health,” said Appili CEO Kevin Sullivan in an email Monday night. “It really is an exciting part of our life cycle/growth strategy that we are keen to show the markets.”

ENTREVESTOR: Appili Names Balboni as CSO

Read the original article here.  Appili Therapeutics, a Halifax-based drug development company, has appointed its first ever Chief Scientific Officer. Armand Balboni, the new CSO, will be responsible for the company’s clinical and scientific strategy as well as steering its 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 Appili CEO Kevin Sullivan in a statement. Balboni has over 20 years of medical and drug development experience across an extensive range of civilian and military organizations. Early in his career, Balboni completed a period of active duty with the U.S. Army as the Deputy Director of its Office of Regulated Activities and was a senior reviewer on the clinical pharmacovigilance team. He is also a partner, senior advisor and member of the Board of Directors of the investment advisory firm Bloom Burton & Co. “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,” Balboni said in a statement. In January, Appili struck a deal with the National Research Council of Canada to work on a vaccine that could protect people against a potential bioterror threat. The vaccine, called ATI-1701, will protect against bacteria called Francisella tularensis. The company, which is considering a listing on the Toronto Stock Exchange, has raised a total of $11.8 million in less than two years. The company is now on a fast-track to get its portfolio of anti-infectious drug candidates to market within the next couple of years. Already, Appili has had positive results from its first clinical trial in Canada and the US for its ATI-1501 drug compound. Said 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.”]]>

Appili Therapeutics Appoints Veteran Drug Development Executive, Dr. Armand Balboni, as Its Inaugural Chief Scientific Officer

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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.

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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]

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Appili Therapeutics Completes Phase 1 Study for ATI-1501, Its Taste-Masked Oral Metronidazole Suspension, Demonstrating Significant Improvements in Taste and Palatability

See original article here 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.
Media Relations Contact: Christy Curran, Sam Brown Inc. T: 615-414-8668 E: [email protected] Investor Relations Contact: Kimberly Stephens, CFO, Appili Therapeutics T: 902-442-4655 E: [email protected]
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Business Wire: Appili Therapeutics to Present at 2018 Bloom Burton & Co. Healthcare Investor Conference

See original story here Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that it will participate in this year’s annual Bloom Burton & Co. Healthcare Investor Conference. The conference takes place May 2-3, 2018 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: Wednesday, May 2, 2018 Time: 2:00 p.m. ET Location: Sheraton Centre Hotel Toronto, 123 Queen Street, Toronto, Ontario, M5H 2M9 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. 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.]]>