Appili Therapeutics Signs $3M USD Grant Contract with the United States Department of Defense to Develop Antibiotics that Target Superbugs

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

HALIFAX, Nova Scotia, July 2, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that  the United States Department of Defense, (DOD) Congressionally Directed Medical Research Programs, Peer Reviewed Medical Research Program (PRMRP) has completed the contract awarding the Company a $3.0 million USD grant.

Appili will use the funds to continue advancing its ATI-1503 antibiotic program, which targets drug-resistant, Gram-negative bacteria also known as ‘superbugs.’ The ATI-1503 program has the ability to target 4 out of 6 “ESKAPE” pathogens, which are the leading cause of hospital acquired infections worldwide [i]. PRMRP grants support military health-related research that has the potential to make a strong impact on patient care.

​“Multi-drug-resistant bacteria continue to spread throughout the world, making them one of the most urgent public health threat we are facing worldwide,” said Kevin Sullivan, CEO of Appili Therapeutics. “We believe that the ATI-1503 program has the potential to address several of the most dangerous superbugs for the military and civilians alike, and we are grateful for PRMRP’s continued support of this promising novel antibiotic class.”

​According to the World Health Organization, drug-resistant bacteria, particularly the superbugs that are resistant to most or sometimes all available anti-infectives, are among the highest threats to human health worldwide. The U.S. Centers for Disease Control and Prevention (CDC) report that they are responsible for more than 2 million infections and 23,000 deaths each year in the U.S. alone. In addition to the widespread civilian vulnerabilities that they present, these superbugs pose serious challenges in both internationally deployed troops and domestic military personnel in veterans’ hospitals. The significance of these threats, and their prevalence worldwide, have made solutions to multi-drug resistant bacteria a priority research area for the Department of Defense (DOD).

​Appili’s ATI-1503 program is a new class of antibiotics based on the negamycin scaffold, which is a naturally occurring compound with intrinsic Gram-negative antibacterial activity.  The class has broad spectrum activity, which allows it to potentially address the deadliest Gram-negative bacteria, including the superbugs Klebsiella pneumoniae, Acinetobactor baumannii, and Pseudomonas aeruginosa.  These are high priority pathogens for the CDC and WHO because of the lack of effective antibiotic treatment options for the most resistant strains [ii][iii].

About the PRMRP Grant

This work is supported by the DOD Congressionally Directed Medical Research Programs through the PRMRP under Award No. W81XWH1910308. As previously disclosed, Appili was informed of the PRMRP grant in February 2019, but such grant remained subject to finalizing the definitive agreement.. Under the terms of PRMRP grants, the investigators conducting this research 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 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.

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 with respect to ATI-1503 and the proposed use of proceeds from the PRMRP grant. 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 final prospectus of the Company dated June 12, 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]

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

Read full Entrevestor article here

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

See the original post here. 

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]

   ]]>

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]
]]>