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.

HALIFAX, Nova Scotia, June 21, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that it will present at the 2018 Atlantic Venture Forum Technology Showcase. The event takes place June 28-29, 2018 in Halifax, 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: Thursday, June 28, 2018

Time: 2 p.m. Atlantic time

Session: Growth Stage Presenting Companies

Location: Halifax Marriott Harbourfront Hotel

Learn more about the Technology Showcase.

 

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.

HALIFAX, Nova Scotia, April 18, 2018 – 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.

HALIFAX, Nova Scotia, February 7, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company developing and commercializing anti-infective drugs, announced today it raised an additional $4,339,000 in an oversubscribed private placement financing, bringing the total equity raised since its seed round in March 2016 to $11,816,000.  In addition, Appili is also pleased to be receiving a $500,000 repayable contribution from the Government of Canada, through the Atlantic Canada Opportunities Agency’s (ACOA) Business Development Program.

“The second wave of financing in the last quarter of 2017 and into early 2018 confirms the confidence of our investors in the company’s strategy to bring to market new anti-infective drugs for resistant or neglected infections,” said Kevin Sullivan, CEO of Appili Therapeutics.

The 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 expand its pipeline of anti-infectives with additional in-licensed assets.

“The Government of Canada is pleased to continue its support of Appili Therapeutics as it expands its portfolio and business, creating more opportunities for export and foreign investment. Appili is contributing to the global community’s search for solutions to combat antibiotic resistance and is a valued member of Canada’s life sciences industry,” said Andy Fillmore, Parliamentary Secretary to the Minister of Democratic Institutions 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 Therapeutics was formed with the intent to create a portfolio of research and development assets, and this funding will allow us to be opportunistic in our in-licensing activities,” added Kimberly Stephens, Appili Therapeutics CFO.

 

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.

HALIFAX, Nova Scotia, January26, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development and commercialization, today announced that Halifax Chamber of Commerce presented Appili with its 2018 ‘New Business of the Year’ award. The announcement was made during a ceremony at the Halifax Business Awards gala event on Thursday, January 25, 2018, held at the Halifax Convention Centre. Kevin Sullivan, Appili’s Chief Executive Officer, accepted the award on behalf of the Company.

“In the first few years since Appili started, our team has generated a balanced-risk pipeline with three thriving programs, two of which are approaching near-to-market, and could start providing much-needed options for addressing significant unmet medical needs. In our third program, we’ve laid the groundwork to address one of the biggest health crises of our time: antibiotic resistance,” said Kevin Sullivan, MBA, Chief Executive Officer of Appili Therapeutics. “The Chamber of Commerce awards ceremony provided an occasion to recognize not only our successes within Appili, but also the critical component that the Halifax community, and other Canadian resources, have played in our accomplishments. From funding and human capital, to access to cutting-edge academic research and technology, this community has been an integral part of our story.”

The ‘New Business of the Year’ award honours an active business located in Halifax that has been operating for less than two years. Appili was founded by a team of drug development, infectious disease, and commercialization experts to advance the global fight against infectious disease and the mounting threat of drug-resistant pathogens.

 

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.

HALIFAX, Nova Scotia, January 9, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today it has signed a licence agreement with the National Research Council of Canada (NRC) to develop ATI-1701, a vaccine to protect against Francisella tularensis, a potential bioterrorism agent that causes tularemia.

The U.S. Centers for Disease Control and Prevention (CDC) ranks F. tularensis, the bacteria that causes tularemia, as a Category A pathogen (i.e., an organism that poses the highest risk to national security and public health). Aerosolized F. tularensis is on this list because it is considered to have high potential as a biological weapon and has been studied prior to and during World War II, and it was also examined for military purposes by the Soviet Union during the Cold War.

“Francisella tularensis is a very infectious bacteria. A small number (approximately 10 to 50 organisms) can cause tularemia disease. If used as a weapon, the bacteria would likely be made airborne for exposure by inhalation. People who inhale an infectious aerosol would generally experience severe respiratory illness, including life-threatening pneumonia and systemic infection, if they are not treated,” said Sean McBride, Vice President, Business Development at Appili Therapeutics.

Although a vaccine was developed in the former Soviet Union that partially protects against respiratory challenges, it may have limited effectiveness when used in a mass casualty, bioterrorism attack and is currently not approved for use by the U.S. Food and Drug Administration (FDA). Various antibiotic regimens are effective as post-exposure prophylaxis and treatment for tularemia and would likely comprise the first line of public health intervention in response to a deliberate release of F. tularensis; however a highly effective vaccine has long been sought after to protect vulnerable populations.

“If an adversary finds a way to make Francisella tularensis resistant to antibiotics and uses it as an aerosolized bioweapon, the results could be devastating,” continued Mr. McBride. “We are proud to be a part of the team working to advance a vaccine to protect civilians and military personnel in the event of an attack.”

ATI-1701 is based on research led by Dr. Wayne Conlan at the NRC. Dr. Conlan’s team used genetic engineering to disable a previously virulent strain of F. tularensis and develop a live attenuated vaccine.  Their research showed the genetically modified bacterium induced a strong immune response that triggers a protective immune response to F. tularensis.

“It is very rewarding to see our team’s research on this vaccine progress from our labs to the next stage of development. We are delighted to partner with Appili on this important program designed to protect the health of Canadians exposed to bioterror threats,” said Dr. Conlan.

Some of the development work for the vaccine is being funded by the Defense Threat Reduction Agency (DTRA), part of the U.S. Department of Defense, which recently announced a $6.2 million, 5-year program to develop a tularemia vaccine. Appili will conduct the preclinical and clinical testing required by the FDA to evaluate the safety of the ATI-1701 vaccine and to ensure it offers the desired protection against the bacteria for humans. These pivotal studies could support the regulatory approval of the vaccine under the FDA Animal Rule.

Today’s license agreement with the NRC grants Appili exclusive worldwide rights to develop and commercialize this tularemia vaccine. “This continues to build out our portfolio of products that have dual civilian and military defensive applications,” said Kevin Sullivan, CEO of Appili Therapeutics. “We will continue to identify partnering opportunities to work with defense departments around the world to develop infectious disease solutions for unmet needs in the military and civilian populations alike.”

 

About Tularemia

Tularemia is a disease of animals and humans. Rabbits, hares, and rodents are especially susceptible to tularemia and often die during outbreaks. Humans can become infected in several ways including tick and deer fly bites; skin contact with infected animals; ingestion of contaminated water; inhalation of contaminated dust or aerosols; and acts of bioterrorism.

 

About Appili Therapeutics

Appili is a biopharmaceutical company dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. Its pipeline includes three anti-infective programs: ATI-1501, a novel taste-masking technology applied in an oral suspension for the treatment for anaerobic infections, ATI-1503, a novel antibiotic targeting drug-resistant Gram-negative infections, and ATI-1701, a vaccine reducing the threat of tularemia bioterrorism. For more information visit www.AppiliTherapeutics.com.

HALIFAX, Nova Scotia, November 28, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, is pleased to announce the appointment of Ian C. Mortimer to its Board of Directors. Mr. Mortimer is a seasoned biotechnology executive with proven abilities in leading capital market transactions. He will serve as chair of Appili’s audit committee.

“Mr. Mortimer is a leader in understanding complex business issues relevant to supporting the growth of life science companies,” said Kimberly Stephens, CFO of Appili Therapeutics. “His expertise is a welcomed addition to our Board as we expand and advance our pipeline of anti-infectives and continue to build shareholder value.”

“Ian brings significant financial acumen onto our Board and we look forward to leveraging his industry experience as Appili advances its cutting-edge anti-infective therapeutics,” said Stephen Nicolle, Appili Therapeutics Board director and president of Cape Bear Advisors. “His acceptance of this role is a testament to the market potential of Appili’s pipeline and to the strength of the leadership we have assembled via the management and Board.”

Mr. Mortimer has over 20 years of experience in the biotechnology sector. He is currently Chief Financial Officer and Chief Operating Officer of Xenon Pharmaceuticals Inc. (NASDAQ: XENE), a company developing medicines to treat neurological disorders. Prior to joining Xenon in 2013, Mr. Mortimer spent six years at Tekmira Pharmaceuticals, now Arbutus Biopharma Corporation (NASDAQ: ABUS), as Executive Vice President and Chief Financial Officer. He is accredited with leading both Xenon’s and Tekmira’s listings on the NASDAQ, in 2014 and 2010 respectively. Mr. Mortimer has an M.B.A. from Queen’s University, a B.Sc. in Microbiology from the University of British Columbia, and is a Chartered Professional Accountant, Certified Management Accountant.

“I am pleased to join Appili’s Board at this pivotal time in the company’s development as the team prepares to take its first antibiotic candidate into clinical trials,” said Mr. Mortimer. “I look forward to contributing to Appili’s future growth in advancing novel treatments to address the growing threat of anti-microbial resistance and other public health challenges caused by infectious diseases.”

 

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, November 7, 2017 – Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today it has been awarded a $1.2 million USD grant by the Department of Defense, Congressionally Directed Medical Research Programs, Peer Reviewed Medical Research Program.

The Peer Reviewed Medical Research Program (PRMP) supports military health-related research that has the potential to make a strong impact on patient care. Appili will use the funds to develop a lead compound as a preclinical candidate for its ATI-1503 antibiotic program targeting drug-resistant, Gram-negative bacteria.

“Drug-resistant bacteria threaten a doctor’s ability to care for battlefield wounds among military service men and women,” said Kevin Sullivan, CEO of Appili Therapeutics. “We are honoured to have been selected for this PRMRP award, which helps us advance our most promising antibiotic candidate through the critical early stages of development.”

Drug-resistant bacteria constitute some of the highest threats to human health, with over 2 million infections and at least 23,000 deaths each year in the U.S. alone. These superbugs can present serious challenges in both battlefield situations, as well as in veterans’ hospitals, making it a priority research area for the Department of Defense (DOD).

ATI-1503 is a synthetic version of the naturally-occurring antibiotic called Negamycin. Its broad spectrum activity allows it to tackle the most deadly Gram-negative bacteria, including Klebsiella pneumoniae, Acinetobactor baumannii, and Pseudomonas aeruginosa. These are high priority pathogens for the Centers for Disease Control and Prevention and the World Health Organization because of the lack of effective antibiotic treatment options for the most resistant strains.

Appili’s expert drug development team will use the PRMRP funding to optimize the potency of ATI-1503 to effectively target Gram-negative bacteria. Because Gram-negative bacteria have two protective cellular walls, it is hard for existing 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 the Gram-negative bacteria.

 

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, 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, 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.