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.]]>

ENTREVESTOR: Appili Raises $4.3M in Equity Funding

See original story here Halifax drug discovery company Appili Therapeutics Inc., has raised $4.3 million in equity financing to further its operations and add to its number of drug candidates. The company said in a press release it raised the money through a private placement, which was over-subscribed. It received money from new and existing investors, including Innovacorp, Nova Scotia’s innovation and venture capital organization. Appili, which previously has raised money with the help of the Toronto investment boutique Bloom Burton & Co., said it has now raised a total of $11.8 million in less than two years. Appili also said it would borrow a further $500,000 through the Atlantic Canada Opportunities Agency‘s 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 CEO Kevin Sullivan in a statement Wednesday. Appili has been working to develop a portfolio of anti-infectious drug candidates. In the statement Wednesday, the company said it plans to “expand its pipeline of anti-infectives with additional in-licensed assets.” In October, Appili’s first drug candidate ATI-1501 received approval to begin clinical trials in both Canada and the U.S. It treats clostridium difficile infection, or CDI, in children. ATI-1501 removes the bitter taste from Metronidazole, a drug that has been used to treat the condition since the 1970s. Metronidazole is effective, but it tastes awful, so children often won’t take it, thereby limiting its effectiveness. By removing the bitter taste, ATI-1501 improves the results of the drug. Last month, the company struck an agreement to work on a vaccine that could protect people against a potential bioterror threat. It signed a licence agreement with the National Research Council of Canada to help develop ATI-1701, to vaccinate against tularemia. The vaccine will protect against bacteria called Francisella tularensis, which can cause tularemia, a highly infectious disease also known as rabbit fever. The company is also working on a compound called ATI-1503, an antibiotic that could fight deadly infections such as Klebsiella pneumonia. Sullivan has said the drug could combat viruses that are resistant to antibiotics, but it’s a longer-term, riskier project than the other candidates. “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,” said CFO Kimberly Stephens in the statement. Disclosure: Innovacorp and ACOA are clients of Entrevestor. ]]>

ENTREVESTOR: Appili To Work on Anti-Bioterror Vaccine

See original Entrevestor post here Appili Therapeutics has struck an agreement to work on a vaccine that could protect people against a potential bioterror threat. The Halifax drug discovery company said Monday it signed a licence agreement with the National Research Council of Canada to help develop ATI-1701, to vaccinate against tularemia. The vaccine will protect against bacteria called Francisella tularensis, which can cause tularemia, a highly infectious disease also known as rabbit fever. People can become infected with tularemia through tick and deer fly bites, drinking infected water or by simply inhaling the disease if it becomes airborne. This is why the U.S. Centers for Disease Control and Prevention lists F. Tularensis (the bacteria that causes the disease) as a Category A pathogen, a bacteria that poses the highest threat to national security and public health. “Francisella tularensis is a very infectious bacteria,” Sean McBride, Appili vice-president of business development, said in the announcement. “A small number (of bacteria) can cause tularemia disease. If used as a weapon, the bacteria would likely be made airborne for exposure by inhalation.” He added: “People who inhale an infectious aerosol would generally experience severe respiratory illness, including life-threatening pneumonia and systemic infection, if they are not treated,” Aerosolized F. tularensis was studied by the Soviet Union during the Second World War and the Cold War for military purposes. The Soviets also developed a vaccine, but with limited effectiveness. The NRC’s ATI-1701 compound was developed through genetic engineering and has shown a strong immune response to the F. tularensis strain. “The NRC has developed an elegant attenuated vaccine that is showing dramatic results, better than the current vaccination,” Appili CEO Kevin Sullivan said in an interview. Wayne Conlan led the team that developed NRC’s ATI-1701 compound. In the statement, he said: “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.” Part of the funding to develop the vaccine is from the Defense Threat Reduction Agency, a part of the U.S. Department of Defense, which has invested $6.2 million into a five-year program to develop the tularemia vaccine. The licence agreement with the NRC grants Appili — which has raised money from Innovacorp and through the investment boutique Bloom Burton  & Co. — exclusive worldwide rights to develop and commercialize the tularemia vaccine. Under the agreement, Appili is responsible for the preclinical and clinical testing to evaluate the safety of the ATI-1701 vaccine in humans as per the guidelines from the Food and Drug Administration and Health Canada. The vaccine won’t be commercially available for another 3-5 years but Sullivan says this is the right step to hinder the development of a tularemia bioweapon. “It’s one of the goals of the West to develop the tularemia vaccine in case there is a bioterror attack,” said Sullivan. “We want to minimize the threat of a bioterror weapon to a point where the adversary doesn’t even bother making one.”]]>

Appili Therapeutics Receives $1.2M USD from the Department of Defense to Advance Antibiotic Targeting Drug-Resistant Bacteria

See original post here For Immediate Release November 7, 2017 – HALIFAX, Nova Scotia –– 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. Media Relations Contact: Jennifer Cameron T: 902-209-4704 E: [email protected] Investor Relations Contact: Kevin Sullivan, CEO, Appili Therapeutics T: 902-442-4655 E: [email protected]]]>

Appili Receives FDA and Health Canada Clearance to Begin Clinical Trials of its Antibiotic Oral Liquid Reformulation

For Immediate Release 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 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. Media Relations Contact: Jennifer Cameron T: 902-209-4704 E: [email protected] Investor Relations Contact: Kevin Sullivan, CEO, Appili Therapeutics T: 902-442-4655 E: [email protected]]]>

Appili Therapeutics Raises $3M to Advance Its Anti-Infective Pipeline

For Immediate Release October 23, 2017 – HALIFAX, Nova Scotia –– 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 clinic. “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. 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 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. These drug-resistant infections have been identified by the U.S. 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. For more information, please contact: Jennifer Cameron 902.209.4704 [email protected] Investor Relations Kimberly Stephens, CFO Appili Therapeutics [email protected]]]>