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--()--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 worldwide1. PRMP 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.2 3

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.

1 Biomed Res Int. 2016; 2016: 2475067. Published online 2016 May 5. doi: 10.1155/2016/2475067
2 WHO (2017): Global Priority List of Antibiotic-Resistant Bacteria to Guide Research, Discovery, and Development of New Antibiotics
3 CDC (2013): Antibiotic Resistance Threats in the United States

Contacts

Media Relations:
Andrea Cohen, Sam Brown Inc.
T: 917-209-7163
E: andreacohen@sambrown.com

Investor Relations:
Kimberly Stephens, CFO
Appili Therapeutics
E: Info@AppiliTherapeutics.com

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Contacts

Media Relations:
Andrea Cohen, Sam Brown Inc.
T: 917-209-7163
E: andreacohen@sambrown.com

Investor Relations:
Kimberly Stephens, CFO
Appili Therapeutics
E: Info@AppiliTherapeutics.com