Researchers Present Positive Interim Data on Appili Therapeutics’ ATI-1701 Biodefense Program at 2020 ASM Biothreats  

ATI-1701 demonstrated durable protective response against Francisella tularensis, a Category A pathogen and potential biological weapons threat

 

Safety and efficacy data support ongoing development under U.S. Food and Drug Administration’s medical countermeasure guidelines  

HALIFAX, Nova Scotia, January 28, 2020 – Appili Therapeutics Inc. (TSXV: APLI) (the Company or Appili), a biopharmaceutical company developing anti-infective drug candidates, today announced that Dr. Carl Gelhaus, Senior Program Manager of the Medical Countermeasures Division at MRIGlobal, will present positive interim data on Appili’s ATI-1701 program at the 2020 ASM Biothreats conference. Hosted by the American Society for Microbiology, the conference is being held from January 28–30, 2020 in Arlington, Virginia.

“These interim results add to a growing body of evidence supporting advanced development of ATI-1701 as a medical countermeasure against one of the most significant bioterrorism threats we might face,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “We remain very encouraged by these results and look forward to sharing the 365-day challenge study data later this year. We are committed to working with our biodefense partners at the U.S. DOD, MRIGlobal, and the National Research Council of Canada toward the first approved vaccine for the prevention of weaponized tularemia.”

 

Presentation details are as follows:

 

Title: A ClpB Mutant of Francisella Tularensis SCHU S4 is an Effective Vaccine in Fisher 344 Rat and Cynomolgus Macaque Models of Pneumonic Tularemia

Poster Number: 083

Date: Tuesday, January 28, 2020

Time: 4:15 - 5:15 p.m. ET

Location: Independence Center, Hyatt Regency Crystal City at Reagan National Airport

The ASM poster presentation summarizes the findings from the ongoing preclinical study of ATI-1701, which showed complete (100%) protection 90 days after vaccination from a lethal exposure to the pathogen Francisca tularensis. This duration is the longest vaccine protection period tested to date in this model. Researchers will conduct an additional evaluation of vaccine efficacy up to 365 days in the same model in the first half of 2020. The U.S. Defense Threat Reduction Agency (DTRA), an arm of the U.S. Department of Defense (DOD), is funding this trial. MRIGlobal is managing the study under the DTRA contract HDTRA1-16-C-0028.

 

About ATI-1701

Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which the U.S. National Institutes of Health (NIH) defines as a Category A pathogen (an organism that poses the highest risk to national security and public health). As it is 1,000 times more infectious than anthrax, experts consider the aerosolized form to have a high potential use in a bioterrorist attack.[i]  Several countries may already have operational weapons programs leveraging this pathogen, making the need for a vaccine to counter this biological weapons threat exceedingly important.[ii]

 

About ASM Biothreats

ASM Biothreats is the leading annual conference on biodefense, biosecurity and biological threats. Hosted by the American Society for Microbiology, ASM Biothreats offers a unique program that explores the latest developments and emerging technologies in the industry. This unique meeting draws stakeholders from government, academia, and industry for an important exchange of knowledge and ideas that will shape the future of high consequence pathogen research.

About MRIGlobal

Celebrating its 75th year of business, MRIGlobal addresses some of the world’s greatest threats and challenges. Founded in 1944 as an independent, non-profit organization, MRIGlobal performs contract research for government, industry, and academia. It offers customized solutions in national security and defense and health include research and development capabilities in clinical research support, infectious disease and biological threat agent detection, global biological engagement, in vitro diagnostics, and laboratory management and operations. MRIGlobal is one of two partners in the Alliance for Sustainable Energy, LLC, which manages and operates the National Renewable Energy Laboratory (NREL) in Golden, Colo., for the U.S. Department of Energy. For more information, visit www.mriglobal.org

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 a pipeline of assets designed to address a broad range of urgent threats in global public health. ATI-2307, a novel, broad spectrum, clinical stage antifungal, is in development to address severe and difficult-to-treat invasive fungal infections. Via an in-licensing program, Appili is developing ATI-1701, a vaccine for tularemia, to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program developing 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 the antibiotic metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Toronto, 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 its product. 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.

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Investor Relations Contact:

Kimberly Stephens, CFO

Appili Therapeutics

TSX-V: APLI

E: Info@AppiliTherapeutics.com

[i] PHAC PSDS (2011) Anthrax; PHAC PSDS (2011) Tularemia

[ii] Oyston P (2004) Nat Rev Microbiol 2: 967-979