Appili Therapeutics Announces Additional Funding for Its ATI-1701 Biodefense Program

Agreement with Ology Bioservices and a $6.3MM DTRA contract enable next stage of manufacturing and development for world’s first vaccine to prevent F. tularensis, a potential biological weapons threat

HALIFAX, Nova Scotia--(BUSINESS WIRE)--Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the Company or Appili), a biopharmaceutical company developing anti-infective drug candidates, today announced updates for the continued development of its ATI-1701 biodefense vaccine program. Appili has entered into an agreement with Ology Biosciences, a biologics contract development and manufacturing organization (CDMO), under which Ology will manufacture ATI-1701, a novel live attenuated tularemia vaccine candidate. The U.S. Department of Defense (DOD), through the Joint Science and Technology Office of the Defense Threat Reduction Agency (DTRA), awarded Ology Bioservices $6.3MM USD for ATI-1701 manufacturing and development work under contract # MCDC18-04-13-006. DTRA-funded manufacturing work will be used to provide vaccine supply for future development of Appili’s ATI-1701 program.

​“Tularemia is a potentially deadly biological weapon for which there is no approved vaccine. ATI-1701 has the potential to address this critical biodefense gap and we are eager to start the next stage of its development,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “We are grateful for the work of our partners Ology Bioservices an MRI-Global, along with the continued support from DTRA, to address this urgent need.”

Appili is developing ATI-1701 as a vaccine to combat F. 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.¹ 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.² Appili is developing ATI-1701 under the ‘Animal Rule’ regulatory pathway.

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 critical disease space. Appili has built a 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, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FFTC’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific 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. 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. Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 24, 2020 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. 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.

Efforts sponsored by the U.S. Government under Other Transaction Number W15QKN-16-9-1002 between the MCDC, and the Government. The U.S. Government is authorized to reproduce and distribute reprints for governmental purposes notwithstanding any copyright notation thereon.

¹ PHAC PSDS (2011) Anthrax; PHAC PSDS (2011) Tularemia
² Oyston P (2004) Nat Rev Microbiol 2: 967-979