Dr. Don Cilla reports

APPILI THERAPEUTICS SECURES CONTRACT FOR ATI-1701 FUNDING FROM THE U.S. AIR FORCE ACADEMY

Appili Therapeutics Inc. has executed the initial contract with the U.S. Air Force Academy (USAFA) for the previously announced funding of the ATI-1701 program. This contract represents the first stage of funding from the previously announced award from the U.S. Department of Defense (DOD). This initial funding, in the amount of $7.3-million (U.S.), will be used to kick off ATI-1701 early-stage development and regulatory activities. As the initial activities progress, Appili will be engaging USAFA for additional tranches of funding to continue development through IND (investigational new drug). ATI-1701, Appili's biodefence vaccine candidate, is the company's potential first-in-class vaccine candidate for the prevention of infection with Francisella tularensis, the causative agent of tularemia and a top-priority biothreat.

"Successfully securing the first stage of funding from the DOD marks another exciting milestone for Appili and enables us to ramp up our efforts to develop an urgently needed vaccine for this serious bioterrorism threat," said Don Cilla, PharmD, MBA, president and chief executive officer of Appili. "In addition to providing Appili with certain direct labour reimbursement and overhead recovery, this support is a clear indication of the importance of this program to the DOD and will further strengthen non-clinical, manufacturing and regulatory activities around ATI-1701, helping Appili deliver on our mission to address a variety of urgent unmet needs in infectious disease and biodefence."

Francisella tularensis has been classified as a Category A pathogen by the U.S. National Institutes of Health due to its high rates of infectiousness and ability to cause lethal pneumonia and systemic infection. As the transmission of Francisella tularensis in the aerosolized form is more infectious than anthrax, it is considered to be a high bioterrorism threat.

Earlier this year, the company announced positive one-year results from its preclinical study evaluating the efficacy of biodefence vaccine candidate ATI-1701 in a lethal model of tularemia. In a one-year NHP study, ATI-1701 exhibited significant efficacy at days 28 and 90, with 100 per cent of ATI-1701 vaccinated animals surviving a lethal aerosol challenge at day 90, while no unvaccinated animals survived. The one-year data demonstrate that a single vaccination with ATI-1701 can provide sustained protection. At the one-year time point, there was a statistically significant improvement in survival in ATI-1701 vaccinated animals compared with mock vaccinated controls. These positive one-year data, in addition to the significant efficacy demonstrated at earlier time points, well position ATI-1701 to become the first approved vaccine for the prevention of tularemia. The study was funded by DTRA (Defense Threat Reduction Agency) and conducted by MRIGlobal.

About USAFA contract

USAFA is the prime contractor to DTRA for this program. Dr. Balboni, assistant professor and director at the Life Sciences Research Center of USAFA, is the principal investigator. The contract with USAFA establishes Appili as the top-tier performer, managing the development activities through IND. The anticipated total program funding amount is expected to be approximately $14-million (U.S.), depending on U.S. federal budget funding activities, with the first tranche of $7.3-million (U.S.) authorized with this contract. This, and other tranches of planned funding, are expected to advance the ATI-1701 program to an IND submission to the FDA in 2024.

About ATI-1701

Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which is classified by the U.S. National Institutes of Health (NIH) as a Category A pathogen, an organism that poses the highest risk to national security and public health. Estimated to be 1,000-fold more infectious than anthrax, experts consider the aerosolized form to have a high potential for use in a bioterrorism attack.

About Appili Therapeutics Inc.

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili's goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The company is currently advancing a diverse range of anti-infectives, including a vaccine candidate to eliminate a serious biological weapon threat, a topical anti-parasitic for the treatment of a disfiguring disease, and a novel easy-to-use, liquid oral formulation targeting parasitic and anaerobic infections. Led by a proven management team, Appili is at the epicentre of the global fight against infection.

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