Mr. Don Cilla reports

APPILI THERAPEUTICS ANNOUNCES ISSUANCE OF PATENT FOR ATI-1701 BIODEFENSE VACCINE CANDIDATE TO PROTECT AGAINST TULAREMIA AND PROVIDES UPDATE ON BRIDGE LOAN

Appili Therapeutics Inc. has noted that the United States Patent and Trademark Office (USPTO) has published patent claims for ATI-1701 under the U.S. application No. 16/982,322 filed on Sept. 18, 2020, and titled "A Method for Lyophilizing Live Vaccine Strains of Francisella Tularensis." The patent covers the composition and preparation methods for the vaccine through 2039.

This patent was issued to Appili's partner, the National Research Council of Canada (NRC), and protects against the unauthorized use of methods claimed to lyophilize Francisella tularensis strains, including Appili's proprietary live vaccine strain ATI-1701. Appili licensed the biodefence vaccine candidate ATI-1701 from NRC in December, 2017. The licence agreement with NRC grants Appili exclusive worldwide rights to develop and commercialize ATI-1701. The new patent protects additional manufacturing methods for the final drug product.

"This patent protects an improvement in the method of lyophilizing F. tularensis live vaccine strains, such as the Ft clpB mutant (ATI-1701). The patent also protects a special media which preserves the viability of the vaccine in a manner which is clinically useful and allows long-term storage," said Don Cilla, PharmD, MBA, president and chief executive officer of Appili Therapeutics. "This patent strengthens ATI-1701's position and the new methods are expected to allow Appili to further develop a valuable vaccine that is urgently needed on the market."

Appili's development program ATI-1701, for the prevention of tularemia, has received awards totalling $14-million (U.S.) from the U.S. Air Force Academy (USAFA). This year, as ATI-1701 early-stage development activities and regulatory activities progressed, the company successfully completed a knowledge transfer and executed a technology transfer to the phase 1 contract manufacturing organization (CMO). Appili expects the ATI-1701 CMO to successfully produce engineering batches and GMP (good manufacturing practice) batches in 2024.

Additionally, Appili was granted a pre-IND (investigational new drug) meeting with the Food and Drug Administration to discuss ATI-1701's regulatory, CMC, toxicology and phase 1 strategies and expects to receive feedback in early 2024. The goal of the ATI-1701 program is to evaluate the immunogenicity, efficacy and safety of the ATI-1701 vaccine and ultimately submit a biological licence application.

The company also announced that the company and Bloom Burton & Co. have agreed to amend the terms of the existing $300,000 bridge loan advanced to the company by Bloom Burton in June, 2023. Under the amended terms, the bridge loan will now mature on March 31, 2024, subject to acceleration in connection with certain corporate events.

About ATI-1701

ATI-1701 is the company's potential first-in-class vaccine candidate for the prevention of infection with F. tularensis, the causative agent of tularemia and a top-priority biothreat. Appili is developing ATI-1701 as a vaccine to combat F. 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 at least 1,000-fold more infectious than anthrax, experts consider the aerosolized form to have a high potential for use in a bioterrorism attack.

Appili secured a $14-million (U.S.) funding commitment for ATI-1701 from USAFA, which is working in partnership with the Defense Threat Reduction Agency. These funds, along with other potential financing sources, are anticipated to continue to advance the ATI-1701 program toward an IND submission to the FDA in 2025.

About Appili Therapeutics Inc.

Appili Therapeutics is a biopharmaceutical company that is purposefully built, portfolio-driven and people-focused to fulfill its mission of solving life-threatening infectious diseases. 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 an FDA-approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicentre of the global fight against infection.

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