ATI-1701 provides full protection against lethal tularemia in animal models after one year

Company to provide update on tularemia vaccine candidate ATI-1701 and present new data on efficacy

Presentation scheduled for 3:15 pm ET on October 17, 2024

HALIFAX, Nova Scotia, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced that Gary Nabors, Ph.D., Chief Development Officer, and key members of Appili’s scientific team, will participate at IDWeek 2024™, and present an update on the Appili biodefense program ATI-1701. The conference is being held from October 16-19 2024, at the Los Angeles Convention Center.

The poster presentation will provide an update on ATI-1701, Appili’s potential first-in-class vaccine candidate for the prevention of tularemia caused by F. tularensis and will summarize the latest findings from preclinical studies. These studies have demonstrated that a single dose of ATI-1701 provides full protection in animal models against lethal tularemia one year after vaccination.

Appili secured a US$14M funding commitment for ATI-1701 from the United States Air Force Academy, who is working in partnership with the Defense Threat Reduction Agency. These funds along with other potential funding sources, are anticipated to advance the ATI-1701 program to IND submission to the United States Food and Drug Administration (“FDA”) in 2025.

“Appili and our government partners are greatly encouraged by our manufacturing progress, and the results from the 365-day vaccination and challenge study,” said Dr. Gary Nabors, Chief Development Officer. “These findings, along with government funding commitments strengthen ATI-1701’s advanced development and are expected to position the program for an IND submission in 2025.”

Presentation details for Appili are as follows:

Poster Title: Toward the clinical development of ATI-1701, a genetically defined live attenuated tularemia vaccine
Date: October 17^th, 2024
Time: 12:15 PM PT / 3:15 PM ET
Location: Los Angeles Convention Center, Los Angeles, CA, Hall J & K

Appili management is also in attendance at the meeting and is available for in-person meetings throughout the conference. To request a meeting with Appili, please contact info@appilitherapeutics.com.

About ATI-1701
ATI-1701 is a novel, live-attenuated vaccine for F. tularensis, which causes tularemia, a Category A pathogen which can be aerosolized and is over 1,000 times more infectious than anthrax. Since it is a highly infectious pathogen capable of causing severe illness, medical countermeasures for F. tularensis are a top biodefense priority for the United States and governments around the world. There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets.

About IDWeek 2024
IDWeek 2024™ is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). With the theme “Advancing Science, Improving Care,” IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2024™ takes place Oct. 16-19 at the Los Angeles Convention Center (1201 S Figueroa St) in Los Angeles, CA. For more information, visit www.idweek.org.

About Appili Therapeutics
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 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 epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

Forward Looking Statements
This news release contains “forward-looking statements”, including with respect to the potential for ATI-1701 as a treatment for tularemia and the proposed development plan for ATI-1701 (including the timing of filing an IND). 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 forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 25, 2024, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). 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.

Media Contact:
Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:
Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: Info@AppiliTherapeutics.com