Appili Therapeutics secures funding, progresses development of multiple programs

From GlobeNewswire: 2024-08-13 17:19:00

Appili Therapeutics Inc. has finalized an agreement with Aditxt that, if approved by shareholders, will provide a premium and resources to support key programs. Funding commitments from the U.S. Air Force Academy for ATI-1701 and interactions with the FDA confirm the development pathway for the program through IND submission.

ATI-1701, a biodefense vaccine candidate to prevent F. tularensis, has secured $14 million in funding from the U.S. Air Force Academy. Appili will manage a comprehensive development program to support an IND submission in 2025. Engagement with the FDA through a pre-IND meeting is progressing the development pathway for ATI-1701.

ATI-1801, a topical antiparasitic product for cutaneous leishmaniasis, is in advanced clinical development. Appili has submitted a meeting request to the FDA to discuss the necessary registration package for a New Drug Application submission. Non-dilutive funding and partnerships with organizations focused on tropical diseases are being pursued.

LIKMEZ™ (ATI-1501), a liquid oral reformulation of metronidazole, was approved by the FDA in September 2023. Saptalis Pharmaceuticals launched LIKMEZ and it is now available in the U.S. for pediatric patients and those with dysphagia. Appili will receive sales-based milestone payments and royalties from Saptalis based on product sales.

Appili Therapeutics has entered into a definitive arrangement agreement with Aditxt for the acquisition of all outstanding shares by Aditxt’s subsidiary. Shareholders will receive a combination of Aditxt common stock and cash for each share held. Further details will be provided in a management information circular for a special shareholder meeting.

Appili reported a net loss of $1.6 million for the first quarter of fiscal year 2025. The financial statements show an increase in research and development expenses and financing costs, offset by government assistance. The company had cash of $0.3 million as of June 30, 2024, with issued shares, stock options, and warrants outstanding.



Read more at GlobeNewswire:: Appili Therapeutics Reports Financial and Operational