Mr. Don Cilla reports

APPILI THERAPEUTICS ANNOUNCES ALIGNMENT WITH FDA ON DEVELOPMENT REQUIREMENTS FOR ATI-1801 TOPICAL ANTIPARASITIC PRODUCT NDA SUBMISSION

The U.S. Food and Drug Administration (FDA) has provided positive feedback regarding the development strategy for Appili Therapeutics Inc.'s ATI-1801 and agreed on the necessary registration package to support a new drug application (NDA). ATI-1801, a novel topical formulation of paromomycin (15 per cent weight by weight), is under advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally.

"This positive response from the FDA simplifies and derisks our development program for ATI-1801," said Don Cilla, president and chief executive officer of Appili Therapeutics. "The agency's agreement with our proposed strategy enables Appili to leverage key results from the clinical dossier for ATI-1801 licensed from U.S. Army Medical Materiel Development Activity (USAMMDA), including the successful results of a phase 3 study, and provides a clear path towards an NDA submission."

In a recent response to Appili's Type B meeting request, the FDA agreed with the company's proposed strategy to establish a scientific bridge between previous clinical trial material and new drug product batches. This approach includes developing an appropriately validated in vitro release test (IVRT) method and manufacturing a new reference standard to use in IVRT studies to support the scientific bridge to products used in prior studies. This will allow completion and submission of an NDA much sooner than if additional clinical data were required.

Subject to securing the requisite financing, Appili expects to implement the agreed-upon strategy and continue to advance ATI-1801 topical paromomycin cream (15 per cent weight by weight) program to NDA submission.

ATI-1801 has received orphan drug designation from the FDA for certain forms of cutaneous leishmaniasis. The company is evaluating ATI-1801's eligibility for a priority review voucher (PRV), which, if confirmed, would make it the second PRV-eligible program at Appili, alongside ATI-1701, which is potentially eligible for a PRV pending renewal of certain U.S. legislation.

Aditxt Inc. arrangement

On April 2, 2024, the company announced that it had entered into a definitive arrangement agreement, pursuant to which Aditxt, through its wholly owned subsidiary, Adivir Inc., agreed to acquire all of the issued and outstanding Class A common shares of the company. Under the terms of the arrangement agreement, shareholders of the company will receive: (i) 4.67 U.S. cents in cash; and (ii) 0.0000686251 of a share of Adixt common stock.

This transaction represents a premium to Appili's recent trading price and, assuming the completion of the transaction, provides shareholders with immediate value.

On Oct. 1, 2024, the company obtained an interim order from the Ontario Superior Court of Justice in connection with the transaction. The order permits the mailing of all requisite meeting materials in connection with the special meeting of Appili shareholders scheduled to be held virtually on Nov. 6, 2024, at 11 a.m. ET.

Shareholders are encouraged to vote their shares as soon as possible.

The notice of the special meeting of shareholders and management information circular containing all relevant details with respect to the meeting (including voting instructions) and the transaction are available on the company's website as well as under Appili's profile on SEDAR+.

About ATI-1801

Licensed from the U.S. Department of Defense through the U.S. Army Medical Materiel Development Activity, Appili's ATI-1801 is a novel topical product with demonstrated safety and efficacy across multiple phase 2 and phase 3 studies. As current treatments are often invasive and require hospitalization, ATI-1801 has the potential to significantly reduce suffering from cutaneous leishmaniasis by providing patients in need with a safe and effective topical therapy that can be used in the outpatient setting.

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 an FDA-approved, ready-made suspension of metronidazole for the treatment of anti-microbial infections, a vaccine candidate to eliminate a serious biological weapon threat and a topical anti-parasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicentre of the global fight against infection.

We seek Safe Harbor.