Mr. Don Cilla reports

APPILI THERAPEUTICS REPORTS FINANCIAL AND OPERATIONAL RESULTS FOR THIRD QUARTER OF FISCAL YEAR 2024

Appili Therapeutics Inc. has released its financial and operational results for the third quarter of its fiscal year 2024, which ended on Dec. 31, 2023.

"In recent months, we've achieved significant milestones by solidifying ATI-1701 government partnerships, engaging regulatory authorities for ATI-1801 and bringing our most advanced innovative asset, Likmez (ATI-1501), to market through our partner. Beginning 2024, Appili's skilled team stands with a clear vision and committed funding enabling us to execute on our infectious disease program priorities," said Don Cilla, PharmD, MBA, president and chief executive officer of Appili. "Additionally, the issuance of the patent claims for ATI-1701, shortly after receiving an additional funding commitment from USAFA, strengthens the programs position in biodefence, and the new methods are expected to allow Appili to further develop a valuable vaccine that is urgently needed on the market."

Operational highlights

Likmez ATI-1501: Food and Drug Administration-approved product

In September, 2023, Appili announced the FDA approval of Likmez (ATI-1501), its proprietary taste-masked liquid suspension reformulation of metronidazole, through its U.S. partner, Saptalis Pharmaceuticals LLC.

Likmez is the first and only Food and Drug Administration-approved ready-made suspension of metronidazole for the treatment of anti-microbial infections that addresses the unmet need in patients with dysphagia to avoid risks associated with drug compounding and discontinuation-related anti-microbial resistance. Saptalis launched Likmez in November, 2023, and commercial sales in the United States are continuing.

The FDA approval of Likmez, shortly after securing patent coverage through 2039, is an important milestone that demonstrates Appili's ability to identify promising opportunities and develop and monetize them for the benefit of both patients and shareholders. Collaborating with Saptalis, Appili earned $600,000 (U.S.) in milestone payments in fiscal 2024. Appili expects to receive sales-based milestone payments and royalties from Saptalis based on sale of the product.

ATI-1701, its biodefence vaccine candidate with strong government support

ATI-1701 is a novel, live-attenuated vaccine for the prevention of F. Tularensis, has received awards totalling $14-million (U.S.) from the U.S. Air Force Academy. Under the terms of the USAFA co-operative agreement, Appili oversees a comprehensive development program for ATI-1701, which includes non-clinical studies, CMC/manufacturing, clinical preparatory and regulatory activities to support an investigational new drug submission in 2025.

Appili was granted a pre-IND meeting with the FDA to discuss ATI-1701's regulatory, CMC, toxicology and phase 1 strategies, and expects to receive feedback in early 2024.

ATI-1801, its licensed topical anti-parasitic product

ATI-1801 is a novel topical formulation of paromomycin (15 per cent w/w) under advanced clinical development for the treatment of cutaneous leishmaniasis, a disfiguring infection of the skin that affects hundreds of thousands of people around the world annually.

In January, 2024, Appili requested a meeting with the FDA to discuss the previously generated phase 3 data and agree on the necessary registration package to support a new drug application submission, which the company expects will include available non-clinical, manufacturing and clinical data generated to date.

Annual financial results

The company prepares its financial statements in accordance with international financial reporting standards as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada handbook -- accounting.

The net loss and comprehensive loss of $200,000 or nil loss per share for the three months ended Dec. 31, 2023, were $2.4-million lower than the net loss and comprehensive loss of $2.6-million or two-cent loss per share during the three months ended Dec. 31, 2022. This relates mainly to an increase in milestone revenue of $500,000, an increase in government assistance of $2.0-million and a decrease in general and administrative expenses of $900,000. These decreases were offset by an increase in research and development expenses of $900,000 and an increase in financing costs of $200,000.

As of Dec. 31, 2023, the company had cash of $600,000 compared with $2.5-million on March 31, 2023.

As of Feb. 13, 2024, the company had 121,266,120 issued and outstanding common shares, 7,957,000 stock options and 44,856,874 warrants outstanding.

This press release should be read in conjunction with the company's unaudited interim condensed financial statements for the third quarter of the 2024 fiscal year and the related management's discussion and analysis, copies of which are available under the company's profile on SEDAR+.

About Appili Therapeutics Inc.

Appili, a biopharmaceutical company, 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 has a goal 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 Food and Drug Administration-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.