Appili Therapeutics Reports Financial and Operational Results for First Quarter of Fiscal Year 2026

Rhea-AI Summary

Appili Therapeutics (OTC:APLIF), a biopharmaceutical company specializing in infectious diseases and medical countermeasures, reported its Q1 FY2026 financial results. The company has submitted seven U.S. government funding proposals totaling US$137 million and joined the U.S. Medical CBRN Defense Consortium.

Key developments include: LIKMEZ® re-launch in the U.S. market, progress on ATI-1701 tularemia vaccine development with US$11.6 million in USAFA funding, and advancement of ATI-1801 for leishmaniasis treatment. The company reported a reduced net loss of $1.2 million compared to $1.6 million in the previous year, with cash position of $1.1 million as of June 30, 2025.

Positive

• Secured membership in U.S. Medical CBRN Defense Consortium, enhancing government partnership opportunities
• Submitted seven U.S. government funding proposals worth potential US$137 million
• Reduced net loss by $0.4 million year-over-year
• FDA endorsed faster path to NDA submission for ATI-1801 without additional trials
• Successfully re-launched LIKMEZ® in U.S. market with potential milestone and royalty payments

Negative

• Reduced funding under USAFA Cooperative Agreement affecting ATI-1701 IND application completion
• Declining cash position from $1.2M to $1.1M quarter-over-quarter
• Government assistance decreased by $1.9 million

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Submitted two additional U.S. government funding proposals during the quarter, bringing the total proposals to US$137 million

Accepted as a new member of U.S. Medical CBRN Defense Consortium, strengthening government and biodefense partnerships

HALIFAX, Nova Scotia, Aug. 14, 2025 (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 its financial and operational results for the first quarter of its fiscal year 2026, which ended on June 30, 2025. All figures are in Canadian dollars unless otherwise stated.

“Appili continues to strengthen our position within government and biodefense industries, highlighted by our recent participation in the U.S. Medical CBRN Defense Consortium (“MCDC”) Membership Meeting and the publication of new ATI-1701 data,” said Don Cilla, Pharm.D., M.B.A., President and CEO of Appili Therapeutics.

“In the first quarter of fiscal 2026, we focused on building commercial momentum for LIKMEZ®, advancing ATI-1701 through ongoing funded activities, and securing a partner for ATI-1801. With seven non-dilutive funding proposals submitted to U.S. government agencies—representing up to US$137 million— Appili is positioned to advance infectious disease and biodefense products.”

Update on U.S. Federal Government Funding Proposals

Appili has submitted a total of seven funding proposals to U.S. government agencies, representing a potential combined award value of up to US$137 million. This includes a recently submitted proposal to the Congressionally Directed Medical Research Program’s Peer Reviewed Medical Research Program (“PRMRP”) (described herein), two proposals submitted to the U.S. Medical CBRN Defense Consortium (“MCDC”), and two proposals submitted to the National Institute of Allergy and Infectious Diseases (“NIAID”). If awarded, the funding would support the development of these projects, advancing them through manufacturing, non-clinical development, and regulatory activities required for IND submissions, and Phase 1 clinical trials for the two proposals submitted to NIAID.

MCDC Membership

Appili was recently accepted as a member of the MCDC, further solidifying its role in U.S. preparedness and biodefense. With over US$7 billion in awarded project funding to date, the MCDC fosters public–private partnerships that accelerate the development of safe and effective medical countermeasures.

In July 2025, Dr. Gary Nabors, Chief Development Officer of Appili, participated in the MCDC Consortium event, joining government and industry leaders to align shared biodefense priorities. Through the consortium membership, Appili can actively engage with government stakeholders, collaborate with industry partners, and pursue new funding opportunities that align with the objectives of the DOD.

ATI-1701, Biodefense Vaccine Candidate with Funding Awarded from the U.S. Air Force Academy

ATI-1701, Appili’s live-attenuated vaccine candidate for the prevention of tularemia, continues to progress under a Cooperative Agreement with the U.S. Air Force Academy (“USAFA Cooperative Agreement”), with total program funding allotted of approximately US$11.6 million.

In July 2025, Appili’s Director of Non-Clinical Research, Dr. Carl Gelhaus, Ph.D., co-authored a manuscript titled “Vaccination with a novel live attenuated strain of Francisella tularensis subsp. tularensis protects cynomolgus macaques against aerosol F. tularensis infection.” The publication presents data demonstrating robust and durable protection against lethal tularemia in non-human primates and contributes to the growing body of evidence supporting the potential of ATI-1701 as a leading tularemia vaccine candidate.

Appili previously announced a reduction in funding under its USAFA Cooperative Agreement for ATI-1701, which prevents the Company from completing the investigational new drug (“IND”) application for the program as originally planned. In response, Appili recently submitted a new application to the PRMRP valued at over US $3.3 million. If awarded, these funds are expected to advance ATI-1701 to IND submission to the FDA.

LIKMEZ™ (ATI-1501), re-launched activities ongoing in the U.S.

In May 2025, the Company’s manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC (“Saptalis”) re-launched LIKMEZ^® metronidazole oral suspension, (500 mg/5 mL) in the U.S. LIKMEZ is the first and only FDA-approved, ready-to-use liquid oral suspension of metronidazole, developed specifically for patients who have difficulty swallowing tablets or who are sensitive to taste.

Under the terms of the agreement between the Company and Saptalis, Appili is eligible to receive multiple milestone and royalty payments on the development and sale of LIKMEZ in the U.S.

ATI-1801 – Topical Antiparasitic Program with Positive Phase 3 Data and Funding Opportunity

ATI-1801 is a novel topical formulation of paromomycin (15% w/w) in advanced development for the treatment of cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands of people globally each year.

Following a recent Type B meeting, the FDA endorsed Appili’s proposed strategy to bridge existing clinical data with new product batches, allowing a faster path to new drug application (“NDA”) submission without requiring additional trials.

Appili is actively pursuing non-dilutive funding from global health organizations and NGOs aligned with its focus on neglected tropical diseases. If secured, this funding would support execution of the FDA-aligned development plan and advance the program toward NDA submission.

The Company is also assessing the program’s eligibility for a Priority Review Voucher (“PRV”), which, pending renewal of legislation in the U.S., could make ATI-1801 the second PRV-eligible program at Appili, alongside ATI-1701.

Financial Results

The Company prepares its financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are in Canadian dollars unless otherwise stated.

The net loss and comprehensive loss for the three months ended June 30, 2025, totaled $1.2 million ($0.01 loss per share), reflecting a $0.4 million decrease compared to the $1.6 million net loss ($0.01 loss per share) reported for the same period in 2024. This decrease was primarily due to a $0.8 million decrease in financing costs, a $0.4 million increase in foreign exchange gain, a $1.1 million decrease in research and development expenses and a $0.1 million decrease in general and administration expenses. However, these factors were partially offset by a $1.9 million decrease in government assistance. As of June 30, 2025, the Company had cash of $1.1 million, compared to $1.2 million on March 31, 2025.

As of August 14, 2025, the Company had 121,266,120 issued and outstanding Common Shares, 11,910,281 stock options, and 37,139,874 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements for the first quarter of the 2026 fiscal year and the related MD&A, copies of which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca.

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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 resistant 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 partnered projects to be developed, the potential that Appili will receive government awards and / or contracts related to its proposal submissions, further anticipated milestones and the timing thereof, the Company’s development plans and timelines with respect to ATI-1501, ATI-1701 and ATI-1801, the timing of any milestone and/or royalty payments in respect of ATI-1501,   and the Company’s expectations with respect to its ability to operate as a going concern and satisfy its ongoing working capital requirements. 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, (i) the risk that the Company may not secure any government funding in respect of any proposal submitted prior to the date hereof, (ii) risks relating to the ability of the Company to repay the LZH Loan and the Bloom Burton Loan as and when they become due, and (iii) those risks listed in the annual information form of the Company dated June 25, 2025, 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, Communications Manager
Appili Therapeutics
E: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:
Don Cilla, President and CEO
Appili Therapeutics
E: Info@AppiliTherapeutics.com

FAQ

What is the total value of Appili Therapeutics' (APLIF) submitted U.S. government funding proposals in 2025?

Appili has submitted seven funding proposals to U.S. government agencies with a potential combined award value of up to US$137 million.

How much funding has Appili Therapeutics (APLIF) received for its ATI-1701 tularemia vaccine program?

The ATI-1701 program has received approximately US$11.6 million in total program funding through a Cooperative Agreement with the U.S. Air Force Academy.

What was Appili Therapeutics' (APLIF) net loss for Q1 FY2026?

Appili reported a net loss of $1.2 million ($0.01 per share) for Q1 FY2026, down from $1.6 million in the same period last year.

What is the current status of LIKMEZ in the U.S. market?

LIKMEZ® was re-launched in May 2025 by Saptalis Pharmaceuticals as the first and only FDA-approved, ready-to-use liquid oral suspension of metronidazole.

What is Appili Therapeutics' (APLIF) cash position as of June 2025?

As of June 30, 2025, Appili had a cash position of $1.1 million, compared to $1.2 million on March 31, 2025.