Appili Therapeutics Reports Fiscal Year 2026 Financial and Operational Results
LIKMEZ® (ATI-1501) commercial momentum building in U.S. market
US$40 million NIAID award supporting VXV-01 advancement through Phase 1
HALIFAX, Nova Scotia, June 26, 2026 (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 fiscal year ended March 31, 2026 (“FYE 2026”), and provided an update on fiscal 2027. All figures are stated in Canadian dollars unless otherwise stated.
"Fiscal year 2026 marked a significant transition for Appili as we advanced commercial-stage programs and continued to build our non-dilutive funding base,” said Don Cilla, Pharm.D., M.B.A., President and CEO of Appili Therapeutics. "With LIKMEZ gaining traction in the U.S., our pipeline progressing with government backing, and US$40 million in new awards, we are executing on the strategy we set out to build. "
“With a clear roadmap in place, the Company is focused on growing LIKMEZ, advancing our funded pipeline programs, and securing additional non-dilutive and equity capital as we move into fiscal 2027” adds Dr. Don Cilla.
ATI-1801, Topical Antiparasitic with Aligned Regulatory Path
ATI-1801 is a novel topical formulation of paromomycin (15% 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 annually and remains a priority for governments and non-governmental organizations globally.
Appili licensed the exclusive worldwide rights to ATI-1801 from the U.S. Army Medical Materiel Development Activity and holds a complete clinical dossier, including a randomized, vehicle-controlled Phase 3 study conducted in Tunisia that met its primary endpoint, with ATI-1801 demonstrating a significant improvement in the rate of clinical cure of the index lesion compared to vehicle at 6 months.
Following Appili’s Type B meeting with the U.S. Food and Drug Administration (“FDA”), the agency agreed with the Company’s proposed scientific bridging strategy between previously used clinical trial material and new drug product batches. This approach centers on developing a validated in vitro release test and manufacturing a new reference standard to support an NDA submission without the need for additional clinical efficacy studies, potentially accelerating time to registration.
ATI-1801 has received Orphan Drug Designation from the FDA for the treatment of certain forms of cutaneous leishmaniasis, and Appili believes the program may be eligible to receive a Priority Review Voucher (“PRV”) upon approval. Appili is actively pursuing non-dilutive funding and partnership opportunities with NGOs and government agencies to implement the agreed-upon regulatory strategy and complete remaining development work.
LIKMEZ® (ATI-1501), Seeing Commercial Momentum in the U.S. Market
LIKMEZ® (metronidazole oral suspension, 500 mg/5 mL), Appili’s licensed, taste-masked oral liquid formulation of metronidazole, is being commercialized in the U.S. by Saptalis Pharmaceuticals, LLC (“Saptalis”). LIKMEZ is the first and only FDA-approved, ready-to-use liquid oral suspension of metronidazole, designed for patients who have difficulty swallowing tablets or who are sensitive to taste.
Saptalis re-launched LIKMEZ in May 2025, and the product has demonstrated steady sales growth reflecting increasing clinician adoption and patient demand. Under the agreement with Saptalis, Appili receives sales-based milestone payments and royalties, providing a growing source of commercial revenue.
In April 2025, additional patents covering the composition and preparation methods for LIKMEZ were issued in the U.S. and Mexico, extending patent protection through 2039 and further strengthening the commercial profile of the product.
ATI-1701, Critical Biodefense Vaccine Candidate
ATI-1701 is Appili’s live-attenuated vaccine candidate for the prevention of tularemia, a Category A pathogen-associated disease identified by the U.S. National Institutes of Health as a serious threat to national security and public health. There is currently no approved vaccine for tularemia in the U.S. or other major global markets.
Appili holds exclusive worldwide rights to ATI-1701 and is advancing the program under a cooperative agreement with the U.S. Air Force Academy (“USAFA”), in collaboration with the Defense Threat Reduction Agency. USAFA has awarded approximately US$14 million in total funding for ATI-1701, of which approximately US$11.7 million has been allotted to pay for services under the agreement.
During FYE 2026, Appili achieved a key operational milestone with the successful GMP manufacture of ATI-1701 drug substance and drug product at the Walter Reed Army Institute of Research. The drug product met all release specifications and may be dispositioned for use in future clinical studies. The period of performance under the agreement with USAFA has been extended to August 31, 2026.
Appili continued to engage with global biodefense stakeholders, with presentations at the NATO CBRN Conference and the U.S. Medical CBRN Defense Consortium Annual Membership Meeting, reinforcing ATI-1701 's profile as a critical biodefense asset. The Company remains focused on securing additional non-dilutive funding to support an Investigational New Drug application and advance ATI-1701 to the clinic.
Subject to the renewal of certain U.S. legislation, Appili believes that ATI-1701 may be eligible to receive a PRV, if approved by the FDA.
VXV-01, NIAID-Funded Antifungal Vaccine Program
VXV-01 is a novel, dual-antigen vaccine targeting invasive Candida infections, being advanced by Appili in collaboration with Vitalex Biosciences (“Vitalex”).
In October 2025, Appili and Vitalex announced a contract by the U.S. National Institute of Allergy and Infectious Diseases (“NIAID”), part of the National Institutes of Health, valued at up to US$40 million. The contract includes an initial US$3.6 million base period and additional options intended to support development through IND submission and Phase 1 clinical trials, with Appili serving as the prime contractor and Vitalex as a key scientific subcontractor.
Under an exclusive option agreement with Vitalex, Appili retains the right to acquire full worldwide rights to VXV-01, positioning the Company to transition from development lead to asset owner upon achievement of defined milestones.
Globally, an estimated 6.5 million people are affected by invasive fungal infections annually, resulting in approximately 3.8 million deaths, and there are currently no approved fungal vaccines for human use, underscoring the significant unmet need VXV-01 aims to address.
Update on U.S. Federal Government Funding Proposals
Appili continues to execute a non-dilutive funding strategy, leveraging its expertise in government contracting to advance its infectious disease and biodefense programs.
Since inception, the Company has secured over US$66 million in government funding and currently has additional proposals in active review. If awarded, these new proposals would further strengthen Appili 's funding base and advance critical development activities, including manufacturing, preclinical studies, regulatory activities, and clinical trial preparation and conduct, while preserving shareholder value.
Lender Extensions
Appili has secured extensions to the amounts due under each of (1) the amended and restated secured loan agreement with Long Zone Holdings Inc. (the “LZH Loan”) and (2) the unsecured promissory notes with Bloom Burton & Co. Inc. (the “Bloom Burton Loan”). Pursuant to the terms of such extensions, all amounts owing under the Bloom Burton Loan, together with all accrued and unpaid interest, will be due on June 30, 2026. All amounts owing under the LZH Loan, together with all accrued and unpaid interest, will be due on June 30, 2026 unless Appili completes an equity financing with minimum gross proceeds of at least CAD $350,000 by June 30, 2026, in which case the extension will continue in full force and effect until July 31, 2026. The Company is working with lenders to secure further extensions.
Annual Financial Results
The Company prepares its financial statements in accordance with IFRS 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 $4.2 million or $0.03 loss per share for FYE 2026, was $1.6 million higher than the net loss and comprehensive loss of $2.6 million or $0.02 loss per share during the year ended March 31, 2025. This relates mainly to a $7 million decrease in government assistance, relating to the USAFA Cooperative Agreement, a $0.9 million decrease in other income representing waiver fees from Aditxt Inc., offset by a $0.4 million decrease in general and administrative expenses, a $3 million decrease in research and development expenses, a $2.5 million decrease in financing costs and a $0.5 million increase in foreign exchange gain.
On March 31, 2026, the Company had cash of $0.04 million compared to $1.2 million on March 31, 2025. The Company has included a going concern note in its financial statements for the FYE 2026. In particular, the Company is dependent in large part on successfully raising additional financing through equity and/or non-dilutive funding. For further details, please refer to the Company’s going concern note in the Company’s management’s discussion and analysis (the “MD&A”) for the FYE 2026.
As of June 25, 2026, the Company had 132,366,120 issued and outstanding Common Shares, 11,910,281 stock options and 41,368,000 warrants outstanding.
This press release should be read in conjunction with the Company’s audited annual consolidated financial statements for the FYE 2026, and the related MD&A, copies of which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca.
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, ATI-1801 and VXV-01, the timing of any milestone and/or royalty payments in respect of ATI-1501, the Company’s expectations of PRV eligibility for certain of its programs 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 be reimbursed for services provided under approved US government contracts or secure additional 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 or, alternatively, the ability of the Company to secure extensions to the maturity date thereof, and (iii) those risks listed in the annual information form of the Company dated June 26, 2026, 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
© 2026 GlobeNewswire, Inc. All Rights Reserved.
