Appili Therapeutics Reports FY2026 Results, Highlights US$40M NIAID Award for Antifungal Vaccine and LIKMEZ Commercial Momentum
核心洞察
Appili Therapeutics (搜索) reported fiscal year 2026 financial results, posting a net loss of $4.2 million as the company advanced its infectious disease pipeline with government-backed funding.
The company and partner Vitalex Biosciences (搜索) secured a NIAID (搜索) contract valued at up to US$40 million to advance the dual-antigen antifungal vaccine candidate VXV-01 through Phase 1 clinical trials.
LIKMEZ (metronidazole oral suspension), relaunched in May 2025 by partner Saptalis Pharmaceuticals (搜索), demonstrated steady U.S. sales growth and received patent extensions through 2039.
Appili Therapeutics (搜索) Inc. (TSX:APLI; OTCPink: APLIF) announced its financial and operational results for the fiscal year ended March 31, 2026, highlighting significant progress across its infectious disease pipeline, including a landmark US$40 million contract from the National Institute of Allergy and Infectious Diseases (NIAID (搜索)) to advance its antifungal vaccine candidate and growing commercial traction for its FDA-approved metronidazole oral suspension.
"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 (搜索). "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."
VXV-01: NIAID (搜索)-Funded Antifungal Vaccine Targeting Invasive Candida
A centerpiece of Appili's pipeline advancement is VXV-01, a novel dual-antigen vaccine targeting invasive Candida infections (搜索), developed in collaboration with Vitalex Biosciences (搜索). In October 2025, the NIAID (搜索), part of the National Institutes of Health, awarded a contract valued at up to US$40 million to support the program. The contract includes an initial US$3.6 million base period with additional options intended to fund development through Investigational New Drug (IND) submission and Phase 1 clinical trials. Appili serves as the prime contractor, with 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.
The global burden of invasive fungal infections underscores the significance of this program: an estimated 6.5 million people are affected annually, resulting in approximately 3.8 million deaths. Currently, no fungal vaccines are approved for human use anywhere in the world.
LIKMEZ (ATI-1501): Building Commercial Momentum
LIKMEZ (metronidazole oral suspension, 500 mg/5 mL), the first and only FDA-approved ready-to-use liquid oral suspension of metronidazole, is being commercialized in the U.S. by Saptalis Pharmaceuticals (搜索), LLC. The product is 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, 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.
ATI-1801: Regulatory Pathway Aligned with FDA
ATI-1801, a novel topical formulation of paromomycin (15% w/w), is under advanced clinical development for the treatment of cutaneous leishmaniasis (搜索), a disfiguring skin infection that affects hundreds of thousands of people annually. Appili licensed exclusive worldwide rights 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, demonstrating a significant improvement in the rate of clinical cure of the index lesion compared to vehicle at 6 months.
Following a Type B meeting with the FDA, the agency agreed with Appili'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, and Appili believes the program may be eligible to receive a Priority Review Voucher upon approval.
ATI-1701: Biodefense Vaccine Advancing
ATI-1701, a live-attenuated vaccine candidate for the prevention of tularemia (搜索) — a Category A pathogen-associated disease identified by the NIH as a serious threat to national security and public health — continues to advance. No approved vaccine for tularemia currently exists in the U.S. or other major global markets.
During FYE 2026, Appili achieved 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 U.S. Air Force Academy has awarded approximately US$14 million in total funding for ATI-1701, of which approximately US$11.7 million has been allotted for services. The period of performance under the agreement has been extended to August 31, 2026.
Financial Results and Funding Strategy
Appili reported a net loss and comprehensive loss of $4.2 million, or $0.03 per share, for FYE 2026, compared to a loss of $2.6 million, or $0.02 per share, in the prior year. The increased loss was driven primarily by a $7 million decrease in government assistance related to the USAFA Cooperative Agreement and a $0.9 million decrease in other income, partially offset by reductions in R&D expenses ($3 million), financing costs ($2.5 million), and general and administrative expenses ($0.4 million).
As of March 31, 2026, the company held cash of $0.04 million, down from $1.2 million a year earlier. Appili has included a going concern note in its financial statements and is dependent on successfully raising additional financing through equity and/or non-dilutive funding.
Since inception, Appili has secured over US$66 million in government funding and currently has additional proposals in active review. The company has also secured extensions on its loans with Long Zone Holdings Inc. and Bloom Burton & Co. Inc., with amounts now due on June 30, 2026, subject to potential further extension if the company completes an equity financing of at least CAD $350,000.
"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," added Dr. Cilla.