HALIFAX, Nova Scotia — February 12, 2026 — Leads & Copy —
Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, announced its financial and operational results for the third quarter of its fiscal year 2026, which ended on December 31, 2025.
According to Dr. Don Cilla, President and CEO of Appili, the company made progress in advancing multiple U.S. federal funding proposals that could support its key pipeline and collaborator programs. He noted the recent award of up to US $40 million for VXV-01 and continued access to non-dilutive capital, Appili is strengthening its funding base to drive infectious disease assets forward.
The company reported a net and comprehensive loss of $1 million ($0.01 per share) for the three months ending December 31, 2025, representing an increase of $0.5 million compared to the net loss of $0.5 million ($0.004 per share) for the same period in 2024. The higher loss was mainly driven by a $2.6 million reduction in government assistance, partially offset by a $1.2 million decrease in research and development expenses, $0.2 million decrease in general and administrative expenses and a $0.7 million increase in foreign exchange gains. As of December 31, 2025, the Company’s cash balance was $0.2 million, down from $1.2 million as of March 31, 2025.
Appili continues to leverage government partnerships to advance its infectious disease and biodefense pipeline. Since its inception, the company has secured over US$75 million in cumulative government funding and has an additional US$82 million in proposals in active review across multiple programs. These funding sources enable Appili to advance development activities, including manufacturing, preclinical studies, regulatory activities, and clinical trial preparation and conduct.
Following feedback from the U.S. Food and Drug Administration (“FDA”) on its scientific bridging strategy, ATI-1801, a topical formulation of paromomycin for cutaneous leishmaniasis has a defined registration pathway to support an NDA submission. Appili is pursuing non-dilutive funding from global health organizations and government agencies to execute this strategy and complete the remaining development work.
Appili’s ATI-1801 is potentially eligible to receive a Priority Review Voucher (“PRV”) upon FDA approval, which is anticipated as early as the fourth quarter of 2029 subject to securing the requisite funding. Recent PRV transactions have reached US$200 million.
Saptalis Pharmaceuticals, Appili’s manufacturing and commercialization partner, continues to commercialize LIKMEZ (metronidazole oral suspension, 500 mg/5 mL), the first FDA-approved liquid oral formulation of metronidazole. Since the re-launch in May 2025, LIKMEZ has demonstrated sales growth.
Under the agreement with Saptalis, Appili is eligible to receive sales-based milestone payments and royalties. In April 2025, additional patents protecting LIKMEZ’s composition and preparation methods were published in the U.S. and Mexico, with patent protection extending through 2039.
ATI-1701, a live-attenuated vaccine candidate for tularemia, achieved a key operational milestone with the successful GMP manufacture of drug substance and drug product. The GMP drug product may be formally dispositioned for use in Phase 1 clinical trials. Subject to renewal of certain pending legislation in the U.S., Appili believes that ATI-1701 may be eligible for a PRV, if approved by the FDA.
During the third quarter, Appili was awarded a contract by the U.S. National Institute of Allergy and Infectious Disease (“NIAID”) valued at up to US$40 million to advance VXV-01, Vitalex Biosciences’ (“Vitalex”) dual-antigen vaccine targeting multidrug-resistant Candida species. Appili leads development as the prime contractor, with Vitalex providing asset development and scientific expertise as subcontractor.
Under an agreement with Vitalex, Appili retains an exclusive option to acquire worldwide rights to VXV-01. Nearly 6.5 million people annually are affected by invasive fungal infections, resulting in approximately 3.8 million deaths. Currently, no fungal vaccines are approved for human use.
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 March 31, 2026. All amounts owing under the Long Zone Holdings Loan, together with all accrued and unpaid interest, unless Appili completes an equity financing with minimum gross proceeds of at least CAD$450,000 by February 28, 2026, in which case the extension will continue in full force and effect until March 31, 2026.
As of December 31, 2025, the Company had 128,366,120 issued and outstanding Common Shares, 11,910,281 stock options, and 39,048,000 warrants outstanding.
This press release should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements for the second 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.
Appili Therapeutics is an infectious disease biopharmaceutical company that is built to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is advancing anti-infectives, including a ready-made suspension of metronidazole, a vaccine candidate, and a topical antiparasitic.
Source: Appili Therapeutics
