Appili Therapeutics Reports Financial and Operational Results for First Quarter of Fiscal Year 2027
Rhea-AI Summary
Appili Therapeutics (OTC Pink: APLIF) reported first quarter fiscal 2027 operational highlights and outlined a revised strategy emphasizing biodefence and health security, while keeping ATI-1801 (TRUQUESTA) as its key near‑term regulatory asset.
Following positive FDA feedback on its scientific bridging strategy, TRUQUESTA for cutaneous leishmaniasis now has a clearly defined registration pathway toward an NDA, and may be eligible for a Priority Review Voucher if approved, potentially as early as Q4 2029, subject to securing non‑dilutive funding. LIKMEZ (ATI‑1501), commercialized by Saptalis Pharmaceuticals, has shown U.S. sales growth since its May 2025 re‑launch and benefits from patents in the U.S. and Mexico extending to 2039.
According to Appili, lender extensions require repayment of the Bloom Burton Loan by September 30, 2026 and the Long Zone Holdings Loan by that date if at least CAD$350,000 is raised in equity by August 31, 2026. For the three months ended December 31, 2025, Appili reported a net loss of $1.0 million versus $0.5 million a year earlier, mainly due to a $2.6 million drop in government assistance, partly offset by lower R&D and G&A expenses and higher foreign exchange gains. Cash stood at $0.2 million at December 31, 2025, down from $1.2 million at March 31, 2025.
Positive
- Defined FDA pathway for TRUQUESTA (ATI-1801) toward NDA following positive feedback
- Potential Priority Review Voucher for TRUQUESTA, with approval anticipated as early as Q4 2029, subject to funding
- LIKMEZ U.S. sales growth since May 2025 re-launch, indicating market uptake
- LIKMEZ patent protection in U.S. and Mexico extended through 2039
- Operating cost reductions with $1.2M lower R&D and $0.2M lower G&A expenses YoY
- Foreign exchange gains increased by $0.7M, partially offsetting reduced government assistance
Negative
- Net loss widened to $1.0M from $0.5M for the three months ended December 31, 2025
- Government assistance decreased by $2.6M, driving higher net loss
- Cash balance declined to $0.2M at December 31, 2025 from $1.2M at March 31, 2025
- Loan repayments due with all Bloom Burton Loan amounts payable by September 30, 2026
- Financing condition requiring minimum CAD$350,000 equity raise by August 31, 2026 to maintain Long Zone Holdings Loan extension to September 30, 2026
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Appili adopts a new business strategy that focuses on the biodefence sector
Halifax, Nova Scotia--(Newsfile Corp. - August 14, 2026) - Appili Therapeutics Inc. (TSX: APLI) (OTC Pink: 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 2027, which ended on June 30, 2026. All figures are in Canadian dollars unless otherwise stated.
"While ATI-1801 remains the Company's principal near-term regulatory and value-creation opportunity, Appili is expanding its portfolio strategy to build a broader biodefence and health-security company, with an increased emphasis on defence-related medical needs," said Dr. Don Cilla, President and CEO of Appili.
Revised Business Strategy
The Company was founded to acquire, develop, and commercialize novel therapeutics addressing infectious diseases and biodefense priorities. Our revised strategic focus is driven by the significant unmet medical and public health need for innovative countermeasures against naturally occurring and emerging infectious diseases, antimicrobial resistance, and biological threats, as well as the expanding regulatory, procurement, and non-dilutive funding mechanisms available to support development. These opportunities are increasingly supported by U.S. Government agencies, allied governments, and international organizations seeking resilient biodefense and health security capabilities.
TRUQUESTATM (ATI-1801) - Topical Antiparasitic Program with an Aligned Regulatory Path
Following positive feedback from the U.S. Food and Drug Administration ("FDA") on its scientific bridging strategy, TRUQUESTATM, a topical formulation of paromomycin in development for cutaneous leishmaniasis has a clearly defined registration pathway to support an NDA submission. Appili is actively pursuing non-dilutive funding from global health organizations and government agencies that share the Company's focus on tropical diseases to execute this strategy and complete the remaining development work.
Appili's TRUQUESTATM 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
LIKMEZ® (ATI-1501), Commercial Momentum Building in U.S. Market
Saptalis Pharmaceuticals, Appili's manufacturing and commercialization partner, continues to commercialize LIKMEZ (metronidazole oral suspension, 500 mg/5 mL), the first and only FDA-approved liquid oral formulation of metronidazole. Since the re-launch in May 2025, LIKMEZ has demonstrated sales growth, reflecting clinician and patient demand.
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.
Lender Extensions
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 September 30, 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
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.
For the three months ending December 31, 2025, the Company reported a net and comprehensive loss of
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.
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About Appili Therapeutics
Appili Therapeutics is building a National Security Healthcare company that develops, acquires, and advances medical technologies to protect military personnel, strengthen national resilience, and address critical healthcare needs. Guided by a force health protection framework, Appili is building a portfolio spanning infectious disease, physiological readiness, diagnostics, biosurveillance, and protection against chemical, biological, radiological, and nuclear threats. The Company emphasizes dual-use technologies with applications across defense, government, and commercial healthcare markets. Appili's current portfolio includes programs addressing biological threats, serious infections, and other urgent unmet medical needs.
Appili Therapeutics: Advancing National Security Healthcare. Protecting the warfighter. Strengthening resilience. Advancing healthcare solutions.
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 potential PRV eligibility of ATI-1701 and ATI-1801 and the Company's expectations with respect to its ability to operate as a going concern and satisfy its ongoing working capital requirements. (ii) ,. 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 (including the risk that any waivers the Company may require thereunder will not be provided), 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.
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Media and Investor Relations Contact:
Don Cilla, President and CEO
Appili Therapeutics
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/309716