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Appili Therapeutics Inc. (APLIF) is a biopharmaceutical leader focused on infectious disease treatments and biodefense solutions. This page provides investors and stakeholders with timely updates on the company’s clinical developments, regulatory milestones, and strategic initiatives.
Access the latest press releases, earnings reports, and partnership announcements in one centralized location. Stay informed about APLIF’s progress in advancing therapies for antimicrobial resistance, vaccine development, and public health threats.
Key updates include progress on genetically defined vaccines, FDA submissions, and collaborative research efforts. Bookmark this page for direct access to verified information that impacts investment decisions and industry trends.
Appili Therapeutics (OTC:APLIF) reported its fiscal year 2025 results and operational updates. Key highlights include the successful re-launch of LIKMEZ™, their FDA-approved liquid metronidazole oral suspension, with commercial sales ongoing. The company has submitted five U.S. government proposals totaling up to US$125 million in potential funding.
The company reported a reduced net loss of $2.6 million ($0.02 per share) compared to $3.8 million in FY2024. Cash position improved to $1.2 million as of March 31, 2025. Progress continues on key programs including ATI-1701 (tularemia vaccine) under US$11.6M USAF funding and ATI-1801 for leishmaniasis treatment, which received positive FDA feedback for development strategy.
Appili Therapeutics (TSX: APLI; OTCPink: APLIF) has secured new patents in the United States and Mexico for LIKMEZ, its oral formulation of metronidazole. The patents, expiring in 2039, protect the drug's unique taste-masked composition and therapeutic applications.
The U.S. patent (20230086660A1) and Mexican patent (2020007494) have been granted for 'Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same.' Notably, Saptalis Pharmaceuticals, Appili's partner, has successfully listed the U.S. patent in the FDA's Orange Book.
Saptalis plans to re-launch LIKMEZ under its own label in May 2025. The drug's proprietary formulation offers improved stability and palatability, which are important factors for patient medication adherence and better treatment outcomes.
Appili Therapeutics (TSX: APLI; OTCPink: APLIF) announced that President and CEO Don Cilla will participate in Aditxt Weekly Update on April 4, 2025, alongside Aditxt CEO Amro Albanna. The discussion will focus on:
- The company's ongoing going-private transaction with Aditxt
- $117 million in new federal funding applications
- The growing threat of emerging infectious diseases
- Appili's near-to-market portfolio addressing unmet patient needs
The company highlighted its success in securing non-dilutive funding, including $33.2 million in prior government awards. The event will include a Q&A session, with Appili planning to participate in additional Aditxt Weekly Updates throughout the year.
Appili Therapeutics (APLIF) has submitted four new federal funding proposals totaling US$117.5 million to advance infectious disease treatments. Two proposals to NIAID seek US$46.3M for fungal infection vaccine development and US$36.4M for antifungal antibody development. Two additional proposals to MCDC request US$34.8M for viral infection treatments.
The company has joined the Medical CBRN Defense Consortium and received modifications to its USAFA Cooperative Agreement, including an increased G&A overhead recovery rate. However, due to budget constraints, no additional funds beyond the US$11.6M already allotted for ATI-1701 are expected, potentially delaying FDA submission.
The company's going-private transaction with Aditxt has been extended to March 31, 2025, with Aditxt providing a US$250,000 waiver payment.
Appili Therapeutics reported its Q3 FY2025 financial results, highlighting key developments in its infectious disease pipeline. The company received strong shareholder support for a take-private transaction with Aditxt, pending financing completion by February 28, 2025.
Key pipeline updates include: ATI-1701, a biodefense vaccine program with US$14M in USAFA funding, showing full protection against tularemia; ATI-1801, a topical antiparasitic treatment advancing toward NDA submission with FDA alignment; and LIKMEZ™, an FDA-approved liquid metronidazole formulation now commercially available.
Financial results showed a net loss of $0.5M ($0.00 per share) for Q3, up from $0.1M loss in the same period of 2023. Cash position was $0.2M as of December 31, 2024, compared to $0.09M on March 31, 2024.
Appili Therapeutics reported Q2 FY2025 financial results with a net loss of $0.8 million ($0.01 per share), showing a $0.2 million improvement from Q2 FY2024. The company highlighted three key developments: ATI-1701, a biodefense vaccine showing full protection against tularemia for one year; ATI-1801, advancing toward NDA submission for leishmaniasis treatment; and LIKMEZ™, an FDA-approved liquid metronidazole formulation now available in the US. Shareholders overwhelmingly approved (99.79%) a take-private transaction with Aditxt, expected to close in December 2024. Cash position was $0.7 million as of September 30, 2024.
Aditxt (NASDAQ: ADTX) announced a significant milestone in its acquisition plans for Appili Therapeutics (TSX: APLI; OTCPink: APLIF). At a special meeting, Appili's shareholders voted overwhelmingly in favor of a plan of arrangement that would allow Aditxt to acquire all issued and outstanding Class A common shares of Appili. This development marks a important step forward in Aditxt's strategy to expand its healthcare innovation platform.
Aditxt (NASDAQ: ADTX) has announced a significant development regarding its target acquisition, Appili Therapeutics (TSX: APLI; OTCPink: APLIF). The U.S. Food and Drug Administration (FDA) has provided positive feedback on the development strategy for ATI-1801, Appili's topical antiparasitic product. This feedback aligns with the requirements for the New Drug Application (NDA) submission.
Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) announced an update on their biodefense program ATI-1701 at IDWeek 2024™. The presentation, scheduled for October 17, 2024, will showcase new data on the efficacy of ATI-1701, a potential first-in-class vaccine candidate for tularemia prevention. Preclinical studies have demonstrated that a single dose of ATI-1701 provides full protection against lethal tularemia in animal models one year after vaccination.
Appili has secured a US$14 million funding commitment from the United States Air Force Academy, in partnership with the Defense Threat Reduction Agency. This funding is expected to advance the ATI-1701 program towards an IND submission to the FDA in 2025. The company's management will be available for meetings throughout the conference.
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