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Appili Therapeutics Inc. develops anti-infective products for infectious diseases and biodefense. Company updates cover its portfolio of LIKMEZ (ATI-1501), an FDA-approved ready-made metronidazole suspension; ATI-1701, a live-attenuated tularemia vaccine candidate; ATI-1801, a topical antiparasitic program for cutaneous leishmaniasis; and collaborations involving VXV-01, a fungal vaccine program.
Recurring news also addresses non-dilutive government funding, NIAID and U.S. Air Force Academy-supported development work, manufacturing and regulatory activities, financial and operational results, scientific and biodefense conference participation, and shareholder meeting outcomes.
Appili Therapeutics (OTC:APLIF) has published significant findings in the journal Vaccine demonstrating the effectiveness of ATI-1701, their biodefense vaccine candidate against tularemia. The study showed 100% survival rates in rats challenged with aerosolized F. tularensis SCHU S4, even at doses exceeding 10,000 times the median lethal dose.
The vaccine demonstrated up to 100% protection in cynomolgus macaques, with reduced disease severity and improved outcomes. ATI-1701, being developed in partnership with the U.S. Department of Defense, represents a first-in-class vaccine candidate for tularemia prevention, addressing an unmet need as there are currently no approved vaccines in major global markets.
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.