Appili Therapeutics and its Partner Vitalex Biosciences Awarded Contract from NIAID Valued at up to US$40 Million to Develop Fungal Vaccine VXV-01

Executive Summary

• Appili Therapeutics and partner Vitalex Biosciences received a five‑year NIAID contract worth up to US$40 million (US$3.6 M base period plus twelve option periods) to develop the VXV-01 vaccine for invasive fungal infections.
• The contract will fund manufacturing, non‑clinical work, IND filing and completion of Phase 1 clinical trials for VXV-01.
• Appili has also submitted four additional U.S. government funding proposals that could bring up to US$97 million in further non‑dilutive capital if awarded.

Key Details

• Contract Value: Approx. US$40 million total (US$3.6 M base period, ~US$36.3 M across twelve option periods).
• Performance Period: 22‑month base period; up to five years with options.
• Scope of Work: Manufacturing, non‑clinical studies, clinical and regulatory activities for VXV-01 vaccine; generation of data for IND submission and Phase 1 trial execution.
• Partner Roles: Appili – prime contractor managing subcontractors; Vitalex – owner of VXV-01 and collaborator on development.
• Vaccine Target: Dual‑antigen vaccine against invasive Candida species (C. albicans, C. auris) and related healthcare‑associated fungal infections. No FDA‑approved fungal vaccines currently exist.
• Funding Proposals Submitted: Four additional U.S. government proposals totaling a potential US$97 million in awards; pending decision.
• Prior Government Funding: Appili has previously secured US$34.9 million in non‑dilutive government funds.
• Strategic Importance: Non‑dilutive financing supports high‑priority infectious disease programs, reduces reliance on equity dilution, and aligns with public health/biodefense priorities.

Notable Quotes

• “VXV-01 has the potential to significantly reduce serious invasive infections caused by Candida albicans, Candida auris, and other related healthcare‑associated infections,” – Don Cilla, President & CEO, Appili Therapeutics.
• “Vitalex’s second generation VXV-01 vaccine shows impressive protection against lethal invasive and mucosal Candida infections,” – Dr. Ashraf S. Ibrahim, CEO, Vitalex Biosciences.

All forward‑looking statements are subject to risks and uncertainties detailed in the release.