Appili, Vitalex win up to $40M (U.S.) VXV-01 contract

Executive Summary

• Appili Therapeutics and partner Vitalex Biosciences were awarded a NIAID contract valued at up to US$40 million to develop the fungal vaccine VXV‑01.
• The award includes a 22‑month base period of US$3.6 million with twelve optional extensions that could bring total funding to ≈US$40 million for IND filing and Phase 1 trials.
• Appili has also submitted four additional U.S. government proposals worth up to US$97 million, highlighting a broader non‑dilutive financing strategy.

Key Details

• Contract Number: 75N93025C00033 (NIAID).
• Base Period: 22 months, US$3.6 M.
• Option Periods: Up to 12 options, total optional value ≈US$36.3 M, bringing the contract’s maximum value to ≈US$40 M.
• Purpose: Fund development of VXV‑01 vaccine covering manufacturing, non‑clinical studies, clinical and regulatory activities; support IND submission and Phase 1 trial completion.
• Vaccine Target: Invasive fungal infections caused by Candida albicans, C. auris, and related pathogens. No FDA‑approved fungal vaccines currently exist.
• Partner Roles: Appili – prime contractor, manages subcontractors, generates IND data; Vitalex – owns VXV‑01, provides scientific expertise.
• Funding Strategy: Apart from the awarded contract, Appili has four pending government proposals totaling up to US$97 M; prior non‑dilutive funding totals US$34.9 M.

Notable Quotes

• “VXV‑01 has the potential to significantly reduce serious invasive infections caused by Candida species…” – Don Cilla, President & CEO, Appili Therapeutics.
• “The vaccine is expected to reduce mortality rates of lethal multidrug Candida infections…” – Dr. Ashraf S. Ibrahim, CEO, Vitalex Biosciences.

This release contains material information regarding a significant government contract and related funding strategy, which is likely to be viewed as material‑positive by investors.