Vitrafy Life Sciences (VFY) investor relations material

Company highlights

• Cryopreservation platform combines Guardion hardware, LifeChain software and consumables, targeting blood, animal reproduction and cell & gene therapy markets.

• USAISR Study II recorded 94.4% mean post-thaw, no-wash platelet recovery, exceeding U.S. fresh and European guideline benchmarks.

• Partnerships signed across three sectors; agreements include Vitalant, Hoxworth, Versiti, Charter Medical and IMV Technologies.

• FY26 animal revenue rose 159% YoY to $169k; contracted revenue across FY26 and FY27 was ~ $1.0m.

• Cash and term deposits totaled $41.2m at 30 June 2026.

Blood market and commercial traction

• U.S. blood donations declined 40% over 20 years; 3% of eligible people donate annually, and most donors are over 50.

• U.S. red blood cell collections fell 19% from 2013 to 2023, while the population aged 65+ increased 30%.

• Platelets have a room-temperature shelf life under 7 days; annual U.S. platelet wastage is estimated at ~US$250m, with no FDA-approved cryopreserved platelet product on the market.

• Legacy U.S. red blood cell cryopreservation technology is being phased out by 2027, with no approved replacement identified.

• Existing blood partnerships cover ~179 fixed sites and ~2.4m annual collections; four units are planned for deployment in FY27.

Product, regulatory and manufacturing progress

• Guardion transitioned to research-use-only manufacturing, with first units delivered in Q2 2026; LifeChain launched alongside it with device control, workflow orchestration and 21 CFR Part 11 compliance.

• FDA Class II 510(k)-exempt listing for Guardion is expected in 1H FY27, following engineering, biological and user validation work.

• Ten Guardion units were built in FY26; 15 more are scheduled for 1H FY27, with U.S. manufacturing operations planned to commence in 1H FY27.

• U.S. customer demonstration operations are active; a U.S.-based COO was hired in Q1 FY27 and CEO relocation is planned for 1H FY27.

• FY27 ecosystem availability covers the Guardion freezer and LifeChain for research and commercial use, subject to applicable FDA requirements; the thawer and consumables are future releases.