2025 Corporate Review

Executive Summary

• BioVaxys announced positive Phase 1 results for MVP‑S in HR⁺/HER2⁻ stage II‑III breast cancer, showing a ≥50% median Ki‑67 reduction and an 8‑fold increase in survivin‑specific IFN‑γ T cells.
• The company disclosed multiple strategic collaborations and out‑licensing efforts, including a research agreement with Sona Nanotech on DPX + Targeted Hyperthermia Therapy, prospective animal‑health mRNA partnership, and ongoing licensing talks for MVP‑S in ovarian cancer.
• New scientific advisors were added (Dr. James Tartaglia to the Board; Dr. Marianne Stanford as Scientific Advisor) and existing animal‑health licenses with Zoetis and SpayVac are generating royalty revenue.

Key Details

• Phase 1 MVP‑S Clinical Data – Median Ki‑67 dropped from 24% pre‑treatment to 6% post‑treatment; one patient exhibited an 8‑fold rise in survivin‑specific IFN‑γ T cells.
• Market Context – Global HER2‑negative breast cancer market valued at $14.4 bn (2024) and projected $21.5 bn by 2030; HR⁺/HER2⁻ accounts for ~57.8% of that revenue.
• Future Clinical Plans – BioVaxys will expand systemic immunity profiling and pursue a Phase II study of MVP‑S in high‑risk HR⁺ breast cancer.
• Collaboration with Sona Nanotech (May 2025) – Joint research on DPX platform combined with Sona’s Targeted Hyperthermia Therapy™; studies to be conducted at Dalhousie University under Dr. Carman Giacomantonio and Dr. Barry Kennedy.
• Out‑licensing Discussions – Early‑stage talks with a global pharma partner for MVP‑S in ovarian cancer; potential licensing of DPX‑mRNA formulation for rabies in animal health (agreement expected early 2026).
• DPX‑RSV Update – Phase 1 completed; 93% of subjects showed antigen‑specific responses, 100% durability at one year in the 25 µg single‑dose cohort.
• Animal Health Licenses – Revenue‑generating licenses with Zoetis (cattle immunocontraception) and SpayVac for Wildlife (feral horse/deer contraceptive vaccine); expanded fields of use to commercial aquaculture in April 2025.
• Scientific & Board Appointments – Dr. James Tartaglia joins Board; Dr. Marianne Stanford appointed Scientific Advisor, bringing extensive DPX platform expertise.
• CEO Statement – “In 2025, we have continued to build a world‑class team…we anticipate aggressive business development activity and booking our first royalty income in 2026.”

Notable Quotes

• Kenneth Kovan (President & COO): “The clinical data from MVP‑S is very compelling…it makes more sense for remaining clinical studies with MVP‑S to be pursued by a company with the appropriate resources.”
• James Passin (CEO): “We look forward to advancing and crystallizing ongoing out‑licensing and research collaboration discussions in 2026, a year in which we anticipate aggressive business development activity and booking our first royalty income.”

Materiality Assessment: Material – Positive**