Laverdia Partnership

Laverdia & Dechra: Financing Engine

Overview:

Laverdia is our financing engine for the vaccine. The way we ran that program demonstrates what makes Anivive different.

Largest Nationwide Canine Lymphoma Study

Our pivotal canine lymphoma trial, powered by software:

99.5% Statistical Confidence

Far exceeding the 95% bar FDA requires

Largest Nationwide Study

By scale and geographic distribution, one of the largest lymphoma studies conducted in dogs

Software-Powered Enrollment

AniTrial platform drove 40% of enrollment, increased daily applications by 460%, and generated over 600 qualified applicants across 14 states

Global Milestone Potential: $29.5M

Laverdia now represents $29.5M in potential global milestone payments:

Global Milestone Potential ($29.5M)
  • United States
  • EU
  • UK
  • Australia
  • Brazil
  • Canada
RegionMilestone AmountStatus
United States$15.0MFDA Full Approval Confirmed
EU$5.0MYear-end filing prepared
UK$2.5MYear-end filing prepared
Australia$2.5MSubmission completed
Brazil$2.5MSubmission completed
Canada$2.0MTo follow
TOTAL$29.5M

Six-Country Regulatory Blitz in ~90 Days

Following U.S. submission, our team executed a six-country regulatory blitz:

U.S. NDA: Filed July 9, 2025

FDA Full Approval Confirmed

Australia, NZ, Brazil: Completed

EU & UK: Year-end filing

Canada: To follow

Scaling regulatory submissions across six countries in a single quarter is the kind of work most companies do with a far larger headcount. For us, it's a demonstration of what a focused, software-enabled team can do.

The Dechra Amendment We Signed

The original Dechra agreement pays a $15M U.S. milestone on Laverdia FDA approval, plus $14.5M in international milestones. This creates a timing gap: we invest heavily in launch before revenue arrives.

Executed Amendment:

  • • Convert $15M U.S. milestone into $1M monthly payments (Nov '25–Jan '27)
  • • Smooth funding for vaccine launch
  • • Make us immediately cash-flow positive
  • • Slightly reduce Canada milestone by $500K

Then Something Important Happened:

  • • Laverdia's review progressed with active participation from Matt Lucia, head of FDA's new animal drug programs
  • • USDA confirmed front-of-line status for vaccine meeting
  • • NIH and diagnostic revenue visibility improved

With that increased regulatory and revenue clarity, we made the deliberate decision to execute the Dechra amendment.

Why This Matters:

  1. Depth of Dechra's conviction: They were prepared to start paying us as if approval were already in hand
  2. Our discipline: We were offered a near-term cash solution and said yes, because it eliminates financing risk and makes us immediately cash-flow positive.