Stage 1: Scientific Review
Illustrative goal: USD 0.1M–0.5M
The first stage would commission an independent review of existing FIV and HIV research, identify promising approaches, define measurable treatment requirements, and invite proposals from qualified laboratories or pharmaceutical companies.
The NIH Assay Guidance Manual estimates:
- target identification: USD 0.200M;
- target validation: USD 0.269M;
- combined cost: USD 0.469M in the source-year prices, or approximately USD 0.68M in May 2026 prices.
EndFIV's proposed USD 0.1M–0.5M range is lower because this stage would not identify a completely unknown viral target. Reverse transcriptase, integrase, protease, and other lentiviral targets are already known. The work would primarily review and select among existing possibilities.
Source and cost table: NIH Assay Guidance Manual cost table.
Stage 2: Laboratory Proof of Concept
Illustrative goal: USD 0.5M–3M
This stage would test selected compounds or therapeutic concepts against FIV in laboratory systems and determine whether any approach produces sufficiently promising antiviral activity.
The same NIH model lists the following costs after target validation:
- identification of active compounds: USD 0.473M;
- confirmation of hits: USD 0.522M;
- identification of a chemical lead: USD 0.353M;
- selection of an optimized lead: USD 0.303M;
- selection of a development candidate: USD 0.275M.
The total is:
USD 0.473M + 0.522M + 0.353M + 0.303M + 0.275M = USD 1.926M in the source-year prices, approximately USD 2.8M in May 2026 prices.
This directly supports an illustrative range of USD 0.5M–3M. The lower end assumes that existing compounds can be screened without conducting a complete new-drug discovery program.
Source and complete cost table: NIH Assay Guidance Manual cost table.
Stage 3: Therapy Development
Illustrative goal: USD 5M–30M
A successful laboratory result would then need to be developed into a practical candidate therapy. This could include compound optimization, combination selection, feline pharmacokinetics, toxicology, formulation, dosing, and preparation for larger veterinary studies.
A U.S. Department of Health and Human Services analysis estimated approximately USD 21M in 2012 prices for preclinical development leading to identification of a lead molecule. Adjusted by the U.S. Consumer Price Index, this is approximately USD 31M in May 2026 prices.
EndFIV therefore proposes USD 5M–30M:
- approximately USD 30M represents a relatively complete preclinical program;
- the lower end is an EndFIV assumption that reuse of existing compounds, targets, or antiviral knowledge could avoid much of the normal discovery work.
Sources: HHS ASPE analysis and BLS Consumer Price Index table.
Stage 4: Advanced Veterinary Development
Illustrative goal: USD 30M–300M
This stage could include controlled feline safety and efficacy studies, manufacturing development, regulatory submissions, and preparation for practical veterinary availability.
No published FIV-specific cost estimate exists. This range is therefore an EndFIV extrapolation.
Wouters and colleagues estimated median capitalized R&D investment of USD 1.142B for a newly approved human medicine, including the cost of failed projects. Adjusted approximately to May 2026 prices, that is about USD 1.6B.
For preliminary planning, EndFIV assumes that advanced veterinary development might require roughly 2%–20% of that human-drug benchmark. This scaling factor is an EndFIV planning assumption, not a published veterinary cost ratio:
- 2% × USD 1.6B is approximately USD 32M;
- 20% × USD 1.6B is approximately USD 320M.
Rounded, this produces the proposed USD 30M–300M range. The reduction assumes smaller veterinary studies and substantial reuse of HIV research.
Sources: Wouters et al., JAMA and BLS Consumer Price Index table.
What the Stages Mean
EndFIV would not need to raise hundreds of millions immediately.
The first practical target would be USD 0.1M–0.5M for an independent scientific assessment. Only encouraging results would justify proceeding to the USD 0.5M–3M laboratory stage. Larger development funding would be sought only after evidence showed that a promising therapeutic path existed.
Using the upper end of every stage gives:
USD 0.5M + USD 3M + USD 30M + USD 300M = USD 333.5M.
This is the origin of the approximately USD 300M optimistic planning estimate. It represents a relatively successful development path with limited failed approaches, not an amount that EndFIV expects to raise at the beginning and not an extra amount after a usable therapy exists.
If early candidates fail and multiple development programs must be attempted, the eventual total could be substantially higher.
Intellectual Property and Treatment Cost
The ownership and licensing of any intellectual property resulting from EndFIV-funded research will be determined during later stages of the project through agreements with the implementing research organizations and funding partners.
EndFIV's objective is to encourage innovation while ensuring that successful FIV therapies become widely available and affordable for cats worldwide.
Depending on the funding model and development partnership, EndFIV may seek arrangements such as reasonable licensing terms, broad manufacturing rights, or other mechanisms that promote accessibility while providing appropriate incentives for successful developers.
Although the final treatment cost cannot yet be estimated reliably, EndFIV's long-term objective is that an effective suppressive therapy should be affordable for routine long-term use by ordinary cat owners rather than being limited to specialist clinics or exceptionally expensive treatments.
Specific intellectual property and licensing policies will be published before any major development agreements are signed.
Important Limitation
These are transparent planning estimates, not quotations from pharmaceutical companies and not published estimates for FIV therapy. EndFIV will revise them when qualified veterinary researchers, pharmaceutical developers, and regulatory specialists provide project-specific budgets.