Anivive Shareholder Letter
USDA schedules final vaccine meeting. Dechra paying $15M early at $1M/month. $52.5M locked revenue funds launch without dilution. Anivive 2.0 executing.
October 2025
Dear Shareholders,
Action is happening up and down the Anivive stack: the USDA scheduled our key regulatory meeting (postponed only by government shutdown, first in line when reopens), the FDA is on track to finish review of our lymphoma submission by year-end, Dechra has proposed paying $27.5M in 2026 to Anivive starting this month, and we signed the first-ever long-term commercial supply agreement for a systemic fungal vaccine.
What's new:
Over the past six months, we realigned the entire company—from Board composition to office leases, from cancer investments to R&D priorities—around a singular strategy: drive our Valley Fever vaccine across the finish line once and for all.
Why it matters:
Few companies have an opportunity like the one before Anivive. We're pursuing a once-in-a-generation shot to vaccinate a pathogen category that's evaded medicine for over a century. The way we win, the way you get a return, and the way we give millions of people extra years with their dog—it all starts with our vaccine.
1 big thing: Realigning everything around the vaccine
What's new:
Over the past six months, we made a strategic decision to realign Anivive from top to bottom around one goal: launching our Valley Fever vaccine. Board composition. Office leases. R&D priorities. Cancer investments. Everything filtered through this lens.
Why it matters:
No one since Pasteur or Salk has successfully vaccinated a new pathogen category—bacteria in 1880, viruses in 1950. For more than a century, fungi have evaded the advances of modern medicine. Until Anivive. If this wasn't significant, why would the U.S. Government award a pet company one of its largest contracts to make a human vaccine?
What we paused
For those asking: yes. We paused all efforts related to FIP, hemangiosarcoma, and every other program. The way we win, the way you get a return, and the way we give millions of people extra years with their dog—it all starts with our vaccine.
What we accelerated
Laverdia investment:
We increased investment into our lymphoma drug to secure the key Dechra payments that will fund our vaccine launch. That strategy worked—Dechra is now proposing to pay the first $15M U.S. milestone early at $1M per month, increasing total 2026 payments to $27.5M.
Operational discipline:
We paused non-core development to focus bandwidth, capital, and talent where it matters most. Subleased facilities in California and Arizona, saving $2M over four years. Every dollar not spent on overhead flows directly into vaccine launch.
Board realignment:
Added Dr. Steve Fisher (former Global Head of Purchasing for 30M pets at VCA/Mars) to complement Kevin McCarthy's government expertise. The Board now reflects our evolution from development to commercialization.
Executive recruitment:
Finalizing offers for a Chief Financial Officer and Head of Investor Relations—both from leading animal health companies whose market cap exceeds $120 billion. These hires strengthen our discipline, expand our reach, and position Anivive for long-term growth.
The strategic transformation
This is what we call Anivive 2.0—and the strategy is simple: "What would the business look like if we were starting it today?"
The answer: A lot like what we've built. We reorganized the Board, recruited top executives from across the industry, de-risked our supply chain, and blitzed regulatory filings for both our vaccine and lymphoma drug.
By the numbers:
- $52.5M in locked revenue (Dechra $27.5M, NIH biodefense $6M, vaccine pre-orders $18M, FDA grants $600K)
- Cancer pipeline: On track to deliver $27M next year
- Vaccine pre-orders: $20M from suppliers ready to fill orders
- Commercial platform: Scaled to handle demand—7,500 orders processed, 400 hospitals, 15,000 pet owners served
- Team leverage: 20 people executing like 100 through technology
The comprehensive foundation we built
Over the past decade, we systematically built capabilities from discovery through distribution:
Regulatory excellence:
- Finished lymphoma filings in U.S., Australia, New Zealand, Brazil
- EU and UK filings on track for year-end completion
- Pivotal trial hit 99.5% confidence (FDA requires 95%)
- Signed first-ever fungal vaccine commercial supply agreement for USDA facility
- Secured first fungal vaccine production permit for FDA human use
Software-powered execution:
- 40% of pivotal lymphoma patients enrolled through our platform
- Increased daily applications 460%
- Generated 600+ qualified applicants across 14 states
- Reached 20,000 monthly users
- Completely overhauled AI software stack
- Shipped and processed 20,000 tumor biopsies to help 25,000 dogs across 38 states—without a sales team
Biodefense portfolio:
- Secured $9M additional NIH grant for DNA/mRNA vaccine development
- Encouraged to apply for $30M+ more
- Trump administration declared our biodefense work "Essential Service" during government shutdown
Team and advisors:
- Dr. Ed Robb received the Iron Paw Award (industry's highest honor) for impact on drug development
- Recruited former USDA Director to advisory board
- Recruited top executives from manufacturing, business development, and R&D to join full-time Q1 2026
Vaccine program: Final chapter
Our vaccine program is entering its final chapter. Over the past few months:
- Submitted cat, rabbit, and manufacturing data packages
- Successfully completed U.S. submission
- Finalized filings in Brazil and Australia
- Scheduled USDA meeting for final alignment on approval steps (postponed by shutdown, first in line when reopens)
Timeline:
USDA meeting expected approximately 2 weeks after government reopens. Approval typically follows 90-120 days after, positioning us for Q1 2026 launch.
Dechra partnership: Outperforming expectations
Our lymphoma partnership with Dechra is outperforming. The success has led Dechra to propose paying the first $15M U.S. milestone early—at $1M per month—and increase total payments to $27.5M in 2026.
What this means:
Once we sign this amendment (expected shortly), Anivive becomes cash-flow positive and gains the staying power to execute at full speed without raising new capital.
What Anivive 2.0 means
Anivive 2.0 is a company built to bring our vaccine to market and use that success to fuel a broader mission: using technology to drive a wave of affordable treatments that give our best friends more time.
We've systematically addressed outstanding risks, renegotiated our Dechra partnership to fund the vaccine launch, and invested heavily in Laverdia to drive revenue—transforming our development-stage company into a fully integrated pharmaceutical firm executing across six countries.
The discipline:
Every decision made serves one mission—to launch the world's first systemic fungal vaccine and build a self-funding company that gives pets, and the people who love them, more time.
The takeaway:
Anivive 2.0 is focused and disciplined as we enter our commercial years. The foundation is built. The capabilities are proven. The revenue is locked. Now we execute on the largest opportunity in animal health—and prove that a new model works.
2. Laverdia milestones fund vaccine launch
What's new:
Dechra agreed to pay our $15M FDA approval milestone early — at $1M per month starting now — and increased total 2026 payments to $27.5M.
Why it matters:
This restructure eliminates financing risk entirely. We become immediately profitable, gain runway through 2027, and can invest fully in vaccine launch — all without raising equity or diluting shareholders.
The partnership evolution
Our Dechra collaboration ranks among the most successful in animal health. Under our 2023 licensing agreement, Anivive handles regulatory approvals and manufacturing while Dechra manages global sales and distribution.
The timing challenge: Our pivotal trial achieved 99.5% statistical confidence in April 2025 — crushing FDA's 95% threshold. But the original deal structured milestone payments around approval events. We needed capital now to fund vaccine launch prep, but the $15M wouldn't hit until Q1 2026 approval.
The solution: Dechra CEO Jesper Moller — someone I've known for years from early-career industry conferences — proposed a restructure that benefits both parties.
| Metric | Before Amendment | After Amendment |
|---|---|---|
| Monthly P&L | -$500K (red) | +$500K (black) |
| Cash unlock | N/A | $1M/month x 15 months |
| 2026 total revenue | N/A | $27.5M |
| Runway extension | To mid-2026 | Into 2027 |
| Dilution | Required | Zero |
Three strategic benefits
1. Capital six months early:
We receive launch funding before the Q1 2026 milestone. This lets us pre-position inventory, finalize distribution agreements, and execute pre-launch marketing while competitors fundraise.
2. Refinancing unlocks more capital:
Month-to-month profitability opens access to lenders who can refinance our Leonid loan at lower rates. Lower interest expense = more capital for vaccine launch.
3. Finish line investment:
As James Cavanaugh (one of the most accomplished life-science investors on our cap table) told me: "The most foolish thing you can do is underinvest at the finish line." This funding ensures we won't. We can hire sales support, execute market development, and scale distribution without constraints.
Revenue pipeline through 2026
| Revenue Stream | Timing | Value |
|---|---|---|
| Dechra monthly payments | Oct 2025 - Q1 2027 | $15,000,000 |
| Dechra international milestones | Mid-2026 | $12,500,000 |
| NIH biodefense contract | 2025-2026 | $6,000,000 |
| FDA grants (secured) | 2024-2025 | $600,000 |
| TOTAL LOCKED REVENUE | $34,100,000 |
Critical protection:
Our $33M NIH biodefense contract is classified as "Essential Service" — protected from federal shutdowns. Payments continue flowing even during government closures. Our $600K in FDA grants cover submission fees, ensuring reviews continue uninterrupted.
The CEO-to-CEO relationship: Jesper understands our vision, trusts our execution, and has been instrumental in structuring this amendment. This kind of relationship — built on mutual respect and long-term thinking — is rare in pharma and gives us confidence Dechra will be a strong partner as we scale.
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3. AniTrial platform proves competitive edge
What's new:
Our software platform powered 40% of Laverdia enrollment and achieved 99.5% statistical confidence — the first time we've validated our platform in an FDA regulatory trial.
Why it matters:
This success led Dechra to pay milestones early and attracted outside partners who want to use our platform for their studies. AniTrial is becoming its own revenue stream.
What the platform delivered
Accelerated enrollment:
Increased daily applications 460%, generating 600+ qualified applicants across 14 states.
Kept milestones on track:
Without AniTrial, this milestone would have been realized a year later and cost $1.8M more to achieve.
Exceeded FDA requirements:
Study hit 99.5% confidence vs. FDA's 95% threshold.
The bigger picture:
Traditional pharma can't replicate this. Our software platform creates competitive advantages that fundamentally change how trials run. Dechra and other pharmaceutical companies have approached us to help with their studies.
Global execution at unprecedented speed
Following U.S. success, we blitzed international regulatory filings — scaling teams across 6 countries in 30 days.
| Region | Status | Expected Timeline | Est. Milestone Payment |
|---|---|---|---|
| United States | Filed (FDA Approval Pending) | Q1 2026 | $15,000,000 |
| European Union | Final stages of prep | Filing by YE 2025 | $6,250,000 |
| United Kingdom | Final stages of prep | Filing by YE 2025 | $6,250,000 |
| Australia | Filed | Mid-2026 | Included in regional |
| Brazil | Filed | Mid-2026 | Included in regional |
| Canada | In process | H2 2026 | TBD |
| TOTAL UNLOCKED BY MID-2026 | $27,500,000+ | ||
FDA leadership joins review
Matt Lucia — head of all new animal drug programs at FDA — personally joined our Laverdia review team and allocated additional resources. I met with Matt in person half a dozen times last year to build this relationship. His involvement signals FDA's recognition of Laverdia's importance.
No shutdown delays:
While USDA vaccine review was postponed by the government shutdown, our Laverdia FDA review remains fully on track. FDA is funded by industry user fees, not government appropriations. Our $600K in secured grants cover submission fees, ensuring reviews continue regardless of shutdown politics.
Supply chain secured:
We renegotiated manufacturing agreements to ensure continuity post-approval. We continue as international distributor for Dechra from our FDA-licensed warehouse in Long Beach, California. This vertical integration gives us control over critical supply chain elements and creates additional revenue through distribution fees.
The takeaway:
AniTrial made our study so successful that Dechra is paying milestones before FDA provides final feedback. This early payment structure reflects their confidence in our execution and their recognition that investing in Anivive's success benefits both companies.
4. Valley Fever vaccine enters final USDA review
What's new:
We submitted the most comprehensive vaccine data package in recent USDA history and were scheduled for final review October 9th — postponed only by government shutdown. USDA confirmed we're first in line when government reopens.
Why it matters:
After a decade of development, we're 90-120 days from approval once our meeting happens. Every regulatory, manufacturing, and political variable has been systematically addressed.
Data submission complete
We submitted all required data to USDA:
Animal studies:
Mice, rabbit, cat, and dog studies across subcutaneous and intramuscular injection routes
Stability:
Room temperature, refrigerated, and frozen conditions tested
Formulations:
Lyophilized freeze-dried and liquid versions
Environmental:
Cleanup and handling protocols
Manufacturing:
Production, packaging, and labeling protocols
Genetic sequencing:
Master seed stock and 7 years of historical study materials
Environmental assessment:
Categorical exclusion documentation across three regulatory pathways
The delay:
This submission was originally expected March 2025, but our contract manufacturer HRA received multiple acquisition offers. All new vaccine submissions paused during 5 months of due diligence. In late July, Kemin Industries acquired HRA with commitment to maintain third-party relationships. We signed our supply agreement the same day and immediately resumed submissions.
USDA leadership engagement
I meet informally with Dr. Geetha Raghavan (USDA Director) almost quarterly in person. She's fully up to speed on our program, has joined key meetings, and allocated dedicated headcount to our review.
She delivered on her promise:
Our October 9th meeting was confirmed within two weeks of submission completion — before the shutdown intervened.
Post-shutdown priority:
David White (second-in-command to Dr. Geetha) confirmed we're slotted for the first review session once shutdown ends. We expect our meeting approximately 2 weeks after government reopening. Based on USDA precedent, approval typically follows 90-120 days after this final meeting — positioning us for Q1 2026 launch.
De-risking regulatory pathway
Former USDA Director recruited:
We brought on Dr. Paul Hauer — former Director of USDA's Center for Veterinary Biologics — as lead advisor on regulatory risk mitigation. Paul is guiding our NEPA categorical exclusion positioning, recommending who to invite to review meetings, and suggesting additional "nice-to-have" studies that strengthen our submission. He literally wrote the USDA playbook we're following.
FDA guidance release:
FDA issued guidance in September 2025 creating opportunity for scientific community feedback on fungal vaccine development. This bolsters our NEPA and environmental arguments by preemptively addressing them through public scientific discourse.
How we made this happen:
This guidance release is a direct result of our lobbying efforts in D.C. — we got this mandate written into the previous omnibus bill. Kevin McCarthy (Anivive Board Member, former Speaker of the U.S. House) helped round up necessary cross-aisle support.
Cross-government alignment
FDA, CDC, and NIH are all in alignment on the need for fungal vaccines:
- FDA held cross-agency workshop endorsing vaccine administration to humans for fungal diseases
- NIH released their March 2025 Strategic Plan (coordinated with our original expected submission date) which explicitly endorses our vaccine platform
- McCarthy made introductions to head of APHIS (the agency USDA CVB reports to in D.C.) and is coordinating introduction to Secretary of Agriculture, who has veto rights on USDA CVB decisions
The scale of coordination:
This level of federal coordination is unprecedented for a company our size and demonstrates the national importance of solving fungal disease.
The takeaway:
We've submitted more data than most vaccine approvals require, secured direct access to USDA leadership, and coordinated federal support across multiple agencies. We're at the front of the line for review post-shutdown, with approval expected 90-120 days after our meeting. This is the most de-risked regulatory pathway we could have built.
5. Manufacturing continuity secured with backup
What's new:
We signed commercial supply agreement with HRA/Kemin and secured Zoetis's 16,237 sq ft BSL-2 certified USDA facility in Texas as backup — eliminating single-source manufacturing risk entirely.
Why it matters:
The biggest risk to vaccine launch was manufacturing continuity. We've systematically eliminated that risk through primary supply agreement and unprecedented access to backup capacity.
The existential threat we solved
When HRA entered acquisition discussions, we faced potential catastrophe. Had certain strategic buyers acquired the facility, they would have canceled all third-party contracts — creating a 2-3 year delay and requiring $5M+ to build alternative capacity.
The problem:
Manufacturing for fungal vaccines is extraordinarily specialized. Alternative facilities simply don't exist.
The solution:
Dealmaking at the highest levels.
Primary supply secured
Commercial agreement signed:
First-ever fungal vaccine commercial supply agreement for a USDA-licensed facility. Agreement includes production guarantees and penalty clauses that protect Anivive from supply disruptions.
Acquisition outcome:
Kemin Industries acquired HRA with commitment to maintain third-party relationships. We signed same day.
Backup facility: The Zoetis deal
Our Board member Dr. Steve Fisher leveraged his relationships to negotiate directly with Kristin Peck, CEO of Zoetis (world's largest animal health company).
What Zoetis offered:
Their 16,237 sq ft BSL-2 certified USDA facility in College Station, Texas — a turnkey biomanufacturing asset with $30M+ replacement cost. Kristin personally signed off, effectively leaving $10M on the table to ensure Anivive could secure backup manufacturing capacity.
Deal terms:
- First 6 months rent-free (~$50K/month operating costs thereafter)
- 4,360 sq ft of active cleanrooms with 2,400+ sq ft expansion capacity
- Complete equipment suite including fill-finish lines and isolators
- Congressional permit for foot-and-mouth disease (FMD) work — making it the only private FMD-licensed facility in the U.S. outside DoD's Plum Island
Team secured:
We recruited the former Zoetis facility process manager to join Anivive and have identified our Head of Manufacturing to hire in 2026 once revenue scales.
Operational discipline
We subleased our California warehouse and Arizona lab facilities, eliminating $2 million in expenses over the next four years ($50K/month savings). We successfully moved diagnostic lab operations to our Long Beach facility, consolidating operations and reducing overhead.
Net result:
These savings exactly offset our Texas facility costs — giving us backup manufacturing at zero net expense.
6. Distribution platform proven at commercial scale
What's new:
Our direct-to-vet platform processed 7,500 orders from 400 hospitals this year, serving 15,000 pet owners across 38 states — all without a sales team.
Why it matters:
We didn't wait for approval to test our distribution infrastructure. We're generating revenue now while validating the exact platform we'll use for vaccine launch. When approved, we flip a switch — not build from scratch.
The Anivive integrated commercial platform
AniEngage:
Processed 7,500 orders from 400 veterinary hospitals using the same infrastructure built for vaccine distribution. Every order solved edge cases in clinic workflows, cold chain logistics, and payment processing.
Vaccine ordering ready:
We've already beta-tested vaccine ordering functionality. When approved, we can distribute vaccine to 30,000+ U.S. clinics with minimal overhead.
Engage V2 launches Q4 2025:
CRM analytics and direct vaccine ordering go live.
AniSelect:
Built the world's largest sequenced canine tumor database. This enables precision targeting of vaccine messaging by breed, location, and health profile — critical for identifying high-risk Valley Fever geographies.
AniTrial:
Powered 40% of Laverdia enrollment, reached 20,000 monthly users, and is now attracting interest from Dechra and other pharmaceutical companies as a standalone service.
Market demand validated
$50M+ in vaccine commitments secured before approval:
- $33M NIH biodefense contract (classified "Essential Service" — protected from shutdowns)
- $18M in pre-orders from 600+ hospitals, including approximately 450,000 doses planned for Arizona alone
- Partners include Petco Love and major veterinary networks (all subject to regulatory approval)
The takeaway:
Our platform isn't theoretical — it's generating real revenue with real customers. We've processed 7,500 orders, helped 15,000 pet owners, and secured $50M+ in vaccine pre-orders. When the vaccine launches, we're not hoping the platform works — we've proven it works.
7. Board rebuilt for commercial execution
What's new:
Dr. Steve Fisher joined our Board, bringing distribution expertise from overseeing vaccine procurement for 30 million pets annually at VCA/Mars.
Why it matters:
Our Board now blends regulatory navigation (McCarthy), large-scale distribution expertise (Fisher), USDA regulatory mastery (Hauer as advisor), and biodefense portfolio expansion (Christensen as advisor) — exactly the expertise mix we need for approval and launch.
Steve Fisher: Distribution at national scale
Former Global Head of Purchasing at VCA/Mars:
- 3,000 hospitals
- 70,000 veterinary professionals
- 30 million pets annually
Fisher brings distribution expertise at exactly the scale we need for national vaccine rollout. He oversaw vaccine procurement for 30 million pets annually and brings deep commercial relationships across hospitals, shelters, and insurers.
The Zoetis facility deal — proof of value:
Fisher negotiated directly with CEO Kristin Peck to secure our backup manufacturing facility. This demonstrates his ability to operate at the highest industry levels and solve problems money alone can't fix.
Executive hiring underway
We're recruiting a Chief Financial Officer and Head of Investor Relations from leading animal-health companies to strengthen financial strategy and communication as we scale into commercial-stage operations.
Ed Robb: Industry recognition
Chief Strategy Officer Ed Robb was honored with the Iron Paw Award for his career-long impact on veterinary medicine. Ed spearheads development of our Valley Fever vaccine, serves as Principal Investigator on our NIH biodefense contract, is an Anivive investor, and has been a key leader for eight years.
Norm Christensen: Biodefense expertise
Founder and CEO of Karman Space & Defense joined Anivive's Advisory Board. Christensen successfully led his company in securing billions in U.S. government contracts and completed one of the most successful defense IPOs of the past year. His experience building and scaling advanced technology platforms within the national security sector will guide Anivive as we expand our biodefense portfolio.
The takeaway:
The Board structure now delivers exactly what we need: regulatory navigation to get across the finish line (McCarthy, Hauer) combined with commercial execution expertise to dominate launch and distribution (Fisher).
8. Extending leadership beyond first vaccine
What's new:
We secured exclusive license to Dr. Deborah Fuller's DNA/mRNA fungal vaccine platform at University of Washington, helped secure $9M in NIH funding for the research, and are advancing both human vaccine and biodefense programs.
Why it matters:
We're not just building a Valley Fever vaccine — we're building a fungal vaccine platform with applications across veterinary medicine, human health, and national biodefense. This positions Anivive as the category leader.
Next-generation IP secured
The UW DNA/mRNA platform license gives us access to next-generation vaccine technology. By securing rights now, we extend our competitive moat beyond our first product and position Anivive to defend market leadership across multiple vaccine generations and formulations.
Human vaccine program
This summer, I met with the FDA Commissioner and submitted our application for a priority-review voucher through the CNPV pilot program.
Progress:
- Pre-IND meeting complete
- IND work underway
- Boston manufacturing partner secured and producing Phase 1 clinical trial batches
Strategic logic:
The program shares manufacturing infrastructure with our veterinary vaccine — reducing costs for both while expanding into human markets worth billions. The veterinary vaccine validates the science first; the human program extends the platform second.
Growing biodefense portfolio
Our $33M NIH biodefense contract was classified as "Essential Service" — within days of the shutdown, an order ensured work continues uninterrupted with payments flowing through.
Pipeline expansion:
- Secured $9M additional NIH contract
- Encouraged to apply for $30M+ more
- Norm Christensen (Karman CEO) joined Board to guide biodefense portfolio expansion and position future vaccines for government procurement
FMD opportunity:
Within weeks of securing our Texas facility, USDA approached us to co-develop their foot-and-mouth disease (FMD) vaccine — a national priority with $20M-$130M annual stockpile potential. The Secretary of Agriculture's office, APHIS Director, and head of the National Stockpile all encouraged us to pursue it.
AbbVie discussions:
We've had initial licensing discussions with AbbVie regarding our fungal vaccine platform for potential human applications.
Trademark secured
We secured the trademark: "Giving Our Best Friends More Time™"
This phrase captures our mission as we enter our commercial chapter.
The takeaway:
We're not just building a Valley Fever vaccine — we're building a fungal vaccine platform with applications across veterinary medicine, human health, and national biodefense. This positions Anivive as the leader in an entirely new category.
9. Shareholder meeting: November 2025
We are finalizing dates for our next Shareholder Meeting, planned for November 2025 at Lido House in Newport Beach, California.
What to expect:
- Full overview of Anivive's current state and path forward
- Introduction of our newest Board Member and CFO/Head of Investor Relations
- Executives from several partner companies
- NIH Director behind our biodefense contract (pending confirmation)
- Guest speaker who lost their only child to Valley Fever
- Leading veterinarian who treats 100+ Valley Fever cases per month
- Leading Animal Health investment banker sharing industry insights
After the meeting:
Private dinner for shareholders and guests.
Formal invitations:
Will be sent end of next week once date is confirmed. If you plan to travel, we will provide room-accommodation link and introduce you to our event coordinator for RSVPs and inquiries.
10. What we built vs. what we're worth
The context:
Comparable animal-health peers raising hundreds of millions are valued above $425 million, despite being years from revenue.
Where we stand:
Anivive is approaching its second and third approvals, owns rights to our vaccine in humans, and can self-fund growth.
The inflection:
Our flywheel is finally beginning to turn. We now have the opportunity to turn something good into something truly great.
The next 90 days
| Phase | Q4 2025 (Oct-Dec) | Q1 2026 (Jan-Mar) |
|---|---|---|
| Key Events | • USDA meeting post-shutdown (~2 weeks) • UK/EU Laverdia filings ($12.5M trigger) • Dechra monthly payments begin ($1M/month) | • Valley Fever approval expected (90-120 days post-meeting) • Laverdia FDA approval ($15M milestone) • Commercial launch prep |
| Focus | Regulatory momentum & cash-flow positive | Revenue unlock & launch execution |
| Impact | De-risk path, establish profitability | Fund scaled rollout, validate commercial model |
If Anivive were starting today
If we were building Anivive from scratch in 2025, we'd be in an enviable position:
$50M+ in vaccine commitments before approval — validated commercial demand
$52.5M in locked revenue (Dechra $27.5M, NIH biodefense $6M, vaccine pre-orders $18M, FDA grants $600K) — capital to fund operations without dilution
Proven distribution platform — 7,500 real customer orders, 400 hospitals, 15,000 pet owners served
Board built for commercialization — Fisher (VCA/Mars distribution), McCarthy (regulatory navigation), Hauer (USDA expertise), Christensen (biodefense), new CFO/IR from animal health
Manufacturing secured with backup — HRA/Kemin supply agreement plus Zoetis Texas facility ($30M value, zero net cost)
IP moat extended — UW DNA/mRNA license, human vaccine program, FMD partnership opportunity
The difference:
We didn't start today. We built this over a decade, and now it's all operational at once.
Closing
We're excited for what's next and grateful for your partnership as we execute on the largest opportunity in Anivive's history.
This is Anivive 2.0 — disciplined, focused, and built to scale. Every decision serves one mission: launch the world's first systemic fungal vaccine and build a self-funding company that gives pets — and the people who love them — more time.
Sincerely,
Dylan Balsz
Founder & CEO
Anivive Lifesciences, Inc.
"Giving Our Best Friends More Time™"
Forward-Looking Statements
This letter contains forward-looking statements regarding vaccine licensure, Dechra payments, launch timeline, regulatory approvals, clinical milestones, revenue forecasts, partnership amendments, international submissions, and future R&D based on current assumptions. Actual results may differ materially due to risks and uncertainties, including regulatory outcomes, manufacturing scale-up, market dynamics, contractual performance, financing conditions, government shutdowns, and other factors. Anivive undertakes no obligation to update these statements. References to pre-orders and demand relate to non-binding commitments subject to regulatory approval.