Vaxylove
$VXRT
The Plot Thickens
I'm following up on ’s post that our potential revenue streams could occur before FDA approval. Some revenue streams are substantially more actionable after 2b validation. All we need is one; after 2b we could get multiple streams.
Current Potential Revenue Streams:
• Individual vaccine licensing
• VAAST/oral vaccine platform licensing
• Co-development partnerships
• Norovirus franchise
• Influenza franchise
• COVID franchise / Dynavax-Sanofi
• HPV therapeutic vaccine
• New infectious-disease franchises
• Government/BARDA contracts
• Proprietary assays + assay licensing
• Antibody discovery partnerships
• Antibody/IP licensing
• Research collaborations
• Manufacturing/formulation IP + technology transfer
• Antigen optimization engine
2. Post-2B — New Revenue Streams
• Direct vaccine/product sales
• Combination-product partnerships
• Therapeutic antibody opportunities
3. Post-P3/Approval — New Revenue Streams
• None — all revenue streams are already represented.
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As far as I know, the following hasn’t been factored into our valuation.
How much money will Sanofi (or whoever eventually acquires us) save by running much smaller trials? During the last decade, Sanofi has run hundreds of P3 trials (depending on the source, anywhere from 100-700). Large scale P3 studies can exceed $250 million. Sanofi typically runs 25–35 Phase 3 programs at any given time.
The savings could be hundreds of millions of dollars PER PROGRAM, depending on trial design, because one drug can generate multiple Phase 3 trials. For example, all of these trials might belong to a single Phase 3 development program:
• One study in North America
• One in Europe
• One confirmatory study
• One study in a different patient population
The total savings for Sanofi could be potentially billions of dollars over the next decade, because Sanofi has spent $60–80 billion on R&D during the last 10 years, with a substantial portion of that supporting Phase 3 trials.
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The 42-month PNG timeline in BARDA’s RFI ends July 2027, if you start the countdown from our initial funding announcement in January 2024.
Perfect timing, the end of Q2 next year will close out the trial.
The average quarterly cash burn was roughly $23M in the three years prior to 2b (2021-2023):
• 2021
• Employees: 110
• Avg. OpEx / Quarter: $18.41M
• Trials: COVID P1, Noro P1, COVID P2
• 2022
• Employees: 164
• Avg. OpEx / Quarter: $28.67M
• Trials: COVID P2, Noro P2
• 2023
• Employees: 109
• Avg. OpEx / Quarter: $22.68M
• Trials: Noro P2, Noro P1
• 2024
• Employees: 105
• Avg. OpEx / Quarter: $23.75M
• Trials: COVID P2b, Noro P1, Noro P2
*Important: We had nearly 2-3x the number of employees, AND 2 non-funded trials running during the quarters prior to 2b.
Now imagine what our cash burn will be once 2b is closed out by the end of Q2 next year. Our expenses will be minimal, significantly less than the numbers posted below.
That’s why I’m assuming a burn of $10M or less beginning in Q3 next year, which takes our runway deep into 2028 (without Sanofi’s $50M), provided the remaining $60M BARDA funding covers the bulk of our operating expenses until then, which they’ve done for the last 6 quarters. So roughly an average of $15M per quarter. I’m expecting OpEx to drop significantly this quarter or next.
If so, we’ll still have the majority of our current cash. With the $50M Sanofi payment, we could be sitting on $100M, or 10 quarters of runway BEGINNING in Q3 next year, taking us through 2029, when Sanofi and Altesa payments should start kicking in.
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On occasion, Vaxart has given us clues as to what is going to happen. Remember when Andrei told us the PNG RFI looked like it was written for us, and he even threw out a $100M (or was it $150M?) funding number?
Then Lo told us they were switching gears, focusing on being data-driven.
And then the confident, forward-looking statements from Sean in his interview.
Much of my faith comes from Sean. I put more weight behind his statements than anybody else at Vaxart. If data was poor, he wouldn’t be making statements like this:
1. "We have carried out machine learning and other computational analyses to drill down into which immune responses correlate most strongly with protection."
2. "Subsequent modeling suggested that a modest mucosal response is just as good as a really strong serum response. We were surprised at just how much protection a small mucosal response could provide compared to very high serum antibodies."
3. “So it took us a while to get to the point where we could actually get the preliminary data to convince people that are funders that we've solved it.”
4. Re: HPV: “This has been de-risked completely from the preclinical and essentially we're ready to get into the clinic.”
5. “Again, we're very bullish about the potential of our COVID vaccine for treatment of Long COVID."
6. "If our efficacy is comparable and the product is delivered as a tablet...we're confident it will generate strong enthusiasm."
7. "...we have made significant improvements to our manufacturing processes in preparation for Phase 3."
He really let the cat out of the bag with that last statement.
Why would he say they’re preparing for P3?
Because they know it’s coming, otherwise Lopeman doesn’t come on board, they don’t hire two Senior Directors in HR, and a new QA position that reports to Lopeman.
Lo: “We’re prepared for whatever the FDA wants.”
“Best case, you could be looking at end of 2028, sometime in 2029, where this technology will be out in the marketplace.”
JJ: He said, “Will be” out in the marketplace. Not maybe.
That means a P3.
There’s too much at risk and too much invested not to see it through.
It's been roughly two years since PNG began. We've been asking: What are our employees doing?
They've been working on improving our vaccines. Imagine how much they've learned in two years.
They'll have a Next Gen II construct for P3.
Vaxart has said Phase 2b is a cornerstone platform-validation study.
For shareholders, it’s a platform-value inflection point.
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I'm working on a major discovery. It's legit, and I believe I've solved a mystery surrounding the craziest chapter in the Vaxart saga. Working on it for tomorrow.
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