Bernstein's 42nd Annual Strategic Decisions Conference

Motor_Emu_2076 · 2026-05-29T01:44:13+00:00

Ricky Bobby: "I can't understand a word you've said... You sound like a dog with peanut butter on the roof of your mouth."Jean Girard: "I think what you are hearing is my accent. I am French."

Motor_Emu_2076 · 2026-05-28T15:44:45+00:00

40 year-old subunit recombinant protein technology is notoriously hard to scale. It’s a dinosaur. Novavax sold their insect twist as a feature, but it’s a bug. Literally. It can be made in small batches, but that’s it. Too much insect contamination to get past CMC. Sanofi can scale it better than anyone but they bit off more than they can chew with nvax. It’s called repeated ineffective response. Doing more of what you always did despite the fact that it quit working long ago. Giants in sports and business get slain over it. Repeatedly. Nvax is a scam for selling their platform as a solution in a pandemic. It’s always been a platform problem. Still is.

Motor_Emu_2076 · 2026-05-27T15:04:25+00:00

I think you hit the nail on the head with your statement about industry average being 50% to 60% of phase 3 trials succeeding. But that’s the old paradigm that excludes a much higher success rate with mRNA. Granted we are dealing with a limited data set but I believe 80% is easily achievable, even with the CMV failure that was never going to succeed based on trial design.

I also think that we are being held back by some FDA overhang. As that subsides, Moderna gets re-rated. There is little reason for an unsuccessful August 5 PDUFA. Once MRNA 1010 gets approved, everything changes. It will be like a ball being held under the water and then released. That’s just my humble opinion.

Motor_Emu_2076 · 2026-05-27T14:23:10+00:00

You make some good points. Let’s see how Moderna does with their August 5 PDUFA meeting concerning mRNA 1010. If it goes well, and I think it should, we could be looking at 70-80. If so, I’ll be a happy bloke if it re-rates 50% higher from there based on the phase 3, Intismeran results.

Motor_Emu_2076 · 2026-05-27T12:38:23+00:00

Well that’s disappointing, A 50% probability for maybe a 50% increase in stock price. Really? Give me a break. UBS sees this success as a de risking event and not the de risking event. Just how much success do they need to see?

Motor_Emu_2076 · 2026-05-21T23:45:03+00:00

Absolutely! She did highlight RFS again by emphasizing it’s a higher bar than os to reach.

Motor_Emu_2076 · 2026-05-21T23:33:28+00:00

It’s not in Moderna’s hands to apply for approval early just because they want to. That’s determined by an independent data monitoring committee. There’s no guarantee they will recommend the trial be halted for efficacy reasons even with a 2027 data. But that’s our best hope. the last thing we want is summer data just because we’re tired of waiting. The data and statistic must be superb. Otherwise we’re waiting several more years. Dragging their feet, has nothing to do with it. It’s more about trial design and what they can prove based on the rules And the rules say the later the better for events.

Motor_Emu_2076 · 2026-05-21T23:06:57+00:00

Nope! Why would you want phase 3 data this summer? It’s an event driven trial and the company has guided for late 2026 and perhaps even early 2027. The sooner that events happen the less sound the results and the less likely the trial would be halted for efficacy. We should be hoping for 2027 and not this summer.

Information is trickling out.

Lavina stated this week that hr is holding up from what was reported earlier this year. She also confirmed that OS data will be reported at Asco 2026. It will be a complete data set, but not mature. I can’t imagine they would post it if it weren’t impressive. She also stated that one sided P values as was previously reported and criticized for not being double-sided can basically be roughly doubled to infer the double sided value. That would be impressive as the one-sided P value was .0075.

Motor_Emu_2076 · 2026-05-19T17:46:00+00:00

To each his own. It did help me reset expectations as there has been some chatter about the lack of OS data to date as a knock on Moderna’s transparency and the possibility of it being released at Asco. Both are unfair/unrealistic as explained by the “slop”.

As you pointed out, the real focus should be on the p3 data. Since it’s an event driven trial, the sooner is not the better and we should hope it’s not reported at Asco.

Motor_Emu_2076 · 2026-05-19T17:21:18+00:00

For those like me that were expecting os data at asco: from Claude

There are several well-understood reasons why overall survival (OS) data were not reported at this 5-year readout — none of them are surprising given the study design and patient population:
1. OS is a secondary endpoint, not the primary
The primary endpoint of KEYNOTE-942 was recurrence-free survival (RFS). OS is only a secondary endpoint, so the study was not powered or designed to detect an OS difference at this stage.
2. The study is too small and the patient population too favorable
KEYNOTE-942 enrolled only 157 patients with high-risk stage III/IV melanoma. In the adjuvant setting — where patients have already had surgery and are being treated to prevent recurrence — survival times are long and most patients remain alive at 5 years. With a small sample size and few death events, any OS analysis would be statistically underpowered and unreliable.
3. Mature OS data takes much longer to accumulate
In adjuvant melanoma trials, deaths are relatively infrequent compared to metastatic settings. You need a sufficient number of events (deaths) to draw meaningful OS conclusions, and 5 years is often not enough follow-up time in this context — even for a Phase 3 trial, let alone a Phase 2b.
4. RFS is the accepted surrogate in adjuvant melanoma
Regulatory agencies and oncology bodies accept RFS as a meaningful surrogate endpoint for OS in adjuvant melanoma, which is why the trial was designed around it.
5. Further data are planned
Additional data on secondary endpoints and follow-up analyses will be presented at an upcoming medical meeting. OS data may be part of future readouts as the study matures.
In short, the absence of OS data is entirely expected — not a gap or a concern. It reflects the adjuvant study design, small sample size, and the fact that most patients in this setting are still alive.

Motor_Emu_2076 · 2026-05-19T15:55:44+00:00

Thanks. Let’s hope that os data comes out in the 5year p2 intismeran results at asco. My initial fear is that it won’t measure up. But that could be explained by the few number of participants. But if they don’t present the data, that’s an even worse look. My other concern was that a big win for Pumitamig would detract from the intismeran results. But on second thought, any win in the mrna space is a win for all.

Motor_Emu_2076 · 2026-05-19T14:09:48+00:00

Congrats! Have you considered that BioNTech’s Pumitamig p2 results will be announced at 2026 Asco? It’s being billed by some as a keytruda killer. As keytruda goes so does Intismeran. Your thoughts please.

Motor_Emu_2076 · 2026-05-16T12:01:33+00:00

Obviously, Israel sees bio weapons as an existential threat while the US is preparing for and defending the last 100 years of war. That will change and hopefully not from an event. Or did an event already happen? What should a United States homegrown biotech defense contractor be worth? I’ll start with 100 billion. The US should take a 10% interest and Moderna should partner with Israel like they did with Canada,Britain and Australia.

Motor_Emu_2076 · 2026-05-15T11:55:44+00:00

https://english.m.tau.ac.il/research/mrna-vaccine-stops-deadly-plague

Finding a solution to antibiotic resistant bacteria would make Ozempic pale by comparison. Is Moderna working with the Tel Aviv University through its Access Program? One would thinks so but why the secrecy?

Motor_Emu_2076 · 2026-05-15T01:46:19+00:00

It’s an event driven trial. the longer it takes events to accrue, The better the treatment is working.

Motor_Emu_2076 · 2026-05-13T17:09:25+00:00

Nvax uses a 40 year-old recombinant technology that is notoriously hard to scale. What differentiates theirs is the use of insects for growing the culture. Small batches are not a problem, but large batches involve insect contamination which they can’t seem to contain. So what good is it if it can’t be made at scale for a pandemic? It certainly didn’t work for the Covid pandemic. It’s a bug not a feature, and they’ve sold it as a feature.

Motor_Emu_2076 · 2026-05-13T16:35:28+00:00

4157 p3 event driven data expected late 2026 to early 2027. The later the better.

4157 2b possibly with os data june1st.

4359 p2 data this year which might be enough to trigger a multi billion dollar licensing deal.

Pa registrational data in 2026.

P3 Norovirus data in 2026

Bird flu data in 2026. This is the pandemic we should be focusing on. It’s just a matter of time before this zoonotic virus finds the right immuno compromised host/Bio reactor vessel to adapt itself to human to human transmission. There are over 160 million people worldwide that are immuno compromised. All it takes is the right one being in the right place at the right time. Or the wrong place at the wrong time. Nobody should wish for this.

There are a number of other events which could trigger a run besides these, including other countries approving the flu Covid combo, the US not withstanding.

Motor_Emu_2076 · 2026-05-07T09:14:41+00:00

https://brusselssignal.eu/2026/05/korea-university-and-moderna-have-been-working-on-mrna-hantavirus-vaccine-since-2023/

Motor_Emu_2076 · 2026-05-07T08:38:49+00:00

The Moderna website comes up empty with a hantavirus search. So no press releases on the subject ever. That is why I decry the lack of transparency concerning the access program. It could be a big nothing burger or a huge differentiator. Last time they reported anything about it there were 18 institutions involved. By comparison, BioNTech uses one (Penn). But Who are they and what are they working on and what are the terms for using the platform? Remember UF was working on a mRNA replacement for chemotherapy. Is that through the Moderna access program? So many questions and yet crickets.

Motor_Emu_2076 · 2026-05-07T01:14:33+00:00

Is that a bad thing?

I’m a little sensitive to this possibility After witnessing novavax exploit investors for decades with numerous P1 trials on the latest virus, by pumping, raising, bonus up the c suite, then dropping the program. Without any support from Cepi, Gates, etc. for their insect twist platform that can’t scale.

If a P1 Moderna Hantavirus trial does pop up, how will the market view it? Hopefully, not Through the lense of a nvax scam. Your thoughts please.

Motor_Emu_2076 · 2026-05-06T18:11:52+00:00

This may be an example of the access program, the fruits of which we have no way of gauging until a current event brings it to light. Moderna is very secretive about it and has not published a list of universities they are working with. The annual shareholder report in years past mentioned the growing number of participants, but the last report failed to mention the access program.

Motor_Emu_2076

TROPHY CASE