Abivax_shareholder_Sss

[Abivax_shareholder_Sss @Biotech_8899]

@MartinShkreli Just adding more

[Seedy19 @seedy19tron]

$abvx ***update***
Monday evening read:

Firstly, if you’ve not had the chance to sign up to slingshots , they do some great KOL calls.

The most recent with Dr. David Sachar.

Ps this is an independent call nothing to do with $abvx so the takes are very impartial

Who is this guy?
- Former Chairman of the FDA GI Drug Advisory Committee: He has literally sat in the regulator’s chair deciding GI drug approvals and labels, so his read on “warning vs. boxed warning” carries unusual weight.

he’s both a top IBD clinician and a former FDA GI advisory chair, so he can speak to causation and to regulatory outcome

Look him up

Anyways here’s some tidbits from the call:

Q: Can you elaborate a little bit on the cancers?… They did have an imbalance. Tofacitinib also has an imbalance on the label. How do you think this imbalance compares… Is it a real imbalance?

Key Quotes:

On the solid tumors: “prostate, breast, colon are almost certainly not related to treatments. They were not clustered into any particular organ system.”
He also notes the colon case “wasn’t even cancer” — i.e., the dysplasia.

On NMSC severity and confounding by age: “non-melanoma skin cancers aren’t very serious. They’re basal cell and squamous cell carcinomas, which have close to 100% cure rate anyhow.”
and “The patients who got the skin cancers were 20 years older than most of the patients in the study.”

Overall magnitude: “this handful of cases… maybe seven cases of something happening in this population are not enough to worry about.”

Q (follow-up framing): the TYSABRI/PML comparison — why isn’t this the same kind of drug-caused catastrophe?

Key quote (the causation argument): “with TYSABRI, it was clear that the disease of PML… was directly attributable to the TYSABRI itself. The cases of prostate, breast, colon cancer, skin cancer, there’s no way to pin the wrap on obefazimod. There’s no rationale for why that should be a problem.”

Q (preclinical/metabolite): “Do we know if there’s any preclinical work… that there might be a cancer signal and that applies not just the primary drug, but any metabolites?”

Key quote:
He said that animal signals routinely fail to translate, citing upa pregnancy data and the historical 6 MP/azathioprine pregnancy scare
“People may say, ‘Oh, you mustn’t give this drug because it causes cancer.’ I don’t think that’s going to pan out.”

Q (Call Leader): “While there’s no direct causal link between obefazimod and cancer, they did have a numerically higher number. Could that result in warning language on the label when they do get approved ultimately?”

This is the really important bit

“I doubt it. Although I am aware that the FDA is very careful about covering its ass… I think that’s a political decision. Biologically, I don’t think we have to worry about it very much. And I suspect in time, very shortly… the stock will recover.”

Q: why tofacitinib got a black box and RINVOQ’s situation

“the gastroenterology community has learned to pretty much ignore it” and that experienced IBD docs keep patients on high dose upa despite the box i.e., even if cautionary language appears, prescriber behavior is largely unaffected.

——————-

So what are we all doing here? Honestly all of this is so silly. For those who made it all the way to the end. Here’s something interesting
Mgmt has been unblinded to the malignancies for a while now. The most plausible reason for why they haven’t presented the part 2 data yet is that they’ve given this window to BP to make up their mind otherwise they’ll raise , fund till CD and BP will have to come back buy this at a higher price.

Thus the end of June guide, I can say with confidence that it’s not because they’re sitting on anything that could be damaging to the story. That is based on my understanding and read of the entire fiasco.

I remain long $abvx

[Adam May @A_May_MD]

I think we are now in the range where the $ABVX Part 2 dataset could be released after hours any day, providing an even larger safety dataset than the original Part 1 did.

Given the large sample size, OBVIOUSLY more cases of non-nonmelanoma skin cancers are EXPECTED. Exactly how many cases would be "in range" depends on the final patient-year (PY) sample size *and* on which arms (25mg vs 50mg) the cases occur in.

Ultimately what matters here is that the non-NMSC rate falls near/within the expected rate when including all of the P2 and P3 patient years.

As I and others have calculated, that currently rests well-within range at ~0.6/100PY, which INCLUDES an extra case of prostate cancer that the FDA would absolutely not care about at all (given that it happened early in during induction - essentially impossible to have been drug related, zero doubt that it was pre-existing) and totally excludes *all* of the hundreds of squeaky clean 25mg PYs. The calculations I have run so far are very conservative, and still completely confirm Obefazimod's safety without cance risk.

Basically, unless the Part 2 data show new cases of cancer occurring wildly above expected background rates, we can already disprove the cancer risk scare with existing data.

Why is the stock not responding to these facts? Who knows. I do suspect that some of the people who panic sold on the Part 1 data before taking a moment to run some basic calculations are hoping that the EXPECTED new cancer cases that we WILL see in Part 2 will spook the market a 2nd time, allowing them to buy back in lower.

Hopefully the market knows better this time around, and can see that (again, assuming Part 2 cancer rates don't *wildly* exceed background rates), cancer occurring in a clinical trial at the EXPECTED BACKGROUND RATE is absolutely meaningless. This is something so basic I am shocked that I am having to talk about it at all, but here we are. Speaking the OBVIOUS and watching the market ignore it.

If nothing else, getting this catalyst out of the way can "remove the overhang" of remaining safety data, even though, again - the existing data already disprove the notion of a cancer problem to begin with.

Once this is (hopefully) cleared up, what are we looking at for the $ABVX stock price? Consistently, sellside models had efficacy bull case scenarios at well over $175, including some even over $210 (ehem, Jefferies). This flock of lemmings all lowered their price targets on "safety concerns" despite efficacy *EXCEEDING* every single firm's bull case scenario. Of course this is sellside reacting to the stock price moving, not actually trying to read the data and see whether a safety signal existed or not.

So, once there's no made up safety narrative to obfuscate with, we are back to $ABVX having otherworldly best-in-disease efficacy with squeaky clean safety in a once-daily pill with a unique MoA that has ZERO near-term me-too competition (unheard of in modern pharma).

Why couldn't the stock go back to the $175-$185 range that the sellside firms predicted and which the stock briefly traded to before spooked panic sellers started dumping the stock on a "cancer signal" narrative that they could've debunked in 30 minutes?

I see no rational/logical reason why the stock can't go back to those levels. If the signal isn't real, it isn't real. "But it really crashed for a couple weeks when people thought it was real" is not a reasonable argument to explain why the stock would remain undervalued after the risk has been debunked.

Obviously I can't know exactly where the stock goes on Part 2, but my prediction is that $ABVX will be able to definitively prove the "cancer signal" narrative is nonsense, the stock will trade up significantly, and the company will run an offering at much higher prices - which they originally expected to do on Part 1.

With no black box warning, I have this as a $4-5B/year drug in UC, and a $4-$5B in Crohn's should it hit there as well. Very rough M&A valuation math from my perspective would be:
➡️UC $4.5B peak x 3.5x multiple = $15.75B
➡️CD $4.5B peak x 1.5x multiple =$6.75B
↪️$22.5B peak w/ ~91M sOS = $247/share

That's rough math obviously, and the big lever would be success/failure in CD moving that 1.5x multiple. Obviously if $ABVX waits long enough for Crohn's to read out and it hits...the numbers rise significantly.

Once Part 2 data are released, all of the big P3 data are in. We can combine with the P2 safety data and (hopefully...IMO likely) be completely confident that no black box warning is impending (although a black box warning seems to be what the stock is pricing in today...).

In my mind, M&A before or around JPM '27 then becomes extremely likely, and I would be disappointed by any price tag that does not exceed $225.

Hopefully the market can wake up and see the value here once the "cancer signal overhang" is removed, and this time next week we are trading much higher after a big successful secondary offering! At that point, I would finally say we would be entering the likely M&A window for $ABVX after spending the last year saying "not yet!".

[Abivax_shareholder_Sss @Biotech_8899]

@adamfeuerstein The most absurd deal of the year

[Abivax_shareholder_Sss @Biotech_8899]

@seedy19tron Stupid deal

[Martin Shkreli @MartinShkreli]

these are the values if $ABVX launches equivalent to:

Entyvio: $200/share
Rinvoq: $350/share
Skyrizi: $600/share

this assumes the patent(s) hold up! (2039 LOE)

[MASi @TOWiU2]

@Biotech_8899

[Abivax_shareholder_Sss @Biotech_8899]

@TOWiU2 Do you have screen shots? Can’t see the repost

[Abivax_shareholder_Sss @Biotech_8899]

@BiotechTV @FT $ABBV to acquire $APGE - The stupidest deal of the year.

[Abivax_shareholder_Sss @Biotech_8899]

@a_a_free I think JNJ’s BD is much wiser than ABBV’s so they won’t pay premium for this😹

[Adam May @A_May_MD]

Not the word I’d use. $ABBV knows what they’re doing, it’s just that this is a bet on the American medical system being completely broken and screwing people over. $ABBV has no problem getting in bed with the PBMs to pervert the intellectual property system that is *SUPPOSED* to make high branded drug prices acceptable.

If $ABBV has their way they’ll be selling branded Zumi at $70K/year while cheap biosimilar Dupi sits on the shelves, all due to perverse incentives generated by insurers/PBMs that both $ABBV and the insurers will profit from.

Make no mistake that this is the goal of this deal, and it absolutely is designed to screw over the American consumer.

It’s complex, but if people can put in the effort to understand how this intentionally obfuscated system works, they’ll see this for the scam that it is and be enraged.

[Abivax_shareholder_Sss @Biotech_8899]

@A_May_MD @augurbio @JoseRestonVA Can't assume there's another BP as retarded as $ABBV

[Abivax_shareholder_Sss @Biotech_8899]

@business Idiot

[Biotech2k @Biotech2k1]

$11 billion buyout for a phase 2 company shows how bubbly this market has become. $ABBV has to be the biggest idiot.

[Abivax_shareholder_Sss @Biotech_8899]

@adamfeuerstein Ridiculous

[Abivax_shareholder_Sss @Biotech_8899]

@threadanddoc $ABBV BD team should be fired

[Abivax_shareholder_Sss @Biotech_8899]

@A_May_MD The most ridiculous deal of the year

[Abivax_shareholder_Sss @Biotech_8899]

An $11 billion valuation for this is quite ridiculous.

$ABBV $APGE

https://t.co/8TipWd8zyp

[bnuoH @lcbnuoH]

$ABVX the part 2 induction non-responder efficacy that nobody cares about.

[Adam May @A_May_MD]

Thanks to @YetAnotherValue and @AndrewRangeley for having me back on the podcast to discuss $ABVX!