# Episode 169 - January 16, 2026

An episode of [Biotech Hangout](https://invisiblenetwork.ai/podcast/1568911820), 16 Jan 2026, 59 min.

Audio: https://anchor.fm/s/55bdff38/podcast/play/114112536/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-0-16%2F416266229-44100-2-4aab34cbc78b3.m4a

On this week’s episode, Chris Garabedian, Paul Matteis, Mike Yee, and Sam Fazeli recap the 2026 J.P. Morgan Healthcare Conference, noting that the biotech outlook for 2026 is broadly positive. Investor sentiment is noted as healthy but not overheated, and from the specialist community, the outlook is similarly upbeat. On the venture side, the M&A landscape also looks strong, with one of the best pre‑JPM financing weeks in at least a decade. The conversation turns to company updates, with Alnylam’s 2030 strategy as well as Moderna’s cost-cutting initiatives and upcoming vaccine readouts. On the deal front, the group covers AbbVie’s $650M partnership with China-based RemeGen on a next‑gen PD‑1/VEGF bispecific antibody. AI developments were another key theme at JPM, including Pfizer’s claim that AI contributed to $5.6B in cost reductions. In regulatory news, FDA flexibility, new CMC guidance for cell and gene therapies, and updates on Dr. Makary’s CNPVs are overviewed. Next, the co-hosts cover the latest obesity news, including new oral GLP-1s and potential competition from Pfizer and Amgen in the monthly injectables market, as well as BMS and AbbVie’s interest in entering the space. The episode concludes with rapid‑fire round of data updates in DMD, gene therapy, myeloma, cystic fibrosis, and Alzheimer’s prevention. *This episode aired on January 16, 2026.

## Transcript

[0:00] You're listening to Biotech Hangout, a live and unedited
[0:03] weekly discussion of all the latest news in our industry with
[0:06] a group of biotech leaders and experts.
[0:09] I'm Chris Garabedian and my Co host today are Mikey Paul
[0:12] Matisse and Sam Fazeli. For more information about our
[0:15] hosts and guest speakers or to listen to the most recent
[0:19] episode, please go to biotechhangout.com.
[0:21] So we're going to go ahead and get started.
[0:24] So first, obviously biggest week of the year and probably the
[0:28] biggest signal for sentiment coming out of the JP Morgan
[0:33] conference, which just ended yesterday or today if you've got
[0:37] some follow on meetings. So you know, I'll just say it
[0:41] was my first JPM since 2019 and it felt really good.
[0:47] I mean, I think, you know, all positive signals were on, you
[0:52] know, I think, you know, Mike, he's going to talk about this a
[0:55] little further in terms of investor sentiment.
[0:58] You know, the, the big news was that there wasn't as much M&A,
[1:02] but actually Adam Forstein and Daphne Zohar posted his article,
[1:06] did a really nice article I thought on why this is a good
[1:09] thing, why this could mean, you know, some positive momentum
[1:13] that there wasn't as much M&A announced this week.
[1:16] And I think there's some good reasons for that.
[1:18] But overall, I think short of a macro existential, you know, non
[1:25] biotech, you know, geopolitical crisis, I think things should
[1:30] look good for 2026. But Paul, why don't you weigh in
[1:34] on this? What What were your thoughts
[1:36] coming out of the week? Yeah.
[1:41] I mean, I think in general, like I on Monday, some of the chatter
[1:45] was there's not much news, not much going on.
[1:50] XBI sold off a little bit on that.
[1:52] But I mean, it feels like a lot of investors are coming off a
[1:55] great year last year to say the least.
[1:59] And you know, I think we've talked about on this podcast,
[2:02] like a lot of structural tailwinds to the sector, right?
[2:05] I mean, it feels like, you know, drug pricing risk is knock on
[2:08] wood, like not not that significant right now.
[2:11] A lot of successful commercial launches, a lot of great data
[2:14] readouts, investors getting rewarded on taking data risk.
[2:17] We saw some financings early in the year that were really
[2:20] significant and that didn't take the wind out of the sails.
[2:23] And so especially with the red men news the week before, which
[2:26] realizing that's not a done deal, but you know, that's a,
[2:28] that's a really, really big M and a ticket.
[2:31] My conversations were generally very positive.
[2:34] And I also think they're positive, but things like aren't
[2:37] overheated, right, Which I think is also good.
[2:38] Like you almost, if you're an investor or a company in this
[2:41] sector, like you want sentiment to be 7 out of 10, right?
[2:44] Like you don't want it to be 3 out of 10.
[2:45] You don't want it to be 10 out of 10 because 10 out of 10 is
[2:47] scary too. So I feel pretty good.
[2:52] Yeah. And I know Sam you you you
[2:53] didn't attend, but I'm just curious what your thoughts were
[2:56] from just reading the news flow or following X and any post.
[3:00] Did you have any other take away?
[3:02] Yeah. So the, the way that's so
[3:08] everybody went in as as Paul said, looking for maybe some M&A
[3:11] and of course you look after the, you know, we didn't get
[3:14] that and healthcare space did. We didn't.
[3:17] And you look at the share price action during the week and it
[3:21] tells you, I really quite like the way that Paul put it, 7 out
[3:25] of 10, which is which is nice, tells you a little bit what the
[3:31] feeling was out of the conference.
[3:33] You know, on our drug chat, we have a pretty hefty drug chat
[3:37] where there's over 2000 people. It just felt to me that people
[3:42] were taking it in their stride. Is, is that the best phrase?
[3:45] That's the best phrase I can come up with now.
[3:47] There was an over enthusiasm. There were some questions about
[3:50] the way that people were, were commenting on their on their
[3:54] week, etcetera. But I think the sentiment was,
[3:57] I've just asked the question actually and I didn't ask was
[4:00] the sentiment, was your sentiment negative coming out of
[4:02] the meeting? And, and I think, I think it
[4:05] was, it was in that in that same zone of six to seven out of 10,
[4:09] which sounds which is great. And you know, and also we
[4:12] started the year with a super strong week where we got M&A and
[4:18] a whole host of secondaries. So would love to hear with Mike
[4:24] Thorpe. Yeah.
[4:26] Mike, you talked to a lot of investors and just companies and
[4:30] yeah, we'd love to hear your perspective from the kind of
[4:33] insider investor scoop and did they have similar sentiment?
[4:42] Yes, we can. Perfect to the coin 1 is on
[4:55] specialists and hedge funds and those that we are quite familiar
[4:59] with. And then of course just the
[5:00] broader, a mutual fund, broader generalist community, which is
[5:04] important. And I and I think that you guys
[5:06] said it well, a lot of things have passed.
[5:09] Drug pricing stocks are acting a lot better and I think that
[5:13] folks coming into 2026, specialists definitely more
[5:19] optimistic about putting money to work.
[5:22] You know, you're seeing follow ONS.
[5:24] Obviously there was also an IPO that happened that traded up
[5:28] well. I think that's notable.
[5:31] And there's definitely a buzz in the specialist community about
[5:35] privates and crossovers and all all that sort of action getting
[5:39] done, all on the expectation. And I would say agree that a lot
[5:45] of this is coming down the pipe and is all going to go public
[5:48] this year. So that's all a good telltale
[5:50] sign obviously that there is some anticipation, expectation
[5:54] and ability to to go out and that's all from a lot of
[5:58] specialist money. So I think that's that's
[6:01] important and that is a reflection of the optimism that
[6:04] I think pet people generally see not one of frothy, you know,
[6:08] bull market climactic, you know, IP OS trading up 100 and 200%.
[6:14] Those are probably bad signs and obviously not IPO's that
[6:18] presumably are just gonna gonna tank.
[6:20] So that's that's on that side. And the other, the other side of
[6:22] the coin, I think is also important, which of course, just
[6:25] the broader market, broader portfolio mutual funds, profile
[6:29] management mutual funds where they don't obviously traffic so
[6:32] much in small biotechs. But obviously the idea that
[6:38] people feel better about putting more money to work in large
[6:41] pharma and large biotech and just broader biotech.
[6:44] And it's obviously a bit of a reflection of the fears and
[6:47] concerns about the broader S&P 500, which is at an all time
[6:51] high. And obviously the whole AI
[6:52] trade, which is not so relevant to this podcast, but fears that
[6:56] growth and things are a little bit expensive.
[6:59] Make pharma and biotech inexpensive at 1514 or even Lily
[7:04] at 30 times. It's not expensive if cost on
[7:06] Walmart trade at 40 times that's good and that makes our Group A
[7:10] little bit more focused on as money comes in and that's good
[7:13] for both sides of the coin and that's good for.
[7:15] Hey, Mike. Mike.
[7:16] Do you feel like General's interest in the sector is still
[7:19] largely restricted to the like momentum E large caps or, or do
[7:25] you, or do you get the sense that it's actually even broader
[7:26] than that? Exactly why we are more
[7:31] optimistic about the whole pharma biotech group and
[7:34] actually pharma to some extent because it's more than just I
[7:39] like Lily or I like Abby and that is that people definitely
[7:44] care more about Merck and Bristol and Pfizer even that.
[7:48] And then that means that Gilead and Amgen, which by the way I've
[7:51] traded pretty well in the last six months are also a
[7:54] beneficiary. And again, that's part of,
[7:56] because the whole sector has been so bad for the past few
[8:00] years and everyone is nervous about the rest of the market
[8:04] getting a little tipsy. So that makes our space better.
[8:07] Now obviously fundamentals are good too, which is happening
[8:10] right then that makes it better. And it's not just what we call
[8:13] renting, renting the space or leasing the space, but rather
[8:15] wanting to own the group more this year.
[8:18] And I think you could also so see if he's going to potentially
[8:22] buy Rev Med. The stock traded up when Avi was
[8:25] looking to buy Rev Med at least for an hour.
[8:28] The stock was actually up 6% that hour.
[8:31] So it speaks to people who do care about wanting to buy the
[8:34] group. If these pharma companies and
[8:35] biotech companies are putting money to work and making the
[8:37] stories better patent closer so bad that there is broader money
[8:41] going out because it's certainly not specialist buying Avi or
[8:43] Merck to make to make the stock a lot that much.
[8:46] So that's that's. So kind of just, I heard from
[8:51] folks who were there, did it feel like a lighter JPM, do you
[8:54] have the stats already? Because when I listen to the
[8:57] very nice stats actually read out loud, it was the, the OR
[9:04] whatever it's called the the podcast that they have, they
[9:08] start, they started off by saying actually, and it was very
[9:11] easy for us to get here. It was not difficult to book a
[9:13] flight. It wasn't full and it just felt
[9:17] like they were in saying that it's not.
[9:20] It wasn't as busy. Did you did you get that feeling
[9:24] anyone? You know, I, I haven't been
[9:28] since 2019 as I mentioned, but it seemed one noticeable thing
[9:33] is there wasn't as much St. traffic.
[9:35] That's what I remember from old JPM's is that the streets seemed
[9:40] as crowded as the hotel lobbies and all of that.
[9:44] But I do know that the traffic was still very tough.
[9:47] To get an Uber to just go, you know, half a mile was really
[9:52] challenging. You still saw, you know, you
[9:56] know, you know, many lobbies full.
[9:57] But, you know, I, I think it abated during the downturn and I
[10:01] don't think we're totally, fully back.
[10:03] I, you know, I don't know the numbers.
[10:05] I'm sure somebody's capturing that.
[10:07] I wouldn't necessarily put stock in that the flights weren't
[10:10] necessarily full out of Boston. That is notable, but definitely
[10:14] there was a lot of activity there.
[10:15] It felt it felt good and it felt, you know, buzzy.
[10:19] But I don't know if anybody else wants to comment,
[10:36] let me comment on how all of this how I see it as it relates
[10:40] from the venture side. So first, everybody, you know
[10:43] venture is a lagging indicator. So we very much follow the
[10:47] public markets, the valuations, the IPO window, all of that
[10:52] tells us that it is a safer market for VC, especially if we
[10:57] have portfolio companies that might be candidates to go
[10:59] public. And here's my take on it.
[11:01] First of all, the last quarter was really healthy follow on,
[11:08] you know, it was the best quarter for a long time and the
[11:12] valuations came up. I think that's why companies
[11:14] were comfortable raising money usually off of data readouts and
[11:18] stock, you know, a movement, you know, stocks are moving on data
[11:22] generally speaking. And so that bodes well to do
[11:25] follow on offerings. And then the first half, you
[11:28] know, first week was, you know, a record.
[11:32] You know, week before JP Morgan, somebody did an analysis going
[11:35] back at least 10 years, I think, and it was like the best first
[11:38] week of financings prior to JP Morgan or at least one of the
[11:42] the best. And the reason I think this is
[11:45] important is, you know, management generally doesn't
[11:49] look to sell quickly unless they have to.
[11:53] And so, you know, they'll take a big premium, they'll take a
[11:55] exit. And I think you're seeing a
[11:57] wave. And this is related to the idea
[11:59] that we didn't see as much M&A this week is I think you've got
[12:03] more companies that are flush with cash.
[12:05] They don't need to be acquired. They can still execute and
[12:09] continue to grow value. We're seeing a larger group of
[12:13] companies with data that, you know, has a pathway forward
[12:16] toward a commercial product and to, you know, have the dream of
[12:20] becoming that, you know, you know, 1020, thirty, $40 billion
[12:24] stock valued stock. You've got a number of companies
[12:28] that have entered that category who want to be the next, you
[12:31] know, Vertex, if you will. And so I think that's part of
[12:34] the theme that I see on why there may not be as much M&A.
[12:39] And I think this means that, you know, maybe the market is
[12:42] shifting a little bit to being, you know, you know, a biotech
[12:47] market versus a pharma market, you know, buyers market versus,
[12:51] I'm sorry, sellers market versus the buyers market.
[12:53] And so I think, you know, that really bodes well and, and I
[12:58] think, you know, people are seeing those companies as stay
[13:00] independent that, you know, they do reap the rewards of that.
[13:04] And so, you know, I'm, I'm intrigued by that because what
[13:08] it means for VC is that, you know, there will be more
[13:11] opportunities for companies to feel like if they have a good
[13:14] data set or they have a really differentiated product that if
[13:17] the IPO windows, that's what we're, we're all waiting for,
[13:20] you know, can IPOs go out there? Can they hold their value and
[13:25] and you know, does the window really open up in the first
[13:27] quarter, the second quarter? And so that's what we're going
[13:29] to be looking at. But I think also VCs are
[13:31] deploying capital not to miss out on 2026 if the IPO window
[13:37] does open. They don't want to be on the
[13:39] sidelines if a lot of, you know, those bets go public and they
[13:44] have good aftermarket performance because they're
[13:46] LP's. All of our LP's are you know
[13:49] waiting for money to come back and so but if the, you know, M&A
[13:52] isn't the possibility than the IPO is the other way to exit.
[13:55] So I'm feeling pretty optimistic for Venture in 2026 that, you
[13:59] know, like we've all been saying, it's not exuberant, but
[14:02] it's kind of a healthy steady state that I think we've all
[14:05] been hoping for. You know what's interesting
[14:07] there, Paul, you just pretty much, you know what what he said
[14:11] about the M&A companies are cash and they can just wait.
[14:16] Management don't have to sell. You literally describe Redmed
[14:18] there, right, which is perhaps why it hasn't come to pass
[14:24] because they've got plenty of cash that just did the deal with
[14:27] the royalty pharma a few months ago.
[14:29] They have assets that look really interesting and
[14:32] meaningful probability of getting to market.
[14:34] So what's the rush? Yeah, absolutely Sam.
[14:41] So and that was Chris who made those comments, but I'm going to
[14:43] go to Paul next. So Al Nilam, you know
[14:47] interesting they they borrowed a little bit of the playbook from
[14:49] John Morgan or a way if we all remember way back when, when he
[14:52] had that five year plan and then he updated it again and kind of
[14:56] delivered on that pipeline. And now if on Green St.
[14:59] Had another kind of longer term plan unveiled.
[15:02] You want to you want to speak to that, Paul?
[15:04] Yeah. So Milan had a really, really
[15:05] interesting JP Morgan going into this year, right?
[15:09] They launched Ambutra and TCR Amyloidosis.
[15:12] It's been one of these, you know, biotech launches that
[15:15] we've seen over the past few years with the midcap graduating
[15:17] to a large cap like our Genex and insped where really just
[15:21] crush numbers to the point that the stock arguably got ahead of
[15:25] itself, right. And I think the chart tells you
[15:26] that where for three Q, you know they destroyed the sell side
[15:30] number and get the stock traded off.
[15:31] And then going into four Q, there was a lot of concern.
[15:34] Shares traded down due to weak script data and we were left
[15:41] with an interesting JP Morgan situation where they missed the
[15:44] fourth quarter but gave really strong guidance for 2026 and
[15:48] some interesting five year goals for 2030.
[15:52] You know, all of this was kind of received in a way that I I
[15:54] thought was like somewhat polarizing.
[15:56] You know, on the one hand, the 2026 guidance was strong enough
[15:59] in the backdrop of the weaker 4 Q that you had some people
[16:02] wondering if, you know, hey, is this actually too high of a bar,
[16:05] right. And then on the 2030 side, you
[16:09] know, there was some satisfaction with the revenue
[16:11] guide that they gave a 25% kegger, but some consternation
[16:15] around the margin guide. They gave a 30% operating
[16:17] margin, which you know, I think people look at as not really all
[16:21] that competitive with other large cap companies.
[16:24] I'll just give our our view quickly if anyone wants to say
[16:26] anything else. I mean, we thought that, you
[16:28] know, maybe this 2026 guide is not as much of A reach as others
[16:32] think. From meeting with Al Milam, they
[16:34] talked about a lot of factors that impacted the four Q that
[16:37] you know could turn into tailwinds going forward.
[16:39] They had inventory drawdown, some, some price concessions
[16:42] that you know, maybe we're not going to see as big of A1 the
[16:44] next couple quarters. And then on the 2030 side, you
[16:47] know, I mean, I think it's a really tricky situation for a
[16:50] company like El Nylam as it relates to managing to a margin
[16:54] because they, they, they talked about a 30% operating margin,
[16:57] which again, you know, relative to the kind of market cap years
[17:00] revenue appears is not that compelling.
[17:02] But you know, people have to remember that they pay in these
[17:05] peak years about 1/4 of Amvutra to Santa Fe.
[17:11] So when you think about a 30% operating margin X royalty, it's
[17:14] really over 50%. And if you're a company with a
[17:17] real R&D engine, unless you're like a spec pharma company,
[17:20] you're not going to optimize your underlying business to
[17:22] something that is that much greater than a 50% operating
[17:25] margin. So we still felt like the update
[17:27] here from a fundamental perspective is still overall
[17:30] positive for all Mallam as it relates to the PTR franchise and
[17:34] the fact that they're going to be spending 30% of revenues on
[17:37] R&D. So you have to believe with, you
[17:38] know, 4I and DS a year, they're going to get more meaningful
[17:41] drugs coming out of this company and not in the model.
[17:43] But but you know, just an interesting example, right, of a
[17:46] company that crushed numbers to the point that, you know, it
[17:49] created what people on Wall Street refer to as, I don't love
[17:52] this term, but a whisper number, right?
[17:53] Like a sort of true buy side consensus that is always, you
[17:57] know, kind of ethereal and higher than the sell side
[17:59] consensus, you know, and then now I think people are
[18:01] struggling with how to how to value this company.
[18:03] Do we think about the margin? Do we think about revenues?
[18:06] You know, how much credit do we give to the platform?
[18:08] But still feels like they're relatively well positioned, even
[18:11] if the stock has taken a breather.
[18:13] Yeah. It is interesting to to drive a
[18:15] operating margin that far in advance because you know they
[18:18] have will have many opportunities to adjust for the
[18:20] right reasons presumably over time.
[18:23] But I think they're signaling that we're going to be a, you
[18:26] know, cash flow positive company with good R&D and so that those
[18:31] are the two things people are looking for right in in any long
[18:34] term biotech play. Let's go to the next topic we
[18:39] have is Moderna. Sam, I know you've talked a lot
[18:42] about Modern. I want to go to Mike too on just
[18:44] the MRA space in general. But Sam, what was the update
[18:47] from Moderna? Sure.
[18:49] So Chris, this, this is a, a name that if you look at the
[18:54] share price move action since a low of 23 in November, it seems
[18:58] it's almost doubled. We're now at $41.00 and pretty
[19:02] much three things have been driving this.
[19:04] One of course is perhaps a little bit, I mean I'm
[19:07] speculating on some of this right, the the Super flu that
[19:11] people are talking about. Maybe some folks have got a bit
[19:14] more into the groove about thinking again is this to be
[19:20] need to be invested and perhaps a lot of this is retail, I don't
[19:23] know exactly back in the vaccine names.
[19:27] And of course, the company's guidance has been pretty wide,
[19:31] 1.6 to 2 billion, which has been cut all along the year, except
[19:35] until we came to the first week or second week of Jan, which was
[19:38] the the announcement just ahead of JP Morgan, which was several
[19:43] positive things in it. One, they updated the guidance
[19:46] with regards to cash, which is great.
[19:49] So that they said they're going to, they're going to come out of
[19:51] the year with about eight, $8.1 billion versus 6 1/2 to 7 that
[19:56] was guided in November. So that's a pretty big jump
[19:59] about .6 of that, about half of that is coming from.
[20:05] A draw down on the on the loan facility that they have, which
[20:07] kind of also brought me some questions in my mind.
[20:10] I'd love to hear what Mike thinks of that later.
[20:12] Why are they drawing down? There's no obvious need with
[20:15] that cash balance in the bank. We've asked our credit folks,
[20:19] they don't say, they didn't say that there's any necessity to
[20:21] draw down as part of deals usually anyway.
[20:24] So that's that happened. And of course, they guided
[20:26] slightly above the middle of the range, but which was in line
[20:30] with consensus that Bloomberg gathers and they gave, you know,
[20:36] they stuck with their 10% growth in 2026.
[20:39] I mean, I don't know how much stock you put by that, because
[20:41] at the end of the day, they had a pretty big numbers at the
[20:44] beginning of the year last year and they we ended up at a much
[20:46] lower number in terms of revenue.
[20:49] And of course, the latest thing is the Arbitrus situation who
[20:53] had a patent invalidated in Europe and Arbitrus says this
[20:58] has got nothing. They'll appeal that this is
[21:00] nothing to do with the has no impact on the US litigation
[21:04] that's going on. And why I mentioned this is that
[21:06] this is the key bear argument on the name at the minute, apart
[21:11] from COVID shots, sales dropping and the company's cash burn
[21:14] being high and all that which they're addressing.
[21:18] So the arbiter's deal court case, I think it's coming up,
[21:21] the trials coming up in in March and there are people who believe
[21:26] that this is going to be a major, major problem for the
[21:29] company. We're doing our own analysis
[21:31] hopefully out next week with our patent attorney colleagues
[21:35] within Bloomberg will have a view on that.
[21:38] But this was someday this was the one thing that particularly
[21:41] drove the stock up today's backup, he's up about 5% today.
[21:45] So, and I suspect it's going to give it some momentum and, and
[21:49] and change the maybe people's view with the with the risk of
[21:53] this trial anyway. And 26 is important for them
[21:57] because they might they might get the cancer vaccine data for
[22:04] the adjuvant Melanoma phase three trial readout this year,
[22:07] Although the company says it could be obviously it's event
[22:10] driven. It's the usual argument.
[22:12] It might push out to 2027. Over to Mike.
[22:15] Over to Mike. Yeah, I just want to comment
[22:17] that on Moderna, you know, Newbar did a couple, he did, you
[22:20] know, I think a couple interviews and he definitely was
[22:23] throwing shade on the FDA about mRNA.
[22:26] And so he he's doing his kind of PR to, you know, revive, you
[22:31] know why mRNA is so important and and needs to go.
[22:33] But but Mike, any comments on that?
[22:37] Hey you can hear me OK? I got my ex working.
[22:39] Yeah, we got you on X. Cool, cool.
[22:42] So three things. One, I think coming into the
[22:45] year, obviously Moderna was one of the worst performers and has
[22:49] been. So you know, the start of the
[22:51] year you're we definitely, we're seeing some unwind of a lot of
[22:56] short positions. That definitely was part of an
[22:59] early move on a hugely crowded short stock That also started to
[23:05] unwind as people thought about the cash expenses that Sam just
[23:14] alluded to. They gave improved cost cutting
[23:19] or more cost cutting, I should say in November at their analyst
[23:22] event and then yet again here in January.
[23:24] So because there's a significant fear that this company is just
[23:28] burning through all the cash, it's definitely been helpful
[23:31] that they've cut the burn down from about 3 to 4 billion a year
[23:35] down to about two. So that's been helpful.
[23:38] So there were two fundamental things going on.
[23:41] One is that there is definitely some view that the cancer
[23:46] vaccine data is coming later this year from Melanoma.
[23:50] Sam mentioned that you know, we're at about a 50% probability
[23:53] that's going to work. That would be a significant
[23:56] catalyst to stock, but it was something we also picked up is
[23:58] that they're talking about a randomized phase two renal cell
[24:01] adjuvant renal cell study reading out this year.
[24:04] And they reiterated that that's also possible suggest if you've
[24:07] been short this stock or you know, have been put this one out
[24:10] a favor. They're saying that this renal
[24:13] cell carcinoma study if it reads out actually could be filed to
[24:16] the FDA if it's positive on a phase two and they have
[24:19] statistical protocols and all that kind of thing with with
[24:22] with the agency on that to a talk about the other second part
[24:26] is the patent situation. So yes, I agree that there is
[24:31] significant concern because if the companies burning multiple
[24:34] billions of dollars a year based on various calculations, depends
[24:39] if you're a Arbutus bull or not, then you could be putting 5%
[24:44] royalties on the COVID sales or 10 or 15 plus percent royalty
[24:51] damages on all of the COVID sales in the US.
[24:55] Funny enough or interested in a non pandemic portion.
[24:58] So if you go back, there's a in the contract, the initial first
[25:01] year contract, the government protects you from any damages on
[25:03] the pandemic portion. But excluding the pandemic
[25:06] portion, a $15 billion of of sales outside of the pandemic,
[25:11] should you put anywhere between a 5% royalty or a 1520% royalty,
[25:15] you're up to multiple billions of dollars of damages.
[25:17] So if you're running out of cash and then that could happen, that
[25:20] could be pretty bad. So trying to point that that is
[25:23] coming up. But the company pointed to,
[25:26] well, people, many people think there could be a settlement.
[25:28] So if there's a settlement with the trial starting in March,
[25:31] that could be a positive. And then yes, as of today,
[25:35] again, another example that they beat Biontech on some patents or
[25:39] I guess they're from Arbutus, but also they appreciate they
[25:41] beat Biontech and some patents in Europe and no one's paying
[25:44] attention to that. And so actually Pfizer and
[25:46] Biontech may actually owe owe them money.
[25:47] So a lot of negativity on Moderna, don't want to spend too
[25:50] much time on that, but some positive things flipping around
[25:53] for 2026. Great.
[25:55] Thanks. All right.
[25:56] We're going to go to the AbbVie deal and let's go to Mike if you
[26:01] want to talk about that. By the way, there were other
[26:03] China deals. I mean the China's still a
[26:05] presence and a player. I think they're going to remain
[26:08] so to continue to do deals, but Abbie did a big one.
[26:14] So why don't you talk to that and then we can go straight to
[26:16] Sam to comment as well. Yeah.
[26:19] So this has been a consistent theme all of last year, right.
[26:23] And so here we go again. Actually this is the second
[26:27] Chinese PD1 VEGF deal in a row. Obviously Pfizer 3 has bio
[26:32] connected with one of the largest with the largest upfront
[26:35] payment for APD 1 VEGF. And then here AbbVie did one as
[26:41] well as speaking to this whole idea that pharma can go to China
[26:47] and look for all of these assets and bringing all of this stuff
[26:52] in. So Avi, which definitely has
[26:56] firepower and capacity to go out and get more things is jumping
[27:01] into the race in terms of the PD1 VEGF competition.
[27:07] And you know, what was interesting about that is 1 is
[27:11] another China deal following Pfizer.
[27:15] And and two it's kind of funny is obviously Abby, one of Abby's
[27:20] most significant and successful transactions were with former
[27:23] cyclics and Bob Duggan and that whole crew, which has been
[27:26] phenomenal for Abby. And of course, all of that
[27:29] management team is at Summit and Summit theoretically looking for
[27:34] a partner. There was speculation that those
[27:37] two could connect there and of course they didn't and and Abby
[27:40] went to China to do the deal. So Summit still looking, but
[27:45] they didn't end up connected on that despite the prior
[27:48] management relationships. That was an interesting angle.
[27:53] Oh, that's, that's if you don't mind, Chris, that is quite
[27:57] interesting. I hadn't, I mean, I remember
[27:59] that deal. I'm old enough to remember the
[28:02] deal, but so just a couple of things to add here.
[28:06] What I've just been looking at our licensing data in the
[28:09] Bloomberg Terminal. Biontech steel was the 6th
[28:13] largest upfront based on the data that I've got in the past
[28:17] five years above it was of course the Daiichi Merc,
[28:21] Galapagos, Gilead, Novartis, Boucher Long.
[28:23] I mean, it's that that's not quite the same kind of ballpark
[28:26] with Zealand and and, and Russia.
[28:28] And then of course the 6th 1 was Biontech and the and three S bio
[28:34] was the 8th largest. So clearly there's plenty of
[28:36] excitement in here, but the Abbey $650 million kind of pales
[28:41] into relative insignificance compared to the 1.25 billion
[28:46] that that 3S got and 1 1/2 billion that Bionte got, perhaps
[28:51] because of the stage of development or whatever.
[28:55] And of course, the, the other interesting thing is listening
[28:57] to all the companies at the conference and they're, they're
[29:01] all falling over each other trying to suggest that there's,
[29:05] there's a reason why their drug is different, better, best in
[29:09] class, etcetera. But what we know for sure is
[29:12] that Summit is going to be first in class to market, assuming the
[29:16] trial works and, and gives you sufficient clinical benefits.
[29:19] So what I, I'd love to hear what Mike's, how Mike's modeling this
[29:24] is. How do you, how do you share
[29:26] the, the, the, the piece of the market that they get from the
[29:29] future by similar PD ones between these drugs as they
[29:35] come? I mean, we can obviously take it
[29:37] and say, well, Summit's going to be first.
[29:38] So it's going to be there the largest, but then they don't
[29:41] have a partner yet. Pfizer comes along or
[29:44] Bristol-Myers comes along. So it's going to be quite
[29:48] interesting and quite fun to model this.
[29:50] I hope for hopefully some of us will get it right.
[29:56] Mike, any further comments on that?
[29:59] I don't have a strong view either way on that.
[30:00] I mean, I think and and two points is 1, how big is the
[30:05] market going to be and 2 is I'm fairly, fairly confident someone
[30:09] is going to is going to have to partner up at some point there.
[30:11] So your guess is as good as mine.
[30:16] Great, Sam. There were some AI news.
[30:19] I, I know Jensen Huang of NVIDIA was there a lot of people crack
[30:22] capturing selfies and they had their own news this week about
[30:25] China, you know, potentially restricting the competition
[30:29] there. But what was the AI news of of
[30:31] the week? Yeah, so obviously and so one
[30:33] thing I have to say first, I'm not sure what what was he
[30:35] wearing? Was he wearing a glitter jacket
[30:37] or a or or a toned down jacket? Because.
[30:41] He's got his own Steve Jobs E type look.
[30:44] Yeah, sure. No, look, there's never a
[30:46] shortage of interesting comments from from the company in
[30:50] general. But of course, the day, the week
[30:52] again alongside of the Moderna news started with NVIDIA Lily
[30:55] deal putting a billion dollars together into this structure to
[31:00] fund over five years AI for, for using pharma, Everybody's at it.
[31:06] So you know, one of the things that that kind of stood out as I
[31:09] was listening to these things, you know, sometimes things just
[31:11] get stuck in your head. Pfizer said AI was a significant
[31:14] contributor in our ability to take out $5.6 billion of cost
[31:19] plus even more in manufacturing if you can't so and now we are
[31:24] ready to scale it up to levels across the entire organization.
[31:28] What does that mean? Did it help the company reduce
[31:32] headcount by handing over some administrative stuff to to AII?
[31:38] Doubt that would have made much of a difference to the 5.6
[31:40] billion cost cuts. Did it help with automation,
[31:47] hence maybe then the comments on manufacturing.
[31:50] I wish the questioner, of course Chris Schott does his best in a
[31:53] 40 minute space to get the most out of the conference comments
[31:58] or identify duplication, etcetera.
[32:00] I don't know. And we know we've recently at BI
[32:03] done a very massive 600CC suite survey on AI.
[32:10] And frankly, nobody's really talking about headcount
[32:14] reductions. Maybe they're not hiring or
[32:17] reducing the hiring rate, certainly increasing
[32:20] productivity within teams, but very few are looking at it as a
[32:24] way of reducing headcount, which I think a lot of AI companies
[32:27] actually do say that. And so what's going to be
[32:31] interesting is the all the comments that were made by
[32:33] NVIDIA again Reviti, Salesforce, Viva on, on all how their AI
[32:39] systems are helping through the true agentic systems helping
[32:48] pharma and drug development. And I think we're going to have
[32:51] to wait a while before we see an actual drug make it through
[32:56] serious clinical trials where AI was a significant contributor to
[33:02] its discovery and maybe another three or four years that that's
[33:05] my prediction. Yeah, that sounds.
[33:08] Yeah, that sounds right. And I think, you know, this is
[33:11] going to take a while to see who the real winners are based on
[33:14] the number of drugs that are truly driven off AI that emerges
[33:18] truly best in class or or really differentiated.
[33:22] I I thought it was notable. I can't remember if it was that
[33:25] news or endpoints or somebody interviewed Eric Tokat.
[33:29] And the most fascinating, you know, was a question that said,
[33:33] is a pharma going to step in to buy an AI company?
[33:36] And it was, I mean, for anybody who would understand and know
[33:39] that dynamic, it would be Eric. And he, he had a definitive no,
[33:43] it's he doesn't see it happening in 2026.
[33:46] And he says they're trying to build stuff organically,
[33:48] internally, they're doing collaborations and partnerships.
[33:51] But he did not see a AIM&A on the near term horizon.
[33:56] I thought that was notable. So let's go to the regulatory
[34:00] front. And you know, if for one thing,
[34:03] you know, Mccarry was, was was there at the conference and FDA
[34:06] was there to do some talks. And I think that's JP Morgan
[34:09] conference itself. But he he definitely knows PR
[34:13] and he was doing little videos and obviously waited to this
[34:16] week to announce some things. So Paul, why don't you take one
[34:20] of the notable things and then and Mike, you can take the
[34:23] other? Yeah, sure.
[34:28] And you know, whether this FDA is flexible and libertarian or
[34:32] stricter than any FDA, we've seen a long time continues to be
[34:34] this push and pull that investors are grappling with,
[34:37] Especially for some of the smaller companies that cover
[34:39] that are focused on gene therapy or or rare diseases.
[34:42] Where we've seen now a number of times where a company thinks
[34:45] that they have alignment around something like a single arm
[34:48] Natural History controlled trial or analysis or a biomarker.
[34:52] And then, you know, they're saying the rug got pulled out
[34:54] from under them. And we're kind of left to say,
[34:56] OK, when we analyze public companies, us, you know,
[34:59] analysts and investors, we don't see meeting minutes.
[35:01] We're not sitting in the meeting, right.
[35:03] So it's, it ends up being he said, she said.
[35:05] But I think at this point, right, we've seen a number of
[35:07] things now that is suggesting that this FDA when Mccary is, is
[35:12] on TV and talking about expediting things in flexibility
[35:15] that at least so far that feels like it's more talk than than
[35:19] reality. And so there was another example
[35:21] of this, right, where Doctor Mccary was talking about
[35:24] streamlining certain things on the CMC side for cell and gene
[35:28] therapy, which Chrissy probably would have a more intimate
[35:31] understanding the implications of that than me.
[35:32] But you know, optically sounds very good.
[35:35] But then you had Atara announced a regulatory update for their T
[35:40] cell product for Epstein Barr virus, right where they received
[35:44] the CRL And, you know, they felt like they had alignment on their
[35:47] path. And you know, of course, the
[35:48] stock trades down 50%. And so, you know, I, we've
[35:52] talked about this in this podcast, I cover unicure, which
[35:54] has become like the poster child symbol of kind of, you know, FDA
[35:59] flexibility. You know, company has alignment.
[36:01] They have breakthrough now they don't.
[36:04] And I still feel like, you know, again, in the from a from a
[36:06] sector perspective, like in most cases, right, if you're
[36:09] investing in a company that has, you know, a defined clinical
[36:13] trial path with clear precedent, you know, placebo-controlled
[36:16] clinical outcomes endpoint like this probably doesn't matter for
[36:21] the most part. But you know, for companies in
[36:23] that kind of flexibility space where you know, data maybe are
[36:26] more up to interpretation, you know, this continues to
[36:29] continues to be an overhang. And maybe just the last thing
[36:31] I'll say before I turn it over to Mike is just, you know,
[36:35] someone, another analyst at Stifel said to me, you know, I
[36:37] don't remember the last drug that got approved on time and
[36:42] that I'm sure that's like hyperbolic.
[36:44] But then he and I were talking about our coverage and all the
[36:47] drugs that have gotten approved coverage so far under review
[36:50] have been delayed in the past six months.
[36:51] So I still feel like an FDA is a small, small overhang here as
[36:56] we're all still trying to figure out like how do we sort of price
[37:00] this risk and uncertainty going forward?
[37:02] Yeah, Mike. Yeah.
[37:05] So another interesting development is if you've been
[37:10] following one of Marty Makary's ideas for accelerating drug
[37:18] development is this whole Commissioner priority review
[37:22] voucher, Commissioner National Priority Review voucher.
[37:25] And you know what, whatever you think about it, the idea of
[37:29] approving drugs in as fast as two months sounds pretty
[37:35] amazing. And they have given CNPVS to
[37:40] what 15 plus drugs? There's been two different
[37:43] rounds of that. And what is interesting if you
[37:47] go read the method to get the drugs of course unmet need
[37:53] addressing particular big areas of, of of health is that there
[37:59] is an angle that you would work with the administration to also
[38:05] reduce drug prices. So that's the whole interesting
[38:07] angle of course and perhaps it's a discussion with the FDA.
[38:12] So with all the insights into CNPV, there were a number of
[38:18] these drugs that could be approved and as fast as two
[38:21] months. And of course, that's better
[38:22] than priority reviews, which are 8 months.
[38:24] And so while there's only been one or maybe 2 drugs that have
[38:28] been actually approved under this, there's a number of drugs
[38:31] that are on file under and using currently under review.
[38:34] The voucher that would have included Santa Fe's T Zealed, a
[38:38] Type 1 diabetes drug, and also Lily's Orphoglypron, which got
[38:45] the voucher as well and has been filed and is under review.
[38:49] And hopefully it's going to be a fast approval.
[38:50] And people were thinking that could be very soon in Q1 ahead
[38:55] of of Lily's guidance of Q2. And obviously oral Wagovi pill
[39:00] just got approved. And actually if you're walking
[39:02] around the conference, there were some taxis or cars that had
[39:07] a whole rap on them that said the pill is here.
[39:10] That was actually the oral Wagovi advertising for for that.
[39:14] That was interesting. But going back to what what the
[39:17] point is, is that it was a report out saying that the FDA
[39:23] is scrutinizing a lot of the drugs and that there were at
[39:26] least two delays. One was the Santa Fe T Zealed
[39:30] because there are some safety things that they're looking at.
[39:34] And two, specifically, and I'm not exactly sure how they got
[39:37] this insight, was that Lily's orpho is looking for an April
[39:42] 10th approval. So that was a, a, a date that is
[39:49] farther out than what Wall Street was expecting.
[39:51] And so Lily traded down as much as 5%, I think into the day,
[39:54] down 3%. So what is the point?
[39:56] The point is, oh, it's not All these drugs are not going to get
[39:59] approved in two months. Each one is going to be
[40:01] different. I stand by the idea that these
[40:03] are going to be approved faster than a priority review and you
[40:06] should expect that the FDA is going to take a look at stuff
[40:09] and you'd want them to take a look at stuff rather than just
[40:11] blindly approving drugs in two months.
[40:13] So they should look at Orpho. It does not matter if it's Q2 or
[40:17] Q1, even though the stock traded down, it's all very fast.
[40:20] And and that's that's kind of a positive, I guess that's come
[40:23] out. One of the positives has come
[40:24] out of the administration I would say.
[40:27] Anyone have any thoughts on CNPD?
[40:29] Yeah, Let me just add so, So first a corollary is the
[40:34] priority review voucher that companies get that are
[40:37] transferable. I thought it was notable that
[40:39] Jazz was able to sell theirs to an undisclosed buyer for 200
[40:43] million. So those prices were coming
[40:44] down. That is a higher priority.
[40:47] Just a shout out to my boss, Joe Edelman did an interview.
[40:50] He rarely does interviews, but he did it on biotech TV.
[40:53] And 1, he wasn't too concerned about the overall FDA policy
[40:57] that I'll work itself out, but he was concerned about staffing
[41:00] and being able to hit timelines and all of that.
[41:02] And then he also just related the gene therapy guidance.
[41:05] He thought he was asked what's the most under hyped area and he
[41:10] was more bullish that gene therapy is still, you know,
[41:14] valid and and should come back after this kind of cold period.
[41:17] But anybody else want to comment on the regulatory FDA policy
[41:21] front? Chris, did we lose you?
[41:45] I'm still here, Mike. Chris is Mike, why don't you,
[41:51] why don't you keep going on on the next topic that we wanted to
[41:54] chat about, which was all the obesity you did to a degree, but
[41:58] you didn't talk about engine yet.
[42:00] Perfect, perfect. That is a perfect segue.
[42:02] So I just wanted to say obviously obesity remains top of
[42:07] mind. It is top of mind for most
[42:11] mutual fund investors. It is still obviously a huge
[42:14] situation for small cap and mid cap biotech investors and
[42:17] biotech. And I just wanted to point to
[42:20] three things. Obviously, we already know we
[42:22] don't need to run through that oral govie pill is now approved.
[42:26] And I think the first scripts were out.
[42:28] I think that that number just came out over 3000, which is
[42:31] which is good. I think Novo's trading up a few
[42:33] percent on that. But there are three developments
[42:35] on the obesity front that I think are important for for our
[42:39] audience. 1 is Lily is imminent and it's going to be big.
[42:43] And so this is going to be the year of how big the first year
[42:46] of oral GLP one drugs are. And then 2 is the people coming
[42:52] right behind them. And if you haven't been paying
[42:56] attention in the last couple of months alone, obviously the
[43:01] Metcera deal closed with a bidding war.
[43:04] I'm sure you guys talked about that.
[43:05] We met with Pfizer and the as expected, the Metcera data
[43:12] should be out and is kind of going to be presented at ADA in
[43:16] June. We could be getting some
[43:18] disclosure on that beforehand. And they have a monthly
[43:22] injection and a monthly Amylin. And why that's interesting, of
[43:25] course is because both Pfizer and Amgen would probably be the
[43:30] next two companies that are getting approvals and obesity
[43:33] other than Novo and Lily. And Amgen is is finishing their
[43:37] phase three with their monthly. So the race for the 2 next guys
[43:41] is the monthly drugs. Now Amgen was supposed to come
[43:45] out with big data on their monthly drug for the two year
[43:47] data. And they did come out with
[43:49] something, except there were 0 numbers around it.
[43:53] So they came out and then did the whole fireside presentation.
[43:56] They said the data was positive. It looks like it's at least a
[43:59] monthly or a quarterly. But there was actually no
[44:02] numbers, no datas, no charts. And Wall Street was left a
[44:05] little bit a little bit disappointed there.
[44:07] So I just wanted to say that there's some controversy around
[44:09] that, but perhaps you're being, you know, keeping it close to
[44:12] the vest is competition. And then the last part of it is
[44:15] it's still not over because every single company I spoke
[44:18] with and I met with Abbie and and Bristol and, and obviously
[44:22] Merck and others, and they're all still looking for more
[44:24] obesity assets. Abby has got one thing.
[44:26] They're looking for more. Amazon's looking for more in
[44:28] Bristol. Don't be surprised if they do
[44:30] something. In fact, there was speculation
[44:32] they were one of the early bidders on Met Sarah.
[44:34] So more to come on that, but you know, we're going to hear a lot
[44:37] about obesity this year. So Mike, where are you on
[44:41] Mobicity 2013 sales? We've got, we had Albert Borla
[44:47] of Pfizer talk about $150 billion.
[44:49] I'm not sure of who whose model that is.
[44:54] I think we are at about 100 and 210.
[44:58] Where, where? Where are you at?
[45:00] You're you're at 2:10. That's 100 hundred hundred.
[45:04] Oh my God, we, I think we're like at 1/15, 1:20 we, we have
[45:12] that split, obviously majority Lily, then Novo, then the others
[45:18] and we have orals at about 25% of that.
[45:22] You know, the good thing I think, which you could
[45:24] appreciate and everyone could appreciate is that even though
[45:28] the price went down, which would be expected, is that they did do
[45:30] the Medicare deal, which opens up a significant portion of the
[45:33] population and the cash pay portion of that.
[45:36] The price came way down as expected.
[45:38] But that offers a lot of people the ability to get these drugs
[45:43] for an affordable price. We could debate who can and
[45:46] can't afford, you know, 299 a month and 399 a month.
[45:49] But an interesting data point for you and for everybody is
[45:52] that actually you're outside the United States where it's all
[45:56] cash pay has been crushing sales numbers In last quarter.
[46:00] Lily blew out the number and that's all cash pay.
[46:04] The European governments do not pay for the drugs and obesity
[46:08] and yet the sales are crushing it and it's all cash pay.
[46:11] So yes, there is demand for it at 300 bucks a month.
[46:14] I mean, so where do we stand on that?
[46:15] A lot. A lot more to come, and a lot
[46:16] more. Interesting.
[46:19] I'm not that I I look forward to other future podcasts here where
[46:22] we're going to talk about, if you haven't already, or maybe
[46:25] you did last month, the, the NAB stuff, the activity stuff.
[46:28] That's cool. And obviously some of the other
[46:31] agents that are coming. So that's that's pretty cool.
[46:33] Yeah. And the numbers in terms of cash
[46:40] pay in the UK, the, the, the reimbursed version version by by
[46:51] through through Nice is, is for people with BMI of 40 plus at
[46:58] least a certain number of and maybe I can't remember, is it
[47:01] 3-4 comorbidities? I mean I think we've worked out
[47:06] the number there is something in the region of 100 and 5200
[47:08] thousand subject patients and that's not even that's only been
[47:13] going on since June. So I don't know how many people
[47:15] have actually got a paid prescription.
[47:18] So I'm not surprised that most of it is cash.
[47:22] And then of course we've got the interesting dynamic between Lily
[47:26] and Novo, Novo being only 10% of their business in the US being
[47:31] the cash channel, the DTC channel.
[47:34] And then and then about 30% for for Lily.
[47:38] That's let's see if that the launch of the Orals changes that
[47:43] or does or whatever Lily does maybe change.
[47:45] Sorry, Novo does changes that. And so let's move on to some
[47:50] data. We haven't got a lot of time
[47:51] left and we've had so much technical.
[47:53] Yeah, yeah, I'll send. Out, Sam, Can you?
[47:55] Can you hear me, Sam? I can hear you now.
[47:57] Yes, I can. OK, Yeah.
[47:59] So let's go a little rapid fire. We've got five data readouts
[48:03] before we close. Paul, do you want to cover Lexio
[48:06] and Bio Marin 1st and then we'll go to Sam for J&J.
[48:10] Yeah, sure. And Chris, I'll cover Bomber in
[48:11] first because I want to hear your perspective to given your
[48:14] long history in this space. So Bomber in had some top line
[48:18] data for their DMD candidate, which is an Exxon 51 drug that
[48:23] is an oligonucleotide therapy that on efficacy really
[48:27] surprised to the upside. We haven't seen the full data,
[48:30] but they got up to 5% dystrophen, 5% of wild type.
[48:35] This was unadjusted for muscle content.
[48:38] So to my knowledge, that's the highest number someone has
[48:41] gotten in this Exxon. And if you follow DMD closely,
[48:44] you know, each Exxon is really different because the baseline
[48:46] district quantity is different. So there's there's a ceiling, I
[48:50] think how well you can do to some of these, right?
[48:52] Maybe Exxon, you know, 4445 you'll be able to get a lot
[48:54] higher. So it's really interesting
[48:56] because there's really not a lot of pricing to bomber in.
[48:58] You know, I take a little bit more of a not cautious to you,
[49:02] but like wait and see view here because and then, Chris, this is
[49:06] where I want your history for our listeners.
[49:08] This drug comes from, I wanna say it comes from pro sensa
[49:13] because you know, it didn't exist when persons it was
[49:14] acquired. But you know, it's out of that
[49:16] project, right, with Dries a person, the original oligo from
[49:20] this portfolio, which, you know, did make some dystrophin, but
[49:23] was super toxic. And I think the underlying issue
[49:27] here is that these oligos are not conjugated to either TFR one
[49:31] or a peptide. So they stay around in
[49:34] circulation. They're immunogenic.
[49:35] There can be risk for thrombocytopenia or renal toxin.
[49:38] Again, we haven't seen anything but for this molecule, like
[49:42] there's actually no safety signal that's been reported.
[49:44] But I thought it was notable that really nothing was said on
[49:46] safety at all and we just need to wait for a medical meeting,
[49:49] which to me remains kind of the most salient question for the
[49:52] competitiveness of this product. So yeah, I mean, Chris, anything
[49:55] you want to add from your history here?
[49:56] Well, yeah, I mean, one, I I do think that their, their
[50:00] chemistry is more toxic. And so I think I always look at
[50:03] what is any company in DMD not sharing and that usually raises
[50:08] flags. The other thing is, while, you
[50:10] know, I also argued for, you know, district and being a good
[50:13] surrogate marker, but there still is not a hard correlation
[50:16] between the district and production and outcomes.
[50:19] And so I think, you know, in this space and we still need to
[50:22] see what happens to surreptus exon skipping and what the FDA
[50:25] ultimately addresses with that. So I I still have a lens of
[50:30] skepticism until we see full data sets and really understand
[50:34] what's going on. But I think it's good for the
[50:36] field that there's another player and obviously an
[50:39] expansion of different exons that are being targeted.
[50:42] Obviously with Avidity and Dyne and others other players in the
[50:44] mix, I think it's overall good. But yeah, I I want to see the
[50:47] full data set before I would I would render judgments.
[50:51] Makes sense. You know, maybe very quickly on
[50:53] Lexia, since you're talking about gene therapy, they had
[50:56] more data for their PKPQ gene therapy.
[51:00] This is a rare cardiac disease. It's it's got, you know, kind of
[51:04] a cult following among biotech investors because there's 10s of
[51:07] thousands of patients with PKP 2 deficiency.
[51:09] So it's actually one of the bigger gene therapy
[51:11] opportunities out there. You know, I think the challenge
[51:14] in this disease and you saw it from the Lexio data and how the
[51:16] stock reacted is really finding the right end point.
[51:19] You know, Lexio Rocket, Tenaya, they're they're forging the path
[51:23] here. And so, you know, Lexio show to
[51:25] signal on NSVT non sustained ventricular tachycardia PVCS of
[51:30] these kind of electrical measures of how the heart
[51:33] behaves and you know, they're trending in the right direction,
[51:36] but a lot of variability. All I would say is that, you
[51:40] know, this is kind of, you know, I think investors get impatient,
[51:43] right? They want the signal to be
[51:44] totally unequivocal in the first data set or the second data set.
[51:47] Who doesn't? But this reminds me a little bit
[51:50] of how the fridges and taxia program played out for Alexia,
[51:52] where some of the early data were interesting.
[51:55] There was variability, you know, at six months there's a signal,
[51:58] but people are debating how big that signal is.
[52:00] But the data got a lot better over time.
[52:02] And then they were able to kind of forge a pass with the FDA on
[52:06] a perspective phase three study that is Natural History
[52:09] controlled. And so, you know, like still
[52:12] risk here, but but you know, I think, you know, the reaction
[52:16] maybe just kind of was I think an overreaction because again,
[52:19] when you're sort of first in first in indication, you know,
[52:22] sometimes you have to kind of generate some data before you
[52:24] can really know what to focus. On yeah, I also think, you know,
[52:27] gene therapy, if it's going to come back, people are watching
[52:29] valuations closely. And I think, you know, companies
[52:32] like Lexio, like Solid, like others with gene therapy, you
[52:35] know, hovering around 1/2 a billion.
[52:36] I think it'll be interesting to see where valuations go with as
[52:40] these gene therapy companies mature.
[52:42] All right, rapid fire, Sam, do you want to hit J&J myeloma?
[52:44] And then we'll go back to Paul. Yeah, J&J keeps moving the goal
[52:49] posts on, on, on myeloma. We've gone from Majestic 3.
[52:54] We just had data from Majestic 9, which is the the bispecific
[53:01] BCMA CD3T cell engager and and we everyone's going to keep
[53:08] comparing to Cartoon 4, which is our which is Legend and Johnson
[53:12] and Johnson's themselves, car T therapy Car Victi and, and
[53:17] you've and you all you have to do is look at the share price
[53:19] chart for for legend to see what the the streets and the markets
[53:23] thinking about this evolution, not just from their buy
[53:26] specifics, but also from competing parties over.
[53:31] Great, Paulie, we got two more news items for you to cover and
[53:34] we went. We started a couple minutes
[53:35] late, so we're going to go a couple minutes over.
[53:37] But Paulie, you got a couple other news items.
[53:40] Yeah, what do you want me to start with?
[53:41] Chris, why don't you go to Vertex and then you can go to
[53:43] Lily? Yeah, Vertex and Fiona, their
[53:47] emerging competitor, had some interesting updates in both of
[53:50] their programs for cystic fibrosis.
[53:52] All I'll say is that this is evolving into like a really,
[53:56] really interesting year for both companies.
[53:58] I mean, Vertex has obviously really diversified their
[54:01] pipeline and their drug portfolio over the past five
[54:03] years since really the last time there was a competitive overhang
[54:07] with AbbVie and CF. And I don't even want to say
[54:09] that Fiona is an overhang because, you know, Vertex is a
[54:12] huge market cap and Fiona doesn't have many patient data
[54:15] yet. But you know, Siona has a
[54:17] really, really interesting drug that targets NBD, one, which I
[54:22] would call a different mechanism of CFTR stabilization.
[54:25] I think Vertex is kind of making this sort of taking this
[54:28] reservation with the term mechanism, right?
[54:30] Because all these drugs are correctors, but it's a different
[54:32] binding site on the protein that is not directly bound by the
[54:37] Vertex drugs as as we understand it.
[54:40] And so Siona has some data the middle of this year, Vertex has
[54:43] data for their next Gen. CFTR modulators later this year.
[54:46] And they're not saying anything about those compounds for
[54:48] competitive reasons. You know, Mike and I attended
[54:50] the Vertex event. It was the first time I really
[54:52] saw them getting multiple questions from different
[54:55] analysts about this in a public forum.
[54:57] You know, I met the Siona team, we cover that stock.
[54:59] And so just kind of heating up as as being an interesting year
[55:02] in CF potentially. I think the other news I want to
[55:05] just briefly touch upon was, you know, the Lily commentary on
[55:08] their TB three study and how people are trying to figure out
[55:12] how to interpret that commentary.
[55:14] You saw Biogen sell off, You know, for context, this is to me
[55:18] as as a neuro person, I mean, this is the catalyst I am by far
[55:21] the most interested in out interested in over the next 12
[55:24] to 18 months. It's a readout that I am this is
[55:27] not a Stockholm Lily, but I am super bullish on this readout.
[55:29] And I think it can be paradigm shifting for neurodegenerate
[55:32] disease. This is a study where they're
[55:34] essentially trying to prevent the onset of Alzheimer's disease
[55:36] and patients, patients at risk. You know, we know amyloid beta
[55:39] has gone through a very, very long history.
[55:41] But if you look at the evolution of a beta treatments, you know,
[55:45] first studies in moderate to severe Alzheimer's don't work.
[55:47] Some of the studies in early MCI show a small benefit, But in a
[55:51] subset of early MCI, in the Biogen and Lilly trials, in the
[55:54] patients who have the earliest disease, you see a considerably
[55:57] bigger effect size. Our view is that in these
[55:59] prevention trials, you should see an outsize effect size.
[56:02] And also, you know, again, a lot of the infrastructure has to be
[56:04] built, but I think who wouldn't want their plaques?
[56:07] Taken. Out if it's going to lower their
[56:09] risk of Alzheimer's substantially as long as these
[56:11] drugs are safe, which I think in an earlier population they
[56:13] likely will be. You know, Lily was more
[56:15] affirming that the data are expected in 2027, which is not
[56:18] new, but people have been looking to 2026 as the time for
[56:22] a potential interim. I think the question is like,
[56:24] you know, does this 2027 reaffirmation suggest an interim
[56:28] has already happened or not? I wouldn't interpret this as at
[56:30] all negative to the POS of the study.
[56:32] I mean, Lily remains very confident.
[56:34] And I also think an interim analysis here is just going to
[56:36] be subject to the number of events.
[56:38] The biggest uncertainty with these prevention studies is no
[56:40] one really knows how to power them, right?
[56:42] Like no one knows what to expect for the control arm and the rate
[56:44] of progression. But the Lily study is an
[56:46] inventor of in study, which should be a good hedge against
[56:48] powering. So Biogen is laterally exposed
[56:50] here with lecanumab, right, which has been a really
[56:53] significant disappointment. But we think if we get
[56:55] prevention data and it's great and the safety's clean, I think
[56:58] it can really change the narrative on this.
[57:00] Sam, do you have any comments on that?
[57:03] Just just that I, I as just as Paul is excited by this, so am I
[57:09] of, you know, I used to work on amyloid.
[57:11] And, and I think this is going to be quite a, we all hope a
[57:18] shift, the sort of shift that we hadn't seen yet with any of them
[57:22] in the, in the later stages of the disease.
[57:24] And, and I just hope it doesn't fail because it takes the wind
[57:28] out of the sails of all the other ideas that that people are
[57:30] trying here. So fingers crossed, crossed,
[57:32] excited. Yeah.
[57:34] And I know Biogen, I didn't see the presentation or this is what
[57:37] I heard people talking about that they are definitely leaning
[57:40] into other areas, therapeutic areas.
[57:42] So they're trying to make sure they have hedges against the the
[57:45] Alzheimer's space. But I want to say thanks to
[57:48] everyone. Well, overall, I think we all
[57:50] came out with a positive feeling that 2026 is going to be a
[57:53] Goodyear coming out of JPM. So if you weren't there, I think
[57:56] there's there's a lot of signs you can read from all the final
[57:59] reports that are coming out today and probably next week.
[58:01] So thanks to everyone who attended this JPM Hangout event
[58:05] earlier this week at JPM. It was a great time.
[58:09] I was there. I didn't see as many Co hosts
[58:11] that I was hoping to see. I saw Brad, I saw Test Cameron.
[58:15] I was there for about an hour and a half, but I think I missed
[58:18] a lot of the large group there. But it was a great great to meet
[58:21] so many of you in the room. Special thanks to our gold badge
[58:24] sponsors, CFGO, Incubate Coalition and Cineos Health
[58:29] Communications, and our blue badge sponsors FTI Consulting,
[58:33] Catalytic Agency and MISPRO. The event wouldn't have been
[58:37] possible without them. We're already looking forward to
[58:39] next year and I hope we see all of our audience there in turn
[58:42] out next year.

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