Biotech Hangout: Episode 184 - May 29, 2026

Sourced by podcast-ingest on 2026-05-30. Auto-transcribed via AssemblyAI (universal-2, en). Speakers identified by AssemblyAI Speaker Identification using the per-podcast host/regulars hints; the resulting label→name mapping is in the frontmatter. Duration: 58m. Episode page: https://podcasters.spotify.com/pod/show/biotechhangout/episodes/Episode-184---May-29--2026-e3k379o. Audio: https://anchor.fm/s/55bdff38/podcast/play/120740600/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-4-29%2F425155483-44100-2-72648194007b8.m4a.

Show notes (from RSS)

On this week's episode, Chris Garabedian, Brian Skorney, Graig Suvannavejh, and special guest Ginkgo Bioworks CEO, Jason Kelly, kick off with a market update, highlighting a continued positive sentiment, citing Endpoints' recent Biopharma Sentiment Index. The conversation shifts to China, with Jason suggesting that genetic engineering is a strategic technology extending beyond therapeutics, warning that the U.S. is offshoring critical innovation to China. In deals: Lilly's acquisition of three vaccine companies for up to $3.8 billion and Apogee's $1.3 billion strategic collaboration with Blackstone. Revolution Medicines Phase 3 trial results for pancreatic cancer at ASCO 2026. Updates on the FDA following the recent leadership changes after the departure of Dr. Marty Makary.

Transcript

Chris Garabedian: You're listening to Biotech Hangout, a live and unedited weekly discussion of all the latest news in our industry with a group of biotech leaders and experts. I'm Chris Garabedian and my co hosts today are Brian Scorney, Greg Suwanaway and our special guest, the co founder and CEO of Ginkgo Bioworks, Jason Kelly. And really glad to have you. For more information about our hosts and guest speakers or to listen to the most recent episode, please go to biotechhangout.com so first we always like to touch on kind of market overview. I'll just mention we saw another IPO filing, Cardigan. This was following last week's parabolas. You know, IPO and cardigan is the latest filing. It's about the 11th biotech filing this year, already beating or matching the total number that we saw in 2025. Cardigan is led by the former CEO and management team of Myocardia. So Tassos Giannakakos is the CEO. He brought on his former CMO and CSO from Myocardia, which was acquired by BMS for 13 billion. So they've assembled, acquired several clinical stage products. They have three unique products with different mechanisms in phase 2b studies going after genetic cardiomyopathy and severe hypertension and aortic valve atherosclerosis, et cetera. So they've got a late stage pipeline. And again, they've raised more than half a billion in their series A and Series B just in less than the last 18 months. And so going public, this will be one of those record setting amounts raised for and tracked to IPO within 18 months that we've seen. So again, I think we're all watching. So far the IPOs have held pretty well. And just wanted to ask Greg and Brian, as we sit here about to enter June, the sixth month of the year, 11 IPOs. How are you guys reading this in terms of. We were all looking at the beginning of the year with an eye toward IPOs as a marker of how healthy the current states of biotech are. How do you guys see it where we are today at the end of May?

Brian Scorney: I'll jump in first and Greg, feel free to correct me with your thoughts. Look, I mean, I think it's good. Certainly capital markets is, is a big driver. These companies all consume a lot of cash. So being able to raise decent valuations, raise a lot of money, have an IPO window open, that kind of makes everyone happy, I think. IPOs and as things move earlier and earlier that's also somewhat of a signal of moving into bubble territory. I don't really think it's there yet, but there's certainly been an acceleration. I think earlier in the year, maybe January, we, we talked about this a lot. I think on one of these with Matisse and Shimmer and I, I think Shimmer said he was looking at like 50 plus IPOs. I think if I remember, I don't remember exactly what Matisse's number was. I think he was maybe like 13. I said I was, you know, sort of in the middle.

Greg Suwanaway: He was 15. I remember being on that 15.

Brian Scorney: All right, so, so, so, you know, unless things go really south, Paul's going to wind up undershooting that number. So. So we'll have to see. You know, I think, I think it's healthy. I think the, the follow ons have looked really healthy. Right. I mean strong companies with strong data have done really well and been able to trade up. So I think capital markets overall looks healthy for biotech. I get the question of like is it past healthy? Are we getting past the point where too many companies are raising too much money? And we all remember, I mean everyone's been in this game long enough to kind of remember 2000 and the peaks of COVID and the kind of dearth of IPOs that followed as the market market kind of cratered after that. But I don't think we're anywhere near that. Right. I mean, you know, this is not a frothy biotech market to any extent.

Chris Garabedian: I'll just say, Brian, my comment is I think this collection of IPOs a little bit different later stage clinical. We see companies that have had clinical data, you know, like Avalon, that have gone out. And so, you know, if this was a preclinical. Right. We have ideas to have a bunch of drugs that are moving into the clinic with a great management team that has a proven track record like Cardigan does. I'd be much more worried than having three phase 2B, you know, shots on goal. Makes it a little, I guess, less frothy in my opinion. Let me just continue with endpoint does these quarterly biopharma sentiment indexes. And it's kind of a nice way to just track where things are going with different stakeholders. And they just released one this past week and the, the overall index, so 100 kind of being the standard average. The overall index moved from 78 across all stakeholders in fourth quarter of 25 to 90 in first quarter of 26 to 96 in second quarter of 26. This latest survey. But again that is an average among various stakeholders. And so when they cut it by investors and the finance group, they have a finance investment and then they have different levels within that. But they basically moved pretty considerably from Q1 to Q2. The business conditions currently moved 50 points over the index. The overall average among finance investment went to 120 even though the overall average was 96. So it seems that the investment community and the finance are definitely more feeling more bullish in this second quarter. They rate subcategories like business conditions I mentioned moved 50 points, funding climate moved 54 points. They also look at the 12 month outlook and that moved 26 points. And regulatory environment over the next 12 months. Now it's not clear if this was surveyed before and or after McCary's departure. I think the survey might have gone out before McCary's departure and they might have collected more after. But that that moved 53 points in terms of expectations of the regulatory policy environment. So whether that would have gone down knowing that the commissioner left or if it went up maybe because he did leave, I don't know. But anyway the overall sentiment is shifting across all stakeholders including CEOs, biotech, CEOs, CROs and CDMOs. They poll those are still tracking below the 100 index but are all moving in the right direction. So overall things are looking pretty positive. And again on the venture side, we're still seeing good deal flow on the private side. So we wanted to move to our special guests. So Jason Kelly, who I mentioned at the top of the hour, co founder and CEO of Ginkgo Bioworks and he's been speaking about the China issue. China's been a main topic for our industry now, at least for the last year to two years in terms of the reliance of pharma and biotech increasingly to access drugs in China. And this has sparked quite a debate on social media. Peter Kulchinsky, Tess Cameron from RA Capital put a kind of a white paper out in kind of an anti protectionist stance. And Jason wanted to thank you for coming on and kind of speaking about your position. I will mention and I just want to ask about this. So besides being co founder and CEO of Ginkgo Bioworks, your own profile on the website says you served as chair of the U.S. national Security Commission on Emerging Biotechnology, which oversees how advancements in emerging biotechnology will shape current and future activities of the US Department of Defense. And so you know, just trying to understand how much that has colored your lens. Maybe there's if there are things that you have Insight on about China and the threat of biotech working with China would love to understand that better because you have a unique vantage point having served in that role. But also I want to kind of challenge the idea that, you know, we've been quote, outsourcing for a long time now. I mean, you know, you know, chemistry to India and China and. And so many of us view this as just a natural extension of what has gone on for decades in terms of outsourcing, you know, globally, even going to Australia for a phase one. You know, there's many different ways that we access other. But anyway, I wanted to set that up for our audience. But yeah. What's your perspective on it all?

Jason Kelly: Yeah, and I think like, all that complexity just in sort of the supply chain that goes into both the discovery of a drug, the clinical trials associated with the drug, the ultimate then manufacturing and commercialization of the drug, it's very complicated.

Chris Garabedian: Right.

Jason Kelly: Which is why it makes this, like, a pretty tricky topic to talk about. So I will try to like, drill down on what I'm specifically worried about. And it is informed by my experience with the nscdb. Right. So I chaired that for two years. And then now Senator Young is the chair of that commission. And like, just to give like a little bit of background, there was a commission like this now, I guess six or seven years ago that Eric Schmidt was the chair of that was focused on AI.

Brian Scorney: Yep.

Jason Kelly: And then one before that, like way back in the day on like cyber. Right. And so the idea is, hey, there are these strategic technologies that matter ultimately to national security. And we want to make sure that the US is like the leader in those technologies. We don't have to be the only place that does them, but. But we want to make sure the frontier is happening here. Right. And. And you can kind of feel this viscerally like if anthropic and open AI and all that energy was happening in China right now, and we were sort of here in the US deciding if we wanted to use a Chinese model, you know, like. Like that, like, to me, like the power of that technology, regardless, like, we know that one is going to be deployed for military purposes, both for economic and national security. Military reasons. I certainly feel a lot better that that technology is centered here in the United States.

Brian Scorney: Yep. Okay.

Jason Kelly: And so. So I think we have this question, which is how do we feel about biotechnology? Right. And what's weird about biotech? And again, this is. This is a call very much focused on the therapeutics industry. But I think part of the reason I was asked, invited to be the chair of that commission was we had actually done a lot of work at Ginkgo over the years in industrial biotechnology. So this is, you know, the development of enzymes and things like that for production of chemicals also in agricultural biotechnology. And we did work in therapeutics. And so we kind of cross cut. And what I would say is I believe we are very much at the infancy of biotech. Right. It's sort of like if you rewind the clock on computers, you know. Yeah, we look at computers today, but they were really invented sort of in like the 40s and 50s. And then IBM kind of got them off the ground in the 60s and 70s in a big way with mainframes. And then we all noticed them as consumers in the 1980s and 90s when they were like fully 60 years into sort of like computation, moving to machines. Sure, right. And you know, genetic engineering really began in 1978 and Genentech in the early 80s, Monsanto in the 90s, you know, so, so here we are kind of like 40 years into our journey. All right, so it's still early and we're still seeing what are the first uses of this technology. But to me, the engineering of a cell, the designing of DNA, this is our other sort of programmable substrate alongside computers. And we should not assume the only use of this technology is to make protein therapeutics.

Chris Garabedian: Sure.

Brian Scorney: Yeah.

Jason Kelly: Okay. Like, that feels really short sighted.

Brian Scorney: Yeah.

Jason Kelly: About genetic engineering.

Chris Garabedian: Yeah. And I considering, Let me.

Jason Kelly: All of our food is made with genetic engineering. The atmosphere, sorry, is made with biology. The atmosphere is produced by biology. Our human bodies are made out of biology. Like, the idea that genetic engineering and biotechnology is just therapeutics in terms of what it could be used for is, Is to me is naive or people are just saying that because they have other motivations. To me, ultimately it is very clearly a technology that has dual use. Very clearly a strategic technology we experienced with COVID that, you know, a single RNA virus can shut whole countries down. Right. Like. Like we cannot be. I think it's time for the biotech industry to grow up a little bit and, and appreciate that this technology has great potential and great power. And thus it is strategic and. And countries will treat it that way. And so my experience with the NSCB was just looking and noticing quite how strategic China was being about it. And so. But I'll pause there for a second. Yeah, well, yeah, before I dive into drugs. Like, like what has got me on about this is I watch the, the one commerce. Like the, you know, the weird thing about genetic engineering today is that 90% of the market for cell engineering is basically therapeutics.

Chris Garabedian: Yeah.

Jason Kelly: You know, it's proteins, it's cell therapies, it's gene therapy, it's rna. Right. But that whole like line of like designing nucleic acids and having the talent and the technology base, it all sits downstream of basically one app area at the moment. And so whoever controls that application area ultimately controls genetic engineering. It's a little bit like controlling computers in the 60s and 70s. And what's woken me up is I'm watching us offshore that to China and I'm watching us actively US investors, US pharmaceutical companies supporting the out the offshoring of what I consider to be strategic technology that will ultimately be more important than computers. Yeah. So let me, I'm just not going to watch it happen. So I'll.

Chris Garabedian: Yeah, let me just provide a different counter. So look, I think it's a healthy debate, especially as you look at longer term, I'll call more existential kind of, you know, meta narratives around technology and you know, who will kind of control that and own that. But you know, the real issue is, and the reason this was elevated recently was the idea of the COINS act, which you know, depending your interpretation and the reading of it, and I'm not an expert in the legislation, but it's, you know, really gonna be curtailing this activity of, you know, licensing drugs and really finding opportunities to advance and accelerate human therapeutics for real disease applications. When I was a public company CEO, I was partnering with the Department of Defense, this was what became Sarepta, called AVI Biopharma. And you know, we were definitely working on medical countermeasures and you know, bioterror threats and all of that. So you know, definitely there's a place for that to understand how protect our country from misuse or using those technologies against us and the people of the United States. But in the cases that I think are being brought up, it really is about why curtail our ability where we most would argue the US is best practice in terms of drug development and the ability to take something that might be found preclinically wherever it may come from, or you know, designing a drug de novo and working with an India supplier or China supplier, taking the next step of all right, let's see. A well characterized asset or even one that has even entered the clinic in China is even more well characterized before it's brought over. Right. And, and you know, having had have to do the clinical trials, the pivotal studies, you know, that makes it A real therapeutic. And so the idea is that aren't we really just arguing over the next incremental step of outsourcing that the industry's come to rely upon? And then I'll just add that I didn't read the entire detailed white paper, but RA came up with this idea of Euro washing, which is the idea that you're incorporating unintended circumstances where just like when we were offshoring to Ireland and domiciling there for tax benefits and you know, are you going to see the same thing happening? Because you know, we can have European or multinationals and we already see this with deals with China, with, you know, gsk, a UK based company, but BMS and even, you know, today Pfizer. Right. Another announcement of China. So I don't think we're going to be able to put, you know, the toothpaste back in the tube. And aren't we just hurting the US by trying to restrict us from being able to have that, that free market capacity?

Jason Kelly: Yeah, so, so two questions embedded in there. And I'll, I'll get to both. So, so the, and maybe I'll go quickly through the first one. We can circle back on, get to, to your, to the second point. You just brought up the. So on the first one, I think the. From my perspective, again, sort of what I just said, the. I, I think it is a bit simplistic to, to say that whoever, that this is just about the therapeutic uses of this technology. I think it is about a industrial capability in the area of biotechnology and it's fine if it's, hey, other places are going to have it. All I insist is that the US is the frontier and I don't agree with you that we are assured that. I think we are in the process of offshoring the innovation engine of biotechnology right now. And you see this reflecting. I'm here in Massachusetts, right? We, for the first time since MassBio has tracked it, we saw a decrease of 1100 R&D jobs in 2024.

Brian Scorney: Right.

Jason Kelly: These are like US scientists who cannot get work anymore in the biopharma industry because that work is now happening in China. These are discovery scientists. These are the people who lead the frontier.

Brian Scorney: Okay.

Jason Kelly: We have one third of our lab space here in the Massachusetts area empty right now. And so I, and you know, this is not cyclical in my opinion. This is a consequence of an offshoring. Okay, so, so, so that's sort of. And we could talk more about that. But that, my point number one is I do think what we are starting to lose here is not. I'm handing off to a chemist to make a molecule that was designed here, you know, in the United States, but rather I am actually just moving the science of genetic engineering offshore. Okay, and then to your second point. Yes, Peter, I think think that the article is long enough, it's convincing. But, but I, you know, the you're watching thing I don't think makes any sense. And the, and the basic reason is that if you look at the market for drugs, it is not a free market. Okay. And you can tell because 70% of the profits for therapeutics originate with US consumers who make up 4% of the world's population. Right. So are you operating in a free market environment here at all? And so then the question is just what do we want to do about that? We could go to a scenario where, you know, we spread the cost of R and D across a wider set of countries. Or we could say, hey, the cost, you know, if you want to have the national security and strategic value of a biotechnology industry with high quality scientist jobs and moving the frontier of technology, if you want that. And by the way, I think it's real valuable to have that. As I already said at the beginning, well then you better have a domestic therapeutics industry to support it.

Chris Garabedian: Yeah, I'm sorry, but why is it

Jason Kelly: you don't get the industry, but what we're doing right now is we are paying for all the R and D that is going to be creating a capability in China, even though the US voter and the US consumer is the one paying for everything. And that there is no Euro washing, that's like a nonsense term that just got made up. The US can obviously block whatever it wants. We can control our market. And we are in this case uniquely so, like unlike say cars or electronics or software where there's a large ex. US market, quite simply, we are the market for drugs. So the rules we set. I do not believe that you'll see some magical merger of like Europe and China because who will they sell to?

Chris Garabedian: Yeah, yeah, but Jason, I'm sorry, it seems sounds like your argument of the US being the beneficiary of the profits. Right. Which Peter's talked largely.

Jason Kelly: You're Ms. You're missing not the beneficiary of the profits or. Go ahead, finish your comment.

Chris Garabedian: No, but you just said 75% of the profit that's made is in the

Jason Kelly: U.S. i'm saying it is. No, no, the, the buying. Like who is buying the drugs? Like, like there's a certain amount of.

Chris Garabedian: I know, but how does China benefit from that when. When we're talking about multinationals who sell these drugs or even US Biotechs that are able to, even if they license the drug from China, if they commercialize that and are hugely successful. Yeah. China might have a small equity position that gets diluted over time, but I'm not clear on how that's benefiting China. If we license a drug from China, successfully commercialize it. Right. Pay the R and D, but become the beneficiary of the revenues and profits disproportionately. Right. To the rest of the world.

Jason Kelly: Yeah. And again, I'll focus back on what I said at the beginning. Yeah. The, the thing I consider to be national security relevant is who has the capability to do the frontier of biotechnology.

Chris Garabedian: But are you talking like new tools and new technologies that are emerging? Let's call it like as when CRISPR and base editing evolved.

Jason Kelly: Absolutely. That kind of stuff. Yeah. 100%. Okay. Those types of things, DNA synthesis, whatever it might be, there's new technologies all the time.

Chris Garabedian: And I just think that's a narrow view. And part of the controversy around here is the COINS act seems to be wanting to overreach and make it very overly restrictive because I would argue that drug discovery, like we know already that 99 plus percent of drugs that look good in a rodent model never make it to approval. Okay. So this is a industry that lives with failure. And 90% plus the latest data when Atlas did their annual review was 97% don't make it to FDA approval for products that are entering into the clinic. So this is not a game that's going to be easy. And I think the argument is that we need to figure out and access wherever those technologies might be coming from. I understand your idea about like biodefense and existential threats over that, but if we're talking about trying to just develop a technology for a unmet need disease, and that's why I brought up the human therapeutics, I don't see how having it overly restrictive of being able to license an antibody from a China company. Right. Is a problem. I'll be honest. I've spoken about this. I think the bigger risk is that Pharma bypasses US Biotech and goes straight to China to do the deals that GSK has done with Hangro and BMS has done and Pfizer's doing with an event like that is a bigger threat where they don't need US Biotech, they don't need the financing behind that. They'll just go direct.

Jason Kelly: That is exactly what I'm talking about. Yes.

Chris Garabedian: Yeah. Well, all right. But that's different than the biotech industry. Right. And the idea that, you know, biotech can thrive and actually, I mean, I would argue that Ginkgo, again, just reading your website, I don't know your business model like you know fully, but like autonomous labs, I mean you speak about

Jason Kelly: like jobs, that's the easiest.

Chris Garabedian: Yeah, yeah. But still, I mean if you're worried about us jobs, isn't Ginkgo contributing to eliminating jobs? Which I don't think is bad. I think we need to get more efficient.

Jason Kelly: No, no, we're not actually. Yeah, it's a good question. Yeah. So I'll speak to a couple of things. But, but let me.

Chris Garabedian: Okay, so autonomous labs is not going to eliminate jobs. Human jobs.

Jason Kelly: Yeah. So like for example, the, there's a great ad. I'll post it on Twitter after this. From 1952 IBM ad. And it's, it talks about the, the IBM mechanical calculator. And there's this great picture of this like refrigerator sized electronics device and it says, does the work of 150 extra engineers. And it shows 150 all men of course, holding slide rules. Okay. 150 of these engineers. And you might have imagined that the IBM electronic calculator would be bad for engineer jobs considering they'd be out of work moving the slide rules. Now of course that's the opposite of what happened.

Chris Garabedian: Yeah.

Jason Kelly: As we made the ROI on what was in the heads of those engineers more valuable because we made the work no longer manual.

Chris Garabedian: Yeah. I understand the debate that AI will create more jobs.

Jason Kelly: Jobs for engineers. And so I think the only way in the long run that we are able to. Because I do agree, like no one fights about that we should make us R and D more efficient. No one fights that we should make our clinical trials more efficient. Everyone's just getting upset when I talk about things we should do to slow down China. So this is a thing in the bucket of making us more efficient. And no, I think it would expand the number of jobs just like it

Chris Garabedian: did in the look generally. And I think that we can move to it. Yeah, yeah. No, no. And Jason, oh, I appreciate it because I think the reason we wanted to have you on was to allow you to articulate your view more precisely. Right. And there's Nicholas Tillmans was also representing more of that. The view you're describing online so people can check that out. His X threads and posts and read Peter Kolchinsky's to have a better nuance of this. I think at the end of the day, the argument as I see it is that when you start to put impose specific controls and incentives and disincentives, it does invite unintended consequences and oftentimes those are actually worse than the original intent. Yeah.

Jason Kelly: And again, I really think it's not appreciating how unique it is that we. And this is the thing I want to not lose here. The reason I'm bringing up the 70% of the profits is not about that the US companies make that money. It's that the US consumer pays that.

Chris Garabedian: Yep.

Jason Kelly: The US voter pays for the profits of the drug industry, period. And so if the US Voter wants to have this industry operate in a certain way because it's in our national security interest in the country or it's good for jobs for the US Voter or whatever it might be, boy can they decide that. And there isn't some weaselly way to get around that. When you are 70% of the market, you can set the rules.

Chris Garabedian: Yeah, I understand what you're saying about Medicaid, Medicare and the payment there. You've got a lot of private pay. You've got the investors are the ones putting the capital at risk to try to benefit. And look, we're all agreeing that we need Europe and other countries to pay their fair share and that we've been carrying the brunt of the profitability of this industry. Otherwise it's going to go away completely and I think it hurts the entire industry. But this has been helpful. Let me just invite our other co hosts if there's any other questions or comments for Jason, Greg or Brian or anything that I missed in terms of a commentary on this topic.

Brian Scorney: No, that was great. I'm just listening with fascination myself. Same.

Chris Garabedian: Great, great. Well, look, Jason, I think I appreciate

Jason Kelly: you giving me the time. Yeah, yeah, it was fun to chat.

Brian Scorney: Yeah.

Chris Garabedian: And I know we had to go and, and that's why we, we covered this topic first. Jason, appreciate your time. I know you've got to run at the half hour and we've got a lot more to cover here, so.

Jason Kelly: Thank you.

Chris Garabedian: Thanks.

Jason Kelly: And by the way, I appreciate you guys doing this. Like in general, the biotech hangout, like I, I'll put in a plug that. Yeah. More people should be listening. I listen to it frequently. So the, I just think we need more people talking about our industry on social media and things like that. So I'm glad you got it.

Chris Garabedian: All right, Jason, thanks so much for joining. Okay, so let's move again. Hopefully the audience enjoyed that because it has been kind of a raging back and forth on social media. But again, I mentioned the Pfizer deal. Again, this is just another continuation of China. I'll also mention that Wuxi announced a deal with Veridian, a biotech company, for a manufacturing deal. Wuxi also announced that they grew in 2025. Their numbers grew despite concerns about the Biosecure Act. So there's still a lot of biotechs that are outsourcing to China. That doesn't seem to be going away. And I think we'll have to see what ultimately happens with the COINS act and the final provisions or anything around that. But anyway, it's something. But anyway, Greg or Brian, do you want to cover just the Pfizer? Any further comments on that? Again follows the BMS deal with Hengro. These are bio dollar deals. So this was only 650 million up front, but I don't know, do you guys have any different perspectives on the whole licensing from China, whether it's pharma or biotech. Or not?

Brian Scorney: Sorry.

Chris Garabedian: All right, let's move to a Lilly deal. Again, Lilly has been bolstering the M and a numbers for 2026. Very active in this case. They bought three vaccine companies announced in one day for up to. And again these are Biodollar with milestones but up to 3.8 billion. And very specifically they bought Curvo for up to 1.5 billion for a shingles vaccine. They bought the vaccine company, it's called Vaccine Company for an Epstein Barr vaccine for another 1.55 billion. And they also bought Limatech for a Staph Aureus vaccine that is really used to prevent kind of hospital based infections associated with surgery for 780 million. Notably, Lilly hired Peter Marks who is the FDA official in charge of vaccine approvals. We talk a lot about migration from FDA to industry, but presumably he shared his expertise about vaccines and vaccine approvals. So it seems like Lilly's solidly in the vaccine business with these three acquisitions. Let's see. Brian, why don't we go to some of the antiviral stuff. I know you've covered Gilead for a long time. Do you want to cover the HPV data that came out that kind of had some of the best functional cure rates that we've seen and then bioheave and R and D day. Are you good to cover that?

Brian Scorney: Yeah, yeah, of course. Yeah. So Hepatitis B has been funny, funny disease area. I covered all the hep C companies and this Big change in standard of care. That pharmaceutical, first Vertex, then Pharmaceutical, then ultimately Gilead, wound up being the big winner alongside of AbbVie. And for years on the peak of that, people were looking to HPV as sort of like the next place to go from chronic or very low rates of cure to sort of a shorter oral therapy cure eventually. And that's sort of like always been the goal to get patients. Right now, patients with Hep B will be on antiviral therapy that just chronically suppresses them. And as long as they're on the therapy, you don't have the virus really inflaming the liver, causing liver damage. But ultimately, like in hep C, we want people to just be cured. You know, some short, easy to take regimen and the virus goes away. And it has been a long, long, slow development path. And you know, a number of companies have come and gone trying to do this. And Glaxo just the other day announced data from two phase three studies of, of their treatment, BEPI Roverson, which is actually one of Ionis's old drugs, I believe, and it's an injectable targeted agent. They show not fantastic functional cure rates, but functional cure rates. In these studies, they got about a 19% functional cure rate. And a functional cure is when you both have undetectable levels of DNA and surface antigen in the blood for at least six months after all therapy is stopped. Right. So this is actually a very, very treatment course. So patients will stop all treatment after 48 weeks if they meet a specific secondary endpoint. And of those patients, about 19% were able to maintain those markers without seeing relapse. Now this is arguably better than what we've seen. There is data in publications to kind of indicate that like pegylated interferon combination therapy with viriad can, can maybe drive 5, 10% functional cure rates after very, very long time. So I haven't heard people particularly enthusiastic about this, but I wonder if it brings back interest into the hep B realm once again, knowing and seeing that we can maybe push the functional cure rates up higher. And as we evolve scientifically, maybe we'll get to that point. But we were hoping for 10 years ago on the peak of Hep C to be replicated shortly thereafter with hefty. It's not the case, but science, you know, often moves a lot slower than we anticipate.

Chris Garabedian: Well, and I'm dating myself, but I remember like CCC DNA was the really hard, like, you know, hard to crack that code. And like, have they just figured out mechanistically how to generate that more sustained right. S antigen. Right. Like clearance and like, just. I don't know, because I know it was very, very hard. Much harder than in hcv. And so is that kind of what we're seeing? Obviously it creates the unmet need and then maybe just speak a little bit. The HDV approval that Gilead got, this was a subset. You have to have HBV in order to have the hdv, which is a more severe phenotype. Maybe you want to speak to that at all?

Brian Scorney: Yeah, sure. So, yeah, I mean, this isn't physically targeted to cccdna, but, you know, the presence of CCCDNA and sort of its latency within hepatocytes is, you know, thought to be one of the, you know, the primary reasons why you see relapse of hepatitis B. And you never quite get a cure. That it just kind of sitting around in those hepatocytes and not subject to viral inhibition or clearance. Viral clearance. So you get rid of the hbv, but eventually the CCC DNA can produce HBV virus and you wind up with a rebound. So this isn't targeted to CCC DNA directly. That's been a very, very hard nut to crack. This is targeted to inhibiting a number of the RNA components of the hepatitis B virus. It's an antisense oligonucleotide. And, you know, I think the mechanism of how exactly. Very, very long suppressive inhibition of parts of the virus, components of the virus ultimately leads to functional cure. People believe, you know, maybe there's an immunomodulatory approach. Maybe if you just keep it sustained, sustainably down long enough, the hepatocytes with CCCDNA ultimately turn over and the CCDNA is not there to source virus anymore. You know, whatever it is, you know, it seems like if you really throw the kitchen sink at this virus for a long time, you know, some patients will wind up with functional cures. But yeah, I think we have a long way to go and a lot more to understand about sort of the latency of the virus and how to really kind of turn that over. So hdv. So Gilead got accelerated approval of Hep. Plutox. And this is a. This is a product that they bought in an acquisition a number of years ago. They wound up getting approval in Europe and is approved in Europe. And Hep D is, I think, also a very, very interesting virus. It basically lives off of S antigen. So it's a prerequisite to have hepatitis B to effectively have infection with hep delta. And it is, these patients are very severe. It's Hep B. The virus is kind of slow. It can take a decade, even untreated to really lead to liver impairment. Liver failure. Patients with that co infection progress very rapidly. So there's definitely a significant need for Hep Delta treatments. This is the first treatment for chronic HDV infection. The data is. Okay. I think there's a number of companies that have been working on products to substantially improve upon this. I actually follow one of these companies in Mirim Pharmaceuticals where they're targeting S antigen specifically to basically prevent HDV from utilizing and binding to S antigen to ultimately C vial replication. This has been a long time coming in the approval. You know, it doesn't, Gilead doesn't break out Hep Kudex cells in Europe right now. So it's not a very big drug. I don't think there's high expectations that hepkludex is going to be a big driver for Gilead. But you know, I think it's a, it's a very severe disease and I think, you know, even though it's mostly in third world countries, you know, I think you see a lot of pricing power here.

Jason Kelly: Yeah.

Chris Garabedian: And continues to just, you know, create their, their strong foothold on the antiviral space and hepatitis. So Greg, are you, are you back with us? Can you, I want to make sure we test out your voice. Yeah.

Greg Suwanaway: Can you hear me?

Chris Garabedian: Yeah. You sound great. Great to hear.

Greg Suwanaway: I'm so sorry about that.

Chris Garabedian: No worries. Now you were going to touch on the Apogee Blackstone and then you've got a lot of cancer update to cover. We might have to go a little more rapid fire, but why don't you go ahead and start?

Greg Suwanaway: Yeah. So again, apologies to the audience for my technical issues, but yeah, Apogee reported some very positive top line phase two data earlier this week for its lead asset which is called Zamilo Kaibart, if I'm saying that correctly. It's a. And it's an antibody for atopic dermatitis. The data were positive, although there was some debate as to what they saw with the dose response where the high dose did not work as well as the middle dose. But in any case, they are moving forward that program into phase three. And what's really interesting here is that while most of us assume that the standard playbook for biotech is that you raise capital via post good data via a follow on equity based financing instead, concurrent with the data released, Apogee announced financing with the Folks at Blackstone Life Sciences and what looks to be a pretty creative deal structure. Deal structure. So there's up to 1.3 billion available in a non dilutive deal with 800 million available in what's being called a synthetic royalty financing and another 500 million available as a more traditional senior debt offering that can be, you know, elected to be used at a time in the future when the. When both parties agree. So very interesting structure. We've seen Blackstone, you know, become more active in this space. Certainly we've seen royalty pharma get involved, but I think most of us thought that, you know, on good data there'd be a big capital raise and all the, you know, the banks would be jockeying for seeing who could get on the deal, but instead, I guess no banks got paid and black Blackstone came in and provided the financing. So very creative structure there.

Chris Garabedian: Great. And just a new player. I guess if they got comfortable around another royalty buyout, maybe we'll see more coming out of Blackstone on that because they just did close a large fund again this year. So they've got a lot of fresh, fresh powder.

Greg Suwanaway: Yeah. And then with that, maybe I'll go into, you know, a bit of an ASCO preview. So part of my technical issues is I just landed in Chicago about two hours ago and hoofed it over to my hotel to be able to do this podcast. And so again, apologies for my technical issues, but let's talk about asco. So, as most of we all know, asco, the annual ASCO Cancer Conference, which takes place in Chicago, officially kicks off today. And ASCO is the largest cancer conference in the world. An estimated 35,000 to 45,000 people from all over the world attending. There are doctors, cancer care providers and cancer caregivers, researchers, and of course, pharma and biotech that are here to present their latest data here, the latest and greatest that's happening in the oncology space. And there's also a small army of folks from the investment community like myself, who will be attending as well. So with that said, I think as we think about ASCO this year from an investment community perspective, I think it's relatively light this year in terms of the major data sets that we think could really move stocks. But that being said, I still think there's still so much to be excited about at ASCO this year. I decided to make the trip, obviously, with some really great advances in the field and innovations that will be presented with so much going on over the next five days. It's really hard to capture all that will take place. But with that said, I think some of the key technologies and asset classes that have been really gaining traction and the attention of investors would be things like bispecific antibodies, antibody drug conjugates, cell therapies like CAR T which have had great success in the hemodial hematology oncology space, but you know, trying to make, you know, make their way into solid tumors. And then there's this class of drugs that's called the RAS inhibitors. And you know, we've probably spoken about the RAS inhibitors a lot over these past several podcasts, but the plenary sessions take place on Sunday and there are a couple of presentations that I think a lot of people will want to, you know, listen and hear. And speaking about the RAS inhibitors Revolution medicines which has a drug for pancreatic cancer called Diraxon Rasib, you know, they will be presenting the results of their Phase 3 Resolute 302 study and recall. Back in April the company announced second line data where patients who received Daracs on Rasib again in a second line setting they were able to achieve a median overall survival of 13.2 months and that compares with 6.7 months for standard chemotherapy. So you're talking about practically a doubling of the survival benefit, but that was just top lined. So on Sunday here at ASCO we'll get more details from that phase 3 Resolute 302 study. Importantly, we'll all be looking at the overall survival data on a patient by patient basis, progression free survival, duration of response, duration of treatment and notably safety tolerability at adverse events. I'm sure some of you on the podcast may have seen the New York Times video based interview with former Senator Ben Sasse who unfortunately has late stage pancreatic cancer. He very brave in coming out and to show everyone how he's living with this disease but he's being treated with Dirox on Rasib and doing relatively well. But that being said, rash that some of you may have seen, particularly on his face, is something that's undesirable. So with that said, we are going to try to get more of a view on the overall safety tolerability of Dirax on Rasib. They are going to be sharing data at some point later this year I think in a first line setting. But these RAS inhibitors are really exciting. There are several companies right behind Revolution Medicine that are working on other flavors of RAS inhibitors and some of these companies and it's not meant to be an exclusive list or an exhaustive list. But this includes a Rasca that at Mizuho we cover and also Veris Stem which is a company that I cover. These are earlier stage but clearly revolution medicines with their Pan RAS inhibitor set, an impressive efficacy bar. That said, we've also I think right after that we're going to have data from Summit Therapeutics, Summit in licensed PD1VEGF bispecific from a Chinese company. And so you know, very topical, you know, they are presenting study data from a Chinese study that's late stage. It's called the Harmony six study if I've got that correctly. But we'll be very interested in seeing how that data evolve. And I think a lot of excitement amongst investors has been about the potential of this PD1VEGF bispecific being perhaps a better keytruda like drug. And remember last year Keytruda generated some $32.5 billion in sales. So all eyes will be certainly on that plenary session. In my own coverage universe we've got three companies in particular that will have interesting data. One that I'll mention is called Corbis Pharmaceuticals. They're advancing a nectin 4 targeting antibody drug conjugate for several cancers. In particular treatment with their CRB701 drug was shown. And the company on Steam announced this data last week. I'll talk about that in a little bit. But that led to a 43% response rate in patients with a certain type of head and neck cancer called oropharyngeal cancer. And that compares with like teens response rates that you see with current standard of care. So that's one company we'll be paying close attention to. Another smaller cap company is called Immuneering. They have a novel MEK pathway inhibitor and with what we consider to be very tantalizing data in a first line pancreatic cancer setting, they just announced 17 months of median overall survival in patients and depending on which chemotherapy based standard of care, that is more than doubling of what patients usually see. And then lastly a company that I'll briefly mentioned, that company is called Ematics. Ematix has a presence in Germany, but they're Houston based and they are tackling prame which is an antigen that is expressed in over 50 cancers. And Maddox has a broad portfolio of therapeutics to hopefully attack prame which is highly expressed in melanoma. But I think Asco is going to be very important for this company because not only will they show the power of their platform, but they have both cell therapies and bispecifics that can go after pram. And I think the key here at this conference is to also show that they can go beyond melanoma. So those are some of the companies that we're paying close attention to. But there is so much happening at asco and hopefully that's just some, some high level snippets there.

Chris Garabedian: Well, it sounds like you got a busy week ahead with as many companies covered and I'm glad we got you back online, otherwise we might have had to end biotech hangout early this this week. I'll also just mention that there was a phase 3 data with mesicdomide in multiple myeloma. This is from BMS. This is extending their strong multiple myeloma franchise that they acquired from Celgene just briefly in a phase three trial. Adding mesegdomide helped keep cancer at bay for roughly 10 months longer than the standard treatment of carfilzomib and dexamethasone alone. The study was conducted in relapse or refractory multiple myeloma patients and in addition the treatment led to a higher response rate of 80.2% compared to 53.4% with the standard treatment alone. So again, kind of a follow on to Revlimid and Pomalyst for the BMS multiple myeloma franchise. Brian, let's go to you. I think you had a Biohaven R and D day you covered and then you can then speak to Dine as well.

Brian Scorney: Dan, that sounds great. Yeah, I mean just a. I want to comment on the mesotomide side of things to a covered Celgene back in the day actually have the protein structure in a little deal toy that they gave out probably a decade ago. So you know, I think it's notable they didn't have another imid in that they were comparing it to. So I just, I just wonder, right? I mean something like a lenolidomide or a pomalidomide. Plus carlflizomib and dex would really be sort of a second line standard of care. So I'd wonder how that would fare versus Mezidomide because Pomalist and Revlimid have obviously shown good results as well in the indication maybe moving on Biohaven. Yeah, there's like a hotly debated name. One of the most highly debated names that I cover on the street. It's a company with a very, very big pipeline. Sometimes that is a bit of their downfall because they do spend a lot of capital. So one of the things that you hear criticism from investors is the dilution but they have a number of things that they updated on I thought were all interesting people really focus on sort of their KV7 channel mod channel opener which is in phase three for focal onset seizure. They provided some interesting update from the open label extensions from their phase three studies. We're going to see the full phase three data later this year. Everyone's really looking to compare it to Azova Colner which is a program also KB7 that is from Xenon and they had really great phase three data earlier this year. So you know there's really kind of like this head to head competition to show who could put up the better data sets here. I would say, you know, we felt like it was a little bit of a positive incremental update just in terms of producing some data that people haven't seen before in terms of some of the reductions in seizure frequency. The obesity side of the story, they have a drop quote Tel Defraud Alpha which is a myostatin antibody. You know, kind of one of the big debates in the obesity space is because you lose so much weight, a lot of that weight on GLP1s is actually muscle mass. Myostatin targeted therapies have been shown to in the case of an Atlas venture company that got bought by Lilly, their drug Bimagramab they've shown you know, about 10% weight loss as all monotherapy. And what it really does in combinations with semaglutide versus data they presented last year is it changes sort of the body composition. So patients are losing weight but they're primarily losing just fat weight and they're maintaining or even increasing muscle mass. There's this big concern if everyone's going to lose 40% of their weight and it's all half muscle, half fat. Particularly for patients who wind up getting that weight back, they usually gain it all weight and, and there's concerns that are going to lead to significant problems as people will take much longer to rebuild muscle. Bioavan is going to have phase two data and you know, one of the nocturnal agramab had had a pretty hairy tolerability profile in that Lilly data and doesn't seem like it's moving forward. So they could kind of replicate the binagrimab data in combination with semaglutide. Ultimately I think that becomes a really important piece of the puzzle for treating obesity. But the thing that I care the most about at Biohaven is I think they have this molecular degrader and TRAP program that utilizes receptor on hepatocytes to really turn over extracellular proteins really quickly. They showed some very interesting Igan data. IgA nephropathy, which is a pathogenic antibody autoantibodies targeting the kidney leads to very significant morbidity and mortality. There's a lot of patients out there who will ultimately go on to progressive kidney failure as a result of Igan. This really targets the underlying, the exact underlying pathogen, which is Gdiga 1. They showed very good protein reduction data, very good hematuria resolution data. And I think, you know, there's a number of companies that are involved in this space targeting broad B cells and lowering sort of all immuno globulins. And we have a launch and I gain from Atsuka and Vertex and Vera are have submitted applications for more B cell targeted therapies. There's a number of B cell targeted therapies, but I think this is really like a very, very targeted specific therapy that doesn't really suppress the immune system. I think it's really interesting and they're planning to start a pivotal program in the next couple of weeks here. So I thought that was an interesting update maybe moving on to. Well, I'll mention the dying thing, but I think there's a broader. You know, I've gotten a lot of questions on fda.

Chris Garabedian: Oh right.

Brian Scorney: All the time really. And I think, you know, one of the Biohaven has a piece of this. Dime has a piece of this. But there's a number of things. But you know, with the turnover of sort of this most recent guard at FDA of Marty Macri, Vinay Prasad, Tracy Beth Hogue, sort of all of these people who are viewed by industry as you know, maybe kind of talking out of both sides of their mouths in terms of having like the flexibility that the GOP wants. But maybe this level of rigor that is more characteristic of Maha certainly in sort of pharmaceutical products. And you know, there's been a lot of like CRLs, you know, whether they're fair or not. We could debate those. But you know, there are a lot of places where you know, sort of Macri was saying, oh, we're going to be super flexible and like we're going to prove anything even on like theoretical mechanism. But the reality was that, you know, there were a number of CRLs and with him gone, the interim FDA commissioner is actually, he's been at the agency for a little bit. Kyle Diamanthus, he was actually under Scott Gottlieb I think previously. He's evidently good friends with Trump. We're hearing kind of nice ish things about him, I think Very reserved. I mean, I think it's that he faces. It was a really tough job. Right. There's a lot of conflict between GOP and Maha in sort of the, you know, what they want the FDA to do and he's going to have to work in that dynamic. But what we're really seeing is there's been a lot of turnaround in terms of these companies that were sort of pushed aside, you know, at least getting a second chance. So. Right. Just this morning we have Reflimunoff substantially on announcing an agreement to resubmit the BLA for their melanoma therapy. Earlier this week, Outlook announced that they are resubmitting their application for bevacizumab in ophthalmology. This is interesting because in their press release they're basically like the FDA agreed that we have demonstrated substantial evidence of effectiveness. It's going to be a Class 1 submission. Class 1 submission. So, you know, if all of that's true, you know, it's almost like the FDA is guaranteeing an approval if manufacturing is okay. You know, Dyn has announced that they submitted their bla. This is on time. This is not necessarily a surprise. But covering Dyne, there's a lot of debate and you know, Chris, you kind of know this. There's a lot of debate as to what the FDA is going to do with sort of next generation Exxon skippers because you sort of have precedent that was started with a Teplerson that if you show dystrophin expression with, with an Exon skipper, then that's an approvable drug. Dynes drug certainly does more, I think in every measure more production of dystrophin than any of sort of the naked PMOs have. So it has better data there. So just on precedent, you would think this would be a layup, but obviously it's been super controversial. You know, I'm sure like if was still there. I mean, you know, he's, he's kind of said some pretty mean things about your ex company.

Greg Suwanaway: Yeah.

Jason Kelly: So.

Chris Garabedian: And the Ritz profile would have gone up if he was still there for sure.

Brian Scorney: For sure. For approval.

Chris Garabedian: So yeah, Brian, that's a great overview. And look, the hard part is that I don't know that we really, if we were seeing the full potential fruits of the reforms of Makary and there was this kind of schizophrenic kind of perspective. But let's hope that this is a harbinger of more positive. Right. And predictability, most importantly of the fda. But that's great. Wrap so we're at the hour. Just want to say thanks to our co hosts, Brian and Greg. Thanks for Jason, who signed off earlier as a special guest, and thank you all for tuning into this episode of Biotech Hangout.