Latest / BioSpace / Novo’s turnaround plan, weight loss wins, Ultragenyx’s Sanfilippo approval, IPO blitz
Transcript
- Jef: Hello and welcome to Biospaces the Weekly. I'm your host, Jeff Axt. Novo has grabbed several headlines this week as they hosted their Capital Markets Day in London on Monday. The Danish pharma plans to hit $23 billion in revenue by twenty thirty five, but investors were left unconvinced, and Novo's stock dipped eight percent by the close of markets on Monday. The company also said that day that it was boosting manufacturing capacity for its Wogovi pill, aiming to serve ten times as many patients by twenty thirty as they do now. And they also announced additional employee cuts that could bring the total workforce down to thirteen thousand fewer staffers than Novo had just last year. So a lot to unpack there. We'll we'll have those updates for you and more from Novo. they also announced a couple of deals this week. Meanwhile, looking to compete with Novo in the weight loss space, we have new results from Viking Therapeutics and Roche, which each announced positive results for investigational assets. Vikings readout in particular was highly anticipated and exceeded analysts' expectations, shooting their stock up by 30%. Finally, the San Filipo patient community got some good news late last week as the FDA approved Ultragenics' gene therapy, now to be called FIUVI. And the IPO train keeps on chugging as four more biotechs announce plans to debut on the public markets. Let's get started. Phew! Hi guys, you're all surviving this busy, busy news morning? Heather: Yeah, it is much later than usual when we're recording this, just so you all know out there. Jef: Yes, man, Tuesday just hit like a ton of bricks. There was a lot of good news coming out today. We stayed on top of it as Heather: Mm-hmm. Jef: best we could, filled our daily new news email gene pool, and and barely surviving, I feel like. Annalee Armstrong: And just so much clinical news, like so many different clinical trials read out today. It was crazy. Jef: Yeah, with some pretty nuanced findings too that took us a little bit to unpack. Heather: I was gonna say those were very complex, especially Viking was was quite complex. It was a maintenance study and that took a few minutes to to wrap my mind around. Jef: Yes, absolutely. gabby: Which we were talking yesterday. I wonder if it's because maybe the Jewish holiday yesterday, if people were holding some of their news, waiting for today and that Heather: Hm. gabby: it all just came today. we were ready. Jef: Yeah. I also like Heather: Yeah. Either yeah. Jef: Heather's theory, which like we're getting to the end of the third quarter and maybe some of these results were promised in the third quarter and they're down to the Heather: Mm. Hm. Jef: wire. Nothing like gabby: Yeah. Jef: a good deadline to get you moving. Annalee Armstrong: We journalists love a deadline, but maybe not all on the same deadline. Heather: So we can pretty much Jef: Right. Heather: Yeah, like Wednesday, Thursday, Friday. You split him up a little bit. Not not much on Friday though, okay guys? Just not much on Friday. Yeah. Yeah. Yeah. Annalee Armstrong: Yeah. No Friday news. We don't like that. Jef: Yeah. gabby: No Friday. Well we can't speak for Wednesday Thursday this week. Still could be crazy. Yeah. Jef: Yeah, there's eight more days in the quarter, so all right. Well, obviously we have a lot to cover, so let's dive in. Gabby, you wanna kick us off with intros this week? gabby: Yeah, sure. I'm Gabrielle Mason, senior editor with Biospace, and I put together our weekly manufacturing news brief, which goes out every Tuesday. And then I also curate our daily gene pool newsletter. Jef: Awesome, thank you. And Heather? Heather: I am Heather Mackenzie, senior editor at Biospace, and I put together your Clinica Space email, which is going to be very busy next week, and that'll hit your inbox on Monday. Jef: I was about to say Clinica Space is definitely gonna be a full one with all all the clinical news coming out this week. All right, and last but not least, Annalie. Annalee Armstrong: I am Annalie Armstrong and I do our biofarm executive newsletter, which is also busy because of everything Novo did. So don't sleep on that one either. Jef: Yes, Novo. Okay, we're gonna start with Novo. before I forget one last time, I am Jeff Axe, managing editor. But that was a perfect segue, Annalie. Thank you. We are going to start with Novo, which snagged no fewer than five headlines from us in the past week. So I guess in some ways that's not too surprising, given that as I mentioned, the farmer was hosting its Capital Markets Day in London on Monday. So Annalie, you tuned into that event. What can you tell us? Annalee Armstrong: Yes, so investors were were really looking forward to this capital markets day and they were hoping to hear about a renewed strategy from Novo. If you remember last week we talked about this on the podcast, Novo rolled out a rebrand. They dropped the Nordisk from their name and presented a more streamlined unified company. So analysts thought the rebrand was just fine. However, they all kind of said This is great, but we really need to see a major change in direction come from CEO Maziar Mike Dewstar. And on Monday, they got to hear more about his plans. He unveiled his path to hitting $23 billion in revenue in 2035 with five multi-blockbusters expected to be on the market by 2030. So these include the upcoming weight loss meds Kagrintide and Kagrasema. Kagrasema combines Kagrintide. with Novo's already massive weight loss juggernaut semiglutide. So just for comparison, Novo had about two twenty billion dollars in revenue last year. Jef: So not too much of a stretch to hit that twenty three, but investors weren't impressed. Annalee Armstrong: No, they were really underwhelmed, unfortunately. Analysts said that everything that Deostar laid out was pretty much like in line with what investors and analysts expected. so that unfortunately set this the stock down 8% by close on Monday. Jef: That's a lot. Annalee Armstrong: Yeah, it was it was a tough day for Novo. they tried to really present a unified front with Doostar saying, you know, I we have conviction, but we'd like to bring you on side. And it doesn't seem like they were able to do that. So there were obviously a ton of updates. This wasn't an all day event. so one of those was that you know, last year Novo conducted a major workforce restructuring. and at that time, they said that about 9,000 people were leaving the company. Dewstar disclosed that an additional 4,000 people have now left. Those were not necessarily layoffs. We got some clarification from Novo. Those reductions came through things like attrition, not backfilling positions, some retirements, that kind of stuff. but that brings the total number of people that have left Novo since last year to about 13,000 people, full time equivalent. So that's a that's a major Jef: Yeah. Big reduction. Annalee Armstrong: reduction. Jef: Yeah. Annalee Armstrong: So and then finally, another big thing that we covered from the Capital Markets Day is that Dewstar and his his team outlined a plan to boost their manufacturing capacity tenfold for the Wagovi pill to bring on a ton of new patients. Now, just quickly, Wagovi is, you know, by all accounts doing very, very well. and Deustar kind of underscored that it is probably the most successful pharma launch that has ever happened. Jef: Yeah, it really like took off with a bang when it launched in January. Doestar said they have about one point five million patients on oral wagove currently. And he assured investors that they can support the continued growing demand for the the weight loss pill. There has been concern though, because this is a high dose peptide. So for oral wagovy, it can contain an order of magnitude more semaglutide than the injectable. So they just need a lot of this peptide, and peptides are not the easiest to manufacture, especially as compared with Eli Lila Lee's small molecule, Foundo. So Analysts had speculated that Lily might have the manufacturing edge here. So I think that's why Deustar was really emphasizing we got this. You don't need to worry about it. We are going to be able to serve ten times as many patients for with oral agobi in in short order. So Annalee Armstrong: He he literally said, You don't have to worry about this anymore. Like that is a quote. Jef: Right. Exactly. So those are the highlights from Novo's Capital Markets Day. But like I said, the company also grabbed a few additional headlines with a couple of deals. In one, Novo is looking to expand its weight loss pipeline. They picked up three early stage obesity molecules from Calliope. this included a a potentially first in class therapeutic peptide, but also two small molecule candidates. We were just talking about that peptide small molecule distinction. So that was interesting. And then Novo has also struck a partnership with a fellow Danish company called Orbis Medicines. That's a multi drug deal worth up to one point four billion, and that's focused on oral cardiometabolic drugs. So a lot going on for the Danish giant right now. We will keep an eye on all these initiatives and of course report on how they pan out. but that's your Novo update for today. Okay, so moving on to our weight loss segment for today. It's been a while since we had that dedicated weekly weight loss segment segment. Obviously, the space is still very hot, and this week is definitely warranted that we discuss again. So we had a couple interesting readouts. today, Tuesday, as we're recording. So yesterday, as you're listening to this, it made for one of the busiest news mornings in recent memory. You could hear it in our voices as we started the show Heather: Hm. Jef: today. but very interesting readouts. So let's start with Viking Therapeutics. They have Been a very closely watched contender chasing frontrunners Novo and Eli Lilly. In June, actually, we reported a story on the space, and William Blair analyst Andy Sai named Vikings dual GLP one Jip Agonist as one to watch. so this week's readout came from a maintenance study of that asset, which is called VK two seven three five, that one I can pronounce. and by all analysts by all analyst accounts, Viking really hit this one out of the ballpark. So, Heather, give us the breakdown. Heather: Yeah, maybe they should rename that into something we can't pronounce just to be like everyone else. Jef: Right. Heather: but yeah, Viking couldn't have gotten much better news in this phase one exploratory maintenance study. so Truis said the results landed in their best case scenario. William Blair actually said the Viking achieved a quote maintenance trifecta. so great news. just for a bit further detail. So this is the injectable version of VK2735. They also have an oral version. But it led to 17.7% weight loss after 21 weeks. And the efficacy held up under less frequent dosing regimens. So they they tested it in both monthly and biweekly. Those were a couple of cohorts. So that really, you know, to to analysts indicated its potential in a maintenance setting. And the safety profile, importantly, was also strong. rates of GI related adverse events were comparable to placebo, Viking said during the twelve week maintenance dosing period. Jef: Yeah, maintenance has been a big point of conversation in this space, right? Obviously, there's a lot of these drugs, including the big hitters on the market, that are really helping patients lose weight. But it's a big question of how will they be able to maintain that body weight after they start to wean from these drugs. So that's really what Viking was going for here. And obviously good news for Viking, because they did take that hit for tolerability with the pill version of this drug. Heather: Yeah, they did. In a phase true trial last summer, Viking reported that twenty percent of patients treated with the the oral version of VK two seven three five dropped out of the study due to side effects. and that was compared to just thirteen percent of those in the placebo group. at the time the company's stock crashed around forty percent. Jef: I wonder if that's similar to a Govian needing just a higher dose for the oral version and maybe Heather: Mm. Jef: that higher dose is causing the greater side effects. I haven't taken a deep dive into that, but would make sense to me. Heather: Yeah, I had that same thought and you know, just good to see them succeed in in this area. good to see another another up and comer with with possibly a more tolerable profile, which is which is really important, especially in the maintenance setting. Jef: Absolutely. So then that same day, we also got an update on one of the assets that Roche picked up in its two point seven billion dollar acquisition of Karma Therapeutics in twenty twenty three. Annalie, what can you tell us about this one? Annalee Armstrong: Yeah, so some good news for Roche here. They presented some data for nasepatide, which is an injectable GLP1 GLP dual receptor agonist. So the drug helped reduce blood glucose and body weight in patients who have type 2 diabetes. This was at the 48-week mark in a phase two trial. So this is one of many key catalysts that analysts have been watching for from Roche's metabolic portfolio. They also have a lot of work underway with Zeeland Pharma. They are combining medicines from the Karma acquisition with Zeeland. So lots to come this year still from Roche. Jef: Yeah, so obviously a lot going on in this space. And, you know, it will be interesting to see who will be the first to market to challenge the Novo Lily Duopoly. but we will Keep you updated as more and more results come out. In the meantime, we've also covered the many things that GLPs can do outside of weight loss. And Lily, of course, one of the front owners in the weight loss and diabetes space, has been pursuing these other areas as well. So one of those areas is psychiatric conditions. And late last week, Lily presented some data supporting the use of a GLP1 GIP dual agonist, same type of drug we were just talking about. This is one of Lily's next gen assets. It's called renopatine. And they presented these data in alcohol use disorder and depression. So that was pretty interesting. Heather, break it down for us. Heather: Yeah, so the the data they presented was from a phase one study. and it showed what Rob Nicholson, he's the associate VP of US and Global Neuroscience Medical Affairs for Psychiatry and Substance Use Disorders. What a title. but he told me that it was a quote, distinct profile compared to other incretins. And it seems like it may be. So the the GI adverse effects were. comparable between brnipetide and placebo. he also emphasized the drug's half-life, which was between nine and twelve days, which he said could have contributed to the positive tolerability and and make it a good potential treatment for for alcohol use disorder and depression. Jef: Yeah, definitely good to see those are two areas with high unmet needs. So I mean, is there anything GLP ones can't do? Hopefully they can help here too. Heather: Well we'll we'll see in I guess a couple of years, might be a little less than a couple of years from from brinipotite at least. It's so yeah, it's in two phase three studies for for those two indications, and both are expected to top line in early twenty eight. Jef: Man, that is less than two years away. That's crazy. All right. Well, pivoting now, we have some good news in the rare disease space. I love when we can talk about happy things for a very, very hard patient population or a patient population that struggles with a very, very hard disease. So late last week, UltraZenex got FDA approval for its gene therapy for San Filipo syndrome. This is a rare fatal genetic brain disease. Often called childhood Alzheimer's, it just causes severe neurodegeneration in children and like I said is is universally fatal. So obviously really good news for this patient community to have a treatment now on the market and also good news for ultragenetics. Heather: Yeah, it's definitely good news for for this patient population. This is one of the diseases I think I've read about the most. I I know Shauna Williams, who writes a lot for us, did a did a feature on it a couple of years ago. but yeah, Ultra Genics itself has had a very up and down quarter. they they won approvals for two products, including their first gene therapy. But sandwiched in between those was a painful failure in Angelman syndrome, which is a another brutal genetic disease. this this San Filippo one, you know, I spoke with CEO Emil Cakis yesterday, and he said this one is really special to him. he's been to tons of meetings where he's had an opportunity to meet kids with San Filippo and their families. he told me about one young patient who was treated when she was five. And normally by the time these kids are teenagers, they're bedridden. but she's still running around. he said. So that's a real, a real win. you know, Jef: Absolutely, yeah. Heather: yeah. You know, unfortunately he said that after a certain point there is too much damage done by the disease to affect a lot of improvement. most of these children don't live past the age of 15. Jef: Yeah, like with so many things, the earlier you can catch it, the better. And, you know, you need a treatment when you do catch it. So really good news to to see that treatment is now available if it can be caught early, hopefully save some lives or prolong some lives. it's also, you know, this was only a month after Ultragenyx got its very first gene therapy approval. And that was for glycogen glycogen excuse me, glycogen storage disease type one A. So another rare disease, and they got a gene therapy approved for that one. Heather: Yeah, a lot of ultragenics is even disease targets are hard to say. But but yeah, so so that was another big win for them. It's another very difficult to manage condition. but it's not all good news for ultragenics. so earlier this month, I think we we probably spoke about it on this show, they announced that another asset, Apa Zunerson, failed to improve. Cognition in a phase three trial in Angelman syndrome. So the success of this program was a key driver of Ultragenics' value, according to William Blair at the time. Ultragenics said that it would assess its assess its planned operations to define and implement significant expense reductions. Jef: Yeah, that's not great news. Did this does the San Felipo approval kind of dial down that urgency at all? Heather: Yeah, so I asked him all about that. And he indicated that the company has to be strict and disciplined in terms of expenses to allow for profitability next year. he said that this is always he said that, you know, the these two approvals will will certainly help in in terms of that profit profitability. but but he indicated that it was still gonna be a bit of a a rough road, as it kind of always is in in rare disease. Jef: Yeah, that's the thing is you know, these are really important therapeutics to bring to market and high unmet need, but not the biggest market potential. Heather: Yeah. Yeah. Jef: Right, well, turning now to the performance of the public markets, which we've had a lot of fun watching this year because they're actually doing okay. so we have talked several times about how that IPO window has just flung wide open. there's already been this major turnaround as com especially as compared to last year's slump. And we have now seen the highest number of IPOs since the pandemic-driven high of twenty twenty-one, but they just keep coming. Gabby, you covered a couple of these. Let us know what's going on. gabby: Yeah, so last week actually we saw Electrotherapeutics debut on the market. and that marked the 26th biotech to go public this year, which is quite a feat, especially compared to the frozen over conditions we saw previously last year. so since then, four other biotechs have filed to go public. one of those is Nvidia backed Iambic Therapeutics. they're an AI platform-based company and they're developing cancer treatment. And this week Iambic also announced a partnership with Big Pharma Abvi to discover and develop small molecule drugs in neurology, oncology, and immunology. And then one of the other biotechs that filed to go public is Adrex Pharmaceuticals. They're a California company, and they're hoping to raise around $318 million at around $16 per share. So that's a pretty sizable IPO. and that money will go towards fueling the biotech's pipeline of SIRNA candidates. I'm excited to see, you know, when they actually hit the market, if they kind of fit into that upsize financing trend that we've been seeing so far for a lot of other biotechs this year. Jef: Yeah, I was gonna say that is a big number, but we've seen it this year before and even more than that. We've s be seen some real big raises. gabby: Yeah, somehow not the biggest number at all that we've seen this year. Jef: Right. Awesome. Well, like I said, we love to see happy public markets. So we will continue to watch those closely. if you haven't caught it yet, Gabby has a great IPO performance tracker out there for all these newly launched companies or newly public companies, I should say, and specifically how they're doing. And a lot of them are are up some way up. Veridermic's still up, however many hundredths of percent we talked about them a while back. So again, really, really good news to see how these companies are performing. All right, and as we always like to end our show, Annalie, give us a little sneak peek as to what we can see in Biofarm Executive this week. Annalee Armstrong: Well, I'm super excited about this one. Gabby and I have been working on our annual Women in Biopharma series. the past couple years we have chosen kind of a theme and written a series of stories about women and their leadership in this industry. so this time around, we are taking a focus at women who are first-time CEOs. So our first feature will be going out today, Wednesday, as you listen to this. And we talked to Recode Therapeutics. They just underwent a CEO transition. You're gonna hear from both sides of that transition with outgoing CEO Shinez Suleiman and incoming CEO Heather Clark telling their stories. So definitely do not miss that one. Jef: I love that. A real good story, a little peek behind the curtain to understand how those leadership transitions can happen sometimes. All right. Well, if you're not already subscribed, definitely hit subscribe in the top right corner for BioPharma Executives so you get that email. You will also want to subscribe to Clinica Space, as we said at the top of the show, because there's going to be so much good clinical news in it this week that'll come out on Monday. And as always, please subscribe to this podcast on all your favorite podcast channels. Thanks for just listening. We'll see you next week.