@SolomouYiannis @Sanctuary_Bio Thankfully, I was right about $MLTX.
A suggestion: No more Dirk $MLTX dunking. Let's all be better. Move on.
A coda on $MLTX MoonLake can’t spin away this disastrous autoimmune drug failure This was one of the biotech’s most contentious bull-bear fights. The bears won. https://t.co/GQoxr26oQu
Here's another $MLTX piece from June 2025 MoonLake Immunotherapeutics is for sale? This sounds like a cry for help MoonLake management must be worried about the outcome of its upcoming and much-hyped Phase 3 studies. Or, maybe one of the biotech’s shareholders wants to lighten their position ahead of the data. Either way, Monday’s story in the Financial Times reporting Merck made a $3 billion offer to acquire MoonLake — the bid was rejected but talks could be revived, sources told the paper — screams to me bad news is on the way. Prediction: The MoonLake studies in a debilitating autoimmune skin condition called hidradenitis suppurativa, or HS, are going to fail. The study readouts are coming in September. The Swiss biotech is testing its drug, an IL-17A/F antibody called sonelokimab, against a placebo in the 16-week trials. Response to treatment, defined as a 75% reduction in abscesses and inflamed skin nodules that characterize HS, or HiSCR75, are the studies’ primary efficacy goals. Sonelokimab will beat placebo. That’s a ridiculously low bar. The real measure of sonelokimab’s efficacy — and the only result that matters — will come from comparing the MoonLake drug against Bimzelx, an anti-IL-17A/F drug from UCB that’s already approved for the treatment of HS. This is where sonelokimab will falter. That’s what I’m hearing from two of my best biotech investor sources, both with excellent track records on the short side. They’re both short MoonLake. It also helps explain, to me, why MoonLake or an interested party close to the company floated a takeout rumor this week. I asked MoonLake for a comment, but the company did not respond. In studies conducted by UCB, Bimzelx showed 33% and 36% response rates, per the HiSCR75 criteria, compared to 15% and 20% responses for placebo, respectively. MoonLake will need to beat those scores significantly for sonelokimab to matter. The company claims a 20 percentage-point improvement over placebo is the threshold for sonelokimab to be best in class — better than Bimzelx. Not really. In one of its studies, Bimzelx beat placebo by 20 percentage points. What seems to be happening is MoonLake is trying to lower the bar, which is a concerning pivot because company executives have spent the past two-plus years touting the superiority of sonelokimab despite the fact that it and Bimzelx both target the same IL-17A/F cytokines. MoonLake claims its “nanobodies” technology is the difference maker. Except, it isn’t. In the company’s Phase 2 study in HS, a high dose of sonelokimab performed worse than a lower dose, and the high dose underperformed Humira, which at that time was the only other biologic treatment (and a less effective one) approved for HS. In a separate Phase 2 study in psoriatic arthritis, the two doses of sonelokimab beat placebo on a key measure of skin clearance but the margins were less than expected. The drug failed to outperform Humira, again. The Phase 2 studies were conducted in 2023. MoonLake worked hard to spin the results. It buried the failures against Humira and brushed off questions about why a lower dose of its drug was more effective than a higher dose in the HS study. I wrote about both studies at the time, you can read those articles here and here. All of those worries have now been flushed down the memory hole. When MoonLake talks about the Phase 2 study in HS today, all it wants investors to remember is that 43% of patients on sonelokimab achieved the HiSCR75 response versus 15% of placebo patients — a 28 percentage-point improvement. The caveats and asterisks that make that result suspect have been erased. Except, I remember. We’re now roughly three months from the readout of the sonelokimab studies in HS. This is a fraught time for MoonLake. The study is completed, and soon, the data will be analyzed. The company might have access to blinded and blended efficacy data. Would a pharma company buy MoonLake so soon before the arrival of pivotal Phase 3 data, particularly a risky drug like sonelokimab? Very unlikely. I recall one such deal and it ended really badly. In 2008, the Danish drugmaker Lundbeck spent $100 million to acquire European rights to an Alzheimer’s treatment from Myriad Genetics. The drug failed its Phase 3 study one month later. A more recent example: AbbVie spent $9 billion to acquire Cerevel Therapeutics only to watch the lead schizophrenia drug blow up in a Phase 3 study. In the aftermath, pharma executives are taking a more risk-averse approach. But from what we read, Merck is willing to spend $3 billion to buy MoonLake now? Please … Someone is nervous.
I wrote again on $MLTX in Nov. 2023 https://t.co/ilDcTePkQY MoonLake’s credibility takes another hit with mid-stage study spin job MoonLake Immunotherapeutics, a Swiss biotech, was buried Monday under an avalanche of its own data spin. It’s been awhile since I encountered a management team that speaks so arrogantly about the supposed supremacy of its own drug, but then fails to back up the talk with real data. MoonLake claimed its experimental antibody called sonelokimab delivered “landmark” results in a mid-stage study of psoriatic arthritis. Landmark? That’s a strange way of describing the results of a clinical trial that showed sonelokimab topping a placebo — an easy hurdle — but failing to separate from an active treatment comparator, the generic drug adalimumab (known better as Humira). Two different doses of sonelokimab given over 12 weeks induced skin-clearance response rates of 46% and 47%, respectively, in patients with psoriatic arthritis, compared to 20% for a placebo. The result was statistically significant, achieving the main goal of the study, but the mid-20% difference was far lower than hoped. On a conference call Monday, MoonLake executives said the placebo in its study was more effective than anticipated, while continuing to insist its drug is best in class. But real data — not the dozens of spin-heavy slides presented by the company — reveal a more sobering reality. Bimzelx, an antibody treatment that is made by UCB that was recently approved for psoriatic arthritis, showed a 35% skin clearance rate (placebo adjusted) in its own Phase 2 study. Acelyrin, a smaller biotech developing an experimental antibody similar to sonelokimab, showed a placebo-adjusted skin-clearance response rate of 39% in a mid-stage study. Back to adalimumab, for a moment. MoonLake made a big deal about the rigor of its mid-stage study including an active treatment comparator — the only way to truly assess the efficacy of sonelokimab, it argued. And then MoonLake buried the actual skin-response data comparing sonelokimab to adalimumab in the footnotes of its slides. On one measure, 43% of psoriatic arthritis patients showed a response to adalimumab — barely indistinguishable from the 46% and 47% response rates for MoonLake’s drug. When it came time for the Q&A portion of Monday’s call, MoonLake executives asked and answered their own pre-screened questions. This was right before MoonLake CEO Jorge Santos da Silva dropped hints about pursuing “strategic opportunities” with potential partners, or … ahem … acquirers. Monday’s data and management performance were very much like what MoonLake pulled off last June with sonelokimab data in another autoimmune disease called hidradenitis suppurativa. The difference this time: Investors can see through the boasts.
On $MLTX ... foreseeing today's Ph3 failure. My stories are published behind STAT's paywall, but for those who are not subscribers, I've written critically / skeptically about sonelokimab going back two years. Here is what I wrote in June 2023: https://t.co/hYwsI5xRMO For two days starting on Sunday, Moonlake Immunotherapeutics happily crunched numbers and shared results from a mid-stage clinical trial that depicted its experimental antibody in the most flattering terms possible. The drug, called sonelokimab, was “changing the game” for the treatment of a debilitating skin condition called hidradenitis suppurativa, or HS, said Moonlake CEO Jorge Santos da Silva, on a call for investors and analysts. The drug’s benefit for patients placed it “at the top of the heap,” he added. For other, equally important data from the same study that did not fit Moonlake’s home-run narrative, the company took a DIY approach. Curious about how sonelokimab performed against a treatment that’s already approved for HS? Pull out a calculator and do the math yourself. How badly did a higher dose of the drug underperform a lower dose? Take a guess. No rule requires biotech companies to be fully transparent with study results, and investors expect management teams to shade discussions of data in ways that accentuate the positives. But Moonlake did a lot more than just brush aside potentially troubling findings. The company worked hard to keep that information from surfacing. Why? Perhaps to help raise money. Moonlake’s strategy worked. On Monday, the stock rose 78% to $46. On Tuesday, shares rose another 13% to $52. The company floated a $250 million stock offering, which was upsized to $400 million and priced at $50, the company said Wednesday. Is sonelokimab a blockbuster drug in the making and a “best in class” treatment for hidradenitis suppurativa? It’s entirely possible, as the market reaction suggests. The data not shared freely by Moonlake also raise meaningful doubts. In its Phase 2 study, 43% of patients treated with a 120 mg dose of sonelokimab showed a 75% reduction in abscesses and inflamed skin nodules that characterize HS. The corresponding response rate in the placebo group was 15%. The result achieved the study’s primary goal, but was also not much of a surprise. But Moonlake also tested a higher, 240 mg dose of sonelokimab that also beat placebo, but performed worse than the lower dose. Moonlake didn’t disclose the exact response rate, making investors guess based on a line on a chart. The lack of a dose response is typically a warning sign, particularly for antibodies where blocking more of the inflammatory target — in this case a cytokine called IL-17 — should result in greater symptomatic improvement. Moonlake said the 120 mg dose was an “optimum level” of sonelokimab, so don’t worry about the higher dose proving less effective. The same study also randomized a group of participants to receive Humira (or adalimumab), which is currently the only approved antibody treatment for HS. Moonlake predicted with confidence that sonelokimab would demonstrate superiority over Humira. Investors expected it. But when Moonlake announced the study results in a press release on Sunday, the sonelokimab versus Humira comparison wasn’t disclosed. On Monday’s conference call, management only addressed the issue in the most opaque terms. I got the same treatment when I reached out to a company spokesperson for answers to questions about the study. Sonelokimab beat Humira, the company insisted, but refused to offer specifics. Charts and tables from the study compared the sonelokimab and placebo response rates, but the comparable — and highly relevant — Humira response rates weren’t included. Some relatively easy calculations explained Moonlake’s behavior: Approximately 36% of participants treated with Humira showed a 75% improvement in their HS symptoms. When that DIY result is overlaid on the data Moonlake chose to disclose, Humira actually beat the higher 240 mg dose of sonelokimab. The lower dose of sonelokimab performed better than Humira, but by a margin smaller than Moonlake expected. Moonlake has a Humira problem. It has sold investors on the idea sonelokimab is the best treatment for HS. Its own data don’t fully support the claim. The company plans to start Phase 3 studies next year, but comparing sonelokimab against Humira (to show superiority) now looks like a riskier endeavor than it anticipated. Soon, Humira likely won’t be the only treatment for HS. Bimzelx and Cosentyx are currently approved antibody treatments for other autoimmune diseases, marketed by UCB and Novartis, respectively. Both drugs are likely to secure expanded labels covering HS relatively soon, based on successful Phase 3 studies. Bimzelx and Cosentyx both work by blocking the inflammatory IL-17 cytokine, just like sonelokimab. That makes it harder for Moonlake to include a placebo arm in its Phase 3 studies because people with HS might balk at the prospect of receiving dummy injections when other anti-IL-17 treatments are approved and available. Phase 2 studies, even when randomized, tend to produce the best results. Sonelokimab will probably never look better than it did this week. I tip my cap in respect to Moonlake — a little cynically — for stage managing a data presentation that resulted in a $400 million windfall. The company now has the money it needs to pay for the Phase 3 studies. If drug development history is a guide, the gloss applied to sonelokimab will wear off.
Poor study results. $MLTX bears win this one.
Damn, step away for a few minutes and miss a Sunday PR from $MLTX https://t.co/aAASu0Dy4g
@DickMedChem Yes. This is what I wrote about $MLTX in my June 5 newsletter: MoonLake management must be worried about the outcome of its upcoming and much-hyped Phase 3 studies. Or, maybe one of the biotech’s shareholders wants to lighten their position ahead of the data. Either way, Monday’s story in the Financial Times reporting Merck made a $3 billion offer to acquire MoonLake — the bid was rejected but talks could be revived, sources told the paper — screams to me bad news is on the way. Prediction: The MoonLake studies in a debilitating autoimmune skin condition called hidradenitis suppurativa, or HS, are going to fail. The study readouts are coming in September. The Swiss biotech is testing its drug, an IL-17A/F antibody called sonelokimab, against a placebo in the 16-week trials. Response to treatment, defined as a 75% reduction in abscesses and inflamed skin nodules that characterize HS, or HiSCR75, are the studies’ primary efficacy goals. Sonelokimab will beat placebo. That’s a ridiculously low bar. The real measure of sonelokimab’s efficacy — and the only result that matters — will come from comparing the MoonLake drug against Bimzelx, an anti-IL-17A/F drug from UCB that’s already approved for the treatment of HS. This is where sonelokimab will falter. That’s what I’m hearing from two of my best biotech investor sources, both with excellent track records on the short side. They’re both short MoonLake. It also helps explain, to me, why MoonLake or an interested party close to the company floated a takeout rumor this week. I asked MoonLake for a comment, but the company did not respond. In studies conducted by UCB, Bimzelx showed 33% and 36% response rates, per the HiSCR75 criteria, compared to 15% and 20% responses for placebo, respectively. MoonLake will need to beat those scores significantly for sonelokimab to matter. The company claims a 20 percentage-point improvement over placebo is the threshold for sonelokimab to be best in class — better than Bimzelx. Not really. In one of its studies, Bimzelx beat placebo by 20 percentage points. What seems to be happening is MoonLake is trying to lower the bar, which is a concerning pivot because company executives have spent the past two-plus years touting the superiority of sonelokimab despite the fact that it and Bimzelx both target the same IL-17A/F cytokines. MoonLake claims its “nanobodies” technology is the difference maker. Except, it isn’t. In the company’s Phase 2 study in HS, a high dose of sonelokimab performed worse than a lower dose, and the high dose underperformed Humira, which at that time was the only other biologic treatment (and a less effective one) approved for HS. In a separate Phase 2 study in psoriatic arthritis, the two doses of sonelokimab beat placebo on a key measure of skin clearance but the margins were less than expected. The drug failed to outperform Humira, again. The Phase 2 studies were conducted in 2023. MoonLake worked hard to spin the results. It buried the failures against Humira and brushed off questions about why a lower dose of its drug was more effective than a higher dose in the HS study. I wrote about both studies at the time, you can read those articles here and here. All of those worries have now been flushed down the memory hole. When MoonLake talks about the Phase 2 study in HS today, all it wants investors to remember is that 43% of patients on sonelokimab achieved the HiSCR75 response versus 15% of placebo patients — a 28 percentage-point improvement. The caveats and asterisks that make that result suspect have been erased. Except, I remember. We’re now roughly three months from the readout of the sonelokimab studies in HS. This is a fraught time for MoonLake. The study is completed, and soon, the data will be analyzed. The company might have access to blinded and blended efficacy data. Would a pharma company buy MoonLake so soon before the arrival of pivotal Phase 3 data, particularly a risky drug like sonelokimab? Very unlikely. I recall one such deal and it ended really badly. In 2008, the Danish drugmaker Lundbeck spent $100 million to acquire European rights to an Alzheimer’s treatment from Myriad Genetics. The drug failed its Phase 3 study one month later. A more recent example: AbbVie spent $9 billion to acquire Cerevel Therapeutics only to watch the lead schizophrenia drug blow up in a Phase 3 study. In the aftermath, pharma executives are taking a more risk-averse approach. But from what we read, Merck is willing to spend $3 billion to buy MoonLake now? Please.… Someone is nervous.
$MLTX From my Aug. 28 newsletter How to analyze the results of MoonLake's looming VELA study readout MoonLake Immunotherapeutics has guided to a September readout for the sonelokimab Phase 3 VELA studies in hidradenitis suppurativa, an autoimmune skin condition. When the results arrive, pay close attention to the method used to analyze sonelokimab’s efficacy before making the comparison to UCB’s Bimzelx. The company claims a 20 percentage-point improvement over placebo is the threshold for sonelokimab to be best in class — and better than Bimzelx. How MoonLake accounts for the use of antibiotics during the treatment phase of its hidradenitis suppurativa (HS) studies when calculating that improvement matters. The most conservative way of analyzing the data is to mark participants as nonresponders if their physician prescribes an antibiotic for any reason during the 16-week treatment period of the study. This “all antibiotic” method was used by UCB for the analysis of its twin Phase 3 studies, which resulted in Bimzelx showing 33% and 36% skin response rates compared to 15% and 20% skin responses for placebo, respectively. That’s an average, placebo-adjusted difference of 17%. Response is defined as a 75% or greater reduction in skin abcesses and inflammatory nodules associated with the HS. MoonLake is using a less stringent (but still acceptable) analysis method for its Phase 3 studies in which a participant is counted as a nonresponder if the treating physician prescribes an antibiotic specifically for symptoms related to HS, or if the participant is on an antibiotic for more than one week. The “HS antibiotic” method should result in a numerically greater placebo-adjusted response rate compared to the “all antibiotic” method. When UCB applied the “HS antibiotic” method to its Phase 3 studies, Bimzelx showed a 40% response rate in both studies compared to 18% and 16% for placebo, respectively. That’s an average, placebo-adjusted difference of 23%. This is an in-the-weeds detail but it’s important given how much weight investors are placing on comparing sonelokimab to Bimzelx — and the impact that will have on MoonLake’s stock price when the Phase 3 results are reported.
$MLTX survey: Your prediction for "HS antibiotic" HiSCR75?
Happy Friday evening. $MLTX and $QURE readouts still pending as we roll towards the end of September.
Second newsletter item: How to analyze the results of MoonLake’s $MLTX looming HS study readout It's all about how you account for antibiotic use. https://t.co/ri1ANO9feN
