Moonlake Immunotherapeutics AG

MoonLake Immunotherapeutics gets financing worth up to $500M: The company will get $75 million upfront from Hercules Capital. MoonLake, which went public in 2022, had about $448 million in cash before the financing was announced. It will have access to additional tranches if it hits certain milestones. OSR Holdings makes a deal with White Lion GBM Innovation Fund: The South Korean company, which partners with biopharmas and other healthcare companies, is selling up to $80 million in common stock to the GBM Innovation Fund, which supports the development of glioblastoma drugs. OSR operates a Swiss biotech that’s developing a GBM vaccine called VXM01, which is being tested to see if it can add to the immune response in glioblastoma patients.

Incyte’s topline pivotal data for its oral therapy for a painful inflammatory skin condition appear somewhat disappointing, with efficacy falling short of analysts’ expectations and in comparison with marketed drugs like UCB’s Bimzelx. The company’s shares $INCY fell about 10% on Monday morning. Incyte said Monday that the STOP-HS1 and STOP-HS2 studies of povorcitinib met their primary endpoints in patients with moderate-to-severe hidradenitis suppurativa (HS). After three months of treatment, significantly more patients given the JAK1 inhibitor than those given placebo had a reduction of at least 50% in the number of abscesses and inflammatory nodules, with no increase in abscess or draining tunnel count. This measure is known as HiSCR50. But the improvements over placebo were not as extensive as some had hoped. With the lower dose of povorcitinib — 45 mg once daily — the HiSCR50 delta was 10.5 percentage points in STOP-HS1 and 13.7 points in STOP-HS2. The differences versus placebo seen with the higher dose — 75 mg per day — were almost identical. That’s an odd finding, since a higher dose would be expected to work better. “We’ll have to wait for longer-term follow-up to see if there’s a separation of the 45 and 75 [mg doses],” Incyte head of R&D Pablo Cagnoni said during an analyst call to discuss the data. He added that Incyte plans to provide more data on this point later this year. Incyte also said the drug’s efficacy was better in patients who had previously been treated with biologics. Here the deltas over placebo were larger, but the p-value for the difference between the 45 mg dose and placebo in the HS-1 trial was 0.096, missing the generally accepted threshold for significance. William Blair analysts pointed out that the data came in well below the Phase 2 results, which showed placebo-adjusted HiSCR50 response rates of 18 to 28 percentage points. They added that even on an absolute basis, the Phase 3 HiSCR50 response rates for povorcitinib were markedly lesser than those seen in Phase 2. Incyte intends to wait for further data from the trial before seeking approval for the pill, and it’s aiming for an NDA submission at the end of this year or early next year. The Phase 3 data might be good enough for approval, with Incyte saying on the call that it believes regulators will greenlight povorcitinib for both biologic-naïve and -experienced patients. But doctors might have little reason to prescribe the pill when several approved injected drugs still look more effective. For example, in the pivotal HS trials for Bimzelx, the HiSCR50 delta was 19 to 26 percentage points. This was after four weeks of treatment, which is slightly longer than Incyte’s STOP-HS1 and STOP-HS2 trials, but the effect size is much greater. Another competitor is not far behind. There are high expectations for the pivotal data on MoonLake Immunotherapeutics’ antibody sonelokimab in HS. Those data should be revealed in the third quarter of this year.

MIAMI — MoonLake Immunotherapeutics is expected to have one of the biotech industry’s biggest stock-moving clinical readouts around the middle of this year for a pair of Phase 3 trials in a painful inflammatory skin condition. The Swiss biotech’s CEO, Jorge Santos da Silva, spoke with Endpoints News on the sidelines of this week’s Leerink Partners healthcare conference in Miami to discuss the upcoming readout, plans for commercializing solo and squashing the Street’s “conspiracy theories.” Da Silva said there’s been “a lot of M&A noise” around the company, but he’s not planning for that, and he’s confident MoonLake can commercialize its anti-IL-17A/F nanobody on its own. The company was reported to have been exploring a sale in 2023. Known as sonelokimab, the candidate is being tested in Phase 3 for hidradenitis suppurativa, in which patients have abscesses, nodules and draining tunnels. “As a CEO, I would never plan for anything other than making the company grow over the years,” da Silva said. “I would never, and I will never and have never managed the company for anything like that. We’re building the commercial structure.” The company will report data from about 800 patients across two similar pivotal trials in HS this summer. It’s also being explored for other indications. It’s a ripe moment for the space. Novartis markets Cosentyx, UCB recently gained approval for Bimzelx in HS and other molecules are in development. After its looming efficacy data readout, MoonLake will have to wait until next year for longer-term safety data, and by that point, it should also have late-stage data from a trial in adolescents, da Silva said. It could launch the treatment in 2027 if approved, he added. TD Cowen analysts earlier this week projected more than $4 billion in peak sales for sonelokimab. “In the next two or three years, we could really start changing the narrative around this horrible disease,” da Silva said. MoonLake enrolled its two Phase 3 trials rapidly, at about “double the speed of what pharma typically does in this space,” the CEO said. The trials have identical protocols and geographies, but the clinical sites are different. He said he expects one of the trials to gather data in July and the other within a couple of weeks of that, but the company will report both at the same time. “MoonLake has always had a very big short position, and the short has always been very vocal for obvious reasons, and there is one of these conspiracy theories that we’re too aggressive and that we won’t deliver on the trial,” da Silva said. The company will have a capital markets update in the second quarter in which they’ll disclose the exact timing of the readouts and a “couple of other cool messages” that he declined to elaborate on. MoonLake will also open a US office early next year, but he declined to disclose which city. “I expect the capital markets update to quench one of these last conspiracy theories,” da Silva said, referring to the ability to replicate mid-stage results. If MoonLake’s results are positive, the company could tap additional funding. “Obviously tapping the equity markets on the readout I think that’s a no-brainer,” he said. The company’s shares $MLTX are down about 28% year-to-date. It carries a market capitalization of about $2.4 billion. MoonLake went public via a combination with Bihua Chen’s special purpose acquisition company a few years ago. Chen’s second SPAC announced late last month it will take BridgeBio Oncology Therapeutics onto the Nasdaq. “I don’t know if SPACs are still the bastard sons of biotech, but I think as we’ve shown — and a couple of others have shown, I agree not many —  I don’t think it matters if it’s a SPAC or not,” da Silva said. “It matters that you have a proper team that reports well so that after two or three quarters, people go, ‘OK, these guys are not doing something crazy here.’ And then the data, right? I really like BBOT. I think it could be interesting. And obviously, I’m a big fan of Bihua and her ability to choose good things.”