MoonLake Immunotherapeutics Q1 FY2023 earnings call

• VELA-1 met all primary and secondary endpoints with a 17% delta for HiSCR75 at week 16. VELA-2 had a higher-than-expected placebo arm but the company believes the trial has merit to proceed. • Key endpoints include lesion counts and patient-reported outcomes like pain and quality of life. • Safety profile is favorable with no new safety signals. • Subcutaneous dosing is convenient with a 1 mL, 120-mg injection for induction and monthly maintenance. • Used composite and treatment policy strategies required by regulators to test robustness of primary endpoint significance.

No traditional product segment performance reported as the focus is on the VELA program for sonelokimab in hidradenitis suppurativa (HS).

• Will seek advice from regulators and continue the VELA trial process. • Plan to present valid data at the end of October in Nashville. • Confident in the drug's profile despite one trial issue, with strong data in other indications also. • Expect to engage with regulators in short order to confirm the registration path.

• Higher-than-expected placebo arm in VELA-2 which required deeper investigation with regulators. • Need to resolve the significance of the primary endpoint at week 16 in VELA-2 through discussion with regulators.

Q: What is the reason for the higher-than-expected placebo arm in VELA-2?

A: Short answer, no clarity yet. The HS community has observed such phenomena before, and no specific reason has been identified yet. We are continuing to investigate and discuss with regulatory authorities.

Q: How confident are you in the path to approval for VELA studies?

A: Confident due to the concordance of data, quality of the study, and statements from external experts like Professor Kimball who noted the drug's high efficacy range. There are precedents like Secukinumab which was approved despite not meeting significance in one Phase III HS trial. We are preparing to engage with regulators soon.

Q: How does the company view competing against existing therapies?

A: Professor Kimball stated sonelokimab operates in the high efficacy range with strong performance on pain, quality of life, safety, and convenience. We believe the data is strong enough for competition, and we will continue to showcase the drug's advantages in lesion scores, pain, quality of life, safety, and convenience.

Q: What is the company's capital position and plan regarding the Hercules debt facility?

A: Not planning to draw the next tranche from the Hercules facility. The company has $425 million in cash as reported in the 10-Q and operates efficiently with low cash burn. We are prudent with capital allocation but not in a dire situation.