Last Updated on: 22nd November 2023, 12:47 pm
MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the second quarter of 2023.
MoonLake continues to make significant progress with the clinical development of sonelokimab, which is currently being investigated in two Phase 2 clinical trials: the first, “MIRA”, in moderate-to-severe hidradenitis suppurativa (HS) and the second, “ARGO”, in active psoriatic arthritis (PsA). Sonelokimab has already been successfully assessed in a randomized, placebo-controlled, Phase 2b trial in patients with moderate-to-severe plaque-type psoriasis, in which it demonstrated a rapid and durable skin clearance (Psoriasis Area Severity Index (PASI) 100 response). Sonelokimab is an investigational Nanobody® designed to inhibit IL-17F in addition to IL-17A and therefore could represent a major improvement in treating inflammation in these dermatological and rheumatological diseases. The Nanobody’s® smaller size versus traditional antibodies and its albumin-binding domain provide an opportunity for further efficacy. The MIRA and the ARGO trials both achieved their target patient enrollment and randomization faster than anticipated, reflecting the Company’s strong execution and interest from physicians and patients in MoonLake’s clinical development programs.
Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “This quarter has been transformational for MoonLake. The positive Phase 2 results from our MIRA trial were a landmark milestone. We look ahead with confidence to a number of key catalysts for sonelokimab this year, including the final 24-week data in HS, expected in mid-October, and the topline 12-week data in active PsA, expected in the first half of November, and to creating long-term value for both patients and shareholders.”
Second Quarter 2023 Business Highlights (including Post-Quarter End):
- On April 19, MoonLake held a Capital Markets Day, which featured a series of presentations from its executive team, who provided a look to the year ahead at near-term catalysts and a financial update. External speaker, Professor Kenneth B. Gordon, Chair of Dermatology at the Medical College of Wisconsin, provided an update on the treatment landscape for HS, reflecting on data and key takeaways from the American Academy of Dermatology Annual Meeting.
- On May 3, MoonLake announced a collaboration agreement with SHL Medical to develop an autoinjector for clinical and potential subsequent commercial supply of MoonLake’s Nanobody® sonelokimab.
- On June 25, MoonLake announced it achieved a landmark milestone with positive top-line 12-week data readout from its global Phase 2 MIRA trial evaluating the efficacy and safety of the Nanobody® sonelokimab in patients with moderate-to-severe HS. The trial met its primary endpoint with a significantly greater proportion of patients treated with both sonelokimab 120mg and 240mg achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 compared to those on placebo at week 12. The results suggest that, as early as week 12, the Nanobody® sonelokimab, relative to placebo, reaches the highest clinical activity among all other therapies tested in similarly stringent pivotal-like trials.
- On July 25 (post period-end), MoonLake announced that:
- it successfully completed randomization of the target 200 patients ahead of schedule in its global Phase 2 ARGO trial in active PsA; and
- a Capital Markets Day will be held on September 11, 2023 to discuss the PsA market and to share expectations on the ARGO 12-week data readout in PsA (results expected in the first half of November 2023) and the MIRA 24-week data readout in HS (results expected in mid-October 2023).
Second Quarter 2023 Financial Highlights:
- On June 30, 2023, MoonLake closed a public offering of 8,000,000 Class A Ordinary Shares at a public offering price of $50.00 per Share. MoonLake also granted the underwriters of this offering the option to purchase up to an additional 1,200,000 Class A Ordinary Shares at the public offering price less the underwriting discounts and commissions, and this option was exercised in full, bringing total gross proceeds of this offering to $460 million.
- In addition, during the three months ended June 30, 2023, MoonLake sold 544,894 Class A Ordinary Shares through an At-the-Market facility, yielding gross proceeds of $15.2 million.
- As of June 30, 2023, MoonLake held cash and cash equivalents and short-term marketable debt securities of $501.8 million, compared to $63.1 million as of March 31, 2023.
- Research and development expenses for the quarter ended June 30, 2023, were $8.7 million, compared to $7.4 million in the previous quarter. The increase was primarily driven by expenses for the conduct of the MIRA and ARGO studies.
- General and administrative expenses for the quarter ended June 30, 2023, were $4.5 million, compared to $5.5 million in the previous quarter. The decrease was primarily driven by lower expenses for professional services and share-based compensation.
Matthias Bodenstedt, Chief Financial Officer of MoonLake Immunotherapeutics, said: “The past quarter has seen MoonLake raise significant new funds, enabling us to fund the advancement of sonelokimab into multiple Phase 3 programs and putting us in a very strong position for the next phase of growth. We welcome our new shareholders who recognize the value of our Nanobody® and are as excited as we are by our continued advancement of sonelokimab’s clinical development to address some of the fastest growing markets in inflammatory diseases.”
Important upcoming anticipated events and next expected data readouts for MoonLake:
September:
- Capital Markets Day to discuss PsA market and provide guidance for upcoming 12-week ARGO PsA and 24-week MIRA HS readouts
October:
- MIRA trial top-line 12-week data to be presented at a scientific meeting
- R&D Day virtual webcast to share top-line 24-week MIRA HS trial data and Phase 3 plans in HS
November:
- R&D Day virtual webcast to share top-line 12-week ARGO PsA trial data
December:
- End of Phase 2 meeting with the FDA to discuss Phase 2 HS data and Phase 3 development plan
Early 2024:
- R&D Day to share the final Phase 3 plans and other clinical and business catalysts in 2024 and beyond
Calendar of upcoming investor conferences in the second half of 2023:
- Wedbush 2023 PacGrow Healthcare Conference: August 8-9
- Wells Fargo Healthcare Conference 2023: September 6-8
- Stifel 2023 Immunology & Inflammation Virtual Summit: September 19
- Cantor Fitzgerald Global Healthcare Conference 2023: September 26-28
- Guggenheim Securities 5th Annual Inflammation & Immunology Conference: November 6-7
- UBS Biopharma Conference 2023: November 8-9
