MoonLake Immunotherapeutics Reports First Quarter 2024 Financial Results and Provides a Business Update
- Announced positive feedback from both FDA and EMA on the regulatory path for the Phase 3 program of the Nanobody® sonelokimab in hidradenitis suppurativa (HS) and outlined the development plan with topline results anticipated in mid-2025
- Reported significant improvements observed across all key outcomes with sonelokimab over 24 weeks in the ARGO Phase 2 trial in active psoriatic arthritis (PsA) including unprecedented multi-domain responses across joints, skin and other domains, supporting potential best-in-class profile of sonelokimab
- Announced the imminent commencement of four additional clinical trials of sonelokimab across dermatology, and rheumatology, including innovative trials in palmo-plantar pustulosis (PPP), juvenile HS and seronegative spondyloarthritis
- Ended the first quarter with
$547.1 million in cash, cash equivalents and short-term marketable debt securities, expected to support a roadmap rich in potential catalysts and a cash runway to the end of 2026
Dr.
Q1 highlights (including post-period end)
- Provided an update on the development of sonelokimab in HS including details on Phase 3 trial design and timelines for this program, named VELA, which is set to enroll 800 patients, and which follows positive feedback from both FDA and EMA
- Presented MIRA trial data of sonelokimab in HS as a late breaker at the
American Academy of Dermatology (AAD) Annual Meeting 2024, including unprecedented primary endpoint Hidradenitis Suppurativa Clinical Response (HiSCR)75 treatment effects at week 12 (~43% HISCR75) and week 24 (~57% HiSCR75) and International Hidradenitis Suppurativa Severity Score System (IHS4)100 responses (~1/4 of patients reaching this level of inflammatory remission) - Hosted an R&D Day alongside the AAD Annual Meeting, featuring presentations from eminent key opinion leaders in dermatology and rheumatology
- Announced significant improvements with sonelokimab over 24 weeks in the ARGO Phase 2 trial of sonelokimab in active PsA including unprecedented multi-domain responses, such as up to 52% of patients achieving ACR50 + Psoriasis Area and Severity Index (PASI)100 and up to 61% of patients achieving Minimal Disease Activity (MDA)
- Announced the planned commencement of four additional clinical trials of sonelokimab across dermatology and rheumatology, including innovative trials in palmo-plantar pustulosis, juvenile HS and seronegative spondyloarthritis
- Signed a three-year technology partnership with
Komodo Health to advance research on inflammatory skin and joint conditions and presented initial data from this partnership, indicating that at least two million Americans have been diagnosed with HS as of 2023, highlighting a significant unmet need and impact on healthcare systems and a potential market opportunity exceeding$10bn by 2035
First quarter 2024 financial results
As of
Research and development expenses for the quarter ended
Important upcoming anticipated events for MoonLake:
- Q2-2024: Initiation of the Phase 3 VELA program in HS
- Q2-2024: End-of-Phase 2 meetings with the FDA and EMA for PsA
- 2H-2024: Initiation of the Phase 3 program in PsA
- 2H-2024: Initiation of additional studies as announced for dermatology and rheumatology indications
Upcoming banking conferences
Jefferies Healthcare Conference ,June 5 – 6,New York , US- Goldman Sachs 45th Annual Global Healthcare Conference,
June 10 – 12,Miami , US - Stifel European Healthcare Summit, 25 – 27 June,
Lyon, France
-Ends-
About
About Sonelokimab
Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHH domains covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.
Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PSA), and the Company is pursuing other indications in dermatology and rheumatology.
For HS, sonelokimab is being assessed in two Phase 3 trials, VELA I and VELA II following the successful outcome of MoonLake’s end-of-Phase 2 interactions with the FDA and as well as positive feedback from its interactions with the EMA announced in
For PsA, Phase 3 initiation is anticipated in Q4 2024 following the announcement in
A Phase 2 trial is expected to be initiated in palmo-plantar pustulosis (PPP), a debilitating disease affecting a significant number of patients. In addition, a Phase 3 trial is expected to initiate in juvenile HS, a disease that typically begins at this early stage of a patient’s life, and also the period in which irreversible damage and inflammatory remission is most critical.
Sonelokimab will also be assessed for seronegative spondyloarthritis with a Phase 2 trial in radiographic and non-radiographic axial spondyloarthritis (axSpA) expected to start in 2024. The trials will feature an innovative design complementing traditional clinical outcomes with modern imaging techniques.
Sonelokimab has also been assessed in a randomized, placebo-controlled Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al.
In an earlier Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203).
About Nanobodies®
Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations.
The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company.
About the VELA program
The VELA program is expected to enroll 800 patients across two similarly designed Phase 3 trials (VELA I and VELA II) with the aim to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint of the program is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trial will also evaluate a number of secondary endpoints, including the proportion of patients achieving Hidradenitis Suppurative Clinical Response (HiSCR50), the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total score of ≤5, and the proportion of patients achieving at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in the Patient’s Global Assessment of
About the MIRA trial
The MIRA trial (M1095-HS-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate to severe hidradenitis suppurativa. The trial will comprise over 200 patients, and will evaluate two different doses of sonelokimab, with placebo control and adalimumab as an active control reference arm. The primary endpoint of the trial is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trial will also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total score of ≤5, and the proportion of patients achieving at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in the Patient’s Global Assessment of
About the ARGO trial
The ARGO trial (M1095-PSA-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the sonelokimab, administered subcutaneously, in the treatment of adult patients with active PsA. The trial is expected to comprise of approximately 200 patients, and is designed to evaluate different doses of sonelokimab, with placebo control and adalimumab as an active reference arm. The primary endpoint of the trial is the percentage of participants achieving ≥50% improvement in signs and symptoms of disease from baseline, compared to placebo, as measured by the
About Hidradenitis Suppurativa
Hidradenitis suppurativa is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects 0.05–4.1% of the global population, with three times more females affected than males. Real-world data indicates that at least 2 million Americans have been diagnosed with HS as of 2023, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity exceeding
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic and progressive inflammatory arthritis associated with psoriasis primarily affecting the peripheral joints. The clinical features of PsA are diverse, involving pain, swelling, and stiffness of the joints, which can result in restricted mobility and fatigue. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. The symptom burden of PsA can have a substantial negative impact on patient quality of life. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology.
Cautionary Statement Regarding Forward Looking Statements
This press release contains certain “forward-looking statements” within the meaning of the
Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history, difficulty enrolling patients in clinical trials, state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates and reliance on third parties to conduct and support its preclinical studies and clinical trials and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended
Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based.
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CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in USD, except share data)
December 31.2023 | ||||
Current assets | ||||
Cash and cash equivalents | $ 458,441,051 | $ 451,169,337 | ||
Short-term marketable debt securities | 88,613,700 | 59,838,900 | ||
Other receivables | 1,495,876 | 1,056,862 | ||
Prepaid expenses - current | 5,039,343 | 2,102,203 | ||
Total current assets | 553,589,970 | 514,167,302 | ||
Non-current assets | ||||
Operating lease right-of-use assets | 3,698,514 | 3,628,480 | ||
Property and equipment, net | 509,816 | 320,865 | ||
Prepaid expenses - non-current | 6,318,838 | 8,423,468 | ||
Total non-current assets | 10,527,168 | 12,372,813 | ||
Total assets | $ 564,117,138 | $ 526,540,115 | ||
Current liabilities | ||||
Trade and other payables | $ 3,482,790 | $ 1,837,684 | ||
Short-term portion of operating lease liabilities | 1,304,426 | 1,197,876 | ||
Accrued expenses and other current liabilities | 4,123,304 | 6,930,120 | ||
Total current liabilities | 8,910,520 | 9,965,680 | ||
Non-current liabilities | ||||
Long-term portion of operating lease liabilities | 2,357,495 | 2,499,990 | ||
Pension liability | 462,735 | 583,426 | ||
Total non-current liabilities | 2,820,230 | 3,083,416 | ||
Total liabilities | 11,730,750 | 13,049,096 | ||
Commitments and contingencies (Note 15) | ||||
Equity | ||||
Class A Ordinary Shares: | 6,287 | 6,047 | ||
Class | 100 | 251 | ||
Additional paid-in capital | 670,185,376 | 609,969,236 | ||
Accumulated deficit | (130,331,128) | (116,657,472) | ||
Accumulated other comprehensive income | 2,693,096 | 2,357,621 | ||
Total shareholders’ equity | 542,553,731 | 495,675,683 | ||
Noncontrolling interests | 9,832,657 | 17,815,336 | ||
Total equity | 552,386,388 | 513,491,019 | ||
Total liabilities and equity | $ 564,117,138 | $ 526,540,115 | ||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(Amounts in USD, except share and per share data)
For the Three Months Period Ended | ||||
2024 | 2023 | |||
Operating expenses | ||||
Research and development | $ (13,014,049) | $ (8,097,794) | ||
General and administrative | (6,806,440) | (6,931,096) | ||
Total operating expenses | (19,820,489) | (15,028,890) | ||
Operating loss | (19,820,489) | (15,028,890) | ||
Other income, net | 5,915,220 | 7,185,810 | ||
Loss before income tax | (13,905,269) | (7,843,080) | ||
Income tax expense | (70,252) | (44,309) | ||
Net loss | $ (13,975,521) | $ (7,887,389) | ||
Of which: net loss attributable to controlling interests shareholders | (13,673,656) | (7,437,074) | ||
Of which: net loss attributable to noncontrolling interests shareholders | (301,865) | (450,315) | ||
Net unrealized gain on marketable securities and short term investments | 182,273 | (716,437) | ||
Actuarial gain (loss) on employee benefit plans | 81,230 | (317,256) | ||
Other comprehensive income (loss) | 263,503 | (1,033,693) | ||
Comprehensive loss | $ (13,712,018) | $ (8,921,082) | ||
Comprehensive loss attributable to controlling interests shareholders | (13,415,707) | (8,415,796) | ||
Comprehensive loss attributable to noncontrolling interests | (296,311) | (505,286) | ||
Weighted-average number of Class A Ordinary Shares, basic and diluted | 62,637,212 | 59,914,592 | ||
Basic and diluted net loss per share attributable to controlling interests shareholders | $ (0.22) | $ (0.12) |
Source:
2024 GlobeNewswire, Inc., source