MoonLake Immunotherapeutics Reports Third Quarter 2022 Financial Results and Provides Recent Business Update
- Global trial of sonelokimab in Hidradenitis Suppurativa (HS) has continued to meet recruitment targets with an expected primary endpoint readout in mid-2023
- Global Psoriatic Arthritis (PsA) trial received FDA clearance and US central IRB approval
- Quarter-end position of
$83.5 million in cash, cash equivalents and short-term marketable debt securities, providing cash runway into 2H2024 and at least 12 months beyond expected key readouts
MoonLake continues to develop its novel IL-17A and IL-17F inhibiting Nanobody® sonelokimab (“SLK” or “sonelokimab”) in multiple inflammatory diseases in dermatology and rheumatology where the pathophysiology is known to be driven by IL-17F and IL-17A. Sonelokimab is an investigational Nanobody® designed to treat inflammatory disease by inhibiting the IL-17A/A, IL-17A/F and IL-17F/F dimers that drive inflammation. In addition, being one third the size of a traditional monoclonal antibody and containing a human albumin-binding domain, SLK is designed to penetrate difficult-to-reach inflamed tissues and directly target sites of inflammation.
In
MoonLake also remains on schedule with its global Phase 2 trial of sonelokimab in PsA (M1095-PSA-201) (“ARGO”). MoonLake previously announced FDA clearance for this trial, and has since received US central IRB approval. This global trial is designed to evaluate the efficacy and safety of different doses of SLK compared to placebo, with adalimumab as an active reference arm. The trial is expected to recruit approximately 200 patients with active PsA, and is the first known trial in PsA to use a Nanobody®.
Dr.
As of
Research and development expenses for the quarter ended
General and administrative expenses for the quarter ended
Other income and other comprehensive income for the quarter ended
Net loss for the quarter ended
About MoonLake Immunotherapeutics
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 the ability to design multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company.
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 has been assessed in a randomized, placebo-controlled Phase 2b trial in 313 patients with moderate-to-severe plaque-type psoriasis. Sonelokimab demonstrated a rapid and durable clinical response (Investigator’s Global Assessment Score 0 or 1, Psoriasis Area and Severity Index 90/100) 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). On
Sonelokimab is not yet approved for use in any indication.
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 SLK, administered subcutaneously, in the treatment of adult patients with active moderate to severe HS. The trial is expected to comprise of over 200 patients, and is designed to 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 HiSCR75, defined as a ≥75% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count relative to baseline. The trial is also designed to evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System, the proportion of patients achieving a Dermatology Life Quality Index total score of ≤5, and the proportion of patients achieving at least 30% reduction from baseline in Numerical Rating Scale in the Patient’s Global Assessment of
Further details are available on: https://www.clinicaltrials.gov/ct2/show/NCT05322473
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 SLK, 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
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.
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.
CONTACT
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Tel: +44 (0) 20 3709 5700
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MoonLake@consilium-comms.com
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in USD, except share data)
| Current assets | ||||
| Cash and cash equivalents | $ 41,204,667 | $ 8,038,845 | ||
| Short-term marketable debt securities | 42,254,788 | — | ||
| Other receivables | 600,536 | 148,774 | ||
| Prepaid expenses | 4,479,194 | 1,449,096 | ||
| Total current assets | 88,539,185 | 9,636,715 | ||
| Non-current assets | ||||
| Property and equipment, net | 52,679 | 45,739 | ||
| Total non-current assets | 52,679 | 45,739 | ||
| Total assets | $ 88,591,864 | $ 9,682,454 | ||
| Current liabilities | ||||
| Trade and other payables | $ 1,056,253 | $ 1,569,290 | ||
| Short-term loans | — | 15,000,000 | ||
| Accrued expenses and other current liabilities | 4,962,470 | 4,518,311 | ||
| Total current liabilities | 6,018,723 | 21,087,601 | ||
| Non-current liabilities | ||||
| Pension liability | 4,985 | 239,860 | ||
| Total non-current liabilities | 4,985 | 239,860 | ||
| Total liabilities | 6,023,708 | 21,327,461 | ||
| Commitments and contingencies (Note 15) | ||||
| Equity (deficit) | ||||
| Series A Preferred Shares, |
— | 72,466 | ||
| Common Shares, |
— | 38,537 | ||
| Treasury Shares, 1,942,837 as of |
— | (6,202) | ||
| Class A Ordinary Shares: |
3,693 | — | ||
| Class |
1,578 | — | ||
| Additional paid-in capital | 123,825,896 | 42,061,984 | ||
| Accumulated deficit | (68,788,276) | (53,643,615) | ||
| Accumulated other comprehensive income (loss) | 245,283 | (168,177) | ||
| Total shareholders’ equity (deficit) | 55,288,174 | (11,645,007) | ||
| Noncontrolling interests | 27,279,982 | — | ||
| Total equity (deficit) | 82,568,156 | (11,645,007) | ||
| Total liabilities and equity (deficit) | $ 88,591,864 | $ 9,682,454 |
MOONLAKE IMMUNOTHERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(Amounts in USD, except share and per share data)
| Three Months Ended |
Nine Months Ended |
|||||||
| 2022 | 2021 (As restated) | 2022 | 2021 (As restated) | |||||
| Operating expenses | ||||||||
| Research and development | (9,024,437) | (669,528) | (30,679,842) | (30,536,746) | ||||
| General and administrative | (5,746,064) | (5,597,688) | (17,685,152) | (8,762,925) | ||||
| Total operating expenses | (14,770,501) | (6,267,216) | (48,364,994) | (39,299,671) | ||||
| Operating loss | (14,770,501) | (6,267,216) | (48,364,994) | (39,299,671) | ||||
| Other income (expense), net | 37,593 | (20,840) | 352,227 | |||||
| Loss before income tax | (14,732,908) | (6,288,056) | (48,012,767) | (39,325,510) | ||||
| Income tax expense | (8,740) | – | (25,354) | – | ||||
| Net loss | (14,741,648) | (6,288,056) | (48,038,121) | (39,325,510) | ||||
| Of which: net loss attributable to controlling interests shareholders | (10,110,452) | (6,288,056) | (32,865,429) | (39,325,510) | ||||
| Of which: net loss attributable to noncontrolling interests shareholders | (4,631,196) | – | (15,172,692) | – | ||||
| Net unrealized gain on marketable securities and short term investments | 77,006 | – | 77,006 | – | ||||
| Foreign currency Translation | – | – | 567 | – | ||||
| Actuarial income (loss) on employee benefit plans | 89,586 | 1,000 | 456,883 | – | ||||
| Other comprehensive income (loss) | 166,592 | 1,000 | 534,456 | – | ||||
| Comprehensive loss | (14,575,056) | (6,287,056) | (47,503,665) | (39,325,510) | ||||
| Comprehensive loss attributable to controlling interests shareholders | (9,998,892) | (6,287,056) | (32,507,526) | (39,325,510) | ||||
| Comprehensive loss attributable to noncontrolling interests | (4,576,164) | – | (14,996,139) | – | ||||
| Weighted-average number of Class A Ordinary Shares, basic and diluted | 36,925,639 | – | 25,830,560 | – | ||||
| Basic and diluted net loss per share attributable to controlling interests shareholders | $ (0.27) | – | $ (1.27) | – | ||||
| Weighted-average number of Common Shares | – | 2,390,587 | – | 9,689,627 | ||||
| Basic and diluted net loss per Common Share | – | $ (2.63) | – | $ (4.06) | ||||
| 1 For additional details, refer to Note 3 – Basis of Presentation and Significant Accounting Policies - Restatement of Consolidated Financial Statements as of and for the Three and Nine-months Ended 2 As a result of the Business Combination, the Company has retroactively restated the weighted average number of shares outstanding prior to |
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Source: MoonLake Immunotherapeutics AG
