MoonLake Immunotherapeutics Reports Full Year 2023 Financial Results, Recent Business Highlights and Announces an R&D Day on March 10
MoonLake Immunotherapeutics reports positive financial results for 2023, highlights successful Phase 2 trials for sonelokimab, and plans R&D Day. Cash reserves of $511.0 million, R&D Day scheduled for March 10 alongside AAD meeting.
Positive
Successful Phase 2 trials for sonelokimab in HS and PsA
Phase 3 preparation for sonelokimab in HS nearing completion
Year-end cash reserves of $511.0 million to support future catalysts
R&D Day planned for March 10 to share 24-week data and future plans
MoonLake Immunotherapeutics' report of a solid financial position with $511.0 million in cash, cash equivalents and short-term marketable debt securities reflects a robust balance sheet, providing the company with a substantial runway until the end of 2026. This financial stability is critical for sustaining the company's R&D efforts in developing sonelokimab for hidradenitis suppurativa (HS) and psoriatic arthritis (PsA). The report of positive Phase 2 trial results positions MoonLake favorably in the market for anti-inflammatory treatments, potentially enhancing investor confidence.
The company's strategic at-the-market offerings have raised $85 million with minimal dilution, indicating strong market interest and a prudent capital management approach. The decrease in R&D expenses from $42.0 million to $31.8 million year-over-year, despite advancing clinical trials, suggests effective cost control measures are in place. However, investors should monitor future R&D expenses as the company transitions into Phase 3 trials, which could lead to increased spending. Additionally, the increase in non-operating income, primarily from interest income on investments, contributes positively to the financial health of the company.
The positive data from two Phase 2 trials of sonelokimab in HS and PsA indicate a potential best-in-class profile for the treatment. The primary endpoint achieved in the HS trial, HiSCR75, is a significant measure of efficacy, implying a 75% reduction in inflammatory lesion count, which highlights the drug's potential impact on patients' quality of life. The upcoming Phase 3 trials, with designs informed by regulatory feedback, suggest a clear path to potential approval. The analysis of the HS market size and the anticipation of 24-week data from the ARGO PsA study at the R&D Day will provide further insights into the drug's commercial potential.
Stakeholders should note that the inflammatory disease market is highly competitive, with several established biologics targeting IL-17A and IL-17F pathways. The differentiation of sonelokimab in this space will be key to its success. The long-term impact on MoonLake's valuation will depend on the outcomes of the Phase 3 trials and the ability to capture market share from competitors.
The announcement of R&D Day in conjunction with the AAD annual meeting is a strategic move to garner attention from key stakeholders in dermatology and rheumatology. The presence of leading clinicians at the event underscores MoonLake's commitment to engaging with the medical community and may influence the drug's adoption if approved. The market opportunities for HS and PsA are significant, given the unmet needs in these areas and MoonLake's positioning of sonelokimab as a potential leader in these indications could drive investor interest.
However, investors should consider the inherent risks associated with clinical-stage biotech companies, including regulatory hurdles and market penetration challenges. MoonLake's future performance will hinge on successful trial outcomes, regulatory approvals and effective commercialization strategies. The company's participation in upcoming banking conferences could further shape market perceptions and investor sentiment.
02/29/2024 - 08:00 AM
MoonLake Immunotherapeutics Reports Full Year 2023 Financial Results, Recent Business Highlights and Announces an R&D Day on March 10
A successful year including the announcements of positive data from two Phase 2 trials of sonelokimab in hidradenitis suppurativa (HS), at 12 and 24 weeks, and active psoriatic arthritis (PsA), at 12 weeks, supporting a potential best-in-class profile across two key indications Phase 3 preparation for sonelokimab in HS nearing completion, following positive feedback from both FDA and EMA Year-end cash, cash equivalents and short-term marketable debt securities of $ 511.0 million, expected to support a roadmap rich in potential catalysts whilst providing a cash runway to the end of 2026 R&D Day to be held on Sunday March 10 – alongside the American Academy of Dermatology (AAD) annual meeting – expected to include 24 week data from the ARGO PsA study and PsA program next steps, final plans for the HS Phase 3 VELA program, analysis of the size of the HS market, as well as catalyst updates including new pipeline indications ZUG, Switzerland, February 29, 2024 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (“MoonLake”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the fourth quarter and year ended December 31, 2023, and provided recent business highlights.
Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “2023 was another momentous year for MoonLake in the inflammation and immunology field. We reported positive results from two global Phase 2 trials of our Nanobody ® sonelokimab in hidradenitis suppurativa (HS) and active psoriatic arthritis. We were highly selective in our choice of endpoints for these trials in a deliberate plan to raise the bar for patients suffering from these diseases characterized by profound patient burden and significant unmet medical need. Following highly encouraging interactions with both the FDA and EMA regarding our data and forthcoming Phase 3 trial designs for HS, we are completing plans to initiate our Phase 3 trials for both indications. On top of this, support from world-renowned experts, clinicians, and patient organizations for our data, science and methodologies continues to mount. We look forward to sharing more information with everyone at our upcoming R&D Day on 10 March.”
Q4 highlights (including post-quarter end)
Announced landmark top-line 12-week data from the global Phase 2 ARGO clinical trial of sonelokimab in patients with PsA in November, supporting a potential best-in-class profile Announced positive full 24-week data from the global Phase 2 MIRA clinical trial in October, achieving the primary endpoint, HiSCR75, with sonelokimab in patients with HS, in support of a highly promising and differentiated therapeutic solution Announced positive feedback from both FDA and EMA on the regulatory path for the Phase 3 VELA program of sonelokimab in HS, with the Phase 3 trial having a similar design to the validated Phase 2 trial and being in line with MoonLake’s prior communications and expectations Fourth quarter and year-end financial results
As of December 31, 2023, MoonLake held cash, cash equivalents and short-term marketable debt securities of $511.0 million , compared to $496.0 million as of September 30, 2023. The increase of $15.0 million was primarily attributable to the gross proceeds of at-the-market offerings, partially offset by cash used in the Company’s operations.
Matthias Bodenstedt, Chief Financial Officer at MoonLake Immunotherapeutics, said: “MoonLake has added considerable shareholder value over the past year, and we are driven to continue building on this. In December of last year, and in early 2024, we pursued at-the-market offerings, bringing in gross proceeds of $85 million at minimal dilution. The new funds allow us to double down on the clinical development of sonelokimab across multiple indications, whilst securing an additional expected cash runway to the end of 2026. We are looking forward to sharing updates on our roadmap rich in potential catalysts, together with the highly anticipated 24 week data from our ARGO study in active psoriatic arthritis, at our upcoming R&D Day.”
Research and development expenses for the fourth quarter ended December 31, 2023 were $8.1 million , compared to $7.6 million in the previous quarter. Research and development expenses for the year ended December 31, 2023 were $31.8 million , compared to $42.0 million in the previous year. The decrease was primarily driven by a decrease in milestone expense incurred under the in-licensing agreement of sonelokimab.
General and administrative expenses for the fourth quarter ended December 31, 2023 were $6.9 million , compared to $5.4 million in the previous quarter. General and administrative expenses for the year ended December 31, 2023 were $22.3 million which was similar to the $23.0 million incurred in the prior year.
Other non-operating income increased from $0.6 million in the prior year to $10.1 million for the year ended December 31, 2023. The increase was primarily attributable to interest income achieved from investments in short-term marketable debt securities.
Net loss for the year ended December 31, 2023 was $44.1 million , compared to $64.5 million for the prior year ending December 31, 2022.
R&D Day, on Sunday, March 10
MoonLake will be hosting an R&D Day for investors and analysts in San Diego, USA on Sunday, March 10 alongside the American Academy of Dermatology (AAD) annual meeting. The event will take place from 09:00 – 11:30 PST/ 12:00 – 14:30 EST/18:00 – 20:30 CET at the Hotel Westin Bayview, San Diego and will be webcast for virtual attendees.
The R&D Day will provide important business updates from MoonLake’s executive team including:
Outcome of the end-of-Phase 2 (EoP2) interactions with the FDA and EMA, and plans for the Phase 3 VELA program for the Nanobody® sonelokimab in HS, expected to randomize the first patient in Q2 2024 Analysis of the HS and PsA market opportunities and leadership potential for sonelokimab 24-week data from the ARGO trial in active PsA, plans related to EoP2 FDA meeting in Q2 2024 and expectation to randomize the first patient in Q4 2024 Pipeline updates and details on the additional catalysts for 2024 and 2025, including new indications to be pursued Financials The event will feature presentations from leading clinicians in dermatology and rheumatology. Professor Joesph F. Merola, Founding President of the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network Consortium (PPACMAN) and Vice President of GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis), and Professor Kenneth B. Gordon, Chair of Dermatology at the Medical College of Wisconsin, will share their perspectives on the potential of MoonLake’s investigational Nanobody® sonelokimab in IL-17A and IL-17F driven inflammatory diseases.
A live Q&A session involving all presenters will follow the event. Register to attend either the in-person event or webcast here www.ir.moonlaketx.com
Upcoming banking conferences
Leerink Partners Global Biopharma Conference: March 11-13 (Miami) Jefferies Biotech on the Bay Summit: March 11-13 (Miami) Barclays 26th Annual Global Healthcare Conference: March 12-14 (Miami) H.C. Wainwright 2nd Annual Autoimmune & Inflammatory Disease Virtual Conference, March 28 (virtual) 23rd Annual Needham Virtual Healthcare Conference: April 8-11 (virtual) Van Lanschot Kempen Life Sciences Conference Amsterdam: April 16-17 (Amsterdam) - Ends -
About MoonLake Immunotherapeutics
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com.
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.® 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 human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.
Sonelokimab is being assessed in two trials, the Phase 2 ARGO trial in PsA and the Phase 2 MIRA trial in HS. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR)75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October 2023, the full dataset from the MIRA trial at 24 weeks showed that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other clinically relevant outcomes. In November 2023, MoonLake announced positive top-line results from its global Phase 2 ARGO trial evaluating the efficacy and safety of the Nanobody® sonelokimab in patients with active psoriatic arthritis (PsA). The trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an American College of Rheumatology (ACR)50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction.
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. Lancet. 2021; 397:1564-1575).
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). Sonelokimab is not yet approved for use in any indication.
Sonelokimab is not yet approved for use in any indication.
About the MIRA trial ® sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate-to-severe hidradenitis suppurativa. The trial recruited 234 patients, with the aim to evaluate two different doses of sonelokimab (120mg and 240mg) with placebo control and adalimumab as an active 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 also evaluated 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 Skin Pain (PGA Skin Pain). Further details are available at:
About the ARGO trial ® sonelokimab, administered subcutaneously, in the treatment of adult patients with active PsA. The trial 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 American College of Rheumatology (ACR) 50 response. The trial also evaluates a number of secondary endpoints, including improvement compared to placebo in ACR20, complete skin clearance as measured by at least a 100% improvement in the Psoriasis Area and Severity Index (PASI), physical function as measured by the Health Assessment Questionnaire-Disability Index, enthesitis as measured by the Leeds Enthesitis Index and pain as measured by the Patients Assessment of Arthritis Pain. Further details are available at:
Cautionary Statement Regarding Forward Looking Statements
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; expectations regarding the timing of the Phase 3 programs in HS and PsA; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical studies; MoonLake’s substantial dependence on the success of its Nanobody® sonelokimab; 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 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:
MoonLake Immunotherapeutics Investors
Matthias Bodenstedt, CFO
ir@moonlaketx.com
MoonLake Immunotherapeutics Media
Patricia Sousa, Director Corporate Affairs
media@moonlaketx.com
ICR Consilium
Tel: +44 (0) 20 3709 5700
MOONLAKE IMMUNOTHERAPEUTICS
CONSOLIDATED BALANCE SHEETS
(Amounts in USD, except share data)
December 31, 2023 September 30, 2023 (Unaudited) Current assets Cash and cash equivalents $ 451,169,337 $ 318,165,809 Short-term marketable debt securities 59,838,900 177,812,899 Other receivables 1,056,862 720,755 Prepaid expenses - current 2,102,203 3,310,281 Total current assets 514,167,302 500,009,744 Non-current assets Operating lease right-of-use assets 3,628,480 169,422 Property and equipment, net 320,865 39,520 Prepaid expenses - non-current 8,423,468 — Total non-current assets 12,372,813 208,942 Total assets $ 526,540,115 $ 500,218,686 Current liabilities Trade and other payables $ 1,837,684 $ 3,404,728 Short-term portion of operating lease liabilities 1,197,876 156,338 Accrued expenses and other current liabilities 6,930,120 6,746,951 Total current liabilities 9,965,680 10,308,017 Non-current liabilities Long-term portion of operating lease liabilities 2,499,990 13,084 Pension liability 583,426 255,399 Total non-current liabilities 3,083,416 268,483 Total liabilities 13,049,096 10,576,500 Commitments and contingencies Equity (deficit) Class A Ordinary Shares: $0.00 01 par value; 500,000,000 shares authorized; 60,466,453 shares issued and outstanding as of December 31, 2023; 53,561,488 shares issued and outstanding as of September 30, 2023 6,047 5,356 Class C Ordinary Shares: $0.00 01 par value; 100,000,000 shares authorized; 2,505,476 shares issued and outstanding as of December 31, 2023; 8,884,517 shares issued and outstanding as of September 30, 2023 251 889 Additional paid-in capital 609,969,236 531,271,953 Accumulated deficit (116,657,472) (109,220,396) Accumulated other comprehensive income 2,357,621 2,875,198 Total shareholders’ equity (deficit) 495,675,683 424,933,000 Noncontrolling interests 17,815,336 64,709,186 Total equity 513,491,019 489,642,186 Total liabilities and equity $ 526,540,115 $ 500,218,686
MOONLAKE IMMUNOTHERAPEUTICS
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in USD, except share and per share data)
For the Three Months Period Ended For the Year Ended December 31, September 30, December 31, December 31, 2023 2023 2023 2022 Operating expenses Research and development $ (8,097,794) $ (7,585,136) $ (31,801,880) $ (42,048,954) General and administrative (6,931,096) (5,391,607) (22,321,216) (23,012,463) Total operating expenses (15,028,890) (12,976,743) (54,123,096) (65,061,417) Operating loss (15,028,890) (12,976,743) (54,123,096) (65,061,417) Other income, net 7,185,810 1,386,313 10,138,367 591,732 Loss before income tax (7,843,080) (11,590,430) (43,984,729) (64,469,685) Income tax expense (44,309) (28,923) (94,388) (36,366) Net loss $ (7,887,389) $ (11,619,353) $ (44,079,117) $ (64,506,051) Of which: net loss attributable to controlling interests shareholders (7,437,074) (9,426,049) (36,007,260) (49,973,249) Of which: net loss attributable to noncontrolling interests shareholders (450,315) (2,193,304) (8,071,857) (14,532,802) Net unrealized gain on marketable securities and short-term investments (716,437) 3,437,291 2,330,101 390,753 Actuarial income (loss) on employee benefit plans (317,256) 39,157 (336,579) 269,893 Other comprehensive income (1,033,693) 3,476,448 1,993,522 660,646 Comprehensive loss $ (8,921,082) $ (8,142,905) $ (42,085,595) $ (63,845,405) Comprehensive loss attributable to controlling interests shareholders (8,415,796) (6,590,259) (34,511,723) (49,437,461) Comprehensive loss attributable to noncontrolling interests (505,286) (1,552,646) (7,573,872) (14,407,944) Weighted-average number of Class A Ordinary Shares, basic and diluted 59,914,592 53,517,655 49,122,534 29,361,353 Basic and diluted net loss per share attributable to controlling interests shareholders $ (0.12) $ (0.18) $ (0.73) $ (1.70)
MoonLake held cash, cash equivalents, and short-term marketable debt securities of $511.0 million at the end of 2023.
MoonLake reported positive data from Phase 2 trials of sonelokimab in HS and PsA.
MoonLake's R&D Day is scheduled for March 10 alongside the AAD meeting.
MoonLake's R&D Day will include 24-week data from the ARGO trial, plans for Phase 3 VELA program, market analysis, and pipeline updates.
Professor Joesph F. Merola and Professor Kenneth B. Gordon will share their perspectives on sonelokimab at the R&D Day.
