MoonLake Immunotherapeutics 8-K, filed Nov 6, 2023
MoonLake Immunotherapeutics (MLTX)
8-K
2023-11-06
For: 2023-11-05
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April 08, 2026
About this 8-K
MoonLake Immunotherapeutics filed this 8-K on November 6, 2023, reporting on events of November 5, 2023.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 or 15(d) of the
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 5, 2023
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Item 7.01. Regulation FD Disclosure.
On November 5, 2023, MoonLake Immunotherapeutics (the “Company”) issued a press release announcing positive top-line results from its global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab in patients with active psoriatic arthritis. The Company is hosting a webcast today, Monday, November 6, 2023 at 8:00 am, Eastern Time, to discuss the data results.
A copy of the press release and the webcast presentation are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein. The exhibits furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.
Item 8.01. Other Events.
Top-line Results from Phase 2 ARGO Trial
On November 5, 2023, the Company 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 ARGO trial (M1095-PSA-201), which enrolled 207 patients, 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. Specifically, for the 60mg and 120mg doses with induction, respectively, 46% and 47% of patients treated with sonelokimab achieved ACR50 (p<0.01 versus placebo); 78% and 72% of patients achieved ACR20; and 29% and 26% achieved ACR70. The primary analyses were based on the most stringent type of analysis for such trials, intention-to-treat with non-responder imputation (“ITT-NRI”). As expected, the 60mg dose without induction did not reach statistical significance, confirming the 60mg and 120mg with induction as the potential dose regimens to carry forward into Phase 3.
All key secondary endpoints were met for the 60mg and 120mg doses with induction. The key secondary endpoint Psoriasis Area and Severity Index (“PASI”) 90 was met for all doses with induction; 77% of patients responding at week 12 to the 60mg dose (ITT-NRI, p<0.001 versus placebo). For this dose, 58% of patients achieved complete skin clearance (PASI100) at week 12. PASI responses across dose arms were consistent with the previously reported Phase 2b data of sonelokimab in moderate-to-severe plaque-type psoriasis, with the 120mg dose achieving the highest responses for PASI100 (close to 60% of patients at week 12, ITT-NRI) in patients with more severe skin lesions (PASI score ≥ 10 at baseline).
Other clinically relevant secondary endpoints, such as Minimal Disease Activity (MDA), the modified Nail Psoriasis Severity Index (mNAPSI), the Leeds Enthesitis Index (LEI) and the patient self-reported Psoriatic Arthritis Impact of Disease (PsAID-12), each show promising levels of response at week 12.
Adalimumab was used as an active reference to validate responses across arms (not powered for statistical comparisons to active treatment). Sonelokimab 60mg and 120mg (with induction) numerically outperformed adalimumab on the primary endpoint and all key secondary endpoints, with the observed deltas further supporting the potential for sonelokimab as a future leading therapy.
The patient discontinuation rate in the ARGO trial was low at week 12 (less than 4%), similar to what was observed in previous trials of sonelokimab in psoriasis and hidradenitis suppurativa. The safety profile of sonelokimab in ARGO was consistent with previously reported studies with no new safety signals. Specifically, oral candidiasis was observed in less than 2% of patients on sonelokimab, with no case leading to discontinuation. No cases of inflammatory bowel disease (IBD), major adverse cardiovascular events (MACE) or suicidal ideation and behavior (“SI/B”) were observed. Overall, sonelokimab continues to show a favorable safety profile. Across the sonelokimab clinical program to date, the Company has not seen any signal of SI/B or liver enzyme elevations related to sonelokimab treatment.
The results suggest that, as early as week 12, the Nanobody® sonelokimab reaches levels of clinical response at or above those seen with other therapies tested in similarly stringent trials. The high performance of sonelokimab and its favorable safety profile continue to support the potential of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F for the treatment of inflammatory diseases.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. The following exhibits are being furnished herewith:
| Exhibit Number | Exhibit Title or Description | |||||||
| 99.1 | ||||||||
| 99.2 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MOONLAKE IMMUNOTHERAPEUTICS | |||||||||||
| Date: | November 6, 2023 | By: | /s/ Matthias Bodenstedt | ||||||||
| Name: | Matthias Bodenstedt | ||||||||||
| Title: | Chief Financial Officer | ||||||||||
Exhibit 99.1
MoonLake Immunotherapeutics announces landmark Phase 2 results for Nanobody® sonelokimab in active psoriatic arthritis
•First placebo-controlled randomized trial in active psoriatic arthritis (PsA) using a Nanobody® to report positive topline results in support of potential best-in-class profile
•Primary endpoint ACR50 met with up to 47% (p<0.01 versus placebo) of patients on sonelokimab achieving ACR50 as early as week 12
•All key secondary endpoints met including up to 77% (p<0.001 versus placebo) of patients on sonelokimab achieving PASI90 as early as week 12
•Other secondary endpoints also reached statistical significance at week 12, including endpoints focused on deep tissue inflammation, Minimal Disease Activity (MDA) and patient reported outcomes
•High threshold outcomes, including ACR70 and PASI100, continue to improve beyond week 12, consistent with previous studies of sonelokimab
•Discontinuation rate below 4% and safety results of sonelokimab consistent with previously reported studies with no new safety signals
•The top-line data will be discussed on Monday 6 November, at 2pm CET/8am ET, via webcast (registration link below)
ZUG, Switzerland, November 5, 2023 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today 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 ARGO trial (M1095-PSA-201), which enrolled 207 patients, 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. Specifically, for the 60mg and 120mg doses with induction, respectively, 46% and 47% of patients treated with sonelokimab achieved ACR50 (p<0.01 versus placebo); 78% and 72% of patients achieved ACR20; and 29% and 26% achieved ACR70. The primary analyses were based on the most stringent type of analysis for such trials, intention-to-treat with non-responder imputation (ITT-NRI). As expected, the 60mg dose without induction did not reach statistical significance, confirming the 60mg and 120mg with induction as the potential dose regimens to carry forward into Phase 3.
All key secondary endpoints were met for the 60mg and 120mg doses with induction. The key secondary endpoint Psoriasis Area and Severity Index (PASI) 90 was met for all doses with induction; 77% of patients responding at week 12 to the 60mg dose (ITT-NRI, p<0.001 versus placebo). For this dose, 58% of patients achieved complete skin clearance (PASI100) at week 12. PASI responses across dose arms were consistent with the previously reported Phase 2b data of sonelokimab in moderate-to-severe plaque-type psoriasis, with the 120mg dose achieving the highest responses for PASI100 (close to 60% of patients at week 12, ITT-NRI) in patients with more severe skin lesions (PASI score ≥ 10 at baseline).
Other clinically relevant secondary endpoints, such as Minimal Disease Activity (MDA), the modified Nail Psoriasis Severity Index (mNAPSI), the Leeds Enthesitis Index (LEI) and the patient self-reported Psoriatic Arthritis Impact of Disease (PsAID-12), each show promising levels of response at week 12.
Jorge Santos da Silva, PhD, Founder and Chief Executive Officer at MoonLake, said: “As part of our efforts to elevate outcomes for patients, we set ambitious goals for our Nanobody® sonelokimab. ARGO is MoonLake’s third Phase 2 trial and the first trial in psoriatic arthritis using a Nanobody® to report positive topline results, setting another landmark milestone. Again, we met the objectives we set out for ourselves, in this case for PsA. As with our hidradenitis suppurativa program, the preparation of our Phase 3 program in PsA is rapidly advancing and expected timing of end-of-Phase 2 regulatory meetings will be announced in due course.”
Adalimumab was used as an active reference to validate responses across arms (not powered for statistical comparisons to active treatment). Sonelokimab 60mg and 120mg (with induction) numerically outperformed adalimumab on the primary endpoint and all key secondary endpoints, with the observed deltas further supporting the potential for sonelokimab as a future leading therapy.
The patient discontinuation rate in the ARGO trial was low at week 12 (less than 4%), similar to what was observed in previous trials of sonelokimab in psoriasis and hidradenitis suppurativa. The safety profile of sonelokimab in ARGO was consistent with previously reported studies with no new safety signals. Specifically, oral candidiasis was observed in less than 2% of patients on sonelokimab, with no case leading to discontinuation. No cases of inflammatory bowel disease (IBD), major adverse cardiovascular events (MACE) or suicidal ideation and behavior (SI/B) were observed. Overall, sonelokimab continues to show a favorable safety profile. Across the sonelokimab clinical program to date, the company has not seen any signal of SI/B or liver enzyme elevations related to sonelokimab treatment.
The results suggest that, as early as week 12, the Nanobody® sonelokimab reaches levels of clinical response at or above those seen with other therapies tested in similarly stringent trials. The high performance of sonelokimab and its favorable safety profile continue to support the potential of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F for the treatment of inflammatory diseases.
Kristian Reich, MD, PhD, Founder and Chief Scientific Officer at MoonLake, commented: “The positive topline results from the pivotal-like ARGO trial establish the Nanobody® sonelokimab as an innovative potential treatment in another chronic inflammatory disease, psoriatic arthritis. Importantly, the results confirm our expectations in terms of dosing, clinical responses and safety findings. We believe that we have elevated the therapeutic bar by reaching important clinical outcomes at week 12. The data also support sonelokimab’s unique molecule characteristics and mode of action to effectively inhibit IL-17F in addition to IL-17A in deep tissue inflammation. The positive outcome of the ARGO trial would not have been possible without the support and participation of the patients and investigators to whom we are grateful.”
Joseph F. Merola, MD, MMSc, Professor of Dermatology, Medicine and Rheumatology, Distinguished Chair of Dermatology at UT Southwestern Medical Center added: “Psoriatic arthritis is a chronic, inflammatory, recurrent, and debilitating multidomain disease that has profound and wide-ranging impacts across many aspects of patients’ lives. As a physician, I see tremendous need for new treatment options for people living with PsA, particularly for therapies that reach high thresholds of response (e.g., ACR70, PASI100) and that simultaneously improve the disease domains that matter most for patients. The positive high clinical responses across joint and skin endpoints and stringent composite measures such as minimal disease activity observed with sonelokimab as early as week 12 in the Phase 2 ARGO trial are encouraging, demonstrating its promise as a potential future treatment option.”
These topline data will be discussed on Monday November 6, 2023 at 2pm CEST/8am ET before the Nasdaq market opens, via webcast at:
https://edge.media-server.com/mmc/p/bp43a4xr
A replay of the webcast and the presentation document will be made available at https://ir.moonlaketx.com.
The ARGO trial proceeds to week 24, with a 4-week safety follow-up. Important data is being collected regarding longer-term efficacy and safety of sonelokimab, as well as results from the cross-over of patients treated with placebo or adalimumab to sonelokimab and the continued monthly dosing of sonelokimab.
Today’s top-line data announcement follows the announcement in July 2023 that the ARGO trial successfully completed randomization of its target 200 patients, several weeks ahead of schedule (read more here). Full results from the ARGO trial will be submitted for publication in a peer-reviewed medical journal and for presentation at an upcoming scientific meeting.
The positive top-line12-week results from the Phase 2 ARGO trial in PsA follows the positive top-line 12-week and 24-week results from the Phase 2 MIRA trial in hidradenitis suppurativa (HS) as announced in June 2023 (read more here) and October 2023 (read more here). The MIRA trial set a landmark milestone as the first placebo-controlled randomized trial in HS to report positive top-line results using HiSCR75 as the primary endpoint.
Sonelokimab is not yet approved for use in any indication.
- Ends -
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.
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 Nanobody® 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 on: https://clinicaltrials.gov/ct2/show/NCT05640245
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 trials, the Phase 2 ARGO trial in PsA (trial ongoing) 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.
Sonelokimab has also been assessed in a randomized, placebo-controlled Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. Clinical response (considering the Investigator’s Global Assessment Score 0 or 1, and the Psoriasis Area and Severity Index 90/100) was 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).
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 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. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company.
Cautionary Statement Regarding Forward Looking Statements
This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for clinical trials and research and development programs; and the anticipated timing of the results from those trials, including completing the MIRA trial and top-line data from the ARGO trial; and the efficacy of our products, if approved, including in relation to other products. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking.
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, and reliance on third parties to conduct and support its 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 December 31, 2022 and subsequent filings with the Securities and Exchange Commission.
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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W: moonlaketx.com | E: info@moonlaketx.com© 2023 | Proprietary | MoonLake TX MoonLake Immunotherapeutics R&D Day Webcast Presentation Document – Results ARGO trial November 6th 2023
© 2023 | Proprietary | MoonLake TXSource: Welcome to our R&D Day MoonLake Corporate 2 Date: November 6th, 2023 Time: 8am EDT Location: Nasdaq (Webcast) Sub-topicsTopic Lead Timing - Conclusions - Overall value of MLTX - Path forward Moving Forward Jorge Santos da Silva 10 mins - Key messagesIntro Jorge Santos da Silva 5 mins - ARGO’s profile, incl. baseline - Efficacy data at primary & secondary endpoints - Safety data & other secondaries - Discussing impact of ARGO in PsA PsA – ARGO trial Primary Endpoint Readout Kristian Reich 30 mins Q&A To endMatthias Bodenstedt
Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate 3 Disclaimer Forward Looking Statements Certain statements in this presentation may constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding our expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for clinical trials and research and development programs, including our MIRA trial in HS; the anticipated timing of the results from those trials expected near-term catalysts with respect to our clinical trials; and expectations regarding the time period over which our capital resources will be sufficient to fund our anticipated operations. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate”, “believe”, continue”, “could”, “estimate”, “expect”, “intend”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “should”, “ strive”, “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that such statement is not forward looking. Forward- looking statements are based on current expectations and assumptions that, while we and our management consider reasonable, 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 our business in general and limited operating history, the risk that past results may not be predictive of future results, difficulty enrolling patients in clinical trials, and reliance on third parties to conduct and support our clinical trials, and the other risks described in or incorporated by reference into our Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent filings with the Securities and Exchange Commission. Nothing in this presentation 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 presentation, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. We neither undertake nor accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in our expectations or in the events, conditions or circumstances on which any such statement is based. This presentation does not purport to summarize all of the conditions, risks and other attributes of MoonLake Immunotherapeutics. Industry and Market Data Certain information contained in this presentation relates to or is based on studies, publications, surveys and our own internal estimates and research. In this presentation, we rely on, and refer to, publicly available information and statistics regarding market participants in the sector in which we compete and other industry data. Any comparison of us to any other entity assumes the reliability of the information available to us. We obtained this information and statistics from third-party sources, including reports by market research firms and company filings. In addition, all of the market data included in this presentation involve a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our internal research is reliable, such research has not been verified by any independent source and we have not independently verified the information. Trademarks This presentation may contain trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this presentation may be listed without the TM, SM © or ® symbols, but we will assert, to the fullest extent under applicable law, the rights of the applicable owners, if any, to these trademarks, service marks, trade names and copyrights.
© 2023 | Proprietary | MoonLake TXSource: Instructions for this session MoonLake Corporate 4 Please take note of the disclaimer on the prior page You can submit your questions through the Q&A function – we will address as many questions as possible at the end of this session For any technical issues during the webcast, please also use the Q&A function to request support The presentation and a replay will be made available on our IR website Other requests should be directed to ir@moonlaketx.com or media@moonlaketx.com
© 2023 | Proprietary | MoonLake TX Introduction 5
Source: © 2023 | Proprietary | MoonLake TX 6 PsA: IL-17F dependent multi-domain disease in difficult-to-reach tissues …with 3x IL-17F vs IL-17A1… IL-17A PsA IL-17F PsA Nail psoriasis Axial disease Enthesitis Dactylitis MoonLake Medical, Clinical pictures K. Reich 1 van Baarsen LG, et al. Arthritis Res Ther. 2014; 16:426-436; 2 Schett G, et al. Nature Reviews Rheumatology. 2017; 13:731-741; 3 Prinz JC, et al. J Exp Med. 2020 Jan 6;217(1):e20191397; 4 Sweet K, et al. RMD Open 2021;7e001679; 5 Shao M, et al. Clin Immunol 2020;213:108374; 6 Lories RJ and McInnes IB, Nature Medicine. 2012; 18:1018-1019; 7 Reich K. J Eur Acad Dermatol Venereol. 2009; 23 Suppl 1:15-21; Clinical pictures K. Reich …and causing devastating damage (PsA starts as enthesitis2, with IL-17F producing cells in associated plaques3 and axial disease4-6, and with 80% of patients suffering from nail psoriasis7) Plaques Nail Psoriasis Joint & spine disease PsA is a multi-domain deep-tissue disease… Disease Activity Peripheral arthritis Psoriasis PASI 90ACR50 10+ USD bn sales beyond 2030 10% skin involvement in PsA patients – severe skin disease 0.5% Global prevalence 80% or more patients with multiple disease domains 20% is still standard ACR level of improvement Market size Unmet Needs
© 2023 | Proprietary | MoonLake TXSource: The key messages MoonLake Corporate 7 MLTX’s ARGO trial is a SUCCESS ▪ Joints: ACR50 primary endpoint met at wk 12 for 60mg and 120mg induction doses – up to 47% ACR50 (p<0.01 vs placebo) ▪ Skin: PASI90 secondary endpoint met at wk 12 also for 60mg and 120mg induction doses – up to 77% PASI90 (p<0.001 vs placebo) ▪ Other secondary end points met at wk 12, wk16 data indicated continued improvement– impact of SLK for PsA patients is clear (e.g., PASI100, ACR70, MDA) ▪ No new safety signals – continues to indicate favorable safety profile MLTX’s SLK Nanobody® continues to open a new era in therapy ▪ Differentiating on multi-domain responses – consistency across skin & joint scores ▪ Potential to use both doses (60mg and 120mg), advantageous for label ▪ Highest numbers on higher level outcomes (e.g., ACR70, PASI100) at week 12 ▪ Impact in important disease activity scores as early as week 12 ▪ Differentiating with favorable safety profile MLTX positioned to become a leader in I&I ▪ Our view: SLK now a leading potential asset in HS, PsA & PsO (all multi-bn markets) ▪ A wealth of potential indications to further pursue ($30bn+) ▪ Soon Ph3-ready in 3+ TAs – expected to start Ph3s in 2024
© 2023 | Proprietary | MoonLake TX ARGO Trial Results 8
Source: © 2023 | Proprietary | MoonLake TX 9 ARGO: Phase 2 trial design ▪ Global study with approx. 50 sites, with 207 patients randomized ▪ Double-blind, placebo-controlled, active reference arm ▪ Active PsA (TJC68 ≥3, SJC≥3, current active PsO and/or confirmed PsO) ▪ ACR50 as primary endpoint, PASI90 as key secondary endpoint ▪ ITT-NRI primary analysis; Stratification by sex, previous bio use ▪ Groups 1 (“SLK 120mg” with induction) and 2 (“SLK 60mg” with induction) are doses previously used in SLK trials ▪ Group 3 (“SLK 60mg NI”, no induction) was used to support requirement for induction dosing Notes: 1 Randomization stratified by sex and prior exposure to biologics; 2 At Week 0/Day 1, all eligible participants were randomized 1:1:1:1:1; 3 In the cross-over period, starting at Week 12, participants on sonelokimab 120 mg who did not achieve an adequate response switched to adalimumab 40 mg Q2W until Week 24; participants on sonelokimab 60 mg (started at baseline Q2W or Q4W) who did not achieve an adequate response switched to sonelokimab 120 mg Q4W until week 24; participants on adalimumab who did not achieve an adequate response switched to sonelokimab 120 mg Q4W until Week 24; an adequate response is defined as a reduction of the tender and swollen joint count of ≥20%. Participants on placebo at Week 12 were switched to sonelokimab Q4W until Week 24 MoonLake Clinical Focus of today’s results Key design elements of ARGOPart A Nov 6th R&D Day Week 12 SLK 120mg ADA 40mg SLK 60mg PLC SLK 60mg NI
Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 10 Baseline: All arms of the ARGO trial are well balanced Main arms Active reference Patient characteristics Overall ARGO (n=207) Placebo (n=40) Sonelokimab 60mg NI (n=41) Sonelokimab 60mg (n=41) Sonelokimab 120mg (n=43) Adalimumab (n=42) Age, yrs, mean 49 47 50 48 50 48 Female, % 49 48 51 49 49 50 BMI, kg/m2, mean 29.0 27.9 29.6 27.7 30.3 29.3 Duration of PsA, yrs, mean 5.4 5.7 6.0 6.2 4.9 4.1 Prior biologic use, % 17 15 20 17 19 17 Concomitant non-biologic DMARD, % 70 68 81 63 67 69 Concomitant MTX, % 67 65 78 56 67 67 Tender Joint Count (TJC68), mean 17 17 18 17 17 16 Swollen Joint Count (SJC66), mean 9 9 11 9 9 10 Affected BSA ≥ 3%, % 69 67 78 63 63 76 PASI (BSA ≥ 3%), mean 7.2 7.1 6.7 8.0 7.2 7.3 Nail psoriasis (mNAPSI > 0), % 55 55 59 54 40 67 mNAPSI, mean 13.4 15.2 16.0 11.5 14.4 10.5 Presence of enthesitis (LEI > 0), % 32 36 34 39 26 24 LEI score, mean 2.4 1.9 2.9 2.9 2.7 1.6 Presence of dactylitis, % 12 13 10 12 12 12 Patient Pain (PtAAP), mean 58 56 60 60 55 58 PsA Impact of Disease (PsAID) 12, mean 4.2 3.9 4.3 4.6 3.9 4.5
Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical Disposition: The ARGO trial has a drop-out of rate of < 4% Disposition (Part A) 11 Note: Part A (week 12)database lock 12th October 2023. AE =Adverse Event, Wdw by S = Withdrawal by Subject; Completed Part A = completed treatment up to Week 10 and completed assessments to Week 12; 1 1x Not Treated, 1x Wdw by S & 1 x Lack of Effect; 2: 1x Protocol withdrawal criteria; 3: 1x AE (not related to treatment) & 1x Wdw by S; 4: 1x Wdw by S 265 Screened 58 screen failed 207 Randomized 40 Placebo 41 Sonelokimab (SLK) 60mg NI (No induction) 41 Sonelokimab (SLK) 60mg 42 Adalimumab 40mg Q2W (reference arm) Completed: 37 Completed: 41 Completed: 40 Completed: 41 Discontinued (3)1 Discontinued (0) Discontinued (1)2 Discontinued (2)3 43 Sonelokimab (SLK) 120mg Completed: 41 Discontinued (1)4 Part B, 24-week data plus FU (Q1/Q2 2024)
Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 12 ACR50: SLK reaches the highest scores seen at week 12 37 46 47 SLK 60mg NI SLK 60mg SLK 120mg ARGO ARGO ARGO 40 30 33 35 31 26 Ixekizumab Guselkumab Risankizumab ADEPT FUTURE 2 SPIRIT-P1/P2 BE OPTIMAL / BE COMPLETE DISCOVER 1/2 KEEPSAKE 1/2SELECT 1/2 For reference: ADA 43% ACR50 (ARGO); ADA 46% ACR50 (BE OPTIMAL) ACR50 response (SLK Primary endpoint) Percent (%) pts reaching score, primary analysis 37 38 36 32 Bimekizumab Upadacitinib Note: This is a comparison across trials, with inherent limitations. No head-to-head trials. Multiplicity-controlled p-values from a logistic regression with covariates for sex and prior biologic use 1 Not the primary analysis, estimated from trial published data BE OPTIMAL / BE COMPLETE1 44 43 Bimekizumab 36 Adalimumab 35 Secukinumab At Week 12 Week 16 Week 24 p≤0.01 vs. placebo BKZ BE OPTIMAL (Week 12)
Source: © 2023 | Proprietary | MoonLake TX 37.5 78.0 0 10 20 30 40 50 60 70 80 0 2 4 6 8 10 12 MoonLake Clinical 13 ACR50 primary endpoint responses increase over time ACR20 response Percent (%) pts reaching score, ITT-NRI Weeks Primary endpoint met for 60mg and 120mg – SLK 60mg NI not significantly different from PLC High response levels across all ACR levels measured As expected, 60mg dose of SLK is sufficient to drive promising ACR50 responses Scores increase over time esp. for the higher scores PLC higher vs. 4-13% in similar trials1, and before control with the ADA active reference arm * p<0.001 (60mg) ** p=0.002 (120mg) * ** 20.0 46.5 53.5 0 10 20 30 40 50 60 0 2 4 6 8 10 12 16 ACR50 response (Primary endpoint) Percent (%) pts reaching score, ITT-NRI Weeks * ** * p=0.012 (60mg) ** p=0.009 (120mg) Cross overs PLC SLK 60mg NI SLK 60mg SLK 120mg *, ** multiplicity-controlled p-values from a logistic regression with covariates for sex and prior biologic use. All patients have reached week 16, week 24 database to be locked in Q1 2024 1 Including comparable trials: ADEPT, DISCOVER 1 and 2, SPIRIT-P1, BE OPTIMAL (BKZ, 7%), FUTURE 2, KEEPsAKE 2, SELECT 1 (highest PLC, 13%)
Source: © 2023 | Proprietary | MoonLake TX ACR50 responses at week 16 Percent (%) of patients in each arm, ITT1 MoonLake Clinical 14 Beyond week 12: continued ACR50 improvement for main doses 46.5 53.5 Week 12 Week 16 +7.0 46.3 53.6 Week 12 Week 16 +7.3 SLK ACR50 response increases with monthly maintenance dosing, reaching to 50%+ (60mg NI plateaus at week 16) SLK 120mg (n=43) SLK 60mg (n=41) 1 Subjects who switched treatment at Wk 12 were counted as non-responders at Wk 16. Subjects who ended the study per protocol had their Wk 12 ACR50 response carried forward. All patients have reached week 16, week 24 database to be locked in Q1 2024 Placebo to SLK cross over (n=37) 21.6 62.2 PLC Week 12 ► SLK 120mg Week 16 +40.6
Source: © 2023 | Proprietary | MoonLake TX ACR70 responses at week 16 Percent (%) of patients in each arm, ITT1 MoonLake Clinical 15 Beyond week 12: the same is observed for ACR70 25.6 37.2 Week 12 Week 16 +11.6 29.3 34.1 Week 12 Week 16 +4.8 ACR70 response also continues to increase with monthly maintenance dosing to levels over 35% - above competitors SLK 120mg (n=43) SLK 60mg (n=41) Note: Comparisons across trials, with inherent limitations. No head-to-head trials. 1 Subjects who switched treatment at Wk 12 were counted as non-responders at Wk 16. Subjects who ended the study per protocol had their Wk 12 ACR70 response carried forward. All patients have reached week 16, week 24 database to be locked in Q1 2024 Placebo to SLK cross over (n=37) 13.5 29.7 PLC Week 12 ► SLK 120mg Week 16 +16.2
Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 16 SLK reaches the highest PASI90 scores already at week 12 50 77 59 SLK 60mg NI SLK 60mg SLK 120mg ARGO ARGO ARGO 56 45 52 44 55 55 Ixekizumab Guselkumab Risankizumab ADEPT FUTURE 2 SPIRIT-P1/P2 BE OPTIMAL / BE COMPLETE DISCOVER 1/2 KEEPSAKE 1/2SELECT 1/2 For reference: ADA 50% PASI90 (ARGO); ADA 41% PASI90 (BE OPTIMAL) PASI90 response (SLK secondary endpoint) Percent (%) pts reaching score 57 31 60 29 Bimekizumab Upadacitinib Note: This is a comparison across trials, with inherent limitations. No head-to-head trials. Multiplicity-controlled p-values for SLK from a logistic regression with covariates for baseline PASI, sex and prior biologic use 1 Estimated from trial published data BE OPTIMAL / BE COMPLETE1 61 69 Bimekizumab 33 Secukinumab At Week 12 Week 16 Week 24 SLK120mg at 67% at wk16 p<0.001 vs. placebo p=0.003 vs. placebo 30 Adalimumab BKZ BE OPTIMAL (Week 12)
Source: © 2023 | Proprietary | MoonLake TX 84.6 0 10 20 30 40 50 60 70 80 90 0 2 4 6 8 10 12 26.9 MoonLake Clinical 17 ARGO met PASI90 key secondary endpoint in PsA PASI75 response Percent (%) pts reaching score, ITT-NRI Weeks ▪ All doses significantly respond across PASI scores ▪ Above all comparable data for other products at week 12 incl. BKZ ▪ Versus ACR, 60 and 120 mg doses separate for PsA skin lesions ▪ 60mg performs well in terms responses for overall PsA skin lesions at week 12 ▪ A higher dose likely required for PsA subgroups with moderate-to-severe skin involvement and deeper responses * * p<0.001 (60mg) ** p=0.007 (120mg) ** 15 77 73 67 0 10 20 30 40 50 60 70 80 0 2 4 6 8 10 12 16 PASI90 response (Key secondary endpoint) Percent (%) pts reaching score, ITT-NRI Weeks * ** Cross overs PLC SLK 60mg NI SLK 60mg SLK 120mg * p=<0.001 (60mg) ** p=0.003 (120mg) PASI90 multiplicity-controlled and PASI75 nominal p-values from a logistic regression with covariates for sex and prior biologic use. All patients have reached week 16, week 24 database to be locked in Q1 2024
Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 18 The 120mg is the most effective dose for moderate-to-severe skin PsO 57 29 83 17 86 57 PASI90 PASI100 0 0 PASI responses in ARGO patients with PASI ≥ 10 Percent (%) pts reaching score per arm, Week 12, ITT-NRI Similar skin to our PsO trial1 Whereas 60mg is sufficient for overall PsA population, 120mg is still most effective for PsO (as per our 313 patient Phase 2b1) Nominal P values from a logistic regression with covariates for baseline PASI, sex, prior biologic use, treatment and treatment by baseline PASI interaction 1 Papp et al. Lancet. 2021;397:1564–75 p=0.02 vs. placebo p=0.05 vs. placebo p=0.07 vs. placebo Placebo SLK 60mg (NI) SLK 120mg SLK 60mg
Source: © 2023 | Proprietary | MoonLake TX PASI90 responses at week 16 MoonLake Clinical 19 Beyond week 12: Cross overs show continued PASI90 improvement 16.7 45.8 PLC Week 12 ► SLK 120mg Week 16 +29.1 59.3 66.7 Week 12 Week 16 +7.476.9 73.1 Week 12 Week 16 Placebo switch to SLK rapidly elevates PASI90 responses All monthly doses of SLK drive PASI90 to close or above 70% to week 16 (above other PsA leading assets) Percent (%) of patients in each arm, ITT Placebo to SLK cross over (n=24) SLK 120mg (n=27) SLK 60mg (n=26) Note: Comparisons across trials, with inherent limitations. No head-to-head trials. For placebo cross overs to SLK the responses only include patients that received SLK in Part B. Subjects who ended the study per protocol or switched treatment at Wk 12 had their Wk 12 PASI 90 response carried forward. All patients have reached week 16, week 24 database to be locked in Q1 2024
Source: © 2023 | Proprietary | MoonLake TX PASI100 responses at week 16 MoonLake Clinical 20 Beyond week 12: Cross overs show continued PASI100 improvement 16.7 37.5 PLC Week 12 ► SLK 120mg Week 16 +20.8 48.1 59.3 Week 12 Week 16 +11.2 57.7 53.8 Week 12 Week 16 Placebo switch to SLK rapidly elevates PASI100 responses All monthly doses of SLK drive PASI100 above 50% to week 16 (and above other PsA leading assets) Percent (%) of patients in each arm, ITT Placebo to SLK cross over (n=24) SLK 120mg (n=27) SLK 60mg (n=26) Note: Comparisons across trials, with inherent limitations. No head-to-head trials. For placebo cross overs to SLK the responses only include patients that received SLK in Part B. Subjects who ended the study per protocol or switched treatment at Wk 12 had their Wk 12 PASI 100 response carried forward. All patients have reached week 16, week 24 database to be locked in Q1 2024
Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 21 How does SLK compare to BKZ in ACR50 and PASI90? 20.0 42.9 46.3 53.6 ADA SLK (60mg) SLK (60mg) Week 16 PLC +3 10.0 45.7 43.9 ADA BKZPLC -2 15.4 50.0 76.9 73.1 ADA SLK (60mg) SLK (60mg) Week 16 PLC +27 ARGO Week 12 (Primary endpoint) ACR50 PASI90 41.2 61.3 ADA BKZ 3.0 PLC +20 BE OPTIMAL1 Week 16 (Primary endpoint) Percent (%) pts reaching score, ITT-NRI Comparison of ARGO and BE OPTIMAL using active reference arm Note: Comparisons across trials, with inherent limitations. No head-to-head trials. 1 Ritchlin et al. Ann Rheum Dis 2023;82:1404–1414 BE OPTIMAL At primary endpoint, SLK performs better than BKZ in ACR50 or PASI90 using the ADA active reference arm to compare (most reliable comparison) Also, using the active ADA reference arms in each trial, we can reliably determine delta to placebo – 39ppt for ACR50 SLK delta to placebo for PASI90 is 62ppt
Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 22 SLK brings over 40% of patients to both ACR50 and PASI90 at week 12 Note: Nominal p-values from a logistic regression with covariates for sex and prior biologic use; all patients with BSA>=3% at baseline, and distribution of such patients is balanced between arms (see baseline details). Comparison across trials, with inherent limitations. No head-to-head trials. Patients reaching both ACR50 and PASI90 Percent (%) pts reaching score, ITT-NRI 7.7 21.9 42.3 44.4 25.0+37 Week 12 Placebo (PLC) SLK 60mg NI SLK 60mg SLK 120mg ADA 40mg p<0.01 vs. placebo p<0.01 vs. placebo ▪ Over 40% of patients reach both ACR50 and PASI90 ▪ Both 60 mg and 120mg with induction behave similarly ▪ As would be expected in PsA, for some subgroups and some timepoints one dose performs better than the other, e.g., ― 120mg better in patients with moderate-to-severe or nail PsO ― 60mg is sufficient to control joint inflammation ▪ The non-induction dose is not sufficient to optimally control inflammation in PsA
Source: © 2023 | Proprietary | MoonLake TX ACR70 response (% of patients) MoonLake Clinical 23 Let’s look further: In ACR70 SLK further differentiates 29 26 21 18 SLK 60mg SLK 120mg BKZ1 160mg IZO2 80mg 34 37 24 20 SLK 60mg SLK 120mg BKZ1 160mg IZO2 80mg Week 12 Week 16 Note: Comparisons across trials, with inherent limitations. No head-to-head trials. Placebo for SLK is 12.5%, for BKZ is 3% and for IZO is 5%. All patients have reached week 16, week 24 database to be locked in Q1 2024 1 Ritchlin et al. Ann Rheum Dis 2023;82:1404–1414 BE OPTIMAL 2 Behrens et al. 2022 EULAR OP Similar for PASI100 where delta to placebo is also higher +17+13 22 25 20 15∆ to PLC
Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 24 Let’s look further: SLK brings 1 in 3 patients to both ACR50 and PASI100 Note: Comparisons across trials, with inherent limitations. No head-to-head trials. Nominal p-values from a logistic regression with covariates for sex and prior biologic use; all patients with BSA>=3% at baseline, and distribution of such patients is balanced between arms (see baseline details) 1 Warren et al., EADV 2021, P0353 Patients reaching both ACR50 and PASI100 at week 12 Percent (%) pts reaching score, ITT-NRI 7.7 18.8 30.8 33.3 21.9 +26 11 Placebo (PLC) SLK 60mg NI SLK 60mg SLK 120mg ADA 40mg p<0.01 vs. placebo p<0.01 vs. placebo ▪ One third of patients reach ACR50 and PASI100 ▪ That is higher than other competitors have shown, including BKZ, IXE, or SEC ▪ ACR50+PASI100 SLK above BKZ (16.1%, wk 121) ▪ While data from other products has not been disclosed for ACR70 and PASI100, SLK numbers already show close to 1 in 4 patients could aspire to this level of response ACR70 & PASI100 (%) 7.7 15.6 26.9 22.2 15.6
Source: © 2023 | Proprietary | MoonLake TXProf Joseph Merola 25 MDA: A composite of ambitious clinical response targets in joints & skin 23% Responder 77% Non-responder >3 in 4 patients do not achieve MDA within 6 months of biologic initiation1 Achievement of MDA clinical responses with any biologic remains low 1 Data from the CorEvitas registry (N=1,251); Ogdie et al. ACR 2021;abstract 1344; 2 BSA, body surface area; HAQ-DI, Health Assessment Questionnaire Disability Index; PASI, Psoriasis Area and Severity Index; PRO, patient-reported outcome; S/TJC, swollen/tender joint count; VAS, visual analog scale; Gossec et al. J Rheumatol. 2018;45:6–13 MDA breakdown2 MDA (Minimal Disease Activity) denotes a patient who has achieved ≥5 of the following 7 criteria: 1. Joints: TJC ≤1 2. Joints: SJC ≤1 3. Skin: PASI ≤1 (or BSA ≤3%) 4. Entheses: Tender entheseal points ≤1 5. PRO: Patient pain VAS ≤15 6. PRO: Patient global activity VAS ≤20 7. PRO: HAQ-DI VAS ≤0.5 % of patients who were MDA responders
Source: © 2023 | Proprietary | MoonLake TX Minimal Disease Activity (MDA) response in ARGO Percent (%) of patients in each arm, ITT-NRI MoonLake Clinical 26 Achievement of leading MDA responses already at week 12 for SLK At week 12, MDA responses of SLK already above what would was observed in data from other products At week 16, the ADA arm was similar to week 12 whereas SLK responses keep increasing – 120 mg close to 50% 44 36 35 41 41 49 36 +8 +13 Note: Comparisons across trials, with inherent limitations. No head-to-head trials. Nominal p-value from a logistic regression with covariates for sex and prior biologic use. All patients have reached week 16, week 24 database to be locked in Q1 2024 1 Estimated from data published for the respective study (Merola et al. Lancet. 2023;401:38–48 BE COMPLETE, McInnes et al. Lancet. 2023;401:25–37 BE OPTIMAL) p=0.02 vs. placebo SLK Best Dose (60mg) ADA ADA BE COMPLETE (Wk 12)1 SLK Best Dose (120mg) ARGO (Wk 12) BE OPTIMAL (Wk 12)1 ADABKZ BKZ ARGO (Wk 16)
Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 27 SLK has highest responses in deep tissue inflammation -10.2 -9.1 -8.4 Nail PsO Severity Index ((m)NAPSI) Note: Comparisons across trials, with inherent limitations. No head-to-head trials. Nominal p-values, from MMRM including co-variates: baseline mNAPSI , sex, prior biologic use, visit, treatment and visit-by-treatment interaction 1 Merola et al. ACR 2023 Abstract #1433 2 Kurt de Vlam et al. ACR 2022 Poster #2151 (estimated from graph) 3 Mease et al. Ann Rheum Dis 2017;76:79–87 (NAPSI and LEI) Mean change from baseline p=0.002 vs. placebo ARGO (Wk 12) SLK Best Dose (120mg) ADA IXE SPIRIT-P1 (Wk 123) Leeds Enthesitis Index (LEI) -1.5 -1.1 -0.9 71 60 Mean change from baseline Percent (%) of pts with LEI 2+ at baseline that improved 2+ pt, ITT-NRI ARGO (Wk 12) SLK Best Dose (120mg) ADA IXE SPIRIT-P1 (Wk 123) Izokibep at Wk 16 (-1.2)2 mNAPSI=0 for SLK is 47% (vs 34% for BKZ at week 161) ARGO (Wk 12) SLK Best Dose (120mg) ADA Leeds Enthesitis Index (LEI)
Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 28 SLK impacts outcomes reported by patients and physicians Physician global assessment of disease (PhGADA) Percent (%) of patients, MMRM PsA Impact of Disease (PsAID-12) Note: Comparisons across trials, with inherent limitations. No head-to-head trials. Nominal p-values vs. placebo. 1 SLK analysis MMRM including co-variates: baseline, sex, prior biologic use, visit, treatment and visit-by-treatment 2 McInnes et al. Lancet. 2023;401:25–37 3 Merola et al. Lancet. 2023;401:38–48 4 Ritchlin et al. Ann Rheum Dis 2023;82:1404–1414 5 Coates et al. ACR 2023 Abstract #2230 Mean change from baseline, MMRM1 SLK continues to impact outcomes that matter for patients, with higher performance versus competitors already at week 12 -2.3 -2.2 -1.8 -2.1 -2.2 p<0.001 vs. placebo SLK Best Dose (60mg) ADA BKZ ADA ARGO (Wk 121) BKZ BE COMPLETE (Wk 163) BE OPTIMAL (Wk 162) -45.2 -36.1 -37.4 -37.3 -39.5 SLK Best Dose (120mg) ADA BKZ ADA ARGO (Wk 121) BKZ BE COMPLETE (Wk 165) BE OPTIMAL (Wk 164) P<0.001 vs. placebo
Source: © 2023 | Proprietary | MoonLake TX Placebo Sonelokimab 60 mg NI Sonelokimab 60 mg Sonelokimab 120 mg Adalimumab (active reference) Patients with events, n (%) 39 41 41 43 42 Any TEAE 15 (38.5%) 12 (29.3%) 14 (34.1%) 17 (39.5%) 14 (33.3%) Any SAE 0 0 1 (2.4%)2 0 0 Any TEAE leading to discontinuation 0 0 0 1 (2.3%)3 0 Fatal TEAE 0 0 0 0 0 Most frequent TEAEs1 Upper respiratory tract infection 1 (2.6%) 3 (7.3%) 2 (4.9%) 1 (2.3%) 1 (2.4%) Injection site erythema (reaction) 0 0 2 (4.9%) 3 (7.0%) 1 (2.4%) Headache 0 0 1 (2.4%) 2 (4.7%) 0 Adverse events of special interest IBD 0 0 0 0 0 Diarrhea 0 0 1 (2.4%) 0 1 (2.4%) Candidiasis Oral Candidiasis 0 1 (2.4%) 1 (2.4%) 0 0 Oropharyngeal Candidiasis 0 0 0 0 0 Esophageal Candidiasis 0 0 0 0 0 Vulvovaginal Candidiasis 0 0 0 0 0 Skin Candidiasis 0 0 0 0 0 Genital Candidiasis 0 0 0 0 0 Other adverse events of interest Serious hypersensitivity 0 0 0 0 0 Serious infection 0 0 1 (2.4%)2 0 0 MACE 0 0 0 0 0 Liver AST/ALT > 5x ULN 0 0 0 0 0 MoonLake Clinical 29 Safety: no notable signals indicating a strong profile in PsA TEAE, treatment emergent adverse event; SAE, serious adverse event 1 Preferred terms (PTs) as per MEDRA (v26); 2 acute appendicitis leading to appendectomy, SAE due to hospitalization, not-related. 3 Patient discontinued at Week 10 due to AE of tonic clonic seizure, not related to treatment. One case with elevated transaminases >3x ULN in adalimumab arm reported as an AE; one case of transient elevated transaminases and CK concurrent with a reported event of exercise-related muscle inflammation in SLK 60 mg
© 2023 | Proprietary | MoonLake TXSource: ▪ From the ARGO trial ― No notable signals and no new signals ― No MACE, no IBD, no malignancies, no SI/B ― mAb-like ISR levels, no liver signals ― Less than 3% oral candidiasis on 60mg, none in 120mg - No discontinuations due to candidiasis ▪ Beyond the ARGO trial ― SLK has a favorable safety profile based on multiple trials (PsO, HS, PsA) involving ~700 pts ― We see no signal of SI/B related to SLK treatment ― We have not observed any signal related to liver enzyme elevations in patients exposed to SLK SLK continues to show a favorable benefit-risk profile MoonLake Clinical 30
Source: © 2023 | Proprietary | MoonLake TX 31 Guidance: What to expect from the second part of the ARGO trial Notes: 1 Randomization stratified by sex and prior exposure to biologics; 2 At Week 0/Day 1, all eligible participants were randomized 1:1:1:1:1; 3 In the cross-over period, starting at Week 12, participants on sonelokimab 120 mg who have not achieved an adequate response will receive adalimumab 40 mg Q2W until Week 24; participants on sonelokimab 60 mg (started at baseline Q2W or Q4W) who have not achieved an adequate response will receive sonelokimab 120 mg Q4W until week 24; participants on adalimumab who have not achieved an adequate response will receive sonelokimab 120 mg Q4W until Week 24; an adequate response is defined as a reduction of the tender and swollen joint count of ≥20%. Participants on placebo will receive sonelokimab Q4W until Week 24 MoonLake Clinical What we are looking for at Week 24 ▪ Early data from wk 16 confirming cross- over of patients from placebo elevates responses – this will be analyzed in Part B ▪ It appears responses on the SLK arms with induction (60 and 120mg) are either maintained or improved at week 16 – this will be determined further in Part B ▪ Specific improvements on switches to monthly dosing also planned to be shared ▪ Results will be shared either through a presentation like today – as of early 2024 – or through a conference ▪ A peer-reviewed publication is expected in due courseFocus of early Q1/Q2-24 results Part B Early 2024 Week 12-24
Source: © 2023 | Proprietary | MoonLake TX A clear path towards Phase 3 MoonLake Clinical 32 ▪ Dose-response pattern in line with findings in plaque-type Psoriasis (PsO, 313 patients) and Hidradenitis Suppurativa (HS, 234 patients) ▪ Doses with optimal benefit-risk profile identified for PsA – 60 mg & 120mg (with induction) ▪ Support of favorable safety profile ▪ Main ARGO study design elements will be replicated in Phase 3 design ▪ Larger trial size (potentially ~800 per trial) expected to reduce variations driven by small groups (e.g., prior biologics in ACR50 PLC) ▪ Endpoints confirmed for Phase3 – ACR50 & PASI90 – but with expected primary endpoint at week 16 ▪ Currently planning two trials ▪ TNF-IR PLC-controlled trial ▪ Bio-naïve PLC- and adalimumab-controlled trial What we already know at week 12 Open points to week 24 ▪ Additional ARGO data to be considered in terms of e.g., expected responses, powering requirements, secondary endpoints ▪ 24-week results also need to be considered, for example impact of weight etc. to determine key sub- groups ▪ Considerations for two doses or dose escalation to address different sub- groups (e.g., with PASI≥10) ▪ ARGO full safety profile to confirm benefit-risk and any adjustments required to inclusion/exclusion
© 2023 | Proprietary | MoonLake TXSource: Research & Clinical Summary The scientific rationale for a unique molecule ▪ SLK has unique IL-17F and A binding properties, a key inflammation MoA ▪ SLK has enhanced tissue penetration, reaching where mAbs cannot ▪ Direct evidence in animal models of differential penetration into joints What ARGO shows – impact of SLK Nanobody® in PsA ▪ ACR50 primary endpoint met with highest scores observed so far ▪ PASI90 secondary endpoint also met with highest scores observed so far ▪ Higher outcomes (ACR70, PASI100) vs current standards ▪ Impact on what matters for patients & physicians: MDA, mNAPSI, LEI, etc. ▪ Favorable safety tolerability profile, as observed previously in other trials Optimal outcome for fast clinical development ▪ Winning dose regimen and endpoints now known for Phase 3 ▪ Builds on HS and PsO data and de-risks next MLTX trials MoonLake Clinical 33 Note: Comparisons across trials, with inherent limitations. No head-to-head trials. SLK binding properties and tissue penetration data have been presented previously
© 2023 | Proprietary | MoonLake TX Moving Forward 34
Source: © 2023 | Proprietary | MoonLake TX PsO Phase 2b 313 Largest delta vs market leader Cosentyx™ at PASI100, compared to BKZ, IL-23, etc. ✓ IL-17A & F IL-23 & IL-17A MoonLake Corporate 35 SLK is a potential leader in large inflammatory diseases Trial Patients (n) SLK leading asset PsA ARGO 24 week data in early 2024, also decisions on other indications Leading MoA HS Highest ever primary endpoint (HiSCR75), largest deltas to placebo, depth of responses Phase 2b (MIRA) 234 ✓ IL-17A & F TNF & IL-17A Other Rheum & Derm IL-17A & F inhibition best data in AS, nr-AxSpA, enthesitis… TBA TBA IL-17A & F Other PsA Highest responses in skin/joints, MoA shows best data Phase 2b (ARGO) 207 IL-17A & F TNF & IL-17A ✓ Placebo-controlled with Cosentyx™ Placebo-controlled with Humira™ Placebo-controlled with Humira™
Source: © 2023 | Proprietary | MoonLake TXDRG, MoonLake Corporate 36 Differentiation: SLK combines properties like no other asset A promising MoA… … and a differentiated molecule ▪ Highest responses IL-17A & F inhibition showed highest & most durable responses (BKZ & SLK) ▪ Favorable safety profile Long history of consistent safety for IL-17, where Candida (“thrush”) is main adverse event – vs. TB, ISRs, cancer, infections, CV events, death… (with TNFα or JAK1) ▪ Improved convenience Monthly 1ml maintenance injections and leading benefit-risk profile ▪ Higher goals Combines higher primary clinical endpoints in comparisons to gold-standards like Humira® (or Cosentyx®) ▪ Elevated Performance SLK shows highest responses at high treatment goals, HiSCR75, IHS4-100, PsO PASI100, PsA ACR50/70+PASI90/100 and key patient outcomes ▪ Leading potential Top 2 typically get 2/3 of indication bio sales (avg. $4bn+)1 Note: Comparisons across trials, with inherent limitations. No head-to-head trials. 1 Based on analysis of 2023 sales of 11 indications (PsO, RA, Asthma, AD, AxSpA, CU, SLE, PsA, COPD, CD, UC) – 2030 ranges are even higher
Source: © 2023 | Proprietary | MoonLake TX Neutrophil Th17 Th22 ILC3 IL-17 IL-22 IL-23 MoonLake Corporate 37 SLK is a potential leader in Type 3 diseases Th2 cell ILC2 Mast cell BasophilTfh Eosinophil IL-4 IL-13 IL-5 IL-31 Type 2 Macrophage Th1 ILC1 NK IL-12 IFN IL-2 IL-6TNF Type 1 Primary immune cells1,2 Key cytokines1-3 Diseases related to dysregulated immunity (examples)4,6 Inflammatory Pathway UC, CD SLE, other CTD Rheumatoid Arthritis Atopic dermatitis Allergic asthma CRSwNP Eosinophilic esophagitis Food allergy, BP PsO, PsA, HS, NR & R Ax-SpA, GPP, PPP, PG, GCA, SSc, Myositis, AIH, Cholangitis, Glomerulosis, A- HCC etc. B cell B cell dominated Pemphigus, ITP Autoinflammatory Other IL-1 IL-36 CAPS, DIRA Note: Simplified depiction based on key published information, not meant to be exhaustive in nature. AD, atopic dermatitis; IFNγ, interferon gamma; IL, interleukin; ILC, innate lymphoid cell; NK, natural killer; Tfh, follicular helper; Th, T helper. 1 Kaiko GE, et al. Immunology. 2008;123:326-338 2 Eyerich K, Eyerich S. J Eur Acad Dermatol Venereol. 2018;32:692-703 3 Raphael I, et al. Cytokine. 2015;74:5-17 4 Nakayama T, et al. Annu Rev Immunol. 2017;35:53-84 5 Coates LC, et al. Semin Arthritis Rheum. 2016;46:291-304 6 Gandhi NA, et al. Expert Rev Clin Immunol. 2017;13(5):425-437. E.g., αTL1A E.g., Dupixent E.g., Sonelokimab Type 3
Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate 38 MLTX has a full set of expected catalysts to year end, more in 2024 2023 Jun 26 HS primary data Successful Ph2b 1ry endpoint at wk 12 SLK shows promising results in all scores incl. innovative HISCR75 & DT100 Fast onset, favorable safety profile December FDA EoP2 meeting November PsA primary data ACR50 and PASI90 scores at week 12 Step up of scores to ACR70 and PASI100 Additional scores of relevance it matters (deep inflammation, disease activity) Choice of dose for Ph3 2024 Expected cash runway beyond Ph 3 results Ph3 readiness expected across indications 800+ patients treated Supply capacity into 3rd year of launch Catalysts throughout the year PsA Ph2b 24-wk Start of HS Ph3 Start of PsA Ph3 FDA EoP2 meeting New Ph2 programs Sep 11 Capital Markets Day Landscape & opportunity in PsA ARGO trial and baseline demonstrating robustness of MLTX trial Guidance on PsA data Guidance on HS 24 wk data, and vs izokibep Oct 16 HS 24-week data Increased response at highest scores with maintenance dosing Confirmation of 120mg as “winning dose” TNF switching to SLK Today
Source: © 2023 | Proprietary | MoonLake TXMoonLake Finance 39 MLTX operates from a position of strength June 30, 2023 September 30, 2023 (preliminary) 501.8 496.0 -5.8 Strong balance sheet with USD 496M in cash, cash equivalents and short-term marketable debt securities as per September 30, 2023 Low cash burn of USD 5.8M in Q3-2023 demonstrating cost-efficient set up and focus of MLTX Expected cash runway until the end of 2026, covering − Completion of ongoing Ph2 programs in HS & PsA − Ph3 program in HS − Ph3 program in PsA − Additional Ph2 program − Submission of BLA − All other base spend 1 Differences may not add up due to rounding Cash, cash equivalents & short-term marketable securities in USD M
© 2023 | Proprietary | MoonLake TXSource: MLTX has the potential to become a leader in I&I MoonLake Corporate 40 ▪ Best in class potential – SLK is a promising molecule as shown by Ph 2b data in HS and PsO, and now the primary endpoint data in PsA ▪ Rarefied air – only 2 molecules can inhibit all IL-17 pro- inflammatory dimers, only SLK combines that MoA with unique molecular characteristics that differentiate it ▪ MLTX = Robust trials – pivotal-like designs provide differentiating insight, esp. in diseases like HS, PsA, PsO & related inflammatory conditions ▪ Potential multi Bn drug – SLK may impact very large markets that are growing fast now, with potential over $70bn, as a leading asset in Type 3 inflammation ▪ Our time – MLTX has key near-term catalysts and is in a position of financial stability and strength
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