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Item 7.01. Regulation FD Disclosure.
On March 10, 2024, MoonLake Immunotherapeutics (the “Company”) issued a press release titled “MoonLake announces significant improvements with Nanobody sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day.”
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit 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 Securities Exchange Act of 1934, as amended (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.
On March 10, 2024, MoonLake Immunotherapeutics (the “Company”) made available the presentation used in the Company’s March 10, 2024 R&D Day on the Company’s website. A copy of the presentation is filed herewith as Exhibit 99.2 and incorporated herein by reference
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. The following exhibit is being furnished herewith:
| Exhibit Number |
Exhibit Title or Description | |
| 99.1 | Press Release, dated March 10, 2024 | |
| 99.2 | Slide Presentation, dated March 10, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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: March 11, 2024 | By: | /s/ Matthias Bodenstedt |
| Name: | Matthias Bodenstedt | |
| Title: | Chief Financial Officer | |
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Exhibit 99.1
MoonLake
announces significant improvements with Nanobody® sonelokimab over 24
weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day
| ● | Positive 24-week data from the ARGO trial of sonelokimab in PsA: |
| o | Significant improvements observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an ACR50 response at week 24 |
| o | Unprecedented multi-domain responses across joints, skin and other domains, including up to 52% of patients achieving ACR50+PASI100 and up to 61% of patients achieving Minimal Disease Activity (MDA), supporting potential best-in-class profile of sonelokimab |
| o | Monthly maintenance with 60mg or 120mg doses showed leading responses above TNF reference arm across all key outcomes including in higher treatment goals (ACR70, PASI100, composites) – 120mg added benefit for specific patient subgroups |
| o | Low discontinuation rate around 5% and safety profile of sonelokimab consistent with previously reported studies with no new safety signals |
| ● | Update on sonelokimab in hidradenitis suppurativa (HS): |
| o | Following interactions with the FDA and EMA, MoonLake intends to commence Phase 3 trials in HS in Q2 2024, under the VELA program; the program is expected to enroll 800 patients and reflect a similar protocol design to that used in the MIRA Phase 2 trial, with top-line primary endpoint data expected as early as mid-2025 |
| o | Real-world data indicates that at least 2 million Americans have been diagnosed with HS as of 2023, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity exceeding $10bn by 2035 |
| ● | MoonLake further announces that it will imminently commence four additional clinical trials of sonelokimab across dermatology, and rheumatology, including innovative trials in palmo-plantar pustulosis, juvenile HS and seronegative spondyloarthritis |
| ● | The Company is hosting an R&D Day on Sunday, March 10 at 09:00 PDT/12:00 EDT/17:00 CET via webcast (registration link below), alongside the American Academy of Dermatology (AAD) annual meeting |
ZUG, Switzerland, March 10, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces that continued treatment with Nanobody® sonelokimab led to significant improvements across all key outcomes at 24-week data from the ARGO trial in psoriatic arthritis (PsA) and other important R&D updates. These updates will be presented and discussed in detail at the Company’s R&D Day to be held today, Sunday, March 10 (see access details below).
Positive 24-week data from the ARGO trial in PsA
The ARGO trial, which involved 207 patients with active PsA, demonstrated that the primary endpoint, the American College of Rheumatology (ACR) 50, continued to improve from week 12 and exceeded 60% by week 24. The more rigorous ACR70 outcome was achieved by approximately 40% of patients by week 24. In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively. Both doses of sonelokimab yielded similar results. The responses surpassed those for adalimumab, the active reference arm in the study, and were also higher when indirectly compared to competitors using the same active reference arm as a standard.
Treatment with sonelokimab resulted in unprecedented improvements in composite scores that reflect responses in different domains simultaneously. ACR50+PASI90 up to 59%, ACR 50+PASI 100 up to 52%, ACR 70+PASI 100 up to 48% and MDA up to 61% response. In all composite scores, sonelokimab showed 16-29 percentage point differences to the reference adalimumab arm, comparatively higher to competitors using the same reference arm. While the 60mg dose was found to be sufficient to reach high levels of response in the general trial population, the 120mg dose was found to improve responses further in specific patient sub-groups, which suggests two doses being carried over to Phase 3.
The safety profile of sonelokimab was consistent with previous trials with no new safety signals detected. The discontinuation rate of the second part of ARGO remained low at 5%, in line with other sonelokimab trials. Overall, sonelokimab continues to show a favorable safety profile. Across the sonelokimab clinical program to date, the company has not seen any signal of suicide ideation/behavior (SI/B) or liver enzyme elevations related to sonelokimab treatment.
Kristian Reich, MD, PhD, Founder and Chief Scientific Officer at MoonLake, commented: “These positive results from the ARGO trial at week 24, showing that continued treatment with sonelokimab led to significant improvements across all key outcomes, reinforce the advantages of using a smaller biologic with albumin-binding capability to effectively inhibit IL-17F in addition to IL-17A for the treatment of deep tissue inflammation. We are particularly grateful to the patients and investigators who participated in our Phase 2 program and look forward to initiating our Phase 3 trials in PsA and HS this year.”
Professor Joseph F. Merola, MD, MMSc, Founding President of the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network Consortium (PPACMAN), added: “There is a vital need for new treatment options for psoriatic arthritis - a chronic, inflammatory, recurrent, and debilitating multidomain disease that has profound impact across many aspects of patients’ lives. It is highly encouraging to see that the positive high clinical responses across joint and skin endpoints and stringent composite measures, such as minimal disease activity, observed as early as week 12 with sonelokimab were further increased through week 24.”
The 24-week results build upon the 12-week results announced in November 2023. Full results from the ARGO trial will be submitted for publication in a peer-reviewed medical journal. Sonelokimab is not yet approved for use in any indication.
HS positive regulatory status and market opportunity
MoonLake has recently announced the successful outcome of its end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA) the E.U. European Medicines Agency (EMA), with both regulatory bodies supporting MoonLake’s proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab in hidradenitis suppurativa (HS). During the R&D Day, the Company will provide further details on trial design, expectations for the single 120mg dose being tested and timelines for this program, named VELA which is set to enroll 800 patients.
Furthermore, the Company will share findings from a recent analysis of US real-world data pertaining to the HS market.i It revealed that between 2016 and 2023, two million unique patients were diagnosed and treated for HS, with an average of 240,000 new patients each year as per claims. This corresponds to a ~1% prevalence of diagnosed and treated patients, aligning well with estimates that over 2% of the population, including those undiagnosed and untreated, have HS. These real-world data also substantiate a potential market size exceeding $10bn by 2035. Notably there is a low penetration of current biologics (around 3%) and a high dropout rate from treatment with current biologics within the first year (median of 11 months). Moreover, claims show that HS patients are lost in their treatment journey (e.g., more than 50-60% of patients are on long term on antibiotics and many of them are also on steroids / opioids, and 15% of patients receive surgery in year 1) representing a bleak prognosis for patients, physicians, and healthcare systems. This real-world perspective substantiates the company’s market size estimates and highlights the need for more effective therapies.
Professor Kenneth B. Gordon, Chair of Dermatology at the Medical College of Wisconsin, commented: “The positive data that is being generated for the Nanobody® sonelokimab across chronic inflammatory indications, including HS, is raising the bar on the level of outcomes that can be achieved for patients. Patients are waiting for new treatment options with a prolonged effect, and the start of the Phase 3 trials is bringing hope that sonelokimab could be a promising potential option to the many patients that live and suffer with HS, a disease that has not received the attention it deserves until recently.”
New indications
MoonLake further announces that it will imminently commence four additional development programs, across dermatology and rheumatology where IL-17A and IL17-F inhibition in deep tissues has the opportunity to lead among all therapies.
| i | © 2023 Komodo Health, Inc. All rights reserved. Reprinted with permission. |
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In dermatology, Phase 2 work is expected to be initiated in palmo-plantar pustulosis (PPP), a debilitating disease affecting a significant number of patients (estimated 0.3% prevalence) and for which there are no currently approved therapies. This new indication will strengthen MoonLake’s standing within the dermatology community. Furthermore, MoonLake expects to initiate a Phase 3 trial in juvenile HS a disease that typically begins at this early stage of a patient’s life, and also the period in which irreversible damage and inflammatory remission is most critical. It is anticipated that this trial will run concurrently with MoonLake’s adult Phase 3 program, marking the first time clinical trial evidence is generated specifically for this demographic.
In rheumatology, MoonLake will also extend its development work in seronegative spondyloarthritis. Phase 2 work in radiographic and non-radiographic axial spondyloarthritis (axSpA) is expected to start this year, with trials featuring an innovative design complementing traditional clinical outcomes with modern imaging techniques, adding two new indications to the pipeline. The Company plans to also run an additional trial in PsA, to link the impact of sonelokimab in traditional clinical outcomes (e.g., ACR50) with objective imaging measurements in different domains. The new axSpA and PsA studies are designed to employ cutting-edge MRI-PET imaging.
Jorge Santos da Silva, PhD, Founder and Chief Executive Officer at MoonLake, said: “The robust data that we continue to amass with our Nanobody® shows that sonelokimab has the potential to be a best-in-class product in the fast-growing inflammation field, providing us with conviction to help even more patients by expanding into further indications beyond HS and PsA. With the positive feedback received to date from the FDA and EMA, together with our strong financials, we are now rapidly pursuing plans to commence Phase 3 trials in both HS and PsA before the end of this year and are expanding the development pipeline with the aim of elevating care with our next-level therapies via truly innovative clinical trials.”
R&D Day today, Sunday, March 10
MoonLake will hold an R&D Day today, Sunday, March 10 alongside the AAD annual meeting. The event will take place from 09:00 – 11:30 PDT/12:00 – 14:30 EDT/17:00 – 19:30 CET at Hotel Westin Bayview, San Diego and will be webcast for virtual attendees.
The R&D Day will highlight the 24-week ARGO data, discuss regulatory interactions and paths to Phase 3, and other important business updates from MoonLake’s executive team including:
| ● | Analysis of the HS and PSA market opportunities and leadership potential for sonelokimab. |
| ● | Pipeline updates and details of additional catalysts for 2024 and 2025, including new indications to be pursued. |
| ● | Summary and financials. |
The event will feature presentations from leading clinicians in dermatology and rheumatology. Professor Joseph Merola, Chair of Dermatology, Professor of Dermatology, Medicine and Rheumatology, UT Southwestern Medical Center 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. A recording and additional details will be available on the Events & Presentations section of the Company’s website at www.ir.moonlaketx.com.
Late breaker presentation of the 24-week data from the MIRA trial in HS at the AAD
As announced in March 2024, the 24-week data from the Phase 2 MIRA trial with Nanobody® sonelokimab in moderate to severe HS, will be presented by Professor Brian Kirby MD, FRCPI on March 10 at 14:00 PDT/ 17:00 EDT / 22:00 CET during the late breaking research session 2 (S050) in room 20B at the AAD Annual Meeting, taking place from March 8-12, in San Diego, California.
- Ends -
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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 Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests
as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated
inflammation can result in irreversible tissue destruction and scarring. The disease affects 0.05–4.1% of the global population,
with three times more females affected than males. Onset typically occurs in early adulthood and HS has a profound negative impact on
quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A-
and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette
smoking, and obesity.
About the MIRA trial
The MIRA trial (M1095-HS-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate-to-severe hidradenitis suppurativa. The trial 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: https://www.clinicaltrials.gov/ct2/show/NCT05322473
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.
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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 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).
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; including the initiation of clinical programs in new indications; anticipated support from regulatory agencies with respect to the Company’s development plans, anticipated size and timing of enrollment for the VELA trial, the sufficiency of data from the VELA trial to support regulatory filings in the US and EU, the anticipated trial design for the VELA trial and the timing of expected readouts; our expectations regarding the potential market size for HS; the Company’s plans with respect to the commencement of a Phase 3 trial in PsA; 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.
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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, 2023 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.
MoonLake Immunotherapeutics Investors
Matthias Bodenstedt, CFO
info@moonlaketx.com
MoonLake Immunotherapeutics Media
Patricia Sousa
media@moonlaketx.com
ICR Consilium
Mary-Jane Elliott, Namrata Taak, Ashley Tapp
Tel: +44 (0) 20 3709 5700
MoonLake@consilium-comms.com
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Exhibit 99.2
W: moonlaketx.com | E: info@moonlaketx.com © 2024 | Proprietary | MoonLake TX MoonLake Immunotherapeutics March 10 th 2024 R&D Day San Diego, during AAD
Welcome to our R&D Day Agenda Sub - topics Topic Speaker Timing Date: March 10th, 2024 Time: 09.00 - 11:30 PST Location: Westin San Diego Bayview (Webcast also available) Logistics - Welcome & session details Introduction Matthias Bodenstedt 5 mins - PsA, a multi - domain challenge - SLK in a competitive context - ARGO data read - out (24 weeks) - Next steps on Ph 3 program PsA Going beyond in Rheumatology Prof. Joseph Merola Kristian Reich 40 mins - HS, a devastating disease - The MIRA data in context Source: MoonLake Corporate © 2024 | Proprietary | MoonLake TX 2 HS A franchise in Derm Prof. Ken Gordon Kristian Reich Jorge Santos da Silva building indication - Regulatory feedback & Ph 3 program - Market size & potential 20 mins Jorge Santos da Silva - Unlocking the value of SLK - New Indications - Path forward catalysts 2024/2025 New frontiers for SLK and MLTX 5 mins Matthias Bodenstedt - Financials & next steps - Next steps for MLTX Moving Forward To end Q&A session 40 mins
Disclaimer Source: MoonLake Corporate © 2024 | Proprietary | MoonLake TX 3 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 preclinical studies, clinical trials and research and development programs ; the anticipated timing of the results from those studies and trials ; potential market opportunities, estimates of market size, and estimates of market growth ; potential indications ; the timing of regulatory meetings ; the occurrence and timing of market engagement ; expectations regarding the time period over which our capital resources will be sufficient to fund our anticipated operations ; the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts ; and effects on liquidity and capital resources, including cash position . 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 . Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in the section entitled “Risk Factors” and “Cautionary Statement Regarding Forward - Looking Statements” in our Annual Report on Form 10 - K that was filed with the U . S . Securities and Exchange Commission (the “SEC”) on February 29 , 2024 , as well as factors associated with companies, such as MoonLake Immunotherapeutics, that operate in the biopharma industry . 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 .
Instructions for this session Please take note of the disclaimer on the previous page You can submit your questions through the Q&A function – questions are only visible to the moderators – we will address as many questions as possible at the end of this session The presentation and a replay will be made available on our IR website For any technical issues during the webcast, also use the Q&A function to request support Other requests should be directed to ir@moonlaketx.com or media@moonlaketx.com Source: MoonLake Corporate © 2024 | Proprietary | MoonLake TX 4
© 2024 | Proprietary | MoonLake TX Source: Founded in 2021 in Switzerland Nanobody ® technology Iicensed in initial private round Unique molecule with sonelokimab , tri - specific IL - 17A & IL - 17F Nanobody ® to elevate treatment in inflammation in a $40bn+ market Public on Nasdaq since April 2022 and ~$750m raised to date Clinical phase company successfully concluded phase 2b studies in psoriasis (n=313), HS (“MIRA”, n=234), and PsA (“ARGO”, n=207) Commencing Phase 3 programs in 2024 with first commercial launches expected in 2027 Driven by a top - tier team, target is to unlock a pipeline - in - a - product across large indications from 2023 (> $ 5 bn in HS & PsA alone) MoonLake Corporate
A differentiated molecule – Do you still Antibody? Sonelokimab is a ~40kDa humanized Nanobody® consisting of three VHH domains covalently linked by flexible spacers - around a quarter of the size of traditional antibodies With 2 domains, it binds with high affinity to IL - 17A and IL - 17F – a third domain binds human albumin Subcutaneous administration, Q4W IL - 17A & IL - 17F Nanobodies® are much smaller than traditional antibodies They can be designed to have multiple and different binding domains Source: MoonLake Research © 2024 | Proprietary | MoonLake TX 6
It’s all about the dimers IL - 17A and IL - 17F function as dimers to drive inflammation, through activation of IL - 17RA & RC receptor complexes Different IL - 17RA & RC chains combine to form complexes, and those have different affinity for different dimers 1,2 Not all IL - 17 - targeting therapeutics can inhibit IL - 17A/A, IL - 17A/F and IL - 17F/F dimers A/A A/F F/F Illustrative Dimer affinity of receptor A/A F/F 1 Liu S, et al. Nat Commun. 2013;4:1888; 2 Goepfert A, et al. Immunity. 2020 Mar 17;52(3):499 - 512 SLK is the only asset that binds all dimers and with similar affinity Source: MoonLake Research © 2024 | Proprietary | MoonLake TX 7
Source: © 2024 | Proprietary | MoonLake TX PsA incl. critical composite scores Phase 2b (ARGO) Placebo - controlled with Humira 207 IL - 17A & F TNF & IL - 17A x Highest responses in skin/joints, MoonLake Corporate 8 SLK rapidly becoming a leader in large inflammatory diseases Trial Patients (n) SLK leading asset PsA ARGO 24 - eek data presented today, also information on other indications Leading MoA HS Highest ever primary endpoint placebo, depth of responses Phase 2b (MIRA) Placebo - controlled with Humira 234 x (HiSCR75), largest deltas to IL - 17A & F TNF & IL - 17A Other Rheum & Derm IL - 17A & F inhibition best data in AS, nr - AxSpA, PPP… TBA TBA IL - 17A & F Other PsO Phase 2b Placebo - controlled with Cosentyx 313 Largest delta vs market leader compared to BKZ, IL - 23, etc. x Cosentyx at PASI100, IL - 17A & F IL - 23 & IL - 17A
© 2024 | Proprietary | MoonLake TX PsA Going beyond in Rheumatology 9
© 2024 | Confidential and Proprietary | MoonLake TX 10 PsA – A multidomain challenge Prof. Joseph F. Merola
11 © 2024 | Proprietary | MoonLake TX Prof. Merola is a consultant and/or investigator for Amgen, Boehringer Ingelheim, Bristol - Myers Squibb, AbbVie, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Sun Pharma, Biogen, Pfizer, MoonLake Immunotherapeutics Disclosures
12 PsA is a multidomain disease, involving joints and skin 1 https:// www.psoriasis.org/psoriasis - statistics/ Accessed Mar 2024 2 Merola et al Dermatol Ther 2023;13:2635 – 2648 3 Luce et al AAD 2024;Poster 50361 4 Coates et al Nat Rev Rheumatol 2022;18:465 – 479 | Dactylitis and nai/skin images courtesy of Prof. Joseph F. Merola and Prof. Kristian Reich, respectively (please do not reproduce) | Other images reproduced (CC - BY licenses) from Mochizuki et al Case Rep Rheumatol 2018:2018:4216938, Jurik Insights Imaging 2011;2:177 – 191, McQueen et al Arthritis Res Ther 2006;8:207 5 Gossec et al J Rheumatol 2018;45:6 – 13 PsA is a multidomain disease Treatments are assessed using clinical and patient - reported outcomes across domains Key clinical endpoints Joints and skin 4 Other clinical domains 4 Axial Enthesitis Nail Dactylitis Patient - reported outcomes 5 Function e.g. HAQ Pain e.g. VAS Disease severity e.g. PGA Multidomain composite outcomes 5 Multidomain composite outcomes are used with increasing prominence in clinical trials to assess treatment impact simultaneously across domains MDA Minimal Disease Activity = ≥5 out of 7 stringent multidomain outcomes Tender joints Swollen joints Skin lesions Tender HAQ Pain PGA entheses ACR + PASI Response in joints + skin Can we elevate to ACR70 + PASI 100? ACR50 PASI100 © 2024 | Proprietary | MoonLake TX
41% already had joint symptoms, but in most cases had not discussed treating these symptoms with their doctor 6 13 PsA is common and often underdiagnosed — and undertreated 1 Johns Hopkins Medicine [https:// www.hopkinsarthritis.org/arthritis - info/psoriatic - arthritis ] Accessed Mar 2024 2 National Psoriasis Foundation [https:// www.psoriasis.org/psoriasis - statistics ] Accessed Mar 2024 3 Merola et al Dermatol Ther 2023;13:2635 – 2648 4 Mease et al. J • 1.5 million Americans are thought to be living with PsA 1 30% of patients with PSO progress to a PsA diagnosis 2 • 47% of patients already have musculoskeletal symptoms at PSO diagnosis 3 PsA is common New research at AAD 2024 Among surveyed US patients with PSO: ~2 in 5 patients diagnosed with PsA are not on biologics in a recent international survey 5 ~2 in 5 patients with PsA were underdiagnosed in the PREPARE non - interventional study 4 However, PsA is often underdiagnosed or undertreated 41% 41% Am Acad Dermatol. 2013;69:729 – 35 5 Tillett et al. Rheumatol Ther. 2020;7:617 – 37 6 Luce et al AAD 2024;Poster 50361 © 2024 | Proprietary | MoonLake TX
14 The symptom burden of PsA leads to substantial work impairment Using treatments that better resolve symptoms will have wide - ranging benefits for patients and society A >30% and >25% prevalence in PsA of anxiety and depression 2 4 in 5 patients report fatigue, 3 with a major impact on physical activity 1 Shadick et al ACR 2023;Poster 0488 2 Vestergaard et al RMD Open 2024;10:e003412 3 Gossec et al J Rheumatol 2022;49:1221 – 8 4 Haugeberg et al Arthritis Res Ther 2020;22:198 5 Gossec et al Ann Work impairment among patients with PsA in the COPPAR registry (N=113) 1 44 % • Fatigue , pain, anxiety , depression and disturbed sleep 1,5,6 are interconnected symptoms 4 linked to work impairment • Multidomain disease 7 is also associated with work impairment, including skin , polyarticular , and entheseal involvement Functional impairment Anxiety Fatigue Pain Depression Disturbed sleep Rheum Dis 2020;79 (suppl 1):AB0821 6 Spindler et al J Am Acad Dermatol 2021;85:910 – 922 7 Walsh et al Joint Bone Spine 2023;90:105534 © 2024 | Proprietary | MoonLake TX
15 High clinical response in skin, in addition to joints, is critical for patients Image credits: skin — courtesy of Prof. Kristian Reich, joints — Mochizuki et al Case Rep Rheumatol 2018:2018:4216938 1 Quality of life data from 402 patients with PsA and moderate - to - severe skin involvement (≥3% BSA) after 24 weeks on It is critical to assess treatment response in both joints and skin to make the biggest difference to patients Multidomain PsA leads to more pronounced QoL impairment 2 • A greater risk of flare • More substantial work impairment • Higher rates of anxiety and depression • Worse overall quality of life scores Joints DAPSA response Skin PASI response Biggest QoL impact 1 – 10 0 10 20 30 QoL improvement Change in EQ - 5D - VAS ACR + PASI Assess response in both joints + skin therapy/placebo in the SPIRIT Phase 3 clinical study program (heat map image reproduced with permission from Prof. Merola) | Kavanaugh et al Arthritis Rheumatol 2017;69(suppl 10);AB2539 2 Tillett et al Rheumatol Ther 2020;7:617 – 37 © 2024 | Proprietary | MoonLake TX
16 Most patients currently do not achieve MDA, even with biologics Treatment ceiling in PsA: advances in PsA treatment have led to success in some domains, but achievement of MDA with biologics remains challenging, even for newer therapies % of patients who achieved MDA in a US real - world study Patients who do not achieve MDA may also have a higher overall disease burden, e.g.: 2 More fatigue Worse physical function Worse mental function Greater quality of life impact >3 in 4 patients do not achieve MDA within 6 months of biologic initiation 1 77% did not achieve MDA 1 Data from the CorEvitas registry (N=1,251); Ogdie et al ACR 2021;abstract 1344 2 Coates et al RMD Open 2019;5:e001002. © 2024 | Proprietary | MoonLake TX
Radiographic progression Nails Dactylitis Enthesitis Axial 17 Psoriasis Peripheral arthritis Preferred biologic(s) 1 IL - 17i TNFi IL - 12/23i IL - 23i IL - 17i is the only biologic class preferred in all clinical domains of PsA 1 Preferred biologic classes are based on the expert interpretation of clinical study results by Prof. Merola, Dactylitis and nai/skin images courtesy of Prof. Joseph F. Merola and Prof. Kristian Reich, respectively (please do not reproduce) | Other images Skin Joints Other domains reproduced (CC - BY licenses) from Mochizuki et al Case Rep Rheumatol 2018:2018:4216938, Jurik Insights Imaging 2011;2:177 – 191, McQueen et al Arthritis Res Ther 2006;8:207 © 2024 | Proprietary | MoonLake TX
49 62 46 67 Week 16 ITT - NRI Week 48 ITT - NRI SEC A only BKZ A+F SEC A only BKZ A+F +13 Improvement 18 Can we optimize IL - 17 inhibition? PASI 100 BE RADIANT Phase 3b H2H BKZ vs SEC 1 IL - 17A - only inhibitor Secukinumab mAb IL - 17A+IL - 17F inhibitor Bimekizumab mAb As the class of choice for addressing all domains in PsA, innovation on MOA is centered on optimizing IL - 17i , based on increasing evidence that IL - 17F drives psoriatic inflammation alongside IL - 17A… Inhibition of both IL - 17A+IL - 17F provides greater benefits in skin vs. inhibition of IL - 17A only A study in patients with moderate - to - severe psoriasis; only a subset of participants had PsA and the clinical significance of the findings is unclear (there are no head - to - head studies of these two MOAs in PsA); Reich et al N Engl J Med. 2021;385:142 – 52 P<0.001 P<0.001 +19 Skin: Plaque psoriasis (Moderate - to - severe) Primary endpoint: PASI 100 at Week 16 Image of skin courtesy of Prof. Kristian Reich © 2024 | Proprietary | MoonLake TX
3 41 PLC ADA ref BKZ 10 46 44 PLC ADA ref BKZ 19 IL - 17A and IL - 17F dual inhibition is a newly validated MOA in PsA Bimekizumab IL - 17A and IL - 17F inhibitor (160 mg Q4W) | BE OPTIMAL (Phase 3 PsA ) 1 1 NRI, non - responder impuation; McInnes et al Lancet 2023;401:25 – 37; 2 Merola et al Lancet 2023;401:38 – 48 ▪ Patients enrolled in the study were biologic - naïve — similar results were seen a TNF - IR study 2 Primary endpoint Key secondary endpoint Multidomain endpoint ACR 50 (joints) PASI 90 (skin) MDA 61 13 45 45 ADA ref BKZ PLC Week 16 NRI - ITT Inhibition of both IL - 17A and IL - 17F provided high levels of skin + joints responses at Week 16 © 2024 | Proprietary | MoonLake TX
20 Sonelokimab is a novel humanized Nanobody ® targeting IL - 17A+IL - 17F Anti - IL - 17A Anti - albumin Anti - IL - 17A or IL - 17F A A A F F F Inhibits IL - 17A/A, IL - 17A/F, and IL - 17F/F dimers Sonelokimab Nanobody ® ~40 kDa 1,2 © 2024 | Proprietary | MoonLake TX IL, interleukin; mAb, monoclonal antibody; PASI, Psoriasis Area and Severity Index. 1. Papp KA, et al Lancet. 2021; 397:1564 – 1575; 2. Svecova D, et al J Am Acad Dermatol . 2019; 81:196 – 203. Sonelokimab Phase 2b in psoriasis 1 • Rapid and durable skin clearance (PASI 100) with no unexpected safety findings As a Nanobody ® , sonelokimab (SLK) is designed to penetrate difficult - to - reach tissues and directly target sites of inflammation: 1,2 • Small size (~40 kDa vs. ~150 kDa for a conventional mAb) • Albumin - binding domain to extend half - life and target sites of inflammation
21 SLK achieved high levels of response in joints and skin by Week 12 Sonelokimab IL - 17A and IL - 17F inhibitor (Nanobody) | ARGO (Phase 2 PsA ) ▪ Both bio - naïve and - experienced patients were enrolled in the study Inhibition of IL - 17A and IL - 17F with a Nanobody showed promising efficacy in both skin + joints Week 12 NRI - ITT 15 50 77 20 43 46 PLC N=40 ADA ref N=42 SLK 60 mg N=41 Primary endpoint ACR 50 (joints) Key secondary endpoint PASI 90 (skin) PLC N=26 © 2024 | Proprietary | MoonLake TX ADA ref N=32 SLK 60 mg N=26
22 The SLK Nanobody ® also showed promising responses in composite scores 8 16 27 ADA ref SLK 60 mg PLC Sonelokimab ARGO Week 12 ITT - NRI SLK treatment provided a multidomain response in the ARGO trial that met stringent, high - threshold endpoints such as MDA and ACR 70 + PASI 100 Multidomain endpoint Joints + skin composite MDA ACR 50 + PASI 100 Higher threshold ACR 70 + PASI 100 8 22 31 PLC ADA ref SLK 60 mg 20 44 36 0 10 20 30 40 50 0 4 8 12 % participants Weeks SLK 60 mg ADA ref Placebo © 2024 | Proprietary | MoonLake TX
23 © 2024 | Proprietary | MoonLake TX Summary Week 12 data in the ARGO trial set high expectations of continuing increases in key endpoints, as well as multidomain composites , to Week 24 with SLK treatment • Unmet need across multiple domains demands novel PsA therapies • MDA is a PsA - specific , stringent endpoint that sets a high bar across domains , while ACR + PASI composites allow simultaneous assessment of key domains • IL - 17A + IL - 17F inhibition has the potential to optimize outcomes across PsA domains, including MDA and joint + skin composites • Sonelokimab is designed to combine the ‘ best of both worlds ’: IL - 17A + IL - 17F inhibition, mediated by a small, albumin - binding Nanobody ® • In the Phase 2 ARGO trial, inhibition of IL - 17A + IL - 17F with the Nanobody ® sonelokimab led to high levels of multidomain response by Week 12, with no sign of plateauing
© 2024 | Confidential and Proprietary | MoonLake TX 24 ARGO trial 24 wk data Kristian 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 Source: MoonLake Medical, Clinical pictures K. Reich © 2024 | Proprietary | MoonLake TX 25 PsA: IL - 17F dependent multi - domain disease in difficult - to - reach tissues …with 3x IL - 17F vs IL - 17A 1 … IL - 17A PsA IL - 17F PsA Nail psoriasis Axial disease Enthesitis Dactylitis …and causing devastating damage (PsA starts as enthesitis 2 , with IL - 17F producing cells in associated plaques 3 and axial disease 4 - 6 , and with 80% of patients suffering from nail psoriasis 7 ) Plaques Nail Psoriasis Joint & spine disease PsA is a multi - domain deep - tissue disease… Disease Activity Psoriasis PASI 90 Peripheral arthritis ACR50 USD bn sales beyond 2030 10% skin involvement in PsA patients – severe skin disease Global prevalence 0.5% 10+ 80% or more patients with multiple disease domains 20% is still standard ACR level of improvement Market size Unmet Needs
ARGO: Phase 2 trial design Key design elements of ARGO ▪ 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 ▪ SLK 120mg and SLK 60mg reached stat sig at wk 12 ▪ Group 3 (“ SLK 60mg NI ”, no induction) had not reached stat sig at wk 12 ▪ Some crossover arms not analyzed separately (small samples, 5 - 7 pts/arm) 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 Q 2 W until Week 24 ; participants on sonelokimab 60 mg (started at baseline Q 2 W or Q 4 W) who did not achieve an adequate response switched to sonelokimab 120 mg Q 4 W until week 24 ; participants on adalimumab who did not achieve an adequate response switched to sonelokimab 120 mg Q 4 W 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 Q 4 W until Week 24 Focus of today’s results SLK 120mg ADA 40mg SLK 60mg PLC SLK 60mg NI Part B Week 24 results Results of Nov 6 th 2023 Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 26
Disposition: The ARGO trial had a drop - out of rate of 5% in Part B Disposition (Part A+B) Part B Database lock 7th February 2024. AE =Adverse Event, Wdw by S = Withdrawal by Subject; Completed Part A = completed treatment up to Week 10 and completed assessments to Week 12; 3 patients did not subsequently enter part B; 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; 5: 3 x AE; 6: 1 1x Wdw by S; 7: 1 x AE 1x Wdw by S; 8: 1 x PD 1 x Wdw by S; 9 1 x AE 1 x PD 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) Discontinued (3) 1 Discontinued (0) Discontinued (1) 2 Discontinued (2) 3 Completed Part A: Completed Part A: Completed Part A: Completed Part A: 41 41 40 41 43 Sonelokimab (SLK) 120mg Discontinued (1) 4 Completed Part A: 37 37 SLK 120mg Completed Part B: 34 Discontinued (3) 5 34 SLK 60mg 5 SLK 120mg Discontinued (0) Discontinued (1) 6 Completed Part B: 38 34 SLK 60mg 5 SLK 120mg Discontinued (0) Discontinued (0) Completed Part B: 39 36 SLK 120mg Completed Part B: 39 Discontinued (2) 7 Discontinued (0) 5 Adalimumab 34 Adalimumab 7 SLK 120mg Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 27 Discontinued (2) 8 Discontinued (2) 9 Completed Part B: 37
46.3 61.0 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Weeks ACR70 response (Secondary endpoint) 70 +15pp 29.3 25.6 43.2 0 2 4 6 8 10 12 14 16 18 20 22 24 0 50 +16pp SLK efficacy in joints continues to improve to wk 24, with high responses Percent (%) pts reaching score, NRI 1 Cross overs Weeks Cross overs Percent (%) pts reaching score, NRI 1 ARGO (NRI 1 ) BE OPTIMAL 2 (NRI) Note: Comparison across trials have inherent limitations. No head - to - head trials 1 ITT - NRI up to Week 24, except that participants who were re - assigned from their original treatment arm at Week 12 as per protocol had last observation carried forward from W12 W24 SLK 60 W12 W24 SLK 120 W12 W24 PLC - > SLK 120 W12 W24 ADA W16 W24 BKZ W16 W24 ADA W12 W24 SLK 60 W12 W24 SLK 120 W12 W24 PLC - > SLK 120 W12 W24 ADA W16 W24 BKZ W16 W24 ADA PLC SLK 60mg ACR50 response (Primary endpoint) SLK 120mg PLC - >SLK 120mg Cross - trial comparison to BKZ 46 47 22 43 44 46 61 58 54 55 45 47 +6 - 2 29 26 24 28 39 42 43 36 29 14 29 30 +6 - 1 Week 12 onwards; 2 Ritchlin et al. Ann Rheum Dis 2023;82:1404 – 1414 BE OPTIMAL; Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 28
Skin outcomes continue to improve to wk 24, beyond competitors PASI90 response Percent (%) pts reaching score, NRI 1 57.7 63.0 75.0 0 4 8 12 16 20 24 Weeks 0 90 15.4 48.1 Percent (%) pts reaching score, NRI 1 Cross overs PASI100 response Cross overs PASI response rates with SLK continue to increase to week 24 - clinical response has not plateaued Placebo crossover arms achieve 83% PASI90 and 75% PASI100 rates after just 12 weeks of SLK treatment Deltas between SLK dose and adalimumab at wk 24 up to 27% for PASI90 and 25% for PASI100 SLK 60mg & 120mg numerically outperform adalimumab on every PASI score tested at wk 24 (as well as ACR) SLK responses are numerically higher than observed with BKZ , (73% PASI90 and 56% PASI100 in BE OPTIMAL at wk 24) 2 20 24 Weeks 76.9 70.4 83.3 0 90 0 4 8 15.4 59.3 12 16 PLC Note: Comparison across trials have inherent limitations. No head - to - head trials 1 Subset of participants with BSA >=3% at baseline, ITT - NRI up to Week 24, except that participants who were re - assigned from their original treatment arm at Week 12 as per protocol had last observation carried forward from Week 12 onwards 2 2 Ritchlin et al. Ann Rheum Dis 2023;82:1404 – 1414 BE OPTIMAL Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 29 SLK 60 SLK 120 PLC - >SLK 120
Most patients meet both joint & skin outcomes – a differentiated profile 31 33 8 22 23 16 46 52 42 34 31 25 +18pp +6pp +11pp +7pp Patients reaching both ACR50 and PASI90 Patients achieving both ACR50 and PASI100 Percent (%) pts reaching score, NRI 1 Percent (%) pts reaching score 42 44 8 25 58 59 46 38 +22pp BE OPTIMAL 2 ARGO ARGO (NRI) (NRI 1 ) (NRI 1 ) 120mg W12 W24 W12 W24 W12 W24 W12 W24 W12 W24 W12 W24 W24 W12 W12 W24 W12 W24 W12 W24 ADA BKZ ADA PLC - >SLK SLK 120 SLK 60 ADA PLC - >SLK 120 SLK 120 SLK 60 Delta grew from 11pp to 18pp between SLK and adalimumab by week 24, a pattern not seen with BKZ in BE OPTIMAL Note: Comparison across trials have inherent limitations. No head - to - head trials 1 Subset of participants with BSA >=3% at baseline, ITT - NRI up to Week 24, except that participants who were re - assigned from their original treatment arm at Week 12 as per protocol had last observation carried forward from Week 12 onwards; 2 Ritchlin et al. Ann Rheum Dis 2023;82:1404 – 1414 BE OPTIMAL Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 30
SLK efficacy is further shown with a higher the treatment goal Almost 50% of patients reach both ACR70 & PASI100 with SLK At week 24 delta to adalimumab in this high bar composite score is close to 30pp Strong signal of elevated efficacy vs adalimumab 2 on this higher hurdle endpoint 1 Subset of participants with BSA >=3% at baseline, ITT - NRI up to Week 24, except that participants who were re - assigned from their original treatment arm at Week 12 as per protocol had last observation carried forward from Week 12 onwards; Patients reaching both ACR70 and PASI100 Percent (%) pts reaching score, NRI 1 27 22 8 16 35 48 38 19 +29pp 2 Nominal p value, post - hoc analysis (p<0.05), study not powered for statistical comparison between SLK and ADA arms Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 31 W12 W24 SLK 60 W12 W24 SLK 120 ADA W12 W24 W12 W24 PLC - >SLK 120
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 Source: Prof Joseph Merola © 2024 | Proprietary | MoonLake TX 32 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 initiation 1 Achievement of MDA clinical responses with any biologic remains low MDA breakdown 2 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
44 37 36 61 51 62 45 22 3 +16pp Impact of SLK on MDA is clear: 60%+ of patients reach this high goal Patients reaching Minimal Disease Activity (MDA) Percent (%) pts reaching score 42 41 48 48 0pp BE OPTIMAL 2 (NRI) Note: Comparison across trials have inherent limitations. No head - to - head trials 1 ITT - NRI up to Week 24, except that participants who were re - assigned from their original treatment arm at Week 12 as per protocol had last observation carried forward from Week 12 onwards; 2 Ritchlin et al. Ann Rheum Dis 2023;82:1404 – 1414 BE OPTIMAL; 3 Differs from the overall PLC rate at Week 12 (20%) because this includes only those participants who were crossed over to SLK 120mg at W12 Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 33 W12 W24 SLK 60 ADA W12 W24 SLK 120 W12 W24 PLC - >SLK 120 ARGO (NRI 1 ) W12 W24 BKZ W12 W24 ADA SLK brought over 50% of patients to MDA response across arms , higher than has been seen in previous PsA trials Delta to adalimumab was observed (up to 16pp) within the trial, which has not been the case with BKZ in the trial that incl. the same reference arm W12 W24
SLK also shows higher responses in deep - tissue at wk 24 73 65 50 61 56 SLK 60 SLK 120 PLC - > ADA SLK 120 BKZ N.d. ADA +12pp 67 86 100 60 SLK 60 SLK 120 PLC - > SLK 120 ADA +26pp Percent (%) of pts with LEI 2+ at baseline that improved 2+ pt Leeds Enthesitis Index (LEI) Nail PsO Resolution (mNAPSI=0) Percent (%) of pts with mNAPSI>0 at baseline that achieve mNAPSI=0 Note: Comparison across trials have inherent limitations. No head - to - head trials. 1 Last observation carried forward for all missing values; 2 ITT - NRI up to Week 24, except that participants who were re - assigned from their original treatment arm at Week 12 as per protocol had last observation carried forward from Week 12 onwards; 3 Merola et al., ACR Convergence 2023 poster 1433, estimate from graph ARGO (Wk 24, NRI 2 ) BE OPTIMAL 3 (Wk 24, NRI) - 9.3 - 10.0 - 8.3 - 13.2 SLK 120 SLK 60 Mean change from baseline Nail PsO Severity (mNAPSI) PLC - > ADA SLK 120 ARGO (Wk 24, LOCF 1 ) ARGO (Wk 24, NRI 2 ) Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 34 Deltas to adalimumab continue to improve from week 12 to week 24
Part B crossover signals potential of SLK in TNF non - responders Note: Comparison across trials have inherent limitations. No head - to - head trials 1 Subset of participants with BSA >=3% at baseline, ITT - NRI up to Week 24, except that participants who were re - assigned from their original treatment arm at Week 12 as per protocol had last observation carried forward from Week 12 onwards; 2 Total of 7 inadequate ADA responders crossed over to SLK 120mg Inadequate response was defined as <20% improvement in either SJC or TJC by Week 12 Patients reaching Minimal Disease Activity (MDA) Percent (%) pts reaching score, NRI 1 ▪ In the 7 participants crossed from ADA to SLK 120mg, MDA response rates at week 24 were similar to the other SLK arms after 12 weeks of SLK exposure ▪ Similar trends were seen on other endpoints (e . g . PASI, mNAPSI, PhGADA, PROs, etc.) ▪ Due to small n numbers, the crossover arms are not sufficiently powered for definitive comparisons with the other arms ▪ We will explore SLK potential in TNF - IR patients in Phase 3 44 37 14 61 51 43 W12 W24 ADA - >SLK 120 W12 W24 W12 W24 SLK 60 SLK 120 ARGO trial design – Adalimumab group re - allocation at Week 12 Only exposed to Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 35 SLK for 12 weeks 2
Higher 120mg efficacy in key subgroups 39 33 62 33 42 86 63 57 All PASI >=10 All PASI >=10 +52pp +24pp +3pp +1pp ACR70 PASI100 1 ITT - NRI up to Week 24, except that participants who were re - assigned from their original treatment arm at Week 12 as per protocol had last observation carried forward from Week 12 onwards; Response rates at week 24 (subgroups) Percent (%) of pts, NRI 1 SLK 60mg SLK 120mg 39 36 62 38 42 59 63 67 All Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 36 hsCRP>ULN All hsCRP>ULN +22pp +29pp +3pp +1pp Moderate - to - severe psoriasis High level of inflammation ▪ Key subgroups may further benefit with 120mg vs 60 mg ▪ Incl. those with high level of skin involvement (moderate - to - severe PsO) and high level of inflammation (high CRP) ▪ Or patients with high PsA disease activity (DAPSA≥28) and presence of nail disease (mNAPSI>0) ▪ Other subgroups benefit at wk12 but the 60mg “catches - up” in many patients at wk 24 – up - titration likely a case - by - case decision for these patients (e.g., high MTX use, high weight, prio Bx use) ▪ Patients benefiting from higher dosing (from start or up - titration) estimated to be 20 - 30% of the trial population
Part A + B Part A Sonelokimab Sonelokimab Adalimumab Sonelokimab Sonelokimab 120mg 60mg (active reference) 120mg w/induction 6 0 mg w/induction Placebo 97 82 42 43 41 39 Patients with events, n 57 (58.8%) 37 (45.1%) 14 (33.3%) 17 (39.5%) 14 (34.1%) 15 (38.5%) Any TEAE 4 (4.1%) 2 1 (2.4%) 2 0 0 1 (2.4%) 0 Any SAE 6 (6.2%) 4 0 0 1 (2.3%) 0 0 Any TEAE leading to discontinuation 0 0 0 0 0 0 Fatal TEAE Most frequent TEAEs 1 5 (5.2%) 5 (5.6%) 3 (7.1%) 0 1 (2.4%) 1 (2.6%) Nasopharyngitis 4 (4.1%) 5 (5.6%) 1 (2.4%) 1 (2.3%) 2 (4.9%) 1 (2.6%) Upper respiratory tract infection 3 (3.1%) 3 (3.7%) 1 (2.4%) 3 (7.0%) 2 (4.9%) 0 Injection site erythema (reaction) Adverse events of special interest 0 0 0 0 0 0 IBD 2 (2.1%) 1 (1.2%) 1 (2.4%) 0 1 (2.4%) 0 Diarrhea Candidiasis 2 (2.1%) 2 (2.4%) 0 0 1 (2.4%) 0 Oral Candidiasis 0 0 0 0 0 0 Oropharyngeal Candidiasis 0 0 0 0 0 0 Esophageal Candidiasis 0 0 0 0 0 0 Vulvovaginal Candidiasis 0 0 0 0 0 0 Skin Candidiasis 0 0 0 0 0 0 Genital Candidiasis Other adverse events of interest 0 0 0 0 0 0 Serious hypersensitivity 1 (1.0%) 2 1 (2.4%) 2 0 0 1 (2.4%) 0 Serious infection 0 0 0 0 0 0 MACE 0 0 0 0 0 0 Liver AST/ALT > 5x ULN 3 Safety: no notable signals, a favorable benefit - risk profile in PsA Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 37 ALT, Alanine aminotransferase and AST, Aspartate transaminase ; IBD, inflammatory bowel disease ; MACE, major adverse cardiovascular event ; SAE, serious adverse event ; TEAE, treatment - emergent adverse event ; ULN, upper limit of normal ; 1 Top three most frequent AEs in the SLK groups . Note : The adalimumab therapy used in the MIRA trial was the originator drug (citrate - free formulation) ; 2 No SAEs judged to be treatment related ; 3 One case with elevated transaminases > 3 x 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 ; 4 TEAEs leading to discontinuation included 1 x tonic - clonic seizure, 1 x Furuncle, 1 x Pharyngeal abscess & Subcutaneous emphysema, 1 x Tonsillar inflammation, 1 x Epididymitis, 1 x Arthritis
PK data shows ARGO PsA doses behave as expected 0 2 4 6 24 Weeks 0.01 0.1 1 10 100 3 μg/ml* 8 10 12 14 16 18 20 22 Last dose SLK 60mg SLK 120mg PLC ʇ SLK 120mg ADA - > SLK 120mg Sonelokimab geometric mean trough concentration (μg/mL) SLK trough concentrations Trough concentrations of crossed over arms replicate data from first 12 weeks, rapidly bringing SLK above optimal plasma concentration (to reduce large amounts of target) and remaining above level as patients move to maintenance dose * indicating optimal plasma concentration for tissue anti - inflammatory activity Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 38
No signs of clinically relevant immunogenicity SLK 120mg geometric mean trough concentration (μg/mL) by ADA status SLK trough concentrations were unaffected by treatment - emergent ADA status 0.01 0.10 1 10 100 Weeks 0 0 2 4 6 8 10 12 14 16 18 20 22 24 0 2 4 6 8 10 12 14 16 18 20 22 24 Weeks 10 20 30 40 50 60 Treatment emergent ADA Yes (Y) Furthermore, clinical response was unaffected by anti - drug antibodies 1 No (N) SLK 120mg ACR50 response rate (%) by ADA status Similar for 60mg dose Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 39
PsA: A clear path towards Phase 3 (current plan) What know now from ARGO ▪ 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 program size (potentially ~1,100 - 1400) expected to reduce variations driven by small groups ▪ Sub - groups with up - titration potential identified ▪ Endpoints confirmed for Phase3 – ACR50 & PASI90 – but with expected primary endpoint at week 16 and emphasis on composite secondaries ▪ Currently planning two trials ▪ TNF - IR trial ▪ Bio - naïve trial Planned FDA EoP2 timeline (parallel with EMA): ▪ Submission of FDA meeting request: Q1 2024 ▪ Submission of FDA briefing book: Q1 2024 ▪ FDA Meeting: Expected Q2 2024 ▪ Full TFLs from the Ph 2 PsA trial (ARGO) due by Q2 2024 Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 40
41 IL - 17 expected to become largest MoA in PsA in the next years 1.1 1.6 2.2 5.5 7.3 7.9 2021 2031E 2035E 2 6.5 9.0 PsA market size estimates 1 USD m ▪ IL - 17 becomes largest drug class in the next years in PsA (already estimated as 35 - 40% of market in 2031) ▪ Most data sources, incl. DRG/Carivate have BKZ latest estimates performed before BE COMPLETE (Ph 3) results ▪ SLK is not yet part of general, publicly available estimates – although an all - analysts - average places sales for PsA above blockbuster leve l ▪ BKZ is ~18% of IL - 17 class by 2031 according to DRG/Clarivate, which is likely an underestimation versus SEC or IXE ▪ Most analysts suggest a small percentage market share for SLK only (~1 - 15%) – likely an underestimation versus any biologic leading any immunology market 4 Bio Non - Bio 1 Based on DRG/Clarivate data (“Bio” included TNFs, IL - 12/23, IL - 17 and IL - 23 related assets; “Non - Bio” includes all DMARDs, JAK inhibitors and selection co - stimulation modulators); 2 Based on extending sales to 2035 using a 5 - year historical CAGR (2027 - 2031); 3 Upper bound of range indicated in Analyst Reports that cover MLTX (where available); 4 Considering DRG data from 16 Immunology indications: PsA, RA, Asthma, Moderate adult AD, Severe adult AD, nr - axSpA, AS, CU, LN, SLE, PsO, COPD, Acute CD, Maintenance CD, Acute UC, Maintenance UC (where avg. biologic share per indication is ~13%, share of second leading biologic is ~23% and share of leading Biologic is 36% Source: MoonLake, DRG/Clarivate, Analyst Reports © 2024 | Proprietary | MoonLake TX ~15 3 Key notes ~10 3
Source: © 2024 | Proprietary | MoonLake TX 42 PsA: ARGO results confirm SLK as the potential leader in PsA MoonLake Corporate Unprecedented multi - domain response 60% of patients reach MDA and ~60% reach ACR50+PASI90 , at wk 24 - confirming consistent multi - domain impact of SLK Greater depth of response 40%+ reach ACR70 and 60%+ reach PASI100 by wk 24, with ~50% patients reaching the ACR70+PASI100 composite – long lasting effect and not yet maxed out More disease control Fast onset (ACR50, 27% wk 8) coupled with increasing efficacy at wk 24 (ACR50, 61% wk 24) – also reflected in deep tissue (70% nail clearance) and patient reported outcomes Flexible dosing 60mg confirmed as sufficient to achieve leading results in most domains, 120mg adds benefit in specific subgroups – highly convenient regimens (monthly maintenance) Beyond current biologics At wk 24, patients respond better with SLK vs. ADA in all critical scores and higher than other Bx – a differentiated step - up Favorable safety profile No new signals, mAb - like ISR rate, Candida (if present) transient and with no discontinuations
© 2024 | Proprietary | MoonLake TX HS Franchise building indication 43
© 2024 | Confidential and Proprietary | MoonLake TX 44 HS – A devastating disease Prof Kenneth B. Gordon
45 © 2024 | Proprietary | MoonLake TX Prof Gordon has received honoraria and/or research support from the following pharmaceutical companies: AbbVie, Amgen, Arcutis, Bristol - Myers Squibb, Boehringer Ingelheim, Dermavant, DICE, Incyte, Eli Lilly, Janssen, LEO Pharma, MoonLake Immunotherapeutics, Novartis, Pfizer, Protagonist, UCB, Union Disclosures
…we need HS therapies that are developed with all patients in mind — reflecting many millions of people …we need HS therapies that provide sustained and significant improvements to patients’ lives …we need HS therapies that treat all types of lesions , with the opportunity for inflammatory remission HS is progressive and results in irreversible tissue destruction over time… 1 46 Hidradenitis suppurativa: a challenge and an opportunity Draining tunnel T Abscesses T T Ulceration Late - stage disease with extensive scarring and ulceration 4 1 Sabat et al Nat Rev Dis Primers 2020;6:18 2 Krueger et al Br J Dermatol 2024;190:149 – 162 3 Ingram et al EADV 2023;Poster P0046 4 T, tunnel | Pictures courtesy of Prof. Kenneth B. Gordon and Dr Gretchen M. Roth Delayed and insufficient treatment are critical gaps in disease management… 2 Delayed (and under - ) diagnosis drive conservative prevalence estimates… 2,3 2% Est. global prevalence Advanced disease with deep abscesses and tunnels 4 © 2024 | Proprietary | MoonLake TX
47 HS is characterized by a profound burden for patients and society NIS, National Inpatient Sample Symptoms 1 Key symptoms include... • Pain • Malodorous drainage • Low mood/depression …and may be more burdensome in patients with draining tunnels Hospitalizations Hospitalization and ER visits are common for patients with HS 2 • 30% of patients with HS were hospitalized as an inpatient on ≥1 occasion, in a US claims database covering 2016 – 2019 2 • 6 days in hospital and $33k costs represent a typical hospitalization of a patient with HS, according to NIS data 3 Work and employment burden In the US, HS leads to >2x days of lost work and nearly 3x disability days vs controls 4 18 8 11 8 4 4 0 5 10 15 20 Observed annual rate Patients with HS Control groups Total days of lost work Medically related absenteeism days Disability days N=6020 N=1204 >2x ~3x 2x 1 Ingram et al EHSF 2023;Poster P139 2 Chopra et al SID 2022;Poster 343 3 Bhattaru et al AAD 2023;Poster 43666 4 Tzellos et al Br J Dermatol 2019;181:147 – 154 5 Schneider - Burrus et al Br J Dermatol 2023;188:122 – 130 © 2024 | Proprietary | MoonLake TX A similarly severe impact on work and employment is seen in Europe 5
48 Chronic inflammation in HS progresses to irreversible tissue destruction Resolution of nodules, abscesses and tunnels in a ‘Window of Opportunity’ may offer the possibility of remission Figure adapted from Martorell et al Actas Dermosifiliogr 2016;107(Suppl 2):32 – 42 Cutaneous damage HS activity Tunnels Scars Abscess Nodules Disease onset Early disease Late disease Functional impairment Tunnels are active sites of inflammation 2,3 Early disease can lead to persistent, deep - seated nodules and abscesses 2 Minor surgery Window of opportunity Psychosocial burden 1 Major surgery 1 Ooi et al JAAD Int 2023;10:89 – 94 2 Sabat et al. Nat Rev Dis Primers 2020;6:18 3 Navrazhina et al J Allergy Clin Immunol 2021;147:2213 – 2224 © 2024 | Proprietary | MoonLake TX
© 2024 | Proprietary | MoonLake TX 2 Can we treat HS more effectively in the ‘Window of Opportunity’? We need • More treatment options • Better therapies • Shorter time to treatment to allow health systems to move patients onto treatment more quickly, and to keep them there 49 HS Psoriasis 12 Only 2 biologics are approved for HS FDA - approved biologic therapies 1 1 Drugs @ FDA: HS — adalimumab, secukinumab. Psoriasis — etanercept, infliximab, adalimumab, ustekinumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, bimekizumab, guselkumab, tildakizumab, risankizumab
50 Current therapy with adalimumab has high discontinuation rates <1 year Median drug survival Adalimumab in US patients with HS 1 1 in 3 US patients with HS discontinue adalimumab within 6 months 1 Patient groups with the highest burden of drug discontinuation… 1 Women Medicaid coverage Younger adults Recent surgery 1 Kimball et al EHSF 2024;T6 - P - 08 2 Data also available for Austria | Ring et al JAMA Dermatol 2022;158:184 – 188, Prens et al Br J Dermatol 2021;185:177 – 184, Wiala et al EADV 2023;P0134, Ring et al Br J Dermatol 2024;doi:10.1093/bjd/ljae042 Similar rates observed in Europe: median drug survival reported from 8 – 9 months (Denmark) to 18 months (Netherlands) 2 © 2024 | Proprietary | MoonLake TX
51 What do we need from an effective therapy in HS? The consequences of uncontrolled HS are substantial for all aspects of patients’ lives and society 1 Ingram et al EHSF 2023;T6 - O - 15 2 Ring et al Br J Dermatol 2024;doi:10.1093/bjd/ljae042 5 Schneider - Burrus et al Br J Dermatol 2023;188:122 – 130 6 Willems et al Patient 2023;16:153 – 164 3 Garg et al J Am Acad Dermatol 2020;82:366 – 376 4 Krueger et al Br J Dermatol 2024;190:149 – 162 Established safety profile 1,6 — Risk of serious adverse events is another important consideration for both derms and patients Sustained efficacy is key for both derms and patients 1,2 and is central to other aims of treatment Hospitalizations 3,4 • Reduce the burden of inpatient and ER visits • Reduce surgical interventions © 2024 | Proprietary | MoonLake TX Work and employment burden 5 • Enable employment • Increase personal happiness and social integration Symptoms 6 Alleviate symptom burden by resolution of all inflammatory lesion types, including tunnels
52 Treatment goals have not been advanced in eight years Additional therapeutics with alternative mechanisms of action and higher levels of response urgently needed 26 28 42 59 HiSCR 50 response, (%) 180 183 180 N = 180 163 163 153 154 N = SEC Q4W Placebo ADA Placebo +16 +31 Adalimumab (Humira ®1 ) FDA HS approval 2015 1 ▪ TNF inhibitor Traditional mAb (~148kDa) PIONEER I HiSCR 50 at Week 12 (ITT - NRI) PIONEER II HiSCR 50 at Week 12 (ITT - NRI) 50% improvement (HiSCR50) in approx. 50% of patients 1 ITT - NRI, non - responder imputation in an intention - to - treat population | Humira ® Prescribing Information, Kimball et al N Engl J Med 2016;375:422 – 434 34 31 42 46 HiSCR 50 response, (%) +8 +15 Secukinumab (Cosentyx ®3 ) FDA HS approval 2023 2 ▪ IL - 17A inhibitor Traditional mAb (~150 kDa) SUNSHINE I HiSCR 50 at Week 16 (ITT - mNRI) SUNRISE II HiSCR 50 at Week 16 (ITT - mNRI) 50% improvement (HiSCR 50) in approx. 45% of patients 8 years 2 ITT - mNRI, modified non - responder imputation in an intention - to - treat population | Cosentyx ® Prescribing Information, Kimball et al. Lancet 2023;40:747 – 761 © 2024 | Proprietary | MoonLake TX
29 45 48 32 54 52 BKZ Placebo BKZ BKZ Placebo BKZ BKZ BKZ Placebo BKZ BKZ Placebo Q2W Q4W Q2W Q4W Q2W Q4W Q2W Q4W Primary endpoint HiSCR 50 at Week 16 (ITT - mNRI) BE HEARD I BE HEARD II PBO N=~73, BKZ N=~290 per arm 53 Can targeting IL - 17A + IL - 17F advance treatment goals in HS? +19 Bimekizumab (Bimzelx ® ) ▪ IL - 17A and IL - F inhibitor Traditional mAb (~150kDa) • Safety profile: No unexpected findings (oral candidiasis as expected from MOA) • Maintenance of response: Phase 3 data showed continued efficacy to Week 48 +16 +22 +20 18 25 33 16 34 36 +15 +7 +18 +20 Secondary endpoint HiSCR 75 at Week 16 (ITT - mNRI) BE HEARD I BE HEARD II PBO N=~73, BKZ N=~290 per arm Kimball et al AAD 2023;late - breaking presentation © 2024 | Proprietary | MoonLake TX mNRI; modified non - responder imputation, with missing data due to adverse events or lack of efficacy, and systemic antibiotic initiation or intensification, imputed as non - response Elevating trial endpoints • Primary endpoint response was within the range of reports from earlier HS trials • HiSCR 75 data suggested possibility of achieving higher threshold responses in HS than HiSCR 50
54 Elevated IL - 17A + IL - 17F in HS: rationale for targeting both cytokines Both IL - 17A and IL - 17F are elevated in HS lesions, including inflammatory nodules and draining tunnels 1 10 100 IL - 17F (pg/mL) 0.1 1 10 100 IL - 17A (pg/mL) * P <0.05 * P <0.05 * P <0.05 0.1 Perilsional Nodule Tunnel Perilesional Nodule Tunnel IL - 17A and IL - 17F protein levels measured by cytokine array Data represent mean “ SEM. N=6 biopsy lysate samples for each tissue CXCL 1 CXCL 8 CCL 20 IL - 17A IL - 17F IL - 1 β TNF IL - 17A and IL - 17F in HS pathogenesis 1 MoonLake research 2 1 Figure reproduced under the terms of the CC - BY license | Krueger et al Br J Dermtol 2024 23;190:149 – 162 2 SEM, standard error of the mean | Reich et al EHSF 2024;T1 - P - 03 © 2024 | Proprietary | MoonLake TX
55 Can Nanobodies ® improve outcomes in HS? Albumin - binding domains target inflammation Smaller biologics higher tissue uptake 1 Accumulation of Nanobodies ® 24 h after treatment 2 Distribution of anti - TNF Nanobodies ® +/ - albumin - binding site 24h after a single injection in mice with collagen - induced arthritis 100 90 80 70 60 50 40 30 20 10 0 0 200 50 100 150 Molecular weight of biologic (kDa) Biodistribution coefficient 1 (%) - 50% - 50% Smaller biologics such as Nanobodies ® may include an albumin - binding domain to target inflammation and extend half - life 2 Nanobody ® without albumin - binding site Nanobody ® with albumin - binding site Anti - TNF Anti - TNF Anti - TNF Anti - TNF Anti - albumin Arthritis induced in left paws only Paws with induced arthritis 1 Biodistribution coefficient, calculated as tissue concentration/plasma concentration in muscle (other tissues ranged from 14 to 41 kDa molecular weight change required for a 50% difference in tissue penetration); Li et al. mAbs 2016;8:113 – 9 Tissue penetration decreases 50% with every ~35 kDa Nanobodies ® are designed to directly target sites of inflammation in difficult - to - reach tissues, such as the deep dermal tunnels in HS 3 2 Coppieters et al. Arthritis Rheum 2006;54:1856 – 66 3 Krueger et al Br J Dermatol 2024;190:149 – 162 © 2024 | Proprietary | MoonLake TX
27.9 65.7 53.0 Placebo N=68 SLK 120 mg N=67 SLK 240 mg N=66 14.7 43.3 34.8 0 20 40 60 80 Placebo N=68 SLK 120 mg N=67 SLK 240 mg N=66 Participants achieving response (%) 56 High levels of response were seen with sonelokimab in the MIRA trial MIRA efficacy at Week 12 SLK achieved pain responses at the high threshold of NRS 50 Peer - reviewed Week 24 data will be presented today at AAD Late - breaking research session, 14:00 PST Sonelokimab was well tolerated with no unexpected safety findings 4.3 0 20 40 60 80 Placebo N=47 SLK 120 mg N=50 SLK 240 mg N=46 Participants achieving NRS 50 (%) *** 32.0 *** 41.3 Pain at Week 12 NRS 50 (ITT - NRI) Primary endpoint 1 st time in an HS trial HiSCR 75 (ITT - NRI) Key secondary endpoint HiSCR 50 (ITT - NRI) +29 +20 +38 +25 Kimball et al EADV 2023;late - breaking presentation D1T01.1H © 2024 | Proprietary | MoonLake TX Highest levels of placebo - adjusted HiSCR responses reported to date Higher pain threshold than earlier HS studies
57 An exploratory ultrasound sub - study measured direct evidence of draining tunnel changes with SLK Imaging lesions beneath the skin shows a direct effect on tunnels Baseline Week 12 • Case study of a participant randomized to the sonelokimab 240 mg treatment arm • Reduction in tunnel diameter and inflammatory activity observed at Week 12 32.7 30 23.8 20 41 * .1 0 10 40 50 Placebo (n=63) Sonelokimab 120 mg (n=56) Sonelokimab 240 mg (n=52) Participants achieving DT 100 (%) Complete resolution of draining tunnels (DT 100) at Week 12 (NRI) Phase 3 will be critical to better understand the potential of SLK as a Nanobody to improve clinical outcomes Ultrasound images show the same draining tunnel (white arrow) at baseline and week 12; color - shaded areas indicate active inflammation (duplex signal of increased blood flow in the peri - tunnel area; grey arrow) | Kirby et al ISDS 2023;P260 © 2024 | Proprietary | MoonLake TX
58 A key goal of Phase 3 will be to show consistency with Phase 2, while always maintaining a patient - centered focus After MIRA: what I would like to see in a Phase 3 program ENDPOINT SELECTION High level endpoints, such as HiSCR 75 , DT 100 , IHS4 - 100 Looking at high level endpoints and including patients with severe disease reflects patients in clinical practice MAINTENANCE OF RESPONSE Assessing the longevity of treatment effect is critical PATIENT POPULATION Baseline disease severity is key for interpreting results OPTIMAL DOSE Dose based on risk – benefit evidence per regulators SIMPLE PROTOCOL A protocol consistent with MIRA , attractive to derms COHORT SIZE Enroll sufficient number of patients to satisfy regulators Expert opinion of Prof. Kenneth B. Gordon © 2024 | Proprietary | MoonLake TX Phase 3
© 2024 | Confidential and Proprietary | MoonLake TX 59 SLK differentiation & Phase 3 program Kristian Reich
Note : This is a comparison across trials, with inherent limitations . No head - to - head trials . 1 POV used mean AN count reduction as primary endpoint 2 Estimation of HiSCR 75 delta to PLC at wk 16 using the avg . response of the 2 crossed - over groups from PLC to SLK doses at wk 12 (PLC plateaus already from week 8 ) and the wk 16 response for the 120 mg arm ; PLC, Placebo ; SLK, Sonelokimab (MIRA study) ; BKZ, Bimekizumab (pooled BE HEARD I/II) ; ADA, Adalimumab (pooled PIONEER I/II) ; POV, Povorcitinhib (NCT 04476043 ) ; UPA, Upadacitinib (NCT 04430855 ) ; SEC, Secukinumab (pooled SUNRISE/SUNSHINE) Source : MoonLake Clinical (R&D Day June 27 th 2023 ) © 2024 | Proprietary | MoonLake TX 60 Recap: Setting a new bar in HS for primary endpoints 19 24 17 15 11 SLK BKZ ADA POV UPA SEC 18 16 13 POV Wk 16 75mg (mNRI) n.d. SEC Wk 16 300mg (mNRI) n.d. UPA Wk 12 30mg (mNRI) SLK BKZ ADA Wk 12 Wk 16 Wk 12 120 mg 320mg 40mg (NRI) (mNRI, All - Abx) (NRI) HiSCR50 delta to PLC (Primary endpoint for others 1 ) Percent delta for best doses, primary analysis * p<0.0001 38 Key elements Wk 16 320mg (mNRI, All - Abx) Wk 16 75mg (mNRI) Wk 16 300mg (mNRI) Wk 12 30mg (mNRI) Wk 12 40mg (NRI) Wk 12 120 mg (NRI) SLK performs better than BKZ, already at week 12 HiSCR75 delta to PLC (Primary endpoint only for SLK) Percent delta for best doses, primary analysis *p=0.0002 29 SLK performs better than others, already at HiSCR50
HS: Response with SLK increases through week 24, with monthly dose HiSCR90 response Percent (%) pts reaching score Weeks Weeks Significant increase in number of patients reaching HiSCR75 with convenient monthly injection Deepening of responses with monthly maintenance dosing, as close to 40% of patients reach HiSCR90 by week 24 1 ITT - NRI data up to Wk 12 (Part A) 2 As observed data from Wk 14 - 24 (Part B) 43.3 56.9 0 10 20 30 40 50 HiSCR75 response (Primary endpoint) Percent (%) pts reaching score 60 0 2 4 6 8 10 12 14 16 18 20 22 24 PLC SLK 120mg SLK 240mg 14.7 Part A 1 Part B 2 22.4 37.9 7.4 Part A 1 0 10 20 30 40 0 2 4 6 8 10 12 14 16 18 20 22 24 Part B 2 HiSCR100 = 29.3% (W24, SLK 120mg) 10 ppt + 40 ppt + 14 ppt + 30 ppt + Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 61
4 in 10 pts 1 in 4 pts HS: SLK allows patients & physicians to aim for inflammatory remission Monthly SLK deepens IHS4 response (e.g., IHS4 - 90 and IHS4 - 100) About 1 in 4 four HS patients on monthly SLK 120mg achieve inflammatory remission (IHS4 - 100) 1 ITT - NRI data up to Wk 12; as observed data after week 12 10.3 23.9 39.7 18.2 22.4 SLK 120mg SLK 120mg PLC SLK 240mg SLK 240mg IHS4 - 90 response Percent (%) pts reaching score 1 Week 12 (Part A) Week 24 (Part B) Week 12 (Part A) Week 24 (Part B) ~15 ppt Week 12 (Part A) Week 24 (Part B) Week 12 (Part A) Week 24 (Part B) SLK 120mg SLK 120mg PLC SLK 240mg SLK 240mg IHS4 - 100 response Percent (%) pts reaching score 1 ~12 ppt 5.9 Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 62 11.9 24.1 9.1 15.5
Source: © 2024 | Proprietary | MoonLake TX 63 HS: The results are staggering and confirm SLK as the potential leader MoonLake Corporate Higher HiSCR75 with Q4W dosing 57% of patients reach HiSCR75 at week 24 with 120mg ( 10ppt +) Greater depth of responses 40% patients reach HiSCR90 and IHS4 - 90 by week 24 ( 14ppt +) More disease control 1 in every 4 patients in inflammatory remission (IHS4 - 100) & 40%+ report absent or minimal disease activity (PGI - S) Best dose confirmed 120mg is best performing dose across the board and dose behavior replicated from wk 12 Effect on TNF patients At wk 24 patients respond better with SLK vs. ADA; non - responders reach SLK - like responses within 12 weeks Favorable safety profile No new signals, no IBD, or malignancy , mAb - like ISR rate, Candida (if present) transient and with no discontinuations
1 Randomization stratified by Hurley stage status (II vs. III) and prior biologic use (Y/N). Patients in Hurley stage III limited to ~40%; 2 responder: HiSCR75 on two consecutive visits 4 weeks apart Source: MoonLake Clinical Development © 2024 | Proprietary | MoonLake TX HS: Very positive FDA & EMA EoP2 meeting, HS highly de - risked 64 Placebo Screening (2 to 4 weeks) Placebo - controlled Placebo crossover Sonelokimab 120mg: Weeks 0, 2, 4, 6, 8, then Q4W Sonelokimab 120mg: Weeks 16, 18, 20, 22, 24, then Q4W Group 1 (n=266) R 1 Group 2 (n=133) OLE (up to 2 yrs) Week 0 4 16 1 Σ EP vs PLC 52 2 Σ EP 8 24 ▪ One dose phase 3 – FDA agrees HS dosing is very clear (120mg) ▪ 800 patients only (compared with Novartis, UCB, others) – FDA sees Ph 2 as registrational and considers patient data from other indications ▪ All other areas including stats, analytics etc. all clear and low risk ▪ Allows being forward with primary endpoint already in mid 2025, launch in 2027 (within 18 - 24 months of BKZ launch) ▪ Cash in hand for HS trial with no risk to other trials ▪ Simpler protocol compared to Phase 2 with stats that will likely favor delta to PLC (e.g., mNRI vs. NRI) Phase 3 protocol post FDA EoP2 meeting Detailed interaction correspondence with FDA and EMA available Comparable Phase 2 and 3 protocols available Protocol repeated 2x (n=800 pts) – VELA I and II (both follow the same protocol)
Source: © 2024 | Proprietary | MoonLake TX MoonLake ClinDev 65 2. HS: VELA builds on the success of MIRA Announcing Phase 3 HS program: VELA I VELA II The MoonLake HS clinical trials continue to be the only ones with HiSCR75 as the primary endpoint
Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 66 HS: Pivotal - like MIRA design is replicated in Ph3, in contrast to other trials 1 Glatt et al. JAMA Dermatol 2021;157:1279 – 88; 2 NCT03248531; 3 Kimball et al. AAD 2023;oral presentation; 4 NCT04242498; 5 Sensitivity analysis presented as key data in primary publication; 6 No prior TNFi or IL - 17i as per protocol — other prior biologic experience is not clarified in study publications 7 No primary failures or patients unsuitable for therapy 8 Mean AN # 17.2 for Q2W Q4W arm and 14.7 for Q2W Q2W arm 9 previous IL - 17A/F excluded, no primary failure to IL - 17i Note: comparisons across trials, with inherent limitations. Not head - to - head trials. Not all trial details might be captured in full. VELA designs subject to final regulatory approval Trial structure Stats analyses Cohort characteristics BKZ Ph2 1,2 n=90 BKZ Ph3 (BH II) 3,4 n=509 MLTX Ph2 (MIRA) n=234 MLTX Ph3 (VELA) n=800 PPS with no clear Abx Tx rules NRI, as observed 5 Bayesian augmentation +40 PBO, ADA 9% placebo HiSCR 75 12% discontinuations primary period Only one dose tested Loading dose 21 patients received placebo Double Blinded/Placebo - controlled 0% prior biologic use 6 Mandatory topical antiseptic ≥3 AN lesions Mean AN # 14.5 BKZ vs 22.1 PBO 49% Hurley II No limit on concomitant Abx (% not reported) 1 stratification factor (Hurley) Two doses tested No loading dose 74 patients received placebo 13% prior biologic use No mandatory antiseptic ≥5 AN lesions Mean AN # 17.7 BKZ Q4W 8 vs 14.4 PBO 61% Hurley II Concomitant Abx limit not reported (9% at baseline in overall population) 2 stratification factors (Hurley, ABX) Double Blinded/Placebo - controlled ITT with Abx Tx rules mNRI No Bayesian augmentation 16% placebo HiSCR 75 ~8% discontinuations primary period ITT with Abx Tx rules NRI No Bayesian augmentation 15% placebo HiSCR 75 ~5% discontinuations primary period Two doses tested No loading dose 68 patients received placebo Double Blinded/Placebo - controlled 18% prior biologic use 7 with 30% cap No mandatory antiseptic ≥5 AN lesions Mean AN # balanced 14.6 SLK 120 vs 14.5 PBO 64% Hurley II 30% limit on concomitant Abx (11% at baseline in overall population) 2 stratification factors (Hurley, prior Bx) ITT with Abx Tx rules mNRI No Bayesian augmentation Replication of PhII expected Low discontinuations expected One dose tested No loading dose 266 patients receive placebo Double Blinded/Placebo - controlled 30% prior biologic cap 9 No mandatory antiseptic ≥5 AN lesions Balanced mean AN expected 40% Hurley III cap 30% limit on concomitant Abx 3 stratification factors (Hurley, prior Bx, region)
© 2024 | Confidential and Proprietary | MoonLake TX 67 HS is the next large indication in Derm Jorge Santos da Silva
Source: MoonLake Commercial, DRG/Clarivate, academic journals, CBO; Komodo Health © 2024 | Proprietary | MoonLake TX Recap: The HS market is expected to growth to >10bn USD by 2035 $2bn+ $10bn+ 2035 Today Future TNF α (mAb) AbbVie Only ~50% of patients achieve HiSCR50 at wk 12 IL - 17 A (mAb) Novartis Marginally lower efficacy vs. Humira but durable response and good safety Limited durability of response (<11 m) Key strategic focus for Novartis Note: This is a comparison across trials, with inherent limitations. No head - to - head trials. 1 POV used mean AN count reduction as primary endpoint; PLC, Placebo; SLK, Sonelokimab (MIRA study); BKZ, Bimekizumab (pooled BE HEARD I/II); ADA, Adalimumab (pooled PIONEER I/II); POV, Povorcitinhib (NCT04476043); UPA, Upadacitinib (NCT04430855); SEC, Secukinumab (pooled SUNRISE/SUNSHINE), Launch dates based on MoonLake estimate IL - 17 A+F (mAb) UCB Data supporting IL 17A&F inhib. as best MoA in HS US launch expected in 2025, as key driver for UCB SLK IL - 17A & F (small bio) MoonLake SLK uses best MoA and is highly differentiated (efficacy and likely safety) Unique features (tunnels, convenience etc.) JAK - inhibitors JAKs (chem) AbbVie / Incyte No improvements in efficacy vs approved drugs Focus on later line treatments SLK as “Best of both worlds” MoA & molecule characteristics x Leading HiSCR75 response x Effect on tunnels (penetration) x Speed and depth of response x Inflammatory Remission x Patient Reported outcomes x TNF - IR switching advantageous x Safety profile U.S. HS Biologics Market estimation, examples of main MoAs 68
Market: Large market size is substantiated by real - world data Note: Biologics (Bx) includes other targeted therapies (e.g., JAKs, PDE4i); 1. Patients ≥18 years with a HS diagnosis in 2016 - 2023; Extrapolated based on ~75% claims coverage rate (U.S. claims data); 2. historic average of annually net new diagnosed HS patients in 2016 - 2023, based on~75% coverage rate; 3. Patients with a HS - related Bx prescription in 2023 AND a HS diagnosis in 2016 - 2023; 4. Based on historic growth of patients with a HS - related Bx prescription in the given year and a preceding HS diagnosis Key insights (extrapolated to 100% of U.S. population) ▪ Source are unique U.S. patients from prescription claims data ▪ ~250m U.S. patient lives (~75% coverage) ▪ Diagnosed & treated patients with HS diagnosis (ICD - 10 L73.2) ~2.0m Unique patients diagnosed and treated in 2016 - 2023 1 Confirms large existing HS population ~25% Growth p.a. in Biologics - treated pts in 2016 - 2023 4 Confirms high unmet need & Bx market growth potential ~30% Bx prescriptions are non - Adalimumab in 2023 3 Confirms high unmet need & need for new treatments ~240k New diagnosed and treated patients every year (previously undiagnosed) 2 Confirms underdiagnosis & future growth potential Claims methodology ~40k/56k Adalimumab / Biologics treated patients in 2023 3 Confirms current Bx market size estimates 1 2 U.S. adult HS patients Source: MoonLake Commercial, © 2023 Komodo Health, Inc. All rights reserved. © 2024 | Proprietary | MoonLake TX 69
Market: Claims alone show ~2M HS patients – not incl. undiagnosed 2.0 2.9 0.9 1.9 4.8 1. Includes patients ≥18 years with a HS diagnosis in 2016 - 2023; Extrapolated based on ~75% claims coverage – showing a 0.8% of U.S. Population HS diagnosed and treated; 2. Scaling the 2M patients (0.8%) to 2.1% prevalence (as per literature – see footnote 4); 3. Based on extrapolating historic average of annually net new diagnosed HS patients from 2024 - 2027; based on ~75% U.S. claims coverage; 4. Prens L. et al. Br J Dermatol. 2022 Prevalence 240k net new patients p.a. – projecting historic average U.S. adult HS patients Diagnosed today already 1 Likely diagnosed until launch 3 Additional growth opportunity until peak 3 Claims confirm significant HS market already today we see ~1% of the population being diagnosed & treated Market size based at peak (2035) 3 Market potential at launch (2027) 3 240k net new patients p.a. – projecting historic average 1 ~1% ~2% Literature estimate 4 Diagnosed & treated 1 ~5.5 2 Source: MoonLake Commercial, © 2023 Komodo Health, Inc. All rights reserved. © 2024 | Proprietary | MoonLake TX 70
1. HS patients receiving respective care in the first year after diagnosis; 2. HS patients receiving respective care in years 2 and 3 post diagnosis, as a % of year 1 patients, 3. Consecutively on drug for >24m Source: Market research, © 2023 Komodo Health, Inc. All rights reserved. © 2024 | Proprietary | MoonLake TX Market: HS patients face challenging journey – even years after Dx U.S. adult HS patients Therapy post HS diagnosis Year 2 - 3, Year 1 1 of year 1 2 Patients are cycling through various supportive care treatments – pre and post biologics 71 1 Patients on antibiotics or steroids – most continue longer - term 55% + 65% + 30% + 55% + 15% 20% 3% 0.6% Patients that undergo HS related surgery – continue to have surgeries Patients visiting an emergency room – most continue to have visits Patients on biologics – few remain on drug uninterruptedly 3
Source: MoonLake Commercial, © 2023 Komodo Health, Inc. All rights reserved.. N Engl J Med 2016; 375:422 - 434; JAMA Dermatol. 2022 Feb; 158(2): 1 – 5. © 2024 | Proprietary | MoonLake TX Trial results: Maintenance of response ~55% did not maintain response after 9m ~35% ~55% ~30% <6 months <12 months <18 months >18 months % of patients by months on therapy (prescription fill breaks >3 months treated as new treatment) xx Median duration (m) on therapy Claims data confirms limited duration of therapy (~11m median) for Adalimumab in real - world patients, leaving them without efficacious HS treatment option Claims: Duration of therapy (N=53k) 1 2 ~11m median duration of treatment Not linked to U.S. access & affordability hurdles, 9 15 ~70% 29 11 given European studies show similar results 2 Market: Adalimumab with limited duration of response in real world 1. Average duration of treatment for the period of 2016 - 2023 for HS - relevant Adalimumab patients with a prescription start in until 2022; 2. E.g., Prens L.M. et al. Br J Dermatol. 2021 Jul;185(1):177 - 184. doi: 10.1111/bjd.19863, Ring H.C. et al. JAMA Dermatol. 2022 Feb 1;158(2):184 - 188. doi: 10.1001/jamadermatol.2021.4805. 72 1
17 21 12 11 25 15 32 17 17 7 13 6 19 22 29 32 50 56 240 - 310 9 39 13 10 9 40 +24% 1. Patients with a HS - relevant biologics prescription in the respective year and a preceding HS diagnosis; includes JAKs and PDE4i; 2. Annual growth in Bx for patients with a preceding AD diagnosis in 2017 - 2023; 3. Share of patients with a HS - relevant biologics prescription in the respective year as % of the annually treated HS population (~65%); 4. Share of patients with a relevant Biologics prescription for PsO / axSpA / PsA in 2023 as % of the total patients with a PsO / axSpA / PsA diagnosis in 2016 - 2023 Bx as % of yearly treated patients 3 : ▪ Bx treatments with strong grows at ~25% p.a. from 2016 to 2023 ▪ Today’s Bx share is starting from a small base due to limited effective Bx treatments and low durability of Adalimumab (~3% of yearly treated patients) ▪ ~30% of Bx treatments other than Humira (e.g., ixekizumab), further highlighting the need for a novel and effective treatment options in HS Market: Growth and unmet need expected to remain high HS Biologics and targeted treatment patients in U.S. (k) 1 3% 8 - 10% 100% captured Existing Net new Analogs at 8 - 15% (PsO, axSpA, PsA, AD) 4 ~40% Bx growth p.a. in AD since Bx launch 2 2016 2017 2018 2019 2020 2021 2022 2023 2035 2023 claims not Assumes historic growth, 8 - 10% Bx share in peak 2 Source: MoonLake Commercial, Market research, © 2023 Komodo Health, Inc. All rights reserved. © 2024 | Proprietary | MoonLake TX 73
0.5 0.5 0.3 0.5 Market: Humira accounts for most of current $2bn+ biologics market Competitors Patients treated (k) 1 2023 claims not 100% captured yet (time lag) HS market (2023 – Q4 claims not fully covered) X 2023 fill rate (yrs) 2 X Net price (USDk) 3 = Revenue (USDbn) Total 1. Includes patients with a prescription of the respective drug in 2023 AND a corresponding HS diagnosis (U.S. claims data); 2. Based on average days supplied across all patients on the respective drug in 2023 (Avg. fill rate for all patients with a prescription in 2023) ; 3. Calculated as annualized WAC (for maintenance therapy) net of total GTN incl. service fees, statutory & confidential discretionary rebates, etc. (based on market research); 4. Includes JAKs and PDE4i 41 4 4 12 1.6 0.1 <0.1 0.3 80 60 45 45 2.1 Other TNFi Other biologics and targeted treatments 4 Approval only in Oct 2023 2 Source: MoonLake Commercial, Market research, © 2023 Komodo Health, Inc. All rights reserved. © 2024 | Proprietary | MoonLake TX 74
1. Patients with a biologics prescription in the respective year and a preceding PsO diagnosis; Source: Market research, © 2023 Komodo Health, Inc. All rights reserved. © 2024 | Proprietary | MoonLake TX 35% 9% 32% 11% 28% 13% 2% 23% 13% 5% 23% 11% 9% 36% 21% 10% 12% 18% 9% 19% 7% 154 262 305 367 419 447 513 573 +21% ▪ Better clinical profile matters most : After their respective launches Cosentyx and Skyrizi are capturing a big share of the market ▪ New entrants are growing the market : Upon their launches the biologics market has grown substantially (Skyrizi accounted for 40% of market growth) ▪ Disease area leadership can be built despite launching later : Skyrizi is market leader in PsO (~19% share in 2023) among 20+ biologics competitors Market: PsO shows clinical differentiation wins over time - to - market PsO biologics patients in U.S. (k) 1 2 New entrants capture substantial share in PsO and increase market growth rate by improving efficacy and setting a new bar for treatment outcomes (e.g., PASI100), despite not being first - to - market Other Share delta ‘23 vs. 16’ - 2pt Humira (2005) Cosentyx (2015) Skyrizi (2019) Drug: (launch) - 18pt +2pt +19pt ~40% of total market growth since launch Includes 20+ products Cosentyx with a fast market share ramp - up after launch, up to 13% 2016 2017 2018 2019 2020 2021 2022 2023
U.S. adults HS Biologics Market estimation 4.8m based on claims extrapolation 1 ~10% analogs ~15% (PsA, axSpA 3 ) ~8% Diagnosed prevalence Biologics adoption 1. Patients ≥18 years with a HS diagnosis in 2016 - 2023; Extrapolated based on ~75% claims coverage rate, further conservatively extrapolating historic average of annually net new diagnosed HS patients from 2024 - 2027 and ~70% of historic average of annually net new diagnosed HS patients from 2028 - 2035; Assumes based on ~75% claims coverage rate, 2. Share of patients with a relevant Bx prescription for PsO / axSpA / PsA in 2023 as % of the total patients with a PsO / axSpA / PsA diagnosis in 2016 - 2023; 3. extrapolated based on SLK opportunity and Humira - like prices Source: MoonLake Commercial, © 2023 Komodo Health, Inc. All rights reserved. © 2024 | Proprietary | MoonLake TX Market: The HS market might be even larger than $10bn in 2035 Through recent claims analyses we cannot only substantiate the projected 2035 $10bn HS market in the U.S. but we believe the true HS market in the U.S. has potential to become $15bn+ $15bn+ 2035 2035 $10bn+ 5m+ likely given claims only capture diagnosed & treated 2 Higher HS awareness increases diagnosis and treatment rate More efficacious treatment options increase Bx adoption to levels of analogs ~$10bn+ U.S. market size projection based on very conversative extrapolations of historic growth 76
1. Based on Komodo Health claims data: Includes patients with a Bx prescription in 2022 and a HS diagnosis in 2015 - 2022 Source: Market research, © 2023 Komodo Health, Inc. All rights reserved., MoonLake Commercial © 2024 | Proprietary | MoonLake TX 0 20 40 60 % of HCOs % of pts 15 states in the U.S. cover ~70% of Biologics treated patients 1 12% of HCOs cover ~70% of Biologics patients 1 (within top 15 states) Targeted Go - To - Market approach enables to unlock SLK blockbuster status in concentrated HS landscape 5% 12% 5% (~210) of HCOs cover 50% of Bx pts 100 80 ~12% (~520) of HCOs cover 70% of Bx pts Distribution by state Distribution by HCO in top 15 states Targeting: Achieving SLK blockbuster status in concentrated landscape Top 5 cities in CA / TX cover 60 - 70% of Bx patients High concentration of patients also driven by established HS - COEs (65) (as per HS Foundation) U.S. adult HS patients on biologics 77
Note: Comparisons across trials, with inherent limitations. No head - to - head trials. 1 Warren et al., EADV 2021, P0353 Source: MoonLake Commercial, IQVIA, Barclays Research, RAPID Weekly Audit, November 2023 - December 2023 (Copyright IQVIA), Company statements © 2024 | Proprietary | MoonLake TX Christmas week (25 - 31 December) Bimzelx confirms A&F as winning MoA with fast market uptake and good clinical data (in Plaque Psoriasis) SLK shows a differentiated profile across multiple trials and clinical outcomes ▪ SLK has shown leading responses at wk 12 and week 24 in across all relevant outcomes in HS ( MIRA trial), incl. being the first to use HiSCR75 as primary endpoint, showing largest deltas to placebo in different HiSCRs , bringing one quarter of patients to inflammatory remission , demonstrating impact on tunnels etc. ▪ SLK shows leading responses across all relevant outcomes in PsA (ARGO trial) at wk 12 and wk 24 , especially in multi - domain scores where other drugs appear to struggle ▪ Original data in Psoriasis (PsO) indicates that SLK also has leading responses in skin inflammation and can sustain longer - term responses Bimzelx has achieved leadership in the dynamic market share of the IL - 17 class, withnshare reaching ~40% Competition: Bimzelx above expectations – SLK is further differentiated 78
Source: Product leaflets, Company information, MoonLake Commercial © 2024 | Proprietary | MoonLake TX 79 HS: SLK is most convenient Maintenance injection schedule 15s injection time per 1ml syringe 1 3s injection time per 1ml syringe Substantially fewer and quicker injections (5x faster injection) Note: 320 mg for Bimzelx and 300mg for Cosentyx require 2 syringes per application – then every two weeks [Q2W] applied 1. Trial includes Q2W and Q4W dosing regimens (both requiring 2 injections) – TBD on actual label injections) and 300mg/2ml pens; Standard dose as Q4W, but possibility to move to 300mg Q2W 2. Available as 2x 150mg (4 SLK 15s injection time per 1ml syringe 2
© 2024 | Proprietary | MoonLake TX Source: Recap: HS provides a sizable market with high unmet need MoonLake Commercial 80 ▪ Sizeable, underdiagnosed market: 2m patients today, >240k newly diagnosed patients every year ▪ Albeit starting from a small base (~13k in 2016) biologics market is growing rapidly (25% p.a.): similar trajectory to other markets such as PsO, AD etc. ▪ Severe unmet need with current options: patients cycled through with no disease control ▪ HS causes a significant burden to patients and health systems (ER visits, surgeries, medications) ▪ SLK has potential to be the most differentiated: Patients ~11m in ADA, ~4x SEC patients needed to get to SLK outcome (HiSCR50), 10 - 20ppt higher in key scores versus BKZ Market likely among the largest across Inflammation (15bn+) and able to accommodate different players: SLK positioned as potential leader
© 2024 | Proprietary | MoonLake TX New indications New frontiers for SLK and MLTX 81
1 Liu S, et al. Nat Commun. 2013;4:1888; 2 Goepfert A, et al. Immunity. 2020 Mar 17;52(3):499 - 512 Source: MoonLake Research © 2024 | Proprietary | MoonLake TX 82 SLK is a unique molecule: Nanobody® that targets IL - 17 A & F IL - 17A and IL - 17F function as dimers to drive inflammation, through activation of IL - 17RA & RC receptor complexes Different IL - 17RA & RC chains combine to form complexes, and those have different affinity for different dimers 1,2 Not all IL - 17 - targeting therapeutics can inhibit IL - 17A/A, IL - 17A/F and IL - 17F/F dimers A/A A/F F/F Illustrative Dimer affinity of receptor A/A F/F SLK is the only asset that binds all dimers and with similar affinity
Source: © 2024 | Proprietary | MoonLake TX Adaptive T cells Th, Tc cells Innate lymphocytes Tcells, ILC3, MAIT Neutrophils IL - 23 IL - 1 IL - 1 IL - 18 IL - 6 TGF TCR activation TNF IL - 12 C5a differential activation differential production IL - 17A IL - 17F IL - 19 IL - 36 CXCL1 CXCL8 CCL20 MoonLake Clinical 83 Key MoA: IL - 17A & F is at the crux of many inflammation pathways Different cell types preferentially produce IL - 17 A and/or F Multiple stimuli induce subsets of immune cells to produce IL - 17A and F IL - 17A and F induce multiple pro - inflammatory effectors, e.g. activation of keratinocytes IL - 17A and F as ”bottleneck” in many pathologies Targeting upstream or downstream pathways to IL - 17A and F has led to several failures as pathways are redundant
84 Many diseases involve IL - 17A&F as a key pathway, beyond HS and PsA MLTX Core indications Other Adjacent indications Other indications (Onco, CV) Addressable Market Size USD bn NSCLC Nr - axSpA PM DM GCA Takayasu SLE LN SSc Behcet's PPP GPP Pityriasis (PRP) Pyoderma (PG) BC RCC GC OC A - HCC AIH UC CD SC PBC(PSC) MIR GvHD GBS COPD RA NIU AS HS PsA Plaque PsO Plaque Plus PsO Excluded indications (examples) Derm Rheum Auto 43 37 150+ JIA (RF - ) Juv HS Abbreviations: HS (Hidradenitis suppurativa), PsA (psoriatic arthritis), AS (Ankylosing Spondylitis or adiographic axial spondyloarthritis), nr - axSpA (non - radiographic axial spondyloarthritis), PsO (Psoriasis), AIH (Autoimmune Hepatitis), PSC (Primary Sclerosing Cholangitis), PBC (Primary Biliary Cholangitis), GvHD (Graft - vs - Host disease), GBS (Guillan - Barre Syndrome), PM (Polymyositis), DM (Dermatomyositis), GCA (Giant Cell Arteritis), NIU (Non - infectious uveitis), SLE (Systemic lupus erythematosus ), LN (Lupus Nephritis), SSc (Systemic Sclerosis), JIA (Juvenile Idiopathic Arthritis), PPP (Palmo - plantar pustulosis), GPP (Generalized Pustular Psoriasis), BC (Breast Cancer, NSCLC (Non - small cell lung carcinoma), GC (Gastric Cancer), RCC (Renal Cell Carcinoma), A - HCC (Alcohol - related Hepatocellular Carcinoma), MIR (Myocardial ischaemia and reperfusion) Source: Clinical and scientific publications, MoonLake © 2024 | Proprietary | MoonLake TX
▪ MLTX has a robust late - stage development program ongoing ― HS Phase 3 ― PsA Phase 3 ― Commercialization - enabling data in 2025/2026 ▪ Portfolio expansion is driven on the strengths of MLTX ― Focus on building the leadership of SLK in Derm & Rheum (vs. “opening” new TAs) ― Significant value that can be unlocked with our Nanobody® against IL - 17 A&F ― Where elevating treatment goals with stellar science can make a real difference MLTX will expand its portfolio of SLK indications in Derm & Rheum Derm Palmo - Plantar pustulosis (Phase 2) Juvenile HS (Phase 3) axSpA (Phase 2) PsA (Phase 2) Rheum Source: MoonLake © 2024 | Proprietary | MoonLake TX 85
How the new indications drive value for MLTX 1 Merola J. et al. (2018). Dermatologic Therapy; 31:e12589 . doi.org/10.1111/dth.12589 and Chimenti et al. (2020). Biologics;14:53 - 75. doi: 10.2147/BTT; 2 Passeron et al. (2023). JAMA Dermatol . doi:10.1001/jamadermatol.2023.5051; 3 Limited disease control – even at lower levels: ~40% of Humira pts do not reach ASAS20 at w12 based on ATLAS trial data; 4 Based on BE MOBILE trial results PPP (Phase 2) ▪ “HS - like” disease, key priority for Derms, large unmet need ▪ Up to ~10 - 15% of PsO patients have palmoplantar involvement 1 ▪ IL17 A&F relevance shown through BKZ case series 2 Derm Rheum Source: MoonLake © 2024 | Proprietary | MoonLake TX 86
1. Passeron et al. (2023). JAMA Dermatol . doi:10.1001/jamadermatol.2023.5051; 2 Brunasso A. & Massone C (2021). Fac Rev .; Twelves et al. (2019. J Allergy Clin Immunol, 143(3):1021 - 1026 . and Misiak - Galazka, M. (2020). Am J Clin Dermatol 21, 355 – 370 .; 3 Merola J. et al. (2018). Dermatologic Therapy; 31:e12589 . doi.org/10.1111/dth.12589 and Chimenti et al. (2020). Biologics;14:53 - 75. doi: 10.2147/BTT Source: MoonLake team © 2024 | Proprietary | MoonLake TX PPP: Elevating position as the leading innovator in Derm 87 SLK can be highly differentiated… … in a severe disease without effective treatments… …by breaking new ground where others have given up ppPASI as primary endpoint to elevate the bar vs previous attempts Objective inflammation endpoints as additional scores to establish broader treatment goals Competitive number of patients in trial, with attractive design for the main PPP sites Deemed as sufficient to move to Phase 3 or even approval with successful read - outs USD bn sales beyond 2037 Of PsO patients with palmoplantar involvement 3 0.3% 4+ ~10 - 15% Global prevalence 0 Approved or effective treatment options IL - 17 A&F is most promising MoA considering BKZ cases 1 and previously shown relative performance of SLK vs BKZ Nanobody benefit given deep - tissue location of lesions (similarly to HS tunnels, pustules in deep skin) Potential to be first - to - market in U.S. and US, and add yet another distinctive therapy for Derms Market size Chronic inflammation: Crops of pustules causing pain & bleeding 2 No approved therapy Multiple MoAs failed (e.g., IL - 1, IL - 12/23s, IL - 36, IL - 17) Unmet Needs
How the new indications drive value for MLTX PPP (Phase 2) ▪ “HS - like” disease, key priority for Derms, large unmet need ▪ Up to ~10 - 15% of PsO patients have palmoplantar involvement 1 ▪ IL17 A&F relevance shown through BKZ case series 2 Derm Rheum ▪ First clinical trial in juvenile HS , addressing critical gap for derms ▪ Opportunity to control progressive disease pre - irreversible damage ▪ Parallel to adult HS Ph 3, allowing further differentiation as “HS leader” Juv HS (Phase 3) 1 Merola J. et al. (2018). Dermatologic Therapy; 31:e12589 . doi.org/10.1111/dth.12589 and Chimenti et al. (2020). Biologics;14:53 - 75. doi: 10.2147/BTT; 2 Passeron et al. (2023). JAMA Dermatol . doi:10.1001/jamadermatol.2023.5051; 3 Limited disease control – even at lower levels: ~40% of Humira pts do not reach ASAS20 at w12 based on ATLAS trial data; 4 Based on BE MOBILE trial results Source: MoonLake © 2024 | Proprietary | MoonLake TX 88
How the new indications drive value for MLTX PPP (Phase 2) ▪ “HS - like” disease, key priority for Derms, large unmet need ▪ Up to ~10 - 15% of PsO patients have palmoplantar involvement 1 ▪ IL17 A&F relevance shown through BKZ case series 2 axSpA (Phase 2) ▪ Multi - bn markets (r/nr - axSpA) with limited efficacy of current SoC 3 ▪ With PsA allows MLTX to further lead in seronegative Spondylarthritis ▪ IL17 A&F relevance shown through BKZ cases 4 , small size an advantage Derm Rheum ▪ First clinical trial in juvenile HS , addressing critical gap for derms ▪ Opportunity to control progressive disease pre - irreversible damage ▪ Parallel to adult HS Ph 3, allowing further differentiation as “HS leader” Juv HS (Phase 3) 1 Merola J. et al. (2018). Dermatologic Therapy; 31:e12589 . doi.org/10.1111/dth.12589 and Chimenti et al. (2020). Biologics;14:53 - 75. doi: 10.2147/BTT; 2 Passeron et al. (2023). JAMA Dermatol . doi:10.1001/jamadermatol.2023.5051; 3 Limited disease control – even at lower levels: ~40% of Humira pts do not reach ASAS20 at w12 based on ATLAS trial data; 4 Based on BE MOBILE trial results Source: MoonLake © 2024 | Proprietary | MoonLake TX 89
1. BKZ with durable response and effective in treating co - morbidities (i.e., uveitis) based on BE MOBILE trial results; 2. Based on U.S. claims data and estimations for AS: Unique patients diagnosed between 2015 - 2023 (ICD - 10 code: M45.*) and assuming 50:50 split between AS and nr - axSpA as per literature; 3. ~40% of Humira pts do not reach ASAS20 at w12 based on ATLAS trial data; 4. Ruderman E. et al. (2013). Arthritis Rheum. 2013;65:S1052 – S1053. Source: MoonLake team; Lubrano (E.) (2018). Clin Rev Allergy Immunol ; 9298.; Tahir H. et al. (2021). J Exp Pharmacol . 2;13:627 - 635 ; MyAS; © 2024 Komodo Health, Inc. All rights © 2024 | Proprietary | MoonLake TX axSpa: Broadening leadership in Rheum by elevating care in axSpA 90 SLK to elevate care to new efficacy levels… … in a disease with high unmet need… …with innovative imaging to redefine outcome measurements USD bn market 10+ potential in next 10 yrs 40% Of pts do not reach relevant improvements with current therapies 3 1.5% level of global prevalence 30% As current upper limit of nr - axSpA patients that progress to r - axSpA 4 Market size As current upper Chronic inflammation of axial skeleton Large unmet needs , at least 1.5M US patients diagnosed & treated in 2015 - 2023 2 Limited disease control for SoC – even at lower levels 3 Unmet Needs Strong rationale for SLK to elevate care in axSpA − Winning MoA, with IL - 17A&F inhibition showing most durable responses − Strong SLK PsA data in joints and nails as proxy for spinal inflammation − Nanobody benefit in difficult - to - treat deep inflammation and co - morbidities 1 With PsA allows MLTX to further lead in seronegative Spondylarthritis Innovative design incl. PET plus MRI imaging in parallel with clinical read - outs Accelerated path to Phase 3 Competitive number of patients in trial, with attractive design for the specialized sites reserved. Reprinted with permission.
How the new indications drive value for MLTX 1 Merola J. et al. (2018). Dermatologic Therapy; 31:e12589 . doi.org/10.1111/dth.12589 and Chimenti et al. (2020). Biologics;14:53 - 75. doi: 10.2147/BTT; 2 Passeron et al. (2023). JAMA Dermatol . doi:10.1001/jamadermatol.2023.5051; 3 Limited disease control – even at lower levels: ~40% of Humira pts do not reach ASAS20 at w12 based on ATLAS trial data; 4 Based on BE MOBILE trial results PPP (Phase 2) ▪ “HS - like” disease, key priority for Derms, large unmet need ▪ Up to ~10 - 15% of PsO patients have palmoplantar involvement 1 ▪ IL17 A&F relevance shown through BKZ case series 2 axSpA (Phase 2) ▪ Multi - bn markets (r/nr - axSpA) with limited efficacy of current SoC 3 ▪ With PsA allows MLTX to further lead in seronegative Spondylarthritis ▪ IL17 A&F relevance shown through BKZ cases 4 , small size an advantage PsA (Phase 2) ▪ Double down on PsA (and spondyloarthritis) by elevating bar on outcomes ▪ Innovation to measure disease - modification in joints, enthesitis, dactylitis ▪ Parallel to current Ph 3, further enabling commercial success Derm Rheum ▪ First clinical trial in juvenile HS , addressing critical gap for derms ▪ Opportunity to control progressive disease pre - irreversible damage ▪ Parallel to adult HS Ph 3, allowing further differentiation as “HS leader” Juv HS (Phase 3) Source: MoonLake © 2024 | Proprietary | MoonLake TX 91
Source: MoonLake Internal Opportunity Model, © 2024 Komodo Health, Inc. All rights reserved. Reprinted with permission. © 2024 | Proprietary | MoonLake TX 92 New indications provide sizeable opportunity in multi - bn markets 1 See Bimekizumab case series: Passeron et al. (2023). JAMA Dermatol. doi:10.1001/jamadermatol.2023.5051; 2 Based on BE MOBILE trial results; 3 Prevalence based on literature and U.S. claims data / Global market size estimates based on forecasting historic growth in prevalence and MLTX research on key assumptions (e.g., net prices, adherence, etc.) 4. Humira label in juvenile based on safety data from other indications; 5 ~40% of Humira pts do not reach ASAS20 at w12 based on ATLAS trial data PPP (Phase 2) Juv HS (Phase 3) axSpA (Phase 2) PsA (Phase 2) Key challenge Mkt size ($, 2035) Prevalence (%) Leading MoA IL - 17A&F 1 IL - 17A&F TNF (no trial) IL - 17A&F 2 TNF & IL - 17A IL - 17A&F TNF & IL - 17A 0.3% 1% 1.5% 1% 3.5 - 4bn (12% growth from ‘22) USD 1 - 2bn (9% growth from ‘22) USD 10 - 12bn (6% growth from ‘22) USD 15bn (5% growth from ‘22) No approved or effective therapy No clinically studied product 4 Limited efficacy of SOC 5 Outcomes sub - optimal (e.g., ACR) Derm Rheum
1 Assuming current Phase 3 planning is agreed with regulators (+/ - 6 months) Source: MoonLake team © 2024 | Proprietary | MoonLake TX New indications further enrich the potential catalyst calendar in 2024 - 25 Jun - 23: Ph2b 1ry end - point (12 wk) Q2 2023 Q3 2023 Q4 2023 H1 2025 Mar - 24: PsA Ph2b 24 - week readout Oct - 23: HS Ph2b 24 - week read out HS HS H1 2024 HS Q3/Q4 - 24: Initiate Ph3 trial(s) PsA PsA PsA PsO Ph3 ready (2022) H2 2025 H2 2024 Q4 - 25/Q1 - 26: Ph3 1ry end - point (16 wk)1 PsA x x x New studies add 150 - 200 patients and 25+ sites to SLK overall program PPP H2 - 24: Study start (FPI) H1/H2 - 25: Full readout H1 - 25: Last patient out (LPO) axSpA H1 - 25: Last patient out (LPO) H2 - 25: Full readout H2 - 24: Study start (FPI) PsA H2 - 25: Last patient out (LPO) H2 - 25: Full readout H2 - 24: Study start (FPI) H2 - 24: Study start (FPI) H1 - 26: Full readout H1 - 26: Last patient out (LPO) Juvenile HS 93 Q3 - 25: Ph3 1ry end - point (16 wk) 1 Nov - 23: PsA Ph2b 1ry end - point (12 wk) HS x x Q1/Q2 - 24: Initiate Ph3 trial(s)
Source: © 2024 | Proprietary | MoonLake TX MoonLake Corporate 94 Potential new indications could further build out SLK’s potential $8bn+ (2035) MoonLake continues to address the most pressing unmet needs in inflammatory diseases The additional programs result in USD 3Bn+, continuing to push the potential of SLK as a leading drug in inflammation Risk profile of company remains similar as data supports portfolio expansion and operations can be scaled up from current structured MLTX comfortably financed to support development plan and growth into market launch axSpA PPP PsA HS Juv HS
Source: © 2024 | Proprietary | MoonLake TX Moonlake Clinical 95 Taking a step back: Overview of R&D programs at MLTX Phase 3 (BLA enabling) PsA Phase 3 (2025/26) HS Phase 3 (2025/26) Juv HS Phase 3 (2026) Next wave (Ph 3 enabling) PPP Phase 2 (2025) axSpA Phase 2 (2025) PsA Phase 2 (2025) Research (incl. collaboration) Deep tissues SLK penetration based on clinical sampling (2025 - 26) New TAs Portfolio expansion based on human models (2024/25) Bio - IP - enabling Derm & markers Rheum program (2024 - 25)
© 2024 | Proprietary | MoonLake TX Moving Forward 96
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: DRG, MoonLake Corporate © 2024 | Proprietary | MoonLake TX 97 SLK combines properties like no other asset A promising MoA… … and a differentiated molecule ▪ Elevated Performance SLK shows highest responses at high treatment goals, HiSCR75, IHS4 - 100, PsO PASI100, PsA MDA, ACR50/70+PASI90/100 and key patient outcomes ▪ Higher goals Combines higher primary clinical endpoints in comparisons to gold - standards like Humira® (or Cosentyx®) ▪ Improved convenience Monthly 1ml maintenance injections and leading benefit - risk profile ▪ 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) ▪ Leading potential Top 2 typically get 2/3 of indication bio sales (avg. $4bn+) 1
Strategic path forward remains unchanged Current owner Source: MoonLake © 2024 | Proprietary | MoonLake TX 98 Better owner
Operating from a position of strength: over $500m in cash on the B/S Cash, cash equivalents and short - term marketable debt securities in USD M 564 September 30, 2023 16 Q4 2023 Q4 - 2023 ATM December cash burn proceeds 31, 2023 (excl. ATM) 31 53 Post - period ATM proceeds Pro Forma Cash 496 511 Includes - 8.4m in prepayments for 2025 manufacturing runs Expected sufficient cash runway until the end of 2026 , covering Source: MoonLake © 2024 | Proprietary | MoonLake TX 99 ▪ Ph3 program in HS ▪ Ph3 program in PsA ▪ Additional indication work ▪ Submission of BLA ▪ All other base spend Low cash burn continues to demonstrate cost - efficient set up and focus of MLTX $85.0m added via ATM at minimal dilution to double down on SLK development – no current plans for further raises
Source: MoonLake Corporate © 2024 | Proprietary | MoonLake TX Neutrophil Th17 Th22 ILC3 IL - 17 IL - 22 IL - 23 100 Focus on strengthening the story of SLK as leader in Type 3 diseases Th2 cell ILC2 Mast cell T fh Basophil Eosinophil IL - 4 IL - 13 IL - 5 IL - 31 Type 2 Macrophage Th1 ILC1 NK IL - 12 IFN IL - 2 IL - 6 TNF Type 1 Primary immune cells 1,2 Key cytokines 1 - 3 Diseases related to dysregulated immunity (examples) 4,6 Inflammatory Pathway UC, CD SL E, other C TD 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
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