Core Insights - MoonLake Immunotherapeutics has initiated three new clinical trials for sonelokimab, targeting adolescent hidradenitis suppurativa (HS), palmoplantar pustulosis (PPP), and axial spondyloarthritis (axSpA), expanding its clinical program to ten trials [1][4][20] - The company aims to enroll over 3,000 patients in clinical trials since its founding in 2021, with significant data readouts expected in 2025 and 2026 [1][4][9] - The market for HS is projected to reach $15 billion by 2035, highlighting the potential commercial opportunity for sonelokimab [3][13] Company Developments - The Phase 3 VELA-TEEN trial is the first dedicated clinical trial for adolescent patients with moderate-to-severe HS, while the Phase 2 LEDA trial focuses on PPP and the Phase 2 S-OLARIS trial on axSpA [4][6][12] - Sonelokimab is designed to inhibit IL-17A and IL-17F, targeting inflammation in difficult-to-reach tissues, which is crucial for the pathophysiology of these diseases [2][19] - The company has a robust cash position and is progressing towards registration and commercialization of sonelokimab [3][4] Clinical Trial Insights - The VELA-TEEN trial will evaluate the pharmacokinetics, safety, and tolerability of sonelokimab in adolescents aged 12-17 with HS, with a primary endpoint over 24 weeks [5][12] - The LEDA trial aims to assess the efficacy and safety of sonelokimab in adult patients with PPP, focusing on the percent change in the Palmoplantar Psoriasis Area and Severity Index (ppPASI) [10][16] - The S-OLARIS trial will combine traditional clinical outcomes with PET/MRI imaging to evaluate sonelokimab's impact on axSpA [11][14] Market Context - HS affects approximately 2% of the population, with significant unmet medical needs, particularly in adolescents [5][13] - PPP is a chronic condition with limited treatment options, emphasizing the need for innovative therapies like sonelokimab [7][18] - AxSpA has a global prevalence of 0.5% to 1.5%, with many patients experiencing inadequate responses to current therapies, indicating a demand for new treatment approaches [8][15]

Financial Performance - Total current assets decreased to $512.32 million as of September 30, 2024, from $514.17 million as of December 31, 2023, a decline of 0.36%[5]. - The net loss for the three months ended September 30, 2024, was $36.11 million, compared to a net loss of $11.62 million in the same period of 2023, representing a 210.5% increase[6]. - Net loss for the nine months ended September 30, 2024, was $74.85 million, compared to a net loss of $36.19 million for the same period in 2023, representing a 106.5% increase in losses[5]. - The company reported a net loss attributable to controlling interests shareholders of $35,390,337 for the three months ended September 30, 2024, compared to a loss of $9,426,049 for the same period in 2023[97]. - The net loss for the three months ended June 30, 2023, was $12,353,387, with a total comprehensive loss of $12,353,387[9]. - The company incurred a loss of $74.8 million for the nine months ended September 30, 2024[61]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $35.74 million, up 370.5% from $7.59 million in the same period of 2023[6]. - Total operating expenses for the nine months ended September 30, 2024, reached $93.51 million, compared to $39.09 million for the same period in 2023, an increase of 138.0%[6]. - General and administrative expenses rose to $21.1 million for the nine months ended September 30, 2024, compared to $15.4 million in 2023, marking a 37.1% increase[178]. - Share-based compensation expense was $5.35 million for the nine months ended September 30, 2024, slightly down from $5.50 million in 2023[5]. - The company expects to incur significant research and development expenses as it continues the development of SLK and expands its pipeline[157]. Cash Flow and Liquidity - Cash and cash equivalents decreased to $375.66 million as of September 30, 2024, from $451.17 million as of December 31, 2023, a reduction of 16.7%[5]. - Net cash flow used in operating activities for the nine months ended September 30, 2024, was $68.11 million, up from $30.43 million in 2023, indicating a 123.8% increase in cash outflow[5]. - The company reported cash and cash equivalents of $375.7 million, with total cash, cash equivalents, and short-term marketable securities amounting to $493.9 million, expected to fund operations until the end of 2026[140]. - The company anticipates that its existing cash and cash equivalents will be sufficient to advance the development of SLK in multiple indications[163]. Shareholder Equity - Total shareholders' equity decreased to $488.20 million as of September 30, 2024, from $495.68 million as of December 31, 2023, a decline of 1.0%[5]. - The accumulated deficit rose to $189.99 million as of September 30, 2024, compared to $116.66 million as of December 31, 2023, an increase of 62.7%[5]. - The weighted-average number of Class A Ordinary Shares increased to 62.90 million for the three months ended September 30, 2024, from 53.52 million in the same period of 2023, a growth of 17.5%[6]. - The total number of Class A Ordinary Shares issued and outstanding as of September 30, 2024, was 63,046,025[82]. Investments and Acquisitions - The company executed a buyback of unvested shares, resulting in a treasury increase of $114,058[10]. - The company evaluates acquisitions to determine if they should be accounted for as a business combination or asset acquisition, with a notable transaction being the in-licensing agreement with Merck Healthcare KGaA for the Sonelokimab program[45]. - The milestone payments under the In-License Agreement with MHKDG could reach up to €299.6 million ($335.2 million) based on specific regulatory and commercialization milestones[121]. Future Outlook - The company expects to continue incurring significant expenses and operating losses for at least the next three years as it develops SLK and prepares for commercial launches[60]. - The company plans to commence additional Phase 3 trials for SLK in juvenile HS and Phase 2 trials in palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA) around year-end 2024[137]. - The company has not generated any revenue from product sales and relies on the successful development and commercialization of SLK for future profitability[139]. Legal and Compliance - The company is not currently subject to any material legal proceedings[202]. - There have been no material changes to the risk factors included in the Annual Report[203].

Financial Performance - Net loss for Q2 2024 was $24.76 million, compared to a net loss of $12.35 million in Q2 2023, representing a 100.0% increase in losses year-over-year[6] - Comprehensive loss for Q2 2024 was $24.18 million, compared to $12.78 million in Q2 2023, reflecting an increase of 89.0%[6] - The net loss for the three months ended March 31, 2024, was $13,975,521, compared to a net loss of $301,865 for the previous period[11] - For the six months ended June 30, 2024, the net loss was $38,734,275, an increase from $24,572,374 in the same period of the previous year[14] - The net loss for the three months ended June 30, 2024, was $24.8 million, compared to a net loss of $12.4 million in 2023, indicating a 100.4% increase[140] - The net loss attributable to controlling interests for the three months ended June 30, 2024, was $24,267,012, compared to a net loss of $10,139,279 for the same period in 2023, representing an increase of approximately 139%[79] - The net loss per share for the three months ended June 30, 2024, was $(0.39), compared to $(0.23) for the same period in 2023, indicating a decline in performance[79] - The net loss for the six months ended June 30, 2024, was $38.7 million, compared to a net loss of $24.6 million for the same period in 2023, indicating a 57.6% increase in losses[146][153] Research and Development - Research and development expenses for Q2 2024 were $23.66 million, up 171.5% from $8.70 million in Q2 2023[6] - Research and development expenses increased to $23.7 million for the three months ended June 30, 2024, compared to $8.7 million for the same period in 2023, representing a 171.9% increase[140] - Significant increases in research and development expenses included $9.4 million for clinical development trials and $4.0 million for supply and logistics services[142] - The company expects to incur additional research and development expenses as it continues to develop SLK and expand its pipeline[130] - Research and development expenses increased to $36.7 million for the six months ended June 30, 2024, from $16.1 million in the same period of 2023, representing a 127.5% increase[146][148] Cash and Liquidity - Cash and cash equivalents decreased to $342.79 million from $451.17 million at the end of 2023, a decline of 24.1%[5] - As of June 30, 2024, the company had $342.8 million in cash and cash equivalents, which is projected to be sufficient to fund operations until the end of 2026[54] - The company had total cash, cash equivalents, and short-term marketable securities of $519.8 million as of June 30, 2024, sufficient to fund operations until the end of 2026[153] - The company reported a net cash flow used in operating activities of $42,838,778 for the six months ended June 30, 2024[14] - Cash used in operating activities was $42.8 million for the six months ended June 30, 2024, compared to $21.2 million for the same period in 2023, representing an increase of $21.6 million[155][156] Shareholder Information - The weighted-average number of Class A Ordinary Shares increased to 62,874,637 in Q2 2024 from 43,718,464 in Q2 2023, indicating a 43.8% increase in shares outstanding[6] - As of June 30, 2024, the total number of Class A Ordinary Shares issued and outstanding was 62,874,637, with a maximum authorized amount of 500,000,000 shares[68] - The total weighted average number of outstanding shares for the three months ended June 30, 2024, was 62,874,637, compared to 43,718,464 for the same period in 2023, reflecting an increase in share count[79] - The company has authorized up to 100,000,000 Class C Ordinary Shares, with 995,267 shares issued and outstanding as of June 30, 2024[69] - The company executed a conversion of Class C Ordinary Shares into Class A Ordinary Shares, impacting the total number of shares outstanding[80] Operating Expenses - The company reported total operating expenses of $30.58 million for Q2 2024, which is a 131.7% increase from $13.19 million in Q2 2023[6] - Total operating expenses for the three months ended June 30, 2024, were $30.6 million, a 131.9% increase from $13.2 million in the same period of 2023[140] - General and administrative expenses rose to $6.9 million for the three months ended June 30, 2024, up from $4.5 million in 2023, marking a 54.3% increase[143] - General and administrative expenses rose to $13.7 million for the six months ended June 30, 2024, compared to $10.0 million in the prior year, marking a 37.2% increase[146][149] Market and Product Development - The company has a focus on developing Sonelokimab, a novel tri-specific IL-17A and IL-17F inhibiting Nanobody for inflammatory skin and joint diseases[15] - The company is currently a single asset company, indicating a focused strategy on its primary product development[15] - The company plans to commence Phase 3 clinical trials for SLK in psoriatic arthritis in the second half of 2024, following positive feedback from the FDA and EMA[115] - The company has plans for additional Phase 3 trials in juvenile hidradenitis suppurativa and Phase 2 trials in palmoplantar pustulosis and axial spondyloarthritis, expected to start in the second half of 2024[115] - The company has not generated any revenue from product sales to date and expects to incur significant operating losses for at least the next three years as it continues the development of SLK[117] Financial Obligations - Total contractual obligations amounted to $129.1 million as of June 30, 2024, with $83.0 million due within one year[160] - The company is obligated to make milestone payments of up to €299.6 million ($320.6 million) upon achieving specific regulatory and commercialization milestones[100] Tax and Compliance - The effective tax rate for the three months ended June 30, 2024, was 0.3%, compared to 0.1% for the same period in 2023[97] - A valuation allowance has been recorded against the full amount of the deferred tax assets, indicating that it is not likely that these assets will be realized[170] Miscellaneous - The company has not been subject to any material legal proceedings as of the reporting date[183] - There were no changes in internal control over financial reporting during the three months ended June 30, 2024, that materially affected the company's internal controls[180] - The design and operation of the company's disclosure controls and procedures were concluded to be effective at the reasonable assurance level as of June 30, 2024[179]

Core Insights - MoonLake Immunotherapeutics has made significant progress in developing sonelokimab for moderate-to-severe hidradenitis suppurativa (HS), having received positive feedback from both the FDA and EMA to advance to late-stage clinical testing with the initiation of the phase 3 VELA program [1][3] - The VELA program includes two phase 3 studies, VELA-1 and VELA-2, both utilizing the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR)75, with a notable delta difference of 29 compared to placebo at a 120 mg dose, achieving statistical significance (p=0.0002) [1][6] - The company is also advancing the IZAR program for treating psoriatic arthritis (PsA), with the first patient expected to be dosed in Q4 2024 and primary endpoint data readout anticipated by the end of 2026 [3][7] Development Programs - The VELA program aims to evaluate sonelokimab in HS patients over a 52-week period, with the primary endpoint assessed at 16 weeks, and results expected by mid-2025 [6][7] - The IZAR program will consist of two studies, IZAR-1 and IZAR-2, targeting biologic-naive and TNF inhibitor refractory patients, respectively, with a total of 1,500 patients planned for treatment [7][8] - Sonelokimab has shown versatility, with plans to initiate additional studies for juvenile HS and palmoplantar pustulosis (PPP) in 2024 [3][7] Competitive Landscape - Sonelokimab is positioned against existing biologics like Humira and Cosentyx, which have been approved for HS and PsA, but MoonLake aims to leverage the more stringent HiSCR75 endpoint to demonstrate superior efficacy [6][7] - The drug's unique mechanism targets both IL-17A and IL-17F, potentially offering a competitive advantage over other treatments that do not target these cytokines as effectively [6][7] Financial Position - As of March 31, 2024, MoonLake had cash and equivalents totaling $547.1 million, bolstered by financial transactions in 2023, including a sales agreement that generated $52.5 million from the sale of Class A Ordinary Shares [8] - The company has a cash burn rate of $19.8 million per quarter, indicating a sufficient cash runway to support operations through the end of 2026 [8]

Core Insights - MoonLake Immunotherapeutics has received positive regulatory feedback from both the FDA and EMA for its Phase 3 program of sonelokimab in psoriatic arthritis (PsA) [1][4][17] - The Phase 3 program, named IZAR, will enroll approximately 1,500 patients and includes two trials: IZAR-1 for biologic-naïve patients and IZAR-2 for TNF-IR patients [1][4][5] - The primary endpoint for both trials is the ACR 50 response at Week 16, with results expected by the end of 2026 [4][5][22] Company Overview - MoonLake Immunotherapeutics is a clinical-stage biotechnology company focused on developing therapies for inflammatory diseases, particularly hidradenitis suppurativa (HS) and psoriatic arthritis [32] - The company was founded in 2021 and is headquartered in Zug, Switzerland [32] - Sonelokimab is a novel investigational Nanobody® that inhibits IL-17A and IL-17F, which are key drivers of inflammation in these diseases [32] Psoriatic Arthritis (PsA) Insights - PsA is a chronic inflammatory arthritis that affects up to 30% of patients with psoriasis, primarily impacting individuals aged 30 to 60 [2][18] - The disease is characterized by joint pain, swelling, and stiffness, significantly affecting patients' quality of life [2][18] - The IL-17 pathway is believed to play a crucial role in the pathophysiology of PsA [2] Clinical Trial Details - The IZAR program will consist of two global, randomized, double-blind, placebo-controlled trials: IZAR-1 and IZAR-2 [4][5] - IZAR-1 will focus on biologic-naïve patients and assess radiographic progression, while IZAR-2 will include a risankizumab active reference arm for TNF-IR patients [4][5] - The primary endpoint for both trials is the ACR 50 response, with secondary endpoints reflecting various disease manifestations [5][20] Hidradenitis Suppurativa (HS) Insights - HS is a chronic skin condition affecting 0.05–4.1% of the global population, with a significant unmet need for effective treatments [12] - The condition leads to painful inflammatory lesions and can result in irreversible tissue destruction [12] - MoonLake is also conducting Phase 3 trials for sonelokimab in HS, following positive outcomes from earlier trials [7][21]

Core Insights - MoonLake Immunotherapeutics has initiated the Phase 3 VELA program for sonelokimab, targeting moderate-to-severe hidradenitis suppurativa (HS) with a primary endpoint of HiSCR75 [1][3][4] - The program aims to enroll 800 patients across two identical trials, VELA-1 and VELA-2, with topline results expected by mid-2025 [3][5][6] - Sonelokimab is designed to inhibit IL-17A and IL-17F, addressing a significant unmet need in HS treatment [2][18] Company Overview - MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on developing sonelokimab, a novel investigational Nanobody® for inflammatory diseases [18] - The company was founded in 2021 and is headquartered in Zug, Switzerland [18] Product Details - Sonelokimab is a ~40 kDa humanized Nanobody® that selectively binds to IL-17A and IL-17F, facilitating targeted treatment of inflammation [7][18] - The drug is currently being evaluated for HS and psoriatic arthritis (PsA), with plans for additional indications in dermatology and rheumatology [8][10] Clinical Trial Information - The Phase 3 VELA program will assess the efficacy and safety of sonelokimab over 52 weeks, with a focus on achieving a ≥75% reduction in total abscess and inflammatory nodule count [3][6] - The trials will also evaluate secondary endpoints, including HiSCR50 and changes in quality of life metrics [6] Market Context - HS affects up to 4.1% of the global population, with significant morbidity and a market opportunity exceeding $10 billion by 2035 [2][17] - There is a critical need for new treatment options, as only two biologics are currently FDA approved for HS [4][17]

bymuratdenizMoonLake Rises, Competition Wanes: The Sonelokimab Saga Continues MoonLake Immunotherapeutics (NASDAQ:MLTX) is a clinical-stage biotech company developing treatments for autoimmune conditions. Their lead asset, sonelokimab, is an IL-17 inhibitor targeting psoriasis (Phase 3 ready), hidradenitis suppurativa [HS] (Phase 2), and psoriatic arthritis [PsA] (Phase 2). These are all large US markets. Psoriasis is estimated to eclipse $50 billion by 2030. HS is expected to be a $2.24 billion global ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39630 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (State or other ...

MoonLake Immunotherapeutics Reports First Quarter 2024 Financial Results and Provides a Business Update Announced positive feedback from both FDA and EMA on the regulatory path for the Phase 3 program of the Nanobody® sonelokimab in hidradenitis suppurativa (HS) and outlined the development plan with topline results anticipated in mid-2025Reported significant improvements observed across all key outcomes with sonelokimab over 24 weeks in the ARGO Phase 2 trial in active psoriatic arthritis (PsA) including u ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (MARK ONE) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39630 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (IRS Employer Identi ...