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 ...

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 September 30, 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 (State or o ...

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 June 30, 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 (State or other ...

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, 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 (State or other ...

Clinical Development and Efficacy - SLK is a tri-specific Nanobody that inhibits IL-17A and IL-17F, showing therapeutic activity in plaque-type psoriasis with significant improvements in PASI scores[17]. - The company is advancing Phase 2 trials for SLK in hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), with enrollment in the MIRA trial completed in February 2023 and primary endpoint readout expected in mid-2023[20]. - SLK has demonstrated a PASI 100 response rate of 57% in the highest dosage group after 24 weeks in the Phase 2b study, indicating significant efficacy in treating plaque psoriasis[34]. - The ongoing clinical development of SLK is supported by positive Phase 1 trial results, demonstrating acceptable safety and tolerability[31]. - The MIRA trial, evaluating SLK for hidradenitis suppurativa, completed enrollment in February 2023, with primary endpoint readouts expected in mid-2023[46]. - The ARGO trial for psoriatic arthritis is ongoing, with approximately 200 patients and primary endpoint defined as ACR50 response[48]. - SLK is the first Nanobody to show responses in a Phase 2b study of psoriasis, marking a significant advancement in the treatment of IL-17 driven diseases[36]. Safety and Adverse Events - The safety profile of SLK in the Phase 2b study showed an overall Candida infection rate of 2.9% from week 0 to week 12 and 6.4% from week 12 to week 52, comparable to other IL-17A inhibitors[34]. - Sonelokimab showed a treatment-emergent adverse event rate of 58.8% in the 120 mg group during weeks 0-12, compared to 42.3% in the placebo group[38]. - Serious adverse events occurred in 2.0% of participants in the Sonelokimab 120 mg group, while the placebo group reported 1.9%[38]. - Common treatment-emergent adverse events included nasopharyngitis at 13.5% in the Sonelokimab group during weeks 0-12[38]. Manufacturing and Supply Chain - The company aims to build its manufacturing capabilities to ensure sufficient supply for clinical trials and future commercial requirements, with technology transfers executed in 2022[27]. - The company has a contract manufacturing agreement with Richter-Helm Biologics for the production of SLK, effective July 1, 2021[50]. - The company partners with third-party CMOs for drug substance and finished product manufacturing, with no plans to establish its own facilities[49]. Intellectual Property and Licensing - The company plans to deepen its intellectual property portfolio to protect SLK and its applications, ensuring competitive advantage in the market[27]. - As of December 31, 2022, the company holds exclusive rights to a patent family for IL-17 Nanobodies, including SLK, with 22 patents issued[54]. - The License Agreement with Merck Healthcare KGaA includes a development plan for conducting clinical trials in major markets, including the U.S. and Europe[56]. - The aggregate purchase price for the License Agreement was $29.9 million, including an upfront cash payment and a 9.9% equity stake in MoonLake Immunotherapeutics AG[57]. - Potential milestone cash payments of up to EUR 307.1 million ($327.5 million) are payable, with $8.0 million recognized as R&D expense in 2022[57]. - The License Agreement requires royalty payments ranging from low to mid-teen percentages of net sales, continuing for ten years from the first commercial sale or until patent claims expire[59]. Regulatory Environment - The FDA and other regulatory authorities extensively regulate the research, development, and marketing of biologics, requiring substantial time and financial resources for compliance[62]. - The BLA submission process includes completion of preclinical studies, submission of an IND, and successful clinical trials, with a typical review period of ten months for standard applications[76]. - The FDA may require additional Phase 4 studies post-approval to monitor safety and efficacy, which could affect marketing limitations[81]. - The company must navigate various regulatory requirements for clinical trials, including approvals from independent ethics committees and compliance with Good Clinical Practices (GCP)[69]. - The FDA's review process for a BLA includes inspections of manufacturing facilities to ensure compliance with current Good Manufacturing Practices (cGMP)[77]. - The FDA's fast track program allows for expedited review of new products intended to treat serious diseases, with opportunities for more frequent interactions with the review team[82]. - Products with fast track designation may also be eligible for priority review, aiming for FDA action within six months compared to ten months under standard review[83]. - Accelerated approval may be granted if a product shows effects on a surrogate endpoint likely to predict clinical benefit, with post-marketing studies required to verify this[84]. - The RMAT designation facilitates efficient development and review of regenerative medicine therapies, providing benefits similar to breakthrough therapy designation[86]. - Breakthrough therapy designation allows for expedited development for products showing substantial improvement over existing therapies, with increased FDA interaction[87]. - Orphan drug designation is available for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S., providing potential exclusivity for seven years upon approval[89]. - The FDA requires compliance with extensive regulations post-approval, including record-keeping and reporting of adverse experiences[93]. - Non-compliance with FDA regulations can lead to severe consequences, including product withdrawal and civil penalties[94]. Financial Performance and Projections - The company incurred a net loss of $64.5 million for the year ended December 31, 2022, and expects to continue incurring significant losses for the foreseeable future[210]. - The company has not generated any revenue from its product SLK and may never achieve profitability[208]. - The company has a limited operating history and has not completed any clinical trials, with no products approved for commercial sale[203]. - The company anticipates that its existing cash and cash equivalents will be sufficient to fund operations into the second half of 2024[211]. - The company does not have any committed external sources of funds and may need to seek additional financing sooner than planned, which could dilute shareholder ownership[212]. - There is substantial doubt about the company's ability to continue as a going concern, which may affect its ability to secure additional funding on reasonable terms[215]. - The company has delayed some research-stage programs and clinical trials due to funding issues and incurred additional debt to support operations[214]. - The company is no longer pursuing a clinical trial in axSpA due to redemptions at the time of the Business Combination[214]. Workforce and Corporate Structure - The company plans to continue hiring additional employees in 2023, focusing on expanding expertise in clinical development and corporate functions[188]. - The company has approximately 20 employees as of December 31, 2022, located in Switzerland, the United Kingdom, and Belgium[187]. - The company emphasizes the importance of attracting and retaining highly skilled employees, offering competitive salaries and opportunities for equity ownership[190]. - The company relies on licensing rights from MHKDG, which can be terminated under certain circumstances, impacting its ability to develop SLK[201]. - The company's business relies on licensing rights from MHKDG, which can be terminated under certain circumstances, impacting the development and commercialization of SLK[216]. Market and Competitive Landscape - The company faces substantial competition in the biopharmaceutical market, which may affect its ability to successfully commercialize SLK[201].

Financial Performance - MoonLake Immunotherapeutics has incurred significant losses since inception and expects to continue incurring substantial losses for the foreseeable future [150]. - The net loss for Q3 2022 was $14.7 million, a 134.4% increase compared to a net loss of $6.3 million in Q3 2021 [177]. - For the nine months ended September 30, 2022, total operating expenses were $48.4 million, up 23.1% from $39.3 million in the same period of 2021 [184]. - The net loss for the nine months ended September 30, 2022, was $48.0 million, representing a 22.2% increase from $39.3 million in the same period of 2021 [184]. - The company anticipates ongoing fluctuations in net losses due to the timing of clinical trials and expenditures on research and development activities [172]. - The company expects to incur significant expenses and operating losses for at least the next five years as it continues clinical development and seeks regulatory approval for its product candidate [193]. Cash and Funding - As of September 30, 2022, the company had $41.2 million in cash and cash equivalents, with total cash, cash equivalents, and short-term marketable securities amounting to $83.5 million, sufficient to fund operations into the second half of 2024 [155]. - Net cash used in operating activities was $44.3 million for the nine months ended September 30, 2022, compared to $27.7 million in the same period of 2021 [197]. - Net cash provided by financing activities was $119.7 million for the nine months ended September 30, 2022, significantly higher than $28.3 million in the same period of 2021 [199]. - The company anticipates that its available cash will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2024 [192]. Research and Development - The company has not generated any revenue from product sales to date and will depend on the successful development and commercialization of its product SLK for future revenue [154][163]. - Research and development expenses for Q3 2022 were $9.0 million, a significant increase of 1,247.9% compared to $0.7 million in Q3 2021 [178]. - The company expects to incur significant additional research and development expenses as it progresses into Phase 3 clinical trials for SLK [167]. - Research and development expenses for the nine months ended September 30, 2022, were $30.7 million, slightly up from $30.5 million in the same period of 2021 [185]. - The company is substantially dependent on the success of its novel tri-specific nanobody, sonelokimab, licensed from Merck Healthcare KGaA [150]. Clinical Trials and Product Development - In the Phase 2b clinical trial for SLK, 57% of patients achieved total skin clearance after 24 weeks, demonstrating significant efficacy compared to placebo [152]. - The company plans to develop SLK for inflammatory diseases driven by IL-17A and IL-17F, with initial target diseases including hidradenitis suppurativa and psoriatic arthritis [153]. - The primary endpoint data readout for the Phase 2 trials in hidradenitis suppurativa is expected in mid-2023, while enrollment for psoriatic arthritis trials is anticipated to commence before the end of 2022 [153]. - The company has not completed any clinical trials and has no products approved for commercial sale [147][154]. Operating Expenses - Total operating expenses for Q3 2022 reached $14.8 million, reflecting a 135.7% increase from $6.3 million in Q3 2021 [177]. - General and administrative expenses for Q3 2022 were $5.7 million, slightly up by 2.7% from $5.6 million in Q3 2021 [179]. - General and administrative expenses increased to $17.7 million for the nine months ended September 30, 2022, compared to $8.8 million for the same period in 2021, reflecting an increase of $8.9 million [186]. - Operating expenses are expected to fluctuate significantly from year to year based on the timing of clinical development programs and regulatory approval efforts [156]. Other Financial Information - The company recognized a foreign currency transaction gain of $344,914 for the nine months ended September 30, 2022 [175]. - The company recognized $352,227 in other income for the nine months ended September 30, 2022, a significant increase from an expense of $25,839 in the same period of 2021 [187]. - An income tax expense of $25,354 was recorded for the nine months ended September 30, 2022, related to the U.K. subsidiary, with no tax recorded in the same period of 2021 [188]. - Total contractual obligations as of September 30, 2022, amounted to $37.7 million, with $27.3 million due within one year [200]. Regulatory and Compliance - The company is utilizing the extended transition period under the JOBS Act, which may affect comparability with other public companies [218]. - The company will cease to be an emerging growth company when total annual gross revenue reaches $1.235 billion or more [220]. - The company may still qualify as a "smaller reporting company" after losing its emerging growth status, allowing it to maintain some disclosure exemptions [221]. - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company [222].

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 June 30, 2022 ☐ 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 N/A (State or other jurisdi ...

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, 2022 ☐ 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 N/A (State or other jurisd ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ 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 HELIX ACQUISITION CORP. (Exact name of registrant as specified in its charter) | Cayman Islands | | N/A | | --- | --- ...

Financial Performance - For the three months ended September 30, 2021, the company reported a net loss of $2,092,025, primarily due to general and administrative expenses of $2,093,506, offset by interest earned on marketable securities of $1,481[118]. - For the nine months ended September 30, 2021, the company had a net loss of $2,320,649, with general and administrative expenses totaling $2,346,085 and interest income of $25,436[118]. Initial Public Offering - The company completed its Initial Public Offering on October 22, 2020, raising gross proceeds of $115,000,000 from the sale of 11,500,000 Public Shares at $10.00 per share[121]. - The company incurred transaction costs of $6,750,447 related to the Initial Public Offering, including $2,300,000 in underwriting fees[122]. Cash and Securities - As of September 30, 2021, the company held $115,040,353 in cash and marketable securities in the Trust Account, intended for completing a Business Combination[125]. - As of September 30, 2021, the company had $1,028,752 in cash held outside the Trust Account, primarily for identifying and evaluating target businesses[126]. Business Combination Plans - The company announced a Business Combination Agreement with MoonLake Immunotherapeutics AG on October 4, 2021, involving a cash contribution and equity exchange[114]. - The company expects to incur significant costs in pursuing its acquisition plans and cannot assure the success of completing a Business Combination[110]. - The company may need additional financing to complete a Business Combination or to cover redemptions of public shares, which could involve issuing additional securities or incurring debt[129]. Financial Position - The company has no long-term debt or off-balance sheet financing arrangements as of September 30, 2021[130]. - Management does not anticipate any material effect on condensed financial statements from recently issued accounting standards[138]. - The company qualifies as a smaller reporting company and is not required to provide additional market risk disclosures[139].