MoonLake Immunotherapeutics

Previous wording

A discussion regarding our results of operations for the year ended December 31, 2023 compared to December 31, 2022 can be found under Part II - Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on February 29, 2024, as amended by Amendment No. 1 on Form 10-K/A for the year ended December 31, 2023, which was filed with the SEC on May 7, 2024.

Current wording

A discussion regarding our results of operations for the year ended December 31, 2024 compared to December 31, 2023 can be found under Part II - Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (“SEC”) on February 26, 2025.

Previous wording

We are a clinical stage biotechnology company advancing therapies to address significant unmet needs in inflammatory skin and joint diseases. We are currently a single asset company focused on the development of Sonelokimab (“SLK”), a novel tri-specific IL-17A and IL-17F inhibiting Nanobody, that we exclusively licensed from Merck Healthcare KGaA, Darmstadt, Germany (“MHKDG”) and that has the potential, based on response levels seen in clinical trials, to drive disease modification in dermatology and rheumatology patients.

Current wording

We are a clinical stage biotechnology company advancing therapies to address significant unmet needs in inflammatory skin and joint diseases. We are currently a single asset company focused on the development of Sonelokimab (“SLK”), a novel tri-specific IL-17A and IL-17F inhibiting Nanobody, that we exclusively licensed from Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (“MHKDG”) and that has the potential, based on response levels seen in clinical trials, to drive disease modification in dermatology and rheumatology patients.

Previous wording

SLK is a proprietary Nanobody that was discovered by Ablynx N.V., Belgium, a Sanofi company (“Ablynx”), and previously studied by MHKDG and Avillion LLP under a 2017 co-development agreement. The terms “Nanobody” and “Nanobodies” used herewith are registered trademarks of Ablynx. Nanobodies are able to bind selectively to a specific antigen with high affinity. Nanobodies have a fraction of the molecular weight compared to traditional antibodies. They offer a number of potential advantages over traditional monoclonal antibodies, including the potential to create multivalent molecules with enhanced ability to penetrate inflamed tissue, especially when containing an additional albumin binding domain such as SLK, an easier manufacturing process and a higher thermostability.

Current wording

SLK is a proprietary Nanobody that was discovered by Ablynx N.V., Belgium, a Sanofi company (“Ablynx”), and previously studied by MHKDG and Avillion LLP (“Avillion”) under a 2017 co-development agreement. The terms “Nanobody” and “Nanobodies” used herewith are registered trademarks of Ablynx. Nanobodies are able to bind selectively to a specific antigen with high affinity. Nanobodies have a fraction of the molecular weight compared to traditional antibodies. They offer a number of potential advantages over traditional monoclonal antibodies, including the potential to create multivalent molecules with enhanced ability to penetrate inflamed tissue, especially when containing an additional albumin binding domain such as SLK, an easier manufacturing process and a higher thermostability.

Previous wording

In May 2022, we initiated a Phase 2b trial of SLK in patients with moderate-to-severe HS (the MIRA trial (M1095-HS-201)), and in June 2023, we announced positive top-line results from this trial, which met its primary endpoint of Hidradenitis Suppurativa Clinical Response (“HiSCR”) 75. In October 2023, we announced positive 24-week top-line results showing that the maintenance treatment with SLK led to further improvements in HiSCR75 response rates and other clinically relevant outcomes in patients with moderate-to-severe HS. In February 2024, we announced the successful outcome of our end-of-Phase 2 interactions with the U.S. Food and Drug Administration (“FDA”), as well as positive feedback from our interactions with the E.U. European Medicines Agency (“EMA”), with both regulatory bodies supporting our proposed approach for advancing our Phase 3 program of SLK in HS. In May 2024, we announced the screening of the first patients in the VELA-1 trial (M1095-HS-301) and VELA-2 trial (M1095-HS-302). We expect primary endpoint data from the VELA-1 and VELA-2 clinical trials as of mid-2025.

Current wording

In May 2022, we initiated a Phase 2b trial of SLK in patients with moderate-to-severe HS (the MIRA trial (M1095-HS-201)), and in June 2023, we announced positive top-line results from this trial, which met its primary endpoint of Hidradenitis Suppurativa Clinical Response (“HiSCR”) 75 with 43% of patients treated with SLK 120mg achieving such response at week 12. In October 2023, we announced positive 24-week top-line results showing that the maintenance treatment with SLK led to further improvements in HiSCR75 response rates and other clinically relevant outcomes in patients with moderate-to-severe HS. In February 2024, we announced the successful outcome of our end-of-Phase 2 interactions with the U.S. Food and Drug Administration (“FDA”), as well as positive feedback from our interactions with the E.U. European Medicines Agency (“EMA”), with both regulatory bodies supporting our proposed

Previous wording

We expect to submit a first Biologics License Application (“BLA”) for SLK in 2026 and, subject to FDA approval, a first commercial launch in the U.S. in 2027.

Current wording

In November 2025, we were granted a Type B meeting with the FDA to discuss adequacy of the current clinical evidence package of SLK in HS to support a Biologics License Application (“BLA”) and in January 2026, we announced positive feedback from this interaction, confirming that we may establish substantial evidence of effectiveness (“SEE”) without additional clinical trials in HS. The FDA specifically advised to include the results of the MIRA trial together with the results of the VELA trials in the submission to establish SEE. Based on the positive feedback, we expect to submit a BLA for SLK in adult and adolescent HS in the second half of 2026. Subject to FDA approval, we expect a first commercial launch in the United States in the second half of 2027.

Previous wording

In December 2022, we initiated a Phase 2b trial in patients with active PsA (the ARGO trial (M1095-PSA-201)) and in November 2023, we announced positive top-line results from this trial, which met its primary endpoint of American College of Rheumatology (“ACR”) 50. In March 2024, we announced positive 24-week data from the ARGO trial in PsA showing that continued treatment with SLK led to significant improvements across all key outcomes. In June 2024, we announced the successful outcome of our end-of-Phase 2 interactions with the FDA, as well as positive feedback from our interactions with the EMA, with both regulatory bodies supporting our proposed approach for advancing our Phase 3 program of SLK in PsA. In November 2024, we announced the screening of the first patients in the IZAR-1 trial (M1095-PSA-301) and IZAR-2 trial (M1095-PSA-302).

Current wording

In December 2022, we initiated a Phase 2b trial in patients with active PsA (the ARGO trial (M1095-PSA-201)), and in November 2023, we announced positive top-line results from this trial, which met its primary endpoint of American College of Rheumatology (“ACR”) 50 with 46% of patients on 60mg SLK achieving such response at week 12. In March 2024, we announced positive 24-week data from the ARGO trial in PsA showing that continued treatment with SLK led to significant improvements across all key outcomes. In June 2024, we announced the successful outcome of our end-of-Phase 2 interactions with the FDA, as well as positive feedback from our interactions with the EMA, with both regulatory bodies supporting our proposed approach for advancing our Phase 3 program of SLK in PsA. In November 2024, we announced the screening of the first patients in the IZAR-1 trial (M1095-PSA-301) and IZAR-2 trial (M1095-PSA-302). In February 2026, we announced completion of enrollment for the IZAR-1 trial. We expect a readout of the primary and key secondary endpoints of the IZAR-1 clinical trial in mid-2026 and of the IZAR-2 clinical trial in the second half of 2026. In addition, in January 2025, we initiated another Phase 2 clinical trial of SLK in patients with PsA where we are applying novel imaging techniques (the P-OLARIS trial (M1095-snSpA-202)). We expect results of the P-OLARIS trial to become available at the end of 2026.

Previous wording

SLK was also studied in a Phase 2b trial in PsO patients where it showed a significant improvement in the primary end point as compared with placebo and for which results were presented in peer-reviewed scientific publications and conferences. In addition to the three Phase 2b trials, Phase 1 single ascending and multiple ascending dosing trials were previously completed, bringing the total number of patients in completed SLK-related trials to more than 700.

Current wording

SLK was also studied in a Phase 2b trial in PsO patients where it showed a significant improvement in the primary end point as compared with placebo and for which results were presented in peer-reviewed scientific publications and conferences. In addition, Phase 1 single ascending and multiple ascending dosing trials were previously completed.

Previous wording

We do not have any product candidates approved for commercial sale, and we have not generated any revenue from product sales. Our ability to generate revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of SLK in one or more indications, which we expect to take a number of years. We expect to continue to incur significant expenses and operating losses for at least the next three years as we continue the development of SLK and prepare for commercial launches. It is expected that operating losses will fluctuate significantly from year to year depending on the timing of our planned clinical development programs and efforts to achieve regulatory approval.

Current wording

We do not have any product candidates approved for commercial sale, and we have not generated any revenue from product sales. Our ability to generate revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of SLK in one or more indications, which we expect to take a number of years. We expect to continue to incur substantial expenses and operating losses for at least the next two years as we continue the development of SLK and prepare for commercial launches. We expect that operating losses will fluctuate notably from year to year depending on the timing of our planned clinical development programs, efforts to achieve regulatory approval, and planned marketing and sales expenditures leading up to a commercial launch.

Previous wording

As of December 31, 2024, we had $180.4 million of cash and cash equivalents. Based on our current operating plans, we believe that our existing cash, cash equivalents and short-term marketable securities, together amounting to $448.0 million, will be sufficient to fund our operating expenses and capital expenditure requirements until the end of 2026.

Current wording

As of December 31, 2025, we had $334.5 million in cash and cash equivalents. Based on our current operating plans and the Loan and Security Agreement (as defined below), we believe that our existing cash, cash equivalents and short-term marketable securities, together amounting to $394.0 million, will be sufficient to fund our operating expenses and capital expenditure requirements into the second half of 2027.

Previous wording

•costs related to manufacturing material for our research program and clinical studies;

Current wording

•costs related to manufacturing material for our research program, clinical studies, and pre-launch inventory;

Previous wording

The successful development of SLK is highly uncertain. We expect to incur significant research and development expenses for the foreseeable future as we continue the development and manufacturing partnerships for SLK, conduct research activities and potentially expand our pipeline by pursuing additional indications for SLK or including new product candidates in our portfolio. We cannot determine with certainty the timing of initiation, the duration, or the completion costs of current or future research studies and clinical trials of SLK due to the inherently unpredictable nature of research activities and clinical development. Clinical development timelines, the probability of success and the development costs can differ materially from expectations. We anticipate that we will make determinations as to which indications to pursue and how much funding to direct to each indication on an ongoing basis in response to the results of ongoing and future research studies and clinical trials, regulatory developments, and our ongoing assessments as to each indication’s commercial potential.

Current wording

The successful development of SLK is highly uncertain. We expect to incur considerable research and development expenses for the foreseeable future as we continue the development and manufacturing partnerships for SLK, conduct research activities and potentially expand our pipeline by pursuing additional indications for SLK or including new product candidates in our portfolio. We cannot determine with certainty the timing of initiation, the duration, or the completion costs of current or future research studies and clinical trials of SLK due to the inherently unpredictable nature of research activities and clinical development. Clinical development timelines, the probability of success and the development costs can differ materially from expectations. We anticipate that we will make determinations as to which indications to pursue and how much funding to direct to each indication on an ongoing basis in response to the results of ongoing and future research studies and clinical trials, regulatory developments, and our ongoing assessments as to each indication’s commercial potential.

Previous wording

Any changes in the outcome of any of these variables with respect to the development of SLK could mean a significant change in the costs and timing associated with its development. We may never succeed in achieving regulatory approval for SLK. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify

Current wording

Any changes in the outcome of any of these variables with respect to the development of SLK could mean a notable change in the costs and timing associated with its development. We may never succeed in achieving regulatory approval for SLK. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify

Previous wording

clinical trials or focus on other product candidates. For example, if the FDA, the EMA, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of SLK’s clinical development.

Current wording

clinical trials or focus on other product candidates. For example, if the FDA, the EMA, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience delays in enrollment in any of our planned clinical trials, we could be required to expend additional financial resources and time on the completion of SLK’s clinical development.

Previous wording

•Completing the development of SLK in our current focus indications, HS, PsA, axSpA and PPP—We expect to incur significant research and development expenses, and G&A expenses as we: (i) conduct clinical trials for SLK including the ongoing Phase 3 clinical trials in HS, PsA and adolescent HS and the ongoing Phase 2 clinical trials in PPP and axSpA; (ii) attract, hire and retain additional clinical, scientific, quality control, and administrative personnel; and (iii) add clinical, operational, financial and management information systems and personnel.

Current wording

•Completing the development of SLK in our current focus indications, HS, PsA, axSpA and PPP— We expect to incur considerable research and development expenses, and G&A expenses as we: (i) conduct clinical trials for SLK including the ongoing Phase 3 clinical trials in HS, PsA and adolescent HS, the ongoing Phase 2 clinical trial in PsA, and potential future Phase 3 clinical trials in PPP and axSpA; (ii) attract, hire and retain additional clinical, scientific, quality control, and administrative personnel; and (iii) add clinical, operational, financial and management information systems and personnel.

Previous wording

•Preparing for commercialization of SLK— We have started preparing the BLA to seek approval of SLK in the U.S. in HS and adolescent HS. We expect to incur significant research and development expense, and G&A expenses in this process, as we make milestone and commercial payments under the In-License Agreement, dated April 29, 2021, by and between MoonLake AG and MHKDG (the "In-License Agreement") (based on regulatory filing acceptances, first commercial sales, and aggregate annual net sales) and as we establish a sales, marketing and distribution infrastructure to commercialize SLK including establishing a presence in the U.S. We expect to submit the BLA in 2026 after completion of the VELA program, and, subject to FDA approval, we expect a commercial launch in the U.S. in 2027.

Current wording

•Preparing for commercialization of SLK — We have started preparing the BLA to seek approval of SLK in the United States in HS and adolescent HS. We expect to incur research and development expense, and G&A expenses in this process, as we make milestone and commercial payments under the In-License Agreement, dated April 29, 2021, by and between MoonLake AG and MHKDG (the "In-License Agreement") (based on regulatory filing acceptances, first commercial sales, and aggregate annual net sales) and as we establish a sales, marketing and distribution infrastructure to commercialize SLK including establishing a presence in the United States. We expect to submit the BLA in the second half of 2026 after completion of the VELA program, and, subject to FDA approval, we expect a commercial launch in the United States in the second half of 2027.

Previous wording

•Building our manufacturing capabilities — We do not own or operate manufacturing facilities, and currently have no plans to establish any. We partner with third-party CMOs for both drug substance and finished drug product. We obtain our supplies from these manufacturers based on purchase orders. Therefore, we expect to incur research and development costs for the purchase of our supplies on an as needed basis to conduct our clinical trials. Technology transfers for drug substance and drug product to commercial scale CMOs have already been executed in 2022, but we may pursue additional technology transfers and process improvements. This is designed to allow us to scale up while SLK is in clinical development and advance potential commercial requirements. The improvement of our manufacturing capabilities will be important in driving efficiency, maintaining high standards of quality control, and ensuring that investigators, physicians, and patients have adequate access to our product candidates, if approved. We also plan to start the stock-piling of drug substance as pre-launch inventory in 2025.

Current wording

•Building our manufacturing capabilities— We do not own or operate manufacturing facilities, and currently have no plans to establish any. We partner with third-party CMOs for both drug substance and finished drug product. We obtain our supplies from these manufacturers based on purchase orders. Therefore, we expect to incur research and development costs for the purchase of our supplies on an as needed basis to conduct our clinical trials. We have executed technology transfers for drug substance and drug product to commercial scale CMOs, and we have successfully manufactured Process Performance Qualification batches, but we may pursue additional technology transfers and process improvements. This is designed to allow us to scale up while SLK is in clinical development and advance potential commercial requirements. The improvement of our manufacturing capabilities will be important in driving efficiency, maintaining high standards of quality control, and ensuring that investigators, physicians, and patients have adequate access to our product candidates, if approved. We began stock-piling drug substance as pre-launch inventory during the third quarter of 2025 and expect to continue doing so in 2026.

Previous wording

•Deepening our intellectual property portfolio to support our Nanobody technology and product candidates — We expect to continue to incur additional research and development expenditures as we continue extending our global intellectual property portfolio consisting of patents and patent applications, trade secrets, trademarks, and know-how to protect the product candidates developed from our Nanobody technology. We plan to expand our intellectual property portfolio as we continue to advance and develop existing product candidates.

Current wording

•Deepening our intellectual property portfolio to support our Nanobody technology and product candidates — We expect to continue to incur additional research and development expenditures as we continue extending our global intellectual property portfolio consisting of patents and patent applications, trade secrets, trademarks, and know-how to protect the product candidates developed from our Nanobody technology. We

Previous wording

•Granting share-based compensation awards and vesting of existing plans— We expect to continue to grant awards to selected employees, directors and non-employees pursuant to the MoonLake Immunotherapeutics 2022 Equity Incentive Plan (“Equity Incentive Plan”). Further, we expect to continue to incur share-based compensation charges in connection with the above-mentioned plan and the vesting of awards made under MoonLake AG’s Employee Share Participation Plan (“ESPP”).

Current wording

•Granting share-based compensation awards and vesting of existing plans — We expect to continue to grant awards to selected employees, directors and non-employees pursuant to the MoonLake Immunotherapeutics 2022 Equity Incentive Plan. Further, we expect to continue to incur share-based compensation charges in connection with the above-mentioned plan and the vesting of awards made under MoonLake AG’s Employee Share Participation Plan.

Previous wording

We also expect to incur additional legal, accounting, investor relations and other expenses associated with operating as a public company and as we continue to grow our business. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.

Current wording

We also expect to incur additional IT, legal, accounting, leasing, and other expenses as we continue to grow our business. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.

Previous wording

We expect our existing cash and cash equivalents to be sufficient to advance the development of SLK in multiple indications, including the above-mentioned clinical trials in HS, PsA, adolescent HS, PPP and axSpA, and to submit a Biologics License Application for SLK. Clinical development involves a lengthy and expensive process with uncertain outcomes and is subject to risks described in Item 1A, including that our preclinical studies or clinical trials may not be conducted as planned or completed on schedule and may not satisfy the requirements of the FDA, EMA, or other comparable foreign regulatory authorities. If we are required to conduct additional preclinical studies or clinical trials of SLK beyond those that we currently contemplate, if we are delayed or unable to successfully complete clinical trials of SLK or other testing, or if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may require additional funding. Moreover, we will require additional capital to commercialize SLK and to discover, develop, obtain regulatory approval and commercialize any future product candidates, as applicable. We do not have any committed external source of funds. We expect to finance future cash needs through public or private equity or debt offerings or product collaborations. Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. The current market environment for small biotechnology companies, like us, and broader macroeconomic factors, including recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures, may preclude us from successfully raising additional capital.

Current wording

We expect our existing cash and cash equivalents to be sufficient to advance the development of SLK in multiple indications, including the above-mentioned clinical trials in HS, PsA, adolescent HS, PPP and axSpA, and to submit a BLA for SLK. Clinical development involves a lengthy and expensive process with uncertain outcomes and is subject to risks described in Item 1A. Risk Factors, including that our non-clinical studies or clinical trials may not be conducted as planned or completed on schedule and may not satisfy the requirements of the FDA, EMA, or other comparable foreign regulatory authorities. If we are required to conduct additional preclinical studies or clinical trials of SLK beyond those that we currently contemplate, if we are delayed or unable to successfully complete clinical trials of SLK or other testing, or if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may require additional funding. Moreover, we will require additional capital to commercialize SLK and to discover, develop, obtain regulatory approval and commercialize any future product candidates, as applicable. We expect to finance future cash needs through public or private equity, additional debt, or product collaborations. Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. The current market environment for small biotechnology companies, like us, and broader macroeconomic factors may preclude us from successfully raising additional capital.

Previous wording

Gains or losses from foreign currency translation are included in the consolidated statements of operations and comprehensive loss in “other income, net”. We recognized a foreign currency transaction loss of $42,186 for the year

Current wording

Gains or losses from foreign currency transactions are included in the consolidated statements of operations and comprehensive loss in “Other income, net”. We recognized a net foreign currency transaction gain of $599 thousand for the year ended December 31, 2025, a net foreign currency transaction loss of $42 thousand for the year ended December 31, 2024, and a net foreign currency transaction gain of $151 thousand for the year ended December 31, 2023.

Previous wording

Research and development expenses were $112.8 million for the year ended December 31, 2024, compared to $31.8 million for the year ended December 31, 2023. The increase of $81.0 million primarily related to an increase of $47.7 million in expenses pertaining to clinical development trials with CROs, including the Phase 3 VELA program in HS and the Phase 3 IZAR program in PsA, as well as the additional trials in adolescent HS (the VELA-TEEN trial), PPP (the LEDA trial), axSpA (the S-OLARIS trial) and PsA (the P-OLARIS trial). An additional increase of $23.7 million related to supply and logistic services for such clinical development trials, including the purchase of a comparator drug for the IZAR-2 trial in PsA, and an increase of $5.4 million in personnel-related costs to support our research and development efforts. In the years ended December 31, 2024 and 2023, research and development expenses were predominantly made up of external costs.

Current wording

Research and development expenses were $202.9 million for the year ended December 31, 2025, compared to $112.8 million for the year ended December 31, 2024. The increase of $90.1 million, or 79.9%, is primarily related to an increase of $54.5 million in expenses pertaining to clinical development trials with CROs, including the Phase 3 VELA program in HS and the Phase 3 IZAR program in PsA, as well as the additional trials in adolescent HS (the VELA-TEEN trial), PPP (the LEDA trial), axSpA (the S-OLARIS trial) and PsA (the P-OLARIS trial), an increase of $21.6 million in manufacturing, supply and logistics expenses through CMOs, which is primarily related to the production of stockpiled pre-launch inventory, and increases of $5.5 million and $4.7 million in personnel-related costs and consulting expenses, respectively, to support our research and development efforts.

Previous wording

General and administrative expenses were $30.3 million for the year ended December 31, 2024, compared to $22.3 million for the year ended December 31, 2023. The increase of $8.0 million primarily related to an increase of $3.3 million in personnel-related costs to support organizational growth, an increase of $2.4 million in expenses for advisory and professional services to support organizational growth, an increase of $1.6 million in office expenses driven by the new leases for additional office space, and an increase of $1.2 million in market research expenses.

Current wording

General and administrative expenses were $42.0 million for the year ended December 31, 2025, compared to $30.3 million for the year ended December 31, 2024. The increase of $11.7 million, or 38.4%, is primarily related to an increase of $7.0 million in personnel-related costs, an increase of $3.2 million in expenses for advisory and professional services, both to support organizational growth, an increase of $1.4 million in legal expenses to support the Loan and

Previous wording

Other income, net was $22.1 million for year ended December 31, 2024, compared to $10.1 million for the year ended December 31, 2023. The increase of $12.0 million primarily related to an increase of $12.3 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities.

Current wording

Other income, net was $22.4 million for year ended December 31, 2025, compared to $22.1 million for the year ended December 31, 2024. The increase of $0.2 million, or 1.1%, is primarily related to an increase of $0.6 million in net currency gains, partially offset by a decrease of $0.5 million in realized interest on cash held in banks and cash investments in short-term marketable debt securities.

Previous wording

Income tax expense was $0.3 million for the year ended December 31, 2024, compared to $0.1 million for the year ended December 31, 2023. The expense is related to corporate income tax of our subsidiaries in the U.K. and Portugal.

Current wording

Income tax expense was $0.6 million for the year ended December 31, 2025, compared to $0.3 million for the year ended December 31, 2024. The expense for each period is related to corporate income tax of our subsidiaries in the United Kingdom and Portugal.

Previous wording

Other comprehensive income was $2.6 million for the year ended December 31, 2024, compared to $2.0 million for the year ended December 31, 2023. The increase of $0.6 million primarily related to an increase in net unrealized gain in short-term marketable debt securities.

Current wording

Other comprehensive loss was $4.5 million for the year ended December 31, 2025, compared to other comprehensive income of $2.6 million for the year ended December 31, 2024. The decrease in other comprehensive income of $7.1 million, or (272.5)%, is primarily related to the reclassification of unrealized gains from investments in short-term marketable debt securities recorded in accumulated other comprehensive income to other income, net during the year ended December 31, 2025.

Previous wording

•contract with third parties, including CROs and CMOs, to support the clinical trials of SLK, including trials in HS, PsA, adolescent HS, PPP and axSpA;

Current wording

•contract with third parties, including CROs and CMOs, to support the clinical trials of SLK, including trials in HS, PsA, adolescent HS, PPP and axSpA, and to produce pre-launch inventory;

Previous wording

•continue operating as a public company.

Current wording

•operate as a public company.

Previous wording

For the year ended December 31, 2024, we incurred a loss of $121.2 million, which includes non-cash items such as share-based compensation expense of $7.3 million, and cash outflow from operations of $116.6 million. As of December 31, 2024, we had a total of $448.0 million in cash, cash equivalents and short-term marketable securities. Based on our current operating plans, we believe our available cash, cash equivalents and short-term marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements until the end of 2026.

Current wording

For the year ended December 31, 2025, we incurred a loss of $230.3 million, which includes non-cash items such as share-based compensation expense of $12.9 million, and cash outflow from operations of $196.0 million. As of December 31, 2025, we had a total of $394.0 million in cash, cash equivalents and short-term marketable securities. Based on our current operating plans and the Loan and Security Agreement, we believe our available cash, cash

Previous wording

We expect to incur significant expenses and operating losses for at least the next three years, assuming we continue the clinical development of, and seek regulatory approval for, our product candidate under an in-licensing agreement. It is expected that operating losses will fluctuate significantly from year to year due to the timing of clinical development programs, efforts to achieve regulatory approval, and sales and marketing efforts. We will require substantial additional funding to bring our product candidate to market and support our continuing operations. Until such time that we can generate significant revenue from product sales or other sources, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which may include income from collaborations, strategic partnerships, or marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. If we are unable to acquire additional capital or resources, we will be required to modify our operational plans to fund our operating expense requirements. Refer to “Risk Factors—Risks Related to Our Limited Operating History, Business, Financial Condition, and Results of Operations” in this Annual Report on Form 10-K for further details related to the risk of raising additional capital to fund our operations.

Current wording

We expect to incur notable expenses and operating losses for at least the next two years, assuming we continue the clinical development of, and seek regulatory approval for, our product candidate under an in-licensing agreement. It is expected that operating losses will fluctuate significantly from year to year due to the timing of clinical development programs, efforts to achieve regulatory approval, and sales and marketing efforts. We may require additional funding to bring our product candidate to market and support our continuing operations. In addition, with a change in the presidential administration in 2025, there has been an economic policy shift towards increasing tariffs, which in turn has led and could lead to further retaliatory tariffs. These may have the potential to impact expenses as well as our ability to, if ever, generate revenue or maintain profitability. Until such time that we can generate significant revenue from product sales or other sources, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which may include income from collaborations, strategic partnerships, or marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. If we are unable to acquire additional capital or resources, we will be required to modify our operational plans to fund our operating expense requirements. Refer to“Risk Factors—Risks Related to Our Limited Operating History, Business, Financial Condition, and Results of Operations” in this Annual Report on Form 10-K for further details related to the risk of raising additional capital to fund our operations.

Previous wording

On August 31, 2023, we entered into a Sales Agreement with Leerink Partners (the “August 2023 Sales Agreement” and together with the May 2023 Sales Agreement, the “Sales Agreements”), through which we could issue and sell up to $350.0 million of our Class A Ordinary Shares (the “August 2023 ATM Shares”), through Leerink Partners as sales agent. The August 2023 ATM Shares to be sold under the August 2023 Sales Agreement, if any, would be issued and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-274286), which was declared effective by the SEC on September 11, 2023, and a prospectus supplement thereto filed with the SEC on August 31, 2023. As of December 31, 2024, there was $265.0 million remaining for future sales under the August 2023 ATM Sales Agreement.

Current wording

to $350.0 million of our Class A Ordinary Shares (the “August 2023 ATM Shares”), through Leerink Partners as sales agent. The August 2023 ATM Shares to be sold under the August 2023 Sales Agreement, if any, would be issued and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-274286), which was declared effective by the SEC on September 11, 2023, and a prospectus supplement thereto filed with the SEC on August 31, 2023. As of December 31, 2025, there was $265.0 million remaining for future sales under the August 2023 ATM Sales Agreement.

Previous wording

For the years ended December 31, 2024 and 2023, we sold 914,828 and 1,070,818 Class A Ordinary Shares, respectively, through the Sales Agreements for net proceeds of $52.5 million and $45.8 million, respectively, after deducting sales agent's commissions and transaction costs. For the three months ended December 31, 2024, there were no sales under the August 2023 Sales Agreement.

Current wording

For the year ended December 31, 2024, we sold 914,828 Class A Ordinary Shares through the Sales Agreements for net proceeds of $52.5 million after deducting sales agent's commissions and transaction costs. For the three months and year ended December 31, 2025, there were no sales under the August 2023 Sales Agreement.

Previous wording

On June 27, 2023, we entered into an underwriting agreement with Leerink Partners and Guggenheim Securities LLC as the representatives of the underwriters named therein to issue and sell 8,000,000 Class A Ordinary Shares at a public offering price of $50.00 per share (the “Offering”). In addition, we granted the underwriters an option for a period of 30 days to purchase up to an additional 1,200,000 Class A Ordinary Shares at the public offering price less the underwriting discounts and commissions (the “Option”), and such Option was exercised in full by the underwriters.

Current wording

On June 27, 2023, we entered into an underwriting agreement with Leerink Partners and Guggenheim Securities LLC as the representatives of the underwriters named therein to issue and sell 8,000,000 Class A Ordinary Shares at a public offering price of $50.00 per share (the “2023 Offering”). In addition, we granted the underwriters an option for a period of 30 days to purchase up to an additional 1,200,000 Class A Ordinary Shares at the public offering price less the underwriting discounts and commissions (the “Option”), and such Option was exercised in full by the underwriters.

Previous wording

The Offering closed on June 30, 2023, and net proceeds from the Offering, including proceeds from the exercise in full by the underwriters of the Option, were $436.7 million, after deducting the underwriting discounts and commissions and the offering expenses in the amount of $23.3 million.

Current wording

The 2023 Offering closed on June 30, 2023, and net proceeds, including proceeds from the exercise in full by the underwriters of the Option, were $436.7 million, after deducting the underwriting discounts and commissions and the offering expenses in the amount of $23.3 million.

Previous wording

Following the completion of the Offering, we opted to direct a substantial portion of the net proceeds to MoonLake Immunotherapeutics AG, a Swiss stock corporation (Aktiengesellschaft) registered with the commercial register of the Canton of Zug, Switzerland under the number CHE-433.093.536 (“MoonLake AG”). This was executed as a two-step process: (i) we acquired the remaining 22,756 common shares in MoonLake AG (“MoonLake AG Common Shares”) held in treasury through a share purchase and assignment agreement formally executed on July 09, 2023 ($38.9 million) and (ii) additional funds were contributed to MoonLake AG’s capital reserves through a cash contribution agreement formally executed on July 10, 2023 ($275 million). A stamp duty tax of $2.8 million was levied on the aforementioned capital contribution which we have classified as cash flows from financing activities in order to correctly mirror the underlying nature of the transaction.

Current wording

Following the completion of the 2023 Offering, we opted to direct a substantial portion of the net proceeds to MoonLake Immunotherapeutics AG, a Swiss stock corporation (Aktiengesellschaft) registered with the commercial register of the Canton of Zug, Switzerland under the number CHE-433.093.536 (“MoonLake AG”). This was executed as a two-step process: (i) we acquired the remaining 22,756 common shares in MoonLake AG (“MoonLake AG Common Shares”) held in treasury through a share purchase and assignment agreement formally executed on July 09, 2023 ($38.9 million) and (ii) additional funds were contributed to MoonLake AG’s capital reserves through a cash contribution agreement formally executed on July 10, 2023 ($275 million). A stamp duty tax of $2.8 million was levied on the aforementioned capital contribution which we have classified as cash flows from financing activities in order to correctly mirror the underlying nature of the transaction.

Previous wording

Net cash used in operating activities was $116.6 million and $42.8 million for the year ended December 31, 2024 and 2023, respectively. The increase of net cash used in operating activities of $73.8 million was primarily driven by the increase in operating loss of $77.2 million and the increase in cash paid for changes in prepaid expenses of $6.5 million. The increases were partially offset by an increase in cash from changes in trade and other payables of $5.6 million and a decrease in cash paid for changes in accrued expenses and other current liabilities of $5.5 million.

Current wording

Net cash used in operating activities was $196.0 million and $116.6 million for the year ended December 31, 2025 and 2024, respectively. The increase of net cash used in operating activities of $79.4 million was primarily driven by the increase in net loss of $109.1 million, a decrease in cash from changes in accrued expenses and other current liabilities of $2.6 million and an increase in cash paid for changes in other non-current assets of $0.6 million. The increase in cash used was partially offset by a decrease in cash paid for changes in prepaid expenses of $13.5 million and an increase in cash from changes in trade and other payables of $13.4 million.

Previous wording

During the year ended December 31, 2024, net cash used by investing activities was $205.6 million, consisting predominantly of $350.3 million related to the purchase of short-term marketable debt securities, partially offset by $145.2 million in proceeds received from maturities of short-term marketable debt securities with original maturities longer than three months. During the year ended December 31, 2023, net cash used in investing activities was $25.2 million, consisting predominantly of $175.7 million related to the purchase of short-term marketable debt securities, partially offset by $150.8 million in proceeds received from maturities of short-term marketable debt securities with original maturities longer than three months.

Current wording

During the year ended December 31, 2025, net cash provided by investing activities was $203.0 million, consisting predominantly of $468.4 million in proceeds received from maturities of short-term marketable debt securities, partially offset by $265.4 million related to the purchase of short-term marketable debt securities. During the year ended December 31, 2024, net cash used in investing activities was $205.6 million, consisting predominantly of $350.3 million related to the purchase of short-term marketable debt securities, partially offset by $145.2 million in proceeds received from maturities of short-term marketable debt securities with original maturities longer than three months.

Previous wording

During the year ended December 31, 2024, net cash provided by financing activities was $51.3 million consisting primarily of $52.5 million in net proceeds from the shares sold under the August 2023 Sales Agreement. During the year ended December 31, 2023, net cash provided by financing activities was $479.7 million consisting primarily of $482.5 million in the net proceeds from the shares sold under the Sales Agreements and the Offering.

Current wording

During the year ended December 31, 2025, net cash provided by financing activities was $146.0 million consisting primarily of $73.0 million in net proceeds from the Loan and Security Agreement and $72.4 million in net proceeds from the shares sold under the 2025 Offering. During the year ended December 31, 2024, net cash provided by financing activities was $51.3 million consisting primarily of $52.5 million in net proceeds from the shares sold under the August 2023 Sales Agreement.

Previous wording

We evaluate acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first assessing whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. The In-License Agreement for the SLK program has been accounted for as an asset purchase on the basis that there were no tangible assets acquired or liabilities assumed by us under the In-License Agreement and substantially all of the fair value of the gross assets acquired related to the in-process research and development expenditure (“IPR&D”) of SLK.

Current wording

We evaluate acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first assessing whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. The In-License Agreement for the SLK program has been accounted for as an asset purchase on the basis that there were no tangible assets acquired or liabilities assumed by us under the In-License Agreement and substantially all of the fair value of the gross assets acquired related to the in-process research and development expenditure (“IPR&D”) of SLK. IPR&D represents incomplete technologies we acquire, which at the time of acquisition, are still under development and have no alternative future use.

Previous wording

We measure all share-based awards granted to employees, directors and non-employees based on the fair value on the date of grant and recognize compensation expense of those awards over the requisite service period, which is generally

Current wording

We measure all share-based awards granted to employees, directors and non-employees based on the fair value on the date of grant and recognize compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. Forfeitures are accounted for as they occur. We grant share options and restricted share awards that are subject to either service or performance-based vesting conditions.