MoonLake Immunotherapeutics

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2025, appearing elsewhere in this quarterly report (“Quarterly Report”) on Form 10-Q, and with our audited consolidated financial statements and notes thereto for the year ended December 31, 2024 included in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 26, 2025 (our “Annual Report”). Our unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2025 were prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and presented in United States dollars ($).

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements as of and for the three and nine months ended September 30, 2025, appearing elsewhere in this quarterly report (“Quarterly Report”) on Form 10-Q, and with our audited consolidated financial statements and notes thereto in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 26, 2025 (our “Annual Report”). Our unaudited condensed consolidated financial statements as of and for the three and nine months ended September 30, 2025 were prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and presented in United States dollars ($).

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). In April 2025, we announced completion of enrollment of the VELA program and presented baseline characteristics of enrolled patients. We expect primary endpoint data from the VELA-1 and VELA-2 clinical trials around September 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. 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). In April 2025, we announced completion of enrollment of the VELA program and presented baseline characteristics of enrolled patients. In September 2025, we announced primary endpoint data from the VELA-1 and VELA-2 clinical trials. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001). In VELA-1, SLK achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001). In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). From week 16, all patients are expected to continue to receive the 120mg dose of SLK through to 48 weeks, with a last assessment planned at week 52, followed by an open-label extension for up to two years. We are currently seeking FDA input on the adequacy of the current clinical evidence package to support a Biologics License Application (“BLA”) submission for SLK in HS and expect to receive such input around the end of this year. We expect the 1-year data of VELA-1 and VELA-2 to become available in the second quarter of 2026.

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. 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). We expect a readout of the primary and key secondary endpoints of the IZAR-1 clinical trial in the second quarter of 2026 and of the IZAR-2 clinical trial in the second half of 2026.

Previous wording

In March 2024, we announced plans to initiate clinical studies of SLK in additional indications, including a Phase 3 trial in adolescent patients with HS (the VELA-TEEN trial (M1095-HS-304)), a Phase 2 trial in patients with PPP (the LEDA trial (M1095-PPP-201)), a Phase 2 trial in patients with axSpA (the S-OLARIS trial (M1095-axSpA-202)) and another Phase 2 trial applying novel imaging techniques in patients with PsA (the P-OLARIS trial (M1095-snSpA-202)). In January 2025, we announced that first patients have been screened in the VELA-TEEN, the LEDA, and the S-OLARIS clinical trials. In April 2025, we announced completion of enrollment of the LEDA clinical trial and presented an interim analysis of efficacy, suggesting strong effects of SLK in PPP. We expect patient enrollment for the P-OLARIS trial to commence in the third quarter of 2025.

Current wording

In March 2024, we announced plans to initiate clinical studies of SLK in additional indications, including a Phase 3 trial in adolescent patients with HS (the VELA-TEEN trial (M1095-HS-304)), a Phase 2 trial in patients with PPP (the LEDA trial (M1095-PPP-201)), a Phase 2 trial in patients with axSpA (the S-OLARIS trial (M1095-axSpA-202)) and another Phase 2 trial applying novel imaging techniques in patients with PsA (the P-OLARIS trial (M1095- snSpA-202)). In January 2025, we announced that first patients have been screened in the VELA-TEEN, the LEDA, and the S-OLARIS clinical trials. In November 2025, we presented the results of the LEDA clinical trial, as well as an interim analysis of the VELA-TEEN clinical trial. In the LEDA clinical trial, patients treated with SLK achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (“PPPASI”) of 64% at week 16, and 39% of patients achieved a ≥75% reduction in the PPPASI (“PPPASI75”), suggesting that SLK could provide clinically meaningful improvements in patients with PPP. We expect to commence a Phase 3 clinical trial in PPP in the third quarter of 2026. The interim analysis of the VELA-TEEN clinical trial showed that 46% of patients achieved a HiSCR75 response at week 16 (n=11). The trial is expected to enroll a total of 30-35 patients and we expect topline results in the second quarter of 2026. Results of the S-OLARIS trial are expected to become available in the first quarter of 2026.

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

We expect to submit a first BLA for SLK in the third or fourth quarter of 2026 and, subject to FDA approval, a first commercial launch in the U.S. in 2027.

Previous wording

As of June 30, 2025, we had $306.7 million of 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 $425.1 million, will be sufficient to fund our operating expenses and capital expenditure requirements into 2028.

Current wording

As of September 30, 2025, we had $350.7 million of 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 $380.5 million, will be sufficient to fund our operating expenses and capital expenditure requirements into the second half of 2027.

Previous wording

On March 8, 2024, we executed a similar transaction as a two-step process: (i) we acquired 501 MoonLake AG Common Shares held in treasury through a share purchase and assignment agreement ($0.8 million) and (ii) we contributed an additional $150.0 million of funds to MoonLake AG's capital reserves through a cash contribution. A stamp duty tax of $1.6 million, was levied on the capital contribution which we have classified as cash flows from financing activities in order to correctly mirror the underlying nature of the transaction. The aforementioned increase in treasury shares occurred during the three months ended March 31, 2024 as a result of an employee termination entitling MoonLake AG to repurchase such employee's unvested shares (501 MoonLake AG Common Shares and 16,853 Class C Ordinary Shares) previously awarded as part of a share-based compensation program. Since the shares were subsequently sold to MoonLake, the corresponding Class C Ordinary Shares were canceled.

Current wording

On March 8, 2024, we executed a similar transaction as a two-step process: (i) we acquired 501 MoonLake AG Common Shares held in treasury through a share purchase and assignment agreement ($0.8 million) and (ii) we contributed an additional $150.0 million of funds to MoonLake AG's capital reserves through a cash contribution. A stamp duty tax of $1.5 million, net of refund received, was levied on the capital contribution which we have classified as cash flows from financing activities in order to correctly mirror the underlying nature of the transaction. The aforementioned increase in treasury shares occurred during the three months ended March 31, 2024 as a result of an employee termination entitling MoonLake AG to repurchase such employee's unvested shares (501 MoonLake AG Common Shares and 16,853 Class C Ordinary Shares) previously awarded as part of a share-based compensation program. Since the shares were subsequently sold to MoonLake, the corresponding Class C Ordinary Shares were canceled.

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

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 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, the ongoing Phase 2 clinical trials in axSpA and 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

•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 the second half of 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. 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 began stock-piling of drug substance during the third quarter of 2025.

Previous wording

Gains or losses from foreign currency translation are included in the condensed consolidated statements of operations and comprehensive loss in “Other income, net”. We recognized a foreign currency transaction gain of $378 thousand and $343 thousand for the three and six months ended June 30, 2025, respectively, and a foreign currency transaction loss of $39 thousand and $99 thousand for the three and six months ended June 30, 2024, respectively.

Current wording

Gains or losses from foreign currency translation are included in the condensed consolidated statements of operations and comprehensive loss in “Other income, net”. We recognized a foreign currency transaction loss of $267 thousand for the three months ended September 30, 2025, a foreign currency transaction gain of $75 thousand for the nine months ended September 30, 2025, and a foreign currency transaction loss of $27 thousand and $126 thousand for the three and nine months ended September 30, 2024, respectively.

Previous wording

Research and development expenses were $49.8 million for the three months ended June 30, 2025, compared to $23.7 million for the three months ended June 30, 2024. The increase of $26.1 million, or 110.3%, is primarily related to an increase of $15.8 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 $6.1 million in manufacturing, supply and logistics expenses, increases of $1.4 million and $1.3 million in consulting expenses and personnel-related costs, respectively, to support the research and development effort, and an increase of $1.3 million related to contracted non-clinical research and development expenses.

Current wording

Research and development expenses were $60.6 million for the three months ended September 30, 2025, compared to $35.7 million for the three months ended September 30, 2024. The increase of $24.9 million, or 69.7%, is primarily related to an increase of $18.0 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 $4.0 million in manufacturing, supply and logistics expenses through CMOs, of which $2.9 million is related to the production of stockpiled pre-launch inventory, and an increase of $1.8 million in personnel-related costs to support research and development efforts.

Previous wording

General and administrative expenses were $22.0 million for the six months ended June 30, 2025, compared to $13.7 million for the six months ended June 30, 2024. The increase of $8.3 million, or 60.0%, is primarily related to an increase of $3.5 million in advisory and legal expenses, an increase of $4.5 million in personnel-related costs, both to support organizational growth, and an increase of $0.5 million for marketing and communication expenses.

Current wording

General and administrative expenses were $10.8 million for the three months ended September 30, 2025, compared to $7.4 million for the three months ended September 30, 2024. The increase of $3.4 million, or 46.4%, is primarily related to an increase of $2.4 million in personnel-related costs and an increase of $0.7 million in advisory and legal expenses, both to support organizational growth, and an increase of $0.5 million in marketing and communications expenses related to pre-commercial customer engagement.

Previous wording

Interest expense was $2.0 million, or 100.0%, for the three months ended June 30, 2025, compared to $nil for the three months ended June 30, 2024. The interest expense during the current period is related to recognized interest on the new Loan and Security Agreement.

Current wording

Interest expense was $3.2 million for the three months ended September 30, 2025, compared to $nil for the three months ended September 30, 2024. The interest expense during the current period is related to recognized interest on the Loan and Security Agreement.

Previous wording

Other income, net was $6.8 million for the three months ended June 30, 2025, compared to $5.9 million for the three months ended June 30, 2024. The increase in income of $0.9 million, or 14.9%, primarily related to an increase of $1.0 million in net realized currency gains and an increase of $0.5 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities, partially offset by an increase of $0.6 million in net unrealized currency losses.

Current wording

Other income, net was $4.1 million for the three months ended September 30, 2025, compared to $7.1 million for the three months ended September 30, 2024. The decrease in income of $3.0 million, or (42.8)%, primarily related to a decrease of $2.8 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities and an increase of $0.5 million in net unrealized currency losses, partially offset by an increase of $0.3 million in net realized currency gains.

Previous wording

Other comprehensive loss was $1.9 million for the three months ended June 30, 2025, compared to other comprehensive income of $0.6 million for the three months ended June 30, 2024. The decrease in other comprehensive income of $2.5 million, or (429.0)%, is primarily related to a decrease in net unrealized gain in short-term marketable debt securities.

Current wording

Other comprehensive loss was $0.2 million for the three months ended September 30, 2025, compared to $0.4 million for the three months ended September 30, 2024. The decrease in other comprehensive loss of $0.2 million, or (44.1)%, is primarily related to a decrease in net unrealized loss in short-term marketable debt securities.

Previous wording

Research and development expenses were $86.2 million for the six months ended June 30, 2025, compared to $36.7 million for the six months ended June 30, 2024. The increase of $49.5 million, or 135.1%, is primarily related to an increase of $31.7 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 VELA-TEEN trial, the LEDA trial, the S-OLARIS trial and the P-OLARIS trial, an increase of $9.4 million in manufacturing, supply, and logistics expenses, increases of $3.1 million and $2.6 million in consulting expenses and personnel-related costs, respectively, to support the research and development effort, and an increase of $2.6 million related to contracted non-clinical research and development expenses.

Current wording

Research and development expenses were $146.9 million for the nine months ended September 30, 2025, compared to $72.4 million for the nine months ended September 30, 2024. The increase of $74.4 million, or 102.8%, is primarily related to an increase of $49.7 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 VELA-TEEN trial, the LEDA trial, the S-OLARIS trial and the P-OLARIS trial, an increase of $13.4 million in manufacturing, supply, and logistics expenses through CMOs, of which $2.9 million is related to the production of stockpiled pre-launch inventory, and increases of $4.3 million and $3.7 million in personnel-related costs and consulting expenses, respectively, to support research and development efforts.

Previous wording

General and administrative expenses were $10.9 million for the three months ended June 30, 2025, compared to $6.9 million for the three months ended June 30, 2024. The increase of $4.0 million, or 58.1%, is primarily related to an increase of $2.5 million in personnel-related costs and an increase of $1.6 million in advisory and legal expenses, both to support organizational growth.

Current wording

General and administrative expenses were $32.8 million for the nine months ended September 30, 2025, compared to $21.1 million for the nine months ended September 30, 2024. The increase of $11.7 million, or 55.3%, is primarily related to an increase of $6.8 million in personnel-related costs and an increase of $2.8 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 Security Agreement, and an increase of $1.0 million for marketing and communication expenses related to pre-commercial customer engagement.

Previous wording

Interest expense was $2.1 million, or 100.0%, for the six months ended June 30, 2025, compared to $nil for the six months ended June 30, 2024. The interest expense during the current period is related to recognized interest on the new Loan and Security Agreement.

Current wording

Interest expense was $5.3 million for the nine months ended September 30, 2025, compared to $nil for the nine months ended September 30, 2024. The interest expense during the current period is related to recognized interest on the Loan and Security Agreement.

Previous wording

Other income, net was $13.9 million for the six months ended June 30, 2025, compared to $11.8 million for the six months ended June 30, 2024. The increase in income of $2.1 million, or 17.5%, is primarily related to an increase of $1.7 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities, an increase of $1.3 million in net realized currency gains, partially offset by an increase of $0.9 million in net unrealized currency losses.

Current wording

Other income, net was $17.9 million for the nine months ended September 30, 2025, compared to $18.9 million for the nine months ended September 30, 2024. The decrease in other income of $1.0 million, or (5.1)%, is primarily related to a decrease of $1.1 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities and an increase of $1.4 million in net unrealized currency losses, both of which are partially offset by an increase of $1.6 million in net realized currency gains.

Previous wording

Income tax expense was $0.2 million for the six months ended June 30, 2025, compared to $0.1 million for the six months ended June 30, 2024. The expense for each period is related to corporate income tax of our subsidiaries in the U.K. and Portugal.

Current wording

Income tax expense was $0.4 million for the nine months ended September 30, 2025, compared to $0.2 million for the nine months ended September 30, 2024. The expense for each period is related to corporate income tax of our subsidiaries in the U.K. and Portugal.

Previous wording

Other comprehensive loss was $4.6 million for the six months ended June 30, 2025, compared to other comprehensive income of $0.8 million for the six months ended June 30, 2024. The decrease in other comprehensive income of $5.4 million, or 643.0%, is primarily related to a decrease in net unrealized gain in short-term marketable debt securities.

Current wording

Other comprehensive loss was $4.8 million for the nine months ended September 30, 2025, compared to other comprehensive income of $0.4 million for the nine months ended September 30, 2024. The decrease in other comprehensive income of $5.2 million, or (1,307.0)%, is primarily related to the net unrealized gain position in short-term marketable debt securities shifting to a net unrealized loss in the current period.

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

For the six months ended June 30, 2025, we incurred a loss of $96.6 million, which includes non-cash items such as share-based compensation expense of $5.6 million, and cash outflow from operations of $92.7 million. As of June 30, 2025, we had a total of $425.1 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 equivalents and short-term marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2028.

Current wording

For the nine months ended September 30, 2025, we incurred a loss of $167.3 million, which includes non-cash items such as share-based compensation expense of $9.3 million, and cash outflow from operations of $137.2 million. As of September 30, 2025, we had a total of $380.5 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 equivalents and short-term marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into the second half of 2027.

Previous wording

In March 2025, we entered into a loan and security agreement (the “Loan and Security Agreement”) with Hercules Capital, Inc. (“Hercules”) and certain of its affiliates (collectively with Hercules, the “Lenders”) for an aggregate principal amount of $500.0 million, of which $300.0 million is fully committed subject to achievement of milestones (the “Credit Facility”). An initial tranche of $75.0 million (the “Tranche 1 Loan”) was funded under the Loan and Security Agreement on March 31, 2025 (the “Closing Date”). In addition to the Tranche 1 Loan, the Credit Facility provides for additional tranches as follows:

Current wording

In March 2025, we entered into a loan and security agreement (the “Loan and Security Agreement”) with Hercules Capital, Inc. (“Hercules”) and certain of its affiliates (collectively with Hercules, the “Lenders”) for an aggregate principal amount of $500.0 million, of which $300.0 million was fully committed subject to achievement of milestones (the “Credit Facility”). An initial tranche of $75.0 million (the “Tranche 1 Loan”) was funded under the Loan and Security Agreement on March 31, 2025 (the “Closing Date”). In addition to the Tranche 1 Loan, the Credit Facility provides for additional tranches as follows:

Previous wording

a. Subject to MoonLake’s announcement that the VELA-1 and VELA-2 Phase 3 studies of SLK in adult patients with moderate to severe hidradenitis suppurativa each achieved their protocol-specified primary endpoint with SLK having demonstrated an acceptable safety profile (the “Tranche 2 Milestone”), a second tranche with additional term loans in an aggregate principal amount of up to $125.0 million, available on the Tranche 2 Milestone achievement date through the earlier of (i) 30 days following such date and (ii) December 31, 2025,

Current wording

a. Subject to our announcement that the VELA-1 and VELA-2 Phase 3 studies of SLK in adult patients with moderate to severe hidradenitis suppurativa each achieved their protocol-specified primary endpoint with SLK having demonstrated an acceptable safety profile (the “Tranche 2 Milestone”), a second tranche with additional term loans in an aggregate principal amount of up to $125.0 million, available on the Tranche 2 Milestone achievement date through the earlier of (i) 30 days following such date and (ii) December 31, 2025,

Previous wording

b. Subject to MoonLake's announcement that the IZAR-1 and IZAR-2 Phase 3 studies of SLK in patients with active psoriatic arthritis each achieved their protocol-specified primary endpoint with SLK having demonstrated an acceptable safety profile (the “Tranche 3 Milestone”), a third tranche with additional term loans in an aggregate principal amount of up to $50.0 million, available on the Tranche 3 Milestone achievement date through the earlier of (i) 60 days following such date and (ii) September 15, 2026,

Current wording

b. Subject to our announcement that the IZAR-1 and IZAR-2 Phase 3 studies of SLK in patients with active psoriatic arthritis each achieved their protocol-specified primary endpoint with SLK having demonstrated an acceptable safety profile (the “Tranche 3 Milestone”), a third tranche with additional term loans in an aggregate principal amount of up to $50.0 million, available on the Tranche 3 Milestone achievement date through the earlier of (i) 60 days following such date and (ii) September 15, 2026,

Previous wording

c. Subject to the Company’s achievement of the Tranche 2 Milestone and Tranche 3 Milestone and the FDA’s acceptance of the Company’s submission of a BLA for SLK (collectively, the “Tranche 4 Milestone”), a fourth tranche with additional term loans in an aggregate principal amount of up to $50.0 million, available on the Tranche 4 Milestone achievement date through the earlier of (i) 60 days following such date and (ii) March 15, 2027,

Current wording

c. Subject to our achievement of the Tranche 2 Milestone and Tranche 3 Milestone and the FDA’s acceptance of the Company’s submission of a BLA for SLK (collectively, the “Tranche 4 Milestone”), a fourth tranche with additional term loans in an aggregate principal amount of up to $50.0 million, available on the Tranche 4 Milestone achievement date through the earlier of (i) 60 days following such date and (ii) March 15, 2027, and

Previous wording

d. Subject to approval by the Lenders’ in their discretion, a fifth tranche of additional term loans in an aggregate principal amount of up to $200.0 million, and

Current wording

d. Subject to approval by the Lenders’ in their discretion, a fifth tranche of additional term loans in an aggregate principal amount of up to $200.0 million.

Previous wording

The Credit Facility matures on April 1, 2030 (the “Maturity Date”) and bears interest at an annual rate equal to the greater of (i) prime rate as reported in The Wall Street Journal plus 1.45% and (ii) 8.45% with the initial interest rate equal to 8.95%. This rate is subject to a 0.25% reduction upon achievement of the U.S. Food and Drug Administration’s approval of a BLA for SLK. Certain additional commitment and undrawn amount fees are also payable in connection with the Credit Facility.

Current wording

The Credit Facility matures on April 1, 2030 (the “Maturity Date”) and bears interest at an annual rate equal to the greater of (i) prime rate as reported in The Wall Street Journal plus 1.45% and (ii) 8.45% with the initial interest rate equal to 8.95%. As of September 30, 2025, the Credit Facility bears interest at 8.70%. This rate is subject to a 0.25% reduction upon achievement of the U.S. Food and Drug Administration’s approval of a BLA for SLK. Certain additional commitment and undrawn amount fees are also payable in connection with the Credit Facility.

Previous wording

The Loan and Security Agreement contains customary covenants, such as financial covenants and certain events of default after which loans under the Credit Facility may be due and payable immediately. The Company was in compliance with all covenants as of June 30, 2025.

Current wording

The Loan and Security Agreement contains customary covenants, such as financial covenants and certain events of default after which loans under the Credit Facility may be due and payable immediately. We were in compliance with all covenants as of September 30, 2025.

Previous wording

Net cash used in operating activities was $92.7 million and $42.8 million for the six months ended June 30, 2025 and June 30, 2024, respectively. The increase of net cash used in operating activities of $49.9 million was primarily driven by the increase in net loss of $57.9 million, an increase in cash paid for changes in accrued expenses and other current liabilities of $2.3 million, and an increase in cash paid for changes in other non-current assets of $1.7 million. The increases were partially offset by a decrease in cash paid for changes in prepaid expenses of $5.4 million, and an increase in cash from changes in trade and other payables of $4.8 million

Current wording

Net cash used in operating activities was $137.2 million and $68.1 million for the nine months ended September 30, 2025 and September 30, 2024, respectively. The increase of net cash used in operating activities of $69.1 million was primarily driven by the increase in net loss of $92.5 million and an increase in cash paid for changes in other non- current assets of $0.6 million. The increase in cash outflows was partially offset by a decrease in cash paid for changes in accrued expenses and other current liabilities of $8.5 million, an increase in cash inflows from changes in trade and other payables of $7.4 million, and a decrease in cash paid for changes in prepaid expenses of $4.2 million.

Previous wording

During the six months ended June 30, 2025, net cash provided by investing activities was $144.5 million, consisting predominantly of $350.7 million in proceeds received from maturities of short-term marketable debt securities with original maturities longer than three months, partially offset by $206.2 million related to the purchase of short-term marketable debt securities. During the six months ended June 30, 2024, net cash used in investing activities was $116.5 million, consisting predominantly of $174.2 million related to the purchase of short-term marketable debt securities, partially offset by $57.8 million in proceeds received from maturities of short-term marketable debt securities with original maturities longer than three months.

Current wording

During the nine months ended September 30, 2025, net cash provided by investing activities was $232.9 million, consisting predominantly of $439.1 million in proceeds received from maturities of short-term marketable debt securities with original maturities longer than three months, partially offset by $206.2 million related to the purchase of short-term marketable debt securities. During the nine months ended September 30, 2024, net cash used in investing activities was $58.3 million, consisting predominantly of $203.3 million related to the purchase of short-term marketable debt securities, partially offset by $145.4 million in proceeds received from maturities of short-term marketable debt securities with original maturities longer than three months.

Previous wording

During the six months ended June 30, 2025, net cash provided by financing activities was $73.1 million consisting primarily of $73.0 million in net proceeds from the Loan and Security Agreement. During the six months ended June 30, 2024, net cash provided by financing activities was $51.0 million consisting primarily of $52.5 million in net proceeds from the shares sold under the August 2023 Sales Agreement.

Current wording

During the nine months ended September 30, 2025, net cash provided by financing activities was $73.6 million consisting primarily of $73.0 million in net proceeds from the Loan and Security Agreement. During the nine months ended September 30, 2024, net cash provided by financing activities was $51.2 million consisting primarily of $52.5 million in net proceeds from the shares sold under the August 2023 Sales Agreement.

Previous wording

A summary of our critical accounting policies and estimates is presented in Part II, Item 7 of our Annual Report. There were no material changes to our critical accounting estimates during the six months ended June 30, 2025.

Current wording

A summary of our critical accounting policies and estimates is presented in Part II, Item 7 of our Annual Report. There were no material changes to our critical accounting estimates during the nine months ended September 30, 2025.