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MoonLake Immunotherapeutics

For the period ended Jun 30, 2025. Filed Aug 5, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2025 · Filed Aug 5, 2025

MLTX$11.53+6.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-03-31; filed 2025-05-12.

0001821586-25-000011

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-06-30; filed 2025-08-05.

0001821586-25-000018

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 132 previous paragraphs and 148 current paragraphs.

107 unchanged; 25 reworded; 12 added; 0 removed; 0 previous and 4 current paragraphs rearranged.

Tables are not compared: 3 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (12)

Current report

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 report

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 report

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 report

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.
Reworded paragraphs (25)

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 months ended March 31, 2025, appearing elsewhere in this quarterly report (“Quarterly Report”) on Form 10-Q, and with our audited 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 three months ended March 31, 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 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 ($).

Previous wording

This Quarterly Report on Form 10-Q contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical fact contained in this Quarterly Report on Form 10-Q, including, without limitation, statements regarding the following, are forward-looking statements: our future results of operations and financial position, our expectations regarding industry trends, the sufficiency of our cash and cash equivalents, the anticipated sources and uses of cash, the anticipated investments in our business, our business strategy, the plans and objectives of management for future operations and capital expenditures, and other information referred to in the sections titled “Business” and “Risk Factors” in our Annual Report and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Quarterly Report. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “could”, “intend”, “target”, “project”, “contemplate”, “believe”, “estimate”, “predict”, “potential”, “might”, “possible”, or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report contains forward-looking statements that reflect our plans and strategy for our business and related financing as well as expectations regarding the timing of regulatory submissions and potential commercialization for SLK. Our actual results and the timing of events could differ materially from those anticipated in the forward-looking statements. These forward-looking statements are subject to a number of important risks, uncertainties and other factors that could cause actual results to differ materially from those in the forward-looking statements expressed or implied in this Quarterly Report on Form 10-Q. Such risks, uncertainties and other factors include, among others, the risks, uncertainties and factors set forth in the section titled “Risk Factors” included in our Annual Report a…

Excerpt shortened here; the source contains the full paragraph.

Current wording

This Quarterly Report on Form 10-Q contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical fact contained in this Quarterly Report on Form 10-Q, including, without limitation, statements regarding the following, are forward-looking statements: our future results of operations and financial position, our expectations regarding industry trends, the sufficiency of our cash and cash equivalents, the anticipated sources and uses of cash, the anticipated investments in our business, our business strategy, the plans and objectives of management for future operations and capital expenditures, and other information referred to in the sections titled “Business” and “Risk Factors” in our Annual Report and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and "Risk Factors" in this Quarterly Report. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “could”, “intend”, “target”, “project”, “contemplate”, “believe”, “estimate”, “predict”, “potential”, “might”, “possible”, or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report contains forward-looking statements that reflect our plans and strategy for our business and related financing as well as expectations regarding the timing of regulatory submissions and potential commercialization for SLK. Our actual results and the timing of events could differ materially from those anticipated in the forward-looking statements. These forward-looking statements are subject to a number of important risks, uncertainties and other factors that could cause actual results to differ materially from those in the forward-looking statements expressed or implied in this Quarterly Report on Form 10-Q. Such risks, uncertainties and other factors include, among others, the risks, uncertainties and factors set forth in the sections titled “Risk Factors” included in…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

•the impact of adverse business and economic conditions including inflationary pressures, general economic slowdown or a recession, fluctuating interest rates, new or increased tariffs and other barriers to trade, changes in fiscal and monetary policy or government budget dynamics, banking institution instability and the prospect of a shutdown of the U.S. federal government;

Current wording

•the impact of adverse business and economic conditions including inflationary pressures, general economic slowdown or a recession, fluctuating interest rates, new or increased tariffs and other barriers to trade and changes in fiscal and monetary policy or government budget dynamics;

Previous wording

There may be other factors that may cause our actual results to differ materially from the forward-looking statements, including factors disclosed in “Risk Factors” in our Annual Report or “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Quarterly Report. You should read this Quarterly Report on Form 10-Q and the documents that we reference herein completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

Current wording

There may be other factors that may cause our actual results to differ materially from the forward-looking statements, including factors disclosed in “Risk Factors” in our Annual Report or “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and "Risk Factors" in this Quarterly Report. You should read this Quarterly Report on Form 10-Q and the documents that we reference herein completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

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 mid 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 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.

Previous wording

As of March 31, 2025, we had $271.6 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 $480.1 million, will be sufficient to fund our operating expenses and capital expenditure requirements into 2028.

Current 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.

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 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 ($275.0 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

•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

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.

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. 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.

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, lease 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 under the heading "Risk Factors" in our most recent Annual Report on Form 10-K, 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 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 Biologics License Application for SLK. Clinical development involves a lengthy and expensive process with uncertain outcomes and is subject to risks described under the heading “Risk Factors” in our most recent Annual Report on Form 10-K, 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 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, 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.

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 $35 thousand for the three months ended March 31, 2025 and a foreign currency transaction loss of $60 thousand for the three months ended March 31, 2024.

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 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.

Previous wording

Research and development expenses were $36.5 million for the three months ended March 31, 2025, compared to $13.0 million for the three months ended March 31, 2024. The increase of $23.4 million 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 $3.5 million in manufacturing expenses for products used in clinical trials, an increase of $1.6 million and $1.3 million in consulting expenses and personnel-related costs, respectively, to support the research and development effort, and an increase of $1.2 million related to contracted non-clinical research and development expenses.

Current 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.

Previous wording

Other income, net was $7.1 million for the three months ended March 31, 2025, compared to $5.9 million for the three months ended March 31, 2024. The increase of $1.2 million primarily related to an increase of $1.2 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities.

Current 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.

Previous wording

Other comprehensive loss was $2.7 million for the three months ended March 31, 2025, compared to other comprehensive income of $0.3 million for the three months ended March 31, 2024. The decrease in other comprehensive income of $2.9 million related to a decrease in net unrealized gain in short-term marketable debt securities.

Current 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.

Previous wording

General and administrative expenses were $11.0 million for the three months ended March 31, 2025, compared to $6.8 million for the three months ended March 31, 2024. The increase of $4.2 million primarily related to an increase of $1.6 million in personnel-related costs and an increase of $1.0 million in expenses for advisory and professional services, both to support organizational growth, and an increase of $0.9 million in legal expenses to support the Loan and Security Agreement.

Current 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.

Previous wording

Income tax expense was $0.2 million for the three months ended March 31, 2025, compared to $0.1 million for the three months ended March 31, 2024. The expense is related to corporate income tax of our subsidiaries in the U.K. and Portugal.

Current 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.

Previous wording

For the three months ended March 31, 2025, we incurred a loss of $40.6 million, which includes non-cash items such as share-based compensation expense of $2.3 million, and cash outflow from operations of $38.1 million. As of March 31, 2025, we had a total of $480.1 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 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.

Previous wording

In March 2025 (the “Closing Date”), 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 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:

Previous wording

The Loan and Security Agreement allows for us to satisfy a portion of the cash interest payments by capitalizing such interest payments as payment-in-kind (“PIK”). No PIK interest relating to the term loan has been recorded and included in the condensed consolidated balance sheet as of March 31, 2025.

Current wording

The Loan and Security Agreement allows for us to satisfy a portion of the cash interest payments by capitalizing such interest payments as payment-in-kind (“PIK”). No PIK interest relating to the term loan has been recorded and included in the condensed consolidated balance sheets as of June 30, 2025.

Previous wording

Net cash used in operating activities was $38.1 million and $14.9 million for the three months ended March 31, 2025 and March 31, 2024, respectively. The increase of net cash used in operating activities of $23.2 million was primarily driven by the increase in net loss of $26.6 million and the increase in cash paid for changes in prepaid expenses of $1.1 million. The increases were partially offset by an increase in cash from changes in trade and other payables of $1.4 million and a decrease in cash paid for changes in accrued expenses and other current liabilities of $1.3 million.

Current 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

Previous wording

During the three months ended March 31, 2025, net cash provided by investing activities was $56.2 million, consisting predominantly of $144.8 million in proceeds received from maturities of short-term marketable debt securities with original maturities longer than three months, partially offset by $88.5 million related to the purchase of short-term marketable debt securities. During the three months ended March 31, 2024, net cash used in investing activities was $28.8 million, consisting predominantly of $87.7 million related to the purchase of short-term marketable debt securities, partially offset by $59.1 million in proceeds received from maturities of short-term marketable debt securities with original maturities longer than three months.

Current 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.

Previous wording

During the three months ended March 31, 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 three months ended March 31, 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 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.

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 three months ended March 31, 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 six months ended June 30, 2025.
Rearranged current paragraphs (4)

Current report — wording carried from elsewhere

•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

Current report — wording carried from elsewhere

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

Current report — wording carried from elsewhere

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 report — wording carried from elsewhere

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.