MoonLake Immunotherapeutics
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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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.
Sep 30, 2024 · Filed Nov 7, 2024
MLTX$11.53+6.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-07.
0001821586-24-000025
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001821586-24-000029
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 150 previous paragraphs and 132 current paragraphs.
101 unchanged; 24 reworded; 6 added; 25 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 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 (6)
Current report
Options Exercised under the Equity Incentive Plan
Current report
In the three months ended September 30, 2024, certain participants exercised their stock options under the Equity Incentive Plan (as defined below) for an aggregate of 17,390 Class A Ordinary Shares and total cash consideration of $91,298.
Current report
Comparison of the nine months ended September 30, 2024 and 2023
Current report
Other Comprehensive Income
Current report
During the nine months ended September 30, 2023, net cash provided by financing activities was $451.3 million consisting primarily of the net proceeds from the shares sold under the Sales Agreements and in the Offering.
Current report
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, 2024.
Removed paragraphs (25)
Previous report
Comparison of the six months ended June 30, 2024 and 2023
Previous report
Other Comprehensive Income (Loss)
Previous report
The preparation of the consolidated financial statements in accordance with U.S. GAAP requires us to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and related disclosures. We continually evaluate these judgments, estimates and assumptions based on the most recently available information, our own historical experience and various other assumptions that we believe to be reasonable under the circumstances. Since the use of estimates is an integral component of the financial reporting process, actual results could differ from our expectations as a result of changes in estimates.
Previous report
An accounting policy is considered critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time such an estimate is made, and if different accounting estimates that reasonably could have been used, or changes in the accounting estimates that are reasonably likely to occur periodically, could materially impact the financial statements. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our financial condition, results of operations and cash flows.
Previous report
Acquisitions
Previous report
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.
Previous report
IPR&D represents incomplete technologies we acquire, which at the time of acquisition, are still under development and have no alternative future use. Our management’s judgement was required to determine whether the IPR&D had any alternative future use. Our management determined that at the time of acquisition, and without significant additional research, there was no alternative future use other than the development of SLK for the treatment of immunological diseases. Therefore, in accordance with our policy, the aggregate consideration for the IPR&D was recorded as research and development expenses during the year ended December 31, 2021.
Previous report
Share-Based Compensation
Previous report
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.
Previous report
We classify share-based compensation expense in our consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.
Previous report
Determination of Fair Value – Common Shares and Class A Ordinary Shares
Previous report
Prior to the completion of the Business Combination, given that there had been no public market for MoonLake AG's Common Shares, the estimated fair value of MoonLake AG’s Common Shares was determined by reference to separate market-based transactions involving the sale of its shares to two third-party investors that were not considered related parties to us or MHKDG.
Previous report
All of our share-based compensation arrangements contain service and performance conditions that, depending on the relevant equity plan, are settled with shares of MoonLake or MoonLake AG, as applicable and meet the definition of a share-based compensation arrangements. All awards granted under our various share-based compensation plans were classified as equity-settled share-based arrangements.
Previous report
Subsequent to the closing of the Business Combination, the fair value of each of MoonLake AG's Common Shares granted is determined based on the closing price of MoonLake's Class A Ordinary Shares as reported by Nasdaq on the date of grant and multiplied by the Exchange Ratio.
Previous report
Determination of Fair Value – Share Option Awards
Previous report
The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model, which requires inputs based on certain subjective assumptions, including the expected share price volatility, the expected term of the award, the risk-free interest rate and expected dividends.
Previous report
We estimate our expected share price volatility based on the historical volatility of publicly traded peer companies and expect to continue to do so until such time as we have adequate historical data regarding the volatility of our own traded share price. The expected term of options granted has been determined based on the expected period that share-based awards are expected to be outstanding. The risk-free interest rate is determined by reference to the U.S. Treasury yield for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that we have never paid cash dividends on MoonLake AG's Common Shares and do not expect to pay any cash dividends in the foreseeable future.
Previous report
Recoverability of Deferred Tax Assets
Previous report
In assessing the recoverability of our deferred tax assets, we considered whether it was more likely than not that some or all of our deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. We considered the scheduled reversal of deferred tax liabilities, the seven-year expiry of tax losses carried forward under Swiss tax legislation, projected future taxable income (including the risks associated with the completion of the development and obtaining regulatory approvals to commercialize the product), and tax planning strategies in making this assessment. Based on the weight of all evidence, we determined that it is not more likely than not that the net deferred tax assets will be realized. A valuation allowance has been recorded against the full amount of the deferred tax assets.
Previous report
Accrued Research and Development Expenses
Previous report
As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated costs incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of the estimates with the service providers and make adjustments if necessary. Examples of estimated accrued research and development expenses include fees paid to:
Previous report
•vendors, including research laboratories, in connection with preclinical development activities;
Previous report
•CROs and investigative sites in connection with preclinical studies and clinical trials; and
Previous report
•CMOs in connection with drug substance and drug product formulation of preclinical studies and clinical trial materials.
Previous report
We base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple research institutions and CROs that supply, conduct and manage preclinical studies and clinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period.
Reworded paragraphs (24)
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, 2024, appearing elsewhere in this quarterly report (“Quarterly Report”) on Form 10-Q, and with MoonLake’s audited financial statements and notes thereto for the year ended December 31, 2023 included in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on February 29, 2024 (our “Annual Report”). Our unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2024 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, 2024, appearing elsewhere in this quarterly report (“Quarterly Report”) on Form 10-Q, and with MoonLake’s audited financial statements and notes thereto for the year ended December 31, 2023 included in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on February 29, 2024 (our “Annual Report”). Our unaudited condensed consolidated financial statements as of and for the three and nine months ended September 30, 2024 were prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP") and presented in United States dollars ($).
Previous wording
We currently develop SLK in inflammatory diseases in dermatology and rheumatology where the pathophysiology is known to be driven by IL-17A and IL-17F. This group of diseases comprises our initial target diseases, hidradenitis suppurativa (“HS”) and psoriatic arthritis (“PsA”), and several other inflammatory conditions, including axial spondyloarthritis (“axSpA”), palmoplantar pustulosis (“PPP”) and psoriasis (“PsO”). Our initial target diseases affect millions of people worldwide, and we believe there is a need for improved treatment options. We believe that SLK has a differentiated mechanism of action and that its purposefully designed molecular characteristics, including its small size and its albumin binding site, facilitate deep tissue penetration in the skin and joints. We envision SLK as a key therapeutic alternative in our initial target indications and potentially in multiple other IL-17 driven inflammatory conditions.
Current wording
We currently develop SLK in inflammatory diseases in dermatology and rheumatology where the pathophysiology is known to be driven by IL-17A and IL-17F. This group of diseases comprises our current target diseases, hidradenitis suppurativa (“HS”), psoriatic arthritis (“PsA”), axial spondyloarthritis (“axSpA”), palmoplantar pustulosis (“PPP”), and several other inflammatory conditions, including psoriasis (“PsO”). Our current target diseases affect millions of people worldwide, and we believe there is a need for improved treatment options. We believe that SLK has a differentiated mechanism of action and that its purposefully designed molecular characteristics, including its small size and its albumin binding site, facilitate deep tissue penetration in the skin and joints. We envision SLK as a key therapeutic alternative in our initial target indications and potentially in multiple other IL-17 driven inflammatory conditions.
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 unanimously supporting our proposed approach for advancing our Phase 3 program of SLK in PsA. We expect to commence Phase 3 clinical trials in PsA in the second half of 2024.
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 unanimously supporting our proposed approach for advancing our Phase 3 program of SLK in PsA. We expect enrollment of first patients in our Phase 3 clinical trials to commence imminently.
Previous wording
In March 2024, we announced plans to commence an additional Phase 3 clinical trial of SLK in juvenile HS, and Phase 2 clinical trials in PPP and axSpA. We expect these trials to commence in the second half of 2024.
Current wording
In March 2024, we announced plans to commence an additional Phase 3 clinical trial of SLK in juvenile HS, and Phase 2 clinical trials in PPP and axSpA. We expect these trials to commence around year-end.
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 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 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.
Previous wording
As of June 30, 2024, we had $342.8 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 $519.8 million, will be sufficient to fund our operating expenses and capital expenditure requirements until the end of 2026.
Current wording
As of September 30, 2024, we had $375.7 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 $493.9 million, will be sufficient to fund our operating expenses and capital expenditure requirements until the end of 2026.
Previous wording
For the year ended December 31, 2023, we sold 1,070,818 Class A Ordinary Shares through the Sales Agreements for net proceeds of $46 million, after deducting sales agent's commission and transaction costs. In the three months ended March 31, 2024, we sold 914,828 Class A Ordinary Shares under the August 2023 Sales Agreement at a weighted average share price of $58.31, for aggregate net proceeds of approximately $53 million. In the three months ended June 30, 2024, there were no sales under the August 2023 Sales Agreement. As of June 30, 2024, the total number of shares sold under the August 2023 ATM Sales Agreement was 1,440,752 for total net proceeds of $84 million.
Current wording
For the year ended December 31, 2023, we sold 1,070,818 Class A Ordinary Shares through the Sales Agreements for net proceeds of $46 million, after deducting sales agent's commission and transaction costs. In the three months ended March 31, 2024, we sold 914,828 Class A Ordinary Shares under the August 2023 Sales Agreement at a weighted average share price of $58.31, for aggregate net proceeds of approximately $52.5 million. In the three months ended June 30, 2024 and the three months ended September 30, 2024, there were no sales under the August 2023 Sales Agreement. As of September 30, 2024, the total number of shares sold under the August 2023 ATM Sales Agreement was 1,440,752 for total net proceeds of $83.7 million.
Previous wording
•Building the leading efficacy and safety profile of SLK for patients —We expect to incur significant research and development expenses, and G&A expenses as we: (i) conduct and initiate further clinical trials for SLK including Phase 3 clinical trials in HS, PsA and juvenile HS and Phase 2 clinical trials in PPP and axSpA; (ii) seek regulatory approvals for SLK; (iii) 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); (iv) establish a sales, marketing and distribution infrastructure to commercialize SLK; (v) attract, hire and retain additional clinical, scientific, quality control, and administrative personnel; and (vi) add clinical, operational, financial and management information systems and personnel.
Current wording
•Building the leading efficacy and safety profile of SLK for patients —We expect to incur significant research and development expenses, and G&A expenses as we: (i) conduct and initiate further clinical trials for SLK including Phase 3 clinical trials in HS, PsA and juvenile HS and Phase 2 clinical trials in PPP and axSpA; (ii) seek regulatory approvals for SLK; (iii) make milestone and commercial payments under the In-License
Previous wording
Gains or losses from foreign currency translation are included in "other income, net" in the unaudited condensed consolidated statements of operations and comprehensive loss. We recognized a foreign currency transaction loss of $39,293 and $98,834 for the three and six months ended June 30, 2024, respectively. For the three and six months ended June 30, 2023, we recognized a foreign currency transaction gain of $108,844 and $280,652, respectively.
Current wording
Gains or losses from foreign currency translation are included in "other income, net" in the unaudited condensed consolidated statements of operations and comprehensive loss. We recognized a foreign currency transaction loss of $26,746 and $125,581 for the three and nine months ended September 30, 2024, respectively. For the three and nine months ended September 30, 2023, we recognized a foreign currency transaction loss of $557,144 and $276,491, respectively.
Previous wording
Research and development expenses were $23.7 million for the three months ended June 30, 2024, compared to $8.7 million for the three months ended June 30, 2023. The increase of $15.0 million primarily related to an increase of $9.4 million in expenses pertaining to clinical development trials with CROs for the commencement of the Phase 3 clinical trials in HS, an increase of $4.0 million related to supply and logistic services for clinical development trials, an increase of $1.4 million and $0.5 million in personnel-related costs and consulting expenses, respectively, to support the research and development effort.
Current wording
Research and development expenses were $35.7 million for the three months ended September 30, 2024, compared to $7.6 million for the three months ended September 30, 2023. The increase of $28.1 million primarily related to an increase of $15.4 million in expenses pertaining to clinical development trials with CROs, including for the conduct of Phase 3 clinical trials in HS and preparatory activities for the clinical trials of SLK, including the Phase 3 clinical trials in PsA, Phase 2 clinical trial in axSpA and Phase 2 clinical trial in PPP, an increase of $9.2 million related to supply and logistic services for such clinical development trials, including the purchase of a comparator drug for the Phase 3 clinical trials in PsA, an increase of $1.6 million and $1.0 million in personnel-related costs and consulting expenses, respectively, to support the research and development effort, and $0.9 million related to contracted non-clinical research and development expenses.
Previous wording
General and administrative expenses were $6.9 million for the three months ended June 30, 2024, compared to $4.5 million for the three months ended June 30, 2023. The increase of $2.4 million primarily related to an increase of $1.0 million in expenses for advisory and professional services to support organizational growth and operating as a large-accelerated filer, and an increase of $0.8 million in personnel-related costs to support organizational growth.
Current wording
General and administrative expenses were $7.4 million for the three months ended September 30, 2024, compared to $5.4 million for the three months ended September 30, 2023. The increase of $2.0 million primarily related to an increase of $0.9 million in personnel-related costs to support organizational growth.
Previous wording
Other income, net was $5.9 million for the three months ended June 30, 2024, compared to $0.8 million for the three months ended June 30, 2023. The increase of $5.1 million primarily related to an increase of $5.3 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities.
Current wording
Other income, net was $7.1 million for the three months ended September 30, 2024, compared to $1.4 million for the three months ended September 30, 2023. The increase of $5.7 million primarily related to an increase of $5.2 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities.
Previous wording
Income tax expense was $78,701 for the three months ended June 30, 2024, compared to $10,149 for the three months ended June 30, 2023. The expense is related to corporate income tax of our U.K. and Portugal subsidiaries in 2024 and of our U.K subsidiary in 2023.
Current wording
Income tax expense was $92,106 for the three months ended September 30, 2024, compared to $28,923 for the three months ended September 30, 2023. The expense is related to corporate income tax of our U.K. and Portugal subsidiaries in 2024 and of our U.K subsidiary in 2023.
Previous wording
Other comprehensive income was $0.6 million for the three months ended June 30, 2024, compared to other comprehensive loss of $0.4 million for the three months ended June 30, 2023. The increase in income of $1.0 million primarily related to an increase in net unrealized gain in short-term marketable debt securities of $1.1 million.
Current wording
Other comprehensive loss was $0.4 million for the three months ended September 30, 2024, compared to other comprehensive income of $3.5 million for the three months ended September 30, 2023. The decrease in other comprehensive income of $3.9 million primarily related to a decrease in net unrealized gain in short-term marketable debt securities of $3.8 million.
Previous wording
Research and development expenses were $36.7 million for the six months ended June 30, 2024, compared to $16.1 million for the six months ended June 30, 2023. The increase of $20.6 million primarily related to an increase of $13.3 million in expenses pertaining to clinical development trials with CROs for the commencement of the Phase 3 clinical trials in HS, an increase of $4.8 million related to supply and logistic services for clinical development trials, and an increase of $2.1 million and $0.7 million in personnel-related costs and consulting expenses, respectively, to support the research and development effort.
Current wording
Research and development expenses were $72.4 million for the nine months ended September 30, 2024, compared to $23.7 million for the nine months ended September 30, 2023. The increase of $48.7 million primarily related to an increase of $28.7 million in expenses pertaining to clinical development trials with CROs, including for the conduct of Phase 3 clinical trials in HS and preparatory activities for the clinical trials of SLK, including the Phase 3 clinical trials in PsA, Phase 2 clinical trial in axSpA and Phase 2 clinical trial in PPP, an increase of $14.0 million related to supply and logistic services for such clinical development trials, including the purchase of a comparator drug for the Phase 3 clinical trials in PsA, an increase of $3.7 million and $1.9 million in personnel-related costs and consulting expenses, respectively, to support the research and development effort, and an increase of $1.0 million related to non-clinical research and development expenses. The increases were partially offset by a decrease in $0.6 million in other research and development expenses.
Previous wording
General and administrative expenses were $13.7 million for the six months ended June 30, 2024, compared to $10.0 million for the six months ended June 30, 2023. The increase of $3.7 million primarily related to an increase of $1.6 million in personnel-related costs to support organizational growth, an increase of $1.9 million in expenses for advisory and professional services to support organizational growth and operating as a large-accelerated filer, and an increase of $0.7 million in office expenses driven by the new leases for additional office space. The increases were partially offset by a decrease of $0.6 million in share-based compensation due to the restricted founder shares becoming fully vested in April 2023.
Current wording
General and administrative expenses were $21.1 million for the nine months ended September 30, 2024, compared to $15.4 million for the nine months ended September 30, 2023. The increase of $5.7 million primarily related to an increase of $2.5 million in personnel-related costs to support organizational growth, an increase of $2.2 million in expenses for advisory and professional services to support organizational growth and operating as a large-accelerated filer, an increase of $1.0 million in office expenses driven by the new leases for additional office space, and an increase of $0.5 million in market research expenses.
Previous wording
Other income, net was $11.8 million for the six months ended June 30, 2024, compared to $1.6 million for the six months ended June 30, 2023. The increase of $10.2 million primarily related to an increase of $10.8 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities, and a decrease of $1.1 million in realized currency losses. The increases were partially offset by a decrease of $1.6 million in realized currency gains.
Current wording
Other income, net was $18.9 million for the nine months ended September 30, 2024, compared to $3.0 million for the nine months ended September 30, 2023. The increase of $15.9 million primarily related to an increase of $16.0 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities.
Previous wording
Income tax expense was $148,953 for the six months ended June 30, 2024, compared to $21,157 for the six months ended June 30, 2023. The expense is related to corporate income tax of our U.K. and Portugal subsidiaries in 2024 and of our U.K subsidiary in 2023.
Current wording
Income tax expense was $241,059 for the nine months ended September 30, 2024, compared to $50,080 for the nine months ended September 30, 2023. The expense is related to corporate income tax of our U.K. and Portugal subsidiaries in 2024 and of our U.K subsidiary in 2023.
Previous wording
Other comprehensive income was $0.8 million for the six months ended June 30, 2024, compared to other comprehensive loss of $0.5 million for the six months ended June 30, 2023. The increase in income of $1.3 million primarily related to an increase in net unrealized gain in short-term marketable debt securities of $1.2 million.
Current wording
Other comprehensive income was $0.4 million for the nine months ended September 30, 2024, compared to other comprehensive income of $3.0 million for the nine months ended September 30, 2023. The decrease in income of $2.6 million primarily related to an decrease in net unrealized gain in short-term marketable debt securities of $2.5 million.
Previous wording
For the six months ended June 30, 2024, we incurred a loss of $38.7 million, which includes non-cash items such as share-based compensation expense, and a cash outflow from operations of $42.8 million. As of June 30, 2024, we had a total of $519.8 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 nine months ended September 30, 2024, we incurred a loss of $74.8 million, which includes non-cash items such as share-based compensation expense, and a cash outflow from operations of $68.1 million. As of September 30, 2024, we had a total of $493.9 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.
Previous wording
Net cash used in operating activities was $42.8 million and $21.2 million for the six months ended June 30, 2024 and June 30, 2023, respectively. The increase of net cash used in operating activities of $21.6 million was primarily driven by the increase in operating loss of $14.2 million, the increase in cash paid for changes in prepaid expenses of $9.2 million, and the decrease in cash from changes in trade and other payables of $0.8 million. The increases were partially offset by a decrease in cash paid for changes in accrued expenses and other current liabilities of $3.5 million.
Current wording
Net cash used in operating activities was $68.1 million and $30.4 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. The increase of net cash used in operating activities of $37.7 million was primarily driven by the increase in operating loss of $38.7 million and the increase in cash paid for changes in prepaid expenses of $8.4 million. The increases were partially offset by an increase in cash from changes in trade and other payables of $5.7 million and a decrease in cash paid for changes in accrued expenses and other current liabilities of $4.2 million.
Previous wording
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. During the six months ended June 30, 2023, net cash provided by investing activities was $32.3 million and related to the maturities of the principal of short-term marketable debt securities with original maturities longer than three months.
Current wording
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. During the nine months ended September 30, 2023, net cash used in investing activities was $142.1 million, consisting predominantly of $175.7 million related to the purchase of short-term marketable debt securities, partially offset by $33.7 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, 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, 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
(2)We have committed ourselves to four leases, with terms that commenced on November 1, 2021, October 9, 2023, October 13, 2023, and January 15, 2024. We have accounted for the office lease arrangements as operating leases under the guidance ASU 2016-02, Leases Topic 842 through the unaudited condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2024. The future lease commitments relate to the office leases for our headquarters in Zug, Switzerland, Cambridge, United Kingdom, and Porto, Portugal, and reflect minimum payments due.
Current wording
(2)We have committed ourselves to five leases, with terms that commenced on November 1, 2021, October 9, 2023, October 13, 2023, January 15, 2024, and September 8, 2024. We have accounted for the office lease arrangements as operating leases under the guidance ASU 2016-02, Leases Topic 842 through the unaudited condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024. The future lease commitments relate to the office leases for our headquarters in Zug, Switzerland, Cambridge, United Kingdom, and Porto, Portugal, and reflect minimum payments due.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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); (iv) establish a sales, marketing and distribution infrastructure to commercialize SLK; (v) attract, hire and retain additional clinical, scientific, quality control, and administrative personnel; and (vi) add clinical, operational, financial and management information systems and personnel.