MoonLake Immunotherapeutics
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
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Sep 30, 2025 · Filed Nov 5, 2025
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Notes to Condensed Consolidated Financial Statements
s
Note 1 —Overview of the Company
Corporate Information
MoonLake Immunotherapeutics is a clinical stage biotechnology company advancing therapies to address significant unmet needs in inflammatory skin and joint diseases. MoonLake Immunotherapeutics is currently a single asset company focused on the development of Sonelokimab (“SLK”), a novel tri-specific IL-17A and IL-17F inhibiting Nanobody that has the potential, based on response levels seen in clinical trials, to drive disease modification in dermatology and rheumatology patients.
Unless the context otherwise requires, “MoonLake” and the “Company” refer to the combined company following the Business Combination (as defined in Note 2 — Business Combination Agreement with Helix and Recapitalization included in MoonLake’s audited consolidated financial statements and notes thereto in MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (“SEC”) on February 26, 2025 (the “Annual Report”)) consummated on April 5, 2022, together with its subsidiaries.
Note 2 —Basis of Presentation and Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include those of the Company and its subsidiaries, 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"), MoonLake Immunotherapeutics Ltd., a private limited company incorporated in the United Kingdom, and MNLK Immunotherapeutics, Unipessoal Lda, a private limited company incorporated in Portugal, after elimination of all intercompany accounts and transactions. The accompanying unaudited condensed consolidated financial statements and notes hereto have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) as set forth by the Financial Accounting Standards Board (“FASB”) and in conformity with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X for interim financial reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the FASB.
In the opinion of management, all material adjustments necessary for a fair presentation of the financial information, which are of a normal and recurring nature, have been made for the interim periods reported. Results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results for the entire fiscal year or any other period. The unaudited condensed consolidated financial information for the three and nine months ended September 30, 2025 and 2024 have been prepared on the same basis as and should be read in conjunction with MoonLake’s audited consolidated financial statements and notes thereto for the year ended December 31, 2024 included in the Annual Report.
In the current year, the Company has changed its presentation from ones to thousands and, as a result, rounding adjustments have been made to amounts disclosed in prior years.
The presentation currency of MoonLake is the U.S. Dollar (“$”) and all amounts are presented as such, unless otherwise indicated. The term “Swiss franc” and “CHF” refer to the legal currency of Switzerland, "GBP" refers to the legal currency of the United Kingdom, and “€” and "Euro" refer to the legal currency of Portugal.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires the Company to make judgments, estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses. The significant judgments, estimates and assumptions relevant to the Company relate to:
determining whether a transaction should be accounted for as a business combination or an asset acquisition;
determining whether the in-process research and development expenditure (“IPR&D”) has an alternative future use;
determining assumptions used in estimating the fair value of share-based compensation;
estimating the recoverability of the deferred tax asset; and
estimating the amount of accruals in connection with the completion of clinical trial milestones.
The Company bases its judgments and estimates on various factors and information, which may include, but are not limited to, the Company’s forecasts and future plans, current economic conditions and observable market-based transactions of its own shares, the results of which form the basis for making judgments about the carrying value of assets and liabilities and recorded amounts of expenses that are not readily apparent from other sources. To the extent there are material differences between the Company’s estimates and the actual results, the Company’s future results of operations may be affected.
Segment Information
The Company operates as a single operating segment. The Company’s chief operating decision maker (“CODM”), its Chief Executive Officer, manages the Company’s operations on a stand-alone basis for the purposes of allocating resources and assessing financial performance.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents are recorded at cost, which approximates fair value. The Company considers $nil and $59.7 million short-term marketable debt securities in the form of eurocommercial papers and certificates of deposit to be cash equivalents as of September 30, 2025 and December 31, 2024, respectively.
Marketable Securities and Short-Term Investments
The Company invests in short-term marketable securities in the form of debt securities. At the time of purchase, the Company assesses whether such debt security should be classified as held-to-maturity or available-for-sale debt securities.
Debt securities are classified as held-to-maturity when the Company has the positive intent and ability to hold the securities to maturity. Held-to-maturity debt securities are carried at amortized cost, adjusted for accretion of discounts or amortization of premiums to maturity computed under the effective interest method. Such accretion or amortization is included in “Other income, net”. Marketable debt securities not classified as held-to-maturity are classified as available-for-sale and reported at fair value.
Net unrealized gains and losses on available-for-sale debt securities are excluded from the determination of earnings and are instead recognized in the “Accumulated other comprehensive income” component of shareholders’ equity until realized. Realized gains and losses on available-for-sale debt securities are computed based upon the historical cost of these securities, using the specific identification method.
Interest income is recognized when earned. Realized gains and losses are included in "Other income, net" and the cost of securities sold is determined using the specific-identification method.
Marketable debt securities are classified as either “Cash and cash equivalents” or “Short‑term marketable debt securities” according to their original maturity at the time of acquisition. Changes in unrealized gains and losses pertaining to cash equivalent securities are added back into the condensed consolidated statements of cash flows as those are excluded from the determination of earnings but impact the cash and cash equivalents position.
The Company estimates credit losses expected over the life of financial assets based on historical experience, current conditions and reasonable and supportable forecasts. There is no material impact to the unaudited condensed consolidated financial statements given the investments are highly liquid thereby carrying negligible credit loss risk and are all held with reputable companies with a low risk of default.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist of cash accounts in large financial institutions which, at times, may exceed the CHF 100 thousand deposit protection limit in Switzerland, the $250 thousand Federal Deposit Insurance Corporation deposit insurance coverage limit in the United States, the GBP 85 thousand Financial Services Compensation Scheme deposit protection limit in the United Kingdom, or the €100 thousand Fundo de Garantia de Depósitos deposit protection limit in Portugal. The Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash and cash equivalents are held. Additionally, the Company ensures further protection against credit risk by diversifying its cash holdings across a variety of credit institutions, thereby minimizing the potential impact of any adverse events on a single institution. Further, the Company's investment strategy for cash (in excess of current business requirements) is set to invest in short-term marketable debt securities. Management actively monitors credit risk in the investment portfolio. Credit risk exposures are controlled in accordance with policies approved by the board of directors to identify, measure, monitor and control credit risks.
Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
There are three levels of inputs to fair value measurements:
Level 1, meaning the use of quoted prices for identical instruments in active markets;
Level 2, meaning the use of quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active or are directly or indirectly observable; and
Level 3, meaning the use of unobservable inputs. Observable market data is used when available.
Transfers between Levels 1, 2 or 3 within the fair value hierarchy are recognized at the end of the reporting period when the respective transaction occurred.
Long-Term Debt
Long-term debt is recognized as the amount of cash proceeds received plus the accreted present value of the End of Term Charge (as defined in the Loan and Security Agreement, as defined in Note 4 —Debt), less the unamortized End of Term Charge, debt issuance costs, and debt discount. It is subsequently reported at amortized cost. Interest expense is calculated using the effective interest method and any difference between the proceeds (net of unamortized debt discount, debt issuance costs, End of Term Charge, and accreted present value of End of Term Charge) and the principal amount is recognized through interest expense over the estimated life of the related debt. For the undrawn term loan tranches, allocated issuance costs are recorded as deferred charges - long-term debt, which is included in "Other non- current assets" on the Company’s condensed consolidated balance sheet until drawn. In the case of a milestone event not being met or the tranche availability window expiring undrawn, the deferred asset will be recorded as interest expense on the Company's condensed consolidated statements of operations and comprehensive loss.
Leases
The Company determines if an arrangement is or contains a lease at contract inception. For these arrangements, it is evaluated if the arrangement involves an identified asset that is physically distinct or whether the Company has the right to substantially all of the capacity of an identified asset that is not physically distinct. In arrangements that involve an identified asset, there is also judgment in evaluating if the Company has the right to direct the use of that asset.
MoonLake does not have any finance leases. As of September 30, 2025, the Company hasfive operating leases related to the office spaces located in (i) Dorfstrasse 29, 6300, Zug, Switzerland (comprised oftwo leases), (ii) 95 Regent Street, CB2 1AW, Cambridge, England, United Kingdom, and (iii) Rua Manuel Pinto de Azevedo 860, 4150-335, Porto, Portugal (comprised oftwo leases). The operating leases are recognized on a straight-line basis over the lease term commencing on the date the Company has the right to use the leased property. Right-of-use assets and lease liabilities are measured at the lease commencement date based on the present value of the remaining lease payments over the lease term, determined using the discount rate for the lease at the commencement date. Because the rate implicit in the leases is not readily determinable, the Company uses the incremental borrowing rate as the discount rate, which approximates the interest rate at which the Company could borrow on a collateralized basis with similar terms and payments and in similar economic environments.
Leases with an initial term of 12 months or less that do not have the option to purchase the underlying asset are not recorded on the balance sheet, with lease expense for these leases recognized on a straight-line basis over the lease term commencing on the date the Company has the right to use the leased property.
Property and Equipment
Property and equipment, net is stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method based on the estimated useful lives ofthree tofive years. As of September 30, 2025, property and equipment, net relates to information technology, office equipment, and leasehold improvements.
Impairment of Long-Lived Assets
The Company reviews all long-lived asset groups, which consist of operating lease right-of-use assets, and property and equipment, whenever events or changes in circumstance indicate that these assets may not be recoverable. When evaluating long-lived assets, if the Company concludes that the estimated undiscounted cash flows attributable to the assets are less than their carrying value, the Company recognizes an impairment loss based on the excess of the carrying amount of the assets over their respective fair values. There wasno impairment of long-lived assets for the nine months ended September 30, 2025, and 2024.
Research and Development Contract Costs and Accruals
Research and development expenses include employee payroll, consulting, contract research, contract manufacturing costs attributable to research and development activities and manufacturing of pre-launch inventory, which are expensed as incurred.
Upfront payments and milestone payments made for the licensing of technology are expensed as research and development expenses in the period in which it is probable that a liability has been incurred. Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
The Company has entered into various research and development contracts with companies both inside and outside of the United States. These agreements are generally cancellable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs.
Pre-Launch Inventory
Prior to obtaining regulatory approval of a product candidate, the Company may incur production costs to support the commercial launch of such product. Until the date at which regulatory approval has been received or it is considered probable, and the future economic benefit is expected to be realized, all such costs are recorded as research and development expenses as incurred.
Share-Based Compensation
The Company recognizes compensation expense based on estimated fair values for all stock-based payment awards made to eligible employees, members of the board of directors and independent contractors that are expected to vest.
The valuation of stock option awards is determined at the date of grant using the Black-Scholes option pricing model. The Black-Scholes option pricing model requires the Company to make assumptions and judgments about the inputs used in the calculations, such as the fair value of the common stock, expected term, expected volatility of the Company’s common stock, risk-free interest rate and expected dividend yield. The valuation of restricted stock awards is measured by the fair value of the Company’s common stock on the date of the grant.
For all stock options granted, the Company calculated the expected term as the period that share-based awards are expected to be outstanding. The estimate of expected volatility is based on comparative companies’ volatility within the Company's industry. The risk-free rate is based on the yield available on United States Treasury zero-coupon issues corresponding to the expected term of the award.
The fair value of the common stock granted under the ESPP (as defined in Note 14 —Share-Based Compensation) was historically estimated by management with reference to the market-based transaction with its Series A investors, as there was no public market for the common stock.
Share-based payment arrangements are accounted for under the fair value method. Total compensation is measured at grant date, based on the fair value of the award at that date, and recorded in earnings over the period the employees are required to render service. The Company recognizes compensation cost only for those awards expected to meet the service conditions on a straight-line basis over the requisite service period of the award.
Foreign Currency
The functional currency of the Company and its subsidiaries is the U.S. dollar. Balances and transactions denominated in foreign currencies are converted as follows: monetary assets and liabilities are translated using exchange rates in effect at the balance sheet dates and non-monetary assets and liabilities are translated at historical exchange rates. Income and expenses are translated at the daily exchange rate on the respective transaction date.
Gains or losses from foreign currency translation are included in the condensed consolidated statements of operations and comprehensive loss in "Other income, net". The Company 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.
Income Taxes
The Company accounts for income taxes by using the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. A valuation allowance is recorded to the extent it is more likely than not that all or a portion of the Company's deferred tax assets will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date.
Net Loss per Class A Ordinary Shares
Basic net loss per Class A Ordinary Share is calculated using the two-class method under which earnings are allocated to both Class A Ordinary Shares and participating securities. Basic net loss per share is calculated by dividing the net loss attributable to Class A Ordinary Shares by the weighted-average number of Class A Ordinary Shares outstanding for the period. The diluted net loss per Class A Ordinary Share is computed by dividing the net loss using the weighted-average number of Class A Ordinary Shares and, if dilutive, potential Class A Ordinary Shares outstanding during the period.
In periods in which the Company reports a net loss attributable to shareholders of Class A Ordinary Shares, diluted net loss per share attributable to shareholders of Class A Ordinary Shares is the same as basic net loss per share attributable to shareholders of Class A Ordinary Shares, since dilutive Class A Ordinary Shares are not assumed to be outstanding if their effect is anti-dilutive.
Acquisitions
The Company evaluates 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. On April 29, 2021, MoonLake AG entered into an in-licensing agreement (the “In-License Agreement”) with Merck Healthcare KGaA, Darmstadt, Germany (“MHKDG”) to acquire the Sonelokimab program (the “SLK Program”) and determined that substantially all of the fair value of the gross assets acquired related to IPR&D of SLK. Therefore, this transaction was accounted for as an asset acquisition.
IPR&D represents incomplete technologies that the Company acquires, which at the time of acquisition, are still under development and have no alternative future use. The fair value of such technologies is expensed upon acquisition. A technology is considered to have an alternative future use if it is probable that the Company will use the asset in its current, incomplete state as it existed at the acquisition date, in another research and development project that has not yet commenced, and economic benefit is anticipated from that use. If a technology is determined to have an alternative future use, then the fair value of the program would be recorded as an asset on the balance sheet rather than expensed.
Contingent consideration payments (for example milestone payments due upon the occurrence of a specific event) in asset acquisitions are recognized in the period in which it is probable that a liability has been incurred (unless the contingent consideration meets the definition of a derivative, in which case the amount becomes part of the cost in the asset acquired). Upon recognition of the contingent consideration payment, the amount is expensed if it relates to IPR&D or capitalized if it relates to a developed product which is generally considered to be when clinical trials have been completed and regulatory approval obtained.
Future royalty payments due on net sales will be recognized in cost of goods sold when net sales are recognized.
Pension
The Company accounts for pension assets and liabilities, which requires the recognition of the funded status of pension plans in the Company’s condensed consolidated balance sheets. The liability in respect to defined benefit pension plans is the projected benefit obligation calculated annually by independent actuaries using the projected unit credit method. The projected benefit obligation as of September 30, 2025 represents the actuarial present value of the estimated future payments required to settle the obligation that is attributable to employee services rendered before that date. Service costs for such pension plans, represented in the net periodic pension benefit cost, are included in the personnel expenses of the various functions where the employees are engaged. The other components of net benefit cost are included in the condensed consolidated statements of operations and comprehensive loss separately from the service cost component, in “Other income, net”. Plan assets are recorded at their fair value.
Gains or losses arising from plan curtailments or settlements are accounted for at the time they occur. Any net pension asset is limited to the present value of the future economic benefits available to the Company in the form of refunds from the plan or expected reductions in future contributions to the plan. Actuarial gains and losses arising from differences between the actual and the expected return on plan assets are recognized in “Accumulated other comprehensive income”.
Recently Issued Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, Income Taxes - Improvements to Income Taxes Disclosures, which amends guidance on to enhance the transparency and decision usefulness of income tax disclosures. It is effective for fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosure (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires a public entity to disclose additional information about specific expense categories in the notes to financial statements on an annual and interim basis. It is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The Company is currently evaluating the impact.
In September 2025, the FASB issued ASU 2025-07, Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract, which amends the ASC guidance to address stakeholders’ concerns about (1) the application of derivative accounting to contracts with features based on the operations or activities of one of the parties to the contract and (2) the diversity in accounting for share-based, non-cash consideration from a customer that is consideration for the transfer of goods or services. The amendments will be effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within those annual reporting periods. The Company is currently evaluating the impact.
Prior Period Reclassification
The amortization expense in the condensed consolidated statements of cash flows in prior periods has been reclassified to conform with the current period presentation. The amortization expense of $938 thousand was reclassified from “Other non-cash items” to “Depreciation and amortization”. The change did not have any impact on the net cash flow used in operating activities.
Note 3 –Risks and Liquidity
Going Concern, Liquidity and Capital Resources
MoonLake is subject to risks common to companies in the biopharmaceutical industry, and the Company believes that changes in any of the following areas could have a material adverse effect on the Company's future financial position or results of operations: ability to obtain future financing, regulatory approval and market acceptance of, and reimbursement for, product candidates, performance of third-party contract research organizations and manufacturers upon which the Company relies, protection of the Company's intellectual property, litigation or claims against the Company based on intellectual property, patent, product, regulatory, clinical or other factors, and the Company's ability to attract and retain employees necessary to support its growth.
The Company is dependent on third-party manufacturers to supply products for research and development activities in its programs and for eventual commercialization. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply the Company with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. These programs could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients and formulated drugs.
The Company's ability to generate revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of SLK in one or more indications, which is expected to take a number of years. The Company expects to continue to incur significant expenses and operating losses for at least the next two years as the Company continues the development of SLK and prepares for commercial launches. It is expected that operating losses will fluctuate significantly from year to year depending on the timing of the Company's planned clinical development programs, efforts to achieve regulatory approval, and marketing and sales expenditures.
The Company incurred a loss of $167.3 million for the nine months ended September 30, 2025. As of September 30, 2025, the Company’s current assets exceeded its current liabilities by $362.8 million.
As of September 30, 2025, the Company had $350.7 million of cash and cash equivalents. Based on the Company's current operating plan and the Loan and Security Agreement as defined in Note 4 —Debt, management believes that the Company has sufficient capital to fund its operations and capital expenditures into the second half of 2027.
Note 4 – Debt
On March 31, 2025 (the “Closing Date”), MoonLake as a guarantor entered into a loan and security agreement (the “Loan and Security Agreement”) with its subsidiary, MoonLake AG, as borrower, the lenders party thereto (the “Lenders”), and Hercules Capital, Inc. (“Hercules”), as the administrative and collateral agent for itself and the Lenders. The Loan and Security Agreement provides a non-dilutive senior secured term loan facility (the “Credit Facility”) of up to an aggregate principal amount of $500.0 million. 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%, subject to a 0.25% reduction upon achievement of the U.S. Food and Drug Administration's (“FDA”) approval of a Biologics License Application (“BLA”) for SLK.
The Credit Facility comprises:
a. A first tranche (the “Tranche 1 Loan”) in an aggregate principal amount of $75.0 million fully funded on the Closing Date,
b. 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,
c. 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,
d. 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, and
e. Subject to approval by the Lenders’ in their discretion, a fifth tranche (the "Tranche 5 Loan") of additional term loans in an aggregate principal amount of up to $200.0 million.
On September 28, 2025, the Company announced the primary endpoint results of the VELA-1 and VELA-2 Phase 3 studies. While VELA-1 met the primary endpoint, a higher-than-expected placebo response at week 16 precluded VELA-2 from meeting the pre-specified primary endpoint and, as a result, the Company did not achieve the Tranche 2 and Tranche 4 Milestones.
As of September 30, 2025, the Company's carrying value of long-term debt and recognized deferred charges on the condensed consolidated balance sheets consists of the following:
| (in thousands) | |
|---|---|
| Non-current liabilities | September 30, 2025 |
| Principal amount | $75,000 |
| Accreted present value of End of Term Charge | 3,525 |
| Unamortized End of Term Charge | (3,004) |
| Unamortized debt issuance cost | (1,014) |
| Unamortized debt discount | (766) |
| Carrying value | $73,741 |
| Non-current assets | |
| Deferred charges - long-term debt | $587 |
| Total | $587 |
The effective interest rate is 10.41% and the Company recognized interest expense of $3.2 million and $5.3 million on the Loan and Security Agreement for the three and nine months ended September 30, 2025, respectively. A portion of the debt issuance costs related to the undrawn third and fifth tranches are recognized as deferred charges until drawn. The debt issuance costs related to the second and fourth tranches have been recognized as interest expense in the current period.
The Company may prepay advances in whole at any time subject to a prepayment charge. Upon repayment of all term loans on or after April 1, 2027, the Company is further required to pay an additional charge equal to 6.95% for the
Tranche 1 Loan and any draws under the Tranche 3 Loan;4.25% for any draw under the Tranche 5 Loan, and if repayment occurs prior to 24 months, the charge applied will be 4.25% ("End of Term Charge"). As of September 30, 2025, the End of Term Charge is accrued at 6.95% of the Tranche 1 Loan balance and is recorded at present value as an addition to the long-term debt in non-current liabilities whereas the unamortized portion is recorded as contra non-current liabilities. The unamortized contra-liability will be amortized and the present value will be accreted up to the future value over the loan term as interest expense. The Tranche 1 Loan has a maturity requirement of $75.0 million due in 2030, with no other principal payments due for each of thefive years following the date of the latest condensed consolidated balance sheets presented. Additional fees will be payable in connection with the Credit Facility upon drawing of future tranches.
The Loan and Security Agreement allows for the Company 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 September 30, 2025.
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 September 30, 2025.
All obligations under the Loan and Security Agreement will be secured on a first-priority basis, subject to certain exceptions, by security interests in substantially all assets of the Company and material subsidiaries of the Company, including its intellectual property, and will be guaranteed by material subsidiaries of the Company, including foreign subsidiaries, subject to certain exceptions.
Note 5 –Fair Value Measurements
The following table presents information about the Company's short-term marketable debt securities measured at fair value on a recurring basis and indicate the level in the fair value hierarchy in which the Company classifies the fair value measurement:
| (in thousands) | September 30, 2025 | December 31, 2024 | ||
|---|---|---|---|---|
| Level 2 | Total | Level 2 | Total | |
| Eurocommercial Papers | $29,743 | $29,743 | $207,701 | $207,701 |
| Certificates of Deposit | — | — | 119,583 | 119,583 |
| Total | $29,743 | $29,743 | $327,284 | $327,284 |
Cash and accounts payable approximate their fair values as of September 30, 2025 and December 31, 2024, due to their short-term nature. Pension plan assets fair value is determined based on Level 2 inputs. The fair value of the long-term debt is estimated using the net present value of the payments, discounted at an interest rate that is consistent with a market interest rate, which is a Level 2 input as it is not actively traded. As of September 30, 2025, long-term debt of $73.7 million is reported at amortized cost which approximates the fair value.
Note 6 –Investments
The fair value and amortized cost of investments in short-term marketable debt securities by major security type as of September 30, 2025 and December 31, 2024 are as follows:
| (in thousands) | September 30, 2025 | |||
|---|---|---|---|---|
| Amortized cost | Gross unrealized gains | Gross unrealized losses | Fair value | |
| Eurocommercial Papers | $29,256 | $487 | $— | $29,743 |
| Total | $29,256 | $487 | $— | $29,743 |
| Of which classified within short-term marketable debt securities | 29,256 | 487 | — | 29,743 |
| (in thousands) | December 31, 2024 | |||
|---|---|---|---|---|
| Amortized cost | Gross unrealized gains | Gross unrealized losses | Fair value | |
| Eurocommercial Papers | $204,572 | $3,129 | $— | $207,701 |
| Certificates of Deposit | 117,305 | 2,278 | — | 119,583 |
| Total | $321,877 | $5,407 | $— | $327,284 |
| Of which classified within cash and cash equivalents | 59,311 | 372 | — | 59,683 |
| Of which classified within short-term marketable debt securities | 262,566 | 5,035 | — | 267,601 |
The following table presents the changes in fair values of the Company’s short-term marketable debt securities, classified as Level 2 financial assets, and recognized in the “Accumulated other comprehensive income” as of September 30, 2025 and 2024:
| (in thousands) | |
|---|---|
| Beginning balance, January 1, 2025 | $5,407 |
| Other comprehensive income before reclassifications | 8,663 |
| Amounts reclassified from accumulated other comprehensive income | (13,583) |
| Ending balance, September 30, 2025 | $487 |
| (in thousands) | |
|---|---|
| Beginning balance, January 1, 2024 | $2,721 |
| Other comprehensive income before reclassifications | 13,001 |
| Amounts reclassified from accumulated other comprehensive income | (12,492) |
| Ending balance, September 30, 2024 | $3,230 |
As of September 30, 2025, the Company’s marketable debt securities maturities are all due within one year.
Note 7 —Prepaid Expenses
| (in thousands) | September 30, 2025 | December 31, 2024 |
|---|---|---|
| Non-clinical research and clinical development services | $17,576 | $14,136 |
| Supply and manufacturing services | 6,694 | 7,716 |
| Insurances | 1,036 | 1,113 |
| Other prepayments | 1,408 | 453 |
| Total | $26,714 | $23,418 |
Note 8 —Trade and Other Payables
| (in thousands) | September 30, 2025 | December 31, 2024 |
|---|---|---|
| Research and development services | $19,576 | $5,081 |
| Supply and manufacturing fees payable | 4,242 | 3,597 |
| Consulting and advisory services | 660 | 39 |
| Legal advisory services | 151 | 93 |
| Other payables | 653 | 182 |
| Total | $25,282 | $8,992 |
Note 9 —Accrued Expenses and Other Current Liabilities
| (in thousands) | September 30, 2025 | December 31, 2024 |
|---|---|---|
| Research and development services and license fees | $10,679 | $2,022 |
| Supply and manufacturing services | 4,637 | 4,474 |
| Bonuses and related employee compensation expenses | 4,199 | 4,237 |
| Tax liabilities | 1,014 | 642 |
| Accrued debt interest | 553 | — |
| Consultant and other fees | 418 | 586 |
| Legal fees | 87 | 138 |
| Total | $21,587 | $12,099 |
Note 10 —Leases
In August 2021, the Company entered into an open-ended office lease agreement, effective November 1, 2021, to lease approximately 2,300 square feet of space on the last two floors of the building located at Dorfstrasse 29, 6300 Zug,
Switzerland. In December 2023, the contract was extended, leading to a new estimated effective duration of the lease period of 3 years, with expected expiration in January 2027.
On October 9, 2023, the Company entered into an office lease agreement, effective as of October 9, 2023, to lease approximately 3,900 square feet of office space on the fifth floor of the building located at Rua Manuel Pinto de Azevedo 860, 4150-335, Porto, Portugal. This lease has a 3-year initial term, withtwo extendable periods of 3 years each. The Company expects to exercise the first available option and extend this lease through October 2029.
On October 13, 2023, the Company entered into an office lease agreement, effective as of October 16, 2023, to lease approximately 6,000 square feet of office space on the first floor of the building located at 95 Regent Street, CB2 1AW, Cambridge, England, United Kingdom. This lease has a 3-year term agreement and is set to expire in October 2026.
On December 12, 2023, the Company entered into an open-ended office lease agreement, effective as of January 15, 2024, to lease approximately 1,700 square feet of additional office space at its existing corporate headquarters located at Dorfstrasse 29, 6300 Zug, Switzerland. The Company estimated the duration of the lease at inception and determined a 3-year term.
On August 14, 2024, the Company entered into an office lease agreement, effective as of September 8, 2024, to lease approximately 2,000 square feet of additional office space at its existing office located at Rua Manuel Pinto de Azevedo 860, 4150-335, Porto, Portugal. This lease has a 2-year initial term, withtwo extendable periods of 3 years each. The Company expects to exercise the first available option and extend this lease through October 2029.
The weighted average remaining lease term and weighted average discount rate for the operating leases as of September 30, 2025 and December 31, 2024 were as follows:
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Weighted average remaining lease term (in months) | 23 | 29 |
| Weighted average discount rate | 4.7% | 4.7% |
The future minimum annual lease payments under these operating leases as of September 30, 2025 are as follows:
| (in thousands) | |
|---|---|
| Fiscal Year | Amount |
| 2025 (remainder of the year) | $400 |
| 2026 | 1,269 |
| 2027 | 147 |
| 2028 | 147 |
| 2029 | 100 |
| Thereafter | — |
| Total lease payments | 2,064 |
| Less imputed interest | (79) |
| Total lease liability | 1,985 |
| Less current portion of lease liability | (1,499) |
| Long-term portion of operating lease liability | $486 |
Operating cash outflows for amounts included in the measurement of lease liabilities were $1,161 thousand and $1,102 thousand for the nine months ended September 30, 2025 and 2024, respectively.
The Company recorded the following lease and variable lease expenses for the three and nine months ended September 30, 2025 and 2024:
| (in thousands) | Three Months Ended September 30, 2025 | Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2025 | Nine Months Ended September 30, 2024 |
|---|---|---|---|---|
| Operating lease expense | $365 | $359 | $1,095 | $1,061 |
| Variable lease expense | 13 | 5 | 36 | 5 |
| Total lease expense | $378 | $364 | $1,131 | $1,066 |
Note 11 —Employee Benefit Plans
The Company operates a defined benefit pension plan in Switzerland (the “Plan”) and a defined contribution pension plan in the United Kingdom, in accordance with local regulations and practices. As of September 30, 2025, the Plan covers the Company’s employees in Switzerland with benefits in the event of death, disability, retirement, or termination of employment.
Components of Net Periodic Benefit Cost under the Plan
| (in thousands) | Three Months Ended September 30, 2025 | Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2025 | Nine Months Ended September 30, 2024 |
|---|---|---|---|---|
| Service cost | $86 | $71 | $246 | $210 |
| Interest cost | 9 | 8 | 24 | 25 |
| Expected return on plan assets | (21) | (15) | (60) | (45) |
| Amortization of unrecognized loss | 3 | 3 | 9 | 8 |
| Prior service credit recognized in current year | (3) | (3) | (8) | (8) |
| Net periodic benefit cost | $74 | $64 | $211 | $190 |
The components of net periodic benefit cost other than the service cost component are included in general and administrative expense in the Company's condensed consolidated statements of operations and comprehensive loss.
Employer Contributions under the Plan
For the nine months ended September 30, 2025, contributions of $238 thousand (CHF 200 thousand) were made to the Plan. The Company presently anticipates contributing an additional estimated amount of $79 thousand (CHF 67 thousand) to fund the Plan in 2025 for a total of $317 thousand (CHF 266 thousand).
Note 12 —Shareholders’ Equity
| Class A Ordinary Shares(1) | Class C Ordinary Shares(1) | Total Number of Ordinary Shares | ||||
|---|---|---|---|---|---|---|
| Authorized | Issued and Outstanding | Authorized | Issued and Outstanding | Authorized | Issued and Outstanding | |
| Balance at January 1, 2025 | 500,000,000 | 63,077,431 | 100,000,000 | 841,269 | 600,000,000 | 63,918,700 |
| Conversion of Class C Ordinary Shares into Class A Ordinary Shares | — | 111,949 | — | (111,949) | — | — |
| Option exercised and converted under the Employee Stock Option Plan | — | 93,347 | — | — | — | 93,347 |
| Issuance of Restricted Stock Awards under the MoonLake Immunotherapeutics 2022 Equity Incentive Plan | — | 191,526 | — | — | — | 191,526 |
| Balance at March 31, 2025 | 500,000,000 | 63,474,253 | 100,000,000 | 729,320 | 600,000,000 | 64,203,573 |
| Balance at June 30, 2025 | 500,000,000 | 63,474,253 | 100,000,000 | 729,320 | 600,000,000 | 64,203,573 |
| Conversion of Class C Ordinary Shares into Class A Ordinary Shares | — | 203,142 | — | (203,142) | — | — |
| Options exercised under the MoonLake Immunotherapeutics 2022 Equity Incentive Plan Equity Incentive Plan | — | 27,149 | — | — | — | 27,149 |
| Balance at September 30, 2025 | 500,000,000 | 63,704,544 | 100,000,000 | 526,178 | 600,000,000 | 64,230,722 |
(1) Fully paid-in registered shares with a par value of $0.0001
Class A Ordinary Shares
On April 6, 2022, the Company's Class A Ordinary Shares began trading on The Nasdaq Capital Market ("Nasdaq") under the symbol “MLTX”. As of September 30, 2025, there were 63,704,544 Class A Ordinary Shares issued and outstanding. The Company is authorized to issue up to 500,000,000 Class A Ordinary Shares, par value $0.0001 per share. Holders of Class A Ordinary Shares are entitled toone vote per share.
Class C Ordinary Shares
As of September 30, 2025, there were 526,178 Class C Ordinary Shares issued and outstanding. The Company is authorized to issue up to 100,000,000 Class C Ordinary Shares, with a par value $0.0001 per share. Each Class C Ordinary Share entitles the holders thereof toone vote per share, but carries no economic rights.
At the closing of the Business Combination, MoonLake, MoonLake AG and each ML Party (as defined in Note 2 —Business Combination Agreement with Helix and Recapitalization, included in MoonLake's audited consolidated financial statements and notes thereto for the year ended December 31, 2024 included in the Annual Report) entered into a Restated and Amended Shareholders' Agreement (the “A&R Shareholders' Agreement”). With the intent to approximate the rights, obligations and restrictions that an ML Party would enjoy if it were a holder of Class A Ordinary Shares, the A&R Shareholders’ Agreement (i) imposes certain transfer and other restrictions on the ML Parties, (ii) provides for the waiver of certain statutory rights and (iii) establishes certain mechanics whereby MoonLake and each of the ML Parties are able to effect the conversion of MoonLake AG Common Shares and Class C Ordinary Shares into a number of Class A Ordinary Shares equal to the Exchange Ratio of 33.638698 (as defined in Note 3 —Basis of Presentation, included in MoonLake's audited consolidated financial statements and notes thereto for the year ended December 31, 2024 included in the Annual Report). On September 2, 2025, pursuant to the A&R Shareholders’ Agreement, certain holders of Class C Ordinary Shares submitted exchange notices to the Company, pursuant to which such holders of Class C Ordinary Shares effected the conversion of 6,039 MoonLake AG Common Shares and 203,142 Class C Ordinary Shares into 203,142 Class A Ordinary Shares using the Exchange Ratio. The foregoing description of the A&R Shareholders' Agreement is not complete and is qualified in its entirety by reference to, and should be read in connection with, the full text of the A&R Shareholders' Agreement filed as an exhibit on the Company's Current Report on Form 8-K filed with the SEC on April 11, 2022.
Equity Offerings
At-the-Market Offering
On May 11, 2023, the Company entered into a Sales Agreement (the “May 2023 Sales Agreement”) with Leerink Partners LLC (formerly known as SVB Securities LLC) (“Leerink Partners”), through which the Company could issue and sell up to $200.0 million of its Class A Ordinary Shares (the “May 2023 ATM Shares”), through Leerink Partners as its sales agent. The May 2023 ATM Shares to be sold under the May 2023 Sales Agreement, if any, would be issued and sold pursuant to the Company's shelf registration statement on Form S-3 (File No. 333-271546), which was declared effective by the SEC on May 9, 2023, and a prospectus supplement thereto filed with the SEC on May 11, 2023.
On June 27, 2023, the Company reduced the maximum aggregate offering amount of its Class A Ordinary Shares that could be issued and sold under the May 2023 Sales Agreement to $0 and no longer intends to sell Class A Ordinary Shares under the May 2023 Sales Agreement unless the Company files a further prospectus supplement indicating an amount of shares proposed to be sold.
On August 31, 2023, the Company entered into a Sales Agreement with Leerink Partners (the “August 2023 Sales Agreement” and together with the May 2023 Sales Agreement, the “Sales Agreements”), through which the Company could issue and sell up to $350.0 million of its Class A Ordinary Shares (the “August 2023 ATM Shares”), through Leerink Partners as its sales agent. The August 2023 ATM Shares to be sold under the August 2023 Sales Agreement, if any, would be issued and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-274286), which was declared effective by the SEC on September 11, 2023, and a prospectus supplement thereto filed with the SEC on August 31, 2023. As of September 30, 2025, there was $265.0 million remaining for future sales under the August 2023 Sales Agreement.
For the three months ended September 30, 2025, there wereno sales under the August 2023 Sales Agreement.
Public Offering of Class A Ordinary Shares
On June 27, 2023, the Company entered into an underwriting agreement with SVB Securities LLC and Guggenheim Securities LLC as the representatives of the underwriters named therein, to issue and sell 8,000,000 Class A Ordinary Shares at a public offering price of $50.00 per share (the “Offering”). In addition, the Company granted the underwriters an option for a period of 30 days to purchase up to an additional 1,200,000 Class A Ordinary Shares at the public offering price less the underwriting discounts and commissions (the “Option”), and such Option was exercised in full by the underwriters.
The Offering closed on June 30, 2023, and net proceeds from the Offering, including proceeds from the exercise in full by the underwriters of the Option, were $436.7 million, after deducting the underwriting discounts and commissions and the offering expenses in the amount of $23.3 million.
Following the completion of the Offering, the Company opted to direct a substantial portion of the net proceeds to MoonLake AG. This was executed as a two-step process: (i) the Company acquired the remaining 22,756 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) the Company contributed additional funds 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 the Company has classified as cash flows from financing activities in order to correctly mirror the underlying nature of the transaction.
On March 8, 2024, the Company executed a similar transaction as a two-step process: (i) the Company acquired 501 MoonLake AG Common Shares held in treasury through a share purchase and assignment agreement ($0.8 million) and (ii) the Company 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 the Company has 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.
Note 13 —Net Loss Per Share
The following table sets forth the net loss per share calculations for the three and nine months ended September 30, 2025 and 2024:
| (in thousands, except share and per share data) | Three Months Ended September 30, 2025 | Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2025 | Nine Months Ended September 30, 2024 |
|---|---|---|---|---|
| Numerator | ||||
| Net loss attributable to controlling interests shareholders | $(69,729) | $(35,390) | $(164,891) | $(73,331) |
| Denominator | ||||
| Total weighted average number of outstanding shares | 63,369,984 | 62,896,782 | 63,295,999 | 62,803,220 |
| Net loss per share – basic and diluted | $(1.10) | $(0.56) | $(2.61) | $(1.17) |
There were 1,632,266 and 973,800 common stock equivalents outstanding in the form of stock options and restricted stock awards under the Equity Incentive Plan (as defined below) as of September 30, 2025 and 2024, respectively, that have been excluded from the calculation of net loss per share – diluted as their effect would be anti-dilutive.
Class C Ordinary Shares have been excluded from the weighted average number of outstanding shares used to calculate the net loss per share – basic and diluted as they do not carry economic rights.
If the ML Parties elected to convert all of their MoonLake AG Common Shares and associated Class C Ordinary Shares into Class A Ordinary Shares as of January 1, 2024, the weighted average number of shares outstanding would have been 64,037,478 and 64,013,095 for the three and nine months ended September 30, 2025, respectively, resulting in a net loss per share of $1.10 and $2.61, respectively. Upon conversion, all 526,178 Class C Ordinary Shares would be forfeited and there would no longer be any non-controlling interests.
Note 14 —Share-Based Compensation
As of September 30, 2025, the Company had the following share-based compensation arrangements:
a. Restricted Founder Shares (as defined below) – created in April 2021 by MoonLake AG (fully vested as of April 2023);
b. The Employee Share Participation Plan (“ESPP”) – created in July 2021 by MoonLake AG;
c. The Employee Stock Option Plan (“ESOP”) – created in July 2021 by MoonLake AG (fully vested as of January 2024);
d. MoonLake Immunotherapeutics 2022 Equity Incentive Plan ("Equity Incentive Plan") – created in April 2022 by MoonLake Immunotherapeutics.
The purpose of the arrangements is to attract and retain the best available personnel and to provide participants with additional incentive to increase their efforts on behalf and in the best interest of the Company and its subsidiaries. The reference to “Common Shares” refers to shares in MoonLake AG.
MoonLake AG's compensation plans are settled with its Common Shares and with a number of Class C Ordinary Shares of the Company, determined by multiplying the number of Common Shares by the Exchange Ratio. The owners of Common Shares have the right to exchange their Common Shares for a number of Class A Ordinary Shares derived using the Exchange Ratio. In the event MoonLake AG shareholders elect to exchange their Common Shares, such MoonLake AG shareholder forfeits a number of Class C Ordinary Shares equal to the number of Class A Ordinary Shares issued (refer to Note 12 — Shareholders’ Equity -Class C Ordinary Shares).
As of January 1, 2024, the Company executed the conversion of the majority of the outstanding ESOP awards into an equivalent number of Equity Incentive Plan option awards that are settled with Class A Ordinary Shares, thereby eliminating the intermediary right to the exchange step noted above. From an accounting perspective, there is no underlying modification to the economic, control or legal rights of the awards, including vesting terms and conditions, exercise price and accounting classification. This is purely an administrative change as opposed to an accounting modification whereby the plan issuer is amended from MoonLake AG to MoonLake Immunotherapeutics. Consequently, there is no incremental fair value generated following the conversion and therefore no incremental expense recorded. Any remaining unvested compensation expense will be recorded over the remaining vesting period of the original awards, thereby resulting in no change to the unaudited condensed consolidated financial statements if the conversion had not occurred.
As a result of this administrative conversion, thetwo plans which remain active as of September 30, 2025 are the ESPP and Equity Incentive Plan, whereas the Restricted Founder Shares and ESOP are fully vested as of April 2023 and January 2024, respectively.
For the three and nine months ended September 30, 2025, the Company has recognized an increase in equity in the condensed consolidated balance sheets due to share-based compensation expense in the condensed consolidated statements of operations and comprehensive loss of $3.7 million and $9.3 million, respectively, and $1.8 million and $5.3 million for the three and nine months ended September 30, 2024, respectively. The share-based compensation expense was driven by the aforementionedtwo active share-based compensation plans and programs:
| (in thousands) | ||||
|---|---|---|---|---|
| Compensation Plan | Three Months Ended September 30, 2025 | Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2025 | Nine Months Ended September 30, 2024 |
| ESPP | $741 | $741 | $2,199 | $2,192 |
| ESOP | — | — | (18) | — |
| Equity Incentive Plan | 2,967 | 1,102 | 7,127 | 3,156 |
| Total share-based compensation expense | $3,708 | $1,843 | $9,308 | $5,348 |
| Of which: included in research and development expense | 1,190 | 509 | 2,723 | 1,446 |
| Of which: included in general and administrative expense | 2,518 | 1,334 | 6,585 | 3,902 |
We expect that all future employee awards will be made under the Equity Incentive Plan. As of September 30, 2025,2,552,390 Class A Ordinary Shares from the authorized pool of 4,353,948 Class A Ordinary Shares remain available for future grants, and 1,440,740 Class A Ordinary Shares are reserved for issuance upon exercise of stock options granted under the Equity Incentive Plan.
Restricted Founder Shares 2021-2023 - MoonLake AG
On April 28, 2021, the shareholders’ agreement between the co-founders, the Series A investors and MoonLake AG imposed a reverse vesting condition on 90% of the total 110,000 Common Shares (the equivalent of 3,700,257 Class C Ordinary Shares) held by each of thethree co-founders. Therefore,99,000 Common Shares (the equivalent of 3,330,231 Class C Ordinary Shares) held by each of the co-founders were subject to these restrictions and considered unvested (the “Restricted Founder Shares”). The Restricted Founder Shares vested on the 28th of each month at a rate of 4.166% over a period oftwo years until April 28, 2023. In the event of termination of the contractual relationship of the relevant co-founder before the end of the vesting period, MoonLake AG in first priority, or any third party designated by it, and the other shareholders in second priority pro rata to their shareholdings, had an option to purchase all or a pro rata portion of the leaver shares that remained unvested on the effective day of the termination at nominal value of CHF 0.10.
Employee Share Participation Plan (ESPP) 2021-2026 - MoonLake AG
The ESPP grants will vest 25% on each anniversary of the grant date. In the event of a termination of contractual relationship between the Company and the entitled employee, the awards can be deemed forfeited by MoonLake AG if certain conditions are met. Awards feature an accelerated vesting condition linked to a “Change of Control”, defined as any transfer of shares that results in the proposed acquirer holding more than 50% of the then issued share capital of MoonLake AG or the Company, as the case may be, where all the outstanding awards (whether currently outstanding or granted in the future) will be deemed fully vested.
| ESPP | Number of Shares | Weighted-Average Grant Date Fair Value |
|---|---|---|
| Awards unvested as of January 1, 2025 | 319,769 | 10.00 |
| Awards vested for the nine months ended September 30, 2025 | (220,401) | 10.00 |
| Awards unvested as of September 30, 2025 | 99,368 | 10.00 |
As of September 30, 2025, MoonLake AG had $0.9 million of total unrecognized compensation expense related to the ESPP that will be recognized over the weighted average period of 0.3 years.
Employee Stock Option Plan (ESOP) 2021-2025 - MoonLake AG
The ESOP grants vested 25% on each anniversary of the grant date. In the event of a termination of the contractual relationship between the Company and the entitled employee, options could have been deemed forfeited by MoonLake AG if certain conditions were met. The awards featured an accelerated vesting condition linked to a “Change of Control”, defined as any transfer of shares that resulted in the proposed acquirer holding more than 50% of the then issued share capital of MoonLake AG or the Company, as the case may be, where all the outstanding awards (whether currently outstanding or granted in the future) would have been deemed fully vested.
| ESOP | Number of Options | Weighted-Average Exercise Price | Aggregate Intrinsic Value (in thousands) | Weighted-Average Remaining Contractual Term (in years) |
|---|---|---|---|---|
| Awards outstanding as of January 1, 2025 | 98,393 | 1.50 | 5,180 | 6.73 |
| Awards exercised for the nine months ended September 30, 2025 | (93,347) | 1.30 | n/a | n/a |
| Awards forfeited for the nine months ended September 30, 2025 | (5,046) | 5.25 | n/a | n/a |
| Awards outstanding as of September 30, 2025 | — | — | — | — |
| Awards exercisable as of September 30, 2025 | — | — | — | — |
MoonLake Immunotherapeutics 2022 Equity Incentive Plan
On April 5, 2022 (the “Effective Date”), the Company created the Equity Incentive Plan to promote and closely align the interests of employees, officers, non-employee directors and other service providers of MoonLake Immunotherapeutics and its shareholders by providing share-based compensation and other performance-based compensation.
The Equity Incentive Plan provides for the grant of options, stock appreciation rights, restricted stock units, restricted stock and other share-based awards and for incentive bonuses, which may be paid in cash, Common Shares or a combination thereof, as determined by the compensation committee of the board of directors or such other committee as designated by the board of directors to administer the Equity Incentive Plan. The Equity Incentive Plan shall remain available for the grant of awards until the 10 th anniversary of the Effective Date.
| Equity Incentive Plan (Options) | Number of Options | Weighted-Average Exercise Price | Aggregate Intrinsic Value (in thousands) | Weighted-Average Remaining Contractual Term (in years) |
|---|---|---|---|---|
| Awards outstanding as of January 1, 2025 | 972,476 | $24.94 | $28,588 | 8.18 |
| Awards granted for the nine months ended September 30, 2025 | 563,332 | $43.19 | n/a | n/a |
| Awards exercised for the nine months ended September 30, 2025 | (27,149) | $17.68 | n/a | n/a |
| Awards forfeited for the nine months ended September 30, 2025 | (67,919) | $47.55 | n/a | n/a |
| Awards outstanding as of September 30, 2025 | 1,440,740 | $31.15 | $1,603 | 8.15 |
| Awards exercisable as of September 30, 2025 | 566,602 | $17.42 | $1,168 | 6.85 |
The aggregate intrinsic value represents the difference between the exercise price and the selling price received by option holders upon the exercise of stock options during the period.
The total intrinsic value of options exercised was $0.9 million and $0.7 million for the three months ended September 30, 2025 and 2024, respectively.
As of September 30, 2025, the Company had $19.8 million of total unrecognized compensation expense related to options under the Equity Incentive Plan that will be recognized over the weighted average period of 2.94 years.
| Weighted average assumptions for the awards issued during the nine months ended September 30, 2025 | |
|---|---|
| Estimated fair value of the option on the grant date using Black-Scholes model ($) | 29.65 |
| Exercise price ($) | 43.19 |
| Expected term of the award on the grant date (years) (1) | 6 |
| Expected volatility of the share price (2) | 75% |
| Risk-free interest rate (3) | 4.4% |
| Expected dividend rate | —% |
| (1) The expected term represents the period that share-based awards are expected to be outstanding.(2) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company’s industry.(3) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected term. | |
| Weighted average assumptions for the awards issued during the nine months ended September 30, 2024 | |
|---|---|
| Estimated fair value of the option on the grant date using Black-Scholes model ($) | 31.31 |
| Exercise price ($) | 45.63 |
| Expected term of the award on the grant date (years) (1) | 6 |
| Expected volatility of the share price (2) | 75% |
| Risk-free interest rate (3) | 4.3% |
| Expected dividend rate | —% |
| (1) The expected term represents the period that share-based awards are expected to be outstanding.(2) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company’s industry.(3) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected term. | |
| Equity Incentive Plan (Restricted Stock Awards) | Number of Shares | Weighted-Average Grant Date Fair Value |
|---|---|---|
| Awards unvested as of January 1, 2025 | — | $— |
| Awards granted for the nine months ended September 30, 2025 | 191,526 | 41.77 |
| Awards unvested as of September 30, 2025 | 191,526 | $41.77 |
| Weighted average assumptions for the awards issued during the nine months ended September 30, 2025 | |
|---|---|
| Estimated fair value of Common Shares on the grant date ($) | 41.77 |
As of September 30, 2025, the Company had $6.8 million of total unrecognized compensation expense related to restricted stock awards under the Equity Incentive Plan that will be recognized over the weighted average period of 3.42 years.
Note 15 —Income Taxes
The Company's effective tax rate (“ETR”) was (0.2)% and (0.2)% for the three and nine months ended September 30, 2025, respectively, and (0.3)% and (0.3)% for the three and nine months ended September 30, 2024, respectively. The Company is not aware of any items that would cause the quarterly ETR to be significantly different from the Company's annual ETR. The difference between the income tax provision that would be derived by applying the statutory rate to the Company's loss before income taxes and the income tax provision recorded was primarily attributable to the change in the valuation allowance. The Company continues to incur losses for the entities domiciled in the Cayman Island and Switzerland, and its ability to utilize the deferred tax asset related to the tax losses is not considered more likely than not. A full valuation allowance has been recorded against the deferred tax asset.
Note 16 —Commitments and Contingencies
Commitments
The Company has entered into agreements as of September 30, 2025 primarily in regards to the clinical and non-clinical development services with contract research organizations ("CROs"), as well as supply and logistics services with contract manufacturing organizations ("CMOs"), for the advancement of SLK. As of September 30, 2025, the total committed expense under these agreements amounted to $191.0 million.
The Company's In-License Agreement with MHKDG includes contractual milestone payments related to the achievement of pre-specified research, development, regulatory and commercialization events and indemnification provisions, which are common in such agreements. Pursuant to the agreements, the Company is obligated to make research and development and regulatory milestone payments upon the occurrence of certain events. Subject to the terms of the license, additional milestone payments of up to €299.6 million ($351.8 million using a September 30, 2025 exchange rate) are potentially payable upon satisfying specific milestones related to regulatory filing acceptance, first commercial sales, and aggregate annual net sales. The milestone payments are payable in cash. Milestone payments due prior to obtaining regulatory approval will be recorded as research and development expense upon determination that a milestone payment is probable to occur. Milestone payments due after obtaining regulatory approval will be capitalized when and if incurred. The Company will use commercially reasonable efforts to cause the milestones to occur. However, if the Company reasonably determines that a technical failure or commercial failure has occurred with respect to all or a part of the SLK Program, the Company, at its sole discretion, can terminate all or part of the SLK Program. As of September 30, 2025, the Company made a total of €7.5 million ($8.1 million using the then applicable exchange rate) in additional milestone payments.
In addition, on May 12, 2023, MoonLake AG entered into an agreement with Research Cooperation Technologies, Inc. (“RCT”) and MHKDG, effective as of June 1, 2023, pursuant to which the Company was granted a royalty-bearing, nonexclusive, sublicensable right and license under RCT’s patents and know-how related to a manufacturing process using an underlying yeast strain, Pichia pastoris, to develop, manufacture, use, sell, offer for sale, and import and otherwise commercialize SLK on a world-wide basis, subject to certain restrictions. This agreement replaces the Company’s sublicense for similar rights under the In-License Agreement. In the aggregate, the Company is required to pay royalties within the range of low to mid-teen percent of net sales under the aforementioned agreements with MHKDG and RCT.
Royalties will be recognized as cost of sales in the condensed consolidated statements of operations and comprehensive loss when net sales are recognized.
Note 17 -Segment Information
The Company operates as a single operating segment, focusing exclusively on the research, development, and eventual commercialization of its product. As the entire Company is centered around these activities, all consolidated parts of the Company are reviewed and analyzed as part ofone segment.
As of September 30, 2025, the Company's single operating segment had not generated revenue from any programs or services. The accounting policies of the segment are the same as those described in the Note 2 — Basis of Presentation and Significant Accounting Policies section. The measure of segment assets is reported on the condensed consolidated balance sheets as total assets. The measure of segment profit or loss is reported on the condensed consolidated statement of operations and comprehensive loss as net loss. The CODM uses this as a starting point alongside significant non-cash items and working capital changes to evaluate cash burn and determine financial sustainability, cost management patterns and overall business viability as the clinical trials progress. The CODM also uses this to manage operations and ensure the most efficient use of Company resources against current budgets, alignment with strategic goals and preparation of future forecasts.
Significant Segment Expenses
The measure of significant segment expenses is reported in the accompanying condensed consolidated statements of operations and comprehensive loss as “Research and development” and “General and administrative” for the nine months ended September 30, 2025 and 2024, respectively.
Non-cash share-based compensation is reported in Note 14 —Share-Based Compensation for the nine months ended September 30, 2025 and 2024, respectively. Non-cash depreciation and amortization for the nine months ended September 30, 2025 and 2024 was $1.9 million and $1.0 million, respectively.
Geographical Data
Long-lived assets, consisting of property and equipment, net, and operating lease right-of-use assets by geographical area as of September 30, 2025 and December 31, 2024 are as follows:
| (in thousands) | ||
|---|---|---|
| Country | September 30, 2025 | December 31, 2024 |
| Switzerland | $395 | $610 |
| United Kingdom | 1,051 | 1,777 |
| Portugal | 1,086 | 1,257 |
| Total | $2,532 | $3,644 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.