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MoonLake Immunotherapeutics

For the period ended Dec 31, 2024. Filed Feb 26, 2025.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Feb 26, 2025

MLTX$12.62+9.5%Stored close · as of Nov 9, 2026

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Contents

Notes to Consolidated Financial Statements

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), together with its subsidiaries.

Note 2 —Business Combination Agreement with Helix and Recapitalization

On April 5, 2022 (the “Closing Date”), MoonLake Immunotherapeutics, a Cayman Islands exempted company (formerly known as Helix Acquisition Corp.) (prior to the Closing Date, “Helix” and after the Closing Date, “MoonLake” or the “Company”) consummated the previously announced business combination (the “Closing”) pursuant to that certain Business Combination Agreement dated October 4, 2021 (the “Business Combination Agreement”), by and among Helix, 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”), the existing equityholders of MoonLake AG set forth on the signature pages to the Business Combination Agreement and the equityholders of MoonLake AG that executed joinders to the Business Combination Agreement (collectively, the “ML Parties”), Helix Holdings LLC, a Cayman Islands limited liability company and the sponsor of Helix (the “Sponsor”), and the representative of the ML Parties (such transactions contemplated by the Business Combination Agreement collectively, the “Business Combination”). Net proceeds from the Business Combination totaled $134.7 million, which included funds held in Helix’s trust account and the completion of a concurrent PIPE investment.

Pursuant to the Business Combination Agreement, approved by the boards of directors of each of MoonLake AG and Helix, (i) the Company changed its name from Helix Acquisition Corp. to MoonLake Immunotherapeutics, and (ii) MoonLake AG merged with and into MoonLake, with MoonLake AG as the surviving company in the Business Combination and, after giving effect to such Business Combination, MoonLake AG as a subsidiary of MoonLake.

The Business Combination Agreement provided for, among other things, the following transactions:

i. Two business days prior to the Closing Date, the ML Parties and MoonLake AG effectuated a restructuring of MoonLake AG’s share capital to, among other things, (x) convert the Series A preferred shares of MoonLake AG, par value of CHF 0.10 per share, into an equal number of MoonLake AG Common Shares such that the ML Parties held a single class of capital share of MoonLake AG immediately prior to the Closing and (y) approve a capital increase for the issuance of 4,006,736 Class V Voting Shares of MoonLake AG, par value CHF 0.01 per share, to Helix, each Class V Voting Share due to its lower par value havingten times the voting power of a MoonLake AG Common Share (the “Restructuring”).

ii. At the Closing,2,875,000 Class B ordinary shares of Helix, par value $0.0001 per share (the “Class B Ordinary Shares”), constituting all of the then-outstanding Class B Ordinary Shares, were automatically converted into Class A Ordinary Shares on aone-for-one basis.

iii. At the Closing, Helix amended and restated its existing memorandum and articles of association to, among other things, establish a share structure consisting of the Class A Ordinary Shares, which carry economic and voting rights, and Class C Ordinary Shares, which carry voting rights but no economic rights.

iv. On the Closing Date, Helix paid all unpaid transaction expenses and contributed $134.7 million to MoonLake AG, including $15.0 million loan repayment pursuant to a convertible loan agreement dated March 20, 2022, by and between MoonLake AG and Cormorant Asset Management LP (“Cormorant”), and assigned by Cormorant to Helix on March 31, 2022.

v. On the Closing Date, following the Restructuring, Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., and Biotechnology Value Trading Fund OS, L.P. (collectively, the “BVF Shareholders”) assigned all of their MoonLake AG Common Shares to Helix and Helix issued to the BVF Shareholders 18,501,284 Class A Ordinary Shares.

vi. On the Closing Date, following the Restructuring, Helix issued 15,775,472 Class C Ordinary Shares to the ML Parties (other than the BVF Shareholders). Please refer to Note 12 — Shareholders’ Equity for additional details on the exchange mechanism adopted.

Additionally, on the Closing Date, Helix issued to the PIPE Investors (as defined below in the section entitled “PIPE Financing”) an aggregate of 11,700,000 Class A Ordinary Shares.

As of the open of trading on April 6, 2022, the Class A Ordinary Shares, formerly those of Helix, began trading on The Nasdaq Capital Market (“Nasdaq”) under the trading symbol “MLTX”.

PIPE Financing

On October 4, 2021, concurrently with the execution of the Business Combination Agreement, and subsequently on March 31, 2022 and April 4, 2022, Helix entered into subscription agreements with certain investors (collectively, the “PIPE Investors”, which includes affiliates of the Sponsor and certain existing equityholders of MoonLake AG) pursuant to which, and on the terms and subject to the conditions of which, the PIPE Investors have collectively subscribed for 11,700,000 Class A Ordinary Shares,11,600,000 shares of which were issued at a price of $10.00 per share for gross proceeds of $116.0 million and 100,000 shares of which were issued to placement agents of the PIPE in satisfaction of an aggregate of $1.0 million of fees owed by Helix to such placement agents.

Summary of Net Proceeds

The following table summarizes the elements of the net proceeds from the Business Combination:

in thousands
Investments held in Trust Account$115,051
Less cash to cover redemptions of the Class A Ordinary Shares issued by Helix prior to the Closing Date(80,842)
Plus PIPE investment116,000
Less Helix transaction expense(15,520)
of which accrued expenses(5,798)
of which deferred IPO underwriting fee(4,025)
of which other transaction expenses(5,697)
Available Closing Date Cash$134,689

Summary of Ordinary Shares Issued

The following table summarizes the number of Ordinary Shares outstanding immediately following the consummation of the Business Combination:

Helix Acquisition Corp. Ordinary Shares prior to the Business Combination14,805,000
Of which Class A Ordinary Shares (Helix management - IPO private placement shares)430,000
Of which Class A Ordinary Shares redeemable11,500,000
Of which Class B Ordinary Shares (Helix management - sponsor promote)2,875,000
Less redemptions of the Class A Ordinary Shares issued by Helix prior to the Closing Date(8,080,645)
Plus issuance of Helix Class A Ordinary Shares to PIPE Investors11,700,000
Plus issuance of Helix Class A Ordinary Shares to BVF Shareholders18,501,284
Total MoonLake Class A Ordinary Shares Outstanding at Closing36,925,639
Plus issuance of Helix Class C Ordinary Shares to ML Parties (other than the BVF Shareholders)15,775,472
Total MoonLake Class A and Class C Ordinary Shares Outstanding at Closing52,701,111

Further information about the Business Combination can be found on Form S-1/A filed with the SEC on July 26, 2022, declared effective on August 2, 2022 and to the exhibits included therein, available at www.sec.gov.

Note 3 —Basis of Presentation and Significant Accounting Policies

Basis of Presentation

The accompanying consolidated financial statements include those of the Company and its subsidiaries, MoonLake AG, MoonLake Immunotherapeutics Ltd., a private limited company incorporated in the United Kingdom, and MNLK Immunotherapeutics, Unipessoal Lda (“MNLK PT”), a private limited company incorporated in Portugal, after elimination of all intercompany accounts and transactions. The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). 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 Financial Accounting Standards Board (“FASB”).

Pursuant to ASC 805, for financial accounting and reporting purposes, MoonLake AG was deemed the accounting acquirer and Helix was treated as the accounting acquiree, and the Business Combination was accounted for as a reverse recapitalization. Accordingly, the Business Combination was treated as the equivalent of MoonLake AG issuing shares for the net assets of Helix, accompanied by a recapitalization. The net assets of Helix were stated at historical costs, with no goodwill or other intangible assets recorded, and are consolidated with MoonLake AG’s financial statements on the Closing Date.

In accordance with the Business Combination Agreement, the ML Parties received 33.638698 Ordinary Shares in the Company for every MoonLake AG Common Share or Series A Preferred Share (the “Exchange Ratio”). The BVF Shareholders received 18,501,284 Class A Ordinary Shares whereas the rest of the ML Parties (excluding the BVF Shareholders) received 15,775,472 Class C Ordinary Shares which can be converted into Class A Ordinary Shares at the discretion of the shareholder (refer to Note 12 — Shareholders’ Equity for further details on the classes of ordinary shares). The number of shares, and the number of shares within the net loss per share held by the ML Parties in MoonLake AG prior to the Business Combination have been adjusted by the Exchange Ratio to reflect the equivalent number of ordinary shares in the Company (identified as “the equivalent of” throughout these consolidated financial statements).

Certain MoonLake AG shareholders (ML Parties other than the BVF Shareholders) did not exchange their shares in MoonLake AG for Class A Ordinary Shares in the Company and therefore continued to hold an economic interest in MoonLake AG and Class C Ordinary Shares in the Company. The Company recognized a noncontrolling interest equal to the ML Parties’ (other than the BVF Shareholders) proportionate interest in the net assets of MoonLake AG.

All amounts are presented in U.S. Dollar (“$”), 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. Items of significance for 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 operation may be affected.

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. As of December 31, 2024, the Company considers $59.7 million of short-term marketable debt securities in the form of eurocommercial papers and certificates of deposit to be cash equivalents. As of December 31, 2023, the Company considered $129.4 million of short-term marketable debt securities in the form of eurocommercial papers and certificates of deposit to be cash equivalents.

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 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 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 100,000 deposit protection limit in Switzerland, the $250,000 Federal Deposit Insurance Corporation deposit insurance coverage limit in the United States, the GBP 85,000 Financial Services Compensation Scheme deposit protection limit in the United Kingdom, or the €100,000 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

The Company follows the guidance included in ASC 820, Fair Value Measurement. 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.

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.

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 December 31, 2024, property and equipment, net relates to information technology, office equipment, and leasehold improvements.

Impairment of Long-Lived Assets

The Company reviews all long-lived assets, 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, which could adversely affect its results of operations. There wasno impairment of long-lived assets for the years ended December 31, 2024, 2023, and 2022.

Research and Development Contract Costs and Accruals

Research and development expenses include employee payroll, consulting, contract research and contract manufacturing costs attributable to research and development activities and 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.

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 judgements 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) has historically been 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 consolidated statements of operations and comprehensive loss in "other income, net". The Company recognized foreign currency transaction loss of $42,186 for the year ended December 31, 2024, a foreign currency transaction gain of $151,493 for the year ended December 31, 2023, and a foreign currency transaction gain of $325,317 for the year ended December 31, 2022.

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 in accordance with ASC 715, Compensation – Retirement Benefits, which requires the recognition of the funded status of pension plans in the Company’s consolidated balance sheet. 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 December 31, 2024 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 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.

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 December 31, 2024, 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 Azedevo 860, 4150-335, Porto, Portugal (comprised oftwo leases). The operating leases are recognized over 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 and that do not have the option to purchase the underlying asset are not recorded on the consolidated 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.

Recently Adopted Accounting Pronouncements

In November 2023, the FASB issued ASU 2023-07, Segment reporting — Improvements to Reportable Segment Disclosures, which amends guidance on reportable segment disclosure requirements. It is effective for fiscal years beginning after December 15, 2023. The Company adopted ASU No. 2023-07 during the year ended December 31, 2024. See Note 17 —Segment Information and Geographic Datafor further detail.

Recently Issued Accounting Pronouncements Not Yet Adopted

In December 2023, the FASB issued ASU 2023-09, Income taxes -Improvements to Income Taxes Disclosure, 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, 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. In January 2025, the FASB issued ASU 2025-01 to clarify that all public entities, including non-calendar year-end entities, should adopt the disclosure requirements of ASU 2024-03. The Company is currently evaluating the impact.

Prior Period Reclassifications

The amortization expense in the consolidated statements of cash flows in prior periods has been reclassified to conform with the current period presentation. The amortization expense 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 4— 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 three 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 and efforts to achieve regulatory approval.

The Company incurred a loss of $121.2 million for the year ended December 31, 2024. As of December 31, 2024, the Company’s current assets exceeded its current liabilities by $451.8 million.

As of December 31, 2024, the Company had $180.4 million of cash and cash equivalents. Based on the Company's current operating plan, management believes that the Company has sufficient capital to fund its operations and capital expenditures until the end of 2026.

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:

December 31, 2024December 31, 2023
Level 2TotalLevel 2Total
Eurocommercial Papers$207,701,100$207,701,100$109,608,915$109,608,915
Certificates of Deposit119,582,400119,582,40079,626,72779,626,727
Total$327,283,500$327,283,500$189,235,642$189,235,642

Cash and accounts payable approximate their fair values as of December 31, 2024 and 2023, due to their short-term nature. Pension plan assets fair value is determined based on Level 2 inputs.

Note 6— Investments

The fair value and amortized cost of investments in short-term marketable debt securities by major security type as of December 31, 2024 and 2023 are as follows:

Amortized costGross unrealized gainsGross unrealized lossesFair value
Eurocommercial Papers$204,571,819$3,129,280$—$207,701,099
Certificates of Deposit117,304,6062,277,794—119,582,400
Total$321,876,425$5,407,074$—$327,283,499
Of which classified within cash and cash equivalents59,310,976371,623—59,682,599
Of which classified within short-term marketable debt securities262,565,4495,035,451—267,600,900
Amortized costGross unrealized gainsGross unrealized lossesFair value
Eurocommercial Papers$107,624,341$1,984,574$—$109,608,915
Certificates of Deposit78,890,447736,280—79,626,727
Total$186,514,788$2,720,854$—$189,235,642
Of which classified within cash and cash equivalents128,197,5811,199,161—129,396,742
Of which classified within short-term marketable debt securities58,317,2071,521,693—59,838,900

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 accumulated other comprehensive income as of December 31, 2024 and 2023:

Beginning balance, January 1, 2024$2,720,854
Other comprehensive income before reclassifications16,433,112
Amounts reclassified from accumulated other comprehensive income(13,746,892)
Ending balance, December 31, 2024$5,407,074
Beginning balance, January 1, 2023$390,753
Other comprehensive income before reclassifications8,751,307
Amounts reclassified from accumulated other comprehensive income(6,421,206)
Ending balance, December 31, 2023$2,720,854

As of December 31, 2024, the Company’s marketable debt securities maturities are all due within one year.

Note 7 —Prepaid Expenses

Prepaid expenses - currentDecember 31, 2024December 31, 2023
Non-clinical research and clinical development services$14,136,396$842,729
Supply and manufacturing services7,715,6211,205
Insurance1,112,7581,077,478
Other prepayments453,523180,791
Total$23,418,298$2,102,203
Prepaid expenses - non-currentDecember 31, 2024December 31, 2023
Supply and manufacturing services$—$8,423,468
Total$—$8,423,468

Supply and manufacturing services, current and non-current, primarily relate to advance payments made to a contract manufacturing organization pursuant to a manufacturing run reservation agreement for the commercial-scale manufacturing of SLK in 2025.

Note 8 —Trade and Other Payables

December 31, 2024December 31, 2023
Research and development services$5,081,306$911,454
Supply and manufacturing fees payable3,597,102553,459
Legal advisory services92,59147,095
Other payables221,480325,676
Total$8,992,479$1,837,684

Note 9 —Accrued Expenses and Other Current Liabilities

December 31, 2024December 31, 2023
Supply and manufacturing services$4,474,060$1,603,739
Bonuses and related employees compensation expenses4,237,0292,780,219
Research and development services and license fees2,022,0111,226,281
Tax liabilities642,114367,976
Consultant and other fees585,786853,905
Legal fees138,42098,000
Total$12,099,420$6,930,120

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. The Company estimated the effective duration of the lease at inception and determined a period of 3 years, with expected expiration in November 2024. 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 Azedevo 860, 4150-335, Porto, Portugal. This lease has a 3-year initial term, withtwo extendable periods of 3 years each. It is expected to be extended once until 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 Azevodo 860, 4150-335, Porto, Portugal. This lease has a 2-year initial term, withtwo extendable periods of 3 years each. The Company currently expects that it will be extended until October 2029.

The weighted average remaining lease term and weighted average discount rate for the operating leases as of December 31, 2024 and 2023 were as follows:

December 31, 2024December 31, 2023
Weighted average remaining lease term (in months)2939
Weighted average discount rate4.7%4.9%

The future minimum annual lease payments under these operating leases as of December 31, 2024 are as follows:

Year ending December 31,Amount
2025$1,468,313
20261,160,459
2027130,395
2028130,395
202988,867
Thereafter—
Total lease payments2,978,429
Less imputed interest(148,869)
Total lease liability2,829,560
Less current portion of lease liability(1,371,962)
Long-term portion operating lease liability$1,457,598

Operating cash outflows for amounts included in the measurement of lease liabilities was $1,474,865, $422,250 and $150,650 for the years ended December 31, 2024, 2023 and 2022, respectively.

The Company recorded the following lease and variable lease expenses:

Year Ended December 31, 2024Year Ended December 31, 2023Year ended December 31, 2022
Operating lease expense$1,424,265$399,882$155,552
Variable lease expense116,021——
Total lease expense$1,440,286$399,882$155,552

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 December 31, 2024, the Plan covers the Company’s employees in Switzerland with benefits in the event of death, disability, retirement, or termination of employment.

A summary of the changes in projected benefit obligations (“PBO”) and plan assets is presented below:

Year Ended December 31, 2024Year Ended December 31, 2023Year ended December 31, 2022
Beginning PBO$2,494,481$1,321,969$1,322,874
Service cost280,627122,698451,075
Interest cost33,09730,6395,056
Contributions by plan participants259,937200,424138,243
Actuarial (gain) / losses41,260487,991(374,317)
Benefits paid10,917229,902(204,695)
Foreign currency exchange rates changes(199,065)208,608(16,267)
Plan amendment—(107,750)—
Ending PBO$2,921,254$2,494,481$1,321,969
Year Ended December 31, 2024Year Ended December 31, 2023Year ended December 31, 2022
Beginning fair value of plan assets$1,911,056$1,039,763$1,083,014
Expected return on plan assets60,53036,52315,522
Return on plan assets above / (below) expected return(47,492)48,938(115,877)
Contributions by the employer259,937200,424138,243
Contributions by plan participants259,937200,424138,243
Benefits paid10,917229,902(204,695)
Foreign currency exchange rates changes(154,315)155,082(14,687)
Ending fair value of plan assets$2,300,570$1,911,056$1,039,763

1 Variable lease expense resulting from increased lease payments linked to changes in the reference index.

Amounts recorded on the consolidated balance sheets:

December 31, 2024December 31, 2023
Fair value of plan assets$2,300,570$1,911,056
Present value of projected benefit obligation(2,921,254)(2,494,481)
Funded status$(620,684)$(583,425)

Amounts recorded in accumulated other comprehensive income:

Year Ended December 31, 2024Year Ended December 31, 2023Year ended December 31, 2022
Actuarial (gain) / loss beginning of year$234,863$(101,716)$168,177
Actuarial (gain) / loss of current year87,384444,329(268,076)
Amortization(10,284)—(1,817)
Prior service (cost) / credit recognized in current year10,178(107,750)—
Total$322,141$234,863$(101,716)

The assumptions used to calculate the ASC 715 liabilities are summarized in the table below:

December 31, 2024 · December 31, 2023
Discount rate1.00%p.a.1.35%p.a.
Expected return on plan assets2.70%p.a.3.00%p.a.
Inflation1.00%p.a.1.80%p.a.
Long-term expected rate of salary increase1.50%p.a.2.30%p.a.

Service cost of $280,627, $122,698, and $451,075 was recognized in the net periodic benefit cost for the years ended December 31, 2024, 2023, and 2022, respectively.

The allocation of plan assets is presented below:

December 31, 2024December 31, 2023
Equities34.00%34.00%
Bonds32.00%32.00%
Mortgages4.00%4.00%
Liquidity1.00%1.00%
Real estate26.00%26.00%
Alternative investments3.00%3.00%

The fair value of plan assets is determined based on Level 2 inputs. As all members of the Plan are active, no future expected benefit payments are currently being made and are not foreseen to occur within the next ten years. For fiscal year 2025, the Company presently anticipates contributing an estimated amount of $259,937 to fund the Plan.

Note 12 —Shareholders’ Equity

MoonLake AG Series A Preferred Shares(1) · MoonLake AG Common Shares(1) · MoonLake AG Common Shares Held In Treasury(2) · Class A Ordinary Shares(3) · Class C Ordinary Shares(3) · Total Number of Shares
AuthorizedIssuedAuthorizedIssuedIssuedAuthorizedIssuedAuthorizedIssuedAuthorizedIssued and Outstanding
Balance at January 1, 202222,880,90822,880,90813,119,09212,161,331(1,942,837)————36,000,00033,099,402
Share-based payment under the ESPP————1,177,354—————1,177,354
Issuance of Class A Ordinary Shares upon Business Combination—————500,000,00018,424,355100,000,000—600,000,00018,424,355
Conversion of MoonLake AG shares into Class A Ordinary Shares and Class C Ordinary Shares following the Business Combination(22,880,908)(22,880,908)(13,119,092)(12,161,331)765,483—18,501,284—15,775,472(36,000,000)—
Conversion of Class C Ordinary Shares into Class A Ordinary Shares——————2,051,961—(2,051,961)——
Balance at December 31, 2022—————500,000,00038,977,600100,000,00013,723,511600,000,00052,701,111
Issuance of Class A Ordinary Shares——————10,270,818———10,270,818
Conversion of Class C Ordinary Shares into Class A Ordinary Shares——————11,218,035—(11,218,035)——
Balance at December 31, 2023—————500,000,00060,466,453100,000,0002,505,476600,000,00062,971,929
Conversion of Class C Ordinary Shares into Class A Ordinary Shares——————1,647,354—(1,647,354)——
Issuance of Class A Ordinary Shares under the ATM facility——————914,828———914,828
Cancellation of Class C shares following an employee contract termination in MoonLake AG————————(16,853)—(16,853)
Options exercised under the Equity Incentive Plan——————48,796———48,796
Balance at December 31, 2024—————500,000,00063,077,431100,000,000841,269600,000,00063,918,700

(1)Fully paid-in registered shares in MoonLake AG with a par value of CHF 0.10, share amounts after applying the exchange ratio

(2)Registered shares in MoonLake AG with a par value of CHF 0.10 held in treasury, share amounts after applying the exchange ratio

(3)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 December 31, 2024, there were 63,077,431 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 for each share.

Class C Ordinary Shares

As of December 31, 2024, there were 841,269 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 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. During the year ended December 31, 2022, pursuant to the A&R Shareholders’ Agreement,61,000 MoonLake AG Common Shares and 2,051,961 Class C Ordinary Shares were converted into 2,051,961 Class A Ordinary Shares. During the year ended December 31, 2023, pursuant to the A&R Shareholders’ Agreement,333,486 MoonLake AG Common Shares and 11,218,035 Class C Ordinary Shares were converted into 11,218,035 Class A Ordinary Shares. During the year ended December 31, 2024, pursuant to the A&R Shareholders’ Agreement,48,972 MoonLake AG Common Shares and 1,647,354 Class C Ordinary Shares were converted into 1,647,354 Class A Ordinary Shares. 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 December 31, 2024, there was $265.0 million remaining for future sales under the August 2023 ATM Sales Agreement.

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

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 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.

Options Exercised under the Equity Incentive Plan

In the year ended December 31, 2024, certain participants exercised their stock options under the Equity Incentive Plan (as defined below) for an aggregate of 48,796 Class A Ordinary Shares and total cash consideration of $242,004.

There wereno options exercised in the years ended December 31, 2023 and 2022.

Note 13 —Net Loss per Share

As a result of the Business Combination, the Company has retroactively restated the weighted average number of outstanding shares prior to April 5, 2022 to give effect to the Exchange Ratio.

The following table sets forth the net loss per share calculations for the years ended December 31, 2024, 2023, and 2022:

Year Ended December 31, 2024Year Ended December 31, 2023Year Ended December 31, 2022
Numerator
Net loss attributable to controlling interests shareholders$(118,935,517)$(36,007,260)$(49,973,249)
Denominator
Total weighted average number of outstanding shares62,870,23749,122,53429,361,353
Net loss per share – basic and diluted$(1.89)$(0.73)$(1.70)

There were 972,476,312,400, and 180,000 common stock equivalents outstanding in the form of stock options under the Equity Incentive Plan as of December 31, 2024, 2023, and 2022, 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 63,835,002 for the year ended December 31, 2024, resulting in a net loss per share – basic and diluted of $1.90. Upon conversion, all 841,269 Class C Ordinary Shares would be forfeited and there would no longer be any non-controlling interests.

Note 14 —Share-Based Compensation

As of December 31, 2024, 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 consolidated financial statements if the conversion had not occurred.

As a result of this administrative conversion, thetwo main plans which remain active as of December 31, 2024 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 years ended December 31, 2024, 2023, and 2022, the Company has recognized an increase in equity in the consolidated balance sheets and share-based compensation expense in the consolidated statements of operations and comprehensive loss of $7.3 million, $7.1 million, and $9.7 million, respectively. The share-based compensation expense was driven by the aforementionedtwo main active share-based compensation plans and programs:

Compensation PlanYear Ended December 31, 2024Year Ended December 31, 2023Year Ended December 31, 2022
MoonLake AG Restricted Founder Shares$—$1,574,300$4,840,608
ESPP2,932,7113,352,8853,910,076
ESOP—973,868539,713
MoonLake Immunotherapeutics 2022 Equity Incentive Plan4,348,8851,204,952364,381
Total share-based compensation expense$7,281,596$7,106,005$9,654,778
Of which: included in research and development expense1,971,0031,524,715954,379
Of which: included in general and administrative expense5,310,5935,581,2908,700,399

We expect that all future employee awards will be made under the Equity Incentive Plan. As of December 31, 2024,3,234,283 Class A Ordinary Shares from the authorized pool of 4,353,948 Class A Ordinary Shares remain available for future grants, and 972,476 and 98,393 Class A Ordinary Shares are reserved for issuance upon exercise of stock options granted under the Equity Incentive Plan and ESOP, respectively. The latter relate to awards not yet subjected to the conversion described above.

MoonLake AG - Restricted Founder Shares

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 a 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) 2021-2025 - 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.

Weighted average assumptions for the awards issued during the year ended December 31, 2022
Estimated fair value per share of Common Shares on the grant date ($) (1)336.39
Purchase price (CHF)0.10
(1) MoonLake AG estimated the fair value of the Common Shares by dividing the Company Enterprise Value ($360,000,000) as defined by the Business Combination Agreement by the Company’s fully diluted shares (1,070,196).
ESPPNumber of SharesWeighted-Average Grant Date Fair Value
Awards unvested as of January 1, 2024630,490$10.00
Awards forfeited for the twelve months ended December 31, 2024(16,853)10.00
Awards vested for the twelve months ended December 31, 2024(293,868)10.00
Awards unvested as of December 31, 2024319,769$10.00

As of December 31, 2024, MoonLake AG had $3.1 million of total unrecognized compensation expense related to the ESPP that will be recognized over the weighted average period of 1.05 years.

Employee Stock Option Plan (ESOP) 2021-2025 - MoonLake AG

The ESOP grants will vest 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 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.

ESOPNumber of OptionsWeighted-Average Exercise PriceAggregate Intrinsic Value (in thousands)Weighted-Average Remaining Contractual Term (in years)
Awards outstanding as of January 1, 2024585,078$10.04$29,4568.41
Awards converted from ESOP to Equity Incentive Plan for the year ended December 31, 2024(486,685)11.77
Awards outstanding as of December 31, 202498,393$1.50$5,1806.73
Awards exercisable as of December 31, 202498,393$1.50$5,1806.73
Weighted average assumptions for the awards issued during the year ended December 31, 2023(4)
Estimated fair value of the option on the grant date using Black-Scholes model ($)25.53
Exercise price ($)37.11
Expected term of the award on the grant date (years) (1)6
Expected volatility of the share price (2)75%
Risk-free interest rate (3)4%
Expected dividend rate—%
(1) The expected term represents the period that share-based awards are expected to be outstanding.(2) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company’s industry.(3) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected term.(4) The issued awards include awards that were converted from the ESOP to the EIP as of January 1, 2024.
Weighted average assumptions for the awards issued during the year ended December 31, 2022(4)
Estimated fair value of the option on the grant date using Black-Scholes model ($)4.21
Exercise price ($)3.64
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)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.(4) The issued awards include awards that were converted from the ESOP to the EIP as of January 1, 2024.

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 10th anniversary of the Effective Date.

EIPNumber of OptionsWeighted-Average Exercise PriceAggregate Intrinsic Value (in thousands)Weighted-Average Remaining Contractual Term (in years)
Awards outstanding as of January 1, 2024312,400$22.83$11,7338.87
Awards granted for the year ended December 31, 2024293,79946.36
Awards converted from ESOP to Equity Incentive Plan for the year ended December 31, 2024486,68511.77
Awards exercised for the year ended December 31, 2024(48,796)4.962,263
Awards forfeited for the year ended December 31, 2024(71,612)27.68
Awards outstanding as of December 31, 2024972,476$24.94$28,5888.18
Awards exercisable as of December 31, 2024385,654$13.39$18,1727.52

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 $2.3 million for the year ended December 31, 2024. No options were exercised for the years ended December 31, 2023 and 2022.

Weighted average assumptions for the awards issued during the year ended December 31, 2024(4)
Estimated fair value of the option on the grant date using Black-Scholes model ($)31.82
Exercise price ($)46.36
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.(4) The issued awards exclude awards that were converted from the ESOP to the EIP as of January 1, 2024.
Weighted average assumptions for the awards issued during the year ended December 31, 2023
Estimated fair value of the option on the grant date using Black-Scholes model ($)25.58
Exercise price ($)37.22
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%
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 year ended December 31, 2022
Estimated fair value of the option on the grant date using Black-Scholes model ($)8.25
Exercise price ($)12.25
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)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.

As of December 31, 2024, the Company had $11.1 million of total unrecognized compensation expense related to the Equity Incentive Plan that will be recognized over the weighted average period of 1.82 years.

Note 15 —Income Taxes

The Company's effective tax rate (“ETR”) was -0.2%, -0.3%, and 0.1% for the years ended December 31, 2024, 2023, and 2022, respectively. The Company is not aware of any items that would cause the quarterly or period-to-date 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 non-deductible expense which includes the Swiss entity's recognition of taxable income associated with the sale of treasury shares from MoonLake AG to MoonLake Immunotherapeutics. The Company continues to incur losses for the Cayman Island and Swiss entity and its ability to utilize the deferred tax asset related to the tax losses is not considered more likely than not.

The Company's main operating affiliate, MoonLake AG, is subject to taxation in the Canton of Zug, Switzerland. For the years ended December 31, 2024, 2023, and 2022, the Company did not incur any significant income tax expense or benefit, as the Company incurred tax losses and provided a full valuation allowance.

The components of loss before income tax were as follows:

Year Ended December 31, 2024Year Ended December 31, 2023Year Ended December 31, 2022
Switzerland$(120,417,158)$(43,469,946)$(62,115,251)
Foreign(545,043)(514,783)(2,354,434)
Total$(120,962,201)$(43,984,729)$(64,469,685)

The provision for income taxes differs from the amount computed by applying the statutory income tax rate to loss before income taxes as follows:

Year Ended December 31, 2024Year Ended December 31, 2023Year Ended December 31, 2022
Statutory income tax rate11.8%11.8%11.9%
Effect of income taxed at different rates(0.3)%(0.4)%—%
Change in prior year estimates—%(0.5)%0.1%
Utilization of unrecognized losses—%0.6%—%
Change in valuation allowance(11.3)%0.5%(10.0)%
Non-deductible expense(0.5)%(12.3)%(1.4)%
Other—%—%(0.5)%
Effective income tax rate(0.2)%(0.3)%0.1%

Significant components of the Company’s deferred tax assets (liabilities) were:

December 31, 2024December 31, 2023
Intangible assets$4,491,147$4,493,559
Defined benefit plan73,55169,173
Lease liabilities63,80956,527
Net operating loss carry forward20,372,9896,715,534
Total deferred tax assets25,001,49611,334,793
Operating lease right-of-use assets(69,639)(55,862)
Total deferred tax liabilities(69,639)(55,862)
Total deferred tax assets (net)24,931,85711,278,931
Valuation allowance(24,931,857)(11,278,931)
Total deferred tax (net)$—$—

As of December 31, 2024, the Company’s net deferred tax assets before valuation allowance were $24.9 million. In assessing the realizability of its deferred tax assets, the Company considers whether it is more likely than not that some portion or all of its deferred tax assets will not 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. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based on the weight of all evidence, the Company has determined that it is not more likely than not that the net deferred tax assets will be realized. A valuation allowance of $24.9 million has been recorded against the deferred tax assets.

As of December 31, 2024, MoonLake AG had net operating losses of approximately $171.9 million of which $12.6 million will expire in 2028, $44.0 million will expire in 2029 and $115.3 million will expire in 2031.

The Company’s net operating losses will not be subject to any limitation due to change in ownership according to Swiss Income Tax Law.

The Company has no unrecognized tax benefits and does not expect that uncertain tax benefits will change significantly in the next twelve months.

Note 16 —Commitments and Contingencies

Commitments

The Company has entered into agreements as of December 31, 2024 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 December 31, 2024, the total committed expense under these agreements amounted to $220.9 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 ($311.5 million using a December 31, 2024 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 December 31, 2024, 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 in the 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 December 31, 2024, 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 3 — Basis of Presentation and Significant Accounting Policies section. The measure of segment assets is reported on the consolidated balance sheet as total assets. The measure of segment profit or loss is reported on the consolidated statement of operations 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 consolidated statements of operations as "Research and development" and "General and administrative" for the years ended December 31, 2024, 2023, and 2022.

Non-cash share-based compensation is reported in Note 14 —Share-Based Compensation for the years ended December 31, 2024, 2023, and 2022. Non-cash depreciation and amortization for the years ended December 31, 2024, 2023, and 2022 was $1.4 million, $0.4 million, and $0.2 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 December 31, 2024 and 2023 are as follows:

CountryDecember 31, 2024December 31, 2023
Switzerland$610,743$507,392
United Kingdom1,776,8432,704,555
Portugal1,256,851737,398
Total$3,644,437$3,949,345

Note 18 —Subsequent Events

Share Conversion

In January 2025, pursuant to the A&R Shareholders’ Agreement,3,328 MoonLake AG Common Shares and 111,949 Class C Ordinary Shares were converted into 111,949 Class A Ordinary Shares and 2,775 MoonLake AG Common Shares were converted to 93,347 Class A Ordinary Shares. Please refer to Note 12— Shareholders’ Equity — Class C Ordinary Shares for more information regarding the conversion mechanics.

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