mnlk-20240630

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(MARK ONE)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2024

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number: 001-39630

MOONLAKE IMMUNOTHERAPEUTICS

(Exact Name of Registrant as Specified in Its Charter)


Cayman Islands						98-1711963
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

Dorfstrasse 29
6300 Zug
Switzerland						N/A
(Address of principal executive offices)						(ZIP Code)

41 415108022

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Class A ordinary share, par value $0.0001 per share

MLTX

The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☒ Accelerated filer ☐

Non-accelerated filer ☐ Smaller reporting company ☐

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 1, 2024, there were 62,888,637 Class A Ordinary Shares, $0.0001 par value (the "Class A Ordinary Shares"), and 995,267 Class C Ordinary Shares, $0.0001 par value (the "Class C Ordinary Shares"), issued and outstanding.

MOONLAKE IMMUNOTHERAPEUTICS

FORM 10-Q FOR THE QUARTER ENDED JUNE 30, 2024

TABLE OF CONTENTS


PART I. FINANCIAL INFORMATION			2
Item 1. Financial Statements (Unaudited)			2
Condensed Consolidated Balance Sheets			2
Condensed Consolidated Statements of Operations and Comprehensive Loss			3
Condensed Consolidated Statements of Changes In Equity			4
Condensed Consolidated Statements of Cash Flows			6
Notes to Condensed Consolidated Financial Statements			7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			25
Item 3. Quantitative and Qualitative Disclosures About Market Risk			40
Item 4. Controls and Procedures			40
PART II. OTHER INFORMATION			42
Item 1. Legal Proceedings			42
Item 1A. Risk Factors			42
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			42
Item 3. Defaults Upon Senior Securities			42
Item 4. Mine Safety Disclosures			42
Item 5. Other Information			42
Item 6. Exhibits			43
SIGNATURES			44

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

MOONLAKE IMMUNOTHERAPEUTICS

CONDENSED CONSOLIDATED BALANCE SHEETS

(Amounts in USD, except share data)


	June 30, 2024 (Unaudited)		December 31, 2023
Current assets
Cash and cash equivalents	$	342,791,142	$	451,169,337
Short-term marketable debt securities	177,008,400		59,838,900


Other receivables	1,676,813		1,056,862
Prepaid expenses - current	15,405,526		2,102,203

Total current assets	536,881,881		514,167,302

Non-current assets
Operating lease right-of-use assets	3,384,953		3,628,480
Property and equipment, net	481,705		320,865
Prepaid expenses - non-current	4,129,151		8,423,468




Total non-current assets	7,995,809		12,372,813
Total assets	$	544,877,690	$	526,540,115

Current liabilities
Trade and other payables	$	5,142,853	$	1,837,684
Short-term portion of operating lease liabilities	1,321,727		1,197,876

Accrued expenses and other current liabilities	5,817,384		6,930,120


Total current liabilities	12,281,964		9,965,680

Non-current liabilities
Long-term portion of operating lease liabilities	2,022,280		2,499,990
Pension liability	541,949		583,426

Total non-current liabilities	2,564,229		3,083,416
Total liabilities	14,846,193		13,049,096
Commitments and contingencies (Note 15)

Equity



Class A Ordinary Shares: $0.0001 par value; 500,000,000 shares authorized; 62,874,637 shares issued and outstanding as of June 30, 2024; 60,466,453 shares issued and outstanding as of December 31, 2023	6,287		6,047
Class C Ordinary Shares: $0.0001 par value; 100,000,000 shares authorized; 995,267 shares issued and outstanding as of June 30, 2024; 2,505,476 shares issued and outstanding as of December 31, 2023	100		251
Additional paid-in capital	671,998,583		609,969,236
Accumulated deficit	(154,598,140)		(116,657,472)
Accumulated other comprehensive income	3,256,907		2,357,621
Total shareholders’ equity	520,663,737		495,675,683
Noncontrolling interests	9,367,760		17,815,336
Total equity	530,031,497		513,491,019
Total liabilities and equity	$	544,877,690	$	526,540,115

The accompanying Notes are an integral part of these Unaudited Condensed Consolidated Financial Statements.

MOONLAKE IMMUNOTHERAPEUTICS

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Amounts in USD, except share and per share data)

(Unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
	2024		2023		2024		2023


Operating expenses
Research and development	$	(23,662,147)	$	(8,703,849)	$	(36,676,194)	$	(16,118,949)
General and administrative	(6,916,054)		(4,482,041)		(13,722,500)		(9,998,510)
Total operating expenses	(30,578,201)		(13,185,890)		(50,398,694)		(26,117,459)
Operating loss	(30,578,201)		(13,185,890)		(50,398,694)		(26,117,459)

Other income, net	5,898,148		842,652		11,813,372		1,566,242



Loss before income tax	(24,680,053)		(12,343,238)		(38,585,322)		(24,551,217)

Income tax expense	(78,701)		(10,149)		(148,953)		(21,157)
Net loss	$	(24,758,754)	$	(12,353,387)	$	(38,734,275)	$	(24,572,374)
Of which: net loss attributable to controlling interests shareholders	(24,267,012)		(10,139,279)		(37,940,668)		(19,144,135)
Of which: net loss attributable to noncontrolling interests shareholders	(491,742)		(2,214,108)		(793,607)		(5,428,239)

Net unrealized gain (loss) on marketable securities and short term investments	652,097		(415,225)		834,370		(390,753)

Actuarial gain (loss) on employee benefit plans	(76,479)		(16,336)		4,751		(58,481)
Other comprehensive income (loss)	575,618		(431,561)		839,121		(449,234)
Comprehensive loss	$	(24,183,136)	$	(12,784,948)	$	(37,895,154)	$	(25,021,608)
Comprehensive loss attributable to controlling interests shareholders	(23,703,201)		(10,488,185)		(37,118,908)		(19,505,667)
Comprehensive loss attributable to noncontrolling interests	(479,935)		(2,296,763)		(776,246)		(5,515,941)

Weighted-average number of Class A Ordinary Shares, basic and diluted	62,874,637		43,718,464		62,755,925		41,403,084
Basic and diluted net loss per share attributable to controlling interests shareholders	$	(0.39)	$	(0.23)	$	(0.60)	$	(0.46)

The accompanying Notes are an integral part of these Unaudited Condensed Consolidated Financial Statements.

MOONLAKE IMMUNOTHERAPEUTICS

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(Amounts in USD, except share data)

(Unaudited)


	Class A Ordinary Shares	Class C Ordinary Shares			Additional Paid-In Capital	Accumulated Deficit	Accumulated Other Comprehensive Income	Total Shareholders' Equity		Noncontrolling Interests		Total Equity
		Shares	Amount															Shares		Amount
Balance at December 31, 2022		38,977,600	$	3,898			13,723,511	$	1,373	$	129,192,291	$	(80,650,212)	$	350,946	$	48,898,296	$	19,868,402	$	68,766,698
Share-based compensation under the ESPP, ESOP, Equity Incentive Plan and reverse vesting of Restricted Founder Shares		—	—				—	—		1,875,992		—		—		1,875,992		701,195		2,577,187
Refund of stamp duty fees		—	—				—	—		3,517		—		—		3,517		1,406		4,923
Net loss for the three months ended March 31, 2023		—	—				—	—		—		(9,004,856)		—		(9,004,856)		(3,214,131)		(12,218,987)
Other comprehensive income		—	—				—	—		—		—		(12,625)		(12,625)		(5,047)		(17,672)
Conversion of MoonLake Class C Ordinary Shares into Class A Ordinary Shares		176,603	18				(176,603)	(18)		237,049		—		1,787		238,836		(238,836)		—
Balance at March 31, 2023		39,154,203	$	3,916			13,546,908	$	1,355	$	131,308,849	$	(89,655,068)	$	340,108	$	41,999,160	$	17,112,989	$	59,112,149
Share-based compensation under the ESPP, ESOP, Equity Incentive Plan and reverse vesting of Restricted Founder Shares		—	—				—	—		1,247,416		—		—		1,247,416		250,245		1,497,661
Issuance of Class A Ordinary Shares, net of transaction costs (Note 11)		9,744,894	974				—	—		451,284,119		—		—		451,285,093		—		451,285,093
Net loss for the three months ended June 30, 2023		—	—				—	—		—		(10,139,279)		—		(10,139,279)		(2,214,108)		(12,353,387)
Other comprehensive loss		—	—				—	—		—		—		(348,906)		(348,906)		(82,655)		(431,561)
Conversion of MoonLake Class C Ordinary Shares into Class A Ordinary Shares		4,587,713	459				(4,587,713)	(459)		5,709,595		—		43,922		5,753,517		(5,753,517)		—
Balance at June 30, 2023		53,486,810	$	5,349			8,959,195	$	896	$	589,549,979	$	(99,794,347)	$	35,124	$	489,797,001	$	9,312,954	$	499,109,955

The accompanying Notes are an integral part of these Unaudited Condensed Consolidated Financial Statements.

MOONLAKE IMMUNOTHERAPEUTICS

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(Amounts in USD, except share data)

(Unaudited)


	Class A Ordinary Shares	Class C Ordinary Shares			Additional Paid-In Capital	Accumulated Deficit	Accumulated Other Comprehensive Income	Total Shareholders' Equity		Noncontrolling Interests		Total Equity
		Shares	Amount															Shares		Amount
Balance at December 31, 2023		60,466,453	$	6,047			2,505,476	$	251	$	609,969,236	$	(116,657,472)	$	2,357,621	$	495,675,683	$	17,815,336	$	513,491,019
Share-based compensation under the ESPP and Equity Incentive Plan		—	—				—	—		1,693,101		—		—		1,693,101		(15,893)		1,677,208
Net loss for the three months ended March 31, 2024		—	—				—	—		—		(13,673,656)		—		(13,673,656)		(301,865)		(13,975,521)
Other comprehensive loss		—	—				—	—		—		—		257,949		257,949		5,554		263,503
Conversion of MoonLake Class C Ordinary Shares into Class A Ordinary Shares		1,493,356	149				(1,493,356)	(149)		10,536,980		—		76,603		10,613,583		(10,613,583)		—
Buyback of unvested MoonLake AG Common Shares by MoonLake AG into treasury following an employee contract termination (Note 11)		—	—				—	—		113,154		—		904		114,058

SEC Form 10-Q filed by MoonLake Immunotherapeutics