mnlk-20240930

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 September 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 November 1, 2024, there were 63,063,929 Class A Ordinary Shares, $0.0001 par value (the "Class A Ordinary Shares"), and 841,269 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 SEPTEMBER 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			26
Item 3. Quantitative and Qualitative Disclosures About Market Risk			39
Item 4. Controls and Procedures			39
PART II. OTHER INFORMATION			41
Item 1. Legal Proceedings			41
Item 1A. Risk Factors			41
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			41
Item 3. Defaults Upon Senior Securities			41
Item 4. Mine Safety Disclosures			41
Item 5. Other Information			41
Item 6. Exhibits			42
SIGNATURES			43

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

MOONLAKE IMMUNOTHERAPEUTICS

CONDENSED CONSOLIDATED BALANCE SHEETS

(Amounts in USD, except share data)


	September 30, 2024 (Unaudited)		December 31, 2023
Current assets
Cash and cash equivalents	$	375,656,291	$	451,169,337
Short-term marketable debt securities	118,268,400		59,838,900


Other receivables	2,407,062		1,056,862
Prepaid expenses - current	15,984,425		2,102,203

Total current assets	512,316,178		514,167,302

Non-current assets
Operating lease right-of-use assets	3,251,197		3,628,480
Property and equipment, net	581,378		320,865
Prepaid expenses - non-current	2,064,575		8,423,468




Total non-current assets	5,897,150		12,372,813
Total assets	$	518,213,328	$	526,540,115

Current liabilities
Trade and other payables	$	10,710,603	$	1,837,684
Short-term portion of operating lease liabilities	1,444,893		1,197,876

Accrued expenses and other current liabilities	7,925,524		6,930,120


Total current liabilities	20,081,020		9,965,680

Non-current liabilities
Long-term portion of operating lease liabilities	1,935,709		2,499,990
Pension liability	694,959		583,426

Total non-current liabilities	2,630,668		3,083,416
Total liabilities	22,711,688		13,049,096
Commitments and contingencies (Note 15)

Equity



Class A Ordinary Shares: $0.0001 par value; 500,000,000 shares authorized; 63,046,025 shares issued and outstanding as of September 30, 2024; 60,466,453 shares issued and outstanding as of December 31, 2023	6,305		6,047
Class C Ordinary Shares: $0.0001 par value; 100,000,000 shares authorized; 841,269 shares issued and outstanding as of September 30, 2024; 2,505,476 shares issued and outstanding as of December 31, 2023	84		251
Additional paid-in capital	675,343,443		609,969,236
Accumulated deficit	(189,988,477)		(116,657,472)
Accumulated other comprehensive income	2,833,970		2,357,621
Total shareholders’ equity	488,195,325		495,675,683
Noncontrolling interests	7,306,315		17,815,336
Total equity	495,501,640		513,491,019
Total liabilities and equity	$	518,213,328	$	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 September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023


Operating expenses
Research and development	$	(35,735,514)	$	(7,585,136)	$	(72,411,709)	$	(23,704,087)
General and administrative	(7,376,495)		(5,391,607)		(21,099,001)		(15,390,117)
Total operating expenses	(43,112,009)		(12,976,743)		(93,510,710)		(39,094,204)
Operating loss	(43,112,009)		(12,976,743)		(93,510,710)		(39,094,204)

Other income, net	7,089,691		1,386,313		18,903,070		2,952,557



Loss before income tax	(36,022,318)		(11,590,430)		(74,607,640)		(36,141,647)

Income tax expense	(92,106)		(28,923)		(241,059)		(50,080)
Net loss	$	(36,114,424)	$	(11,619,353)	$	(74,848,699)	$	(36,191,727)
Of which: net loss attributable to controlling interests shareholders	(35,390,337)		(9,426,049)		(73,331,005)		(28,570,184)
Of which: net loss attributable to noncontrolling interests shareholders	(724,087)		(2,193,304)		(1,517,694)		(7,621,543)

Net unrealized gain (loss) on marketable securities and short term investments	(325,510)		3,437,291		508,860		3,046,538

Actuarial gain (loss) on employee benefit plans	(115,629)		39,157		(110,878)		(19,323)
Other comprehensive income (loss)	(441,139)		3,476,448		397,982		3,027,215
Comprehensive loss	$	(36,555,563)	$	(8,142,905)	$	(74,450,717)	$	(33,164,512)
Comprehensive loss attributable to controlling interests shareholders	(35,822,526)		(6,590,259)		(72,941,435)		(26,095,926)
Comprehensive loss attributable to noncontrolling interests	(733,037)		(1,552,646)		(1,509,282)		(7,068,586)

Weighted-average number of Class A Ordinary Shares, basic and diluted	62,896,782		53,517,655		62,803,220		45,485,650
Basic and diluted net loss per share attributable to controlling interests shareholders	$	(0.56)	$	(0.18)	$	(1.17)	$	(

SEC Form 10-Q filed by MoonLake Immunotherapeutics