Did MoonLake report positive clinical data in Q4 2025?

Yes. MoonLake reported positive Phase 2 S-OLARIS trial results in axial spondyloarthritis (axSpA), with 81% of patients achieving ASAS40 response at Week 12—a clinically meaningful and statistically significant result.

What is MoonLake's cash runway after Q4 2025?

MoonLake ended Q4 2025 with $394M in cash and securities. Combined with $400M in available non-dilutive debt from Hercules Capital, the company expects runway into the second half of 2027.

When will MoonLake file its BLA for hidradenitis suppurativa?

MoonLake expects to submit a Biologics License Application (BLA) for sonelokimab in hidradenitis suppurativa (HS) in H2 2026, following a Type B FDA meeting in December 2025.

MoonLake Immunotherapeutics (MLTX)·Q4 2025 Earnings Summary

MoonLake Surges on Positive Phase 2 axSpA Data, Stock Jumps 8% After Hours

February 23, 2026 · by Fintool AI Agent

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MoonLake Immunotherapeutics delivered a catalyst-rich Q4 2025 update, headlined by positive Phase 2 data in axial spondyloarthritis (axSpA) and an extended cash runway. The clinical-stage biotech reported 81% of patients achieved ASAS40 response at Week 12 in its S-OLARIS trial, while maintaining a strong $394 million cash position with access to up to $400 million in additional non-dilutive debt .

Did MoonLake Report Positive Clinical Data?

Yes—and it was the headline driver. The Phase 2 S-OLARIS trial in axSpA showed:

Endpoint	Result	Significance
ASAS40 Response (Week 12)	81% (n=26)	Clinically meaningful, statistically significant
ASDAS-CRP Improvement	>80%	"Clinically important improvement" achieved
SPARCC MRI (SIJ)	Improved	Confirmed rapid onset of action
PET Imaging	Significant reduction	Inflammation and osteoblast activity reduced in affected joints

This represents sonelokimab's fifth indication with positive clinical data across Phase 2 and Phase 3 trials . The PET imaging data showing reduced osteoblast activity is particularly notable—it suggests potential for disease modification in axSpA by targeting the irreversible ossification process that causes mobility restriction .

"The combination of clinical, imaging, and biomarker data presents one of the clearest demonstrations to date of how targeting IL-17A and IL-17F with a Nanobody can meaningfully reduce inflammation in the axial structures." — Prof. Xenofon Baraliakos, President of EULAR

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What is MoonLake's Cash Position?

Metric	Q4 2025	Q3 2025	Change
Cash & Securities	$394.0M	$380.5M	+$13.5M
R&D Expenses	$56.0M	$60.6M	-$4.6M (-8%)
G&A Expenses	$9.2M	$10.8M	-$1.6M (-15%)
Debt Outstanding	$100M	$75M	+$25M
Debt Available	$400M	$425M	-$25M

The sequential increase in cash despite continued R&D spending was supported by a $75 million equity raise (gross proceeds) earlier in the quarter . Combined with available debt, MoonLake has runway into H2 2027 .

What Changed With the Debt Facility?

MoonLake amended its Hercules Capital loan agreement on February 20, 2026, drawing an additional $25 million and modifying future tranche milestones :

Tranche	Amount	Milestone	Status
Tranche 1	$75M	Initial funding	Drawn (Mar 2025)
Tranche 2	$25M	Amendment closing	Drawn (Feb 2026)
Tranche 3	$50M	IZAR-1/2 Phase 3 primary endpoints	Available through Mar 2027
Tranche 4	$50M	VELA 52-week HS data + $1.5B mkt cap	Available through Dec 2026
Tranche 5	$100M	FDA BLA approval	Available through Dec 2027
Tranche 6	$200M	Lender discretion	Subject to approval

Total facility: $500M | Drawn: $100M | Available: $400M

The facility matures April 1, 2030 with interest at prime + 1.45% (floor 8.45%) .

How Did the Stock React?

Metric	Value
Close (Feb 20)	$18.77
After-Hours	$20.32 (+8.3%)
52-Week High	$62.75
52-Week Low	$5.95
YTD 2026	+57.1%
Feb 2026 Performance	+18.9%

The stock has recovered sharply from early February lows near $15, driven by anticipation of clinical catalysts. The after-hours move suggests the axSpA data exceeded expectations.

Stock is trading at 22.6% of its 52-week range, well below the $62.75 peak from early 2025—likely reflecting broader biotech sector weakness and the September 2025 VELA-2 mixed results.

What Are the Upcoming Catalysts?

Timeline	Catalyst	Significance
Q2 2026	VELA-1/2 52-week data (HS)	Supports BLA filing, durability data
Mid 2026	IZAR-1 Phase 3 readout (PsA)	Primary endpoint in biologic-naïve patients
Mid 2026	VELA-TEEN readout (Adolescent HS)	First adolescent HS trial
H2 2026	BLA submission for HS	Pivotal regulatory milestone
H2 2026	IZAR-2 Phase 3 readout (PsA TNF-IR)	Includes risankizumab reference arm

An Investor Day was held today (February 23) at 8:00 AM ET where management discussed the axSpA data, FDA Type B meeting outcomes for HS, and 2026 outlook .

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What About the Board Changes?

Simon Sturge notified the Board of his resignation effective February 28, 2026 . His departure was not due to any dispute with the company. In response:

Dr. Jorge Santos da Silva appointed Interim Chair of the Board
Spike Loy appointed Lead Independent Director

The Board will reduce from six to five directors .

What Changed From Last Quarter?

Area	Q3 2025	Q4 2025	Delta
Clinical Milestones	LEDA (PPP) positive	S-OLARIS (axSpA) positive	Fifth positive indication
Cash Position	$380.5M	$394.0M	+$13.5M
R&D Burn	$60.6M	$56.0M	Reduced burn rate
Debt Utilization	$75M	$100M	+$25M drawn
Regulatory Path	FDA Type B scheduled	FDA Type B completed	BLA path clarified

The reduced R&D spending in Q4 may reflect timing of clinical trial expenses rather than a structural change—management noted continued ramp-up for BLA preparation .

Key Risks to Monitor

VELA-2 Overhang: The September 2025 VELA-2 trial narrowly missed statistical significance using the composite strategy (p=0.053) . The upcoming 52-week data needs to demonstrate durability.
Dilution Risk: Despite non-dilutive debt, the company may require additional equity financing beyond H2 2027 if commercial launch is delayed.
Competitive Landscape: IL-17 inhibitors from J&J (Tremfya), Novartis (Cosentyx), and others are established in the market.
Tariff Exposure: Management noted potential supply chain impacts from evolving trade policy .

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The Bottom Line

MoonLake delivered a strong Q4 with positive axSpA data representing the fifth clinical win for sonelokimab. The company's financial position is solid with $394M cash and $400M in available debt, providing runway to potential HS approval. The 2026 catalyst calendar is packed with four major data readouts and a BLA submission—any of which could significantly move the stock from current levels 77% below its 52-week high.

Key numbers to watch:

81%: ASAS40 response rate in axSpA (vs. historical IL-17 benchmarks of 40-50%)
$394M: Cash position
H2 2027: Cash runway
H2 2026: Expected HS BLA submission

Data sources: MoonLake 8-K filed February 23, 2026; Q3 2025 10-Q; market data as of February 20, 2026.