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MoonLake Immunotherapeutics (MLTX)
NASDAQ:MLTX
US Market

MoonLake Immunotherapeutics (MLTX) AI Stock Analysis

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MLTX

MoonLake Immunotherapeutics

(NASDAQ:MLTX)

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Neutral 55 (OpenAI - 5.2)
Rating:55Neutral
Price Target:
$18.50
▲(1.65% Upside)
Action:ReiteratedDate:02/25/26
The score is held back mainly by weak financial performance (no revenue, accelerating losses and cash burn, and rising debt). Offsetting factors include constructive technical momentum and notably positive corporate catalysts (strong trial results, supportive FDA feedback, and expanded non-dilutive financing), while valuation remains difficult to support due to ongoing losses.
Positive Factors
Strong Phase 2 efficacy
Robust Phase 2 efficacy across clinical endpoints, imaging (SPARCC MRI, PET) and biomarkers suggests sonelokimab has deep anti‑inflammatory activity and potential disease‑modifying effects. That durable clinical profile supports differentiation, long‑term market positioning and partner interest across indications.
Regulatory de‑risking (FDA Type B)
FDA agreement that existing MIRA/VELA data can support a BLA materially reduces regulatory execution risk and development time. Avoiding new HS trials lowers program cost and shortens path to approval, increasing the probability of commercialization and improving strategic optionality for partnerships or launch planning.
Material cash runway & facility
A combination of ~$394M cash, recent equity proceeds and an expanded, milestone‑contingent credit facility materially extends runway into H2 2027. This durable financing cushion supports execution of multiple late‑stage readouts and regulatory filings without immediate dilutive equity, lowering near‑term funding uncertainty.
Negative Factors
No revenue; widening losses
As a pre‑revenue biotech, MoonLake depends entirely on financing until commercialization. The substantial increase in net losses in 2025 doubles the magnitude of operating deficits versus prior year, raising persistent financing need and dilutive risk if development timelines slip or commercialization is delayed.
High and rising cash burn
Rapidly worsening operating cash flow demonstrates material negative cash generation that will require repeated external funding until products generate revenue. Sustained high burn constrains optionality, increases refinancing risk, and could force program prioritization or delay if capital markets tighten.
Rising secured debt & restrictive covenants
The sharp increase in secured debt and asset pledging reduces balance sheet flexibility and puts IP and subsidiaries as collateral. Facility drawdowns are milestone‑contingent and include revenue covenants, which could limit strategic moves, complicate future financings, or accelerate repayment pressure if milestones falter.

MoonLake Immunotherapeutics (MLTX) vs. SPDR S&P 500 ETF (SPY)

MoonLake Immunotherapeutics Business Overview & Revenue Model

Company DescriptionMoonLake Immunotherapeutics, a clinical-stage biopharmaceutical company, engages in developing therapies. It is developing Sonelokimab, a novel investigational Nanobody therapy for the treatment of inflammation. The company is involved in conducting Phase II trials for hidradenitis suppurativa, psoriatic arthritis, ankylosing spondylitis, or radiographic axial spondyloarthritis. MoonLake Immunotherapeutics was founded in 2021 and is headquartered in Zug, Switzerland.
How the Company Makes MoneyMoonLake Immunotherapeutics makes money primarily through the development and commercialization of its proprietary drug candidates. The company generates revenue by advancing its therapeutic products through clinical trials and ultimately seeking regulatory approval for marketing and sales. Additionally, MoonLake may engage in strategic partnerships or collaborations with other pharmaceutical companies, which can include licensing agreements, joint ventures, or co-development opportunities to enhance its product pipeline and expand market reach. These partnerships can provide upfront payments, milestone payments, and royalties, contributing to the company's overall revenue. Furthermore, MoonLake might receive funding through grants, public offerings, or private investments to support its research and development activities.

MoonLake Immunotherapeutics Financial Statement Overview

Summary
Development-stage profile with $0 revenue, widening net losses (about $229M in 2025 vs. about $119M in 2024) and sharply more negative operating cash flow (about -$196M in 2025 vs. about -$117M in 2024). Balance sheet remains a support with positive equity (about $304M in 2025), but debt rose sharply (about $75.7M vs. about $2.8M in 2024) and assets declined, increasing financing risk if burn persists.
Income Statement
28
Negative
The income statement reflects a pre-revenue biotech profile: revenue is consistently $0 across the annual periods provided, with persistent operating losses. Losses have widened materially in the most recent year (net loss of about $229M in 2025 vs. about $119M in 2024), indicating rising spend and a heavier burn phase. The main strength is that losses are expected for the industry stage, but the lack of revenue and the recent acceleration in net losses weigh heavily on the score.
Balance Sheet
63
Positive
The balance sheet is a relative bright spot: stockholders’ equity remains solidly positive in recent years (about $304M in 2025) and leverage is still moderate in absolute terms (about $75.7M of total debt in 2025). However, debt increased sharply versus 2024 (from roughly $2.8M to $75.7M), and total assets declined from about $478M (2024) to $424M (2025), consistent with cash usage. Overall, the company appears funded today, but the trend shows weakening balance sheet flexibility as burn continues and debt steps up.
Cash Flow
30
Negative
Cash generation is weak and deteriorating: operating cash flow is meaningfully negative and worsened to about -$196M in 2025 from about -$117M in 2024, with free cash flow similarly negative. While free cash flow growth is shown as positive in 2025, the business is still deeply cash-consuming, implying continued reliance on external funding (equity raises or additional debt) until revenue ramps. The key positive is that the company’s cash burn is broadly aligned with its reported losses, but the absolute burn level is high.
BreakdownDec 2025Dec 2024Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue0.000.000.000.000.00
Gross Profit0.000.000.000.00-4.97K
EBITDA-219.85M-141.71M-53.75M-64.90M-53.63M
Net Income-229.10M-118.94M-36.01M-49.97M-53.64M
Balance Sheet
Total Assets424.43M477.93M526.54M76.84M9.68M
Cash, Cash Equivalents and Short-Term Investments393.97M448.03M511.01M72.11M8.04M
Total Debt75.71M2.83M3.70M282.58K15.00M
Total Liabilities119.95M24.54M13.05M8.08M21.33M
Stockholders Equity304.48M446.83M495.68M48.90M-11.65M
Cash Flow
Free Cash Flow-196.04M-117.11M-43.06M-55.91M-35.23M
Operating Cash Flow-196.01M-116.59M-42.78M-55.89M-35.18M
Investing Cash Flow202.99M-205.60M-25.18M-32.34M-50.71K
Financing Cash Flow146.00M51.31M479.70M119.69M43.26M

MoonLake Immunotherapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price18.20
Price Trends
50DMA
15.36
Positive
100DMA
13.29
Positive
200DMA
30.99
Negative
Market Momentum
MACD
0.83
Negative
RSI
63.39
Neutral
STOCH
82.28
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For MLTX, the sentiment is Positive. The current price of 18.2 is above the 20-day moving average (MA) of 16.46, above the 50-day MA of 15.36, and below the 200-day MA of 30.99, indicating a neutral trend. The MACD of 0.83 indicates Negative momentum. The RSI at 63.39 is Neutral, neither overbought nor oversold. The STOCH value of 82.28 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for MLTX.

MoonLake Immunotherapeutics Risk Analysis

MoonLake Immunotherapeutics disclosed 66 risk factors in its most recent earnings report. MoonLake Immunotherapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

MoonLake Immunotherapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
64
Neutral
$4.56B-9.82-44.42%-21.96%
61
Neutral
$5.46B137.977.80%-35.39%-72.97%
58
Neutral
$2.80B74.5414.10%42.11%
55
Neutral
$1.30B-5.47-54.17%-157.74%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
48
Neutral
$2.16B-9.93-28.97%23.73%30.16%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
MLTX
MoonLake Immunotherapeutics
18.22
-24.15
-57.00%
PTGX
Protagonist Therapeutics
87.10
50.95
140.94%
ZLAB
Zai Lab
19.39
-15.68
-44.71%
APLS
Apellis Pharmaceuticals
21.42
-4.91
-18.65%
CRNX
Crinetics Pharmaceuticals
43.39
10.84
33.30%

MoonLake Immunotherapeutics Corporate Events

Business Operations and StrategyExecutive/Board ChangesFinancial DisclosuresPrivate Placements and Financing
MoonLake Highlights Positive S-OLARIS Data and Investor Day
Positive
Feb 23, 2026

On February 20, 2026, MoonLake Immunotherapeutics amended its loan and security agreement with Hercules Capital, expanding a senior secured credit facility to six tranches totaling up to $500 million and drawing an additional $25 million. The amended structure leaves up to $400 million of non-dilutive debt available, largely contingent on key clinical and regulatory milestones for sonelokimab in hidradenitis suppurativa and psoriatic arthritis, and introduces a conditional revenue covenant tied to future product sales.

All obligations under the facility are secured by substantially all of MoonLake’s and its material subsidiaries’ assets, including intellectual property, and the loans feature no scheduled amortization with principal due at maturity. The financing package bolsters MoonLake’s balance sheet alongside its existing cash, cash equivalents and short-term marketable debt securities of $394 million as of December 31, 2025, supporting the costly late-stage development and potential commercialization of sonelokimab.

On February 18, 2026, board member Simon Sturge notified MoonLake he would resign effective February 28, 2026, after which the board will shrink from six to five directors. The company said his departure was not due to any disagreement on operations or policies, and it appointed CEO Jorge Santos da Silva as interim chair and director Spike Loy as lead independent director from the same date, signaling continuity in governance during a pivotal clinical phase.

On February 22, 2026, MoonLake reported positive topline results from its Phase 2 S-OLARIS trial of sonelokimab in axial spondyloarthritis, where 81% of treated patients achieved an ASAS40 response at week 12. Additional clinical, imaging and biomarker data, including SPARCC MRI and PET measures of inflammation and osteoblast activity, indicated rapid, deep-tissue effects and a safety profile consistent with prior trials, reinforcing the drug’s potential to modify disease pathways in axial spondyloarthritis.

The same day, the company released financial results for the fourth quarter and full year 2025, posting research and development expenses of $56 million and general and administrative expenses of $9.2 million for the quarter. MoonLake said its year-end cash and marketable securities, together with recent equity proceeds and the amended Hercules facility, are expected to fund operations into the second half of 2027, underpinning multiple upcoming data readouts and regulatory steps in its late-stage pipeline.

MoonLake also confirmed it would hold an Investor Day webcast on February 23, 2026 to present the S-OLARIS data, discuss outcomes of a recent Type B FDA meeting for hidradenitis suppurativa and outline its biologics license application plans. Management intends to share interim Phase 3 hidradenitis suppurativa data, adolescent trial results and detail 2026 catalysts, including Phase 3 readouts in psoriatic arthritis and palmo-plantar pustulosis program plans, indicating an intense news flow that could influence investor expectations and partner interest.

The most recent analyst rating on (MLTX) stock is a Buy with a $33.00 price target. To see the full list of analyst forecasts on MoonLake Immunotherapeutics stock, see the MLTX Stock Forecast page.

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
MoonLake Advances Sonelokimab After Positive FDA Feedback
Positive
Jan 8, 2026

On January 8, 2026, MoonLake Immunotherapeutics reported that a recent Type B meeting with the U.S. Food and Drug Administration delivered positive regulatory feedback on the clinical evidence package for sonelokimab in hidradenitis suppurativa, confirming that the company may pursue a Biologics License Application in the second half of 2026 without conducting additional HS clinical trials. The FDA agreed that data from MoonLake’s existing MIRA, VELA‑1 and VELA‑2 studies—together enrolling more than 1,000 HS patients and showing significant efficacy and a favorable safety profile—can collectively establish substantial evidence of effectiveness, while emphasizing the inclusion of VELA‑2 primarily to inform safety, a stance that reinforces the value of the current HS program and de-risks the regulatory path. The company said preparations for the BLA submission remain on track and highlighted a catalyst-heavy 2026, including multiple Phase 2 and Phase 3 data readouts in axial spondyloarthritis, psoriatic arthritis and adolescent HS, alongside an Investor Day set for February 23, 2026 to discuss the FDA feedback, new clinical data and its broader development roadmap for sonelokimab.

The most recent analyst rating on (MLTX) stock is a Hold with a $13.50 price target. To see the full list of analyst forecasts on MoonLake Immunotherapeutics stock, see the MLTX Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Feb 25, 2026