MoonLake Immunotherapeutics (MLTX) AI Stock Analysis

• Market Cap: $1.16B
• Dividend Yield: N/A
• Average Volume (3M): 2.66M
• Price to Earnings (P/E): ―
• Beta (1Y): 0.78
• Revenue Growth: N/A
• EPS Growth: -157.74%
• Country: US
• Employees: 100
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -1.10
• Shares Outstanding: 70,847,404
• 10 Day Avg. Volume: 1,474,177
• 30 Day Avg. Volume: 2,663,867
• PEG Ratio: -0.18
• Price to Book (P/B): 7.62
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -29.07
• Enterprise Value/Market Cap: 0.72
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -561.65
• Enterprise Value/Ebitda: -4.01
• 1Y Price Target: $26.44
• Price Target Upside: 63.11% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 11
• EPS Forecast (FY): -3.61
• Revenue Forecast (FY): N/A

• Rating: 55 Neutral
• Price Target: $16.50 ▲(1.79% Upside)

The score is held back primarily by accelerating losses and significant ongoing cash burn despite a solid balance sheet. Technicals are mixed—improving in the short term but still weak longer term. Offsetting these risks, corporate updates were meaningfully positive, including FDA feedback that de-risks the sonelokimab regulatory path and supportive clinical trial readouts.

Positive Factors

Regulatory de‑risking (BLA path)

FDA confirmation that existing MIRA, VELA‑1 and VELA‑2 data can support a BLA materially reduces the regulatory binary risk for sonelokimab. This lowers the need for new large HS trials, shortens the path to approval and preserves capital and timeline predictability over the next 2–6 months.

Robust clinical program momentum

Positive Phase 2 data and interim Phase 3 signals strengthen the therapeutic profile and validate development strategy across indications. Durable clinical momentum increases optionality for label expansion, partnership or licensing opportunities and raises the probability of commercial viability long term.

Meaningful cash runway reported

A reported cash balance that funds operations into H2 2027 provides a multi-quarter runway to complete key readouts and BLA preparations. This reduces immediate financing pressure and allows management to advance pivotal programs, preserving strategic optionality across development milestones.

Negative Factors

Accelerating cash burn

Substantial negative operating and free cash flow indicate rising R&D and operating spending that outpaces resources. Persistently steep burn increases the likelihood of future financing, forces prioritization of programs, and elevates execution risk if clinical or regulatory timelines slip.

Pre‑revenue, binary business model

With no product sales, MoonLake’s value depends entirely on clinical and regulatory success for sonelokimab. This creates a binary outcome profile where failed readouts or approval delays materially impair future cash generation and strategic options over the medium term.

Ongoing reliance on external financing

The recent equity offering underscores dependence on capital markets to fund operations. Recurring dilution risk and variable market access can constrain long-term planning, force unfavorable financing terms if conditions worsen, and increase stakeholder dilution absent successful commercialization.

MoonLake Immunotherapeutics Business Overview & Revenue Model

Company Description

MoonLake 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 Money

MoonLake 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

Financial profile is mixed for a pre-revenue biotech: the balance sheet is a relative strength (sizeable equity and moderate leverage), but losses are accelerating (TTM net income about -$210.5M) and cash burn is heavy (TTM operating cash flow about -$185.7M and free cash flow about -$185.9M), increasing future financing risk without revenue.

Income Statement

The company remains pre-revenue (revenue is 0 across annual periods and in TTM (Trailing-Twelve-Months)), so operating losses are being driven by R&D and operating expenses rather than weak pricing or demand. Losses have widened materially versus prior years, with TTM (Trailing-Twelve-Months) net income at about -$210.5M compared with -$118.9M in 2024 and -$36.0M in 2023, indicating accelerating spend and/or scaling costs ahead of commercialization. While this is common in biotechnology, the lack of revenue and the sharp increase in losses reduce near-term earnings quality and visibility.

Balance Sheet

The balance sheet is a relative strength: stockholders’ equity remains sizable at ~$288.9M in TTM (Trailing-Twelve-Months) and total assets are ~$414.3M, providing financial flexibility despite ongoing losses. Leverage is still moderate with debt-to-equity around 0.21 in TTM (Trailing-Twelve-Months), but this is a notable step-up from very low leverage in 2022–2024, signaling increased reliance on debt. Returns on equity are negative (TTM (Trailing-Twelve-Months) return on equity roughly -0.42), reflecting persistent losses and ongoing capital consumption risk if burn continues.

Cash Flow

Cash generation is weak and consistently negative, with TTM (Trailing-Twelve-Months) operating cash flow around -$185.7M and free cash flow around -$185.9M, implying meaningful ongoing cash burn. Cash burn has increased substantially versus 2024 (operating cash flow about -$116.6M), even though TTM (Trailing-Twelve-Months) free cash flow growth is shown as positive—this improvement is off a still-deeply-negative base rather than a shift toward positive cash generation. A positive relationship between free cash flow and net income is largely mechanical here (both are negative), so the key issue remains funding runway and the need for future financing without a revenue offset.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	0.00	0.00	0.00	0.00	0.00	0.00
Gross Profit	-1.49M	0.00	0.00	0.00	-4.97K	0.00
EBITDA	-208.10M	-141.71M	-53.75M	-64.90M	-53.63M	-90.84K
Net Income	-210.50M	-118.94M	-36.01M	-49.97M	-53.64M	-90.84K
Balance Sheet
Total Assets	414.33M	477.93M	526.54M	76.84M	9.68M	116.63M
Cash, Cash Equivalents and Short-Term Investments	380.48M	448.03M	511.01M	72.11M	8.04M	1.34M
Total Debt	75.73M	2.83M	3.70M	282.58K	15.00M	58.06K
Total Liabilities	123.14M	24.54M	13.05M	8.08M	21.33M	4.15M
Stockholders Equity	288.91M	446.83M	495.68M	48.90M	-11.65M	112.48M
Cash Flow
Free Cash Flow	-185.90M	-117.11M	-43.06M	-55.91M	-35.23M	-316.69K
Operating Cash Flow	-185.69M	-116.59M	-42.78M	-55.89M	-35.18M	-316.69K
Investing Cash Flow	85.57M	-205.60M	-25.18M	-32.34M	-50.71K	-115.00M
Financing Cash Flow	73.75M	51.31M	479.70M	119.69M	43.26M	116.65M

MoonLake Immunotherapeutics Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 16.21
• 50DMA: Positive
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Neutral

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 16.21 is above the 20-day moving average (MA) of 15.32, above the 50-day MA of 14.41, and below the 200-day MA of 32.94, indicating a neutral trend. The MACD of 0.62 indicates Positive momentum. The RSI at 55.75 is Neutral, neither overbought nor oversold. The STOCH value of 51.06 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for MLTX.

MoonLake Immunotherapeutics Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
CRNX	64 Neutral	$5.26B	-11.44	-44.42%	―	―	-21.96%
PTGX	61 Neutral	$5.11B	125.88	7.80%	―	-35.39%	-72.97%
MLTX	55 Neutral	$1.16B	-4.87	-54.17%	―	―	-157.74%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
APLS	50 Neutral	$2.92B	77.64	14.10%	―	42.11%	―
ZLAB	48 Neutral	$1.98B	-8.85	-28.96%	―	23.73%	30.16%

MoonLake Immunotherapeutics Corporate Events

MoonLake Advances Sonelokimab After Positive FDA Feedback

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.

MoonLake Immunotherapeutics Announces $75M Share Offering

On November 5, 2025, MoonLake Immunotherapeutics entered into an underwriting agreement with Leerink Partners LLC to issue and sell 7,142,857 Class A ordinary shares at $10.50 per share, aiming to raise $75 million in gross proceeds. The offering, filed with the SEC, is expected to close on November 6, 2025, and includes indemnification provisions for the underwriter against certain liabilities.

The most recent analyst rating on (MLTX) stock is a Buy with a $16.00 price target. To see the full list of analyst forecasts on MoonLake Immunotherapeutics stock, see the MLTX Stock Forecast page.

MoonLake Reports Promising Phase 2 Trial Results

On November 5, 2025, MoonLake Immunotherapeutics announced promising results from its Phase 2 clinical trial of Sonelokimab in palmoplantar pustulosis and an interim analysis of its Phase 3 trial in adolescents with hidradenitis suppurativa. The company also reported its third-quarter financial results, highlighting a cash position of $380.5 million, expected to fund operations into the second half of 2027. These developments underscore MoonLake’s strategic progress in advancing Sonelokimab’s clinical program, potentially enhancing its market position in the inflammatory disease sector.

The most recent analyst rating on (MLTX) stock is a Buy with a $30.00 price target. To see the full list of analyst forecasts on MoonLake Immunotherapeutics stock, see the MLTX Stock Forecast page.