MoonLake Immunotherapeutics (MLTX) AI Stock Analysis

• Market Cap: $805.81M
• Dividend Yield: N/A
• Average Volume (3M): 1.49M
• Price to Earnings (P/E): ―
• Beta (1Y): 0.62
• 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: 1,034,332
• 30 Day Avg. Volume: 1,489,971
• 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: 0.19
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -102.15
• Enterprise Value/Ebitda: -0.73
• 1Y Price Target: $24.10
• Price Target Upside: 113.46% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 12
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 48 Neutral
• Price Target: $11.00 ▼(-2.57% Downside)

The score is held down primarily by the pre-revenue model with accelerating losses and significant cash burn, alongside weak technical momentum (price below key moving averages and negative MACD). Offsetting these are a comparatively supportive balance sheet and positive regulatory/clinical updates that de-risk the development path, while valuation inputs are not very informative due to negative earnings and no dividend yield data.

Positive Factors

Regulatory De‑risking (BLA Path)

Positive Type B feedback that supports a BLA submission from existing HS studies materially reduces regulatory uncertainty and potential trial costs. This shortens the pathway to approval, accelerating commercialization timing and preserving R&D capital versus running new pivotal HS trials.

Robust Clinical Evidence Base

A large, consistent clinical dataset across multiple trials strengthens the evidentiary case for effectiveness and safety, enhancing regulatory credibility and competitive differentiation. Durable trial evidence raises barriers for competitors and supports label claims and payer discussions post-approval.

Near‑term Cash Runway

A sizable cash position plus a committed debt facility gives the company funding visibility into H2 2027, enabling continued trials and BLA preparations. This financial cushion lowers immediate refinancing risk and permits execution of clinical milestones that determine long‑term value.

Negative Factors

Pre‑Revenue with Accelerating Losses

Persistent pre‑revenue status combined with sharply widening losses reduces financial resilience and heightens dependence on external capital. Over the coming months this pressure can force financing decisions that dilute shareholders or constrain strategic investments needed for commercialization.

High Negative Cash Flow

Substantial negative operating and free cash flow indicate heavy burn to fund trials and operations. Even with current cash, sustained negative cash generation shortens runway absent revenue or significant non‑dilutive funding, elevating execution and financing risk over the medium term.

Rising Leverage / Financing Dependence

An increased reliance on debt signals growing fixed obligations and less financial flexibility. Combined with ongoing losses, higher leverage can raise the cost of capital, constrain strategic options, and increase sensitivity to future funding conditions or covenant pressures.

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

MoonLake Immunotherapeutics is in an early-stage, pre-revenue phase, typical for a biotech company focused on R&D. Despite a strong balance sheet supported by equity funding, the absence of revenue and negative cash flows reflect the company's reliance on future product success and financing.

Income Statement

MoonLake Immunotherapeutics reported zero revenue over the past years, indicating a lack of commercialized products or services. This absence of revenue leads to an inability to calculate standard profitability metrics like Gross Profit Margin and Net Profit Margin. The persistent negative net income highlights ongoing operational losses, typical for a biotech company in its development phase.

Balance Sheet

The company's balance sheet shows a robust stockholders' equity position with a low level of debt, leading to a strong equity ratio. The Debt-to-Equity ratio is also favorable, indicating low financial leverage. However, the absence of revenue raises concerns about the sustainability of its equity and asset base without future revenue streams.

Cash Flow

The company exhibits significant negative free cash flow, which is typical for a biotech firm in the R&D phase. Financing activities have been substantial, suggesting reliance on external funding. However, the negative operating cash flow indicates the current lack of cash-generating operations, posing a risk if financing sources decline.

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: 11.29
• 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 11.29 is below the 20-day moving average (MA) of 13.43, below the 50-day MA of 12.78, and below the 200-day MA of 34.37, indicating a neutral trend. The MACD of -0.42 indicates Positive momentum. The RSI at 56.48 is Neutral, neither overbought nor oversold. The STOCH value of 24.22 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
PTGX	68 Neutral	$5.15B	126.62	7.80%	―	-35.39%	-72.97%
CRNX	59 Neutral	$5.06B	-11.74	-44.42%	―	―	-21.96%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
APLS	50 Neutral	$3.35B	88.45	14.10%	―	42.11%	―
MLTX	48 Neutral	$805.81M	-4.31	-54.17%	―	―	-157.74%
ZLAB	48 Neutral	$2.12B	-9.49	-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.