Milestone Pharmaceuticals (MIST) AI Stock Analysis

• Market Cap: $172.89M
• Dividend Yield: N/A
• Average Volume (3M): 7.76M
• Price to Earnings (P/E): ―
• Beta (1Y): 2.18
• Revenue Growth: N/A
• EPS Growth: 3.70%
• Country: US
• Employees: 33
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -0.12
• Shares Outstanding: 85,169,340
• 10 Day Avg. Volume: 3,442,450
• 30 Day Avg. Volume: 7,756,427
• PEG Ratio: 0.07
• Price to Book (P/B): 11.17
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -5.08
• Enterprise Value/Market Cap: 0.97
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -283.13
• Enterprise Value/Ebitda: -3.12
• 1Y Price Target: $8.00
• Price Target Upside: 294.09% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 3
• EPS Forecast (FY): -0.51
• Revenue Forecast (FY): $37.95M

• Rating: 52 Neutral
• Price Target: $2.00 ▼(-1.48% Downside)

The score is held back primarily by weak financial performance (no current revenue, widening losses, and significant cash burn with elevated leverage). Offsetting this, corporate events are strongly positive, highlighted by FDA approval, progress in Europe, and meaningful non-dilutive financing. Technical indicators remain weak-to-neutral and do not yet confirm a sustained positive trend, while valuation is difficult to assess given negative earnings and no dividend.

Positive Factors

FDA approval of CARDAMYST

U.S. FDA approval transforms Milestone from pure R&D to a commercial-stage company, enabling first revenue streams, commercialization planning, payer engagement and distribution arrangements. This materially reduces regulatory risk and supports durable market entry and product adoption over the next 2–6+ months.

EMA MAA acceptance for etripamil

EMA acceptance extends potential launch to Europe and supports global market penetration for a likely first patient self-administered PSVT therapy. If approved, it opens an addressable population (~2M European patients), strengthens competitive position and diversifies commercial opportunity beyond the U.S.

Non-dilutive $75M royalty financing

The $75M royalty sale provides significant non-dilutive capital contingent on U.S. approval, improving near-term liquidity and funding commercialization without immediate equity issuance. This durable financing extends runway and de-risks execution while shifting a portion of long-term U.S. sales upside to the financier.

Negative Factors

No current revenue and widening losses

Milestone remains pre-commercial with no recurring product revenue and materially larger net losses. Until etripamil achieves sustained sales, profitability is unlikely; persistent negative earnings increase reliance on external financing and raise execution risk for long-term commercialization plans.

Heavy operating cash burn

Substantial negative operating and free cash flow indicate the business cannot self-fund operations or launch costs. Continued high burn will necessitate additional financings or partnership monetization, constraining flexibility to execute commercialization and to invest in further clinical programs.

Elevated leverage and shrinking equity

Material increase in leverage and reduced equity weaken the balance sheet and limit financial flexibility. Higher debt amplifies refinancing and covenant risk, potentially forcing dilutive equity raises or expensive funding terms that could dilute shareholders and constrain long-term strategic options.

Milestone Pharmaceuticals Business Overview & Revenue Model

Company Description

Milestone Pharmaceuticals Inc., a biopharmaceutical company, focuses on the development and commercialization of cardiovascular medicines. The company is developing etripamil, a novel channel blocker, which is in Phase III clinical trial for the treatment of paroxysmal supraventricular tachycardia in the United States and Canada; and Phase II clinical trial for the treatment of atrial fibrillation and rapid ventricular rate. It has a license and collaboration agreement with Ji Xing Pharmaceuticals to develop and commercialize etripamil prophylactic and therapeutic uses in humans. The company was incorporated in 2003 and is headquartered in Montréal, Canada.

How the Company Makes Money

Milestone Pharmaceuticals generates revenue through the development and commercialization of its pharmaceutical products, primarily etripamil. The company aims to secure regulatory approvals and bring its products to market, targeting healthcare providers and institutions as its primary customers. Revenue streams are expected from product sales, potential partnerships, and licensing agreements with larger pharmaceutical companies that may include upfront payments, milestones, and royalties. Additionally, strategic collaborations and partnerships can enhance its market reach and provide funding to support further research and development efforts, contributing to its overall earnings.

Milestone Pharmaceuticals Financial Statement Overview

Summary

Milestone Pharmaceuticals faces significant financial challenges, with no revenue in the latest period, high leverage, and negative cash flows. The company must address its revenue generation and operational efficiency to improve financial health. Despite these challenges, liquidity remains relatively strong, providing a short-term buffer.

Income Statement

The income statement reveals that Milestone Pharmaceuticals is struggling with revenue generation, recording zero revenue for the most recent year and significant net losses consistently. Gross and net profit margins are negative, reflecting ongoing operational challenges in achieving profitability.

Balance Sheet

The balance sheet indicates high leverage with a debt-to-equity ratio increasing over time due to declining equity. The equity ratio is low, and the company's liabilities are a significant portion of its assets, raising concerns about financial stability. However, cash reserves are relatively robust compared to liabilities, providing some liquidity cushion.

Cash Flow

Cash flow from operations is negative, and free cash flow remains substantially negative, indicating ongoing cash burn. While there is some improvement in financing cash flows, the reliance on external financing highlights the need for sustainable cash generation from operations.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	0.00	0.00	1.00M	5.00M	15.00M	0.00
Gross Profit	-592.00K	0.00	1.00M	5.00M	15.00M	0.00
EBITDA	-53.73M	-37.83M	-57.04M	-58.30M	-42.98M	-50.61M
Net Income	-58.01M	-41.52M	-59.69M	-58.39M	-42.85M	-49.97M
Balance Sheet
Total Assets	87.75M	75.50M	75.23M	74.48M	119.85M	149.97M
Cash, Cash Equivalents and Short-Term Investments	82.58M	69.69M	66.00M	64.58M	114.14M	142.31M
Total Debt	57.21M	54.80M	51.77M	2.49M	698.00K	941.00K
Total Liabilities	67.25M	62.35M	58.45M	8.13M	7.25M	6.86M
Stockholders Equity	20.50M	13.15M	16.77M	66.35M	112.60M	143.12M
Cash Flow
Free Cash Flow	-43.22M	-28.88M	-46.54M	-52.74M	-33.22M	-50.73M
Operating Cash Flow	-43.18M	-28.85M	-46.42M	-52.47M	-33.22M	-50.73M
Investing Cash Flow	27.21M	8.28M	4.76M	-57.12M	70.00M	-70.00M
Financing Cash Flow	49.86M	32.12M	47.79M	3.09M	5.05M	73.22M

Milestone Pharmaceuticals Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 2.03
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For MIST, the sentiment is Negative. The current price of 2.03 is below the 20-day moving average (MA) of 2.06, below the 50-day MA of 2.21, and above the 200-day MA of 1.76, indicating a neutral trend. The MACD of -0.07 indicates Positive momentum. The RSI at 44.96 is Neutral, neither overbought nor oversold. The STOCH value of 21.44 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for MIST.

Milestone Pharmaceuticals Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
ANRO	56 Neutral	$533.10M	-7.40	-45.01%	―	―	-7.87%
MIST	52 Neutral	$172.89M	-2.35	-260.65%	―	―	3.70%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
MCRB	50 Neutral	$145.47M	25.00	15.95%	―	448.44%	―
CRBP	49 Neutral	$144.99M	-1.48	-55.65%	―	―	-17.43%
AVTX	47 Neutral	$299.72M	-1.79	-174.79%	―	-76.59%	94.03%
ELTX	43 Neutral	$140.44M	-2.30	―	―	―	17.36%

Milestone Pharmaceuticals Corporate Events

Milestone Pharmaceuticals Secures $75M Non-Dilutive Royalty Financing

On January 12, 2026, Milestone Pharmaceuticals closed a previously arranged royalty financing transaction under a Royalty Purchase Agreement with RTW Royalty I DAC, an affiliate of RTW Investments, whereby funds managed by RTW paid $75 million to acquire a royalty interest in future tiered quarterly royalty payments on U.S. net product sales of etripamil. The closing of this sale, contingent on prior U.S. Food and Drug Administration approval of etripamil, provided Milestone with significant non-dilutive capital in exchange for a portion of future U.S. sales, potentially strengthening its financial position while shifting some long-term revenue upside to RTW.

The most recent analyst rating on (MIST) stock is a Sell with a $2.00 price target. To see the full list of analyst forecasts on Milestone Pharmaceuticals stock, see the MIST Stock Forecast page.

Milestone’s PSVT nasal spray MAA accepted by EMA

On January 6, 2026, Milestone Pharmaceuticals announced that the European Medicines Agency has accepted its Marketing Authorization Application for etripamil nasal spray, under the conditionally approved brand name TACHYMIST, for the treatment of paroxysmal supraventricular tachycardia outside the healthcare setting, with a decision on approval expected by the first quarter of 2027. The filing, supported by data from more than 1,800 participants and the pivotal RAPID Phase 3 trial published in 2023, underscores etripamil’s potential to become the first patient self-administered PSVT therapy in Europe, which could significantly reduce emergency visits and invasive procedures for approximately two million European patients and strengthen Milestone’s position in the cardiovascular therapeutics market.

The most recent analyst rating on (MIST) stock is a Hold with a $2.00 price target. To see the full list of analyst forecasts on Milestone Pharmaceuticals stock, see the MIST Stock Forecast page.

Milestone Pharmaceuticals Gains FDA Approval for CARDAMYST

On December 12, 2025, Milestone Pharmaceuticals announced that the U.S. Food and Drug Administration approved their New Drug Application for CARDAMYST (etripamil) nasal spray, intended for managing paroxysmal supraventricular tachycardia (PSVT). This approval marks a significant milestone for the company, potentially enhancing its market position by offering a novel treatment option that could reduce healthcare costs and empower patients to manage symptomatic attacks effectively.

The most recent analyst rating on (MIST) stock is a Buy with a $5.00 price target. To see the full list of analyst forecasts on Milestone Pharmaceuticals stock, see the MIST Stock Forecast page.