Milestone Pharmaceuticals (MIST) AI Stock Analysis

• Market Cap: $159.27M
• Dividend Yield: N/A
• Average Volume (3M): 2.87M
• Price to Earnings (P/E): ―
• Beta (1Y): 2.19
• 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: 2,063,319
• 30 Day Avg. Volume: 2,866,268
• 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: 1.07
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -286.81
• Enterprise Value/Ebitda: -3.16
• 1Y Price Target: $8.00
• Price Target Upside: 327.81% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 3
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 49 Neutral
• Price Target: $2.00 ▲(6.95% Upside)

The score is held down primarily by weak financial performance (no current revenue, widening losses, and significant cash burn with elevated leverage). Offsetting this, corporate events are strongly positive—FDA approval/commercial launch and non-dilutive financing materially improve the business outlook—while technical signals remain soft and valuation provides limited support due to ongoing losses.

Positive Factors

FDA approval and U.S. commercial launch

Regulatory approval and retail availability create a durable revenue pathway absent during development, enabling direct product sales and reimbursement interactions. A successful rollout and capture of PSVT prescriptions can materially shift the company from financing dependence toward operating cash generation over the medium term.

Non-dilutive $75M royalty financing

Securing significant non-dilutive capital strengthens near-term liquidity to fund commercialization without issuing equity, preserving existing shareholders while enabling launch investments. It does cede a portion of long-term revenue, but materially reduces immediate refinancing and dilution risk during commercialization build-out.

EMA MAA acceptance expands geography

A validated EU regulatory filing opens a structural pathway to a multi‑regional commercial footprint. Approval in Europe would expand the addressable market, diversify revenue streams, and leverage published pivotal data, strengthening long-term growth prospects beyond the U.S. market if executed well.

Negative Factors

No recurring revenue; heavy cash burn

The company remains effectively pre-revenue with sustained large operating losses and cash burn. Persistent negative cash flow requires ongoing financing to fund sales, marketing, and operations, limiting financial flexibility and increasing execution pressure to convert approval into profitable, self-sustaining product sales.

Elevated leverage and weakened equity base

Material leverage and a diminished equity base constrain strategic options and raise refinancing and covenant risks. High obligations relative to equity reduce resilience to launch setbacks or slower uptake, and may force costly financing terms or further dilution if sales ramp is delayed or commercialization costs exceed forecasts.

Single-product dependence and small organization

Dependence on a single newly commercialized product and a compact workforce heighten execution risk for national launch, payer negotiations, and scale-up. Any clinical, regulatory, or commercial setback could disproportionately impact prospects; scaling a sales and support model will require sustained investment and operational expansion.

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

Financials remain weak for a development-to-early-commercial biotech: revenue is $0 in 2024 and TTM, losses are large and widening (net loss ~$41.5M in 2024 to ~$58.0M TTM), and cash burn is heavy (operating cash flow about -$43.2M TTM). Balance sheet leverage is elevated with debt (~$57.2M) exceeding equity (~$20.5M), reducing flexibility and increasing financing risk.

Income Statement

The business is still pre-commercial, with revenue at $0 in both 2024 (annual) and 2025-09-30 TTM (Trailing-Twelve-Months). Losses remain very large: net loss was about $41.5M in 2024 and widened to about $58.0M in TTM, indicating operating expenses are outpacing progress toward monetization. Earlier years show intermittent revenue (e.g., $15M in 2021, $5M in 2022, $1M in 2023), but the overall trajectory has been down to zero revenue, keeping profitability and margin profile weak.

Balance Sheet

Leverage has increased materially: debt rose to ~$57.2M in TTM while equity declined to ~$20.5M, pushing debt-to-equity to ~2.79x (still better than ~4.17x in 2024, but far worse than the very low leverage seen in 2020–2022). The company remains loss-making, reflected in deeply negative returns on equity (TTM). The balance sheet still shows a moderate asset base (~$87.8M TTM), but shrinking equity and elevated leverage reduce financial flexibility and raise dilution/refinancing risk if losses persist.

Cash Flow

Cash burn remains heavy: operating cash flow was about -$28.8M in 2024 and deteriorated to about -$43.2M in TTM, with free cash flow similarly negative (~- $43.2M TTM). While free cash flow growth is positive in the provided data (TTM and 2024), the absolute level of burn is still substantial and ongoing. Cash generation is not yet self-funding, implying continued reliance on financing to support 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: 1.87
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Positive
• MACD: Negative
• 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 1.87 is below the 20-day moving average (MA) of 1.99, below the 50-day MA of 2.20, and above the 200-day MA of 1.85, indicating a neutral trend. The MACD of -0.06 indicates Negative momentum. The RSI at 39.32 is Neutral, neither overbought nor oversold. The STOCH value of 40.00 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	$466.00M	-6.52	-45.01%	―	―	-7.87%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
MCRB	50 Neutral	$123.30M	22.45	15.95%	―	448.44%	―
MIST	49 Neutral	$159.27M	-2.16	-260.65%	―	―	3.70%
CRBP	49 Neutral	$140.60M	-1.45	-55.65%	―	―	-17.43%
AVTX	47 Neutral	$266.03M	-1.65	-174.79%	―	-76.59%	94.03%
ELTX	43 Neutral	$137.29M	-2.31	―	―	―	17.36%

Milestone Pharmaceuticals Corporate Events

Milestone Launches CARDAMYST Nasal Spray in U.S. Pharmacies

On January 26, 2026, Milestone Pharmaceuticals announced that CARDAMYST (etripamil) nasal spray, the first and only FDA-approved self-administered treatment for adults with paroxysmal supraventricular tachycardia, became available through U.S. retail pharmacies following its December 12, 2025 FDA approval, marking the first new PSVT therapy in more than three decades. The company is executing a rapid commercial rollout that includes deploying a national sales force in mid-February 2026 and launching a comprehensive patient assistance program with benefits verification, reimbursement support, and an expected $25 copay cap for eligible commercially insured patients, a strategy that could significantly expand access, reduce emergency department reliance, 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 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.