Milestone Pharmaceuticals Inc. (MIST): Business Model Canvas [Dec-2025 Updated]

You're analyzing a biotech at the make-or-break moment, and Milestone Pharmaceuticals Inc. is defintely there: pivoting from clinical to commercial, fueled by an imminent FDA call and a $75 million financing milestone. With $82.6 million cash on hand as of September 30, 2025, and a 60-person sales team ready to deploy, the strategy is clear but the execution risk is high. See the full breakdown of their nine building blocks below to understand the path to product sales post-approval.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Key Partnerships

The Key Partnerships block for Milestone Pharmaceuticals Inc. centers on securing the necessary capital, regulatory clearance, and scientific validation to bring CARDAMYST to market for paroxysmal supraventricular tachycardia (PSVT).

The relationship with RTW Investments, LP is foundational for near-term commercialization funding. Milestone Pharmaceuticals Inc. has an amended Royalty Purchase Agreement (RPA) with RTW Investments, LP, and certain affiliates, structured as a $75 million purchase and sale agreement. This $75 million milestone payment is contingent upon FDA approval of etripamil on or prior to December 31, 2025, and other customary closing conditions. As of the third quarter of 2025, Milestone Pharmaceuticals Inc. expected to receive these anticipated funds upon FDA approval to drive a successful commercial launch.

Regulatory bodies, specifically the U.S. Food and Drug Administration (FDA), dictate the timeline for unlocking this capital and market access. Milestone Pharmaceuticals Inc.'s New Drug Application (NDA) for CARDAMYST has a Prescription Drug User Fee Act (PDUFA) target action date set for December 13, 2025. This followed the FDA issuing a Complete Response Letter (CRL) in March 2025. The FDA accepted Milestone Pharmaceuticals Inc.'s response to the CRL on July 11, 2025. The FDA has not raised clinical safety or efficacy concerns regarding etripamil.

Contract Manufacturing Organizations (CMOs) are critical for meeting the Chemistry, Manufacturing, and Controls (CMC) requirements raised in the CRL. Milestone Pharmaceuticals Inc. transferred manufacturing testing to vendors with recent FDA inspection histories to align with updated FDA guidance on nitrosamines. Research and development expense for the first quarter of 2025 included higher consulting costs related to drug manufacturing.

Key opinion leaders (KOLs) and clinical trial investigators provide the necessary scientific validation. New analysis of etripamil clinical data was presented at the American Heart Association (AHA) Scientific Sessions 2025 on November 10.

• Results showed consistent efficacy across multiple study phases.
• Data involved more than 600 unique enrolled patients.
• The therapy is referenced in recent AHA ACLS Guidelines.

Here is a quick look at the key financial and regulatory figures tied to these partnerships as of late 2025:

Partnership Element	Metric/Amount	Date/Status Reference
RTW Investments, LP (RPA)	$75 million	Contingent payment upon FDA approval
FDA Review Timeline	December 13, 2025	New PDUFA Target Action Date
Cash Position	$82.6 million	Cash, cash equivalents, and short-term investments as of September 30, 2025
KOL/Clinical Validation	November 10, 2025	Date of AHA Scientific Sessions 2025 presentation
Manufacturing/Regulatory Costs (Q1 2025)	Higher consulting costs	Related to drug manufacturing and regulatory costs

The commercial build-out is also reflected in partnership-adjacent spending. Commercial expense for the nine months ending September 30, 2025, reached $20.1 million, up from $6.6 million for the same period in 2024, reflecting increased operational expenses related to launch preparation.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Key Activities

You're preparing for a major transition, moving Milestone Pharmaceuticals Inc. from clinical-stage to a commercial entity, all hinging on a key regulatory date. This means your Key Activities are laser-focused on execution and readiness.

Managing the complex regulatory process and compliance

The most immediate activity is navigating the final regulatory hurdle for CARDAMYST in its lead indication, Paroxysmal Supraventricular Tachycardia (PSVT). The U.S. Food and Drug Administration (FDA) has set the Prescription Drug User Fee Act (PDUFA) target action date for December 13, 2025. This follows the successful resolution of the Complete Response Letter (CRL) issues, which involved addressing Chemistry, Manufacturing, and Controls (CMC) concerns, including Nitrosamine Impurities. To support the submission, Milestone Pharmaceuticals presented new analysis of etripamil clinical data at the American Heart Association (AHA) Scientific Sessions 2025 on November 10, drawing from results across more than 600 unique enrolled patients to show consistent efficacy and safety.

Preparing for the commercial launch of CARDAMYST™ post-approval

With the PDUFA date looming, Milestone Pharmaceuticals is ramping operational expenditures to ensure a quick-start capability upon potential approval. This pre-launch investment is clearly visible in the financial reporting. For the nine months ending September 30, 2025, commercial expense totaled $20.1 million, a significant jump from the $6.6 million reported for the same period in 2024. This spending covers the necessary build-out and operational setup for market entry. Furthermore, the balance sheet was strengthened to support this effort, with cash, cash equivalents, and short-term investments reported at $82.6 million as of September 30, 2025, bolstered by a recent public equity offering and an amended Royalty Purchase Agreement (RPA) in July 2025. You can expect a $75 million milestone payment from RTW Investments, LP and certain of its affiliates immediately following FDA approval, which will further fund the launch.

Here's the quick math on the commercial spend leading up to the decision:

Metric	Q3 2025 Amount	Nine Months Ended Sept 30, 2025 Amount
Commercial Expense	$4.6 million	$20.1 million
Prior Year Nine Months Commercial Expense	$1.9 million (Q3 2024)	$6.6 million (Nine Months 2024)
Cash Position (as of Sept 30, 2025)	$82.6 million
Expected Post-Approval Payment	$75 million

The personnel build is a core part of this activity. You are focused on building and training the initial 60-person sales team, which is a major driver of the increased personnel costs within the commercial expense line. If onboarding takes 14+ days, churn risk defintely rises.

Key components of the commercial readiness include:

• Finalizing the commercial strategy overview presented on February 25, 2025.
• Securing intellectual property protection until July 2042 for the repeat dose regimen.
• Ensuring operational expenditures are ramped to launch quickly post-approval.

Conducting the pivotal Phase 3 trial (ReVeRA-301) for AFib-RVR

While PSVT is the immediate focus, the pipeline for the second indication, Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR), is structured. The pivotal Phase 3 protocol, ReVeRA-301, has been finalized. However, to concentrate resources on the impending PSVT launch, Milestone Pharmaceuticals has paused enrollment initiation for this study. The plan is to leverage the data from the PSVT New Drug Application (NDA) alongside the results from the single planned AFib-RVR Phase 3 study to pursue a supplemental NDA pathway later.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Key Resources

You're looking at the core assets Milestone Pharmaceuticals Inc. (MIST) is relying on right now to push CARDAMYST™ across the finish line. These aren't just line items; they are the foundation for their potential commercial future, especially with the Prescription Drug User Fee Act (PDUFA) target date for the New Drug Application (NDA) in Paroxysmal Supraventricular Tachycardia (PSVT) set for December 13, 2025.

The most immediate, tangible resource is the capital base. As of September 30, 2025, Milestone Pharmaceuticals had $82.6 million in cash, cash equivalents, and short-term investments. This figure is up from $69.7 million at the close of December 31, 2024. This liquidity was bolstered by a successful underwritten public offering in July 2025, which provided immediate net proceeds of approximately $48.7 million.

The intellectual property surrounding etripamil is critical. The lead drug candidate is Etripamil, delivered as CARDAMYST™ nasal spray. Milestone Pharmaceuticals secured a Notice of Allowance for a new Method of Use patent from the United States Patent and Trademark Office (USPTO). This specific patent covers the repeat dose regimen used in the RAPID Phase 3 study.

Here's a breakdown of what that IP protection looks like:

• Method of Use Patent covers repeat dose regimen.
• Potential U.S. intellectual property protection extends until July 2042.
• This represents an additional 6 years of potential protection.
• The repeat dose involves administering a second 70 mg dose ten minutes after the initial dose.

The clinical evidence supporting Etripamil is another primary resource. The data comes from extensive trials, including the Phase 3 NODE program. New analysis presented at the American Heart Association (AHA) Scientific Sessions 2025 included data from 622 unique enrolled patients across multiple studies.

You can see how the investment has been allocated leading up to this critical period:

Financial Metric (Nine Months Ended September 30, 2025)	Amount
Research and Development Expense	$12.6 million
Commercial Expense	$20.1 million
Net Loss	$45.6 million

Furthermore, the company has a contingent financial resource tied to regulatory success. They are expecting a $75 million royalty payment upon FDA approval for CARDAMYST™. The operational spending reflects launch readiness, with commercial expense for the nine months ending September 30, 2025, at $20.1 million, up from $6.6 million for the same period in 2024. Still, the third quarter of 2025 saw a net loss of $11.9 million. Finance: review the burn rate against the $82.6 million cash position by next Tuesday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Value Propositions

You're looking at the core benefit Milestone Pharmaceuticals Inc. (MIST) is bringing to the table with CARDAMYST (etripamil) nasal spray, especially as we approach the Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025. This isn't just another drug; it's a fundamental shift in how symptomatic Paroxysmal Supraventricular Tachycardia (PSVT) is managed.

Self-administered, rapid-response therapy for PSVT episodes.

The primary value is speed and patient control. Clinical data, presented at the American Heart Association Scientific Sessions 2025 on November 10, clearly shows how quickly etripamil works when a patient uses it themselves. Honestly, this speed is what differentiates it from current standards of care that often require an emergency setting.

Efficacy Metric	Data Point	Context
Median Time to Conversion	18.5 minutes (95% CI: 15.7 to 21.0 minutes)	Across patients self-administering etripamil
Conversion Rate by 30 Minutes	59.6% (Range: 53.6% to 64.3%)	Kaplan-Meier estimate from pooled data
Conversion Rate by 60 Minutes	63.2% to 75.1%	Across multiple studies
Safety Data Volume	Over 1,050 patients	Favorable and predominantly mild/transient adverse events
Test-Dose Failure Rate	1.4%	Among over 1,100 patients administered in Sinus Rhythm (SR)

This robust dataset, covering analysis from 622 unique enrolled patients across multiple trial designs, supports the claim of consistent efficacy right after self-administration. Also, the safety profile is strong, with favorable data from over 1,050 etripamil-treated patients.

Potential to reduce costly and inconvenient emergency room visits.

You know the drill: a PSVT episode hits, and the patient often ends up in the Emergency Department (ED), which is both a huge burden on the patient and a significant cost driver for the healthcare system. Milestone Pharmaceuticals is positioning CARDAMYST as the tool to stop this cycle. The potential for rapid, self-administered termination of symptomatic PSVT episodes is precisely what's needed to bypass the ED for many events, a condition that frequently leads to those costly visits.

First new pharmacological option for PSVT in defintely decades.

This is a major differentiator. If approved, CARDAMYST will be the first and only self-administered therapy for the rapid termination of PSVT episodes. This novelty is recognized by the market; results from an independent survey published on May 6, 2025, showed that 40% of respondents, including payers, providers, and academics, selected CARDAMYST as the new drug expected to make the biggest difference in patient health. It's a first-in-class opportunity.

Portable, on-demand treatment empowering patient self-management.

The product is designed to be carried and used immediately, bypassing the need for immediate medical oversight. This aligns perfectly with the company's initial design goal for etripamil nasal spray. The financial preparation for this launch is evident in their Q3 2025 figures, showing a significant ramp-up in commercial expense, which hit $4.6 million for the third quarter of 2025, up from $1.9 million the prior year, reflecting the operational readiness for a commercial rollout.

Here's a quick look at the financial backing for this launch, as of September 30, 2025:

• Cash, cash equivalents, and short-term investments: $82.6 million
• Net proceeds from recent public equity offering: approximately $48.7 million
• Contingent royalty payment upon FDA approval: $75 million
• Commercial expense for nine months ended September 30, 2025: $20.1 million

The ability to deploy this portable treatment is backed by a balance sheet strengthened by the recent equity raise and the expected royalty payment, which management believes will fund a successful commercial launch.

Finance: draft 13-week cash view by Friday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Customer Relationships

You're preparing for a product launch that hinges on physician adoption and patient self-management, so the relationships you build now are critical. Milestone Pharmaceuticals Inc. (MIST) is clearly structuring its customer relationships around deep clinical engagement and readiness for commercial execution, even while pre-revenue as of late 2025.

High-touch engagement with cardiologists and electrophysiologists

Milestone Pharmaceuticals Inc. has been actively engaging with the cardiology community, using clinical data presentation as a primary touchpoint. This engagement is focused on specialists who manage patients with paroxysmal supraventricular tachycardia (PSVT), which affects over two million Americans, with a target addressable market of approximately 60% of those patients actively managed by cardiologists.

The company presented new analysis from its etripamil clinical trials at the American Heart Association (AHA) Scientific Sessions 2025 on November 10, 2025. This scientific outreach is key to building trust with the prescribers. The data presented covered efficacy and safety from studies involving more than 600 unique enrolled patients. For the self-administered nature of CARDAMYST, the clinical data points are the core of the relationship-building effort:

• Median time to conversion for PSVT to sinus rhythm was 18.5 minutes across studies.
• The Kaplan-Meier estimate for conversion by 30 minutes was 59.6% (range: 53.6% to 64.3%).
• Safety data was favorable across over 1,050 etripamil-treated patients.
• Test-dose failures were low at 1.4% among over 1,100 patients administered etripamil.

This focus on clinical evidence is supported by significant pre-launch spending. Commercial expense for the nine months ending September 30, 2025, reached $20.1 million, up from $6.6 million in the prior year period, directly reflecting the ramp-up in operational expenditures related to launch preparation. That's a big spend before the first dollar of revenue.

Dedicated patient support and education programs post-launch

While Milestone Pharmaceuticals Inc. reported no revenue for the third quarter ended September 30, 2025, as it remains pre-commercial, the nature of its lead product, CARDAMYST (etripamil) nasal spray, mandates a strong patient support infrastructure for self-administration without medical supervision. The company's stated focus is on improving the patient experience and providing patients with an active role in self-managing their care.

The planned customer relationship structure for patients is implied by the commercial readiness activities, though specific post-launch patient support enrollment numbers aren't available yet as of late 2025. Here is what we know about the readiness context:

Metric	Value/Status (As of Q3 2025)
PSVT Target Addressable Market Managed by Cardiologists	Approximately 60% of over 2 million Americans
AFib-RVR Target Market (by 2030)	Up to four to five million patients
Commercial Expense (9 Months Ended 9/30/2025)	$20.1 million
Launch Readiness Posture	Quick-start capability emphasized following the December 13, 2025 PDUFA date

The company is preparing for a potential launch around the December 13, 2025 PDUFA date, which means patient education materials and support systems are a top priority for the commercial team.

Direct communication with investors and financial markets

Milestone Pharmaceuticals Inc. maintains a transparent, though pre-revenue, dialogue with the financial community, which is crucial given its capital-intensive development stage. The company's financial position as of September 30, 2025, reflects recent successful capital raising efforts to support this commercial build-out.

The company completed an underwritten public offering providing immediate net proceeds of approximately $48.7 million in July 2025. This, combined with an amended Royalty Purchase Agreement (RPA), is expected to fund the launch, which includes a $75 million royalty payment upon FDA approval.

Key financial metrics as of the end of Q3 2025 show the capital base supporting these relationships:

• Cash, cash equivalents, and short-term investments: $82.6 million as of September 30, 2025.
• Net Loss for Q3 2025: $11.9 million.
• Management expressed confidence in sustaining operations over the next 12 months.

Direct communication is executed through regular updates and participation in key industry conferences. For instance, the company provided updates at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, and the Jefferies Global Healthcare Conference on June 5, 2025. This consistent presence helps manage market expectations ahead of the critical PDUFA date.

Finance: draft 13-week cash view by Friday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Channels

You're preparing for a product launch that hinges entirely on effective outreach, so understanding Milestone Pharmaceuticals Inc. (MIST)'s channel strategy as of late 2025 is key. Since the Prescription Drug User Fee Act (PDUFA) target action date for CARDAMYST™ was set for December 13, 2025, the channels discussed here reflect the company's pre-launch build-out and 'quick-start capability' readiness for a mid-2026 revenue ramp, despite earlier mid-2025 launch targets.

Specialty pharmaceutical distributors and pharmacies

For a self-administered therapy like CARDAMYST, access through the right distribution network is non-negotiable. While Milestone Pharmaceuticals Inc. (MIST) hasn't disclosed specific contracts with major specialty pharmaceutical distributors as of late 2025, the entire commercial infrastructure build-out signals that these relationships are being finalized. The company's focus on market access, which is a key component of commercial readiness, means securing favorable formulary placement with payers and establishing efficient logistics with third-party logistics (3PL) providers and specialty pharmacies to ensure the product reaches the patient post-approval. This is the backbone for getting the product from the manufacturer to the patient's hands.

Direct sales force targeting high-volume prescribers

Milestone Pharmaceuticals Inc. (MIST) has been actively scaling its commercial team in anticipation of a positive FDA decision. The initial launch sales team is planned to consist of approximately 60 professionals, with regional sales management expected to be on board in February 2025 to lead this effort. This team is designed to target high-volume prescribers of Paroxysmal Supraventricular Tachycardia (PSVT) treatments. The investment in this channel is evident in the rising commercial expenses reported through the third quarter of 2025.

Here's a look at the financial commitment to activating these commercial channels:

Metric	Q3 2025 Amount	Nine Months Ended Sept 30, 2025 Amount
Commercial Expense	$4.6 million	$20.1 million
Prior Year Q3 Commercial Expense	$1.9 million	$6.6 million (Nine Months Ended Sept 30, 2024)

The jump in commercial expense to $4.6 million in Q3 2025 from $1.9 million in Q3 2024 shows a clear ramp-up in pre-launch activities, including hiring and initial marketing groundwork. Honestly, that nine-month spend of $20.1 million is what you spend when you're serious about a national rollout.

Medical conferences (e.g., AHA, ACC) and peer-reviewed journals

The medical affairs channel is crucial for establishing clinical credibility for CARDAMYST, a first-in-class therapy. Milestone Pharmaceuticals Inc. (MIST) uses major medical meetings to disseminate data and engage key opinion leaders. You can track their channel activity through their conference presence:

• Data from the NODE-303 trial was presented at the American College of Cardiology (ACC25) in March 2025.
• The company participated in the Jefferies Global Healthcare Conference on June 3-5, 2025.
• Executive updates were provided at the H.C. Wainwright 27th Annual Global Investment Conference on September 8-10, 2025.
• New analyses from etripamil clinical trials were presented at the American Heart Association (AHA) Scientific Sessions 2025 on November 10.

Also, etripamil gained recognition in the latest AHA Advanced Cardiovascular Life Support (ACLS) Guidelines, which is a massive channel endorsement.

Digital marketing and patient advocacy groups

While specific digital marketing spend figures aren't itemized separately from the general commercial expense, the strategy is clearly in place. The company highlighted CARDAMYST in an independent Survey of Managed Care professionals in Q1 2025, which is a form of targeted professional outreach that bridges marketing and market access. Furthermore, the product is designed to empower patients to self-manage episodes, which inherently requires a strong patient-facing digital and advocacy channel strategy to drive adoption and adherence. The company's focus on patient-centric care suggests this channel is a high priority for post-approval execution.

Finance: finalize the Q4 2025 commercial expense projection by next Tuesday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Customer Segments

You're preparing for the CARDAMYST (etripamil) nasal spray launch, pending the December 13, 2025, PDUFA date. Understanding who needs this product is step one.

Patients with symptomatic Paroxysmal Supraventricular Tachycardia (PSVT)

This is the immediate, primary target. The prevalence data suggests a significant, though relatively rare, patient pool in the US. We project annual prevalence estimates based on claims data for patients under age 65 ranged from 1,107,101 to 1,396,182 unique PSVT patients over a single study year. You should know that the national prevalence of symptomatic PSVT has been estimated as high as 168 per 100,000 adults. To be fair, in a prior analysis, the prevalence of symptomatic PSVT was 140 per 100,000 (95% confidence interval, 100 to 179). Also, 24% of incident cases documented PSVT at the first symptomatic episode, indicating a segment that may not have prior treatment experience.

Here's the quick math on the US symptomatic PSVT population estimates:

Metric	Value	Source Context
Estimated National Prevalence (High)	168 per 100,000 adults	General US Population Estimate
Estimated National Prevalence (Low)	140 per 100,000 adults	Kaiser Permanente Study Estimate
Projected Annual Unique Patients (<65 Yrs)	Max 1,396,182	Claims Data Projection
PSVT Prevalence (General Population)	Approx. 0.2%	General Prevalence Figure

If onboarding takes 14+ days, churn risk rises.

Cardiologists and Electrophysiologists (primary prescribers)

These are the gatekeepers who will write the first prescriptions for CARDAMYST, especially given that contemporary guidelines recommend electrophysiology study and ablation as first-line treatment, leaving a gap for acute, self-administered management. We have data from the clinical program that supports their interest.

• Results from over 600 unique enrolled patients showed aligned efficacy and safety of etripamil across multiple study phases presented at AHA Scientific Sessions 2025 on November 10.
• A 2024 Citi survey polled 72 specialized physicians on new technologies, split evenly between 36 electrophysiologists and 36 cardiovascular surgeons.
• The company's commercial expense ramped to $20.1 million for the nine months ending September 30, 2025, reflecting investment in the prescriber base preparation.

Managed Care Organizations (MCOs) and other third-party payers

Payer acceptance dictates patient access and, ultimately, revenue realization. The company is preparing for launch with a strengthened balance sheet, which includes $82.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025. Furthermore, a $75 million royalty payment is contingent upon FDA approval. This financial footing supports the planned quick-start launch capability.

Payer sentiment is a key leading indicator for formulary success:

Survey/Metric	Finding	Date Context
Top Drug for Patient Health Impact (Payer/Provider Survey)	Selected by 40% of respondents	May 6, 2025
Q3 2025 Commercial Expense	$4.6 million	Pre-launch/Payer Engagement Costs
Net Proceeds from Equity Offering (July 2025)	Approx. $48.7 million	Funding Launch Readiness

Patients with Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) (future)

This represents a significant future expansion segment, though the NDA for this indication was submitted in October 2023, and enrollment for the Phase 3 trial was paused to prioritize the PSVT CRL resolution. The broader Atrial Fibrillation market provides context for this potential market size. The Global Atrial Fibrillation Market is estimated to be valued at USD 26.43 Bn in 2025. In the US specifically, approximately 5 million Americans were living with AFib as of March 2025, with projections surpassing 12 million by 2030. The pharmacological treatments segment held the largest revenue share of 53.6% in 2025 globally.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Cost Structure

You're looking at the cost side of Milestone Pharmaceuticals Inc. as they stand right before the December 13, 2025, PDUFA date for CARDAMYST. The costs are heavily weighted toward getting the drug to market, which is typical for a pre-commercial biotech.

The primary cost drivers reflect the ramp-up for the potential launch of CARDAMYST (etripamil) nasal spray for symptomatic PSVT (Paroxysmal Supraventricular Tachycardia). You can see the financial commitment in the operating expenses reported through the third quarter of 2025.

Expense Category	Q3 2025 Amount	Nine Months Ended September 30, 2025 Amount
Commercial Expense	$4.6 million	$20.1 million
Research and Development (R&D) Expense	$3.9 million	$12.6 million
General and Administrative (G&A) Expense	$3.3 million	$12.2 million

Commercial launch expenses totaled $20.1 million through the first nine months of 2025, a significant jump from $6.6 million in the prior year period. This spending covers the necessary operational expenditures to launch quickly upon potential FDA approval.

Research and Development (R&D) costs for pipeline expansion, specifically for etripamil in the AFib-RVR indication, show a continued investment, though enrollment initiation for the Phase 3 ReVeRA-301 study is paused to prioritize the PSVT launch readiness.

• R&D expense for the nine months ended September 30, 2025, was $12.6 million.
• This R&D increase was primarily due to higher consulting and outside service costs.
• The Phase 3 protocol for AFib-RVR was finalized, but enrollment start is currently paused.

Manufacturing, quality control, and supply chain logistics costs are embedded within the operating expenses, particularly the rising Commercial Expense, which includes operational expenses for launch preparation. Milestone Pharmaceuticals Inc. is currently pre-revenue, with no sales reported for Q3 2025.

General and Administrative (G&A) overhead and personnel costs saw a slight moderation year-over-year for the nine-month period, though they still represent a fixed cost base.

• G&A expense for the nine months ended September 30, 2025, was $12.2 million.
• The Q3 2025 G&A expense was $3.3 million, down from $3.7 million in Q3 2024, primarily due to a decrease in professional fees and personnel costs between those quarters.

The company's cash position is a key factor in funding these costs. As of September 30, 2025, Milestone Pharmaceuticals Inc. held $82.6 million in cash, cash equivalents, and short-term investments. This balance was bolstered by net proceeds of approximately $48.7 million from an equity offering and an amended Royalty Purchase Agreement in July 2025. Furthermore, a potential $75 million royalty payment upon FDA approval is expected to support the commercial launch.

The overall cost of operations resulted in a net loss of $45.6 million for the first nine months of 2025.

Finance: draft 13-week cash view by Friday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Revenue Streams

You're looking at Milestone Pharmaceuticals Inc.'s revenue picture as of late 2025, which is entirely focused on the near-term binary event of the FDA decision for CARDAMYST™ (etripamil) nasal spray. Honestly, the current revenue is zero, which is expected for a pre-commercial company, but the potential future inflows are what matter right now.

Milestone Payment Upon Potential FDA Approval

The most immediate, concrete financial event tied to revenue streams is the milestone payment contingent on FDA approval for the lead indication, Paroxysmal Supraventricular Tachycardia (PSVT). Milestone Pharmaceuticals has an agreement in place to receive this cash infusion, which is a key component of their launch funding.

• Contingent payment amount: $75 million.
• Trigger: Potential FDA approval of CARDAMYST for PSVT.
• PDUFA target action date: December 13, 2025.
• The associated Royalty Purchase Agreement (RPA) with RTW Investments was extended to December 31, 2025, to cover this eventuality.

This $75 million is expected to be a non-dilutive source of capital, bolstering the balance sheet which stood at $82.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025. That cash position was strengthened by a recent equity financing of approximately $48.7 million in net proceeds.

Product Sales of CARDAMYST™ (etripamil) Post-Commercial Launch

As of the third quarter of 2025, Milestone Pharmaceuticals reported no revenue, which aligns with the expectation that 2025 sales would be $0.0M since the company is pre-commercial and awaiting the December regulatory decision. The commercial team is fully prepared for a 'quick-start capability' upon approval, meaning sales would realistically begin generating revenue in early 2026, not 2025.

The market opportunity for the PSVT indication alone is estimated to be a $1.2 billion market by 2028, assuming 15% market penetration.

Potential Future Royalty Payments from the RTW Investments Agreement

The $75 million payment is tied to a Royalty Purchase Agreement (RPA) with RTW Investments, which converts into tiered royalty payments on U.S. net sales of etripamil post-approval. This structure creates a long-term, albeit variable, revenue stream dependent on commercial success.

Here's how those tiered royalty rates are structured based on annual net sales thresholds:

Annual Net Sales Threshold	Royalty Rate Paid to RTW Investments
Up to $500 million	7% (Initial Tier Royalty)
Greater than $500 million and less than or equal to $800 million	4%
Greater than $800 million	1%

To be fair, if certain revenue thresholds are missed, the Initial Tier Royalty can increase to 9.5% starting January 1 of the following calendar year until a subsequent sales threshold is met.

Future Product Sales from the AFib-RVR Indication (Pipeline)

While PSVT is the immediate focus, the second indication for Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) represents a significant upside to future product sales, though it is further out on the timeline. Milestone Pharmaceuticals has finalized the Phase 3 protocol (ReVeRA-301), but enrollment initiation is currently paused to prioritize the PSVT launch readiness.

• The Phase 3 protocol for AFib-RVR is finalized.
• Enrollment initiation is paused to focus on the PSVT launch.
• Analyst projections suggest potential revenue over $1 billion if both PSVT and AFib-RVR indications are approved.

So, you're looking at a revenue model that transitions from a single, large, contingent payment in late 2025 to a commercial product stream in 2026, with a second, major revenue driver still in the pipeline. Finance: draft 13-week cash view by Friday.