Milestone Pharmaceuticals Reports Third Quarter 2026 Financial Results and Announces Cost-Efficiency Measures Designed to Extend Cash Runway Through AFib-RVR Phase 3 Data
Launch of CARDAMYST ® (etripamil) nasal spray marked by steady prescription growth, new prescriber expansion and improving commercial coverage
Company is reducing operating expenses by approximately 30% while prioritizing sales force efforts for CARDAMYST; expects cash runway into late 2028
AFib-RVR Phase 3 trial on schedule with data expected in 2H 2028
MONTREAL and CHARLOTTE, N.C., Nov. 13, 2026 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the quarter ended September 30, 2026, and announced cost-efficiency measures designed to extend cash runway through the topline results from its Phase 3 trial of etripamil in atrial fibrillation with rapid ventricular rate (AFib-RVR), while preserving the sales force and core commercial activities for CARDAMYST ® (etripamil) nasal spray. CARDAMYST is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
Third Quarter and Recent Updates
“We are encouraged by the early progress of CARDAMYST, and as we gain experience in the market, we believe we are better able to identify where our investments can have the greatest potential impact,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “The actions we are announcing today reflect a more efficient approach to capital allocation, which we believe will drive continued prescription growth, expand our prescriber base and improve patient access for CARDAMYST, while reducing operating expenses. Importantly, we expect these measures to extend our cash runway beyond the anticipated Phase 3 readout of ReVeRA-301 in the second half of 2028.”
Key elements of the cost-efficiency measures include:
Financial Outlook
Third Quarter 2026 Financial Results
As of September 30, 2026, Milestone had cash, cash equivalents, and short-term investments of $145.4 million, compared to $106.0 million as of December 31, 2025.
Product revenues were $1.0 million during the three months ended September 30, 2026. For the nine months ended September 30, 2026, product revenues were $1.8 million. There was no product revenue during the three months or nine months ended September 30, 2025.
Research and development expense, net of tax credits, for the three months ended September 30, 2026, was $3.5 million, compared with $3.9 million for the prior year period. For the nine months ended September 30, 2026, research and development expense, net of tax credits, was $10.2 million, compared with $12.6 million for the same period in 2025. The decrease for the three-month period was primarily due to a decrease in outside service costs related to drug development and research. The decrease for the nine-month period was primarily due to decreases in personnel costs and outside service costs related to drug development and research.
Selling, general and administrative expense for the three months ended September 30, 2026, was $24.2 million, compared with $7.9 million for the prior year period. For the nine months ended September 30, 2026, selling, general and administrative expense was $67.5 million, compared with $32.3 million for the same period in 2025. The increases were primarily due to additional personnel costs, professional costs, and other operational expenses related to the launch of CARDAMYST.
For the three months ended September 30, 2026, net loss was $25.8 million, or $0.18 per share, compared with a net loss of $11.9 million, or $0.12 per share, for the prior year period. For the nine months ended September 30, 2026, net loss was $80.5 million, or $0.59 per share, compared with $45.6 million, or $0.60 per share, for the same period in 2025. All net loss per-share amounts are basic and diluted.
For further details on the Company’s financials, refer to the Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, filed with the U.S. Securities and Exchange Commission (SEC) today.
Conference Call and Webcast
Milestone will host a conference call and webcast at 8:30 am ET today, Friday, November 13. To access the live conference call, participants may register here.
Conference Call Details:
Participants can use Guest dial-in #s above and be answered by an operator OR click the Call Me™ link for instant telephone access to the event. The Call Me™ link will be made active 15 minutes prior to scheduled start time.
A replay of the audio webcast of the call will be available under the News & Events section of Milestone's website, www.milestonepharma.com.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST® (etripamil) nasal spray, a novel calcium channel blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in Phase 3 development for the control of symptomatic episodic attacks associated with AFib-RVR. https://milestonepharma.com/.
About CARDAMYST
CARDAMYST ® (etripamil) nasal spray is approved by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. It is a novel calcium channel blocker nasal spray designed as a self-administered rapid response therapy for patients, thereby bypassing the need for immediate medical oversight. The product is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT. Currently, etripamil is in Phase 2 development for treatment of PSVT in pediatric patients and Phase 3 development for control of acute atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults. For more information, please visit CARDAMYST.com.
Indication
CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
IMPORTANT SAFETY INFORMATION FOR CARDAMYST (etripamil)
What is CARDAMYST?
CARDAMYST is a prescription medicine used to help restore normal sinus heart rhythm in adults who have symptoms of sudden episodes of fast heartbeat called paroxysmal supraventricular tachycardia (PSVT).
It is not known if CARDAMYST is safe and effective in children.
Do not use CARDAMYST if you:
Before using CARDAMYST, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of CARDAMYST?
CARDAMYST may cause serious side effects, including:
The most common side effects of CARDAMYST include:
These are not all of the possible side effects for CARDAMYST. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see the full Prescribing Information
https://milestonepharma.com/etripamilprescribinginformation.pdf for CARDAMYST.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: the continued commercialization and adoption of CARDAMYST and Milestone’s planned commercial priorities; the implementation, timing and anticipated benefits of Milestone’s cost-efficiency measures and associated one-time charges; the anticipated reduction in operating expenses of approximately 30%; planned leadership changes and their timing; Milestone’s continued funding and development of the Phase 3 AFib-RVR program, the expected timing of topline data from ReVeRA-301 and the program’s potential value to Milestone; the estimated addressable patient population for AFib-RVR; the anticipated sufficiency of Milestone’s cash resources to fund operations into late 2028 and through the anticipated ReVeRA-301 readout; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to whether Milestone’s future interactions with the EMA will have satisfactory outcomes; whether and when, if at all, Milestone’s MAA for etripamil will be approved by the EMA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of Milestone’s clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs and conflicts, and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related to the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the SEC, including in its annual report on Form 10-K for the year ended December 31, 2025, under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC, including Milestone’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Contacts
Investor Relations
Kevin Gardner, kgardner@lifesciadvisors.com
Media Relations
Rebecca Novak, rnovak@milestonepharma.com
Milestone Pharmaceuticals Inc.
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