-- FDA approval of CARDAMYST represents first new option in 30 years for the
more than two million patients with PSVT
-- Participants using CARDAMYST in clinical studies were 2x more likely to
convert symptomatic PSVT to sinus rhythm and did so more than 3x faster
compared with placebo
-- CARDAMYST launch execution on track with positive initial engagement in
the product from healthcare providers and payers
-- $200 million pro forma cash supports strong launch and operating runway
into late 2027; includes $106 million of cash at year-end and net
proceeds from subsequent financing activities1
-- Company to host investor call and webcast at 8:30am ET today
MONTREAL and CHARLOTTE, N.C., March 20, 2026 (GLOBE NEWSWIRE) -- Milestone$(R)$ Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the fourth quarter and full year ending December 31, 2025, and provided corporate and regulatory updates. The main drivers of the fourth quarter and full year 2025 activities include the U.S. Food and Drug Administration (FDA) approval of CARDAMYST$(TM)$ (etripamil) nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults and product launch during this transformational year.
"We are excited to see that our commercial launch of CARDAMYST and the initial engagement with providers, patients and payers is tracking or exceeding our pre-launch expectations," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Our national sales force was fully deployed within eight weeks of our mid-December approval. Feedback from prescribers supports our belief that there is meaningful demand for a convenient, self-administered option to treat episodes of PSVT, and patient reactions to having CARDAMYST in hand is inspiring."
Launch Progress for CARDAMYST
-- CARDAMYST nasal spray was approved by the FDA on December 12, 2025. The
FDA approval marks the first time that more than two million Americans
with PSVT have a rapid-acting treatment option they can self-administer
outside the emergency department or other healthcare setting.
-- CARDAMYST became broadly available through retail pharmacies in the
United States in late January 2026.
-- National sales force deployed with promotional launch initiated in
mid-February. The sales force, consisting of approximately 60 sales
representatives, is engaging primarily with cardiologists,
electrophysiologists and advanced practice providers in the office-based
setting.
-- Initial prescription status. Early prescription fills support underlying
demand and the effectiveness of our investments in reimbursement support
ahead of coverage by payers. Most of the prescriptions filled to date are
new patient starts and have been written by providers who are targeted by
our sales force. As we accumulate a critical mass of data, future
quarterly announcements are expected to report figures on prescriptions
and prescribers, including total prescriptions, unique prescribers and
new patient starts.
-- Marketing authorization application $(MAA)$ for etripamil nasal spray in
PSVT accepted by the European Medicines Agency $(EMA)$. The MAA
incorporates the global clinical data package that supported
the FDA approval of etripamil for the treatment of PSVT. A European
decision on approval is expected by the first half of 2027. TACHYMIST(TM)
is the conditionally approved brand name for etripamil nasal spray
in Europe.
Presentation of CARDAMYST at the American College of Cardiology (ACC) Scientific Session
-- A poster "Minimal Blood Pressure Effects of Intranasal Etripamil for
PSVT" will be presented at the ACC Annual Scientific Session, March 30,
in New Orleans. The poster summarizes analysis of mean heart rate and
blood pressure changes measured during clinical trials of CARDAMYST. The
results demonstrate minimal blood pressure reduction during test dose and
rare symptoms of hypotension or syncope, supporting the potential safe,
self-administration of CARDAMYST for PSVT treatment.
-- ACC Scientific Session to serve as a major launch event for the
cardiology community. The meeting will provide an opportunity to
highlight CARDAMYST's clinical profile and engage prescribing physicians
as commercial activities accelerate.
Etripamil for Patients with Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR)
-- Phase 3 program in AFib-RVR planned. The Company has developed a Phase 3
registrational program (incorporating the FDA's guidance) to evaluate
self-administered etripamil as a potential treatment for patients with
AFib-RVR. The Company intends to follow the supplemental New Drug
Application (sNDA) regulatory approval pathway and expects to leverage
the initial PSVT indication along with the results from the planned
single Phase 3 study.
Subsequent Financing Activities
-- $75 million payment received under the Purchase and Sale Agreement (as
amended, the Royalty Purchase Agreement) with RTW. Milestone received a
$75 million payment from RTW Royalty I DAC, an affiliate of RTW
Investments, LP (RTW), on January 12, 2026, in connection with the FDA
approval of CARDAMYST. Milestone and RTW entered into the Royalty
Purchase Agreement in 2023 (amended in July 2025) providing RTW with the
right to receive tiered quarterly royalty payments, or "royalty interest,
" on the annual net product sales of CARDAMYST in the United States.
-- $19 million in net proceeds from ATM sales and Series A Warrant
exercises. Milestone sold 5,526,590 shares through the Open Market Sale
AgreementSM with Jeffries LLC for net proceeds of $10.9 million, after
deducting sales agent commissions payable by the Company of $0.3 million.
In addition, 5,666,666 Series A Warrants were exercised for net proceeds
of $8.0 million, after deducting underwriting commissions payable by the
Company of $0.5 million.
Corporate Updates
-- David Sandoval appointed as General Counsel and Chief Compliance Officer.
Milestone announced the appointment of David Sandoval as General Counsel
and Chief Compliance Officer on February 10, 2026. Mr. Sandoval brings
more than 15 years of experience leading legal and compliance functions
across the life sciences sector, with a particular focus on late-stage
development, regulatory approval and first-product commercialization.
Fourth Quarter and Full Year 2025 Financial Results
-- As of December 31, 2025, Milestone had cash, cash equivalents, and
short-term investments of $106.0 million, compared to $69.7
million on December 31, 2024.
-- There was $1.5 million of revenue recorded for the fourth quarter or full
year ended December 31, 2025. The current year revenue was the result of
a milestone pursuant to the Company's License and Collaboration Agreement
with Corxel Pharmaceuticals due upon the successful NDA approval by the
FDA in the U.S. of CARDAMYST for the treatment of PSVT.
-- Research and development expense for the fourth quarter of 2025 was $5.5
million, compared with $3.9 million for the prior year period. For the
full year ended December 31, 2025, research and development expense
was $18.1 million, compared with $14.4 million for the prior year. The
increase was primarily due to higher consulting and outside service costs,
which were partially offset by lower personnel-related costs.
-- General and administrative expense for the fourth quarter of 2025
was $5.1 million, compared with $4.0 million for the prior year period.
For the full year ended December 31, 2025, general and administrative
expense was $17.3 million, compared with $16.7 million for the prior
year. This increase was driven primarily by an increase in outside
service costs and higher personnel costs.
-- Commercial expense for the fourth quarter of 2025 was $8.2 million,
compared with $4.4 million for the prior year period. For the full year
ended December 31, 2025, commercial expense was $28.3 million, compared
with $11.0 million for the prior year. This increase is primarily a
result of additional personnel costs, professional costs and other
operational expenses related to preparation for the launch of CARDAMYST.
-- For the fourth quarter of 2025, net loss was $17.4 million or $0.16 per
share, compared to a net loss of $12.4 million or $0.19 per share for the
prior year period. For the full year ended December 31, 2025, Milestone's
net loss was $63.1 million or $0.75 per share, compared to a net loss
of $41.5 million or $0.67 per share for the prior year.
For further details on the Company's financials, refer to the Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 20, 2026.
Conference Call and Webcast Details
Conference Dial-in: 1-877-407-0792 International Dial-in: 1-201-689-8263 Conference ID: 13759195 Webcast link: click here
Call me(TM): Participants can use Guest dial-in numbers above and be answered by an operator OR click the Call me(TM) link for instant telephone access to the event. The Call me(TM) 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 "Investors and Media" section of Milestone's corporate website, www.milestonepharma.com.
About CARDAMYST
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