Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
Indicate by check mark
whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405
of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).
If an emerging growth
company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
On August 12, 2026, Milestone Pharmaceuticals
Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2026 and other business highlights.
A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
The information provided in this Item 2.02, including
Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in
such filing.
(d) Exhibits.
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Exhibit 99.1
Milestone Pharmaceuticals Announces Second
Quarter 2026 Financial Results and Provides Corporate Update
Over 50%
of commercially insured lives in the U.S., representing a recent and significant increase, now have coverage for CARDAMYST®
(etripamil) nasal spray
Phase 3 registrational trial of
etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR) first clinical sites activated, advancing Milestone’s
potential, second cardiovascular indication
$170.6 million in cash, cash equivalents and short-term
investments as of June 30, 2026, provides runway into H2 2027
Company to host investor call and webcast at 8:30am
ET today
MONTREAL and CHARLOTTE,
N.C., August 12, 2026 – Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical
company focused on the development and commercialization of innovative cardiovascular medicines, today announced financial results for
the second quarter ended June 30, 2026, and provided corporate and regulatory updates.
“We continue to make steady progress on
the launch of CARDAMYST for PSVT supported by prescription growth from a widening base of new prescribers and a meaningful recent increase
in insurance coverage. We are confident that this increased coverage paired with optimized sales and marketing strategies positions us
to drive acceleration of CARDAMYST prescriptions moving forward,” said Joseph Oliveto, President and Chief Executive Officer of
Milestone Pharmaceuticals. “Separately, we have activated several sites in our Phase 3 ReVeRA-301 trial in AFib-RVR and look forward
to enrolling the first patient. AFib-RVR is one of the most common heart arrhythmias, affecting millions of Americans. The trial is evaluating
the same self-administered regimen already approved in PSVT, giving us a clear path toward extending etripamil to a larger, adjacent patient
population.”
Launch Progress for CARDAMYST
CARDAMYST®
(etripamil) nasal spray was launched for paroxysmal supraventricular tachycardia (PSVT) in mid-February 2026.
| · | More than 800 unique prescribers have
started patients on CARDAMYST through June 30, compared to approximately 200 at the
end of Q1. |
| · | More than 1,500 scripts for CARDAMYST
have been filled for more than 1,300 patients with PSVT through June 30, 2026, compared
to approximately 300 scripts for 300 patients at the end of Q1. |
| · | Commercial
lives covered remained relatively unchanged through Q2 at approximately 25%; however, covered lives have significantly grown to approximately
50% to date as a result of recently reported formulary coverage for CARDAMYST from UnitedHealthcare and several other prominent commercial
insurers. |
| · | CARDAMYST
has been nominated for the 2026 Prix Galien USA Awards for “Best Pharmaceutical Product.” |
Regulatory and Clinical Updates
Regulatory review of the marketing
authorization application for etripamil for PSVT in Europe remains on track for a decision from the European Medicines Agency (EMA) in
the first half of 2027. The New Drug Application for etripamil for PSVT in China is currently under review by China’s National
Medical Products Administration (NMPA). Our partner, Everest Medicines, is responsible for engagement with the NMPA for the program.
Two new articles have been published in the peer-reviewed
Journal of the American College of Cardiology: Advances, supporting the efficacy, safety and emerging role of CARDAMYST for the
management of PSVT.
| · | Paroxysmal
Supraventricular Tachycardia Treatment: Evaluating the Evidence for Established and Newly
Approved Options, a summarization of the current acute PSVT treatment landscape, that
includes the limitations of existing management approaches and the emerging role of etripamil
nasal spray as an acute, self-administered option for outside of the healthcare setting.
|
| · | Minimal
Blood Pressure Effects of Intranasal Etripamil for Paroxysmal Supraventricular Tachycardia,
an analysis showing that intranasal etripamil has minimal blood pressure effects, with hypotension
and syncope occurring rarely across more than 1,600 clinical trial participants. |
Additionally, “The
Impact of Paroxysmal Supraventricular Tachycardia on Patients’ Daily Life and Quality of Life Between Episodes,” an analysis
which demonstrates the substantial burden between PSVT episodes, PSVT patients’ quality of life and full participation in daily
activities, will be presented at the upcoming European Society of Cardiology (ESC) Congress, August 28-31, 2026.
Phase
3 registrational trial in atrial fibrillation with rapid ventricular rate (AFib-RVR) is now
open and enrolling patients. The ReVeRA-301 Phase 3 registrational trial evaluating self-administered
etripamil as a potential treatment for patients with AFib-RVR is now open, with several sites activated and evaluating patients for enrollment.
Previously announced plans to enroll the first patient in the second half of 2026 remain on track. The Company intends to follow the supplemental
New Drug Application (sNDA) regulatory approval pathway and expects to leverage the initial PSVT indication and its safety database along
with the results from the planned Phase 3 study in AFib-RVR.
Second Quarter 2026 Financial Results
As of June 30, 2026, Milestone had cash,
cash equivalents, and short-term investments of $170.6 million, compared to $106.0 million as of December 31, 2025. The Company
currently expects its cash, cash equivalents and short-term investments to be sufficient to cover operating expenses and capital expenditure
into the second half of 2027.
Product revenues were $0.6 during the three months
ended June 30, 2026. There was no product revenue during the three months ended June 30, 2025. For the six months ended June 30,
2026, product revenues were $0.8 million. There was no product revenue during the six months ended June 30, 2025.
Research and development expense for the three
months ended June 30, 2026, was $3.5 million, compared with $3.7 million for the prior year period. For the six months ended June 30,
2026, research and development expense was $6.8 million, compared with $8.6 million for the same period in 2025. The decrease was a result
of a decrease in outside service costs related to drug development and research.
Selling, general and administrative expense for
the three months ended June 30, 2026, was $22.6 million, compared with $8.9 million for the prior year period. For the six months
ended June 30, 2026, selling, general and administrative expense was $43.3 million, compared with $24.4 million for the same period
in 2025. The increase was a result of additional personnel costs, professional costs, and other operational expenses related to the launch
of CARDAMYST.
For the three months ended June 30, 2026,
net loss was $28.6 million or $0.21 per share, compared to a net loss of $13.0 million or $0.20 per share for the prior year period.
For the six months ended June 30, 2026, net loss was $54.7 million, or $0.41 per share, compared with $33.7 million, or $0.51 per
share, for the same period in 2025.
For further details on the Company’s financials,
refer to the Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the U.S. Securities and Exchange
Commission (SEC) today.
Conference Call and Webcast Details
| Conference Dial-in: |
1-877-407-0792 |
| International Dial-in: |
1-201-689-8263 |
| Conference ID: |
13761073 |
| Webcast link: |
click here |
CallMe™ link:
https://callme.viavid.com/viavid/?callme=true&passcode=13756738&h=true&info=company-email&r=true&B=6
CallMe™: Participants can use guest dial-in
numbers above and be answered by an operator OR click the CallMe™ link for instant telephone access to the event. The CallMe™
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
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:
| · | are
allergic to CARDAMYST or any of its ingredients. See the Patient Information for a complete
list of ingredients in CARDAMYST. |
| · | have
limitations in activities due to heart failure (moderate to severe heart failure). |
| · | have
Wolff-Parkinson-White (WPW) syndrome, Lown-Ganong-Levine syndrome, or an abnormal heart rhythm
pattern called pre-excitation (delta wave) on an electrocardiogram (ECG). |
| · | have
sick sinus syndrome without a permanent pacemaker. |
| · | have
second degree or higher atrioventricular (AV) block. |
Before using CARDAMYST, tell your healthcare
provider about all of your medical conditions, including if you:
| · | have
a history of fainting. |
| · | have
low blood pressure. |
| · | are
pregnant or plan to become pregnant. It is not known if CARDAMYST will harm your unborn baby. |
| · | are
breastfeeding or plan to breastfeed. It is not known if CARDAMYST passes into your breast
milk. You should stop breastfeeding for 12 hours after treatment with CARDAMYST. During this
time, pump and throw away your breast milk. Talk to your healthcare provider about the best
way to feed your baby after using CARDAMYST. |
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:
| · | Fainting
due to CARDAMYST effects on blood pressure, heart rate, and electrical activity of the heart. CARDAMYST
may cause dizziness and fainting, especially in people with a history of fainting and certain
heart problems, or people with a history of fainting during an episode of PSVT. Use CARDAMYST
while sitting in a safe area where you will not fall if you become dizzy or lightheaded.
Lie down if you feel dizzy or lightheaded after using CARDAMYST. If fainting occurs after
using CARDAMYST, caregivers should place you on your back and seek medical help. |
The most common side effects of CARDAMYST
include:
·
nasal discomfort
·
nasal congestion
·
runny nose |
·
throat irritation
·
nosebleed |
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.
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/
Cautionary Note on 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 commercialization and adoption of CARDAMYST; the timing and outcomes of future interactions with U.S. and foreign regulatory
bodies, including the FDA, EMA and NMPA; the expected timing of initiation, completion, and results and data of Milestone’s ongoing
and planned clinical studies, including the Phase 3 study in AFib-RVR; Milestone’s anticipated cash runway; 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 MMA 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 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. 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.
# # #
Contact:
Investor Relations
Kevin Gardner, kgardner@lifesciadvisors.com
Media Relations
Rebecca Novak, rnovak@milestonepharma.com
Milestone Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands of U.S. dollars, except share
data)
| | |
June 30, 2026 | | |
December 31, 2025 | |
| Assets | |
| | | |
| | |
| | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 169,728 | | |
$ | 73,046 | |
| Short-term investments | |
| 881 | | |
| 32,914 | |
| Accounts receivable, net | |
| 2,720 | | |
| — | |
| License receivable | |
| — | | |
| 1,546 | |
| Research and development tax credits receivable | |
| 515 | | |
| 316 | |
| Prepaid expenses | |
| 1,035 | | |
| 1,805 | |
| Inventory, net | |
| 4,722 | | |
| 648 | |
| Other receivables | |
| 726 | | |
| 1,646 | |
| Total current assets | |
| 180,327 | | |
| 111,921 | |
| Operating lease right-of-use assets | |
| 829 | | |
| 1,129 | |
| Property and equipment, net | |
| 469 | | |
| 511 | |
| Total assets | |
$ | 181,625 | | |
$ | 113,561 | |
| | |
| | | |
| | |
| Liabilities, and Shareholders' Equity | |
| | | |
| | |
| | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable | |
$ | 8,454 | | |
$ | 5,645 | |
| Accrued liabilities | |
| 11,983 | | |
| 7,644 | |
| Operating lease liabilities | |
| 670 | | |
| 647 | |
| Deferred revenue | |
| 1,034 | | |
| — | |
| Other current liabilities | |
| 43 | | |
| 43 | |
| Total current liabilities | |
| 22,184 | | |
| 13,979 | |
| Operating lease liabilities, net of current portion | |
| 192 | | |
| 539 | |
| Senior secured convertible notes | |
| 59,207 | | |
| 57,191 | |
| Royalty financing obligation, long-term | |
| 81,763 | | |
| — | |
| Other long-term liabilities | |
| 61 | | |
| 83 | |
| Total liabilities | |
| 163,407 | | |
| 71,792 | |
| | |
| | | |
| | |
| Shareholders’ Equity | |
| | | |
| | |
| Common shares, no par value, unlimited shares authorized, 124,497,980 shares issued and outstanding as of June 30, 2026, 106,236,344 shares issued and outstanding as of December 31, 2025 | |
| 384,985 | | |
| 352,619 | |
| Pre-funded warrants - 16,412,925 issued and outstanding as of June 30, 2026, and 16,412,925 as of December 31, 2025 | |
| 55,649 | | |
| 55,649 | |
| Additional paid-in capital | |
| 62,867 | | |
| 64,104 | |
| Accumulated deficit | |
| (485,283 | ) | |
| (430,603 | ) |
| | |
| | | |
| | |
| Total shareholders’ equity | |
| 18,218 | | |
| 41,769 | |
| Total liabilities and shareholders’ equity | |
$ | 181,625 | | |
$ | 113,561 | |
Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Loss (Unaudited)
(in thousands of U.S. dollars, except share
and per share data)
| | |
Three months ended June 30, | | |
Six months ended June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Revenues | |
| | | |
| | | |
| | | |
| | |
| Product revenue, net | |
$ | 559 | | |
$ | — | | |
$ | 797 | | |
$ | — | |
| License and other revenue | |
| — | | |
| — | | |
| — | | |
| — | |
| Total revenues | |
| 559 | | |
| — | | |
| 797 | | |
| — | |
| | |
| | | |
| | | |
| | | |
| | |
| Operating Expenses | |
| | | |
| | | |
| | | |
| | |
| Cost of product sales | |
| 32 | | |
| — | | |
| 46 | | |
| — | |
| Research and development, net of tax credits | |
| 3,509 | | |
| 3,669 | | |
| 6,760 | | |
| 8,647 | |
| Selling, general and administrative | |
| 22,648 | | |
| 8,862 | | |
| 43,284 | | |
| 24,407 | |
| Total operating expenses | |
| 26,189 | | |
| 12,531 | | |
| 50,090 | | |
| 33,054 | |
| | |
| | | |
| | | |
| | | |
| | |
| Loss from operations | |
| (25,630 | ) | |
| (12,531 | ) | |
| (49,293 | ) | |
| (33,054 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Interest income | |
| 1,741 | | |
| 516 | | |
| 3,473 | | |
| 1,213 | |
| Interest expense | |
| (4,725 | ) | |
| (951 | ) | |
| (8,860 | ) | |
| (1,886 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss and comprehensive loss | |
$ | (28,614 | ) | |
$ | (12,966 | ) | |
$ | (54,680 | ) | |
$ | (33,727 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average number of shares and pre-funded warrants outstanding, basic and diluted | |
| 138,691,580 | | |
| 66,380,118 | | |
| 134,512,026 | | |
| 66,333,024 | |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss per share, basic and diluted | |
$ | (0.21 | ) | |
$ | (0.20 | ) | |
$ | (0.41 | ) | |
$ | (0.51 | ) |
