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 November 13, 2026, Milestone Pharmaceuticals
Inc. issued a press release announcing its financial results for the third quarter ended September 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 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., -- November 13,
2026 – 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
| • | Net product revenue for CARDAMYST of $1.0 million for Q3 2026, up 73% from the second quarter ended June
30, 2026; approximately 3,400 total prescriptions written by approximately 1,600 unique prescribers since launch; current payer coverage
has increased to approximately two-thirds of commercially covered lives. |
| • | Corporate cost-efficiency measures expected to reduce operating expenses by approximately 30%; executives,
Mr. Amit Hasija (Chief Financial Officer) and Dr. David Bharucha (Chief Medical Officer) have departed from the leadership team, with
David transitioning to an advisor to the Company. |
| • | Amendment to Note Purchase Agreement
with RTW Investments LP and certain of its affiliates (“RTW”) extends the payment-in-kind interest period on its convertible
notes from March 31, 2027 to March 2029. |
| • | Cash and equivalents of $145.4
million as of September 30, 2026, expected to provide operating runway into late 2028, more than one year beyond prior guidance. |
| • | Ongoing Phase 3 pivotal trial (ReVeRA-301) evaluating etripamil nasal spray in atrial fibrillation with
rapid ventricular rate (AFib-RVR) is on schedule; topline data expected in the second half of 2028. |
“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:
| · | Bringing the sales force in-house: the
Company plans to retain the existing field sales team of approximately 45 dedicated representatives, transitioning them from a contracted
model to company employees at a lower overhead cost while maintaining current sales coverage. This team reflects the territory optimization
completed in August, when the field force was reduced from approximately 60 representatives to focus on the strongest-performing representatives
and territories, including those covering electrophysiology and highest-prescribing cardiology accounts. |
| · | Operating efficiencies and cost reductions:
The Company will also concentrate on its most productive targeted marketing, market access and patient support programs while discontinuing
less productive initiatives. The Company is also rightsizing and internalizing selected outsourced activities and reducing its headquarters
workforce. These actions are expected to reduce the Company’s operating expenses by approximately 30% and to be complete by the
first quarter of 2027. The Company expects to incur approximately $2 million in one-time charges, primarily severance, conversion fees
and costs related to the workforce reduction. |
| • | Leadership changes: Consistent with the organizational reduction and runway extension, Mr. Amit
Hasija (Chief Financial Officer) and Dr. David Bharucha (Chief Medical Officer) have departed from the leadership team. Anthony Krick,
the Company’s Vice President of Finance, has been named Principal Financial and Principal Accounting Officer, and will lead the
Finance function. |
| • | R&D Commitment Maintained:
The AFib-RVR Phase 3 program (ReVeRA-301) remains fully funded; non-essential short-term activities, including certain manufacturing
scale-up work, have been deferred. AFib-RVR has an estimated addressable patient population of approximately 3 to 4 million patients in
the United States (approximately 3 to 4 times the size of that for PSVT). |
Financial Outlook
| • | As of September 30, 2026, Milestone had cash, cash equivalents, and short-term investments of $145.4 million.
The Company currently expects its cash, cash equivalents and short-term investments to be sufficient to cover operating expenses and capital
expenditure into late 2028, more than one year beyond prior guidance. |
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:
| Conference
Dial-in: |
1-877-407-0792 |
| International
Dial-in: |
1-201-689-8263 |
| Conference
ID: |
13763324 |
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:
| • | 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.
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.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands of U.S. dollars, except share
data)
| | |
September 30, 2026 | | |
December 31, 2025 | |
| Assets | |
| | | |
| | |
| | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 144,472 | | |
$ | 73,046 | |
| Short-term investments | |
| 882 | | |
| 32,914 | |
| Accounts receivable, net | |
| 3,929 | | |
| — | |
| License receivable | |
| 2,000 | | |
| 1,546 | |
| Research and development tax credits receivable | |
| 623 | | |
| 316 | |
| Prepaid expenses | |
| 2,513 | | |
| 1,805 | |
| Inventory, net | |
| 6,676 | | |
| 648 | |
| Other receivables | |
| 509 | | |
| 1,646 | |
| Total current assets | |
| 161,604 | | |
| 111,921 | |
| Operating lease right-of-use assets | |
| 675 | | |
| 1,129 | |
| Property and equipment, net | |
| 416 | | |
| 511 | |
| Total assets | |
$ | 162,695 | | |
$ | 113,561 | |
| | |
| | | |
| | |
| Liabilities and Shareholders' (Deficit) Equity | |
| | | |
| | |
| | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable | |
$ | 9,235 | | |
$ | 5,645 | |
| Accrued liabilities | |
| 14,496 | | |
| 7,644 | |
| Operating lease liabilities | |
| 686 | | |
| 647 | |
| Deferred revenue | |
| 1,321 | | |
| — | |
| Other current liabilities | |
| 43 | | |
| 43 | |
| Total current liabilities | |
| 25,781 | | |
| 13,979 | |
| Operating lease liabilities, net of current portion | |
| 14 | | |
| 539 | |
| Senior secured convertible notes | |
| 60,237 | | |
| 57,191 | |
| Royalty financing obligation, long-term | |
| 82,829 | | |
| — | |
| Other long-term liabilities | |
| 51 | | |
| 83 | |
| Total liabilities | |
| 168,912 | | |
| 71,792 | |
| | |
| | | |
| | |
| Shareholders’ (Deficit) Equity | |
| | | |
| | |
| Common shares, no par value, unlimited shares authorized, 124,498,693 shares issued and outstanding as of September 30, 2026, 106,236,344 shares issued and outstanding as of December 31, 2025 | |
| 384,987 | | |
| 352,619 | |
| Pre-funded warrants - 16,412,925 issued and outstanding as of September 30, 2026, and 16,412,925 as of December 31, 2025 | |
| 55,649 | | |
| 55,649 | |
| Additional paid-in capital | |
| 64,226 | | |
| 64,104 | |
| Accumulated deficit | |
| (511,079 | ) | |
| (430,603 | ) |
| | |
| | | |
| | |
| Total shareholders’ (deficit) equity | |
| (6,217 | ) | |
| 41,769 | |
| | |
| | | |
| | |
| Total liabilities and shareholders’ (deficit) equity | |
$ | 162,695 | | |
$ | 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 September 30, | | |
Nine months ended September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Revenues | |
| | | |
| | | |
| | | |
| | |
| Product revenue, net | |
$ | 963 | | |
$ | — | | |
$ | 1,760 | | |
$ | — | |
| License and other revenue | |
| 2,000 | | |
| — | | |
| 2,000 | | |
| — | |
| Total revenues | |
| 2,963 | | |
| — | | |
| 3,760 | | |
| — | |
| | |
| | | |
| | | |
| | | |
| | |
| Operating Expenses | |
| | | |
| | | |
| | | |
| | |
| Cost of product sales | |
| 325 | | |
| — | | |
| 371 | | |
| — | |
| Research and development, net of tax credits | |
| 3,458 | | |
| 3,940 | | |
| 10,191 | | |
| 12,587 | |
| Selling, general and administrative | |
| 24,232 | | |
| 7,889 | | |
| 67,543 | | |
| 32,296 | |
| Total operating expenses | |
| 28,015 | | |
| 11,829 | | |
| 78,105 | | |
| 44,883 | |
| | |
| | | |
| | | |
| | | |
| | |
| Loss from operations | |
| (25,052 | ) | |
| (11,829 | ) | |
| (74,345 | ) | |
| (44,883 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Interest income | |
| 1,438 | | |
| 874 | | |
| 4,911 | | |
| 2,087 | |
| Interest expense | |
| (2,182 | ) | |
| (967 | ) | |
| (11,042 | ) | |
| (2,853 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss and comprehensive loss | |
$ | (25,796 | ) | |
$ | (11,922 | ) | |
$ | (80,476 | ) | |
$ | (45,649 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average number of shares and pre-funded warrants outstanding, basic and diluted | |
| 140,910,921 | | |
| 96,494,588 | | |
| 136,668,430 | | |
| 76,497,361 | |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss per share, basic and diluted | |
$ | (0.18 | ) | |
$ | (0.12 | ) | |
$ | (0.59 | ) | |
$ | (0.60 | ) |
