Form 8-K

8-K — Milestone Pharmaceuticals Inc.

Accession: 0001104659-26-059780

Filed: 2026-05-13

Period: 2026-05-13

CIK: 0001408443

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2614433d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2614433d1_ex99-1.htm)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

May 13, 2026

MILESTONE

PHARMACEUTICALS INC.

(Exact name of registrant as specified in its

charter)

Québec

001-38899

Not

applicable

(state or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer Identification No.)

1111

Dr. Frederik-Philips Boulevard,

Suite

420

Montréal,

Québec CA

H4M

2X6

(Address of principal executive offices)

(Zip Code)

Registrant's telephone number, including area

code: (514)

336-0444

(Former

name or former address, if changed since last report.)

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):

¨ Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b)

of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which

registered

Common

MIST

The

Nasdaq Stock Market LLC

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).

Emerging growth company

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. ¨

Item 2.02.

Results of Operations and Financial Condition.

On May 13, 2026, Milestone Pharmaceuticals Inc.

issued a press release announcing its financial results for the first quarter ended March 31, 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.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

99.1

Press Release, dated May 13, 2026

104

Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document

SIGNATURES

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.

MILESTONE PHARMACEUTICALS INC.

By:

/s/Amit Hasija

Amit Hasija

Chief Financial Officer

Dated: May 13, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2614433d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Milestone Pharmaceuticals Announces First Quarter

2026 Financial Results and Provides Corporate Update

· CARDAMYST™

(etripamil) nasal spray launch for PSVT is gaining traction; breadth of unique prescribers

supports potential future adoption

· Express

Scripts national formulary coverage secured as company makes progress toward broad patient

access

· Atrial Fibrillation-RVR

Phase 3 registration trial initiated: patient enrollment to begin in H2 2026

· Strong balance

sheet of $184.2M provides runway into H2 2027 to fund commercial and operational priorities

· Company to host

investor call and webcast at 8:30am ET today

Montreal and Charlotte, N.C., May

13, 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 first quarter ending March 31, 2026, and provided corporate and regulatory updates.

“We’re

excited to report on our first quarter of sales for CARDAMYST for paroxysmal supraventricular tachycardia, or PSVT.

Healthcare professionals’ initial reaction to the product is positive and we

are very encouraged by the early breadth of unique prescribers writing for their patients,’’

said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “Gaining

Express Scripts’ national formulary coverage in March reflects meaningful early payor

adoption, highlighting the value CARDAMYST offers to insurers. We are also observing clinician

enthusiasm for expanded development of etripamil in patients with AFib-RVR, as we have now kicked off our Phase 3 pivotal trial and are

actively engaging potential clinical trial sites.”

Launch Progress for CARDAMYST

· Promotional

launch for CARDAMYST™ (etripamil) nasal spray was initiated in mid-February 2026. The

product was commercialized within approximately eight weeks of U.S. Food and Drug Administration

(FDA) approval, including a 60-person national sales force engaging primarily with cardiologists,

electrophysiologists and advanced practice providers in an office-based setting.

· A

total of approximately 600 scripts for CARDAMYST have been filled for 560 patients with PSVT

through April.

· Approximately

400 unique prescribers have started patients on CARDAMYST.

· Over

25% of commercially insured lives in the U.S. now have coverage for CARDAMYST.

· Express

Scripts added CARDAMYST nasal spray to its commercial national formularies, effective March

27, 2026. This inclusion made CARDAMYST broadly accessible

and more affordable for their commercially insured lives across the United States.

· Etripamil

global expansion advancing in Europe and China.

· The

marketing authorization application (MAA) for etripamil nasal spray in PSVT was accepted

for review 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. TACHYMIST™ is the conditionally approved brand

name for etripamil nasal spray in Europe. A European decision on approval is expected

by the first half of 2027.

· Separately,

in March 2026, Everest Medicines announced it had acquired the rights from the Company’s

China licensing partner, Corxel Pharmaceuticals to develop, manufacture, and commercialize

CARDAMYST in Greater China, including Chinese Mainland, Hong Kong, Macao and Taiwan regions.

In China, the New Drug Application (NDA) for etripamil nasal spray was accepted by the National

Medical Products Administration (NMPA) on January 17, 2025.

Clinical Updates and Presentations

· Details

on RESET-PSVT, a planned Phase 4, multicenter, prospective, observational registry

intended to generate real-world evidence on the use of CARDAMYST in adults with PSVT

were presented at the Preventive Cardiovascular Nurses

Association (PCNA) 2026 Cardiovascular Nursing Symposium in Scottsdale,

Ariz. The study will be led by the Duke Clinical Research Institute (DCRI).

· “Minimal Blood Pressure Effects of Intranasal Etripamil for PSVT”

was presented at the American College of Cardiology (ACC) Annual Scientific Session in New Orleans. The

presentation summarizes analysis of mean heart rate and blood pressure changes measured during clinical trials of CARDAMYST. The

results demonstrate minimal blood pressure reductions during test dose and rare symptoms consistent with hypotension, supporting the

potential safe self-administration of CARDAMYST for PSVT treatment.

· “Reduction

in Health Care Utilization & Emergency Department Visits with Acutely Self-Administered

Etripamil for SVT: Study Data” was presented at the Stanford BioDesign Arrhythmia

Technologies Meeting held prior to HRS.2026 in Chicago, Ill. Data were described on the level

and growth in U.S. healthcare burden from PSVT along with relevant data from the CARDAMYST

development program.

Etripamil

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

· Phase

3 program in AFib-RVR now initiated. The Company has initiated a Phase 3 registrational

program to evaluate self-administered etripamil as a potential treatment for patients with

AFib-RVR, and is currently onboarding clinical sites. The Company expects to enroll the first

patient in the trial in the second half of 2026. 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 single Phase

3 study in AFib-RVR.

First Quarter

2026 Financial Results

· As

of March 31, 2026, Milestone had cash, cash equivalents, and short-term investments

of $184.2 million, compared to $106.0 million on 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, including

expenses expected in connection with the initiation of the Phase 3 trial in AFib-RVR, as

described above.

· Product

revenues were $0.2 million during the three months ended March 31, 2026. There was no product

revenue during the three months ended March 31, 2025.

· Research

and development expense for the first quarter of 2026 was $3.3 million, compared with $5.0

million for the prior year period. The decrease compared with the prior year was primarily

due to a decrease in outside service costs related to drug development and research.

· General

and administrative expense for the first quarter of 2026 was $4.8 million, compared

with $5.2 million for the prior year period. The decrease was primarily due to

a decrease in professional costs partially offset by an increase in personnel costs.

· Commercial

expense for the first quarter of 2026 was $15.8 million, compared with $10.4 million for

the prior year period. This increase was primarily a result of additional personnel costs,

professional costs, and other operational expenses related to the launch of CARDAMYST.

· For

the first quarter of 2026, net loss was $26.1 million or $0.20 per share, compared

to a net loss of $20.8 million or $0.31 per share for the prior

year period.

For further details

on the Company’s financials, refer to the Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May

13, 2026.

Conference

Call and Webcast Details

Conference Dial-in:

1-877-407-0792

International Dial-in:

1-201-689-8263

Conference ID:

13760062

Webcast link:

click here

Call me™:

Participants can use Guest dial-in numbers 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 “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 healthcare 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 development for the control of symptomatic episodic attacks associated

with AFib-RVR.

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:

regarding the commercialization and adoption of CARDAMYST; expectations in regards to etripamil’s efficacy; 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 U.S. Securities and

Exchange Commission (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 US dollars, except share

data)

March 31, 2026

December 31, 2025

Assets

Current assets

Cash and cash equivalents

$ 71,317

$ 73,046

Short-term investments

112,899

32,914

Accounts receivable, net

1,605

—

License receivable

1,546

Research and development tax credits receivable

425

316

Prepaid expenses

1,210

1,805

Inventory, net

1,826

648

Other receivables

1,425

1,646

Total current assets

192,253

111,921

Operating lease right-of-use assets

981

1,129

Property and equipment, net

500

511

Total assets

$ 193,734

$ 113,561

Liabilities, and Shareholders' Equity

Current liabilities

Accounts payable

$ 10,023

$ 5,645

Accrued liabilities

9,803

7,644

Operating lease liabilities

659

647

Deferred revenue

416

—

Other current liabilities

Total current liabilities

20,944

13,979

Operating lease liabilities, net of current portion

366

539

Senior secured convertible notes

58,192

57,191

Royalty financing obligation, long-term

78,111

—

Other long-term liabilities

Total liabilities

157,685

71,792

Shareholders’ Equity

Common shares, no par value, unlimited shares authorized, 117,794,417 shares issued and outstanding as of March 31, 2026, 106,236,344 shares issued and outstanding as of December 31, 2025

373,702

352,619

Pre-funded warrants - 16,412,925 issued and outstanding as of March 31, 2026 and 16,412,925 as of December 31, 2025

55,649

Additional paid-in capital

63,367

64,104

Accumulated deficit

(456,669 )

(430,603 )

Total shareholders’ equity

36,049

41,769

Total liabilities and shareholders’ equity

$ 193,734

$ 113,561

Milestone Pharmaceuticals Inc.

Condensed Consolidated Statements of Loss (Unaudited)

(in thousands of US dollars, except share

and per share data)

Three months ended March 31,

2026

2025

Revenues

Product revenue, net

$ 238

$ —

License and other revenue

—

Total revenues

238

—

Operating Expenses

Cost of product sales

—

Research and development, net of tax credits

3,251

4,978

General and administrative

4,824

5,167

Commercial

15,812

10,378

Total operating expenses

23,901

20,523

Loss from operations

(23,663 )

(20,523 )

Interest income

1,732

697

Interest expense

(4,135 )

(935 )

Net loss and comprehensive loss

$ (26,066 )

$ (20,761 )

Weighted average number of shares and pre-funded warrants outstanding, basic and diluted

130,286,033

66,285,406

Net loss per share, basic and diluted

$ (0.20 )

$ (0.31 )

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Local phone number for entity.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Title of a 12(b) registered security.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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