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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):
December
12, 2025
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
Shares |
|
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 7.01. |
Regulation FD Disclosure. |
On December 15,
2025, Milestone Pharmaceuticals Inc. (“Milestone” or the “Company”) provided a corporate presentation that
may be used in connection with presentations at conferences and investor meetings. The full text of the Company’s corporate presentation
is filed as Exhibit 99.1 hereto, and incorporated herein by reference, and may also be accessed through the “Investors &
Media” section of the Company’s website at www.milestonepharma.com.
The Company intends to
use its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation
FD. Such disclosures will be included on its website in the “Investors & Media” section. Accordingly, investors should
monitor such portions of its website, in addition to following press releases, filings with the U.S. Securities Exchange Commission (the
“SEC”) and public conference calls and webcasts.
The information furnished
under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, or
the Securities Act. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into
any other filing with the SEC, made by the Company, whether made before or after the date hereof, regardless of any general incorporation
language in such filing.
On December 12,
2025, the Company issued a press release announcing that the U.S. Food and Drug Administration has approved the Company’s New Drug
Application for CARDAMYST (etripamil) nasal spray for the management of paroxysmal supraventricular tachycardia (PSVT). A copy of the
press release is filed herewith as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.
| Item 9.01 |
Financial Statements and Exhibits |
(d) Exhibits.
| Exhibit Number |
Description of Exhibit |
| 99.1 |
Corporate Presentation,
dated December 15, 2025 |
| 99.2 |
Press Release dated December 12,
2025 |
| 104 |
Cover Page Interactive
Data (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: December 15, 2025 |
