0001104659-25-059671.txt : 20250616 0001104659-25-059671.hdr.sgml : 20250616 20250616080613 ACCESSION NUMBER: 0001104659-25-059671 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20250616 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20250616 DATE AS OF CHANGE: 20250616 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Milestone Pharmaceuticals Inc. CENTRAL INDEX KEY: 0001408443 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences EIN: 000000000 STATE OF INCORPORATION: A8 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38899 FILM NUMBER: 251048574 BUSINESS ADDRESS: STREET 1: 1111 BOUL. DR.-FREDERIK-PHILIPS, STE 420 CITY: MONTREAL STATE: A8 ZIP: H4M 2X6 BUSINESS PHONE: (514) 336-0444 MAIL ADDRESS: STREET 1: 1111 BOUL. DR.-FREDERIK-PHILIPS, STE 420 CITY: MONTREAL STATE: A8 ZIP: H4M 2X6 8-K 1 tm2518093d1_8k.htm FORM 8-K
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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):

June 16, 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 8.01 Other Events.

 

On June 16, 2025, Milestone Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the submission of its response to the U.S. Food and Drug Administration’s Complete Response Letter regarding its New Drug Application for CARDAMYST (etripamil) nasal spray for the management of paroxysmal supraventricular tachycardia.

 

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
No.		   Description
99.1   Press Release, dated June 16, 2025
104   Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document)

 

 

 

 

SIGNATURE

 

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.
   
Dated: June 16, 2025 By: /s/Amit Hasija
    Amit Hasija
    Chief Financial Officer

 

 

 

 EX-99.1 2 tm2518093d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

Milestone Pharmaceuticals Submits Response to the FDA’s CRL for CARDAMYST (etripamil) Nasal Spray for PSVT Following Type A Meeting

  

Montreal and Charlotte, N.C., June 16, 2025 -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced submission of its response to the U.S. Food and Drug Administration (FDA)’s Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. The response follows a Type A meeting recently held with the FDA. The acceptance of the response and corresponding Prescription Drug User Fee Act (PDUFA) date will be determined within the next thirty days per FDA policy. The review time is expected to be within 2 or 6 months from the resubmission, depending on the classification.

 

“Our recent Type A meeting with the FDA was productive and we believe it provided the guidance necessary to submit our response to the CRL directly after the meeting,” said Joe Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We appreciate the engagement with the FDA and are excited to prepare for a potential new PDUFA date this year. We continue to believe in the value of CARDAMYST which, if approved, will be the first and only self-administered therapy for the rapid termination of episodes of PSVT.”

 

About Etripamil

 

Etripamil is Milestone's lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients, thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR.

 

About Milestone Pharmaceuticals

 

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone's lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR.

 

 

 

 

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 outcomes of future interactions with the FDA; the outcome of the NDA resubmission; CARDAMYST’s potential as a novel treatment option to help patients with PSVT; the timing and expectations related to a new PDUFA date; 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 our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our 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, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza 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, 2024, under the caption “Risk Factors,” as such discussion 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

 

 

 

 

 

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Jun. 16, 2025
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Jun. 16, 2025
Entity File Number 001-38899
Entity Registrant Name MILESTONE PHARMACEUTICALS INC.
Entity Central Index Key 0001408443
Entity Tax Identification Number 00-0000000
Entity Incorporation, State or Country Code A8
Entity Address, Address Line One 1111 Dr. Frederik-Philips Boulevard
Entity Address, Address Line Two Suite 420
Entity Address, City or Town Montréal
Entity Address, State or Province QC
Entity Address, Country CA
Entity Address, Postal Zip Code H4M 2X6
City Area Code 514
Local Phone Number 336-0444
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Shares
Trading Symbol MIST
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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