false
0001408443
A8
00-0000000
QC
0001408443
2023-11-07
2023-11-07
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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):
November 7, 2023
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 x
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 November 7, 2023, Milestone
Pharmaceuticals Inc. (“Milestone” or the “Company”) issued a press release announcing the Company will host
a virtual investor and analyst webcast on Monday, November 13, 2023 at 8:00 a.m. ET, which will focus on results from the
ReVeRA Phase 2 study of investigational new drug etripamil in patients with atrial fibrillation with rapid ventricular rate. A copy
of the press release is attached hereto as Exhibit 99.1. To access a live or recorded webcast of the event and accompanying
slides, please visit the News & Events section of Milestone’s investor relations website at
investors.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 and 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.
Item 9.01. |
Financial Statements and Exhibits |
(d) Exhibits.
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. |
|
|
Date: November 7, 2023 |
By: |
/s/ Amit Hasija |
|
|
Amit Hasija |
|
|
Chief Financial Officer Principal Financial Officer |
Exhibit 99.1
Milestone Pharmaceuticals to Host Investor and
Analyst Webcast to Review Data from ReVeRA Phase 2 Study of Etripamil in AFib-RVR
- Cardiac
Electrophysiology Key Opinion Leaders joining the webcast include A. John Camm, MD, and Sean Pokorney, MD
- Conference
call and webcast on Monday, November 13, 2023 at 8:00 a.m. ET
MONTREAL and CHARLOTTE,
N.C., Nov. 7, 2023 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced that the
Company will host a virtual investor and analyst webcast on Monday, November 13, 2023 at 8:00 a.m. ET. The webcast will focus
on results from the ReVeRA Phase 2 study of investigational new drug etripamil in patients with atrial fibrillation with rapid ventricular
rate (AFib-RVR), which is being presented as a Featured Science presentation at the American Heart Association (AHA) Scientific Sessions
2023.
Joining Milestone’s
management team will be:
| · | A. John Camm, M.D., Author on the
ReVeRA AHA Featured Science presentation and British Heart Foundation Emeritus Professor of Clinical Cardiology, The Cardiology
Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's
University of London, London, UK |
| · | Sean Pokorney, MD, MBA, Director of the Arrhythmia
Core Laboratory, Duke Clinical Research Institute, Assistant Professor of Medicine, Duke University School of Medicine, Durham,
NC |
To access the live
call by phone, dial (877) 870-4263 (domestic) or (412) 317-0790 (international) and ask to be connected to the Milestone Pharmaceuticals
call. To access a live or recorded webcast of the event and accompanying slides, please visit the News & Events section of Milestone's
investor relations website at investors.milestonepharma.com.
About Atrial Fibrillation
with Rapid Ventricular Rate
An estimated five million
Americans suffer from atrial fibrillation (AFib), a common arrhythmia marked by an irregular, disruptive and often rapid heartbeat. Incidence
of atrial fibrillation (AFib) in the United States is expected to grow to approximately 10 million by 2025 and up to about 12
million by 2030. A subset of AFib patients experience episodes of abnormally high heart rate most often accompanied by palpitations, shortness
of breath, dizziness, and weakness. While these episodes, known as AFib-RVR, may be treated by oral calcium channel blockers and/or beta
blockers, patients frequently seek acute care in the emergency department to address symptoms. In 2016, nearly 800,000 patients were admitted
to the emergency department due to AFib symptoms where treatment includes medically supervised intravenous administration of calcium channel
blockers or beta blockers, or electrical cardioversion. With little available data for AFib-RVR, Milestone's initial market research indicates
that 30-40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a target
addressable market of approximately three to four million patients in 2030 for etripamil in patients with AFib.
About Etripamil
Etripamil is Milestone's
lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for elevated and often highly
symptomatic heart-rate attacks associated with paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with a rapid ventricular
rate (AFib-RVR). It is designed to be a rapid-response therapy that is self-administered by the patient, without the need for direct 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. If approved, the portable treatment, studied as self-administered, may provide patients with active management
and a greater sense of control over their condition. Etripamil, proposed brand name CARDAMYST™, 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 proof-of-concept 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 medicines to benefit people living with
certain heart conditions. Milestone recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for
etripamil for treatment of an abnormal heart rhythm, paroxysmal supraventricular tachycardia or PSVT. Find out more at www.milestonepharma.com.
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" 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 anticipated growth of incidence of AFib and
AFib-RVR by 2030; and the ability of etripamil to act as a rapid-response therapy that is self-administered by the patient, without the
need for direct medical oversight and to provide health care providers with a new treatment option to enable on demand care and patient
self-management. Important factors that could cause actual results to differ materially from those in the forward-looking statements include,
but are not limited to, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain
regulatory approval process; 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 and Russian hostilities
in Ukraine 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, including
in its annual report on Form 10-K for the year ended December 31, 2022, under the caption "Risk Factors," as such
discussion may be updated from time to time by subsequent filings, we may make with the U.S. Securities and Exchange Commission. 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
Kim Fox, Vice President, Communications
kfox@milestonepharma.com
704-803-9295
v3.23.3
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionISO 3166-1 alpha-2 country code.
+ References
+ Details
Name: |
dei_EntityAddressCountry |
Namespace Prefix: |
dei_ |
Data Type: |
dei:countryCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean 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.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean 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.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean 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.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean 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.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Milestone Pharmaceuticals (NASDAQ:MIST)
Historical Stock Chart
From May 2024 to Jun 2024
Milestone Pharmaceuticals (NASDAQ:MIST)
Historical Stock Chart
From Jun 2023 to Jun 2024