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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):
August 8, 2024
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 2.02. |
Results of Operations and
Financial Condition. |
On August 8, 2024, Milestone Pharmaceuticals
Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2024,
which also provided a clinical and corporate update. A copy of the press release is attached as Exhibit 99.1 hereto and is incorporated
herein by reference.
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. |
|
|
|
By: |
/s/Amit Hasija |
|
|
Amit Hasija |
|
|
Chief Financial Officer |
|
|
|
Dated: August 8, 2024 |
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1408443/000110465924087301/tm2421158d1_ex99-1img001.jpg)
Milestone
Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Regulatory and Corporate Update
– NDA for CARDAMYST™ in PSVT accepted by FDA in 2Q 2024; PDUFA in March 2025
– Cash of $83.3 million as of June 30, 2024 expected to fund operations into 2026
– Stuart Duty and Andrew Saik Appointed as Independent Board Directors
MONTREAL
and CHARLOTTE, N.C., August 8, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results
for the second quarter ended June 30, 2024 and provided a regulatory and corporate update.
“The
FDA acceptance of our New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray (an investigational new drug), has
enabled our commercial team to advance preparations for potential approval and launch in 2025,” said Joseph Oliveto, President
and Chief Executive Officer of Milestone Pharmaceuticals. “Further, we are encouraged by the interest and input from
cardiology experts in our Phase 3 AFib-RVR study that we plan to commence in the first half of 2025.”
Second Quarter
and Recent Program Updates
CARDAMYST
for patients with paroxysmal supraventricular tachycardia (PSVT)
| · | FDA accepted the NDA
of CARDAMYST for PSVT. On May 26, 2024, the U.S. Food and Drug Administration (FDA) accepted the resubmission of the NDA for CARDAMYST.
The FDA Prescription Drug User Fee Act (PDUFA) target date has been set for March 2025. |
| · | Milestone
hosted a KOL webinar entitled “Learnings
from the Field: Expert Perspectives on Managing PSVT in the Community Setting.”
The event, which is the first of a series of planned webinars
learning from community-based health care providers, featured George
Mark, MD, FACC and Vivek Sailam, MD from The Heart
House and Cooper University Health Care.
Both physicians discussed the burden of PSVT on patients and their practice, current treatments
and unmet needs, and expectations for how the treatment landscape is likely to evolve in
coming years. A replay of the webinar is available on the Milestone corporate website here.
The second event of the webcast series is planned
for this Fall. |
Etripamil for patients with
atrial fibrillation with rapid ventricular rate (AFib-RVR)
| · | Planning and Design
of Phase 3 pivotal trial is ongoing, following guidance received from FDA in 1Q 2024 meeting. Milestone is working with experts
to finalize the design of a Phase 3 trial for etripamil in AFib-RVR. The Company plans to propose to the FDA a Phase
3 clinical study, conducted in the at-home setting, that will enroll patients with a history of symptomatic episodes and use a self-administered,
repeat-dose regimen of 70 mg of etripamil nasal spray, similar to what was investigated in the RAPID trial in patients with PSVT. Enrollment
is expected to commence in the first half of 2025. |
| · | Data
from previously published studies on etripamil in PSVT and AFib-RVR were featured in presentations
at ISPOR 2024 (May 5-8), the 2024 Stanford BioDesign Arrhythmia Technologies
Retreat (May 15),
and the Annual meeting of the Heart Rhythm Society, Heart
Rhythm 2024 (May 16-19).
The publications add to a growing body of literature on the patient- and system-burdens,
and costs of PSVT, and to the support for the potential of etripamil to reduce ED visits
for patients who are able to self-treat their PSVT episodes. Further information presented
included the findings from Milestone’s investigation of etripamil in patients with
AFib-RVR and the rationale for the Company’s Phase 3 program. Copies of the presentations and posters
can be found here.
|
Corporate Updates
| · | In July, Stuart
Duty and Andrew Saik were appointed as independent directors to the board
of directors. Mr. Duty brings over 30 years of experience in investment banking and operations primarily in the biotechnology and
specialty pharmaceuticals sectors. Mr. Saik brings over 25 years of accounting and finance experience, including leading numerous capital
structure transformations. |
Second
Quarter 2024 Financial Results
| · | As of June 30, 2024, Milestone
had cash, cash equivalents, and short-term investments of $83.3 million, compared to $66.0 million as of December 31, 2023. |
| · | Research and
development expense, net of tax credits for the second quarter of 2024 was $2.8 million, compared with
$8.6 million for the same period in 2023. For the six months ended June
30, 2024, research and development expense was $6.5 million compared
with $18.9 million for the same period in 2023. This decrease in research and development expenses was driven by lower
clinical development costs and clinical personnel-related costs driven by completion of phase 3 studies, as well as a decrease in
drug manufacturing professional fees and personnel-related costs. |
| · | General and administrative
expense for the second quarter of 2024 was $5.0 million, compared with the $4.4 million reported for the same
period in 2023. For the six months ended June 30, 2024,
general and administrative expense was $9.0 million, compared with the with $8.3 million for the prior year period.
The increases between the periods are primarily due to an increase in legal and professional fees, partially offset by a decrease in personnel
costs. |
| · | Commercial expense
for the second quarter of 2024 was $1.8 million, compared with $3.4 million for the same period in 2023. For
the six months ended June 30, 2024, commercial expense was $4.7 million compared with $5.7 million for
the prior year period. The decreases are a result of decreases in personnel costs, professional costs and other operational expenses related
to commercialization. |
| · | For the second
quarter of 2024, net loss was $9.4 million, compared to $16.0 million for the prior year period. For
the six months ended June 30, 2024, Milestone's net loss was $19.7 million,
compared to $31.0 million in 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 June 30, 2024, filed with
the SEC on August 8, 2024.
About
Paroxysmal Supraventricular Tachycardia
An estimated
two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. PSVT
is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable
and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness
or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike
or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and
morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart
failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment
options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation
procedures.
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. The incidence of AFib is expected to grow to approximately 10 million by 2025 and up to about 12 million by 2030. A subset
of patients with AFib 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 to 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-RVR.
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™ (etripamil) nasal spray, 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: our expected cash runway into 2026; the timing and outcomes of future interactions with U.S. and foreign
regulatory bodies, including the FDA, including the timing of the FDA’s review of the NDA; the potential of etripamil to help patients
living with these serious heart arrythmias and to reduce ED visits for patients who are able to self-treat their PSVT episodes; the timing
of the launch of etripamil; and the timing, design and outcomes of our clinical trials, including our Phase 3 study in AFib-RVR. 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; whether the FDA will require additional trials or data which may significantly delay and put at risk our efforts
to obtain approval and may not be successful, 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,
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, 2023 and its quarterly report on Form 10-Q for the quarter ended June 30, 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:
Kim Fox, Vice
President, Communications, kfox@milestonepharma.com
Investor Relations
Chris Calabrese,
ccalabrese@lifesciadvisors.com
Kevin Gardner,
kgardner@lifesciadvisors.com
Milestone Pharmaceuticals
Inc.
Condensed Consolidated
Statements of Loss (Unaudited)
(in thousands
of US dollars, except share and per share data)
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | 1,000 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development, net of tax credits | |
| 2,815 | | |
| 8,622 | | |
| 6,454 | | |
| 18,879 | |
General and administrative | |
| 5,046 | | |
| 4,445 | | |
| 8,999 | | |
| 8,334 | |
Commercial | |
| 1,801 | | |
| 3,369 | | |
| 4,685 | | |
| 5,725 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (9,662 | ) | |
| (16,436 | ) | |
| (20,138 | ) | |
| (31,938 | ) |
| |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 1,186 | | |
| 1,213 | | |
| 2,180 | | |
| 1,801 | |
Interest expense | |
| (887 | ) | |
| (820 | ) | |
| (1,759 | ) | |
| (856 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss and comprehensive loss | |
$ | (9,363 | ) | |
$ | (16,043 | ) | |
$ | (19,717 | ) | |
$ | (30,993 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of shares and pre-funded warrants outstanding, basic and diluted | |
| 66,165,461 | | |
| 42,937,036 | | |
| 58,160,286 | | |
| 42,895,387 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (0.14 | ) | |
$ | (0.37 | ) | |
$ | (0.34 | ) | |
$ | (0.72 | ) |
Milestone Pharmaceuticals
Inc.
Condensed Consolidated
Balance Sheets (Unaudited)
(in thousands
of US dollars, except share data)
| |
June 30, 2024 | | |
December 31, 2023 | |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 13,262 | | |
$ | 13,760 | |
Short-term investments | |
| 69,991 | | |
| 52,243 | |
Research and development tax credits receivable | |
| 776 | | |
| 643 | |
Prepaid expenses | |
| 1,713 | | |
| 3,178 | |
Other receivables | |
| 1,617 | | |
| 3,208 | |
Total current assets | |
| 87,359 | | |
| 73,032 | |
Operating lease right-of-use assets | |
| 1,651 | | |
| 1,917 | |
Property and equipment | |
| 222 | | |
| 277 | |
Total assets | |
$ | 89,232 | | |
$ | 75,226 | |
| |
| | | |
| | |
Liabilities, and Shareholders' Equity | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable and accrued liabilities | |
$ | 4,000 | | |
$ | 6,680 | |
Operating lease liabilities | |
| 567 | | |
| 546 | |
Total current liabilities | |
| 4,567 | | |
| 7,226 | |
Operating lease liabilities, net of current portion | |
| 1,156 | | |
| 1,457 | |
Senior secured convertible notes | |
| 51,531 | | |
| 49,772 | |
Total liabilities | |
| 57,254 | | |
| 58,455 | |
| |
| | | |
| | |
| |
| | | |
| | |
Shareholders’ Equity | |
| | | |
| | |
Common shares, no par value, unlimited shares authorized 53,269,565 shares issued and outstanding as of June 30, 2024, 33,483,111 shares issued and outstanding as of December 31, 2023 | |
| 287,932 | | |
| 260,504 | |
Pre-funded warrants - 12,910,590 issued and outstanding as of June 30, 2024 and 9,577,257 as of December 31, 2023 | |
| 53,076 | | |
| 48,459 | |
Additional paid-in capital | |
| 36,713 | | |
| 33,834 | |
Accumulated deficit | |
| (345,743 | ) | |
| (326,026 | ) |
| |
| | | |
| | |
Total shareholders’ equity | |
| 31,978 | | |
| 16,771 | |
| |
| | | |
| | |
Total liabilities and shareholders’ equity | |
$ | 89,232 | | |
$ | 75,226 | |
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Milestone Pharmaceuticals (NASDAQ:MIST)
過去 株価チャート
から 7 2024 まで 8 2024
Milestone Pharmaceuticals (NASDAQ:MIST)
過去 株価チャート
から 8 2023 まで 8 2024