- New Drug Application submitted to the U.S. Food and Drug
Administration for CARDAMYST™, the conditionally
approved brand name for etripamil nasal spray, for patients
with PSVT
- Positive Phase 2 data evaluating etripamil in AFib-RVR were
a Featured Science Presentation at 2023 AHA Scientific Sessions;
Phase 3 program expected to begin enrollment in mid-2024
- Company to host Investor and Analyst Webcast to review data
from ReVeRA Phase 2 study of etripamil in atrial fibrillation with
rapid ventricular rate today at 8:00 a.m.
ET
MONTREAL and CHARLOTTE,
N.C., Nov. 13, 2023 /CNW/ -- Milestone
Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial
results for the third quarter ended September 30, 2023, and provided a clinical and
corporate update.
"This quarter was transformational for our company. We believe
the combination of the submission of our first New Drug Application
for CARDAMYST in treating PSVT and the release of positive results
from our Phase 2 study evaluating etripamil to treat patients with
AFib-RVR, demonstrates that we are on track to advance our clinical
development program," said Joseph
Oliveto, President, and Chief Executive Officer of Milestone
Pharmaceuticals. "We are approaching 2024 with a well-defined
strategy and even greater confidence around the potential of our
lead asset, etripamil, to help people living with these serious
heart arrythmias."
Recent Program Updates
Etripamil for Patients with PSVT
- New Drug Application (NDA) Submitted to U.S. Food and Drug
Administration (FDA) for Etripamil in Patients with Paroxysmal
Supraventricular Tachycardia (PSVT). In October, Milestone
announced the submission of an NDA to the FDA for etripamil
(CARDAMYST™ conditionally approved tradename, subject to FDA final
review) in patients with PSVT. Representing the largest data
package ever studied in PSVT, the Company believes the clinical
trial program demonstrates that etripamil provided superior time to
conversion to normal heart rhythm compared to placebo. The primary
analysis and supportive assessments from the pivotal RAPID Phase 3
clinical trial were recently published in The Lancet. The
FDA determination of whether the NDA is complete and accepted for
review is expected by the end of 2023. If accepted, Milestone
Pharmaceuticals expects a standard review of 10 months from the the
filing of the company's NDA. Milestone continues to advance
commercial preparations to support the anticipated launch of
etripamil.
Etripamil for Patients with AFib-RVR
- Positive Results from ReVeRA Phase 2 Study of
Etripamil in Atrial Fibrillation with Rapid Ventricular Rate
(AFib-RVR) Presented at the American Heart Association (AHA)
Scientific Sessions 2023 and Simultaneously Published in
Circulation: Arrhythmia and Electrophysiology.
In November, Milestone announced data from the ReVeRA Phase 2 study
that show that patients with AFib-RVR receiving etripamil
demonstrated rapid and statistically superior ventricular rate
reduction and improved symptom-relief when compared to placebo.
Safety and tolerability reported in the 56-patient safety
population who received etripamil was generally consistent with
that observed in the Company's program for PSVT. The results were
presented as a Featured Science presentation at the American Heart
Association (AHA) Scientific Sessions 2023 and simultaneously
published in Circulation: Arrhythmia and
Electrophysiology.
- AFib-RVR Phase 3 Registrational Program Planned to Begin in
2024. Based on preliminary guidance from FDA, Milestone is
developing a Phase 3 registrational program to evaluate
self-administered etripamil as a potential treatment for patients
with AFib-RVR. The Company expects to initiate this program in
mid-2024.
Third Quarter 2023 Financial Results
- As of September 30, 2023,
Milestone had cash, cash equivalents, and short-term investments of
$75.7 million and 33.5 million common
shares issued and outstanding, with an additional 9.6 million
common shares issuable upon exercise of pre-funded warrants. Cash
resources as of September 30, 2023
are expected to fund operations into mid-2025.
- Research and development expense for the third quarter of 2023
was $6.7 million, compared with
$9.8 million for the prior year
period. For the nine months ended September
30, 2023, research and development expense was $25.6 million compared with $29.3 million for the prior year period. The
decreases in research and development expenses were related to
lower clinical expenses and clinical personnel-related costs as a
result of the completion of phase 3 studies.
- General and administrative expense for the third quarter of
2023 was $4.2 million, compared with
$4.0 million for the prior year
period. For the nine months ended September
30, 2023, general and administrative expense was
$12.6 million compared with
$11.6 million for the prior year
period. The increases were related to personnel-related costs and
consulting fees.
- Commercial expense for the third quarter of 2023 was
$4.4 million, compared with
$2.7 million for the prior year
period. For the nine months ended September
30, 2023, commercial expense was $10.1 million compared with $6.5 million for the prior year period. The
increases were related to additional personnel and professional
costs required to expand capabilities and operations in
anticipation of potential commercialization.
- For the third quarter of 2023, operating loss was $15.4 million, compared to $15.0 million for the prior year period. For the
nine months ended September 30, 2023,
Milestone's operating loss was $47.3
million, compared to $45.9
million in the prior year period.
Investor and Analyst Conference Call and
Webcast
The Company will host an investor and analyst conference call
and webcast on Monday, November 13,
2023, at 8:00 a.m. Eastern
Time. The event will feature a review of the ReVeRA data, an
overview of AFib-RVR and current treatment landscape,
characteristics of etripamil, and commentary on next steps for
Milestone's clinical development program for etripamil. To join 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 the live or recorded webcast and
accompanying slides, please visit the News & Events section of
Milestone's investor relations website
at investors.milestonepharma.com.
About Paroxysmal Supraventricular Tachycardia (PSVT)
An estimated 2 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 rapid heartbeats often exceeding 150 to 200 beats
per minute. Key features of PSVT include the sudden occurrence of
episodes and very rapid heart rate. The heart rate can spike
unpredictably and rapidly during an episode. The rapid heart rate
often causes 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 in addition to a prolonged, burdensome, and costly trip to
the emergency department or, for some patients, an invasive
ablation procedure.
About Atrial Fibrillation with Rapid Ventricular Rate
(AFib-RVR)
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 2030.1,2,3 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 elevated and often highly symptomatic heart-rate
attacks associated with PSVT and 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, 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 proof-of-concept trial for the
treatment of patients with AFib-RVR.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a
biopharmaceutical company focused on the development and
commercialization of innovative cardiovascular medicines.
Milestone's lead product candidate etripamil recently completed its
Phase 3 clinical-stage program for the treatment of PSVT and a
Phase 2 proof-of-concept trial for the treatment of patients with
AFib-RVR. The AFib-RVR study, ReVeRA, was recently presented
as a Featured Science presentation at the American Heart
Association (AHA) Scientific Sessions 2023 and simultaneously
published in Circulation: Arrhythmia and
Electrophysiology. Milestone Pharmaceuticals operates
in Canada and the United
States. 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 etripamil's potential to help patients living with these
serious heart arrythmias; etripamil's continued ability to achieve
statistically superior ventricular rate reduction and improved
symptom-relief when compared to placebo; the timing and outcome of
the FDA determination of whether the NDA is complete and accepted
for review; the timing of the FDA's potential review of the NDA;
the timing of the launch of etripamil; the clinical benefit of
etripamil for self-treating recurrent episodes of PSVT without
medical supervision; the timing of a Phase 3 registrational program
for etripamil; and the anticipated growth in incidences of AFib by
2025 and 2030 and the target addressable market of patients with
AFib-RVR by 2030. 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, 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, 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 Milestone may make with the U.S. Securities
& 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.
Milestone
Pharmaceuticals Inc.
Condensed
Consolidated Statements of Loss (Unaudited)
(in thousands of
US dollars, except share and per share data)
|
|
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
—
|
|
$
|
1,500
|
|
$
|
1,000
|
|
$
|
1,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development, net of tax credits
|
|
|
6,721
|
|
|
9,826
|
|
|
25,600
|
|
|
29,251
|
General and
administrative
|
|
|
4,227
|
|
|
4,034
|
|
|
12,561
|
|
|
11,595
|
Commercial
|
|
|
4,412
|
|
|
2,670
|
|
|
10,137
|
|
|
6,537
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(15,360)
|
|
|
(15,030)
|
|
|
(47,298)
|
|
|
(45,883)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,120
|
|
|
474
|
|
|
2,921
|
|
|
672
|
Interest
expense
|
|
|
(841)
|
|
|
—
|
|
|
(1,697)
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
|
$
|
(15,081)
|
|
$
|
(14,556)
|
|
$
|
(46,074)
|
|
$
|
(45,211)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares and pre-funded
warrants outstanding, basic and diluted
|
|
|
42,973,160
|
|
|
42,491,787
|
|
|
42,920,620
|
|
|
42,339,123
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.35)
|
|
$
|
(0.34)
|
|
$
|
(1.07)
|
|
$
|
(1.07)
|
Milestone
Pharmaceuticals Inc.
Condensed
Consolidated Balance Sheets (Unaudited)
(in thousands of
US dollars, except share data)
|
|
|
|
September 30,
2023
|
|
December 31,
2022
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
9,879
|
|
$
|
7,636
|
Short-term
investments
|
|
|
65,867
|
|
|
56,949
|
Research and
development tax credits receivable
|
|
|
569
|
|
|
331
|
Prepaid
expenses
|
|
|
6,961
|
|
|
6,005
|
Other
receivables
|
|
|
1,521
|
|
|
882
|
Total current
assets
|
|
|
84,797
|
|
|
71,803
|
Operating lease
assets
|
|
|
2,047
|
|
|
2,423
|
Property and
equipment
|
|
|
272
|
|
|
257
|
Total
assets
|
|
$
|
87,116
|
|
$
|
74,483
|
|
|
|
|
|
|
|
Liabilities, and
Shareholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
7,584
|
|
$
|
5,644
|
Operating lease
liabilities
|
|
|
530
|
|
|
495
|
Total current
liabilities
|
|
|
8,114
|
|
|
6,139
|
Operating lease
liabilities, net of current portion
|
|
|
1,583
|
|
|
1,996
|
Senior secured
convertible notes
|
|
|
48,915
|
|
|
—
|
Total
liabilities
|
|
|
58,612
|
|
|
8,135
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
Equity
|
|
|
|
|
|
|
Common shares, no par
value, unlimited shares authorized 33,481,787 shares issued
and outstanding as of September 30, 2023, 34,286,002 shares issued
and
outstanding as of December 31, 2022
|
|
|
260,502
|
|
|
273,900
|
Pre-funded warrants -
9,577,257 issued and outstanding as of September 30, 2023
and 8,518,257 as of December 31, 2022
|
|
|
48,459
|
|
|
34,352
|
Additional paid-in
capital
|
|
|
31,958
|
|
|
24,437
|
Accumulated
deficit
|
|
|
(312,415)
|
|
|
(266,341)
|
|
|
|
|
|
|
|
Total shareholders'
equity
|
|
|
28,504
|
|
|
66,348
|
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
|
$
|
87,116
|
|
$
|
74,483
|
Contact:
Kim Fox, Vice President,
Communications
kfox@milestonepharma.com
704-803-9295
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SOURCE Milestone Pharmaceuticals, Inc.