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Milestone Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Regulatory and Corporate Update - NDA for etripamil in PSVT resubmitted in 1Q 2024 - Cash resources as of

Key Takeaway: Milestone Pharmaceuticals reported its first quarter 2024 financial results and provided a regulatory update on its lead investigational product, etripamil. The company has resubmitted the NDA for etripamil for treating paroxysmal supraventricular tachycardia (PSVT) and is engaged in finalizing the Phase 3 protocol for atrial fibrillation with rapid ventricular rate (AFib-RVR). Expected cash resources are projected to sustain operations until 2026, with the potential FDA approval for CARDAMYST anticipated in the first half of 2025. The product aims to provide a new self-administered treatment option for patients experiencing these heart conditions.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA approval for CARDAMYST (etripamil) anticipated in the first half of 2025.
  • Current cash resources expected to support operations through 2026.
  • Ongoing discussions with FDA to finalize Phase 3 protocol for AFib-RVR.
  • Etripamil offers a new self-administered treatment option for patients with PSVT and AFib-RVR.

Full Press Release Details

Milestone Pharmaceuticals
Reports First Quarter 2024 Financial Results and Provides Regulatory and Corporate Update
- NDA for etripamil in
PSVT resubmitted in 1Q 2024
- Cash resources as of March 31, 2024
expected to fund operations into 2026
- Dialogue with FDA to finalize Phase 3 protocol
for etripamil in AFib-RVR is progressing
MONTREAL and CHARLOTTE, N.C., May 13,
2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the first quarter
ended March 31, 2024 and provided a regulatory and corporate update.
"We're currently on track for the
potential FDA approval of CARDAMYST (etripamil) nasal spray in the first half of 2025 to deliver a valuable treatment option to
patients suffering from PSVT," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We
remain focused on working with FDA through the review process and preparing for commercialization and launch readiness. We expect that
our current cash position, together with a potential future synthetic royalty payment, provides the needed resources to launch CARDAMYST
in the U.S. market for patients suffering from PSVT."
First Quarter and Recent Program Updates
for Patients with paroxysmal supraventricular tachycardia (PSVT)
for Patients with atrial fibrillation with a rapid ventricular rate (AFib-RVR)
First Quarter 2024 Financial Results
on the Company's financials, refer to Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 13,
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.
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.
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.
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 timing of the receipt of the future synthetic royalty payment, if at all; our use of proceeds from the March 2024
private placement financing; the potential of etripamil to help patients living with these serious heart arrythmias; the continued ability
of etripamil to achieve statistically superior ventricular rate reduction and improved symptom-relief when compared to placebo; the timing
of the launch of etripamil; and the timing and outcomes of our clinical trials. 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 March 31, 2023, 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.
Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Loss (Unaudited)
(in thousands of US dollars, except share
Three months ended March 31,
2024 2023
Revenue $ - $ 1,000
Operating expenses
Research and development, net of tax credits 3,639 10,257
General and administrative 3,953 3,889
Commercial 2,884 2,356
Loss from operations (10,476 ) (15,502 )
Interest income 994 585
Interest expense (872 ) (33 )
Net loss and comprehensive loss $ (10,354 ) $ (14,950 )
Weighted average number of shares and pre-funded warrants outstanding, basic and diluted 50,155,111 42,853,275
Net loss per share, basic and diluted $ (0.21 ) $ (0.35 )
Milestone Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands of US dollars, except share
March 31, 2024 December 31, 2023
Assets
Current assets
Cash and cash equivalents $ 10,131 $ 13,760
Short-term investments 79,350 52,243
Research and development tax credits receivable 711 643
Prepaid expenses 2,362 3,178
Other receivables 1,413 3,208
Total current assets 93,967 73,032
Operating lease right-of-use assets 1,785 1,917
Property and equipment 249 277
Total assets $ 96,001 $ 75,226
Liabilities, and Shareholders' Equity
Current liabilities
Accounts payable and accrued liabilities $ 3,575 $ 6,680
Operating lease liabilities 555 546
Total current liabilities 4,130 7,226
Operating lease liabilities, net of current portion 1,306 1,457
Senior secured convertible notes 50,644 49,772
Total liabilities 56,080 58,455
Shareholders' Equity
Common shares, no par value, unlimited shares authorized 53,245,165 shares issued and outstanding as of March 31, 2024, 33,483,111 shares issued and outstanding as of December 31, 2023 287,879 260,504
Pre-funded warrants - 12,910,590 issued and outstanding as of March 31, 2024 and 9,577,257 as of December 31, 2023 53,076 48,459
Additional paid-in capital 35,346 33,834
Accumulated deficit (336,380 ) (326,026 )
Total shareholders' equity 39,921 16,771
Total liabilities and shareholders' equity $ 96,001 $ 75,226
Kim Fox, Vice President, Communications, kfox@milestonepharma.com

Frequently Asked Questions

What is Milestone Pharmaceuticals' lead product?

Milestone Pharmaceuticals' lead product is etripamil, a calcium channel blocker nasal spray.

When is the FDA approval for CARDAMYST expected?

FDA approval for CARDAMYST is anticipated in the first half of 2025.

How many people in the U.S. are diagnosed with PSVT?

Approximately two million people in the U.S. are diagnosed with paroxysmal supraventricular tachycardia (PSVT).

What conditions does etripamil target?

Etripamil targets symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR).

What financial resources does Milestone have?

Milestone has cash resources expected to fund operations into 2026.

Last updated: May 13, 2024