Full Press Release Details
Milestone Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Clinical and Corporate Update
submission for etripamil in patients with PSVT expected in October 2023
featured during oral session at Heart Rhythm 2023 Annual Meeting support the potential of etripamil in patients with AFib-RVR
complete in Phase 2 ReVeRA study of etripamil in patients with AFib-RVR; topline data expected in fourth quarter of 2023
Montreal and Charlotte,
N.C., August 10, 2023 -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused
on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the second quarter
ended June 30, 2023, and provided a clinical and corporate update.
"The remainder of 2023 represents a transformative
time for the Company as we approach our first New Drug Application (NDA) submission for etripamil and continue to lay the groundwork required
to successfully launch what could serve as the first and only U.S. Food and Drug Administration (FDA) approved treatment for patients
to self-treat their paroxysmal supraventricular tachycardia (PSVT)," said Joseph Oliveto, President, and Chief Executive Officer
of Milestone Pharmaceuticals. "Expanding assessment of the potential clinical utility of etripamil, we have completed enrollment
in ReVeRA, our Phase 2 study of etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR), and we look forward
to sharing topline data from this study in the fourth quarter of this year."
Recent Program Updates
Etripamil for AFib-RVR
Supraventricular Tachycardia
Paroxysmal Supraventricular
Tachycardia (PSVT) is a highly symptomatic and impactful heart arrhythmia characterized by unpredictable attacks of a racing heart that
afflicts approximately two million Americans. Symptoms of PSVT, including palpitations, chest pressure, and shortness of breath are often
debilitating, causing the patient to stop their current activities or avoid pursuits altogether. 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. The uncertainty of when an episode of SVT will strike or how long it will persist can provoke anxiety in patients,
which can have a negative impact on their day-to-day life. Many doctors are unsatisfied by the lack of effective treatment options besides
a prolonged, unpleasant, and costly trip to the emergency department or, for some patients, an invasive ablation procedure.
About Atrial Fibrillation
with Rapid Ventricular Rate
Atrial fibrillation (AFib) is a common arrhythmia
marked by an irregular and often rapid heartbeat. AFib is estimated to affect five million patients in the United States, a prevalence
projected by the Centers for Disease Control to increase to twelve million patients by 2030. Atrial fibrillation with rapid ventricular
rate (AFib-RVR) is a condition that many patients with AFib experience and includes episodes of abnormally high heart rate, often with
symptoms of palpitations, shortness of breath, dizziness, and weakness. Oral calcium channel blockers and/or beta blockers are used to
reduce the heart rate in this condition. When AFib-RVR occurs, symptoms are often burdensome enough to cause patients to seek acute care
in the emergency department, where standard-of-care procedures include intravenous administration of calcium channel blockers or beta
blockers, or electrical cardioversion, under medical supervision. 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.
Etripamil, Milestone's
lead investigational product, is a novel calcium channel blocker nasal spray. It is designed to be a rapid-response therapy that is self-administered
by the patient, without the need for direct medical oversight, and is being developed for elevated and often highly symptomatic heart
rate attacks associated with PSVT and AFib-RVR. If approved, etripamil is intended to provide health care providers with a new tool to
enable virtual care and patient self-management, and to impart upon the patient a greater sense of control over their condition. Milestone
is conducting a comprehensive development program for etripamil, with Phase 3 trials completed and an NDA submission expected in October 2023
in paroxysmal supraventricular tachycardia (PSVT). Milestone also has a Phase 2 proof-of-concept trial that has completed enrollment and
will report topline data in patients experiencing atrial fibrillation with rapid ventricular rate (AFib-RVR) in the fourth quarter of
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 paroxysmal
supraventricular tachycardia (PSVT) and is in a Phase 2 proof-of-concept trial for the treatment of patients with atrial fibrillation
with rapid ventricular rate (AFib-RVR). Milestone Pharmaceuticals operates in Canada and the United States.
For more information, visit www.milestonepharma.com and follow Milestone on Twitter at @MilestonePharma.
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 potential of etripamil to serve as a promising therapy for PSVT patients; the timing
of the NDA submission for etripamil nasal spray; the potential for etripamil to serve as the first and only FDA-approved treatment for
patients to self-treat their PSVT; the potential for clinical trial data from the Phase 2 ReVeRA program later this year; the ability
for the data from the Company's previously completed global Phase 3 clinical program, including the RAPID and RAPID-extension studies,
NODE-303, and NODE-301, to fulfill the safety and efficacy requirements for the planned NDA submission; and our ability to fund operations
into the middle of 2025. 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 & 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
Condensed Consolidated
Statements of Loss (Unaudited)
(in thousands of US dollars, except share
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | $ | - | $ | - | $ | 1,000 | $ | - | ||||||||
| Operating expenses | ||||||||||||||||
| Research and development, net of tax credits | 8,622 | 10,657 | 18,879 | 19,425 | ||||||||||||
| General and administrative | 4,445 | 3,918 | 8,334 | 7,561 | ||||||||||||
| Commercial | 3,369 | 2,231 | 5,725 | 3,867 | ||||||||||||
| Loss from operations | (16,436 | ) | (16,806 | ) | (31,938 | ) | (30,853 | ) | ||||||||
| Interest income | 1,213 | 158 | 1,801 | 198 | ||||||||||||
| Interest expense | (820 | ) | - | (856 | ) | - | ||||||||||
| Net loss and comprehensive loss | $ | (16,043 | ) | $ | (16,648 | ) | $ | (30,993 | ) | $ | (30,655 | ) | ||||
| Weighted average number of shares and pre-funded warrants outstanding, basic and diluted | 42,937,036 | 42,278,563 | 42,895,387 | 42,260,682 | ||||||||||||
| Net loss per share, basic and diluted | $ | (0.37 | ) | $ | (0.39 | ) | $ | (0.72 | ) | $ | (0.73 | ) |
Milestone Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands of US dollars, except share
| June 30, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 32,591 | $ | 7,636 | ||||
| Short-term investments | 55,000 | 56,949 | ||||||
| Research and development tax credits receivable | 483 | 331 | ||||||
| Prepaid expenses | 5,400 | 6,005 | ||||||
| Other receivables | 1,092 | 882 | ||||||
| Total current assets | 94,566 | 71,803 | ||||||
| Operating lease assets | 2,175 | 2,423 | ||||||
| Property and equipment | 278 | 257 | ||||||
| Total assets | $ | 97,019 | $ | 74,483 | ||||
| Liabilities, and Shareholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 6,287 | $ | 5,644 | ||||
| Operating lease liabilities | 522 | 495 | ||||||
| Total current liabilities | 6,809 | 6,139 | ||||||
| Operating lease liabilities, net of current portion | 1,729 | 1,996 | ||||||
| Senior secured convertible notes | 48,073 | - | ||||||
| Total liabilities | 56,611 | 8,135 | ||||||
| Shareholders' Equity | ||||||||
| Common shares, no par value, unlimited shares authorized 33,363,971 shares issued and outstanding as of June 30, 2023, 34,286,002 shares issued and outstanding as of December 31, 2022 | 260,169 | 273,900 | ||||||
| Pre-funded warrants - 9,577,257 issued and outstanding as of June 30, 2023 and 8,518,257 as of December 31, 2022 | 48,459 | 34,352 | ||||||
| Additional paid-in capital | 29,114 | 24,437 | ||||||
| Accumulated deficit | (297,334 | ) | (266,341 | ) | ||||
| Total shareholders' equity | 40,408 | 66,348 | ||||||
| Total liabilities and shareholders' equity | $ | 97,019 | $ | 74,483 |