Full Press Release Details
Milestone Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Clinical and Corporate Update
submission for etripamil in patients with PSVT currently on track for 3Q23
to host virtual KOL event focused on etripamil for the potential treatment of AFib-RVR on Monday, May 22, 2023
data from Phase 2 ReVeRA study evaluating etripamil in patients with AFib-RVR expected in 2H, 2023
resources as of March 31, 2023, together with strategic March 2023 financing, expected to fund operations into mid-2025
Montreal and Charlotte,
N.C., May 11, 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 first quarter
ended March 31, 2023, and provided a clinical and corporate update.
Application (NDA) submission currently on track for the third quarter of this year and the expansion of our market preparation activities,
we believe we are well positioned to execute on our mission of establishing etripamil as the first fast-acting, patient-administered
treatment for paroxysmal supraventricular tachycardia (PSVT)," said Joseph Oliveto, President and Chief Executive Officer of Milestone
Pharmaceuticals. "In parallel, we increased our efforts toward assessing the potential application of etripamil in patients experiencing
atrial fibrillation with rapid ventricular rate (AFib-RVR) and we are making significant progress in our Phase 2 ReVeRA program which
we expect to deliver topline data from later this year. We look forward to hosting a virtual KOL event later this month highlighting
this important therapeutic area with data from a subset of patients with AFib-RVR in the NODE-303 study."
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
(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, 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 soon to be submitted in the third quarter of 2023 in paroxysmal
supraventricular tachycardia (PSVT). Milestone also has a Phase 2 proof-of-concept trial that is ongoing in patients with atrial fibrillation
with rapid ventricular rate (AFib-RVR).
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 clinical trial data from the
Phase 2 ReVeRA program later this year; 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 Inc.
Consolidated Statements of Loss
(in thousands of US dollars, except share
| Three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenue | $ | 1,000 | $ | - | ||||
| Operating expenses | ||||||||
| Research and development, net of tax credits | 10,257 | 8,768 | ||||||
| General and administrative | 3,889 | 3,643 | ||||||
| Commercial | 2,356 | 1,636 | ||||||
| Loss from operations | (15,502 | ) | (14,047 | ) | ||||
| Interest income, net | 552 | 40 | ||||||
| Net loss and comprehensive loss | $ | (14,950 | ) | $ | (14,007 | ) | ||
| Weighted average number of shares and pre-funded warrants outstanding, basic and diluted | 42,853,275 | 42,243,021 | ||||||
| Net loss per share, basic and diluted | $ | (0.35 | ) | $ | (0.33 | ) |
The accompanying notes are an integral part of
these interim condensed consolidated financial statements.
Pharmaceuticals Inc.
Consolidated Balance Sheets
(in thousands of US dollars, except share data)
| March 31, 2023 | December 31,2022 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 73,953 | $ | 7,636 | ||||
| Short-term investments | 27,000 | 56,949 | ||||||
| License receivable | 1,000 | - | ||||||
| Research and development tax credits receivable | 414 | 331 | ||||||
| Prepaid expenses | 5,447 | 6,005 | ||||||
| Other receivables | 694 | 882 | ||||||
| Total current assets | 108,508 | 71,803 | ||||||
| Operating lease assets | 2,300 | 2,423 | ||||||
| Property and equipment | 272 | 257 | ||||||
| Total assets | $ | 111,080 | $ | 74,483 | ||||
| Liabilities, and Shareholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 7,423 | $ | 5,644 | ||||
| Operating lease liabilities | 507 | 495 | ||||||
| Interest Payable | 33 | - | ||||||
| Total current liabilities | 7,963 | 6,139 | ||||||
| Operating lease liabilities, net of current portion | 1,862 | 1,996 | ||||||
| Senior secured convertible notes | 47,320 | - | ||||||
| Total liabilities | 57,145 | 8,135 | ||||||
| Shareholders' Equity | ||||||||
| Common shares, no par value, unlimited shares authorized 33,337,214 shares issued and outstanding as of March 31, 2023, 34,286,002 shares issued and outstanding as of December 31, 2022 | 260,126 | 273,900 | ||||||
| Pre-funded warrants - 9,577,257 issued and outstanding as of March 31, 2023 and 8,518,257 as of December 31, 2022 | 48,459 | 34,352 | ||||||
| Additional paid-in capital | 26,641 | 24,437 | ||||||
| Accumulated deficit | (281,291 | ) | (266,341 | ) | ||||
| Total shareholders' equity | 53,935 | 66,348 | ||||||
| Total liabilities and shareholders' equity | $ | 111,080 | $ | 74,483 |
The accompanying notes are an integral part of
these interim condensed consolidated financial statements.