- Phase 3 RAPID trial of etripamil in patients with PSVT achieved primary efficacy endpoint; safety and tolerability data from repeat dose administration consistent with prior studies utilizing single-dose administration of etripamil
- Analyses from etripamil Phase 3 PSVT studies featured during Late-Breaking session at AHA Scientific Sessions 2022 demonstrated significant reductions in emergency department utilization for etripamil-treated patients
- Company plans to submit NDA for etripamil in PSVT to the U.S. FDA in mid-2023 pending Agency feedback
MONTREAL and CHARLOTTE, N.C., Nov. 10, 2022 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the third quarter ended September 30, 2022, and provided a clinical and corporate update.
"The positive feedback we received from both clinicians and patient advocacy groups following the presentation of further RAPID data at the American Heart Association (AHA) meeting earlier this week strengthen our conviction that etripamil has the potential to serve as a promising option for patients with paroxysmal supraventricular tachycardia (PSVT)," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We are keenly focused on preparations for our planned New Drug Application (NDA), which we expect to submit to the U.S. Food and Drug Administration (FDA) in mid-2023 pending agency feedback."Recent Updates
Paroxysmal supraventricular tachycardia (PSVT) is a condition affecting approximately two million Americans that is characterized by intermittent episodes of a rapid heartbeat that starts and stops suddenly. Episodes of supraventricular tachycardia (SVT) are often associated with symptoms such as palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain intravenous medications, including adenosine, beta-blockers and calcium channel blockers, have long been used for the acute treatment of PSVT. However, these medications must be administered under medical supervision, usually in an emergency department or other acute care setting.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 within the next 10 years. Atrial fibrillation with rapid ventricular rate (AFib-RVR) is a condition that some patients with AFib experience and includes episodes of abnormally high heart rate, often with symptoms such as palpitations, shortness of breath, dizziness and weakness. Oral calcium channel blockers and/or beta blockers are commonly used to reduce the heart rate in this condition. When AFib-RVR occurs, symptoms often 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 under medical supervision. Milestone's 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.About Etripamil
Etripamil, a new chemical entity, is Milestone's lead investigational product. It is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to a medically unsupervised setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and a Phase 2 proof-of-concept trial that is underway in patients with atrial fibrillation with rapid ventricular rate (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 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.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 the potential of etripamil to serve as a promising therapy for PSVT patients, the potential for clinical trial data from the phase 3 RAPID clinical trial of etripamil nasal spray in patients with PSVT to support an NDA in mid-2023 pending agency feedback, the design, progress, timing, scope, recruitment and results of the RAPID and ReVeRA trials; Milestone's ability to execute on the remainder of the PSVT program; the receipt of milestone payments from Ji Xing, Milestone's ongoing plans to study etripamil in atrial fibrillation patients, the sufficiency of Milestone's current cash resources to support its operations, and estimates about the addressable market and commercial potential for treatments of atrial fibrillation with rapid ventricular rate. 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, including those related to the ongoing COVID-19 pandemic, and risks related the sufficiency of Milestone's capital resources and its ability to raise additional capital. 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, 2021, 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.
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,
2022
2021
2022
2021
Revenue
$
1,500
$
—
$
1,500
$
15,000
Operating expenses
Research and development, net of tax credits
9,826
9,733
29,251
27,755
General and administrative
4,034
2,961
11,595
8,612
Commercial
2,670
1,579
6,537
4,788
Loss from operations
(15,030)
(14,273)
(45,883)
(26,155)
Interest income, net
474
48
672
186
Net loss
$
(14,556)
$
(14,225)
$
(45,211)
$
(25,969)
Weighted average number of shares and pre-funded warrants outstanding, basic & diluted
42,491,787
42,187,887
42,339,123
41,707,563
Net loss per share, basic and diluted
$
(0.34)
$
(0.34)
$
(1.07)
$
(0.62)
CONSOLIDATED BALANCE SHEETS
(Unaudited, in thousands of US dollars, except share data)
September 30, 2022
December 31, 2021
Assets
Current assets
Cash and cash equivalents
$
37,286
$
114,141
Short-term investment
39,947
—
Research and development tax credits receivable
195
356
Prepaid expenses
5,058
4,299
Other receivables
435
127
Total current assets
82,921
118,923
Operating lease assets
2,545
711
Property and equipment
303
215
Total assets
$
85,769
$
119,849
Liabilities, and Shareholders' Equity
Current liabilities
Accounts payable and accrued liabilities
$
6,035
$
6,551
Operating lease liabilities
487
224
Total current liabilities
6,522
6,775
Operating lease liabilities (net of current portion)
2,092
474
Total liabilities
8,614
7,249
Shareholders' Equity
Common shares, no par value, unlimited shares authorized 30,388,109 shares issued and outstanding as of September 30, 2022, 29,897,559 shares issued and outstanding as of December 31, 2021
254,937
251,901
Pre-funded warrants - 12,327,780 issued and outstanding as of September 30, 2022 and 12,327,780 as of December 31, 2021
52,941
52,941
Additional paid-in capital
22,441
15,711
Cumulative translation adjustment
(1,634)
(1,634)
Accumulated deficit
(251,530)
(206,319)
Total shareholders' equity
77,155
112,600
Total liabilities and shareholders' equity
$
85,769
$
119,849
Contact:
David Pitts
Argot Partners
212-600-1902
milestone@argotpartners.com
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SOURCE Milestone Pharmaceuticals, Inc.