Canada NewsWire
MONTREAL and CHARLOTTE, N.C., May 14, 2020
MONTREAL and CHARLOTTE, N.C., May 14, 2020 /CNW/ -- 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, 2020 and provided a clinical and corporate update.
"While the NODE-301 trial of etripamil for patients with paroxysmal supraventricular tachycardia (PSVT) did not meet its primary endpoint over the five hour observation period, we are encouraged by the topline data from the trial. With a favorable safety and tolerability profile as well as efficacy signals observed across earlier time points, topline results from NODE-301 reinforce our belief that etripamil has the potential to serve as the first self-administered therapy for the rapid termination of supraventricular tachycardia (SVT) episodes in the at-home setting," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We look forward to working with regulators to determine next steps, with the goal of ensuring that etripamil is able to realize its full potential in patients with PSVT. In parallel, we continue to execute on the balance of the NODE program, including NODE-301B as well as open-label safety studies NODE-302 and NODE-303."
Recent Updates
First Quarter 2020 Financial Results
About Paroxysmal Supraventricular Tachycardia
Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions; however, when calcium channel blockers are used for the termination of SVT episodes, they must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.
About Etripamil
Etripamil, the Company's lead investigational product, is designed to be a rapid response therapy for episodic cardiovascular conditions. The novel calcium channel blocker is self-administered via a nasal spray which may shift the current treatment paradigm for many patients with PSVT from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials underway in PSVT, and plans to commence a Phase 2 proof-of-concept trial in atrial fibrillation patients with rapid ventricular rate, with subsequent studies expected in other conditions where calcium channel blockers are used.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines. Milestone Pharmaceuticals operates in Canada and the United States. For more information, visit www.milestonepharma.com and follow the Company 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 "may," "will," "expect," "plan," "anticipate," "estimate," "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 (i) the design, progress, timing, scope and results of clinical trials, (ii) potential interactions with regulators, (iii) future operating expense reductions and (iv) the possibility that data will support future development. 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 and evaluation of clinical trials, and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, as well as risks related to pandemics and public health emergencies, including those related to COVID-19, and risks related the sufficiency of our capital resources and our 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 quarterly report on Form 10-Q for the quarter ended March 31, 2020, under the caption "Risk Factors." 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.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS | |||
(Unaudited) | |||
'000 | |||
[In US dollars] | Three months ended March 31, | ||
2020 | 2019 | ||
$ | $ | ||
Operating expenses | |||
Research and development, net of tax credits | 11,872 | 7,765 | |
General and administrative | 2,703 | 979 | |
Commercial | 2,183 | 2,186 | |
Loss from operations | (16,758) | (10,930) | |
Interest income, net of bank charges | 415 | 500 | |
Loss and comprehensive loss before income taxes | (16,343) | (10,430) | |
Income tax expense | — | 22 | |
Net loss and comprehensive loss for the period | (16,343) | (10,452) | |
Weighted average number of shares outstanding, | |||
basic and diluted | 24,548,777 | 603,040 | |
Net loss per share, basic and diluted | $ (0.67) | $ (17.32) |
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | ||
(Unaudited) | ||
[In US dollars] | '000 | |
March 31, | December 31, | |
2020 | 2019 | |
$ | $ | |
ASSETS | ||
Current Assets | ||
Cash and Cash Equivalents | 101,816 | 119,818 |
Prepaid expenses and other current assets | 2,508 | 2,681 |
Total current assets | 104,324 | 122,499 |
Operating lease right of use asset | 451 | 524 |
Property and equipment | 381 | 405 |
Total assets | 105,156 | 123,428 |
LIABILITIES | ||
Current liabilities | ||
Accounts payable and accrued liabilities | 5,170 | 7,997 |
Operating lease liabilities | 196 | 330 |
Total current liabilities | 5,366 | 8,327 |
Operating lease liabilities | 158 | 184 |
Total liabilities | 5,524 | 8,511 |
Shareholders' Equity | ||
Share capital | ||
Common shares, no par value, unlimited shares authorized, | ||
24,559,470 shares issued at March 31, 2020 and | 226,378 | 226,245 |
Additional paid in Capital | 4,730 | 3,805 |
Cumulative translation adjustment | (1,634) | (1,634) |
Accumulated Deficit | (129,842) | (113,499) |
Total shareholders' equity | 99,632 | 114,917 |
Total liabilities and shareholders' deficit | 105,156 | 123,428 |
Contact
David Pitts
Argot Partners
212-600-1902
[email protected]
View original content:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-reports-first-quarter-2020-financial-results-and-provides-clinical-and-corporate-update-301059300.html
SOURCE Milestone Pharmaceuticals, Inc.
View original content: http://www.newswire.ca/en/releases/archive/May2020/14/c4773.html
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