Canada NewsWire
MONTREAL and CHARLOTTE, N.C., March 6, 2020
– Topline data from Phase 3 NODE-301 trial of etripamil in patients with PSVT expected this month –
MONTREAL and CHARLOTTE, N.C., March 6, 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 fourth quarter and year ended December 31, 2019 and provided a clinical and corporate update.
"Our team is keenly focused on delivering the near-term topline readout of the pivotal Phase 3 efficacy and safety trial, NODE-301," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Results from NODE-301, if favorable, have the potential to serve as the sole efficacy registration trial required for an NDA submission with the United States (U.S.) Food and Drug Administration (FDA), bringing us one step closer to providing paroxysmal supraventricular tachycardia (PSVT) patients with a much-needed novel therapeutic option. Supported by compelling results from the Phase 2 NODE-1 trial, we believe etripamil has the potential to alter the PSVT treatment paradigm as the first self-administered therapy for the rapid termination of supraventricular tachycardia (SVT) episodes wherever and whenever they occur."
Mr. Oliveto added, "As we focus on topline results from NODE-301, we remain diligent in executing on the balance of our Phase 3 program of etripamil for PSVT, including the NODE-302 and NODE-303 safety studies, preparing for the potential commercialization of etripamil, and building out our pipeline beyond PSVT. This includes the expected initiation of our first clinical trial of etripamil in patients with atrial fibrillation and rapid ventricular rate."
Recent Updates
Fourth Quarter 2019 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 utilized.
About Milestone Pharmaceuticals
Milestone 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) the anticipated timing of disclosure of results of clinical trials, (iii) the potential benefits and success of the commercialization of product candidates, and (iv) the likelihood 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 and completion of clinical trials, and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others. 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, 2019, 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.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS | ||||||
'000 | '000 | |||||
[In US dollars] | Three months ended December 31, | Twelve months ended December 31, | ||||
2019 | 2018 | 2019 | 2018 | |||
$ | $ | $ | $ | |||
Operating expenses | ||||||
Research and development, net of tax credits | 14,149 | 7,296 | 41,985 | 16,849 | ||
General and administrative | 2,279 | 1,218 | 7,004 | 3,052 | ||
Commercial | 2,464 | 1,592 | 8,892 | 3,921 | ||
Loss from operations | (18,892) | (10,106) | (57,881) | (23,822) | ||
Interest income, net of bank charges | 604 | 446 | 2,596 | 711 | ||
Loss and comprehensive loss before income taxes | (18,288) | (9,660) | (55,285) | (23,111) | ||
Income tax (recovery) expense | - | 56 | (56) | 74 | ||
Net loss and comprehensive loss for the year | (18,288) | (9,716) | (55,229) | (23,185) | ||
Weighted average number of shares outstanding, | ||||||
basic and diluted | 24,496,347 | 441,601 | 15,784,750 | 319,202 | ||
Net loss per share, basic and diluted | $ (0.75) | $ (22.00) | $ (3.50) | $ (72.63) |
CONSOLIDATED BALANCE SHEET | |||||
[In US dollars] | '000 | ||||
December 31, | December 31, | ||||
2019 | 2018 | ||||
$ | $ | ||||
ASSETS | |||||
Current Assets | |||||
Cash, Cash Equivalents and Short-term Investments | 119,818 | 85,976 | |||
Prepaid expenses and other current assets | 2,681 | 2,075 | |||
Total current assets | 122,499 | 88,051 | |||
Operating lease right of use asset | 524 | - | |||
Property and equipment | 405 | 30 | |||
Total assets | 123,428 | 88,081 | |||
LIABILITIES | |||||
Current liabilities | |||||
Accounts payable and accrued liabilities | 7,997 | 4,477 | |||
Operating lease liabilities | 330 | - | |||
Income taxes payable | - | 56 | |||
Total current liabilities | 8,327 | 4,533 | |||
Operating lease liabilities | 184 | - | |||
Total liabilities | 8,511 | 4,533 | |||
Convertible preferred shares | - | 138,758 | |||
Shareholders' Equity (deficit) | |||||
Share capital | |||||
Common shares, no par value, unlimited shares authorized, | |||||
24,505,748 shares issued at December 31, 2019 and | |||||
596,787 shares issued at December 31, 2018 | 226,245 | 2,039 | |||
Additional paid-in capital | 3,805 | 2,655 | |||
Cumulative translation adjustment | (1,634) | (1,634) | |||
Accumulated deficit | (113,499) | (58,270) | |||
Total shareholders' equity (deficit) | 114,917 | (55,210) | |||
Total liabilities and shareholders' equity (deficit) | 123,428 | 88,081 | |||
Contact
David Pitts
Argot Partners
212-600-1902
[email protected]
View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-reports-fourth-quarter-and-year-end-2019-financial-results-and-provides-clinical-and-corporate-update-301018597.html
SOURCE Milestone Pharmaceuticals, Inc.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/March2020/06/c0745.html
We use cookies to tailor your experience, measure site performance and present relevant offers and advertisements. By clicking ‘Accept’ or any content on this site, you agree that cookies can be placed on your browser. You can view our privacy policy to learn more.
If you would like to get more data, alerts and access to Real Vision videos, join us as an Insider Tracking Advantage Ultra member