Canada NewsWire
MONTREAL and CHARLOTTE, N.C., Nov. 13, 2019
– NODE-301 topline data readout expected in mid-1H20 –
– Richard Pasternak, M.D. appointed to the Company's Board of Directors –
MONTREAL and CHARLOTTE, N.C., Nov. 13, 2019 /CNW/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a Phase 3 clinical-stage biopharmaceutical company dedicated to developing and commercializing etripamil for the treatment of cardiovascular indications, today reported financial results for the third quarter ended September 30, 2019 and provided a clinical and corporate update.
"Thanks to the hard work of our study team, a dedicated group of clinical sites, and, importantly, the patients participating in our study, NODE-301 continues to exceed our enrollment and PSVT event rate expectations, with topline data now expected in the middle of the first half of 2020," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "In addition, progress continues with efforts to ramp up our recently initiated global safety study, NODE-303, the largest study ever conducted in PSVT."
Mr. Oliveto added, "I am honored to welcome Dr. Richard Pasternak to our Board of Directors. A cardiologist by training, he brings a wealth of cardiovascular drug development experience that incorporates academia, large pharma and small entrepreneurial companies."
NODE-301 Update
Milestone today announced that it now expects to report topline data for the NODE-301 trial in the middle of the first half of 2020. The NODE-301 trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of etripamil, the Company's novel short-acting calcium channel blocker, for terminating paroxysmal supraventricular tachycardia (PSVT) episodes in the outpatient setting. The study is designed to treat an enriched population of those PSVT patients who historically experience 20 minutes or longer PSVT episodes or episodes requiring termination in the emergency department. The primary endpoint of the NODE-301 study is time to conversion of PSVT to sinus rhythm after the administration of study drug, as confirmed by a central independent adjudication committee. Secondary study endpoints include relief of symptoms commonly associated with an episode of PSVT such as heart palpitations, chest pain, anxiety, shortness of breath, dizziness, or fainting, and rating of treatment satisfaction questionnaire for medication (TSQM).
As previously announced, after the NODE-301 trial reaches its target number of adjudicated PSVT events, collection of blinded data from randomized patients who have not yet experienced an event will continue. These data will be analyzed separately as a secondary data set, referred to as NODE-301B, and may contribute further to sub-population analyses and pharmacoeconomic assessments.
Recent Updates
Third Quarter 2019 Financial Results
About Etripamil in Paroxysmal Supraventricular Tachycardia
Paroxysmal Supraventricular Tachycardia (PSVT) is a rapid heart rate condition that starts and stops without warning, often experienced by patients with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting and anxiety. Calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions, however, for episodes of PSVT calcium channel blockers are currently administered intravenously under medical supervision, usually in the emergency department. By contrast, etripamil is designed to serve as a self-administered therapy for the rapid termination of episodes of PSVT. With its combination of convenient delivery, rapid onset and short duration of action, etripamil has the potential to shift the current treatment paradigm for PSVT away from the burdensome and costly emergency department settings by treating episodes of PSVT wherever and whenever they occur.
About Milestone Pharmaceuticals
Milestone is a Phase 3 clinical-stage biopharmaceutical company dedicated to developing and commercializing the investigational new drug etripamil for the treatment of cardiovascular indications. Milestone is actively recruiting patients for a Phase 3 clinical trial of etripamil for the treatment of PSVT. Milestone plans to initiate a Phase 2 clinical trial in atrial fibrillation, another rapid heart rate condition, and expects to subsequently initiate an additional Phase 2 clinical trial in angina to establish proof-of-concept for the broader use of etripamil.
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 quarterly report on Form 10-Q for the period ended September 30, 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.
CONDENSED CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS | |||||
(Unaudited) | |||||
'000 | '000 | ||||
[In US dollars] | Three months ended September 30, | Nine months ended September 30, | |||
2019 | 2018 | 2019 | 2018 | ||
Operating expenses | |||||
Research and development, net of tax credits | $ 9,545 | $ 3,911 | $ 27,836 | $ 9,552 | |
General and administrative | 2,104 | 646 | 4,725 | 1,834 | |
Commercial | 2,076 | 1,228 | 6,428 | 2,329 | |
Loss from operations | $ (13,725) | $ (5,785) | $ (38,989) | $ (13,715) | |
Interest income, net of bank charges | 821 | 85 | 1,993 | 265 | |
Loss and comprehensive loss before income taxes | (12,904) | (5,700) | (36,996) | (13,450) | |
Income tax (recovery) expense | (73) | — | (55) | 18 | |
Net loss and comprehensive loss for the year | $ (12,831) | $ (5,700) | $ (36,941) | $ (13,468) | |
Weighted average number of shares outstanding, basic and diluted | 24,490,742 | 282,771 | 12,848,974 | 277,917 | |
Net loss per share, basic and diluted | $ (0.52) | $ (20.16) | $ (2.87) | $ (48.46) |
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
(Unaudited) | |||||
[In US dollars] | '000 | ||||
September 30, | December 31, | ||||
2019 | 2018 | ||||
ASSETS | |||||
Current Assets | |||||
Cash, Cash Equivalents and Short-term Investments | $ 136,501 | $ 85,976 | |||
Prepaid expenses and other current assets | 4,470 | 2,075 | |||
Total current assets | 140,971 | 88,051 | |||
Operating lease right of use asset | 593 | — | |||
Property and equipment | 328 | 30 | |||
Total assets | $ 141,892 | $ 88,081 | |||
LIABILITIES | |||||
Current liabilities | |||||
Accounts payable and accrued liabilities | $ 8,478 | $ 4,477 | |||
Operating lease liabilities | 358 | — | |||
Income taxes payable | — | 56 | |||
Total current liabilities | 8,836 | 4,533 | |||
Operating lease liabilities | 224 | - | |||
Total liabilities | 9,060 | 4,533 | |||
Convertible preferred shares | - | 138,758 | |||
Shareholders' Equity (Deficit) | |||||
Share capital | |||||
Common shares, no par value, unlimited shares authorized, | 226,211 | 2,039 | |||
Additional paid in Capital | 3,466 | 2,655 | |||
Cumulative translation adjustment | (1,634) | (1,634) | |||
Deficit | (95,211) | (58,270) | |||
Total shareholders' equity (deficit) | 132,832 | (55,210) | |||
Total liabilities, convertible preferred shares and shareholders' equity (deficit) | $ 141,892 | $ 88,081 |
Contact
David Pitts
Argot Partners
212-600-1902
[email protected]
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SOURCE Milestone Pharmaceuticals, Inc.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/November2019/13/c3867.html
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