Canada NewsWire
MONTREAL and CHARLOTTE, N.C., Nov. 13, 2020
MONTREAL and CHARLOTTE, N.C., Nov. 13, 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 third quarter ended September 30, 2020 and provided a clinical and corporate update.
"We remain on track to reopen enrollment in the pivotal Phase 3 RAPID trial by year-end, and are confident that the updated study design will help us to best characterize the potential clinical utility of our product candidate etripamil in patients with paroxysmal supraventricular tachycardia (PSVT)," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "In light of the safety and efficacy data from the completed NODE-301 trial, as well as positive feedback from the physicians charged with treating patients with PSVT, we believe that etripamil has the potential to serve as a much needed at-home intervention for this population. Backed by a strong balance sheet, which includes gross proceeds of $51.7 million from our recent public offering, we look forward to continuing to execute the etripamil PSVT program, with the goal of bringing this investigational therapy to as many appropriate patients as possible if approved by the FDA."
Recent Updates
Mr. Oliveto added, "On behalf of the entire Board of Directors, I would like to thank Paul for his insights and contributions over the last two years. We wish him the very best of luck in all of his future endeavors."
Third Quarter 2020 Financial Results
About Paroxysmal Supraventricular Tachycardia
PSVT is a rapid heart rate condition characterized by intermittent episodes of 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, calcium channel blockers approved for the termination of SVT episodes 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 has the potential to 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 patients with atrial fibrillation with rapid ventricular rate.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of etripamil, a Phase 3 clinical-stage program, for the treatment of cardiovascular indications. 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," "potential," "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 the potential of etripamil as a promising therapy for PSVT patients, the design, progress, timing, scope and results of the RAPID trial , Milestone's expectations regarding an NDA filing and potential FDA approval for etripamil, Milestone's ability to execute on the remainder of the PSVT program and Milestone's plans to study etripamil in atrial fibrillation patients. 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 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 quarterly report on Form 10-Q for the quarter ended September 30, 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 COMPRENHENSIVE LOSS | ||||||
(Unaudited) | ||||||
'000 | '000 | |||||
[In US dollars] | Three months ended September 30, | Nine months ended September 30, | ||||
2020 | 2019 | 2020 | 2019 | |||
$ | $ | $ | $ | |||
Operating expenses | ||||||
Research and development, net of tax credits | 8,228 | 9,545 | 28,722 | 27,836 | ||
General and administrative | 2,952 | 2,104 | 8,611 | 4,725 | ||
Commercial | 905 | 2,076 | 4,615 | 6,428 | ||
Loss from operations | (12,085) | (13,725) | (41,948) | (38,989) | ||
Interest income, net of bank charges | 89 | 821 | 630 | 1,993 | ||
Loss and comprehensive loss before income taxes | (11,996) | (12,904) | (41,318) | (36,996) | ||
Income tax recovery | (17) | (73) | (17) | (55) | ||
Net loss and comprehensive loss for the period | (11,979) | (12,831) | (41,301) | (36,941) | ||
Weighted average number of shares outstanding, | ||||||
basic and diluted | 29,774,065 | 24,490,742 | 26,329,581 | 12,848,974 | ||
Net loss per share, basic and diluted | $ (0.40) | $ (0.52) | $ (1.57) | $ (2.87) |
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | ||||
(Unaudited) | ||||
[In US dollars] | '000 | |||
September 30, | December 31, | |||
2020 | 2019 | |||
$ | $ | |||
ASSETS | ||||
Current Assets | ||||
Cash and Cash Equivalents | 102,910 | 119,818 | ||
Prepaid expenses and other current assets | 4,509 | 2,681 | ||
Total current assets | 107,419 | 122,499 | ||
Operating lease right of use asset | 1,045 | 524 | ||
Property and equipment | 333 | 405 | ||
Total assets | 108,797 | 123,428 | ||
LIABILITIES | ||||
Current liabilities | ||||
Accounts payable and accrued liabilities | 5,647 | 7,997 | ||
Operating lease liabilities | 234 | 330 | ||
Total current liabilities | 5,881 | 8,327 | ||
Operating lease liabilities | 718 | 184 | ||
Total liabilities | 6,599 | 8,511 | ||
Shareholders' Equity | ||||
Share capital | ||||
Common shares, no par value, unlimited shares authorized, | ||||
24,727,000 shares issued at September 30, 2020 and | 226,758 | 226,245 | ||
Pre-funded Warrants - 6,655,131 issued at September 30, 2020 | 24,770 | - | ||
Additional paid in Capital | 7,104 | 3,805 | ||
Cumulative translation adjustment | (1,634) | (1,634) | ||
Accumulated Deficit | (154,800) | (113,499) | ||
Total shareholders' equity | 102,198 | 114,917 | ||
Total liabilities and shareholders' deficit | 108,797 | 123,428 | ||
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/November2020/13/c8006.html
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