PR Newswire
MONTREAL and CHARLOTTE, N.C., Aug. 11, 2021
MONTREAL and CHARLOTTE, N.C., Aug. 11, 2021 /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 second quarter ended June 30, 2021 and provided a clinical and corporate update.
"The second quarter of 2021 was marked by continued progress advancing our ongoing programs evaluating etripamil in patients with PSVT and AFib-RVR," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "With respect to the Phase 3 RAPID trial of etripamil in patients with PSVT, we are encouraged by continued improvements in study enrollment rates. We look forward to building on this momentum in the coming quarters and remain on track to report topline data in the second half of 2022."
Mr. Oliveto added, "Beyond PSVT, recent market research with cardiologists has strengthened our belief that etripamil has the potential to become a valuable treatment option for patients experiencing episodes of AFib-RVR."
Recent Updates
Second Quarter 2021 Financial Results
About Paroxysmal Supraventricular Tachycardia
Paroxysmal supraventricular tachycardia (PSVT) is a condition characterized by intermittent episodes of rapid heart beat (SVT) that starts and stops suddenly and without warning that affects approximately two million Americans. 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 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 in which patients with AFib experience 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 manage heart rate in this condition. When episodes do occur, the corresponding symptoms often cause patients to seek care in the acute care setting such as the emergency department, where standard of care procedures include intravenous administration of calcium channel blockers or beta blockers under medical supervision. Milestone's initial qualitative market research indicates that approximately 40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a target addressable market for etripamil in patients with AFib of approximately two million patients.
About Etripamil
Etripamil, Milestone's lead investigational product, 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 the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and now a Phase 2 proof-of-concept trial underway in patients with atrial fibrillation and 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 is currently in a Phase 3 clinical-stage program for the treatment of paroxysmal supraventricular tachycardia (PSVT) and in a Phase 2 proof-of-concept trial for the treatment of patients with atrial fibrillation and rapid ventricular rate (AFib-RVR). 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 and ReVeRA trials, Milestone's ability to execute on the remainder of the PSVT program, Milestone's plans to study etripamil in atrial fibrillation patients, the sufficiency of Milestone's current cash resources to support its operations, Milestone's and Ji Xing's intention and ability to develop and commercialize etripamil in Greater China 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 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 annual report on Form 10-K for the year ended December 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 COMPRENHENSIVE LOSS | ||||||
(Unaudited, in thousands of US dollars, except share and per share data) | ||||||
Three months ended | Six months ended | |||||
2021 | 2020 | 2021 | 2020 | |||
$ | $ | $ | $ | |||
Collaboration Revenue | 15,000 | - | 15,000 | - | ||
Operating expenses | ||||||
Research and development, net of tax credits | 9,427 | 8,622 | 18,022 | 20,493 | ||
General and administrative | 3,018 | 2,956 | 5,651 | 5,659 | ||
Commercial | 1,843 | 1,527 | 3,209 | 3,710 | ||
Total Operating expenses | 14,288 | 13,105 | 26,882 | 29,862 | ||
Income (Loss) from operations | 712 | (13,105) | (11,882) | (29,862) | ||
Interest income, net of bank charges | 58 | 126 | 138 | 540 | ||
Net income (loss) and comprehensive loss for the period | 770 | (12,979) | (11,744) | (29,322) | ||
Weighted average number of shares and | ||||||
pre-funded warrants outstanding, basic and diluted | 41,673,370 | 24,548,777 | 41,465,961 | 24,588,413 | ||
Net income (loss) per share, basic and diluted | 0.02 | (0.53) | (0.28) | (1.20) | ||
Weighted average number of shares and | ||||||
pre-funded warrants outstanding, basic and diluted | 44,530,121 | 24,548,777 | 41,465,961 | 24,588,413 | ||
Net income (loss) per share, basic and diluted | 0.02 | (0.53) | (0.28) | (1.20) |
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | ||
(Unaudited, in thousands of US dollars, except share data) | ||
June 30, | December 31, | |
2021 | 2020 | |
$ | $ | |
ASSETS | ||
Current Assets | ||
Cash, cash equivalents and short-term investments | 135,794 | 142,310 |
Prepaid expenses and other current assets | 8,592 | 6,376 |
Total current assets | 144,386 | 148,686 |
Operating lease right-of-use asset | 847 | 980 |
Property and equipment | 262 | 308 |
Total assets | 145,495 | 149,974 |
LIABILITIES | ||
Current liabilities | ||
Accounts payable and accrued liabilities | 5,069 | 5,914 |
Current portion of operating lease liabilities | 259 | 245 |
Total current liabilities | 5,328 | 6,159 |
Operating lease liabilities | 573 | 696 |
Total liabilities | 5,901 | 6,855 |
Shareholders' Equity | ||
Share capital | ||
Common shares, no par value, unlimited shares authorized 29,846,000 shares issued and outstanding as of June 30, 2021, 29,827,997 shares issued and outstanding as of December 31, 2020 | 251,716 | 251,682 |
Pre-funded warrants - 12,327,780 issued and outstanding as of June 30, 2021 and 11,417,034 as of December 31, 2020 | 52,927 | 48,007 |
Additional paid in capital | 11,795 | 8,530 |
Cumulative translation adjustment | (1,634) | (1,634) |
Accumulated deficit | (175,210) | (163,466) |
Total shareholders' equity | 139,594 | 143,119 |
Total liabilities and shareholders' equity | 145,495 | 149,974 |
Contact:
David Pitts
Argot Partners
212-600-1902
[email protected]
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SOURCE Milestone Pharmaceuticals, Inc.
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