Milestone Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Clinical and Corporate Update
MONTREAL and CHARLOTTE, N.C., May 14, 2020 /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 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
-- Reported Topline Results from Phase 3 NODE-301 Trial, Anticipates
Regulatory Update in Early 3Q 2020. In March 2020, Milestone reported
topline results from its Phase 3, multicenter, randomized, double-blind,
placebo-controlled NODE-301 trial of its investigational new drug,
etripamil nasal spray, the Company's novel short-acting calcium channel
blocker, in patients with PSVT. Despite early activity, including the
conversion of 61% of etripamil patients vs. 45% of placebo patients by
45 minutes (p=0.02), a time period consistent with etripamil's known
pharmacological activity, the study did not achieve its primary endpoint
of time to conversion of SVT to sinus rhythm compared to placebo over
the five hour period following study drug administration (p=0.12). The
small number of placebo patients and prolonged efficacy measurement
period was found to have confounded the results. The study did
demonstrate statistically significant improvements in favor of etripamil
over placebo in the important secondary endpoint of patient reported
treatment satisfaction. Milestone believes the safety and tolerability
data from the NODE-301 study will be supportive of at-home use of
etripamil, with adverse events consistent with those observed in prior
trials. The Company is determining next steps with regulators and
expects to provide an update early in the third quarter of 2020. The
Company's full PSVT clinical program, including NODE-301B, NODE-302 and
NODE-303, remains ongoing. NODE-301B, which was designed to collect
double-blind data from randomized patients who had not yet experienced
an event after the NODE-301 trial reached its target number of
adjudicated SVT events, is expected to be analyzed separately as a
second safety and efficacy data set.
-- Reduction in Operating Expenses. Milestone expects to reduce planned
operating expenses by 20-25% in order to focus its efforts on an
optimized clinical development pathway for etripamil that will be
determined following regulatory feedback. The cuts will primarily affect
pre-commercialization activities. The goal of the operating cuts is to
facilitate an additional efficacy study for etripamil in PSVT and to
extend the Company's cash runway. The Company will update its cash
runway guidance after meeting with regulators.
-- Jeff Nelson Promoted to Chief Operating Officer. In March 2020,
Milestone announced the promotion of Jeff Nelson to Chief Operating
Officer. Mr. Nelson, who joined the Company in 2018 as Vice President of
Program Management, brings to this new role over 15 years of experience
in the pharmaceutical and biotech field, working primarily in project
management, clinical operations, regulatory affairs, drug supply and
distribution and public finance.
First Quarter 2020 Financial Results
-- As of March 31, 2020, Milestone had cash and cash equivalents of $102
million and 24.6 million shares outstanding.
-- Research and development expense for the first quarter of 2020 was $11.9
million compared with $7.8 million for the prior year period. The
increase in expense was primarily driven by increased clinical
development costs and manufacturing and formulation activities
supporting its Phase 3 clinical trials.
-- General and administrative expenses for the first quarter of 2020 were
$2.7 million compared with $1.0 million for the prior year period. The
increase was driven by additional headcount, professional fees and
increased insurance costs.
-- Commercial expense for the first quarter of 2020 was $2.2 million and
remained consistant with the prior year period.
-- For the first quarter of 2020, operating loss was $16.8 million compared
to $10.9 million for the prior year period.
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
24,505,748 shares issued at December 31, 2019
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
david@argotpartners.com
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SOURCE Milestone Pharmaceuticals, Inc.
