Milestone Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Clinical and Corporate Update
- 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 /PRNewswire/ -- 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
-- Richard C. Pasternak, M.D. Appointed to Board of Directors. The Company
also today announced that Richard C. Pasternak, M.D. has been appointed
to its Board of Directors. He brings to Milestone over 40 years of
clinical, academic, and biopharmaceutical industry experience in the
area of cardiology. He will serve as a member of the Company's
compensation committee. Dr. Pasternak recently retired from Cerenis
Therapeutics (now ABIONYX Pharma), a French publicly-traded company
focused on developing treatments for cardiovascular diseases, where he
served as Chief Executive Officer and Chair of the Board of Directors.
He previously served as Vice President, Head of Cardiovascular Clinical
Research, and Head of Global Scientific Affairs and Scientific
Leadership, at Merck & Co. from 2004 to 2010. Prior to joining Merck, he
was the Director of Preventive Cardiology and Cardiac Rehabilitation at
Massachusetts General Hospital, and an Associate Professor of Medicine
at Harvard Medical School. Dr. Pasternak is currently a Clinical
Professor at the Weill Cornell Medical College, and serves on the Boards
of Anthos Therapeutics and Magenta Medical Ltd. He previously served on
the Boards of Essentialis Therapeutics and Haptocure Ltd., as well as
several nonprofit organizations. He was also previously a senior advisor
to Bay City Capital and Bridge Medicines. Dr. Pasternak has authored
more than 100 publications and has lectured internationally on
cardiovascular disease drug development. He received his B.A. and M.D.
from Yale University, and completed his medical and cardiology training
at Massachusetts General Hospital.
-- Company to Commence Clinical Evaluation of Etripamil in Atrial
Fibrillation with Rapid Ventricular Rate (RVR). In 2020, Milestone plans
to initiate a proof-of-concept clinical trial of etripamil for the
treatment of patients with atrial fibrillation with RVR, another type of
supraventricular tachycardia in which most patients experience episodes
of elevated heart rates and for which L-type calcium channel blockers
are approved for rate control.
-- Enrolled First Patient in NODE-303 Study. In October 2019, Milestone
announced enrollment of the first patient in the Company's Phase 3
open-label, global safety study of etripamil in patients with PSVT. The
study will primarily evaluate the safety of etripamil when
self-administered without medical supervision during single or multiple
PSVT episodes. Important secondary measures include efficacy, patient
quality of life and pharmacoeconomic assessments. The study represents
the largest study ever conducted in PSVT, assessing up to 1,500 patient
episodes from patients who did not participate in NODE-301 or its
open-label safety extension study, NODE-302.
-- Announced Appointment of Amit Hasija as Chief Financial Officer and
Executive Vice President of Corporate Development. In September 2019,
the Company announced the appointment of Amit Hasija as Chief Financial
Officer and Executive Vice President of Corporate Development. Mr.
Hasija brings to Milestone two decades of experience in corporate
finance and business development within the healthcare industry.
Third Quarter 2019 Financial Results
-- As of September 30, 2019, Milestone had cash, cash equivalents, and
short-term investments of $136.5 million and 24.5 million shares
outstanding.
-- Research and development expense for the third quarter of 2019 was $9.5
million compared with $3.9 million for the prior year period. For the
nine months ended September 30, 2019, research and development expense
was $27.8 million compared with $9.6 million for the prior year period.
The increase in 2019 amounts reflects spending on Milestone's full Phase
3 clinical program evaluating etripamil for the treatment of PSVT.
-- General and administrative expenses for the third quarter of 2019 were
$2.1 million compared with $0.6 million for the prior year period. For
the nine months ended September 30, 2019, general and administrative
expense was $4.7 million compared with $1.8 million for the prior year
period. During 2019, Milestone increased its managerial headcount and,
as a result, the related personnel costs. In addition, Milestone
incurred increased spending for consulting fees, recruiting fees and
professional fees, including legal and accounting services incurred to
support its IPO.
-- Commercial expense for the third quarter of 2019 was $2.1 million
compared with $1.2 million for the prior year period. For the nine
months ended September 30, 2019, commercial expense was $6.4 million
compared with $2.3 million for the prior year period. These increases
reflect increased commercial headcount and related costs, continued
commercial and market research, increases in Milestone's patient
advocacy activities and costs for its medical affairs team focused on
key opinion leaders' engagement and disease awareness.
-- For the third quarter of 2019, operating loss was $12.9 million compared
to $5.7 million in 2018. For the nine months ended September 30, 2019,
Milestone's operating loss was $37.0 million compared to $13.5 million
in the prior year period.
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
24,490,742 shares issued at September 30, 2019 and 596,787 shares issued at
December 31, 2018
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
david@argotpartners.com
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SOURCE Milestone Pharmaceuticals, Inc.
