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Montreal and Charlotte, NC, May 8, 2019 -- 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 announced the pricing of its upsized initial public offering of 5,500,000 of its common shares at a public offering price of $15.00 per share. The gross proceeds to Milestone, before deducting underwriting discounts, commissions and offering expenses, are expected to be approximately $82.5 million. All of the common shares are being offered by Milestone. In addition, Milestone has granted certain of the underwriters a 30-day option to purchase up to 825,000 additional common shares at the initial public offering price, less the underwriting discounts and commissions.

MONTREAL and CHARLOTTE, N.C., Oct. 25, 2018 -- Milestone Pharmaceuticals, a late-stage biopharmaceutical company developing interventions for tachycardias, today announced the completion of an $80 million private financing. The equity financing included the support of new and existing institutional investors. Among new investors were RTW Investments, LP, who led the round, Venrock Healthcare Capital Partners, and Boxer Capital of Tavistock Group. Existing investors included Novo Holdings A/S, Forbion, funds managed by Tekla Capital Management LLC, Domain Associates, BDC Capital, Pappas Capital, GO Capital, and Fonds de solidarité FTQ. This builds on the company's prior series C financing, led by Novo Holdings, which occurred in July 2017.

Montreal, Aug. 8, 2018 /PRNewswire/ -- Milestone Pharmaceuticals, a clinical-stage cardiovascular company, today announced that the first patient has been randomized in its Phase 3 clinical study of etripamil. Etripamil is a new investigational, rapid-onset, short-acting calcium channel blocker administered intranasally by the patient designed to terminate paroxysmal supraventricular tachycardia (PSVT) episodes wherever they occur. PSVT is a recurring and sporadic heart arrhythmia caused by abnormalities in the cardiac conduction system. The current standard of care to terminate these episodes is intravenous medication delivered in the emergency department.

The Phase 3, multicenter, randomized, double-blind, placebo-controlled, event-driven study is planned to be conducted in more than 50 cardiology centers in the United States and Canada and will enroll up to 500 patients. Following an in-office test dose of etripamil, patients will take home either 70 mg of etripamil or placebo for when a PSVT episode occurs. Upon onset of an episode, patients will apply a wireless cardiac monitor to their chest to record their heart rhythm, perform a vagal maneuver, and if symptoms persist, administer study drug.

“The design of the NODE-301 study of etripamil will allow us to obtain more clinical evidence of the benefits of this potential treatment for PSVT in an outpatient, real-world setting,” said Bruce Stambler, MD, FHRS, Piedmont Heart Institute, Atlanta, GA. “PSVT is an unpredictable disorder and the potential for a fast-acting therapy to resolve the symptoms of PSVT wherever the episodes occur could significantly reduce the burden this condition puts on patients and the healthcare system.”

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, and fainting.

“The initiation of the NODE-301 study is an example of our ongoing commitment to improve the lives of patients with PSVT,” said Francis Plat, MD, Milestone’s Chief Medical Officer. “Etripamil, if approved by regulatory authorities, could empower patients to take control of this anxiety-producing arrhythmia without being reliant on chronic medications or trips to an acute-care facility for treatment.”

The study will enroll patients at least 18 years of age with a documented history of PSVT. Patients receiving study treatment in NODE-301 will be eligible to participate in an open-label extension study (NODE-302) where etripamil will be provided for subsequent PSVT episodes. Information regarding the NODE-301 clinical trial can be found here (clinicaltrials.gov study identifier NCT03464019).

“There are well over a million people in the US living with PSVT, resulting in hundreds of thousands of emergency department and doctor’s office visits each year,” said Eileen Handberg, PhD, ANP-BC, FAHA, FACC, FPCNA, Research Professor of Medicine at the University of Florida. “In addition, countless other patients exist who don’t seek care and suffer through their episodes in silence as the current approved treatment options are unpleasant, inconvenient, and/or costly.  Providing a way to self-manage PSVT episodes could offer immediate relief for those living with this arrhythmia.”

About Etripamil

Etripamil is a new, potent, short-acting, investigational calcium channel blocker being developed as a rapid-onset nasal spray that can be administered by the patient to terminate paroxysmal supraventricular tachycardia (PSVT) episodes wherever and whenever they occur. A Phase 2 clinical trial (NODE-1) was completed in the United States and Canada and published in the Journal of the American College of Cardiology[1]. Milestone is actively recruiting patients and clinical sites globally for the Phase 3 program of etripamil in the at-home setting enrolling patients with confirmed diagnosis of atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular re-entry tachycardia (AVRT). Etripamil is not currently approved for the treatment of PSVT or for any other indication anywhere in the world.

About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia is a condition that afflicts more than 1.7 million people and results in at least 600,000 healthcare claims per year in the U.S. alone[2]. During a PSVT episode, patients may feel palpitations while heart rate increases dramatically, sometimes exceeding 250 beats per minute[3]. Although the condition is not life threatening, it causes great distress to the patient and can result in an emergency department visit where a patient is usually administered intravenous medication.

About Milestone Pharmaceuticals

Milestone, headquartered in Montreal, Canada with a US subsidiary in Charlotte, NC, is a clinical-stage drug development company focused on developing an investigational new drug intended to provide rapid-onset and short-acting treatment of PSVT episodes and other episodic conditions. For more information, please visit www.milestonepharma.com.

Contact:

David Pitts
Argot Partners
212-600-1902
david@argotpartners.com

^[1] Stambler, B.S. et al.; Etripamil Nasal Spray for Rapid Conversion of Supraventricular Tachycardia to Sinus Rhythm; J Am Coll Cardiol. 2018;72(5):489–97

[2] Sacks, N.C. et al; Prevalence of Paroxysmal Supraventricular Tachycardia (PSVT) in the US in Patients Under 65 Years of Age; Abstract and Oral Presentation at the International Academy of Cardiology Annual Scientific Sessions 2018, 23rd World Congress on Heart Disease; Precision Xtract, Boston, MA, USA

[3] Colucci, R.A.; Common types of supraventricular tachycardia: diagnosis and management.; Am Fam Physician. 2010;82(8), 942-952.

SOURCE Milestone Pharmaceuticals USA, Inc.

Related Links
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Montreal, QC, CA, August 1, 2017 – Milestone Pharmaceuticals Montreal, Canada, Inc., a clinical stage cardiovascular company, today announced the completion of a US$55 million Series C financing. The round was led by Novo Holdings A/S, and included new investors Forbion Capital Partners and funds managed by Tekla Capital Management, with significant participation from Milestone’s existing investors Domain Associates, Fonds de solidarité FTQ, BDC Capital, Pappas Capital, and GO Capital.

Montreal, QC, CA, May 11, 2017 – Milestone Pharmaceuticals Montreal, Canada, Inc., a clinical stage cardiovascular company, today announced positive data from its Phase 2 NODE-1 trial evaluating etripamil, a novel, potent, fast-acting and short-acting calcium channel blocker in development for the acute treatment of patients with paroxysmal supraventricular tachycardia (PSVT), a potentially debilitating cardiac arrhythmia. The data were presented in a late breaking oral presentation at Heart Rhythm 2017, the Heart Rhythm Society’s 38th Annual Scientific Sessions in Chicago. The results from the Phase 2 NODE-1 trial show that etripamil demonstrated statistically significant efficacy compared to placebo for the acute termination of PSVT induced in an electrophysiology laboratory.

MONTREAL, March 7, 2017 – Milestone Pharmaceuticals USA, Inc., a clinical stage cardiovascular company, today announced the appointment of Joseph G. Oliveto as President and Chief Executive Officer, effective immediately. His appointment follows a recent, successful outcome from the company's Phase 2 study of lead candidate etripamil for the acute treatment of paroxysmal supra-ventricular tachycardia (PSVT), a potentially debilitating cardiac arrhythmia. Mr. Oliveto brings more than 25 years of pharmaceutical and biotech experience across the areas of drug development, commercialization, manufacturing and business development to Milestone. Philippe Douville, Ph.D., who founded the company and served as CEO, will now assume the newly created position of Chief Scientific Officer.

MONTREAL, QC, June 15, 2015 – Milestone Pharmaceuticals Inc., a clinical stage cardiovascular company in Phase 2, today announced the close of a US$17 million Series B financing. The round was led by Domain Associates and included participation from all of Milestone’s existing investors including Fonds de solidarité FTQ (FSTQ), Pappas Ventures, BDC Capital, GO Capital, and iNovia Capital. The funding will be used to complete Phase 2 clinical development of MSP-2017. In connection with this financing, Domain’s Debra Liebert will join Milestone’s board of directors.

MONTREAL, Jan. 12, 2015 /PRNewswire/ - Milestone Pharmaceuticals, Inc. announced today that it received clearance of its Investigational New Drug (IND) Application from the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 study of MSP-2017 for the treatment of acute episodes of Paroxysmal Supraventricular Tachycardia (PSVT). The trial is expected to begin patient enrollment in early 2015.

Montreal, QC, November 24, 2014 – Milestone Pharmaceuticals, Inc. today announced data from a Phase 1 clinical trial conducted in Melbourne, Australia of MSP-2017, a novel calcium channel antagonist for the potential treatment of paroxysmal supraventricular tachycardia (PSVT). The results demonstrated that an intra-nasal formulation of MSP-2017 was well tolerated at single doses up to and including 140 mg with an excellent safety profile, desirable PK properties including rapid onset, and validating proof of concept by PR interval prolongation as measured by ECG. Milestone expects to initiate a Phase 2 clinical trial of MSP-2017 in patients with PSVT during the first half of 2015.