On November 13, 2020 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported financial results for the third quarter ended September 30, 2020 and provided a clinical and corporate update (Press release, Milestone Pharmaceuticals, NOV 13, 2020, View Source [SID1234570948]).
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"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
Pivotal Phase 3 RAPID Trial on Track to Reopen by Year-End. The Company remains on track to reopen enrollment in the pivotal Phase 3 RAPID trial by the end of the year. The RAPID trial is expected to randomize up to 500 patients and will be completed after a total of 180 confirmed supraventricular tachycardia (SVT) events are reached. Patients in the RAPID trial will be randomized 1:1 to etripamil or placebo. To help maximize the potential treatment effect of etripamil, patients who do not experience symptom relief within 10 minutes of the first study drug administration will be directed to administer a second dose of study drug. As previously announced, the primary efficacy endpoint for both the RAPID trial and the already-completed NODE-301 trial will be time to conversion of SVT within 30 minutes following initial study drug administration, with a target p-value of less than 0.05 for each trial. Milestone expects to report data from the RAPID trial in late 2021/early 2022. The RAPID and completed NODE-301 trials could potentially serve to fulfill the efficacy requirement for a future New Drug Application (NDA) for etripamil in patients with PSVT.
Raised $51.7 Million in Public Offering. In October 2020, Milestone announced the closing of an underwritten public offering of 5,095,897 of its common shares and, to certain investors in lieu thereof, pre-funded warrants to purchase 4,761,903 of its common shares at an exercise price of $0.01 per share. The public offering price of each common share was $5.25 and the public offering price of each pre-funded warrant was $5.24 per underlying share. Total gross proceeds to Milestone were approximately $51.7 million before deducting underwriting discounts and offering expenses.
Recent Changes to Board of Directors. In September 2020, Milestone announced the appointment of highly accomplished industry veterans Lisa Giles and Robert Wills to its Board of Directors. In addition, the Company reported that Dr. Wills will replace Paul R. Edick as Chairman of the Board of Directors. Mr. Edick will be stepping down from the Board, effective January 1, 2021, to focus on his role as Chief Executive Officer at Xeris Pharmaceuticals and their recent product launch.
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
As of September 30, 2020, Milestone had cash, cash equivalents, and short-term investments of $102.9 million, 24.7 million shares outstanding and 6.7 million pre-funded warrants outstanding.
Research and development expenses for the third quarter of 2020 were $8.2 million compared with $9.5 million for the prior year period. For the nine months ended September 30, 2020, research and development expenses were $28.7 million compared with $27.8 million for the prior year period. The increase for the nine-month period ending September 30, 2020 reflects increased clinical development costs supporting Milestone’s Phase 3 clinical trials and efforts in developing a clinical trial pathway for etripamil.
General and administrative expenses for the third quarter of 2020 were $3.0 million compared with $2.1 million for the prior year period. For the nine months ended September 30, 2020, general and administrative expenses were $8.6 million compared with $4.7 million for the prior year period. The increase in the nine-month period ending September 30, 2020 reflects increasing insurance costs, as well as additional professional fees and head count to support the compliance requirements of being a public company.
Commercial expenses for the third quarter of 2020 were $0.9 million compared with $2.1 million for the prior year period. For the nine months ended September 30, 2020, commercial expense was $4.6 million compared with $6.4 million for the prior year period. The decrease in expenses in the nine-month period ending September 30, 2020 reflects efforts in reducing operating expenses affecting primarily pre-commercialization activities as Milestone focused its efforts on an optimized clinical development pathway for etripamil.
For the third quarter of 2020, operating loss was $12.1 million compared to $13.7 million in 2019. For the nine months ended September 30, 2020, Milestone’s operating loss was $41.9 million compared to $39.0 million in the prior year period.
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.