1. MONTREAL and CHARLOTTE, N.C., March 29, 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 fourth quarter and year ended December 31, 2020 and provided a clinical and corporate update.

    "We are keenly focused on executing on our etripamil development program for patients with PSVT following clear regulatory guidance in the second half of 2020 and commencement of the pivotal Phase 3 RAPID study," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We believe that etripamil has the potential to overcome the limitations of the current standard…

    MONTREAL and CHARLOTTE, N.C., March 29, 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 fourth quarter and year ended December 31, 2020 and provided a clinical and corporate update.

    "We are keenly focused on executing on our etripamil development program for patients with PSVT following clear regulatory guidance in the second half of 2020 and commencement of the pivotal Phase 3 RAPID study," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We believe that etripamil has the potential to overcome the limitations of the current standard of care for PSVT, which is invasive, anxiety-provoking and costly, and to serve as a meaningful new therapeutic option for patients."

    Mr. Oliveto added, "Beyond PSVT, we are pleased to announce that the Phase 2 ReVeRA study of etripamil in patients with atrial fibrillation and rapid ventricular rate is now underway. We are committed to assessing the full potential of etripamil and helping patients with episodic cardiovascular conditions, and we look forward to providing updates on our progress in the coming months."   

    Recent Updates

    • Company Continues to Guide to Topline Data from Pivotal Phase 3 RAPID Trial in Late 2021/Early 2022. The pivotal Phase 3 RAPID trial, which is targeting a total of 180 adjudicated paroxysmal supraventricular tachycardia (PSVT) events, is expected to randomize approximately 500 patients 1:1 to receive either etripamil nasal spray or placebo. As previously announced, patients will be directed to administer a second dose of study drug if they do not experience symptom relief within 10 minutes of the first study drug administration to help maximize the potential treatment effect of etripamil. The primary efficacy analysis 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. The RAPID and NODE-301 trials could potentially serve to fulfill the efficacy requirement for a future New Drug Application (NDA) for etripamil in patients with PSVT.



      While clinical site initiations and patient enrollment have been impacted by COVID-19 pandemic-related factors, the Company has initiated mitigation activities including increasing the number of clinical sites and continues to guide toward topline data in late 2021/early 2022.



    • First Patient Enrolled in ReVeRA Phase 2 Proof-of-Concept Trial Evaluating Etripamil in Patients with Atrial Fibrillation and Rapid Ventricular Rate (AFib-RVR). Milestone today announced that the first patient has been enrolled in ReVeRA, its Phase 2 proof-of-concept study of etripamil nasal spray in patients experiencing AFib-RVR. The Phase 2 double blind, placebo controlled, proof-of-concept study is designed to assess the safety and efficacy of etripamil nasal spray to reduce ventricular rate in patients with AFib-RVR experiencing an episode of elevated heart rate requiring treatment. The trial, which will be conducted in Canada in collaboration with the Montreal Heart Institute and other research centers, is expected to enroll approximately 50 patients randomized 1:1 to receive either 70 mg of etripamil nasal spray or placebo. The primary endpoint will assess reduction in ventricular rate, with key secondary endpoints including the time to achieve the maximum reduction in rate and duration of the effect.



    • Julia Gaebler, Ph.D., appointed as Vice President, Commercial Strategy and Portfolio Planning. Today, Milestone announces the appointment of Julia Gaebler, Ph.D., as Vice President, Commercial Strategy and Portfolio Planning. Dr. Gaebler is a highly accomplished industry veteran with over 25 years of commercial strategy, market access, health services research, and corporate development experience. Dr. Gaebler joins Milestone from Health Advances, where she was Partner, and Head of Global Market Access, Pricing and Policy. Prior experience includes positions of increasing responsibility at Biogen, Amylin Pharmaceuticals, global and affiliate positions within Hoffman La Roche, and the RAND Corporation. She received her Ph.D. in Health Policy and Decision Sciences from Harvard University, M.A. in International Economics from Johns Hopkins University and B.A. in European Intellectual History from the University of Pennsylvania.

    Fourth Quarter and Full Year 2020 Financial Results

    • As of December 31, 2020, Milestone had cash, cash equivalents, and short-term investments of $142.3 million compared to $119.8 million as of December 31, 2019, and 29.8 million common shares and 11.4 million pre-funded warrants outstanding.
    • Research and development expense for the fourth quarter of 2020 was $5.8 million compared with $14.1 million for the prior year period. For the full year ended December 31, 2020, research and development expense was $34.5 million compared with $42.0 million for the prior year. The COVID-19 pandemic contributed to delays in new clinical site initiation and patient enrollment, which translated into lower than expected research and development spending in the quarter and in the year ended December 31, 2020.
    • General and administrative expense for the fourth quarter of 2020 was $1.7 million compared with $2.3 million for the prior year period. For the full year ended December 31, 2020, general and administrative expense was $10.3 million compared with $7.0 million for the prior year. The increase of general and administrative expense in the year is mainly attributable to higher insurance costs, additional headcount and non-cash compensation cost related to share-based compensation expense.
    • Commercial expense for the fourth quarter of 2020 was $1.3 million compared with $2.5 million for the prior year period. For the full year ended December 31, 2020, commercial expense was $5.9 million compared with $8.9 million for the prior year. The decrease of commercial expense in the year ended December 31, 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 fourth quarter of 2020, operating loss was $8.8 million compared to $18.9 million for the prior year period. For the full year ended December 31, 2020, Milestone's operating loss was $50.0 million compared to $55.3 million for the prior year.
    • The Company believes its current cash, cash equivalents, and short-term investments will be sufficient to fund anticipated operating expenses and capital expenditure requirements through 2022. This guidance includes anticipated costs associated with the Phase 3 RAPID trial, which are expected to increase as study enrollment progresses.

    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 which 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 and 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 and 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 approximately 40% of patients with AFib experience one or more symptomatic episodes of AFib-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, 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 quarterly 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.

     

    CONSOLIDATED STATEMENTS OF LOSS AND COMPRENHENSIVE LOSS

    (Unaudited, in thousands of US dollars, except share and per share data)











    Three months Ended December 31,



    Years Ended December 31,



    2020

    2019



    2020

    2019



    $

    $



    $

    $

    Operating expenses











    Research and development, net of tax credits

    5,766

    14,149



    34,488

    41,985

    General and administrative

    1,674

    2,279



    10,285

    7,004

    Commercial

    1,322

    2,464



    5,937

    8,892

    Loss from operations

    (8,762)

    (18,892)



    (50,710)

    (57,881)

    Interest income, net of bank charges

    96

    604



    726

    2,596

    Loss before income taxes

    (8,666)

    (18,288)



    (49,984)

    (55,285)

    Income tax recovery



    (17)

    (56)

    Net loss and comprehensive loss for the period

    (8,666)

    (18,288)



    (49,967)

    (55,229)













    Weighted average number of shares and pre-funded warrants outstanding, basic and diluted

    38,424,384

    24,496,347



    29,344,993

    15,784,750













    Net loss per share, basic and diluted

    (0.23)

    (0.75)



    (1.70)

    (3.50)

     

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited, in thousands of US dollars, except share data)







    December 31,

    December 31,



    2020

    2019



    $

    $

    ASSETS





    Current Assets





    Cash, cash equivalents and short-term investments

    142,310

    119,818

    Prepaid expenses and other current assets

    6,376

    2,681

    Total current assets

    148,686

    122,499

    Operating lease right-of-use asset

    980

    524

    Property and equipment 

    308

    405

    Total assets

    149,974

    123,428







    LIABILITIES





    Current liabilities





    Accounts payable and accrued liabilities

    5,914

    7,997

    Current portion of operating lease liabilities

    245

    330

    Total current liabilities

    6,159

    8,327







    Operating lease liabilities

    696

    184

    Total liabilities

    6,855

    8,511







    Shareholders' Equity





    Share capital





    Common shares, no par value, unlimited shares authorized, 29,827,997 shares issued and outstanding as of December 31, 2020 and 24,505,748 shares issued and outstanding as of December 31, 2019

    251,682

    226,245

    Pre-funded Warrants - 11,417,034 issued and outstanding as of December 31, 2020 and nil at December 31, 2019

    48,007

    -

    Additional paid in capital

    8,530

    3,805

    Cumulative translation adjustment

    (1,634)

    (1,634)

    Accumulated deficit

    (163,466)

    (113,499)

    Total shareholders' equity

    143,119

    114,917

    Total liabilities and shareholders' equity

    149,974

    123,428

    Contact:

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

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    SOURCE Milestone Pharmaceuticals, Inc.

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  2. MONTREAL and CHARLOTTE, N.C., March 29, 2021 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the first patient has been enrolled in its Phase 2 proof-of-concept study of etripamil nasal spray for the Reduction of Ventricular Rate in patients experiencing Atrial fibrillation and rapid ventricular rate (AFib-RVR), or the ReVeRA study.

    "Initiation of the AFib ReVeRA trial represents a key advancement in our strategic effort to expand the development program for etripamil beyond paroxysmal supraventricular tachycardia," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals…

    MONTREAL and CHARLOTTE, N.C., March 29, 2021 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the first patient has been enrolled in its Phase 2 proof-of-concept study of etripamil nasal spray for the Reduction of Ventricular Rate in patients experiencing Atrial fibrillation and rapid ventricular rate (AFib-RVR), or the ReVeRA study.

    "Initiation of the AFib ReVeRA trial represents a key advancement in our strategic effort to expand the development program for etripamil beyond paroxysmal supraventricular tachycardia," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We believe etripamil, if approved by FDA, has the potential to offer patients with AFib-RVR a treatment for symptomatic episodes of elevated heart rate in the at–home setting."

    The Phase 2 double blind, placebo controlled, proof-of-concept study is designed to assess the safety and efficacy of etripamil nasal spray to reduce ventricular rate in patients with AFib-RVR experiencing an episode of elevated heart rate requiring treatment. The trial, which will be conducted in Canada in collaboration with the Montreal Heart Institute and other research centers, is expected to enroll approximately 50 patients randomized 1:1 to receive either 70 mg of etripamil nasal spray or placebo. The primary endpoint will assess reduction in ventricular rate, with key secondary endpoints including the time to achieve the maximum reduction in rate and duration of the effect.

    About Atrial Fibrillation and 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 and 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 approximately 40% of patients with AFib experience one or more symptomatic episodes of AFib-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,", "continue" "estimate," "potential,", "prepare", "believe," "remain," "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 endpoints of the ReVeRA trial, (ii) potential clinical trials in other cardiac conditions, (iii) the possibility that etripamil will provide patient benefit and, (iv) 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, including the ReVeRA trial, and whether the clinical trials will validate the safety and efficacy of etripamil for atrial fibrillation with rapid ventricular rate, PSVT or other indications, among others, as well as risks related to pandemics and public health emergencies, including those related to COVID-19,  risks related the sufficiency of Milestone's capital resources and its ability to raise additional capital,  and risk inherent in estimating the market for and commercial potential of etripamil.  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-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.

    Contact:

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

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  3. MONTREAL and CHARLOTTE, N.C., Feb. 25, 2021 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Joseph Oliveto, President and Chief Executive Officer, will present at the following investor conferences:

    • The Cowen 41st Annual Health Care Conference's panel on Cardiovascular Disease and Hospital Products on Thursday, March 4, 2021 at 1:30 p.m. Eastern Time.
    • The H.C. Wainwright Global Life Sciences Conference on Tuesday, March 9, 2021 on demand beginning at 7:00 a.m. Eastern Time.
    • The Oppenheimer 31st Annual Healthcare Conference on Tuesday, March 16, 2021 at 10:00 a.m. Eastern Time.

    A replay of the…

    MONTREAL and CHARLOTTE, N.C., Feb. 25, 2021 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Joseph Oliveto, President and Chief Executive Officer, will present at the following investor conferences:

    • The Cowen 41st Annual Health Care Conference's panel on Cardiovascular Disease and Hospital Products on Thursday, March 4, 2021 at 1:30 p.m. Eastern Time.
    • The H.C. Wainwright Global Life Sciences Conference on Tuesday, March 9, 2021 on demand beginning at 7:00 a.m. Eastern Time.
    • The Oppenheimer 31st Annual Healthcare Conference on Tuesday, March 16, 2021 at 10:00 a.m. Eastern Time.

    A replay of the pre-recorded H.C. Wainwright presentation and live webcast Oppenheimer presentation can be accessed in the News & Events section of Milestone's website at www.milestonepharma.com. An archived replay of the webcasts will be available on the same website for approximately 90 days following the presentations.

    About Milestone Pharmaceuticals

    Milestone Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of etripamil, a Phase 3 clinical-stage program, for the treatment of cardiovascular indications. Milestone Pharmaceuticals operates in Canada and the United States. For more information, visit www.milestonepharma.com and follow the Company on Twitter at @MilestonePharma. 

    Contact

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-to-present-at-upcoming-investor-conferences-301235125.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  4. MONTREAL and CHARLOTTE, N.C., Nov. 23, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Joseph Oliveto, President and Chief Executive Officer, will present at the following investor conferences:

    • The Piper Sandler 32nd Virtual Annual Healthcare Conference.
    • The Evercore ISI 3rd Annual HealthCONx Conference on Thursday, December 3, 2020 at 4:20 p.m. Eastern Time.

    A replay of the pre-recorded Piper Sandler fireside chat is currently available in the News & Events section of Milestone's website at www.milestonepharma.com, and a live webcast of the Evercore fireside chat can be accessed in the…

    MONTREAL and CHARLOTTE, N.C., Nov. 23, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Joseph Oliveto, President and Chief Executive Officer, will present at the following investor conferences:

    • The Piper Sandler 32nd Virtual Annual Healthcare Conference.
    • The Evercore ISI 3rd Annual HealthCONx Conference on Thursday, December 3, 2020 at 4:20 p.m. Eastern Time.

    A replay of the pre-recorded Piper Sandler fireside chat is currently available in the News & Events section of Milestone's website at www.milestonepharma.com, and a live webcast of the Evercore fireside chat can be accessed in the same section of Milestone's website. An archived replay of the webcasts will be available on the same website for approximately 90 days following the presentations.

    About Milestone Pharmaceuticals

    Milestone Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of etripamil, a Phase 3 clinical-stage program, for the treatment of cardiovascular indications. Milestone Pharmaceuticals operates in Canada and the United States. For more information, visit www.milestonepharma.com and follow the Company on Twitter at @MilestonePharma. 

    Contact

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-to-present-at-upcoming-investor-conferences-301178279.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  5. – RAPID and completed NODE-301 studies could potentially fulfill efficacy requirement for future NDA for etripamil in patients with PSVT –

    – RAPID investigates efficacy of second dose of etripamil for patients with persistent PSVT –

    – RAPID results expected late 2021/early 2022 –

    MONTREAL and CHARLOTTE, N.C., Nov. 18, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the first patient has been enrolled in RAPID, a pivotal Phase 3 trial of etripamil nasal spray. Etripamil is a novel, short-acting calcium channel blocker in development for the treatment of patients with paroxysmal supraventricular…

    – RAPID and completed NODE-301 studies could potentially fulfill efficacy requirement for future NDA for etripamil in patients with PSVT –

    – RAPID investigates efficacy of second dose of etripamil for patients with persistent PSVT –

    – RAPID results expected late 2021/early 2022 –

    MONTREAL and CHARLOTTE, N.C., Nov. 18, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the first patient has been enrolled in RAPID, a pivotal Phase 3 trial of etripamil nasal spray. Etripamil is a novel, short-acting calcium channel blocker in development for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT).

    "Commencement of RAPID marks an important milestone for the PSVT etripamil program," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We remain very encouraged by physicians' reactions to the safety and efficacy results from the NODE-301 trial and believe the RAPID trial has the potential to demonstrate increased efficacy and improved overall clinical utility of etripamil. We appreciate and thank the clinical investigators, trial coordinators, etripamil trial team, and patients for their contributions and continued support of RAPID."

    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 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 and NODE-301 trials 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.

    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 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 patients with atrial fibrillation 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 etripamil, a Phase 3 clinical-stage program, for the treatment of cardiovascular indications. 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,", "continue" "estimate," "potential,", "prepare", "believe," "remain," "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 the RAPID trial, (ii) potential clinical trials in other cardiac conditions and (iii) the possibility that data will support FDA approval.  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, including the RAPID trial, 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 quarterly report on Form 10-Q for the quarter ended September 30, 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.

    Contact:

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

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    SOURCE Milestone Pharmaceuticals, Inc.

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  6. MONTREAL and CHARLOTTE, N.C., Nov. 13, 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 third quarter ended September 30, 2020 and provided a clinical and corporate update.

    "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…

    MONTREAL and CHARLOTTE, N.C., Nov. 13, 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 third quarter ended September 30, 2020 and provided a clinical and corporate update.

    "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 today announced 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.

    About Milestone Pharmaceuticals

    Milestone Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of etripamil, a Phase 3 clinical-stage program, for the treatment of cardiovascular indications. 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 trial , Milestone's expectations regarding an NDA filing and potential FDA approval for etripamil, Milestone's ability to execute on the remainder of the PSVT program and Milestone's plans to study etripamil in atrial fibrillation patients. 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 quarterly report on Form 10-Q for the quarter ended September 30, 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)





    '000



    '000

















    [In US dollars]

    Three months ended September 30,



    Nine months ended September 30,





    2020

    2019



    2020

    2019





    $

    $



    $

    $

















    Operating expenses













    Research and development, net of tax credits

    8,228

    9,545



    28,722

    27,836



    General and administrative

    2,952

    2,104



    8,611

    4,725



    Commercial

    905

    2,076



    4,615

    6,428



    Loss from operations

    (12,085)

    (13,725)



    (41,948)

    (38,989)



    Interest income, net of bank charges

    89

    821



    630

    1,993



    Loss and comprehensive loss before income taxes

    (11,996)

    (12,904)



    (41,318)

    (36,996)



    Income tax recovery

    (17)

    (73)



    (17)

    (55)



    Net loss and comprehensive loss for the period

    (11,979)

    (12,831)



    (41,301)

    (36,941)

















    Weighted average number of shares outstanding,













          basic and diluted

    29,774,065

    24,490,742



    26,329,581

    12,848,974

















    Net loss per share, basic and diluted

    $                (0.40)

    $                (0.52)



    $                (1.57)

    $                (2.87)

     



    INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS





    (Unaudited)



































    [In US dollars]

    '000







    September 30,

    December 31,







    2020

    2019







    $

    $





    ASSETS









    Current Assets









    Cash and Cash Equivalents 

    102,910

    119,818





    Prepaid expenses and other current assets

    4,509

    2,681





    Total current assets

    107,419

    122,499





    Operating lease right of use asset

    1,045

    524





    Property and equipment 

    333

    405





    Total assets

    108,797

    123,428















    LIABILITIES









    Current liabilities









    Accounts payable and accrued liabilities

    5,647

    7,997





    Operating lease liabilities

    234

    330





    Total current liabilities

    5,881

    8,327















    Operating lease liabilities

    718

    184





    Total liabilities

    6,599

    8,511















    Shareholders' Equity









    Share capital









    Common shares, no par value, unlimited shares authorized,









    24,727,000 shares issued at September 30, 2020 and 

    24,505,748 shares issued at December 31, 2019

    226,758

    226,245





    Pre-funded Warrants - 6,655,131 issued at September 30, 2020

    24,770

    -





    Additional paid in Capital

    7,104

    3,805





    Cumulative translation adjustment

    (1,634)

    (1,634)





    Accumulated Deficit

    (154,800)

    (113,499)





    Total shareholders' equity

    102,198

    114,917





    Total liabilities and shareholders' deficit

    108,797

    123,428













     

    Contact:

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-reports-third-quarter-2020-financial-results-and-provides-clinical-and-corporate-update-301172505.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  7. MONTREAL and CHARLOTTE, N.C., Nov. 11, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Joseph Oliveto, President and Chief Executive Officer, will present at the Jefferies Virtual London Healthcare Conference on Wednesday, November 18, 2020 at 7:55 AM ET. The conference will be held in a virtual meeting format.

    A live webcast of the presentation can be accessed in the News & Events section of Milestone's website at www.milestonepharma.com. An archived replay of the webcast will be available on the same website for approximately 30 days following the presentation.

    About Milestone Pharmaceuticals

    MONTREAL and CHARLOTTE, N.C., Nov. 11, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Joseph Oliveto, President and Chief Executive Officer, will present at the Jefferies Virtual London Healthcare Conference on Wednesday, November 18, 2020 at 7:55 AM ET. The conference will be held in a virtual meeting format.

    A live webcast of the presentation can be accessed in the News & Events section of Milestone's website at www.milestonepharma.com. An archived replay of the webcast will be available on the same website for approximately 30 days following the presentation.

    About Milestone Pharmaceuticals

    Milestone Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of etripamil, a Phase 3 clinical-stage program, for the treatment of cardiovascular indications. Milestone Pharmaceuticals operates in Canada and the United States. For more information, visit www.milestonepharma.com and follow the Company on Twitter at @MilestonePharma.

    Contact

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-to-present-at-the-jefferies-virtual-london-healthcare-conference-301170433.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  8. MONTREAL and CHARLOTTE, N.C., Oct. 23, 2020 /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 announced the pricing of its previously announced underwritten public offering of 3,810,097 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 is $5.25 and the public offering price of each pre-funded warrant is $5.24 per underlying share. In addition, Milestone has granted the underwriters a 30-day option to purchase…

    MONTREAL and CHARLOTTE, N.C., Oct. 23, 2020 /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 announced the pricing of its previously announced underwritten public offering of 3,810,097 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 is $5.25 and the public offering price of each pre-funded warrant is $5.24 per underlying share. In addition, Milestone has granted the underwriters a 30-day option to purchase up to an additional 1,285,800 common shares. The offering is expected to close on October 27, 2020, subject to customary closing conditions.

    Jefferies and Piper Sandler are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as lead manager for the offering.

    Milestone expects to receive gross proceeds of $45 million from the offering, before deducting underwriting discounts and offering expenses. Milestone intends to use the net proceeds from the offering primarily to fund the clinical development of its lead product candidate etripamil, and for working capital, capital expenditures and other general corporate purposes.

    The securities described above are being offered by Milestone pursuant to a shelf registration statement on Form S-3 (File No. 333-239318) filed with the Securities and Exchange Commission ("SEC") on June 19, 2020 and declared effective by the SEC on July 6, 2020. A preliminary prospectus supplement relating to the offering is, and a final prospectus supplement related to the offering will be, filed with the SEC and available on the SEC's website at http://www.sec.gov. Copies of the preliminary and final prospectus supplements relating to the offering may be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340 or by email at ; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Milestone Pharmaceuticals

    Milestone, headquartered in Montreal, Canada with a U.S. subsidiary in Charlotte, N.C., is a Phase 3 clinical-stage biopharmaceutical company dedicated to developing and commercializing the investigational new drug etripamil for the treatment of cardiovascular indications. Etripamil is a novel, potent and short-acting calcium channel blocker designed by Milestone and being developed as a rapid-onset nasal spray to be administered by the patient to terminate episodes of paroxysmal supraventricular tachycardia as they occur.

    Cautionary Note on 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," "should," "expect," "believe" 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 that could cause Milestone's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the size, completion, timing and use of proceeds relating to the offering.  Many factors may cause differences between current expectations and actual results, including market conditions and the satisfaction of customary closing conditions related to the offering. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Milestone's filings with the SEC, including the "Risk Factors" contained therein. 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.

    Contact:

    David Pitts

    Argot Partners

    212-600-1902

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-pricing-of-a-public-offering-of-45-million-of-common-shares-and-pre-funded-warrants-301158701.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  9. MONTREAL and CHARLOTTE, N.C., Oct. 22, 2020 /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 announced that it intends to offer and sell common shares and, to certain investors in lieu thereof, pre-funded warrants to purchase common shares, in an underwritten public offering. All of the securities in the offering will be sold by Milestone. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    Jefferies and Piper Sandler are acting as joint book-running…

    MONTREAL and CHARLOTTE, N.C., Oct. 22, 2020 /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 announced that it intends to offer and sell common shares and, to certain investors in lieu thereof, pre-funded warrants to purchase common shares, in an underwritten public offering. All of the securities in the offering will be sold by Milestone. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    Jefferies and Piper Sandler are acting as joint book-running managers for the offering. Milestone expects to grant the underwriters a 30-day option to purchase additional common shares in the proposed offering of up to 15% of the aggregate number of common shares plus the common shares underlying the pre-funded warrants being offered in the offering. 

    Milestone intends to use the net proceeds from the offering primarily to fund the clinical development of its lead product candidate etripamil, and for working capital, capital expenditures and other general corporate purposes.

    The securities described above are being offered by Milestone pursuant to a shelf registration statement on Form S-3 (File No. 333-239318) filed with the Securities and Exchange Commission ("SEC") on June 19, 2020 and declared effective by the SEC on July 6, 2020. A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov. Copies of the preliminary and final prospectus supplements relating to the offering may be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at ; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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.

    Cautionary Note on 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," "should," "expect," "believe" 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 that could cause Milestone's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the intention, size, completion, timing and use of proceeds relating to the proposed offering.  Many factors may cause differences between current expectations and actual results, including market conditions and the satisfaction of customary closing conditions related to the proposed offering. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Milestone's filings with the SEC, including the "Risk Factors" contained therein. 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.

    Contact:

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-proposed-public-offering-of-common-shares-and-pre-funded-warrants-301158370.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  10. MONTREAL and CHARLOTTE, N.C., Sept. 22, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the appointment of Lisa Giles and Robert Wills to its Board of Directors, effective October 1, 2020. Ms. Giles will serve as a member of the Audit Committee of the Board and Dr. Wills will serve as a member of the Nominating & Corporate Governance Committee of the Board. 

    "On behalf of the entire Board of Directors, it is a pleasure to welcome Lisa and Rob, two highly accomplished industry veterans, to our team," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Their…

    MONTREAL and CHARLOTTE, N.C., Sept. 22, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the appointment of Lisa Giles and Robert Wills to its Board of Directors, effective October 1, 2020. Ms. Giles will serve as a member of the Audit Committee of the Board and Dr. Wills will serve as a member of the Nominating & Corporate Governance Committee of the Board. 

    "On behalf of the entire Board of Directors, it is a pleasure to welcome Lisa and Rob, two highly accomplished industry veterans, to our team," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Their collective experience across a range of diverse strategic roles will be highly instrumental as we continue to advance our Phase 3 program of etripamil for the treatment of paroxysmal supraventricular tachycardia, prepare for commercialization, and build out our pipeline. I look forward to working with them and leveraging their unique expertise."

    Ms. Giles brings to the Milestone Board of Directors over 35 years of experience in the pharmaceutical industry, including strategic planning, operations, and business development. She is the founder, managing director and Chief Executive Officer of Giles & Associates Consultancy, Inc. (GAC). From 2013 until 2020, Ms. Giles served as Chief Executive Officer of Optivara, Inc., a cloud-based software and predictive analytics company serving the life sciences industry. Prior to founding GAC and Optivara, Ms. Giles was the Vice President of Strategy Development at G.D. Searle Pharmaceutics, Monsanto; and held various leadership roles with Abbott Laboratories. She currently serves on the Board of Directors of GenMark Diagnostics, Inc. (NASDAQ:GNMK) and the Northwestern Memorial Hospital Foundation, and previously served as a member of the Board of Directors of Durata Therapeutics, Inc. (NASDAQ:DRTX) and Intranasal Therapeutics, Inc. She received her B.S. in Economics from Juniata College, and completed executive management programs at Stanford University and the University of Chicago.

    Dr. Wills joins the Board with over 35 years of experience in the pharmaceutical industry, including preclinical and clinical research and development, business development, and strategic partnering. Prior to his retirement in 2015, Dr. Wills spent over 25 years in a variety of executive roles at Johnson & Johnson, most recently as Vice President, Alliance Management, where he was responsible for managing worldwide strategic alliances. Prior to Johnson & Johnson, he spent ten years in drug development roles at Hoffmann-La Roche Inc. Dr. Wills currently serves as Chairman of the Board of Directors of CymaBay Therapeutics, Inc. (NASDAQ:CBAY) and is on the Board of Directors of Oncternal Therapeutics, Inc. (NASDAQ:ONCT), Parion Sciences, Inc., and Go Therapeutics, Inc. He was previously a member of the Board of Directors of GTx, Inc., where he served as Executive Chairman and Chair of the Scientific and Development Committee. Dr. Wills holds a B.S. in Biochemistry and a M.S. in Pharmaceutics from the University of Wisconsin and a Ph.D. in Pharmaceutics from the University of Texas.

    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,", "continue" "estimate," "potential,", "prepare", "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, Milestone's future board members, Milestone's ongoing clinical trials and Milestone's preparations to commercialize etripamil for PSVT.  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 quarterly report on Form 10-Q for the quarter ended June 30, 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.

    Contact:

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-strengthens-board-of-directors-with-two-new-appointments-301135061.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  11. MONTREAL and CHARLOTTE, N.C., Sept. 8, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Joseph Oliveto, President and Chief Executive Officer, will present at the following investor conferences:

    • The H.C. Wainwright & Co. 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 11:30 a.m. Eastern Time
    • The Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Wednesday, September 23, 2020 at 2:30 p.m. Eastern Time

    A live webcast of the presentations can be accessed in the News & Events section of Milestone's website at www.milestonepharma.com. An archived replay of…

    MONTREAL and CHARLOTTE, N.C., Sept. 8, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Joseph Oliveto, President and Chief Executive Officer, will present at the following investor conferences:

    • The H.C. Wainwright & Co. 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 11:30 a.m. Eastern Time
    • The Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Wednesday, September 23, 2020 at 2:30 p.m. Eastern Time

    A live webcast of the presentations can be accessed in the News & Events section of Milestone's website at www.milestonepharma.com. An archived replay of the webcasts will be available on the same website for approximately 30 days following the presentations.

    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.

    Contact

    David Pitts

    Argot Partners

    212-600-1902

     

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-to-present-at-upcoming-investor-conferences-301124643.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  12. MONTREAL and CHARLOTTE, N.C., Aug. 12, 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 second quarter ended June 30, 2020 and provided a clinical and corporate update.

    "With the benefit of having completed our first Phase 3 clinical trial and a clear and efficient registration path defined for etripamil in paroxysmal supraventricular tachycardia (PSVT), we remain fully committed to bringing this therapy to PSVT patients highly in need of better treatment options," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We are on track…

    MONTREAL and CHARLOTTE, N.C., Aug. 12, 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 second quarter ended June 30, 2020 and provided a clinical and corporate update.

    "With the benefit of having completed our first Phase 3 clinical trial and a clear and efficient registration path defined for etripamil in paroxysmal supraventricular tachycardia (PSVT), we remain fully committed to bringing this therapy to PSVT patients highly in need of better treatment options," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We are on track to reopen the RAPID study later this year and believe the updated study design will allow us to best maximize the potential clinical utility of etripamil, including in patients with more persistent supraventricular tachycardia (SVT) events. With our recent $25 million private placement, we believe we are well positioned to execute on the remainder of the PSVT program and look forward to providing updates on our progress in the coming months."

    Recent Updates

    • Announced Regulatory Guidance and Updated Clinical Development Plan for Etripamil in PSVT. In July 2020, Milestone announced a clinical and regulatory update for its pivotal program with etripamil in PSVT following interactions with the U.S. Food and Drug Administration (FDA).



      The FDA indicated that two studies, the second part of NODE-301, which the Company has renamed the RAPID study, and the completed NODE-301 study could potentially fulfill the efficacy requirement for Milestone's New Drug Application for etripamil in patients with PSVT. In addition, the FDA agreed to the following program changes:



      • An updated statistical analysis plan (SAP) for both the RAPID and NODE-301 studies under which the primary efficacy endpoint will be defined as time to conversion over the first 30 minutes, with a target p-value of less than 0.05 for each study. When employing this updated SAP, results from the NODE-301 study show that 54% of etripamil patients vs. 35% of placebo patients converted within 30 minutes (HR 1.87, p=0.02).

      • In an effort to maximize the potential treatment effect of etripamil, the RAPID study will allow for an optional repeat administration of study drug (either 70 mg of etripamil or placebo) in patients who have not experienced symptom relief within 10 minutes of the first study drug administration.

    Milestone expects to reopen enrollment in the RAPID study later this year, with data anticipated in late 2021 or early 2022.



    • Raised $25 Million Through Private Placement. In July 2020, Milestone entered into a securities purchase agreement with affiliates of an existing shareholder, RTW Investments, LP, whereby Milestone sold pre-funded warrants to acquire an aggregate 6,655,131 common shares at a purchase price of $3.7465 per pre-funded warrant. Each pre-funded warrant is exercisable for one common share at an exercise price of $0.01 per share, has no expiration date, and is immediately exercisable, subject to certain beneficial ownership limitations. Aggregate proceeds received by the Company were $25 million.

    Second Quarter 2020 Financial Results

    • As of June 30, 2020, Milestone had cash, cash equivalents, and short-term investments of $85.4 million and 24.7 million shares outstanding.
    • Research and development expenses for the second quarter of 2020 were $8.6 million compared with $10.5 million for the prior year period. For the six months ended June 30, 2020, research and development expenses were $20.5 million compared with $18.3 million for the prior year period. The increase in the first half of 2020 reflects the increased clinical development costs and manufacturing and formulation activities supporting Milestone's Phase 3 clinical trial and the efforts in developing a clinical pathway for etripamil.
    • General and administrative expenses for the second quarter of 2020 were $3.0 million compared with $1.6 million for the prior year period. For the six months ended June 30, 2020, general and administrative expenses were $5.7 million compared with $2.6 million for the prior year period. The increase reflects additional increasing insurance costs, professional fees and administrative headcount in the first half of 2020 compared to the same period in 2019 primarily to support the compliance requirements of being a public company.
    • Commercial expenses for the second quarter of 2020 were $1.5 million compared with $2.2 million for the prior year period. For the six months ended June 30, 2020, commercial expense was $3.7 million compared with $4.4 million for the prior year period. The decrease in the three and six months ended June 30, 2020 reflects the efforts in reducing operating expenses affecting primarily pre-commercialization activities as Milestone focuses its efforts on an optimized clinical development pathway for etripamil.
    • For the second quarter of 2020, operating loss was $13.1 million compared to $14.3 million in 2019. For the six months ended June 30, 2020, Milestone's operating loss was $29.9 million compared to $25.3 million in 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 patients with atrial fibrillation with a 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," "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 RAPID and other clinical trials, Milestone's ability to execute on the remainder of the PSVT program, Milestone's plans to study etripamil for atrial fibrillation patients and other conditions where calcium channel blockers are used.  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 quarterly report on Form 10-Q for the quarter ended June 30, 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)



    '000



    '000













    [In US dollars]

    Three months ended June 30,



    Six months ended June 30,



    2020

    2019



    2020

    2019



    $

    $



    $

    $













    Operating expenses











    Research and development, net of tax credits

    8,622

    10,527



    20,493

    18,292

    General and administrative

    2,956

    1,641



    5,659

    2,620

    Commercial

    1,527

    2,166



    3,710

    4,352

    Loss from operations

    (13,105)

    (14,334)

    #

    (29,862)

    (25,264)

    Interest income, net of bank charges

    126

    672



    540

    1,172

    Loss and comprehensive loss before income taxes

    (12,979)

    (13,662)



    (29,322)

    (24,092)

    Income tax expense

    -

    (4)



    -

    18

    Net loss and comprehensive loss for the period

    (12,979)

    (13,658)



    (29,322)

    (24,110)













    Weighted average number of shares outstanding,











          basic and diluted

    24,628,049

    13,190,638



    24,588,413

    6,931,611













    Net loss per share, basic and diluted

    $                (0.53)

    $                (1.04)



    $                (1.20)

    $                (3.48)

     

    INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited)



















    [In US dollars]

    '000



    June 30,

    December 31,



    2020

    2019



    $

    $

    ASSETS





    Current Assets





    Cash, cash equivalents and short-term investments

    85,426

    119,818

    Prepaid expenses and other current assets

    6,980

    2,681

    Total current assets

    92,406

    122,499

    Operating lease right of use asset

    377

    524

    Property and equipment 

    356

    405

    Total assets

    93,139

    123,428







    LIABILITIES





    Current liabilities





    Accounts payable and accrued liabilities

    4,834

    7,997

    Operating lease liabilities

    157

    330

    Total current liabilities

    4,991

    8,327

    Operating lease liabilities

    132

    184

    Total liabilities

    5,123

    8,511







    Shareholders' Equity





    Share capital





    Common shares, no par value, unlimited shares authorized,





    24,692,953 shares issued at June 30, 2020 and     

    24,505,748 shares issued at December 31, 2019

    226,676

    226,245

    Additional paid in Capital

    5,795

    3,805

    Cumulative translation adjustment

    (1,634)

    (1,634)

    Accumulated Deficit

    (142,821)

    (113,499)

    Total shareholders' equity

    88,016

    114,917

    Total liabilities and shareholders' deficit

    93,139

    123,428

    Contact:

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-reports-second-quarter-2020-financial-results-and-provides-clinical-and-corporate-update-301110448.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  13. MONTREAL and CHARLOTTE, N.C., Aug. 6, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Joseph Oliveto, President and Chief Executive Officer, will present at the Canaccord Genuity 40th Annual Growth Conference on Thursday, August 13, 2020 at 1:00 PM ET. The conference will be held in a virtual meeting format.

    A live webcast of the presentation can be accessed in the News & Events section of Milestone's website at www.milestonepharma.com. An archived replay of the webcast will be available on the same website for approximately 30 days following the presentation.

    About Milestone Pharmaceuticals

    MONTREAL and CHARLOTTE, N.C., Aug. 6, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that Joseph Oliveto, President and Chief Executive Officer, will present at the Canaccord Genuity 40th Annual Growth Conference on Thursday, August 13, 2020 at 1:00 PM ET. The conference will be held in a virtual meeting format.

    A live webcast of the presentation can be accessed in the News & Events section of Milestone's website at www.milestonepharma.com. An archived replay of the webcast will be available on the same website for approximately 30 days following the presentation.

    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.

    Contact

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-to-present-at-the-canaccord-genuity-40th-annual-growth-conference-301107132.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  14. - NODE-301B, renamed the RAPID study, will reopen to enrollment and incorporate a repeat dosing regimen; results anticipated in late 2021/early 2022 -

    - Proceeds from $25 million private placement expected to fund planned operations into the second quarter of 2022 -

    - Company to host conference call today, July 23, 2020, at 8:30 a.m. ET -

    MONTREAL and CHARLOTTE, N.C., July 23, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced a clinical…

    - Recently completed NODE-301 and ongoing NODE-301B studies can be used as two efficacy studies supporting a future NDA submission (target p-values of <0.05) -

    - NODE-301B, renamed the RAPID study, will reopen to enrollment and incorporate a repeat dosing regimen; results anticipated in late 2021/early 2022 -

    - Proceeds from $25 million private placement expected to fund planned operations into the second quarter of 2022 -

    - Company to host conference call today, July 23, 2020, at 8:30 a.m. ET -

    MONTREAL and CHARLOTTE, N.C., July 23, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced a clinical and regulatory update for its pivotal program with etripamil following recent interactions with the U.S. Food and Drug Administration (FDA). Etripamil nasal spray is the Company's investigational novel short-acting calcium channel blocker for patients with paroxysmal supraventricular tachycardia (PSVT).

    "We are pleased with the outcome of our recent interactions with the FDA, as they outline an efficient path to registration for etripamil which eliminates the need to start a new Phase 3 study," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "The FDA agreed with our plan to modify the ongoing NODE-301B study, now known as the RAPID study, to highlight the unique pharmacology of etripamil, including a primary endpoint of time to conversion within 30 minutes. This study, together with our recently completed NODE-301 study, which will also now use a 30 minute endpoint, will serve to fulfill the efficacy requirements for a New Drug Application (NDA) for etripamil in PSVT."

    Mr. Oliveto added, "In addition to expanding the RAPID study, the modified design will direct patients to administer an additional dose of study drug 10 minutes after the first dose if they still experience signs and symptoms of a supraventricular tachycardia (SVT) episode. We believe this dosing regimen provides a tailored approach to increase efficacy in patients with more persistent events and improve the overall clinical utility of etripamil. We look forward to reopening enrollment in the RAPID study later this year, with results anticipated in late 2021/early 2022."

    The Company announced separately today that it has entered into a securities purchase agreement with existing shareholder RTW Investments, LP for a $25 million private placement. The Company believes that net proceeds from the private placement, together with its existing cash, cash equivalents and short-term investments, will be sufficient to fund its planned operations into the second quarter of 2022. Commenting on the agreement, Mr. Oliveto said, "We are pleased to have the strong, continued support of our largest shareholder, RTW, and to be in a position to fund the RAPID study through to topline data readout."

    Regulatory Updates and Clinical Development Plan in Detail

    The FDA indicated that two studies, the RAPID study and the completed NODE-301 study, could fulfill the efficacy requirement for the Company's NDA for etripamil in patients with PSVT. The Company proposed and the FDA agreed to the following program changes:

    • Both the RAPID and NODE-301 studies will assess the time to conversion over the first 30 minutes after drug administration as the primary endpoint. Under an updated statistical analysis plan (SAP), the primary efficacy endpoint for both the RAPID and NODE-301 studies will be defined as time to conversion over the first 30 minutes, with a target p-value of less than 0.05 for each study. This endpoint supports the desire of patients to rapidly address their PSVT symptoms during an episode and ideally avoid visiting the emergency department. Later and earlier time points will also be assessed as part of secondary analyses to fully characterize the efficacy profile of etripamil.

    When employing the updated SAP, results from NODE-301 show that 54% of etripamil patients vs. 35% of placebo patients converted within 30 minutes (HR 1.87, p=0.02), which clinicians and cardiovascular thought leaders indicate is a clinically-meaningful outcome given the symptomatic nature of SVT episodes and the lack of approved at-home treatments. Assuming a positive outcome in the RAPID study, this data could serve to fulfill the efficacy requirement for the NDA.

    • RAPID study to reopen enrollment with tailored dosing regimen to optimize clinical utility. The RAPID study, which was originally designed to collect double-blind data from randomized patients who had not yet experienced an SVT event after the NODE-301 study reached its target number of adjudicated SVT events, will be amended and expanded to serve as a pivotal efficacy and safety study. The study will include the 170 patients who are already enrolled, and will be completed after a total of 180 confirmed SVT events are reached, including those that have already occurred in the study. Additional patients enrolled in the RAPID study will be randomized 1:1.

    Based on discussions with the FDA regarding maximizing the treatment effect of etripamil, the RAPID study will allow for an optional repeat administration of study drug (either 70 mg of etripamil or placebo) for patients who have not experienced symptom relief within 10 minutes of the first study drug administration. This tailored regimen, which is similar to current PSVT treatment practices in the emergency department setting, is enabled by the favorable safety data from the NODE-301 study. The Company expects that the repeat administration could benefit a broader group of patients, including those with more persistent episodes. In the NODE-301 study, 32% of etripamil patients and 14% of placebo patients converted to sinus rhythm within 10 minutes. The FDA agreed that the single and repeat administrations of etripamil will be pooled and compared to placebo for the primary analysis, resulting in no increase in the sample size.

    The Company expects to reopen enrollment in the RAPID study later this year, with data anticipated in late 2021/early 2022.

    Conference Call

    Milestone will host a conference call and webcast to discuss the regulatory guidance and updated clinical development plan today, July 23, 2020 at 8:30 a.m. ET. To access the live call by phone, dial (800) 529-3311 (domestic) or (470) 495-9164 (international); the conference ID is 4085796. A live audio webcast of the event may also be accessed through the "Investors" section of Milestone's website at www.milestonepharma.com. A replay of the webcast will be available for 30 days following the event.

    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 approved 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 studies underway in PSVT, and plans to commence a Phase 2 proof-of-concept trial in atrial fibrillation patients with rapid ventricular rate, with subsequent trials expected in other conditions where calcium channel blockers are used.

    About NODE-301

    NODE-301 is a Phase 3, multicenter, randomized (2:1), double-blind, placebo-controlled single administration study of etripamil nasal spray in patients with PSVT. The study targeted a total of 150 adjudicated SVT events. Top line results were reported in March 2020. Despite early activity at 30 minutes, a time period consistent with the relevant pharmacodynamic effect of etripamil, the study did not achieve its primary endpoint of time to conversion of SVT to sinus rhythm (SR) compared to placebo over the pre-specified 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 statistical analysis of 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, as well as a trend toward a reduction in emergency department visits. The Company believes the safety and tolerability data from the NODE-301 study is supportive of at-home use of etripamil, with adverse events consistent with those observed in prior trials. 

    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 the RAPID study, (ii) potential clinical trials in other cardiac conditions and (iii) the possibility that data will support FDA approval. 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, including the RAPID trial, 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.

    Contact

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-regulatory-guidance-and-updated-clinical-development-plan-for-etripamil-in-psvt-301098526.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  15. MONTREAL and CHARLOTTE, N.C., July 23, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it has entered into a securities purchase agreement with affiliates of an existing shareholder, RTW Investments, LP, for a $25 million private placement. The private placement is expected to close on or about July 24, 2020, subject to the satisfaction of customary closing conditions.

    The Company is selling pre-funded warrants to acquire an aggregate 6,655,131 common shares for aggregate gross proceeds of $25 million, or a purchase price of $3.7465 per pre-funded warrant. Each pre-funded warrant is exercisable…

    MONTREAL and CHARLOTTE, N.C., July 23, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it has entered into a securities purchase agreement with affiliates of an existing shareholder, RTW Investments, LP, for a $25 million private placement. The private placement is expected to close on or about July 24, 2020, subject to the satisfaction of customary closing conditions.

    The Company is selling pre-funded warrants to acquire an aggregate 6,655,131 common shares for aggregate gross proceeds of $25 million, or a purchase price of $3.7465 per pre-funded warrant. Each pre-funded warrant is exercisable for one of the Company's common shares at an exercise price of $0.01 per share, have no expiration date, and are immediately exercisable, subject to certain beneficial ownership limitations.

    Milestone expects to use the proceeds from the sale of the pre-funded warrants for general corporate purposes, research and development, business development, working capital and general and administrative expenses. The Company believes that net proceeds from the private placement, together with its existing cash, cash equivalents and short-term investments, will be sufficient to fund its planned operations into the second quarter of 2022.

    The securities to be sold in the private placement, including the shares issuable upon exercise thereof, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the common shares issuable upon the exercise of the pre-funded warrants issued in the private placement no later than the 30th day after the closing of the private placement. In addition, the issuance of the pre-funded warrants under the private placement constitutes a related-party transaction under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") due to the participation by an insider of the Company. The transaction is exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 pursuant to sections 5.5(a) and 5.7(1)(a) of MI 61-101 as neither the fair market value of the securities issued to nor the consideration paid by such person exceeds 25% of the Company's market capitalization. The Company has not filed a material change report 21 days prior to the issuance of the pre-funded warrants set out above as no agreement was in place at that time.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

    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 paroxysmal supraventricular tachycardia ("PSVT") from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 studies underway in PSVT, and plans to commence a Phase 2 proof-of-concept trial in atrial fibrillation patients with rapid ventricular rate, with subsequent trials 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 closing of the private placement, and (ii) the anticipated use of proceeds therefrom and expected sufficiency thereof, and (iii) development program for etripamil.  Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, market risks and uncertainties and the satisfaction of customary closing conditions for private placement of securities, 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.

    Contact

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-25-million-private-placement-301098519.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  16. TORONTO, May 20, 2020 /CNW/ - Canadian venture capital (VC) disbursements reached historical high in 2019, completing 642 financings totalled $7.263 billion (excluding Verafin financing which is not a VC deal1), according to results released today by CPE Analytics, the data analytic division of CPE Media Inc. 

    "These 2017-19 results clearly indicate that venture capital was full-throttle on the upswing of its regular business cycle with fund raising and disbursements both growing strongly across most categories, notably US and foreign investment," commented Richard Rémillard, President of Remillard Consulting Group (RCG). "The strong 2017 - 2019 numbers should position VC-funded companies and VC funds themselves in good stead to withstand the ravages of COVID-19, particularly those firms that entered the pandemic crisis with substantial dry-powder remaining and who most likely raised considerable sums in the latter half of 2019."

    2019 - Venture Capital disbursements (where the funding went to - companies, not investors in recap and secondary transactions)

    • 642 financings totalled $7,263 million, up 28% and 48% respectively in number of financings and amount disbursed from 2018.
    • 26 large deals with deal value of $50 million or more attracted $3,418 million or 47% of the total disbursements.
    • Ontario and Quebec led all provinces with $2,812 million (39%) and $2,116 million (29%) respectively.
    • Three billion-dollar cities: Toronto - $2,027 million (28%), Montreal - $1,588 milion (22%), Vancouver - $1,475 million (20%)
    • Series A and B financing captured $1,162 million (16%) and $1,421 million (20%) respectively.
    • ICT and biotech companies raised $4,020 million (55%) and $1,594 million (22%) respectively.
    • Early stage companies raised $3,408 million or 47% of the total disbursements.
    • Small sized companies with the number of employees under 50 were dominating recipients of VC disbursements for the past three years, raising $1,874 million (48%), $2,280 million (49%) and $3,220 million (44%) respectively.

    ___________________________

    1 The $515 million Verafin recapitalization backed by senior secured debt is not a venture capital deal. The deal was a recap in which new equity from a new group of investors/funds together with leveraged senior secured debt (secured by their equity stakes) was used to buy out a previous group of investors/funds (an exit event for them). Management managed to use the senior debt to increase their stakes following the recap.

    2019 - Venture Capital funding sources (where the funding came from) – Canada's Only Source

    • Canadian companies secured funding from investors from 45 countries or regions or overseas territories.
    • US investors - $3,321 million (46%), Canadian investors - $3,261 million (45%), European investors - $320 million (4%), Asian investors - $312 million (4%), all others - $48 million (1%).
    • Top five investor types: Private VC funds - $2,180 million (43%); Corporate - $936 million (18%); Family Offices - $491 million (10%); Angels - $293 million (6%) and Government – $289 million (6%).
    • Top five individual sub types: US Private VC - $1,615 million (32%); Canadian Private VC - $466 million (9%); US Corporate - $407 million (8%); Canadian Institutional VC – $408 million (8%); Canadian Government - $288 million (6%).

    2019 - USA and Foreign Investment Breakdowns

    • BC companies attracted largest US investors with $1,087 million or 61% of total disbursements to BC companies. US and foreign investors together invested $1,387 million or 78% of the total disbursements.
    • Quebec and the Prairies attracted least amount of US and other foreign investments, securing 38% and 43% of their respective total disbursements.

    2019 Fundraising by Canadian venture capital firms and top exits

    • 61 funds raised $4.4 billion, of which $3.1 billion by 46 private VC funds.
    • Top IPOs: Lightspeed POS Inc. (TSX:LSPD) - $276M raised with valuation of $1.4B; Milestone Pharmaceuticals Inc. (NASDAQ:MIST) – US $95 million raised with US $402 million valuation.
    • Top M&As: Wave HQ acquired by H&R Block for US $407M; Aeryon Labs acquired by FLIR Systems for US $206M; Mnubo acquired by Aspen for CDN $102 million.

    2019 Active law firms 

    • Top five active VC law firms: Dentons Canada LLP, Osler, Hoskin & Harcourt LLP, Fasken Martineau DuMoulin LLP, LaBarge Weinstein LLP, Burstall LLP

    The full report can be downloaded from financings.ca website:  https://www.financings.ca/reports/

    About Remillard Consulting Group (RCG)

    Remillard Consulting Group (RCG) is a unique, Ottawa-based, bilingual consulting firm specializing in providing private sector, government & trade association clients with creative, research-grounded solutions to business issues and public policies involving the Canadian financial services industry. For more information: https://remillardconsulting.com/

    About CPE Media Analytics

    CPE Analytics is a provider of comprehensive and unbiased and verified information on Canadian venture capital and all financing activities, private and public alike. 

    CPE Analytics is Canada's only data provider that actively tracks and provides analysis on where the Canadian venture capital funding came from - by investor type and by provinces, countries or regions.  It is the essential information for truly evidence-based policy analysis and decision making, and the true understanding of the Canadian venture capital ecosystem. 

    For more information: https://cpeanalytics.ca, https://financings.ca

    About CPE Media Inc.

    CPE Media Inc. is Canada's all financing news and intelligence provider. We provide trusted, unbiased and verified, private and public market news and intelligence to all industry stakeholders. For more information: https://cpemedia.ca.

    SOURCE CPE Media Inc.

    Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2020/20/c9410.html

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  17. 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…

    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 
    24,505,748 shares issued at December 31, 2019

    226,378

    226,245

    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

    Cision View original content:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-reports-first-quarter-2020-financial-results-and-provides-clinical-and-corporate-update-301059300.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  18. – Study missed primary endpoint of mean time to conversion of SVT to SR over a five-hour period following dosing (p=0.12) –

    – Etripamil showed rapid conversion of SVT to SR during the first 45 minutes (p=0.02), consistent with its known pharmacology –

    – Study demonstrated a positive safety profile showing etripamil was well tolerated in the at-home setting –

    – Small number of placebo patients and prolonged efficacy measurement period confounded results –

    – Company plans to discuss next steps with regulators and continue its full PSVT clinical program, including NODE-301B, NODE-302 and NODE-303 –

    Company to host conference call today at 5:00 p.m. ET

    MONTREAL and CHARLOTTE, N.C., March 23, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc…

    – Study missed primary endpoint of mean time to conversion of SVT to SR over a five-hour period following dosing (p=0.12) –

    – Etripamil showed rapid conversion of SVT to SR during the first 45 minutes (p=0.02), consistent with its known pharmacology –

    – Study demonstrated a positive safety profile showing etripamil was well tolerated in the at-home setting –

    – Small number of placebo patients and prolonged efficacy measurement period confounded results –

    – Company plans to discuss next steps with regulators and continue its full PSVT clinical program, including NODE-301B, NODE-302 and NODE-303 –

    Company to host conference call today at 5:00 p.m. ET

    MONTREAL and CHARLOTTE, N.C., March 23, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced 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 paroxysmal supraventricular tachycardia (PSVT).

    The NODE-301 trial, which enrolled a total of 431 patients across 65 sites in the U.S. and Canada, is an event-driven Phase 3 efficacy trial of etripamil for terminating supraventricular tachycardia (SVT) episodes in the at-home setting.  Etripamil (70mg) did not achieve its primary endpoint of time to conversion of SVT to sinus rhythm (SR) compared to placebo over the five hour period following study drug administration (median time to conversion of 25 minutes [95% CI: 16, 43] for etripamil vs. 50 minutes [95% CI: 31,101] for placebo, p=0.12). 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, results from the latter part of the analysis confounded the statistical analysis of the primary endpoint.

    The study demonstrated statistically significant improvements in favor of etripamil over placebo in the important secondary endpoint of patient reported treatment satisfaction, as measured by a treatment satisfaction questionnaire for medication (TSQM-9), including global satisfaction (p=0.0069) and effectiveness scores (p=0.0015), with questions addressing the relief of symptoms commonly associated with an episode of SVT, such as rapid pulse, heart palpitations, anxiety, shortness of breath and dizziness. Additionally, there was a trend in improvement in the percentage of patients seeking rescue medical intervention, including in the emergency department, with etripamil and placebo patients reporting 15% and 27%, respectively (p=0.12).

    The safety and tolerability data from the NODE-301 study are supportive of at-home use of etripamil, with adverse events (AE) consistent with those observed in prior trials. The most common AEs observed in patients receiving etripamil were local to the nose, including nasal irritation and congestion, and these events were typically transient in nature and most commonly characterized by the patient as mild in severity. There were no significant differences in incidences of severe adverse events or adverse events of interest, such as atrioventricular nodal blocks or blood pressure-related symptoms, across the etripamil and placebo groups.

    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, continues. These data will be analyzed separately as a second data set. In addition, open-label safety studies of etripamil in subjects with PSVT, NODE-302 and NODE-303, are ongoing with active recruitment underway. The Company is actively monitoring the potential impact of the COVID-19 pandemic on its ongoing trials and will provide updates on any delayed timelines or cost impacts in the future. The Company expects to request a meeting with regulators to discuss the NODE-301 results and its ongoing studies.

    "Efficacy signals across the earlier time points in NODE-301, in both primary and secondary endpoints, correlate directly with our understanding of the drug's known pharmacologic activity. We are also encouraged to see very good safety and tolerability across the broad population enrolled in this study. That said, outcomes after 100 minutes, which were affected by a very small number of placebo patients remaining in the study at that time, suggest that the design and analysis plan used in NODE-301 negatively impacted the study's outcome,"  said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "The overall results of the study reinforce our understanding of the promising profile of etripamil and meaningfully inform us how best to prove its efficacy moving forward."

    Mr. Oliveto added: "We will continue to execute as prudently possible on the ongoing NODE studies, including NODE-301B, and look forward to reviewing these data with regulators. The ongoing pandemic highlights the need for, and strengthens our commitment to, home use therapies."

    "PSVT places a significant burden on patients and the healthcare system, and a fast-acting therapy to resolve its symptoms when and where episodes occur would have a material impact on both," said Bruce Stambler, MD, FHRS, Piedmont Heart Institute, Atlanta, GA. "NODE-301 is a first-of-its-kind study, and as such encountered  a number of challenges relative to studying SVT episodes outside of a controlled electrophysiology laboratory environment. The safety results support at-home use and the multiple efficacy signals show us that, with a confirmatory study, etripamil could fulfill the promise of delivering a fast-acting, patient administered therapy for PSVT."

    Conference Call and Webcast

    Milestone will host a conference call and webcast to discuss the results of the NODE-301 trial today, March 23, 2020 at 5:00 p.m. ET. To access the live call by phone, dial (800) 529-3311 (domestic) or (470) 495-9164 (international); the conference ID is 6152207. A live audio webcast of the event may also be accessed through the "Investors" section of Milestone's website at www.milestonepharma.com. A replay of the webcast will be available for 30 days following the event.

    About NODE-301

    The NODE-301 trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of etripamil, the Company's lead investigational product. Etripamil is a novel calcium channel blocker in the form of a nasal spray, intended for the acute treatment of PSVT and other episodic cardiovascular conditions wherever they occur. The study is designed for a population of those PSVT patients who historically experience 20 minutes or longer SVT episodes or episodes requiring termination in the emergency department. Following an in-office test dose of etripamil, 97.5% of patients were randomized (2:1) to receive either 70 mg of etripamil or placebo. Upon onset of PSVT symptoms, patients applied a wireless cardiac monitor to their chest to record heart rhythm, performed a vagal maneuver, and, if symptoms persisted, administered study drug. Of the 198 patient-reported events for which study drug was administered, a total of 156 were confirmed to be SVT events by a central independent adjudication committee and used to assess the study's efficacy endpoints.

    The primary endpoint of the NODE-301 study is time to conversion of an SVT episode 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 SVT such as heart palpitations, chest pain, anxiety, shortness of breath, dizziness, or fainting, and rating of treatment satisfaction questionnaire for medication (TSQM). 

    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, and (iii) 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 annual report on Form 10-K for the year ended December 31, 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.

    Contact

    David Pitts
    Argot Partners
    212-600-1902

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-topline-results-from-first-of-its-kind-phase-3-node-301-trial-of-etripamil-for-at-home-acute-psvt-treatment-301028371.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  19. – Topline data from Phase 3 NODE-301 trial of etripamil in patients with PSVT expected this month  

    MONTREAL and CHARLOTTE, N.C., March 6, 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 fourth quarter and year ended December 31, 2019 and provided a clinical and corporate update.

    "Our team is keenly focused on delivering the near-term topline readout of the pivotal Phase 3 efficacy and safety trial, NODE-301," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals.  "Results from NODE-301, if favorable, have the potential to serve as…

    – Topline data from Phase 3 NODE-301 trial of etripamil in patients with PSVT expected this month  

    MONTREAL and CHARLOTTE, N.C., March 6, 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 fourth quarter and year ended December 31, 2019 and provided a clinical and corporate update.

    "Our team is keenly focused on delivering the near-term topline readout of the pivotal Phase 3 efficacy and safety trial, NODE-301," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals.  "Results from NODE-301, if favorable, have the potential to serve as the sole efficacy registration trial required for an NDA submission with the United States (U.S.) Food and Drug Administration (FDA), bringing us one step closer to providing paroxysmal supraventricular tachycardia (PSVT) patients with a much-needed novel therapeutic option. Supported by compelling results from the Phase 2 NODE-1 trial, we believe etripamil has the potential to alter the PSVT treatment paradigm as the first self-administered therapy for the rapid termination of supraventricular tachycardia (SVT) episodes wherever and whenever they occur."

    Mr. Oliveto added, "As we focus on topline results from NODE-301, we remain diligent in executing on the balance of our Phase 3 program of etripamil for PSVT, including the NODE-302 and NODE-303 safety studies, preparing for the potential commercialization of etripamil, and building out our pipeline beyond PSVT. This includes the expected initiation of our first clinical trial of etripamil in patients with atrial fibrillation and rapid ventricular rate."

    Recent Updates

    • Topline Data from NODE-301 Trial Expected This Month. Milestone expects to report topline data for the NODE-301 trial this month. 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, designed to terminate SVT episodes in the at-home setting. The primary endpoint of the NODE-301 trial is time to conversion of PSVT to sinus rhythm after the administration of trial drug, as confirmed by a central independent adjudication committee. A statistically significant result for NODE-301 would support the trial's ability to fulfill the U.S. FDA's previously guided efficacy review requirement for etripamil.
       
      Milestone's pivotal Phase 3 program of etripamil in PSVT, which was designed in consultation with U.S. and European Union regulatory authorities, consists of three distinct trials: NODE-301, the sole efficacy trial; NODE-302, the ongoing open-label safety extension trial; and NODE-303, the ongoing global safety trial and the largest trial ever conducted in PSVT. Additional blinded data will be collected from randomized patients who have not yet experienced an event at the time the NODE-301 trial reaches its target number of adjudicated SVT events. 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 of the NODE-301 trial.
       
    • Enrolled First Patient in NODE-303 Trial. In October 2019, Milestone announced enrollment of the first patient in the Company's Phase 3 open-label, global safety trial of etripamil in patients with PSVT. The trial will primarily evaluate the safety of etripamil when self-administered without medical supervision during single or multiple SVT episodes. Important secondary measures include efficacy, patient quality of life and pharmacoeconomic assessments. The trial will enroll up to 3,000 patients in order to collect data on approximately 1,000 patients who did not participate in NODE-301 or its open-label safety extension trial, NODE-302.
       
    • Jeff Nelson Promoted to Chief Operating Officer. Milestone today announced the recent 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.
       
    • Richard C. Pasternak, M.D. Appointed to Board of Directors. In November 2019, Milestone announced the appointment of Richard C. Pasternak, M.D. to its Board of Directors. Dr. Pasternak brings to Milestone over 40 years of clinical, academic, and biopharmaceutical industry experience in the area of cardiology.

    Fourth Quarter 2019 Financial Results

    • As of December 31, 2019, Milestone had cash, cash equivalents, and short-term investments of $119.8 million compared to $86.0 million as of December 31, 2018, and 24.5 million shares outstanding.
    • Research and development expense for the fourth quarter of 2019 was $14.1 million compared with $7.3 million for the prior year period. For the full year ended December 31, 2019, research and development expense was $42.0 million compared with $16.8 million for the prior year.
    • General and administrative expense for the fourth quarter of 2019 was $2.3 million compared with $1.2 million for the prior year period. For the full year ended December 31, 2019, general and administrative expense was $7.0 million compared with $3.1 million for the prior year.
    • Commercial expense for the fourth quarter of 2019 was $2.5 million compared with $1.6 million for the prior year period. For the full year ended December 31, 2019, commercial expense was $8.9 million compared with $3.9 million for the prior year.
    • For the fourth quarter of 2019, operating loss was $18.9 million compared to $10.1 million for the prior year period. For the full year ended December 31, 2019, Milestone's operating loss was $57.9 million compared to $23.8 million for the prior year.

    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 utilized.

    About Milestone Pharmaceuticals

    Milestone 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) 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 annual report on Form 10-K for the year ended December 31, 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.

     

     

    CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS










    '000


    '000


    [In US dollars]

    Three months ended December 31,


    Twelve months ended December 31,



    2019

    2018


    2019

    2018



    $

    $


    $

    $









    Operating expenses







    Research and development, net of tax credits

    14,149

    7,296


    41,985

    16,849


    General and administrative

    2,279

    1,218


    7,004

    3,052


    Commercial

    2,464

    1,592


    8,892

    3,921


    Loss from operations

    (18,892)

    (10,106)


    (57,881)

    (23,822)


    Interest income, net of bank charges

    604

    446


    2,596

    711


    Loss and comprehensive loss before income taxes

    (18,288)

    (9,660)


    (55,285)

    (23,111)


    Income tax (recovery) expense

    -

    56


    (56)

    74


    Net loss and comprehensive loss for the year

    (18,288)

    (9,716)


    (55,229)

    (23,185)









    Weighted average number of shares outstanding,







          basic and diluted

    24,496,347

    441,601


    15,784,750

    319,202









    Net loss per share, basic and diluted

    $                (0.75)

    $              (22.00)


    $                (3.50)

    $              (72.63)


     

     

    CONSOLIDATED BALANCE SHEET










    [In US dollars]

    '000





    December 31,

    December 31,





    2019

    2018





    $

    $




    ASSETS






    Current Assets






    Cash, Cash Equivalents and Short-term Investments

    119,818

    85,976




    Prepaid expenses and other current assets

    2,681

    2,075




    Total current assets

    122,499

    88,051




    Operating lease right of use asset

    524

    -




    Property and equipment 

    405

    30




    Total assets

    123,428

    88,081










    LIABILITIES






    Current liabilities






    Accounts payable and accrued liabilities

    7,997

    4,477




    Operating lease liabilities

    330

    -




    Income taxes payable

    -

    56




    Total current liabilities

    8,327

    4,533




    Operating lease liabilities

    184

    -




    Total liabilities

    8,511

    4,533










    Convertible preferred shares

    -

    138,758










    Shareholders' Equity (deficit)






    Share capital






    Common shares, no par value, unlimited shares authorized,






    24,505,748 shares issued at December 31, 2019 and 






    596,787 shares issued at December 31, 2018

    226,245

    2,039




    Additional paid-in capital

    3,805

    2,655




    Cumulative translation adjustment

    (1,634)

    (1,634)




    Accumulated deficit

    (113,499)

    (58,270)




    Total shareholders' equity (deficit)

    114,917

    (55,210)




    Total liabilities and shareholders' equity (deficit)

    123,428

    88,081










     

    Contact

    David Pitts
    Argot Partners
    212-600-1902

     

    (PRNewsfoto/Milestone Pharmaceuticals)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-reports-fourth-quarter-and-year-end-2019-financial-results-and-provides-clinical-and-corporate-update-301018597.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  20. TORONTO, Nov. 27, 2019 /CNW/ - Canadian venture capital (VC) disbursements are continuing red-hot record-setting pace, completing 452 financings totalled $5.1billion (excluding Verafin deal1) in the first three quarters (3Qs) of 2019, according to the results released today by CPE Media Analytics, the data analytic service of CPE Media Inc. 

    Top 10 cities in attracting VC: Toronto, Vancouver, Montreal, Laval, Ottawa, Hamilton, Kitchener, Burnaby, Calgary, Saskatoon (CNW Group/CPE Media Inc.)

    "Canadian VC disbursements are on a historical record setting pace for the first three quarters of 2019. At the midpoint of Q4, 2019, total VC disbursements were already tracked at $6.1 billion; 2019 is posed to best the $6.5 billion record reported in 2000. With continuing and unabated investments from US and foreign investors, 2019 is truly shaping up to be a record year for the Canadian venture capital…

    TORONTO, Nov. 27, 2019 /CNW/ - Canadian venture capital (VC) disbursements are continuing red-hot record-setting pace, completing 452 financings totalled $5.1billion (excluding Verafin deal1) in the first three quarters (3Qs) of 2019, according to the results released today by CPE Media Analytics, the data analytic service of CPE Media Inc. 

    Top 10 cities in attracting VC: Toronto, Vancouver, Montreal, Laval, Ottawa, Hamilton, Kitchener, Burnaby, Calgary, Saskatoon (CNW Group/CPE Media Inc.)

    "Canadian VC disbursements are on a historical record setting pace for the first three quarters of 2019. At the midpoint of Q4, 2019, total VC disbursements were already tracked at $6.1 billion; 2019 is posed to best the $6.5 billion record reported in 2000. With continuing and unabated investments from US and foreign investors, 2019 is truly shaping up to be a record year for the Canadian venture capital industry," said Ted Liu, President of CPE Media Inc.  "As Canada's only complete VC data provider, we are focused on providing accurate and comprehensive information not only on information where the VC money went to, but on fundamental information where the VC money came from, so industry stakeholders can have better intelligence and understanding about the ever evolving and changing Canadian VC ecosystem."

    "The data reveal many continuing trends, including the growing presence of foreign, largely US investments and the increasing prominence of larger funding rounds. The overall strength in investing and fundraising volumes in Canada largely mirrors the pattern of activity elsewhere, including the US and speaks to the full onset of the fourth industrial revolution globally," commented Richard Remillard, President of Remillard Consulting Group (RCG).

    First nine months, 2019 - Venture Capital disbursements (where all the funding went - to companies, not to investors in secondary transactions or recaps)

    • 452 financings totalled $5,068 million, up 28% and 48% respectively in total number of financings and total amount from the same period last year.
    • 24 large deals with deal value of $50 million or more attracted $2,523 million or 50% of the total disbursements. 
    • Ontario led all provinces with $2,055 million (41%), followed by BC ($1,337 million), Québec ($1,328 million), Alberta ($150 million) and Nova Scotia ($54 million).
    • City of Toronto led all municipal cities with $1,451 million (29%), followed by Vancouver ($1,068 million), Montréal ($1,057 million), Laval ($157 million) and Ottawa ($150 million).
    • Series B deals secured $1,303 million, representing 26% of the total disbursements.
    • ICT and biotech companies raised $3,099 million (61%) and $1,136 million (22%) respectively.
    • Early stage companies raised $2,878 million or 57% of the total disbursements.
    • Small sized companies with the number of employees under 50 were the largest recipients of VC disbursements for the past three years, accounting for 48%, 49% and 48% of the total disbursements respectively.

    First nine months, 2019 - Venture Capital funding sources (where all the funding came from)

    • Canadian companies secured funding from investors from 38 countries or overseas territories.
    • US investors' share of the total disbursements for the first time reached 50%, up from 42% in 2018 and 46% in 2017.
    • US and other foreign investors combined contributed 61% (2019), 58% (2018) and 65% (2017) of the total disbursements.
    • Top five investor types: Private VC funds - $2,180 million (43%); Corporate - $936 million (18%); Family Offices - $491 million (10%); Angels - $293 million (6%) and Government – $289 million (6%).
    • Top five individual investor types: US Private VC - $1,615 million (32%); Canadian Private VC - $466 million (9%); US Corporate - $407 million (8%); Canadian Institutional VC – $408 million (8%); Canadian Government - $288 million (6%).

    First nine months, 2019 - USA and Foreign Investment Breakdowns

    • BC companies attracted the largest share of overall disbursements from US investors with $828 million or 62% of total disbursements to all BC companies. 78% of the total disbursements in BC were contributed by US and other foreign investors.
    • US investors contributed 48% of Ontario $2,005M total disbursements.
    • The Prairies attracted least amount of US and other foreign investors, securing 47% of the total disbursements in the Prairies.
    • Out of the $1,303 million raised by Series B financings, 59% came from US investors and 8% from other foreign investors.
    • Out of the $3,099 million raised by ICT companies, 52% came from US investors and 8% from other foreign investors.
    • Out of the $1,135 million raised by Biotech companies, 63% from US investors and 10% from other foreign investors.

    Fundraising by Canadian venture capital firms and others

    • 49 funds2 raised $3.6 billion, of which $2,327 million by 31 private VC funds.
    • Top IPOs:  Lightspeed POS Inc. (TSX:LSPD) - $276M with valuation of $1.4B; Milestone Pharmaceuticals Inc. (NASDAQ:MIST) – US $95 million with US $402 million valuation.
    • Top M&As: Wave HQ acquired by H&R Block for US $407M; Aeryon Labs acquired by FLIR Systems for US $206M; Mnubo acquired by Aspen for CDN $102 million.
    • Top five active VC law firms: Osler, Hoskin & Harcourt LLP, Fasken Martineau DuMoulin LLP, LaBarge Weinstein LLP, Burstall LLP, Dentons Canada LLP

    Full report can be downloaded from financings.ca website:  https://www.financings.ca/reports/

    About CPE Media Analytics, a service of CPE Media Inc.

    Backed with over 25 years of private capital research experience, CPE Media Analytics, through financings.ca, offers verified and comprehensive data coverage and analysis on venture capital and private and public capital. We are Canada's only data provider that specifically tracks and provides complete venture capital information, including fundamental information on where VC money came from (by investor types and by geographic sources), and VC firm fundraising. https://financings.ca

    About CPE Media Inc.

    CPE Media Inc. is Canada's all financing, private capital and public market, news and intelligence provider. We provide trusted, unbiased and verified, private and public market news and intelligence to all industry stakeholders. For more information: https://cpemedia.ca.

    -----------------------------

    1

     The $515 million Verafin recapitalization backed by senior secured debt is not a venture capital deal. The deal was a recap in which new equity from a new group of investors/funds together with leveraged senior debt, secured by their equity stakes, was used to buy out a previous group of investors/funds (an exit event for previous investors).



    2

     Fund of Funds fundraising is excluded to eliminate double counting, as many of the Private VC funds are raising large portion of their capital from Fund of Funds.

     


    US investors' share of total VC disbursements reached 50% for the first time (CNW Group/CPE Media Inc.)

    CPE Media Inc. (CNW Group/CPE Media Inc.)

    SOURCE CPE Media Inc.

    View original content to download multimedia: http://www.newswire.ca/en/releases/archive/November2019/27/c1712.html

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  21. MONTREAL and CHARLOTTE, N.C., Nov. 14, 2019 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST) today announced that Joseph G. Oliveto, President and Chief Executive Officer, will present at the following investor conferences:

    • The Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019 at 3:20 p.m. Greenwich Mean Time (10:20 a.m. Eastern Time)
    • The Piper Jaffray 31st Annual Healthcare Conference in New York on Wednesday, December 4, 2019 at 3:30 p.m. Eastern Time

    A live webcast of each presentation can be accessed in the News & Events section of Milestone's website at www.milestonepharma.com. An archived replay of each webcast will be available on the same website for approximately 30 days following the presentation…

    MONTREAL and CHARLOTTE, N.C., Nov. 14, 2019 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST) today announced that Joseph G. Oliveto, President and Chief Executive Officer, will present at the following investor conferences:

    • The Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019 at 3:20 p.m. Greenwich Mean Time (10:20 a.m. Eastern Time)
    • The Piper Jaffray 31st Annual Healthcare Conference in New York on Wednesday, December 4, 2019 at 3:30 p.m. Eastern Time

    A live webcast of each presentation can be accessed in the News & Events section of Milestone's website at www.milestonepharma.com. An archived replay of each webcast will be available on the same website for approximately 30 days following the presentation.

    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. Etripamil is a novel, potent and short-acting calcium channel blocker designed by Milestone and being developed as a rapid-onset nasal spray to be administered by the patient to terminate episodes of PSVT as they occur. Milestone is actively recruiting patients for a Phase 3 clinical trial of etripamil for the treatment of PSVT. Top-line data from the phase 3 pivotal efficacy trial (NODE-301) is expected in the middle of the first half of 2020.

    Contact:

    David Pitts
    Argot Partners
    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-to-present-at-upcoming-investor-conferences-300957945.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  22. – 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…

    – 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, 
    24,490,742 shares issued at September 30, 2019 and 596,787 shares issued at
    December 31, 2018

    226,211

    2,039




    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

    (PRNewsfoto/Milestone Pharmaceuticals)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-reports-third-quarter-2019-financial-results-and-provides-clinical-and-corporate-update-300956054.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  23. MONTREAL and CHARLOTTE, N.C., Oct. 3, 2019 /CNW/ -- 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 that the first patient has been enrolled in the Phase 3 NODE-303 study. NODE-303 is the Company's open-label, global safety study of etripamil, the Company's novel, potent and short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT).

    "Commencement of enrollment in NODE-303 marks an important step forward for our Phase 3 program of etripamil in PSVT, where current standards of care are restricted to the burdensome and costly acute care…

    MONTREAL and CHARLOTTE, N.C., Oct. 3, 2019 /CNW/ -- 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 that the first patient has been enrolled in the Phase 3 NODE-303 study. NODE-303 is the Company's open-label, global safety study of etripamil, the Company's novel, potent and short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT).

    "Commencement of enrollment in NODE-303 marks an important step forward for our Phase 3 program of etripamil in PSVT, where current standards of care are restricted to the burdensome and costly acute care setting," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We believe etripamil has the potential to alter the PSVT treatment paradigm, providing patients with a self-administered intervention to effectively terminate PSVT episodes wherever and whenever they occur. We remain focused on the execution of the entirety of the program, and continue to expect topline results from NODE-301 in the first half of 2020."

    Milestone's pivotal Phase 3 program of etripamil in PSVT, which was designed in consultation with U.S. and European Union regulatory authorities, is designed to support potential filings in the U.S. and European Union. It consists of three distinct trials, including one randomized, double-blind, placebo-controlled efficacy trial, NODE-301, its open-label safety extension study, NODE-302, and NODE-303.

    NODE-303 is a global study which 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 NODE-302. As previously announced, the U.S. Food and Drug Administration agreed to allow initiation of patient enrollment in the NODE-303 study in a population consistent with NODE-301 and NODE-302, including older patients and those patients taking concomitant beta-blockers and calcium channel blockers, and without the in-office safety test dose that is currently required in NODE-301.

    About Etripamil in Paroxysmal Supraventricular Tachycardia (PSVT)

    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, 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. Etripamil is a novel, potent and short-acting calcium channel blocker designed by Milestone and being developed as a rapid-onset nasal spray to be administered by the patient to terminate episodes of PSVT as they occur. 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 June 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.

    Contact

    David Pitts
    Argot Partners
    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-first-patient-enrolled-in-node-303-open-label-safety-study-of-etripamil-in-psvt-300930260.html

    SOURCE Milestone Pharmaceuticals, Inc.

    View original content to download multimedia: http://www.newswire.ca/en/releases/archive/October2019/03/c9704.html

    View Full Article Hide Full Article
  24. MONTREAL and CHARLOTTE, N.C., Oct. 3, 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 announced that the first patient has been enrolled in the Phase 3 NODE-303 study. NODE-303 is the Company's open-label, global safety study of etripamil, the Company's novel, potent and short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT).

    "Commencement of enrollment in NODE-303 marks an important step forward for our Phase 3 program of etripamil in PSVT, where current standards of care are restricted to the burdensome and costly acute…

    MONTREAL and CHARLOTTE, N.C., Oct. 3, 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 announced that the first patient has been enrolled in the Phase 3 NODE-303 study. NODE-303 is the Company's open-label, global safety study of etripamil, the Company's novel, potent and short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT).

    "Commencement of enrollment in NODE-303 marks an important step forward for our Phase 3 program of etripamil in PSVT, where current standards of care are restricted to the burdensome and costly acute care setting," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We believe etripamil has the potential to alter the PSVT treatment paradigm, providing patients with a self-administered intervention to effectively terminate PSVT episodes wherever and whenever they occur. We remain focused on the execution of the entirety of the program, and continue to expect topline results from NODE-301 in the first half of 2020."

    Milestone's pivotal Phase 3 program of etripamil in PSVT, which was designed in consultation with U.S. and European Union regulatory authorities, is designed to support potential filings in the U.S. and European Union. It consists of three distinct trials, including one randomized, double-blind, placebo-controlled efficacy trial, NODE-301, its open-label safety extension study, NODE-302, and NODE-303.

    NODE-303 is a global study which 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 NODE-302. As previously announced, the U.S. Food and Drug Administration agreed to allow initiation of patient enrollment in the NODE-303 study in a population consistent with NODE-301 and NODE-302, including older patients and those patients taking concomitant beta-blockers and calcium channel blockers, and without the in-office safety test dose that is currently required in NODE-301.

    About Etripamil in Paroxysmal Supraventricular Tachycardia (PSVT)

    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, 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. Etripamil is a novel, potent and short-acting calcium channel blocker designed by Milestone and being developed as a rapid-onset nasal spray to be administered by the patient to terminate episodes of PSVT as they occur. 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 June 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.

    Contact

    David Pitts
    Argot Partners
    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-first-patient-enrolled-in-node-303-open-label-safety-study-of-etripamil-in-psvt-300930260.html

    SOURCE Milestone Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  25. MONTREAL and CHARLOTTE, N.C., Sept. 10, 2019 /CNW/ -- 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 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.

    "It is a pleasure to welcome Amit to the Milestone team," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "His extensive experience across a range of financial and business development roles will…

    MONTREAL and CHARLOTTE, N.C., Sept. 10, 2019 /CNW/ -- 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 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.

    "It is a pleasure to welcome Amit to the Milestone team," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "His extensive experience across a range of financial and business development roles will be invaluable as we continue to advance our Phase 3 program of etripamil for PSVT, prepare our commercialization strategy, and begin to build out our pipeline. I look forward to working with Amit as we strive towards our goal of bringing effective therapies to patients with episodic cardiovascular conditions."

    "I am excited to be joining such a highly accomplished team at this important juncture for the Company," said Mr. Hasija. "I look forward to contributing to Milestone's continued success as the etripamil development program progresses."

    Mr. Hasija most recently served as Chief Financial Officer and Chief Business Officer at Fulcrum Therapeutics, a publicly traded, clinical-stage biopharmaceutical company focused on developing therapies for genetically defined rare diseases. Prior to Fulcrum, he spent five years at Sanofi, most recently serving as Vice President of Integrated Care, where he was responsible for developing cardiovascular and diabetes value-based contracting models. While at Sanofi, he also served as Vice President of North America Pharmaceutical Business Development, and was responsible for identifying external opportunities and executing in-licensing, co-promotion, partnership, and acquisition activities in multiple therapeutic areas, including cardiovascular, immunology, diabetes, oncology, renal, and biosurgery. Prior to joining Sanofi, Mr. Hasija spent more than a decade at Goldman Sachs, Credit Suisse and Deutsche Bank, where he executed mergers and acquisitions and corporate finance transactions for healthcare clients. He began his career at Merck as a Planning and Logistics Analyst and Operations Manager. Mr. Hasija earned a B.S. in Chemical Engineering from Drexel University and received an MBA from New York University's Stern School of Business.

    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. Etripamil is a novel, potent and short-acting calcium channel blocker designed by Milestone and being developed as a rapid-onset nasal spray to be administered by the patient to terminate episodes of paroxysmal supraventricular tachycardia (PSVT) as they occur. 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.

    Contact

    David Pitts
    Argot Partners
    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-appointment-of-amit-hasija-as-chief-financial-officer-and-executive-vice-president-of-corporate-development-300914329.html

    SOURCE Milestone Pharmaceuticals, Inc.

    View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2019/10/c9218.html

    View Full Article Hide Full Article
  26. MONTREAL and CHARLOTTE, N.C., Sept. 10, 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 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.

    "It is a pleasure to welcome Amit to the Milestone team," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "His extensive experience across a range of financial and business development…

    MONTREAL and CHARLOTTE, N.C., Sept. 10, 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 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.

    "It is a pleasure to welcome Amit to the Milestone team," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "His extensive experience across a range of financial and business development roles will be invaluable as we continue to advance our Phase 3 program of etripamil for PSVT, prepare our commercialization strategy, and begin to build out our pipeline. I look forward to working with Amit as we strive towards our goal of bringing effective therapies to patients with episodic cardiovascular conditions."

    "I am excited to be joining such a highly accomplished team at this important juncture for the Company," said Mr. Hasija. "I look forward to contributing to Milestone's continued success as the etripamil development program progresses."

    Mr. Hasija most recently served as Chief Financial Officer and Chief Business Officer at Fulcrum Therapeutics, a publicly traded, clinical-stage biopharmaceutical company focused on developing therapies for genetically defined rare diseases. Prior to Fulcrum, he spent five years at Sanofi, most recently serving as Vice President of Integrated Care, where he was responsible for developing cardiovascular and diabetes value-based contracting models. While at Sanofi, he also served as Vice President of North America Pharmaceutical Business Development, and was responsible for identifying external opportunities and executing in-licensing, co-promotion, partnership, and acquisition activities in multiple therapeutic areas, including cardiovascular, immunology, diabetes, oncology, renal, and biosurgery. Prior to joining Sanofi, Mr. Hasija spent more than a decade at Goldman Sachs, Credit Suisse and Deutsche Bank, where he executed mergers and acquisitions and corporate finance transactions for healthcare clients. He began his career at Merck as a Planning and Logistics Analyst and Operations Manager. Mr. Hasija earned a B.S. in Chemical Engineering from Drexel University and received an MBA from New York University's Stern School of Business.

    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. Etripamil is a novel, potent and short-acting calcium channel blocker designed by Milestone and being developed as a rapid-onset nasal spray to be administered by the patient to terminate episodes of paroxysmal supraventricular tachycardia (PSVT) as they occur. 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.

    Contact

    David Pitts
    Argot Partners
    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

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    SOURCE Milestone Pharmaceuticals, Inc.

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