MIST Milestone Pharmaceuticals Inc.

3.76
-0.13  -3%
Previous Close 3.89
Open 3.89
52 Week Low 1.69
52 Week High 24.01
Market Cap $92,590,707
Shares 24,625,188
Float 15,596,693
Enterprise Value $-5,670,019
Volume 140,535
Av. Daily Volume 1,765,214
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Upcoming Catalysts

Drug Stage Catalyst Date
Etripamil - NODE-302
Paroxysmal supraventricular tachycardia (PSVT)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Etripamil
Atrial fibrillation
Phase 2/3
Phase 2/3
Phase 2 trial to be initiated in 2020.
Etripamil
Angina
Phase 2
Phase 2
Phase 2 trial planned.
Etripamil - NODE-301
Paroxysmal supraventricular tachycardia (PSVT)
Phase 3
Phase 3
Phase 3 top-line data released March 23, 2020 did not meet primary endpoint.
Etripamil - NODE-303
Paroxysmal supraventricular tachycardia (PSVT)
Phase 3
Phase 3
Phase 3 open label commencement of dosing announced October 3, 2019.

Latest News


  1. 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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  2. 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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  3. – 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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  4. – 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)

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    SOURCE Milestone Pharmaceuticals, Inc.

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  5. 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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