Milestone Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Clinical and Corporate Update

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
    --  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 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.




     [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)



              [In US dollars]                                                                                                   '000

                                                                                                                               June 30, 
     December 31,

                                                                                                                                   2020                  2019




                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


                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                                                                    226,676               226,245
    24,505,748 shares issued at December 31, 2019

              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


David Pitts
Argot Partners

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SOURCE Milestone Pharmaceuticals, Inc.