MONTREAL and CHARLOTTE, N.C.,
"The second quarter of 2021 was marked by continued progress advancing our ongoing programs evaluating etripamil in patients with PSVT and AFib-RVR," said
Recent Updates
- Entered Exclusive License Agreement with Ji Xing Pharmaceuticals to Develop and Commercialize Etripamil for PSVT in Greater China. In
May 2021 , the Company announced that it entered an exclusive license and collaboration agreement with Ji Xing Pharmaceuticals (Ji Xing ), a biotechnology company headquartered in Shanghai and backed by RTW Investments, LP (RTW) focused on advancing innovative medicines in China, to develop and, if approved, commercialize the investigational drug etripamil in patients with paroxysmal supraventricular tachycardia (PSVT) and additional cardiovascular conditions in Greater China. In connection with the agreement, Milestone received an upfront cash payment consisting of $15 million and a $5 million equity investment by RTW Investments. In addition, the Company could receive up to $107.5 million in total development and sales milestone payments as well as tiered royalty payments on all products sold in theGreater China territory. Milestone will supply etripamil and delivery devices toJi Xing .Ji Xing will be responsible for development and commercialization costs in Greater China. - Company Remains on Track to Report Topline Data from Pivotal Phase 3 RAPID Trial in the Second Half of 2022. Enrollment continues in the ongoing pivotal Phase 3 RAPID trial of etripamil nasal spray in patients with PSVT. As previously announced, the Company is working closely with study investigators to identify potential site-specific solutions to mitigate COVID-related enrollment and site initiation delays, and has also increased the number of participating centers. The Company continues to expect to report topline data in the second half of 2022.
The RAPID trial, which is targeting a total of 180 adjudicated PSVT events, is expected to randomize approximately 500 patients 1:1 to receive either etripamil or placebo. As previously announced, to maximize the potential treatment effect of etripamil, 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. The primary efficacy analysis for both the RAPID trial and the completed NODE-301 trial will be time to conversion of SVT over the first 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. - Open-Label NODE-303 Safety Amended to Include Repeat Dosing of Etripamil. In
May 2021 , the Company announced that theU.S. Food and Drug Administration agreed to allow future patients enrolled in the ongoing NODE-303 study to utilize a repeat dose of etripamil if symptoms persist for 10 minutes after the first dose. NODE-303 is Milestone's global open-label study, which primarily evaluates 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 Company is in the process of implementing the repeat dose regimen in the study. - Data from Study of Prevalence and Incidence of Patients with PSVT in the
U.S. Published in theJournal of Cardiovascular Electrophysiology . InMay 2021 , findings from an observational retrospective longitudinal study using claims estimated the incidence and prevalence of PSVT in contemporary practice were published in theJournal of Cardiovascular Electrophysiology . The article, titled "Prevalence and incidence of patients with paroxysmal supraventricular tachycardia inthe United States ", estimated that 1.3 – 2.1 million people in theU.S. have PSVT, which includes patients with potentially comorbid atrial fibrillation/atrial flutter. - Enrollment Continues in ReVeRA Phase 2 Proof-of-Concept Trial Evaluating Etripamil in Patients Experiencing Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR). Enrollment is ongoing in ReVeRA, Milestone's Phase 2 proof-of-concept study of etripamil nasal spray in patients experiencing AFib-RVR, in which patients will be randomized 1:1 to receive either 70 mg of etripamil or placebo. The Phase 2 double blind, placebo controlled, proof-of-concept in-patient study is designed to assess the safety and efficacy of etripamil nasal spray to reduce the ventricular rate in patients with AFib-RVR requiring treatment. The trial will be conducted in
Canada in collaboration with theMontreal Heart Institute and other research centers. 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.
Second Quarter 2021 Financial Results
- As of
June 30, 2021 , Milestone had cash, cash equivalents, and short-term investments of$135.8 million and 29.8 million common shares issued and outstanding and 12.3 million common shares issuable upon exercise of pre-funded warrants outstanding. - Revenue of
$15 million was generated from the upfront payment under the License Agreement during the three months and six months endedJune 30, 2021 . - Research and development expense for the second quarter of 2021 was
$9.4 million compared with$8.6 million for the prior year period. The difference is due to an increase in clinical expense of$0.8 million . For the six months endedJune 30, 2021 , research and development expense was$18.0 million compared with$20.5 million for the prior year period. 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 six months endedJune 30, 2021 . - General and administrative expenses for the second quarter of 2021 and 2020 were
$3.0 million . For both of the six month periods endedJune 30, 2021 and 2020, respectively, general and administrative expense was$5 .7 million. - Commercial expense for the second quarter of 2021 was
$1.8 million compared with$1.5 million for the prior year period. During the second quarter of 2020, the Company reduced commercial costs in order to focus its efforts on an optimized clinical development pathway for etripamil. During the three months endedJune 30, 2021 , the Company increased our investment in commercialization activities resulting in higher commercial expenses. For the six months endedJune 30, 2021 , commercial expense was$3.2 million compared with$3.7 million for the prior year period. The decrease of commercial expense in the six months ended June 30, 2021 reflects efforts reducing operating expenses from pre-commercialization activities. - For the second quarter of 2021, operating income was
$0.7 million compared to operating loss of$13.1 million in 2020. For the six months endedJune 30, 2021 , Milestone's operating loss was$11.9 million compared to$29.9 million in the prior year period.
About Paroxysmal Supraventricular Tachycardia
Paroxysmal supraventricular tachycardia (PSVT) is a condition characterized by intermittent episodes of rapid heart beat (SVT) that starts and stops suddenly and without warning that 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 with 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
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
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, the sufficiency of Milestone's current cash resources to support its operations, Milestone's and
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF LOSS AND COMPRENHENSIVE LOSS | ||||||
(Unaudited, in thousands of US dollars, except share and per share data) | ||||||
Three months ended | Six months ended | |||||
2021 | 2020 | 2021 | 2020 | |||
$ | $ | $ | $ | |||
Collaboration Revenue | 15,000 | - | 15,000 | - | ||
Operating expenses | ||||||
Research and development, net of tax credits | 9,427 | 8,622 | 18,022 | 20,493 | ||
General and administrative | 3,018 | 2,956 | 5,651 | 5,659 | ||
Commercial | 1,843 | 1,527 | 3,209 | 3,710 | ||
Total Operating expenses | 14,288 | 13,105 | 26,882 | 29,862 | ||
Income (Loss) from operations | 712 | (13,105) | (11,882) | (29,862) | ||
Interest income, net of bank charges | 58 | 126 | 138 | 540 | ||
Net income (loss) and comprehensive loss for the period | 770 | (12,979) | (11,744) | (29,322) | ||
Weighted average number of shares and | ||||||
pre-funded warrants outstanding, basic and diluted | 41,673,370 | 24,548,777 | 41,465,961 | 24,588,413 | ||
Net income (loss) per share, basic and diluted | 0.02 | (0.53) | (0.28) | (1.20) | ||
Weighted average number of shares and | ||||||
pre-funded warrants outstanding, basic and diluted | 44,530,121 | 24,548,777 | 41,465,961 | 24,588,413 | ||
Net income (loss) per share, basic and diluted | 0.02 | (0.53) | (0.28) | (1.20) |
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | ||
(Unaudited, in thousands of US dollars, except share data) | ||
2021 | 2020 | |
$ | $ | |
ASSETS | ||
Current Assets | ||
Cash, cash equivalents and short-term investments | 135,794 | 142,310 |
Prepaid expenses and other current assets | 8,592 | 6,376 |
Total current assets | 144,386 | 148,686 |
Operating lease right-of-use asset | 847 | 980 |
Property and equipment | 262 | 308 |
Total assets | 145,495 | 149,974 |
LIABILITIES | ||
Current liabilities | ||
Accounts payable and accrued liabilities | 5,069 | 5,914 |
Current portion of operating lease liabilities | 259 | 245 |
Total current liabilities | 5,328 | 6,159 |
Operating lease liabilities | 573 | 696 |
Total liabilities | 5,901 | 6,855 |
Shareholders' Equity | ||
Share capital | ||
Common shares, no par value, unlimited shares authorized 29,846,000 shares issued and outstanding as of | 251,716 | 251,682 |
Pre-funded warrants - 12,327,780 issued and outstanding as of | 52,927 | 48,007 |
Additional paid in capital | 11,795 | 8,530 |
Cumulative translation adjustment | (1,634) | (1,634) |
Accumulated deficit | (175,210) | (163,466) |
Total shareholders' equity | 139,594 | 143,119 |
Total liabilities and shareholders' equity | 145,495 | 149,974 |
Contact:
212-600-1902
david@argotpartners.com
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