MIST Milestone Pharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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Etripamil - (RAPID)
Paroxysmal supraventricular tachycardia (PSVT)
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Etripamil (ReVeRA)
Atrial fibrillation
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Phase 2/3
Phase 2/3
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Phase 2 commencement of enrollment announced March 29, 2021.
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Etripamil - NODE-302
Paroxysmal supraventricular tachycardia (PSVT)
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Phase 3
Phase 3
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Phase 3 trial ongoing.
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Etripamil - NODE-301
Paroxysmal supraventricular tachycardia (PSVT)
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Phase 3
Phase 3
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Phase 3 top-line data released March 23, 2020 did not meet primary endpoint.
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Etripamil - NODE-303
Paroxysmal supraventricular tachycardia (PSVT)
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Phase 3
Phase 3
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Phase 3 open label commencement of dosing announced October 3, 2019.
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Latest News
-
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- Statistically Significant Improvements in PSVT-Associated Symptoms and Less ER Visits Observed in Patients Treated with Etripamil Compared to Placebo in the NODE-301 Trial -
- Data Presented at the American College of Cardiology's 70th Annual Scientific Session -
MONTREAL and Charlotte, N.C., May 17, 2021 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the presentation of data related to key secondary endpoints from its Phase 3, multicenter, randomized, double-blind, placebo-controlled NODE-301 trial of etripamil nasal spray, the Company's novel investigational, short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT). The oral presentation, titled "Etripamil Nasal Spray Relieves Symptoms And Reduces Emergency Room Interventions In Patients With Paroxysmal Supraventricular Tachycardia (PSVT): Analysis Of Clinical Outcomes In The Node-301 Trial", was featured during a late-breaker session at the American College of Cardiology's 70th Annual Scientific Session (ACC.21) that was held in a virtual format. A copy of the presentation will be available in the Publications section of Milestone's website.
"With current standards of care for the acute termination of PSVT restricted to the burdensome and costly acute care setting, this condition represents an area of particularly high unmet need," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Etripamil holds the potential to enable patients to treat their episodes in the at-home setting and ultimately take control of their condition. We remain focused on the execution of our ongoing Phase 3 program and our vision to help patients suffering from episodes of SVT."
"Data support the potential for etripamil to improve the patient's experience, both decreasing common PSVT symptoms and reducing the need for emergency room visits relative to placebo," said Bruce Stambler, MD, FHRS, Piedmont Heart Institute, Atlanta, GA, and lead author of the presentation. "Once approved by FDA, etripamil could potentially serve as an effective, meaningful addition to the currently limited PSVT treatment armamentarium."
The NODE-301 trial, which enrolled a total of 431 patients across 65 sites in the U.S. and Canada, was an event-driven Phase 3 efficacy trial of etripamil versus placebo for terminating supraventricular tachycardia (SVT) episodes in the at-home setting. Data presented at ACC.21 build on previously reported data from the NODE-301 trial that showed 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 and effectiveness scores, with questions addressing the relief of symptoms commonly associated with an episode of SVT. Treatment effectiveness (p=0.001) and global satisfaction (p=0.007) scores were greater in patients treated with etripamil than with placebo. Etripamil also had higher scores than placebo related to relief of specific symptoms associated with PSVT, including rapid pulse (p=0.002), palpitations (p<0.001), shortness of breath (p=0.008), dizziness (p=0.012), and anxiety (p=0.006). In addition, a 51% reduction (p=0.051) in the need for an emergency room (ER) visit and a 47% prolongation (p<0.05) in time to ER intervention was observed in patients who received etripamil versus placebo.
Enrollment is now underway in the Company's pivotal Phase 3 RAPID trial of etripamil nasal spray in patients with PSVT. This trial, which is targeting a total of 180 adjudicated PSVT events, is expected to randomize approximately 500 patients 1:1 to receive either etripamil nasal spray or placebo. To help 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 administration of the first dose of study drug. Under an updated statistical analysis plan, the primary efficacy analysis for both the RAPID trial and the already-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.
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. The study is designed for a population of those PSVT patients who historically experience SVT episodes lasting 20 minutes or longer 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. The NODE-301 trial did not meet its primary endpoint. 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 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 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 intended to be 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 a Phase 2 proof-of-concept trial is now 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 trial, and Milestone's ability to execute on the remainder of the PSVT program. 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 annual 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
[email protected]
View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-late-breaker-oral-presentation-of-node-301-data-at-acc21-301292038.htmlSOURCE Milestone Pharmaceuticals, Inc.
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MONTREAL and CHARLOTTE, N.C., May 17, 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 first quarter ended March 31, 2021 and provided a clinical, regulatory, and corporate update.
"We continue to work closely with our existing clinical trial sites, as well as add new sites, to address the impact that the COVID-19 pandemic has had on patient enrollment in the pivotal Phase 3 RAPID trial of etripamil in patients with PSVT. While we are encouraged by recent improvements in enrollment rates, we now expect to report topline data from the RAPID trial in the second half of 2022," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We are also pleased to announce that following FDA's review of the etripamil program's interim safety data, including that from the initial repeat dose experience from the RAPID trial, we will be adding the higher exposure, repeat dose regimen into the ongoing NODE-303 open-label safety study. We continue to believe etripamil has the potential to serve as an important new option for patients with PSVT, and we are committed to ensuring it is able to realize its full potential."
Mr. Oliveto added, "Earlier today, we were excited to announce that we have entered into an exclusive license agreement with Ji Xing Pharmaceuticals to develop and, if approved, commercialize the investigational drug etripamil for PSVT in greater China. This agreement strengthens both our balance sheet and our executional capabilities, and we look forward to working with the Ji Xing team to expand the potential reach of etripamil to patients in the greater China region."
Recent Updates
- Announced Exclusive License Agreement with Ji Xing Pharmaceuticals to Develop and Commercialize Etripamil for PSVT in Greater China. Milestone today announced that it has 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. Milestone will receive an upfront cash payment consisting of $15 million and a $5 million equity investment by RTW Investments. In addition, Milestone is eligible to receive up to $107.5 million in milestone payments and royalties on future sales of etripamil in Greater China. Milestone will supply etripamil and delivery devices to Ji Xing. Ji Xing will be responsible for development and commercialization costs in Greater China.
- Company Expects to Report Topline Data from Pivotal Phase 3 RAPID Trial in 2H22. Enrollment remains ongoing in the pivotal Phase 3 RAPID trial of etripamil nasal spray in patients with PSVT. The ongoing COVID-19 pandemic has restricted access to many medical centers, reduced visits to physician offices, and caused patients to delay medical care. The Company continues to work diligently with investigators to identify potential site-specific solutions to mitigate these COVID-related delays, and has also increased the number of participating centers. Milestone now expects to report topline data in the second half of 2022. The Company believes its current cash resources, including the upfront payment from Ji Xing and proceeds from the equity investment from RTW, will be sufficient to support operations beyond the data readout into mid-2023.
The 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, 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. - NODE-303 Open-Label Safety Study Amended to Include Repeat Dose of Etripamil. Following an interim safety data analysis of the RAPID study, the Company requested and the U.S. Food and Drug Administration (FDA) agreed to amend the ongoing NODE-303 study to allow a repeat dose of etripamil if symptoms persist for 10 minutes after the first dose. NODE-303 is a 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.
- Data from NODE-301 Trial Featured During Oral Presentation at the American College of Cardiology 70th Annual Scientific Session and Expo (ACC.21). An oral presentation titled, "Etripamil Nasal Spray Relieves Symptoms And Reduces Emergency Room Interventions In Patients With Paroxysmal Supraventricular Tachycardia (PSVT): Analysis Of Clinical Outcomes In The NODE-301 Trial" (#403-13), was featured at the recent ACC.21 virtual meeting. The presentation was delivered by Bruce Stambler, MD, FHRS, Piedmont Heart Institute, Atlanta, GA, and investigator in the NODE-301 trial.
- Enrollment Continues in ReVeRA Phase 2 Proof-of-Concept Trial Evaluating Etripamil in Patients with Atrial Fibrillation and Rapid Ventricular Rate (AFib-RVR). In March 2021, Milestone announced that the first patient was enrolled in ReVeRA, its Phase 2 proof-of-concept study of etripamil nasal spray in patients experiencing AFib-RVR. Patient enrollment is ongoing, with the trial expected to enroll approximately 50 patients randomized 1:1 to receive either 70 mg of etripamil nasal spray or placebo. 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 will be conducted in Canada in collaboration with the Montreal 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.
First Quarter 2021 Financial Results
- As of March 31, 2021, Milestone had cash, cash equivalents, and short-term investments of $129.9 million and 29.8 million common shares and 11.4 million common shares issuable upon exercise of pre-funded warrants outstanding.
- Research and development expense for the first quarter of 2021 was $8.6 million compared with $11.9 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 quarter ended March 31, 2021.
- General and administrative expense for the first quarter of 2021 was $2.6 million compared with $2.7 million for the prior year period.
- Commercial expense for the first quarter of 2021 was $1.4 million compared with $2.2 million for the prior year period. The decrease of commercial expense in the quarter ended March 31, 2021 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 first quarter of 2021, operating loss was $12.6 million compared to $16.8 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 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, the sufficiency of Milestone's current cash resources to support its operations, Milestone's and Ji Xing's intention and ability to develop and commercialize etripamil in China 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 annual 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.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF LOSS AND COMPRENHENSIVE LOSS
(Unaudited, in thousands of US dollars, except share and per share data)
Three months ended March 31,
2021
2020
$
$
Operating expenses
Research and development, net of tax credits
8,595
11,872
General and administrative
2,633
2,703
Commercial
1,366
2,183
Loss from operations
(12,594)
(16,758)
Interest income, net of bank charges
80
415
Net loss and comprehensive loss for the period
(12,514)
(16,343)
Weighted average number of shares and
pre-funded warrants outstanding, basic and diluted
41,256,248
24,548,777
Net loss per share, basic and diluted
(0.30)
(0.67)
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in thousands of US dollars, except share data)
March 31,
December 31,
2021
2020
$
$
ASSETS
Current Assets
Cash, cash equivalents and short-term investments
129,859
142,310
Prepaid expenses and other current assets
7,385
6,376
Total current assets
137,244
148,686
Operating lease right-of-use asset
914
980
Property and equipment
285
308
Total assets
138,443
149,974
LIABILITIES
Current liabilities
Accounts payable and accrued liabilities
5,564
5,914
Current portion of operating lease liabilities
252
245
Total current liabilities
5,816
6,159
Operating lease liabilities
635
696
Total liabilities
6,451
6,855
Shareholders' Equity
Share capital
Common shares, no par value, unlimited shares authorized 29,846,000
shares issued and outstanding as of March 31, 2021, 29,827,997 shares
issued and outstanding as of December 31, 2020251,716
251,682
Pre-funded warrants - 11,417,034 issued and outstanding as of
March 31, 2021 and as of December 31, 202048,007
48,007
Additional paid in capital
9,883
8,530
Cumulative translation adjustment
(1,634)
(1,634)
Accumulated deficit
(175,980)
(163,466)
Total shareholders' equity
131,992
143,119
Total liabilities and shareholders' equity
138,443
149,974
Contact:
David Pitts
Argot Partners
212-600-1902
[email protected]
View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-reports-first-quarter-2021-financial-results-and-provides-clinical-regulatory-and-corporate-update-301292106.htmlSOURCE Milestone Pharmaceuticals, Inc.
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MONTREAL and CHARLOTTE, N.C., May 17, 2021 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced an exclusive license and collaboration agreement with Ji Xing Pharmaceuticals (Ji Xing) to develop and, if approved, commercialize the investigational drug etripamil in patients with paroxysmal supraventricular tachycardia (PSVT) and additional cardiovascular conditions in Greater China. Ji Xing is a biotechnology company headquartered in Shanghai and backed by RTW Investments, LP (RTW) focused on advancing innovative medicines in China.
"This agreement marks an important step toward realizing our vision for etripamil to benefit patients living with PSVT globally while strengthening our balance sheet and executional capabilities through partnership," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We look forward to partnering with the talented team at Ji Xing to develop and commercialize this promising therapy in the licensed regions."
"Etripamil has the potential to change the treatment paradigm for PSVT and could serve as a meaningful new therapeutic option for patients," said Peter Fong, Chief Executive Officer of Ji Xing and Head of Company Creation at RTW. "We are delighted to expand Ji Xing's cardiovascular focus by partnering with Milestone and look forward to unlocking the full therapeutic potential of etripamil for patients with PSVT in China."
Under the terms of the agreement, Milestone will grant Ji Xing an exclusive license to develop and, if regulatory approval is obtained, commercialize etripamil in patients with PSVT in Greater China. Milestone will receive an upfront cash payment consisting of $15 million and a $5 million equity investment by RTW. In addition, Milestone is eligible to receive up to $107.5 million in milestone payments and royalties on future sales of etripamil in Greater China. Milestone will supply etripamil and delivery devices to Ji Xing. Ji Xing will be responsible for development and commercialization costs in Greater China.
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 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 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 a Phase 2 proof-of-concept trial is now underway in patients with atrial fibrillation and rapid ventricular rate (AFib-RVR).
About Ji Xing Pharmaceuticals
Backed by RTW Investments, LP, Ji Xing is a privately held, leading biotechnology company headquartered in Shanghai committed to bringing innovative science and medicines to underserved Chinese patients with serious and life-threatening diseases.
About RTW Investments
RTW Investments, LP ("RTW") is a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to support emerging medical therapies and the companies and/or academics developing them.
For further information about RTW, please visit www.RTWfunds.com.
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, and Milestone's and Ji Xing's intention and ability to develop and commercialize etripamil in China. 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.
Contact:
David Pitts
Argot Partners
212-600-1902
[email protected]
View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-exclusive-license-agreement-with-ji-xing-pharmaceuticals-to-develop-and-commercialize-etripamil-for-psvt-in-greater-china-301292087.htmlSOURCE Milestone Pharmaceuticals, Inc.
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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
[email protected]
View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-reports-fourth-quarter-and-full-year-2020-financial-results-and-provides-clinical-and-corporate-update-301257907.htmlSOURCE Milestone Pharmaceuticals, Inc.
- 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.
-
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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
[email protected]
View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-announces-first-patient-enrolled-in-the-revera-study-its-phase-2-trial-of-etripamil-in-atrial-fibrillation-and-rapid-ventricular-rate-301257905.htmlSOURCE Milestone Pharmaceuticals, Inc.