Full Press Release Details
Milestone Pharmaceuticals Reports Second Quarter 2022 Financial Results
Clinical and Corporate Update
Phase 3 RAPID study reached the target of 180 confirmed PSVT events treated with
double-blind study medication required to initiate primary efficacy analysis; topline data
readout for RAPID study remains on track for mid-second half 2022
Phase 3 PSVT study initiated in China
Montreal and Charlotte,
N.C., August 10, 2022 -- 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, 2022, and provided a clinical and corporate update.
across our Phase 3 PSVT clinical program. Notably with the recent crossing of the 180th event in the RAPID trial, we now focus on the
final stages of data cleaning and analysis and look forward to reporting top line data in the middle of the second half of this year,"
said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals.
2022 Financial Results
| As of June 30, 2022, Milestone had cash, cash equivalents, and short-term investments of $86.2 million and 29.9 million common shares and 12.3 million common shares issuable upon exercise of pre-funded warrants outstanding. | ||
| Research and development (R&D) expense for the second quarter of 2022 was $10.7 million, compared with $9.4 million for the prior year period. The difference is primarily the result of an increase in clinical personnel related costs, clinical consulting fees and contract research organization (CRO) costs due to advancing the RAPID Phase 3 efficacy and safety trial in etripamil for the treatment of PSVT. For the six months ended June 30, 2022, R&D expense was $19.4 million compared with $18.0 million for the prior year period. The $1.4 million increase in R&D expense in the six months ended June 30, 2022 is the result of clinical personnel related costs, clinical consulting fees and CRO costs due to advancing the RAPID Phase 3 efficacy and safety trial in etripamil for the treatment of PSVT. These increases were offset by lower drug formulation and manufacturing costs. Additionally, regulatory costs increased primarily due to personnel-related costs. | ||
| General and administrative (G&A) expense for the second quarter of 2022 was $3.9 million, compared with $3.0 million for the prior year period. The difference is primarily the result of an increase in personnel-related costs and consulting fees for general and administrative expenses. For the six months ended June 30, 2022, G&A expense was $7.6 million compared with $5.7 million for the prior year period. The $1.9 million increase in G&A expense in the six months ended June 30, 2022 is primarily the result of personnel-related costs and consulting fees for general and administrative expenses. |
Supraventricular Tachycardia
Paroxysmal supraventricular
tachycardia (PSVT) is a condition characterized by intermittent episodes of a rapid heartbeat that starts and stops suddenly that affects
approximately two million Americans. Episodes of supraventricular tachycardia (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 intravenous medications, including adenosine, beta-blockers and calcium channel blockers, have long been used for the acute treatment
of PSVT. However, these medications must be administered under medical supervision, usually in an emergency department or other acute
About Atrial Fibrillation
with Rapid Ventricular Rate
(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 with rapid ventricular rate (AFib-RVR) is a condition that some patients with AFib experience and includes
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 reduce the heart rate in this condition. When AFib-RVR occurs, symptoms often
cause patients to seek acute care in the emergency department, where standard-of-care procedures include intravenous administration of
calcium channel blockers or beta blockers under medical supervision. Milestone's market research indicates that 30-40% of patients with
AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a target addressable market of approximately
three to four million patients in 2030 for etripamil in patients with AFib.
Etripamil, a new chemical identity being 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 a medically-unsupervised 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 underway in patients
with atrial fibrillation with rapid ventricular rate (AFib-RVR).
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 with rapid ventricular
rate (AFib-RVR). Milestone Pharmaceuticals operates in Canada and the United States. For more information, visit www.milestonepharma.com
and follow Milestone on Twitter at @MilestonePharma.
This press release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "will," "expect,"
"continue," "estimate," "potential," "progress" 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 to serve 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; the timing of release of unblind RAPID results and topline data with respect to the
Company's RAPID trial; Milestone's ongoing plans to study etripamil in atrial fibrillation patients, the sufficiency of Milestone's
current cash resources to support its operations, 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; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing
trial data; 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 the ongoing COVID-19 pandemic, 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, 2021, under the caption "Risk Factors," as such discussion may be updated from time to time by subsequent
filings we may make with the U.S. Securities & Exchange Commission. 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 thousands of US dollars, except share and per share data)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | - | $ | 15,000 | $ | - | $ | 15,000 | ||||||||
| Operating expenses | ||||||||||||||||
| Research and development, net of tax credits | 10,657 | 9,427 | 19,425 | 18,022 | ||||||||||||
| General and administrative | 3,918 | 3,018 | 7,561 | 5,651 | ||||||||||||
| Commercial | 2,231 | 1,843 | 3,867 | 3,209 | ||||||||||||
| Earnings (loss) from operations | (16,806 | ) | 712 | (30,853 | ) | (11,882 | ) | |||||||||
| Interest income, net | 158 | 58 | 198 | 138 | ||||||||||||
| Net earnings (loss) | $ | (16,648 | ) | $ | 770 | $ | (30,655 | ) | $ | (11,744 | ) | |||||
| Weighted average number of shares and pre-funded warrants outstanding, basic | 42,278,563 | 41,673,370 | 42,260,682 | 41,465,961 | ||||||||||||
| Net earnings (loss) per share, basic | $ | (0.39 | ) | $ | 0.02 | $ | (0.73 | ) | $ | (0.28 | ) | |||||
| Weighted average number of shares and pre-funded warrants outstanding, diluted | 42,278,563 | 44,530,121 | 42,260,682 | 41,465,961 | ||||||||||||
| Net earnings (loss) per share, diluted | $ | (0.39 | ) | $ | 0.02 | $ | (0.73 | ) | $ | (0.28 | ) |
in thousands of US dollars, except share data)
| June 30, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 63,237 | $ | 114,141 | ||||
| Short-term investment | 23,000 | - | ||||||
| Research and development tax credits receivable | 539 | 356 | ||||||
| Prepaid expenses | 3,465 | 4,299 | ||||||
| Other receivables | 261 | 127 | ||||||
| Total current assets | 90,502 | 118,923 | ||||||
| Operating lease assets | 570 | 711 | ||||||
| Property and equipment | 227 | 215 | ||||||
| Total assets | $ | 91,299 | $ | 119,849 | ||||
| Liabilities, and Shareholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 4,087 | $ | 6,551 | ||||
| Operating lease liabilities | 169 | 224 | ||||||
| Total current liabilities | 4,256 | 6,775 | ||||||
| Operating lease liabilities (net of current portion) | 384 | 474 | ||||||
| Total liabilities | 4,640 | 7,249 | ||||||
| Shareholders' Equity | ||||||||
| Common shares, no par value, unlimited shares authorized 30,005,884 shares issued and outstanding as of June 30, 2022, 29,897,559 shares issued and outstanding as of December 31, 2021 | 252,236 | 251,901 | ||||||
| Pre-funded warrants - 12,327,780 issued and outstanding as of June 30, 2022 and 12,327,780 as of December 31, 2021 | 52,941 | 52,941 | ||||||
| Additional paid-in capital | 20,090 | 15,711 | ||||||
| Cumulative translation adjustment | (1,634 | ) | (1,634 | ) | ||||
| Accumulated deficit | (236,974 | ) | (206,319 | ) | ||||
| Total shareholders' equity | 86,659 | 112,600 | ||||||
| Total liabilities and shareholders' equity | $ | 91,299 | $ | 119,849 |