Full Press Release Details
Milestone Pharmaceuticals Reports Fourth Quarter
and Full Year 2024 Financial Results and Provides Regulatory and Corporate Update
review goal date of March 27, 2025 for CARDAMYST (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT)
FDA approval, proposed launch in PSVT targeted for mid-2025
Milestone well-capitalized to commercialize
upon approval with royalty financing
CHARLOTTE, N.C., March. 13, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial
results for the fourth quarter and full year ended December 31, 2024 and provided a regulatory and corporate update.
focused on the potential FDA approval for CARDAMYST and the opportunity to help the millions of patients suffering from PSVT," said
Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Our launch preparations are well underway.
We have resources secured to make CARDAMYST available to patients and healthcare providers mid-year, assuming FDA approval."
Fourth Quarter 2024 and Recent
CARDAMYST for patients with PSVT
Etripamil for patients with AFib-RVR
Fourth Quarter and Full Year
2024 Financial Results
details on the Company's financials, refer to the Annual Report on Form 10-K for the year ended December 31, 2024, filed with the
SEC on March 13, 2025.
Etripamil is Milestone's
lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly
symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing
the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option
to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management
and a greater sense of control over their condition. CARDAMYST , the conditionally approved brand name for etripamil nasal spray,
is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT
and Phase 2 trial for the treatment of patients with AFib-RVR.
Milestone Pharmaceuticals
Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve
the lives of people living with complex and life-altering heart conditions. The Company's focus on understanding unmet patient needs
and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing
their care. Milestone's lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for
patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR.
contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe,"
"continue," "could," "demonstrate," "designed," "develop," "estimate," "expect,"
"may," "pending," "plan," "potential," "progress," "will", "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 timing
and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA; the PDUFA review goal date and the potential
approval by the FDA of CARDAMYST for PSVT; commercialization plans for CARDAMYST, if approved; Milestone's plans to commence and
timing of a Phase 3 study in AFib-RVR; the potential extension of protection under Milestone's intellectual property portfolio;
the potential of etripamil to provide health care providers with a new treatment option to enable on-demand care and patient self-management
and provide patients with active management and a greater sense of control over their condition; and other statements not related to historical
fact. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but
are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA
for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results
of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; whether
the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications; general economic, political, and
market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian
hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial
markets in the United States and abroad; risks related to pandemics and public health emergencies; and risks related the sufficiency
of Milestone's capital resources and its ability to raise additional capital in the current economic climate. 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, 2024, under the caption "Risk Factors," as such discussion may be updated from time to time
by subsequent filings Milestone 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
Kim Fox, Vice President, Communications, kfox@milestonepharma.com
Kevin Gardner, kgardner@lifesciadvisors.com
Milestone Pharmaceuticals Inc.
Consolidated Balance Sheets
(in thousands of US dollars, except share
| December 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 25,314 | $ | 13,760 | ||||
| Short-term investments | 44,381 | 52,243 | ||||||
| Research and development tax credits receivable | 901 | 643 | ||||||
| Prepaid expenses | 1,840 | 3,178 | ||||||
| Other receivables | 1,490 | 3,208 | ||||||
| Total current assets | 73,926 | 73,032 | ||||||
| Operating lease right-of-use assets | 1,376 | 1,917 | ||||||
| Property and equipment | 197 | 277 | ||||||
| Total assets | $ | 75,499 | $ | 75,226 | ||||
| Liabilities, and Shareholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 7,555 | $ | 6,680 | ||||
| Operating lease liabilities | 571 | 546 | ||||||
| Total current liabilities | 8,126 | 7,226 | ||||||
| Operating lease liabilities, net of current portion | 874 | 1,457 | ||||||
| Senior secured convertible notes | 53,352 | 49,772 | ||||||
| Total liabilities | 62,352 | 58,455 | ||||||
| Shareholders' Equity | ||||||||
| Common shares, no par value, unlimited shares authorized 53,353,984 shares issued and outstanding as of December 31, 2024, 33,483,111 shares issued and outstanding as of December 31, 2023 | 288,048 | 260,504 | ||||||
| Pre-funded warrants - 12,910,590 issued and outstanding as of December 31, 2024 and 9,577,257 as of December 31, 2023 | 53,076 | 48,459 | ||||||
| Additional paid-in capital | 39,568 | 33,834 | ||||||
| Accumulated deficit | (367,545 | ) | (326,026 | ) | ||||
| Total shareholders' equity | 13,147 | 16,771 | ||||||
| Total liabilities and shareholders' equity | $ | 75,499 | $ | 75,226 |
Milestone Pharmaceuticals Inc.
Consolidated Statements of Loss
(in thousands of US dollars, except share
| Years Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue | $ | - | $ | 1,000 | ||||
| Operating expenses | ||||||||
| Research and development, net of tax credits | $ | 14,357 | $ | 31,052 | ||||
| General and administrative | 16,742 | 15,932 | ||||||
| Commercial | 11,003 | 15,114 | ||||||
| Loss from operations | (42,102 | ) | (61,098 | ) | ||||
| Interest income | 4,164 | 3,967 | ||||||
| Interest expense | (3,581 | ) | (2,554 | ) | ||||
| Net loss and comprehensive loss | $ | (41,519 | ) | $ | (59,685 | ) | ||
| Weighted average number of shares and pre-funded warrants outstanding, basic and diluted | 62,210,702 | 42,955,779 | ||||||
| Net loss per share, basic and diluted | $ | (0.67 | ) | $ | (1.39 | ) |