1. FDA PDUFA date for CARDAMYST set for December 13, 2025. 2. Milestone has $82.6 million in cash for product launch. 3. Etripamil shows promising efficacy for PSVT, backed by recent trials. 4. Company strengthens commercial capabilities ahead of potential FDA approval. 5. Net loss for Q3 2025 is $11.9 million, reflecting operational expenses.
The upcoming NDA approval and strong clinical trial results may drive investor sentiment positively, similar to past cases in biotech where successful drug approvals led to stock price increases.
The article discusses substantial upcoming regulatory milestones that will likely affect MIST's stock valuation.
Immediate effects expected around December 13, 2025, coinciding with PDUFA date, similar to previous market behaviors surrounding drug approvals.
PDUFA Target Date of December 13, 2025 for CARDAMYST™ (etripamil) Nasal Spray in Paroxysmal Supraventricular Tachycardia (PSVT)
Promotional Launch Plans Set with Quick-Start Capability Upon Potential FDA Approval
$82.6 million in Cash at September 30; Successful Equity Offering and Amended Royalty Purchase Agreement Provide Resources for Successful Launch
MONTREAL and CHARLOTTE, N.C., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST) today reported financial results for the third quarter ending September 30, 2025, and provided corporate and regulatory updates.
"We are approaching our December 13 Prescription Drug User Fee Act (PDUFA) date with optimism and excitement for the opportunity to bring CARDAMYST (etripamil) nasal spray to patients suffering from symptomatic PSVT," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Our team has recently increased our pre-launch activities to better enable market readiness. We strengthened our balance sheet with a successful equity financing last quarter, and together with the $75 million royalty payment upon FDA approval, we believe we have resources in place to drive a successful commercial launch."
Third Quarter and Program Updates
Etripamil for patients with PSVT
Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR)
Third Quarter and Recent Corporate Updates
Third Quarter 2025 Financial Results
For further details on the Company's financials, refer to the Quarterly Report on Form 10-Q for the quarter ending September 30, 2025, filed with the SEC on November 12, 2025.
About Etripamil
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.
About Milestone Pharmaceuticals
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.
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 "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 outcomes of future interactions with the FDA, including the potential approval of the NDA for CARDAMYST for PSVT; Milestone's ability to receive additional cash proceeds from the warrants issued in the Offering; Milestone's ability to receive the $75.0 million royalty payment under the Royalty Purchase Agreement on the timeline provided, or at all; Milestone's expected operating runway; CARDAMYST's potential as a novel treatment option to help patients with PSVT; Milestone's ability to make CARDAMYST quickly available to PSVT patients following FDA approval, if received; the success of Milestone's launch infrastructure; the timing of patient enrollment in the Phase 3 study of etripamil for AFib-RVR; and other statements not related to historical facts. 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; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, 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 (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2025, in each case under the caption "Risk Factors," as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. 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:
Investor Relations
Kevin Gardner, kgardner@lifesciadvisors.com
| Milestone Pharmaceuticals Inc. Condensed Consolidated Balance Sheets (Unaudited) (in thousands of US dollars, except share data) | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 46,685 | $ | 25,314 | ||||
| Short-term investments | 35,900 | 44,381 | ||||||
| Research and development tax credits receivable | 808 | 901 | ||||||
| Prepaid expenses | 2,577 | 1,840 | ||||||
| Other receivables | 700 | 1,490 | ||||||
| Total current assets | 86,670 | 73,926 | ||||||
| Operating lease right-of-use assets | 944 | 1,376 | ||||||
| Property and equipment | 136 | 197 | ||||||
| Total assets | $ | 87,750 | $ | 75,499 | ||||
| Liabilities, and Shareholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 10,041 | $ | 7,555 | ||||
| Operating lease liabilities | 483 | 571 | ||||||
| Total current liabilities | 10,524 | 8,126 | ||||||
| Operating lease liabilities, net of current portion | 519 | 874 | ||||||
| Senior secured convertible notes | 56,206 | 53,352 | ||||||
| Total liabilities | 67,249 | 62,352 | ||||||
| Shareholders' Equity | ||||||||
| Common shares, no par value, unlimited shares authorized, 85,169,344 shares issued and outstanding as of September 30, 2025, 53,353,984 shares issued and outstanding as of December 31, 2024 | 311,776 | 288,048 | ||||||
| Pre-funded warrants - 16,412,925 issued and outstanding as of September 30, 2025 and 12,910,590 as of December 31, 2024 | 55,649 | 53,076 | ||||||
| Additional paid-in capital | 66,270 | 39,568 | ||||||
| Accumulated deficit | (413,194 | ) | (367,545 | ) | ||||
| Total shareholders' equity | 20,501 | 13,147 | ||||||
| Total liabilities and shareholders' equity | $ | 87,750 | $ | 75,499 | ||||
| Milestone Pharmaceuticals Inc. Condensed Consolidated Statements of Loss (Unaudited) (in thousands of US dollars, except share and per share data) | |||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | |||||||||
| Operating expenses | |||||||||||||||||
| Research and development, net of tax credits | 3,940 | 3,963 | 12,587 | 10,417 | |||||||||||||
| General and administrative | 3,263 | 3,742 | 12,189 | 12,741 | |||||||||||||
| Commercial | 4,626 | 1,911 | 20,107 | 6,596 | |||||||||||||
| Loss from operations | (11,829 | ) | (9,616 | ) | (44,883 | ) | (29,754 | ) | |||||||||
| Interest income | 874 | 1,080 | 2,087 | 3,260 | |||||||||||||
| Interest expense | (967 | ) | (903 | ) | (2,853 | ) | (2,662 | ) | |||||||||
| Net loss and comprehensive loss | $ | (11,922 | ) | $ | (9,439 | ) | $ | (45,649 | ) | $ | (29,156 | ) | |||||
| Weighted average number of shares and pre-funded warrants outstanding, basic and diluted | 96,494,588 | 66,190,302 | 76,497,361 | 60,856,495 | |||||||||||||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.14 | ) | $ | (0.60 | ) | $ | (0.48 | ) | |||||
