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Milestone Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Regulatory and Corporate Update

MIST 11.12.2024

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Drug:etripamil-001 etripamil

Diseases:paroxysmal supraventricular tachycardia (PSVT)

Date of Upcoming Event:2024-11-12

Name of Upcoming Event:KOL webinar entitled “Learnings from the Field: Managing PSVT and Studying AFib-RVR in the Community Setting.”

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NDA for CARDAMYSTTM in PSVT under review by FDA; PDUFA March 27, 2025

MONTREALandCHARLOTTE, N.C.,Nov. 12, 2024(GLOBE NEWSWIRE) -- Milestone^®Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the third quarter endedSeptember 30, 2024and provided a corporate update.

“Our primary focus at Milestone is preparing for potential FDA approval of CARDAMYST (etripamil) nasal spray for the management of PSVT,” saidJoseph Oliveto, President and Chief Executive Officer ofMilestone Pharmaceuticals. “We believe that CARDAMYST has the potential to improve how PSVT is managed and positions Milestone to deliver meaningful value to patients, providers, and payors. Complementing our efforts in PSVT, we are very encouraged by clinician interest in the etripamil Phase 3 study in AFib-RVR which we are working toward commencing in the first half of 2025.”

Third Quarter and Recent Program Updates

CARDAMYST for patients with paroxysmal supraventricular tachycardia (PSVT)

New Drug Application (NDA) for CARDAMYST forPSVT under review byU.S.FDA.The FDA accepted the NDA for CARDAMYST inMay 2024and has set a Prescription Drug User Fee Act (PDUFA) target date forMarch 27, 2025. Preparations for a commercial launch in 2025 are underway.
Milestone’s partner, Corxel (formerlyJi Xing Pharmaceuticals Ltd), announced positive top line results from a Phase 3 trial of etripamil conducted inChina.In September, Corxel announced positive results from the multi-center, randomized, double-blind, placebo-controlled trial which expands the etripamil global development program to more than 2,000 unique patients treated with etripamil. The trial (JX02002) successfully met its primary endpoint, with aKaplan Meieranalysis showing a statistically significantly greater proportion of patients who self-administered etripamil converted from PSVT to sinus rhythm within 30 minutes compared to placebo (40.5% vs. 15.9%, respectively; hazard ratio [HR] = 3.00; p<0.001). Statistically significant (p<0.05) results were also achieved for the secondary efficacy endpoints for percent of patients’ PSVT converting to sinus rhythm by 10, 15, 45, and 60 minutes after self-administration of study drug. The safety and tolerability data from the trial were consistent with previous clinical studies. Milestone entered into an agreement with Ji Xing in 2021, granting it an exclusive license to develop and, if approved, commercialize etripamil in PSVT in Greater China.
Milestone hosted a KOL webinar entitled “Learnings from the Field: Managing PSVT and Studying AFib-RVR in the Community Setting.”The event, which is the second of a series of planned webinars learning from community-based health care providers, featured Aamer H. Jamali, MD, FACC and Farhad Rafii, MD, FACC, both from Interventional Cardiology Medical Group in West Hills, CA. The physicians discussed how they manage patients with PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR) and highlighted clinical trial experience in PSVT as well as upcoming trials in AFib-RVR with the potential to impact the current standard of care. A replay of the webinar is available on the Milestone corporate websitehere.
Patient Reported Outcomes (PRO) data from PSVT patients receiving etripamil were presented at the annual meeting of the European Society of Cardiology (ESC Congress) in London.OnAugust 30, 2024Professor John Camm of St. George’s University ofLondon, UK, presented PRO data from the NODE-303 Phase 3 trial of etripamil in PSVT in a moderated poster presentation. The poster presentation is availablehere.

Etripamil for patients with AFib-RVR

Milestone is on track to initiate a Phase 3 trial evaluating etripamil in AFib-RVR in H1 2025.The Company has been in communication with the FDA regarding Phase 3 study design and is planning a trial that will be conducted in the at-home setting, comprising approximately 150 events from patients with a history of symptomatic episodes and using a repeat-dose regimen of 70 mg per dose (the same as the self-administration dosing regimen approach that was studied in the RAPID trial in PSVT).

Corporate Updates

In September,Joseph Papawas appointed to the board of directors.Mr. Papabrings more than 35 years of experience, having previously served as Chairman and CEO of Bausch + Lomb, Bausch Health and Perrigo and as a director of SparingVision and Candel Therapeutics. He has broad commercial experience and proven capabilities of advancing innovative products aimed at significantly enhancing patients’ lives.

Third Quarter 2024 Financial Results

As ofSeptember 30, 2024, Milestone had cash, cash equivalents, and short-term investments of$76.4 million, compared to$66.0 millionas ofDecember 31, 2023.
Research and development expense, net of tax credits for the third quarter of 2024 was$4.0 million, compared with$6.7 millionfor the same period in 2023. For the nine months endedSeptember 30, 2024, research and development expense, net of tax credits was$10.4 millioncompared with$25.6 millionfor the same period in 2023. This decrease in research and development expenses was driven by lower clinical development costs and clinical personnel-related costs driven by completion of phase 3 studies, as well as a decrease in drug manufacturing and regulatory costs.
General and administrative expense for the third quarter of 2024 was$3.7 million, compared with the$4.2 millionreported for the same period in 2023. For the nine months endedSeptember 30, 2024, general and administrative expense was$12.7 million, compared with the with$12.6 millionfor the prior year period. The decrease between the third quarter periods is primarily due to a decrease in personnel costs, partially offset by an increase in outside service costs.
Commercial expense for the third quarter of 2024 was$1.9 million, compared with$4.4 millionfor the same period in 2023. For the nine months endedSeptember 30, 2024, commercial expense was$6.6 millioncompared with$10.1 millionfor the prior year period. The decreases are a result of decreases in personnel costs, professional costs and other operational expenses related to commercialization.
For the third quarter of 2024, net loss was$9.4 million, compared to$15.1 millionfor the prior year period. For the nine months endedSeptember 30, 2024, Milestone's net loss was$29.2 million, compared to$46.1 millionin the prior year period.

For further details on the Company’s financials, refer to the quarterly report on Form 10-Q for the quarter endedSeptember 30, 2024, filed with theSEConNovember 12, 2024.

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. CARDAMYSTTM (etripamil) nasal spray, 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.

AboutMilestone 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 timing and outcomes of future interactions withU.S.and foreign regulatory bodies, including the FDA, including the timing of the FDA’s review of the NDA; the ability of CARDAMYST to improve how PSVT is managed and position Milestone to deliver meaningful value to patients and providers; the timing of the commercial launch of etripamil for PSVT; and the timing, design and outcomes of our clinical trials, including our Phase 3 study in AFib-RVR. 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; whether the FDA will require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful, 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, 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, Russian hostilities inUkraineand ongoing disputes inIsraelandGazaand overall fluctuations in the financial markets inthe United Statesand 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 theU.S. Securities and Exchange Commission(SEC), including in its annual report on Form 10-K for the year endedDecember 31, 2023and its quarterly report on Form 10-Q for the quarter endedSeptember 30, 2024, under the caption “Risk Factors,” as such discussion may be updated from time to time by subsequent filings Milestone may make with theSEC. 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:Kim Fox, Vice President, Communications,kfox@milestonepharma.com

Investor RelationsChris Calabrese,ccalabrese@lifesciadvisors.comKevin Gardner,kgardner@lifesciadvisors.com


*Milestone Pharmaceuticals Inc.Condensed Consolidated Statements of Loss (Unaudited)(in thousands of US dollars, except share and per share data)***

	Three months endedSeptember 30,						Nine months endedSeptember 30,
	2024			2023			2024			2023

Revenue	$	—		$	—		$	—		$	1,000

Operating expenses
Research and development, net of tax credits		3,963			6,721			10,417			25,600
General and administrative		3,742			4,227			12,741			12,561
Commercial		1,911			4,412			6,596			10,137

Loss from operations		(9,616	)		(15,360	)		(29,754	)		(47,298	)

Interest income		1,080			1,120			3,260			2,921
Interest expense		(903	)		(841	)		(2,662	)		(1,697	)

Net loss and comprehensive loss	$	(9,439	)	$	(15,081	)	$	(29,156	)	$	(46,074	)

Weighted average number of shares and pre-funded warrants outstanding, basic and diluted		66,190,302			42,973,160			60,856,495			42,920,620

Net loss per share, basic and diluted	$	(0.14	)	$	(0.35	)	$	(0.48	)	$	(1.07	)

*Milestone Pharmaceuticals Inc.Condensed Consolidated Balance Sheets (Unaudited)(in thousands of US dollars, except share data)***

	September 30, 2024			December 31, 2023
Assets

Current assets
Cash and cash equivalents	$	12,799		$	13,760
Short-term investments		63,620			52,243
Research and development tax credits receivable		837			643
Prepaid expenses		2,523			3,178
Other receivables		1,211			3,208
Total current assets		80,990			73,032
Operating lease right-of-use assets		1,515			1,917
Property and equipment		201			277
Total assets	$	82,706		$	75,226

Liabilities, and Shareholders' Equity

Current liabilities
Accounts payable and accrued liabilities	$	4,676		$	6,680
Operating lease liabilities		582			546
Total current liabilities		5,258			7,226
Operating lease liabilities, net of current portion		1,002			1,457
Senior secured convertible notes		52,434			49,772
Total liabilities		58,694			58,455


Shareholders’ Equity
Common shares, no par value, unlimited shares authorized 53,327,908 shares issued and outstanding as ofSeptember 30, 2024, 33,483,111 shares issued and outstanding as ofDecember 31, 2023		288,006			260,504
Pre-funded warrants - 12,910,590 issued and outstanding as ofSeptember 30, 2024and 9,577,257 as ofDecember 31, 2023		53,076			48,459
Additional paid-in capital		38,112			33,834
Accumulated deficit		(355,182	)		(326,026	)

Total shareholders’ equity		24,012			16,771

Total liabilities and shareholders’ equity	$	82,706		$	75,226

Source: Milestone Pharmaceuticals Inc.

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