Milestone Pharmaceuticals Inc.

Good morning, ladies and gentlemen, and welcome to the Milestone Pharmaceuticals fourth quarter and year-end 2025 corporate update conference call. At this time, all participants are in listen-only mode. After the speaker's remarks, there will be a question-and-answer session. As a reminder, this conference is being recorded. I will now turn the call over to your host, Michael Wood of LifeSite Advisors. You may now begin your conference.

Thank you, Operator. Good morning. Good morning, everyone. and welcome to the Milestone Pharmaceuticals full year 2025 financial results and business update conference call. Earlier this morning, the company issued a press release providing an overview of its financial results for the year ended December 31, 2025, and recent corporate highlights. The release can be accessed on the investors' media section of the company's website, milestonepharma.com. Before I begin, I'd like to remind everyone that some of the information presented on this conference call contains forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause actual clinical programs, future results, progress, timing, performances, or achievements to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties associated with milestones, business, and factors could cause or contribute to such differences are described in detail in the company's filings with the SEC, including in the risk factor section of the earnings report on Form 10-K for the year ended December 31, 2025, filed with the SEC today. Speaking on the call this morning will be Joseph Oliveto, President and Chief Executive Officer, Lorenz Muller, Chief Commercial Officer, Amit Hazija, Chief Financial Officer and EVP of Corporate Development. In addition, Dr. David Borussia, the company's Chief Medical Officer, will also be available during the Q&A session. So I'd now like to turn the call over to Joseph Oliveto. Joe, please go ahead.

Thank you, Michael. Good morning and welcome, everyone, to our 2025 year-end earnings call. December 2025 marked a transformational event for Milestone Pharmaceuticals. with the FDA approval of Cardamist, a trypamil nasal spray for paroxysmal supraventricular tachycardia, or more specifically, for the conversion of PSVT to normal sinus rhythm in adults. Milestone is entering an exciting new phase of growth as we focus on bringing this important new therapy to patients and building a strong commercial franchise. The FDA approval of Cardamist was the culmination of years of clinical development and scientific commitment. And as such, I'd like to reiterate my appreciation and thank all the people who helped make this happen. This includes the clinical trial investigators and clinical support staff, our partners who conducted the various clinical manufacturing and regulatory programs, the patients who participated in the studies, and of course, my colleagues here at Milestone who put in the hard work and dedication to bring us to where we are today. We see the FDA approval of cardamom as a foundation for value creation. Let me expand on what I mean. First, our commercial team is now executing on the launch of cardamom, the first new therapeutic option in 30 years. for more than 2 million patients with PSVT. Our goal is that this new product will become a trusted and essential tool for healthcare providers and their patients. Our commercial strategy this year is focused on driving new patient starts and achieving commercial coverage, which, if successful, is expected to accelerate prescription growth. The strategy also includes ensuring patients have a good initial experience with Cardamist. We were successful in having Cardamist available in the market in late January, approximately six weeks after approval, and we began our promotional launch a few weeks later by mid-February. While we're only about a month or so into the launch, we are very encouraged about the initial feedback from prescribers, and Lorenz will be providing more details than what we are seeing regarding the launch later in this call. Second, we believe the FDA approval of Cardamist will enable us to leverage our comprehensive clinical data and seek marketing approvals in other parts of the world. The regulatory process here in the U.S. is seen as the gold standard, and we believe that having an FDA approval adds to the credibility of Cardamist. We filed a marketing authorization application, or MAA, for a trypamil nasal spray or a tachymist, as it will be known in Europe, in the fourth quarter of 2025. We announced the EMA's acceptance of that application in January, and we are engaged with the reviewers, and we expect that review and a decision from that review to occur in the first half of 2027. Moving on to our finances, Milestone Pharmaceutical is well capitalized, and we are reporting today a strengthened balance sheet that we believe supports a successful launch of Cardamis and provides us with expected operating runway into late 2027. We are reporting a pro forma estimated cash figure of $200 million. This includes the year-end audited cash and cash equivalents and short-term investments plus the funds we received in early 2026 from the RTW royalty payment, exercises of a portion of the warrants from our last financing, and the sale of shares through our ATM program. The figure does not include estimated burn to date in Q1. Amit Haseja, our CFO, will provide the details on our financials later in the call. And lastly, we're recently enhanced our leadership team with the addition of David Sandoval to the position of General Counsel and Chief Compliance Officer. David has an established track record with more than 15 years leading legal and compliance functions across the life sciences sector. We believe this experience will be extremely valuable as we scale our operations and build the infrastructure to support long-term growth. With that, I'd like to turn the call over to Lorenz for some additional color on the launch.