Y-mAbs Therapeutics, Inc.

Good morning and welcome to YMAB's Therapeutics first quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. Instructions for the question and answer session will follow the prepared remarks. As a reminder, today's conference will be recorded. I would now like to hand the call over to YMAB's head of IR, Courtney Dugan. Please go ahead.

Thank you, Operator, and good morning, everyone. Welcome to the YNAB's first quarter 2025 financial results conference call. We issued a press release with our results this morning before the market opened. The press release and accompanying slides are available on the IR section of our website. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model, commercialization, and product distribution plans, expectations with respect to our business realignment, expectations with respect to clinical trial data, expectations related to current and future clinical and preclinical studies and our research and development programs and regulatory submissions, potential regulatory, marketing, and reimbursement approvals, collaborations or strategic partnerships, and the potential benefits thereof, expectations related to our anticipated cash runway and cash investment and the sufficiency of our cash resources and assumptions related thereto, financial guidance and estimates for the first quarter and full year of 2025 and beyond, and other statements that are not historical facts. Because forward-looking statements involve risks and uncertainties, actual results may differ materially from those expressed or implied by such statements due to a variety of factors, including those risk factors discussed in the company's previously filed annual report on Form 10-K for the year ended December 31, 2024, as supplemented by the risk factors discussed in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2025, to be filed with the SEC today. In addition, today's discussion will include operating expenses, excluding cost of goods sold, which is a non-GAAP financial measure. A description of this non-GAAP financial measure and a reconciliation of the closest GAAP financial measure is included in today's press release and in the slide presentation available on the IR section of our website at ir.lymabs.com. I would now like to turn the call over to our President and CEO, Mike Rossi.

Thank you, Courtney. Good morning, everyone, and thank you for joining us. Joining me today is Doug Gentilcore, our Daniela Business Unit Head, and Pete Frenchew, our Chief Financial Officer. I will begin by reviewing key highlights from our business units from the first quarter and how those accomplishments align to our long-term strategy, and then discuss our upcoming Radio Pharmaceutical R&D event on May 28th. Doug will provide details on our global Danielza sales performance and commercial strategy. Then Pete will provide a detailed account of the first quarter financial results. We made excellent progress in the first quarter of this year following our business realignment announced in January. Just to remind everyone, the company made the decision to establish two distinct internal business units, Danielza and Radio Pharmaceuticals. The effort is expected to help maximize the potential of Daniela, while at the same time accelerating the development of our novel SADA CRIT platform and high-value target programs. In the first quarter, we recorded Daniela net product revenues of $20.9 million, coming in at the higher end of our guidance range we provided during our fiscal year-end 2024 earnings call in March. This represents an 8% increase from the first quarter of last year. Despite a challenging environment with multiple headwinds, I'm very proud of the team's effort and resilience to deliver this caliber of results. We continue to be prudent in our spending, and our financial position remains strong with $60.3 million in cash with an anticipated runway into 2027 based on our current operations. In our radiopharmaceutical business unit, we completed Part A of our GD2-SATA Phase 1 clinical trial, Trial 1001, and followed tumors. Additionally, we successfully dosed the first patient in our CD38-SATA Phase 1 clinical trial, Trial 1201, in patients with relapsed or refractory non-Hodgkin's lymphoma. Our second clinical program evaluating our novel SATA-PRIP platform and our first in hematologic malignancies. RELAXED or refractory non-Hodgkin's lymphoma presents significant challenges for patients facing limited treatment options and a more aggressive disease course. We look forward to advancing our program in the trial and we'll update you as it progresses. As you may have seen, this morning we announced we will hold a virtual radiopharmaceutical R&D event on the morning of May 28th. At that time, we will provide three key updates. First, the completed data from Part A of Trial 1001, our GD2 SADA Trial 1 clinical trial in solid tumors, and next steps for the program. As a reminder, Part A of Trial 1001 is a dose-finding study. The data we plan to share will predominantly focus on the safety profile, dosing regimen, and pharmacokinetic endosymmetry details. We anticipate the clinical data will align with our preclinical model to help understand tumor uptake, which will be critical as we move into part two of the study. Second, we will review construct optimization as we move into the next stage of both our current and future programs. Specifically, we will outline changes to be made in the new construct for GD2-SATA and provide data supporting why we believe those changes will improve tumor updates. Third, we will provide pipeline updates, including new planned target programs and anticipated timelines. In the past, we've described our systematic evaluation to identify optimal targets for our platforms. We will highlight the compelling commercial opportunities for extending radiation-based therapy to those indications and how we plan to do so with a fiscally prudent strategy. We look forward to providing you with these exciting updates on our radiopharmaceutical business unit in two weeks. Now, let me hand the call over to our Danielsa business unit head, Doug Gentilcore, to discuss our commercial progress.