Y-mAbs Therapeutics, Inc.

Good morning. Welcome to YMAP's Therapeutics Virtual Radio Pharmaceutical R&D Update Webcast and Conference Call. As a reminder, today's conference will be recorded. I would now like to turn the call over to YMAP's Head of Investor Relations, Courtney Dugan. Please go ahead.

Thank you, Operator, and good morning, everyone. Welcome to the YMAB's virtual radiopharmaceutical R&D update webcast and conference call. We issued a press release this morning before the market opened, highlighting key takeaways from today's discussion. 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 preclinical and clinical data, regulatory matters, clinical trial timing and plans, the achievement of clinical and commercial milestones, the potential benefits of the company's programs and product candidates, and other statements that are not historical facts. Because forward-looking statements involve risks and uncertainties, factual 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 report on Form 10-K for the year ended December 31st, 2024, as supplemented by the risk factors discussed in the company's quarterly report on Form 10-Q for the quarter ended March 31st, 2025. I will now turn the call over to our President and Chief Executive Officer, Mike Rossi.

Thank you for joining us today during our virtual radiopharmaceutical R&D update. Joining me today is Natalie Tucker, our radiopharmaceutical business unit head, and Norman LaFrance, our chief medical and development officer. We also have our chief financial officer, Pete Franchu, joining during the Q&A portion of today's update. I will make a few opening remarks and then hand the call over to Natalie. At YMABS, our vision is to pioneer and develop next-generation therapies, leveraging our novel immunotherapy and radiopharmaceutical platforms to transform patient care for a broad range of diseases starting with cancer. YMABS Therapeutics was founded 10 years ago with the urgent mission to make innovative cancer therapies available to patients worldwide. Since then, we have brought an important and differentiated antibody therapy, Danielza, to market in the pediatric oncology space, meeting our mission of helping to improve the lives of patients and their families. Danielza has provided and continues to provide invaluable quality time for patients with relapsed refractory high-risk neuroblastoma in the bone and bone marrow out of the hospital setting, giving the gift of childhood back to patients this legacy of impact in improving people's lives is something we are working to expand with our radiopharmaceutical platform and programs with the establishment of two distinct business units announced earlier this year we have the people and resources in place to further maximize the full potential of danielza in and beyond neuroblastoma while at the same time accelerating the strategic advancement of our novel self-assembling and disassembling pre-targeted radio immunotherapy or SADA PRIT technology platform and programs across targeted disease areas. We are excited to provide you with several updates across our radiopharmaceutical business today. Within our radiopharmaceutical business, We have five strategic enablers, which define our vision for growth, which you can see here. Each of these addresses a significant gap in the current radiopharma space. First, we believe pre-targeting will address the challenge of off-target toxicity associated with many radiopharmaceuticals. Second, we are working toward building a fully operational theranostic platform encompassing both novel radio immunotherapies and accompanying diagnostic tools. Third, we will leverage the multi-isotope modularity of our platform, which will pair the appropriate isotope to the patient-specific disease characteristics. Fourth, we're putting our investment towards strategic R&D and clinical advancement rather than building large manufacturing facilities for complicated radiochemistries. Lastly, we are enhancing physician participation in patient treatment, allowing for a more collaborative and efficient treatment patient journey. Let me touch on these areas a bit more. By executing our vision for our radiopharmaceutical business, we are well positioned to potentially disrupt both the existing treatment paradigm and the commercial pathway for radiopharmaceuticals with much lower cost and increased access for patients and physicians alike. As I mentioned with SADA, we have no need to spend hundreds of millions of dollars on new infrastructure and physical manufacturing plants. With our pre-targeted approach, the assembly of the protein and radioisotope happens in the patient as opposed to a radiopharmaceutical production facility. This allows us to focus our investments on strategic R&D and clinical advancement of high-value target programs and helps keep our overall cost of goods down. Physician participation is a challenge right now with current radioimmunotherapies. Oncology and nuclear medicine largely operate independently when delivering radio pharmaceuticals. SADA better utilizes the existing physician infrastructure as the first dose or the pre-targeted dose, can be administered anywhere by the oncologist. Then, after the appropriate clearance interval, the patient will receive the isotope injection by a radiation oncologist or a nuclear medicine physician. With SADA, each physician plays a role in the delivery of the therapy. SADA is patient-centric and it can accommodate a variety of different isotopes using modular designs. Physicians would essentially personalize their radio immunotherapy treatment for a specific patient. And finally, with SADA's pre-targeted approach, we can deliver an optimal therapeutic dose directly to the tumor while significantly decreasing potential off-target toxicity. Let's take a quick look at the progress we have made over the past year and a half. Since joining the company in November 2023, YMAPS has reinforced its commitment to radiopharmaceuticals and is leading a brand new generation of truly patient-centric theranostics. 2024 was the year of execution for YMAPS. In the past 12 months alone, we have brought an incredible level of radiopharma expertise, in particular with Dr. Norman LaFrance and Natalie Tucker and many others across our clinical, quality, regulatory, and scientific teams. We have learned a lot from our GD2 SADA Phase I Part A data, and the additional molecule optimization work has been completed. We have set a path for strategic growth and clinical advancement, which we will share with you today. Looking to 2026 and 2027, we have several potential high-value inflection points, and clinical milestones ahead. You will hear more about this later today. Today, we will report on the progress of our radiopharmaceutical pipeline and release the results of our completed Trial 1001 Part A data, including our plans for future studies. Let me pass the call to Natalie, who will discuss the results from Phase 1 Part A of our GD2 SADA Trial 1001.