Y-mAbs Therapeutics, Inc.

Good morning and welcome to YMAB's Therapeutics Third Quarter 2023 Earnings Conference Call. Please note that today's event is being recorded. At this time, all participants are in a listen-only mode. Instructions for the question and answer session will follow the prepared remarks. I would now like to turn the conference call over to Courtney Duggan, Vice President, Investor Relations. Please go ahead.

Thank you, Operator, and good morning, everyone. Welcome to our third quarter 2023 earnings conference call. We issued a press release with our results yesterday at market close. The press release and accompanying slides are available on the investor relations section of our website. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements, as defined by the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans, expectations with respect to early trial data, current and future clinical and preclinical studies in our research and development programs, expectations related to the timing of the initiation and completion of regulatory submissions, regulatory marketing and reimbursement approvals, including statements with respect to future development of other development programs, potential for Danielle's and Territory expansion and advancement in SADA, collaborations or strategic partnerships and the potential benefits thereof, expectations related to our anticipated cash farm rights and the sufficiency of our cash resources and assumptions related thereto, guidance and expectations for 2023 and beyond, and our financial performance, including our estimates regarding revenues, expenses, and capital expenditure requirements, and other statements that are not historical facts. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future potential performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors. including those risk factors discussed in the company's quarterly report on Form 10-Q for the quarter ended September 30th, 2023, as filed with the SEC on November 15th, 2023. I would now like to turn the call over to our founder, Vice Chairman of the Board of Directors, and Chief Business Officer, Thomas Gad.

Thank you, Courtney. Good morning, everybody, and thank you for joining us today. I have with me today our Chief Financial Officer, Bo Kruse, our Chief Commercial Officer, Sue Smith, and our Chief Scientific Officer, Dr. Stene Lispry. I'm also very excited to welcome our newly appointed President and Chief Executive Officer, Michael Rossi. On today's call, Mike will begin by reviewing third quarter global highlights on Danielsa sales, updates on our ongoing Nacitimab clinical trials, and high-level updates around our SADA program. Sue will then report further insights into our U.S. Danielsa sales in the third quarter. Next, Dean will provide further details on our Phase 1 DD2 SADA trial currently underway in addition to updates on our CD38 SADA program for which we recently received IND clearance by the U.S. FDA. Then Bo will provide an overview of our third quarter financial performance, our cash resources, and our full year 2023 guidance before we open the line for Q&A. Before we get into the third quarter results, on behalf of the YMAPS Board of Directors and our senior leadership team, I want to extend a very warm welcome to our new president and CEO, Michael Rossi, who officially started on November 6th. Our board has conducted a careful search for the right dedicated leader of our company with deep commercial and radiopharmaceutical experience. And we are very pleased to have found that in Mike. Michael brings over 30 years of experience in the radiopharmaceutical industry. He joins us from Merion Technologies, where he served as the president of the medical group. Prior to that, Mike was the head of radioligand imaging at Advanced Accelerator Applications, better known as AAA, a Novartis company. And before that, he led the growth of Jubilant Radiopharm into a vertical integrated radiopharmaceutical leader. Early on in his career, Mike spent over a decade at GE Healthcare, and he's also a certified nuclear pharmacist. As we continue our efforts to expand the geographic reach of Danielsa and further our indication expansion initiatives to maximize the utility of this therapy, we are also incredibly excited about our novel two-step pre-targeted radiotherapy platform, better known as SADA. and its potential to unlock the value of rated pharmaceuticals in the cancer treatment paradigm. After our reorg in the first quarter of this year, YMS has been positioned as one of the few independent commercial states biotech companies with sufficient financial resources to advance SADA through proof of concept. Is this the right time for me to transition to a new role of Vice Chairman and Chief Business Officer? And I very much look forward to working closely with Mike and our board and the entire YMAPS team on our continued mission to bring novel therapeutics to cancer patients. And with that, I'm very excited to turn the call over to Mike. Go ahead, Mike.