Y-mAbs Therapeutics, Inc.

Good morning, and welcome to YMAB's Therapeutics, Inc. Third Quarter Conference Call for 2024. At this time, all participants are in listen-only mode. Instruction for the question and answer session will follow the prepared remarks. As a reminder, today's conference will be recorded. I will now hand it over to YMAB's Head of IR, Courtney Dugan.

Thank you, Operator, and good morning, everyone. Welcome to the YMAB Third Quarter 2024 Financial Results Conference Call. We issued a press release with our results this morning before 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 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 2024 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 in the company's previously filed annual report on Form 10-K for the year ended December 31, 2023, and its quarterly report on Form 10-Q for the quarters ended March 31 and June 30, 2024, and the company's quarterly report on Form 10-Q for the quarter ended September 30, 2024, to be filed with the SEC today. I would now like to turn the call over to our President and CEO, Mike Rossi.

Thank you, Courtney. Good morning, and thank you for joining us. I have with me today our Chief Commercial Officer, Sue Smith, our Chief Medical Officer, Dr. Vinash Rajah, and our Chief Financial Officer, Pete Frinshaw. This morning, I will begin by reviewing key financial and operational highlights from the third quarter of 2024, including Daniela's sales performance, and the clinical progress of our radiotherapy clinical programs utilizing our self-assembly, disassembly, pre-targeted radioimmune therapy, or SADA print technology platform. Next, Sue will provide details on our global Danielza sales in the third quarter. Vinesh will then provide updates around our ongoing Nexidimab ISS clinical trials. Then Pete will review our third quarter 2024 financial performance, our cash resources, and reiterate our full 2024 guidance before we open the line for Q&A. Let's begin with the key highlights for the third quarter of 2024, starting with Danielza. Danielza, the brand name for a humanized anti-GD2 therapy, Nexidimab, is FDA approved for the treatment of children aged one year and older with relapsed refractory high-risk neuroblastoma in the bone or bone marrow. Neuroblastoma continues to be the most common cancer in infants and the third most common cancer in children. Danielza is specifically designed for children who have had an incomplete response to induction or relapse therapy and also have disease in the bone and or bone marrow. While designated as an outpatient therapy, Danielza can also be administered in the inpatient setting depending on the specific needs of the child. We are nearing the four-year mark since the commercial launch of Danielza in the US. Despite some of the headwinds around competition we saw from the second quarter carry into the third quarter this year, our overall commercial progress since launch back in 2021 shows encouraging continued progress in terms of the number of sites we are able to reach and the patients we are able to treat with Danielza. In the third quarter, we added three new US Danielza accounts and saw a 5% increase in Danielsa demand compared to the second quarter of this year. This signals to us increasing physician adoption of Danielsa across both new and existing accounts and more patients having access to this important anti-GD2 therapy. Our team continues to drive important initiatives around direct-to-parent education and patient advocacy efforts with the goal of thoroughly understanding the current gaps in patient care and increasing awareness of Danielza as an important treatment option for children with relapsed refractory high-risk neuroblastoma to achieve a complete response and remission. You will hear more from Sue on specifics around Danielza's performance across our U.S. and ex-U.S. markets shortly. In the third quarter, we achieved total net revenue of $18.5 million, down 10% from the same period in 2023. The decrease was due to a decline in net product revenues in both the US and our ex-US markets in the quarter, in addition to a half million dollar in licensing revenue recorded in the third quarter of 2023. For the first nine months of the year, we achieved total net revenue of 61.2 million US dollars, relatively consistent with the same period in 2023. We had several corporate updates in the quarter that support our continued global commercial and indication expansion efforts. We are thrilled to have received notification of the accepted patent extension for Danielza, U.S. 9315-585 last month. Our U.S. patent will now expire February 5th, 2034, extended from June 20th, 2031. In the third quarter, we entered into a lease agreement for a future YMAPS headquarters in Princeton, New Jersey. We expect the construction of the premises will be completed in the first half of 2025, and the lease will run for 10 years and nine months from the completion date. Earlier this week, we announced that we have entered an exclusive license agreement and distribution agreement with Noble Pharma for the development and commercialization of Danielza in Japan, if approved in the region. We received an upfront payment of $2 million, which will be recorded in the fourth quarter of this year. Under the terms of the agreement, we are entitled to receive up to 31 million U.S. dollars in product and commercial milestone payments in addition to profit sharing on the commercial sales of Danielsa if successfully approved and commercialized in Japan. Japan represents an important Asia region for Danielsa, and we look forward to partnering with Noble Pharma and expanding access to Danielsa to the region if approved there. Our partner, TR Farm, launched the Danielza Named Patient Program in Turkey in the third quarter of 2024. We are very pleased with how the launch is progressing and look forward to providing further updates in future quarters. In addition, with our Latin American partner, ADM, we plan to submit a regulatory filing for marketing approval of Danielza in Argentina later this year. Overall, we remain confident in our U.S. commercial strategy and trajectory in the continued XUS expansion of Danielza to fill important gaps in the treatment of children with relapsed or refractory high-risk neuroblastoma. Let's now shift to our SADA-PRIP programs, starting with our Phase I trial evaluating the safety and tolerability of GD2 SADA for the treatment of GD2-positive solid tumors. This is a basket trial looking at small-cell lung cancer, sarcomas, and malignant melanomas. In the fourth quarter, we opened cohort six to include adult patients 16 years of age or above with high-risk neuroblastoma. As a reminder, this phase one dose escalation single-arm multicenter safety study has three parts. Part A, which we are currently in, is structured to demonstrate the safety profile of the protein while it explores dose finding for the GD2 SADA molecule and testing of the dose intervals of two to five days between the protein and the lutetium-dota payload. Part B aims to determine the optimal dose of lutetium-177-dota, and Part C will evaluate the safety and initial signs of efficacy using repeat dosing. To date, we have six sites open and have a total of 20 patients in Part A of this trial. We have completed cohorts one through five using a radioactive payload of up to 200 millicuries of lutetium and two to five day interval between SADA protein and payload. The initial blood pharmacokinetic profile of the construct in these patients dosed with 0.3 milligram per kilogram, one milligram per kilogram, and three milligram per kilogram of protein appears to match our preclinical models in the terms of clearance data, and blood PK profiles from patients are comparable and supportive of the current dose interval between two and five days. We continue to be encouraged by what we have seen so far. To date, no patients in the trial have experienced any dose-limiting toxicities, and there have been no instances of treatment-related serious adverse events. Based on the SPECT CT scans and PK activity we have seen to date, We believe we have demonstrated proof of concept in humans that GD2 SADA can both find and bind to tumors. It is important to note that these early data are not complete and not necessarily indicative of a full result or ultimate success of the trial or the SADA development program. We are on track to complete Part A of this Phase 1 study by the end of this year, and we'll look to present a full data set from Part A in the first quarter of 2025. In the anticipated data readout from Part A of the trial, our objective is to demonstrate the safety profile of the protein and determine the optimal timing to administer the radionuclide, all of which will inform Part B. We also plan to show additional scan images and PK data. Because we elected to open a sixth cohort to include adults with neuroblastoma, we are awaiting the full data from Part A before filing an IND for a GD2 SADA Phase I trial in pediatric neuroblastoma. Our second SADA program is CD38 SADA, which we are first studying in the treatment of non-Hodgkin's lymphoma, focusing on B-cell and T-cell lymphoma. This is our first SADA program in circulating tumors. Our planned phase one follows the design comparable to our GD2 SADA phase one trial, which you can see here. We have selected the first six sites and activated two sites and expect to dose the first patient by the end of 2024. In addition, we look forward to highlighting preclinical CD38 SADA data in a poster presentation at the American Society of Hematology annual meeting on December 7th in San Diego. The abstract, titled CD38 SADA, a self-assembling and disassembling bispecific fusion protein for two-step pre-targeted radioimmune therapy of non-Hodgkin's lymphoma, is available on the ASH website. We are very excited for the potential of SADA-PRIT to fill much needed gaps for patients across a range of cancers and potentially other serious diseases, and we continue to believe in its potential advantages in manufacturing, administration, and logistics with traditional radiopharmaceuticals. We look forward to providing further updates on our SADA-PRIT programs going forward. Across both our Danielzit and SADA-PRIT platforms, we are committed to advancing a potential new generation of therapies through clinical development aimed at improving outcomes and long-term quality of life for patients and their families. I will now pass the call over to Sue Smith to provide further color on global Daniela sales for the third quarter of 2024.