Y-mAbs Therapeutics, Inc.

Good morning and welcome to the YMABS Therapeutics Earnings Conference call for the fourth quarter and full year of 2023. At this time, all participants are in a listen-only mode. Instructions for the question and answer session will follow after the prepared remarks. As a reminder, today's conference will be recorded. I'll now turn the call over to YMABS Head of Investor Relations, Courtney Dugan.

Thank you, Operator, and good morning, everyone. Welcome to the YMAP's fourth quarter and full year 2023 financial results conference call. We issued a press release with our results yesterday after market close. 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 and development, commercialization and product distribution plans, expectations with respect to early trial data, current and future clinical and preclinical studies, and our research and development programs, expectations related to the timing of 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 territory and label expansion and potential of an advancement of SADA. Collaborations or strategic partnerships and the potential benefits thereof. Expectations related to our anticipated cash runway and the sufficiency of our cash resources and assumptions related thereto. Guidance and expectations for 2024 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 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 annual report on Form 10-K for the year ended December 31st, 2023, as filed with the SEC on February 29th, 2024. With that, I'd like to now turn the call over to our President and CEO, Mike Raffi.

Thank you, Courtney. Good morning, everybody, and thank you for joining us. I have with me today our Chief Financial Officer, Bo Krause. our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Dr. Vinish Rajan. Thomas Gad, our Founder and Chief Business Officer, and Dr. Steen Lisby, our Chief Scientific Officer, will join us for the Q&A portion of this call. On today's call, I will begin by reviewing our fourth quarter and full year 2023 global highlights on Daniela's sales, and updates on our clinical program utilizing our self-assembly, disassembly, pre-targeted radioimmune therapy, or SADA technology platform. Next, Sue will report further insights into our global Danielsa sales in the fourth quarter. Dinesh will then provide updates around our ongoing Acidimab clinical trials. Bo will then provide an overview of our fourth quarter and full year 2023 financial performance, our cash resources, and our full year 2024 guidance before we open the line for Q&A. 2023 was an important year for YMABS. With the completion of our restructuring plan earlier last year, YMABS emerged as an innovator in radiopharmaceutical therapy development based on our novel and differentiated pre-targeted radioimmune therapy platform, SodaPrit, complemented by our commercial antibody therapy, Danielza, driving annual revenue growth. In addition to our more focused pipeline, we reduced our use of cash to only $27.1 million in the full year 2023 as a direct result of our effective capital management strategy in action. With $78.6 million in cash and cash equivalents as of December 31, 2023, we believe we have sufficient financial resources to advance the clinical development of our SADA platform We'll continue our efforts to expand our global geographic footprint of Danielica and treat more patients impacted by relapsed or refractory high-risk neuroblastoma. I'd be remiss not to mention the incredible hard work and dedication of our YMAPS employees. They've made all this progress possible, and I'm very proud to work alongside team members who put patients at the forefront of all that they do day in and day out. Now let's dive into the key highlights for our fourth quarter and full year 2023, starting with Danielza. For anyone who may be newer to YMABS, let me remind you that Danielza is approved by the US FDA for the treatment of relapsed or refractory high-risk neuroblastomas in the bone or bone marrow for patients who have demonstrated a partial response, minor response, or stable disease with prior therapies. Neuroblastoma is the most common cancer in infants, the third most common cancer in children. We finished 2023 on a strong note, achieving 23.4 million in net product sales of Danielle's in the fourth quarter, an increase of 42% from what we recorded in the fourth quarter of 2022, and an increase of 17% versus the third quarter of 2023. Through continued market penetration across high-volume U.S. accounts, and in ex-US regions, we are pleased to have achieved an annual 2023 net product revenue for Danielza of $84.3 million, which was near the top end of our previously raised guidance range of between 80 and 85 million. This was an increase of 71% compared to full year 2022. The progress is remarkable and indicates increasing adoption of Danielza across approved regions worldwide. We continue to gain momentum in the U.S. with a number of new accounts. As of December 31st, 2023, we had 58 active sites across the U.S. since Danielza's initial launch, with 10 new accounts added in 2023. Our ex-U.S. footprint continues to expand through multiple partnerships. The Danielza launch in China is progressing well, and this January, we accepted the price for Danielza from the Brazilian Medicines Market Regulation Chamber, or CMED, We expect to launch Danielle's in Brazil and Mexico in the second quarter of this year with our partner ADM and look forward to providing progress updates on this anticipated launch in the coming quarters. Our European Early Access Program with Web Pharma Clinical is continuing to progress as we support the needs of children with high-risk relapsed refractory neuroblastoma in Europe. In addition, we plan to submit a VLA for Danielle's in Argentina this year. and could potentially receive additional approval in Asia and Hong Kong within the next 18 months. In addition to geographic expansion, we continue to see progress among our ongoing ISS-sponsored Nexidimab trials in support of our indication expansion strategy. In particular, we look forward to Memorial Spong Kettering's readout from its multicenter phase two trial investigating Nexidimab in patients with relapsed osteosarcoma in the fourth quarter of this year. You will hear more about the progress of the ongoing Nexonimab trials from Dinesh later on this call. Now, let me shift to our SADA PRIT platform. Before I provide a brief update on our lead programs, I want to take a moment to set the stage around some of the current challenges related to commercialization, administration, and manufacturing infrastructure of targeted radiopharmaceutical therapies. There are four key areas. First, infrastructure and manufacturing. There's an enormous investment currently ongoing into specialized radiopharmaceutical manufacturing facilities where targeted radiopharmaceutical therapy is made. Once the therapy is made and released, there's a very limited time window which to deliver that therapy to patients before it expires. Second is physician participation, which has always been an issue. With current radiopharmaceuticals, the oncologist needs to refer the patient to an authorized physician to prescribe and administer radiopharmaceuticals, traditionally a nuclear medicine physician. The oncologist is essentially removed from his or her patient's treatment journey at this time. Third, there's a limited number of administration sites capable of handling radiopharmaceuticals. Right now, we need specialized diagnostic suites in order to be able to administer the radiopharmaceutical therapy, and there are a limited number of these across the globe. And fourth, continued drug shortages are an issue as current demand is increasing for radiopharmaceuticals. As manufacturers work to build the infrastructure I just referred to, drug shortages have become a reality and patient care is delayed. Our goal with SodaPrid is to solve all of these challenges and provide a simpler and more efficient solution for physicians that will have a greatly improved impact on patient care. We are leveraging the existing infrastructure within infusion centers, oncologist offices, freestanding infusion centers, and outpatient centers. We administer SADA print in a two-step process. First, the patient can receive the non-radioactive SADA in existing centers. Then, for the second step, the isotope infusion can be delivered in a nuclear medicine department or licensed imaging centers. Because we are leveraging the existing infrastructure, we are increasing physician participation. and we're able to have more engagement with oncologists, specialists, and nuclear medicine physicians, which we believe will lead to better overall results. Importantly, SOTAPRIC can be isotope agnostic. As long as we can create linkers between the isotope and the SOTA target that is already painted on the tumor, we will have the ability to utilize a multitude of diagnostic and therapeutic isotopes. As we look at these differentiators around infrastructure and manufacturing, administration, and the ability to choose different isotopes in real time, as well as decrease toxicity levels to patient while increasing the targeted activity to tumors, we're very excited about the potential of SADA-PRIT to improve patient experience and expand radiopharmaceutical treatment landscape. Now let's turn to a brief update on our lead programs. Our Phase 1 GD2 SADA As a reminder, our Phase 1 trial evaluating the safety and tolerability of GD2-SATA and the treatment of GD2-positive solid tumors, including small cell lung cancer, sarcomas, and malignant melanoma, got underway in March of 2023. This Phase 1 dose escalation single-arm multi-center safety study has three parts. Part A explores dose finding for GD2-SATA molecule and the testing of dose intervals of two to five days between the protein and the lutetium-177-dota payload. Part B determines the optimal dose of lutetium-177-dota, and Part C evaluates the safety and initial signs of efficacy using repeat dosing. Dose escalation is based on two patients in cohort one and two, followed by a modified three plus three design. It is important to emphasize that in each cohort, patients will be observed after dosing in a so-called six-week dose-limiting toxicity, or DLT, period. We are currently in Part A and are very pleased with how the trial is progressing. We have advanced through cohorts one, two, and three and are now dosing patients at cohort four. We have dosed a total of 10 patients to date. We currently have six active sites and plan to continue adding additional sites. Recall that part A of the trial is investigating the safety profile of the protein and determining the optimal time to deliver the radionuclide. We are very encouraged by what we have seen so far. To date, no patients have experienced any dose-limiting toxicities. Based on SPECT CT scans and PK activity we have seen to date, we believe that we have demonstrated proof of concept, namely that GD2-SATA can both find and bind to tumors It is important to note that this early data are not complete and are not necessarily indicative of a full result or the ultimate success of the trials or the SADA development program. We expect to share data from Part A of this Phase I study at a medical meeting in the second half of this year. Our second SADA-PRIG program is CD38-SADA, which we plan to first study in patients with non-Hodgkin's lymphoma focusing on B and T cell lymphoma. This is our first SADA program to be studied in blood cancer. Our IMD has been approved by the FDA, and as you can see here, our planned phase one follows a comparable design to our GD2 SADA program. We are on track to enroll two sites in April and expect to dose the first patients in this phase one trial this year. We believe the potential of the radiopharmaceutical industry is at a huge inflection point, and piquing the interest of physicians and patients alike. We truly believe that SADA's novel and differentiated approach has the potential to become the targeted radiopharmaceutical delivery platform of choice in the treatment of multiple solid tumors and blood cancers. I will now pass the call over to Sue Smith to provide further color on U.S. Daniels of Sales for the fourth quarter and full year 2023. Sue?