Y-mAbs Therapeutics, Inc.

Good morning and welcome to the YM Labs Therapeutics, Inc.' 's earnings conference call for the second quarter of 2023. At this time, all participants are on 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 will now hand it over to YM Labs Head of IR, Courtney Dugan.

Thank you. 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, current and future clinical and preclinical studies, and 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 Danielsa territory expansion and advancement of FATA, 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 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 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 factors discussed in the company's quarterly report on Form 10-Q for the quarter ended June 30th, 2023, as filed with the SEC on August 10th, 2023. With that, I'd now like to turn the call over to our founder, president, and interim CEO, Thomas Gad.

Thank you, Courtney, and good morning, everyone, and thank you for joining us today. Today I have with me our Chief Financial Officer, Bill Cruz, our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Dr. Vinesh Raja. On today's call, I'll begin by providing a review of our second quarter product sales and then also highlights, updates on the additional Nacitimab research currently underway. I'll also touch on key clinical highlights from the quarter and an update on our novel retargeted two-step radiopharmaceutical platform. the SADA white print. We next will then discuss further details, our ISS programs under Danielsa, as well as our progress on our SADA Phase 1 study, followed by Sue Smith, who will report further insights into our Danielsa U.S. and ex-U.S. sales. Sue will then provide an overview of our second quarter financial performance, our cash position, and reiterate our full year 2023 guidance. And then we'll open up the line for Q&A. Let me begin with a high-level update on the year so far. As you know, we successfully implemented a strategic repatriation of our pipeline, focusing on Danielsa and the SADA platform earlier this year. Our execution has been swift, as our first half financials demonstrate, allowing us to extend our estimated cash runway into 2026. I'm incredibly proud of our team's resilience over the past several months, and their steadfast dedication to realizing our mission of providing innovative therapeutic options in the fight against cancer, particularly pediatric cancers. As we look ahead to the rest of 2023 and beyond, we are in a healthy financial position with 87.9 million in cash and cash equivalents at the end of the second quarter of 2023. We have a firm strategy in place that focuses on growing Danielsa's net sales which we believe will enable us to continue to advance our SADA platform through clinical development while being disciplined on our R&D spend, and at the same time deliver long-term value to both patients and investors alike. Let me turn to the highlights on our Danielsa franchise. As a reminder, Danielsa is approved by the US FDA for the treatment of relapsed and refractory high-risk neuroblastoma in bone and bone marrow for patients but demonstrated a partial response, minor response, or stable disease prior therapies. Neuroblastoma is the most common cancer in infants and the third most common cancer in children. In the second quarter of this year, we achieved 20.8 million in net product sales of Danielson, more than double of 112% from what we recorded in the second quarter of 2022, and up 3% from our previous quarter. Additionally, we made significant progress on our commercialization efforts for Danielsa and continue to gain momentum in the U.S. with a number of new accounts. We now have 56 sites activated across the U.S. We've been making significant progress outside the U.S., marked by the recent regulatory approval of Danielsa in Brazil. In May, we received approval in Brazil, where we have partnered with Adium, also Technopharma. for marketing in the region. Additionally, Cyclone launched Danielson in Greater China late June, early July, further solidifying our presence in the Asian market. We firmly believe that the Asian market holds a great potential as an important revenue driver for Danielson, and we look forward to updating you on the progress of these launches over the coming quarters. We also continue to see progress with our partnerships in Central Eastern Europe through Swix Pharmaceuticals and Takeda in Israel, and our distribution program through WEP in Europe. We continue to seek partnerships to expand our global commercial footprint even further, aiming to enable any patient who may benefit from Danielsa to access it. This is the backbone of our mission at YMAPS, to support children and families in their fight to beat cancer. We couldn't be more pleased with our first two quarters of Danielsa, creating net sales of more than $40 million in 2023 already and gaining market share in the US. We remain confident in our ability to continue to grow our commercial market footprint and meet our full year 2023 Danielsa net product revenue guidance. Sue will provide further call on Danielsa sales for the quarter shortly. In addition to our partnering strategy for Danielson, we continue to collaborate with leading KOLs on investigator-sponsored clinical studies to efficiently advance potential label expansions opportunities for Danielson. We next will provide an update on our ongoing clinical trials with thought leaders at the Beat Childhood Cancer Resource Consortium, MD Anderson Cancer Center, and Ohio State University and Memorial Sloan Kettering Cancer Center. Now let's turn to SADA. On to SADA, our novel and highly differentiated pre-targeted two-step radiopharmaceutical platform in development that we licensed from Memorial Sloan Kettering and MIT in April 2020. With SADA, we are working to pre-target the tumor with a protein-only dose with rapid clearance of any unbound protein from the bloodstream, followed by a radioactive payload. we believe this mechanism offers the potential to substantially increase the amount of radioactive payload delivered to tumors while simultaneously limiting normal tissue uptake and thus resulting in significantly higher therapeutic indices by potentially maximizing on-target efficacy while minimizing off-target side effects. Further, our two-step dosing separates protein dose from the hot payload dota case lutetium dose. simplify our supply chain and facilitate the use of SADA in large infusion centers if approved. The payload is not patient-specific, making it possible to use the same payload for different SADA patients and different SADA constructs, potentially increasing the platform's accessibility and efficiency. We believe our SADA WiPAR theranostic platform, if approved, has the potential to drive significant supply chain improvements. Our first, hopefully, of many SADA constructs targeting GD2 entered the clinic this March. We are pleased to report that we have closed cohorts one and two, and we are currently administering doses in cohort three at one milligram per kilo. I can further say that we have now administered a 200-millimeter therapeutic dose, and we have not seen any pain signals when dosing GD2 SADA. We anticipate sharing PK and imaging data at our annual R&D day in December. Our second development program derived from this platform is the CD38 construct. We have already conducted our pre-IND meeting with the FDA, and we anticipate submitting an IND application for this program in the third quarter of this year. Additionally, we are advancing a number of preclinical target, and have made good progress on both our HER2 and B7H3 constructs, on which we plan to provide an update on our IND day later this year. Lastly, a short update on our business development activities. As mentioned, we remain dedicated to expanding the global commercial footprint of Danielsa through potential partnerships and ISS strategies. Regarding SADA YPRIT, our current approach is multifaceted. We aim to advance internally some of the SADA constructs to at least phase two, while in parallel seeking to out-license other targets. Additionally, we see an important opportunity to collaborate with third-party and their targets to introduce to the SADA platform, and to explore targets from previously unsuccessful phase threes as we seek to maximize the potential of our platform. And with that, I would like to turn this call over to Dr. Ines Raja. Thank you.