Y-mAbs Therapeutics, Inc.

Good day and welcome to the YMAB Therapeutics Inc's third quarter 2021 earnings conference call. Today's conference is being recorded. 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. 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 fiscal year ended December 31, 2020, as filed with the SEC on March 1, 2021, and in the company's subsequently filed SEC reports. At this time, I would like to turn the conference over to Thomas Gadd, the company's founder, chairman, and president. Please go ahead, sir.

Thank you, Hillary. Excuse me. And good morning, everyone, and thank you for joining us today for our third quarter earnings call. During the quarter, we have made notable progress with Danielsa and UmbertoMap, as well as our bi-specific compounds created under the YBiClone platform and the SADA platform, essentially constituting the three pillars of our business. We had a strong 2021 thus far, and the resubmission of the Ombudsman BLA is progressing well. We held a Type B meeting with the FDA in September, during which we confirmed our path towards a pre-BLA meeting in January, potentially followed by a resubmission of that BLA. Both Danielsa revenues and the number of treatment centers have exceeded our internal expectation for the launch, so we're very pleased with the initial adoption of Danielsa. Klaus Müller will provide more details shortly. I'm also pleased to report that we made additional progress in China this quarter, together with Cyclone Pharmaceuticals, our strategic partner for mainland China, Hong Kong, and Macau. The BLA for Danielsa for treatment of patients with relapsed and refractory and high-risk nervous system was accepted by the NMPA in China and subsequently granted priority review by the Center for Drug Evaluation. In addition, it's notable that Daniela has been prescribed for the first time in China, and the first seven patients have received treatment in the Hainan Boa medical tourism pilot zone. Notably, a significant number of new patients are lined up and further cyclone plans to open up a second center in the Xiejin pilot zone. The bi-specific programs under the Y-BiClone platform continues to advance. We are now dosing patients in our Phase II small cell lung cancer study with nivetrotamab and subcutaneous formulation. The IMD for our CD33 bispecific for pediatric AML has been submitted, and this promising treatment will potentially address an important pediatric unmet need. Our excitement over the SADA technology remains strong as we continue to optimize the platform that potentially will be able to deliver medicines to treat many cancers, and it moves closer to the clinic. We are on track to file the first R&D for our DD2 solder in the fourth quarter. Next year, we are planning to file at least one more R&D for the solder construct. We ended the third quarter with $215 million in cash, so we believe we have a strong balance sheet to not only support the continued commercialization of Danielsa and the potential launch of UmbertoMap, but we're also advancing the Leutium-conjugated OnBirdsMap DTPA and Nivotrutamab into late-stage development. At the same time, we continue to advance construct development under our Wi-Fi club and SADA technology platforms, and we are actively working with both our platforms in business development. We are very pleased with our current financial position, which Bo Kus, our Chief Financial Officer, will elaborate on later on this call. And with that, I'm very pleased to turn it over to Klaus. Thank you.

Thank you, Thomas, and welcome to YMF's therapeutic third quarter 2021 earnings calls. We are very pleased that you have chosen to join us today. Let me start out with Nexetamab or Danielsa. Danielsa is approved for the treatment of patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy and was approved by the FDA on the Accelerated Approval Pathway. We recorded Danielsa net sales of $9 million in the third quarter, which reflects a strong 10% while shipment growth over last quarter, offset by an impact of certain rebates reflecting a shift from both the treatment center mix and the patient mix, from inpatient to outpatient. We are particularly encouraged by the increase in the number of treatment centers that have gained experience with Danielsa. At the end of the quarter, we had delivered to 24 centers across the nation. We continue to be very pleased with Danielsa, with the Danielsa launch. While revenues look promising and the number of treatment sites are ramping up nicely, it is also notable that we have seen a more than 40% increase in the number of vials delivered in the U.S. outside MSK compared to second quarter. In other words, a significant increase in the business across the country. The overall number of vials shipped in the U.S. increased, as mentioned, with approximately 10% in the third quarter versus second quarter, and our gross revenue reflected that one-to-one. We did, however, see a shift towards more patients being treated on an outpatient basis, some of which started as inpatient treatments in their first cycles, but then increased thereby becoming subject to available rebates as outpatients from the public health system or PHS. This shift together with a significantly increased share of vials being sold outside MSK has had an impact on the gross to net calculation, and this impacted the reported growth in net revenues for the third quarter. Going forward, I believe the increase in the gross to net calculation related to the PHS eligible hospitals will subside, but the mixed shift in favor of non-MSK institutions is expected to continue into 2022 as more and more centers outside MSK learn about and start prescribing Danielsa. We are very pleased to see Danielsa get substantial traction in the market at this point. It is also notable that we are now seeing commercial uses of Danielsa in early access programs in China, MENA, and LATAM. Royalty income is obviously still very modest, but we have high hopes for future growth and are putting significant effort into expansion into additional international markets. We recently held a key opinion leader webinar that included a detailed review of data from Danielsa in first line, as well as HITS data. HITS refers to chemoimmunotherapy for resistant high-risk neuroblastoma and where Danielsa is given in a combination treatment often referred to as hits consisting of Danielsa, actually humanized Nexidimab, and thereby the AIDS, Irinotecan, Temazolamide, and Sacramastem. The key opinion leaders, as well as other medical doctors in the field, appreciate the solid data that forms the basis for the FDA approval and the convenience of being able to offer an outpatient treatment. which brings new degrees of freedom to the table as opposed to watching the patient nonstop in the ICU day in and day out. I'm very pleased with our commercial and medical affairs organization, whom has done an outstanding job of educating physicians and nurses about Danielsa and guiding the many new treatment centers through their very first experience with Danielsa during the quarter. Our ongoing clinical trials for Danielsa in Barcelona, Spain, and MSK in New York for first-line neuroblastoma maintenance treatment as well as chemocombination trials for refractory neuroblastoma patients are progressing nicely. We are still in the process of initiating an international Phase II multicenter frontline trial, and our multicenter chemocombination trial will start screening patients from next week. We also have a Phase II osteosarcoma trial ongoing. Now turning to Umbertamab for the treatment of pediatric patients with CNS leptomeningo metastasis from neuroblastoma. Based on feedback from the FDA at a Type B meeting in September, where we provided the FDA with additional detailed data and statistical analysis plan, we have recently requested a pre-BLA meeting. Pending a positive pre-BLA meeting in January, we aim to initiate a resubmission of the Umbertamab BLA shortly after the meeting. And we believe we are positioned to complete the submission during the course of the first quarter 2022, potentially allowing for FDA approval of onbertumab in the fourth quarter of 2022. Needless to say, we are very pleased to be aligned with the FDA on next steps and believe that if approved, onbertumab will be a significant benefit to patients with CNS leptomaniacal metastasis from neuroblastoma who are currently facing a major unmet medical need. The European marketing application for Ambertumab was prepared in parallel with the USVLA and was submitted to EMA in April of this year. Preliminary feedback from EMA was received back in September, and we are in the process of responding to questions raised by that agency. We believe the evaluation of our application is progressing as planned. Furthermore, our interim phase one dose escalation data for Ambertumab for diffuse intrinsic pontine, glioma, or DIPG has paved the way for our multicenter Phase II study, known as Study 102, for which we have filed an IND recently. We expect to administer up to three repeated doses of imbertumab in that study. Now turning to the lutetium-labeled imbertumab, our IND for 177-lutetium-imbertumab DTP for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children, is now open and the first patient has been treated. This multi-center phase 1-2 trial is based on our clinical experience from treating medulloblastoma patients with iodine-131-ambertumab, and we are obviously excited to see 177-lutetium-ambertumab DTPA make its way into the clinic to establish the safety profile and determine the maximum tolerated dose. The FDA has granted us rare pediatric disease designation for the lutetium-labeled ambertumab antibody program, for the treatment of medulloblastoma, which makes us eligible for a priority review voucher upon potential approval of the BLA for this rare pediatric cancer. Among our leading compounds under development, four have now rare pediatric disease designation, and this designation for 177-luticinambertum of DTPA further increases our chances of ultimately receiving multiple PRVs. In addition, we have opened a basket trial in B7H3-positive CNS leptomeningo cancers in adults, where we hope to leverage our prior experience from treating adults with B7H3-positive brain metastasis with iodine-131-ambertumab. The study has started screening patients, and we hope to see the first adult patients treated with 177-lutetium-ambertumab PTPA in late November. We are thrilled to widen our technical reach to include adult indications for the lutetium-177 umberto metal also. Our Y-bitelone constructs are a new generation of T-cell-engaging bispecific antibodies that may potentially destroy tumor cells by recruitment of host T-cells. The bitelone format contains two binding arms for the tumor target and two binding arms for the T-cells. The biotinformin was designed to have minimal binding affinity necessary to recruit T-cells. We have expanded Nivotrotumab's clinical trial to include small-cell lung cancer patients in our Phase II study with the subcutaneous administration, and the study is now recruiting patients. We also plan to expand the ongoing study of Nivotrotumab at MSK into two separate Phase II arms, one in neuroblastoma and one in osteosarcoma. We have submitted an IND for our next in line bispecific antibody, the CD33-CD3 bispecific generated on the Y-Biclone platform. And we have already experienced significant interest from multiple clinical sites to participate in the study. We hope to open the study for pediatric AML patients within the next three to six months. Turning to our SADA technology, as you know, we are very excited about the prospect of this technology and we are making good progress. We are preparing a handful of SADA targets for clinical development, and as previously announced, the first SADA IND is expected to be against DD2 and planned for filing in December this year. We are seeing significant partnership interest for the SADA technology, and we are positioned to leverage the SADA platform in the coming months. We believe the SADA technology has already shown great potential and that it can potentially improve the efficacy of radiolabeled therapeutics in tumors and that have not historically demonstrated meaningful responses to radiolabeled agents. We are truly excited about this platform. Thus, let me finish off with some more general comments. We believe we are well-positioned to grow YMAPS as a commercial stage company. With Danielsa already being shipped to multiple treatment centers across the country and significant international progress being made, the Danielsa franchise is progressing even better than we had hoped for. For umbertumab, the resubmission of the BLA is in sight, and the pre-BLA meeting has been requested. At the same time, we are widening and deepening our pipeline by advancing our antibody constructs through the clinic, predominantly the SADA constructs, the bispecifics, and the next generation of umbertumab ratio-labeled antibodies. In other words, we remain busy, and we are very excited to move forward to build a commercial business that helps patients and further elevates our continued development. Now let me invite Bo to share his remarks on this quarter's financial. Thanks.