Y-mAbs Therapeutics, Inc.

Welcome to the YMABS Therapeutics Incorporated's first 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 Security Liquidations Reform Act of 1995. Because forward-looking statements involve risk 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 the fiscal year ended December 31st, 2021, as filed with the SEC on March 1st, 2021, and in the company's frequently filed SEC reports. At this time, I would like to turn the conference over to Thomas Gad, the company's founder, chairman, and president. Please go ahead, sir.

Thank you, Latonya. Good morning, everyone, and thank you for joining us today for our first quarter 21. So during this quarter, we have continued our execution of our strategy and expanded on all three pillars of our business, which is first, our leading, Monoclonal antibodies, secondly, our by specific compounds develop under the white platform. And finally, the start of technology platform, which we also refer to as liquid radiation. We've had a strong start to 2021 and we are thrilled to submit a marketing authorization application for. For the treatment of pediatric patients with CNN. CNS metastases from high-risk neuroblastoma in Europe. We submitted that last week on April 27th. Further, we gave an update on UmbertoMap in the U.S. and after our Type B meeting with the FDA on March 26th. And here we are continuing to working hard towards being able to resubmit the BLA for UmbertoMap late in this second quarter or in the third quarter of this year. We believe these important achievements as on birth map can potentially address a significant unmet medical need and therefore have a substantial impact on the treatment landscape for CNS metastases where there's currently no standard therapy today. As you know, we received U.S. approval for Danielsa in relapsed primary refractory high-risk neuroblastoma in November last year. delivering Danielsa in the beginning of February and saw demand from hospitals throughout the U.S., so this is very exciting. The first quarter net sales of 5.4 million represents less than two months of commercial sales, and we are pleased to report these first revenue numbers. Although we have not provided guidance on Danielsa sales, I'm pleased to note that despite COVID-19 forcing us into a partial virtual launch mode, both revenues and reach exceeded our internal expectations for these first few months, and we could not be more pleased with that. Going on, the SADA technology continues to look very promising. We recently had positive feedback from the FDA on our pre-IND package on our DD2 SADA construct and expect to file an IND in the fourth quarter of this year. In addition, at ACR in April, we reported that pre-targeted radio immunotherapy against GPA 33 in a center graph model of colon cancer demonstrated a high therapeutic index, a favorable tumor to tissue ratio showing radioactivity uptake of 122 measured 24 hours after injection. GPA 33 is expressed on 95% of all colorectal cancers and the IND for the GPA 33 SATA is targeted for next year. So very exciting. The bispecific programs under the Y-Biclone platform continue to advance. Our IND for nevartrotumab was cleared last year, and we are getting ready to dose the first patients in our small cell lung cancer study this quarter. In addition, we are planning for a phase two expansion in neuroblastoma and osteosarcoma later this year. Our CD33 bispecific for pediatric AML is scheduled to enter into the clinic in late 2021 and will potentially be addressing an important pediatric unmet medical need as AML remains one of the most challenging hematological malignancies for children. I'm pleased to note that Cyclone Pharmaceuticals, our strategic partner for mainland China and Hong Kong, received a clinical trial waiver for Danielsa in March which should accelerate our time to market, and we continue to view this opportunity as significant for YMAPs, potentially serving a large unmet medical need in China. We are very pleased with our progress so far in China. I can also note that Takeda filed a BLA in March of this year for Nasitimab in Israel. So overall, we are very pleased with the continued interest in both Danielsa and on Bertamab globally. We ended the first quarter with approximately 252 million in cash after having closed the sale of our Danielsa Priority Review Voucher for 105 million. Under our agreement with MSK, we received 60% or 62 million of proceeds of that sale. In addition, we completed an oversubscribed secondary offering led by J.B. Morgan, Morgan Stanley, and Bank of America. in which we sold approximately 2.8 million shares of our common stock, including the full exercise of the over-allotment option at $41 a share, resulting in net proceeds of approximately 107 million. So we believe we have a strong balance sheet, not only to support the continued commercialization of Danielsa and potential launch of UmbertoMap, but also to advance our lutetium-conjugated UmbertoMap DTPA construct and NivatrotoMap into late-stage development. At the same time, we continue to advance our two platforms, the Wi-Fi clone platform and the SATA platform. We're very pleased with our current financial position, and Bo will talk more about that later in this call. Taking our achievements into consideration, we believe YMMT is very well positioned to expand on our commercial activities while at the same time advancing our clinical pipeline to continue to address unmet medical needs, and we are very excited to continue to do so. And I'm pleased to hand over the call to Dr. Murlau, Chief Executive Officer. Thank you.

Thank you, Thomas, and welcome to YMAP's first quarter 2021 earnings call. We're very pleased that you have chosen to join us today. During the first quarter, we have worked hard to ensure that our pipeline advances towards the market. Our efforts included initiating commercial sales of Danielsa in the U.S., as Thomas just alluded to, while at the same time making progress with the resubmission of the ambertumab BLA and submitting the European marketing authorization application for ambertumab. In addition, we have initiated a Phase II study with nevotrotumab in small cell lung cancer under our own IND and initiated two Phase I-II studies with lutetium-177 ambertumab DTPA in medulloblastoma and in B7H3-positive CNS-leptomynical metastasis tumors in adult patients. and advanced our ongoing studies in other areas. We are also continuing to work on new bispecific constructs in our SADA programs. Now let me turn to Nuxetamab. Thanielsa is indicated in combination with DMCSF for the treatment of pediatric patients one year of age or older and adult patients with relapse 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. This indication was approved by the FDA under accelerated approval regulation based on overall response rate and duration of response. We were thrilled to send out the first commercial vials to treatment centers, including MSK, across the country in early February. The total net sales of 5.4 million, as Thomas just mentioned, we are very pleased with the launch. As you would expect, MSK is our largest customer to date. But vials have been shipped to more than 10 other cancer centers across the country now. And our highly targeted commercial and medical affairs organization has done an outstanding job in educating physicians and nurses about Danielsa. Many treatment centers have had their first experience with Danielsa, and we believe that treatments have gone generally very well. In addition, we have had pre-BLA meetings in China, and together with Cyclone, we expect to submit the Chinese BLA in third quarter this year, which hopefully will lead to a 2022 approval and launch in China. Our clinical trials ongoing with Anielsa in Barcelona, Spain, and at MSK in New York for our first-line neuroblastoma maintenance treatment, as well as chemotherapy combination with Naxidimab, for refractory and over-stomach patients are also progressing nicely. We are working to initiate an international phase two multi-center trials for Danielsa in both frontline and with chemo combination treatments, and we also have a phase two osteosarcoma multi-center trial ongoing. Now, turning to UmbertaMap, on March 26th, we had a Type B meeting with the US FDA to discuss the road towards resubmission of the BLA of for treatment of pediatric patients with CNS leptomaniacal metastasis from . We are maintaining a very close and open dialogue with the FDA regarding the resubmission and have scheduled a second type B meeting on June 1st, where we hope to reach final agreement with the agency on the remaining details concerning the granularity of the data from our identified historical control groups and how we would work forward with this. In order to agree on the statistical analysis plan, this additional granularity data was submitted to the FDA in late April. We still aim to resubmit the UmbertoMap BLA in the form of a rolling BLA by the end of second quarter or insert quarter of 2021. The European marketing application for UmbertoMap was prepared in parallel with the U.S. BLA and was submitted to the European Medicines Agency EMA last week on April 27th. The evaluation of our application is scheduled for 210 days. However, the review clock stops whenever we respond to any questions posed by the FDA, the European regulatory authorities, and the clock resumes only once we have submitted our responses. So the 210 days is without any responses from our side. In addition, we have begun staffing for our European commercial organization this quarter, and we are excited to prepare for our first European product launch. As previously disclosed, We are also developing ombertumab for diffuse intrinsic pontine glioma, known as DIPG, in a Phase I study at MSK, and we are planning to open a multi-center Phase II study for DIPG patients later this year. For desmoplastic small round cell tumors, known as DSSICT, we have a Phase II study ongoing at MSK. Then turning to the lutetium-labeled version of our ombertumab B7H3 antibody. In October 2020, the FDA cleared our IMD for the 177-glutisimum vertum of DTPA for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children. Medulloblastoma are invasive, rapidly growing tumors that, unlike most brain tumors, spread through the cerebrospinal fluid and frequently metastasize to different locations along the surface of the brain and the spinal cord. Our international multi-center phase 1-2 trial is open for pediatric patients with medulloblastoma And based on our clinical experience from treating 27 patients with medulloblastoma with our iodine-131 ambertumab construct, we are very enthusiastic about this new trial. And to see this construct moving into the clinic and to get started on establishing safety profiles to determine the maximum tolerated doses in this mode of using the ambertumab antibody. In this study, known as TRIO-1, we hope to leverage our prior clinical experience from the iodine-131 ombrotumab, once again giving the infusion through an Amaya-Casiton reservoir. In addition, our basket trial in B7H3-positive CNS leptomeningo cancers in adults, known as study TRIO-2, where we hope to leverage our prior experience from treating more than 25 adults with the iodinated version of ombrotumab, is now open for the first adult patients to be screened and treated with the 177 Lutetium and Bertramot DTPA. And we are thrilled to widen our clinical reach to include adult indications. On our bispecifics, we're also excited to widen the Nebotrosomat clinical reach to include adult cancer patients in our phase two study with subcutaneous administration of the bispecific. We also plan to expand the ongoing Nevotrotumab at MSK into separate phase two arms, one in the oblastoma and one in osteosarcoma. In addition, we are preparing an IND for the next in-line bispecific antibody, the CD33 bispecific generated on our Y-Biclone platform. And the IND for pediatric AML is scheduled for second quarter this year, which is the current quarter. Now turning to our starter technology, As you know, we are very excited about the prospects for this technology, and we are making good progress on preparing our four disclosed SATA targets for clinical development. At the AACR annual meeting in April, we presented our first animal data for the DPA33 SATA. In a xenograft model of colorectal peritoneal carcinomatosis, DPA33 SATA showed a favorable tumor-to-blood radioactivity uptake of 122 measured 24 hours after injection. DPA-33 is expressed on 95% of all colorectal cancers, and we are targeting an IND for the DPA-33 next year. Our other publicly announced targets includes DD2-SATA for potential use in DD2-positive solid tumors, for which we expect to submit our first IND in the fourth quarter of 2021. We also have a B783 SADA for the intended use in treatment of prostate cancer, and we have a HER2 SADA for potential use in breast cancer. We believe the SADA technology can potentially improve the efficacy of radiolabeled therapies in tumors that have not historically demonstrated meaningful responses to radiolabeled agents. And we are truly excited about our SADA technology, or liquid radiation technology. With the launch of Thanielsa, already leading to deliveries to multiple treatment centers across the country and internationally, and the planned resubmission of the Ombrtima PLA coming up. We believe that we are well-positioned to continue the development of YMAX as a commercial stage company. Concurrently, we plan to widen and deepen our pipeline by advancing our antibody constructs through the clinic, predominantly the SADA constructs, the bispecifics, and the next-generation Ombrtima PCPA radiolabeled antibodies. In other words, we remain busy, And we are very excited to move forward and build a business that helps patients and elevates our continued development. Now, let me invite Bo to share his remarks on this quarter's financials.