Y-mAbs Therapeutics, Inc.

Good day, and welcome to the YMAB's Third Earnings Conference Call for the Fiscal Fall Year of 2021. 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 31st, 2021, as filed with SEC on February 24th, 2022. At this time, I would like to turn the conference over to Thomas Gad, the company's founder, chairman, and President. Please go ahead.

Thank you, Joe, and thank you, everyone. Good morning, and thank you for joining us for our earnings call today. During the year, we made significant progress on executing our strategy and expanded on all the three pillars of our business. First, our leading monoclonal antibodies, Danielle's hand on Bertramab. Second, our bispecific compounds under the Y-Biclone platform, and finally, the promising targeted radiopharmaceutical SADA technology platform It's been almost exactly a year since we launched Danielsa, the much-needed treatment for children with relapsed refractory high-risk neuroblastoma. We delivered not only an innovative treatment, but also demonstrated our commitment to develop better and safer products addressing the medical needs of these children. We are encouraged by the benefits of Danielsa, and we are squarely focused on expediting Danielsa's adoption, continuous development, in expanded indications, and in parallel, we are leveraging our other platforms to generate groundbreaking data. After we launched Danielza in the U.S. in February 2021, we've seen a nice ramp-up of sales, and we ended the year recording net revenue of $9.6 million in the fourth quarter, corresponding to a 7.1% increase over the third quarter, and total product revenues of $32.9 million for the full year. The resubmission of Onvirzumab BLA is progressing as planned. We held a pre-BLA meeting with the FDA in January, which confirmed our path towards a BLA resubmission in March. Summarizing on our two bispecific programs, we are continuing to dose patients in our small cell lung cancer study and the IND for our CD33 bispecific for pediatric AML has been submitted. And we believe that this promising treatment can potentially address an important pediatric unmet medical need. With SADA, we are entering into a new frontier of radiotherapy with the ability to precisely target multiple tumors. Our excitement over SADA technology grows as we work to optimize that platform that we believe will be able to deliver medicines to treat many cancers. During the fourth quarter, we filed the IND for our first contract the GD2 SATA for GD2-positive solid tumors, and are looking forward to treating the first patients this summer. We are scheduled to file at least one more IND for a new SATA construct later this year, and we plan to file at least one IND per year moving forward. We ended the year with $181.6 million in cash, so we believe we have a strong balance sheet to support both the continued commercialization of Danielsa and the potential launch of UmbertoMap. as well as the advancement of our early stage programs, such as the new constructs developed under the SADA technology platform. We are also actively working with our SADA platform within business development. We are very pleased with our current financial position, which Bo Cruz, our Chief Financial Officer, will elaborate on later on this call. I entered into a loan agreement in 2019, at which point I pledged shares as a collateral. My pledge of shares was disclosed in our prospectus filed in February 2021, so over a year ago. At that time, our insider trading policy allowed for such transactions to occur after approval by our general counsel. Due to the various market factors, including the biotech industry falling out of investors' favors in 2021, our stock price has declined from a high of approximately $55 to where it sits today. The decline in our stock price triggered forced sales by my bank in January and February 2022 to repay that loan. The loan has now been repaid in full and no additional sales under this pledging agreement are coming. In addition, I've terminated my current 10B5 plan and Bo Kruse has done the same. In addition, our board has updated our insider trading policy and the new policy prohibits prohibits the pledging of company shares as collateral in the future and also adopts some of the proposed SEC amendments to Rule 10b-5. This new policy will be posted to our website. In summary, we are very proud of the progress we made in 2021, and we are very optimistic and excited about Danielsa's sales increasing, the reimbursement BLA being on track, and the first SADA IND now submitted, and ongoing preclinical testing for additional SADA constructs. I would also like to take the opportunity to acknowledge the effort of our ambitious team, which we recently expanded by hiring our new Chief Commercial Officer, Sue Smith. Sue brings extensive commercial experience, including several recent successful product launches within cancer and rare disease. We are pleased to have her joining our leadership team and are already benefiting from her prior experience as we continue to optimize our commercial franchise in order to leverage potential future products driven from our core platforms. And with that, I'm very pleased to turn over the call to Dr. Klaus Müller, our Chief Executive Officer. Go ahead, Klaus. Thank you.

Thank you very much, Thomas, and welcome to YMAT's therapeutics fourth quarter and full year 2021 earnings call. We're very pleased that you have chosen to spend this morning with us. During the year, we continue to optimize the value of our pipeline, And our progress included having launched Danielsa and reported increased sales for four consecutive quarters, while at the same time making progress in the resubmission of the ambertumab BLA. And we are also continuing significant investments in the potential game-changing SADA programs. Now turning to Anaxidamab or Danielsa that is approved for treatment of patients with relapsed 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 under the accelerated approval pathway. We recorded Danielsa net sales of 9.6 million in the fourth quarter, which reflects the strong 7% increase from previous quarter. We're also encouraged by the increase in number of treatment centers that have gained experience with Danielsa. We have now delivered Danielsa to 28 centers across the nation, We continue to be very pleased with the Danielsa launch and the traction we are getting in the market at this point. The increase corresponds to four new centers since the last quarter, and approximately 40% of the vials sold in the U.S. are currently sold outside Memorial Strong Kettering. 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 still modest, but given the incident rates in these regions, We have high hopes for future growth and are putting significant effort into expansion into additional international markets with our partners. And I'm very pleased with our commercial and medical affairs organization, which has done an outstanding job of educating physicians and nurses about Danielsa and guided the many new treatment centers through their first experience with Danielsa. At our R&D day in December, Dr. Mora from Barcelona Children's Hospital presented compassionate use data from an investigational infusion protocol of Naxidimab, where he systematically increased the infusion rate during the treatment. By starting dosing at very, very low infusion rate and gradually increasing the rate, Dr. Mora was able to exhaust the nerve fiber signaling within approximately 60 minutes, thereby allowing for a substantial increase of the infusion rate during the remaining infusion. Using this new revised infusion scheme for which a provisional patent application has been filed by YMAPS, Dr. Mora, and Mora from Kettering, it was observed that the protocol may help reducing grade 3 and grade 4 adverse events. We believe this new insight can help us refine the Nexidimab dosing regimen and thereby improve not only the safety profile and therefore the duration of therapy, but also further reduce the frequency of dosing. We consider this to be a strong competitive advantage over other approved DD2 therapies and believe this could open the door to exploring a number of DD2-positive indications in the adult field also. And we are in the process of planning clinical trials for a number of such indications. To summarize, we are very optimistic about the long-term opportunity for Danielsa as underscored by clinicians' feedback. Our focus remains on continued accelerated adoption and looking ahead, we plan additional medical educational training to broaden site activations. Sue Smith, our new chief commercial officer, will execute a marketing strategy aimed at increasing market awareness, utilization, and duration of therapy of Danielsa across the country. We expect YMAPS under SHU's commercial leadership to become a leader in the pediatric oncology field. On Bertamart, we are turning to now for the treatment of pediatric patients with CNS leptomeningo metastasis for neuroblastoma. We had a pre-BLA meeting with the FDA on January 13, 2022. And we are working closely with the FDA on the resubmission of the ambertumab BLA. The agency had some final questions regarding access to the audit of historical data from the German database, which we use as a control group. And we have been working with the doctors responsible for the database to provide clarification on this matter. We are working diligently to meet all requirements from the FDA and expect to resubmit the entire ambertumab BLA by the end of next month's first quarter 2022. Needless to say, we are very pleased to be aligned with the FDA on the next step and believe that if approved, imbertamab will be a significant benefit to patients with CNS leptomaniacal metastasis from neuroblastoma who are currently facing a major unmet medical need. If approved, it will also be a welcome addition to our commercial franchise as the second BLA approval in as many years and will leverage our investment in our commercial organization in the U.S., The European marketing application for UmbertoMap was prepared in parallel with the USBLA and was submitted to EMA in April 2021. Preliminary feedback from EMA has been received, and we are in the process of responding to questions raised by that agency. The evaluation of our applications is progressing as planned. In addition, interim Phase I dose escalation data for UmbertoMap for diffuse intrinsic pontine glioma, or DIPT, has paved the way for our Phase II study known as Study 102, for which we filed an IND in October. We are excited and hope to initiate this multicenter study in DIPG later this year. We expect to administer up to three repeated doses of ambertumab in that study. Turning to the SADA technology, as you know, we are very, very excited about the prospects for this technology, and we are making good progress preparing additional INDs and identifying additional SADA targets for clinical development. As a reminder, the SADA technology platform allows for targeted delivery of radioisotopes and could potentially improve the efficacy and also reduce the toxicity of radio-labeled therapeutics. Additionally, given the versatility of the SADA platform, we believe that SADA technology can be adapted for multiple tumor targets. We filed our first SATA-IND, the DD2-SATA, for treatment of DD2-positive solid tumors last December. We are also seeing significant partnership interest from the SATA technology, and we are well positioned to leverage the SATA platform in the coming months. We are truly excited about the potential of the SATA technology, which we have already shown great promise, and we believe that It can further unlock the potential of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents. Thus, in general, we believe that we are well-positioned to continue to grow YMAPS as a commercial states company. The Danielsa already being shipped to multiple treatment centers across the country and significant international progress being made, the Danielsa franchise continues on a growth trajectory that we believe is just beginning. We are anticipating a DLA resubmission of UmbertoMap soon, and we are leveraging our Danielsa experience to assure a successful launch of UmbertoMap if approved. At the same time, we are expanding our pipeline by advancing our constructs through the clinic, predominantly the SADA constructs. While we believe the best is yet to come, the fiscal year 2021 has certainly been a significant year for us. We are excited to move forward and unlock long-term shareholder value by continuing to build a commercial business that helps patients and further elevates our continued development across each of our platforms. Now let me invite our Chief Financial Officer, Bo Kruse, to share his remarks on the financials. Bo.