YmAbs Therapeutics, Inc. (NASDAQ:YMAB) Q3 2019 Earnings Conference Call - Final Transcript

Nov 13, 2019 • 04:30 pm ET


YmAbs Therapeutics, Inc. (NASDAQ:YMAB) Q3 2019 Earnings Conference Call - Final Transcript


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Thomas Gad

direct result of a highly dedicated teams committed to making both naxitamab and omburtamab available for children everywhere. We are very pleased with our results. We continue to work hard to solidify our position as leaders in pediatric oncology and focus on advancing our therapies to the extent -- to extend and enhance lives of those living with rare pediatric cancers.

And with that, I'm very pleased to turn it over to Claus.

Claus Moller

Thank you very much, Thomas, and welcome to the Y-mAbs Therapeutics third quarter conference call, everybody. We are pleased that you have chosen to join us today. Over the third quarter, we continued to work hard to make sure our lead product candidates naxitamab and omburtamab advance towards BLA submissions, which we plan to initiate in the form of rolling BLA for naxitamab later this year and omburtamab to follow shortly thereafter.

Actually, we expect the first portion of the rolling BLA for naxitamab to be submitted within the next few weeks and we expect a PDUFA date in the first quarter of 2020 for naxitamab and also for omburtamab. We will continue to keep you posted on our progress. On omburtamab, we will have a general guidance meeting with the FDA next week. We expect to complete the omburtamab BLA submission by the end of first quarter 2020 and reconfirm that our projected overall commercialization timeline seems to be unchanged for both products. We expect that a PDUFA date for omburtamab would be in the fourth quarter, also for omburtamab of 2020, and we believe that we have continued to demonstrate our ability to execute our planned commercialization timeline in the third quarter of this year.

We increased our headcount by approximately 9%, so bringing us to a total of 56 employees during the third quarter. The increase is primarily due to commercial -- the commercial team ramping up for the potential launch of our two products. And we continue to believe that we're well positioned to move naxitamab and omburtamab to FDA approval and commercialization in 2020, and concurrently widen our focus to grasp the growth opportunities represented by the earlier stages of our pipeline products such as omburtamab DTPA, the bispecific programs and the GD2-GD3 Vaccine, as well as the next in line indications from naxitamab and omburtamab. In June 2019, we had a promising pre-BLA meeting with the FDA, in which we reached alignment with the FDA on an Accelerated Approval Pathway for naxitamab along with a rolling BLA submission, I just mentioned.

And we have now recruited all patients that we -- will be needed in our Study 201, naxitamab for our BLA filing and for the treatment of relapsed/refractory high-risk neuroblastoma. At a tie up [Phonetic] the International Society of Pediatric Oncology conference in October in France, in Lyon, a total of six presentations by Memorial Sloan Kettering provided significant exposure to naxitamab.

Let me recap a few highlights from the conference. First, we had data from the primary refractory high-risk