YmAbs Therapeutics, Inc. (NASDAQ:YMAB) Q2 2019 Earnings Conference Call - Final Transcript

Aug 14, 2019 • 04:30 pm ET


YmAbs Therapeutics, Inc. (NASDAQ:YMAB) Q2 2019 Earnings Conference Call - Final Transcript


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Greetings, and welcome to the Y-mAbs Therapeutics Incorporated Second Quarter 2019 Earnings Conference Call. [Operator Instructions]

It is now my pleasure to introduce your host Mr. Thomas Gad, Chairman and President of Y-mAbs. Thank you, Mr. Gad. Please you may begin.

Thomas Gad

Thank you, Jerry [Phonetic]. Hello, everyone, and thank you for dialing into our second quarter earnings call. Today, we'll hear remarks from our Chief Executive Officer, Dr. Claus Moller; and our Chief Financial Officer, Bo Kruse. Overall, we are very pleased with our second quarter results. Our reported spending of $27.5 million year-to-date is really a direct result of a highly dedicated and productive [Phonetic] team effort to prepare Y-mAbs to be ready to submit two BLAs in 2019. We ended the quarter with $120 million in cash and taking into consideration our potential approval timelines of Q3 2020 for naxitamab and omburtamab. And also taking into consideration that each product have Rare Pediatric Disease Designation from the FDA, which should entitle both product to a Priority Review Voucher, we are very pleased with our financial position. As a company Y-mAbs continue to work very hard to solidify our position as a leader in pediatric oncology focusing on rare pediatric cancers with clear unmet medical needs.

And with that I am very pleased to give the word to Dr. Moller. Thank you.

Claus Moller

Thank you very much, Thomas, and welcome to Y-mAbs second quarter conference call. This is our first ever earnings call after our IPO in September last year, and we are pleased that you've chosen to join us. Since our IPO, we have worked hard to make sure that our lead product candidates naxitamab and omburtamab continue to advance towards the BLA submissions that Thomas just mentioned. We are planning to initiate this informs of rolling BLAs before the year-end for those assets. And as you previously heard, November is the target timeline for naxitamab and the following months is most likely going to be the omburtamab with that [Phonetic].

We started Y-mAbs in April 2015, and since then we believe that we have demonstrated a strong track record of execution and improved the ability to innovate, compete and go. Since our IPO, we have increased our headcount with about 65% to a total of 48 people by the end of the quarter. And we feel that we are well-positioned to move naxitamab and omburtamab to approval and commercialization next year, and to capitalize on the growth opportunities presented by our earlier stage pipeline. We advanced our bispecific GD2 CD3 antibody in the clinic earlier this year and expect the IND for the omburtamab-DTPA. DTPA to be filed later this year. That's the antibody we are planning to radiolabeled Lutetium-177.

We have recruited all the patients in Study 201 that we need for our BLA filing for the treatment of relapsed/refractory high-risk neuroblastoma and we also have the promising pre-BLA meeting with the US FDA. At the meeting, we've reached alignment with the FDA and accelerated approval pathway for