On November 13, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the third quarter of 2019 (Press release, Y-mAbs Therapeutics, NOV 13, 2019, View Source [SID1234551145]).
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"We are very pleased with our third quarter results, highlighted by prudent spending combined with notable progress in the preparation of our BLAs for naxitamab and omburtamab, as well commercial ramp-up for the potential launch of both compounds. In addition, we succesfully completed a follow-on offering in November, securing gross proceeds of $143.8 million, which we believe will – together with our existing cash – be sufficient to cover our operating costs through 2022," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.
Dr. Claus Moller, Chief Executive Officer, continued, "Over the third quarter, we have continued to work hard to make sure that our lead product candidates, naxitamab and omburtamab, advance towards rolling BLA submissions. We still expect the first portion of the rolling BLA for naxitamab to be submitted within the next few weeks, and we expect to file our BLA submission for omburtamab either via a rolling submission to begin in 2019 or early 2020 or via a single submission ahead of our expected completion date at the end of the first quarter of 2020.
Third Quarter 2019 and Recent Corporate Developments
Subsequent to the end of the third quarter, on November 1, 2019, Y-mAbs announced the pricing of a follow-on shelf public offering, resulting in gross proceeds to the Company of approximately $143.8 million.
·Also, subsequent to the end of the third quarter, on November 1, 2019, Y-mAbs announced that the requested omburtamab pre-BLA meeting with the FDA, had been converted to a general guidance meeting. Y-mAbs still expects to complete the omburtamab BLA submission by the end of the first quarter of 2020, and believes that the overall commercialization timeline will not be affected.
·Also, subsequent to the end of the third quarter, on October 28, 2019, Y-mAbs announced an update on omburtamab data, which was presented at the Interntional Society of Pediatric Oncology conference.
·After the close of the third quarter, on October 25, 2019, Y-mAbs announced an update on naxitamab data, which was presented at the Interntional Society of Pediatric Oncology conference.
On August 30, 2019, Y-mAbs announced the acceptance of abstracts concerning DSRCT for presentation at the Connective Tissue Oncology Society (CTOS) Annual Meeting for omburtamab.
· On July 8, 2019, Y-mAbs announced that it had completed a successful pre-BLA meeting with the FDA regarding a potential pathway for FDA approval of naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma. During the meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for naxitamab along with a rolling BLA submission.
· On July 1, 2019, Y-mAbs announced the status of patient recruitment for the Company’s two pivotal phase II trials, one for omburtamab for the treatment of central nervous system/leptomeningeal metastasis (CNS/LM) from neuroblastoma and the other for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma.
· Also, on July 1, 2019, Y-mAbs announced that the Company has entered into a development, manufacturing and supply agreement with SpectronRx in South Bend, Indiana, to secure access to clinical and commercial scale radiolabeling capacity for omburtamab. Under the terms of the agreement, SpectronRx has agreed to establish a manufacturing unit designated for Y-mAbs within its existing
facilities, at which Y-mAbs believes both clinical and commercial supply of radiolabeled omburtamab can be produced.
Third Quarter 2019 Financial Results
Y-mAbs reported a net loss of $23.9 million, or $0.70 per basic and diluted share, for the three months ended September 30, 2019, compared to a net loss of $11.4 million, or $0.42 per basic and diluted share, for the three months ended September 30, 2018.
For the nine months ended September 30, 2019, Y-mAbs reported a net loss of $57.9 million, or $1.69 per basic and diluted share, compared to a net loss of $29.2 million, or $1.08 per basic and diluted share, reported for the nine months ended September 30, 2018.
Operating Expenses
Research and Development
Research and development expenses were $19.7 million for the three months ended September 30, 2019, compared to $8.7 million for the three months ended September 30, 2018, an increase of $11.0 million. The increase in research and development expenses primarily reflects the following:
·$7.3 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;
· $1.5 million increase in outsourced research and supplies to support expanding development activities; and
· $0.7 million increase in personnel costs.
Research and development expenses were $46.7 million for the nine months ended September 30, 2019, compared to $23.2 million for the nine months ended September 30, 2018, an increase of $23.5 million. The increase in research and development expenses primarily reflects the following:
· $14.5 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;
· $5.0 million increase in outsourced research and supplies to support expanding development activities; and
·$1.9 million increase in personnel costs.
General and Administration
General and administrative expenses were $4.7 million for the three months ended September 30, 2019, compared to $2.7 million for the three months ended September 30, 2018, an increase of $2.0 million. Such increase in general and administrative expenses primarily reflects the following:
· $0.8 million increase in personnel costs; and
·$0.6 million increase in commercial infrastructure.
General and administrative expenses were $12.6 million for the nine months ended September 30, 2019, compared to $5.9 million for the nine months ended September 30, 2018, an increase of $6.7 million. Such increase in general and administrative expenses primarily reflects the following:
·$3.6 million increase in personnel costs; and
· $1.4 million increase in commercial infrastructure costs.
Cash and Cash Equivalents
The Company had approximately $98.2 million in cash and cash equivalents as of September 30, 2019, compared to $147.8 million as of December 31, 2018. The decrease of $49.6 million was primarily attributable to the increased costs of operation as the Company prepares for its submission of rolling BLAs for naxitamab and omburtamab and the build-up of the Company’s commercial infrastructure.
Webcast and Conference Call
The Company will host a conference call today at 4:30 pm eastern time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the access code 13696442. A webcast will be available at: View Source