On March 12, 2020 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 2019 (Press release, Y-mAbs Therapeutics, MAR 12, 2020, View Source [SID1234555485]).
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"We are very pleased with our 2019 results, highlighted by notable progress in the preparation of our BLAs for naxitamab and omburtamab, as well as commercial ramp-up for the potential launch of both compounds. We start 2020 with $207 million in cash, and are excited to enter what we believe will be a truly transformational year for Y-mAbs," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.
Dr. Claus Moller, Chief Executive Officer, continued, "During 2019, we have worked hard to make sure that naxitamab and omburtamab advance towards BLA submissions. We submitted the first portion of the rolling BLA for naxitamab in November 2019, and expect to complete the submission later this month. For omburtamab, we expect the rolling BLA submission to be completed in May."
Fourth Quarter 2019 and Recent Corporate Developments
·After the close of the fourth quarter, on February 26, 2020, Y-mAbs announced a positive Pre-BLA meeting with FDA for omburtamab.
·On December 12, 2019, Y-mAbs announced that its GD2-GD3 Vaccine has been granted a Rare Pediatric Disease Designation by the FDA for the treatment of neuroblastoma.
·On December 11, 2019, Y-mAbs announced positive frontline data for naxitamab at the Company’s R&D event, which took place in New York City. Key opinion leaders discussed the current treatment landscape and unmet medical needs for high-risk neuroblastoma and other solid tumors.
·On December 5, 2019, the Company announced that the European Medicines Agency agreed to the Company’s proposed Pediatric Investigation Plan for omburtamab.
·On November 29, 2019, Y-mAbs announced that it had submitted to the FDA the first portion of its Biologics License Application for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA’s Rolling Review process.
·On November 15, 2019, Y-mAbs announced a clinical update on omburtamab for Desmoplastic Small Round Cell Tumor. The data was presented at the 2019 CTOS Annual Meeting in Tokyo, Japan.
·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.
·On October 28, 2019, Y-mAbs announced an update on omburtamab data, which was presented at the International Society of Pediatric Oncology conference.
·On October 25, 2019, Y-mAbs announced a naxitamab update, which was presented at the International Society of Pediatric Oncology conference.
Financial Results
Y-mAbs reported a net loss for the year ended December 31, 2019 of $81.0 million, or $2.30 per basic and diluted share, compared to a net loss of $43.3 million, or $1.50 per basic and diluted share, reported for the year ended December 31, 2018.
Operating Expenses
Research and Development
Research and development expenses were $63.5 million for the twelve months ended December 31, 2019, compared to $34.3 million for the twelve months ended December 31, 2018, an increase of $29.2 million. The increase in research and development expenses primarily reflects the following:
·$17.1 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;
·$5.4 million increase in outsourced research and supplies to support expanding development activities;
·$3.3 million increase in personnel costs; and
·$2.5 million increase in clinical trials expenses.
General and Administration
General and administrative expenses were $19.5 million for the twelve months ended December 31, 2019, compared to $9.0 million for the twelve months ended December 31, 2018, an increase of $10.5 million. Such increase in general and administrative expenses primarily reflects the following:
·$5.1 million increase in personnel costs; and
·$2.8 million increase in commercial infrastructure costs;
Cash and Cash Equivalents
The Company had approximately $207.1 million in cash and cash equivalents as of December 31, 2019, compared to $147.8 million as of December 31, 2018. The increase of $59.3 million was primarily attributable to the $134.7 million net proceeds from the secondary public offering, completed in November 2019, which was partially offset by the net loss of $81.0 million for the fiscal year 2019 due to the increased costs of operation as the Company prepares for its submission of rolling BLAs for naxitamab and omburtamab, build-up of the Company’s commercial infrastructure, and increased personnel costs.
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 13699294. A webcast will be available at: View Source