On November 5, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a development-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 2020 (Press release, Y-mAbs Therapeutics, NOV 5, 2020, View Source [SID1234570066]).
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"We are very pleased with our third quarter 2020 financial results, especially seen in conjunction with the upcoming
PDUFA date for naxitamab later this month, and the planned resubmission of the omburtamab BLA. We believe that we are well positioned to transform Y-mAbs to a commercial-stage company," stated Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer, continued, "We are making good progress on the omburtamab BLA resubmission, and concurrently we’ve continued to advance many of the earlier stage programs in our pipeline. Nivatrotamab, our leading bispecific antibody, recently received ODD and RPDD from the FDA and our two INDs for 177Lu-omburtamab-DTPA in medulloblastoma and B7-H3 positive CNS/leptomeningeal metastasis in adults were recently cleared by the FDA."
Third Quarter 2020 and Recent Corporate Developments
Subsequent to the end of the third quarter, on October 26, 2020 Y-mAbs announced that the FDA has cleared the Company’s IND for 177Lu-omburtamab-DTPA for the treatment of B7-H3 positive CNS and Leptomeningeal Metastasis from tumors in adult patients
Also subsequent to the end of the third quarter, on October 16, 2020, Y-mAbs announced updates on naxitamab and omburtamab data, which were presented at the International Society of Pediatric Oncology conference
Also subsequent to the end of the third quarter, on October 14, 2020 Y-mAbs announced that the FDA has cleared the Company’s Investigational New Drug application for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children
Also subsequent to the end of the third quarter, on October 7, 2020, Y-mAbs announced that the FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation for its leading bispecific antibody product candidate nivatrotamab for the treatment of neuroblastoma
After the close of the third quarter, on October 5, 2020, Y-mAbs announced that it had received a Refusal to File letter from the FDA for the omburtamab BLA for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. Subsequently, Y-mAbs requested and received what it believes to have been a positive Type A meeting with the FDA, and plans to work in close dialog with the Agency to amend the BLA with the goal of resubmitting by the end of 2020 or in early 2021. The BLA was originally submitted in August 2020
On July 14, 2020, Y-mAbs announced an update on the SADA technology and presented B7-H3 as a new preclinical SADA construct with potential use in prostate cancer
Financial Results
Y-mAbs reported a net loss of $32.8 million, or ($0.82) per basic and diluted share, for the three months ended September 30, 2020, compared to a net loss of $23.9 million, or ($0.70) per basic and diluted share, reported for the three months ended September 30, 2019.
For the nine months ended September 30, 2020, Y-mAbs reported a net loss of $99.4 million, or ($2.49) per basic and diluted share, compared to the net loss of $57.9 million, or ($1.69) per basic and diluted share, reported for the nine months ended September 30, 2019.
Operating Expenses
Research and Development
Research and development expenses were $21.0 million for the three months ended September 30, 2020, compared to $19.7 million for the three months ended September 30, 2019, an increase of $1.3 million. The increase in research and development expenses primarily reflects the following:
$2.4 million increase in personnel costs;
$0.5 million increase in clinical trial expenses;
$0.4 million increase in professional and consulting fees; and
$2.0 million offsetting decrease in outsourced manufacturing cost
Research and development expenses were $69.7 million for the nine months ended September 30, 2020, compared to $46.7 million for the nine months ended September 30, 2019, an increase of $23.0 million. The increase in research and development expenses primarily reflects the following:
$13.3 million increase in milestones and license fees related to the SADA upfront cash payment and stock issuances and accrued milestones;
$6.3 million increase in personnel costs; and
$1.9 million increase in outsourced research and supplies to support the expansion of our product development activities
General and Administration
General and administrative expenses were $11.6 million for the three months ended September 30, 2020, compared to $4.7 million for the three months ended September 30, 2019, an increase of $6.9 million. Such increase in general and administrative expenses primarily reflects the following:
$3.2 million increase in commercial infrastructure costs;
$2.2 million increase in personnel costs; and
$1.6 million increase in business insurance and professional fees
General and administrative expenses were $30.2 million for the nine months ended September 30, 2020, compared to $12.6 million for the nine months ended September 30, 2019, an increase of $17.6 million. Such increase in general and administrative expenses primarily reflects the following:
$8.7 million increase in commercial infrastructure costs;
$5.8 million increase in personnel costs; and
$3.1 million increase in business insurance and professional fees
Cash and Cash Equivalents
The Company had approximately $131.3 million in cash and cash equivalents as of September 30, 2020
Webcast and Conference Call
The Company will host a conference call on Friday, November 6, 2020 at 9 a.m. Eastern Time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the access code 13712633. A webcast will be available at: View Source