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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Y mAbs Therapeutics Inc | NASDAQ:YMAB | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.10 | -0.58% | 17.15 | 15.60 | 18.93 | 17.7775 | 16.987 | 17.50 | 246,023 | 01:00:00 |
“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
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 DevelopmentResearch 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:
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:
General and AdministrationGeneral 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:
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:
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: http://public.viavid.com/index.php?id=142256
About Y-mAbs
Y-mAbs is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including two pivotal-stage product candidates naxitamab and omburtamab—which target tumors that express GD2 and B7-H3, respectively.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development and commercialization plans; current and future clinical and pre-clinical studies and our research and development programs; regulatory, marketing and reimbursement approvals; rate and degree of market acceptance and clinical utility as well as pricing and reimbursement levels; retaining and hiring key employees; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position and strategy; additional product candidates and technologies; collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of our cash and cash equivalents, and the need for, timing and amount of any future financing transaction; our financial performance, including our estimates regarding revenues, expenses, capital expenditure requirements; developments relating to our competitors and our industry; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ “appear,” ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will”, ‘‘would’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with our financial condition and need for additional capital; risks associated with our development work; cost and success of our product development activities and clinical trials; the risks of delay or failure to receive approval of our drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of our product candidates; development of our sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for our products; the risks related to our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of our intellectual property rights; risks related to employee matters and managing growth; risks related to our common stock and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Annual Report on Form 10-K and in our other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
“Y-mAbs” is a registered trademark of Y-mAbs Therapeutics, Inc.
Y-MABS THERAPEUTICS, INC. | ||||||||
Consolidated Balance Sheets | ||||||||
(unaudited) | ||||||||
(in thousands, except share data) | ||||||||
September 30, | December 31, | |||||||
2020 | 2019 | |||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 131,267 | $ | 207,136 | ||||
Other current assets | 1,942 | 4,819 | ||||||
Total current assets | 133,209 | 211,955 | ||||||
Property and equipment, net | 1,888 | 2,052 | ||||||
Operating lease right-of-use assets | 5,123 | 1,989 | ||||||
Other assets | 2,975 | 370 | ||||||
TOTAL ASSETS | $ | 143,195 | $ | 216,366 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
LIABILITIES | ||||||||
Accounts payable | $ | 10,320 | $ | 8,520 | ||||
Accrued liabilities | 7,570 | 4,550 | ||||||
Operating lease liabilities, current portion | 1,887 | 516 | ||||||
Total current liabilities | 19,777 | 13,586 | ||||||
Accrued milestone and royalty payments | 2,466 | 1,921 | ||||||
Operating lease liabilities, long-term portion | 2,517 | 1,714 | ||||||
Other liabilities | 1,923 | 242 | ||||||
TOTAL LIABILITIES | 26,683 | 17,463 | ||||||
STOCKHOLDERS’ EQUITY | ||||||||
Preferred stock, $0.0001 par value, 5,500,000 shares authorized at | ||||||||
September 30, 2020 and December 31, 2019; none issued at | ||||||||
September 30, 2020 and December 31, 2019 | — | — | ||||||
Common stock, $0.0001 par value, 100,000,000 shares authorized at | ||||||||
September 30, 2020 and December 31, 2019; 40,472,435 and 39,728,416 | ||||||||
shares issued at September 30, 2020 and December 31, 2019, respectively | 4 | 4 | ||||||
Additional paid in capital | 381,803 | 364,712 | ||||||
Accumulated other comprehensive income / (loss) | (28 | ) | 50 | |||||
Accumulated deficit | (265,267 | ) | (165,863 | ) | ||||
TOTAL STOCKHOLDERS’ EQUITY | 116,512 | 198,903 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 143,195 | $ | 216,366 | ||||
Y-MABS THERAPEUTICS, INC. | |||||||||||||||||
Consolidated Statements of Net Loss and Comprehensive Loss | |||||||||||||||||
(unaudited) | |||||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||
Three months endedSeptember 30 | Nine months endedSeptember 30 | ||||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||||
OPERATING EXPENSES | |||||||||||||||||
Research and development | $ | 21,005 | $ | 19,660 | $ | 69,686 | $ | 46,665 | |||||||||
General and administrative | 11,636 | 4,699 | 30,155 | 12,581 | |||||||||||||
Total operating expenses | 32,641 | 24,359 | 99,841 | 59,246 | |||||||||||||
Loss from operations | (32,641 | ) | (24,359 | ) | (99,841 | ) | (59,246 | ) | |||||||||
OTHER INCOME | |||||||||||||||||
Interest and other income, net | (191 | ) | 437 | 437 | 1,354 | ||||||||||||
NET LOSS | $ | (32,832 | ) | $ | (23,922 | ) | $ | (99,404 | ) | $ | (57,892 | ) | |||||
Other comprehensive income / (loss) | |||||||||||||||||
Foreign currency translation | (12 | ) | 134 | (78 | ) | 124 | |||||||||||
COMPREHENSIVE LOSS | $ | (32,844 | ) | $ | (23,788 | ) | $ | (99,482 | ) | $ | (57,768 | ) | |||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.82 | ) | $ | (0.70 | ) | $ | (2.49 | ) | $ | (1.69 | ) | |||||
Weighted average common shares outstanding, basic and diluted | 40,187,173 | 34,371,927 | 39,971,766 | 34,253,739 | |||||||||||||
Contact:
Y-mAbs Therapeutics, Inc. 230 Park Avenue, Suite 3350New York, NY 10169USA
+1 646 885 8505
E-mail: info@ymabs.com
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