Y-mAbs Announces Third Quarter 2019 Financial Results and Recent Corporate Developments
“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 successfully completed a follow-on offering in November, securing gross proceeds of
Dr.
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 theFDA , 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 theInternational 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 theInternational Society of Pediatric Oncology conference.
- On
August 30, 2019 , Y-mAbs announced the acceptance of abstracts concerning DSRCT for presentation at theConnective 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 theFDA regarding a potential pathway forFDA approval of naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma. During the meeting, the Company reached alignment with theFDA 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 inSouth 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
For the nine months ended
Operating Expenses
Research and Development
Research and development expenses were
$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
$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
$0.8 million increase in personnel costs; and$0.6 million increase in commercial infrastructure.
General and administrative expenses were
$3.6 million increase in personnel costs; and$1.4 million increase in commercial infrastructure costs.
Cash and Cash Equivalents
The Company had approximately
Webcast and Conference Call
The Company will host a conference call today at
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,’’ ‘‘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
Consolidated Balance Sheets
(unaudited)
(in thousands, except share data)
September 30, 2019 |
December 31, 2018 |
|||||||||||
ASSETS | ||||||||||||
CURRENT ASSETS | ||||||||||||
Cash and cash equivalents | $98,192 | $147,840 | ||||||||||
Restricted cash | - | 31 | ||||||||||
Other current assets | 1,399 | 3,661 | ||||||||||
Total current assets | 99,591 | 151,532 | ||||||||||
Property and equipment, net | 1,689 | 205 | ||||||||||
Operating lease right-of-use lease assets | 2,086 | - | ||||||||||
Other assets | 318 | 187 | ||||||||||
TOTAL ASSETS | $103,684 | $151,924 | ||||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||||
LIABILITIES | ||||||||||||
Accounts payable | $7,628 | $5,872 | ||||||||||
Accrued liabilities | 5,848 | 3,251 | ||||||||||
Operating lease liabilities, current portion | 516 | - | ||||||||||
Total current liabilities | 13,992 | 9,123 | ||||||||||
Accrued milestone and royalty payments | 1,932 | 2,050 | ||||||||||
Operating lease liabilities, long-term portion | 1,821 | - | ||||||||||
Other liabilities | - | 224 | ||||||||||
TOTAL LIABILITIES | 17,745 | 11,397 | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||||
Preferred stock $0.0001 par value, 5,500,000 shares authorized at | ||||||||||||
September 30, 2019 and December 31, 2018; none issued at | ||||||||||||
September 30, 2019 and December 31, 2018 | - | - | ||||||||||
Common stock, $0.0001 par value, 100,000,000 shares | ||||||||||||
authorized at September 30, 2019 and December 31, 2018; | ||||||||||||
34,593,666 and 34,193,666 shares issued at September 30, 2019 | ||||||||||||
and December 31, 2018, respectively | 3 | 3 | ||||||||||
Additional paid in capital | 228,532 | 225,352 | ||||||||||
Accumulated other comprehensive income | 131 | 7 | ||||||||||
Accumulated deficit | (142,727 | ) | (84,835 | ) | ||||||||
TOTAL STOCKHOLDERS' EQUITY | 85,939 | 140,527 | ||||||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $103,684 | $151,924 | ||||||||||
Consolidated Statements of Comprehensive Loss
(unaudited)
(In thousands, except share and per share data)
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||||||
OPERATING EXPENSES | ||||||||||||||||||||
Research and development | $19,660 | $8,731 | $46,665 | $23,228 | ||||||||||||||||
General and administrative | 4,699 | 2,684 | 12,581 | 5,924 | ||||||||||||||||
Total operating expenses | 24,359 | 11,415 | 59,246 | 29,152 | ||||||||||||||||
Loss from operations | (24,359 | ) | (11,415 | ) | (59,246 | ) | (29,152 | ) | ||||||||||||
OTHER INCOME/(EXPENSES) | ||||||||||||||||||||
Interest and other income/(expenses) | 437 | (11 | ) | 1,354 | (62 | ) | ||||||||||||||
NET LOSS | ($23,922 | ) | ($11,426 | ) | ($57,892 | ) | ($29,214 | ) | ||||||||||||
Other comprehensive income | ||||||||||||||||||||
Foreign currency translation | 134 | 39 | 124 | 121 | ||||||||||||||||
COMPREHENSIVE LOSS | ($23,788 | ) | ($11,387 | ) | ($57,768 | ) | ($29,093 | ) | ||||||||||||
Net loss per share attributable to common stockholders, basic and diluted | ($0.70 | ) | ($0.42 | ) | ($1.69 | ) | ($1.08 | ) | ||||||||||||
Weighted average common shares outstanding, basic and diluted | 34,371,927 | 27,330,579 | 34,253,739 | 26,945,432 | ||||||||||||||||
Contact:
+1 646 885 8505
E-mail: [email protected]
Source: Y-mAbs Therapeutics, Inc