Y-mAbs Announces Third Quarter Financial Results and Recent Corporate Developments
“We are very pleased with our third quarter 2021 results. DANYELZA commercialization throughout the
Recent Corporate Developments
- After the close of the quarter, on
November 4, 2021, Y-mAbs announced that the Company has requested a pre-BLA meeting for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The Company believes the pre-BLA meeting will be held in January 2022, and pending a positive meeting, the Company aims to initiate resubmission of the omburtamab BLA shortly thereafter.
- Also, after the close of the third quarter, on
October 7, 2021, Y-mAbs announced that the U.S. Food and Drug Administration (“FDA”) has granted Rare Pediatric Disease Designation (“RPDD”) for the Company’s lutetium labelled omburtamab antibody program for the treatment of medulloblastoma.
September 13, 2021, Y-mAbs announced that its partner in China, SciClone Pharmaceuticals had been granted priority review of the Biologics License Application for DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma by the Center for Drug Evaluation of China’s National Medical Products Administration.
July 6, 2021, Y-mAbs announced that SciClone Pharmaceuticals had submitted the Biologics License Application for DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the National Medical Products Administration(“NMPA”) of China.
Y-mAbs reported a net loss of
For the nine months ended
Y-mAbs reported net revenues of
No revenues were reported for the quarter ended and nine months ended
Research and Development
Research and development expenses were
$1.9 millionin clinical trials; and $1.8 millionin personnel costs.
These increases were partially offset by a reduction of
Research and development expenses were
$13.3 milliondecrease in milestone payments and license acquisition costs driven by the SADA agreement executed in April 2020; and $4.4 milliondecrease in regulatory affairs costs.
These decreases were partially offset by increases of:
$7.3 millionin personnel costs; $2.5 millionin clinical trials; $1.4 millionin expenses related to our manufacturing and supply agreement with Spectron RX; and $1.0 millionin external consulting and software expenses.
Selling, General, and Administration
Selling, general, and administrative expenses were
Selling, general, and administrative expenses were
Cash and Cash Equivalents
The Company had
- The completion of the sale of our DANYELZA priority review voucher in
January 2021. Y-mAbs netted $62.0 millionafter paying 40% of the net proceeds from the sale to MSK pursuant to the terms of the license agreement with MSK, and $107.7 millionin net proceeds raised in our public offering in February 2021.
These increases were partially offset by the net cash used in operational activities of
Webcast and Conference Call
The Company will host a conference call on
A webcast will be available at: https://viavid.webcasts.com/starthere.jsp?ei=1507982&tp_key=2757523ca1
Y-mAbs is a commercial-stage 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 one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
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, commercialization and product distribution plans; current and future clinical and pre-clinical studies and our research and development programs; expectations related to the timing of the initiation and completion of regulatory submissions; 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,’’ “hope,” ‘‘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 in the timing of our regulatory submissions 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, risks associated with the pandemic caused by the coronavirus known as COVID-19 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
“DANYELZA” and “Y-mAbs” are registered trademarks of
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E-mail: [email protected]
|Consolidated Balance Sheets|
|(in thousands, except share data)|
|Cash and cash equivalents||$||215,730||$||114,634|
|Accounts receivable, net||7,264||—|
|Other current assets||2,799||7,729|
|Total current assets||230,580||122,363|
|Property and equipment, net||1,846||1,825|
|Operating lease right-of-use assets||2,802||4,569|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Operating lease liabilities, current portion||1,849||1,966|
|Total current liabilities||25,359||19,535|
|Accrued milestone and royalty payments||2,250||2,695|
|Operating lease liabilities, long-term portion||654||2,013|
|shares issued at
|Additional paid in capital||514,198||391,558|
|Accumulated other comprehensive income / (loss)||225||(526||)|
|TOTAL STOCKHOLDERS’ EQUITY||210,845||105,836|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||239,979||$||132,047|
Consolidated Statements of Net Income/(Loss) and Comprehensive Income/(Loss)
(In thousands, except share and per share data)
|Three months ended
||Nine months ended
|Product revenue, net||$||8,965||$||—||$||23,299||$||—|
|OPERATING COSTS AND EXPENSES|
|Cost of goods sold||550||—||843||—|
|Research and development||23,131||21,005||64,488||69,686|
|Selling, general, and administrative||13,988||11,636||39,433||30,155|
|Total operating costs and expenses||37,669||32,641||104,974||99,841|
|Loss from operations||(28,704||)||(32,641||)||(79,675||)||(99,841||)|
|OTHER INCOME, NET|
|Gain from sale of priority review voucher||—||—||62,010||—|
|Interest and other income / (loss), net||(154||)||(191||)||(717||)||437|
|Other comprehensive income / (loss)|
|Foreign currency translation||238||(12||)||751||(78||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.66||)||$||(0.82||)||$||(0.43||)||$||(2.49||)|
|Weighted average common shares outstanding, basic and diluted||43,598,350||40,187,173||43,019,217||39,971,766|
Source: Y-mAbs Therapeutics, Inc