Y-mAbs Announces Third Quarter 2018 Financial Results and Recent Corporate Developments
“We are very pleased to report our first quarterly financials after Y-mAbs’ successful IPO in September, which have put us in a strong financial position to continue the important work on our two lead pediatric compounds, naxitamab and omburtamab. We plan to file BLAs for both of these compounds next year.” stated Thomas Gad, Founder, President and Head of Business Development and Strategy.
Dr. Moller, Chief Executive Officer continued, “We have made solid progress with naxitamab and omburtamab in the clinic in recent months. Over the remainder of 2018, we have much to do and also numerous catalysts that have the potential to solidify us as a leader in pediatric oncology and a company focused on rapidly developing therapies to extend and enhance the lives of those living with rare pediatrics cancers.”
Third Quarter 2018 and Recent Corporate Developments
- After the close of the quarter, on
November 1, 2018 , Y-mAbs announced that that Dr. Jeong A Park from theDepartment of Pediatrics of Memorial Sloan-Kettering Cancer Center (MSK) will present preclinical data from the Company’s bispecific GD2 antibody in a poster presentation at theAmerican Society of Hematology (ASH) Annual Meeting onDecember 3, 2018 , at9:00 PM Eastern. Bispecific GD2 antibodies were tested in solid tumors in preclinical models with T-cells and were shown to exert anti-tumor effect against GD2(+) tumor xenografts or PDX tumors. Further, the bispecific GD2 antibodies induced rapid and quantitative T-cell homing to tumors, mediating antibody dependent T-cell mediated cytotoxicity (ADTC) against GD2, and were shown to infiltrate tumors with little to no immune response, also known as cold tumors.
- After the close of the quarter, on
October 23, 2018 , Y-mAbs announced that the Committee for Orphan Medicinal Products of theEuropean Medicines Agency recommended the granting of orphan medicinal product designation in theEuropean Union for naxitamab for the treatment of relapsed or refractory high-risk neuroblastoma. Further, the positive opinion for orphan medicinal product designation had been sent to theEuropean Commission , which may grant the orphan drug designation within 30 days thereof.
- On
September 25, 2018 , Y-mAbs announced the closing of its initial public offering of 6,900,000 shares of its common stock, including the exercise in full of the underwriters' option to purchase 900,000 additional shares of common stock, at a public offering price of$16.00 per share. The gross proceeds to Y-mAbs, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, were approximately$110.4 million . All of the shares of common stock were offered by the Company, and Y-mAbs’ common stock is listed on The Nasdaq Global Select Market under the ticker symbol "YMAB."
- On
August 21, 2018 , Y-mAbs announced that it had received Breakthrough Therapy designation for naxitamab, in combination with GM-CSF, for the treatment of high risk neuroblastoma refractory to initial therapy or with incomplete response to salvage therapy in patients older than 12 months of age with persistent, refractory disease limited to bone marrow with or without evidence of concurrent bone involvement.
Financial Results
Y-mAbs reported a net loss of
For the nine months ended
Cost and Operating Expenses
Research and development
Research and development expenses were
$3.4 million increase in outsourced manufacturing for our lead product candidates, naxitamab and omburtamab$1.3 million increase in outsourced research and supplies to support expanding development activities$0.7 million increase in personnel costs
Research and development expenses were
$6.4 million increase in outsourced manufacturing for our lead product candidates, naxitamab and omburtamab$3.5 million increase in outsourced research and supplies to support expanding development activities$2.1 million increase in clinical trial costs due to an increasing number of ongoing clinical trials$2.4 million increase in personnel costs$0.6 million increase in milestone payments
General and administration
General and administrative expenses were
$1.1 million increase in personnel costs$0.5 million increase in fees for auditors, legal advice and other consultancy services
General and administrative expenses were
$1.4 million increase in personnel costs$1.3 million increase in fees for auditors, legal advice and other consultancy services
Cash, Cash Equivalents, Investments and Restricted Investments
The Company had approximately
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 orphan drug and other regulatory approvals, clinical trial timing and plans, the achievement of clinical and commercial milestones, future financial and operating results, business strategies, market opportunities, financing, and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ ‘‘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 the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials including if we encounter difficulties enrolling patients in our clinical trials; the risks of delays in
Y-MABS THERAPEUTICS, INC. Consolidated Balance Sheets (unaudited) (in thousands, except share data) |
||||||||||||
ASSETS | September 30, 2018 |
December 31, 2017 |
||||||||||
CURRENT ASSETS | ||||||||||||
Cash and cash equivalents | $163,292 | $90,483 | ||||||||||
Restricted cash | 31 | 32 | ||||||||||
Other current assets | 2,721 | 840 | ||||||||||
Total current assets | 166,044 | 91,355 | ||||||||||
Property and equipment, net | 162 | - | ||||||||||
Deferred offering costs | - | 772 | ||||||||||
Other assets | 188 | - | ||||||||||
TOTAL ASSETS | $166,394 | $92,127 | ||||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||||
LIABILITIES | ||||||||||||
Accounts payable | $6,827 | $5,909 | ||||||||||
Accrued liabilities | 2,489 | 2,016 | ||||||||||
Total current liabilities | 9,316 | 7,925 | ||||||||||
Accrued milestone and royalty payments | 2,050 | 2,050 | ||||||||||
TOTAL LIABILITIES | 11,366 | 9,975 | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||||
Preferred stock $0.0001 par value, 5,500,000 shares authorized at | ||||||||||||
December 31, 2017, and 5,500,000 shares authorized at September | ||||||||||||
30, 2018; None issued at December 31, 2017 and | - | - | ||||||||||
September 30, 2018 | ||||||||||||
Common stock, $0.0001 par value, 100,000,000 and 50,000,000 shares | ||||||||||||
authorized at September 30, 2018 and December 31, 2017, | ||||||||||||
respectively, 34,193,666 and 26,749,666 shares issued at | ||||||||||||
September 30, 2018 and December 31, 2017, respectively | 3 | 3 | ||||||||||
Additional paid in capital | 225,848 | 123,879 | ||||||||||
Accumulated other comprehensive income | (48 | ) | (169 | ) | ||||||||
Accumulated deficit | (70,775 | ) | (41,561 | ) | ||||||||
TOTAL STOCKHOLDERS' EQUITY | 155,028 | 82,152 | ||||||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $166,394 | $92,127 | ||||||||||
Y-MABS THERAPEUTICS, INC. Consolidated Statements of Net Loss and Comprehensive Loss (unaudited) (In thousands, except share and per share data) |
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For The Three | For The Three | For The Nine | For The Nine | |||||||||||||||||
Months Ended | Months Ended | Months Ended | Months Ended | |||||||||||||||||
September 30, 2018 | September 30, 2017 | September 30, 2018 | September 30, 2017 | |||||||||||||||||
OPERATING EXPENSES | ||||||||||||||||||||
Research and development | $8,731 | $3,076 | $23,228 | $7,682 | ||||||||||||||||
General and administrative | 2,684 | 766 | 5,924 | 2,287 | ||||||||||||||||
Total operating expenses | 11,415 | 3,842 | 29,152 | 9,969 | ||||||||||||||||
Loss from operations | (11,415 | ) | (3,842 | ) | (29,152 | ) | (9,969 | ) | ||||||||||||
OTHER INCOME/(EXPENSES) | ||||||||||||||||||||
Other income (expenses) | (11 | ) | 15 | (62 | ) | 62 | ||||||||||||||
NET LOSS | ($11,426 | ) | ($3,827 | ) | ($29,214 | ) | ($9,907 | ) | ||||||||||||
Other comprehensive income/(loss) | ||||||||||||||||||||
Foreign currency translation | 39 | (53 | ) | 121 | (124 | ) | ||||||||||||||
COMPREHENSIVE LOSS | ($11,387 | ) | ($3,880 | ) | ($29,093 | ) | ($10,031 | ) | ||||||||||||
Net loss per share attributable to common stockholders, basic and diluted | ($0.42 | ) | ($0.21 | ) | ($1.08 | ) | ($0.56 | ) | ||||||||||||
Weighted average common shares outstanding, basic and diluted | 27,330,579 | 17,945,198 | 26,945,432 | 17,745,854 | ||||||||||||||||
Contact:
+1 646 885 8505
E-mail: [email protected]
Source: Y-mAbs Therapeutics, Inc