Y-mAbs Announces Third Quarter 2020 Financial Results and Recent Corporate Developments
“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
Dr.
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 theInternational 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 inAugust 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
For the nine months ended
Operating Expenses
Research and Development
Research and development expenses were
$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
$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
$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
$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
Webcast and Conference Call
The Company will host a conference call on
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
“Y-mAbs” is a registered trademark of
Consolidated Balance Sheets | ||||||||
(unaudited) | ||||||||
(in thousands, except share data) | ||||||||
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, |
||||||||
— | — | |||||||
Common stock, |
||||||||
shares issued at |
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 | ||||
Consolidated Statements of Net Loss and Comprehensive Loss | |||||||||||||||||
(unaudited) | |||||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||
Three months ended |
Nine months ended |
||||||||||||||||
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:
+1 646 885 8505
E-mail: [email protected]
Source: Y-mAbs Therapeutics, Inc