Y-mAbs Announces 2019 Financial Results and Recent Corporate Developments
“We are very pleased with our 2019 results, highlighted by notable progress in the preparation of our BLAs for naxitamab and omburtamab, as well as commercial ramp-up for the potential launch of both compounds. We start 2020 with
Fourth Quarter 2019 and Recent Corporate Developments
- After the close of the fourth quarter, on
February 26, 2020, Y-mAbs announced a positive Pre-BLA meeting with FDA for omburtamab.
December 12, 2019, Y-mAbs announced that its GD2-GD3 Vaccine has been granted a Rare Pediatric Disease Designation by the FDA for the treatment of neuroblastoma.
December 11, 2019, Y-mAbs announced positive frontline data for naxitamab at the Company’s R&D event, which took place in New York City. Key opinion leaders discussed the current treatment landscape and unmet medical needs for high-risk neuroblastoma and other solid tumors.
December 5, 2019, the Company announced that the European Medicines Agency agreed to the Company’s proposed Pediatric Investigation Plan for omburtamab.
November 29, 2019, Y-mAbs announced that it had submitted to the FDA the first portion of its Biologics License Application for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA’s Rolling Review process.
November 15, 2019, Y-mAbs announced a clinical update on omburtamab for Desmoplastic Small Round Cell Tumor. The data was presented at the 2019 CTOS Annual Meeting in Tokyo, Japan.
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.
October 28, 2019, Y-mAbs announced an update on omburtamab data, which was presented at the International Society of Pediatric Oncologyconference.
October 25, 2019, Y-mAbs announced a naxitamab update, which was presented at the International Society of Pediatric Oncologyconference.
Y-mAbs reported a net loss for the year ended
Research and Development
Research and development expenses were
$17.1 millionincrease in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab; $5.4 millionincrease in outsourced research and supplies to support expanding development activities; $3.3 millionincrease in personnel costs; and $2.5 millionincrease in clinical trials expenses.
General and Administration
General and administrative expenses were
$5.1 millionincrease in personnel costs; and $2.8 millionincrease 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
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.
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|
|(in thousands, except share data)|
|Cash and cash equivalents||$||207,136||$||147,840|
|Other current assets||4,819||3,661|
|Total current assets||211,955||151,532|
|Property and equipment, net||2,052||205|
|Operating lease right-of-use assets||1,989||—|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Operating lease liabilities, current portion||516||—|
|Total current liabilities||13,586||9,123|
|Accrued milestone and royalty payments||1,921||2,050|
|Operating lease liabilities, long-term portion||1,714||—|
|shares issued at
|Additional paid in capital||364,712||225,352|
|Accumulated other comprehensive income||50||7|
|TOTAL STOCKHOLDERS’ EQUITY||198,903||140,527|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||216,366||$||151,924|
|Consolidated Statements of Net Loss and Comprehensive Loss|
|(in thousands, except share and per share data)|
|For the year ended
|Research and development||$||63,492||$||34,269|
|General and administrative||19,512||8,961|
|Total operating expenses||83,004||43,230|
|Loss from operations||(83,004||)||(43,230||)|
|Interest and other income/(expenses)||1,976||(44||)|
|Other comprehensive income|
|Foreign currency translation||43||175|
|Net loss per share attributable to common stockholders, basic and diluted||$||(2.30||)||$||(1.50||)|
|Weighted average common shares outstanding, basic and diluted||35,183,488||28,772,384|
|+1 646 885 8505|
|E-mail: [email protected]|
Source: Y-mAbs Therapeutics, Inc