Y-mAbs Announces 2018 Financial Results and Corporate Development Highlights
“We are very pleased to report our first full year financials after Y-mAbs’ successful IPO in September, which we believe has 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 by the end of 2019,” stated Thomas Gad, Founder, President and Head of Business Development and Strategy.
Dr. Moller, Chief Executive Officer, continued, “We believe we have made solid clinical progress with naxitamab and omburtamab during 2018. In 2019, we have much to do and also many catalysts that have the potential to solidify us as a leader in pediatric oncology and as a company focused on rapidly developing therapies to extend and enhance the lives of those living with rare pediatrics cancers.”
Financial Year 2018 and Corporate Development Highlights
December 13, 2018, Y-mAbs announced the appointment of Dr. Gérard Ber, PhD to its board of directors, and the planned departure of Dr. Michael Buschle, PhD. Dr. Ber most recently served as Chief Operating Officer of Advanced Accelerator Applications SA, which he co-founded in 2002. Dr. Ber brings over 30 years of experience in molecular nuclear medicines, including development, production and commercialization of diagnostics and therapeutic products for several indications in oncology, cardiology, neurology and infectious/inflammatory diseases.
December 10, 2018, Y-mAbs announced FDAclearance of the IND for the Company’s humanized bispecific GD2 antibody. The IND was submitted by Memorial Sloan Kettering Cancer Center, who has licensed the antibody to Y-mAbs. A Phase 1/2 clinical trial has been initiated for patients with relapsed/refractory neuroblastoma, high grade osteosarcoma and other GD2(+) solid tumors, where patients have relapsed or refractory disease that is resistant to standard therapy. Y-mAbs expects that this bispecific GD2 antibody may have potential advantages over other bispecific antibodies, such as improved potency due to bivalency, binding to neonatal Fc receptor and longer serum half-life, which obviates continuous infusion and enables more convenient administration to the patient.
November 1, 2018, Y-mAbs announced that that Dr. Jeong A Park from the Department of Pediatrics of Memorial Sloan-Kettering Cancer Centerwould present preclinical data from the Company’s bispecific GD2 antibody at the American Society of Hematology(ASH) Annual Meeting. 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.
October 23, 2018, Y-mAbs announced that the Committee for Orphan Medicinal Products of the European Medicines Agencyrecommended the granting of orphan medicinal product designation in the European Unionfor naxitamab for the treatment of relapsed or refractory high-risk neuroblastoma. Further, the positive opinion for orphan medicinal product designation had been sent to the European Commission, which subsequently granted the orphan drug designation.
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 $16.00per 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.
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.
July 10, 2018, Y-mAbs announced that it had entered into an exclusive sublicense with MabVax Therapeuticsfor its patented neuroblastoma vaccine, which is a bi-valent ganglioside based vaccine intended to treat neuroblastoma. The neuroblastoma vaccine was originally developed by Memorial Sloan Kettering Cancer Centerand licensed to MabVax as part of a portfolio of anti-cancer vaccines. MabVax was granted Orphan Drug Designation for the vaccine. Under the terms of the sublicense, the Company has agreed to pay MabVax up to $1.3 million, consisting of an upfront payment of $700,000, and an additional payment of $600,000on the first anniversary of the sublicense.
April 16, 2018, Y-mAbs announced positive Phase I data from treatment with omburtamab in Desmoplastic Small Round Cell Tumor (DSRCT), which is a rare sarcoma of adolescents and young adults. The phase I study of radioiodinated omburtamab was conducted at Memorial Sloan Kettering Cancer Centerevaluate toxicity, pharmacokinetics, biodistribution and efficacy. A total of 41 DSRCT patients were treated with escalated doses of intraperitoneal omburtamab as radioimmunotherapy, and the compound had a satisfactory safety profile and appeared to have activity against micro-metastatic DSRCT.
Y-mAbs reported a net loss of
Cost and Operating Expenses
Research and development
Research and development expenses were
$7.5 millionincrease in outsourced manufacturing for our lead product candidates, naxitamab and omburtamab $4.6 millionincrease in outsourced research and supplies to support expanding development activities $2.8 millionincrease in clinical trial costs due to an increasing number of ongoing clinical trials $3.2 millionincrease in personnel costs $0.6 millionincrease in milestone payments
General and administration
General and administrative expenses were
$1.8 millionincrease in personnel costs $0.7 millionincrease in fees for auditors, legal advice and other consultancy services $0.4 millionincrease in leasehold expenses
Cash and Cash Equivalents
The Company had approximately
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 Form 10-K and in our other
|Y-MABS THERAPEUTICS, INC.
Consolidated Balance Sheets
(in thousands, except share data)
|Cash and cash equivalents||$147,840||$90,483|
|Other current assets||3,661||840|
|Total current assets||151,532||91,355|
|Property and equipment, net||205||-|
|Deferred offering costs||-||772|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||9,123||7,925|
|Accrued milestone and royalty payments||2,050||2,050|
|Preferred stock $0.0001 par value, 5,500,000 shares authorized at|
|December 31, 2018 and December 31, 2017; none issued at|
|December 31, 2018 and December 31, 2017||-||-|
|Common stock, $0.0001 par value, 100,000,000 and 50,000,000|
|shares authorized at December 31, 2018 and December 31, 2017,|
|respectively; 34,193,666 and 26,749,666 shares issued at December|
|31, 2018 and December 31, 2017, respectively||3||3|
|Additional paid in capital||225,352||123,879|
|Accumulated other comprehensive income||7||(169||)|
|TOTAL STOCKHOLDERS' EQUITY||140,527||82,152|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY||$151,924||$92,127|
|Y-MABS THERAPEUTICS, INC.
Consolidated Statements of Comprehensive Loss
(In thousands, except share and per share data)
|For The Year Ended||For The Year Ended|
|December 31,||December 31,|
|Research and development||$34,269||$14,307|
|General and administrative||8,961||4,937|
|Total operating expenses||43,230||19,244|
|Loss from operations||(43,230||)||(19,244||)|
|Other income (expenses)||(44||)||83|
|Other comprehensive income/(loss)|
|Foreign currency translation||175||(199||)|
|Net loss per share attributable to common stockholders, basic and diluted||($1.50||)||($0.99||)|
|Weighted average common shares outstanding, basic and diluted||28,772,384||19,397,506|
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Source: Y-mAbs Therapeutics, Inc