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Share Name | Share Symbol | Market | Type |
---|---|---|---|
uniQure NV | NASDAQ:QURE | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.11 | 2.41% | 4.68 | 4.50 | 4.78 | 4.68 | 4.495 | 4.59 | 391,694 | 21:00:10 |
LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Nov. 01, 2017 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the third quarter of 2017 and highlighted recent progress across its business.
"In recent months, we have made tremendous progress advancing our gene therapy candidates in hemophilia B and Huntington's disease, and continue to build momentum as we near the end of the year," stated Matthew Kapusta, chief executive officer of uniQure. "Based on recent meetings with the FDA and EMA, we now have what we believe is a clear pathway to initiate a pivotal study in 2018 with AMT-061, an AAV5-Padua gene therapy. We believe AMT-061 has the potential to provide consistent, long-term benefits to nearly all patients with hemophilia B, without the complications often associated with immune responses to the capsid. Preparations for the pivotal study are underway and the manufacturing of AMT-061 for clinical use has been initiated."
"Regarding AMT-130 in Huntington's disease, we received Orphan Drug Designation from the FDA and presented new preclinical data demonstrating functional and survival benefit," added Mr. Kapusta. "We are also pleased to announce that we recently completed dosing of a toxicology study that will support an IND filing in 2018. For the remainder of this year, we remain focused on the execution across our programs and look forward to sharing updates on our progress in the near future."
Third Quarter 2017 and Recent Company Progress:
· Achieved significant progress with hemophilia B gene therapy program by introducing the Padua transgene
· Acquired exclusive patent family covering the use of Padua in gene therapy for hemophilia B
· Continued progress on AMT-130 gene therapy in Huntington's disease
· Added talent to leadership team and Board of Directors
· Completed follow-on offering
Upcoming Anticipated Milestones
Financial Highlights
Cash Position: As of September 30, 2017, the Company held cash and cash equivalents of $88.9 million, compared to $132.5 million as of December 31, 2016. The decrease in cash was primarily related to the advancement of its clinical and preclinical gene therapy targets, general corporate activities and capital expenditures related to its facilities.
Revenues: Revenues for the three months ended September 30, 2017 were $2.3 million compared to $7.2 million for the same period in 2016. Collaboration revenues for the third quarter of 2017 were $1.1 million, compared to $6.0 million for the comparable period in 2016. The decrease in collaboration revenue was primarily due to the termination of the Chiesi co-development agreement in July 2017, as well as nonrecurring revenue recognized in the prior year period associated with the production of AMT-126 product supplies.
R&D Expenses: Research and development expenses for the three months ended September 30, 2017 were $20.1 million compared to $16.6 million for the same period in 2016. The increase primarily results from non-cash changes in fair value of the contingent consideration related to the Company's 2014 acquisition of InoCard.
SG&A Expenses: Selling, general and administrative expenses for the three months ended September 30, 2017 were $5.6 million compared to $5.1 million for the same period in 2016. The increase was primarily related to larger share-based compensation expenses in the current year period.
Other income: Other income for the three months ended September 30, 2017 were $14.4 million compared to $0.3 million for the same period in 2016. The current year period includes the full amortization of the outstanding deferred revenue of $13.8 million following the termination of the Company's collaboration with Chiesi in July 2017.
Net Loss: The net loss for the third quarter of 2017 was $10.2 million, or $0.40 per share, compared to $15.3 million, or $0.61 per share, for the third quarter of 2016.
About uniQure
uniQure is delivering on the promise of gene therapy - single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary and partnered gene therapies to treat patients with liver/metabolic, central nervous system and cardiovascular diseases. www.uniQure.com
uniQure Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to," "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, the development of our gene therapy product candidates, the transition to our AMT-061 product candidate, the success of our collaborations and the risk of cessation, delay or lack of success of any of our ongoing or planned clinical studies and/or development of our product candidates, and the scope of protection provided by our patent portfolio. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our and our collaborators' clinical development activities, collaboration arrangements, corporate reorganizations and strategic shifts, regulatory oversight, product commercialization and intellectual property claims, as well as the risks, uncertainties and other factors described under the heading "Risk Factors" in uniQure's Quarterly Report on Form 10-Q filed on August 8, 2017. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
uniQure Contacts:
FOR INVESTORS:
Maria E. Cantor
Direct: 339-970-7536
Mobile: 617-680-9452
m.cantor@uniQure.com
Eva M. Mulder
Direct: +31 20 240 6103
Mobile: +31 6 52 33 15 79
e.mulder@uniQure.com
FOR MEDIA:
Tom Malone
Direct: 339-970-7558
Mobile: 339-223-8541
t.malone@uniQure.com
uniQure N.V. | |||||
UNAUDITED CONSOLIDATED BALANCE SHEETS | |||||
September 30, | December 31, | ||||
2017 | 2016 | ||||
in thousands, except share and per share amounts | |||||
Current assets | |||||
Cash and cash equivalents | $ | 88,934 | $ | 132,496 | |
Accounts receivables and accrued income | 1,945 | 9,180 | |||
Prepaid assets and other current assets | 1,436 | 2,270 | |||
Total current assets | 92,315 | 143,946 | |||
Non-current assets | |||||
Property, plant and equipment, net | 34,653 | 35,702 | |||
Intangible assets and goodwill | 9,549 | 8,789 | |||
Other non-current assets | 2,469 | 1,828 | |||
Total non-current assets | 46,671 | 46,319 | |||
Total assets | $ | 138,986 | $ | 190,265 | |
Current liabilities | |||||
Accounts payable | $ | 2,987 | $ | 5,524 | |
Accrued expenses and other current liabilities | 10,165 | 9,766 | |||
Current portion of long-term debt | 6,232 | 605 | |||
Current portion of deferred rent | 724 | 684 | |||
Current portion of deferred revenue | 4,249 | 6,142 | |||
Current portion of contingent consideration | 1,017 | - | |||
Total current liabilities | 25,374 | 22,721 | |||
Non-current liabilities | |||||
Long-term debt, net of current portion | 14,353 | 19,631 | |||
Deferred rent, net of current portion | 8,829 | 6,781 | |||
Deferred revenue, net of current portion | 67,863 | 75,612 | |||
Contingent consideration, net of current portion | 2,593 | 1,838 | |||
Other non-current liabilities | 367 | 51 | |||
Total non-current liabilities | 94,005 | 103,913 | |||
Total liabilities | 119,379 | 126,634 | |||
Total shareholders' equity | 19,607 | 63,631 | |||
Total liabilities and shareholders' equity | $ | 138,986 | $ | 190,265 |
uniQure N.V. | ||||||||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
Three months ended September 30, | ||||||||
2017 | 2016 | |||||||
in thousands, except share and per share amounts | ||||||||
Total revenues | $ | 2,260 | $ | 7,221 | ||||
Operating expenses: | ||||||||
Research and development expenses | (20,103 | ) | (16,604 | ) | ||||
Selling, general and administrative expenses | (5,584 | ) | (5,113 | ) | ||||
Total operating expenses | (25,687 | ) | (21,717 | ) | ||||
Other income | 14,413 | 336 | ||||||
Other expense | (261 | ) | - | |||||
Loss from operations | (9,275 | ) | (14,160 | ) | ||||
Non operating items, net | (1,248 | ) | (935 | ) | ||||
Loss before income tax expense | (10,523 | ) | (15,095 | ) | ||||
Income tax benefit / (expense) | 278 | (177 | ) | |||||
Net loss | $ | (10,245 | ) | $ | (15,272 | ) | ||
Basic and diluted net loss per common share | $ | (0.40 | ) | $ | (0.61 | ) | ||
Weighted average shares used in computing basic and diluted net loss per common share | 25,632,642 | 25,142,660 |
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