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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Nightstar Therapeutics Plc ADS | NASDAQ:NITE | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 25.41 | 18.50 | 25.41 | 0 | 01:00:00 |
- Recent initiation of STAR phase 3 trial in Choroideremia -
“2017 was an exceptional year for the company,” said Dave Fellows, Chief Executive Officer. “We set the stage for the recent initiation of the first-ever Phase 3 trial in choroideremia and today announced further data supporting the durability of the treatment effect for NSR-REP1 in choroideremia. Elsewhere in our pipeline, we initiated our Phase 1/2 gene therapy trial for X-linked retinitis pigmentosa and in-licensed our program for Stargardt disease. We also raised more than $130 million of gross proceeds from our successful Series C financing and IPO to continue our pioneering research and development activities.”
Business Highlights Include
Financial Results
Research and development expenses for the year ended December 31, 2017 were $20.5 million versus $10.2 million for the year ended December 31, 2016. The increase of $10.3 million resulted from increases in program-related expenses of $3.4 million for NSR-REP1, and $1.5 million for NSR-RPGR, as well as a $1.9 million increase in personnel-related costs, and a $1.3 million expense to reduce research and development tax relief claims receivable from HM Revenue & Customs in the United Kingdom. Research and development personnel costs increased due to additional employees hired in 2017 to support our growing company and to assist in the further development of our product candidates and pipeline. This increase in research and development personnel-related costs includes $0.5 million of additional non-cash stock-based compensation compared to 2016.
General and administrative expenses for the year ended December 31, 2017 were $7.0 million, compared to $2.1 million for the year ended December 31, 2016. The increase of $4.9 million is mainly due to a $2.1 million increase in consulting and professional fees, including increased legal, accounting and audit fees associated with our corporate reorganization and non-capitalizable costs incurred in connection with our IPO, and a $1.8 million increase in personnel-related costs. General and administrative personnel costs increased to support our increased research and development activities and our status as a public company. This increase in general and administrative personnel-related costs includes $0.7 million of additional non-cash stock-based compensation compared to 2016.
Net loss for the year ended December 31, 2017 was $29.7 million, or ($1.63) basic and diluted net loss per ordinary share, as compared to $12.2 million for the year ended December 31, 2016, or ($1.36) basic and diluted net loss per ordinary share.
As of December 31, 2017, our cash and cash equivalents totaled $129.4 million, compared to $10.1 million at December 31, 2016. In October 2017, we sold 6,164,000 American Depositary Shares (representing the same number of ordinary shares), including the full exercise by the underwriters of their option to purchase additional ADSs, at $14.00 per ADS in our IPO for net proceeds of approximately $77.4 million. In June 2017, we completed a $45 million Series C financing with Syncona, NEA, Wellington and Redmile. As of December 31, 2017, we had 28.9 million ordinary shares outstanding.
Upcoming Conference Participation
Nightstar will participate in the Bloomberg Biotech Innovations Conference on Monday, April 9th, 2018 at 3:30pm ET in New York City. Additional information is available at http://b.bloomberg.com/reg-BiotechInnovations. The link to the live audio webcast and replay of the presentation will be available through Bloomberg terminals at Live <go>.
About Nightstar
Nightstar is a leading clinical-stage gene therapy company focused on developing and commercializing novel one-time treatments for patients suffering from rare inherited retinal diseases that would otherwise progress to blindness. Nightstar’s lead product candidate, NSR-REP1, is currently in Phase 3 development for the treatment of patients with choroideremia, a rare, degenerative, genetic retinal disorder that has no current treatments and affects approximately one in every 50,000 people. Positive results from a Phase 1/2 trial of NSR-REP1 were published in The Lancet in 2014 and in The New England Journal of Medicine in 2016. Nightstar’s second product candidate, NSR-RPGR, is currently being evaluated in a Phase 1/2 clinical trial for the treatment of patients with X-linked retinitis pigmentosa, an inherited X-linked recessive retinal disease that affects approximately one in every 40,000 people.
For more information about Nightstar or its clinical trials, please visit www.nightstartx.com.
Cautionary Language Concerning Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect” or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements contained in this press release other than statements of historical facts are forward-looking statements, including, without limitation: statements about our results of operations for the full-year 2017, cash position and sufficiency of capital resources to fund our operating requirements, our planned clinical trials for NSR-REP1 and NSR-RPGR, including our STAR Phase 3 trial in choroideremia and the expansion of future clinical trials, the continued clinical development of our pipeline, the timelines associated with our research and development programs including the timing of patient enrollment and the release data from ongoing clinical trials and studies, the prevalence of patient populations for our targeted indications, and the utility of prior preclinical and clinical data in determining future clinical results. These forward-looking statements are based on management's current expectations of future events and are subject to a number of involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including the risks and uncertainties set forth in the "Risk Factors" section of our prospectus filed pursuant to Rule 424(b)(4) under the U.S. Securities Act of 1933, as amended, on September 28, 2017, and subsequent reports that we file with the U.S. Securities and Exchange Commission. We may not actually achieve the plans, intentions, estimates or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, estimates and expectations disclosed in the forward-looking statements we make. We anticipate that subsequent events and developments will cause our views to change. We are under no duty to update any of these forward-looking statements after the date of this press release to conform these statements to actual results or revised expectations, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Investors: Senthil Sundaram, Chief Financial Officer Brian Luque, Sr. Manager, Investor Relations investors@nightstartx.com
Media: Alicia Davis, THRUST IR 910-620-3302 alicia@thrustir.com
NIGHTSTAR THERAPEUTICS PLC | ||||||||
Consolidated Statements of Operations and Comprehensive Loss | ||||||||
(In thousands, except share and per share amounts) | ||||||||
Year Ended December 31, | ||||||||
2017 | 2016 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 20,502 | $ | 10,165 | ||||
General and administrative | 7,001 | 2,055 | ||||||
Total operating expenses | 27,503 | 12,220 | ||||||
Other income (expense): | ||||||||
Interest and other income | 709 | 22 | ||||||
Other expense, net | (2,855 | ) | — | |||||
Total other income (expense), net | (2,146 | ) | 22 | |||||
Loss before provision for income taxes | (29,649 | ) | (12,198 | ) | ||||
Provision for income taxes | 37 | — | ||||||
Net loss | (29,686 | ) | (12,198 | ) | ||||
Other comprehensive loss: | ||||||||
Foreign exchange translation adjustment | 3,988 | (1,385 | ) | |||||
Total comprehensive loss | $ | (25,698 | ) | $ | (13,583 | ) | ||
Basic and diluted net loss per ordinary share | $ | (1.63 | ) | $ | (1.36 | ) | ||
Weighted average basic and diluted ordinary shares | 18,186,752 | 8,954,388 | ||||||
NIGHTSTAR THERAPEUTICS PLC | |||||||
Consolidated Balance Sheets | |||||||
(In thousands) | |||||||
December 31, | |||||||
2017 | 2016 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 129,404 | $ | 10,122 | |||
Prepaid expenses and other assets | 5,438 | 4,110 | |||||
Total current assets | 134,842 | 14,232 | |||||
Property and equipment, net | 355 | 363 | |||||
Total assets | $ | 135,197 | $ | 14,595 | |||
Liabilities and shareholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,196 | $ | 1,229 | |||
Accrued expenses and other liabilities | 6,189 | 4,322 | |||||
Total current liabilities | 9,385 | 5,551 | |||||
Total liabilities | 9,385 | 5,551 | |||||
Total shareholders’ equity | 125,812 | 9,044 | |||||
Total liabilities and shareholders’ equity | $ | 135,197 | $ | 14,595 | |||
1 Year Nightstar Therapeutics Plc ADS Chart |
1 Month Nightstar Therapeutics Plc ADS Chart |
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