Neuren Pharmaceuticals Limited Reports Audited Consolidated and Parent Earnings Results for the Year Ended December 31, 2014
Feb 24 15
Neuren Pharmaceuticals Limited reported audited consolidated and parent earnings results for the year ended December 31, 2014. For the period, on consolidated basis, the company reported total revenue of AUD 4.4 million against AUD 5.0 million a year ago. Loss after tax attributable to equity holders was AUD 8.3 million against AUD 10.4 million a year ago. Net loss attributable to equity holders was AUD 8.3 million against AUD 10.4 million a year ago. Basic and diluted loss per share was AUD 0.005 against AUD 0.008 a year ago. Loss before income tax was AUD 8.32 million against AUD 10.5 million a year ago. Net cash used in operating activities was AUD 6.4 million against AUD 7.1 million a year ago. The loss decreased by AUD 2.1 million, mainly due to: An increase of AUD 1.4 million in research and development costs, with higher costs for the Rett syndrome and Fragile X syndrome clinical trials partly offset by lower costs for the Intrepid clinical trial; and A decrease of AUD 1.9 million in grant revenue from the US government, reflecting the lower costs for the Intrepid trial; offset by: An increase of AUD 0.4 million in interest income due to higher cash balances following the share placement in October 2013; Foreign exchange gains of AUD 0.9 million (2013: loss of AUD 1.4 million), mainly due to an increase in value of US dollar denominated cash balances, following the strengthening of the US dollar against the Australian dollar; and A noncash impairment loss in 2013 of AUD 2.7 million following a review of the carrying value of the acquired intellectual property related to MotivaTM. Purchase of property, plant and equipment was AUD 34,000 against AUD 16,000 a year ago. Purchase of intangible assets was AUD 3,000.
For the period, on parent basis, the company reported total income of AUD 1.44 million against AUD 0.2 million a year ago. Loss after income tax was AUD 9.03 million against AUD 12.3 million a year ago. Net loss attributable to equity holders was AUD 9.03 million against AUD 12.3 million a year ago. Loss before income tax was AUD 9.03 million against AUD 12.3 million a year ago. Net cash used in operating activities was AUD 6.91 million against AUD 5.960 million a year ago. Purchase of property, plant and equipment was AUD 34,000 against AUD 16,000 a year ago. Purchase of intangible assets was AUD 3,000.
Neuren Pharmaceuticals Limited to Report Q4, 2014 Results on Feb 25, 2015
Feb 23 15
Neuren Pharmaceuticals Limited announced that they will report Q4, 2014 results on Feb 25, 2015
Neuren Pharmaceuticals Ltd Submits Applications to the US Food and Drug Administration for Orphan Drug Designation and Breakthrough Therapy Designation for NNZ-2566 Treatment for Rett Syndrome
Dec 30 14
Neuren Pharmaceuticals Ltd. has submitted applications to the US Food and Drug Administration (FDA) for Orphan Drug designation and Breakthrough Therapy designation for its NNZ-2566 treatment for Rett Syndrome. Orphan Drug designation is a special status that the FDA may grant to a drug to treat a rare disease or condition. It qualifies the sponsor of the drug for seven years of marketing exclusivity and various development incentives including waiver of the prescription drug user fee for a marketing application. The FDA has previously granted Orphan Drug designation to Neuren for NNZ-2566 in Fragile X syndrome. The company is well funded with cash reserves of about 21 million. It expects to meet with the FDA in the first half of 2015 to discuss the remaining requirements for the development of NNZ-2566 in Rett syndrome. To date 22 subjects have commenced treatment in Neuren’s Phase 2 trial of NNZ-2566 in Fragile X syndrome 19 of which have already completed. The trial represents a significant commitment for families with only 2 subjects entering the trial during the U.S. holiday period in November and December. Neuren is taking a number of steps to accelerate enrolment into the trial including working closely with advocacy organizations to ensure that the recent results of the trial of NNZ-2566 in Rett syndrome are widely communicated. The number of trial sites enrolling will increase from 6 to 9 in January 2015 and further sites will be added to expand the geographical coverage in the United States. Neuren is also currently investigating the feasibility of extending the trial to include sites in Australia Top-line results from the trial that were targeted for the second quarter of 2015 are now expected in the second half of 2015.