Axovant Announces 2015 Fiscal Year-End Financial Results And Corporate Updates

HAMILTON, Bermuda, June 6, 2016 /PRNewswire/ -- Axovant Sciences Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today reported financial results for the fourth fiscal quarter and twelve months ended March 31, 2016.

"Axovant has rapidly established itself as the industry leading company pursuing treatments to address the cognitive, functional and behavioral aspects of multiple forms of dementia by initiating four mid to late-stage clinical studies in Alzheimer's disease and Lewy body dementia," stated Vivek Ramaswamy, Chief Executive Officer of Axovant Sciences. "Axovant is now entering an exciting period with several significant data catalysts expected in 2016 through 2017 for both intepirdine and nelotanserin."

Corporate Highlights since December 31, 2015

• Intepirdine and memantine drug-drug interaction study: No drug-drug interactions were observed between intepirdine and memantine in a group of healthy, elderly subjects.
• Intepirdine HEADWAY-DLB initiation: In February 2016, Axovant initiated a 24-week double blind, randomized, placebo-controlled 240 patient study of intepirdine as a potential treatment for dementia with Lewy bodies (DLB). If the results of this study, referred to as HEADWAY-DLB, are favorable, the Company believes that those results, in combination with positive results from its ongoing MINDSET study, could serve as the basis for seeking regulatory approval of intepirdine in DLB.
• Nelotanserin Visual Hallucinations (VH) study initiation: In January 2016, the Company initiated a double-blind, randomized, placebo-controlled, crossover Phase 2 study of nelotanserin in patients with DLB or Parkinson's disease dementia suffering from visual hallucinations. The study is a pilot program, which the Company expects to inform a subsequent pivotal study design in this indication.
• Nelotanserin REM Behavior Disorder (RBD) study initiation: In March 2016, Axovant initiated a 4-week double blind, randomized, placebo-controlled Phase 2 study in patients with DLB suffering from REM behavior disorder. The study will utilize objective measures of efficacy as assessed in a sleep-lab setting.
• Intepirdine registered as the generic name for RVT-101: The United States Adopted Names Council and the World Health Organization have adopted intepirdine as the nonproprietary (generic) name for Axovant's lead product candidate RVT-101. Pharmacological and/or chemical relationships inform the selection of a drug's United States Adopted Name (USAN) and International Nonproprietary Name (INN) in order to support communications among health care professionals.

Pipeline Programs
Axovant is developing intepirdine and nelotanserin as potential treatments for patients with Alzheimer's disease and Lewy body dementia. The company expects top-line results from four ongoing clinical studies as follows:

• Results from the Phase 3 study of intepirdine in subjects with mild-to-moderate Alzheimer's disease on a stable background of donepezil therapy, the MINDSET Study, as well as a potential NDA filing in 2017.
• Results from the Phase 2b study of intepirdine in subjects with dementia with Lewy bodies, the HEADWAY-DLB study, in 2017.
• Results from the Phase 2 study evaluating nelotanserin for treatment of visual hallucinations in subjects with Lewy body dementia in the second half of 2016.
• Results from the Phase 2 study evaluating nelotanserin for treatment of REM Behavior Disorder in subjects with dementia with Lewy bodies in 2017.

Fourth Quarter Financial Summary
For the fourth fiscal quarter ended March 31, 2016, research and development expenses were $23.4 million, of which $6.2 million was attributable to non-cash, share-based compensation expense. General and administrative expenses for the fourth quarter were $7.2 million, of which $2.2 million was attributable to non-cash, share-based compensation expense. Net loss for the quarter ended March 31, 2016 was $29.7 million, or $(0.30) per share.

Twelve Months Financial Summary
For the year ended March 31, 2016, research and development expenses were $76.6 million, of which $30.6 million was attributable to non-cash, share-based compensation expense. General and administrative expenses for the year ended March 31, 2016 were $56.5 million, of which $41.8 million was attributable to non-cash, share-based compensation expense. Net loss for the year ended March 31, 2016, was $133.1 million, or $(1.41) per share.

Axovant held cash of $276.3 million at March 31, 2016, and net cash used in operating activities was $53.3 million for the twelve months ended March 31, 2016.

About Axovant
Axovant Sciences Ltd. is a leading clinical-stage biopharmaceutical company focused on acquiring, developing and commercializing novel therapeutics for the treatment of dementia. Axovant intends to develop a pipeline of product candidates to comprehensively address the cognitive, functional and behavioral components of dementia and related neurological disorders. Our vision is to become the leading company focused on the treatment of dementia by addressing all forms and aspects of this condition.

About MINDSET
MINDSET is a Phase 3 international, multi-center, double-blind, placebo-controlled clinical study designed to evaluate the safety, tolerability and efficacy of intepirdine in patients with mild-to-moderate Alzheimer's disease. The 24-week trial will compare 35 mg, once-daily oral doses of intepirdine to placebo in approximately 1,150 patients with mild-to-moderate Alzheimer's disease on a stable background of donepezil therapy.

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