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Axovant updates on results, dementia products

August 7, 2017

 Axovant Sciences (NYSE:  AXON) today announced financial results for the three months ended June 30, 2017 as well as general business updates.

Key Highlights

  • Strong balance sheet with $297.9 million of cash as of June 30, 2017 supports Company’s current development plans
  • Completed enrollment in HEADWAY-DLB (dementia with Lewy bodies) clinical study of intepirdine
  • Presented new preclinical data which suggests that intepirdine may have neuroprotective properties against vascular injury and neuronal metabolic dysfunction
  • Announced U.S. Food and Drug Administration (FDA) granted Fast Track designation to nelotanserin for the treatment of visual hallucinations disorder in DLB
  • Anticipate last patient visit in August in the MINDSET Phase 3 clinical study of intepirdine

“This is a very exciting time for Axovant as we expect top-line results from five late-stage clinical studies over the next several months,” said David Hung, M.D., chief executive officer of Axovant. “If successful, we believe that three of these studies — MINDSET, HEADWAY-DLB and the REM Behavior Disorder study — could potentially serve as pivotal studies and may, if approved, lead to new treatment options for people impacted by Alzheimer’s disease and Lewy body dementia.”

First Quarter Financial Summary

For the first fiscal quarter ended June 30, 2017, research and development expenses were $43.7 million, of which $6.3 million was attributable to non-cash, share-based compensation expense. General and administrative expenses for the first fiscal quarter ended June 30, 2017 were $21.5 million, of which $9.3 million was attributable to non-cash, share-based compensation expense. Net loss for the quarter ended June 30, 2017 was $69.3 million, or $0.65 per share.

Axovant held cash of $297.9 million at June 30, 2017. Net cash used in operating activities was $47.9 million for the three months ended June 30, 2017.

Development Update

Intepirdine, nelotanserin, RVT-103 and RVT-104 are being developed as potential treatments for patients with Alzheimer’s disease and Lewy body dementia (LBD). The Company expects top-line results from the following late-stage clinical studies:

  • MINDSET: Phase 3 study of intepirdine in subjects with mild-to-moderate Alzheimer’s disease on a stable background of donepezil therapy. Expected timing: last patient visit in August followed by results in late September 2017.
  • HEADWAY-DLB: Phase 2b study of intepirdine in subjects with dementia with Lewy bodies (DLB). Expected timing: fourth quarter 2017.
  • Phase 2 study of the effects of intepirdine on gait and balance in subjects with Alzheimer’s disease, DLB and Parkinson’s disease dementia (PDD). Expected timing: fourth quarter 2017.
  • Phase 2 study evaluating nelotanserin for treatment of subjects with LBD who experience frequent visual hallucinations. Expected timing: fourth quarter 2017.
  • Phase 2 study evaluating nelotanserin for treatment of REM Behavior Disorder in subjects with LBD. Expected timing: first quarter 2018.

Additionally, events relating to the Company’s investigational products were announced in June 2017 as follows:

  • Recruitment for the Phase 2b HEADWAY-DLB study completed in June with 269 subjects randomized.
  • FDA granted Fast Track designation to nelotanserin for the treatment of visual hallucinations disorder in DLB.
  • Results of a proof of concept study with RVT-103 were disclosed. The Company expects to meet with the FDA to discuss additional studies that could support registration of RVT-103 and initiated a proof of concept study for RVT-104.

In July, the Company presented new data relating to its intepirdine, nelotanserin and RVT-103 programs at the 2017 Alzheimer’s Association International Conference (AAIC) in London, and announced new preclinical data that suggests that intepirdine may have neuroprotective properties against vascular injury and neuronal metabolic dysfunction.

In the animal model used in this study, intepirdine demonstrated neuroprotective effects under hypoxic and hypoglycemic conditions in an in vitro assay of mixed cortical neuron (MCN) cultures at clinically relevant concentrations. Specifically, when pre-treated with intepirdine for 24 hours, a decrease in lactate dehydrogenase (LDH) release, a surrogate marker of cell death, was observed in MCN cultures exposed to oxygen and glucose deprivation (p<0.05 at multiple intepirdine concentrations).

http://prn.to/2uh0ZzF

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