“We look forward to a transformational year ahead for Axovant,” stated Vivek Ramaswamy, Chief Executive Officer of Axovant Sciences. “Our clinical programs are on-track to produce results from multiple late-stage clinical studies in 2017, and we continue to prepare for the potential commercial launches of those drugs if we receive marketing approval. In addition, we recently accomplished a financing that provides additional flexibility to advance or expand our pipeline.”
MINDSET Trial Recruitment:
In January 2017, Axovant declared completion of recruitment for the Phase 3 MINDSET study of its investigational drug intepirdine in patients with mild-to-moderate Alzheimer’s disease. Topline results are expected in the third quarter of 2017.
Venture Debt Financing:
In February 2017, Axovant declared that it reached a $55.0 million debt financing agreement with Hercules Capital, Inc., a leader in customized debt financing for companies in life sciences and technology-related markets. The full amount of the $55.0 million loan was funded at closing.
The loan will mature on March 1, 2021. Payments under the loan are interest only for a period of 18 months, followed by equal monthly installments of principal and interest thereafter. The interest-only period may be extended to 24 months, contingent upon Axovant achieving certain clinical development milestones.
In connection with the debt financing, Axovant issued Hercules a warrant to purchase up to 274,086 of its common shares at an exercise price of $12.04 per share.
Nelotanserin Preliminary Results:
In February 2017, Axovant stated preliminary results from the planned interim analysis of the first 11 patients to complete its Phase 2 study of nelotanserin in Lewy body dementia patients.
In these patients, Axovant observed statistically noteworthyimprovements in the pre-specified primary endpoint of Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II + III for nelotanserin as contrast to placebo. There were no drug-related serious adverse events, and there were no adverse events that led to discontinuation of the study drug. In the interim analysis, secondary endpoints did not demonstrate statistically noteworthydifferences for nelotanserin relative to placebo.
Based on these preliminary results, Axovant plans to expand patient recruitment to confirm the treatment benefits observed in the interim results from this ongoing study. Axovant anticipates the full study to complete in mid-2017.
Additional Corporate Highlights since September 30, 2016:
- Intepirdine Thorough QT (TQT) Study: A TQT study of intepirdine was accomplished with no adverse findings.
- Intepirdine and itraconazole drug-drug interaction study: No clinically relevant drug-drug interactions were observed between intepirdine and itraconazole, a potent inhibitor of metabolic enzymes, in a group of healthy subjects.
- Intepirdine Function and Independence Data Presentations: Axovant presented patient function and independence data analyses from its prior Phase 2b study of investigational drug intepirdine in Alzheimer’s disease at the Clinical Trials in Alzheimer’s Disease (CTAD) Meeting in December 2016.
- Oral Presentation: “An Assessment of Dependence Level Progression Using a Conversion Algorithm of ADCS-ADL to Dependence Scale and Data From a Double Blind Placebo Controlled Trial of Intepirdine (RVT-101)”
- Poster Presentation: “The Efficacy of Intepirdine (RVT-101), a 5-HT6 Receptor Antagonist, as an Adjunct to Donepezil in Adults with Mild-to-Moderate Alzheimer’s Disease: Completer Analysis of a Phase 2b Study”
- Poster Presentation: “Intepirdine (RVT-101) as an Adjunct to Donepezil in Adults with Mild-to-Moderate Alzheimer’s Disease: ADCS-ADL Subscale Analyses”
Axovant is developing intepirdine, nelotanserin, RVT-103, and RVT-104 as potential treatments for patients with Alzheimer’s disease and Lewy body dementia. The company anticipates the following top-line results from its ongoing clinical studies in 2017:
- MINDSET: Results from the Phase 3 MINDSET study in the third quarter of 2017.
- HEADWAY-DLB: Results from the Phase 2b study of intepirdine in patients with dementia with Lewy bodies (DLB), the HEADWAY-DLB study, in the fourth quarter of 2017.
- Nelotanserin Phase 2 Visual Hallucinations Study: Axovant anticipates to complete the expanded study in mid-2017 and plans to present detailed results at a scientific meeting in 2017.
- Nelotanserin Phase 2 REM Behavior Disorder Study: Results from the Phase 2 study evaluating nelotanserin for treatment of REM Behavior Disorder (RBD) in patients with DLB in the second half of 2017.
- Gait and Balance in Patients with Dementia Study: Results from the Phase 2 study of the effects of intepirdine on gait and balance in patients with Alzheimer’s disease, DLB and Parkinson’s disease dementia (PDD) in 2017.
- RVT-103 Proof of Concept Study: Results from the RVT-103 program in the first half of 2017.
Third Quarter 2016 Financial Summary
For the third fiscal quarter ended December 31, 2016, research and development expenses were $36.6 million, of which $4.6 million was attributable to non-cash, share-based compensation expense. General and administrative expenses for the third quarter were $11.3 million, of which $3.7 million was attributable to non-cash, share-based compensation expense. Net loss for the quarter ended December 31, 2016 was $47.8 million, or $(0.48) per share.
Nine Months 2016 Financial Summary
For the nine months ended December 31, 2016, research and development expenses were $94.0 million, of which $14.0 million was attributable to non-cash, share-based compensation expense. General and administrative expenses for the nine months were $33.4 million, of which $13.8 million was attributable to non-cash, share-based compensation expense. Net loss for the nine months ended December 31, 2016 was $128.1 million, or $(1.29) per share.
Axovant held cash of $200.4 million at December 31, 2016. Proceeds from the debt financing with Hercules Capital, accomplished in February 2017, are not included in the cash balance at December 31, 2016. Net cash used in operating activities was $70.8 million for the nine months ended December 31, 2016.