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Bermuda
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001-37418
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98-1333697
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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Suite 1, 3rd Floor
11-12 St. James’s Square
London SW1Y 4LB, United Kingdom
(Address of principal executive offices) (Zip Code)
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¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each Class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Shares, par value $0.00001 per share
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AXGT
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The Nasdaq Stock Market LLC
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Item 2.02
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Results of Operations and Financial Condition.
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Item 9.01
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Financial Statements and Exhibits.
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AXOVANT GENE THERAPIES LTD.
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Dated:
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November 8, 2019
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By:
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/s/ David Nassif
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Name:
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David Nassif
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Title:
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Principal Financial Officer and Principal Accounting Officer
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•
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First evidence of clinical stabilization in two children with Tay-Sachs disease that received AXO-AAV-GM2 presented at ESGCT in October 2019
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•
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Continued enrollment of patients in AXO-AAV-GM1 registrational study, with 6-month data from Part A of the registrational study expected in mid-2020
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•
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3-month data from second cohort of dose-escalation study of AXO-Lenti-PD expected in 1H 2020, and company plans to initiate a randomized, sham-controlled study in Parkinson’s disease by the end of 2020
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•
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Net loss for the quarter ended September 30, 2019 was $13.9 million, or $0.61 per share, compared to a net loss of $33.8 million, or $2.24 per share for the prior-year quarter
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•
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AXO-AAV-GM2: Presented first evidence of clinical disease stabilization in two patients dosed with AXO-AAV-GM2 at the European Society of Gene and Cell Therapy (ESGCT) 27th Annual Congress in October 2019. Initial 3-month follow-up data from a child with early symptomatic Tay-Sachs disease treated at 6-months of age suggests a pattern of stable CHOP-INTEND scores, an improvement from baseline in myelination on brain MRI, and an increase in enzyme activity in CSF. The treatment was generally observed to be well-tolerated in both patients with no serious adverse events related to therapy.
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•
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AXO-AAV-GM1: The first two patients in the AXO-AAV-GM1 Phase 1/2 program were dosed intravenously earlier this year, and the therapy has been generally well tolerated to date with no serious adverse events attributed to the therapy. Axovant expects to present an update from the first child dosed with AXO-AAV-GM1 gene therapy in Q4 2019, and data from Part A (n=5), which is expected to focus on safety and tolerability as well as exploratory measures of efficacy after 6 months of follow-up, is expected in mid-2020. Axovant also announced plans to expand the clinical development plan for AXO-AAV-GM1 to include infantile GM1 gangliosidosis subjects (Type I), the most severely affected population with the disease.
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•
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AXO-Lenti-PD: Axovant expects to present 3-month data from the second dose cohort (n=4) of the SUNRISE-PD Phase 2 study of AXO-Lenti-PD in the first half of calendar year 2020, allowing for an evaluation of safety, tolerability, and various measures of clinical efficacy in Parkinson’s disease. Axovant is actively initiating new clinical sites to expedite patient enrollment by expanding neurosurgical capacity for current and future studies. Based on the outcome of dose-escalation studies, Axovant expects to initiate a randomized, sham-controlled study of AXO-Lenti-PD by the end of calendar year 2020.
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Three Months Ended September 30,
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Six Months Ended September 30,
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2019
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2018
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2019
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2018
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Operating expenses:
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||||||||
Research and development expenses(1)
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||||||||
(includes share-based compensation expense (benefit) of $409 and $(1,128) for the three months ended September 30, 2019 and 2018 and $1,130 and $1,389 for the six months ended September 30, 2019 and 2018, respectively)
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$
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6,833
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$
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21,502
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$
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27,923
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$
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58,920
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General and administrative expenses(2)
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(includes share-based compensation expense of $482 and $3,585 for the three months ended September 30, 2019 and 2018 and $1,896 and $6,927 for the six months ended September 30, 2019 and 2018, respectively)
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5,051
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10,622
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11,519
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22,376
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Total operating expenses
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11,884
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32,124
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39,442
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81,296
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Other (income) expenses:
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Interest expense
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1,313
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1,932
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2,871
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3,902
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Other (income) expense
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560
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(315
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)
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(537
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)
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353
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Loss before income tax expense
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(13,757
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)
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(33,741
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)
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(41,776
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)
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(85,551
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)
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Income tax expense
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127
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94
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165
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172
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Net loss
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$
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(13,884
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)
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$
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(33,835
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)
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$
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(41,941
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)
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$
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(85,723
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)
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Net loss per common share — basic and diluted
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$
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(0.61
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)
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$
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(2.24
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)
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$
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(1.84
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)
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$
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(6.00
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)
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Weighted-average common shares outstanding — basic and diluted
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22,783,182
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15,107,932
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22,781,657
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14,295,301
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September 30, 2019
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March 31, 2019
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Assets
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Current assets:
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Cash and cash equivalents
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$
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60,255
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$
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106,999
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Prepaid expenses and other current assets
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4,503
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5,859
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Income tax receivable
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2,071
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1,726
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Total current assets
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66,829
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114,584
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Long-term investment
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5,871
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5,871
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Other non-current assets
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46
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973
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Operating lease right-of-use assets
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2,237
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—
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Property and equipment, net
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1,081
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1,278
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Total assets
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$
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76,064
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$
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122,706
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Liabilities and Shareholders’ Equity
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Current liabilities:
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Accounts payable
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$
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1,567
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$
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1,698
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Accrued expenses
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21,427
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20,619
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Current portion of operating lease liabilities
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1,672
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—
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Current portion of long-term debt
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22,613
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21,182
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Total current liabilities
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47,279
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43,499
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Operating lease liabilities, net of current portion
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3
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—
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Long-term debt
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11,742
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22,994
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Total liabilities
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59,024
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66,493
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Shareholders’ equity:
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Common shares, par value $0.00001 per share, 1,000,000,000 shares authorized, 22,791,669 and 22,779,891 issued and outstanding at September 30, 2019 and March 31, 2019, respectively
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—
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—
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Additional paid-in capital
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744,506
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741,318
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Accumulated deficit
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(727,957
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)
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(686,016
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)
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Accumulated other comprehensive income
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491
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911
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Total shareholders’ equity
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17,040
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56,213
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Total liabilities and shareholders’ equity
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$
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76,064
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$
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122,706
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