Delaware
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001-34637
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20-1852016
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(State or Other Jurisdiction of
Incorporation)
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(Commission File Number)
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(I.R.S. Employer
Identification No.)
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25801 Industrial Boulevard, Suite B, Hayward,
California
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94545
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(Address of Principal Executive Offices)
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(Zip Code)
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o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Exhibit No.
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Description
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99.1
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Press Release dated November 6, 2015
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Date: November 6, 2015
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Anthera Pharmaceuticals, Inc.
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By:
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/s/ May Liu
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May Liu
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Principal Accounting Officer
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·
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Closed $29 million public offering in July including full exercise of underwriters’ option to purchase additional shares
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·
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Completed capsule manufacturing in support of the SOLUTION clinical study
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·
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Initiated the SOLUTION clinical study of oral Sollpura™
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·
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To regain all Japan rights to blisibimod following termination of Asia partnership
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·
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Sollpura™ (liprotamase)
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o
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Completed Manufacturing, Testing and Release of Sollpura™ Capsules
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o
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Initiated Phase 3 Clinical Study
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o
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Pediatric Clinical Study is Under Development
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·
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Blisibimod - Systemic Lupus Erythematosus (“SLE”)
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o
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Phase 3 CHABLIS-SC1 Clinical Study Enrollment Completed
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o
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Phase 3 CHABLIS 7.5 is Approaching Initiation
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·
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Blisibimod – IgA Nephropathy
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o
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Continued Enrollment in the Phase 2/3 BRIGHT-SC Clinical Study
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·
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Cash Position. Cash and cash equivalents totaled $55.8 million on September 30, 2015, compared to $2.6 million as of December 31, 2014. The increase was mainly attributable to our March and July public offerings of common stock, sale of common stock through an at-the-market program, equity investment and cost reimbursement from our partner in Japan, offset by cash used in operations.
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·
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Revenues. License and collaborative revenues for the third quarter and nine months ended September 30, 2015 totaled $0.7 million and $1.3 million, respectively. As a result of the pending termination of a collaborative arrangement with our partner in Japan, we accelerated the amortization of our deferred revenue to correspond with the shortened collaborative period, which resulted in an increase of $0.4 million in license revenue during quarter ended September 30, 2015.
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·
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R&D Expense. Research and development expenses for the third quarter of 2015 increased by $5.1 million to $10.4 million from $5.3 million in the third quarter of 2014. This increase was mainly driven by expenses associated with manufacturing and initiation of our Phase 3 SOLUTION clinical study of Sollpura™ and higher clinical development expense for our blisibimod program. Additionally, non-cash stock-based compensation expense increased by $0.5 million from the third quarter of 2014 due to equity grants issued during the third quarter of 2015.
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·
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G&A Expense. General and administrative expenses increased by $0.7 million for the third quarter of 2015 to $2.1 million from $1.4 million in the third quarter of 2014. The increase was mainly due to an increase of $0.4 million in non-cash stock based compensation expense compared to the third quarter of 2014 and higher professional services.
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·
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Research Award. Research award, granted to us in March of 2015 by CFFT and recorded as an offset to operating expense, totaled $0.4 million and $1.5 million for the third quarter and nine months ended September 30, 2015. The amount of the research award we recognized represents the value of milestones we have achieved under the award agreement as of September 30, 2015.
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·
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Net Loss. Net loss for the third quarter of 2015 was $11.3 million, or $0.29 per basic and diluted share, compared to $7.0 million, or $0.31 per basic and diluted share, for the third quarter of 2014. The increase in net loss was primarily related to the advancement of our blisibimod program and the initiation of Sollpura™ in a Phase 3 clinical study.
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·
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Warrant Expiration. In September 2015, we reduced our fully diluted shares outstanding by 516,660 due to the expiration of warrants issued in a prior financing transaction.
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ANTHERA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
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||||||||||||
Three Months Ended
September 30,
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Nine Months Ended
September 30,
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|||||||||||
2015
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2014
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2015
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2014
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Revenues:
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License revenue
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$
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548
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$
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—
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$
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743
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$
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—
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||||
Collaboration revenue
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185
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—
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524
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—
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||||||||
Total revenues
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733
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—
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1,267
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—
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||||||||
Operating Expenses:
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||||||||||||
Research and development
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$
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10,359
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$
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5,268
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$
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24,893
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$
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16,312
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General and administrative
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2,091
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1,419
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5,694
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4,849
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Research award
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(367)
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—
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(1,467)
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—
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Total operating expenses
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12,083
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6,687
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29,120
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21,161
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||||||||
Loss from operations
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(11,350)
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(6,687)
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(27,853)
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(21,161)
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||||||||
Other Expenses:
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Interest expense
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—
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(286)
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—
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(905)
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||||||||
Other income (expense)
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24
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(14)
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(28)
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(93)
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||||||||
Total other income (expense)
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24
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(300)
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(28)
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(998)
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Net loss
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$
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(11,326)
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$
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(6,987)
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$
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(27,881)
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$
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(22,159)
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Net loss per share attributable to common stockholders:
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||||||||||||
Basic and diluted
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$
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(0.29)
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$
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(0.31)
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$
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(0.81)
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$
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(1.03)
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Weighted-average number of shares used in per share calculation: basic and diluted
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39,241,738
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22,747,308
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34,260,866
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21,459,516
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ANTHERA PHARMACEUTICALS, INC.
BALANCE SHEET DATA
(in thousands, except share data)
(unaudited)
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September 30,
2015
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December 31, 2014
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Cash and cash equivalents
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$
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55,762
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$
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2,639
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Accounts receivable
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$
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983
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$
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—
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Total assets
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$
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57,454
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$
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3,490
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Total deferred revenue
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$
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1,957
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$
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—
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Total liabilities, excludes deferred revenue
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$
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10,187
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$
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5,751
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Accumulated deficit
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$
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(344,692)
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$
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(316,811)
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||||||||
Total shareholders' equity (deficit)
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$
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45,310
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$
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(2,261)
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||||||||
Common shares outstanding
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39,875,405
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23,005,209
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