Delaware
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001-34637
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20-1852016
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(State or Other Jurisdiction of
Incorporation) |
(Commission File Number)
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(I.R.S. Employer
Identification No.) |
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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Item 2.02 |
Results of Operations and Financial Conditions.
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Item 9.01 |
Financial Statements and Exhibits.
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Exhibit No.
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Description
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99.1
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Date: November 6, 2017
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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
Senior Vice President, Finance and
Administration
(Principal Accounting Officer)
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o |
RESULT, Phase 3 clinical study of Sollpura, topline data expected Q1’2018
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o |
RESULT sanctioned by the European Cystic Fibrosis Society Clinical Trial Network
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o |
Blisibimod granted FDA orphan drug designation for the treatment of IgA nephropathy
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o |
Executed a private placement of equity securities for potentially $15 million in gross proceeds in October 2017
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o |
Phase 3 RESULT study topline expected Q1 2018
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o
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RESULT study approved by the European Cystic Fibrosis Society Clinical Trial Network (“ECFS CTN”)
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o
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Blisibimod for the treatment of IgA Nephropathy (“IgAN”)
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o
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Blisibimod received orphan drug designation from the FDA for the treatment of IgAN
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R&D Expense. Research and development expense for the three and nine months ended September 30, 2017 totaled $6.1 million and $20.9 million, respectively, compared to $14.1 million and $35.7 million for the corresponding periods in 2016. The decrease in 2017 from 2016 is primarily due to lower clinical development expenses as a result of the SOLUTION study in cystic fibrosis patients with EPI and CHABLIS clinical studies in patients with systemic lupus erythematous being substantially completed in 2016. This resulted in the reductions in clinical trial expense by $4.9 million and manufacturing/clinical drug supplies by $1.9 million for the three months ended September 30, 2017. For the nine months ended September 30,2017, this resulted in the reductions in clinical trial expense by $9.3 million and manufacturing/clinical drug supplies by $3.9 million.
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o |
G&A Expense. General and administrative expense for the three and nine months ended September 30, 2017 totaled $1.8 million and $6.3 million, respectively, compared to $2.5 million and $7.3 million for the corresponding periods in 2016. The decrease is primarily due to a 30% reduction in headcount, which resulted in lower payroll related and stock-based compensation expense by $0.4 million and $1.3 million for the three months and nine months ended September 30, 2017, respectively.
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o |
Research Award. A research award, granted to us in March 2015 by the Cystic Fibrosis Foundation Therapeutics, Inc. and recorded as an offset to operating expense, totaled $100,000 for nine months ended September 30, 2017, compared to $261,000 in the comparative period in 2016. The amount of the research award recognized represents the value prescribed to the milestones we achieved under the award agreement during the reporting periods. As of March 31, 2017, we have fully recognized the research award.
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Other Income. For the three and nine months ended September 30, 2017, we recorded $1.6 million and $10.0 million, respectively, in non-operating income, primarily comprising changes in the fair value of warrants issued in connection with a direct offering of common stock and warrants in March 2017 and the fair value of the warrants exceeding the cash proceeds received from the offering. The initial fair value of the liability associated with these warrants was $14.7 million upon issuance in March 31, 2017. As of September 30, 2017, the fair value of the warrant liability decreased to $4.1 million due to a decrease in the fair value of the common stock underlying the warrant shares. The decrease is recorded as part of non-operating income in the statements of operations in 2017.
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o |
Net Income (Loss) Per Basic and Diluted Share. For the three months ended September 30, 2017, we recorded a net loss of $6.3 million or $0.58 per basic and diluted share, compared to net loss of $16.5 million, or $4.85 per basic and diluted share for the corresponding period in 2016. For the nine months ended September 30, 2017, we recorded a net loss of $17.2 million, or $2.12 per basic and diluted share, compared to net loss of $42.5 million, or $10.04 per share.
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Net Loss Applicable to Common Stockholders. In connection with a registered direct offering of convertible preferred stock and warrants to purchase shares of common stock in September 2016, there was an in-the-money conversion feature (beneficial conversion feature, or BCF). The BCF required separate financial statement recognition and was recorded as a discount to the preferred shares. For the nine months ended September 30, 2017 and 2016, we recorded a deemed dividend of $2.5 million and $8.8 million, respectively.
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Three months ended
September 30,
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Nine months ended
September 30,
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2017
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2016
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2017
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2016
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REVENUES:
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License fee
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$
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—
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$
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—
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$
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—
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$
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139
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||||||||
Collaborative revenue
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—
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—
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—
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6
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||||||||||||
Total revenues
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—
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—
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—
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145
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OPERATING EXPENSES:
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Research and development
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$
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6,104
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$
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14,096
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$
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20,939
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$
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35,686
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General and administrative
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1,810
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2,504
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6,338
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7,318
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Research award
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—
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—
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(100
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)
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(261
|
)
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||||||||||
Total operating expenses
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7,914
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16,600
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27,177
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42,743
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||||||||||||
LOSS FROM OPERATIONS
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(7,914
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)
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(16,600
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)
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(27,177
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)
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(42,598
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)
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||||||||
OTHER INCOME (EXPENSE):
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Other (expense)
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$
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(43
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)
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$
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(47
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)
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$
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(74
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)
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(109
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)
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Fair value of warrant liability in excess of proceeds from
financing |
—
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—
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(600
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)
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—
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Change in fair value of warrant liability
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1,650
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169
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10,650
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169
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||||||||||||
Total Other Income (Expense)
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1,607
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122
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9,976
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60
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||||||||||||
Net Loss
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$
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(6,307
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)
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$
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(16,478
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)
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$
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(17,201
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)
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$
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(42,538
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)
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Deemed dividends attributable to preferred stock
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—
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(8,807
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)
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(2,503
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)
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(8,807
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)
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Net loss applicable to common stockholders
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$
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(6,307
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)
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$
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(25,285
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)
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$
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(19,704
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)
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$
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(51,345
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)
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Net loss per share applicable to common stockholders
—basic and diluted (1) |
$
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(0.58
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)
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$
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(4.85
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)
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$
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(2.12
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)
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$
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(10.04
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)
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Weighted-average number of shares used in
per share calculation—basic and diluted (1)
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10,947,338
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5,210,334
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9,296,890
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5,115,560
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(1) |
All per share amounts and shares of the Company’s common stock issued and outstanding for all periods have been retroactively adjusted to reflect the one-for-eight reverse stock split which became effective on April 28, 2017.
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September 30,
2017 |
December 31,
2016
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|||||||
Cash and cash equivalents
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$
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6,076
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$
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20,843
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Accounts receivable
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$
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—
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$
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—
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Total assets
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$
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8,368
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$
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23,471
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Warrant liability
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$
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4,050
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$
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—
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Total liabilities, excludes warrant liability
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$
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3,975
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$
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10,624
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Series X contingently redeemable convertible preferred stock
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$
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—
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$
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377
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||||
Series X convertible preferred stock
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$
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333
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$
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8,614
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Common Stock and additional paid-in capital
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$
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424,765
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$
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411,410
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Accumulated deficit
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$
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(424,755
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)
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$
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(407,554
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)
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Total shareholders' equity
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$
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343
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$
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12,470
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Common shares outstanding (1)
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11,446,920
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5,745,536
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Series X convertible preferred shares outstanding
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430
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9,012
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(1) |
All shares of the Company’s common stock issued and outstanding for all periods have been retroactively adjusted to reflect the one-for-eight reverse stock split which became was effective on April 28, 2017.
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