(Mark One)
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x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended December 31, 2013
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OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from to
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Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
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20-1852016
(I.R.S. Employer
Identification No.)
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25801 Industrial Boulevard, Suite B
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Hayward, California
(Address of Principal Executive Offices)
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94545
(Zip Code)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, par value $0.001 per share
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The NASDAQ Global Market
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Large accelerated filer
o
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Accelerated filer
o
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Non-accelerated filer
o
(Do not check if a
smaller reporting company)
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Smaller reporting company
x
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Page
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PART I
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Item 1.
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Business
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5
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Item 1A.
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Risk Factors
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31
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Item 1B.
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Unresolved Staff Comments
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47
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Item 2.
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Properties
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47
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Item 3.
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Legal Proceedings
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47
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Item 4.
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Mine Safety Disclosures
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47
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PART II
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||
Item 5.
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Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer
Purchases of Equity Securities
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48
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Item 6.
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Selected Financial Data
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49
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Item 7.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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50
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Item 7A.
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Quantitative and Qualitative Disclosures About Market Risk
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59
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Item 8.
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Consolidated Financial Statements and Supplementary Data
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60
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Item 9.
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Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
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60
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Item 9A.
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Controls and Procedures
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61
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Item 9B.
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Other Information
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61
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PART III
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Item 10.
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Directors, Executive Officers and Corporate Governance
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62
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Item 11.
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Executive Compensation
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62
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Item 12.
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Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
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62
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Item 13.
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Certain Relationships and Related Transactions, and Director Independence
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62
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Item 14.
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Principal Accountant Fees and Services
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62
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PART IV
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Item 15.
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Exhibits and Consolidated financial statement Schedules
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F-1
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SIGNATURES
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63
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•
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the progress of, timing of and amount of expenses associated with our research, development and commercialization activities;
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•
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the timing, conduct and success of our clinical studies for our product candidate;
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•
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our ability to obtain U.S. and foreign regulatory approval for our product candidate and the ability of our product candidate to meet existing or future regulatory standards;
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•
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our expectations regarding federal, state and foreign regulatory requirements;
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•
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the therapeutic benefits and effectiveness of our product candidate;
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•
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the accuracy of our estimates of the size and characteristics of the markets that may be addressed by our product candidate;
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•
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our ability to manufacture sufficient amounts of our product candidate for clinical studies and products for commercialization activities;
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•
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our intention to seek to establish strategic collaborations or partnerships for the development or sale of our product candidate;
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•
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our expectations as to future financial performance, expense levels and liquidity sources;
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•
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the timing of commercializing our product candidate;
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•
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our ability to compete with other companies that are or may be developing or selling products that are competitive with our product candidate;
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•
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anticipated trends and challenges in our potential markets;
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•
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our ability to attract and retain key personnel; and
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•
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other factors discussed elsewhere in this report.
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Pooled
Placebo
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200mg QW
Placebo
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200mg QW
blisibimod
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Real Difference versus
Pooled Placebo
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Real Difference
versus 200mg QW
Placebo
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Total Study N
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N=269
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N=92
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N=92
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Subgroup N
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N=138
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N=47
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N=48
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SRI-5
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47.1%
N=65
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40.4%
N=19
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54.2%
N=26
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+7.1%
p=0.48
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+13.8%
p=0.18
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SRI-5 + No Increase in Steroid Dose
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43.5%
N=60
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38.3%
N=18
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52.1%
N=25
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+8.6%
p=0.48
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+13.8%
p=0.18
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SRI-6
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46.4%
N=64
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38.3%
N=18
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54.2%
N=26
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+7.8%
p=0.43
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+15.9%
p=0.12
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SRI-7
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28.3%
N=39
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12.8%
N=6
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41.7%
N=20
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+13.4%
p=0.11
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+28.9%
p=0.002
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SRI-8
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26.1%
N=36
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10.6%
N=5
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41.7%
N=20
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+15.6%
p=0.05
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+31.1%
p < 0.001
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PEARL-SC
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Open-Label
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||
Placebo
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Blisibimod
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Blisibimod
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N=266
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N=280
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N=380
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Overview (% incidence
)
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|||
AEs
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85
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82.5
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60.5
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Serious AEs
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15.8
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11.1
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4.7
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AEs Related to Study Drug
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37.2
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40
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40
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AEs Leading to Withdrawal
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7.9
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5.7
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5.7
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AEs Leading to Death
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1.1
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1.4
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0
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Severe Infection AEs
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1.1
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1.4
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1.3
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Severe Injection Site Reactions
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0
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0
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0
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Serious Adverse Events Occurring in >1 Subject, n(%)
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|||
Herpes zoster
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2 (0.8)
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2 (0.7)
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0
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Pneumonia
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4 (1.5)
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3 (1.1)
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1 (0.3)
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Urinary tract infections
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2 (0.8)
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2 (0.7)
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1 (0.3)
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SLE
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3 (1.1)
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2 (0.7)
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0
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Deep vein thrombosis
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2 (0.8)
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3 (1.1)
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0
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Cellulitis
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0
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0
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3 (0.8)
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o
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Clinical differentiation:
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§
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Potential for improved clinical response due to enriched patient selection;
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§
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A requirement that patients are receiving steroid therapy at time of randomization;
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§
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An improved clinical efficacy endpoint which requires a larger eight-point reduction in the SELENA-SLEDAI;
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§
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Potential to demonstrate reductions in lupus flares;
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§
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Restricting background medications sooner and therefore demonstrating an earlier clinical benefit;
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§
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4 BAFF binding domains, compared to the typical 2 domains; and
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§
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1KD affinity for BAFF, compared to the typical 250-350 picomole;
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o
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Patient convenience: A convenient, at-home, patient-administered subcutaneous product;
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o
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Mechanism of action: Blisibimod is able to inhibit the activity of both membrane-bound and soluble BAFF;
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·
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Potential labeling differentiation: A second study (CHABLIS-SC2) will also aim to enroll patients with stable renal disease (lupus nephritis);
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o
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Manufacturing and peptibody design: Blisibimod represents a novel molecular structure, which confers manufacturing benefits and lower cost of goods based on a bacterial fermentation manufacturing process and utilizes multiple binding sites to achieve highest reported affinity for inhibition of BAFF.
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Compound
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Stage
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Company
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Indications
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Notes
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|||||
Benlysta®
(intravenous and
subcutaneous)
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Approved
Phase 2/3
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GlaxoSmithKline plc
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Lupus (approved), Lupus Nephritis,
Myasthenia Gravis,
Idiopathic
Membranous
Nephropathy
Vasculitis, Pediatric Lupus
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• Monoclonal antibody against soluble BAFF
• Positive results reported in two Phase 3 clinical studies
• Phase 3 trials in lupus (evaluating subcutaneous administration) and lupus nephritis ongoing
• Phase 2 open-label trial in membranous nephropathy ongoing
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Tabalumab
(LY2127399)
(subcutaneous and
intravenous)
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Phase 3
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Eli Lilly and Company
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Lupus,
Multiple
Myeloma
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• Monoclonal antibody against BAFF inhibits soluble and membrane-bound BAFF
• Phase 3 rheumatoid arthritis program terminated
• TACI receptor fused to human Fc which targets BAFF and APRIL
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|||||
Epratuzumab
(intravenous)
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Phase 3
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Immunomedics, Inc./UCB S.A.
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Lupus,
Non-Hodgkin’s
Lymphoma
Acute Lymphoblastic Leukemia
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• Humanized antibody against CD-22, an agent that specifically targets B-cells and leads to decreased activity of peripheral B-cells
• Improvements in disease activity reported in placebo-controlled as well as longer-term OLE studies
• Phase 3 clinical studies in severe lupus ongoing
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Atacicept
(intravenous and
subcutaneous)
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Phase 3
Phase 2
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ZymoGenetics Inc./Merck Serono S.A.
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Lupus
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• Decreased incidence of lupus flares in patients with severe lupus reported from Phase 2/3 trial
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|||||
Lupuzor
(subcutaneous)
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Phase 3
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ImmuPharma plc
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Lupus
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• Modulates CD 4 T cells
• Positive Phase 2b clinical study results
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•
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obtain and maintain patent and other proprietary protection for the technology, inventions and improvements we consider important to our business;
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•
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defend our patents;
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•
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preserve the confidentiality of our trade secrets; and
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•
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operate our business without infringing the patents and proprietary rights of third parties.
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•
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Three U.S. patents;
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•
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One pending U.S. non-provisional patent application;
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•
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Two European Patents, or EP patents, each validated in one or more of Albania, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco, the Netherlands, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom;
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•
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One pending EP patent application;
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•
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Fifteen non-EP foreign patents in Australia, Canada, China, Estonia, Eurasia (validated in all nine Eurasian countries), Hong Kong, Japan, New Zealand, Norway, the Philippines, Poland, Singapore, South Korea and South Africa; and
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•
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Eleven pending non-EP foreign patent applications in Brazil, Bulgaria, China, the Czech Republic, Hong Kong, Hungary, Israel, Mexico, Norway, Poland, Serbia, Montenegro and Slovakia.
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•
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completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices regulations;
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•
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submission to the FDA of an IND, which must become effective before human clinical studies may begin;
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•
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performance of adequate and well-controlled human clinical studies according to Good Clinical Practices, or GCP, to establish the safety and efficacy of the proposed drug or biological product for its intended use;
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•
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submission to the FDA of an NDA for a new drug or BLA for a biological product;
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•
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug or biological product is produced to assess compliance with cGMP; and
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•
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FDA review and approval of the NDA or BLA.
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•
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Phase 1.
The product is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
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•
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Phase 2.
Involves studies in a limited patient population to identify possible adverse effects and safety risks to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage and schedule.
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•
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Phase 3.
Clinical studies are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These studies are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling.
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•
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obtain favorable results for and advance the development of our product candidate blisibimod for the treatment of B-cell mediated autoimmune diseases, including successfully launching and completing clinical studies in patients with systemic lupus erythematosus, or lupus, IgA nephropathy, or other indications related to the development of blisibimod;
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•
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obtain regulatory approval for blisibimod;
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•
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if regulatory approvals are obtained, begin the commercial manufacturing of our product candidate with third-party manufacturers;
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•
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launch commercial sales and effectively market our product candidate, either independently or in strategic collaborations with third parties; and
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•
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achieve broad market acceptance of our product candidate in the medical community and with third-party payors.
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•
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the scope, size, rate of progress, results and costs of our clinical studies and other development activities for our product candidate;
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•
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manufacturing campaign for blisibimod clinical matters, including formulation development and product enhancement;
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•
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non-clinical activities that we may pursue parallel to our clinical studies;
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•
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the cost, timing and outcomes of regulatory proceedings;
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•
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payments received under any strategic collaborations;
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•
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the filing, prosecution and enforcement of patent claims;
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•
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the costs associated with commercializing our product candidate if they receive regulatory approval, including the cost and timing of developing sales and marketing capabilities, or entering into strategic collaboration with others relating to the commercialization of our product candidate; and
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•
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revenues received from approved products, if any, in the future.
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•
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terminate, reduce or delay clinical studies or other development activities for our product candidate; or
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•
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terminate, reduce or delay our (i) pursuit of strategic collaborations with others relating to the development of our product candidate or (ii) other activities that may be necessary to commercialize our product candidate, if approved for sale.
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•
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offer therapeutic or other improvement over existing, comparable therapeutics;
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•
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be proven safe and effective in clinical studies;
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•
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meet applicable regulatory standards;
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•
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be capable of being produced in sufficient quantities at acceptable costs;
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•
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be successfully commercialized; or
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•
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obtain favorable reimbursement.
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•
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obtaining regulatory approval to commence a clinical study or complying with conditions imposed by a regulatory authority regarding the scope or design of a clinical study;
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•
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reaching agreement on acceptable terms with prospective clinical research organizations, or CROs, and study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and study sites;
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•
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manufacturing, including manufacturing sufficient quantities of a product candidate or other materials for use in clinical studies;
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•
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obtaining institutional review board, or IRB, approval or the approval of other reviewing entities to conduct a clinical study at a prospective site;
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•
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recruiting and enrolling patients to participate in clinical studies for a variety of reasons, including size of patient population, nature of clinical study protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical study programs for similar indications;
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•
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severe or unexpected drug-related adverse effects experienced by patients in a clinical study; and
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•
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retaining patients who have initiated a clinical study, but may withdraw due to treatment protocol, adverse effects from the therapy, lack of efficacy from the treatment, personal issues or who are lost to further follow-up.
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•
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failure to conduct the clinical study in accordance with regulatory requirements or our clinical protocols;
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•
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inspection of the clinical study operations or study sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
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•
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unforeseen safety issues or any determination that a clinical study presents unacceptable health risks; and
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•
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lack of adequate funding to continue the clinical study, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional clinical studies and increased expenses associated with the services of our CROs and other third parties.
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•
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regulatory authorities may withdraw their approval of the product;
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•
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regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;
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•
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we may be required to change the way the product is administered, conduct additional clinical studies or change the labeling of the product;
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•
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we could be sued and held liable for harm caused to patients; and
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•
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our reputation may suffer.
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•
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issue warning letters or untitled letters;
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•
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seek an injunction or impose civil or criminal penalties or monetary fines;
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•
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suspend or withdraw regulatory approval;
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•
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suspend any ongoing clinical studies;
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•
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refuse to approve pending applications or supplements to applications filed by us;
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•
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suspend or impose restrictions on operations, including costly new manufacturing requirements; or
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•
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seize or detain products, refuse to permit the import or export of products, or require us to initiate a product recall.
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•
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demonstration of clinical safety and efficacy compared to other products;
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•
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the relative convenience, ease of administration and acceptance by physicians and payors of blisibimod in the treatment of lupus;
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•
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the prevalence and severity of any adverse effects;
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•
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limitations or warnings contained in a product’s FDA-approved labeling;
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•
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availability of alternative treatments;
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•
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pricing and cost-effectiveness;
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•
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the effectiveness of our or any future collaborators’ sales and marketing strategies;
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•
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our ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid; and
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•
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the willingness of patients to pay out-of-pocket in the absence of third-party coverage.
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•
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impairment of our business reputation;
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•
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withdrawal of clinical study participants;
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•
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costs of related litigation;
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•
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distraction of management’s attention from our primary business;
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•
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substantial monetary awards to patients or other claimants;
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•
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the inability to commercialize our product candidate; and
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•
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decreased demand for our product candidate, if approved for commercial sale.
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High
|
Low
|
|||||||
First Quarter 2012
|
$
|
67.33
|
$
|
17.60
|
||||
Second Quarter 2012
|
$
|
25.68
|
$
|
5.41
|
||||
Third Quarter 2012
|
$
|
14.32
|
$
|
4.83
|
||||
Fourth Quarter 2012
|
$
|
9.36
|
$
|
4.64
|
||||
First Quarter 2013
|
$
|
6.72
|
$
|
3.92
|
||||
Second Quarter 2013
|
$
|
5.44
|
$
|
3.70
|
||||
Third Quarter 2013
|
$
|
4.60
|
$
|
3.11
|
||||
Fourth Quarter 2013
|
$
|
4.08
|
$
|
2.68
|
Cumulative
Period From
September
9, 2004
(Inception) to
|
||||||||||||||||||||||||||||||||
Years Ended December 31,
|
December 31,
|
|||||||||||||||||||||||||||||||
2013
|
2012(1)
|
2011(1)
|
2010(2)
|
2009
|
2013
|
|||||||||||||||||||||||||||
|
As restated
|
As restated
|
As reported
|
Adjustments
|
As restated
|
|||||||||||||||||||||||||||
(in thousands, except share and per share data)
|
||||||||||||||||||||||||||||||||
Statement of Operations Data:
|
||||||||||||||||||||||||||||||||
Operating expenses
|
||||||||||||||||||||||||||||||||
Research and development
|
$ | 21,684 | $ | 49,219 | $ | 85,281 | $ | 29,457 | $ | — | $ | 29,457 | $ | 8,415 | $ | 236,965 | ||||||||||||||||
General and administrative
|
6,563 | 6,715 | 7,857 | 6,301 | — | 6,301 | 3,426 | 37,353 | ||||||||||||||||||||||||
Total operating expenses
|
28,247 | 55,934 | 93,138 | 35,758 | — | 35,758 | 11,841 | 274,318 | ||||||||||||||||||||||||
Loss from operations
|
(28,247 | ) | (55,934 | ) | (93,138 | ) | (35,758 | ) | — | (35,758 | ) | (11,841 | ) | (274,318 | ) | |||||||||||||||||
Other income (expense):
|
||||||||||||||||||||||||||||||||
Other income (expense)
|
(15 | ) | (111 | ) | 606 | (15 | ) | — | (15 | ) | (192 | ) | 1,485 | |||||||||||||||||||
Interest expense
|
(2,599 | ) | (3,354 | ) | (2,803 | ) | (845 | ) | — | (845 | ) | (170 | ) | (10,301 | ) | |||||||||||||||||
Mark-to-market adjustment of warrant liability
|
— | 14,070 | (3,738 | ) | (3,796 | ) | (6,300 | ) | (10,096 | ) | — | 236 | ||||||||||||||||||||
Beneficial conversion feature
|
— | — | — | — | — | — | — | (4,309 | ) | |||||||||||||||||||||||
Total other income (expense)
|
(2,614 | ) | 10,605 | (5,935 | ) | (4,656 | ) | — | (10,956 | ) | (362 | ) | (12,889 | ) | ||||||||||||||||||
Net loss
|
$ | (30,861 | ) | $ | (45,329 | ) | $ | (99,073 | ) | $ | (40,414 | ) | $ | (6,300 | ) | $ | (46,714 | ) | $ | (12,203 | ) | $ | (287,207 | ) | ||||||||
Net loss per share — basic and diluted (3)(5)
|
$ | (1.69 | ) | $ | (6.27 | ) | $ | (21,18 | ) | $ | (14.11 | ) | $ | (2.20 | ) | $ | (16.31 | ) | $ | (64.50 | ) | |||||||||||
Weighted average shares used in net loss per share —
basic and diluted (4) (5)
|
18,267,413 | 7,225,406 | 4,677,210 | 2,863,716 | 2,863,716 | 2,863,716 | 189,200 |
December 31,
|
||||||||||||||||||||||||||||||||||||
2013
|
2012(1)
|
2011(2)
|
2010(2)
|
2009
|
||||||||||||||||||||||||||||||||
|
As restated
|
As reported
|
Adjustments
|
As restated
|
As reported
|
Adjustments
|
As restated
|
|
||||||||||||||||||||||||||||
(in thousands)
|
||||||||||||||||||||||||||||||||||||
Balance Sheet Data:
|
||||||||||||||||||||||||||||||||||||
Cash, cash equivalents and short-term investments
|
$ | 25,946 | $ | 24,753 | $ | 67,370 | — | $ | 67,370 | $ | 63,381 | $ | — | $ | 63,381 | $ | 3,803 | |||||||||||||||||||
Restricted cash
|
10,000 | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||
Working capital
|
18,743 | 6,429 | 37,742 | — | 37,742 | 57,241 | — | 57,241 | (14,344 | ) | ||||||||||||||||||||||||||
Total assets
|
37,417 | 26,445 | 69,493 | — | 69,493 | 65,263 | — | 65,263 | 5,889 | |||||||||||||||||||||||||||
Total notes payable
|
17,875 | 20,550 | 24,331 | — | 24,331 | — | — | — | — | |||||||||||||||||||||||||||
Total liabilities
|
22,659 | 29,971 | 50,409 | 16,338 | 66,747 | 8,005 | 12,600 | 20,605 | 18,168 | |||||||||||||||||||||||||||
Convertible preferred stock
|
— | — | — | — | — | — | — | — | 8 | |||||||||||||||||||||||||||
Common stock and additional paid-in capital
|
301,965 | 252,827 | 220,092 | (6,300 | ) | 213,792 | 162,952 | (6,300 | ) | 156,652 | 52,943 | |||||||||||||||||||||||||
Deficit accumulated during the development stage
|
(287,207 | ) | (256,346 | ) | (200,979 | ) | (10,038 | ) | (211,017 | ) | (105,644 | ) | (6,300 | ) | (111,944 | ) | (65,230 | ) | ||||||||||||||||||
Total stockholders’ equity (deficit)
|
14,758 | (3,526 | ) | 19,084 | (16,338 | ) | 2,746 | 57,258 | (12,600 | ) | 44,658 | (12,279 | ) |
Years Ended December 31,
|
For the
Period
September 9,
2004 (Date of
Inception) to
December 31,
|
|||||||||||||||
2013
|
2012
|
2011
|
2013
|
|||||||||||||
Allocated costs:
|
||||||||||||||||
Varespladib
|
$
|
323
|
$
|
20,468
|
$
|
46,139
|
$
|
114,019(1)
|
||||||||
Blisibimod
|
16,824
|
24,151
|
32,300
|
85,244 (2)
|
||||||||||||
Varespladib sodium
|
—
|
51
|
118
|
6,681
|
||||||||||||
Unallocated costs
|
4,537
|
4,549
|
6,724
|
31,021
|
||||||||||||
Total development
|
$
|
21, 684
|
$
|
49,219
|
$
|
85,281
|
$
|
236,965
|
|
(1)
|
Includes license fees of $4.0 million and milestone payment of $3.5 million pursuant to a license agreement and amendment thereto with each of Eli Lilly and Shionogi & Co. Ltd., which were paid in cash, shares of preferred stock and common stock.
|
|
|
|
(2)
|
Includes a one-time license initiation fee of $6.0 million pursuant to a license agreement with Amgen.
|
|
•
|
the number of sites included in the studies;
|
|
•
|
the length of time required to enroll suitable patient subjects;
|
|
•
|
the number of patients that participate in the studies;
|
|
•
|
the number of doses that patients receive;
|
|
•
|
the drop-out or discontinuation rates of patients; and
|
|
•
|
the duration of patient follow-up.
|
|
•
|
fees paid to CROs in connection with clinical studies;
|
|
•
|
fees paid to investigative sites in connection with clinical studies;
|
|
•
|
fees paid to contract manufacturers in connection with the production of clinical study materials; and
|
|
•
|
fees paid to vendors in connection with preclinical development activities.
|
2013
|
2012
|
$ Change
|
% Change
|
|||||||||||||
Research and development expense
|
$
|
21,684
|
$
|
49,219
|
$
|
(27,535
|
)
|
(56
|
)%
|
2013
|
2012
|
$ Change
|
% Change
|
|||||||||||||
General and administrative expenses
|
$
|
6,563
|
$
|
6,715
|
$
|
(152
|
)
|
(2
|
)%
|
2013
|
2012
|
$ Change
|
% Change
|
|||||||||||||
Other expense
|
$
|
(15
|
)
|
$
|
(111)
|
$
|
96
|
(86
|
)%
|
|||||||
Interest expense
|
(2,599
|
)
|
(3,354
|
)
|
755
|
(23)
|
%
|
|||||||||
Mark-to-market adjustment on warrant liability (1)
|
—
|
14,070
|
(14,070
|
)
|
(100)
|
%
|
||||||||||
Total Other income (expense)
|
$
|
(2,614)
|
$
|
10,605
|
$
|
(13,219
|
)
|
(125)
|
%
|
(1) |
See Note 2 “Restatement of Previously Issued Consolidated Financial Statements” of Notes to Consolidated Financial Statements
|
2012
|
2011
|
$ Change
|
% Change
|
|||||||||||||
Research and development expenses
|
$
|
49,219
|
$
|
85,281
|
$
|
(36,062)
|
(42
|
)%
|
2012
|
2011
|
$ Change
|
% Change
|
|||||||||||||
General and administrative expense
|
$
|
6,715
|
$
|
7,857
|
$
|
(1,142)
|
(15)%
|
2012
|
2011
|
$ Change
|
% Change
|
|||||||||||||
Other income (expense)
|
$ | (111 | ) | $ | 606 | $ | (717 | ) | (117 | %) | ||||||
Interest expense
|
(3,354 | ) | (2,803 | ) | (551 | ) | 21 | % | ||||||||
Mark-to-market adjustment on warrant liability (1)
|
14,070 | (3,738 | ) | 17,808 | (476 | %) | ||||||||||
Total Other income (expense)
|
$ | 10,605 | $ | (5,935 | ) | $ | 16,540 | (279 | %) |
(1) See Note 2 “Restatement of Previously Issued Consolidated Financial Statements” of Notes to Consolidated Financial Statements
|
Three Months Ended March 31,
|
||||||||||||||||
2013
|
2012
|
$ Change
|
% Change
|
|||||||||||||
Other income (expense)
|
$
|
25
|
$
|
(10
|
)
|
$
|
35
|
(350
|
%)
|
|||||||
Interest expense
|
(704
|
)
|
(843
|
)
|
139
|
(16
|
%)
|
|||||||||
Mark-to-market adjustment on warrant liability
|
—
|
11,382
|
(11,382
|
)
|
(100
|
%)
|
||||||||||
Total Other income (expense)
|
$
|
(679
|
)
|
$
|
10,529
|
$
|
(11,208
|
)
|
(106
|
%)
|
Three Months Ended June 30,
|
||||||||||||||||
2013
|
2012
|
$ Change
|
% Change
|
|||||||||||||
Other income (expense)
|
$
|
(6
|
)
|
$
|
(28
|
)
|
$
|
22
|
(79
|
%)
|
||||||
Interest expense
|
(1,322
|
)
|
(908
|
)
|
(414
|
)
|
46
|
%
|
||||||||
Mark-to-market adjustment on warrant liability
|
—
|
3,822
|
(3,822
|
)
|
(100
|
%)
|
||||||||||
Total Other income (expense)
|
$
|
(1,328
|
)
|
$
|
2,886
|
$
|
(4,214
|
)
|
(146
|
%)
|
Six Months Ended June 30,
|
||||||||||||||||
2013
|
2012
|
$ Change
|
% Change
|
|||||||||||||
Other income (expense)
|
$
|
19
|
$
|
(38
|
)
|
$
|
57
|
|
(150
|
%)
|
||||||
Interest expense
|
(2,026
|
)
|
(1,751
|
)
|
(275
|
)
|
16
|
%
|
||||||||
Mark-to-market adjustment on warrant liability
|
—
|
15,204
|
(15,204
|
)
|
(100
|
%)
|
||||||||||
Total Other income (expense)
|
$
|
(2,007
|
)
|
$
|
13,415
|
$
|
(15,422
|
)
|
(115
|
%)
|
Three Months Ended September 30,
|
||||||||||||||||
2013
|
2012
|
$ Change
|
% Change
|
|||||||||||||
Other income (expense)
|
$
|
14
|
$
|
(46
|
)
|
$
|
60
|
(130
|
%)
|
|||||||
Interest expense
|
(296
|
)
|
(806
|
)
|
510
|
(63
|
%)
|
|||||||||
Mark-to-market adjustment on warrant liability
|
—
|
(1,134
|
)
|
1,134
|
(100
|
%)
|
||||||||||
Total Other income (expense)
|
$
|
(282
|
)
|
$
|
(1,986
|
)
|
$
|
1,704
|
(86
|
%)
|
Nine Months Ended September 30,
|
||||||||||||||||
2013
|
2012
|
$ Change
|
% Change
|
|||||||||||||
Other income (expense)
|
$
|
33
|
$
|
(84
|
)
|
$
|
117
|
(139
|
%)
|
|||||||
Interest expense
|
(2,322
|
)
|
(2,557
|
)
|
235
|
(9
|
%)
|
|||||||||
Mark-to-market adjustment on warrant liability
|
—
|
14,070
|
(14,070
|
)
|
(100
|
%)
|
||||||||||
Total Other income (expense)
|
$
|
(2,289
|
)
|
$
|
11,429
|
$
|
(13,718
|
)
|
(120
|
%)
|
2013
|
2012
|
|||||||
Cash and cash equivalents
|
$
|
25,946
|
$
|
19,431
|
||||
Short-term investments
|
—
|
5,322
|
||||||
Total
|
$
|
25,946
|
$
|
24,753
|
2013
|
2012
|
|||||||
Net cash used in operating activities
|
$
|
(31,912
|
)
|
$
|
(73,635
|
)
|
||
Net cash used in investing activities
|
(4,687
|
)
|
(3,783)
|
|||||
Net cash provided by financing activities
|
43,115
|
31,256
|
||||||
Effect of exchange rate on cash
|
(1
|
)
|
(31)
|
|||||
Total
|
$
|
6,515
|
$
|
(46,193)
|
2012
|
2011
|
|||||||
Net cash used in operating activities
|
$
|
(73,635
|
)
|
$
|
(73,067
|
)
|
||
Net cash provided by (used in) investing activities
|
(3,783)
|
20,232
|
||||||
Net cash provided by financing activities
|
31,256
|
78,429
|
||||||
Effect of exchange rate on cash
|
(31)
|
—
|
||||||
Total
|
$
|
(46,193)
|
$
|
25,594
|
Payments Due by Period
|
Less than 1 year
|
1 - 3 years
|
3-5 years
|
More than 5
years
|
Total
|
|||||||||||||||
Notes Payable
|
$
|
2,857
|
$
|
5,238
|
$
|
10,000
|
$
|
—
|
$
|
18,095
|
||||||||||
Interest on Notes Payable
|
772
|
700
|
34
|
—
|
1,506
|
|||||||||||||||
Facility Lease
|
217
|
442
|
167
|
—
|
826
|
|||||||||||||||
Total
|
$
|
3,846
|
$
|
6,380
|
10,201
|
—
|
$
|
20,427
|
|
•
|
continue clinical development of blisibimod;
|
|
•
|
hire additional clinical, scientific and management personnel; and
|
|
•
|
implement new operational, financial and management information systems.
|
|
•
|
the progress of clinical studies of our product candidate;
|
|
•
|
the time and costs involved in obtaining regulatory approvals;
|
|
•
|
delays that may be caused by evolving requirements of regulatory agencies;
|
|
•
|
the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims;
|
|
•
|
our ability to establish, enforce and maintain selected strategic alliances; and
|
|
•
|
the acquisition of technologies, product candidate and other business opportunities that require financial commitments.
|
(a)
|
The following documents are filed as part of this report:
|
|
(1)
|
Index list to Consolidated Financial Statements:
|
Page
|
|
Report of Independent Registered Public Accounting Firm
|
F-2
|
Report of Independent Registered Public Accounting Firm
|
F-3
|
Balance Sheets
|
F-4
|
Statements of Operations
|
F-5
|
Statements of Comprehensive Loss
|
F-6
|
Statements of Stockholders’ Equity (Deficit)
|
F-7
|
Statements of Cash Flows
|
F-10
|
Notes to Consolidated Financial Statements
|
F-11
|
|
(2)
|
Consolidated financial statement Schedules
|
|
(3)
|
Exhibits
|
December 31,
2013
|
December 31,
2012
|
|||||||
ASSETS
|
||||||||
(As restated)(1) | ||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
25,946
|
$
|
19,431
|
||||
Short-term investments
|
—
|
5,322
|
||||||
Prepaid expenses and other current assets
|
358
|
426
|
||||||
Total current assets
|
26,304
|
25,179
|
||||||
Property and equipment—net
|
812
|
1,150
|
||||||
Restricted cash
|
10,000
|
—
|
||||||
Other assets
|
301
|
116
|
||||||
TOTAL
|
$
|
37,417
|
$
|
26,445
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY(DEFICIT)
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
3,519
|
$
|
5,206
|
||||
Accrued clinical studies
|
472
|
3,374
|
||||||
Accrued liabilities
|
474
|
497
|
||||||
Accrued payroll and related costs
|
319
|
344
|
||||||
Short term portion of notes payable, net of discount
|
2,777
|
9,329
|
||||||
Total current liabilities
|
7,561
|
18,750
|
||||||
Notes payable, net of discount
|
15,098
|
11,221
|
||||||
Total liabilities
|
22,659
|
29,971
|
||||||
Commitments and contingencies (Note 7)
|
||||||||
Stockholders’ equity (deficit)
|
||||||||
Common stock, $0.001 par value, 100,000,000 shares authorized; 19,415,901 and
9,893,924 shares issued and outstanding as of December 31, 2013 and 2012, respectively
|
19
|
10
|
||||||
Additional paid-in capital
|
301,946
|
252,827
|
||||||
Accumulated other comprehensive loss
|
—
|
(17
|
)
|
|||||
Deficit accumulated during the development stage
|
(287,207
|
)
|
(256,346
|
)
|
||||
Total stockholders’ equity (deficit)
|
14,758
|
(3,526
|
)
|
|||||
TOTAL
|
$
|
37,417
|
$
|
26,445
|
(1)
|
See Note 2 “Restatement of Previously Issued Consolidated Financial Statements” of Notes to Consolidated Financial Statements.
|
Year Ended December 31,
|
Cumulative
Period from
September 9,
2004
(Date of
Inception) to
December 31,
|
|||||||||||||||
2013
|
2012
|
2011
|
2013
|
|||||||||||||
(As restated) (1)
|
(As restated) (1)
|
|||||||||||||||
OPERATING EXPENSES:
|
||||||||||||||||
Research and development
|
$
|
21,684
|
$
|
49,219
|
$
|
85,281
|
$
|
236,965
|
||||||||
General and administrative
|
6,563
|
6,715
|
7,857
|
37,353
|
||||||||||||
Total operating expenses
|
28, 247
|
55,934
|
93,138
|
274,318
|
||||||||||||
LOSS FROM OPERATIONS
|
(28,247
|
)
|
(55,934
|
)
|
(93,138
|
)
|
(274,318
|
)
|
||||||||
OTHER INCOME (EXPENSE):
|
||||||||||||||||
Other income (expense)
|
(15
|
)
|
(111)
|
606
|
1,485
|
|||||||||||
Interest expense
|
(2,599
|
)
|
(3,354
|
)
|
(2,803
|
)
|
(10,301
|
)
|
||||||||
Mark-to-market adjustment of warrant liability
|
—
|
14,070
|
(3,738)
|
236
|
||||||||||||
Beneficial conversion features
|
—
|
—
|
—
|
(4,309
|
)
|
|||||||||||
Total other income (expense)
|
(2,614
|
)
|
10,605
|
(5,935
|
)
|
(12,889
|
)
|
|||||||||
NET LOSS
|
$
|
(30,861
|
)
|
$
|
(45,329
|
)
|
$
|
(99,073
|
)
|
$
|
(287,207
|
)
|
||||
Net loss per share—basic and diluted
|
$
|
(1.69
|
)
|
$
|
(6.27
|
)
|
$
|
(21.18
|
)
|
|||||||
Weighted-average number of shares used in per share
calculation—basic and diluted |
18,267,413
|
7,225,406
|
4,677,210
|
(1)
|
See Note 2 “Restatement of Previously Issued Consolidated Financial Statements” of Notes to Consolidated Financial Statements.
|
Years Ended December 31,
|
Cumulative
Period from
September 9,
2004
(Date of
Inception) to
December 31,
|
|||||||||||||||
2013
|
2012
|
2011
|
2013
|
|||||||||||||
(As restated) (1) | (As restated) (1) | |||||||||||||||
Net loss
|
$ | (30, 861 | ) | $ | (45,329 | ) | $ | (99,073 | ) | $ | (287,207 | ) | ||||
Unrealized gain on short term investments , net
|
17 | 12 | 21 | — | ||||||||||||
Comprehensive loss
|
(30,844 | ) | (45,317 | ) | (99,052 | ) | (287,207 | ) |
(1)
|
See Note 2 “Restatement of Previously Issued Consolidated Financial Statements” of Notes to Consolidated Financial Statements.
|
Convertible
Preferred Stock
|
Common Stock
|
Additional
Paid-In
|
Accumulated
Other
Comprehensive
|
Deficit
Accumulated
During
Development
|
Total
Stockholders’
Equity
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Loss
|
Stage
|
(Deficit)
|
|||||||||||||||||||||||||
DATE OF INCEPTION—September 9, 2004
|
||||||||||||||||||||||||||||||||
Issuance of common stock to founders for cash
|
—
|
$
|
—
|
17,523
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||||||||||
Issuance of common stock to founders for service
|
—
|
—
|
91,997
|
—
|
2
|
—
|
—
|
2
|
||||||||||||||||||||||||
Repurchase of common stock from founder
|
—
|
—
|
(9,126
|
)
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||
Issuance of Series A convertible preferred stock for cash at $1.47 per share, net of issuance cost of $9
|
526,955
|
1
|
—
|
—
|
767
|
—
|
—
|
768
|
||||||||||||||||||||||||
Issuance of Series A convertible preferred stock in exchange for service at $1.47 per share
|
25,575
|
—
|
—
|
—
|
38
|
—
|
—
|
38
|
||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options
|
—
|
—
|
4,161
|
5
|
—
|
—
|
5
|
|||||||||||||||||||||||||
Reclass of early exercise of stock options to liability
|
—
|
—
|
(3,650
|
)
|
—
|
(4
|
)
|
—
|
—
|
(4
|
)
|
|||||||||||||||||||||
Share-based compensation related to equity awards
|
—
|
—
|
—
|
—
|
1
|
—
|
—
|
1
|
||||||||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(554
|
)
|
(554
|
)
|
||||||||||||||||||||||
BALANCE—December 31, 2005
|
552,530
|
1
|
100,905
|
—
|
809
|
—
|
(554
|
)
|
256
|
|||||||||||||||||||||||
Conversion of Series A convertible preferred stock to Series A-1 convertible preferred stock at a ratio of 1:1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
Issuance of Series A-2 convertible preferred stock for cash at $5.14 per share—net of issuance cost of $202
|
1,138,677
|
1
|
—
|
—
|
5,645
|
—
|
—
|
5,646
|
||||||||||||||||||||||||
Issuance of Series A-2 convertible preferred stock upon conversion of convertible promissory notes at $3.85 and $5.14 per share
|
224,248
|
—
|
—
|
—
|
962
|
—
|
—
|
962
|
||||||||||||||||||||||||
Issuance of Series A-2 convertible preferred stock in exchange for licensed technology at $5.14 per share
|
257,744
|
—
|
—
|
—
|
1,324
|
—
|
—
|
1,324
|
||||||||||||||||||||||||
Beneficial conversion feature related to conversion of convertible promissory notes into Series A-1 convertible preferred stock
|
—
|
—
|
—
|
—
|
190
|
—
|
—
|
190
|
||||||||||||||||||||||||
Issuance of Series B convertible preferred stock for cash at $7.28 per share—net of issuance cost of $21
|
2,619,568
|
3
|
—
|
—
|
19,036
|
—
|
—
|
19,039
|
||||||||||||||||||||||||
Issuance of Series B convertible preferred stock in exchange for licensed technology at $7.28 per share
|
127,297
|
—
|
—
|
—
|
926
|
—
|
—
|
926
|
||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options
|
—
|
—
|
15,697
|
—
|
17
|
—
|
—
|
17
|
||||||||||||||||||||||||
Reclass of early exercise of stock options to liability
|
—
|
—
|
(4,601
|
)
|
—
|
(5
|
)
|
—
|
—
|
(5
|
)
|
|||||||||||||||||||||
Share-based compensation related to equity awards
|
—
|
—
|
—
|
—
|
9
|
—
|
—
|
9
|
||||||||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(8,679
|
)
|
(8,679
|
)
|
||||||||||||||||||||||
BALANCE—December 31, 2006
|
4,920,064
|
5
|
112,001
|
—
|
28,913
|
—
|
(9,233
|
)
|
19,685
|
|||||||||||||||||||||||
Issuance of common stock upon exercise of stock options
|
—
|
—
|
61,700
|
—
|
118
|
—
|
—
|
118
|
||||||||||||||||||||||||
Reclass of early exercise of stock options liability
|
—
|
—
|
(30,020
|
)
|
—
|
(60
|
)
|
—
|
—
|
(60
|
)
|
|||||||||||||||||||||
Issuance of common stock for service
|
—
|
—
|
2,044
|
—
|
2
|
—
|
—
|
2
|
||||||||||||||||||||||||
Share-based compensation related to equity awards
|
—
|
—
|
—
|
—
|
87
|
—
|
—
|
87
|
||||||||||||||||||||||||
Unrealized loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
(2
|
)
|
—
|
(2
|
)
|
||||||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(25,695
|
)
|
(25,695
|
)
|
||||||||||||||||||||||
BALANCE—December 31, 2007
|
4,920,064
|
5
|
145,725
|
—
|
29,060
|
(2
|
)
|
(34,928
|
)
|
(5,865
|
)
|
|||||||||||||||||||||
Conversion of Series B convertible preferred stock to Series B-1 convertible preferred stock at a ratio of 1:1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
Issuance of Series B-2 convertible preferred stock for cash at $7.28 per share—net of issuance cost of $242
|
962,066
|
1
|
—
|
—
|
6,512
|
—
|
—
|
6,513
|
||||||||||||||||||||||||
Issuance of Series B-2 convertible preferred stock upon conversion of convertible promissory notes at $5.46 per share
|
2,235,661
|
2
|
—
|
—
|
12,198
|
—
|
—
|
12,200
|
||||||||||||||||||||||||
Issuance of Series B-2 convertible preferred stock in lieu of interest payment at $5.46 per share
|
28,517
|
—
|
—
|
—
|
156
|
—
|
—
|
156
|
||||||||||||||||||||||||
Issuance of warrants in connection with issuance of Series B-2 convertible preferred stock
|
—
|
—
|
—
|
—
|
244
|
—
|
—
|
244
|
||||||||||||||||||||||||
Beneficial conversion feature related to conversion of convertible promissory notes into Series B-2 convertible preferred stock
|
—
|
—
|
—
|
—
|
4,119
|
—
|
—
|
4,119
|
||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options
|
—
|
—
|
22,485
|
—
|
68
|
—
|
—
|
68
|
||||||||||||||||||||||||
Release of early exercise of stock options liability
|
—
|
—
|
16,022
|
—
|
13
|
—
|
—
|
13
|
||||||||||||||||||||||||
Repurchase of common stock upon employee termination
|
—
|
—
|
(2,371
|
)
|
—
|
(5
|
)
|
—
|
—
|
(5
|
)
|
|||||||||||||||||||||
Share-based compensation related to equity awards
|
—
|
—
|
—
|
—
|
195
|
—
|
—
|
195
|
||||||||||||||||||||||||
Unrealized gain on short-term investments
|
—
|
—
|
—
|
—
|
—
|
1
|
—
|
1
|
||||||||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(18,099
|
)
|
(18,099
|
)
|
||||||||||||||||||||||
BALANCE—December 31, 2008
|
8,146,308
|
8
|
181,861
|
—
|
52,560
|
(1
|
)
|
(53,027
|
)
|
(460
|
)
|
Convertible
Preferred Stock
|
Common Stock
|
Additional
Paid-In
|
Accumulated
Other
Comprehensive
|
Deficit
Accumulated
During
Development
|
Total
Stockholders’
Equity
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Loss
|
Stage
|
(Deficit)
|
|||||||||||||||||||||||||
BALANCE—December 31, 2008
|
8,146,308
|
$
|
8
|
181,861
|
$
|
—
|
$
|
52,560
|
$
|
(1
|
)
|
$
|
(53,027
|
)
|
$
|
(460
|
)
|
|||||||||||||||
Issuance of common stock upon exercise
of stock options |
—
|
—
|
2,386
|
—
|
15
|
—
|
—
|
15
|
||||||||||||||||||||||||
Release of early exercise of stock options liability
|
—
|
—
|
11,527
|
—
|
26
|
—
|
—
|
26
|
||||||||||||||||||||||||
Share-based compensation related to equity awards
|
—
|
—
|
—
|
—
|
342
|
—
|
—
|
342
|
||||||||||||||||||||||||
Unrealized gain on short-term investments
|
—
|
—
|
—
|
—
|
—
|
1
|
—
|
1
|
||||||||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,203
|
)
|
(12,203
|
)
|
||||||||||||||||||||||
BALANCE —December 31, 2009
|
8,146,308
|
8
|
195,774
|
—
|
$
|
52,943
|
—
|
(65,230
|
)
|
(12,279
|
)
|
|||||||||||||||||||||
Conversion of convertible preferred stock to common stock at a ratio of 1:1
|
(8,146,308
|
)
|
(8
|
)
|
1,018,288
|
1
|
7
|
—
|
—
|
—
|
||||||||||||||||||||||
Issuance of common stock for cash at $56.00 per share—net of issuance cost of $3,039
|
—
|
—
|
750,000
|
1
|
37,080
|
—
|
—
|
37,081
|
||||||||||||||||||||||||
Issuance of common stock upon conversion of convertible promissory notes and accrued interest at $42.00 and $50.24 per share
|
—
|
—
|
313,904
|
—
|
13,884
|
—
|
—
|
13,884
|
||||||||||||||||||||||||
Issuance of common stock upon release of escrow funds
|
—
|
—
|
324,847
|
—
|
17,100
|
—
|
—
|
17,100
|
||||||||||||||||||||||||
Issuance of common stock upon cashless exercise of warrants
|
—
|
—
|
24,309
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
Issuance of common stock to collaborator in lieu of milestone payment
|
—
|
—
|
66,497
|
—
|
3,500
|
—
|
—
|
3,500
|
||||||||||||||||||||||||
Issuance of common stock upon exercise of overallotment by underwriters net of issuance cost of $17
|
—
|
—
|
75,561
|
—
|
3,961
|
—
|
—
|
3,961
|
||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options
|
—
|
—
|
17,359
|
—
|
116
|
—
|
—
|
116
|
||||||||||||||||||||||||
Issuance of common stock pursuant to employee stock purchase plan
|
—
|
—
|
3,114
|
—
|
81
|
—
|
—
|
81
|
||||||||||||||||||||||||
Issuance of common stock upon private placement transaction, net of issuance cost of $508(1)
|
—
|
—
|
1,312,492
|
2
|
22,800
|
—
|
—
|
22,802
|
||||||||||||||||||||||||
Net change of early exercise of stock options and liability
|
—
|
—
|
4,479
|
—
|
1
|
—
|
—
|
1
|
||||||||||||||||||||||||
Reclass of warrant and derivative liability to equity in conjunction with conversion of convertible promissory notes into common stock
|
—
|
—
|
—
|
—
|
4,473
|
—
|
—
|
4,473
|
||||||||||||||||||||||||
Share-based compensation related to equity awards
|
—
|
—
|
—
|
—
|
702
|
—
|
—
|
702
|
||||||||||||||||||||||||
Unrealized loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
(50
|
)
|
—
|
(50
|
)
|
||||||||||||||||||||||
Net loss(1)
|
—
|
—
|
—
|
—
|
—
|
—
|
(46,714
|
)
|
(46,714
|
)
|
||||||||||||||||||||||
BALANCE—December 31, 2010
|
—
|
—
|
4,106,624
|
4
|
156,648
|
(50
|
)
|
(111,944
|
)
|
44,658
|
||||||||||||||||||||||
Issuance of common stock upon exercise of stock options
|
—
|
—
|
33,793
|
—
|
241
|
—
|
—
|
241
|
||||||||||||||||||||||||
Issuance of common stock for cash at $60.00 per share—net of issuance cost of $198
|
—
|
—
|
958,333
|
1
|
53,852
|
—
|
—
|
53,853
|
||||||||||||||||||||||||
Issuance of common stock upon exercise of warrants
|
—
|
—
|
8,333
|
—
|
220
|
—
|
—
|
220
|
||||||||||||||||||||||||
Issuance of common stock upon release of restricted stock units
|
—
|
—
|
3,918
|
—
|
102
|
—
|
—
|
102
|
||||||||||||||||||||||||
Issuance of common stock pursuant to employee stock purchase plan
|
—
|
—
|
3,535
|
—
|
134
|
—
|
—
|
134
|
||||||||||||||||||||||||
Net change of early exercise of stock options and liability
|
—
|
—
|
2,126
|
—
|
21
|
—
|
—
|
21
|
||||||||||||||||||||||||
Issuance of warrants in conjunction with debt financing
|
—
|
—
|
—
|
—
|
1,276
|
—
|
—
|
1,276
|
||||||||||||||||||||||||
Share-based compensation related to equity awards
|
—
|
—
|
—
|
—
|
1,293
|
—
|
—
|
1,293
|
||||||||||||||||||||||||
Unrealized gain on short-term investments
|
—
|
—
|
—
|
—
|
—
|
21
|
—
|
21
|
||||||||||||||||||||||||
Net loss(1)
|
—
|
—
|
—
|
—
|
—
|
—
|
(99,073
|
)
|
(99,073
|
)
|
||||||||||||||||||||||
BALANCE—December 31, 2011
|
—
|
$
|
—
|
5,116,662
|
$
|
5
|
$
|
213,787
|
$
|
(29
|
)
|
$
|
(211,017
|
)
|
$
|
2,746
|
Convertible
Preferred Stock
|
Common Stock
|
Additional
Paid-In
|
Accumulated
Other
Comprehensive
|
Deficit
Accumulated
During
Development
|
Total
Stockholders’
Equity
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Loss
|
Stage
|
(Deficit)
|
|||||||||||||||||||||||||
BALANCE—December 31, 2011
|
—
|
$
|
—
|
5,116,662
|
$
|
5
|
$
|
213,787
|
$
|
(29
|
)
|
$
|
(211,017
|
)
|
$
|
2,746
|
||||||||||||||||
Issuance of common stock upon
exercise of stock options |
—
|
—
|
19,316
|
—
|
157
|
—
|
—
|
157
|
||||||||||||||||||||||||
Issuance of common stock for cash at $8.00 per share—net of issuance cost of $98
|
—
|
—
|
4,743,750
|
5
|
35,570
|
—
|
—
|
35,575
|
||||||||||||||||||||||||
Issuance of common stock upon release of restricted stock units
|
—
|
—
|
6,862
|
—
|
65
|
—
|
—
|
65
|
||||||||||||||||||||||||
Issuance of common stock pursuant to employee stock purchase plan
|
—
|
—
|
6,749
|
—
|
29
|
—
|
—
|
29
|
||||||||||||||||||||||||
Reclass of warrant liability to equity (1)
|
—
|
—
|
—
|
—
|
2,268
|
—
|
—
|
2,268
|
||||||||||||||||||||||||
Net change of early exercise of stock options and liability
|
—
|
—
|
585
|
—
|
7
|
—
|
—
|
7
|
||||||||||||||||||||||||
Share-based compensation related to equity awards
|
—
|
—
|
—
|
—
|
944
|
—
|
—
|
944
|
||||||||||||||||||||||||
Unrealized loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
12
|
—
|
12
|
||||||||||||||||||||||||
Net loss (1)
|
—
|
—
|
—
|
—
|
—
|
—
|
(45,329
|
)
|
(45,329
|
)
|
||||||||||||||||||||||
BALANCE—December 31, 2012
|
—
|
—
|
9,893,924
|
10
|
252,827
|
(17)
|
(256,346
|
)
|
(3,526)
|
|||||||||||||||||||||||
Issuance of common stock upon release of restricted stock units
|
—
|
—
|
31,081
|
—
|
51
|
—
|
—
|
51
|
||||||||||||||||||||||||
Issuance of common stock pursuant to employee stock purchase plan
|
—
|
—
|
13,961
|
—
|
38
|
—
|
—
|
38
|
||||||||||||||||||||||||
Issuance of common stock for cash at $5.28 per share, net of issuance cost of $474
|
—
|
—
|
8,712,119
|
9
|
42,737
|
—
|
—
|
42,746
|
||||||||||||||||||||||||
Issuance of common stock pursuant to an equity purchase agreement , net of issuance cost of $471
|
—
|
—
|
764,816
|
—
|
2,959
|
—
|
—
|
2,959
|
||||||||||||||||||||||||
Share-based compensation related to equity awards
|
—
|
—
|
—
|
—
|
3,054
|
—
|
—
|
3,054
|
||||||||||||||||||||||||
Issuance of warrants in conjunction with debt financing
|
—
|
—
|
—
|
—
|
280
|
—
|
—
|
280
|
||||||||||||||||||||||||
Unrealized loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
17
|
—
|
17
|
||||||||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(30,861)
|
(30,861)
|
||||||||||||||||||||||||
BALANCE—December 31, 2013
|
—
|
$
|
—
|
19,415,901
|
$
|
19
|
$
|
301,946
|
$
|
—
|
$
|
(287,207
|
)
|
$
|
14,758
|
(1)
|
See Note 2 “Restatement of Previously Issued Consolidated Financial Statements” of Notes to Consolidated Financial Statements
|
Year Ended December 31,
|
September 9,
2004
(Date of
Inception) to
December 31,
|
|||||||||||||||
2013
|
2012
|
2011
|
2013
|
|||||||||||||
(As restated) (1)
|
(As restated) (1)
|
|||||||||||||||
CASH FLOW FROM OPERATING ACTIVITIES:
|
||||||||||||||||
Net loss
|
$
|
(30,861
|
)
|
$
|
(45,329
|
)
|
$
|
(99,073
|
)
|
$
|
(287,207
|
)
|
||||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||||||
Depreciation
|
353
|
331
|
80
|
854
|
||||||||||||
Amortization of premium on short-term investments
|
—
|
—
|
84
|
56
|
||||||||||||
Realized loss/(gain) on short-term investments and foreign currency exchange rates fluctuation
|
12
|
46
|
(8)
|
(106
|
)
|
|||||||||||
Stock-based compensation expense
|
3,145
|
960
|
2,423
|
7,865
|
||||||||||||
Issuance of preferred and common stock for license fee, interest and service
|
—
|
—
|
—
|
6,122
|
||||||||||||
Beneficial conversion feature
|
—
|
—
|
—
|
4,309
|
||||||||||||
Amortization of discount and deferred interest on convertible notes and notes payable
|
979
|
749
|
364
|
3,033
|
||||||||||||
Amortization of debt issuance cost
|
190
|
123
|
374
|
730
|
||||||||||||
Mark-to-market adjustment on warrant liability
|
—
|
(14,070)
|
3,738
|
(236)
|
||||||||||||
Changes in assets and liabilities:
|
||||||||||||||||
Prepaid expenses and other assets
|
66
|
184
|
1,253
|
(361
|
)
|
|||||||||||
Accounts payable
|
(1,833
|
)
|
(12,226)
|
13,574
|
3,564
|
|||||||||||
Accrued clinical studies
|
(2,902
|
)
|
(4,340)
|
4,579
|
474
|
|||||||||||
Accrued liabilities
|
(1,036
|
)
|
(35
|
)
|
(191
|
)
|
(801)
|
|||||||||
Accrued payroll and related costs
|
(25
|
)
|
(28
|
)
|
(264)
|
292
|
||||||||||
Net cash used in operating activities
|
(31,912
|
)
|
(73,635
|
)
|
(73,067
|
)
|
(261,412
|
)
|
||||||||
INVESTING ACTIVITIES:
|
||||||||||||||||
Property and equipment purchases
|
(15
|
)
|
(207
|
)
|
(1,346
|
)
|
(1,675
|
)
|
||||||||
Purchase of short-term investments
|
—
|
(10,671
|
)
|
(4,735
|
)
|
(55,155
|
)
|
|||||||||
Proceeds from maturities of short-term investments
|
5,328
|
7,095
|
26,313
|
55,268
|
||||||||||||
Increase in restricted cash
|
(10,000
|
)
|
—
|
—
|
(10,000)
|
|||||||||||
Net cash provided by (used in) investing activities
|
(4,687
|
)
|
(3,783)
|
20,232
|
(11,562
|
)
|
||||||||||
FINANCING ACTIVITIES:
|
||||||||||||||||
Proceeds from issuance of convertible notes and notes payable, net of issuance costs
|
19,798
|
—
|
24,700
|
70,750
|
||||||||||||
Principal payment against note payable
|
(22,436
|
)
|
(4,468)
|
—
|
(26,904
|
)
|
||||||||||
Proceeds from issuance of preferred stock, net
|
—
|
—
|
—
|
32,210
|
||||||||||||
Proceeds from issuance of common stock, net of offering costs
|
45,746
|
35,575
|
54,012
|
222,602
|
||||||||||||
Proceeds from issuance of common stock pursuant to employee stock purchase plan and exercise of stock options
|
39
|
186
|
376
|
1,022
|
||||||||||||
Proceeds from issuance of common stock pursuant to exercise of warrant
|
—
|
—
|
220
|
220
|
||||||||||||
Withholding taxes paid on vested restricted stock units
|
(32
|
)
|
(37
|
)
|
(879)
|
(948
|
)
|
|||||||||
Net cash provided by financing activities
|
43,115
|
31,256
|
78,429
|
298,952
|
||||||||||||
Effect of exchange rate changes on cash
|
(1
|
)
|
(31)
|
—
|
(32
|
)
|
||||||||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
6,515
|
(46,193)
|
25,594
|
25,946
|
||||||||||||
CASH AND CASH EQUIVALENTS—Beginning of period
|
19,431
|
65,624
|
40,030
|
—
|
||||||||||||
CASH AND CASH EQUIVALENTS—End of period
|
$
|
25,946
|
$
|
19,431
|
$
|
65,624
|
$
|
25,946
|
||||||||
SUPPLEMENTAL CASH DISCLOSURES OF CASH FLOW INFORMATION:
|
||||||||||||||||
Interest paid
|
$
|
2,477
|
$
|
2,583
|
$
|
1,838
|
$
|
6,913
|
||||||||
NONCASH INVESTING AND FINANCING ACTIVITIES:
|
||||||||||||||||
Conversion of convertible promissory notes and accrued interest into common stock, Series A-2 convertible preferred stock and Series B-2 convertible preferred stock, including unamortized debt discount
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
27,386
|
||||||||
Beneficial conversion feature
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
4,309
|
||||||||
Reclassification of issuance costs charged to equity
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
3,565
|
||||||||
Issuance of warrants in conjunction with debt financing
|
$
|
280
|
$
|
—
|
$
|
1,276
|
$
|
1,556
|
(1)
|
See Note 2 “Restatement of Previously Issued Consolidated Financial Statements” of Notes to Consolidated Financial Statements
|
Year ended December 31,
|
||||||||||||||||||||||||
2012
|
2011
|
|||||||||||||||||||||||
As reported
|
Adjustments
|
As restated
|
As reported
|
Adjustments
|
As restated
|
|||||||||||||||||||
Operating expenses
|
||||||||||||||||||||||||
R Research and development
|
$
|
49,219
|
$
|
—
|
$
|
49,219
|
$
|
85,281
|
$
|
—
|
$
|
85,281
|
||||||||||||
General and administrative
|
6,715
|
—
|
6,715
|
7,857
|
—
|
7,857
|
||||||||||||||||||
Total operating expense
|
55,934
|
—
|
55,934
|
93,138
|
—
|
93,138
|
||||||||||||||||||
Loss from operations
|
(55,934
|
)
|
—
|
(55,934
|
)
|
(93,138
|
)
|
—
|
(93,138
|
)
|
||||||||||||||
Other income (expense):
|
||||||||||||||||||||||||
In Other income (expense)
|
(111
|
)
|
—
|
(111)
|
606
|
—
|
606
|
|||||||||||||||||
Interest expense
|
(3,354
|
)
|
—
|
(3,354
|
)
|
(2,803
|
)
|
—
|
(2,803
|
)
|
||||||||||||||
Mark-to-market adjustment of warrants liability
|
—
|
14,070
|
14,070
|
—
|
(3,738
|
)
|
(3,738
|
)
|
||||||||||||||||
Beneficial conversion features
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||
Total other income (expense)
|
(3,465
|
)
|
14,070
|
10,605
|
(2,197
|
)
|
—
|
(5,935
|
)
|
|||||||||||||||
Net loss
|
$
|
(59,399
|
)
|
$
|
14,070
|
$
|
(45,329
|
)
|
$
|
(95,335
|
)
|
$
|
(3,738
|
)
|
$
|
(99,073
|
)
|
|||||||
N Net loss per share — basic and diluted
|
$
|
(8.22
|
)
|
$
|
1.95
|
$
|
(6.27
|
)
|
$
|
(20.38
|
)
|
$
|
(0.80
|
)
|
$
|
(21.18
|
)
|
|||||||
Weighted average shares used in net income (loss) per share — basic and diluted
|
7,225,406
|
—
|
7,225,406
|
4,677,210
|
—
|
4,677,210
|
As Previously
|
As
|
|||||||||||
Reported
|
Adjustments
|
Restated
|
||||||||||
Assets
|
||||||||||||
Current assets:
|
||||||||||||
Cash and cash equivalents
|
$
|
19,431
|
$
|
—
|
$
|
19,431
|
||||||
Short-term investments
|
5,322
|
—
|
5,322
|
|||||||||
Prepaid expenses and other current assets
|
426
|
—
|
426
|
|||||||||
Total current assets
|
25,179
|
—
|
25,179
|
|||||||||
Property and equipment — net
|
1,150
|
—
|
1,150
|
|||||||||
Other assets
|
116
|
—
|
116
|
|||||||||
TOTAL
|
$
|
26,445
|
$
|
—
|
$
|
26,445
|
||||||
Liabilities and Stockholders’ Equity (Deficit)
|
||||||||||||
Current liabilities:
|
||||||||||||
Accounts payable
|
$
|
5,206
|
$
|
—
|
$
|
5,206
|
||||||
Accrued clinical studies
|
3,374
|
—
|
3,374
|
|||||||||
Accrued liabilities
|
497
|
—
|
497
|
|||||||||
Accrued payroll and related costs
|
344
|
—
|
344
|
|||||||||
Short-term portion of notes payable, net of discount
|
9,329
|
—
|
9,329
|
|||||||||
Total current liabilities
|
18,750
|
—
|
18,750
|
|||||||||
Notes payable, net of discount
|
11,221
|
—
|
11,221
|
|||||||||
Total liabilities
|
29,971
|
—
|
29,971
|
|||||||||
Common stock
|
10
|
—
|
10
|
|||||||||
Additional paid-in capital
|
256,859
|
(4,032
|
) |
252,827
|
||||||||
Accumulated comprehensive loss
|
(17
|
)
|
—
|
(17
|
)
|
|||||||
Deficit accumulated during the development stage
|
(260,378
|
)
|
4,032
|
(256,346
|
)
|
|||||||
Total shareholders’ equity (deficit)
|
$
|
(3,526
|
)
|
$
|
—
|
$
|
(3,526
|
)
|
||||
TOTAL
|
$
|
26,445
|
$
|
—
|
$
|
26,445
|
Year Ended
|
||||||||
December 31,
|
||||||||
2011
|
2010
|
|||||||
Additional paid-in capital, as previously reported (1)
|
$
|
220,087
|
$
|
162,948
|
||||
Effect of restatement adjustment on additional paid-in capital for the current period
|
—
|
(6,300
|
)
|
|||||
Cumulative adjustment to additional paid-in capital
|
(6,300
|
)
|
—
|
|
||||
Total restatement adjustments
|
(6,300
|
)
|
(6,300
|
)
|
||||
Additional paid-in capital, as restated (1)
|
$
|
213,787
|
$
|
156,648
|
(1)
|
Adjusted for the Company’s 1-for-8 reverse stock split effectuated on July 15, 2013.
|
Year Ended
|
||||||||
December 31,
|
||||||||
2011
|
2010
|
|||||||
Deficit accumulated during the development, as previously reported
|
$
|
(200,979
|
)
|
$
|
(105,644
|
)
|
||
Effect of restatement adjustment on deficit accumulated during the development stage for the current period
|
(3,738
|
)
|
(6,300
|
)
|
||||
Cumulative adjustment to deficit accumulated during the development stage
|
(6,300
|
)
|
—
|
|
||||
Total restatement adjustments
|
(10,038
|
)
|
(6,300
|
)
|
||||
Deficit accumulated during the development, as restated
|
$
|
(211,017
|
)
|
$
|
(111,944
|
)
|
|
•
|
fees paid to Contract Research Organizations, or CROs, in connection with clinical studies;
|
|
•
|
fees paid to investigative sites in connection with clinical studies;
|
|
•
|
fees paid to contract manufacturers in connection with the production of clinical study materials; and
|
|
•
|
fees paid to vendors in connection with preclinical development activities.
|
Year Ended December 31,
|
||||||||||||
2013
|
2012
|
2011
|
||||||||||
Net loss per share | ||||||||||||
Numerator
|
||||||||||||
Net loss
|
$
|
(30,861
|
)
|
$
|
(45,329
|
)
|
$
|
(99,073
|
)
|
|||
Denominator
|
||||||||||||
Weighted-average common shares outstanding
|
18,267,413
|
7,225,543
|
4,678,881
|
|||||||||
Less: Weighted-average shares subject to repurchase
|
—
|
(137
|
)
|
(1,671
|
)
|
|||||||
Denominator for basic and diluted net loss per share
|
18,267,413
|
7,225,406
|
4,677,210
|
|||||||||
Basic and diluted net loss per share
|
$
|
(1.69
|
)
|
$
|
(6.27
|
)
|
$
|
(21.18
|
)
|
Years Ended December 31,
|
||||||||||||
2013
|
2012
|
2011
|
||||||||||
Total options to purchase common stock
|
1,997,075
|
300,468
|
255,535
|
|||||||||
Total common stock subject to repurchase
|
—
|
—
|
585
|
|||||||||
Total warrants to purchase common stock
|
675,006
|
601,477
|
601,477
|
|||||||||
Total restricted stock units
|
42,042
|
28,106
|
25,794
|
|||||||||
Total
|
2,714,123
|
930,051
|
883,391
|
Amortized
Cost
|
Gross
Unrealized
Gains
|
Fair Value
|
||||||||||
Cash
|
$
|
1,006
|
$
|
—
|
$
|
1,006
|
||||||
Money market funds
|
24,940
|
—
|
24,940
|
|||||||||
Total
|
$
|
25,946
|
$
|
—
|
$
|
25,946
|
Amortized
Cost
|
Gross
Unrealized
Losses
|
Fair Value
|
||||||||||
Cash
|
$
|
3,811
|
$
|
—
|
$
|
3,811
|
||||||
Money market funds
|
15,620
|
—
|
15,620
|
|||||||||
Certificates of deposit
|
5,325
|
(3)
|
5,322
|
|||||||||
Total
|
24,756
|
(3)
|
24,753
|
|||||||||
Less amounts classified as cash and cash equivalents
|
(19,431
|
)
|
—
|
(19,431
|
)
|
|||||||
Total short-term investments
|
$
|
5,325
|
$
|
(3)
|
$
|
5,322
|
|
•
|
Level 1
—Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and trading securities with quoted prices on active markets.
|
|
•
|
Level 2
—Valuations based on inputs other than the quoted prices in active markets that are observable either directly or indirectly in active markets. Examples of assets and liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds, commercial paper, certificates of deposit and over-the-counter derivatives.
|
|
•
|
Level 3
—Valuations based on unobservable inputs in which there are little or no market data, which require us to develop our own assumptions.
|
December 31, 2013
|
||||||||||||||||
Estimated
Fair Value
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Money market funds
|
$
|
24,940
|
$
|
24,940
|
$
|
—
|
$
|
—
|
December 31, 2012
|
||||||||||||||||
Estimated
Fair Value
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Money market funds
|
$
|
15,620
|
$
|
15,620
|
$
|
—
|
$
|
—
|
||||||||
Certificates of deposit
|
5,322
|
—
|
5,322
|
—
|
||||||||||||
Total
|
$
|
20,942
|
$
|
15,620
|
$
|
5,322
|
$
|
—
|
December 31, 2013
|
||||||||||||||||
Estimated
Fair Value
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Notes Payable ($18,095, net of $220 note discount)
|
$
|
17,875
|
$
|
—
|
$
|
—
|
$
|
17,875
|
December 31, 2012
|
||||||||||||||||
Estimated
Fair Value
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Notes Payable ($21,083, net of $553 note discount)
|
$
|
20,550
|
$
|
—
|
$
|
—
|
$
|
20,550
|
December 31,
|
||||||||
2013
|
2012
|
|||||||
Lab equipment
|
$
|
1,312
|
$
|
1,312
|
||||
Computers and software
|
50
|
50
|
||||||
Office equipment and furniture
|
60
|
45
|
||||||
Leasehold improvements
|
206
|
206
|
||||||
Total property and equipment
|
$
|
1,628
|
$
|
1,613
|
||||
Less accumulated depreciation and amortization
|
(816
|
)
|
(463
|
)
|
||||
Property and equipment, net
|
$
|
812
|
$
|
1,150
|
Year Ended
December 31,
|
Period from
September 9,
2004 (Date of
Inception) to
December 31,
|
|||||||||||||||
2013
|
2012
|
2011
|
2013
|
|||||||||||||
Depreciation expense
|
$
|
353
|
$
|
331
|
$
|
80
|
$
|
854
|
Year Ended
December 31,
|
Period from
September 9,
2004 (Date of
Inception) to
December 31,
|
|||||||||||||||
2013
|
2012
|
2011
|
2013
|
|||||||||||||
Rent expense
|
$
|
215
|
$
|
217
|
$
|
184
|
$
|
1,307
|
2014
|
$
|
217
|
||
2015
|
220
|
|||
2016
|
222
|
|||
2017
|
167
|
|||
Total
|
$
|
826
|
2013
|
||||
Notes payable, net of discount
|
$
|
17,875
|
||
Less current maturities, net of discount
|
(2,777)
|
|||
Non-current maturities, net of discount
|
$
|
15,098
|
2012
|
||||
Notes payable, net of discount
|
$
|
20,550
|
||
Less current maturities, net of discount
|
(9,329)
|
|||
Non-current maturities, net of discount
|
$
|
11,221
|
2014
|
$
|
2,857
|
||
2015
|
2,857
|
|||
2016
|
2,381
|
|||
2017
|
10,000
|
|||
Total
|
$
|
18,095
|
Common stock warrants outstanding
|
675,006
|
|||
Common stock options outstanding
|
1,997,075
|
|||
Restricted stock units outstanding
|
42,042
|
|||
Common stock available for future grant under ESPP plan
|
78,873
|
|||
Common stock options available for future grant under stock option plan
|
711,718
|
|||
Total
|
3,504,714
|
March 31,
|
December 31,
|
September 30,
|
||||||||||
2010
|
2009
|
2009
|
||||||||||
Expected Volatility
|
94
|
%
|
78
|
%
|
78
|
%
|
||||||
Dividend Yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||
Risk-Free Interest Rate
|
2.28
|
%
|
2.34
|
%
|
2.38
|
%
|
||||||
Expected Term (years)
|
5.00
|
5.00
|
5.00
|
September 30, 2012
|
June 30, 2012
|
March 31, 2012
|
December 31, 2011
|
December 31, 2010
|
September 30, 2010
|
||||||||||||||||||
Expected Volatility
|
114
|
%
|
108
|
%
|
88
|
%
|
65
|
%
|
63
|
%
|
64
|
%
|
|||||||||||
Dividend Yield
|
0
|
%
|
0
|
%
|
0
|
%
|
0
|
%
|
0
|
%
|
0
|
%
|
|||||||||||
Risk-Free Interest Rate
|
0.33
|
%
|
0.33
|
%
|
0.33
|
%
|
0.35
|
%
|
1.37
|
%
|
1.37
|
%
|
|||||||||||
Expected Term (years)
|
3.00
|
3.25
|
3.50
|
3.75
|
4.75
|
5.00
|
Number of
Options
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Life in Years
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Balance at December 31, 2010
|
159,499 | $ | 10.11 | 5.29 | 4,701 | |||||||||||
Options granted
|
146,689 | $ | 47.65 | |||||||||||||
Options exercised
|
(33,793 | ) | $ | 8.28 | ||||||||||||
Options cancelled
|
(16,860 | ) | $ | 52.22 | ||||||||||||
Balance at December 31, 2011
|
255,535 | $ | 29.12 | 3.07 | $ | 5,762 | ||||||||||
Options granted
|
101,831 | $ | 16.42 | |||||||||||||
Options exercised
|
(19,317 | ) | $ | 8.12 | ||||||||||||
Options cancelled
|
(37,581 | ) | $ | 45.19 | ||||||||||||
Balance at December 31, 2012
|
300,468 | $ | 24.15 | 2.06 | $ | 126 | ||||||||||
Options granted
|
2,124,250 | $ | 4.79 | |||||||||||||
Options exercised
|
— | $ | — | |||||||||||||
Options cancelled
|
(427,643 | ) | $ | 16.41 | ||||||||||||
Balance at December 31, 2013
|
1,997,075 | $ | 5.21 | 9.11 | $ | 48 | ||||||||||
Ending vested at December 31, 2013
|
213,609 | $ | 8.71 | 6.55 | $ | 44 |
Year Ended December 31,
|
Period from
September 9,
2004 (Date of
Inception) to
December 31,
|
|||||||||||||||
2013
|
2012
|
2011
|
2013
|
|||||||||||||
Expected Volatility
|
94%
|
68%
|
63%
|
90%
|
||||||||||||
Dividend Yield
|
0%
|
0%
|
0%
|
0%
|
||||||||||||
Risk-Free Interest Rate
|
1.08%
|
1.26%
|
2.25%
|
1.45%
|
||||||||||||
Expected Term (years)
|
5.79
|
6.25
|
6.25
|
5.88
|
Year Ended December 31,
|
Period from
September 9,
2004 (Date of
Inception) to
December 31,
|
|||||||||||||||
2013
|
2012
|
2011
|
2013
|
|||||||||||||
Weighted-average fair value per share granted
|
$
|
3.55
|
$
|
10.01
|
$
|
28.65
|
$
|
5.29
|
||||||||
Intrinsic value of options exercised
|
$
|
—
|
$
|
683
|
$
|
1,579
|
$
|
3,090
|
||||||||
Proceeds received from the exercise of stock options
|
$
|
—
|
$
|
157
|
$
|
280
|
$
|
782
|
||||||||
Grant date fair value of options vested
|
$
|
550
|
$
|
1,102
|
$
|
1,929
|
$
|
4,225
|
Outstanding, Vested and
Expected to Vest
|
Options Vested
|
|||||||||||||||||
Range of Exercise Price
|
Number of
Shares
|
Weighted-
Average
Remaining
Contractual
Life
(In Years)
|
Weighted
Average
Exercise
Price
|
Number of
Shares
|
||||||||||||||
$ | 2.08 - $4.56 |
192,155
|
8.28
|
$
|
2.29
|
51,071
|
||||||||||||
$ | 4.88 - $65.36 |
1,804,920
|
9.19
|
$
|
10.73
|
162,538
|
||||||||||||
Total
|
1,997,075
|
9.11
|
$
|
8.71
|
213,609
|
Shares
|
Weighted-
Average
Grant
Date Fair
Value
|
|||||||
Outstanding at December 31, 2010
|
37,816
|
$
|
41.02
|
|||||
Restricted stock units granted
|
5,501
|
$
|
46.56
|
|||||
Restricted stock units released
|
(16,257
|
)
|
$
|
41.83
|
||||
Restricted stock units forfeitures and cancellations
|
(1,266
|
)
|
$
|
35.83
|
||||
Outstanding at December 31, 2011
|
25,794
|
$
|
41.95
|
|||||
Restricted stock units granted
|
19,108
|
$
|
37.70
|
|||||
Restricted stock units released
|
(9,263
|
)
|
$
|
41.28
|
||||
Restricted stock units forfeitures and cancellations
|
(7,533
|
)
|
$
|
27.91
|
||||
Outstanding at December 31, 2012
|
28,106
|
$
|
43.04
|
|||||
Restricted stock units granted
|
53,584
|
$
|
5.12
|
|||||
Restricted stock units released
|
(37,774
|
)
|
$
|
24.85
|
||||
Restricted stock units forfeitures and cancellations
|
(1,874
|
)
|
$
|
42.88
|
||||
Outstanding at December 31, 2013
|
42,042
|
$
|
11.06
|
Year Ended December 31, |
Period from
September 9,
2004 (Date of
Inception) to
December 31,
|
|||||||||||||||
2013 | 2012 | 2011 | 2013 | |||||||||||||
Expected Volatility
|
126%
|
129%
|
62%
|
96%
|
||||||||||||
Dividend Yield
|
0%
|
0%
|
0%
|
0%
|
||||||||||||
Risk-Free Interest Rate
|
0.11%
|
0.18%
|
0.08%
|
0.13%
|
||||||||||||
Expected Term (years)
|
0.50
|
0.50
|
0.50
|
0.46
|
Year Ended December 31,
|
Period from
September 9,
2004 (Date of
Inception) to
December 31,
|
|||||||||||||||
2013
|
2012
|
2011
|
2013
|
|||||||||||||
Research and development
|
$
|
1,451
|
(1)
|
$
|
460
|
$
|
1,014
|
$
|
3,508
|
|||||||
General and administrative
|
1,694
|
(2)
|
500
|
1,409
|
4,358
|
|||||||||||
Total employee stock-based compensation
|
$
|
3,145
|
$
|
960
|
$
|
2,423
|
$
|
7,866
|
|
(1)
|
Included in research and development expense was approximately $799,000 in non-cash stock-based compensation associated with the voluntary surrender of stock options by our employees in the quarter ended March 31, 2013.
|
|
(2)
|
Included in general and administrative expense was approximately $661,000 in non-cash stock-based compensation associated with the voluntary surrender of stock options by our employees in the quarter ended March 31, 2013.
|
December 31,
|
||||||||
2013
|
2012
|
|||||||
Deferred tax assets:
|
||||||||
Net operating loss carryforwards
|
$
|
26,306
|
$
|
19,375
|
||||
Tax credits
|
1,857
|
1,080
|
||||||
Intangible assets
|
2,217
|
2,483
|
||||||
Capitalized R&D
|
23,458
|
17,646
|
||||||
Other
|
606
|
1,973
|
||||||
Total deferred tax assets
|
54,444
|
42,557
|
||||||
Deferred tax liabilities
|
—
|
—
|
||||||
Valuation allowance
|
(54,444
|
)
|
(42,557
|
)
|
||||
Net deferred tax asset
|
$
|
—
|
$
|
—
|
2013
|
2012
|
2011
|
||||||||||
(As restated)
|
||||||||||||
Statutory rate
|
34
|
%
|
34
|
%
|
34
|
%
|
||||||
State tax
|
6
|
%
|
(11)
|
%
|
6
|
%
|
||||||
Tax credit
|
2
|
%
|
0
|
%
|
1
|
%
|
||||||
Expiration of tax attributes due to section 382 limitations
|
0
|
%
|
(118)
|
%
|
0
|
% | ||||||
Stock based compensation
|
(3)
|
%
|
0
|
%
|
0 |
%
|
||||||
Revaluation of warrant liability
|
0
|
%
|
11
|
%
|
0 |
%
|
||||||
Valuation allowance
|
(39)
|
%
|
84
|
%
|
(41)
|
%
|
||||||
Effective tax rates
|
0
|
%
|
0
|
%
|
0
|
%
|
Amount
|
Expiration Years
|
||||
Net operating losses—federal
|
$
|
66,070
|
Beginning 2024
|
||
Net operating losses—state
|
$
|
65,852
|
Beginning 2014
|
||
Tax return credits—federal
|
$
|
641
|
Beginning 2032
|
||
Tax return credits—state
|
$
|
1,842
|
Do not expire
|
Amount
|
||||
Balance as of December 31, 2010
|
1,361
|
|||
Additions based on tax positions related to current year
|
404
|
|||
Balance as of December 31, 2011
|
1,765
|
|||
Reductions based on tax positions related to prior years
|
(1,300
|
)
|
||
Additions based on tax positions related to current year
|
80
|
|||
Balance as of December 31, 2012
|
545
|
|||
Additions based on tax positions related to prior year
|
104
|
|||
Additions based on tax positions related to current year
|
179
|
|||
Balance as of December 31, 2013
|
$
|
828
|
Quarter Ended
|
||||||||||||||||
March 31,
|
June 30,
|
September 30,
|
December 31,
|
|||||||||||||
2013
|
||||||||||||||||
OPERATING EXPENSES:
|
||||||||||||||||
Research and development
|
$
|
4,929
|
$
|
5,265
|
$
|
4,051
|
$
|
7,439
|
||||||||
General and administrative
|
1,972
|
1,688
|
1,470
|
1,433
|
||||||||||||
LOSS FROM OPERATIONS
|
(6,901
|
)
|
(6,953
|
)
|
(5,521
|
)
|
(8,872
|
)
|
||||||||
Other income (expense)
|
25
|
(6
|
)
|
14
|
(48
|
)
|
||||||||||
Interest income (expense)
|
(704
|
)
|
(1,322
|
)
|
(296
|
)
|
(277
|
)
|
||||||||
NET LOSS
|
$
|
(7,580
|
)
|
$
|
(8,281
|
)
|
$
|
(5,803
|
)
|
$
|
(9,197
|
)
|
||||
Net loss per share—basic and diluted
|
$
|
(0.49
|
)
|
$
|
(0.43
|
)
|
$
|
(0.30
|
)
|
$
|
(0.48
|
)
|
||||
Shares used in computing basic and diluted net loss per share
|
15,515,502
|
19,059,130
|
19,196,140
|
19,354,950
|
March 31, 2012
|
June 30, 2012
|
September 30, 2012
|
December 31, 2012
|
|||||||||||||||||||||||||||||||||||||||||
Three Months Ended
|
Three Months Ended
|
Six Months Ended
|
Three Months Ended
|
Nine Months Ended
|
Three Months Ended
|
|||||||||||||||||||||||||||||||||||||||
As Reported
|
As Restated
|
As Reported
|
As Restated
|
As Reported
|
As Restated
|
As Reported
|
As Restated
|
As Reported
|
As Restated
|
|||||||||||||||||||||||||||||||||||
Operating expenses
|
||||||||||||||||||||||||||||||||||||||||||||
Research and development
|
$ | 17,738 | $ | 17,738 | $ | 14,865 | $ | 14,865 | $ | 32,603 | $ | 32,603 | $ | 9,527 | $ | 9,527 | $ | 42,130 | $ | 42,130 | $ | 7,089 | ||||||||||||||||||||||
General and administrative
|
2,322 | 2,322 | 1,799 | 1,799 | 4,121 | 4,121 | 1,594 | 1,594 | 5,715 | 5,715 | 1,000 | |||||||||||||||||||||||||||||||||
Total operating expense
|
20,060 | 20,060 | 16,664 | 16,664 | 36,724 | 36,724 | 11,121 | 11,121 | 47,845 | 47,845 | 8,089 | |||||||||||||||||||||||||||||||||
Loss from operations
|
(20,060 | ) | (20,060 | ) | (16,664 | ) | (16,664 | ) | (36,724 | ) | (36,724 | ) | (11,121 | ) | (11,121 | ) | (47,845 | ) | (47,845 | ) | (8,089 | ) | ||||||||||||||||||||||
Other income (expense):
|
||||||||||||||||||||||||||||||||||||||||||||
Other income (expense)
|
(10 | ) | (10 | ) | (28 | ) | (28 | ) | (38 | ) | (38 | ) | (46 | ) | (46 | ) | (84 | ) | (84 | ) | (27 | ) | ||||||||||||||||||||||
Interest expense
|
(843 | ) | (843 | ) | (908 | ) | (908 | ) | (1,751 | ) | (1,751 | ) | (806 | ) | (806 | ) | (2,557 | ) | (2,557 | ) | (797 | ) | ||||||||||||||||||||||
Mark-to-market adjustment of
warrants liability
|
- | 11,382 | - | 3,822 | - | 15,204 | - | (1,134 | ) | - | 14,070 | - | ||||||||||||||||||||||||||||||||
Total other income (expense)
|
(853 | ) | 10,529 | (936 | ) | 2,886 | (1,789 | ) | 13,415 | (852 | ) | (1,986 | ) | (2,641 | ) | 11,429 | (824 | ) | ||||||||||||||||||||||||||
Net loss
|
$ | (20,913 | ) | $ | (9,531 | ) | $ | (17,600 | ) | $ | (13,778 | ) | $ | (38,513 | ) | $ | (23,309 | ) | $ | (11,973 | ) | $ | (13,107 | ) | $ | (50,486 | ) | $ | (36,416 | ) | $ | (8,913 | ) | |||||||||||
Net loss per share — basic and diluted
|
$ | (4.08 | ) | $ | (1.86 | ) | $ | (3.43 | ) | $ | (2.68 | ) | $ | (7.51 | ) | $ | (4.54 | ) | $ | (1.38 | ) | $ | (1.51 | ) | $ | (7.97 | ) | $ | (5.75 | ) | $ | (0.90 | ) | |||||||||||
Weighted average shares used in net
income (loss) per share — basic and diluted
|
5,125,044 | 5,125,044 | 5,137,218 | 5,137,218 | 5,131,126 | 5,131,126 | 8,703,790 | 8,703,790 | 6,330,705 | 6,330,705 | 9,890,094 |
As of March 31, 2012
|
As of June 30, 2012
|
As of September 30, 2012
|
||||||||||||||||||||||
As Reported
|
As Restated
|
As Reported
|
As Restated
|
As Reported
|
As Restated
|
|||||||||||||||||||
Assets
|
||||||||||||||||||||||||
Current assets:
|
||||||||||||||||||||||||
Cash and cash equivalents
|
$
|
42,349
|
$
|
42,349
|
$
|
20,537
|
$
|
20,537
|
$
|
40,985
|
$
|
40,985
|
||||||||||||
Short-term investments
|
1,680
|
1,680
|
2,354
|
2,354
|
1,470
|
1,470
|
||||||||||||||||||
Prepaid expenses and other current assets
|
520
|
520
|
304
|
304
|
547
|
547
|
||||||||||||||||||
Total current assets
|
44,549
|
44,549
|
23,195
|
23,195
|
43,002
|
43,002
|
||||||||||||||||||
Property and equipment — net
|
1,388
|
1,388
|
1,287
|
1,287
|
1,238
|
1,238
|
||||||||||||||||||
O Other assets
|
214
|
214
|
179
|
179
|
147
|
147
|
||||||||||||||||||
Total assets
|
$
|
46,151
|
$
|
46,151
|
$
|
24,661
|
$
|
24,661
|
$
|
44,387
|
$
|
44,387
|
||||||||||||
L Liabilities and Stockholders’ Equity
|
||||||||||||||||||||||||
Current liabilities:
|
||||||||||||||||||||||||
Accounts payable
|
$
|
13,846
|
$
|
13,846
|
$
|
10,299
|
$
|
10,299
|
$
|
4,122
|
$
|
4,122
|
||||||||||||
Accrued clinical studies
|
8,010
|
8,010
|
7,166
|
7,166
|
10,893
|
10,893
|
||||||||||||||||||
Accrued liabilities
|
847
|
847
|
452
|
452
|
488
|
488
|
||||||||||||||||||
Accrued payroll and related costs
|
323
|
323
|
610
|
610
|
850
|
850
|
||||||||||||||||||
S Short-term portion of notes payable, net of discount
|
7,139
|
7,139
|
8,767
|
8,767
|
9,039
|
9,039
|
||||||||||||||||||
T Total current liabilities
|
30,165
|
30,165
|
27,294
|
27,294
|
25,392
|
25,392
|
||||||||||||||||||
Notes payable, net of discount
|
17,340
|
17,340
|
15,920
|
15,920
|
13,585
|
13,585
|
||||||||||||||||||
Warrant liability
|
—
|
4,956
|
—
|
1,134
|
—
|
—
|
||||||||||||||||||
Total liabilities
|
47,505
|
52,461
|
43,214
|
44,348
|
38,977
|
38,977
|
||||||||||||||||||
Common stock
|
5
|
5
|
5
|
5
|
10
|
10
|
||||||||||||||||||
Additional paid-in capital
|
220,565
|
214,265
|
221,024
|
214,724
|
256,906
|
252,874
|
||||||||||||||||||
Accumulated comprehensive income (loss)
|
(32)
|
(32)
|
(90)
|
(90)
|
(41
|
)
|
(41
|
)
|
||||||||||||||||
Deficit accumulated during the development stage
|
(221,892
|
)
|
(220,548
|
)
|
(239,492
|
)
|
(234,326
|
)
|
(251,465
|
)
|
(247,433
|
)
|
||||||||||||
T Total stockholders’ equity (deficit)
|
(1,354)
|
(6,310)
|
(18,553)
|
(19,687)
|
5,410
|
5,410
|
||||||||||||||||||
T Total liabilities and stockholders’ equity (deficit)
|
$
|
46,151
|
$
|
46,151
|
$
|
24,661
|
$
|
24,661
|
$
|
44,387
|
$
|
44,387
|
ANTHERA PHARMACEUTICALS, INC.
|
|||
By:
|
/s/ Paul F. Truex
|
||
Paul F. Truex
|
|||
President and Chief Executive Officer (Principal Executive Officer)
|
|||
Signature
|
Title
|
Date
|
||
/s/ Paul F. Truex
|
President, Chief Executive Officer and Director (Principal Executive Officer)
|
March 28, 2014
|
||
Paul F. Truex
|
||||
/s/ May Liu
|
Senior Vice President, Finance and Administration (Principal Accounting Officer)
|
March 28, 2014
|
||
May Liu
|
||||
/s/ Christopher S. Henney
|
Chairman of the Board of Directors
|
March 28, 2014
|
||
Christopher S. Henney
|
||||
/s/ Bogdan Dziurzynski
|
Director
|
March 28, 2014
|
||
Bogdan Dziurzynski
|
||||
/s/ James I. Healy
|
Director
|
March 28, 2014
|
||
James I. Healy
|
||||
/s/ Daniel K. Spiegelman
|
Director
|
March 28, 2014
|
||
Daniel K. Spiegelman
|
||||
/s/ David E. Thompson
|
Director
|
March 28, 2014
|
||
David E. Thompson
|
||||
/s/ Sanford S. Zweifach
|
Director
|
March 28, 2014
|
||
Sanford S. Zweifach
|
Number
|
Description
|
|||
3.1
|
Fifth Amended and Restated Certificate of Incorporation(1)
|
|||
3.2
|
Certificate of Amendment to the Fifth Amended and Restated Certificate of Incorporation filed October 12, 2012(2)
|
|||
3.3
|
Certificate of Amendment to the Fifth Amended and Restated Certificate of Incorporation filed July 12, 2013 and effective July 15, 2013(3)
|
|||
3.4
|
Amended and Restated Bylaws(4)
|
|||
4.1
|
Specimen certificate evidencing shares of common stock(5)
|
|||
4.2
|
Form of Warrant sold pursuant to that Securities Purchase Agreement, among the Company and the purchasers thereto, dated September 20, 2010(6)
|
|||
4.3
|
Form of Warrant Agreement dated as of March 25, 2011(7)
|
|||
4.4
|
Warrant to Purchase Common Stock issued to MidCap Financial SBIC, LP dated April 3, 2013(8)
|
|||
#10.1
|
2005 Equity Incentive Plan and form agreements thereunder(9)
|
|||
#10.2
|
Amended and Restated 2010 Stock Option and Incentive Plan(10)
|
|||
#10.3
|
Certificate of Amendment to Amended and Restated 2010 Stock Option and Incentive Plan(11)
|
|||
#10.4
|
Form of Non-Qualified Stock Option Agreement for Company Employees Under the Anthera Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan(12)
|
|||
#10.5
|
Form of Non-Qualified Stock Option Agreement for Non-Employee Directors Under the Anthera Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan(12)
|
|||
#10.6
|
Form of Incentive Stock Option Agreement Under the Anthera Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan(12)
|
|||
#10.7
|
Form of Restricted Stock Award Agreement Under the Anthera Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan(12)
|
|||
#10.8
|
Restricted Stock Unit Award Agreement Under the Anthera Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan(13)
|
|||
#10.9
|
2010 Employee Stock Purchase Plan(14)
|
|||
#10.10
|
Amendment No. 1 to 2010 Employee Stock Purchase Plan(15)
|
|||
#10.11
|
Amendment No. 2 to 2010 Employee Stock Purchase Plan(16)
|
|||
#10.12
|
2013
Stock Option and Incentive Plan(17)
|
|||
#10.13
|
Form
of Non-Qualified Stock Option Agreement for Company Employees Under the 2013 Stock Option and Incentive Plan
|
|||
#10.14
|
Form
of Non-Qualified Stock Option Agreement for Non-Employees Under the 2013 Stock Option and Incentive Plan
|
|||
#10.15
|
Form
of Incentive Stock Option Agreement Under the 2013 Stock Option and Incentive Plan
|
|||
#10.16
|
Form
of Restricted Stock Award Agreement Under the 2013 Stock Option and Incentive Plan
|
|||
#10.17
|
Form
of Restricted Stock Unit Award Agreement Under the 2013 Stock Option and Incentive Plan
|
#10.18
|
Form of Amended and Restated Indemnification Agreement(18)
|
|||
#10.19
|
Form of Amended and Restated Change in Control Agreement(19)
|
|||
#10.20
|
Form of Amended and Restated Severance Benefits Agreement(20)
|
|||
+10.21
|
License Agreement between Amgen Inc. and the Company, dated as of December 18, 2007(21)
|
|||
10.22
|
Amendment No. 1 to License Agreement between Amgen Inc. and the Company, dated as of October 16, 2009(22)
|
|||
|
|
|||
10.23
|
Form of Securities Purchase Agreement, among the Company and the purchasers thereto, dated September 20, 2010(23)
|
|||
10.24
|
Credit and Security Agreement by and between the Company and MidCap Financial SBIC, LP, dated as of April 3, 2013(24)
|
|||
10.25
|
Loan and Security Agreement by and between the Company and Square 1 Bank, dated as of April 3, 2013(25)
|
|||
10.26
|
Lease by and between the Company and MEPT Mount Eden LLC, dated as of May 4, 2011(26)
|
|||
10.27
|
Lease Amendment by and between the Company and MEPT Mount Eden LLC, dated as of November 13, 2013
|
|||
10.28
|
Second Amended and Restated Change in Control Agreement, by and between the Company and Dr. Colin Hislop, dated as of August 5, 2011(27)
|
|||
10.29
|
Second Amended and Restated Change in Control Agreement, by and between the Company and Dr. Debra Odink, dated as of August 5, 2011(28)
|
|||
10.30
|
Deferred Compensation Agreement by and between the Company and Paul Truex, effective as of December 27, 2012(29)
|
|||
10.31 | Deferred Compensation Election Form by and between the Company and Paul Truex, effective as of December 7, 2013 | |||
14.1
|
Code of Business Conduct and Ethics(30)
|
|||
16.1
|
Letter from Deloitte & Touche LLP, regarding change in certified accountant(31)
|
|||
21.1
|
Subsidiaries of Anthera Pharmaceuticals, Inc.(32)
|
|||
23.1
|
Consent of BDO USA LLP, independent registered public accounting firm
|
|||
23.2
|
Consent of Deloitte & Touche LLP, independent registered public accounting firm
|
|||
24.1
|
Power of Attorney (included on signature page hereto)
|
|||
31.1
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
31.2
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|||
32.1
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|||
32.2
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant Section 906 of the Sarbanes-Oxley Act of 2002
|
101.INS*
|
XBRL Instance Document.
|
|||
101.SCH*
|
XBRL Taxonomy Extension Schema Document.
|
|||
101.CAL*
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|||
101.DEF*
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|||
101.LAB*
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|||
101.PRE*
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
+
|
Certain provisions of this Exhibit have been omitted pursuant to a request for confidential treatment.
|
#
|
Indicates management contract or compensatory plan, contract or agreement.
|
*
|
In accordance with Rule 406T of Regulation S-T, the XBRL related information in Exhibit 101 to this Quarterly Report on Form 10-Q is furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of the section, and shall not be part of any registration statement or other document filed under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
|
(1)
|
Filed as Exhibit 3.6 to the registrant’s Registration Statement on Form S-1/A (File No. 333-161930), filed with the SEC on February 3, 2010 and incorporated herein by reference.
|
(2)
|
Filed as same numbered exhibit to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 26, 2013 and incorporated herein by reference.
|
(3)
|
Filed as Exhibit 3.1 to the registrant Current Report on Form 8-K, filed with the SEC on July 16, 2013 and incorporated herein by reference.
|
(4)
|
Filed as Exhibit 3.7 to the registrant’s Registration Statement on Form S-1/A (File No. 333-161930) filed with the SEC on February 3, 2010 and incorporated herein by reference.
|
(5)
|
Filed as the same numbered exhibit to the registrant’s Amendment No. 3 to Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on January 29, 2010 and incorporated herein by reference.
|
(6)
|
Filed as Exhibit 4.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on September 22, 2010 and incorporated herein by reference.
|
(7)
|
Filed as Exhibit 10.2 to registrant’s Current Report on Form 8-K, filed with the SEC on March 29, 2011 and incorporated herein by reference.
|
(8)
|
Filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K, filed with the SEC on April 5, 2013, and incorporated herein by reference.
|
(9)
|
Filed as the same numbered exhibit to the registrant’s Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on September 15, 2009 and incorporated herein by reference.
|
(10)
|
Filed as Appendix A to the registrant’s Definitive Proxy Statement on Schedule 14A, filed with the SEC on June 8, 2010 and incorporated herein by reference.
|
(11)
|
Filed as Exhibit 10.2 to registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 12, 2011 and incorporated herein by reference.
|
(12)
|
Filed as Exhibit 10.2 to the registrant’s Amendment No. 4 to Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on February 3, 2010 and incorporated herein by reference.
|
(13)
|
Filed as Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 14, 2010 and incorporated herein by reference.
|
(14)
|
Filed as Appendix B to the registrant’s Definitive Proxy Statement on Schedule 14A, filed with the SEC on June 8, 2010 and incorporated herein by reference.
|
(15)
|
Filed as Exhibit 10.42 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 7, 2011 and incorporated herein by reference.
|
(16)
|
Filed as Exhibit 10.34 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 26, 2013 and incorporated herein by reference.
|
(17)
|
Filed as Annex B to the registrants Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 5, 2013 and incorporated herein by reference.
|
(18)
|
Filed as Exhibit 10.3 to the registrant’s Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on September 15, 2009 and incorporated herein by reference.
|
(19)
|
Filed as the Exhibit 10.4 to the registrant’s Amendment No. 1 to Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on October 19, 2009 and incorporated herein by reference.
|
(20)
|
Filed as the Exhibit 10.5 to the registrant’s Amendment No. 1 to Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on October 19, 2009 and incorporated herein by reference.
|
(21)
|
Filed as Exhibit 10.10 to the registrant’s Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on September 15, 2009 and incorporated herein by reference.
|
(22)
|
Filed as Exhibit 10.18 to the registrant’s Amendment No. 1 to Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on October 19, 2009 and incorporated herein by reference.
|
(23)
|
Filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on September 22, 2010 and incorporated herein by reference.
|
(24)
|
Filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on April 5, 2013, and incorporated herein by reference.
|
(25)
|
Filed as Exhibit 10.3 to the registrant’s Current Report on Form 8-K, filed with the SEC on April 5, 2013, and incorporated herein by reference.
|
(26)
|
Filed as Exhibit 10.4 to registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2011 and incorporated herein by reference.
|
(27)
|
Filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on August 9, 2011, and incorporated herein by reference.
|
(28)
|
Filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K, filed with the SEC on August 9, 2011, and incorporated herein by reference.
|
(29)
|
Filed as Exhibit 10.35 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 26, 2013 and incorporated herein by reference.
|
(30)
|
Filed as the same numbered exhibit to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 7, 2011 and incorporated herein by reference.
|
(31)
|
Filed as the same numbered exhibit to the registrant’s Current Report on Form 8-K, filed with the SEC on September 9, 2013, and incorporated herein by reference.
|
|
|
(32)
|
Filed as the same numbered exhibit to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2012 and incorporated herein by reference.
|
Option Holder:
|
|
Date of Grant:
|
|
Vesting Commencement Date:
|
|
Number of ISO Shares Subject to Option:
|
|
Exercise Price (Per Share):
|
|
Total Exercise Price:
|
|
Expiration Date:
|
Type of Grant:
|
¨
Incentive Stock Option
1
|
x
Nonstatutory Stock Option
|
Exercise Schedule
:
|
¨
Same as Vesting Schedule
|
¨
Early Exercise Permitted
|
Vesting Schedule
:
|
Shares in each period will become fully vested on the date shown below:
|
Shares
|
Vest Type
|
Fully Vest
|
Expiration Date
|
Name of Optionee:
|
|
||
No. of Option Shares:
|
|
||
Option Exercise Price per Share:
|
$
|
|
|
[FMV on Grant Date] | |||
Grant Date:
|
|
||
Expiration Date:
|
|
||
[No more than 10 years] |
Incremental Number of
Option Shares Exercisable
|
Exercisability Date
|
(
%)
|
|
(
%)
|
|
(
%)
|
|
ANTHERA PHARMACEUTICALS, INC. | ||
By: | ||
Title:
|
Dated: | |||
Optionee’s Signature | |||
Optionee’s name and address: | |||
|
|||
|
|||
|
Option Holder:
|
|
Date of Grant:
|
|
Vesting Commencement Date:
|
|
Number of ISO Shares Subject to Option:
|
|
Exercise Price (Per Share):
|
|
Total Exercise Price:
|
|
Expiration Date:
|
Type of Grant: | x Incentive Stock Option 1 | o Nonstatutory Stock Option |
Exercise Schedule : | o Same as Vesting Schedule | o Early Exercise Permitted |
Dated: | |||
Optionee’s Signature
|
|||
Optionee’s name and address:
|
|||
Name of Grantee:
|
|||
No. of Shares:
|
|||
Grant Date:
|
|||
Grant Date Fair Value:
|
Number of
Shares Vested
|
Vesting Date
|
_____________ (___%)
|
____________
|
_____________ (___%)
|
____________
|
_____________ (___%)
|
____________
|
_____________ (___%)
|
____________
|
_____________ (___%)
|
____________
|
ANTHERA PHARMACEUTICALS, INC.
|
||
By:
|
||
Title:
|
||
Dated: | |||
Grantee’s Signature
|
|||
Address:
|
|||
Name of Grantee:
|
|
No. of Restricted Stock Units Granted:
|
|
Grant Date:
|
|
Grant Date Fair Value:
|
Incremental (Aggregate)
Number of
Restricted Stock Units Vested
|
Vesting Date
|
(
%)
|
|
(
%)
|
|
(
%)
|
|
ANTHERA PHARMACEUTICALS, INC. | ||
By:
|
||
Name:
|
||
Title:
|
|
|
Grantee’s Signature
|
|
Grantee’s name and Address
|
|
|
|
|
I.
|
Elective Deferral Percentages
|
Deferral Percentage:
|
Base Annual Salary:
|
35%
|
Annual Bonus:
|
40%
|
II.
|
Form and Timing of Payment of Account
|
|
December 7 th , 2013 | ||
Executive: Paul F. Truex | Date | ||
Title: President & CEO |
Received by: |
|
|
Title: SVP Finance & Administration & Principal Accounting Officer
|
Date signed: December 7
th
2013
|
Applicable Portion of Lease Term
|
Monthly Base
Rent, NNN
|
Annual Base Rent,
NNN
|
|
Beginning first day of:
|
Ending last day of:
|
||
October 1, 2014
|
September 30, 2015
|
$13,332.30
|
$159,987.60
|
October 1, 2015
|
September 30, 2016
|
$13,732.27
|
$164,787.24
|
October 1, 2016
|
September 30, 2017
|
$14,144.24
|
$169,730.88
|
1.
|
I have reviewed this annual report on FORM 10-K of Anthera Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
March 28, 2014
|
/s/ PAUL F. TRUEX
|
||
Paul F. Truex
|
|||
President and Chief Executive Officer
|
|||
(Principal Executive Officer) |
1.
|
I have reviewed this annual report on FORM 10-K of Anthera Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
March 28, 2014
|
/s/ May Liu
|
||
May Liu
|
|||
Senior Vice President, Finance & Administration
|
|||
(Principal Financial Officer) |
By: |
/s/ PAUL F. TRUEX
|
||
Name: |
Paul F. Truex
|
||
Title: |
President and Chief Executive Officer
|
||
(Principal Executive Officer) |
By:
|
/s/ May Liu
|
||
Name:
|
May Liu
|
||
Title: | Senior Vice President, Finance and Administration | ||
(Principal Financial Officer) |