Item 1. Financial Statements
ELEVEN BIOTHRAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
December 31, 2016
|
Assets
|
|
|
|
Current assets:
|
|
|
|
Cash and cash equivalents
|
$
|
11,338
|
|
|
$
|
25,342
|
|
Prepaid expenses and other current assets
|
770
|
|
|
585
|
|
Total current assets
|
12,108
|
|
|
25,927
|
|
Property and equipment, net
|
585
|
|
|
796
|
|
Restricted cash
|
10
|
|
|
10
|
|
Intangible assets
|
46,400
|
|
|
60,500
|
|
Goodwill
|
13,064
|
|
|
16,864
|
|
Other assets
|
101
|
|
|
—
|
|
Total assets
|
$
|
72,268
|
|
|
$
|
104,097
|
|
Liabilities and stockholders’ equity
|
|
|
|
Current liabilities:
|
|
|
|
Accounts payable
|
$
|
1,366
|
|
|
$
|
1,667
|
|
Accrued expenses
|
2,915
|
|
|
1,774
|
|
Deferred revenue
|
—
|
|
|
425
|
|
Due to related party
|
123
|
|
|
114
|
|
Total current liabilities
|
4,404
|
|
|
3,980
|
|
Other liabilities
|
170
|
|
|
—
|
|
Warrant liability
|
—
|
|
|
5
|
|
Deferred tax liability
|
12,528
|
|
|
16,335
|
|
Contingent consideration
|
38,100
|
|
|
45,100
|
|
Commitments and contingencies
|
|
|
|
Stockholders’ equity:
|
|
|
|
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized at September 30, 2017 and December 31, 2016 and no shares issued and outstanding at September 30, 2017 and December 31, 2016
|
—
|
|
|
—
|
|
Common stock, $0.001 par value per share; 200,000,000 shares authorized at September 30, 2017 and December 31, 2016 and 24,698,135 and 24,531,964 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively
|
25
|
|
|
25
|
|
Additional paid-in capital
|
162,825
|
|
|
161,963
|
|
Accumulated deficit
|
(145,784
|
)
|
|
(123,311
|
)
|
Total stockholders’ equity
|
17,066
|
|
|
38,677
|
|
Total liabilities and stockholders’ equity
|
$
|
72,268
|
|
|
$
|
104,097
|
|
See accompanying notes.
ELEVEN BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(unaudited)
(in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenue:
|
|
|
|
|
|
|
|
Collaboration revenue
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
406
|
|
License revenue
|
—
|
|
|
28,650
|
|
|
425
|
|
|
28,750
|
|
Total revenue
|
—
|
|
|
28,650
|
|
|
425
|
|
|
29,156
|
|
Operating expenses:
|
|
|
|
|
|
|
|
Research and development
|
3,619
|
|
|
2,754
|
|
|
9,402
|
|
|
10,684
|
|
General and administrative
|
1,631
|
|
|
6,366
|
|
|
6,085
|
|
|
11,984
|
|
Loss from change in fair value of contingent consideration
|
3,900
|
|
|
—
|
|
|
7,600
|
|
|
—
|
|
Total operating expenses
|
9,150
|
|
|
9,120
|
|
|
23,087
|
|
|
22,668
|
|
(Loss) income from operations
|
(9,150
|
)
|
|
19,530
|
|
|
(22,662
|
)
|
|
6,488
|
|
Other income (expense):
|
|
|
|
|
|
|
|
Other income (expense), net
|
45
|
|
|
(43
|
)
|
|
180
|
|
|
96
|
|
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
(915
|
)
|
Interest expense
|
—
|
|
|
—
|
|
|
—
|
|
|
(247
|
)
|
Total other income (expense), net
|
45
|
|
|
(43
|
)
|
|
180
|
|
|
(1,066
|
)
|
Net (loss) income and comprehensive (loss) income
|
$
|
(9,105
|
)
|
|
$
|
19,487
|
|
|
$
|
(22,482
|
)
|
|
$
|
5,422
|
|
Net (loss) income per share — basic
|
$
|
(0.37
|
)
|
|
$
|
0.95
|
|
|
$
|
(0.91
|
)
|
|
$
|
0.27
|
|
Weighted-average number of common shares used in net (loss) income per share — basic
|
24,691
|
|
|
20,495
|
|
|
24,663
|
|
|
20,004
|
|
Net (loss) income per share — diluted
|
$
|
(0.37
|
)
|
|
$
|
0.91
|
|
|
$
|
(0.91
|
)
|
|
$
|
0.26
|
|
Weighted-average number of common shares used in net (loss) income per share — diluted
|
24,691
|
|
|
21,423
|
|
|
24,663
|
|
|
20,796
|
|
See accompanying notes.
ELEVEN BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
2017
|
|
2016
|
Operating activities
|
|
|
|
Net (loss) income
|
$
|
(22,482
|
)
|
|
$
|
5,422
|
|
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:
|
|
|
|
Depreciation and amortization
|
221
|
|
|
111
|
|
Non-cash interest expense
|
—
|
|
|
26
|
|
Stock-based compensation expense
|
819
|
|
|
3,351
|
|
Change in fair value of warrant liability
|
(5
|
)
|
|
(38
|
)
|
Loss from change in fair value of contingent consideration
|
7,600
|
|
|
—
|
|
Loss on extinguishment of debt
|
—
|
|
|
221
|
|
Gain on sale of equipment
|
(94
|
)
|
|
(14
|
)
|
Changes in operating assets and liabilities, excluding impact of acquisition:
|
|
|
|
Prepaid expenses and other assets
|
(285
|
)
|
|
62
|
|
Restricted cash
|
—
|
|
|
(10
|
)
|
Accounts payable
|
(301
|
)
|
|
(648
|
)
|
Accrued expenses and other liabilities
|
803
|
|
|
(1,189
|
)
|
Deferred revenue
|
(425
|
)
|
|
844
|
|
Due to related party
|
9
|
|
|
—
|
|
Net cash (used in) provided by operating activities
|
(14,140
|
)
|
|
8,138
|
|
Investing activities
|
|
|
|
Cash acquired in the acquisition
|
—
|
|
|
136
|
|
Sales of equipment
|
84
|
|
|
283
|
|
Net cash provided by investing activities
|
84
|
|
|
419
|
|
Financing activities
|
|
|
|
Payments on notes payable
|
—
|
|
|
(14,124
|
)
|
Proceeds from exercise of common stock options
|
40
|
|
|
204
|
|
Proceeds from sale of common stock pursuant to ESPP
|
12
|
|
|
—
|
|
Net cash provided by (used in) financing activities
|
52
|
|
|
(13,920
|
)
|
Net decrease in cash and cash equivalents
|
(14,004
|
)
|
|
(5,363
|
)
|
Cash and cash equivalents at beginning of period
|
25,342
|
|
|
36,079
|
|
Cash and cash equivalents at end of period
|
$
|
11,338
|
|
|
$
|
30,716
|
|
Supplemental non-cash investing and financing activities
|
|
|
|
Viventia Bio Inc. acquisition:
|
|
|
|
Common stock issued in connection with the acquisition
|
$
|
—
|
|
|
$
|
13,525
|
|
Fair value of assets acquired in the acquisition, excluding cash and cash equivalents
|
$
|
—
|
|
|
$
|
48,568
|
|
Fair value of liabilities assumed in the acquisition
|
$
|
—
|
|
|
$
|
13,279
|
|
Adjustment to fair value of assets acquired and liabilities assumed during provisional period (Note 4)
|
$
|
14,600
|
|
|
$
|
—
|
|
Supplemental cash flow information
|
|
|
|
Cash paid for interest
|
$
|
—
|
|
|
$
|
663
|
|
See accompanying notes.
ELEVEN BIOTHERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Organization and Basis of Presentation
Eleven Biotherapeutics, Inc. (the “Company”), a Delaware corporation, is a biologics oncology company focused primarily on designing, engineering and developing targeted protein therapeutics ("TPTs"). The Company's TPTs are single protein therapeutics composed of targeting moieties genetically fused via linker domains to cytotoxic protein payloads that are produced through the Company's proprietary one-step manufacturing process. The Company targets tumor cell surface antigens that allow for rapid internalization into the targeted cancer cell and have limited expression on normal cells. The Company has designed its TPTs to overcome the fundamental efficacy and safety challenges inherent in existing antibody drug conjugates ("ADCs"), where a payload is chemically attached to a targeting antibody.
Basis of presentation
The condensed consolidated financial statements as of
September 30, 2017
and for the
three and nine months ended September 30, 2017
and 2016 and the related information contained within the notes to the condensed consolidated financial statements are unaudited. The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s consolidated financial position as of
September 30, 2017
and its results of operations for the
three and nine months ended September 30, 2017
and 2016 and its cash flows for the
nine months ended September 30, 2017
and 2016. The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the
three and nine-
month periods are also unaudited. The results of operations for the
three and nine months ended September 30, 2017
are not necessarily indicative of the results to be expected for the year ending December 31, 2017 or for any other future annual or interim period. The condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 that was filed with the Securities and Exchange Commission (“SEC”) on March 24, 2017 (the "2016 Form 10-K").
The condensed consolidated financial statements include the accounts of Eleven Biotherapeutics, Inc., its wholly owned subsidiary, Viventia Bio Inc. ("Viventia"), and its indirect subsidiaries, Viventia Bio USA Inc. and Viventia Biotech (EU) Limited. All inter-company transactions and balances have been eliminated in consolidation. The condensed consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles.
The functional currency of Viventia Bio Inc., Viventia Bio USA Inc. and Viventia Biotech (EU) Limited is the U.S. dollar.
Liquidity
The Company has financed its operations to date primarily through debt and equity offerings and collaboration and licensing arrangements. As of
September 30, 2017
, the Company had cash and cash equivalents totaling $
11.3 million
, net working capital of $
7.7 million
and an accumulated deficit of $
145.8 million
. In November 2017, the Company issued and sold
5,525,000
shares of its common stock, pre-funded warrants to purchase an aggregate of
4,475,000
shares of common stock and common warrants to purchase up to an aggregate of
10,000,000
shares of common stock for net proceeds of approximately
$7.0 million
, excluding any proceeds from the potential exercise of the pre-funded warrants and common warrants.
The future success of the Company is dependent on its ability to develop its product candidates and ultimately upon its ability to attain profitable operations. The Company is subject to a number of risks similar to other early-stage life science companies, including, but not limited to, successful discovery and development of its product candidates, raising additional capital with favorable terms, development by its competitors of new technological innovations, protection of proprietary technology and market acceptance of the Company’s products. The successful discovery and development of product candidates requires substantial working capital which may not be available to the Company on favorable terms or not at all.
To date, the Company has no revenue from product sales and management expects continuing operating losses in the future. As of
September 30, 2017
, the Company had available cash and cash equivalents of $
11.3 million
, which it believes, together with the proceeds received in November 2017, is not sufficient to fund the Company’s current operating plan for twelve months from the date of issuance of these financial statements. Management expects to seek additional funds through equity or debt financings or through additional collaboration, licensing transactions or other sources. The Company may be unable to obtain equity or debt financings or enter into additional collaboration or licensing transactions and, if necessary, the Company will be required to implement cost reduction strategies. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The condensed
consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
2. Significant Accounting Policies and Recent Accounting Pronouncements
Recently adopted accounting standards
In November 2015, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2015-17,
Balance Sheet Classification of Deferred Taxes
(“ASU 2015-17”). ASU 2015-17 requires companies to classify all deferred tax assets and liabilities as noncurrent on the balance sheet instead of separating deferred taxes into current and noncurrent amounts. The Company adopted, prospectively, ASU 2015-07 as of January 1, 2017. The adoption of ASU 2015-17 did not have an impact on the Company’s financial statements as the deferred tax liability was classified as noncurrent on the balance sheet as of December 31, 2016.
In March 2016, the FASB issued ASU No. 2016-09,
Improvements to Employee Share-Based Payment Accounting
("ASU 2016-09"). ASU 2016-09 simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The Company adopted ASU 2016-09 as of January 1, 2017 and elected an accounting policy to record forfeitures as they occur. The impact of this change in accounting policy has been recorded as a
$9,000
cumulative effect adjustment to accumulated deficit, as of January 1, 2017. ASU 2016-09 also provides that companies no longer record excess tax benefits or certain tax deficiencies in additional paid-in capital. Instead, all excess tax benefits and tax deficiencies are recorded as income tax expense or benefit in the statement of operations and comprehensive loss. There was no financial statement impact of adopting this provision of ASU 2016-09 as the Company is currently in a net operating loss position and the excess tax benefits that existed from options previously exercised had a full valuation allowance. The effects of adopting the remaining provisions in ASU 2016-09 affecting the classification of awards as either equity or liabilities when an entity partially settles the award in cash in excess of the employer’s minimum statutory withholding requirements and classification in the statement of cash flows did not have a significant impact on the Company’s financial position, results of operations or cash flows.
Recently issued accounting standards
In May 2014, the FASB issued ASU No. 2014-09, codified as Accounting Standards Codification ("ASC") 606,
Revenue from Contracts with Customers
("ASC 606"), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. The new standard will be effective on January 1, 2018 and earlier application is permitted only for annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. ASC 606 allows for either a full retrospective adoption, in which the standard is applied to all of the periods presented, or a modified retrospective application, in which the standard is applied to the most current period presented in the financial statements. The Company expects to adopt this standard using the modified retrospective approach. All of the revenue generated in the
nine months ended September 30, 2017
is from the Company’s license arrangement with Roche. It is expected that the evaluation of variable consideration, and in particular, milestone payments due from Roche will require further judgment to assess the timing of when to include them in the transaction price, which may result in earlier revenue recognition under ASC 606 compared to the current guidance. The Company is continuing to assess the potential impact that ASC 606 may have on its financial position and results of operations as it relates to this arrangement but based on its preliminary assessment does not expect the adoption of ASC 606 to have a material impact on its financial position and results of operations.
In May 2017, the FASB issued ASU No. 2017-09,
Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting
("ASU 2017-09"). This update clarifies the changes to terms or conditions of a share-based payment award that require an entity to apply modification accounting. ASU 2017-09 is effective for annual reporting periods, and interim periods therein, beginning after December 15, 2017. Early application is permitted and prospective application is required. The Company does not expect that the adoption of this guidance will have a significant impact on the Company's financial position, results of operations or cash flows.
There have been no other material changes to the significant accounting policies and recent accounting pronouncements previously disclosed in the 2016 Form 10-K.
3. Fair Value of Financial Instruments
The fair value hierarchy prioritizes the inputs to valuation techniques used to measure fair value into three broad levels as follows: Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2 inputs are
inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and Level 3 inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
The following table presents information about the Company’s financial assets and liabilities that have been measured at fair value, and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value. The Company determines the fair value of the common stock warrants and contingent consideration using Level 3 inputs.
The following table summarizes the assets and liabilities measured at fair value on a recurring basis at
September 30, 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Description
|
September 30,
2017
|
|
Active
Markets
(Level 1)
|
|
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
Assets:
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
$
|
11,338
|
|
|
$
|
11,338
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restricted cash
|
10
|
|
|
10
|
|
|
—
|
|
|
—
|
|
Total assets
|
$
|
11,348
|
|
|
$
|
11,348
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
Warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Contingent consideration
|
38,100
|
|
|
—
|
|
|
—
|
|
|
38,100
|
|
Total liabilities
|
$
|
38,100
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
38,100
|
|
The following table summarizes the assets and liabilities measured at fair value on a recurring basis at
December 31, 2016
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Description
|
December 31, 2016
|
|
Active
Markets
(Level 1)
|
|
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
Assets:
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
$
|
25,342
|
|
|
$
|
25,342
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restricted cash
|
10
|
|
|
10
|
|
|
—
|
|
|
—
|
|
Total assets
|
$
|
25,352
|
|
|
$
|
25,352
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
Warrant liability
|
$
|
5
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5
|
|
Contingent consideration
|
45,100
|
|
|
—
|
|
|
—
|
|
|
45,100
|
|
Total liabilities
|
$
|
45,105
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
45,105
|
|
Warrant Liability
The Company measures the fair value of the warrants classified as a liability at each reporting date using the Black-Scholes option pricing model using the following assumptions:
|
|
|
|
|
|
|
|
September 30,
2017
|
|
December 31, 2016
|
Risk-free interest rate
|
0.96
|
%
|
|
0.85
|
%
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
Expected term (in years)
|
0.17
|
|
|
0.92
|
|
Expected volatility
|
60.04
|
%
|
|
83.39
|
%
|
The following table sets forth a summary of changes in the fair value of the Company’s common stock warrant liability, which represented a recurring measurement classified within Level 3 of the fair value hierarchy, wherein fair value was estimated using significant unobservable inputs (in thousands):
|
|
|
|
|
Beginning balance, January 1, 2017
|
$
|
5
|
|
Change in fair value
|
(5
|
)
|
Ending balance, September 30, 2017
|
$
|
—
|
|
The change in the fair value of the warrant liability is influenced primarily by the price of the underlying common stock. The change in fair value of $
0
and $
64,000
for the three months ended
September 30,
2017 and 2016, respectively, and $
(5,000)
and $
(38,000)
for the
nine
months ended
September 30,
2017 and 2016, respectively, was recorded as other income (expense) in the accompanying condensed consolidated statements of operations and comprehensive income (loss). As of
September 30, 2017
, none of the common stock warrants had been exercised.
Contingent consideration
In connection with the acquisition of Viventia (the "Acquisition"), the Company recorded contingent consideration pertaining to the amounts potentially payable to Viventia's shareholders pursuant to the terms of the share purchase agreement. Contingent consideration is measured at fair value and is based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The valuation of contingent consideration uses assumptions the Company believes would be made by a market participant. The Company assesses these estimates on an on-going basis as additional data impacting the assumptions is obtained. Future changes in the fair value of contingent consideration related to updated assumptions and estimates are recognized within the condensed consolidated statements of operations and comprehensive income (loss).
Contingent consideration may change significantly as development progresses and additional data are obtained, impacting the Company’s assumptions regarding probabilities of successful achievement of related milestones used to estimate the fair value of the liability and the timing in which they are expected to be achieved. In evaluating the fair value information, considerable judgment is required to interpret the market data used to develop the estimates. The estimates of fair value may not be indicative of the amounts that could be realized in a current market exchange. Accordingly, the use of different market assumptions and/or different valuation techniques could result in materially different fair value estimates. The following table sets forth a summary of changes in the fair value of the Company's contingent consideration liability, which represented a recurring measurement classified within Level 3 of the fair value hierarchy, wherein fair value was estimated using significant unobservable inputs (in thousands):
|
|
|
|
|
Beginning balance, January 1, 2017
|
$
|
45,100
|
|
Provisional purchase price accounting adjustment (Note 4)
|
(14,600
|
)
|
Loss from change in fair value of contingent consideration
|
7,600
|
|
Ending balance, September 30, 2017
|
$
|
38,100
|
|
The fair value of the Company’s contingent consideration was determined using probabilities of successful achievement of regulatory milestones and commercial sales, the period in which these milestones and sales are expected to be achieved ranging from 2020 to 2033, the level of commercial sales of Vicinium, and discount rates ranging from
9.3%
to
11.5%
as of December 31, 2016 and
8.6%
to
10.3%
as of
September 30, 2017
. Significant changes in any of these assumptions would result in a significantly higher or lower fair value measurement.
There have been
no
changes to the valuation methods utilized during the
three and nine
months ended
September 30, 2017
. The Company evaluates transfers between levels at the end of each reporting period. There were
no
transfers of assets or liabilities between levels during the
three and nine
months ended
September 30, 2017
.
4. Business Combination
The Company finalized its purchase accounting for the Acquisition during the third quarter of 2017. The Company has valued the acquired assets and liabilities based on their estimated fair values as of September 20, 2016 (the "Acquisition Date"). The fair values included in the condensed consolidated balance sheet as of
September 30, 2017
are based on the best estimates of the Company.
The consideration for the Acquisition and the final allocation of the purchase consideration presented has been updated from the amounts previously disclosed to reflect new information related to facts and circumstances which existed as of the Acquisition Date. The changes in assumptions were primarily due to additional information gathered regarding the potential market for Vicinium outside of the U.S., which resulted in adjustments to the fair value of contingent consideration as of the acquisition date and the in-process research and development assets for Vicinium in the European Union ("E.U.") and the rest of world. The assumptions related to the U.S. market were not updated as sufficient information had previously been gathered to support this estimate. The update of these assumptions also had an effect on the discount rate and certain other valuation assumptions used to value the acquired assets due to an adjustment in the Company specific risk factors, which effected the in-process research and development assets for Vicinium in the U.S., E.U., and the rest of world. As a result of these changes, the Company updated (1) the fair value of the in-process research and development assets for Vicinium, which resulted in a reduction in the fair value of the in-process research and development asset for Vicinium in the rest of the world to a di minimus amount, (2) the fair value of the contingent consideration, and (3) the related deferred tax liability and goodwill.
The preliminary estimate of the purchase price and the final purchase price as of the Acquisition Date are reflected in the following table (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preliminary Fair Value of Consideration*
|
|
Adjustment
|
|
Final Fair Value of Consideration
|
Shares Issued
|
$
|
13,525
|
|
|
$
|
—
|
|
|
$
|
13,525
|
|
Contingent Consideration
|
46,200
|
|
|
(14,600
|
)
|
|
31,600
|
|
|
$
|
59,725
|
|
|
$
|
(14,600
|
)
|
|
$
|
45,125
|
|
*As presented in the Company’s Form 10-K as of and for the year ended December 31, 2016.
The preliminary allocation of the purchase consideration and the final allocation of the purchase consideration as of the Acquisition Date are reflected in the following table (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preliminary Allocation*
|
|
Adjustment
|
|
Final Allocation
|
Cash and cash equivalents
|
$
|
136
|
|
|
$
|
—
|
|
|
$
|
136
|
|
Prepaid expenses and other assets
|
1,162
|
|
|
—
|
|
|
1,162
|
|
Property and equipment
|
867
|
|
|
—
|
|
|
867
|
|
In-process research and development assets (all markets)
|
60,500
|
|
|
(14,100
|
)
|
|
46,400
|
|
Goodwill
|
16,864
|
|
|
(3,800
|
)
|
|
13,064
|
|
Accounts payable
|
(1,163
|
)
|
|
—
|
|
|
(1,163
|
)
|
Accrued expenses
|
(1,494
|
)
|
|
(507
|
)
|
|
(2,001
|
)
|
Other liabilities
|
(812
|
)
|
|
—
|
|
|
(812
|
)
|
Deferred tax liability
|
(16,335
|
)
|
|
3,807
|
|
|
(12,528
|
)
|
|
$
|
59,725
|
|
|
$
|
(14,600
|
)
|
|
$
|
45,125
|
|
*As presented in the Company’s Form 10-K as of and for the year ended December 31, 2016.
The revised fair values of indefinite-lived intangible assets, deferred tax liability and goodwill noted above did not have an impact on the Company’s condensed consolidated statement of operations and comprehensive income (loss), as the effected assets are not amortized. The Company is required to revalue its contingent consideration at each balance sheet date. As such, changes in the fair value of contingent consideration since the Acquisition Date due to updated assumptions and estimates are recognized within the condensed consolidated statements of operations and comprehensive income (loss) (Note 3).
5. License Agreement with Roche
The Company has determined that the License Agreement with Roche contains
four
units of accounting. The Company recognizes arrangement consideration allocated to each unit of accounting when all of the revenue recognition criteria in Accounting Standards Codification ("ASC") Topic 605-25,
Revenue Recognition-Multiple-Element Arrangements
(“ASC 605-25”) are satisfied for that particular unit of accounting. As of
September 30, 2017
, the basic revenue recognition criteria has been met for all units of accounting. Accordingly, the Company recognized
$0.4 million
in revenue related to the License
Agreement for the
nine months ended September 30, 2017
allocated to the transfer of pre-clinical inventory.
No
revenue was recognized during the
three months ended September 30, 2017
.
The Company determined that the milestone payments under the License Agreement were not subject to ASC Topic 605-28 because the achievement of the milestone event depends solely on Roche’s performance. The Company will recognize royalty revenue in the period of sale of the related product(s), based on the underlying contract terms, provided that the reported sales are reliably measurable and the Company has no remaining performance obligations, assuming all other revenue recognition criteria are met.
6. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
December 31, 2016
|
Development costs
|
$
|
2,156
|
|
|
$
|
852
|
|
Employee compensation (including reduction in workforce)
|
453
|
|
|
352
|
|
Professional fees
|
244
|
|
|
413
|
|
Other
|
62
|
|
|
157
|
|
|
$
|
2,915
|
|
|
$
|
1,774
|
|
7. Share-Based Payments
Pursuant to the terms of the Company's 2014 Stock Incentive Plan (the "2014 Plan"), the number of shares authorized for issuance automatically increases on the first day of each fiscal year. On January 1, 2017, the number of shares reserved for issuance under the 2014 Plan increased by
982,164
shares. As of
September 30, 2017
, the total number of shares of common stock available for issuance under the 2014 Plan was
1,989,329
.
The Company also maintains the Eleven Biotherapeutics, Inc. 2009 Stock Incentive Plan, as amended and restated.
Stock-Based Compensation Expense
Stock-based compensation expense by award type was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Stock options
|
$
|
201
|
|
|
$
|
1,932
|
|
|
$
|
656
|
|
|
$
|
2,825
|
|
Restricted stock
|
50
|
|
|
50
|
|
|
152
|
|
|
155
|
|
Restricted stock units
|
—
|
|
|
156
|
|
|
3
|
|
|
354
|
|
Employee stock purchase plan
|
2
|
|
|
6
|
|
|
8
|
|
|
17
|
|
|
$
|
253
|
|
|
$
|
2,144
|
|
|
$
|
819
|
|
|
$
|
3,351
|
|
The Company allocated stock-based compensation expense as follows in the condensed consolidated statements of operations and comprehensive loss (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Research and development expense
|
$
|
56
|
|
|
$
|
971
|
|
|
$
|
179
|
|
|
$
|
1,417
|
|
General and administrative expense
|
197
|
|
|
1,173
|
|
|
$
|
640
|
|
|
1,934
|
|
|
$
|
253
|
|
|
$
|
2,144
|
|
|
$
|
819
|
|
|
$
|
3,351
|
|
At
September 30, 2017
, there was
$1.6 million
of total unrecognized compensation expense related to unvested stock options, unvested restricted stock, and shares issued pursuant to the Company's 2014 Employee Stock Purchase Plan (the "2014 ESPP"). This unrecognized compensation expense is expected to be recognized over a weighted-average period of
2.59
years.
Stock Options
A summary of the stock option activity is presented below:
|
|
|
|
|
|
|
|
|
Shares
|
|
Weighted-Average
Exercise Price
|
Outstanding at December 31, 2016
|
2,024,468
|
|
|
$
|
4.41
|
|
Granted
|
248,025
|
|
|
1.85
|
|
Exercised
|
(140,400
|
)
|
|
0.28
|
|
Cancelled or forfeited
|
(166,887
|
)
|
|
9.85
|
|
Outstanding at September 30, 2017
|
1,965,206
|
|
|
$
|
3.92
|
|
Exercisable at September 30, 2017
|
1,161,259
|
|
|
$
|
4.51
|
|
Vested and expected to vest at September 30, 2017
(1)
|
1,965,206
|
|
|
$
|
3.92
|
|
|
|
(1)
|
Represents the number of vested options, plus the number of unvested options expected to vest. The Company adopted ASU 2016-09 as of January 1, 2017 and elected an accounting policy to record forfeitures as they occur.
|
Restricted Stock
From time to time, upon approval by the Board, certain employees, directors and advisors have been granted restricted shares of common stock. A summary of the restricted stock is presented below:
|
|
|
|
|
|
|
|
|
Restricted
Stock
|
|
Weighted-Average
Grant Date
Fair Value
|
Unvested at December 31, 2016
|
22,150
|
|
|
$
|
11.43
|
|
Vested
|
(13,290
|
)
|
|
11.43
|
|
Unvested at September 30, 2017
|
8,860
|
|
|
$
|
11.43
|
|
Restricted Stock Units
From time to time, upon approval by the Board, certain employees have been granted restricted stock units. A summary of the restricted stock units is presented below:
|
|
|
|
|
|
|
|
|
Restricted
Stock Units
|
|
Weighted-Average
Grant Date
Fair Value
|
Unvested at December 31, 2016
|
3,333
|
|
|
$
|
4.09
|
|
Vested
|
(3,333
|
)
|
|
4.09
|
|
Unvested at September 30, 2017
|
—
|
|
|
$
|
—
|
|
Employee Stock Purchase Plan
On September 14, 2017, the Company issued and sold
6,249
shares of its common stock pursuant to the 2014 ESPP at a purchase price of
$1.19
per share. On March 14, 2017, the Company issued and sold
2,899
shares of its common stock pursuant to the 2014 ESPP at a purchase price of
$1.71
per share. The Company has estimated the number of shares to be issued at the end of the current offering period and recognizes expense over the requisite service period.
8. Net (Loss) Income Per Share
Basic net (loss) income per share is calculated by dividing net (loss) income by the weighted-average shares outstanding during the period, without consideration for common stock equivalents. Diluted net (loss) income per share is calculated by adjusting weighted-average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined
using the treasury-stock method. For purposes of the diluted net (loss) income per share calculation, stock options, unvested restricted stock, restricted stock units and common stock warrants are considered to be common stock equivalents.
The following common stock equivalents, using the treasury-stock method, were included in the calculation of diluted net (loss) income per share for the periods indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended
September 30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Stock options
|
—
|
|
|
891,341
|
|
|
—
|
|
|
776,580
|
|
Unvested restricted stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Restricted stock units
|
—
|
|
|
37,063
|
|
|
—
|
|
|
15,156
|
|
Common stock warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
928,404
|
|
|
—
|
|
|
791,736
|
|
The following common stock equivalents were excluded from the calculation of diluted net (loss) income per share for the periods indicated because including them would have had an anti-dilutive effect or the exercise prices were greater than the average market price of the common shares.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended
September 30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Stock options
|
1,965,206
|
|
|
1,732,954
|
|
|
1,965,206
|
|
|
1,829,193
|
|
Unvested restricted stock
|
8,860
|
|
|
26,580
|
|
|
8,860
|
|
|
26,580
|
|
Common stock warrants
|
926,840
|
|
|
926,840
|
|
|
926,840
|
|
|
926,840
|
|
|
2,900,906
|
|
|
2,686,374
|
|
|
2,900,906
|
|
|
2,782,613
|
|
9. Reduction in Workforce
On August 15, 2017, the Board approved a strategic restructuring of the Company to eliminate a portion of the Company’s workforce in order to preserve the Company’s resources. As of September 30, 2017, the Company estimated total restructuring costs of approximately
$0.2 million
, which included severance and benefits in accordance with the Company's severance benefit plan, all of which was recorded in the three months ended September 30, 2017.
The table below provides a roll-forward of the reduction in workforce liability (in thousands):
|
|
|
|
|
Balance as of January 1, 2017
|
$
|
31
|
|
Charges
|
188
|
|
Payments
|
(28
|
)
|
Balance as of September 30, 2017
|
$
|
191
|
|
On September 22, 2017, the Company announced that it has completed the manufacturing of all Vicinium necessary for its ongoing Phase 3 registration trial in patients with non-muscle invasive bladder cancer ("NMIBC"), and for its Cooperative Research and Development Agreement with the National Cancer Institute. In conjunction with this achievement, the Company is ending its large-scale manufacturing activities and redirecting resources toward completing its Phase 3 trial and preparing for discussions with the U.S. Food and Drug Administration regarding, as appropriate, the submission of a Biologics License Application for Vicinium in patients with NMIBC. This change included the reduction in workforce discussed above.
10. Subsequent Event
On October 4, 2017, the Company granted
1,055,000
options at an exercise price of
$1.59
.
On November 1, 2017, the Company raised approximately
$7.0 million
of net proceeds from the sale of
5,525,000
units (each unit consisting of
one
share of common stock and
one
common warrant to purchase
one
share of common stock) and
4,475,000
pre‑funded units (each pre-funded unit consisting of
one
pre-funded warrant to purchase
one
share of common stock and
one
common warrant to purchase
one
share of common stock) at a purchase price of
$0.80
per unit and
$0.79
per pre-funded unit. Each common warrant contained in a unit or a pre-funded unit has an exercise price of
$0.80
per share and is exercisable
immediately and will expire
five
years from the date of issuance. Each pre-funded warrant contained in a pre-funded unit is exercisable for
one
share of common stock and the exercise price is
$0.01
per share. The Company granted the underwriter an option to purchase up to
1,500,000
additional shares of common stock at a purchase price of
$0.79
per share and/or common warrants to purchase up to an aggregate of
1,500,000
shares of common stock at a purchase price of
$0.01
per common warrant with an exercise price of
$0.80
per share, less underwriting discount and commissions. If the underwriters exercise this option in full, the Company will receive approximately
$1.1 million
of additional net proceeds. The underwriter can exercise this option at any time on or before December 1, 2017.
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the notes to those financial statements appearing elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto and management's discussion and analysis of financial condition and results of operations for the year ended December 31, 2016 included in our Annual Report on Form 10-K. This discussion and analysis contains forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in Part II, Item 1A, "Risk Factors" of this Quarterly Report on Form 10-Q and in Part I, Item IA, “Risk Factors” of our Annual Report on Form 10-K which are incorporated herein by reference, our actual results could differ materially from the results described in or implied by the forward-looking statements.
Overview
We are a biologics oncology company focused primarily on designing, engineering and developing targeted protein therapeutics, or TPTs. Our TPTs are single protein therapeutics composed of targeting moieties genetically fused via linker domains to cytotoxic protein payloads that are produced through our proprietary one-step manufacturing process. We target tumor cell surface antigens that allow for rapid internalization into the targeted cancer cell and have limited expression on normal cells. We have designed our TPTs to overcome the fundamental efficacy and safety challenges inherent in existing antibody drug conjugates, or ADCs, where a payload is chemically attached to a targeting antibody.
Our most advanced product candidate is Vicinium
TM
, which is a locally-administered TPT. In a completed Phase 2 clinical trial, of the 45 evaluable subjects treated with Vicinium, 40% achieved a complete response or no evidence of disease at three months while 16% remained disease-free for at least 18 months. In the third quarter of 2015, we, through our subsidiary, Viventia Bio Inc., or Viventia, commenced in the United States and Canada a Phase 3 clinical trial of Vicinium for the treatment of subjects with high-grade non-muscle invasive bladder cancer, or NMIBC. We anticipate complete enrollment in this clinical trial in the first quarter of 2018 with topline three-month data in mid-2018 and topline twelve-month data in the second quarter of 2019. In June 2017, we entered into a Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute, or NCI, for the development of Vicinium in combination with AstraZeneca’s immune checkpoint inhibitor, durvalumab, for the treatment of NMIBC. Under the terms of the CRADA, the NCI will conduct a Phase 1 clinical trial in subjects with high-grade NMIBC to evaluate the safety, efficacy and biological correlates of Vicinium in combination with durvalumab.
Our second most advanced product candidate is Proxinium
TM
, a locally-administered TPT intended for the treatment of squamous cell carcinoma of the head and neck, or SCCHN. In our two Phase 1 clinical trials, 53% of evaluable subjects treated with Proxinium demonstrated antitumor activity with epithelial cell adhesion molecule, or EpCAM-expressing tumors as assessed by investigator’s clinical measurements, the investigator’s overall assessment including qualitative changes, and assessment of available radiologic data. In addition, three out of the four subjects with complete responses of injected tumors had regression or complete resolution of adjacent non injected lesions. In a Phase 2 clinical trial, we observed tumor shrinkage in 10 of the 14 evaluable subjects (71.4%). We intend to initiate a Phase 1/2a clinical trial that will explore the potential of Proxinium in combination with a checkpoint inhibitor for the treatment of SCCHN and is actively seeking partners for a combination program. In addition to our locally-administered TPTs, our pipeline also includes systemically-administered TPTs in development. Our systemically-administered TPTs are built around our proprietary de-immunized variant of the plant-derived cytotoxin bouganin, or deBouganin. Our lead systemically-administered product candidate, VB6-845d, is being developed for the treatment of multiple types of EpCAM-positive solid tumors. VB6-845d is administered by intravenous infusion. A Phase 1 clinical trial conducted with VB6-845, the prior version of VB6-845d, revealed no clinically relevant immune response to the deBouganin payload. We plan on submitting an Investigational New Drug application, or IND, with VB6-845d, once funding or a partner is secured for this program.
We have deferred further development of Proxinium and VB6-845d in order to focus our efforts and our resources on our ongoing development of Vicinium. We are also exploring collaboration agreements for Vicinium, Proxinium and VB6-845d.
We maintain global development, marketing and commercialization rights for all of our TPT-based product candidates. Upon regulatory approval for our product candidates, we will explore various commercialization strategies to market our products. If we obtain regulatory approval for Vicinium in high-grade NMIBC, we may build a North American specialty urology sales force to market the product or seek commercialization partners. If we obtain regulatory approval for our other product candidates, including Proxinium, we may seek partners with oncology expertise in order to maximize the commercial value of each asset or a portfolio of assets. We also own or exclusively license worldwide intellectual property rights for all of our TPT-based product candidates, covering our key patents with protection ranging from 2018 to 2036.
Our operations to date have been limited to organizing and staffing our company, acquiring rights to intellectual property, business planning, raising capital, developing our technology, identifying potential product candidates, undertaking pre-clinical studies and conducting clinical trials. To date, we have financed our operations primarily through debt and equity offerings and collaboration and licensing arrangements. We have devoted substantially all of our financial resources and efforts to research and development activities. We have not completed development of any of our product candidates. We expect to continue to incur significant expenses and operating losses over the next several years. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year.
License Agreement with Roche and Other Product Candidates
On June 10, 2016, we entered into a License Agreement, which we refer to as the License Agreement, with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., or collectively, Roche, pursuant to which we licensed our monoclonal antibody EBI-031 and all other IL-6 antagonist antibody technology owned by us. Under the License Agreement, Roche is required to continue developing EBI-031 at its cost. At the time of the License Agreement, EBI-031, which was derived using our previous AMP-Rx platform, was in pre-clinical development as an intravitreal injection for diabetic macular edema and uveitis. We have received $30.0 million in payments from Roche pursuant to the License Agreement, including a $7.5 million upfront payment and a $22.5 million milestone payment as a result of the IND application for EBI-031 becoming effective. We are also entitled to receive up to an additional $240.0 million upon the achievement of other specified regulatory, development and commercial milestones, as well as royalties based on net sales of potential future products containing EBI-031 or any other potential future products containing other IL-6 compounds.
We also previously invested a significant portion of our efforts and financial resources in the development of our product candidate isunakinra (EBI-005) for the treatment of subjects with dry eye disease and allergic conjunctivitis. Based on negative results from our completed Phase 3 clinical trials in dry eye disease and allergic conjunctivitis, we do not plan to pursue further development of isunakinra.
Liquidity
Since inception, we have incurred significant operating losses and expect to continue to incur operating losses for the foreseeable future. We had a net loss of
$22.5 million
for the
nine months ended September 30, 2017
. As of
September 30, 2017
, we had an accumulated deficit of
$145.8 million
.
On November 1, 2017, we raised approximately
$7.0 million
of net proceeds from the sale of
5,525,000
units (each unit consisting of one share of common stock and one common warrant to purchase one share of common stock) and
4,475,000
pre-funded units (each pre-funded unit consisting of one pre-funded warrant to purchase one share of common stock and one common warrant to purchase one share of common stock) at a purchase price of $0.80 per unit and $0.79 per pre-funded unit, which we refer to as the November 2017 Financing. Each common warrant contained in a unit or pre-funded unit has an exercise price of $0.80 per share and is exercisable immediately and will expire five years from the date of issuance. Each pre-funded warrant contained in a pre-funded unit is exercisable for one share of common stock and the exercise price is $0.01 per share. These proceeds exclude any amounts that will be received from the exercise of pre-funded or common warrants, if any.
We do not know when, or if, we will generate any revenue from the sale of our product candidates as we seek regulatory approval for, and potentially begin to commercialize, any of our product candidates. We anticipate that we will continue to incur losses for the next several years and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products. We are subject to all of the risks common to the development of new products and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. Until we can generate substantial revenue from commercial sales, if ever, we expect to seek additional capital through a combination of private and public equity offerings, debt financings, strategic collaborations and alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of existing shareholders will be diluted and the terms may include liquidation or other preferences that adversely affect the rights of existing shareholders. Debt financing, if available, may involve agreements that include liens or other restrictive covenants limiting our ability to take important actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through strategic collaborations and alliances or licensing arrangements with third parties we may have to relinquish valuable rights to our technologies or grant licenses on terms that are not favorable to us. If we are unable to raise additional funds when needed we may be required to further delay, limit, reduce or terminate our development or commercialization efforts or grant rights to develop and market our technologies that we would otherwise prefer to develop and market ourselves.
Our future capital requirements will depend on many factors, including:
|
|
•
|
the scope, initiation, progress, timing, costs and results of pre-clinical development and laboratory testing and clinical trials for our product candidates;
|
|
|
•
|
our ability to establish collaborations on favorable terms, if at all, particularly manufacturing, marketing and distribution arrangements for our product candidates;
|
|
|
•
|
the costs and timing of the implementation of commercial-scale manufacturing activities;
|
|
|
•
|
the costs and timing of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval;
|
|
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
|
|
|
•
|
our obligation to make milestone, royalty and other payments to third party licensors under our licensing agreements;
|
|
|
•
|
the extent to which we in-license or acquire rights to other products, product candidates or technologies;
|
|
|
•
|
the outcome, timing and cost of regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities, including Health Canada, to require that we perform more studies or clinical trials than those that we currently expect;
|
|
|
•
|
our ability to achieve certain future regulatory, development and commercialization milestones under the License Agreement with Roche;
|
|
|
•
|
the effect of competing technological and market developments; and
|
|
|
•
|
the revenue, if any, received from commercial sales of any product candidates for which we receive regulatory approval.
|
Accordingly, until such time that we can generate substantial revenue from product sales, if ever, we expect to finance our operations through public or private equity or debt financings or other sources. However, we may be unable to raise additional funds or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our development programs or commercialization efforts or grant to others rights to develop or market product candidates that we would otherwise prefer to develop and market ourselves. Failure to receive additional funding could cause us to cease operations, in part or in full. Furthermore, even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due to favorable market conditions or strategic considerations.
We believe that our cash and cash equivalents of
$11.3 million
as of
September 30, 2017
, together with the
$7.0 million
of net proceeds received in November 2017, will be sufficient to fund our current operating plan into
mid 2018
; however, we have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
Financial Operations Overview
Revenue
To date, we have not generated any revenue from the sale of products. Substantially all of our revenue to date has been derived from the License Agreement with Roche and, to a lesser extent, from our former collaboration with ThromboGenics N.V., or ThromboGenics. We do not expect to generate significant product revenue unless and until we obtain marketing approval for and commercialize our product candidates.
Under the terms of the License Agreement with Roche, Roche paid an upfront license fee of $7.5 million and a development milestone payment of $22.5 million as a result of the IND application for EBI-031 becoming effective. We are also entitled to receive up to an additional $240.0 million upon the achievement of other specified regulatory, development and commercial milestones, as well as royalties based on net sales of potential future products containing EBI-031 or any other potential future products containing other IL-6 compounds. The next licensing milestone payment expected from Roche, if any, will be triggered upon commencement of a Phase 2 clinical trial.
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for the development of our product candidates, which include:
|
|
•
|
employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;
|
|
|
•
|
expenses incurred under agreements with contract research organizations, or CROs, and investigative sites that conduct our clinical trials;
|
|
|
•
|
expenses associated with developing manufacturing capabilities and manufacturing clinical study materials;
|
|
|
•
|
facilities, depreciation, and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance, and other supplies; and
|
|
|
•
|
expenses associated with pre-clinical and regulatory activities.
|
We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and our clinical sites.
The successful development and commercialization of any product candidate is highly uncertain. This is due to the numerous risks and uncertainties associated with product development and commercialization, including the uncertainty of:
|
|
•
|
the scope, progress, outcome and costs of our clinical trials and other research and development activities;
|
|
|
•
|
the efficacy and potential advantages of our product candidates compared to alternative treatments, including any standard of care;
|
|
|
•
|
the market acceptance of our product candidates;
|
|
|
•
|
the cost and timing of the implementation of commercial-scale manufacturing of our product candidates;
|
|
|
•
|
obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
|
|
|
•
|
significant and changing government regulation; and
|
|
|
•
|
the timing, receipt and terms of any marketing approvals.
|
A change in the outcome of any of these variables with respect to the development of any product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials or other testing beyond those that we currently contemplate will be required for the completion of clinical development of any product candidate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.
We allocate direct research and development expenses, consisting principally of external costs, such as fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical trials, and costs related to manufacturing or purchasing clinical trial materials, to specific product programs. We do not allocate employee and contractor-related costs, costs associated with our platform and facility expenses, including depreciation or other indirect costs, to specific product programs because these costs are deployed across multiple product programs under research and development and, as such, are separately classified. The table below provides research and development expenses incurred for our Vicinium, Proxinium, VB6-845d, EBI-031 and isunakinra product programs and other expenses by category. Based on negative results for our completed Phase 3 clinical trials in dry eye disease and allergic conjunctivitis, we are no longer developing isunakinra. We have deferred further development of Proxinium and VB6-845d in order to focus our efforts and our resources on our ongoing development of Vicinium. Since the acquisition of Viventia, our research and development expenses have been related primarily to the development of Vicinium. We expect our research and development expenses for Vicinium will continue to increase during subsequent periods. We did not allocate research and development expenses to any other specific product program during the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
2017
|
|
2016*
|
|
2017
|
|
2016*
|
|
(in thousands)
|
Programs:
|
|
|
|
|
|
|
|
Vicinium (1)
|
$
|
2,133
|
|
|
$
|
164
|
|
|
$
|
5,252
|
|
|
$
|
164
|
|
Proxinium (2)
|
—
|
|
|
—
|
|
|
27
|
|
|
—
|
|
VB6-845d (2)
|
—
|
|
|
—
|
|
|
88
|
|
|
—
|
|
EBI-031 (3)
|
—
|
|
|
230
|
|
|
—
|
|
|
2,982
|
|
Isunakinra/EBI-005 (4)
|
—
|
|
|
34
|
|
|
—
|
|
|
1,564
|
|
Total direct program expenses
|
2,133
|
|
|
428
|
|
|
5,367
|
|
|
4,710
|
|
Personnel and other expenses:
|
|
|
|
|
|
|
|
Employee and contractor-related expenses
|
1,005
|
|
|
2,085
|
|
|
2,821
|
|
|
4,985
|
|
Platform-related lab expenses
|
111
|
|
|
45
|
|
|
402
|
|
|
284
|
|
Facility expenses
|
103
|
|
|
170
|
|
|
297
|
|
|
480
|
|
Other expenses
|
267
|
|
|
26
|
|
|
515
|
|
|
225
|
|
Total personnel and other expenses
|
1,486
|
|
|
2,326
|
|
|
4,035
|
|
|
5,974
|
|
Total research and development expenses
|
$
|
3,619
|
|
|
$
|
2,754
|
|
|
$
|
9,402
|
|
|
$
|
10,684
|
|
(1) We expect our development activities for Vicinium will increase significantly during subsequent periods.
(2) We have deferred further development of Proxinium and VB6-845d in order to focus our efforts and our resources on our ongoing development of Vicinium.
(3) Beginning August 16, 2016, Roche is responsible for all development costs for EBI-031.
(4) Our development activities for isunakinra are no longer ongoing.
* Includes Viventia related expenses since September 20, 2016.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related costs for personnel, including stock-based compensation, in executive, operational, finance, business development and human resource functions. Other general and administrative expenses include facility-related costs and professional fees for legal, patent, consulting and accounting services.
Changes in Fair Value of Contingent Consideration
In connection with the acquisition of Viventia, the Company recorded contingent consideration pertaining to the amounts potentially payable to Viventia's shareholders pursuant to the terms of the share purchase agreement. The fair value of contingent consideration is assessed at each balance sheet date and changes, if any, to the fair value are recognized within the condensed consolidated statements of operations and comprehensive income (loss).
Other Income (Expense), Net
Other income (expense), net consists primarily of interest income earned on cash and cash equivalents, interest expense on outstanding debt, the gain or loss associated with the change in the fair value of our common stock warrant liability that is carried at fair value and the loss on extinguishment of debt.
Critical Accounting Policies and Significant Judgments and Estimates
Our critical accounting policies are those policies which require the most significant judgments and estimates in the preparation of our condensed consolidated financial statements. Management has determined that our most critical accounting policies are those relating to revenue recognition, accrued research and development expenses, stock-based compensation, fair value of warrants to purchase common stock, fair value of intangible assets and goodwill, income taxes including the valuation allowance for deferred tax assets, contingent consideration and going concern considerations.
Recently adopted accounting standards
In March 2016, the FASB issued ASU No. 2016-09,
Improvements to Employee Share-Based Payment Accounting
, or ASU 2016-09. ASU 2016-09 simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. We adopted ASU 2016-09 as of January 1, 2017 and elected an accounting policy to record forfeitures as they occur. The impact of this change in accounting policy has been recorded as a $9,000 cumulative effect adjustment to accumulated deficit, as of January 1, 2017. ASU 2016-09 also provides that companies no longer record excess tax benefits or certain tax deficiencies in additional paid-in capital. Instead, all excess tax benefits and tax deficiencies are recorded as income tax expense or benefit in the statement of operations and comprehensive loss. There was no financial statement impact of adopting this provision of ASU 2016-09 as we are currently in a net operating loss position and the excess tax benefits that existed from options previously exercised had a full valuation allowance. The effects of adopting the remaining provisions in ASU 2016-09 affecting the classification of awards as either equity or liabilities when an entity partially settles the award in cash in excess of the employer’s minimum statutory withholding requirements and classification in the statement of cash flows did not have a significant impact on our financial position, results of operations or cash flows.
Recently issued accounting standards
In May 2014, the FASB issued ASU No. 2014-09, codified as Accounting Standards Codification ("ASC") 606,
Revenue from Contracts with Customers
("ASC 606"), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. The new standard will be effective on January 1, 2018 and earlier application is permitted only for annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. ASC 606 allows for either a full retrospective adoption, in which the standard is applied to all of the periods presented, or a modified retrospective application, in which the standard is applied to the most current period presented in the financial statements. We expect to adopt this standard using the modified retrospective approach. All of the revenue generated in the
nine months ended September 30, 2017
is from our license arrangement with Roche. It is expected that the evaluation of variable consideration, and in particular, milestone payments due from Roche will require further judgment to assess the timing of when to include them in the transaction price, which may result in earlier revenue recognition under ASC 606 compared to the current guidance. We are continuing to assess the potential impact that ASC 606 may have on financial position and results of operations as it relates to this arrangement but based on our preliminary assessment we do not expect the adoption of ASC 606 to have a material impact on our financial position and results of operations.
In May 2017, the FASB issued ASU No. 2017-09,
Scope of Modification Accounting (Topic 718),
or ASU 2017-09, which amends the scope of modification accounting for share-based payment arrangements. ASU 2017-09 provides guidance on the types of changes to the terms or conditions of share-based payment awards to which an entity would be required to apply modification accounting under ASC 718. Specifically, an entity would not apply modification accounting if the fair value, vesting conditions, and classification of the awards are the same immediately before and after the modification. The new standard is effective for annual periods beginning after December 15, 2017 and interim periods within those years. Early adoption is permitted. We are currently evaluating the impact this update will have on our financial statements.
There have been no other significant changes to our critical accounting policies discussed in our Annual Report on Form 10-K for the year ended December 31, 2016, which we refer to as our 2016 Form 10-K.
Results of Operations
Comparison of the Three Months Ended
September 30, 2017
and
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
|
|
2017
|
|
2016
|
|
Change
|
|
(in thousands)
|
Revenue:
|
|
|
|
|
|
License revenue
|
$
|
—
|
|
|
$
|
28,650
|
|
|
$
|
(28,650
|
)
|
Total revenue
|
—
|
|
|
28,650
|
|
|
(28,650
|
)
|
Operating expenses:
|
|
|
|
|
|
Research and development
|
3,619
|
|
|
2,754
|
|
|
865
|
|
General and administrative
|
1,631
|
|
|
6,366
|
|
|
(4,735
|
)
|
Loss from change in fair value of contingent consideration
|
3,900
|
|
|
—
|
|
|
3,900
|
|
Total operating expenses
|
9,150
|
|
|
9,120
|
|
|
30
|
|
(Loss) income from operations
|
(9,150
|
)
|
|
19,530
|
|
|
(28,680
|
)
|
Other income (expense), net
|
45
|
|
|
(43
|
)
|
|
88
|
|
Net (loss) income and comprehensive (loss) income
|
$
|
(9,105
|
)
|
|
$
|
19,487
|
|
|
$
|
(28,592
|
)
|
Revenue
. There was no revenue for the three months ended
September 30, 2017
compared to
$28.7 million
for the three months ended
September 30, 2016
. In August 2016, we recognized the upfront license fee and the development milestone payment under the License Agreement with Roche, relating to the execution of the License Agreement and the successful submission of the IND application for EBI-031.
Research and development expenses
. Research and development expenses were
$3.6 million
for the three months ended
September 30, 2017
compared to
$2.8 million
for the three months ended
September 30, 2016
. The increase of
$0.9 million
was due primarily to increases in Vicinium-related development expenses of
$2.0 million
, which was acquired in connection with our acquisition of Viventia in September 2016. This increase was partially offset by a decrease in EBI-031 related development expenses of
$0.2 million
due to the License Agreement with Roche in which Roche is responsible for all on-going development expenses. In addition, total personnel and other expenses were
$1.5 million
for the three months ended
September 30, 2017
compared to
$2.3 million
for the three months ended
September 30, 2016
.
General and administrative expenses
. General and administrative expenses were
$1.6 million
for the three months ended
September 30, 2017
compared to
$6.4 million
for the three months ended
September 30, 2016
. The decrease of
$4.7 million
was due primarily to a reduction in professional fees as well as salaries and related costs for personnel, including stock-based compensation. For the three months ended September 30, 2016, we had higher professional fees related to the License Agreement with Roche, our 2016 review of strategic alternatives and our acquisition of Viventia. In addition, for the three months ended September 30, 2016, we had higher severance costs related to our acquisition of Viventia.
Loss from change in fair value of contingent consideration
. The change in fair value of contingent consideration was
$3.9 million
for the three months ended
September 30, 2017
compared to
$0 million
for the three months ended
September 30, 2016
was primarily due to updates in the projected revenue assumptions related to Vicinium.
Other income (expense), net
. Other income, net was
$45,000
for the three months ended
September 30, 2017
compared to other expense, net of
$43,000
for the three months ended
September 30, 2016
. The change of
$88,000
was due to an increase in interest income in addition to a change in the fair value of the warrant liability.
Comparison of the
Nine Months Ended
September 30, 2017
and
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2017
|
|
2016
|
|
Change
|
|
(in thousands)
|
Revenue:
|
|
|
|
|
|
Collaboration revenue
|
$
|
—
|
|
|
$
|
406
|
|
|
$
|
(406
|
)
|
License revenue
|
425
|
|
|
28,750
|
|
|
(28,325
|
)
|
Total revenue
|
425
|
|
|
29,156
|
|
|
(28,731
|
)
|
Operating expenses:
|
|
|
|
|
|
Research and development
|
9,402
|
|
|
10,684
|
|
|
(1,282
|
)
|
General and administrative
|
6,085
|
|
|
11,984
|
|
|
(5,899
|
)
|
Loss from change in fair value of contingent consideration
|
7,600
|
|
|
—
|
|
|
7,600
|
|
Total operating expenses
|
23,087
|
|
|
22,668
|
|
|
419
|
|
(Loss) income from operations
|
(22,662
|
)
|
|
6,488
|
|
|
(29,150
|
)
|
Other income (expense), net
|
180
|
|
|
(1,066
|
)
|
|
1,246
|
|
Net (loss) income and comprehensive (loss) income
|
$
|
(22,482
|
)
|
|
$
|
5,422
|
|
|
$
|
(27,904
|
)
|
Revenue
. Revenue was
$0.4 million
for the
nine
months ended
September 30, 2017
compared to
$29.2 million
for the
nine
months ended
September 30, 2016
. The decrease was due primarily to a decrease in license revenue as we recognized the upfront license fee and development milestone payment under the License Agreement with Roche, relating to the execution of the License Agreement and the successful submission of the IND application for EBI-031, as well as a decrease in collaboration revenue from our terminated collaboration with ThromboGenics. This decrease was partially offset by revenue recognized under the License Agreement with Roche in 2017 relating to the transfer of pre-clinical inventory to Roche.
Research and development expenses
. Research and development expenses were
$9.4 million
for the
nine
months ended
September 30, 2017
compared to
$10.7 million
for the
nine
months ended
September 30, 2016
. The decrease of
$1.3 million
was due primarily to a decrease in EBI-031 related development expenses of
$3.0 million
due to the License Agreement with Roche in which Roche is responsible for all on-going development expenses, as well as a decrease of
$1.6 million
of isunakinra-related development expenses, which development activities are no longer ongoing. These decreases were partially offset by increases in Vicinium-related development expenses of
$5.1 million
, which was acquired in connection with our acquisition of Viventia in September 2016. In addition, total personnel and other expenses were
$4.0 million
for the
nine
months ended
September 30, 2017
compared to
$6.0 million
for the
nine
months ended
September 30, 2016
.
General and administrative expenses
. General and administrative expenses were
$6.1 million
for the
nine
months ended
September 30, 2017
compared to
$12.0 million
for the
nine
months ended
September 30, 2016
. The decrease of
$5.9 million
was primarily due to a reduction of professional fees as well as salaries and related costs for personnel, including stock-based compensation. For the nine months ended September 30, 2016, we had higher professional fees related to the License Agreement with Roche, our 2016 review of strategic alternatives and the acquisition of Viventia. In addition, for the nine months ended September 30, 2016, we had higher severance costs related to the acquisition of Viventia.
Loss from change in fair value of contingent consideration
. The change in fair value of contingent consideration was
$7.6 million
for the
nine
months ended
September 30, 2017
compared to
$0 million
for the nine months ended
September 30, 2016
was primarily due to updates in projected revenue assumptions related to Vicinium.
Other income (expense), net
. Other income, net was
$0.2 million
for the
nine
months ended
September 30, 2017
compared to other expense, net of
$1.1 million
for the
nine
months ended
September 30, 2016
. The change of
$1.2 million
was due primarily to the loss on extinguishment of debt recorded in 2016 associated with the prepayment of the loan with Silicon Valley Bank as well as the interest expense incurred until the loan was prepaid.
Liquidity and Capital Resources
Sources of Liquidity
Since inception, we have incurred significant operating losses and expect to continue to incur operating losses for the foreseeable future. To date, we have financed our operations primarily through debt and equity offerings and collaboration and licensing arrangements.
In June 2016, we entered into the License Agreement with Roche and received an up-front license fee of $7.5 million and up to an additional $262.5 million upon the achievement of specified regulatory, development and commercial milestones with respect to up to two unrelated indications. Specifically, an aggregate amount of up to $197.5 million is payable to us for the achievement of specified milestones with respect to the first indication: consisting of $72.5 million in development milestones, $50.0 million in regulatory milestones and $75.0 million in commercialization milestones. We received the first development milestone payment of $22.5 million as a result of the IND for EBI-031 becoming effective. In addition, we are entitled to receive royalty payments in accordance with a tiered royalty rate scale, with rates ranging from 7.5% to 15% for net sales of potential future products containing EBI-031 and at up to 50% of these rates for net sales of potential future products containing other IL-6 compounds, with each of the royalties subject to reduction under certain circumstances and to the buy-out options of Roche.
On November 1, 2017, we raised approximately
$7.0 million
of net proceeds from the sale of
5,525,000
units (each unit consisting of one share of common stock and one common warrant to purchase one share of common stock) and
4,475,000
pre‑funded units (each pre-funded unit consisting of one pre-funded warrant to purchase one share of common stock and one common warrant to purchase one share of common stock) at a purchase price of
$0.80
per unit and
$0.79
per pre-funded unit. Each common warrant contained in a unit or a pre-funded unit has an exercise price of
$0.80
per share and is exercisable immediately and will expire
five
years from the date of issuance. Each pre-funded warrant contained in a pre-funded unit is exercisable for one share of common stock and the exercise price is
$0.01
per share. We granted the underwriter an option to purchase up to 1,500,000 additional shares of common stock at a purchase price of $0.79 per share and/or common warrants to purchase up to an aggregate of 1,500,000 shares of common stock at a purchase price of $0.01 per common warrant with an exercise price of $0.80 per share, less underwriting discount and commissions. If the underwriters exercise this option in full, we will receive approximately $1.1 million of additional net proceeds. The underwriter can exercise this option at any time on or after December 1, 2017.
Cash Flows
As of
September 30, 2017
, we had cash and cash equivalents of
$11.3 million
. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.
The following table sets forth the primary sources and uses of cash for each of the periods set forth below:
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Nine Months Ended
September 30,
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2017
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2016
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(in thousands)
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Net cash (used in) provided by :
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Operating activities
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$
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(14,140
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)
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$
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8,138
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Investing activities
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84
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419
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Financing activities
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52
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(13,920
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)
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Net decrease in cash and cash equivalents
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$
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(14,004
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)
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$
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(5,363
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)
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Operating activities.
Net cash used in operating activities was
$14.1 million
for the
nine
months ended
September 30, 2017
and consisted primarily of net loss of
$22.5 million
, adjusted for non-cash items, including stock-based compensation expense of
$0.8 million
, depreciation expense and impairment of fixed asset expense of
$0.2 million
, change in fair value of contingent consideration of
$7.6 million
, gain on sale of equipment of
$0.1 million
and a net change in operating assets and liabilities of
$(0.2) million
.
Net cash provided by operating activities was
$8.1 million
for the
nine
months ended
September 30, 2016
, and consisted primarily of net income of
$5.4 million
resulting from the License Agreement with Roche, adjusted for non-cash items, including stock-based compensation expense of
$3.4 million
, depreciation expense of
$0.1 million
,
$0.2 million
loss on extinguishment of debt and a net change in operating assets and liabilities of
$(0.9) million
.
Investing activities
. Net cash provided by investing activities consisted of sales of equipment. For the
nine
months ended
September 30, 2017
, we had cash proceeds from the sale of equipment of
$0.1 million
. For the
nine months ended September 30, 2016
, we sold
$0.3 million
of property and equipment. In addition, we also acquired
$0.1 million
of cash from the acquisition of Viventia.
Financing activities
. Net cash provided by financing activities for the
nine
months ended
September 30, 2017
consisted of the proceeds from the exercise of stock options and the sale of common stock pursuant to our ESPP.
Net cash used in financing activities for the
nine
months ended
September 30, 2016
was
$13.9 million
and consisted primarily of the repayment of outstanding debt obligations. On March 1, 2016, we prepaid all outstanding amounts owed to Silicon Valley Bank and terminated the loan agreement. This was partially offset by proceeds from the exercise of stock options of $0.2 million.
Funding Requirements
We will incur substantial expenses if and as we:
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continue our Phase 3 clinical trial for Vicinium;
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continue the research and pre-clinical and clinical development of our other product candidates;
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seek to discover and develop additional product candidates;
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in-license or acquire the rights to other products, product candidates or technologies;
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seek marketing approvals for any product candidates that successfully complete clinical trials;
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establish sales, marketing and distribution capabilities and scale up and validate external manufacturing capabilities to commercialize any products for which we may obtain marketing approval;
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maintain, expand and protect our intellectual property portfolio;
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add equipment and physical infrastructure to support our research and development;
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hire additional clinical, quality control, scientific and management personnel; and
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expand our operational, financial and management systems and personnel.
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We believe that our cash and cash equivalents of
$11.3 million
as of
September 30, 2017
, together with the
$7.0 million
of net proceeds received from the November 2017 Financing, will be sufficient to fund our current operating plan into
mid 2018
; however, we have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
Our future capital requirements will depend on many factors, including:
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the scope, initiation, progress, timing, costs and results of pre-clinical development and laboratory testing of our pre-clinical product candidates;
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our ability to establish collaborations on favorable terms, if at all, particularly manufacturing, marketing and distribution arrangements for our product candidates;
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the costs and timing of the implementation of commercial-scale manufacturing activities;
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the costs and timing of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval;
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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
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our obligation to make milestone, royalty and other payments to third party licensors under our licensing agreements;
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the extent to which we in-license or acquire rights to other products, product candidates or technologies;
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the outcome, timing and cost of regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities, including Health Canada, to require that we perform more studies than those that we currently expect;
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our ability to achieve certain future regulatory, development and commercialization milestones under the License Agreement with Roche;
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the effect of competing technological and market developments; and
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the revenue, if any, received from commercial sales of any product candidates for which we receive regulatory approval.
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Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, government or other third-party funding, collaborations, strategic alliances, licensing arrangements and marketing and distribution arrangements. We do not have any committed external source of funds other than the amounts payable under the License Agreement with Roche. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders’ ownership interest will be diluted, such as the financing we completed in November 2017, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights as holders of our common stock. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, collaborations, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
Contractual Obligations and Commitments
The disclosure of our contractual obligations and commitments is set forth under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Contractual Obligations and Commitments” in our 2016 Form 10-K.
During the
three and nine months ended September 30, 2017
, there were no material changes from the contractual commitments and obligations previously disclosed in our 2016 Form 10-K.
License Agreements
The disclosure of our obligations under our license agreements is set forth under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations — License Agreements” in our 2016 Form 10-K.
During the
three and nine months ended September 30, 2017
, there were no material changes to our obligations under our license agreements previously disclosed in our 2016 Form 10-K.
Off-balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission, or SEC.