Viracta Therapeutics, Inc. - Quarter Report: 2007 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 10-Q
(Mark
One)
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For
the quarterly period ended June 30, 2007
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For
the transition period from __________ to
______________
Commission
file number 000-51531
SUNESIS
PHARMACEUTICALS, INC.
(Exact
name of Registrant as specified in its Charter)
Delaware
|
|
94-3295878
|
(State
or Other Jurisdiction of Incorporation or Organization)
|
|
(I.R.S.
Employer Identification Number)
|
341
Oyster Point Boulevard
South
San Francisco, California 94080
(Address
of Principal Executive Offices including Zip Code)
(650)
266-3500
(Registrant’s
Telephone Number, Including Area Code)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant
was required to file reports), and (2) has been subject to such filing
requirements for the past 90 days. YES x
NO
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer (as defined in Rule 12b-2 of
the Exchange Act).
Large
Accelerated Filer o
Accelerated Filer x
Non-Accelerated Filer o
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Securities Exchange Act). YES o
NO
x
The
registrant had 34,316,773 shares of common stock, $0.0001 par value per share,
outstanding as of July 31, 2007.
Sunesis
Pharmaceuticals, Inc.
TABLE
OF CONTENTS
|
|
Page
No.
|
||
|
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|
||
PART I.
FINANCIAL INFORMATION
|
|
|
||
|
|
|
|
|
Item
1.
|
|
Financial
Statements:
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets as of June 30, 2007 and December 31,
2006
|
|
3
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations for the Three and Six Months
Ended
June 30, 2007 and 2006
|
|
4
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Cash Flows for the Six Months Ended June
30,
2007 and 2006
|
|
5
|
|
|
|
|
|
|
|
Notes
to Condensed Consolidated Financial Statements
|
|
6
|
|
|
|
|
|
Item
2.
|
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
15
|
|
|
|
|
|
Item
3.
|
|
Quantitative
and Qualitative Disclosures About Market Risk
|
|
20
|
|
|
|
|
|
Item
4.
|
|
Controls
and Procedures
|
|
20
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PART II.
OTHER INFORMATION
|
|
|
||
Item
1.
|
Legal
Proceedings
|
21
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||
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|
|
|
Item
1A.
|
|
Risk
Factors
|
|
21
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|
|
|
Item
2.
|
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
25
|
Item
3.
|
Defaults
Upon Senior Securities
|
26
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||
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
26
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||
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|
Item
5.
|
|
Other
Information
|
|
26
|
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|
|
|
Item
6.
|
|
Exhibits
|
|
26
|
|
|
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|
|
Signature
|
|
|
|
28
|
2
SUNESIS
PHARMACEUTICALS, INC.
June
30,
|
December 31,
|
||||||
2007
|
2006
|
||||||
(Unaudited)
|
(Note 1)
|
||||||
ASSETS
|
|
|
|||||
|
|
|
|||||
Current
assets:
|
|
|
|||||
Cash
and cash equivalents
|
$
|
11,702,958
|
$
|
6,075,449
|
|||
Marketable
securities
|
53,498,997
|
57,029,199
|
|||||
Prepaids
and other current assets
|
1,439,214
|
1,082,817
|
|||||
Total
current assets
|
66,641,169
|
64,187,465
|
|||||
|
|||||||
Property
and equipment, net
|
5,008,444
|
4,728,929
|
|||||
Deposits
and other assets
|
359,974
|
359,974
|
|||||
Total
assets
|
$
|
72,009,587
|
$
|
69,276,368
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,372,457
|
$
|
2,477,656
|
|||
Accrued
compensation
|
2,229,293
|
2,323,742
|
|||||
Other
accrued liabilities
|
3,209,400
|
961,766
|
|||||
Current
portion of deferred revenue
|
1,802,144
|
2,260,478
|
|||||
Current
portion of equipment financing
|
937,739
|
885,273
|
|||||
Total
current liabilities
|
9,551,033
|
8,908,915
|
|||||
|
|||||||
Non
current portion of deferred revenue
|
268,161
|
1,143,159
|
|||||
Non
current portion of equipment financing
|
1,305,124
|
955,695
|
|||||
Deferred
rent and other non-current liabilities
|
1,585,719
|
1,464,902
|
|||||
|
|||||||
Commitments
|
|||||||
|
|||||||
Stockholders’
equity:
|
|||||||
Preferred
stock, $0.0001 par value; 5,000,000 shares authorized, no shares
issued
and outstanding at June 30, 2007 and December 31, 2006
|
—
|
—
|
|||||
Common
stock, $0.0001 par value; 100,000,000 shares authorized,
34,308,296 shares issued and outstanding at June 30, 2007;
100,000,000 shares authorized, 29,443,079 shares issued and
outstanding at December 31, 2006
|
3,431
|
2,944
|
|||||
Additional
paid-in capital
|
319,300,467
|
298,073,896
|
|||||
Deferred
stock-based compensation
|
(616,900
|
)
|
(1,006,604
|
)
|
|||
Accumulated
other comprehensive loss
|
(1,665
|
)
|
(21,376
|
)
|
|||
Accumulated
deficit
|
(259,385,783
|
)
|
(240,245,163
|
)
|
|||
Total
stockholders’ equity
|
59,299,550
|
56,803,697
|
|||||
|
|||||||
Total
liabilities and stockholders’ equity
|
$
|
72,009,587
|
$
|
69,276,368
|
Note
1:
|
The
condensed balance sheet at December 31, 2006 has been derived from
the audited financial statements at that date included in the Company’s
Form 10-K for the fiscal year ended December 31,
2006.
|
See
accompanying notes to financial statements.
3
SUNESIS
PHARMACEUTICALS, INC.
Three months ended June
30,
|
Six months ended June
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
(unaudited)
|
(unaudited)
|
||||||||||||
Revenue:
|
|||||||||||||
Collaboration
revenue
|
$
|
1,229,167
|
$
|
4,516,667
|
$
|
1,458,334
|
$
|
5,887,372
|
|||||
Collaboration
revenue from related party
|
2,041,098
|
2,190,986
|
4,078,197
|
3,879,845
|
|||||||||
License
revenue
|
—
|
—
|
250,000
|
—
|
|||||||||
Grant
and fellowship revenue
|
—
|
—
|
—
|
37,901
|
|||||||||
Total
revenues
|
3,270,265
|
6,707,653
|
5,786,531
|
9,805,118
|
|||||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
9,697,462
|
8,847,380
|
19,004,940
|
18,563,475
|
|||||||||
General
and administrative
|
4,044,194
|
3,153,630
|
7,340,341
|
5,835,201
|
|||||||||
Total
operating expenses
|
13,741,656
|
12,001,010
|
26,345,281
|
24,398,676
|
|||||||||
Loss
from operations
|
(10,471,391
|
)
|
(5,293,357
|
)
|
(20,558,750
|
)
|
(14,593,558
|
)
|
|||||
Interest
income
|
743,928
|
957,551
|
1,513,554
|
1,503,704
|
|||||||||
Interest
expense
|
(44,308
|
)
|
(162,103
|
)
|
(96,351
|
)
|
(387,655
|
)
|
|||||
Other
income, net
|
188
|
2,003
|
927
|
3,893
|
|||||||||
Net
loss
|
$
|
(9,771,583
|
)
|
$
|
(4,495,906
|
)
|
$
|
(19,140,620
|
)
|
$
|
(13,473,616
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.31
|
)
|
$
|
(0.15
|
)
|
$
|
(0.63
|
)
|
$
|
(0.52
|
)
|
|
Shares
used in computing basic and diluted loss per share
|
31,175,933
|
29,256,267
|
30,321,338
|
26,129,745
|
See
accompanying notes to financial statements.
4
Six months ended June
30,
|
|||||||
2007
|
2006
|
||||||
(Unaudited)
|
|||||||
Cash
flows from operating activities
|
|
|
|||||
Net
loss
|
$
|
(19,140,620
|
)
|
$
|
(13,473,616
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
858,180
|
777,735
|
|||||
Stock-based
compensation expense
|
1,747,500
|
1,377,322
|
|||||
Non-cash
research and development expense
|
—
|
1,999,999
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Prepaids
and other current assets
|
(356,397
|
)
|
638,172
|
||||
Accounts
payable
|
(1,105,199
|
)
|
(159,879
|
)
|
|||
Accrued
compensation
|
(94,449
|
)
|
(369,737
|
)
|
|||
Other
accrued liabilities
|
2,247,634
|
133,849
|
|||||
Deferred
rent and other non-current liabilities
|
120,817
|
65,734
|
|||||
Deferred
revenue
|
(1,333,332
|
)
|
(2,512,370
|
)
|
|||
Net
cash used in operating activities
|
(17,055,866
|
)
|
(11,522,791
|
)
|
|||
|
|||||||
Cash
flows from investing activities
|
|||||||
Purchases
of property and equipment
|
(1,137,695
|
)
|
(1,622,112
|
)
|
|||
Purchases
of marketable securities
|
(55,055,960
|
)
|
(4,206,857
|
)
|
|||
Maturities
of marketable securities
|
58,605,873
|
18,058,351
|
|||||
Net
cash provided by investing activities
|
2,412,218
|
12,229,382
|
|||||
|
|||||||
Cash
flows from financing activities
|
|||||||
Proceeds
from borrowings under equipment financing
|
906,593
|
238,568
|
|||||
Payments
on equipment financing
|
(504,698
|
)
|
(619,452
|
)
|
|||
Proceeds
from issuance of common stock and exercise of options, net of
repurchases
|
19,869,262
|
44,268,820
|
|||||
Net
cash provided by financing activities
|
20,271,157
|
43,887,936
|
|||||
|
|||||||
Net
increase in cash and cash equivalents
|
5,627,509
|
44,594,527
|
|||||
Cash
and cash equivalents at beginning of period
|
6,075,449
|
17,704,465
|
|||||
Cash
and cash equivalents at end of period
|
$
|
11,702,958
|
$
|
62,298,992
|
|||
|
|||||||
Supplemental
disclosure of cash flow information
|
|||||||
Interest
paid
|
$
|
96,351
|
$
|
136,720
|
|||
Non-cash
activities:
|
|||||||
Deferred
stock-based compensation, net of (reversal)
|
$
|
(13,933
|
)
|
$
|
(352,638
|
)
|
|
Issuance
of common stock for in-licensing agreement
|
$
|
—
|
$
|
1,999,999
|
See
accompanying notes to financial statements.
5
(Unaudited)
1.
Organization and Summary of Significant Accounting
Policies
Organization
Sunesis
Pharmaceuticals, Inc. (“Sunesis” or the “Company”) was incorporated in the
state of Delaware on February 10, 1998, and its facilities are located in
South San Francisco, California. The Company’s initial public offering (“IPO”)
was completed in September 2005. Sunesis is a clinical-stage
biopharmaceutical company focused on discovering, developing and commercializing
novel, small molecule therapeutics for oncology and other unmet medical needs.
The Company’s primary activities since incorporation have been conducting
research and development internally and through corporate collaborators,
in-licensing pharmaceutical compounds, conducting clinical trials, performing
business and financial planning, and raising capital. In January 2007, the
Company formed a wholly-owned subsidiary, Sunesis Europe Limited, a United
Kingdom corporation.
Sunesis,
Tethering and the Company’s logo are registered trademarks of the Company. All
other trademarks, trade names and service marks appearing in this Quarterly
Report on Form 10-Q are the property of their respective owners.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates
and assumptions that affect the amounts reported in the financial statements
and
accompanying notes. Actual results could differ materially from these
estimates.
Basis
of Presentation
The
accompanying unaudited, condensed consolidated financial statements have been
prepared in accordance with U. S. generally accepted accounting principles
for
interim financial information and with the instructions to Form 10-Q and
Article 10 of Regulation S-X. Accordingly, they do not include all of the
information and notes required by U.S. generally accepted accounting principles
for complete financial statements. The financial statements include all
adjustments (consisting only of normal recurring adjustments) that management
believes are necessary for a fair presentation of the periods presented. The
balance sheet at December 31, 2006 was derived from the audited financial
statements at that date. These interim financial results are not necessarily
indicative of results to be expected for the full fiscal year or any other
interim period.
These
unaudited, condensed consolidated financial statements and the notes
accompanying them should be read in conjunction with the Company’s Annual Report
on Form 10-K for the year ended December 31, 2006.
Loss
Per Share
Basic
loss per share is calculated by dividing the net loss by the weighted-average
number of common shares outstanding for the period. Diluted loss per share
is
computed by dividing the net loss by the weighted-average number of common
shares outstanding, and dilutive potential common shares for the period
determined using the treasury stock method. For purposes of this calculation,
options to purchase common stock and warrants to purchase common stock are
considered to be potential common shares but were excluded from the calculation
of diluted loss per common share for all periods presented since their effect
is
anti-dilutive.
Three months ended June 30,
|
Six months ended June
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Outstanding
securities not included in diluted loss per share
calculation:
|
|||||||||||||
Options
to purchase common stock
|
4,046,086
|
3,100,188
|
4,046,086
|
3,100,188
|
|||||||||
Warrants
to purchase common stock
|
2,693,237
|
2,693,237
|
2,693,237
|
2,693,237
|
|||||||||
6,739,323
|
5,793,425
|
6,739,323
|
5,793,425
|
6
Comprehensive
Loss
Comprehensive
loss is comprised of net loss and unrealized gains and losses on marketable
securities. Comprehensive loss is as follows:
Three months ended June 30,
|
Six months ended June 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Net
loss
|
$
|
(9,771,583
|
)
|
$
|
(4,495,906
|
)
|
$
|
(19,140,620
|
)
|
$
|
(13,473,616
|
)
|
|
Change
in unrealized gain on marketable securities
|
12,207
|
16,090
|
19,711
|
43,103
|
|||||||||
Comprehensive
loss
|
$
|
(9,759,376
|
)
|
$
|
(4,479,816
|
)
|
$
|
(19,120,909
|
)
|
$
|
(13,430,513
|
)
|
Accumulated
other comprehensive loss consists of the following:
June
30,
|
December 31,
|
||||||
2007
|
2006
|
||||||
Unrealized
holding loss on marketable securities
|
$
|
(1,665
|
)
|
$
|
(21,376
|
)
|
Employee
Stock-Based Compensation
On
January 1, 2006, the Company adopted Statement of Financial Accounting
Standards No. 123 (revised 2004), “Share-Based Payment” (“FAS
123R”).
FAS
123R
Employee
stock-based compensation expense related to all of the Company’s share-based
awards, including stock options granted prior to the Company’s IPO which
continue to be accounted for under APB 25, is as follows:
Three months ended June 30,
|
Six
months ended June 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Research
and development
|
$
|
361,471
|
$
|
325,281
|
$
|
726,364
|
$
|
608,919
|
|||||
General
and administrative
|
536,304
|
334,264
|
1,017,995
|
670,628
|
|||||||||
Stock-based
compensation
|
$
|
897,775
|
$
|
659,545
|
$
|
1,744,359
|
$
|
1,279,547
|
We
use
the Black-Scholes option-pricing model (“Black-Scholes model”) to value our
stock options with the following assumptions (annualized
percentages):
Three months ended June 30,
|
Six
months ended June 30,
|
||||||||||||
|
2007
|
|
2006
|
2007
|
|
2006
|
|||||||
Volatility
|
68.50
|
%
|
80.00
|
%
|
68.50
|
%
|
80.00
|
%
|
|||||
Risk-free
interest rate
|
4.72
|
%
|
5.04
|
%
|
4.71
|
%
|
4.97
|
%
|
|||||
Dividend
yield
|
none
|
none
|
none
|
none
|
|||||||||
Expected
term (years)
|
5.03
|
5.00
|
5.04
|
5.00
|
The
weighted-average estimated fair value of employee stock options granted during
the three months ended June 30, 2007 and 2006 was $2.61 and $4.16 per share,
respectively, using the Black-Scholes model. The weighted-average estimated
fair
value of employee stock options granted during the six months ended June 30,
2007 and 2006 was $2.63 and $4.19 per share, respectively, using the
Black-Scholes model.
The
weighted average estimated fair value of purchase rights under our Employee
Stock Purchase Plan (“ESPP”) for the three months ended June 30, 2007 and 2006
was $1.98 and $2.57 per share, respectively. The weighted average estimated
fair
value of purchase rights under the ESPP for the six months ended June 30, 2007
and 2006 was $1.94 and $2.82 per share, respectively. The weighted average
estimated fair value of purchase rights under the ESPP was calculated using
the
Black-Scholes model with the following assumptions (annualized
percentages):
7
Three months ended June 30,
|
Six
months ended June 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Volatility
|
68.5%
- 80.00
|
%
|
80.00
|
%
|
68.5%
- 80.00
|
%
|
80.00
|
%
|
|||||
Risk-free
interest rate
|
4.87%
- 5.06
|
%
|
4.36%
- 5.06
|
%
|
4.87%
- 5.06
|
%
|
3.90
- 5.06
|
%
|
|||||
Dividend
yield
|
none
|
none
|
none
|
none
|
|
||||||||
Expected
term (years)
|
0.50
- 1.0
|
0.50
- 1.00
|
0.50
- 1.0
|
0.50
- 1.00
|
Stock-based
Compensation for Options Granted Prior to the IPO
Prior
to
the Company’s IPO in September 2005, certain stock options were granted with
exercise prices that were below the reassessed fair value of the common stock
at
the date of grant. In accordance with APB 25, deferred stock-based compensation
was recorded for the difference between the estimated fair value of the common
stock underlying the options and the exercise price of the options. The deferred
stock-based compensation is being amortized over the related vesting terms
of
the options. The Company recorded amortization of deferred stock-based
compensation of $0.21 million and $0.18 million, respectively, in the three
months ended June 30, 2007 and 2006 under the prospective transition method
of
FAS 123R for stock options granted before December 23, 2004, the date on
which the Company filed its initial registration statement on Form S-1 in
connection with its IPO. The Company recorded amortization of deferred
stock-based compensation of $0.38 million and $0.37 million, respectively,
in
the six months ended June 30, 2007 and 2006 under the prospective transition
method of FAS 123R for the options granted before December 23, 2004. For
stock options granted after December 23, 2004, the associated unamortized
deferred compensation balance of $0.3 million was reversed as of January 1,
2006 due to the adoption of FAS 123R.
As
of
June 30, 2007, the expected future amortization expense for deferred stock-based
compensation during each of the following periods is as follows:
Year ending December 31,
|
|
|||
2007
remaining period
|
$
|
315,196
|
||
2008
|
301,704
|
|||
Total
amount to be amortized
|
$
|
616,900
|
Accounting
for Uncertainty in Income Taxes
On
January 1, 2007, the Company adopted the provisions of Financial Standards
Accounting Board Interpretation No. 48, “Accounting for Uncertainty in Income
Taxes-an interpretation of FASB Statement No. 109” (“FIN 48”). There was no
impact on the Company’s financial statements upon adoption. Because of the
Company’s historical net operating losses, it has not been subject to income tax
since inception. There was no unrecognized tax benefits during all the periods
presented.
The
Company maintains deferred tax assets that reflect the net tax effects of
temporary differences between the carrying amounts of assets and liabilities
for
financial reporting purposes and the amounts used for income tax purposes.
These
deferred tax assets include net operating loss (“NOL”) carryforwards, research
credits and capitalized research and development. The net deferred tax asset
has
been fully offset by a valuation allowance because of the Company’s history of
losses. Under
the
provisions of Section 382 of the Internal Revenue Code of 1986, as amended,
substantial changes in the Company’s ownership may limit the amount of NOL
carryforwards that can be utilized annually in the future to offset taxable
income. If a change in ownership of the Company is deemed to have occurred
or
occurs in the future, the Company’s ability to use its NOL carryforwards in any
year may be limited.
8
The
Regents of the University of California
In
December 1998, the Company entered into an exclusive license agreement with
The Regents of the University of California (the “Regents”) for rights to
certain technology to identify small molecule drug leads. The agreement provides
the Company with an exclusive license to develop, make, use, and sell products
derived from the licensed technology, and will continue for the life of the
last-to-expire patent. To date, the licensed technology has produced two issued
patents, U.S. patent Nos. 6,344,330 and 6,344,334, which are both due to
expire on March 27, 2018. Because the Company no longer uses the licensed
technology, none of the Company’s preclinical or clinical compounds originate
from the licensed technology. The Company has not received written notice from
the Regents to terminate or amend the agreement and the Company continues to
provide the Regents status reports of the state of the licensed technology.
The
Company also continues to maintain patents and patent applications that cover
the licensed technology because of its belief that some aspects of the licensed
technology may provide some value in the future.
Dainippon
Sumitomo Pharma Co., Ltd.
In
October 2003, the Company entered into an agreement with Dainippon Sumitomo
Pharma Co., Ltd. (“Dainippon”) to acquire exclusive worldwide development and
marketing rights for Dainippon’s anti-cancer compound, referred to as
SNS-595.
In
addition to payments already made as of December 31, 2006, the Company may
in the future make a series of milestone payments of up to $8.0 million to
Dainippon based on successful development and regulatory approval of SNS-595
for
cancer indications, as well as royalty payments based on any future product
sales. In return, the Company has received an exclusive, worldwide license
to
develop and market SNS-595. In February 2006, the Company made a $0.5
million milestone payment upon commencement of Phase 2 clinical
trials, which was recorded as research and development expense.
Bristol-Myers
Squibb Company
In
April 2005, the Company entered into an agreement with Bristol-Myers Squibb
Company (“BMS”) to acquire worldwide development and commercialization rights
for BMS’ anti-cancer compound, referred to as SNS-032.
Under
the
terms of this agreement, the Company made an up-front $8.0 million equity
payment through the issuance of 445,663 shares of the Company’s
Series C-2 preferred stock, which converted into 879,094 shares of
common stock upon the Company’s IPO in September 2005. This amount was
included in research and development expense for the year ended
December 31, 2005 due to uncertainties surrounding the remaining efforts
for completion of the research and development activities. The Company may
in
the future be required to make a series of milestone payments of up to $29.0
million in cash, equity or any combination thereof to BMS based on the
successful development and approval for the first indication and formulation
of
SNS-032. In addition, the Company may be required to make a series of
development and commercialization milestone payments totaling up to
$49.0 million in cash, equity or any combination thereof to BMS, as well as
royalty payments, based on any future product net sales. In return, the Company
received worldwide exclusive and non-exclusive diagnostic and therapeutic
licenses to SNS-032 and future CDK inhibitors derived from related intellectual
property. In February 2006, upon commencement of a Phase 1 clinical
trial, the Company made a $2.0 million milestone payment through the
issuance of 404,040 shares of the Company’s common stock, which was
recorded as research and development expense.
The
University of California, San Francisco
In
August 2005, and as amended in April 2006, the Company entered into a
research and license agreement with the University of California, San Francisco
(“UCSF”), that provides UCSF a limited license to use Tethering for academic
purposes. UCSF intends to leverage Tethering to identify novel, small molecule
drug candidates. In return, the Company received an exclusive royalty-free
license to any improvements to Tethering or fragment libraries that emerge
from
UCSF’s research. In the event that any small molecules are discovered using
Tethering, the Company will have a right of first negotiation to in-license
the
compounds. UCSF is precluded from utilizing the technology for commercial
purposes and from conducting research in the kinase field or any other drug
target on which the Company is currently interested. The research at UCSF is
being conducted by Dr. James Wells. Dr. Wells was a founder of the
Company and is a member of the Company’s Board of Directors.
SARcode, Inc.
In
March 2006, and as amended in December 2006, the Company entered into
a license agreement with SARcode, Inc. (“SARcode”), a privately-held
biopharmaceutical company, that provides SARcode an exclusive, worldwide license
to all of the Company’s LFA-1 patents and related know-how. SARcode intends to
use the license to develop small molecule drugs to treat inflammatory diseases.
The Company had previously discontinued its LFA-1 inhibitor program, which
was
outside of the Company’s strategic focus.
9
Pursuant
to the license agreement, in January 2007, the Company received a $0.25
million license fee, which was recorded as revenue, and a $0.25 million note
convertible into preferred stock of SARcode upon certain conditions of the
agreement being met. Both the fee and the note became due upon SARcode’s closing
of its first equity financing. In May 2007, the Company received another
convertible note in the amount of $0.38 million for progress made by SARcode in
the preclinical development of a novel LFA-1 inhibitor candidate. This second
note is convertible into preferred stock of SARcode under the same conditions
as
the original $0.25 million note. The Company did not record these two notes
receivable from SARcode which are due in 2012 due to uncertainty of
collectibility. In addition to the $0.25 million of cash and the convertible
notes already received, the Company may receive up to $0.38 million in license
fees and convertible notes, $31.25 million in development and marketing
milestone payments, and royalties for the commercialization of a licensed
compound.
Johnson &
Johnson Pharmaceutical Research and Development,
L.L.C.
In
May 2002, the Company entered into a research collaboration to discover
small molecule inhibitors of Cathepsin S with Johnson & Johnson
Pharmaceutical Research & Development, L.L.C (“J&J PRD”). The
Company applied its proprietary Tethering technology to discover novel
inhibitors of Cathepsin S in this collaboration.
Under
the
terms of the agreement with J&J PRD, the Company received a non-refundable
and non-creditable technology access fee of $0.5 million in
February 2003, and certain research funding to be paid in advance
quarterly. The Company may in the future receive research and development
milestones of up to $24.5 million as well as royalty payments from J&J
PRD based on future product sales. On December 15, 2002, the Company and
J&J PRD amended the collaboration to increase the number of J&J PRD
funded full-time equivalents for 2003. In December 2002, J&J PRD also
made the first milestone payment of $0.25 million to the Company for the
delivery of a novel lead series of compounds. On December 15, 2003, the
Company and J&J PRD again amended the collaboration to extend the research
funding for one additional year from May 3, 2004 through May 2, 2005.
On December 22, 2004, the Company and J&J PRD amended the collaboration
to extend the research funding from May 3, 2005 until December 31,
2005. The research funding portion of the agreement expired on December 31,
2005. Costs associated with research and development activities attributable
to
this agreement approximated the research funding recognized.
Biogen
Idec, Inc.
In
August 2004, the Company entered into a research collaboration with Biogen
Idec, Inc. (“Biogen Idec”) to discover and develop small molecules
targeting kinases, a family of cell signaling enzymes that play a role in the
progression of cancer. The Company applies its proprietary Tethering technology
to generate novel, small molecule leads that inhibit the oncology kinase targets
that are covered by this collaboration.
One
of
the kinase targets in the collaboration is Raf, and the Company’s Raf program
was folded into the collaboration. Under the terms of the agreement, the Company
received a $7.0 million upfront non-refundable and non-creditable technology
access fee, which is being recognized as revenue over an initial four-year
research term. In the event that Biogen Idec decides to exercise its option
to
extend the initial four-year research term for one additional year, Biogen
Idec
is entitled to pay to the Company an additional technology access fee specified
in the agreement. In addition, the Company receives quarterly research funding
of $1.2 million, subject to inflation adjustments, to be paid by Biogen
Idec in advance to support some of the Company’s scientific personnel, and the
Company may in the future receive pre-commercialization milestone payments
of up
to $60.5 million and royalty payments based on any product sales. The
Company retains an option to participate in the co-development and co-promotion
of product candidates for up to two targets that may emerge from this
collaboration. In April 2006, the Company received a $0.5 million milestone
payment from Biogen Idec for meeting certain preclinical milestones related
to
the Raf program, and the Company recorded it as revenue.
Concurrent
with the signing of the agreement, Biogen Idec made a $14.0 million equity
investment by purchasing shares of the Company’s Series C-2 preferred
stock.
Merck &
Co., Inc.
In
February 2003, the Company and Merck & Co., Inc. (“Merck”)
entered into a research collaboration to identify and optimize inhibitors of
beta-amyloid converting enzyme (“BACE”), which is believed to play a key role in
Alzheimer’s disease. This collaboration had an initial three-year research term
and a one-year option period. In November 2005, the one-year option was not
exercised by Merck and the research term of the collaboration ended in
February 2006. Accordingly, the upfront, non-refundable and non-creditable
technology access fee was recognized as revenue over the 36-month term of the
agreement ending February 2006. However, the Company retains the right to
earn milestone payments and royalties on any compound that results from the
collaboration. In June 2006 and again in May 2007, the Company received
milestone payments of $4.25 million and $1 million, respectively, from Merck
for
meeting certain preclinical milestones related to BACE.
10
In
July
2004, the Company and Merck entered into a multi-year research collaboration
to
discover novel oral drugs for the treatment of viral infections. The Company
provided Merck with a series of small molecule compounds targeting viral
infections. These compounds were derived from Tethering. Merck agreed to be
responsible for advancing these compounds into lead optimization, preclinical
development, and clinical studies. Merck is obligated to pay annual license
fees
for the Company’s consulting services and ongoing access to Tethering as a means
of identifying additional compounds for the treatment of viral
infections.
Under
the
terms of the agreement, the Company received an upfront, non-refundable and
non-creditable technology access fee of $2.3 million, which is being
recognized as revenue over an initial three-year research term. The Company
is
also entitled to receive annual license fees aggregating $0.95 million and
as of
August 1, 2007, the Company has received $0.9 million, and may receive payments
based on the achievement of development milestones of up to $22.1 million.
In addition, the Company is entitled to receive royalty payments based on net
sales for any products resulting from the collaboration. Merck receives an
exclusive worldwide license to any products resulting from the
collaboration.
In
connection with the above collaboration agreements, the Company recognized
the
following revenues in the periods presented, which include the amortization
of
upfront fees received, research funding, and milestones earned:
Three months ended June
30,
|
Six months ended June
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Merck
|
$
|
1,229,167
|
$
|
4,516,667
|
$
|
1,458,334
|
$
|
5,887,372
|
|||||
Biogen
Idec-related party
|
2,041,098
|
2,190,986
|
4,078,197
|
3,879,845
|
|||||||||
Total
collaboration revenue
|
$
|
3,270,265
|
$
|
6,707,653
|
$
|
5,536,531
|
$
|
9,767,217
|
In
June 2000, the Company entered into an equipment financing agreement with
General Electric Capital Corporation (“GECC”). Various credit lines have been
issued under the financing agreement since 2000. The current $2.6 million credit
line is available through March 28, 2008. As of June 30, 2007, the Company
had
drawn a total of $10.1 million under various credit lines under the financing
agreement and the outstanding balance was $2.2 million, which bears interest
at
rates ranging from 7.53% to 10.61% per annum and is due in 36 to 48 monthly
payments. The equipment loans are secured by the equipment financed.
In
conjunction with a credit line of $2.5 million under the GECC agreement which
has since expired, the Company issued warrants to GECC to purchase shares of
the
Company’s Series C preferred stock, which converted into warrants to
purchase 1,046 shares of common stock in connection with the Company’s IPO.
The fair value of the warrants issued is insignificant, as determined using
the
Black-Scholes options-pricing model, and was accounted for as prepaid interest
and expensed on a straight-line basis over the term of the agreement. This
fair
value was fully amortized as of December 31, 2006
As
of
June 30, 2007 and December 31, 2006, the Company was in compliance with all
covenants in the GECC agreement.
In
August 2005, the Company entered into a venture loan and security agreement
with Oxford Finance Corporation and Horizon Technology Funding Company LLC,
pursuant to which the Company could borrow up to $15.0 million. The Company
did not borrow any monies under this loan facility and this agreement has
expired. In conjunction with this transaction, the Company issued warrants
to
the lenders to purchase up to 164,830 shares of common stock at a price of
$9.10 per share. These warrants are currently exercisable for 82,415 shares
of common stock and none of the remaining shares covered by the warrants will
vest or become exercisable.
The
fair
value of the warrants issued is $0.5 million, as determined using the
Black-Scholes options-pricing model, and are accounted for as prepaid interest
and expensed on a straight-line basis over the term of the agreement. This
prepaid interest was fully amortized as of December 31, 2006.
11
5.
Contingencies
The
Company is not currently involved in any material legal proceedings. From time
to time, we may become involved in legal proceedings arising in the ordinary
course of our business.
6.
Stockholders’ Equity
In
March 2006, the Company entered into a common stock and warrant purchase
agreement pursuant to which it sold to certain investors, for an aggregate
purchase price of approximately $45.3 million, 7,246,377 shares of its
common stock and warrants to purchase up to 2,173,914 additional shares of
its
common stock (the “2006 PIPE Financing”). The purchase price for the common
stock and the exercise price for the warrants was $6.21 per share.
Investors in the financing paid an additional purchase price equal to $0.125
for
each share of common stock underlying the warrants. All securities were sold
in
a private placement exempt from registration under the Securities Act of 1933,
as amended, by virtue of Section 4(2) and/or Regulation D promulgated
thereunder as transactions not involving any public offering. The shares sold
in
the 2006 PIPE Financing were subsequently registered on a registration statement
on Form S-1 (Reg. No. 333-133387) which was declared effective by the Securities
and Exchange Commission on May 10, 2006. The Company received net proceeds
of
approximately $43.7 million in this offering.
On
May
30, 2007, the Company completed a public offering of 4,750,000 shares of its
common stock at a public offering price of $4.43 per share. Net cash proceeds
from this offering were approximately $19.5 million after deducting underwriting
discounts and commissions and other offering expenses.
7.
Employee Benefit Plans
Stock
Option Plans
The
Company generally grants options (i) to new employees which vest and become
exercisable 25% on the first anniversary of the vesting commencement date and
then 1/48th each month thereafter, and (ii) to existing employees which
vest and become exercisable at the rate of 1/48th each month following the
date
of grant over a period of four years.
2005
Equity Incentive Award Plan
In
February 2005, the Board of Directors adopted and in September 2005,
the stockholders approved the 2005 Equity Incentive Award Plan (the “2005
Plan”). The 2005 Plan is intended to serve as the successor equity incentive
program to the Company’s 1998 Stock Plan (“1998 Plan”) and its 2001 Stock Plan
(“2001 Plan”). The Company initially reserved a total of 1,779,396 shares
of common stock for issuance under the 2005 Plan plus any options granted under
the Company’s 1998 Plan or 2001 Plan that expire unexercised or are repurchased
by the Company pursuant to the terms of such options. As of June 30, 2007,
options to purchase 2,562,773 shares of the Company’s common stock have been
granted under the 2005 Plan and 2,760 shares of common stock have been
issued under the 2005 Plan.
Beginning
in 2006, the number of shares of common stock reserved under the 2005 Plan
automatically increases on the first trading day each year by an amount equal
to
the lesser of: (i) 4% of the Company’s outstanding shares of common stock
outstanding on such date, (ii) 1,082,352 shares, or (iii) an amount
determined by the Board of Directors. The 2005 Plan was increased by 860,445
shares on January 1, 2006 and by 1,082,352 shares on January 1, 2007 in
accordance with this provision. As of June 30, 2007, the total number of shares
available for future grants under the 2005 Plan was 1,482,308. The maximum
aggregate number of shares which may be issued or transferred over the term
of the 2005 Plan is 11,294,112 shares. In addition, no participant in the 2005
Plan may be issued or transferred more than 235,294 shares of common stock
per calendar year pursuant to awards under the 2005 Plan.
2006
Employment Commencement Incentive Plan
In
November 2005, the Board of Directors adopted the 2006 Employment
Commencement Incentive Plan (“2006 Plan”), which became effective on
January 1, 2006. The awards granted pursuant to the 2006 Plan are intended
to be inducement awards pursuant to Nasdaq Marketplace
Rule 4350(i)(1)(A)(iv). The 2006 Plan is not subject to the approval of the
Company’s stockholders. Effective January 1, 2007, the Company’s Board of
Directors increased the 2006 Plan by an additional 200,000 shares such that
the
aggregate number of shares of common stock reserved for issuance under the
2006
Plan is 400,000 shares. Only those employees who have not previously been
employees or directors of the Company or a subsidiary of the Company, or
following a bona fide period of non-employment by the Company or a subsidiary
of
the Company, are eligible to participate in the 2006 Plan. Additionally, grants
awarded to such employees under the 2006 Plan must be made in connection with
his or her commencement of employment with the Company or a subsidiary of the
Company and must be an inducement material to his or her entering into
employment with the Company or a subsidiary of the Company. As of June 30,
2007,
options to purchase 280,000 shares have been granted under the 2006 Plan and
no shares have been issued under the 2006 Plan.
12
A
summary
of stock option transactions for all of the Company’s stock option plans since
December 31, 2006 follows:
Weighted
|
|||||||||||||
Average
|
Aggregate
|
||||||||||||
Weighted
|
Remaining
|
Intrinsic
|
|||||||||||
Number
|
Average
|
Contractual
|
Value
|
||||||||||
of Shares
|
Exercise Price
|
Term (years)
|
(in thousands)
|
||||||||||
Outstanding
at December 31, 2006
|
3,942,435
|
$
|
4.30
|
||||||||||
Options
granted
|
319,000
|
$
|
4.32
|
||||||||||
Options
exercised
|
(53,109
|
)
|
$
|
2.47
|
|||||||||
Options
canceled/forfeited/expired
|
(162,240
|
)
|
$
|
5.23
|
|||||||||
Balance
at June 30, 2007
|
4,046,086
|
$
|
4.29
|
7.72
|
$
|
1,410
|
|||||||
Exercisable
at June 30, 2007
|
2,128,619
|
$
|
3.72
|
6.59
|
$
|
1,340
|
The
following table summarizes outstanding and exercisable options for all of the
Company’s stock option plans as of June 30, 2007:
OPTIONS OUTSTANDING
|
OPTIONS EXERCISABLE
|
|||||||||||||||
Weighted
|
||||||||||||||||
Average
|
Weighted
|
Weighted
|
||||||||||||||
Number
|
Remaining
|
Average
|
Number
|
Average
|
||||||||||||
Outstanding
|
Contractual
|
Exercise
|
Exercisable
|
Exercise
|
||||||||||||
Range of
Exercise Prices
|
as of 6/30/07
|
Term
|
Price
|
as of 6/30/07
|
Price
|
|||||||||||
|
|
|
|
|
|
|||||||||||
$0.43
- $1.28
|
21,417
|
2.1
|
$
|
0.72
|
21,417
|
$
|
0.72
|
|||||||||
$2.55
|
1,325,556
|
5.42
|
$
|
2.55
|
$
|
1,259,279
|
$
|
2.55
|
||||||||
$3.19
- $4.62
|
412,493
|
9.51
|
$
|
4.23
|
50,218
|
$
|
3.77
|
|||||||||
$4.70
- $4.74
|
33,200
|
8.97
|
$
|
4.71
|
3,266
|
$
|
4.74
|
|||||||||
$4.85
|
712,817
|
9.29
|
$
|
4.85
|
124,449
|
$
|
4.85
|
|||||||||
$4.93
- $5.16
|
127,300
|
9.02
|
$
|
5.04
|
14,742
|
$
|
5.13
|
|||||||||
$5.25
|
1,097,228
|
8.42
|
$
|
5.25
|
479,902
|
$
|
5.25
|
|||||||||
$5.50
- $6.4
|
219,300
|
9.03
|
$
|
6.04
|
105,278
|
$
|
6.11
|
|||||||||
$7.15
|
22,400
|
8.75
|
$
|
7.15
|
7,000
|
$
|
7.15
|
|||||||||
$9.56
|
74,375
|
7.93
|
$
|
9.56
|
63,068
|
$
|
9.65
|
|||||||||
$0.43
- $9.56
|
4,046,086
|
7.72
|
$
|
4.29
|
2,128,619
|
$
|
3.72
|
The
Company’s determination of the fair value of share-based payment awards on the
grant date using an option-pricing model is affected by the Company’s stock
price as well as assumptions regarding a number of highly subjective variables.
The total estimated grant date fair value of stock options that were granted
during the three months ended June 30, 2007 and 2006 was approximately $0.7
million and $0.8 million, respectively. The total estimated grant date fair
value of stock options that were granted during the six months ended June 30,
2007 and 2006 was approximately $0.8 million and $0.9 million, respectively.
The
estimated fair value of shares vested during the three months ended June 30,
2007 and 2006 was $0.8 million and $0.5 million, respectively. The estimated
fair value of shares vested during the six months ended June 30, 2007 and 2006
was $1.4 million and $1.0 million, respectively. At June 30, 2007, total
unrecognized estimated compensation cost related to non-vested stock options
granted prior to that date was $6.5 million and the cost is expected to be
recognized over a weighted average period of 2.6 years. The total intrinsic
value of stock options exercised during the three months ended June 30, 2007
and
2006 was $0.04 million for both periods. The total intrinsic value of stock
options exercised during the six months ended June 30, 2007 and 2006 was $0.1
million and $0.2 million, respectively. The Company recorded cash received
from
the exercise of stock options of $0.1 million for both periods during the three
and six months ended June 30, 2007. As it is more likely than not that all
of
the stock option related tax benefits will not be realized, the Company did
not
record net tax benefits related to the options exercised in the three and six
months ended June 30, 2007 and 2006.
13
Employee
Stock Purchase Plan
In
February 2005, the Board of Directors adopted and in September 2005,
the stockholders approved the 2005 Employee Stock Purchase Plan (“ESPP”). The
Company initially reserved a total of 202,941 shares of common stock for
issuance under the ESPP. The ESPP permits eligible employees to purchase common
stock at a discount through payroll deductions during defined offering periods.
Eligible employees can purchase shares of the Company’s common stock at 85% of
the lower of the fair market value of the common stock at the beginning of
an
offering period or at the purchase date. As of June 30, 2007, 207,660 shares
have been issued under the ESPP.
Beginning
in 2006, the number of shares of common stock reserved under the ESPP
automatically increases on the first trading day each year, by an amount equal
to the lesser of: (i) 0.5% of the Company’s outstanding shares of common
stock outstanding on such date, (ii) 135,294 shares, or (iii) an
amount determined by the Board of Directors. The ESPP was increased by 107,556
shares on January 1, 2006 and by 135,294 shares on January 1, 2007 in accordance
with this provision. At June 30, 2007, the total shares reserved for future
issuance under the ESPP was 238,131. The maximum aggregate number of shares
which may be issued over the term of the ESPP is 1,352,941 shares. In
addition, no participant in the ESPP may be issued or transferred more than
$25,000 of shares of common stock per calendar year pursuant to awards under
the
ESPP. No one may purchase more than 1,176 shares during any purchase period. The
total estimated fair value of purchase rights outstanding under the ESPP that
vested during the three and six months ended June 30, 2007 was approximately
$0.06 million and $0.1 million, respectively.
8.
Guarantees and Indemnification
In
November 2002, the FASB issued Interpretation No. 45, “Guarantor’s
Accounting and Disclosure Requirements for Guarantees, including Indirect
Guarantees of Indebtedness of Others” (“FIN 45”). FIN 45 requires that upon
issuance of a guarantee, the guarantor must recognize a liability for the fair
value of the obligations it assumes under that guarantee.
As
permitted under Delaware law and in accordance with the Company’s Bylaws, the
Company indemnifies its officers and directors for certain events or
occurrences, subject to certain limits, while the officer or director is or
was
serving at the Company’s request in such capacity. The indemnification
agreements with the Company’s officers and directors terminate upon termination
of their employment, but the termination does not affect claims for
indemnification relating to events occurring prior to the effective date of
termination. The maximum amount of potential future indemnification is
unlimited; however, the Company’s officer and director insurance policy reduces
the Company’s exposure and may enable the Company to recover a portion of
any future amounts paid. The Company believes that the fair value of these
indemnification agreements is minimal. In addition, in the ordinary course
of
business the Company enters into agreements, such as licensing agreements,
clinical trial agreements and certain services agreements, containing standard
indemnifications provisions. The Company believes that the likelihood of an
adverse judgment related to such indemnification provisions is remote.
Accordingly, the Company has not recorded any liabilities for any of these
agreements as of June 30, 2007.
9.
Recent Accounting Pronouncements
In
September 2006, the FASB issued Statement No. 157, Fair
Value Measurements
(“SFAS 157”). SFAS 157 defines fair value, establishes a framework and
guidance regarding the methods for measuring fair value, and expands related
disclosures about those measurements. SFAS 157 is effective for financial
statements issued for fiscal years beginning after November 15, 2007, and
interim periods within those fiscal years. We are currently assessing the impact
that SFAS 157 will have on our results of operations and financial
position.
In
February 2007, the FASB issued Statement No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities—including an
amendment to FAS 115 (“SFAS
159”). SFAS 159 allows entities to choose, at specified election dates, to
measure eligible financial assets and liabilities at fair value in situations
in
which they are not otherwise required to be measured at fair value. If a company
elects the fair value option for an eligible item, changes in that item’s fair
value in subsequent reporting periods must be recognized in current earnings.
SFAS 159 also establishes presentation and disclosure requirements designed
to
draw comparison between entities that elect different measurement attributes
for
similar assets and liabilities. SFAS 159 is effective for fiscal years beginning
after November 15, 2007. We are currently assessing the impact that SFAS
159 will have on our results of operations and financial position.
14
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
The
following discussion and analysis of our financial condition as of June 30,
2007
and results of operations for the three and six months ended June 30, 2007
and
2006 should be read together with our financial statements and related notes
included elsewhere in this report. This discussion and analysis contains
forward-looking statements that involve risks, uncertainties and assumptions.
Our actual results may differ materially from those anticipated in these
forward-looking statements as a result of many factors, including but not
limited to those set forth under “Risk Factors” and elsewhere in this report. We
urge you not to place undue reliance on these forward-looking statements, which
speak only as of the date of this report. All forward-looking statements
included in this report are based on information available to us on the date
of
this report, and we assume no obligation to update any forward-looking
statements contained in this report.
In
this
report, “Sunesis,” the “Company,” “we,” “us,” and “our” refer to Sunesis
Pharmaceuticals, Inc.
Business
Overview
We
are a
clinical-stage biopharmaceutical company focused on the discovery, development
and commercialization of novel small molecule therapeutics for oncology and
other unmet medical needs. We have developed a proprietary fragment-based drug
discovery approach, called “Tethering,” that we combine with other drug
discovery tools, such as structure-based design and medicinal chemistry, to
discover and develop novel therapeutics. We have built our product candidate
portfolio through internal discovery and the in-licensing of novel cancer
therapeutics. We are advancing product candidates through in-house research
and
development efforts and strategic collaborations with leading pharmaceutical
and
biopharmaceutical companies.
From
our
incorporation in 1998 through 2001, our operations consisted primarily of
developing and refining our drug discovery technologies. Since 2002, we have
focused on the discovery and development of novel, small molecule drugs mainly
to treat cancer and other unmet medical needs.
We
are
advancing three proprietary oncology product candidates, SNS-595, SNS-032 and
SNS-314, through in-house research and development efforts. Our lead product
candidate, SNS-595, is a novel cell cycle inhibitor. With SNS-595, we are
currently conducting one Phase 2 clinical trial in ovarian cancer and one
Phase 1 clinical trial in acute leukemias. We plan to initiate a Phase 1b
combination clinical trial in acute leukemias with cytarabine in the third
quarter of 2007 and expect to begin enrolling patients in a registration trial
in acute myeloid leukemia, or AML, in 2008. In addition, we are undergoing
a
mid-year portfolio review of our ongoing clinical- and research-stage programs
to prioritize and focus our efforts and the allocation of our financial and
human resources. In connection with this review, we recently announced that
we
are suspending enrollment in our Phase 2 clinical trial in small cell lung
cancer to focus our clinical development efforts for SNS-595 in acute leukemias
and ovarian cancer and we may determine that additional actions are necessary
in
light of this review.
Our
second most advanced product candidate, SNS-032, is a potent and selective
inhibitor of cyclin-dependent kinases, or CDKs, 2, 7 and 9. We currently are
conducting a Phase 1 clinical trial with SNS-032 in patients with advanced
B-cell malignancies. We are also developing SNS-314, a targeted small molecule
inhibitor of Aurora kinases, for the treatment of cancer. We filed an IND for
SNS-314 in February 2007 and expect to begin enrolling patients in a Phase
1 dose escalation trial in patients with advanced solid tumors in the third
quarter of 2007.
We
have
worldwide development and commercialization rights to SNS-595, SNS-032 (for
diagnostic and therapeutic applications) and SNS-314. We may in the future
enter
into collaborations to maximize the commercial potential of these
programs.
We
have
an ongoing strategic collaboration with Biogen Idec, Inc. to discover and
develop small molecules that inhibit certain oncology kinase targets. This
collaboration is still in the research phase and involves active participation
by our personnel. Under this collaboration, we receive quarterly research
funding of $1.2 million, subject to inflation adjustments, during the four-year
research term which, if not extended, expires in August 2008. We may in the
future receive additional pre-commercialization milestone payments and royalty
payments based on product sales by Biogen Idec as a result of this
collaboration.
We
also
have three other ongoing collaborations, with Johnson & Johnson
Pharmaceutical Research and Development, L.L.C. and Merck & Co., Inc., under
which the research funding portions have expired. However, if our collaborators
advance certain product candidates resulting from these collaborations, we
may
be entitled to receive additional milestone payments as well as royalty payments
based on future product sales, if any. As of June 30, 2007, we had received
an
aggregate of approximately $78.6 million in cash from our current and former
collaboration and licensing partners in the form of stock purchase proceeds
and
fees from our current and former collaboration partners.
15
Since
our
inception, we have generated significant losses. As of June 30, 2007, we had
an
accumulated deficit of $259.4 million, including a deemed dividend of
$88.1 million recorded in conjunction with our initial public offering, or
IPO, in September 2005. We expect our net losses to increase in the future,
primarily due to our anticipated clinical trial activities.
Critical
Accounting Policies and Significant Judgments and
Estimates
This
discussion and analysis of our financial condition and results of operations
is
based on our financial statements, which have been prepared in accordance with
U.S. generally accepted accounting principles. The preparation of these
financial statements requires management to make estimates and judgments that
affect the reported amounts of assets, liabilities and expenses and the
disclosure of contingent assets and liabilities at the date of the financial
statements, as well as revenue and expenses during the reporting periods. We
evaluate our estimates and judgments on an ongoing basis. We base our estimates
on historical experience and on various other factors we believe are reasonable
under the circumstances, the results of which form the basis for making
judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results could therefore differ
materially from those estimates under different assumptions or
conditions.
An
accounting policy is deemed to be critical if it requires an accounting estimate
to be made based on assumptions about matters that are highly uncertain at
the
time the estimate is made, and if different estimates that reasonably could
have
been used, or changes in the accounting estimate that are reasonably likely
to
occur periodically, could materially change the financial statements. We believe
there have been no significant changes during the six months ended June 30,
2007
to the items that we disclosed as our critical accounting policies and estimates
under Item 7, “Management’s Discussion and Analysis of Financial Condition and
Results of Operations,” in our Annual Report on Form 10-K for the year
ended December 31, 2006.
Recent
Accounting Pronouncements
In
September 2006, the FASB issued Statement No. 157, Fair
Value Measurements
(“SFAS 157”). SFAS 157 defines fair value, establishes a framework and
guidance regarding the methods for measuring fair value, and expands related
disclosures about those measurements. SFAS 157 is effective for financial
statements issued for fiscal years beginning after November 15, 2007, and
interim periods within those fiscal years. We are currently assessing the impact
that SFAS 157 will have on our results of operations and financial
position.
In
February 2007, the FASB issued Statement No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities—including an
amendment to FAS 115 (“SFAS
159”). SFAS 159 allows entities to choose, at specified election dates, to
measure eligible financial assets and liabilities at fair value in situations
in
which they are not otherwise required to be measured at fair value. If a company
elects the fair value option for an eligible item, changes in that item’s fair
value in subsequent reporting periods must be recognized in current earnings.
SFAS 159 also establishes presentation and disclosure requirements designed
to
draw comparison between entities that elect different measurement attributes
for
similar assets and liabilities. SFAS 159 is effective for fiscal years beginning
after November 15, 2007. We are currently assessing the impact that SFAS
159 will have on our results of operations and financial position.
Results
of Operations
Three
and Six Months Ended June 30, 2007 and 2006
Revenue.
Since
inception, we have not generated any revenue from sales of commercial products
and do not expect to generate any product revenue for the foreseeable future.
To
date, substantially all of our revenue has consisted of collaboration revenue.
In the six months ended June 30, 2007, we received a $0.25 million license
fee
from SARcode, Inc., which was recognized as license revenue. In the six months
ended June 30, 2006, we recognized $0.04 million in grant and fellowship
revenue. We have not received any grant or fellowship revenue since the first
quarter of 2006 and we do not plan to perform any additional work under our
previously awarded Small Business Research Inititative, or SBIR, grants in
the
foreseeable future.
16
Collaboration
Revenue. We
generate revenue primarily through our collaborations. We currently have four
ongoing collaborations, one of which involves active participation by our
personnel. Revenue from these collaborations has included technology access
fees, research funding and milestone payments and in the future also may include
royalties upon sales of future products that may result from the
collaborations. The table below sets forth our revenue for the three and six
months ended June 30, 2007 and 2006 from collaboration partners.
Three months ended June
30,
|
Six months ended June
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Merck
|
$
|
1,229,167
|
$
|
4,516,667
|
$
|
1,458,334
|
$
|
5,887,372
|
|||||
Biogen
Idec-related party
|
2,041,098
|
2,190,986
|
4,078,197
|
3,879,845
|
|||||||||
Total
collaboration revenue
|
$
|
3,270,265
|
$
|
6,707,653
|
$
|
5,536,531
|
$
|
9,767,217
|
Research
and Development Expense. Most
of
our operating expenses to date have been for research and development
activities. Research and development expense represents costs incurred to
discover and develop novel, small molecule therapeutics, including Phase 1
and Phase 2 clinical trial costs for SNS-595 and Phase 1 clinical
trial costs for SNS-032, to develop our proprietary fragment-based Tethering
drug discovery approach, to develop in-house research and preclinical study
capabilities, and to discover and advance our product candidates, including
SNS-314, toward clinical trials. We expense all research and development costs
as they are incurred. The table below sets forth our research and development
expense for the three and six months ended June 30, 2007 and 2006 for each
of
our product candidate programs:
Three months ended June 30,
|
Six months ended June 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
(in thousands)
|
(in thousands)
|
||||||||||||
SNS-595
|
$
|
3,281
|
$
|
2,429
|
$
|
6,306
|
$
|
3,900
|
|||||
SNS-032
|
1,044
|
984
|
1,906
|
1,459
|
|||||||||
SNS-032
- milestone payment to BMS
|
-
|
-
|
-
|
2,000
|
|||||||||
SNS-314
|
1,151
|
1,473
|
2,481
|
2,583
|
|||||||||
Other
kinase inhibitors
|
3,052
|
2,993
|
6,237
|
6,007
|
|||||||||
Discovery
and New Technology
|
1,094
|
879
|
1,972
|
2,098
|
|||||||||
Other
programs
|
76
|
89
|
103
|
516
|
|||||||||
Total
|
$
|
9,698
|
$
|
8,847
|
$
|
19,005
|
$
|
18,563
|
Research
and development expense increased from $8.8 million for the three months ended
June 30, 2006 to $9.7 million for the same period in 2007. This $0.9 million
increase is primarily due to (i) a $0.9 million increase in spending on
development of SNS-595, and (ii) a $0.2 million increase in spending on
discovery and new technologies, partially offset by reduced spending of $0.3
million on the development of SNS-314 in the second quarter of 2007 due to
completion of the filing of the IND for SNS-314 in February 2007.
Research
and development expense increased slightly from $18.6 million for the six months
ended June 30, 2006 to $19.0 million for the same period in 2007. The 2006
period included a non-cash $2.0 million milestone payment to Bristol-Myers
Squibb Company, or BMS, in connection with the commencement of a Phase 1
clinical trial for SNS-032. Net of this payment, research and development
expenses increased from $16.6 million for the six months ended June 30, 2006
to
$19.0 million for the same period in 2007. This $2.4 million increase is
primarily due to (i) a $2.4 million increase in spending on development of
SNS-595, (ii) a $0.4 million increase in spending on the development of SNS-032,
and (iii) a $0.2 million increase in spending for our other kinase inhibitors
program, partially offset by a $0.1 million decrease in spending for the
development of SNS-314 and a $0.5 million decrease in spending on discovery
and
new technologies and other programs.
17
We
expect
to continue to incur substantial research and development expenses over the
next
several years, only a portion of which we expect to be funded by collaboration
partners. As SNS-595, SNS-032 and SNS-314 progress through the clinical
development stage, particularly the expected registration trial for SNS-595
anticipated to begin in 2008, and we potentially bring additional product
candidates through discovery and research and into clinical trials, our spending
will further increase. In addition, under our oncology kinase collaboration
with
Biogen Idec, we have an option to co-fund a portion of the development costs
of
product candidates for up to two targets that may result from this
collaboration. Our decision to exercise this option, if made, would materially
increase our research and development expense.
General
and Administrative Expense. Our
general and administrative expense consists primarily of salaries and other
related costs for personnel in finance, human resources, facilities, management,
legal and general administration and non-cash stock compensation. Other
significant costs include facilities costs and fees paid to outside legal
advisors and auditors and patent-related expenses. General and administrative
expense was $3.2 million and $4.0 million for the three months ended June 30,
2006 and 2007, respectively. This $0.8 million increase is primarily due to
(i)
$0.3 million in payments to former employees who left the Company in the second
quarter of 2007, (ii) a $0.2 million increase in other personnel expenses
primarily due to the increase of temporary services expense to support
transitional staffing in finance and increased activity in human resources,
(iii) a $0.2 million increase in non-cash stock compensation expense primarily
due to options granted to employees since 2006, and (iv) a $0.1 million increase
in rent expense due to the use of additional office space from May 2007. General
and administrative expense increased from $5.8 million for the first six months
in 2006 to $7.3 million for the same period in 2007. This $1.5 million increase
is primarily a result of the $0.8 million increase described above, as well
as
additional increases in personnel expenses and non-cash stock
compensation.
We
expect
that our general and administrative expense will continue to increase in
subsequent periods due to increasing personnel and infrastructure
expenses.
Interest
Income. Interest
income decreased from $1.0 million for the three months ended June 30, 2006
to
$0.7 million for the three months ended June 30, 2007, primarily due to
lower average balances of cash, cash equivalents and marketable securities
during 2007. Interest income remained consistent at $1.5 million for both the
six months ended June 30, 2006 and June 30, 2007.
Interest
Expense. Interest
expense decreased from $0.2 million for the three months ended June 30, 2006
to
$44,000 for the same period in 2007, and decreased from $0.4 million for the
six
months ended June 30, 2006 to $0.1 million for the same period in 2007, due
to
lower average outstanding debt obligations in 2007.
Liquidity
and Capital Resources
Since
our
inception, we have funded our operations primarily through the issuance of
common and preferred stock, research funding and technology access fees from
our
collaboration partners, debt financings and research grants. As of June 30,
2007, we had cash, cash equivalents and marketable securities of
$65.2 million and outstanding borrowing under equipment financings of
$2.2 million.
In
March 2006, we raised net proceeds of $43.7 million through a private
placement of 7,246,377 shares of common stock and warrants to purchase an
additional 2,173,914 shares of common stock. The purchase price for the common
stock and the exercise price for the warrants was $6.21 per share. Investors
in
the financing paid an additional purchase price equal to $0.125 for each share
of common stock underlying the warrants.
In
May
2007, we completed a public offering of 4,750,000 shares of our common stock
at
a public offering price of $4.43 per share. Net cash proceeds from this offering
were approximately $19.5 million after deducting underwriting discounts and
commissions and other offering expenses.
Cash
Flow
Net
cash
used in operating activities was $17.1 million and $11.5 million for the
six months ended June 30, 2007 and 2006, respectively. Net cash used in
operating activities for these periods consisted primarily of our net loss,
partially offset by depreciation and amortization, deferred revenue and
stock-based compensation expense, and for the six months ended June 30, 2006,
a
$2.0 million non-cash milestone payment to BMS upon commencement of a Phase
1
clinical trial for SNS-032.
18
Net
cash
provided by investing activities was $2.4 million and $12.2 million for the
six
months ended June 30, 2007 and June 30, 2006, respectively. The cash provided
during the six months ended June 30, 2007 was primarily attributable to the
net
maturities of $3.5 million of securities, partially offset by the purchase
of
property and equipment totaling $1.1 million. Net cash provided by investing
activities during the six months ended June 30, 2006 was related to the net
maturities of $13.9 million of securities, partially offset by the purchase
of
property and equipment of $1.6 million. Our investing activities for these
periods consisted primarily of the management of proceeds from our sales of
common and preferred stock.
Net
cash
provided by financing activities was $20.3 million and $43.9 million for the
six
months ended June 30, 2007 and 2006, respectively. Our financing activities
for
the 2007 period consisted primarily of (i) $19.5 million in net proceeds from
a
public offering in May 2007; (ii) $0.4 million from an Employee Stock Purchase
Plan purchase and stock option exercises; and (iii) $0.9 million pursuant to
an
equipment loan, partially offset by the repayment of $0.5 million in equipment
loans related to capital equipment purchases in prior periods. Our financing
activities for the six months ended June 30, 2006 consisted primarily of net
proceeds of $43.7 million in a private placement of common stock and warrants
in
March 2006.
Credit
and Loan Arrangements
In
June 2000, we entered into an equipment financing agreement with General
Electric Capital Corporation, or GECC. Various credit lines have been issued
under the financing agreement since 2000. The current $2.6 million credit line
is available through March 28, 2008. As of June 30, 2007, we have drawn a total
of $10.1 million under various credit lines under the financing agreement and
the outstanding balance was $2.2 million, which bears interest at rates ranging
from 7.53% to 10.61% per annum and is due in 36 to 48 monthly payments. The
equipment loans are secured by the equipment financed.
In
conjunction with a credit line of $2.5 million under the GECC agreement which
has since expired, we issued warrants to GECC to purchase shares of our
Series C preferred stock, which converted into warrants to purchase
1,046 shares of common stock in connection with the Company’s IPO. The fair
value of the warrants issued is insignificant, as determined using the
Black-Scholes options pricing model, and is being accounted for as prepaid
interest and expensed on a straight-line basis over the term of the agreement.
This fair value was fully amortized as of December 31, 2006.
As
of
June 30, 2007, we were in compliance with all covenants in the GECC
agreement.
In
August 2005, we entered into a venture loan and security agreement with
Oxford Finance Corporation and Horizon Technology Funding Company LLC, pursuant
to which we may borrow up to $15.0 million. We did not borrow any monies
under this loan facility and this facility has expired. In conjunction with
this
transaction, we issued warrants to the lenders to purchase up to
164,830 shares of common stock at a price of $9.10 per share, half of
which are currently exercisable. These warrants are currently exercisable for
82,412 shares of common stock and none of the remaining warrants will vest
or
become exercisable.
Operating
Capital and Capital Expenditure Requirements
We
expect
to continue to incur substantial operating losses in the future. We will not
receive any product revenue until, and if, a product candidate has been approved
by the United States Food and Drug Administration, or FDA, or similar regulatory
agencies in other countries and successfully commercialized. As of June 30,
2007, our cash, cash equivalents and marketable securities totaled $65.2
million. We currently anticipate that our cash, cash equivalents, marketable
securities and available credit facilities, together with revenue generated
from
our collaborations, will be sufficient to fund our operations at least through
the end of 2008. However, we will need to raise substantial additional funds
to
continue our operations and bring future products to market. We cannot be
certain that any of our programs will be successful or that we will be able
to
raise sufficient funds to complete the development and commercialize any of
our
product candidates currently in development, should they succeed. Additionally,
we plan to continue to evaluate in-licensing and acquisition opportunities
to
gain access to new drugs or drug targets that would fit with our strategy.
Any
such transaction would likely increase our funding needs in the
future.
Our
future funding requirements will depend on many factors, including but not
limited to:
|
·
|
the
rate of progress and cost of our clinical trials, preclinical studies
and
other discovery and research and development
activities;
|
|
·
|
the
costs associated with establishing manufacturing and commercialization
capabilities;
|
|
·
|
the
costs of acquiring or investing in businesses, product
candidates and
technologies;
|
|
·
|
the
costs of filing, prosecuting, defending and enforcing
any patent claims
and other intellectual property
rights;
|
|
·
|
the
costs and timing of seeking and obtaining FDA and
other regulatory
approvals;
|
19
|
·
|
the
effect of competing technological and market
developments; and
|
|
·
|
the
economic and other terms and timing
of any collaboration, licensing or
other arrangements into which we may
enter.
|
Until
we
can generate a sufficient amount of product revenue to finance our cash
requirements, which we may never do, we expect to finance future cash needs
primarily through public or private equity offerings, debt financings or
strategic collaborations. We do not know whether additional funding will be
available on acceptable terms, or at all. If we are not able to secure
additional funding when needed, we may have to delay, reduce the scope of or
eliminate one or more of our clinical trials or research and development
programs. In addition, we may have to partner one or more of our product
candidate programs at an earlier stage of development, which would lower the
economic value of those programs to us.
Off-Balance
Sheet Arrangements
During
the first half year of 2007 and year ended December 31, 2006, we did not have
any off-balance sheet arrangements or relationships with unconsolidated entities
or financial partnerships, such as entities often referred to as structured
finance or variable interest entities, which are typically established for
the
purpose of facilitating off-balance sheet arrangements or other contractually
narrow or limited purposes.
We
believe we are not subject to any meaningful market risks related to currency,
commodity prices or similar matters. We are sensitive to short-term interest
rate fluctuations to the extent that such fluctuations impact the interest
income we receive on the investment of our cash.
The
primary objective of our investment activities is to preserve principal while
at
the same time maximizing the income we receive from our investments without
significantly increasing risk. Some of the securities that we invest in
may have market risk. This means that a change in prevailing interest rates
may cause the principal amount of the investment to fluctuate. For example,
if we hold a security that was issued with a fixed interest rate at the
then-prevailing rate and the prevailing interest rate later rises, the fair
value of our investment will probably decline. To minimize this risk in the
future, we intend to maintain our portfolio of cash equivalents and short-term
investments in a variety of securities, including money market funds, commercial
paper and government and non-government debt securities. For all of 2006 and
the
first six months of 2007, we maintained an investment portfolio primarily in
money market funds and corporate commercial paper. Due to the short-term nature
of the majority of these investments, we believe we do not have a material
exposure to interest risk arising from our investments.
All
of
our revenue, expense, and capital purchasing activities are transacted in U.S.
dollars.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures, as such term is defined in SEC
Rule 13a-15(e), that are designed to ensure that information required to be
disclosed in our Securities Exchange Act of 1934 reports is recorded, processed,
summarized and reported within the time periods specified in the SEC’s
rules and forms and that such information is accumulated and communicated
to our management, including our Chief Executive Officer and Chief Financial
Officer, as appropriate, to allow for timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures,
management recognizes that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the
desired control objectives, and management is required to apply its judgment
in
evaluating the cost-benefit relationship of possible controls and
procedures.
20
Changes
in Internal Control over Financial
Reporting
There
have been no changes in our internal control over financial reporting during
the
quarter ended June 30, 2007 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
We
are
not currently involved in any material legal proceedings. From time to time,
we
may become involved in legal proceedings arising in the ordinary course of
our
business.
Item
1A. Risk Factors
For
the six months ended June 30, 2007, there have been no substantive changes
to the identified risk factors filed in our Annual Report on Form 10-K/A for
the
year ended December 31, 2006 filed with the Securities and Exchange Commission
on May 23, 2007, other than the risk factors, which are discussed
below. You should carefully consider the following risk factors as well as
other
information in our filings under the Securities Exchange Act of 1934,
as amended, before making any investment decisions regarding our common
stock. The risks and uncertainties described herein and in our Annual
Report on Form 10-K/A and in other reports we file with the Securities and
Exchange Commission are not the only ones we face. Additional risks and
uncertainties that we do not presently know or that we currently deem immaterial
may also impair our business, financial condition, operating results and
prospects. If events corresponding to any of these risks actually occur, they
could harm our business, financial condition, operating results or
prospects. In that case, the trading price of our common stock could decline.
We
have incurred losses since inception and anticipate that we will continue to
incur losses for the foreseeable future. We may not ever achieve or sustain
profitability.
We
are a
clinical-stage biopharmaceutical company with a limited operating history.
We
are not profitable and have incurred losses in each year since our inception
in
1998. We do not currently have any products that have been approved for
marketing, and we continue to incur substantial research and development and
general and administrative expenses related to our operations. Our net loss
for
the first half of 2007, 2006, 2005 and 2004 was $19.1 million, $31.2 million,
$27.5 million (excluding a preferred stock dividend of $88.1 million)
and $20.5 million, respectively. As of June 30, 2007, we had an accumulated
deficit of $259.4 million, including an $88.1 million deemed dividend
related to our IPO in September 2005. We expect to continue to incur losses
for the foreseeable future, and we expect these losses to increase
significantly, especially upon commencing Phase 3 clinical trials, as we
continue our research activities and conduct development of, and seek regulatory
approvals for, our product candidates, and commercialize any approved drugs.
Our
losses, among other things, have caused and will continue to cause our
stockholders’ equity and working capital to decrease. To date, we have derived
substantially all of our revenue from collaboration agreements. We do not
anticipate that we will generate revenue from the sale of products for the
foreseeable future. If our product candidates fail in clinical trials or do
not
gain regulatory approval, or if our future products do not achieve market
acceptance, we may never become profitable. Even if we achieve profitability
in
the future, we may not be able to sustain profitability in subsequent
periods.
We
will require substantial additional funding, which may not be available to
us on
acceptable terms, or at all.
We
are
advancing multiple product candidates through discovery and development. We
will
need to raise substantial additional capital to continue our discovery,
development and commercialization activities. We plan to retain the development
and commercialization rights to some of our novel cancer therapeutics at least
until we have completed a Phase 2 clinical trial to maximize our economic
upside, which will require substantial expenditures by us.
We
will
need to raise substantial additional capital to:
·
|
fund
clinical trials and seek regulatory
approvals;
|
·
|
pursue
the development of additional product
candidates;
|
·
|
expand
our research and development
activities;
|
·
|
build
or access manufacturing and commercialization
capabilities;
|
·
|
implement
additional internal systems and
infrastructure;
|
·
|
maintain,
defend and expand the scope of our intellectual property
portfolio; and
|
·
|
hire
additional management and scientific
personnel.
|
21
Our
future funding requirements will depend on many factors, including but not
limited to:
·
|
the
rate of progress and cost of our clinical trials, preclinical studies
and
other discovery and research and development
activities;
|
·
|
the
costs associated with establishing manufacturing and commercialization
capabilities;
|
·
|
the
costs of acquiring or investing in businesses, product candidates
and
technologies;
|
·
|
the
costs of filing, prosecuting, defending and enforcing any patent
claims
and other intellectual property
rights;
|
·
|
the
costs and timing of seeking and obtaining FDA and other regulatory
approvals;
|
·
|
the
effect of competing technological and market
developments; and
|
·
|
the
economic and other terms and timing of any collaboration, licensing
or
other arrangements into which we may
enter.
|
Until
we
can generate a sufficient amount of product revenue to finance our cash
requirements, which we may never do, we expect to finance future cash needs
primarily through public or private equity offerings, debt financings or
strategic collaborations. We do not know whether additional funding will be
available on acceptable terms, or at all. If we are not able to secure
additional funding when needed, we may have to delay, reduce the scope of or
eliminate one or more of our clinical trials or research and development
programs. For example, we
are
undergoing a mid-year portfolio review of our ongoing clinical- and
research-stage programs to prioritize and focus our efforts and the allocation
of our financial and human resources. In connection with this review, we
recently announced that we are suspending enrollment of our Phase 2 clinical
trial in small cell lung cancer of SNS-595 to focus our clinical development
efforts on advancing this product candidate as a therapy in acute leukemias
and
ovarian cancer and we may determine that additional actions are necessary in
light of this review. The suspension of the Phase 2 clinical trial in small
cell
lung cancer may lower the economic value of this asset for a potential
development partner. In
addition, we plan to partner one or more of our product candidate programs
at an
earlier stage of development, which would lower the economic value of such
program or programs to us.
Our
clinical trials for our lead product candidates, SNS-595, SNS-032 and SNS-314,
may not demonstrate safety or efficacy or lead to regulatory
approval.
Our
lead
product candidates, SNS-595, SNS-032 and SNS-314, are small-molecule
therapeutics being developed for the treatment of certain types of cancer.
Many
cancer drugs promote cancer cell death by inhibiting cell proliferation, and
commonly have a narrow dose range between efficacy and toxicity, commonly known
as a “therapeutic window.” Based on the results of our Phase 1 clinical
trials, we may select a dose for use in future clinical trials that may prove
to
be ineffective in treating cancer. If our clinical trials result in unacceptable
toxicity or lack of efficacy, we may have to terminate further clinical trials
for SNS-595, SNS-032 and/or SNS-314. Even if we are able to find a proper dose
that balances the toxicity and efficacy of one or more of our product
candidates, we will be required to conduct extensive additional clinical trials
before we are able to seek the regulatory approvals needed to market them.
If
clinical trials of SNS-595, SNS-032 and/or SNS-314 are halted, or if they do
not
show that these product candidates are safe and effective in the indications
for
which we are seeking regulatory approval, our future growth would be limited
and
we may not have any other product candidates to develop. Furthermore, our
development strategy for each of SNS-595, SNS-032 and SNS-314 has been to first
test the efficacy and toxicity of each product candidate as a single agent.
We
may determine that one or more of these product candidates is more efficacious
and/or less toxic in combination with another approved cancer drug. For example,
later this year we expect to initiate a Phase 1b clinical trial of SNS-595,
studying SNS-595 in comibination with cytarabine in acute leukemias. Likewise,
each of our product candidates may only receive FDA and foreign approvals,
if at
all, in combination with another cancer drug.
In
addition to the risks described above, we are aware of risks that are specific
to SNS-032. In previous Phase 1 clinical trials of SNS-032, significant
safety risks were observed in patients who were administered SNS-032 on either
a
one-hour or a 24-hour infusion once every three weeks. For example, increases
in
certain phases of the cardiac cycle, known as the QT interval, or the corrected
QT interval, or QTc, on the electrocardiograms of patients were observed in
patients receiving the 24-hour infusion regimen. Increased QT intervals may
be
associated with increased risk for cardiac rhythm abnormalities, some of which
can be serious, life-threatening events. In addition, pronounced, rapidly
reversible decreases in white blood cells were observed following infusion
under
the one-hour infusion regimen, most likely associated with higher peak drug
levels in this regimen. Further, some patients also experienced reversible
liver
toxicity, which limited the amount of drug that could be administered to those
patients. Two of these planned clinical trials were discontinued prior to
completion and prior to determination of a maximum tolerated dose. Both of
these
trials were discontinued by the former sponsor, BMS, because of a change in
priorities within BMS’ portfolio. We will not receive regulatory approval for
SNS-032 unless we are able to deliver therapeutically active doses of SNS-032
while keeping toxicities at acceptable levels. In the Phase 1 clinical
trial of SNS-032 in patients with advanced solid tumors, we were delivering
the
drug on a daily basis in a one-hour infusion for five consecutive days. However,
this dose and regimen did not allow us to achieve expected efficacious exposure
without dose-limiting toxicity, and therefore we decided SNS-032 will not
advance at this time as a single-agent therapeutic in that patient
population.
22
In
our
Phase 1 clinical trial of SNS-032 in B-cell lymphoid malignancies, we are aware
that SNS-032 has the potential to kill a large number of cancer
cells rapidly
and all at once and the contents
of those cells may be released into a patient’s bloodstream. This may result in
a higher risk of a severe complication called tumor lysis syndrome. If tumor
lysis syndrome occurs, some chemicals in a patient’s blood, such as potassium,
uric acid and phosphate levels will rise, whereas
some others
like calcium may decline. Tumor lysis syndrome, if severe enough, may result
in
kidney failure and without
treatment, can be life-threatening. We are aware that this severe complication
has a higher risk of occurring early
in
the course
of
treatment and we
are
taking measures, which may not be effective, to prevent, monitor and treat
this
complication should it occur.
In
addition, in clinical trials to date SNS-032 has demonstrated variable
pharmacokinetics, or PK, which is the measure of the concentration of drug
in
the bloodstream over time. The PK variability results in differences in drug
exposure between patients, and in some cases in the same patient, who are
administered the same dose of SNS-032. Dose levels in Phase 2 clinical
trials will be selected primarily based on safety criteria. Because of the
observed PK variability between and among patients, we believe that there
is a risk that some patients may receive sub-therapeutic exposure, limiting
the
opportunity to show activity and efficacy for SNS-032. As with other product
candidates in the biotechnology industry at this stage of development, even
if
we are able to find adequate doses and schedules from our planned Phase 2
clinical trials, we will be required to conduct extensive additional clinical
trials before we are able to seek regulatory approval to market
SNS-032.
Our
approach to developing cancer therapeutics by inhibiting cyclin-dependent
kinases, Aurora kinases and Raf kinases has not been clinically validated and
may not be successful.
We
have
programs to develop small molecule inhibitors of CDKs, Aurora kinases and Raf
kinases for the treatment of cancer. SNS-032 is an inhibitor of CDKs 2, 7 and
9,
and SNS-314 is a pan Aurora kinase inhibitor. The therapeutic benefit of
inhibiting CDKs, Aurora kinases or Raf kinases in the treatment of human cancer
has not been established definitively in the clinic. Although a competitive
kinase inhibitor, Nexavar, was approved recently, this compound inhibits Raf
and
other kinases and its non-Raf kinase activities may be responsible for its
efficacy. There are also other CDKs and Aurora kinase inhibitors in early
clinical development, but they have yet to show therapeutic benefit or they
target other kinases in addition to CDKs and Aurora kinases and their activity
may be associated with inhibition of those other kinases. In addition, there
are
conflicting scientific reports regarding the reliance or necessity of CDK2
in
the cell-cycle. If CDK, Aurora kinase or Raf kinase inhibition is not an
effective treatment of human cancer, SNS-032, SNS-314 and any other drug
candidates from these programs may have little or no commercial
value.
We
rely on a third party to manufacture our product candidates, including SNS-595,
SNS-032 and SNS-314, and depend on a single supplier for the active ingredients
for SNS-595 and SNS-032. There is a limited number of manufacturers that are
capable of manufacturing the active ingredient of
SNS-595
and SNS-032.
We
do not
currently own or operate manufacturing facilities and lack the capability to
manufacture any of our product candidates on a clinical or commercial scale.
As
a result, we rely on third parties to manufacture both the active pharmaceutical
ingredients, or API, and drug products for SNS-595, SNS-032 and SNS-314. The
APIs are classified as toxic substances, limiting the available manufacturers.
We believe that there are at least five contract manufacturers in North America
with suitable capabilities for API manufacture, and at least four that can
manufacture our drug products. We currently have established relationships
with
only one manufacturer for API for SNS-595 and two manufacturers for the finished
drug product. If our third-party manufacturer is unable or unwilling to produce
API for SNS-595, we will need to establish a contract with another supplier.
However, establishing a relationship with an alternative supplier would likely
delay our ability to produce API for six to nine months, during which time
we
will rely on current inventory to supply our drug product manufacturing
activities. We expect to continue to depend on third-party contract
manufacturers for all our API and drug products the foreseeable future.
Our
product candidates require precise, high quality manufacturing. A contract
manufacturer is subject to ongoing periodic unannounced inspection by the FDA
and corresponding state agencies to ensure strict compliance with current Good
Manufacturing Practice, or cGMP, and other applicable government regulations
and
corresponding foreign standards. Our contract manufacturer’s failure to achieve
and maintain high manufacturing standards in compliance with cGMP regulations
could result in manufacturing errors resulting in patient injury or death,
product recalls or withdrawals, delays or interruptions of production or
failures in product testing or delivery, delay or prevention of filing or
approval of marketing applications for our products, cost overruns or other
problems that could seriously harm our business.
To
date,
our product candidates have been manufactured in small quantities for
preclinical studies and clinical trials. Prior to one of our product candidates
being approved for commercial sale, we will need to manufacture that product
in
larger quantities. Significant scale-up of manufacturing will be accompanied
by
significant validation studies, which will be reviewed by the FDA prior to
approval. If we are unable to successfully increase the manufacturing capacity
for a product candidate, the regulatory approval or commercial launch may be
delayed or there may be a shortage in commercial supply.
23
Any
performance failure on the part of a contract manufacturer could delay clinical
development or regulatory approval of our product candidates or
commercialization of our future products, depriving us of potential product
revenue and resulting in additional losses. In addition, our dependence on
a
third party for manufacturing may adversely affect our future profit margins.
Our ability to replace an existing manufacturer may be difficult because the
number of potential manufacturers is limited and the FDA must approve any
replacement manufacturer before it can begin manufacturing our product
candidates for commercial sale. Such approval would require new testing and
compliance inspections. It may be difficult or impossible for us to identify
and
engage a replacement manufacturer on acceptable terms in a timely manner, or
at
all.
Even
if we receive regulatory approval to market our product candidates, the market
may not be receptive to our products.
Even
if
our product candidates obtain regulatory approval, resulting products, if any,
may not gain market acceptance among physicians, patients, healthcare payors
and/or the medical community. We believe that the degree of market acceptance
will depend on a number of factors, including:
·
|
timing
of market introduction of competitive
products;
|
·
|
efficacy
of our product;
|
·
|
prevalence
and severity of any side effects;
|
·
|
potential
advantages or disadvantages over alternative
treatments;
|
·
|
strength
of marketing and distribution
support;
|
·
|
price
of our future products, both in absolute terms and relative to alternative
treatments; and
|
·
|
availability
of reimbursement from health maintenance organizations and other
third-party payors.
|
For
example, the potential toxicity of single and repeated doses of SNS-595 has
been
explored in a number of animal studies that suggest the mechanism-based
dose-limiting toxicities in humans receiving SNS-595 may be similar to some
of
those observed in approved cytotoxic agents, including temporary toxicity to
bone marrow cells, the gastrointestinal system and other systems with rapidly
dividing cells. In our Phase 1 and Phase 2 clinical trials, we have witnessed
the following side effects, irrespective of causality, ranging from mild to
more
severe: lowered white blood cell count that may lead to a serious or possibly
life-threatening infection, hair loss, mouth sores, fatigue, nausea with or
without vomiting, lowered platelet count, which may lead to an increase in
bruising or bleeding, lowered red blood cell count (anemia), weakness,
tiredness, shortness of breath, diarrhea and intestinal blockage. In addition,
in
our
Phase 1 clinical trial of SNS-032 in patients with advanced solid tumors,
we reached a maximum tolerated dose which we do not believe
provides efficacious exposures. Therefore, we decided not to
advance SNS-032 as a single-agent therapeutic in that patient population at
this
time. Our phase 1 clinical trial of SNS-032 in patients with advanced
B-cell malignancies has a limited number of patients enrolled in the trial
thus
far. We can not yet assess the extent and type of side effects and/or
unacceptable toxicities that SNS-032 might exhibit in this patient population
and in this dosing regimen. Similarly,
our Phase 1 clinical trial of SNS-314 is expected to begin enrolling patients
during the third quarter of 2007; no patients have been enrolled at the time
of
this report, and therefore we can not yet assess the extent and type of any
potential side effects or unacceptable toxicities.
If
our
future products fail to achieve market acceptance, due to unacceptable side
effects or any other reasons, we may not be able to generate significant revenue
to achieve or sustain profitability.
The
price of our common stock may continue to be volatile, and the value of an
investment in our common stock may decline.
We
sold
shares of common stock in our IPO in September 2005 at a price of
$7.00 per share, and our stock has subsequently traded as low as
$2.91 per share. An active and liquid trading market for our common stock
may not develop or be sustained. Factors that could cause volatility in the
market price of our common stock include, but are not limited to:
·
|
results
from, and any delays in or discontinuance of, our clinical trial
programs,
including our ongoing and planned clinical trials for SNS-595, SNS-032
and
SNS-314, such as our recent announcement of suspension of enrollment
in
our Phase 2 small cell lung cancer trial of
SNS-595;
|
24
·
|
announcements
of FDA non-approval of our product candidates, including SNS-595,
SNS-032
or SNS-314, delays in filing regulatory documents with the FDA or
other
regulatory agencies, or delays in the review process by the FDA or
other
foreign regulatory agencies;
|
·
|
failure
or discontinuation of any of our research
programs;
|
·
|
announcements
relating to future collaborations or our existing collaborations
with
Biogen Idec, Johnson & Johnson PRD and
Merck;
|
·
|
delays
in the commercialization of our future
products;
|
·
|
market
conditions in the pharmaceutical, biopharmaceutical and biotechnology
sectors and issuance of new or changed securities analysts’ reports or
recommendations;
|
·
|
actual
and anticipated fluctuations in our quarterly operating
results;
|
·
|
developments
or disputes concerning our intellectual property or other proprietary
rights;
|
·
|
introduction
of technological innovations or new products by us or our
competitors;
|
·
|
issues
in manufacturing or supplying the active ingredients for our product
candidates or future products;
|
·
|
market
acceptance of our future products;
|
·
|
deviations
in our operating results from the estimates of
analysts;
|
·
|
third-party
healthcare reimbursement policies;
|
·
|
FDA
or other U.S. or foreign regulatory actions affecting us or our
industry;
|
·
|
litigation
or public concern about the safety of our product candidates or future
drugs;
|
·
|
sales
of our common stock by our officers, directors or significant
stockholders; and
|
·
|
additions
or departures of key personnel.
|
In
addition, the stock markets in general, and the markets for pharmaceutical,
biopharmaceutical and biotechnology stocks in particular, have experienced
extreme volatility that have been often unrelated to the operating performance
of the issuer. These broad market fluctuations may adversely affect the trading
price or liquidity of our common stock. In the past, when the market price
of a
stock has been volatile, holders of that stock have sometimes instituted
securities class action litigation against the issuer. If any of our
stockholders were to bring such a lawsuit against us, we could incur substantial
costs defending the lawsuit and the attention of our management would be
diverted from the operation of our business.
If
we sell shares of our common stock in future financings, common stockholders
may
experience immediate dilution and, as a result, our stock price may go
down.
We
may
from time to time issue additional shares of common stock at a discount from
the
current trading price of our common stock. As a result, our common stockholders
would experience immediate dilution upon the purchase of any shares of our
common stock sold at such discount.
In
addition, as opportunities present themselves, we may enter into financing
or
similar arrangements in the future, including the issuance of debt securities,
preferred stock or common stock. In May 2007, we completed a public offering
of
4,750,000 shares of common stock under our $75 million universal shelf
registration statement on Form S-3 declared effective by the Securities and
Exchange Commission, or SEC, in December 2006. In this offering, we raised
net
proceeds of approximately $19.5 million. If we issue additional common stock
or
securities convertible into common stock, our stockholders could experience
dilution.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
Recent
Sales of Unregistered Equity Securities
There
were no repurchases of securities or any sales of unregistered equity securities
during the quarter ended June 30, 2007.
Use
of Proceeds
We
completed our initial public offering of 6,051,126 shares of our common stock
on
Form S-1 (Reg. No. 333-121646) which was declared effective by the SEC on
September 27, 2005. We issued 6,000,000 shares on September 30, 2005 for gross
proceeds of $42.0 million. We issued an additional 51,126 shares on November
1,
2005 for gross proceeds of $0.36 million in connection with the underwriters’
partial exercise of their over-allotment option. We paid the underwriters a
commission of $3.0 million and incurred additional offering expenses of
approximately $2.2 million. After deducting the underwriters’ commission and the
offering expenses, the registrant received net proceeds of approximately $37.2
million.
25
No
payments for such expenses related to our IPO were made directly or indirectly
to (i) any of our directors, officers or their associates, (ii) any person(s)
owning 10% or more of any class of our equity securities, or (iii) any of our
affiliates.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Submission of Matters to a Vote of Security
Holders
We
held
our 2007 Annual Meeting of Stockholders on June 5, 2007, or the Annual Meeting.
At the Annual Meeting, our stockholders voted upon one matter. A description
of
such matter and a tabulation of the votes is as follows:
The
only
proposal at the Annual Meeting was the election of four directors, each to
serve
until the 2010 Annual Meeting of Stockholders or until their earlier resignation
or removal or their successors have been duly elected and qualified. The
tabulation of votes on this proposal is as follows:
Nominee
|
For
|
Withheld
|
|||
Anthony
B. Evnin, Ph.D.
|
16,738,505
|
72,830
|
|||
Steven
D. Goldby
|
16,750,447
|
60,888
|
|||
Homer
L. Pearce, Ph.D.
|
16,755,106
|
56,229
|
|||
James
A. Wells, Ph.D.
|
16,774,442
|
36,893
|
Stephen
Fodor, Ph.D., Matthew K. Fust, Jonathan S. Leff, David C. Stump, M.D., Daniel
N.
Swisher, Jr. and James W. Young, Ph.D.
also
continued to serve as directors after the Annual Meeting.
None.
Item
6. Exhibits
26
Exhibit
Number
|
|
Description
|
||
|
||||
10.3
|
|
2005
Equity Incentive Award Plan, as amended, and Form of Stock Option
Agreement.
|
||
|
|
|
||
10.51
|
Executive
Severance Benefits Agreement by and between the Company and Valerie
L.
Pierce, dated May 14, 2007 (incorporated by reference to the Company's
Current Report on Form 8-K filed on May 15, 2007).
|
|||
|
|
|
||
31.1
|
|
Certification
of Chief Executive Officer as required by Rule 13a-14(a) of the Securities
Exchange Act of 1934, as amended
|
||
|
|
|
||
31.2
|
|
Certification
of Chief Financial Officer as required by Rule 13a-14(a) of the Securities
Exchange Act of 1934, as amended.
|
||
|
|
|
||
32.1*
|
|
Certification
of Chief Executive Officer as required by Rule 13a-14(b) of the Securities
Exchange Act of 1934, as amended.
|
||
|
|
|
||
32.2*
|
|
Certification
of Chief Financial Officer as required by Rule 13a-14(b) of the Securities
Exchange Act of 1934, as amended.
|
||
*
|
The
certifications attached as Exhibits 32.1 and 32.2 accompany this
Quarterly
Report on Form 10-Q, are not deemed filed with the Securities and
Exchange
Commission and are not to be incorporated by reference into any filing
of
Sunesis Pharmaceuticals, Inc. under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, as amended, whether
made
before or after the date of this Form 10-Q, irrespective of any general
incorporation language contained in such filing.
|
27
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
SUNESIS
PHARMACEUTICALS, INC.
|
||
|
|
(Registrant) |
By: |
/s/
Eric H. Bjerkholt
|
|
Eric
H. Bjerkholt
Senior
Vice President, Corporate Development and Finance, Chief Financial
Officer
|
Date:
August 8, 2007
28
EXHIBIT INDEX
Exhibit
Number
|
|
Description
|
||
|
||||
10.3
|
|
2005
Equity Incentive Award Plan, as amended, and Form of Stock Option
Agreement.
|
||
|
|
|
||
10.51
|
Executive
Severance Benefits Agreement by and between the Company and Valerie
L.
Pierce, dated May 14, 2007
(incorporated
by reference to the Company's Current Report on Form 8-K filed
on May 15,
2007).
|
|||
|
|
|
||
31.1
|
|
Certification
of Chief Executive Officer as required by Rule 13a-14(a) of the
Securities
Exchange Act of 1934, as amended
|
||
|
|
|
||
31.2
|
|
Certification
of Chief Financial Officer as required by Rule 13a-14(a) of the
Securities
Exchange Act of 1934, as amended.
|
||
|
|
|
||
32.1*
|
|
Certification
of Chief Executive Officer as required by Rule 13a-14(b) of the
Securities
Exchange Act of 1934, as amended.
|
||
|
|
|
||
32.2*
|
|
Certification
of Chief Financial Officer as required by Rule 13a-14(b) of the
Securities
Exchange Act of 1934, as amended.
|
||
*
|
The
certifications attached as Exhibits 32.1 and 32.2 accompany this
Quarterly
Report on Form 10-Q, are not deemed filed with the Securities and
Exchange
Commission and are not to be incorporated by reference into any
filing of
Sunesis Pharmaceuticals, Inc. under the Securities Act of 1933,
as
amended, or the Securities Exchange Act of 1934, as amended, whether
made
before or after the date of this Form 10-Q, irrespective of any
general
incorporation language contained in such filing.
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29