ý
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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04-3505116
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(State or Other Jurisdiction of
Incorporation or Organization)
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|
(I.R.S. Employer
Identification No.)
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4 Maguire Road
Lexington, Massachusetts
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02421
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(Address of Principal Executive Offices)
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(Zip Code)
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Large accelerated filer
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¨
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Accelerated filer
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ý
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Non-accelerated filer
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¨
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Smaller reporting company
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¨
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Emerging growth company
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¨
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Page
Number
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PART I.
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FINANCIAL INFORMATION
|
|
Item 1.
|
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Item 2.
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Item 3.
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Item 4.
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PART II.
|
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Item 1A.
|
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Item 5.
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||
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Item 6.
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||
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Item 1.
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CONDENSED FINANCIAL STATEMENTS
|
|
June 30,
2018 |
|
December 31,
2017 |
||||
ASSETS
|
|
|
|
||||
Current Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
30,465
|
|
|
$
|
38,288
|
|
Investments
|
9,955
|
|
|
21,944
|
|
||
Accounts receivable
|
2,505
|
|
|
3,073
|
|
||
Prepaid expenses and other current assets
|
776
|
|
|
989
|
|
||
Total current assets
|
43,701
|
|
|
64,294
|
|
||
Property and equipment, net
|
352
|
|
|
366
|
|
||
Long-term investment – restricted
|
153
|
|
|
153
|
|
||
Goodwill
|
8,982
|
|
|
8,982
|
|
||
Other assets
|
3
|
|
|
3
|
|
||
Total assets
|
$
|
53,191
|
|
|
$
|
73,798
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current Liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
4,275
|
|
|
$
|
5,423
|
|
Accrued liabilities
|
3,263
|
|
|
2,793
|
|
||
Current portion of long-term debt, net
|
6,965
|
|
|
5,886
|
|
||
Total current liabilities
|
14,503
|
|
|
14,102
|
|
||
Long-term debt, net
|
31,532
|
|
|
35,669
|
|
||
Other long-term liabilities
|
46
|
|
|
34
|
|
||
Total liabilities
|
46,081
|
|
|
49,805
|
|
||
Stockholders’ Equity:
|
|
|
|
||||
Common stock, $0.01 par value—67,500,000 shares authorized, 33,181,146 shares issued and outstanding at June 30, 2018; 45,000,000 shares authorized, 33,075,949 shares issued and 32,831,380 shares outstanding at December 31, 2017
|
332
|
|
|
331
|
|
||
Additional paid-in capital
|
978,455
|
|
|
977,453
|
|
||
Treasury stock, at cost, 0 shares at June 30, 2018 and 244,569 shares at December 31, 2017
|
—
|
|
|
(1,524
|
)
|
||
Accumulated deficit
|
(971,676
|
)
|
|
(952,265
|
)
|
||
Accumulated other comprehensive income
|
(1
|
)
|
|
(2
|
)
|
||
Total stockholders’ equity
|
7,110
|
|
|
23,993
|
|
||
Total liabilities and stockholders’ equity
|
$
|
53,191
|
|
|
$
|
73,798
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
||||||||
Royalties
|
$
|
2,394
|
|
|
$
|
2,102
|
|
|
$
|
4,868
|
|
|
$
|
4,294
|
|
Research and development, net
|
(36
|
)
|
|
(41
|
)
|
|
(42
|
)
|
|
(102
|
)
|
||||
Total revenues
|
2,358
|
|
|
2,061
|
|
|
4,826
|
|
|
4,192
|
|
||||
Costs and expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of royalty revenues
|
134
|
|
|
96
|
|
|
263
|
|
|
207
|
|
||||
Research and development
|
6,451
|
|
|
11,255
|
|
|
14,717
|
|
|
24,795
|
|
||||
General and administrative
|
3,633
|
|
|
3,819
|
|
|
7,614
|
|
|
7,351
|
|
||||
Total costs and expenses
|
10,218
|
|
|
15,170
|
|
|
22,594
|
|
|
32,353
|
|
||||
Loss from operations
|
(7,860
|
)
|
|
(13,109
|
)
|
|
(17,768
|
)
|
|
(28,161
|
)
|
||||
Other (expense) income:
|
|
|
|
|
|
|
|
||||||||
Other (expense) income
|
—
|
|
|
—
|
|
|
—
|
|
|
(104
|
)
|
||||
Interest income
|
189
|
|
|
138
|
|
|
375
|
|
|
208
|
|
||||
Interest expense
|
(993
|
)
|
|
(1,119
|
)
|
|
(2,018
|
)
|
|
(1,775
|
)
|
||||
Total other expense, net
|
(804
|
)
|
|
(981
|
)
|
|
(1,643
|
)
|
|
(1,671
|
)
|
||||
Net loss
|
$
|
(8,664
|
)
|
|
$
|
(14,090
|
)
|
|
$
|
(19,411
|
)
|
|
$
|
(29,832
|
)
|
Net loss per common share (basic and diluted)
|
$
|
(0.26
|
)
|
|
$
|
(0.49
|
)
|
|
$
|
(0.59
|
)
|
|
$
|
(1.04
|
)
|
Weighted average common shares (basic and diluted)
|
33,135,391
|
|
|
28,757,341
|
|
|
33,094,772
|
|
|
28,580,829
|
|
||||
Total comprehensive loss
|
$
|
(8,659
|
)
|
|
$
|
(14,087
|
)
|
|
$
|
(19,410
|
)
|
|
$
|
(29,831
|
)
|
|
Six Months Ended
June 30, |
||||||
|
2018
|
|
2017
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(19,411
|
)
|
|
$
|
(29,832
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
99
|
|
|
113
|
|
||
Stock-based compensation expense
|
2,415
|
|
|
2,688
|
|
||
Amortization of debt issuance costs
|
16
|
|
|
128
|
|
||
Non-cash interest (income) expense on investments
|
(128
|
)
|
|
(49
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
568
|
|
|
228
|
|
||
Prepaid expenses and other assets
|
213
|
|
|
299
|
|
||
Accounts payable and accrued and other liabilities
|
(674
|
)
|
|
2,056
|
|
||
Total adjustments
|
2,509
|
|
|
5,463
|
|
||
Net cash used in operating activities
|
(16,902
|
)
|
|
(24,369
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchase of investments
|
(20,932
|
)
|
|
(27,476
|
)
|
||
Sales and maturities of investments
|
33,050
|
|
|
21,608
|
|
||
Purchases of property and equipment
|
(77
|
)
|
|
(126
|
)
|
||
Net cash provided by/(used in) investing activities
|
12,041
|
|
|
(5,994
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds from issuance of common stock associated with offerings, net of issuance costs
|
—
|
|
|
6,214
|
|
||
Proceeds from issuance of common stock under the Company’s share-based compensation plans
|
112
|
|
|
890
|
|
||
Proceeds from credit agreement with HealthCare Royalty Partners, III, L.P.
|
—
|
|
|
45,000
|
|
||
Payment of debt issuance costs
|
—
|
|
|
(192
|
)
|
||
Payment on termination of credit agreement with BioPharma-II
|
—
|
|
|
(18,303
|
)
|
||
Payments on Curis Royalty’s debt
|
(3,074
|
)
|
|
(2,607
|
)
|
||
Net cash (used in)/provided by financing activities
|
(2,962
|
)
|
|
31,002
|
|
||
Net (decrease)/increase in cash and cash equivalents
|
(7,823
|
)
|
|
639
|
|
||
Cash and cash equivalents, beginning of period
|
38,288
|
|
|
26,038
|
|
||
Cash and cash equivalents, end of period
|
$
|
30,465
|
|
|
$
|
26,677
|
|
Non-cash items:
|
|
|
|
||||
Property and equipment purchases in accounts payable
|
$
|
8
|
|
|
$
|
—
|
|
1.
|
Nature of Business
|
2.
|
Basis of Presentation
|
3.
|
Revenue Recognition
|
4.
|
Research and Development Collaborations
|
(a)
|
Genentech
|
1.
|
To grant the license for its Hedgehog (Hh) antagonist programs and to provide service on both a Joint Steering Committee and Co-Development Steering Committee.
This performance obligation has been satisfied and only contingent royalty revenue remains to be recognized in the future.
|
2.
|
To provide reimbursable research and development services.
This performance obligation has been satisfied and no revenue remains to be recognized in the future.
|
(b)
|
Aurigene
|
1.
|
IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948, an orally available small molecule inhibitor of IRAK4.
|
2.
|
PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170, an orally available small molecule antagonist of PDL1 and VISTA.
|
3.
|
PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327, an orally available small molecule antagonist of PDL1 and TIM3.
|
4.
|
In March 2018, the Company exercised its option to license a fourth program, which is an immuno-oncology program.
|
5.
|
Fair Value Measurements
|
Level 1
|
Quoted prices in active markets for identical assets or liabilities.
|
|
|
Level 2
|
Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
|
|
|
Level 3
|
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
|
Quoted Prices in
Active Markets
(Level 1)
|
|
Other Observable
Inputs (Level 2)
|
|
Unobservable
Inputs (Level 3)
|
|
Total Fair Value
|
||||||||
As of June 30, 2018:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
26,813
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
26,813
|
|
Corporate commercial paper, bonds and notes
|
—
|
|
|
1,399
|
|
|
—
|
|
|
1,399
|
|
||||
Municipal and government securities
|
—
|
|
|
190
|
|
|
—
|
|
|
190
|
|
||||
Short-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate commercial paper, stock, bonds and notes
|
—
|
|
|
9,955
|
|
|
—
|
|
|
9,955
|
|
||||
Total assets at fair value
|
$
|
26,813
|
|
|
$
|
11,544
|
|
|
$
|
—
|
|
|
$
|
38,357
|
|
|
Quoted Prices in
Active Markets
(Level 1)
|
|
Other Observable
Inputs (Level 2)
|
|
Unobservable
Inputs (Level 3)
|
|
Total Fair Value
|
||||||||
As of December 31, 2017:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
35,308
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
35,308
|
|
Municipal bonds
|
—
|
|
|
260
|
|
|
—
|
|
|
260
|
|
||||
Short-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate commercial paper, stock, bonds and notes
|
—
|
|
|
21,944
|
|
|
—
|
|
|
21,944
|
|
||||
Total assets at fair value
|
$
|
35,308
|
|
|
$
|
22,204
|
|
|
$
|
—
|
|
|
$
|
57,512
|
|
6.
|
Investments
|
|
Amortized
Cost
|
|
Unrealized
Gain
|
|
Unrealized
Loss
|
|
Total Fair Value
|
||||||||
Corporate bonds and notes – short-term
|
$
|
9,956
|
|
|
$
|
—
|
|
|
$
|
(1
|
)
|
|
$
|
9,955
|
|
Total investments
|
$
|
9,956
|
|
|
$
|
—
|
|
|
$
|
(1
|
)
|
|
$
|
9,955
|
|
|
Amortized
Cost
|
|
Unrealized
Gain
|
|
Unrealized
Loss
|
|
Total Fair Value
|
||||||||
Corporate bonds and notes – short-term
|
$
|
21,946
|
|
|
$
|
—
|
|
|
$
|
(2
|
)
|
|
$
|
21,944
|
|
Total investments
|
$
|
21,946
|
|
|
$
|
—
|
|
|
$
|
(2
|
)
|
|
$
|
21,944
|
|
7.
|
Debt
|
(a)
|
BioPharma-II
|
(b)
|
HealthCare Royalty Partners III
|
(c)
|
Respective Debt Payments to BioPharma-II and HealthCare Royalty Partners III
|
8.
|
Accrued Liabilities
|
|
June 30,
2018 |
|
December 31,
2017 |
||||
Accrued compensation
|
$
|
2,548
|
|
|
$
|
2,187
|
|
Professional fees
|
332
|
|
|
148
|
|
||
Accrued interest on debt (Note 7)
|
169
|
|
|
193
|
|
||
Other
|
214
|
|
|
265
|
|
||
Total
|
$
|
3,263
|
|
|
$
|
2,793
|
|
9.
|
Accounting for Stock-Based Compensation
|
|
Six Months Ended
June 30, |
||
|
2018
|
|
2017
|
Expected life (years) - employees
|
5.5
|
|
5.5
|
Expected life (years) - officers
|
5.5
|
|
5.5
|
Expected life (years) – directors
|
6.25
|
|
6.25
|
Risk-free interest rate
|
2.5-2.8%
|
|
2.0-2.1%
|
Volatility
|
66-72%
|
|
63-64%
|
Dividends
|
None
|
|
None
|
|
Number of
Shares
|
|
Weighted
Average
Exercise
Price per
Share
|
|
Weighted
Average
Remaining Contractual Life
|
|
Aggregate Intrinsic Value
|
|||||
Outstanding, December 31, 2017
|
3,206,858
|
|
|
$
|
12.08
|
|
|
|
|
|
||
Granted
|
1,220,596
|
|
|
3.19
|
|
|
|
|
|
|||
Exercised
|
—
|
|
|
—
|
|
|
|
|
|
|||
Canceled
|
(357,742
|
)
|
|
11.59
|
|
|
|
|
|
|||
Outstanding, June 30, 2018
|
4,069,712
|
|
|
$
|
9.46
|
|
|
7.49
|
|
$
|
—
|
|
Exercisable at June 30, 2018
|
1,894,027
|
|
|
$
|
12.47
|
|
|
5.77
|
|
$
|
—
|
|
Vested and unvested expected to vest at June 30, 2018
|
3,811,106
|
|
|
$
|
9.74
|
|
|
7.36
|
|
$
|
—
|
|
|
Number of
Shares
|
|
Weighted
Average
Grant Date Fair Value
|
|||
Outstanding, December 31, 2017
|
—
|
|
|
$
|
—
|
|
Awarded
|
294,250
|
|
|
3.45
|
|
|
Vested
|
—
|
|
|
—
|
|
|
Forfeited
|
—
|
|
|
—
|
|
|
Outstanding, June 30, 2018
|
294,250
|
|
|
$
|
3.45
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Research and development expenses
|
$
|
436
|
|
|
$
|
414
|
|
|
$
|
849
|
|
|
$
|
703
|
|
General and administrative expenses
|
753
|
|
|
1,171
|
|
|
1,566
|
|
|
1,985
|
|
||||
Total stock-based compensation expense
|
$
|
1,189
|
|
|
$
|
1,585
|
|
|
$
|
2,415
|
|
|
$
|
2,688
|
|
10.
|
Accumulated Other Comprehensive Income (Loss)
|
|
Unrealized Gain on
Securities Available-for-Sale
|
||
Balance, as of December 31, 2017
|
$
|
(2
|
)
|
Unrealized loss on marketable securities
|
1
|
|
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
—
|
|
|
Net current period other comprehensive income
|
1
|
|
|
Balance, as of June 30, 2018
|
$
|
(1
|
)
|
|
Unrealized Losses and
Gain on
Securities Available-for-Sale
|
||
Balance, as of December 31, 2016
|
$
|
(4
|
)
|
Unrealized loss on marketable securities
|
1
|
|
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
—
|
|
|
Net current period other comprehensive income
|
1
|
|
|
Balance, as of June 30, 2017
|
$
|
(3
|
)
|
11.
|
Common Stock and Treasury Stock
|
12.
|
Loss Per Common Share
|
13.
|
New Accounting Pronouncements
|
Item 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
Fimepinostat (CUDC-907), for which our Phase 2 study in patients with relapsed refractory DLBCL including those with MYC alterations is ongoing, was granted Orphan Drug Designation in April 2015 and Fast Track Designation in May 2018 by the U.S. FDA. We are currently in ongoing discussions with the U.S. FDA that we anticipate will facilitate our determination of the most appropriate regulatory path;
|
•
|
CA-170, for which we are currently conducting a Phase 1 study in patients with advanced solid tumors and lymphomas; and
|
•
|
CA-4948, for which, in January 2018 we initiated a Phase 1 study in patients with advanced non-Hodgkin lymphomas including those with MYD88 alterations.
|
1.
|
IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948.
|
2.
|
PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170.
|
3.
|
PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327.
|
4.
|
In March 2018, we exercised our option to license a fourth program, which is an immuno-oncology program.
|
•
|
our ability to successfully plan, finance and complete clinical trials for fimepinostat, CA-170, and CA-4948, and that these clinical trials generate favorable data;
|
•
|
our and Aurigene’s ability to complete preclinical development and IND-enabling studies for CA-327 and a fourth immuno-oncology program, and for us to then finance and complete planned Phase 1 clinical trials for this development candidate;
|
•
|
Aurigene’s ability to advance additional preclinical immuno-oncology, and precision oncology drug candidates, and our ability to license these programs from Aurigene and further progress them clinically;
|
•
|
Genentech and Roche’s ability to continue to successfully commercialize Erivedge in advanced BCC in the United States and in other global territories; and
|
•
|
our ability to raise additional financing through our at-the-market sale facility with Cowen or other potential financing.
|
•
|
105%, after the third anniversary of the closing date through and including the fourth anniversary of the closing date;
|
•
|
102.5%, after the fourth anniversary of the closing date through and including the fifth anniversary of the closing date;
|
•
|
101%, after the fifth anniversary of the closing date through and including the sixth anniversary of the closing date; and
|
•
|
100%, after the sixth anniversary of the closing date.
|
•
|
the scope, quality of data, rate of progress and cost of clinical trials and other research and development activities undertaken by us or our collaborators;
|
•
|
the results of future preclinical studies and clinical trials;
|
•
|
the cost and timing of regulatory approvals and maintaining compliance with regulatory requirements;
|
•
|
the cost and timing of establishing sales, marketing and distribution capabilities;
|
•
|
the cost of establishing clinical and commercial supplies of our drug candidates and any products that we may develop;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the cost and effectiveness of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.
|
|
For the Three Months Ended June 30,
|
|
Percentage
Increase/
(Decrease)
|
|
For the Six Months Ended June 30,
|
|
Percentage
Increase/
(Decrease)
|
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||
Revenues
|
$
|
2,358
|
|
|
$
|
2,061
|
|
|
14
|
%
|
|
$
|
4,826
|
|
|
$
|
4,192
|
|
|
15
|
%
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of royalty revenues
|
134
|
|
|
96
|
|
|
40
|
%
|
|
263
|
|
|
207
|
|
|
27
|
%
|
||||
Research and development
|
6,451
|
|
|
11,255
|
|
|
(43
|
)%
|
|
14,717
|
|
|
24,795
|
|
|
(41
|
)%
|
||||
General and administrative
|
3,633
|
|
|
3,819
|
|
|
(5
|
)%
|
|
7,614
|
|
|
7,351
|
|
|
4
|
%
|
||||
Other expense, net
|
804
|
|
|
981
|
|
|
(18
|
)%
|
|
1,643
|
|
|
1,671
|
|
|
(2
|
)%
|
||||
Net loss
|
$
|
(8,664
|
)
|
|
$
|
(14,090
|
)
|
|
(39
|
)%
|
|
$
|
(19,411
|
)
|
|
$
|
(29,832
|
)
|
|
(35
|
)%
|
|
For the Three Months Ended June 30,
|
|
Percentage
Increase/
(Decrease)
|
|
For the Six Months Ended June 30,
|
|
Percentage
Increase/
(Decrease)
|
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Royalties
|
$
|
2,394
|
|
|
$
|
2,102
|
|
|
14
|
%
|
|
$
|
4,868
|
|
|
$
|
4,294
|
|
|
13
|
%
|
Research and development, net
|
(36
|
)
|
|
(41
|
)
|
|
(12
|
)%
|
|
(42
|
)
|
|
(102
|
)
|
|
(59
|
)%
|
||||
Total revenues
|
$
|
2,358
|
|
|
$
|
2,061
|
|
|
14
|
%
|
|
$
|
4,826
|
|
|
$
|
4,192
|
|
|
15
|
%
|
|
For the Three Months Ended June 30,
|
|
Percentage
Increase/ (Decrease) |
|
For the Six Months Ended June 30,
|
|
Percentage
Increase/
(Decrease)
|
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||
Direct research and development expenses
|
$
|
2,673
|
|
|
$
|
7,546
|
|
|
(65
|
)%
|
|
$
|
6,844
|
|
|
$
|
17,550
|
|
|
(61
|
)%
|
Employee-related expenses
|
3,238
|
|
|
3,272
|
|
|
(1
|
)%
|
|
6,711
|
|
|
6,409
|
|
|
5
|
%
|
||||
Facilities, depreciation and other expenses
|
540
|
|
|
437
|
|
|
24
|
%
|
|
1,162
|
|
|
836
|
|
|
39
|
%
|
||||
Total research and development expenses
|
$
|
6,451
|
|
|
$
|
11,255
|
|
|
(43
|
)%
|
|
$
|
14,717
|
|
|
$
|
24,795
|
|
|
(41
|
)%
|
|
For the Three Months Ended June 30,
|
|
Percentage
Increase/
(Decrease)
|
|
For the Six Months Ended June 30,
|
|
Percentage
Increase/
(Decrease)
|
||||||||||||||
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||
Personnel
|
$
|
1,166
|
|
|
$
|
1,287
|
|
|
(9
|
)%
|
|
$
|
2,492
|
|
|
$
|
2,674
|
|
|
(7
|
)%
|
Occupancy and depreciation
|
132
|
|
|
114
|
|
|
16
|
%
|
|
293
|
|
|
214
|
|
|
37
|
%
|
||||
Legal services
|
719
|
|
|
436
|
|
|
65
|
%
|
|
1,460
|
|
|
846
|
|
|
73
|
%
|
||||
Professional and consulting services
|
566
|
|
|
488
|
|
|
16
|
%
|
|
1,158
|
|
|
1,008
|
|
|
15
|
%
|
||||
Insurance costs
|
98
|
|
|
101
|
|
|
(3
|
)%
|
|
202
|
|
|
201
|
|
|
—
|
%
|
||||
Stock-based compensation
|
753
|
|
|
1,171
|
|
|
(36
|
)%
|
|
1,566
|
|
|
1,985
|
|
|
(21
|
)%
|
||||
Other general and administrative expenses
|
199
|
|
|
222
|
|
|
(10
|
)%
|
|
443
|
|
|
423
|
|
|
5
|
%
|
||||
Total general and administrative expenses
|
$
|
3,633
|
|
|
$
|
3,819
|
|
|
(5
|
)%
|
|
$
|
7,614
|
|
|
$
|
7,351
|
|
|
3
|
%
|
•
|
unanticipated costs in our research and development programs;
|
•
|
the timing and cost of obtaining regulatory approvals for our drug candidates and maintaining compliance with regulatory requirements;
|
•
|
the timing and amount of option exercise fees, milestone payments, royalties and other payments due to licensors, including Aurigene, for patent rights and technology used in our drug development programs;
|
•
|
the costs of commercialization activities for any of our drug candidates that receive marketing approval, to the extent such costs are our responsibility, including the costs and timing of establishing drug sales, marketing, distribution and manufacturing capabilities;
|
•
|
unplanned costs to prepare, file, prosecute, defend and enforce patent claims and other patent-related costs, including litigation costs and technology license fees; and
|
•
|
unexpected losses in our cash investments or an inability to otherwise liquidate our cash investments due to unfavorable conditions in the capital markets.
|
Item 3.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
Item 4.
|
CONTROLS AND PROCEDURES
|
Item 1A.
|
Risk Factors
|
•
|
continue to develop and conduct clinical trials with respect to drug candidates;
|
•
|
seek to identify and develop additional drug candidates;
|
•
|
acquire or in-license other drug candidates or technologies;
|
•
|
seek regulatory and marketing approvals for our drug candidates that successfully complete clinical trials, if any;
|
•
|
establish sales, marketing, distribution, and other commercial infrastructure in the future to commercialize various drugs for which we may obtain marketing approval, if any;
|
•
|
require the manufacture of larger quantities of drug candidates for clinical development and, potentially, commercialization;
|
•
|
maintain, expand, and protect our intellectual property portfolio;
|
•
|
hire and retain additional personnel, such as clinical, quality control and scientific personnel; and
|
•
|
add equipment and physical infrastructure as may be required to support our research and development programs.
|
•
|
unanticipated costs in our research and development programs;
|
•
|
the timing and cost of obtaining regulatory approvals for our drug candidates and maintaining compliance with regulatory requirements;
|
•
|
the timing and amount of option exercise fees, milestone payments, royalties and other payments due to licensors, including Aurigene, for patent rights and technology used in our drug development programs;
|
•
|
the costs of commercialization activities for any of our drug candidates that receive marketing approval, to the extent such costs are our responsibility, including the costs and timing of establishing drug sales, marketing, distribution and manufacturing capabilities;
|
•
|
unplanned costs to prepare, file, prosecute, defend and enforce patent claims and other patent-related costs, including litigation costs and technology license fees; and
|
•
|
unexpected losses in our cash investments or an inability to otherwise liquidate our cash investments due to unfavorable conditions in the capital markets.
|
•
|
if any payment of principal is not made within three days of when such payment is due and payable or otherwise made in accordance with the terms of the credit agreement;
|
•
|
if any representations or warranties made in the credit agreement or any other related transaction document prove to be incorrect or misleading in any material respect when made;
|
•
|
if there occurs a default in the performance of affirmative and negative covenants set forth in the credit agreement or under certain ancillary transaction documents;
|
•
|
the failure by Genentech to pay material amounts owed under the collaboration agreement with Genentech because of an actual breach or default by Curis under the collaboration agreement;
|
•
|
a material breach or default by Curis Royalty under certain ancillary transaction documents with HealthCare Royalty, in each case, which such breach or default is not cured within 30 days after written demand thereof by HealthCare Royalty;
|
•
|
the voluntary or involuntary commencement of bankruptcy proceedings by either Curis or Curis Royalty and other insolvency-related defaults;
|
•
|
any materially adverse effect on the binding nature of any of the transaction documents or the Genentech collaboration agreement;
|
•
|
if any person shall be designated an independent director of Curis Royalty other than in accordance with its limited liability company operating agreement; or
|
•
|
if Curis shall at any time cease to own, of record and beneficially, 100% of the equity interests in Curis Royalty.
|
•
|
payments we may be required to make to collaborators such as Aurigene to exercise license rights and satisfy milestones and royalty obligations;
|
•
|
the status of, and level of expenses incurred in connection with, our programs, including development costs relating to fimepinostat, CA-170 and CA-4948, as well as funding programs that we have licensed or may in the future license and develop under our collaboration with Aurigene;
|
•
|
fluctuations in sales of Erivedge and related royalty payments, including fluctuations resulting from the sales of competing drug products such as sonidegib, which is approved in the U.S. and Europe for the treatment of locally advanced BCC and is now being marketed and sold by Sun Pharmaceuticals Industries Ltd., or Sun Pharmaceuticals;
|
•
|
any intellectual property infringement lawsuit or other litigation in which we may become involved;
|
•
|
the implementation of restructuring and cost-savings strategies;
|
•
|
the occurrence of an event of default under the credit agreement by and among Curis, Curis Royalty and HealthCare Royalty;
|
•
|
the implementation or termination of collaboration, licensing, manufacturing or other material agreements with third parties, and non-recurring revenue or expenses under any such agreement; and
|
•
|
compliance with regulatory requirements.
|
•
|
successful enrollment in, and completion of, ongoing and future clinical trials of fimepinostat, CA-170, CA-4948 and other compounds that we may develop under our collaboration agreement with Aurigene;
|
•
|
Aurigene’s ability to successfully discover and preclinically develop other drug candidates under the collaboration agreement;
|
•
|
a safety, tolerability and efficacy profile that is satisfactory to FDA or any comparable foreign regulatory authority for marketing approval;
|
•
|
receipt of requisite marketing approvals from applicable regulatory authorities;
|
•
|
the extent of any required post marketing approval commitments to applicable regulatory authorities;
|
•
|
establishment of supply arrangements with third party raw materials suppliers and manufacturers;
|
•
|
establishment of arrangements with third party manufacturers to obtain finished drug products that is appropriately packaged for sale;
|
•
|
adequate ongoing availability of raw materials and drug products for clinical development and any commercial sales;
|
•
|
obtaining and maintaining patent, trade secret protection and regulatory exclusivity, both in the U.S. and internationally;
|
•
|
protection of the rights in our intellectual property portfolio;
|
•
|
successful launch of commercial sales following any marketing approval;
|
•
|
a continued acceptable safety profile following any marketing approval;
|
•
|
commercial acceptance by patients, the medical community and third-party payors; and
|
•
|
our ability to compete with other therapies.
|
•
|
incur additional unplanned costs;
|
•
|
be delayed in obtaining marketing approval for our drug candidates;
|
•
|
not obtain marketing approval at all;
|
•
|
obtain approval for indications or patient populations that are not as broad as intended or desired;
|
•
|
obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed warnings;
|
•
|
be subject to additional post-marketing testing or other requirements; or
|
•
|
be required to remove the drug from the market after obtaining marketing approval.
|
•
|
regulators or institutional review boards may not authorize us, any collaborators or our or their investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
•
|
we, or any collaborators, may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
|
•
|
clinical trials of our drug candidates may produce unfavorable or inconclusive results;
|
•
|
we, or any collaborators, may decide, or regulators may require us or them, to conduct additional clinical trials or abandon drug development programs;
|
•
|
the number of patients required for clinical trials of our drug candidates may be larger than we, or any collaborators, anticipate, patient enrollment in these clinical trials may be slower than we, or any collaborators, anticipate or participants may drop out of these clinical trials at a higher rate than we, or any collaborators, anticipate;
|
•
|
our estimates of the patient populations available for study may be higher than actual patient numbers and result in our inability to sufficiently enroll our trials;
|
•
|
the cost of planned clinical trials of our drug candidates may be greater than we anticipate;
|
•
|
our third-party contractors or those of any collaborators, including those manufacturing our drug candidates or components or ingredients thereof or conducting clinical trials on our behalf or on behalf of any collaborators, may
|
•
|
patients that enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the patients from the clinical trial, increase the needed enrollment size for the clinical trial or extend the clinical trial’s duration;
|
•
|
we, or any collaborators, may have to delay, suspend or terminate clinical trials of our drug candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of the drug candidate;
|
•
|
regulators or institutional review boards may require that we, or any collaborators, or our or their investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or their standards of conduct, a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of the drug candidate or findings of undesirable effects caused by a chemically or mechanistically similar drug or drug candidate;
|
•
|
the FDA or comparable foreign regulatory authorities may disagree with our, or any collaborators’, clinical trial designs or our or their interpretation of data from preclinical studies and clinical trials;
|
•
|
the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we, or any collaborators, enter into agreements for clinical and commercial supplies;
|
•
|
the supply or quality of raw materials or manufactured drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; and
|
•
|
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient to obtain marketing approval.
|
•
|
the size and nature of the patient population;
|
•
|
the severity of the disease under investigation;
|
•
|
the availability of approved therapeutics for the relevant disease;
|
•
|
the proximity of patients to clinical sites;
|
•
|
the eligibility criteria and design for the trial;
|
•
|
efforts to facilitate timely enrollment;
|
•
|
competing clinical trials; and
|
•
|
clinicians’ and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.
|
•
|
regulatory authorities may withdraw their approval of the drug or seize the drug;
|
•
|
we, or any future collaborators, may be required to recall the drug, change the way the drug is administered or conduct additional clinical trials;
|
•
|
additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular drug;
|
•
|
we may be subject to fines, injunctions or the imposition of civil or criminal penalties;
|
•
|
regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;
|
•
|
we, or any future collaborators, may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients;
|
•
|
we, or any future collaborators, could be sued and held liable for harm caused to patients;
|
•
|
the drug may become less competitive; and
|
•
|
our reputation may suffer.
|
•
|
the efficacy and safety of the drug;
|
•
|
the potential advantages of the drug compared to competitive therapies;
|
•
|
the prevalence and severity of any side effects;
|
•
|
whether the drug is designated under physician treatment guidelines as a first-, second- or third-line therapy;
|
•
|
our ability, or the ability of any future collaborators, to offer the drug for sale at competitive prices;
|
•
|
the drug’s convenience and ease of administration compared to alternative treatments;
|
•
|
the willingness of the target patient population to try, and of physicians to prescribe, the drug;
|
•
|
limitations or warnings, including distribution or use restrictions, contained in the drug’s approved labeling;
|
•
|
the strength of sales, marketing and distribution support;
|
•
|
changes in the standard of care for the targeted indications for the drug; and
|
•
|
availability and amount of coverage and reimbursement from government payors, managed care plans and other third-party payors.
|
•
|
we may not be able to attract and build a significant and skilled marketing staff or sales force;
|
•
|
the cost of establishing a marketing staff or sales force may not be justifiable in light of the revenues generated by any particular drug; and
|
•
|
our direct sales and marketing efforts may not be successful.
|
•
|
decreased demand for our drug candidates or drugs that we may develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of clinical trial participants;
|
•
|
significant costs to defend resulting litigation;
|
•
|
substantial monetary awards to trial participants or patients;
|
•
|
loss of revenue;
|
•
|
reduced resources of our management to pursue our business strategy; and
|
•
|
the reduced ability or inability to commercialize any drugs that we may develop.
|
•
|
Erivedge becomes no longer accepted as safe, efficacious, cost-effective and preferable for the treatment of advanced BCC to current therapies in the medical community and by third-party payors;
|
•
|
Genentech and/or Roche fail to continue to apply the necessary financial resources and expertise to manufacturing, marketing and selling Erivedge for advanced BCC, and to regulatory approvals for this indication outside of the U.S.;
|
•
|
Genentech and/or Roche do not continue to develop and implement effective marketing, sales and distribution strategies and operations for development and commercialization of Erivedge for advanced BCC;
|
•
|
Genentech and/or Roche do not continue to develop, validate and maintain a commercially viable manufacturing process for Erivedge that is compliant with current good manufacturing practices;
|
•
|
Genentech and/or Roche do not successfully obtain third party reimbursement and generate commercial demand that results in sales of Erivedge for advanced BCC in any geographic areas where requisite approvals have been, or may be, obtained;
|
•
|
we, Genentech, or Roche encounter third-party patent interference, derivation,
inter partes
review, post-grant review, reexamination or patent infringement claims with respect to Erivedge;
|
•
|
Genentech and/or Roche do not comply with regulatory and legal requirements applicable to the sale of Erivedge for advanced BCC;
|
•
|
competing drug products are approved for the same indications as Erivedge, such as is the case with sonidegib, which is being marketed and sold by Sun Pharmaceutical, both in the U.S. and abroad for the treatment of adults with locally advanced BCC;
|
•
|
new safety risks are identified;
|
•
|
Erivedge does not demonstrate acceptable safety and efficacy in current or future clinical trials, or otherwise does not meet applicable regulatory standards for approval in indications other than advanced BCC;
|
•
|
Genentech and/or Roche determine to re-prioritize Genentech’s commercial or development programs and reduce or terminate Genentech’s efforts on the development or commercialization of Erivedge; or
|
•
|
Genentech does not exercise its first right to maintain or defend intellectual property rights associated with Erivedge.
|
•
|
Our collaborators each have significant discretion in determining the efforts and resources that they will apply to their respective collaboration with us. If a collaborator fails to allocate sufficient time, attention and resources to our collaboration, the successful development and commercialization of drug candidates under such collaboration is likely to be adversely affected. For example, we are dependent on Aurigene to successfully discover and advance preclinical programs from which we may exercise our option to license drug candidates for future development.
|
•
|
Our collaborators may develop and commercialize, either alone or with others, drugs that are similar to or competitive with the drug candidates that are the subject of our respective collaborations. For example, Genentech and Roche are involved in the commercialization of many cancer medicines and are seeking to develop several other cancer drug therapies, and Aurigene has other active cancer-focused discovery programs and has also entered into license agreements with other companies that focus on cancer therapies.
|
•
|
Our collaborators may change the focus of their development and commercialization efforts or pursue higher-priority programs.
|
•
|
Our collaborators may enter into one or more transactions with third parties, including a merger, consolidation, reorganization, sale of substantial assets, sale of substantial stock or change of control. Any such transaction could
|
•
|
Our collaborators may, under specified circumstances, terminate their collaborations with us on short notice and for circumstances outside of our control, which could make it difficult for us to attract new collaborators or adversely affect how we are perceived in the scientific, biotech, pharma and financial communities.
|
•
|
Our collaborators may utilize our intellectual property rights in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights, or expose us to potential liability.
|
•
|
Disputes may arise between collaborators and us regarding ownership of or other rights in the intellectual property generated in the course of the collaborations.
|
•
|
If any of our collaborators were to breach or terminate its arrangement with us, the development and commercialization of the affected drug candidate or program could be delayed, curtailed or terminated.
|
•
|
the development of certain of our current or future drug candidates may be terminated or delayed;
|
•
|
our cash expenditures related to development of certain of our current or future drug candidates would increase significantly and we may need to seek additional financing;
|
•
|
we may be required to hire additional employees or otherwise develop additional expertise, such as clinical, regulatory, sales and marketing expertise, for which we have not budgeted;
|
•
|
we will have to bear all of the risk related to the development of any such drug candidates; and
|
•
|
our future prospects may be adversely affected and our stock price could decline.
|
•
|
manufacturing delays if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them, or if unforeseen events in the manufacturing process arise;
|
•
|
the failure of third-party contractors to comply with applicable regulatory requirements;
|
•
|
the possible mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified;
|
•
|
the possibility of clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and
|
•
|
the possible misappropriation of our proprietary information, including our trade secrets and know-how.
|
•
|
we, and any collaborators, may not be able to initiate or continue certain preclinical and/or clinical trials of our drug candidates under development;
|
•
|
we, and any collaborators, may be delayed in submitting applications for regulatory approvals for our drug candidates; and
|
•
|
we, and any collaborators, may not be able to meet commercial demand for any approved drug products.
|
•
|
a diversion of management attention from our existing operations;
|
•
|
increased operating complexity of our business, requiring greater personnel and resources;
|
•
|
significant additional cash expenditures to expand our operations and acquire and integrate new businesses and technologies;
|
•
|
unanticipated expenses and potential delays related to integration of the operations, technology and other resources of any acquired companies;
|
•
|
uncertainty related to the value, benefits or legitimacy of intellectual property or technologies acquired;
|
•
|
retaining and assimilating key personnel and the potential impairment of relationships with our employees;
|
•
|
incurrence of debt, other liabilities and contingent liabilities, including potentially unknown contingent liabilities; and
|
•
|
dilutive stock issuances.
|
•
|
obtain patents to protect our technologies and discoveries;
|
•
|
protect trade secrets from disclosure to competitors;
|
•
|
operate without infringing upon the proprietary rights of others; and
|
•
|
prevent others from infringing on our proprietary rights.
|
•
|
initiation of litigation or other proceedings against third parties to enforce our patent rights, to seek to invalidate the patents held by third parties or to obtain a judgment that our drug candidates do not infringe such third parties’ patents;
|
•
|
participation in interference and/or derivation proceedings to determine the priority of invention if our competitors file U.S. patent applications that claim technology also claimed by us;
|
•
|
initiation of opposition, reexamination, post grant review or
inter partes
review proceedings by third parties that seek to limit or eliminate the scope of our patent protection;
|
•
|
initiation of litigation by third parties claiming that our processes or drug candidates or the intended use of our drug candidates infringes their patent or other intellectual property rights; and
|
•
|
initiation of litigation by us or third parties seeking to enforce contract rights relating to intellectual property that may be important to our business.
|
•
|
restrictions on such drugs, manufacturers or manufacturing processes;
|
•
|
restrictions on the labeling or marketing of a drug;
|
•
|
restrictions on drug distribution or use;
|
•
|
requirements to conduct post-marketing studies or clinical trials;
|
•
|
warning letters or untitled letters;
|
•
|
withdrawal of the drugs from the market;
|
•
|
refusal to approve pending applications or supplements to approved applications that we submit;
|
•
|
recall of drugs;
|
•
|
restrictions on coverage by third-party payors;
|
•
|
fines, restitution or disgorgement of profits or revenues;
|
•
|
suspension or withdrawal of marketing approvals;
|
•
|
refusal to permit the import or export of drugs;
|
•
|
drug seizure; or
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents;
|
•
|
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
|
•
|
expansion of healthcare fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance;
|
•
|
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
•
|
extension of manufacturers’ Medicaid rebate liability;
|
•
|
expansion of eligibility criteria for Medicaid programs;
|
•
|
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
•
|
new requirements to report certain financial arrangements with physicians and teaching hospitals;
|
•
|
a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
|
•
|
the timing and result of clinical trials of our drug candidates;
|
•
|
the success of, and announcements regarding, existing and new technologies and/or drug candidates by us or our competitors;
|
•
|
regulatory actions with respect to our product candidates or our competitors’ products and product candidates;
|
•
|
market conditions in the biotechnology and pharmaceutical sectors;
|
•
|
rumors relating to us or our collaborators or competitors;
|
•
|
commencement or termination of collaborations for our development programs;
|
•
|
litigation or public concern about the safety of our drug candidates;
|
•
|
actual or anticipated variations in our quarterly operating results and any subsequent restatement of such results;
|
•
|
the amount and timing of any royalty revenue we receive from Genentech related to Erivedge;
|
•
|
actual or anticipated changes to our research and development plans;
|
•
|
deviations in our operating results from the estimates of securities analysts;
|
•
|
entering into new collaboration agreements or termination of existing collaboration agreements;
|
•
|
adverse results or delays in clinical trials being conducted by us or any collaborators;
|
•
|
any intellectual property disputes or other lawsuits involving us;
|
•
|
third-party sales of large blocks of our common stock;
|
•
|
sales of our common stock by our executive officers, directors or significant stockholders;
|
•
|
equity sales by us of our common stock to fund our operations;
|
•
|
the loss of any of our key scientific or management personnel;
|
•
|
FDA or international regulatory actions;
|
•
|
limited trading volume in our common stock;
|
•
|
general economic and market conditions, including recent adverse changes in the domestic and international financial markets; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
our or our collaborators’ preclinical studies and clinical trials may not advance or be completed in the time frames we or they announce or expect;
|
•
|
we or our collaborators may not make regulatory submissions, receive regulatory approvals or commercialize approved drugs as predicted; and
|
•
|
we or our collaborators may not be able to adhere to our or their current schedule for the achievement of key milestones under any programs.
|
•
|
delaying, deferring or preventing a change in control of our company;
|
•
|
impeding a merger, consolidation, takeover or other business combination involving our company; or
|
•
|
entrenching our management or the board of directors.
|
Item 5.
|
Other Information
|
Item 6.
|
Exhibits
|
Exhibit
Number
|
Description
|
|
|
3.1
|
|
10.1
|
|
10.2
|
|
10.3
|
|
31.1
|
|
31.2
|
|
32.1
|
|
32.2
|
|
|
|
101.INS
|
XBRL Instance Document
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
CURIS, INC.
|
|
|
|
|
|
Dated:
|
August 2, 2018
|
By:
|
/S/ JAMES E. DENTZER
|
|
|
|
James E. Dentzer
|
|
|
|
Chief Operating Officer and Chief Financial Officer
|
|
|
|
(Principal Financial and Accounting Officer)
|
1.
|
Advisory Services
.
In consideration for your continued cooperation and agreement to perform the advisory services set forth on Schedule A hereto (the “
Advisory Services
”), the Company will provide the following:
|
a.
|
Monthly Retainer
. During the Advisory Period (as defined below), the Company will pay you a monthly retainer of $35,000 for your continued cooperation and Advisory Services. All Advisory Services to be performed by you for the Company will be under the general supervision of the Chief Executive Officer of the Company, or such other officer of the Company as he may designate. Payment of any monthly retainer will be made in arrears within fifteen (15) days of the end of each month and payment for any partial month will be prorated. The Company may also reimburse you for reasonable documented out-of-pocket expenses incurred in the performance of the advisory services hereunder, upon prior written approval. You will submit itemized monthly statements, in a form satisfactory to the Company, of such expenses incurred in the previous month. Invoices will be submitted to the following address via email:
accountspayable@curis.com
.
|
b.
|
Amendment to Stock Options
. Reference is hereby made to the stock option agreements by and between you and the Company, each of which is listed on Schedule B hereto (the “Stock Option Agreements”), which collectively evidence your outstanding stock option awards (“Options”). Notwithstanding anything set forth in such Stock Option Agreements to the contrary, by signing below, you hereby agree that the Options shall cease to vest as of the Retirement Date such that on and after the Retirement Date you will only have the right to exercise the portion of your Options that had vested on or before the Retirement Date (the “Vested Portion”). In accordance with the terms of the Stock Option Agreements, you will still have until the date that is three months after the date you cease to be an Eligible Participant (as defined therein) (i.e., the date of termination or expiration of the Advisory Period), to exercise the Vested Portion, subject to the proviso set forth in each Stock Option Agreement that if, prior to the Final Exercise Date, you violate the NDA (as defined below) or other agreement with the Company, then your right to exercise the Vested Portion shall immediately terminate upon written notice to you from the Company describing such violation.
|
2.
|
Term; Termination
. This Agreement shall commence on August 4, 2018 and continue until May 3, 2019 (such period, as it may be earlier terminated in accordance with the terms of this Agreement, the “Advisory Period”). You and the Company agree that this Agreement may be terminated in the following manner: (i) at any time upon the mutual written consent of the parties hereto, (ii) by the Company at any time if either
|
3.
|
Cooperation
.
You agree to use your best efforts in the performance of your obligations under this Agreement. The Company will provide such access to its information and property as may be reasonably required in order to permit you to perform your obligations hereunder. You agree to cooperate with the Company’s personnel, to not interfere with the conduct of the Company’s business and to observe all rules, regulations and security requirements of the Company concerning the safety of persons and property.
|
4.
|
Status
.
Your relation to Company shall be that of an independent contractor and neither this Agreement nor the Advisory Services to be rendered hereunder shall for any purpose whatsoever or in any way or manner create any employer-employee relationship between the parties. You will not be entitled to any benefits, coverage or privileges, including, without limitation, social security, unemployment, medical or pension payments, made available to employees of the Company. You shall not be deemed an agent for any purpose, is not authorized to assume or create any obligation or responsibility, express or implied, on behalf of, or in the name of, the Company and shall have no authority to bind the Company.
|
5.
|
Continuing Obligations
.
- You acknowledge and reaffirm your confidentiality and non-disclosure obligations as well as your non-competition, non-solicitation and other obligations set forth in the Invention, Non-Disclosure and Non-Competition Agreement, dated April 23, 2015 (the “NDA”), which survive your end of employment with the Company. In addition, you agree that any Advisory Services provided hereunder will be subject to the terms of the NDA.
|
6.
|
U.S. Securities Laws
.
You hereby acknowledges that the United States securities laws prohibit any person who has material, non-public information from purchasing or selling the securities of the Company or the securities of any company doing business with the Company or from communicating such information to any other person under circumstances in which it is reasonably foreseeable that such person is likely to purchase or sell such securities.
|
7.
|
Patient Information
.
In furtherance of the terms of the NDA, you agree to maintain the confidentiality of any and all patient information including, without limitation, patient data, personal and medical information that you may receive in the course of performing the Advisory Services hereunder. You shall comply with all applicable federal and state laws and regulations governing patient privacy and confidentiality of health information, including without limitation the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) medical information, or the field of practice or service that you are providing hereunder.
|
8.
|
Debarment
.
You agree to conduct the Advisory Services in compliance with all applicable laws, rules and regulations, including but not limited to the Federal Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto, and with the standard of care customary in the industry. You hereby certify that you have not been debarred or disqualified by the FDA pursuant to 21 U.S.C. Sec. 355 (a) or (b) and 21 C.F.R. 312.70, respectively.
|
9.
|
Entire Agreement; Amendment and Waiver
.
This Agreement constitutes the entire agreement between the parties and supersedes all prior agreements and understandings, whether written or oral, relating to the subject matter of this Agreement. This Agreement shall be binding upon the parties and may not be modified in any manner, except by an instrument in writing of concurrent or subsequent date signed by duly authorized representatives of the parties hereto. This Agreement is binding upon and shall inure to the
|
10.
|
Notices
. All notices required or permitted under this Agreement shall be in writing and shall be deemed effective upon personal delivery or upon deposit in the United States Post Office, by registered or certified mail, postage prepaid, addressed to the other party at the address shown above, or at such other address or addresses as either party shall designate to the other in accordance with this Section 10.
|
11.
|
Governing Law
. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts without giving effect to any choice or conflict of law provision or rule that would cause the application of laws of any other jurisdiction.
|
12.
|
Survival
. Sections 2, 4-7, and 9-12 shall survive the expiration or termination of this Agreement.
|
/s/ David Tuck, M. D.
___________________
David Tuck, M.D.
|
August 1, 2018
_________________
Date
|
–
|
clinical program data analysis and output;
|
–
|
clinical development PI engagement;
|
–
|
research and translational external engagement and analysis; and
|
–
|
biomarker analysis and bioinformatics infrastructure.
|
Date of Stock
Option Agreement
|
Stock Option Agreement Number
|
Curis
Stock Plan
|
Number of Securities
Underlying Options
(post reverse stock split)
|
Exercise Price Per Share
(post reverse stock split)
|
Vested Portion
As Of
Retirement
Date
|
05/27/2015
|
CU001755
|
Amended and Restated 2010 Stock Incentive Plan
|
22,500
|
$16.00
|
15,625
|
05/27/2015
|
CU001756
|
Amended and Restated 2010 Stock Incentive Plan
|
7,500
|
$16.00
|
6,874
|
11/30/2015
|
CU001770
|
Amended and Restated 2010 Stock Incentive Plan
|
2,919
|
$13.70
|
0
|
11/30/2015
|
CU001771
|
Amended and Restated 2010 Stock Incentive Plan
|
27,080
|
$13.70
|
18,750
|
03/29/2016
|
CU001824
|
Amended and Restated 2010 Stock Incentive Plan
|
3,750
|
$7.55
|
0
|
03/29/2016
|
CU001825
|
Amended and Restated 2010 Stock Incentive Plan
|
56,250
|
$7.55
|
33,751
|
02/14/2017
|
CU001919
|
Second Amended and Restated 2010 Stock Incentive Plan
|
12,126
|
$13.15
|
0
|
02/14/2017
|
CU001920
|
Second Amended and Restated 2010 Stock Incentive Plan
|
94,673
|
$13.15
|
40,050
|
05/15/2018
|
CU002123
|
Third Amended and Restated 2010 Stock Incentive Plan
|
11,030
|
$3.45
|
0
|
05/15/2018
|
CU002124
|
Third Amended and Restated 2010 Stock Incentive Plan
|
95,970
|
$3.45
|
0
|
To the Company:
|
Curis, Inc.
4 Maguire Road
Lexington, MA 02421
Facsimile: (617) 503-6501
Attention: Chief Executive Officer
|
To the Employee:
|
The Employee’s home address as reflected on the Company’s personnel records
|
|
CURIS, INC.
|
|
By:
/s/ Ali Fattaey, Ph. D.
Name: Ali Fattaey, Ph.D.
Title: President and Chief Executive Officer
|
|
EMPLOYEE
|
|
By:
/s/ Robert E. Martell, M.D., Ph.D.
Robert E. Martell, M.D., Ph.D.
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Curis, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
August 2, 2018
|
/
S
/ A
LI
F
ATTAEY
|
|
|
Ali Fattaey
|
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Curis, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
August 2, 2018
|
/
S
/ JAMES E. DENTZER
|
|
|
James Dentzer
|
|
|
Chief Operating Officer and Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|
Date:
|
August 2, 2018
|
/
S
/ A
LI
F
ATTAEY
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Ali Fattaey
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President and Chief Executive Officer
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(Principal Executive Officer)
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Date:
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August 2, 2018
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S
/ JAMES E. DENTZER
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James Dentzer
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Chief Operating Officer and Chief Financial Officer
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(Principal Financial and Accounting Officer)
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