x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
56-2110007
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
4233 Technology Drive
Durham, North Carolina
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27704
|
(Address of principal executive offices)
|
(Zip Code)
|
Large accelerated filer
|
¨
|
Accelerated filer
|
¨
|
Non-accelerated filer
|
x
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
¨
|
PART I. FINANCIAL INFORMATION
|
||
PART II. OTHER INFORMATION
|
||
December 31,
2014
|
March 31, 2015
|
|||||||
Assets
|
||||||||
Current assets
|
||||||||
Cash and cash equivalents
|
$
|
37,223,590
|
$
|
29,030,085
|
||||
Short-term investments
|
19,016,347
|
10,144,325
|
||||||
Prepaid expenses
|
838,420
|
813,165
|
||||||
Deferred financing costs
|
309,927
|
240,620
|
||||||
Other receivables
|
129,019
|
163,715
|
||||||
Total current assets
|
57,517,303
|
40,391,910
|
||||||
Property and equipment, net
|
5,513,555
|
11,183,852
|
||||||
Restricted cash
|
1,325,000
|
1,325,000
|
||||||
Other assets
|
11,020
|
392,054
|
||||||
Total assets
|
$
|
64,366,878
|
$
|
53,292,816
|
||||
Liabilities and Stockholders’ Equity
|
||||||||
Current liabilities
|
||||||||
Accounts payable
|
$
|
1,860,491
|
$
|
3,638,394
|
||||
Other accrued expenses
|
1,405,378
|
1,934,682
|
||||||
Current portion of notes payable
|
30,885
|
23,122
|
||||||
Total current liabilities
|
3,296,754
|
5,596,198
|
||||||
Long-term portion of notes payable
|
19,796,545
|
19,985,819
|
||||||
Long-term portion of manufacturing research and development obligation
|
3,475,552
|
3,853,272
|
||||||
Long-term portion of facility lease obligation
|
3,380,223
|
5,888,711
|
||||||
Deferred liability
|
3,066,000
|
3,066,000
|
||||||
Commitments
|
||||||||
Stockholders’ equity
|
||||||||
Preferred stock $0.001 par value; 5,000,000 shares authorized as of December 31, 2014 and March 31, 2015; 0 shares issued and outstanding as of December 31, 2014 and March 31, 2015
|
—
|
—
|
||||||
Common stock $0.001 par value; 200,000,000 shares authorized as of December 31, 2014 and March 31, 2015; 19,657,412 and 19,688,802 shares issued and outstanding as of December 31, 2014 and March 31, 2015
|
19,657
|
19,689
|
||||||
Accumulated other comprehensive loss
|
(124,841
|
)
|
(132,707
|
)
|
||||
Additional paid-in capital
|
235,627,174
|
236,732,235
|
||||||
Accumulated deficit
|
(204,170,186
|
)
|
(221,716,401
|
)
|
||||
Total stockholders’ equity
|
31,351,804
|
14,902,816
|
||||||
Total liabilities and stockholders’ equity
|
$
|
64,366,878
|
$
|
53,292,816
|
Three Months Ended
March 31,
|
||||||||
2014
|
2015
|
|||||||
Revenue
|
$
|
798,788
|
$
|
178,771
|
||||
Operating expenses
|
||||||||
Research and development
|
8,472,195
|
14,766,982
|
||||||
General and administrative
|
1,933,476
|
2,371,201
|
||||||
Total operating expenses
|
10,405,671
|
17,138,183
|
||||||
Operating loss
|
(9,606,883
|
)
|
(16,959,412
|
)
|
||||
Other income (expense)
|
||||||||
Interest income
|
16,410
|
10,088
|
||||||
Interest expense
|
(174,832
|
)
|
(594,915
|
)
|
||||
Other expense
|
(235,675
|
)
|
(1,976
|
)
|
||||
Other income (expense), net
|
(394,097
|
)
|
(586,803
|
)
|
||||
Net loss
|
(10,000,980
|
)
|
(17,546,215
|
)
|
||||
Accretion of redeemable convertible preferred stock
|
(863,226
|
)
|
—
|
|||||
Net loss attributable to common stockholders
|
$
|
(10,864,206
|
)
|
$
|
(17,546,215
|
)
|
||
Net loss attributable to common stockholders per share, basic and diluted
|
$
|
(1.05
|
)
|
$
|
(0.89
|
)
|
||
Weighted average shares outstanding, basic and diluted
|
10,376,561
|
19,674,245
|
Three Months Ended March 31,
|
||||||||
2014
|
2015
|
|||||||
Net loss
|
$
|
(10,000,980
|
)
|
$
|
(17,546,215
|
)
|
||
Other comprehensive loss
|
||||||||
Foreign currency translation loss
|
(1,503
|
)
|
(933
|
)
|
||||
Unrealized loss on short-term investments
|
(4,550
|
)
|
(6,933
|
)
|
||||
Total comprehensive loss
|
$
|
(10,007,033
|
)
|
$
|
(17,554,081
|
)
|
Three Months Ended
March 31,
|
||||||||
2014
|
2015
|
|||||||
Cash flows from operating activities
|
||||||||
Net loss
|
$
|
(10,000,980
|
)
|
$
|
(17,546,215
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities
|
||||||||
Depreciation and amortization
|
130,151
|
166,432
|
||||||
Compensation expense related to stock options
|
583,036
|
914,515
|
||||||
Interest accrued on long-term debt
|
175,657
|
169,464
|
||||||
Amortization of debt issuance costs | — | 69,307 | ||||||
Amortization of debt discount
|
—
|
24,917
|
||||||
Gain on disposal of equipment
|
(710
|
)
|
—
|
|||||
Changes in operating assets and liabilities:
|
||||||||
Prepaid expenses and other receivables
|
(327,337
|
)
|
(9,441
|
)
|
||||
Deferred financing costs
|
(87,550
|
)
|
—
|
|||||
Other assets
|
—
|
(381,034
|
)
|
|||||
Accounts payable
|
1,654,479
|
1,426,815
|
||||||
Accrued expenses
|
(486,272
|
)
|
221,463
|
|||||
Long-term portion of manufacturing research and development obligation
|
—
|
377,720
|
||||||
Net cash used in operating activities
|
(8,359,526
|
)
|
(14,566,057
|
)
|
||||
Cash flows from investing activities
|
||||||||
Purchase of property and equipment
|
(238,190
|
)
|
(2,669,462
|
)
|
||||
Proceeds from sale of fixed assets
|
1,000
|
—
|
||||||
Purchases of short-term investments
|
(17,955,997
|
)
|
(2,772,983
|
)
|
||||
Proceeds from maturity of short-term investments
|
—
|
11,650,000
|
||||||
Net cash (used in) provided by investing activities
|
(18,193,187
|
)
|
6,207,555
|
|||||
Cash flows from financing activities
|
||||||||
Proceeds from sale of common stock
|
49,829,800
|
—
|
||||||
Stock issuance costs
|
(4,787,854
|
)
|
—
|
|||||
Proceeds from exercise of common stock options
|
—
|
90,492
|
||||||
Proceeds from employee stock purchase plan
|
—
|
100,084
|
||||||
Payments on notes payable
|
(12,870
|
)
|
(12,870
|
)
|
||||
Net cash provided by financing activities
|
45,029,076
|
177,706
|
||||||
Effect of exchange rates changes on cash
|
(1,437
|
)
|
(12,709
|
)
|
||||
Net increase (decrease) in cash and cash equivalents
|
18,474,926
|
(8,193,505
|
)
|
|||||
Cash and cash equivalents
|
||||||||
Beginning of period
|
33,297,970
|
37,223,590
|
||||||
End of period
|
$
|
51,772,896
|
$
|
29,030,085
|
||||
Supplemental disclosure of cash flow information
|
||||||||
Cash paid for interest
|
$
|
1,641
|
$
|
290,345
|
||||
Supplemental disclosure of noncash investing and financing activities
|
||||||||
Conversion of preferred stock into common stock
|
$
|
114,527,695
|
$
|
—
|
||||
Preferred stock accretion
|
$
|
863,226
|
$
|
—
|
||||
Purchases of property and equipment included in accounts payable and accrued expenses
|
$
|
—
|
$
|
658,929
|
||||
Interest accrued on long-term debt
|
$
|
175,657
|
$
|
169,464
|
||||
Recognition of asset and facility lease obligation related to construction of new property
|
$
|
—
|
$
|
2,508,488
|
Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
|
Significant
Other
Observable
Inputs
(Level 2)
|
Significant
Unobservable
Inputs
(Level 3)
|
Balance as of
December 31,
2014
|
|||||||||||||
Assets
|
||||||||||||||||
Money-market funds
|
$
|
35,541,595
|
$
|
—
|
$
|
—
|
$
|
35,541,595
|
||||||||
Corporate debt securities – short-term
|
—
|
20,266,243
|
—
|
20,266,243
|
||||||||||||
Restricted cash – long-term
|
1,325,000
|
—
|
—
|
1,325,000
|
||||||||||||
Total assets at fair value
|
$
|
36,866,595
|
$
|
20,266,243
|
$
|
—
|
$
|
57,132,838
|
Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
|
Significant
Other
Observable
Inputs
(Level 2)
|
Significant
Unobservable
Inputs
(Level 3)
|
Balance as of
March 31,
2015
|
|||||||||||||
Assets
|
||||||||||||||||
Money-market funds
|
$
|
28,778,108
|
$
|
—
|
$
|
—
|
$
|
28,778,108
|
||||||||
Corporate debt securities – short-term
|
—
|
10,144,325
|
—
|
10,144,325
|
||||||||||||
Restricted cash – long-term
|
1,325,000
|
—
|
—
|
1,325,000
|
||||||||||||
Total assets at fair value
|
$
|
30,103,108
|
$
|
10,144,325
|
$
|
—
|
$
|
40,247,433
|
December 31, 2014
|
March 31, 2015
|
|||||||
Office furniture and equipment
|
$
|
458,380
|
$
|
501,468
|
||||
Computer equipment
|
788,563
|
810,864
|
||||||
Computer software
|
629,948
|
629,948
|
||||||
Laboratory equipment
|
5,345,786
|
5,771,750
|
||||||
Leasehold improvements
|
2,646,891
|
2,664,669
|
||||||
Asset related to facility lease obligation
|
3,380,223
|
5,888,711
|
||||||
Construction-in-progress
|
500,093
|
3,316,654
|
||||||
13,749,884
|
19,584,064
|
|||||||
Less: Accumulated depreciation and amortization
|
(8,236,329
|
)
|
(8,400,212
|
)
|
||||
Property and equipment, net
|
$
|
5,513,555
|
$
|
11,183,852
|
Three months ended March 31, 2014
|
$
|
130,151
|
||
Three months ended March 31, 2015
|
$
|
166,432
|
December 31, 2014
|
March 31, 2015
|
|||||||
Notes payable under the venture loan and security agreement
|
$
|
12,500,000
|
$
|
12,500,000
|
||||
Less related debt discount
|
(373,756
|
)
|
(348,839
|
)
|
||||
Notes payable under the venture loan and security agreement, net of debt discount
|
12,126,244
|
12,151,161
|
||||||
Promissory note payable to Medinet including accrued interest
|
7,623,546
|
7,791,728
|
||||||
Other notes payable
|
77,640
|
66,052
|
||||||
Total notes payable
|
19,827,430
|
20,008,941
|
||||||
Less current portion
|
(30,885
|
)
|
(23,122
|
)
|
||||
Long-term portion of notes payable
|
$
|
19,796,545
|
$
|
19,985,819
|
Series A Preferred
|
Series B Preferred
|
Series C Preferred
|
Series D Preferred
|
Series E Preferred
|
Total Preferred Stock
|
|||||||||||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2013
|
1,040,216
|
$
|
332,869
|
9,803,688
|
$
|
5,521,437
|
28,716,679
|
$
|
2,655,884
|
21,040,817
|
$
|
33,262,492
|
56,011,258
|
$
|
71,891,787
|
116,612,658
|
$
|
113,664,469
|
||||||||||||||||||||||||||||||
Accretion
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
336,350
|
—
|
526,876
|
—
|
863,226
|
||||||||||||||||||||||||||||||||||||
Shares converted to common stock
|
(1,040,216
|
)
|
(332,869
|
)
|
(9,803,688
|
)
|
(5,521,437
|
)
|
(28,716,679
|
)
|
(2,655,884
|
)
|
(21,040,817
|
)
|
(33,598,842
|
)
|
(56,011,258
|
)
|
(72,418,423
|
)
|
(116,612,658
|
)
|
(114,527,455
|
)
|
||||||||||||||||||||||||
Stock issuance costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(240
|
)
|
—
|
(240
|
)
|
||||||||||||||||||||||||||||||||||
Balance as of December 31, 2014
|
—
|
$
|
—
|
—
|
$
|
—
|
—
|
$
|
—
|
—
|
$
|
—
|
—
|
$
|
—
|
—
|
$
|
—
|
Three Months Ended
March 31,
|
||||||||
2014
|
2015
|
|||||||
Research and development
|
$
|
308,191
|
$
|
508,324
|
||||
General and administrative
|
274,845
|
406,191
|
||||||
Total stock-based compensation expense
|
$
|
583,036
|
$
|
914,515
|
Number of
Shares
|
Weighted
Average Exercise
Price
|
Weighted
Average
Contractual
Term
(in years)
|
||||||||||
Outstanding as of December 31, 2014
|
2,847,097
|
$
|
5.89
|
|||||||||
Granted
|
111,650
|
$
|
8.60
|
|||||||||
Exercised
|
(18,336
|
)
|
$
|
4.94
|
||||||||
Cancelled
|
(16,629
|
)
|
$
|
8.27
|
||||||||
Outstanding as of March 31, 2015
|
2,923,782
|
$
|
5.98
|
8.45
|
||||||||
Exercisable as of March 31, 2015
|
978,564
|
$
|
5.12
|
7.41
|
||||||||
Vested and expected to vest as of March 31, 2015
|
2,774,000
|
$
|
5.96
|
8.42
|
Stock Option Plans
|
Employee Stock Purchase Plan
|
|||||||||||||||
Three Months Ended
March 31,
|
Three Months Ended
March 31,
|
|||||||||||||||
2014
|
2015
|
2014
|
2015
|
|||||||||||||
Risk-free interest rate
|
2.35
|
%
|
1.76
|
%
|
—
|
0.05
|
%
|
|||||||||
Dividend yield
|
0
|
%
|
0
|
%
|
—
|
0
|
%
|
|||||||||
Expected term (in years)
|
7.0
|
7.0
|
—
|
0.5
|
||||||||||||
Volatility
|
96
|
%
|
94
|
%
|
—
|
85
|
%
|
Type of Warrant
|
Number of Warrants
|
Exercise Price
|
Expiration
Date(s)
|
|||
Common stock
|
1
|
$
|
23,894.34
|
7/13/16
|
||
Common stock
|
82,780
|
$
|
9.06
|
9/29/21
|
Three Months Ended March 31,
|
||||||||
2014
|
2015
|
|||||||
As Reported
|
||||||||
Net loss attributable Argos Therapeutics, Inc.
|
$
|
(10,000,980
|
)
|
$
|
(17,546,215
|
)
|
||
Accretion of redeemable convertible preferred stock
|
(863,226
|
)
|
—
|
|||||
Net loss attributable to common stockholders
|
$
|
(10,864,206
|
)
|
$
|
(17,546,215
|
)
|
||
Weighted average common shares outstanding, basic and diluted
|
10,376,561
|
19,674,245
|
||||||
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(1.05
|
)
|
$
|
(0.89
|
)
|
Three Months Ended March 31,
|
|||||||||
2014
|
2015 | ||||||||
Redeemable convertible preferred stock
|
6,301,053 | — | |||||||
Stock options outstanding
|
1,937,691 | 2,923,782 | |||||||
Warrants outstanding
|
4,587 | 81,781 |
•
|
$215.5 million from the sale of our common stock, convertible debt, warrants and preferred stock;
|
•
|
$32.9 million from the licensing of our technology;
|
•
|
$104.3 million from government contracts, grants and license and collaboration agreements; and
|
•
|
$12.5 million from our venture loan and security agreement, or the Loan Agreement, with Horizon Technology Finance Corporation and Fortress Credit Co LLC, or the Lenders.
|
•
|
continue our ongoing phase 3 clinical trial of AGS-003 for the treatment of mRCC and initiate additional clinical trials of AGS-003 for the treatment of other cancers;
|
•
|
initiate and conduct additional clinical trials of AGS-004 for the treatment of HIV;
|
•
|
seek regulatory approvals for our product candidates that successfully complete clinical trials;
|
•
|
continue to build out and equip a new commercial facility for the manufacture of our Arcelis-based products;
|
•
|
establish a sales, marketing and distribution infrastructure to commercialize products for which we may obtain regulatory approval;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
continue our other research and development efforts;
|
•
|
hire additional clinical, quality control, scientific and management personnel; and
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our product development and planned commercialization efforts.
|
Product Candidate
|
Primary Indication
|
Status
|
|||||
AGS-003
|
mRCC (clear cell)
|
•
|
Ongoing pivotal phase 3 clinical trial; completion of enrollment expected by the end of second quarter 2015; overall survival data expected in the second half of 2016
|
||||
mRCC (non-clear cell)
|
•
|
Phase 2 investigator-initiated clinical trial expected to begin in the second half of 2015
|
|||||
Early stage RCC (neoadjuvant)
|
•
|
Ongoing investigator-initiated phase 2 clinical trial; initial data expected in 2016
|
|||||
Early stage RCC (adjuvant)
|
•
|
Investigator-initiated phase 2 clinical trial expected to begin mid-2015; initial data expected in 2016
|
|||||
Advanced solid tumors
|
•
|
Two investigator-initiated phase 2 clinical trials expected to begin in the second half of 2015
|
|||||
AGS-004
|
HIV
|
•
|
Phase 2b clinical trial complete; data announced in January 2015
|
||||
•
|
Ongoing first stage of investigator-initiated phase 2 clinical trial for HIV eradication; Second stage expected to begin in the second half of 2015
|
||||||
•
|
Investigator-initiated phase 2 clinical trial for long-term viral control in pediatric patients planned for the second half of 2015
|
Three Months Ended
March 31,
|
$
|
%
|
||||||||||||||
2014
|
2015
|
Change
|
Change
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Revenue
|
$
|
799
|
$
|
179
|
$
|
(620
|
)
|
(77.6
|
%)
|
|||||||
Operating expenses
|
||||||||||||||||
Research and development
|
8,472
|
14,767
|
6,295
|
74.3
|
%
|
|||||||||||
General and administrative
|
1,934
|
2,371
|
437
|
22.6
|
%
|
|||||||||||
Total operating expenses
|
10,406
|
17,138
|
6,732
|
64.7
|
%
|
|||||||||||
Loss from operations
|
(9,607
|
)
|
(16,959
|
)
|
(7,352
|
)
|
76.5
|
%
|
||||||||
Interest income
|
16
|
10
|
(6
|
)
|
*
|
|||||||||||
Interest expense
|
(175
|
)
|
(595
|
)
|
(420
|
)
|
*
|
|||||||||
Other expense
|
(235
|
)
|
(2
|
)
|
233
|
*
|
||||||||||
Net loss
|
$
|
(10,001
|
)
|
$
|
(17,546
|
)
|
$
|
(7,545
|
)
|
75.4
|
%
|
*
|
Not meaningful
|
•
|
salaries and related expenses for personnel in research and development functions;
|
•
|
fees paid to consultants and clinical research organizations, or CROs, including in connection with our clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work and statistical compilation and analysis;
|
•
|
commercial manufacturing development consisting of costs incurred under our development agreement with Invetech under which Invetech has agreed to develop and provide prototypes of the automated production system to be used for the manufacture of our Arcelis-based products;
|
•
|
costs incurred under our development agreement with Saint-Gobain Performance Plastics Corporation, or Saint-Gobain, to develop a range of disposables for use in the automated production system;
|
•
|
allocation of facility lease and maintenance costs;
|
•
|
depreciation of leasehold improvements, laboratory equipment and computers;
|
•
|
costs related to production of product candidates for clinical trials;
|
•
|
costs related to compliance with regulatory requirements;
|
•
|
consulting fees paid to third parties related to non-clinical research and development;
|
•
|
costs related to stock options or other stock-based compensation granted to personnel in research and development functions; and
|
•
|
acquisition fees, license fees and milestone payments related to acquired and in-licensed technologies.
|
Three Months Ended March 31,
|
||||||||
2014
|
2015
|
|||||||
(in thousands)
|
||||||||
Direct research and development expense by program:
|
||||||||
AGS-003
|
$
|
3,160
|
$
|
5,441
|
||||
AGS-004
|
454
|
72
|
||||||
Other
|
49
|
3
|
||||||
Total direct research and development program expense
|
3,663
|
5,516
|
||||||
Commercial manufacturing development
|
1,363
|
4,565
|
||||||
Indirect research and development expense
|
3,446
|
4,686
|
||||||
Total research and development expense
|
$
|
8,472
|
$
|
14,767
|
•
|
Direct research and development expense for AGS-003 increased from $3.2 million for the three months ended March 31, 2014 to $5.4 million in the three months ended March 31, 2015. This increase primarily reflects increased patient enrollment in the ongoing phase 3 ADAPT clinical trial in the three months ended March 31, 2015 as compared with the three months ended March 31, 2014; and
|
•
|
Direct research and development expense with respect to AGS-004 decreased from $0.5 million in the three months ended March 31, 2014 to $0.1 million in the three months ended March 31, 2015 primarily due to the decreased activity in our phase 2b clinical trial of AGS-004.
|
•
|
the scope, rate of progress, expense and results of our ongoing clinical trials;
|
•
|
the scope, rate of progress, expense and results of additional clinical trials that we may conduct;
|
•
|
the scope, rate of progress, expense and results of our commercial manufacturing development efforts;
|
•
|
other research and development activities; and
|
•
|
the timing of regulatory approvals.
|
Issue
|
Year
|
Gross
Proceeds
|
||||
(in thousands)
|
||||||
Series A Preferred
|
2000
|
$
|
1,594
|
|||
Series B Preferred
|
2001
|
$
|
39,382
|
|||
Series B-1 Preferred
|
2004
|
$
|
5,000
|
|||
Series C Preferred
|
2008
|
$
|
33,462
|
|||
Series D Preferred
|
2012
|
$
|
9,022
|
|||
Series D-1 Preferred
|
2012
|
$
|
15,978
|
|||
Series E Preferred
|
2013
|
$
|
48,000
|
Three Months Ended
March 31,
|
||||||||
2014
|
2015
|
|||||||
(in thousands)
|
||||||||
Net cash provided by (used in):
|
||||||||
Operating activities
|
$
|
(8,360
|
)
|
$
|
(14,566
|
)
|
||
Investing activities
|
(18,193
|
)
|
6,208
|
|||||
Financing activities
|
45,029
|
177
|
||||||
Effect of exchange rate changes on cash
|
(1
|
)
|
(13
|
)
|
||||
Net increase (decrease) in cash and cash equivalents
|
$
|
18,475
|
$
|
(8,194
|
)
|
•
|
the progress and results of our ongoing pivotal phase 3 clinical trial of AGS-003 and other clinical trials of AGS-003 that we may conduct;
|
•
|
the progress and results of our ongoing phase 2 clinical trial for HIV eradication and other clinical trials of AGS-004 that we may conduct and our ability to obtain additional funding under our NIH contract for our AGS-004 program;
|
•
|
the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other product candidates;
|
•
|
the costs and timing of our planned build-out and equipping of a new commercial manufacturing facility;
|
•
|
the ability to access the second tranche of our Loan Agreement;
|
•
|
the potential need to repay the $9.0 million loan under our license agreement with Medinet;
|
•
|
the costs, timing and outcome of regulatory review of our product candidates;
|
•
|
the costs of commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive regulatory approval;
|
•
|
revenue, if any, received from sales of our product candidates, should any of our product candidates be approved by the FDA or a similar regulatory authority outside the United States;
|
•
|
the costs of preparing, filing and prosecuting patent applications, maintaining, enforcing our intellectual property rights and defending intellectual property-related claims;
|
•
|
the extent to which we acquire or invest in businesses, products and technologies;
|
•
|
our ability to obtain government or other third party funding for the development of our product candidates; and
|
•
|
our ability to establish collaborations on favorable terms, if at all, particularly arrangements to develop, market and distribute AGS-003 outside North America and arrangements for the development and commercialization of our non-oncology product candidates, including AGS-004.
|
•
|
successful completion of clinical trials, including clinical results that are statistically significant as well as clinically meaningful in the context of the indications for which we are developing our product candidates;
|
|
•
|
receipt of marketing approvals from the FDA and similar regulatory authorities outside the United States;
|
|
•
|
establishing commercial manufacturing capabilities by building out and equipping a commercial manufacturing facility for our Arcelis-based product candidates;
|
|
•
|
maintaining patent and trade secret protection and regulatory exclusivity for our product candidates, both in the United States and internationally;
|
|
•
|
launching commercial sales of the products, if and when approved, whether alone or in collaboration with others;
|
|
•
|
commercial acceptance of our products, if and when approved, by patients, the medical community and third party payors;
|
|
•
|
obtaining and maintaining healthcare coverage and adequate reimbursement;
|
|
•
|
effectively competing with other therapies; and
|
|
•
|
a continued acceptable safety profile of the products following any marketing approval.
|
•
|
be delayed in obtaining marketing approval for our product 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 restrictions or safety warnings, including boxed warnings;
|
|
•
|
be subject to additional post-marketing testing requirements;
|
|
•
|
be subject to restrictions on how the product is distributed or used; or
|
|
•
|
have the product removed from the market after obtaining marketing approval.
|
•
|
regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
|
•
|
we 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 product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
|
•
|
the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; for example, in our phase 2b clinical trial of AGS-004, we experienced a higher dropout rate than we anticipated due to the higher than expected number of patients who did not complete the full 12 week antiretroviral treatment interruption required by the protocol for the trial;
|
|
•
|
our third party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
|
|
•
|
we may decide, or regulators or institutional review boards may require us or our investigators to, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
|
|
•
|
the cost of clinical trials of our product candidates may be greater than we anticipate; and
|
|
•
|
the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate.
|
•
|
severity of the disease under investigation;
|
|
•
|
eligibility criteria for the trial in question;
|
|
•
|
perceived risks and benefits of the product candidate under study;
|
|
•
|
efforts to facilitate timely enrollment in clinical trials;
|
|
•
|
patient referral practices of physicians;
|
|
•
|
the ability to monitor patients adequately during and after treatment; and
|
|
•
|
proximity and availability of clinical trial sites for prospective patients.
|
•
|
continue our ongoing phase 3 clinical trial of AGS-003 for the treatment of mRCC and initiate additional clinical trials of AGS-003 for the treatment of cancers;
|
|
•
|
initiate and conduct additional clinical trials of AGS-004 for the treatment of HIV;
|
|
•
|
seek regulatory approvals for our product candidates that successfully complete clinical trials;
|
•
|
continue to build out and equip our new commercial facility for the manufacture of our Arcelis-based products;
|
|
•
|
establish a sales, marketing and distribution infrastructure to commercialize products for which we may obtain regulatory approval;
|
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
|
•
|
continue our other research and development efforts;
|
|
•
|
hire additional clinical, quality control, scientific and management personnel; and
|
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our product development and planned commercialization efforts.
|
•
|
the progress and results of our ongoing pivotal phase 3 clinical trial of AGS-003 and other clinical trials of AGS-003 that we may conduct;
|
•
|
the progress and results of our ongoing phase 2 clinical trial of AGS-004 for HIV eradication and other clinical trials of AGS-004 that we may conduct and our ability to obtain additional funding under our NIH contract for our AGS-004 program;
|
|
•
|
the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other product candidates;
|
|
•
|
the costs and timing of our build-out and equipping of our new commercial manufacturing facility;
|
|
•
|
the costs, timing and outcome of regulatory review of our product candidates;
|
|
•
|
the costs of commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive regulatory approval;
|
|
•
|
the potential need to repay the $9.0 million loan under our license agreement with Medinet;
|
|
•
|
revenue, if any, received from commercial sales of our product candidates, should any of our product candidates be approved by the FDA or a similar regulatory authority outside the United States;
|
|
•
|
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
|
|
•
|
the extent to which we acquire or invest in other businesses, products and technologies;
|
|
•
|
our ability to obtain government or other third party funding for the development of our product candidates; and
|
|
•
|
our ability to establish collaborations on favorable terms, if at all, particularly arrangements to develop, market and distribute AGS-003 outside North America and arrangements for the development and commercialization of our non-oncology product candidates, including AGS-004.
|
•
|
efficacy and potential advantages compared to alternative treatments;
|
|
•
|
the ability to offer our product candidates for sale at competitive prices;
|
|
•
|
convenience and ease of administration compared to alternative treatments;
|
|
•
|
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
|
|
•
|
the strength of sales, marketing and distribution support;
|
|
•
|
the approval of other new products for the same indications;
|
|
•
|
availability and amount of reimbursement from government payors, managed care plans and other third party payors;
|
|
•
|
adverse publicity about the product or favorable publicity about competitive products;
|
|
•
|
clinical indications for which the product is approved; and
|
|
•
|
the prevalence and severity of any side effects.
|
•
|
regulatory authorities may withdraw their approval of the product or seize the product;
|
|
•
|
we may be required to recall the product or change the way the product is administered;
|
|
•
|
additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular product;
|
|
•
|
regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;
|
|
•
|
we may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients;
|
|
•
|
additional restrictions may be imposed on the distribution or use of the product via a risk evaluation and mitigation strategy, or REMS;
|
|
•
|
we could be sued and held liable for harm caused to patients;
|
•
|
the product may become less competitive; and
|
|
•
|
our reputation may suffer.
|
•
|
our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
|
|
•
|
the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe any future products;
|
|
•
|
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
|
•
|
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
•
|
decreased demand for any product candidates or products that we may develop;
|
|
•
|
injury to our reputation and significant negative media attention;
|
|
•
|
withdrawal of clinical trial participants;
|
|
•
|
significant costs to defend the related litigation;
|
|
•
|
substantial monetary awards to trial participants or patients;
|
|
•
|
loss of revenue; and
|
|
•
|
the inability to commercialize any products that we may develop.
|
•
|
terminate agreements, in whole or in part, for any reason or no reason;
|
|
•
|
reduce or modify the government’s obligations under such agreements without the consent of the other party;
|
|
•
|
claim rights, including intellectual property rights, in products and data developed under such agreements;
|
|
•
|
impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;
|
|
•
|
suspend or debar the contractor or grantee from doing future business with the government or a specific government agency;
|
|
•
|
pursue criminal or civil remedies under the False Claims Act, False Statements Act and similar remedy provisions specific to government agreements; and
|
|
•
|
limit the government’s financial liability to amounts appropriated by the U.S. Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.
|
•
|
specialized accounting systems unique to government contracts and grants;
|
|
•
|
mandatory financial audits and potential liability for price adjustments or recoupment of government funds after such funds have been spent;
|
|
•
|
public disclosures of certain contract and grant information, which may enable competitors to gain insights into our research program; and
|
|
•
|
mandatory socioeconomic compliance requirements, including labor standards, non-discrimination and affirmative action programs and environmental compliance requirements.
|
•
|
collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;
|
|
•
|
collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities;
|
|
•
|
collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or, require a new formulation of a product candidate for clinical testing;
|
|
•
|
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
|
|
•
|
a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products;
|
|
•
|
collaborators may have the right to conduct clinical trials of our product candidates without our consent and could conduct trials with flawed designs that result in data that adversely affect our clinical trials, our ability to obtain marketing approval for our product candidates or market acceptance of our product candidates. Pharmstandard, Green Cross, Medinet and Lummy HK each have this right under our license agreements with them;
|
|
•
|
collaborators may hold rights that could preclude us from commercializing our products in certain territories. For example, we have granted Medinet an exclusive license to manufacture in Japan AGS-003 for the treatment of mRCC and an option to acquire a non-exclusive license to sell in Japan AGS-003 for the treatment of mRCC. Even if Medinet does not exercise the option to acquire the license to sell, we will not have the right to manufacture AGS-003 in Japan for the purposes of development and commercialization of AGS-003 for the treatment of mRCC. If we and Medinet are unable to agree to the terms of a supply agreement under these circumstances, we will not be able to sell AGS-003 in Japan unless we repurchase these rights from Medinet;
|
|
•
|
collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation;
|
|
•
|
disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our products or product candidates or that result in costly litigation or arbitration that diverts management attention and resources; and
|
|
•
|
collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates. For example, our collaboration with Kyowa Hakko Kirin Co., Ltd. with respect to AGS-003 and AGS-004 was terminated by our collaborator.
|
•
|
demonstrate that the disposable components and sterilization and packaging methods used in the manufacturing process are suitable for use in manufacturing in accordance with current good manufacturing practice, or cGMP, and current Good Tissue Practices, or cGTP;
|
|
•
|
build and validate processing equipment that complies with cGMP and cGTP;
|
|
•
|
build out and equip a suitable manufacturing facility to accommodate the automated manufacturing process;
|
|
•
|
perform process testing with final equipment, disposable components and reagents to demonstrate that the methods are suitable for use in cGMP and cGTP manufacturing;
|
|
•
|
demonstrate consistency and repeatability of the automated manufacturing processes in the production of AGS-003 in our new facility to fully validate the manufacturing and control process using the actual automated cGMP processing equipment; and
|
|
•
|
demonstrate comparability between AGS-003 that we produce using existing processes in our current facility and AGS-003 produced using the automated processes in our new facility.
|
•
|
failure to obtain a sufficient supply of key raw materials of suitable quality;
|
|
•
|
difficulties in manufacturing our product candidates for multiple patients simultaneously;
|
•
|
difficulties in obtaining adequate patient-specific material, such as tumor samples, virus samples or leukapheresis product, from physicians;
|
|
•
|
difficulties in completing the development and validation of the specialized assays required to ensure the consistency of our product candidates;
|
|
•
|
failure to ensure adequate quality control and assurances in the manufacturing process as we increase production quantities;
|
|
•
|
difficulties in the timely shipping of patient-specific materials to us or in the shipping of our product candidates to the treating physicians due to errors by third party carriers, transportation restrictions or other reasons;
|
|
•
|
destruction of, or damage to, patient-specific materials or our product candidates during the shipping process due to improper handling by third party carriers, hospitals, physicians or us;
|
|
•
|
destruction of, or damage to, patient-specific materials or our product candidates during storage at our facilities; and
|
|
•
|
destruction of, or damage to, patient-specific materials or our product candidates stored at clinical and future commercial sites due to improper handling or holding by clinicians, hospitals or physicians.
|
•
|
restrictions on such products, manufacturers or manufacturing processes;
|
|
•
|
restrictions on the marketing of a product;
|
|
•
|
restrictions on product distribution;
|
|
•
|
requirements to conduct post-marketing clinical trials;
|
|
•
|
warning or untitled letters;
|
|
•
|
withdrawal of the products from the market;
|
|
•
|
refusal to approve pending applications or supplements to approved applications that we submit;
|
|
•
|
recall of products;
|
|
•
|
fines, restitution or disgorgement of profits or revenue;
|
|
•
|
suspension or withdrawal of regulatory approvals;
|
|
•
|
refusal to permit the import or export of our products;
|
|
•
|
product seizure; or
|
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
the federal healthcare anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid;
|
•
|
the federal False Claims Act imposes civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
|
•
|
the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;
|
|
•
|
the federal transparency requirements under the Health Care Reform Law will require manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests; and
|
|
•
|
analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures.
|
•
|
establish a classified board of directors such that not all members of the board are elected at one time;
|
•
|
allow the authorized number of our directors to be changed only by resolution of our board of directors;
|
•
|
limit the manner in which stockholders can remove directors from the board;
|
•
|
establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of directors;
|
•
|
require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent;
|
•
|
limit who may call stockholder meetings;
|
•
|
authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and
|
•
|
require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws.
|
•
|
results of clinical trials of our product candidates or those of our competitors;
|
•
|
the success of competitive products or technologies;
|
•
|
potential approvals of our product candidates for marketing by the FDA or equivalent foreign regulatory authorities or our failure to obtain such approvals;
|
•
|
regulatory or legal developments in the United States and other countries;
|
•
|
the results of our efforts to commercialize our product candidates;
|
•
|
developments or disputes concerning patents or other proprietary rights;
|
•
|
the recruitment or departure of key personnel;
|
•
|
the level of expenses related to any of our product candidates or clinical development programs;
|
•
|
the results of our efforts to discover, develop, acquire or in-license additional product candidates or products;
|
•
|
actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
|
•
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts’ reports or recommendations;
|
•
|
general economic, industry and market conditions; and
|
•
|
the other factors described in this “Risk Factors” section.
|
ARGOS THERAPEUTICS, INC.
|
||
By:
|
/s/ Jeffrey D. Abbey
|
|
Name: Jeffrey D. Abbey
|
||
Title: President and Chief Executive Officer
|
||
(Principal Executive Officer) | ||
By:
|
/s/ Lori R. Harrelson | |
Name: Lori R. Harrelson | ||
Title: Vice President of Finance | ||
(Principal Financial Officer) |
Exhibit
Number
|
Description of Exhibit
|
|
10.1
|
Purchase Agreement dated February 16, 2015, between Argos Therapeutics, Inc. and TKC LXXII, LLC (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on February 20, 2015)
|
|
10.2
*
†
|
License Agreement, dated April 7, 2015, by and between the Registrant and Lummy (Hong Kong) Co., Ltd
|
|
31.1*
|
Certification of principal executive officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
31.2*
|
Certification of principal financial officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
32.1*
|
Certifications pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of The Sarbanes-Oxley Act of 2002, by the Registrant’s principal executive officer and principal financial officer
|
|
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
|
*
|
Filed herewith.
|
†
|
Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Double asterisks denote omissions.
|
(i)
|
is known by the receiving Party at the time of its receipt, and not through a prior disclosure, directly or indirectly, by the disclosing Party, as documented by the receiving Party’s business records;
|
(ii)
|
is in the public domain by use and/or publication before its receipt from the disclosing Party, or thereafter enters the public domain through no fault of the receiving Party or its Related Parties;
|
(iii)
|
is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or
|
(iv)
|
is developed by the receiving Party independently of Confidential Information received from the disclosing Party, as documented by the receiving Party’s business records.
|
(a)
|
first, to reimburse each Party for all expenses of the suit incurred by such Party, including but not limited to attorneys’ fees and disbursements, travel costs, court costs and other litigation expenses;
|
(b)
|
second, (i) if such suit is related to the Argos Technology in the China Company Territory, then China Company shall be entitled to receive that portion of the remaining Recoveries reasonably attributable to Net Sales of a Licensed Product in the China Company Territory (as determined by a court of competent jurisdiction in a final, non-appealable decision); provided, that the Recoveries reasonably attributable to Net Sales of Licensed Product to which China Company is entitled after reimbursement of expenses shall be treated as Net Sales for purposes of this Agreement and Argos shall be entitled to receive royalties on such constructive Net Sales pursuant to the terms of Section 3.2 as if such Net Sales had occurred during the time period of the infringement, and (ii) if such suit is related to China Company Improvements in the Argos Territory, then Argos shall be entitled to receive that portion of the remaining Recoveries reasonably attributable to Net Sales of a Licensed Product in the Argos Territory (as determined by a court of competent jurisdiction in a final, non-appealable decision); and
|
(c)
|
the Party initiating the suit shall be entitled to [**] percent ([**]%), and the non-initiating Party shall be entitled to [**] percent ([**]%), of the balance of the Recoveries.
|
If to Argos, to:
|
Argos Therapeutics, Inc.
|
|
4233 Technology Drive
|
||
Durham, NC 27704
|
||
Attention: President
|
||
Facsimile: 919 287-6336
|
||
Email: jabbey@argostherapeutics.com
|
||
With a copy to:
|
Hutchison PLLC
|
|
3110 Edwards Mill Road, Suite 300
|
||
Raleigh, NC 27612
|
||
Attention: William N. Wofford
|
||
Facsimile No.: (866) 479-7550
|
||
Email: bwofford@hutchlaw.com
|
||
If to China Company, to:
|
Lummy (Hong Kong) Co., Ltd.
|
|
Register Number 2106393
|
||
Rm. 19C, Lockhart Ctr.
|
||
301-307 Lockhart Rd., Wan Chai, Hong Kong
|
||
Attention: Mrs. Mei Leng
|
||
Facsimile +86-23-67300327
|
||
Email: lengmei@cqlummy.com
|
||
With a copy to:
|
Dentons US LLP
|
|
1221 Avenue of the Americas
|
||
New York, NY 10020-1089
|
||
Attention: Kristina E. Beirne
|
||
Facsimile No.: (212) 768-6800
|
||
Email: kristina.beirne@dentons.com
|
LUMMY (HONG KONG) CO., LTD. | ARGOS THERAPEUTICS, INC. | |||||
BY: | /s/ Xuefeng Leng | BY: | /s/ Jeffrey D. Abbey | |||
NAME: | Xuefeng Leng | NAME: | Jeffrey D. Abbey | |||
TITLE: | Director | TITLE: | President & CEO |
•
|
a disease sample from the patient — tumor cells in the case of cancer or a blood sample containing virus in the case of infectious disease — which is generally collected at the time of diagnosis or initial treatment, and
|
•
|
dendritic cells derived from the patient’s monocytes, a particular type of white blood cell, which are obtained from the patient through a laboratory procedure called leukapheresis that occurs after diagnosis and at least four weeks prior to the initiation of our immunotherapy.
|
·
|
Transfer of all GMP documentation related to the manufacture, quality control assays and quality assurance of the Arcelis technology.
|
o
|
This would include MPs, STMs and SOPs for GMP processing
|
·
|
Training of China Company technical personnel at Argos Therapeutics in the RNA and cellular process
|
o
|
Multiple visits required to perform RNA and cellular training runs
|
·
|
Training of China Company technical personnel at Argos on the quality control assays
|
o
|
Multiple visits required to perform quality control assay training
|
·
|
Completion of all documentation, acquisition of reagents and provide information and expertise for upfitting of GMP labs by China Company
|
·
|
Perform initial feasibility runs at China Company with Argos personnel oversight
|
·
|
Perform three successful GMP engineering runs at China Company
|
CHINA COMPANY
|
ARGOS
|
||||||
Section
|
Deliverable
|
Timing
|
Deliverable
|
Timing
|
|||
2.1.4
|
Notify Argos in writing after conceiving or reducing to practice a China Company Improvement
|
Promptly
|
|||||
2.2.2
|
In order to engage one or more Third Parties through sublicenses, China Company must notify and consult with the JSC
|
No timing specified
|
Unless Argos responds in writing within [**] days of receipt of China Company’s notice, then Argos will be deemed to have consented to such notice
|
[**] days
|
|||
2.2.3
|
Provide Argos with copy of fully executed Sublicense Agreement
|
Promptly
|
|||||
2.2.3
|
In the event China Company becomes aware of a material breach of any Sublicense Agreement, China Company must notify Argos
|
Promptly
|
|||||
2.3
|
Provide China Company with true and complete copies of Argos In-Licenses that are relevant to the rights granted to China Company under the Agreement
|
No timing specified
|
2.4
|
Notify Argos in writing of and provide Argos with a copy of any Necessary Third Party IP entered into by China Company after the Effective Date
|
No timing specified
|
If, during the Term, Argos obtains a license to Necessary Third Party IP for the China Company Territory that is not already Controlled by China Company or Argos, then Argos shall notify China Company in writing and include in such notification a summary of such Necessary Third Party IP
|
No timing specified
|
|||
2.4
|
Respond to Argos’ written notice of Necessary Third Party IP
|
[**] days
|
Upon receipt of such notice from China Company, Argos shall grant to China Company a sublicense of such Necessary Third Party IP
|
Upon receipt of notice
|
|||
2.5
|
Provide Argos and Argos Regional Partners any available unblinded China Company Data with respect to a Licensed Product generated during any Clinical Studies
|
[**]
|
Argos to cause Argos Regional Partner to provide China Company with any available unblinded Argos Data with respect to a Licensed Product generated during any Clinical Studies, subject, however, to any conditions placed on China Company’s use of such Argos Data by the applicable Argos Regional Partner
|
[**]
|
|||
3.2.1
3.4
|
Pay Argos royalty of [**]% of Net Sales of Licensed Products
|
Within [**] days of end of Calendar Quarter
|
|||||
3.3
|
Milestone payments
|
No later than [**] days after achievement of milestone event
|
3.4
|
Written quarterly royalty report
|
Within [**] days after the end of each Calendar Quarter
|
|||||
3.4
|
Any additional reports as reasonably required under the Argos In-Licenses
|
Within a time period sufficiently in advance to enable Argos to comply with its obligations under such Argos In-Licenses
|
|||||
3.5.2
|
If a financial audit reveals a discrepancy, the appropriate Party shall pay the other Party the amount of the discrepancy, plus [**]% interest (or such higher rate as may be required pursuant to any applicable In-License)
|
within [**] business days of the date Argos delivers the report to China Company such accounting firm’s
|
If a financial audit reveals a discrepancy, the appropriate Party shall pay the other Party the amount of the discrepancy, plus [**]% interest (or such higher rate as may be required pursuant to any applicable In-License)
|
within [**] business days of the date Argos delivers the report to China Company
|
|||
3.7
|
Upon request by Argos, China Company will promptly provide evidence of China Company’s registrations
|
Promptly upon request by Argos
|
|||||
3.8
|
China Company shall submit appropriate proof of payment of the withholding taxes to Argos within a reasonable period of time.
|
within a reasonable period of time
|
|||||
4.2
|
Deliver Development Plan
|
Commencing with the Initiation of any Clinical Study of a Licensed Product and thereafter by no later than each [**]
|
4.2
|
Deliver Commercialization Plan
|
Commencing with the Initiation of any Pivotal Clinical Study of a Licensed Product and thereafter by no later than each [**]
|
|||||
4.3
|
China Company shall prepare and deliver to Argos, written reports summarizing its Development and Commercialization activities for a Licensed Product performed during the preceding Calendar Year (or updating such report for activities performed since the last such report submitted hereunder, as applicable)
|
no later than each [**] (for the period ending December 31 of the prior Calendar Year) of any Calendar Year during the Term
|
Argos shall prepare and deliver to China Company, written reports summarizing its Development and Commercialization activities for a Licensed Product performed during the preceding Calendar Year (or updating such report for activities performed since the last such report submitted hereunder, as applicable)
|
by no later than each [**] (for the period ending December 31 of the prior Calendar Year)
|
|||
4.3
|
China Company shall provide Argos with written notice of all filings and submissions for Regulatory Approval regarding a Licensed Product in the China Company Territory in a timely manner, provided, however, that China Company shall inform Argos of such event at least [**] business days prior to public disclosure of such event by China Company, subject, however, to applicable laws
|
Notice of all filings in a timely manner
Notice of public disclosure in at least [**] business days prior
|
4.3
|
China Company shall provide Argos with written notice of all Regulatory Approvals obtained or denied, the filing of any IND for a Licensed Product, and the First Commercial Sale of a Licensed Product in the China Company Territory, within [**] days of such event; provided, however, that China Company shall inform Argos of such event at least [**] business days prior to public disclosure of such event by China Company, subject, however, to applicable laws
|
within [**] days of such event
Notice of public disclosure in at least [**] business days prior
|
|||||
4.3
|
China Company shall provide Argos with written notice of the Initiation of each Clinical Study of a Licensed Product by or on behalf of China Company within [**] business days of such event; provided, however, that China Company shall inform Argos of such event at least [**] business days prior to public disclosure of such event by China Company, subject, however, to applicable laws
|
within [**] business days of such event
Notice of public disclosure in at least [**] business days
|
4.3
|
China Company shall use Commercially Reasonable Efforts to prepare and deliver to Argos any additional reports reasonably requested by Argos to enable it to meet its obligations under the Argos In-Licenses
|
in each case sufficiently in advance to enable Argos to comply with its obligations under the Argos In-Licenses
|
|||||
4.3
|
China Company shall also provide such other information to Argos as Argos may reasonably request and shall keep Argos reasonably informed of its Commercialization activities with respect to a Licensed Product
|
Upon request
|
|||||
4.6
|
Promptly inform the other Party of any export activities, and the actions taken to prevent such activities
|
Promptly
|
Promptly inform the other Party of any export activities, and the actions taken to prevent such activities
|
Promptly
|
|||
4.8.1
|
Apprise the other Party of all material communications from Regulatory Authorities
|
as soon as reasonably possible but in any event within [**] business days
|
Apprise the other Party of all material communications from Regulatory Authorities
|
as soon as reasonably possible but in any event within [**] business days
|
4.8.2
|
Each Party will notify the other Party of any complaints
|
within sufficient time to allow the other Party and its Related Parties to comply with any and all regulatory and other requirements imposed upon them in any jurisdiction in which a Licensed Product is being marketed or tested in Clinical Studies and/or Post-Approval Studies
|
Each Party will notify the other Party of any complaints
|
within sufficient time to allow the other Party and its Related Parties to comply with any and all regulatory and other requirements imposed upon them in any jurisdiction in which a Licensed Product is being marketed or tested in Clinical Studies and/or Post-Approval Studies
|
|||
4.8.2
|
Each Party will report to the other Party the details around any adverse events and serious adverse events
|
within the time periods for such reporting as specified in the Pharmacovigilance Agreement
|
Each Party will report to the other Party the details around any adverse events and serious adverse events
|
within the time periods for such reporting as specified in the Pharmacovigilance Agreement
|
|||
4.8.2
|
The Parties will develop and agree in writing upon a pharmacovigilance agreement
|
Within [**] months after the Effective Date
|
The Parties will develop and agree in writing upon a pharmacovigilance agreement
|
Within [**] months after the Effective Date
|
|||
4.8.2
|
Each Party shall promptly notify the other if such Party becomes aware of any information or circumstance that is likely to have a material adverse effect on the Development, Manufacture or Commercialization of a Licensed Product in the other Party’s Territory
|
Promptly
|
Each Party shall promptly notify the other if such Party becomes aware of any information or circumstance that is likely to have a material adverse effect on the Development, Manufacture or Commercialization of a Licensed Product in the other Party’s Territory
|
Promptly
|
4.8.3
|
In the event that any Regulatory Authority issues or requests a recall or takes a similar action, or in the event China Company determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in its own Territory, China Company shall within [**] hours advise Argos thereof by telephone, or by email or facsimile together with telephone confirmation
|
within [**] of being notified of such recall or similar action
|
In the event that any Regulatory Authority issues or requests a recall or takes a similar action, or in the event Argos determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in its own Territory, Argos shall within [**] hours advise China Company thereof by telephone, or by email or facsimile together with telephone confirmation
|
within [**] of being notified of such recall or similar action
|
|||
4.9
|
China Company shall provide Argos with a copy of the fully executed agreement and any amendment thereto with any contract manufacturing organization together with a convenience English translation
|
in each case within [**] days of effectiveness
|
|||||
5.2
|
China Company must provide the JSC with any requested information
|
within [**] days of a request
|
|||||
6.2
|
Argos shall use Commercially Reasonable Efforts to transfer to China Company, or to arrange to have transferred to China Company by a Third Party, the Argos Technology set forth on
Schedule E
|
which transfer will commence as soon as practicable after the target date(s) forth on such schedule
|
6.2
|
China Company shall pay the costs and expenses associated with the technology transfer activities
|
within [**] days of the date of invoice sent by Argos
|
|||||
7.1
|
If a Party is required by judicial or administrative process to disclose Confidential Information that is subject to the non-disclosure provisions of this Section 7.1 or Section 7.2, such Party shall promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations
|
Promptly
|
If a Party is required by judicial or administrative process to disclose Confidential Information that is subject to the non-disclosure provisions of this Section 7.1 or Section 7.2, such Party shall promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations
|
Promptly
|
|||
8.5.4
|
In the event of any such claim against any China Company Indemnitee or Argos Indemnitee, the indemnified Party shall promptly notify the other Party in writing of the claim
|
Promptly
|
In the event of any such claim against any China Company Indemnitee or Argos Indemnitee, the indemnified Party shall promptly notify the other Party in writing of the claim
|
Promptly
|
8.5.4
|
If the indemnifying Party believes that any of the exceptions to its obligation of indemnification of the Indemnitees set forth in Sections 8.5.1, 8.5.2 or 8.5.3 may apply, the indemnifying Party shall promptly notify the Indemnitees
|
Promptly
|
If the indemnifying Party believes that any of the exceptions to its obligation of indemnification of the Indemnitees set forth in Sections 8.5.1, 8.5.2 or 8.5.3 may apply, the indemnifying Party shall promptly notify the Indemnitees
|
Promptly
|
|||
9.3.5
|
China Company shall provide Argos with copies of all material correspondence pertaining to its prosecution with the patent offices in the China Company Territory
|
No timing specified
|
|||||
9.3.5
|
China Company shall, if prosecuting and maintaining the Patent Right, furnish to Argos copies of substantive documents (
e.g.
, applications, office actions and responses) relevant to any such efforts in advance
|
with sufficient time for Argos to review and provide comments on such documents
|
|||||
9.4.1
|
China Company shall promptly report in writing to Argos during the Term any (a) known or suspected infringement or (b) unauthorized use or misappropriation, and shall provide Argos with all available evidence supporting such infringement, or unauthorized use or misappropriation
|
Promptly
|
Argos shall promptly report in writing to China Company during the Term any (a) known or suspected infringement or (b) unauthorized use or misappropriation, and shall provide China Company with all available evidence supporting such infringement, or unauthorized use or misappropriation
|
Promptly
|
9.5.1
|
In the event that after the Effective Date a Third Party at any time provides written notice of a claim to, or brings an action, suit or proceeding against, any Party, or any of their respective Affiliates or Sublicensees, claiming infringement of its patent rights or unauthorized use or misappropriation of its Know-How, , China Company shall promptly notify Argos of the claim or the commencement of such action, suit or proceeding, enclosing a copy of the claim and all papers served
|
Promptly
|
In the event that after the Effective Date a Third Party at any time provides written notice of a claim to, or brings an action, suit or proceeding against, any Party, or any of their respective Affiliates or Sublicensees, claiming infringement of its patent rights or unauthorized use or misappropriation of its Know-How,
,
Argos shall promptly notify China Company of the claim or the commencement of such action, suit or proceeding, enclosing a copy of the claim and all papers served
|
Promptly
|
|||
9.8.4
|
In the event either Party becomes aware of any infringement of any Licensed Product Trademark or Argos Trademark by a Third Party, such Party shall promptly notify the other Party
|
Promptly
|
In the event either Party becomes aware of any infringement of any Licensed Product Trademark or Argos Trademark by a Third Party, such Party shall promptly notify the other Party
|
Promptly
|
|||
10.2.2
|
If China Company or any of its Related Parties challenge directly or indirectly the Argos Patent Rights, then China Company shall give Argos written notice thereof
|
within [**] days of taking such action or within [**] days after Knowledge of such action taken by any Related Party of China Company
|
|||||
10.2.3
|
In the event of termination under 10.2.1 or 10.2.2, China Company shall transfer the various documents and other items listed in section 10.2.3
|
As promptly as practicable
|
Date: May 15, 2015
|
||
By:
|
/s/ JEFFREY D. ABBEY
|
|
Jeffrey D. Abbey
|
||
President and Chief Executive Officer
|
||
(Principal Executive Officer)
|
Date: May 15, 2015
|
||
By:
|
/s/ LORI R. HARRELSON
|
|
Lori R. Harrelson
|
||
Vice President of Finance
|
||
(Principal Financial Officer)
|
By:
|
/ S / JEFFREY D. ABBEY
|
|
Jeffrey D. Abbey
Chief Executive Officer
May 15, 2015
|
By:
|
/ S / LORI R. HARRELSON
|
|
Lori R. Harrelson
Vice President of Finance
(principal financial officer)
May 15, 2015
|