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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Genocea Biosciences Inc | NASDAQ:GNCA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.051 | 0.01 | 0.05 | 0 | 01:00:00 |
|
Delaware
|
|
51-0596811
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
|
(IRS Employer
Identification No.)
|
100 Acorn Park Drive
|
|
|
Cambridge, Massachusetts
|
|
02140
|
(Address of Principal Executive Offices)
|
|
(Zip Code)
|
Large accelerated filer
|
¨
|
|
|
|
|
Accelerated filer
|
x
|
Non-accelerated filer
|
¨
|
|
|
|
|
Smaller reporting company
|
¨
|
|
|
|
|
|
|
Emerging growth company
|
x
|
|
•
|
our estimates regarding the timing and amount of funds we require to initiate clinical trials for GEN-009 and to continue our investments in immuno-oncology;
|
•
|
our estimate for when we will require additional funding;
|
•
|
our plans to commercialize GEN-009 and our other product candidates;
|
•
|
the timing of, and our ability to, obtain and maintain regulatory approvals for our product candidates;
|
•
|
the rate and degree of market acceptance and clinical utility of any approved product candidate;
|
•
|
the potential benefits of strategic partnership agreements and our ability to enter into strategic partnership arrangements;
|
•
|
our ability to quickly and efficiently identify and develop product candidates;
|
•
|
our commercialization, marketing and manufacturing capabilities and strategy;
|
•
|
our intellectual property position; and
|
•
|
our estimates regarding expenses, future revenues, capital requirements, the sufficiency of our current and expected cash resources and our need for additional financing.
|
|
|
Page
|
||
|
||||
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|
|||
|
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|||
|
|
|||
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|||
|
||||
|
||||
|
||||
|
|
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|
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|
||||
|
||||
|
|
September 30, 2018
|
|
December 31, 2017
|
||||
Assets
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
34,494
|
|
|
$
|
12,273
|
|
Prepaid expenses and other current assets
|
1,884
|
|
|
808
|
|
||
Total current assets
|
36,378
|
|
|
13,081
|
|
||
Property and equipment, net
|
2,836
|
|
|
3,460
|
|
||
Restricted cash
|
316
|
|
|
316
|
|
||
Other non-current assets
|
171
|
|
|
631
|
|
||
Total assets
|
$
|
39,701
|
|
|
$
|
17,488
|
|
|
|
|
|
|
|
||
Liabilities and stockholders’ equity (deficit)
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
1,276
|
|
|
$
|
3,516
|
|
Accrued expenses and other current liabilities
|
4,233
|
|
|
5,604
|
|
||
Current portion of long-term debt
|
3,574
|
|
|
6,659
|
|
||
Total current liabilities
|
9,083
|
|
|
15,779
|
|
||
Non-current liabilities:
|
|
|
|
|
|
||
Warrant liability
|
13,021
|
|
|
—
|
|
||
Long-term debt, net of current portion and discount
|
11,064
|
|
|
7,652
|
|
||
Other non-current liabilities
|
35
|
|
|
107
|
|
||
Total liabilities
|
33,203
|
|
|
23,538
|
|
||
Commitments and contingencies (Note 6)
|
|
|
|
|
|
||
Stockholders’ equity (deficit):
|
|
|
|
|
|
||
Preferred stock
|
702
|
|
|
—
|
|
||
Common stock
|
87
|
|
|
29
|
|
||
Additional paid-in-capital
|
298,063
|
|
|
258,114
|
|
||
Accumulated deficit
|
(292,354
|
)
|
|
(264,193
|
)
|
||
Total stockholders’ equity (deficit)
|
6,498
|
|
|
(6,050
|
)
|
||
Total liabilities and stockholders’ equity (deficit)
|
$
|
39,701
|
|
|
$
|
17,488
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
$
|
6,359
|
|
|
$
|
10,155
|
|
|
$
|
18,950
|
|
|
$
|
31,324
|
|
General and administrative
|
4,101
|
|
|
3,750
|
|
|
11,682
|
|
|
10,955
|
|
||||
Restructuring costs
|
—
|
|
|
2,591
|
|
|
—
|
|
|
2,591
|
|
||||
Total operating expenses
|
10,460
|
|
|
16,496
|
|
|
30,632
|
|
|
44,870
|
|
||||
Loss from operations
|
(10,460
|
)
|
|
(16,496
|
)
|
|
(30,632
|
)
|
|
(44,870
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
||||||
Change in fair value of warrants
|
2,894
|
|
|
—
|
|
|
3,093
|
|
|
—
|
|
||||
Interest expense, net
|
(266
|
)
|
|
(366
|
)
|
|
(708
|
)
|
|
(1,094
|
)
|
||||
Other income (expense)
|
(1
|
)
|
|
(6
|
)
|
|
86
|
|
|
(14
|
)
|
||||
Total other income (expense)
|
2,627
|
|
|
(372
|
)
|
|
2,471
|
|
|
(1,108
|
)
|
||||
Net loss
|
$
|
(7,833
|
)
|
|
$
|
(16,868
|
)
|
|
$
|
(28,161
|
)
|
|
$
|
(45,978
|
)
|
|
|
|
|
|
|
|
|
||||||||
Other comprehensive loss:
|
|
|
|
|
|
|
|
||||||||
Comprehensive loss
|
$
|
(7,833
|
)
|
|
$
|
(16,868
|
)
|
|
$
|
(28,161
|
)
|
|
$
|
(45,978
|
)
|
Net loss per share - basic and diluted
|
$
|
(0.09
|
)
|
|
$
|
(0.59
|
)
|
|
$
|
(0.35
|
)
|
|
$
|
(1.61
|
)
|
Weighted-average number of common shares used in computing net loss per share
|
86,626
|
|
|
28,666
|
|
|
81,191
|
|
|
28,568
|
|
|
Nine Months Ended September 30,
|
||||||
|
2018
|
|
2017
|
||||
Operating activities
|
|
|
|
|
|
||
Net loss
|
$
|
(28,161
|
)
|
|
$
|
(45,978
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
|
|||
Depreciation and amortization
|
815
|
|
|
1,234
|
|
||
Stock-based compensation
|
1,702
|
|
|
3,268
|
|
||
Allocation of proceeds to transaction expenses
|
2,115
|
|
|
—
|
|
||
Change in fair value of warrant liability
|
(5,208
|
)
|
|
—
|
|
||
Gain on sale of equipment
|
(50
|
)
|
|
—
|
|
||
Write-off of deferred financing fees
|
355
|
|
|
—
|
|
||
Non-cash interest expense
|
460
|
|
|
383
|
|
||
Asset impairment
|
—
|
|
|
1,001
|
|
||
Changes in operating assets and liabilities
|
(5,085
|
)
|
|
667
|
|
||
Net cash used in operating activities
|
(33,057
|
)
|
|
(39,425
|
)
|
||
Investing activities
|
|
|
|
|
|||
Purchases of property and equipment
|
(213
|
)
|
|
(1,248
|
)
|
||
Proceeds from sale of equipment
|
72
|
|
|
—
|
|
||
Proceeds from maturities of investments
|
—
|
|
|
36,089
|
|
||
Purchases of investments
|
—
|
|
|
(153
|
)
|
||
Net cash (used in) provided by investing activities
|
(141
|
)
|
|
34,688
|
|
||
Financing activities
|
|
|
|
|
|
||
Proceeds from equity offerings, net of issuance costs
|
2,920
|
|
|
246
|
|
||
Proceeds from underwritten public offering, net of issuance costs
|
52,538
|
|
|
—
|
|
||
Payment of deferred financing costs
|
(127
|
)
|
|
—
|
|
||
Proceeds from long-term debt
|
592
|
|
|
—
|
|
||
Repayment of long-term debt
|
(535
|
)
|
|
(1,559
|
)
|
||
Proceeds from exercise of stock options
|
—
|
|
|
459
|
|
||
Proceeds from the issuance of common stock under ESPP
|
31
|
|
|
150
|
|
||
Net cash provided by (used in) financing activities
|
55,419
|
|
|
(704
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
22,221
|
|
|
$
|
(5,441
|
)
|
Cash, cash equivalents and restricted cash at beginning of period
|
12,589
|
|
|
27,424
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
34,810
|
|
|
$
|
21,983
|
|
Supplemental cash flow information
|
|
|
|
|
|
||
Cash paid for interest
|
$
|
786
|
|
|
$
|
922
|
|
Property and equipment included in accounts payable and accrued expenses
|
$
|
—
|
|
|
$
|
33
|
|
Reclassification of warrants to additional paid-in capital
|
$
|
190
|
|
|
$
|
—
|
|
•
|
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
|
•
|
Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly.
|
•
|
Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable.
|
Standard
|
|
Description
|
|
Effect on the financial statements
|
ASU No. 2014-09,
Revenue from Contracts with Customers (Topic 606)
|
|
In May 2014, the FASB issued new revenue guidance under ASU No. 2014-09,
Revenue from Contracts with Customers (Topic 606).
The standard replaces existing revenue recognition standards and significantly expand the disclosure requirements for revenue arrangements. It may be adopted either retrospectively or on a modified retrospective basis to new contracts and existing contracts with remaining performance obligations as of the effective date.
ASU No. 2014-09 is effective for annual reporting periods, and interim periods therein, beginning after December 15, 2017.
|
|
The Company adopted ASU No. 2014-09 as of January 1, 2018. The adoption of ASU No. 2014-09 did not impact the Company's financial statements as the Company does not currently have any contracts with customers.
|
ASU No. 2016-15,
Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments
|
|
In August 2016 the FASB issued ASU No. 2016-15,
Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments
(“ASU No. 2016-15”). This guidance addresses the presentation and classification of certain cash receipts and cash payments in the statement of cash flows.
The standard is effective for annual periods beginning after December 15, 2017 and for interim periods within those fiscal years. Early adoption is permitted.
|
|
The Company adopted ASU No. 2016-15 effective January 1, 2018. The adoption of ASU No. 2016-15 did not have a material impact on the Company’s financial statements.
|
ASU No. 2016-18,
Statement of Cash Flows (Topic 230): Restricted Cash
|
|
In November 2016, the FASB issued ASU 2016-18, which requires additional disclosures related to restricted cash. The new standard requires that amounts generally described as restricted cash and restricted cash equivalents be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows.
ASU No. 2016-18 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017.
|
|
The Company adopted the standard on January 1, 2018 and reclassified $0.3 million of restricted cash to be included with cash and cash equivalents on the statement of cash flows.
|
ASU No. 2017-09,
Compensation-Stock Compensation (Topic 718)
|
|
In May 2017, the FASB issued ASU No. 2017-09,
Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting
(“ASU No. 2017-09”). This update clarifies the changes to terms or conditions of a share-based payment award that require an entity to apply modification accounting.
ASU No. 2017-09 is effective for annual reporting periods, and interim periods therein, beginning after December 15, 2017. Early application is permitted, and prospective application is required.
|
|
The Company adopted ASU No. 2017-09 effective January 1, 2018. The adoption of ASU No. 2017-09 did not have a material impact on the Company’s financial statements.
|
Standard
|
|
Description
|
|
Effect on the financial statements
|
ASU No. 2016-02,
Leases (Topic 842)
|
|
In February 2016, the FASB issued ASU No. 2016-02,
Leases (Topic 842),
which replaces the existing lease accounting standards. The new standard requires a dual approach for lessee accounting under which a lessee would account for leases as finance (also referred to as capital) leases or operating leases. Both finance leases and operating leases will result in the lessee recognizing a right-of-use asset and corresponding lease liability. For finance leases the lessee would recognize interest expense and amortization of the right-of-use asset and for operating leases the lessee would recognize straight-line total lease expense.
ASU No. 2016-02 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018.
|
|
The Company generally does not finance purchases of equipment but it does lease office and lab facilities. The Company is in the process of evaluating the effect that this ASU will have on its consolidated financial statements and related disclosures, but expects the adoption will result in an increase in assets and liabilities on its consolidated balance sheets.
|
ASU No. 2018-07,
Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting
|
|
In June 2018, the FASB issued ASU No. 2018-07,
Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting.
The new standard largely aligns the accounting for share-based payment awards issued to employees and nonemployees by expanding the scope of ASC 718 to apply to nonemployee share-based transactions, as long as the transaction is not effectively a form of financing.
The new guidance will be effective for the Company on January 1, 2019.
|
|
The Company is currently evaluating the potential impact that this guidance may have on its consolidated financial statements.
|
ASU 2018-13,
Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement
|
|
In August 2018, the FASB issued ASU 2018-13,
Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement
which requires public entities to disclose certain new information and modifies some disclosure requirements.
The new guidance will be effective for fiscal years beginning after 15 December 2019 and for interim periods within those fiscal years.
|
|
The Company is currently evaluating the potential impact that this guidance may have on its consolidated financial statements.
|
ASU 2018-15,
Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract.
|
|
In August 2018, the FASB issued ASU 2018-15,
Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract.
ASU 2018-15 requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in Accounting Standards Codification 350-40 to determine which implementation costs to defer and recognize as an asset.
The new guidance will be effective for annual periods, and interim periods within those annual periods, beginning after 15 December 2019.
|
|
The Company is currently evaluating the potential impact that this guidance may have on its consolidated financial statements.
|
|
|
|
Quoted prices in active markets
|
|
Significant other observable inputs
|
|
Significant unobservable inputs
|
||||||||
|
Total
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||||
September 30, 2018
|
|
|
|
|
|
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds, included in cash equivalents
|
$
|
34,262
|
|
|
$
|
34,262
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets
|
$
|
34,262
|
|
|
$
|
34,262
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Common stock warrant liabilities
|
$
|
13,021
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
13,021
|
|
Total liabilities
|
$
|
13,021
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
13,021
|
|
|
|
|
|
|
|
|
|
||||||||
December 31, 2017
|
|
|
|
|
|
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds, included in cash equivalents
|
$
|
11,528
|
|
|
$
|
11,528
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets
|
$
|
11,528
|
|
|
$
|
11,528
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Issuance Date
|
|
September 30, 2018
|
||||
Stock price
|
|
$
|
0.89
|
|
|
$
|
0.78
|
|
Volatility
|
|
111.5
|
%
|
|
105.7
|
%
|
||
Remaining term (years)
|
|
5
|
|
|
4.3
|
|
||
Expected dividend yield
|
|
—
|
%
|
|
—
|
%
|
||
Risk-free rate
|
|
2.4% - 2.5%
|
|
|
2.9
|
%
|
||
Range of annual acquisition event probability
|
|
0.0% - 30.0%
|
|
|
0.0% - 30.0%
|
|
|
|
Common Stock Warrant Liabilities
|
||
Issuance of Warrants
|
|
$
|
18,231
|
|
Change in fair value
|
|
(5,208
|
)
|
|
Warrants exercised
|
|
(2
|
)
|
|
Balance at September 30, 2018
|
|
$
|
13,021
|
|
|
|
Overallotment Option Liability
|
||
Issuance of Overallotment Option
|
|
$
|
2,441
|
|
Change in fair value
|
|
194
|
|
|
Exercise of Overallotment Option
|
|
(877
|
)
|
|
Expiration of Overallotment Option in March 2018
|
|
(1,758
|
)
|
|
Balance at September 30, 2018
|
|
$
|
—
|
|
|
September 30,
|
|
December 31,
|
||||
|
2018
|
|
2017
|
||||
Research and development costs
|
$
|
764
|
|
|
$
|
2,886
|
|
Payroll and employee-related costs
|
1,791
|
|
|
1,830
|
|
||
Other current liabilities
|
1,678
|
|
|
844
|
|
||
Restructuring costs
|
—
|
|
|
44
|
|
||
Total
|
$
|
4,233
|
|
|
$
|
5,604
|
|
|
September 30, 2018
|
||
2019
|
$
|
4,693
|
|
2020
|
7,030
|
|
|
2021
|
4,057
|
|
|
Total
|
$
|
15,780
|
|
|
September 30, 2018
|
||
2018
|
$
|
403
|
|
2019
|
1,637
|
|
|
2020
|
274
|
|
|
Total
|
$
|
2,314
|
|
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
2018
|
|
2017
|
||||||||
Research and development
|
$
|
156
|
|
|
$
|
322
|
|
$
|
456
|
|
|
$
|
1,060
|
|
General and administrative
|
310
|
|
|
771
|
|
1,246
|
|
|
2,208
|
|
||||
Total
|
$
|
466
|
|
|
$
|
1,093
|
|
$
|
1,702
|
|
|
$
|
3,268
|
|
|
Shares
|
|
Weighted-
Average Exercise Price |
|
Weighted-
Average Remaining Contractual Term (years) |
|
Aggregate
Intrinsic Value |
|||||
Outstanding at December 31, 2017
|
4,129
|
|
|
$
|
5.48
|
|
|
7.07
|
|
$
|
—
|
|
Granted
|
3,805
|
|
|
$
|
0.95
|
|
|
|
|
|
|
|
Exercised
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
Canceled
|
(2,242
|
)
|
|
$
|
4.64
|
|
|
|
|
|
|
|
Outstanding at September 30, 2018
|
5,692
|
|
|
$
|
2.78
|
|
|
7.51
|
|
$
|
75,535
|
|
Exercisable at September, 2018
|
2,378
|
|
|
$
|
4.40
|
|
|
5.26
|
|
$
|
—
|
|
|
Nine Months Ended September 30,
|
||||
|
2018
|
|
2017
|
||
Stock options
|
5,692
|
|
|
4,400
|
|
Restricted stock units
|
—
|
|
|
24
|
|
Warrants
|
29,343
|
|
|
78
|
|
Outstanding ESPP
|
82
|
|
|
31
|
|
Total
|
35,117
|
|
|
4,533
|
|
(in thousands)
|
Charges incurred during the year ended December 31, 2017
|
|
Amount paid through December 31, 2017
|
|
Less non-cash charges during the year ended December 31, 2017
|
|
Remaining liability at December 31, 2017
|
|
Amount paid during Q1 2018
|
|
Remaining liability at September 30, 2018
|
||||||||||||
Employee severance, benefits and related costs
|
$
|
1,064
|
|
|
$
|
(1,050
|
)
|
|
$
|
—
|
|
|
$
|
14
|
|
|
$
|
(14
|
)
|
|
$
|
—
|
|
Contract terminations
|
526
|
|
|
—
|
|
|
—
|
|
|
526
|
|
|
(526
|
)
|
|
—
|
|
||||||
Asset impairments
|
1,028
|
|
|
—
|
|
|
(1,028
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Total
|
$
|
2,618
|
|
|
$
|
(1,050
|
)
|
|
$
|
(1,028
|
)
|
|
$
|
540
|
|
|
$
|
(540
|
)
|
|
$
|
—
|
|
Vaccine
Candidate
|
|
Program
|
|
Stage of Development
|
|
Next Milestone
|
|
Anticipated Timeline
|
GEN-009
|
|
First generation neoantigen cancer vaccine
|
|
Clinical
|
|
Immunogenicity data from the first patient cohort
|
|
First half of 2019
|
GEN-010
|
|
Second generation neoantigen cancer vaccine
|
|
Pre-clinical
|
|
Select delivery technology platform
|
|
Ongoing
|
GEN-011
|
|
Adoptive T cell therapy
|
|
Research
|
|
Initiate preclinical program
|
|
Ongoing
|
GEN-006
|
|
Immuno-oncology -tumor‑associated antigen vaccine
|
|
Research
|
|
Select antigen candidates
|
|
Exploring partnering opportunities
|
GEN-007
|
|
Epstein-Barr Virus
|
|
Research
|
|
Select antigen candidates
|
|
Exploring partnering opportunities
|
•
|
personnel-related expenses, including salaries, benefits, stock-based compensation expense, and travel;
|
•
|
expenses incurred under agreements with contract research organizations ("CROs"), contract manufacturing organizations ("CMOs"), consultants, and other vendors that conduct our clinical trials and preclinical activities;
|
•
|
costs of acquiring, developing, and manufacturing clinical trial materials and lab supplies; and
|
•
|
facility costs, depreciation, and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance, and other supplies.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Immuno-oncology programs (1)
|
$
|
5,474
|
|
|
$
|
2,456
|
|
|
$
|
15,870
|
|
|
$
|
7,568
|
|
Other research and development (2)
|
879
|
|
|
1,321
|
|
|
2,524
|
|
|
4,032
|
|
||||
Genital herpes (GEN-003)(3)
|
6
|
|
|
6,378
|
|
|
556
|
|
|
19,724
|
|
||||
Total research and development
|
$
|
6,359
|
|
|
$
|
10,155
|
|
|
$
|
18,950
|
|
|
$
|
31,324
|
|
(1)
|
Includes direct and indirect internal costs and external costs for our immuno-oncology research and development activities.
|
(2)
|
Includes costs that are not specifically allocated by project, including facilities costs, depreciation expense, and other costs. In addition, costs for programs that were paused in 2016 or earlier are included in this line item.
|
(3)
|
Includes direct and indirect internal costs and external costs such as CMO and CRO costs.
|
|
Three Months Ended September 30,
|
|
Increase
|
||||||||
(in thousands)
|
2018
|
|
2017
|
|
(Decrease)
|
||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
$
|
6,359
|
|
|
$
|
10,155
|
|
|
$
|
(3,796
|
)
|
General and administrative
|
4,101
|
|
|
3,750
|
|
|
351
|
|
|||
Restructuring costs
|
—
|
|
|
2,591
|
|
|
(2,591
|
)
|
|||
Total operating expenses
|
10,460
|
|
|
16,496
|
|
|
(6,036
|
)
|
|||
Loss from operations
|
(10,460
|
)
|
|
(16,496
|
)
|
|
(6,036
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
|
|
|
|||
Change in fair value of warrants
|
2,894
|
|
|
—
|
|
|
2,894
|
|
|||
Interest expense, net
|
(266
|
)
|
|
(366
|
)
|
|
(100
|
)
|
|||
Other income (expense)
|
(1
|
)
|
|
(6
|
)
|
|
(5
|
)
|
|||
Total other income (expense)
|
2,627
|
|
|
(372
|
)
|
|
2,999
|
|
|||
Net loss
|
$
|
(7,833
|
)
|
|
$
|
(16,868
|
)
|
|
$
|
(9,035
|
)
|
|
Nine Months Ended September 30,
|
|
Increase
|
||||||||
(in thousands)
|
2018
|
|
2017
|
|
(Decrease)
|
||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
$
|
18,950
|
|
|
$
|
31,324
|
|
|
$
|
(12,374
|
)
|
General and administrative
|
11,682
|
|
|
10,955
|
|
|
727
|
|
|||
Restructuring costs
|
—
|
|
|
2,591
|
|
|
(2,591
|
)
|
|||
Total operating expenses
|
30,632
|
|
|
44,870
|
|
|
(14,238
|
)
|
|||
Loss from operations
|
(30,632
|
)
|
|
(44,870
|
)
|
|
(14,238
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
|
|
|
|||
Change in fair value of warrants
|
3,093
|
|
|
—
|
|
|
3,093
|
|
|||
Interest expense, net
|
(708
|
)
|
|
(1,094
|
)
|
|
(386
|
)
|
|||
Other income (expense)
|
86
|
|
|
(14
|
)
|
|
100
|
|
|||
Total Other income (expense)
|
2,471
|
|
|
(1,108
|
)
|
|
3,579
|
|
|||
Net loss
|
$
|
(28,161
|
)
|
|
$
|
(45,978
|
)
|
|
$
|
(17,817
|
)
|
•
|
the timing and costs of current and planned clinical trials for GEN-009;
|
•
|
the progress, timing, and costs of manufacturing GEN-009 for planned clinical trials;
|
•
|
the initiation, progress, timing, costs, and results of preclinical studies and clinical trials for our other product candidates and potential product candidates;
|
•
|
the outcome, timing, and costs of seeking regulatory approvals;
|
•
|
the costs of commercialization activities for GEN-009 and other product candidates if we receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution, and manufacturing capabilities;
|
•
|
the receipt of marketing approval;
|
•
|
revenue received from commercial sales of our product candidates;
|
•
|
the terms and timing of any future collaborations, grants, licensing, consulting, or other arrangements that we may establish;
|
•
|
the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights, including milestone and royalty payments, and patent prosecution fees that we are obligated to pay pursuant to our license agreements;
|
•
|
the costs of preparing, filing, and prosecuting patent applications, maintaining and protecting our intellectual property rights, and defending against intellectual property related claims; and
|
•
|
the extent to which we in-license or acquire other products and technologies.
|
|
Nine Months Ended September 30,
|
||||||
|
2018
|
|
2017
|
||||
Net cash used in operating activities
|
$
|
(33,057
|
)
|
|
$
|
(39,425
|
)
|
Net cash provided by investing activities
|
(141
|
)
|
|
34,688
|
|
||
Net cash provided by (used in) financing activities
|
55,419
|
|
|
(704
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
22,221
|
|
|
$
|
(5,441
|
)
|
Exhibit
Number
|
|
Exhibit
|
3.1
|
|
|
|
|
|
4.1
|
|
|
|
|
|
10.1
|
|
|
|
|
|
10.2†
|
|
|
|
|
|
10.3†
|
|
|
|
|
|
31.1
|
|
|
|
|
|
31.2
|
|
|
|
|
|
32.1
|
|
|
|
|
|
32.2
|
|
|
|
|
|
101
|
|
The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as of September 30, 2018 and December 31, 2017, (ii) Condensed Consolidated Statements of Operations and Comprehensive Income for the three and nine months ended September 30, 2018 and 2017, (iii) Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2018 and 2017 and (iv) Notes to Unaudited Condensed Consolidated Financial Statements
|
†
|
Indicates a compensatory plan.
|
|
Genocea Biosciences, Inc.
|
|
|
|
|
Date: November 1, 2018
|
By:
|
/s/ WILLIAM D. CLARK
|
|
|
William D. Clark
|
|
|
President and Chief Executive Officer and Director
|
|
|
(Principal Executive Officer)
|
|
|
|
Date: November 1, 2018
|
By:
|
/s/ MICHAEL ALFIERI
|
|
|
Michael Alfieri
|
|
|
Vice President, Finance (Principal Financial and Accounting Officer)
|
1 Year Genocea Biosciences Chart |
1 Month Genocea Biosciences Chart |
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