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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)
|
Title of each class
|
|
Trading symbol(s)
|
|
Name of each exchange on which registered
|
Common stock, $0.001 par value per share
|
|
GNCA
|
|
NASDAQ Capital Market
|
Large accelerated filer
|
¨
|
|
|
|
|
Accelerated filer
|
x
|
Non-accelerated filer
|
¨
|
|
|
|
|
Smaller reporting company
|
x
|
|
|
|
|
|
|
Emerging growth company
|
x
|
|
•
|
our estimates regarding the timing and amount of funds we require to conduct clinical trials for GEN-009, to continue preclinical studies and file an investigational new drug (“IND”) for GEN-011, to continue preclinical studies for our other product candidates and to continue our investments in immuno-oncology;
|
•
|
our estimates regarding expenses, future revenues, capital requirements, the sufficiency of our current and expected cash resources and our need for additional financing;
|
•
|
the timing of, and our ability to, obtain and maintain regulatory approvals for our product candidates;
|
•
|
the potential benefits of strategic partnership agreements and our ability to enter into strategic partnership arrangements;
|
•
|
our intellectual property position;
|
•
|
the rate and degree of market acceptance and clinical utility of any approved product candidate;
|
•
|
our ability to quickly and efficiently identify and develop product candidates; and
|
•
|
our commercialization, marketing and manufacturing capabilities and strategies.
|
|
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Page
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|
September 30,
2019 |
|
December 31,
2018
|
||||
Assets
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
46,649
|
|
|
$
|
26,361
|
|
Prepaid expenses and other current assets
|
1,271
|
|
|
696
|
|
||
Total current assets
|
47,920
|
|
|
27,057
|
|
||
Property and equipment, net
|
2,896
|
|
|
2,582
|
|
||
Operating lease right-of-use asset
|
6,516
|
|
|
—
|
|
||
Restricted cash
|
631
|
|
|
316
|
|
||
Other non-current assets
|
1,324
|
|
|
1,160
|
|
||
Total assets
|
$
|
59,287
|
|
|
$
|
31,115
|
|
|
|
|
|
|
|
||
Liabilities and stockholders’ equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
686
|
|
|
$
|
1,659
|
|
Accrued expenses and other current liabilities
|
4,111
|
|
|
3,816
|
|
||
Operating lease liabilities
|
1,017
|
|
|
—
|
|
||
Current portion of long-term debt
|
5,256
|
|
|
5,257
|
|
||
Total current liabilities
|
11,070
|
|
|
10,732
|
|
||
Non-current liabilities:
|
|
|
|
|
|
||
Warrant liability
|
3,183
|
|
|
3,472
|
|
||
Long-term debt, net of current portion and discount
|
8,041
|
|
|
9,565
|
|
||
Operating lease liabilities, net of current portion
|
5,620
|
|
|
—
|
|
||
Other non-current liabilities
|
—
|
|
|
11
|
|
||
Total liabilities
|
27,914
|
|
|
23,780
|
|
||
Commitments and contingencies (Note 9)
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred stock
|
701
|
|
|
701
|
|
||
Common stock
|
26
|
|
|
11
|
|
||
Additional paid-in capital
|
352,244
|
|
|
298,627
|
|
||
Accumulated deficit
|
(321,598
|
)
|
|
(292,004
|
)
|
||
Total stockholders’ equity
|
31,373
|
|
|
7,335
|
|
||
Total liabilities and stockholders’ equity
|
$
|
59,287
|
|
|
$
|
31,115
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
$
|
6,826
|
|
|
$
|
6,359
|
|
|
$
|
20,135
|
|
|
$
|
18,950
|
|
General and administrative
|
2,758
|
|
|
4,101
|
|
|
8,992
|
|
|
11,682
|
|
||||
Total operating expenses
|
9,584
|
|
|
10,460
|
|
|
29,127
|
|
|
30,632
|
|
||||
Loss from operations
|
(9,584
|
)
|
|
(10,460
|
)
|
|
(29,127
|
)
|
|
(30,632
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
||||||
Change in fair value of warrants
|
2,206
|
|
|
2,894
|
|
|
289
|
|
|
3,093
|
|
||||
Interest expense, net
|
(154
|
)
|
|
(266
|
)
|
|
(755
|
)
|
|
(708
|
)
|
||||
Other income (expense)
|
—
|
|
|
(1
|
)
|
|
(1
|
)
|
|
86
|
|
||||
Total other income (expense)
|
2,052
|
|
|
2,627
|
|
|
(467
|
)
|
|
2,471
|
|
||||
Net loss
|
$
|
(7,532
|
)
|
|
$
|
(7,833
|
)
|
|
$
|
(29,594
|
)
|
|
$
|
(28,161
|
)
|
|
|
|
|
|
|
|
|
||||||||
Comprehensive loss
|
$
|
(7,532
|
)
|
|
$
|
(7,833
|
)
|
|
$
|
(29,594
|
)
|
|
$
|
(28,161
|
)
|
Net loss per share - basic and diluted
|
$
|
(0.28
|
)
|
|
$
|
(0.72
|
)
|
|
$
|
(1.62
|
)
|
|
$
|
(2.77
|
)
|
Weighted-average number of common shares used in computing net loss per share
|
26,681
|
|
|
10,829
|
|
|
18,297
|
|
|
10,149
|
|
|
|
|
|
|
|
Preferred Shares Amount
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Total Stockholders' Equity
|
|||||||||||
|
|
Common Shares
|
|
|
|
|
|||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance at December 31, 2018
|
|
10,847
|
|
|
$
|
11
|
|
|
$
|
701
|
|
|
$
|
298,627
|
|
|
$
|
(292,004
|
)
|
|
$
|
7,335
|
|
Issuance of common stock, net
|
|
3,200
|
|
|
3
|
|
|
—
|
|
|
14,023
|
|
|
—
|
|
|
14,026
|
|
|||||
Exercise of stock options
|
|
3
|
|
|
—
|
|
|
—
|
|
|
12
|
|
|
—
|
|
|
12
|
|
|||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
—
|
|
|
429
|
|
|
—
|
|
|
429
|
|
|||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,567
|
)
|
|
(15,567
|
)
|
|||||
Balance at March 31, 2019
|
|
14,050
|
|
|
$
|
14
|
|
|
$
|
701
|
|
|
$
|
313,091
|
|
|
$
|
(307,571
|
)
|
|
$
|
6,235
|
|
Issuance of common stock, net
|
|
12,074
|
|
|
12
|
|
|
—
|
|
|
38,155
|
|
|
—
|
|
|
38,167
|
|
|||||
Issuance of common stock; ESPP purchase
|
|
24
|
|
|
—
|
|
|
—
|
|
|
48
|
|
|
—
|
|
|
48
|
|
|||||
Exercise of stock options
|
|
2
|
|
|
—
|
|
|
—
|
|
|
9
|
|
|
—
|
|
|
9
|
|
|||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
—
|
|
|
474
|
|
|
—
|
|
|
474
|
|
|||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,495
|
)
|
|
(6,495
|
)
|
|||||
Balance at June 30, 2019
|
|
26,150
|
|
|
$
|
26
|
|
|
$
|
701
|
|
|
$
|
351,777
|
|
|
$
|
(314,066
|
)
|
|
$
|
38,438
|
|
Issuance of common stock, net
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(23
|
)
|
|
—
|
|
|
(23
|
)
|
|||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
—
|
|
|
490
|
|
|
—
|
|
|
490
|
|
|||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,532
|
)
|
|
(7,532
|
)
|
|||||
Balance at September 30, 2019
|
|
26,150
|
|
|
$
|
26
|
|
|
$
|
701
|
|
|
$
|
352,244
|
|
|
$
|
(321,598
|
)
|
|
$
|
31,373
|
|
|
|
|
|
|
|
Preferred Shares Amount
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Total Stockholders' Equity (Deficit)
|
|||||||||||
|
|
Common Shares
|
|
|
|
|
|||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance at December 31, 2017
|
|
3,592
|
|
|
$
|
3
|
|
|
$
|
—
|
|
|
$
|
258,140
|
|
|
$
|
(264,193
|
)
|
|
$
|
(6,050
|
)
|
Issuance of common stock, net
|
|
6,790
|
|
|
7
|
|
|
701
|
|
|
35,156
|
|
|
—
|
|
|
35,864
|
|
|||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
—
|
|
|
644
|
|
|
—
|
|
|
644
|
|
|||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,890
|
)
|
|
(15,890
|
)
|
|||||
Balance at March 31, 2018
|
|
10,382
|
|
|
$
|
10
|
|
|
$
|
701
|
|
|
$
|
293,940
|
|
|
$
|
(280,083
|
)
|
|
$
|
14,568
|
|
Issuance of common stock, net
|
|
440
|
|
|
1
|
|
|
—
|
|
|
2,921
|
|
|
—
|
|
|
2,922
|
|
|||||
Issuance of common stock; ESPP purchase
|
|
6
|
|
|
—
|
|
|
—
|
|
|
31
|
|
|
—
|
|
|
31
|
|
|||||
Issuance of Warrants on Debt Modification
|
|
—
|
|
|
—
|
|
|
—
|
|
|
190
|
|
|
—
|
|
|
190
|
|
|||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
—
|
|
|
592
|
|
|
—
|
|
|
592
|
|
|||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,438
|
)
|
|
(4,438
|
)
|
|||||
Balance at June 30, 2018
|
|
10,828
|
|
|
$
|
11
|
|
|
$
|
701
|
|
|
$
|
297,674
|
|
|
$
|
(284,521
|
)
|
|
$
|
13,865
|
|
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
—
|
|
|
466
|
|
|
—
|
|
|
466
|
|
|||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,833
|
)
|
|
(7,833
|
)
|
|||||
Balance at September 30, 2018
|
|
10,828
|
|
|
$
|
11
|
|
|
$
|
701
|
|
|
$
|
298,140
|
|
|
$
|
(292,354
|
)
|
|
$
|
6,498
|
|
|
Nine Months Ended
September 30, |
||||||
|
2019
|
|
2018
|
||||
Operating activities
|
|
|
|
|
|
||
Net loss
|
$
|
(29,594
|
)
|
|
$
|
(28,161
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
|
|||
Depreciation and amortization
|
825
|
|
|
815
|
|
||
Stock-based compensation
|
1,392
|
|
|
1,702
|
|
||
Allocation of proceeds to transaction expenses
|
—
|
|
|
2,115
|
|
||
Change in fair value of warrant liability
|
(289
|
)
|
|
(5,208
|
)
|
||
Gain on sale of equipment
|
(19
|
)
|
|
(50
|
)
|
||
Write-off of deferred financing fees
|
—
|
|
|
355
|
|
||
Non-cash interest expense
|
471
|
|
|
460
|
|
||
Changes in operating assets and liabilities
|
(1,534
|
)
|
|
(5,085
|
)
|
||
Net cash used in operating activities
|
(28,748
|
)
|
|
(33,057
|
)
|
||
Investing activities
|
|
|
|
|
|||
Purchases of property and equipment
|
(989
|
)
|
|
(213
|
)
|
||
Proceeds from sale of equipment
|
19
|
|
|
72
|
|
||
Net cash used in investing activities
|
(970
|
)
|
|
(141
|
)
|
||
Financing activities
|
|
|
|
|
|
||
Proceeds from equity offerings, net
|
—
|
|
|
2,920
|
|
||
Proceeds from issuance of common stock, net
|
52,171
|
|
|
52,538
|
|
||
Payment of deferred financing costs
|
—
|
|
|
(127
|
)
|
||
Proceeds from long-term debt
|
—
|
|
|
592
|
|
||
Repayment of long-term debt
|
(1,919
|
)
|
|
(535
|
)
|
||
Proceeds from exercise of stock options
|
21
|
|
|
—
|
|
||
Proceeds from the issuance of common stock under ESPP
|
48
|
|
|
31
|
|
||
Net cash provided by financing activities
|
50,321
|
|
|
55,419
|
|
||
Net increase in cash and cash equivalents
|
$
|
20,603
|
|
|
$
|
22,221
|
|
Cash, cash equivalents and restricted cash at beginning of period
|
26,677
|
|
|
12,589
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
47,280
|
|
|
$
|
34,810
|
|
Supplemental cash flow information
|
|
|
|
|
|
||
Cash paid for interest
|
$
|
843
|
|
|
$
|
786
|
|
Property and equipment included in accounts payable and accrued expenses
|
$
|
150
|
|
|
$
|
—
|
|
Reclassification of warrants to additional paid-in capital
|
$
|
—
|
|
|
$
|
190
|
|
Standard
|
|
Description
|
|
Effect on the financial statements
|
ASU No. 2016-02,
Leases (Topic 842)
|
|
In February 2016, the FASB established ASC Topic 842, Leases, (ASC 842) by issuing ASU No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new standard establishes a right-of-use model ("ROU") that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement.
The Company adopted ASC 842 effective January 1, 2019.
|
|
The adoption of ASC 842 resulted in the Company recognizing ROU assets and related operating lease liabilities of $1.7 million and $1.8 million, respectively, in our condensed consolidated balance sheet as of January 1, 2019.
The Company used the modified retrospective method of adoption, with January 1, 2019 as the effective date of initial application. The Company elected the short-term lease recognition exemption for all leases that qualify. The Company elected the package of practical expedients for leases that commenced prior to January 1, 2019, allowing it not to reassess (i) whether any expired or existing contracts contain leases, (ii) the lease classification for any expired or existing leases and (iii) the initial indirect costs for any existing leases.
|
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 Company adopted ASU No. 2018-07 effective January 1, 2019.
|
|
The adoption of ASU No. 2018-07 did not have a material impact on the Company's condensed consolidated financial statements.
|
Standard
|
|
Description
|
|
Effect on the financial statements
|
ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments
|
|
In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses on certain types of financial instruments, including trade receivables and available-for-sale debt securities.
The new guidance will be effective for the Company beginning in the first quarter of 2020, with early adoption permitted.
|
|
Based on the composition of its investment portfolio and other financial assets, current market conditions and historical credit loss activity, the adoption of this standard is not expected to have a material impact on the consolidated financial position and results of operations and related disclosures of the Company.
|
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 December 15, 2019 and for interim periods within those fiscal years.
|
|
The Company does not expect that the adoption of this standard will have a material impact on its disclosures.
|
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 December 15, 2019.
|
|
The Company does not expect that the adoption of this standard will have a material impact on its consolidated financial position and results of operations and related disclosures.
|
•
|
Level 1 - Fair values are determined by utilizing quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access;
|
•
|
Level 2 - Fair values are determined by utilizing quoted prices for similar assets and liabilities in active markets or other market observable inputs such as interest rates, yield curves and foreign currency spot rates; and
|
•
|
Level 3 - Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
|
|
|
|
Quoted prices in active markets
|
|
Significant other observable inputs
|
|
Significant unobservable inputs
|
||||||||
|
Total
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||||
September 30, 2019
|
|
|
|
|
|
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
46,391
|
|
|
$
|
46,391
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets
|
$
|
46,391
|
|
|
$
|
46,391
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
3,183
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,183
|
|
Total liabilities
|
$
|
3,183
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,183
|
|
|
|
|
|
|
|
|
|
||||||||
December 31, 2018
|
|
|
|
|
|
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
24,651
|
|
|
$
|
24,651
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets
|
$
|
24,651
|
|
|
$
|
24,651
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
3,472
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,472
|
|
Total liabilities
|
$
|
3,472
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,472
|
|
|
|
Warrant Liability
|
||
Balance at December 31, 2018
|
|
$
|
3,472
|
|
Change in fair value
|
|
(289
|
)
|
|
Balance at September 30, 2019
|
|
$
|
3,183
|
|
|
September 30,
|
|
December 31,
|
||||
|
2019
|
|
2018
|
||||
Research and development
|
$
|
1,421
|
|
|
$
|
759
|
|
Payroll and employee-related
|
2,037
|
|
|
2,147
|
|
||
Other current liabilities
|
653
|
|
|
910
|
|
||
Total
|
$
|
4,111
|
|
|
$
|
3,816
|
|
|
September 30, 2019
|
||
2020
|
$
|
7,407
|
|
2021
|
6,453
|
|
|
Total
|
$
|
13,860
|
|
|
|
Shares
|
|
Exercise price
|
|
Expiration date
|
|
Classification
|
|||
First Warrant
|
|
9,216
|
|
|
$
|
65.92
|
|
|
Q4 2019
|
|
Equity
|
Second Warrant
|
|
41,177
|
|
|
$
|
6.80
|
|
|
Q2 2023
|
|
Equity
|
2018 Public Offering Warrants
|
|
3,616,944
|
|
|
$
|
9.60
|
|
|
Q1 2023
|
|
Liability
|
Private Placement Warrants
|
|
932,812
|
|
|
$
|
4.52
|
|
|
Q1 2024
|
|
Equity
|
Pre-Funded Warrants
|
|
531,250
|
|
|
$
|
0.08
|
|
|
Q1 2039
|
|
Equity
|
|
|
5,131,399
|
|
|
|
|
|
|
|
|
|
September 30, 2019
|
|
December 31, 2018
|
||||
Stock price
|
|
$
|
2.90
|
|
|
$
|
2.32
|
|
Volatility
|
|
114.7
|
%
|
|
111.3
|
%
|
||
Remaining term (years)
|
|
3.3
|
|
|
4.1
|
|
||
Expected dividend yield
|
|
—
|
|
|
—
|
|
||
Risk-free rate
|
|
1.6
|
%
|
|
2.4%-2.5%
|
|
||
Range of annual acquisition event probability
|
|
20%
|
|
|
0.0%-30.0%
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Research and development
|
$
|
182
|
|
|
$
|
156
|
|
|
$
|
534
|
|
|
$
|
456
|
|
General and administrative
|
308
|
|
|
310
|
|
|
858
|
|
|
1,246
|
|
||||
Total
|
$
|
490
|
|
|
$
|
466
|
|
|
$
|
1,392
|
|
|
$
|
1,702
|
|
|
September 30, 2019
|
||
2019
|
$
|
410,433
|
|
2020
|
1,476,644
|
|
|
2021
|
1,473,800
|
|
|
2022
|
1,510,601
|
|
|
2023 and thereafter
|
3,400,844
|
|
|
Total lease payments
|
8,272,322
|
|
|
Less imputed interest
|
(1,635,192
|
)
|
|
Total
|
$
|
6,637,130
|
|
•
|
Part A of the trial is assessing the safety and immunogenicity of GEN-009 as monotherapy in certain cancer patients with no evidence of disease; and
|
•
|
Part B of the trial, which we have recently initiated, is designed to assess the safety, immunogenicity, and preliminary antitumor activity of GEN-009 in combination with ICI therapy in patients with advanced or metastatic tumors.
|
•
|
100% of patients (N=7 patients) had measurable CD4+ and CD8+ T cell responses to their GEN-009 vaccine;
|
•
|
Responses were detected against 98% of the administered vaccine neoantigens (N=58 administered antigens), which has not been previously established for neoantigen vaccination administered without checkpoint inhibition;
|
•
|
GEN-009 elicited CD8+ T cell responses ex vivo, which is a measure of effector function, for 38% of vaccine neoantigens (N=7 patients);
|
•
|
GEN-009 elicited broad immune responses using an in vitro stimulation assay, which is a measure of central memory, with 86% of neoantigens eliciting a CD4+ response (N=5 patients) and 33% of neoantigens eliciting a CD8+ response (N=2 patients); and
|
•
|
GEN-009 was well tolerated, with no dose-limiting toxicities observed.
|
•
|
personnel-related expenses, including salaries, benefits, stock-based compensation expense, and travel;
|
•
|
expenses incurred under agreements with contract research organizations, contract manufacturing organizations, 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,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Discovery and pre-IND
|
$
|
2,289
|
|
|
$
|
3,793
|
|
|
$
|
4,797
|
|
|
$
|
14,304
|
|
Phase 1/2a programs
|
3,768
|
|
|
1,630
|
|
|
13,076
|
|
|
1,630
|
|
||||
Other research and development
|
769
|
|
|
936
|
|
|
2,262
|
|
|
3,016
|
|
||||
Total research and development
|
$
|
6,826
|
|
|
$
|
6,359
|
|
|
$
|
20,135
|
|
|
$
|
18,950
|
|
|
Three Months Ended September 30,
|
|
Increase
|
||||||||
(in thousands)
|
2019
|
|
2018
|
|
(Decrease)
|
||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
$
|
6,826
|
|
|
$
|
6,359
|
|
|
$
|
467
|
|
General and administrative
|
2,758
|
|
|
4,101
|
|
|
(1,343
|
)
|
|||
Total operating expenses
|
9,584
|
|
|
10,460
|
|
|
(876
|
)
|
|||
Loss from operations
|
(9,584
|
)
|
|
(10,460
|
)
|
|
(876
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
|
|
|
|||
Change in fair value of warrants
|
2,206
|
|
|
2,894
|
|
|
(688
|
)
|
|||
Interest expense, net
|
(154
|
)
|
|
(266
|
)
|
|
(112
|
)
|
|||
Other income (expense)
|
—
|
|
|
(1
|
)
|
|
(1
|
)
|
|||
Total other income
|
2,052
|
|
|
2,627
|
|
|
(575
|
)
|
|||
Net loss
|
$
|
(7,532
|
)
|
|
$
|
(7,833
|
)
|
|
$
|
(301
|
)
|
|
Nine Months Ended September 30,
|
|
Increase
|
||||||||
(in thousands)
|
2019
|
|
2018
|
|
(Decrease)
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
$
|
20,135
|
|
|
$
|
18,950
|
|
|
$
|
1,185
|
|
General and administrative
|
8,992
|
|
|
11,682
|
|
|
(2,690
|
)
|
|||
Total operating expenses
|
29,127
|
|
|
30,632
|
|
|
(1,505
|
)
|
|||
Loss from operations
|
(29,127
|
)
|
|
(30,632
|
)
|
|
(1,505
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Change in fair value of warrants
|
289
|
|
|
3,093
|
|
|
(2,804
|
)
|
|||
Interest expense, net
|
(755
|
)
|
|
(708
|
)
|
|
47
|
|
|||
Other income (expense)
|
(1
|
)
|
|
86
|
|
|
(87
|
)
|
|||
Total other income (expense)
|
(467
|
)
|
|
2,471
|
|
|
(2,938
|
)
|
|||
Net loss
|
$
|
(29,594
|
)
|
|
$
|
(28,161
|
)
|
|
$
|
1,433
|
|
•
|
the timing and costs of our planned clinical trials for GEN-009;
|
•
|
the progress, timing, and costs of manufacturing GEN-009 for planned clinical trials;
|
•
|
the outcome, timing, and costs of seeking regulatory approvals, including an IND for GEN-011;
|
•
|
the initiation, progress, timing, costs, and results of preclinical studies and clinical trials for our other product candidates and potential 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 payments, 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;
|
•
|
the extent to which we in-license or acquire other products and technologies;
|
•
|
the receipt of marketing approval;
|
•
|
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;
|
•
|
revenue received from commercial sales of our product candidates.
|
|
Nine Months Ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Net cash used in operating activities
|
$
|
(28,748
|
)
|
|
$
|
(33,057
|
)
|
Net cash used in investing activities
|
(970
|
)
|
|
(141
|
)
|
||
Net cash provided by financing activities
|
50,321
|
|
|
55,419
|
|
||
Net increase in cash and cash equivalents
|
$
|
20,603
|
|
|
$
|
22,221
|
|
Exhibit
Number
|
|
Exhibit
|
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, 2019, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as of September 30, 2019 and December 31, 2018, (ii) Condensed Consolidated Statements of Operations and Comprehensive Income for the three and nine months ended September 30, 2019 and 2018, (iii) Condensed Consolidated Statements of Stockholders' Equity (Deficit) for the nine months ended September 30, 2019 and 2018, (iv) Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2019 and 2018 and (v) Notes to Unaudited Condensed Consolidated Financial Statements
|
|
Genocea Biosciences, Inc.
|
|
|
|
|
Date: October 24, 2019
|
By:
|
/s/ WILLIAM D. CLARK
|
|
|
William D. Clark
|
|
|
President and Chief Executive Officer and Director
|
|
|
(Principal Executive Officer)
|
|
|
|
Date: October 24, 2019
|
By:
|
/s/ DIANTHA DUVALL
|
|
|
Diantha Duvall
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|
1 Year Genocea Biosciences Chart |
1 Month Genocea Biosciences Chart |
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