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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Genvec, Inc. | NASDAQ:GNVC | 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% | 7.193 | 0.35 | 7.19 | 0 | 01:00:00 |
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DELAWARE
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23-2705690
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification Number)
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910 CLOPPER ROAD, SUITE 220N, GAITHERSBURG, MD
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20878
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(Address of principal executive offices)
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(Zip code)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, Par Value $0.001 Per Share
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The NASDAQ Stock Market
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Large accelerated filer
☐
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Accelerated filer
☐
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Non-accelerated filer
☐
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Smaller reporting company
☒
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| (Do not check if a smaller reporting company) | | |
PART NO.
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ITEM NO.
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DESCRIPTION
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PAGE NO.
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| | | | | | Signatures | | | | |
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Financial Statements
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Milestone Event
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Date
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Amount
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| |||
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(1)
Successful completion of certain preclinical development activities
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September 2010
|
| | | $ | 300,000 | | |
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(2)
Successful completion of certain preclinical development activities
|
| |
December 2011
|
| | | | 300,000 | | |
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(3)
Non-rejection by the FDA of the IND filed by Novartis for CGF166
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February 2014
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| | | | 2,000,000 | | |
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(4)
First patient treated in a clinical trial with CGF166
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October 2014
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| | | | 3,000,000 | | |
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Years ended December 31,
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2016
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2015
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(in millions)
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Therapeutic
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| | | $ | 1.7 | | | | | $ | 0.5 | | |
Vaccines
|
| | | | 0.5 | | | | | | 1.0 | | |
Hearing loss and balance disorders
|
| | | | 0.3 | | | | | | 1.0 | | |
Other programs
|
| | | | — | | | | | | 0.1 | | |
Total
|
| | | $ | 2.5 | | | | | $ | 2.6 | | |
|
Name
|
| |
Age
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| |
Present Position with the Registrant
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|
Douglas J. Swirsky | | |
47
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| |
President and Chief Executive Officer and Corporate Secretary
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|
Douglas E. Brough, Ph.D. | | |
62
|
| | Chief Scientific Officer | |
Bryan T. Butman, Ph.D. | | |
64
|
| | Sr. Vice President, Development | |
James V. Lambert | | |
52
|
| | Sr. Director, Accounting and Finance, Corporate Controller, and Treasurer | |
| | |
HIGH
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| |
LOW
|
| ||||||
First Quarter 2016
|
| | | $ | 18.20 | | | | | $ | 3.80 | | |
Second Quarter 2016
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| | | $ | 9.60 | | | | | $ | 5.73 | | |
Third Quarter 2016
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| | | $ | 7.25 | | | | | $ | 4.70 | | |
Fourth Quarter 2016
|
| | | $ | 4.33 | | | | | $ | 2.85 | | |
First Quarter 2015
|
| | | $ | 43.10 | | | | | $ | 21.60 | | |
Second Quarter 2015
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| | | $ | 30.30 | | | | | $ | 18.50 | | |
Third Quarter 2015
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| | | $ | 29.20 | | | | | $ | 20.10 | | |
Fourth Quarter 2015
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| | | $ | 23.70 | | | | | $ | 15.90 | | |
| | |
YEARS ENDED DECEMBER 31,
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2016
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2015
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2014
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2013
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2012
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| | |
(in thousands, except per share data)
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Revenues
|
| | | $ | 511 | | | | | $ | 885 | | | | | $ | 6,041 | | | | | $ | 3,682 | | | | | $ | 9,353 | | |
Operating expenses: | | | | | | | |||||||||||||||||||||||||
General and administrative
|
| | | | 5,227 | | | | | | 4,901 | | | | | | 6,314 | | | | | | 8,484 | | | | | | 9,102 | | |
Research and development
|
| | | | 2,499 | | | | | | 2,551 | | | | | | 2,264 | | | | | | 5,492 | | | | | | 14,348 | | |
Total operating expenses
|
| | | | 7,726 | | | | | | 7,452 | | | | | | 8,578 | | | | | | 13,976 | | | | | | 23,450 | | |
Operating loss
|
| | | | (7,215 ) | | | | | | (6,567 ) | | | | | | (2,537 ) | | | | | | (10,294 ) | | | | | | (14,097 ) | | |
Other income, net
|
| | | | 1,428 | | | | | | 22 | | | | | | 22 | | | | | | 275 | | | | | | 42 | | |
Net loss
|
| | | $ | (5,787 ) | | | | | $ | (6,545 ) | | | | | $ | (2,515 ) | | | | | $ | (10,019 ) | | | | | $ | (14,055 ) | | |
Basic and diluted net loss per share
|
| | | $ | (2.78 ) | | | | | $ | (3.90 ) | | | | | $ | (1.59 ) | | | | | $ | (7.74 ) | | | | | $ | (10.86 ) | | |
Shares used in computation of basic and diluted net loss per share
|
| | | | 2,080 | | | | | | 1,678 | | | | | | 1,583 | | | | | | 1,295 | | | | | | 1,294 | | |
|
| | |
AS OF DECEMBER 31,
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2016
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2015
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2014
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2013
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2012
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(in thousands)
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Cash, cash equivalents, and short-term investments
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| | | $ | 7,165 | | | | | $ | 8,676 | | | | | $ | 14,692 | | | | | $ | 6,105 | | | | | $ | 15,255 | | |
Working capital
|
| | | | 5,611 | | | | | | 7,393 | | | | | | 13,014 | | | | | | 3,999 | | | | | | 12,741 | | |
Total assets
|
| | | | 7,707 | | | | | | 9,463 | | | | | | 15,609 | | | | | | 7,254 | | | | | | 17,430 | | |
Accumulated deficit
|
| | | | (290,627 ) | | | | | | (284,840 ) | | | | | | (278,295 ) | | | | | | (275,780 ) | | | | | | (265,761 ) | | |
Total stockholders’ equity
|
| | | | 4,705 | | | | | | 7,680 | | | | | | 13,298 | | | | | | 4,610 | | | | | | 13,743 | | |
| | |
Years ended December 31,
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2016
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2015
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(in millions)
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Therapeutic
|
| | | $ | 1.7 | | | | | $ | 0.5 | | |
Vaccines
|
| | | | 0.5 | | | | | | 1.0 | | |
Hearing loss and balance disorders
|
| | | | 0.3 | | | | | | 1.0 | | |
Other programs
|
| | | | — | | | | | | 0.1 | | |
Total
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| | | $ | 2.5 | | | | | $ | 2.6 | | |
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Name
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Age
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Position
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Directors whose terms expire in 2017 | | | | ||||
Stefan D. Loren, Ph.D.
(1)(3)
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| |
53
|
| | Director | |
Marc R. Schneebaum
(1)(2)
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62
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| | Director | |
Directors whose terms expire in 2018 | | | | ||||
Wayne T. Hockmeyer, Ph.D.
(2)(3)
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72
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| | Director | |
Douglas J. Swirsky
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47
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| | Director, President and Chief Executive Officer | |
Michael Richman
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56
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| | Chairman of the Board of Directors | |
Directors whose terms expire in 2019 | | | | ||||
William N. Kelley, M.D.
(2)(3)
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77
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| | Director | |
Quinterol J. Mallette, M.D.
(1)
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42
|
| | Director | |
Name and Principal Position
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Year
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Salary
($) |
| |
Option Awards
($) (1) |
| |
Non-Equity
Incentive Plan Compensation ($) (2) |
| |
All Other
Compensation ($) (3) |
| |
Total
($) |
| ||||||||||||||||||
Douglas J. Swirsky,
Chief Executive Officer |
| | | | 2016 | | | | | | 425,000 | | | | | | 113,826 | | | | | | 212,500 | | | | | | 6,625 | | | | | | 757,951 | | |
| | | 2015 | | | | | | 425,000 | | | | | | 482,730 | | | | | | 127,500 | | | | | | 6,625 | | | | | | 1,041,855 | | | ||
Douglas E. Brough,
Chief Scientific Officer |
| | | | 2016 | | | | | | 310,650 | | | | | | 59,190 | | | | | | 93,195 | | | | | | 6,625 | | | | | | 469,660 | | |
| | | 2015 | | | | | | 310,650 | | | | | | 217,229 | | | | | | 67,100 | | | | | | 6,625 | | | | | | 601,604 | | | ||
Bryan T. Butman,
Senior Vice President, Development |
| | | | 2016 | | | | | | 285,000 | | | | | | 27,318 | | | | | | 85,500 | | | | | | 6,625 | | | | | | 404,443 | | |
| | | 2015 | | | | | | 285,000 | | | | | | 144,819 | | | | | | 51,300 | | | | | | 6,625 | | | | | | 487,744 | | |
| Business Development | | | Licensing and collaborations (weighted 70%) | |
| Hearing Loss Program | | | Ensure uninterrupted supply of CGF166 for Phase 1/2 trial (weighted 10%) | |
| TheraBiologics | | | Enable clinical dosing in 2016 for NSC CE trial (weighted 10%) | |
| Financial Goals | | | Complete financing transaction (weighted 10%) | |
Named Executive Officer
|
| |
Target Award
($) |
| |
Corporate
Goals (%) |
| |
Individual
Goals (%) |
| |
Corporate
Goals Achieved (%) |
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Individual
Goals Achieved (%) |
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% of
Target Award (%) |
| |
Dollar
Amount ($) |
| |||||||||||||||||||||
Douglas J. Swirsky
President & CEO |
| | | | 212,500 | | | | | | 100 | | | | | | n/a | | | | | | 100 | | | | | | n/a | | | | | | 100 | | | | | | 212,500 | | |
Douglas E. Brough, Ph.D.
Chief Scientific Officer |
| | | | 93,195 | | | | | | 70 | | | | | | 30 | | | | | | 100 | | | | | | 100 | | | | | | 100 | | | | | | 93,195 | | |
Bryan T. Butman, Ph.D.
SVP, Development |
| | | | 85,500 | | | | | | 70 | | | | | | 30 | | | | | | 100 | | | | | | 100 | | | | | | 100 | | | | | | 85,500 | | |
| | |
Option Awards
|
| |||||||||||||||||||||
Name
|
| |
Number of
Securities Underlying Unexercised Options Exercisable (#) (1) |
| |
Number of
Securities Underlying Unexercised Options Unexercisable (#) (1)(2) |
| |
Option
Exercise Price ($) (1) |
| |
Option
Expiration Date |
| ||||||||||||
Douglas J. Swirsky
|
| | | | 300 | | | | | | — | | | | | | 261.00 | | | | | | 1/18/2017 | | |
| | | 1,500 | | | | | | — | | | | | | 179.00 | | | | | | 1/16/2018 | | | ||
| | | 2,250 | | | | | | — | | | | | | 41.00 | | | | | | 1/22/2019 | | | ||
| | | 1,500 | | | | | | — | | | | | | 220.00 | | | | | | 1/20/2020 | | | ||
| | | 2,000 | | | | | | — | | | | | | 57.00 | | | | | | 1/19/2021 | | | ||
| | | 6,000 | | | | | | — | | | | | | 24.90 | | | | | | 1/18/2022 | | | ||
| | | 12,239 | | | | | | 261 | | | | | | 15.60 | | | | | | 1/22/2023 | | | ||
| | | 5,469 | | | | | | 2,031 | | | | | | 39.60 | | | | | | 1/23/2024 | | | ||
| | | 9,583 | | | | | | 10,417 | | | | | | 29.70 | | | | | | 1/16/2025 | | | ||
| | | — | | | | | | 25,000 | | | | | | 5.60 | | | | | | 1/29/2026 | | | ||
Douglas E. Brough
|
| | | | 400 | | | | | | — | | | | | | 261.00 | | | | | | 1/18/2017 | | |
| | | 250 | | | | | | — | | | | | | 179.00 | | | | | | 1/16/2018 | | | ||
| | | 400 | | | | | | — | | | | | | 218.00 | | | | | | 4/16/2018 | | | ||
| | | 400 | | | | | | — | | | | | | 41.00 | | | | | | 1/22/2019 | | | ||
| | | 1,250 | | | | | | — | | | | | | 220.00 | | | | | | 1/20/2020 | | | ||
| | | 350 | | | | | | — | | | | | | 179.00 | | | | | | 2/1/2020 | | | ||
| | | 2,000 | | | | | | — | | | | | | 57.00 | | | | | | 1/19/2021 | | | ||
| | | 7,500 | | | | | | — | | | | | | 24.90 | | | | | | 1/18/2022 | | | ||
| | | 8,323 | | | | | | 177 | | | | | | 15.60 | | | | | | 1/22/2023 | | | ||
| | | 3,646 | | | | | | 1,354 | | | | | | 39.60 | | | | | | 1/23/2024 | | | ||
| | | 4,312 | | | | | | 4,688 | | | | | | 29.70 | | | | | | 1/16/2025 | | | ||
| | | — | | | | | | 13,000 | | | | | | 5.60 | | | | | | 1/29/2026 | | | ||
Bryan T. Butman
|
| | | | 750 | | | | | | — | | | | | | 261.00 | | | | | | 1/18/2017 | | |
| | | 1,750 | | | | | | — | | | | | | 179.00 | | | | | | 1/16/2018 | | | ||
| | | 2,250 | | | | | | — | | | | | | 41.00 | | | | | | 1/22/2019 | | | ||
| | | 1,500 | | | | | | — | | | | | | 220.00 | | | | | | 1/20/2020 | | | ||
| | | 2,000 | | | | | | — | | | | | | 57.00 | | | | | | 1/19/2021 | | | ||
| | | 6,000 | | | | | | — | | | | | | 24.90 | | | | | | 1/18/2022 | | | ||
| | | 7,344 | | | | | | 156 | | | | | | 15.60 | | | | | | 1/22/2023 | | | ||
| | | 2,917 | | | | | | 1,083 | | | | | | 39.60 | | | | | | 1/23/2024 | | | ||
| | | 2,875 | | | | | | 3,125 | | | | | | 29.70 | | | | | | 1/16/2025 | | | ||
| | | — | | | | | | 6,000 | | | | | | 5.60 | | | | | | 1/29/2026 | | |
Name
(1)
|
| |
Fees Earned
or Paid in Cash (2) ($) |
| |
Option Awards
($) |
| |
Total
($) |
| |||||||||
Michael Richman
(4)
|
| | | | 60,000 | | | | | | 7,418 (3) | | | | | | 67,418 | | |
Wayne T. Hockmeyer, Ph.D.
|
| | | | 60,000 | | | | | | 4,945 (3) | | | | | | 64,945 | | |
William N. Kelley, M.D.
|
| | | | 60,000 | | | | | | 4,945 (3) | | | | | | 64,945 | | |
Marc R. Schneebaum
|
| | | | 60,000 | | | | | | 4,945 (3) | | | | | | 64,945 | | |
Stefan D. Loren, Ph.D.
|
| | | | 60,000 | | | | | | 4,945 (3) | | | | | | 64,945 | | |
Quinterol J. Mallette, M.D.
|
| | | | 60,000 | | | | | | 4,945 (3) | | | | | | 64,945 | | |
Name
(1)
|
| |
Total
(#) (2) |
| |
Vested
(#) (2) |
| |
Unvested
(#) (2) |
| |||||||||
Wayne T. Hockmeyer, Ph.D.
|
| | | | 8,250 | | | | | | 6,750 | | | | | | 1,500 | | |
William N. Kelley, M.D.
|
| | | | 6,750 | | | | | | 5,250 | | | | | | 1,500 | | |
Marc R. Schneebaum
|
| | | | 6,950 | | | | | | 5,450 | | | | | | 1,500 | | |
Stefan D. Loren, Ph.D.
|
| | | | 8,000 | | | | | | 6,000 | | | | | | 2,000 | | |
Quinterol J. Mallette, M.D.
|
| | | | 6,500 | | | | | | 4,000 | | | | | | 2,500 | | |
Michael Richman
|
| | | | 5,750 | | | | | | 2,000 | | | | | | 3,750 | | |
Name of Beneficial Owner
|
| |
Total Number of
Shares Beneficially Owned |
| |
% of
Class Owned |
| ||||||
Beneficial Owner of More than 5% of the Outstanding Common Stock: | | | | ||||||||||
Aristides Capital, LLC
(1)
|
| | | | 169,519 | | | | | | 7.5 % | | |
Sabby Healthcare Master Fund, LTD
(2)
|
| | | | 120,544 | | | | | | 5.3 % | | |
MMCAP International Inc. SPC
(3)
|
| | | | 114,827 | | | | | | 5.1 % | | |
Directors and Named Executive Officers: | | | | ||||||||||
Wayne T. Hockmeyer, Ph.D.
|
| | | | 14,550 | | | | | | * | | |
William N. Kelley, Ph.D.
|
| | | | 12,800 | | | | | | * | | |
Stefan D. Loren, Ph.D.
|
| | | | 6,500 | | | | | | * | | |
Quinterol J. Mallette, M.D.
|
| | | | 4,000 | | | | | | * | | |
Michael Richman
|
| | | | 2,500 | | | | | | * | | |
Marc R. Schneebaum
|
| | | | 13,000 | | | | | | * | | |
Douglas J. Swirsky
|
| | | | 76,155 | | | | | | 3.3 % | | |
Douglas E. Brough, Ph.D.
|
| | | | 47,504 | | | | | | 2.1 % | | |
Bryan T. Butman, Ph.D.
|
| | | | 37,638 | | | | | | 1.6 % | | |
All directors and executive officers as a group (10 persons)
|
| | | | 225,010 | | | | | | 9.3 % | | |
| | |
(a)
|
| |
(b)
|
| |
(c)
|
| |||||||||
Plan category
|
| |
Number of
securities to be issued upon exercise of outstanding options, warrants and rights |
| |
Weighted-
average exercise price of outstanding options, warrants and rights |
| |
Number of
securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) |
| |||||||||
Equity compensation plans approved by security
holders (1) |
| | | | 280,860 | | | | | $ | 31.11 | | | | | | 99,379 | | |
Equity compensation plans not approved by security holders
(2)
|
| | | | 8,333 | | | | | $ | 25.40 | | | | | | 0 | | |
Total
|
| | | | 289,193 | | | | | $ | 30.95 | | | | | | 99,379 | | |
|
Fee Category
|
| |
2016
|
| |
2015
|
| ||||||
Audit Fees
|
| | | $ | 104,520 | | | | | $ | 109,725 | | |
Audit-Related Fees
|
| | | | 5,250 | | | | | | 70,000 | | |
Tax Fees
|
| | | | — | | | | | | — | | |
All Other Fees
|
| | | | — | | | | | | — | | |
Total
|
| | | $ | 109,770 | | | | | $ | 179,725 | | |
|
EXHIBIT
NUMBER |
| |
DESCRIPTION
|
|
2.1 | | |
Agreement and Plan of Merger dated as of January 24, 2017 among Intrexon Corporation, Intrexon GV Holding, Inc., and the Company.
(19)
|
|
3.1 | | | Amended and Restated Certificate of Incorporation, as amended, of the Company. (10) | |
3.2 | | |
Certificate of Designation of Series B Junior Participating Preferred Stock of the Company.
(11)
|
|
3.3 | | |
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Company.
(17)
|
|
3.4 | | |
Certificate of Amendment of the Amended and Restated Certificate of Incorporation, as amended, of the Company.
(20)
|
|
3.5 | | | Amended & Restated Bylaws of the Company. (23) | |
4.1 | | | Specimen Common Stock Certificate. (1) | |
4.2 | | |
Rights Agreement dated August 11, 2011 between the Company and American Stock Transfer & Trust Company, LLC, the form of Certificate of Designation of Series B Junior Participating Preferred Stock attached as Exhibit A thereto, the form of Summary of Rights attached as Exhibit B thereto, and the form of Rights Certificate attached as Exhibit C thereto.
(11)
|
|
4.3 | | |
Amendment No. 1 to Rights Agreement dated January 24, 2017 between the Company and American Stock Transfer & Trust Company, LLC.
(19)
|
|
4.4 | | | Form of Common Stock Purchase Warrant. (21) | |
10.1 | | | Form of Indemnification Agreement for Directors and Officers.* (1) | |
10.2 | | | 2002 Stock Incentive Plan as amended and forms of agreements thereunder.* (4) | |
10.3 | | | Amendment to the GenVec, Inc. 2002 Stock Incentive Plan.* (8) | |
10.4 | | | 2011 Omnibus Incentive Plan.* (12) | |
10.5 | | | Amendment to 2011 Omnibus Incentive Plan dated July 11, 2012. (13) | |
10.6 | | | Amendment to 2011 Omnibus Incentive Plan dated November 22, 2013.* (18) | |
10.7 | | | GenVec, Inc. 2015 Omnibus Incentive Plan.* (17) | |
10.8 | | |
Form of Incentive Stock Option Agreement under GenVec, Inc. 2015 Omnibus Incentive Plan.*
(22)
|
|
10.9 | | |
Form of Director Non-Qualified Stock Option Agreement (Annual Director Awards) under GenVec, Inc. 2015 Omnibus Incentive Plan.*
(22)
|
|
10.10 | | |
Form of Director Non-Qualified Stock Option Agreement (New Director Awards) under GenVec, Inc. 2015 Omnibus Incentive Plan.*
(22)
|
|
10.11 | | |
Salary Continuation Agreement between the Company and Douglas J. Swirsky dated September 18, 2006.*
(6)
|
|
EXHIBIT
NUMBER |
| |
DESCRIPTION
|
|
10.12 | | |
Amendment to Salary Continuation Agreement between the Company and Douglas J. Swirsky dated December 9, 2008.*
(5)
|
|
10.13 | | |
Change in Control Agreement between the Company and Douglas J. Swirsky dated September 18, 2006.*
(6)
|
|
10.14 | | |
Amendment to Change in Control Agreement between the Company and Douglas J. Swirsky dated December 9, 2008.*
(5)
|
|
10.15 | | |
Salary Continuation Agreement between the Company and Douglas E. Brough dated February 1, 2010.*
(14)
|
|
10.16 | | | Salary Continuation Agreement between the Company and Bryan T. Butman dated October 15, 2002.* (14) | |
10.17 | | |
Amendment to Salary Continuation Agreement between the Company and Bryan T. Butman dated December 9, 2008.*
(15)
|
|
10.18 | | |
Form of Indemnification and Advancement of Expenses Agreement dated December 10, 2003.*
(3)
|
|
10.19 | | |
Research Collaboration and License Agreement, dated January 13, 2010, by and between GenVec, Inc. and Novartis Institutes for BioMedical Research, Inc.+
(7)
|
|
10.20 | | |
Amendment, dated January 24, 2012, to Research Collaboration and License Agreement, dated January 13, 2010, by and between GenVec, Inc. and Novartis Institutes for BioMedical Research, Inc.+
(14)
|
|
10.21 | | |
Second Amendment, dated January 12, 2013, to Research Collaboration and License Agreement, dated January 13, 2010, by and between GenVec, Inc. and Novartis Institutes for BioMedical Research, Inc.+
(15)
|
|
10.22 | | |
Amendment No. 1, dated November 10, 2015, to Research Collaboration and License Agreement, dated January 13, 2010, by and between GenVec, Inc. and Novartis Institutes for BioMedical Research, Inc.
(22)
|
|
10.23 | | | Amended and Restated License Agreement, dated June 23, 1998, between the Company and the Cornell Research Foundation.+ (1) | |
10.24 | | | Amendment to Amended and Restated License Agreement, dated March 18, 2002, between the Company and the Cornell Research Foundation.+ (2) | |
10.25 | | |
Agreement for the Supply of Services related to Development Materials, dated August 4, 2010, between Novartis Pharma AG and GenVec, Inc.+
(9)
|
|
10. 26 | | |
Equity Distribution Agreement, dated February 11, 2014, between the Company and Roth Capital Partners.
(16)
|
|
10.27 | | | Form of Securities Purchase Agreement dated as of May 4, 2016. (21) | |
10.28 | | |
Lease Agreement, dated November 15, 2013, between the Company and ARE-Maryland No. 30, LLC. (filed herewith)
|
|
10.29 | | |
First Amendment to Lease Agreement, dated December 19, 2014, between the Company and ARE-Maryland No. 30, LLC. (filed herewith)
|
|
10.30 | | |
Second Amendment to Lease Agreement, dated February 11, 2015, between the Company and ARE-Maryland No. 30, LLC. (filed herewith)
|
|
10.31 | | |
Third Amendment to Lease Agreement, dated July 27, 2015, between the Company and ARE-Maryland No. 30, LLC. (filed herewith)
|
|
23.1 | | | Consent of Independent Registered Public Accounting Firm. (filed herewith) | |
23.2 | | | Consent of Independent Registered Public Accounting Firm. (filed herewith) | |
24.1 | | | Power of Attorney. (filed herewith) | |
31.1 | | | Rule 13a-14(a) Certification by Principal Executive Officer. (filed herewith) | |
EXHIBIT
NUMBER |
| |
DESCRIPTION
|
|
31.2 | | | Rule 13a-14(a) Certification by Principal Financial Officer. (filed herewith) | |
32.1 | | |
Rule 13a-14(b) Certification by Principal Executive Officer pursuant to 18 United States Code Section 1350. (filed herewith)
|
|
32.2 | | |
Rule 13a-14(b) Certification by Principal Financial Officer pursuant to 18 United States Code Section 1350. (filed herewith)
|
|
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. | |
| | | | GENVEC, INC. | |
| By: | | |
/s/ DOUGLAS J. SWIRSKY
Douglas J. Swirsky
President, Chief Executive Officer and Director |
|
| Date: | | | March 6, 2017 | |
| | | |
TITLE
|
| |
DATE
|
|
|
/s/ DOUGLAS J. SWIRSKY
Douglas J. Swirsky
|
| | President, Chief Executive Officer, Corporate Secretary, and Director (Principal Executive Officer) | | |
March 6, 2017
|
|
|
/s/ JAMES V. LAMBERT
James V. Lambert
|
| | Sr. Director, Accounting & Finance, Corporate Controller, and Treasurer (Principal Financial Officer and Principal Accounting Officer) | | |
March 6, 2017
|
|
|
*
Michael Richman
|
| | Director | | |
March 6, 2017
|
|
|
*
Wayne T. Hockmeyer, Ph.D.
|
| | Director | | |
March 6, 2017
|
|
|
*
William N. Kelley, M.D.
|
| | Director | | |
March 6, 2017
|
|
|
*
Marc R. Schneebaum
|
| | Director | | |
March 6, 2017
|
|
|
*
Stefan D. Loren, Ph.D.
|
| | Director | | |
March 6, 2017
|
|
|
*
Quinterol J. Mallette, M.D.
|
| | Director | | |
March 6, 2017
|
|
| *By: | | |
/s/ DOUGLAS J. SWIRSKY
Douglas J. Swirsky, attorney-in-fact
|
|
| | |
PAGE NO.
|
|
Reports of Independent Registered Public Accounting Firm
|
| | | |
| | | ||
| | | ||
| | | ||
| | | ||
Notes to Financial Statements
|
| | |
| | |
As of December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
| | |
(in thousands, except per share data)
|
| |||||||||
ASSETS | | | | ||||||||||
Current assets: | | | | ||||||||||
Cash and cash equivalents
|
| | | $ | 3,667 | | | | | $ | 7,015 | | |
Investments, at fair value
|
| | | | 3,498 | | | | | | 1,661 | | |
Accounts receivable, net
|
| | | | 22 | | | | | | 166 | | |
Prepaid expenses and other
|
| | | | 271 | | | | | | 245 | | |
Total current assets
|
| | | | 7,458 | | | | | | 9,087 | | |
Property and equipment, net
|
| | | | 191 | | | | | | 279 | | |
Other assets
|
| | | | 58 | | | | | | 97 | | |
Total assets
|
| | | $ | 7,707 | | | | | $ | 9,463 | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | ||||||||||
Current liabilities: | | | | ||||||||||
Accounts payable
|
| | | $ | 957 | | | | | $ | 1,096 | | |
Accrued expenses and other
|
| | | | 890 | | | | | | 598 | | |
Total current liabilities
|
| | | | 1,847 | | | | | | 1,694 | | |
Warrant liabilities, at fair value
|
| | | | 1,059 | | | | | | — | | |
Other liabilities
|
| | | | 96 | | | | | | 89 | | |
Total liabilities
|
| | | | 3,002 | | | | | | 1,783 | | |
Commitments and Contingencies | | | | ||||||||||
Stockholders’ equity: | | | | ||||||||||
Preferred stock, $0.001 par value, 5,000 shares authorized; none issued and outstanding at December 31, 2016 or 2015
|
| | | | — | | | | | | — | | |
Common stock, $0.001 par value; 55,000 shares authorized; 2,274 and 1,726 shares issued and outstanding at December 31, 2016 and 2015, respectively
|
| | | | 2 | | | | | | 2 | | |
Additional paid-in capital
|
| | | | 295,333 | | | | | | 292,523 | | |
Accumulated other comprehensive loss
|
| | | | (3 ) | | | | | | (5 ) | | |
Accumulated deficit
|
| | | | (290,627 ) | | | | | | (284,840 ) | | |
Total stockholders’ equity
|
| | | | 4,705 | | | | | | 7,680 | | |
Total liabilities and stockholders’ equity
|
| | | $ | 7,707 | | | | | $ | 9,463 | | |
|
| | |
Years ended December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
| | |
(in thousands, except per share data)
|
| |||||||||
Revenues | | | | $ | 511 | | | | | $ | 885 | | |
Operating expenses: | | | | ||||||||||
General and administrative
|
| | | | 5,227 | | | | | | 4,901 | | |
Research and development
|
| | | | 2,499 | | | | | | 2,551 | | |
Total operating expenses
|
| | | | 7,726 | | | | | | 7,452 | | |
Operating loss
|
| | | | (7,215 ) | | | | | | (6,567 ) | | |
Other income/(expense): | | | | | | | | | | | | | |
Change in fair value of warrant liabilities
|
| | | | 1,655 | | | | | | — | | |
Financing expense
|
| | | | (250 ) | | | | | | — | | |
Interest and other income, net
|
| | | | 23 | | | | | | 22 | | |
Total other income, net
|
| | | | 1,428 | | | | | | 22 | | |
Net loss
|
| | | $ | (5,787 ) | | | | | $ | (6,545 ) | | |
Basic and diluted net loss per share
|
| | | $ | (2.78 ) | | | | | $ | (3.90 ) | | |
Shares used in computation of basic and diluted net loss per share
|
| | | | 2,080 | | | | | | 1,678 | | |
Comprehensive Loss: | | | | ||||||||||
Net loss
|
| | | $ | (5,787 ) | | | | | $ | (6,545 ) | | |
Unrealized holding gain on securities
|
| | | | 2 | | | | | | 28 | | |
Comprehensive loss
|
| | | $ | (5,785 ) | | | | | $ | (6,517 ) | | |
|
| | |
Common Stock
|
| |
Additional
Paid-in Capital |
| |
Accumulated
Other Comprehensive Loss |
| |
Accumulated
Deficit |
| |
Total
|
| | |||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| | ||||||||||||||||||||||||||||||||
| | |
(in thousands)
|
| | | | |||||||||||||||||||||||||||||||||
Balance, January 1, 2015
|
| | | | 1,727 | | | | | $ | 2 | | | | | $ | 291,624 | | | | | $ | (33 ) | | | | | $ | (278,295 ) | | | | | $ | 13,298 | | | | ||
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (6,545 ) | | | | | | (6,545 ) | | | | ||
Unrealized change in investments,
net |
| | | | — | | | | | | — | | | | | | — | | | | | | 28 | | | | | | — | | | | | | 28 | | | | ||
Common stock issued under shelf registration, net of issuance costs
|
| | | | (1 ) | | | | | | — | | | | | | (24 ) | | | | | | — | | | | | | — | | | | | | (24 ) | | | | ||
Stock-based compensation
|
| | | | — | | | | | | — | | | | | | 923 | | | | | | — | | | | | | — | | | | | | 923 | | | | ||
Balance, December 31, 2015
|
| | | | 1,726 | | | | | $ | 2 | | | | | $ | 292,523 | | | | | $ | (5 ) | | | | | $ | (284,840 ) | | | | | $ | 7,680 | | | | ||
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (5,787 ) | | | | | | (5,787 ) | | | | ||
Unrealized change in investments,
net |
| | | | — | | | | | | — | | | | | | — | | | | | | 2 | | | | | | — | | | | | | 2 | | | | ||
Common stock issued under shelf registration, net of issuance costs
|
| | | | 548 | | | | | | — | | | | | | 2,029 | | | | | | — | | | | | | — | | | | | | 2,029 | | | | ||
Stock-based compensation
|
| | | | — | | | | | | — | | | | | | 781 | | | | | | — | | | | | | — | | | | | | 781 | | | | ||
Balance, December 31, 2016
|
| | | | 2,274 | | | | | $ | 2 | | | | | $ | 295,333 | | | | | $ | (3 ) | | | | | $ | (290,627 ) | | | | | $ | 4,705 | | | | ||
|
| | |
Years ended December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
| | |
(in thousands)
|
| |||||||||
Cash flows from operating activities: | | | | ||||||||||
Net loss
|
| | | $ | (5,787 ) | | | | | $ | (6,545 ) | | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | | | | | | |
Depreciation and amortization
|
| | | | 90 | | | | | | 97 | | |
Non-cash adjustments for financing expense
|
| | | | 250 | | | | | | — | | |
Bad debt expense
|
| | | | — | | | | | | 24 | | |
Non-cash charges for stock-based compensation
|
| | | | 781 | | | | | | 923 | | |
Non-cash consideration for release of security interest
|
| | | | 4 | | | | | | — | | |
Change in fair value of warrant liabilities
|
| | | | (1,655 ) | | | | | | — | | |
Impairment of long lived assets
|
| | | | 16 | | | | | | — | | |
Gain on sale of long lived assets
|
| | | | — | | | | | | (18 ) | | |
Changes in current assets and liabilities, net
|
| | | | 311 | | | | | | (509 ) | | |
Changes in non-current assets, net
|
| | | | 7 | | | | | | 89 | | |
Net cash used in operating activities
|
| | | | (5,983 ) | | | | | | (5,939 ) | | |
Cash flows provided by investing activities: | | | | ||||||||||
Purchases of property and equipment
|
| | | | (19 ) | | | | | | (100 ) | | |
Proceeds from sale of property and equipment
|
| | | | — | | | | | | 18 | | |
Purchases of investment securities
|
| | | | (3,483 ) | | | | | | — | | |
Proceeds from sale or maturity of investment securities
|
| | | | 1,644 | | | | | | 5,092 | | |
Net cash provided by/(used in) investing activities
|
| | | | (1,858 ) | | | | | | 5,010 | | |
Cash flows from financing activities: | | | | ||||||||||
Proceeds/(costs) from issuance of common stock and warrants
|
| | | | 4,493 | | | | | | (24 ) | | |
Net cash provided by/(used in) financing activities
|
| | | | 4,493 | | | | | | (24 ) | | |
Change in cash and cash equivalents
|
| | | | (3,348 ) | | | | | | (953 ) | | |
Beginning balance of cash and cash equivalents
|
| | | | 7,015 | | | | | | 7,968 | | |
Ending balance of cash and cash equivalents
|
| | | $ | 3,667 | | | | | $ | 7,015 | | |
|
| | |
Total Carrying
Value on the Balance Sheet |
| |
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
| |
Significant
Other Observable Inputs (Level 2) |
| |
Significant
Unobservable Inputs (Level 3) |
| ||||||||||||
| | |
(in thousands)
|
| |||||||||||||||||||||
Assets: | | | | | | ||||||||||||||||||||
Corporate notes and bonds
|
| | | $ | 3,498 | | | | | $ | — | | | | | $ | 3,498 | | | | | $ | — | | |
Total assets at fair value
|
| | | $ | 3,498 | | | | | $ | — | | | | | $ | 3,498 | | | | | $ | — | | |
Liabilities: | | | | | | ||||||||||||||||||||
Warrant liabilities
|
| | | $ | 1,059 | | | | | $ | — | | | | | $ | — | | | | | $ | 1,059 | | |
Total liabilities at fair value
|
| | | $ | 1,059 | | | | | $ | — | | | | | $ | — | | | | | $ | 1,059 | | |
|
| | |
Total Carrying
Value on the Balance Sheet |
| |
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
| |
Significant
Other Observable Inputs (Level 2) |
| |||||||||
| | |
(in thousands)
|
| |||||||||||||||
Assets: | | | | | |||||||||||||||
Corporate notes and bonds
|
| | | $ | 1,593 | | | | | $ | — | | | | | $ | 1,593 | | |
Equity securities
|
| | | | 68 | | | | | | 68 | | | | | | — | | |
Total assets at fair value
|
| | | $ | 1,661 | | | | | $ | 68 | | | | | $ | 1,593 | | |
|
| | | | | | | | |
Gross Unrealized
|
| | | | | | | |||||||||
| | |
Amortized Cost
|
| |
Gains
|
| |
Losses
|
| |
Fair Value
|
| ||||||||||||
| | |
(in thousands)
|
| |||||||||||||||||||||
December 31, 2016 | | | | | | ||||||||||||||||||||
Investments | | | | | | ||||||||||||||||||||
Corporate and agency notes
|
| | | $ | 3,496 | | | | | $ | 2 | | | | | $ | — | | | | | $ | 3,498 | | |
Total investments
|
| | | $ | 3,496 | | | | | $ | 2 | | | | | $ | — | | | | | $ | 3,498 | | |
December 31, 2015 | | | | | | ||||||||||||||||||||
Investments | | | | | | ||||||||||||||||||||
Corporate and agency notes and equity securities
|
| | | $ | 1,666 | | | | | $ | — | | | | | $ | (5 ) | | | | | $ | 1,661 | | |
Total investments
|
| | | $ | 1,666 | | | | | $ | — | | | | | $ | (5 ) | | | | | $ | 1,661 | | |
|
| | |
Warrant
Liabilities |
| |||
| | |
(in thousands)
|
| |||
Balance at January 1, 2016
|
| | | $ | — | | |
Warrant issuances
|
| | | | 2,714 | | |
Change in fair value
|
| | | | (1,655 ) | | |
Balance at December 31, 2016
|
| | | $ | 1,059 | | |
|
| | |
2016
|
| |
2015
|
| ||||||
| | |
(in thousands)
|
| |||||||||
Equipment | | | | $ | 863 | | | | | $ | 881 | | |
Leasehold improvements
|
| | | | 80 | | | | | | 66 | | |
Furniture and fixtures
|
| | | | 111 | | | | | | 105 | | |
| | | | | 1,054 | | | | | | 1,052 | | |
Less accumulated depreciation and amortization
|
| | | | (863 ) | | | | | | (773 ) | | |
| | | | $ | 191 | | | | | $ | 279 | | |
|
| | |
2016
|
| |
2015
|
| ||||||
| | |
(in thousands)
|
| |||||||||
Payroll, compensation, and benefits
|
| | | $ | 684 | | | | | $ | 450 | | |
Professional fees
|
| | | | 190 | | | | | | 131 | | |
Other | | | | | 16 | | | | | | 17 | | |
Total accrued expenses
|
| | | $ | 890 | | | | | $ | 598 | | |
|
| | |
2016
|
| |
2015
|
| ||||||
| | |
(in thousands)
|
| |||||||||
Hearing Program
|
| | | $ | 175 | | | | | $ | 424 | | |
Foot and Mouth Disease Program
|
| | | | 100 | | | | | | 180 | | |
Malaria Program
|
| | | | 236 | | | | | | 131 | | |
Other strategic collaborations and research grants
|
| | | | — | | | | | | 150 | | |
| | | | $ | 511 | | | | | $ | 885 | | |
|
|
Milestone Event
|
| |
Date
|
| |
Amount
|
| |||
|
(1)
Successful completion of certain preclinical development activities
|
| |
September 2010
|
| | | $ | 300,000 | | |
|
(2)
Successful completion of certain preclinical development activities
|
| |
December 2011
|
| | | | 300,000 | | |
|
(3)
Non-rejection by the FDA of the IND filed by Novartis for CGF166
|
| |
February 2014
|
| | | | 2,000,000 | | |
|
(4)
First patient treated in a clinical trial with CGF166
|
| |
October 2014
|
| | | | 3,000,000 | | |
|
2017
|
| | | $ | 390 | | |
|
2018
|
| | | $ | 380 | | |
|
2019
|
| | | $ | 387 | | |
|
2020
|
| | | $ | 395 | | |
|
2021
|
| | | $ | 200 | | |
| | |
Years ended December 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
| | |
(in thousands)
|
| |||||||||
General and administrative
|
| | | $ | 520 | | | | | $ | 554 | | |
Research and development
|
| | | | 261 | | | | | | 369 | | |
| | | | $ | 781 | | | | | $ | 923 | | |
|
| | |
2016
|
| |
2015
|
|
Range of risk-free interest rate
|
| |
1.41% – 1.51%
|
| |
1.42% – 1.87%
|
|
Expected dividend yield
|
| |
0.00%
|
| |
0.00%
|
|
Range of expected volatility
|
| |
101.66% – 114.88%
|
| |
103.44% – 103.64
|
|
Expected life (years)
|
| |
6.48
|
| |
6.30
|
|
| | |
Number
of Shares Under Option |
| |
Weighted
Average Exercise Price |
| |
Weighted
Average Contractual Life (years) |
| |
Aggregate
Intrinsic Value |
| ||||||||||||
| | |
(in thousands, except per share data)
|
| |||||||||||||||||||||
Outstanding at January 1, 2015
|
| | | | 167 | | | | | | 47.43 | | | | | ||||||||||
Granted
|
| | | | 57 | | | | | | 27.92 | | | | | ||||||||||
Cancelled
|
| | | | (1 ) | | | | | | 182.75 | | | | | ||||||||||
Outstanding at December 31, 2015
|
| | | | 223 | | | | | | 41.49 | | | | | ||||||||||
Granted
|
| | | | 71 | | | | | | 5.28 | | | | | ||||||||||
Cancelled
|
| | | | (5 ) | | | | | | 136.34 | | | | | ||||||||||
Stock options outstanding at December 31, 2016
|
| | | | 289 | | | | | $ | 30.95 | | | | | | 6.9 | | | | | $ | — | | |
Vested or expected to vest at December 31, 2016
|
| | | | 274 | | | | | $ | 31.95 | | | | | | 6.8 | | | | | $ | — | | |
Exercisable at December 31, 2016
|
| | | | 184 | | | | | $ | 40.98 | | | | | | 5.8 | | | | | $ | — | | |
|
| | |
(in thousands)
|
| |||
Allocated to warrant liabilities
|
| | | $ | 2,511 | | |
Allocated to common stock and additional paid-in capital
|
| | | | 2,489 | | |
Total allocated gross proceeds
|
| | | $ | 5,000 | | |
|
Offering Date
|
| |
Outstanding Warrants
|
| |
Exercise Price
|
| |
Expiration Date
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Status
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May 2016
|
| | | | 410,396.8 | | | | | $ | 8.30 | | | | | | 11/10/2022 | | | | | | Exercisable | | |
May 2016
|
| | | | 38,303.7 | | | | | $ | 11.4220 | | | | | | 5/4/2021 | | | | | | Exercisable | | |
| | | | | 448,700.5 | | | | | | | | | | | | | | | | | | | | |
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| | |
2016
|
| |
2015
|
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(in thousands)
|
| |||||||||
Tax provision computed at the statutory rate
|
| | | $ | (1,968 ) | | | | | $ | (2,225 ) | | |
State income taxes, net of federal income tax provision
|
| | | | (315 ) | | | | | | (356 ) | | |
Book (income) / expenses not taxable or deductible
|
| | | | (548 ) | | | | | | 3 | | |
Nondeductible compensation expense
|
| | | | 153 | | | | | | 151 | | |
Credits and Other
|
| | | | 11 | | | | | | (386 ) | | |
Change in valuation allowance for deferred tax assets
|
| | | | 2,667 | | | | | | 2,813 | | |
Income tax expense
|
| | | $ | — | | | | | $ | — | | |
|
| | |
2016
|
| |
2015
|
| ||||||
| | |
(in thousands)
|
| |||||||||
Net operating loss carryforwards
|
| | | $ | 104,742 | | | | | $ | 102,229 | | |
Research and experimentation tax credit
|
| | | | 14,568 | | | | | | 14,568 | | |
Property and equipment, principally due to differences in depreciation
|
| | | | (73 ) | | | | | | (78 ) | | |
Deferred compensation expense
|
| | | | 1,218 | | | | | | 1,063 | | |
Other
|
| | | | 157 | | | | | | 153 | | |
Total deferred tax assets
|
| | | | 120,612 | | | | | | 117,935 | | |
Valuation allowance
|
| | | | (120,612 ) | | | | | | (117,935 ) | | |
Net deferred tax assets
|
| | | $ | — | | | | | $ | — | | |
|
2016 (unaudited)
|
| |
Q1
|
| |
Q2
|
| |
Q3
|
| |
Q4
|
| ||||||||||||
| | |
(in thousands, except per share data)
|
| |||||||||||||||||||||
Revenue
|
| | | $ | 290 | | | | | $ | 26 | | | | | $ | 173 | | | | | $ | 22 | | |
Operating loss
|
| | | $ | (1,859 ) | | | | | $ | (1,714 ) | | | | | $ | (1,530 ) | | | | | $ | (2,111 ) | | |
Net loss
|
| | | $ | (1,860 ) | | | | | $ | (1,195 ) | | | | | $ | (1,207 ) | | | | | $ | (1,525 ) | | |
Basic and diluted net loss per share
|
| | | $ | (1.08 ) | | | | | $ | (0.59 ) | | | | | $ | (0.53 ) | | | | | $ | (0.67 ) | | |
2015 (unaudited)
|
| |
Q1
|
| |
Q2
|
| |
Q3
|
| |
Q4
|
| ||||||||||||
| | |
(in thousands, except per share data)
|
| |||||||||||||||||||||
Revenue
|
| | | $ | 405 | | | | | $ | 127 | | | | | $ | 193 | | | | | $ | 160 | | |
Operating loss
|
| | | $ | (1,536 ) | | | | | $ | (1,875 ) | | | | | $ | (1,511 ) | | | | | $ | (1,645 ) | | |
Net loss
|
| | | $ | (1,529 ) | | | | | $ | (1,869 ) | | | | | $ | (1,505 ) | | | | | $ | (1,642 ) | | |
Basic and diluted net loss per share
|
| | | $ | (0.90 ) | | | | | $ | (1.10 ) | | | | | $ | (0.90 ) | | | | | $ | (1.00 ) | | |
1 Year Genvec, Inc. Chart |
1 Month Genvec, Inc. Chart |
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