Eloxx Pharmaceuticals, Inc. - Quarter Report: 2009 December (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended December 31, 2009
or
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the transition period from _____________ to _____________
Commission
File No. 001-31326
SENESCO
TECHNOLOGIES, INC.
(exact
name of registrant as specified in its charter)
Delaware
|
84-1368850
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
303
George Street, Suite 420
New
Brunswick, New Jersey 08901
(Address
of principal executive offices)
(732)
296-8400
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
past 12 months (or for such shorter period that the registrant was required to
file such reports), and (2) has been subject to such filing requirements for the
past 90 days.
Yes: x No: ¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes: ¨ No: ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting
company. See definitions of “accelerated filer”, “large accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Smaller
reporting company x
|
Non-accelerated
filer ¨
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes: ¨ No: x
As of
January 31, 2010, 31,017,079 shares of the issuer’s common stock, par value
$0.01 per share, were outstanding.
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
TABLE OF
CONTENTS
Page
|
|||||
PART
I.
|
FINANCIAL
INFORMATION.
|
||||
Item
1.
|
Financial
Statements (Unaudited)
|
1 | |||
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|||||
as
of December 31, 2009 and June 30, 2009
|
2 | ||||
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|||||
For
the Three Months Ended December 31, 2009 and 2008,
|
|||||
For
the Six Months Ended December 31, 2009 and 2008
|
|||||
and
From Inception on July 1, 1998 through December 31, 2009
|
3 | ||||
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
|
|||||
From
Inception on July 1, 1998 through December 31, 2009
|
4 | ||||
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|||||
For
the Six Months Ended December 31, 2009 and 2008,
|
|||||
and
From Inception on July 1, 1998 through December 31, 2009
|
9 | ||||
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
|
10 | ||||
Item
2.
|
Management’s
Discussion and Analysis of Financial
|
||||
Condition
and Results of Operations
|
22 | ||||
Overview
|
22 | ||||
Liquidity
and Capital Resources
|
32 | ||||
Changes
to Critical Accounting Policies and Estimates
|
34 | ||||
Results
of Operations
|
35 | ||||
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
42 | |||
Item
4T.
|
Controls
and Procedures
|
42 | |||
PART
II.
|
OTHER
INFORMATION
|
||||
Item
1A.
|
Risk
Factors
|
43 | |||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
59 | |||
Item
5.
|
Other
Information
|
59 | |||
Item
6.
|
Exhibits
|
59 | |||
SIGNATURES
|
60 |
-i-
PART I. FINANCIAL
INFORMATION.
Item
1.
|
Financial
Statements.
|
Certain
information and footnote disclosures required under United States generally
accepted accounting principles have been condensed or omitted from the following
consolidated financial statements pursuant to the rules and regulations of the
Securities and Exchange Commission. However, Senesco Technologies,
Inc., a Delaware corporation, and its wholly owned subsidiary, Senesco, Inc., a
New Jersey corporation (collectively, “Senesco” or the “Company”), believe that
the disclosures are adequate to assure that the information presented is not
misleading in any material respect.
The
results of operations for the interim periods presented herein are not
necessarily indicative of the results to be expected for the entire fiscal
year.
-1-
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONDENSED CONSOLIDATED
BALANCE SHEETS
December 31,
|
June 30,
|
|||||||
2009
|
2009
|
|||||||
|
(unaudited)
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 751,787 | $ | 380,569 | ||||
Short-term
investments
|
- | 1,050,000 | ||||||
Accounts
receivable
|
140,000 | - | ||||||
Deferred
financing costs
|
361,057 | - | ||||||
Prepaid
expenses and other current assets
|
1,132,004 | 1,161,348 | ||||||
Total
Current Assets
|
2,384,848 | 2,591,917 | ||||||
Property
and equipment, net
|
6,088 | 5,986 | ||||||
Intangibles,
net
|
4,292,859 | 3,884,999 | ||||||
Deferred
financing costs
|
- | 632,324 | ||||||
Security
deposit
|
7,187 | 7,187 | ||||||
TOTAL
ASSETS
|
$ | 6,690,982 | $ | 7,122,413 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 998,192 | $ | 976,680 | ||||
Accrued
expenses
|
$ | 452,371 | $ | 355,937 | ||||
Convertible
note, net of discount
|
52,633 | - | ||||||
Total
Current Liabilities
|
1,503,196 | 1,332,617 | ||||||
Convertible
note, net of discount
|
- | 6,217 | ||||||
Warrant
liability
|
860,767 | - | ||||||
Grant
payable
|
99,728 | 99,728 | ||||||
Other
liability
|
12,038 | 16,017 | ||||||
TOTAL
LIABILITIES
|
2,475,729 | 1,454,579 | ||||||
STOCKHOLDERS’
EQUITY:
|
||||||||
Preferred
stock, $0.01 par value; authorized 5,000,000 shares, no shares
issued
|
— | — | ||||||
Common
stock, $0.01 par value; authorized 120,000,000 shares, issued
and outstanding 28,640,934 and 19,812,043,
respectively
|
286,409 | 198,120 | ||||||
Capital
in excess of par,
|
37,039,937 | 36,687,846 | ||||||
Deficit
accumulated during the development stage
|
(33,111,093 | ) | (31,218,132 | ) | ||||
TOTAL
STOCKHOLDERS’ EQUITY
|
4,215,253 | 5,667,834 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ | 6,690,982 | $ | 7,122,413 |
See Notes
to Condensed Consolidated Financial Statements.
-2-
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(unaudited)
For the Three
Months Ended
December 31,
|
For the Three
Months Ended
December 31,
|
For the Six
Months Ended
December 31,
|
For the Six
Months Ended
December 31,
|
From Inception on
July 1, 1998
through
December 31,
|
||||||||||||||||
2009
|
2008
|
2009
|
2008
|
2009
|
||||||||||||||||
Revenue
|
$ | 140,000 | $ | — | $ | 140,000 | $ | 200,000 | $ | 1,590,000 | ||||||||||
Operating
Expenses:
|
||||||||||||||||||||
General
and administrative
|
685,409 | 649,056 | 1,180,364 | 1,178,921 | 25,111,557 | |||||||||||||||
Research
and development
|
467,544 | 579,286 | 1,042,835 | 1,083,672 | 13,354,394 | |||||||||||||||
Total
Operating Expenses
|
1,152,953 | 1,228,342 | 2,223,199 | 2,262,593 | 38,465,951 | |||||||||||||||
Loss
From Operations
|
(1,012,953 | ) | (1,228,342 | ) | (2,083,199 | ) | (2,062,593 | ) | (36,875,951 | ) | ||||||||||
Sale
of state income tax loss, net
|
— | — | — | — | 586,442 | |||||||||||||||
Fair
value – warrant liability
|
451,208 | — | 2,339,341 | — | 7,071,108 | |||||||||||||||
Other
noncash income
|
— | — | — | — | 321,259 | |||||||||||||||
Interest
income, net
|
679 | 17,994 | 1,026 | 41,051 | 524,339 | |||||||||||||||
Amortization
of debt discount and financing costs
|
(959,946 | ) | (106,342 | ) | (1,767,860 | ) | (212,397 | ) | (2,914,623 | ) | ||||||||||
Interest
expense on convertible notes
|
(182,653 | ) | (307,651 | ) | (382,269 | ) | (571,808 | ) | (1,823,667 | ) | ||||||||||
Net
Loss
|
$ | (1,703,665 | ) | $ | (1,624,341 | ) | $ | (1,892,961 | ) | $ | (2,805,747 | ) | $ | (33,111,093 | ) | |||||
Basic
and Diluted Net Loss Per Common Share
|
$ | (0.06 | ) | $ | (0.09 | ) | $ | (0.08 | ) | $ | (0.15 | ) | ||||||||
Basic
and Diluted Weighted Average
Number of Common
|
||||||||||||||||||||
Shares
Outstanding
|
26,250,566 | 18,629,575 | 24,146,382 | 18,504,477 |
See Notes
to Condensed Consolidated Financial Statements.
-3-
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONDENSED CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FROM INCEPTION ON JULY 1,
1998 THROUGH DECEMBER 31, 2009
(unaudited)
Common Stock
|
Capital in
Excess of
Par Value
|
Deficit
Accumulated
During the
Development
Stage
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||
Common
stock outstanding
|
2,000,462 | $ | 20,005 | $ | (20,005 | ) | — | — | ||||||||||||
Contribution
of capital
|
— | — | 85,179 | — | $ | 85,179 | ||||||||||||||
Issuance
of common stock in reverse merger on January 22, 1999 at $0.01 per
share
|
3,400,000 | 34,000 | (34,000 | ) | — | — | ||||||||||||||
Issuance
of common stock for cash on May 21, 1999 at $2.63437
per share
|
759,194 | 7,592 | 1,988,390 | — | 1,995,982 | |||||||||||||||
Issuance
of common stock for placement fees on May 21, 1999 at $0.01 per
share
|
53,144 | 531 | (531 | ) | — | — | ||||||||||||||
Issuance
of common stock for cash on January 26, 2000 at $2.867647 per
share
|
17,436 | 174 | 49,826 | — | 50,000 | |||||||||||||||
Issuance
of common stock for cash on January 31, 2000 at $2.87875 per
share
|
34,737 | 347 | 99,653 | — | 100,000 | |||||||||||||||
Issuance
of common stock for cash on February 4, 2000 at $2.934582 per
share
|
85,191 | 852 | 249,148 | — | 250,000 | |||||||||||||||
Issuance
of common stock for cash on March 15, 2000 at $2.527875 per
share
|
51,428 | 514 | 129,486 | — | 130,000 | |||||||||||||||
Issuance
of common stock for cash on June 22, 2000 at $1.50 per
share
|
1,471,700 | 14,718 | 2,192,833 | — | 2,207,551 | |||||||||||||||
Commissions,
legal and bank fees associated with issuances for the year ended June 30,
2000
|
— | — | (260,595 | ) | — | (260,595 | ) | |||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2000
|
— | — | 1,475,927 | — | 1,475,927 |
(continued)
See Notes
to Condensed Consolidated Financial Statements.
-4-
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONDENSED CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FROM INCEPTION ON JULY 1,
1998 THROUGH DECEMBER 31, 2009
(unaudited)
Common Stock
|
Capital in
Excess of
Par Value
|
Deficit
Accumulated
During the
Development
Stage
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||
Fair
market value of options and warrants vesting during the year ended June
30, 2001
|
— | — | $ | 308,619 | — | $ | 308,619 | |||||||||||||
Issuance
of common stock and warrants for cash from November
30, 2001 through April
17, 2002 at $1.75 per unit
|
3,701,430 | $ | 37,014 | 6,440,486 | — | 6,477,500 | ||||||||||||||
Issuance
of common stock and warrants associated with bridge loan conversion on
December 3, 2001
|
305,323 | 3,053 | 531,263 | — | 534,316 | |||||||||||||||
Commissions,
legal and bank fees associated with issuances for the year ended June 30,
2002
|
— | — | (846,444 | ) | — | (846,444 | ) | |||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2002
|
— | — | 1,848,726 | — | 1,848,726 | |||||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2003
|
— | — | 848,842 | — | 848,842 | |||||||||||||||
Issuance
of common stock and warrants for cash from January 15,
2004 through February 12, 2004 at $2.37 per unit
|
1,536,922 | 15,369 | 3,627,131 | — | 3,642,500 | |||||||||||||||
Allocation
of proceeds to warrants
|
— | — | (2,099,090 | ) | — | (2,099,090 | ) | |||||||||||||
Reclassification
of warrants
|
— | 1,913,463 | — | 1,913,463 | ||||||||||||||||
Commissions,
legal and bank fees associated with issuances for the year ended June 30,
2004
|
— | (378,624 | ) | — | (378,624 | ) | ||||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2004
|
- | — | 1,826,514 | — | 1,826,514 |
(continued)
See Notes
to Condensed Consolidated Financial Statements.
-5-
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONDENSED CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FROM INCEPTION ON JULY 1,
1998 THROUGH DECEMBER 31, 2009
(unaudited)
Common Stock
|
Capital in
Excess of
Par Value
|
Deficit
Accumulated
During the
Development
Stage
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||
Options
and warrants exercised during
the year ended June 30, 2004 at exercise prices ranging from $1.00 -
$3.25
|
370,283 | $ | 3,704 | $ | 692,945 | — | $ | 696,649 | ||||||||||||
Issuance
of common stock and warrants for cash on May 9, 2005 at $2.11 per
unit
|
1,595,651 | 15,957 | 3,350,872 | — | 3,366,829 | |||||||||||||||
Allocation
of proceeds to warrants
|
— | — | (1,715,347 | ) | — | (1,715,347 | ) | |||||||||||||
Reclassification
of warrants
|
— | — | 1,579,715 | — | 1,579,715 | |||||||||||||||
Commissions,
legal and bank fees associated with issuance on May 9,
2005
|
— | — | (428,863 | ) | — | (428,863 | ) | |||||||||||||
Options
and warrants exercised during the year ended June 30, 2005 at exercise
prices ranging from $1.50 to $3.25
|
84,487 | 844 | 60,281 | — | 61,125 | |||||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2005
|
— | — | 974,235 | — | 974,235 | |||||||||||||||
Fair
market value of options and Warrants granted and vested During the year
ended June 30,2006
|
— | — | 677,000 | — | 677,000 | |||||||||||||||
Warrants
exercised during the year ended June 30, 2006 at an exercise price of
$0.01
|
10,000 | 100 | — | — | 100 | |||||||||||||||
Issuance
of common stock and warrants for cash on October 11, 2006 at $1.135 per
unit
|
1,986,306 | 19,863 | 2,229,628 | — | 2,249,491 | |||||||||||||||
Commissions,
legal and bank fees associated with issuance on October 11,
2006
|
— | — | (230,483 | ) | — | (230,483 | ) | |||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2007
|
— | — | 970,162 | — | 970,162 |
(continued)
See Notes
to Condensed Consolidated Financial Statements
-6-
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONDENSED CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FROM INCEPTION ON JULY 1,
1998 THROUGH DECEMBER 31, 2009
(unaudited)
Common Stock
|
Capital in
Excess of
Par Value
|
Deficit
Accumulated
During the
Development
Stage
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||
Warrants
exercised during the year ended June 30, 2007 at an exercise price of
$0.01
|
10,000 | $ | 100 | — | — | $ | 100 | |||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2008
|
— | — | $ | 1,536,968 | — | 1,536,968 | ||||||||||||||
Allocation
of proceeds from issuance of convertible notes and warrants from September
21, 2007 through June 30, 2008
|
— | — | 9,340,000 | — | 9,340,000 | |||||||||||||||
Issuance
of common stock in lieu of cash payment for interest during the year ended
June 30, 2008
|
345,867 | 3,458 | 430,696 | — | 434,154 | |||||||||||||||
Convertible
notes converted into common stock during the year ended June 30,
2008
|
555,556 | 5,556 | 430,952 | — | 436,508 | |||||||||||||||
Fair
market value of options and warrants vested during the
year ended June 30, 2009
|
— | — | 506,847 | — | 506,847 | |||||||||||||||
Cashless
exercise of warrants during the year ended June 30, 2009 at an exercise
price of $0.74
|
2,395 | 24 | (24 | ) | — | — | ||||||||||||||
Issuance
of common stock in lieu of cash payment for interest during the year ended
June 30,2009
|
1,271,831 | 12,718 | 994,526 | — | 1,007,244 | |||||||||||||||
Convertible
notes converted into common stock during the year ended June 30,
2009
|
50,000 | 500 | 44,433 | — | 44,933 | |||||||||||||||
Issuance
of common stock in connection with the Company’s short term incentive plan
during the year ended June 30, 2009
|
112,700 | 1,127 | (1,127 | ) | — | — |
(continued)
See Notes
to Condensed Consolidated Financial Statements
-7-
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONDENSED CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FROM INCEPTION ON JULY 1,
1998 THROUGH DECEMBER 31, 2009
(unaudited)
Common Stock
|
Capital in
Excess of
Par Value
|
Deficit
Accumulated
During the
Development
Stage
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||
Cumulative
effect of change in accounting principle –implementation of FASB ASC
815.40
|
— | — | $ | (7,931,875 | ) | $ | 4,731,767 | $ | (3,200,108 | ) | ||||||||||
Issuance
of common stock and warrants for cash during the six months ended December
31, 2009 at $0.90 per unit
|
1,700,000 | $ | 17,000 | 1,513,000 | — | 1,530,000 | ||||||||||||||
Issuance
of common stock and warrants for satisfaction of accounts payable during
the six months ended December 31, 2009
|
194,444 | 1,944 | 259,588 | — | 261,532 | |||||||||||||||
Warrants
exercised for cash during the six months ended December 31, 2009 at an
exercise price of $0.01
|
1,003,000 | 10,030 | — | — | 10,030 | |||||||||||||||
Legal
and regulatory fees associated with issuances during the six
months ended December 31, 2009
|
— | — | (175,862 | ) | — | (175,862 | ) | |||||||||||||
Issuance
of common stock in lieu of cash payment for interest during the six months
ended December 31, 2009
|
969,360 | 9,694 | 372,575 | — | 382,269 | |||||||||||||||
Convertible
notes converted into common stock during the six months ended December 31,
2009
|
4,766,087 | 47,661 | 1,402,516 | — | 1,450,177 | |||||||||||||||
Issuance
of common stock in connection with the Company’s short term incentive plan
during the six months ended December 31, 2009
|
116,000 | 1,160 | (1,160 | ) | — | — | ||||||||||||||
Issuance
of common stock for services during the six months ended December 31,
2009
|
80,000 | 800 | 28,000 | — | 28,800 | |||||||||||||||
Fair
market value of options and warrants vested during the six months ended
December 31, 2009
|
— | — | 153,542 | — | 153,542 | |||||||||||||||
Net
loss
|
— | — | — | $ | (37,842,860 | ) | (37,842,860 | ) | ||||||||||||
Balance
at December 31, 2009
|
28,640,934 | $ | 286,409 | $ | 37,039,937 | $ | (33,111,093 | ) | $ | 4,215,253 |
See Notes
to Condensed Consolidated Financial Statements.
-8-
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(unaudited)
For the Six Months Ended
December 31,
|
From Inception on
July 1, 1998 through
December 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (1,892,961 | ) | $ | (2,805,747 | ) | $ | (33,111,093 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Noncash
capital contribution
|
— | — | 85,179 | |||||||||
Noncash
conversion of accrued expenses into equity
|
— | — | 131,250 | |||||||||
Noncash
income related to change in fair value of
warrant liability
|
(2,339,341 | ) | — | (7,392,367 | ) | |||||||
Issuance
of common stock and warrants for interest
|
382,269 | 571,808 | 1,832,982 | |||||||||
Issuance
of common stock for services
|
28,800 | — | 28,800 | |||||||||
Share-based
compensation expense
|
153,542 | 215,157 | 10,356,486 | |||||||||
Depreciation
and amortization
|
60,535 | 53,740 | 632,976 | |||||||||
Amortization
of convertible note discount
|
1,496,593 | 552 | 2,047,810 | |||||||||
Amortization
of deferred financing costs
|
271,267 | 211,845 | 866,812 | |||||||||
Loss
on extinguishment of debt
|
86,532 | — | 86,532 | |||||||||
(Increase)
decrease in operating assets:
|
||||||||||||
Accounts
receivable
|
(140,000 | ) | — | (140,000 | ) | |||||||
Prepaid
expense and other current assets
|
29,344 | (648,363 | ) | (1,132,004 | ) | |||||||
Security
deposit
|
— | — | (7,187 | ) | ||||||||
Increase
(decrease) in operating liabilities:
|
||||||||||||
Accounts
payable
|
196,512 | 99,113 | 1,173,192 | |||||||||
Accrued
expenses
|
96,434 | 99,417 | 452,371 | |||||||||
Other
liability
|
(3,979 | ) | (3,523 | ) | 12,038 | |||||||
Net
cash used in operating activities
|
(1,574,453 | ) | (2,207,001 | ) | (24,076,223 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Patent
costs
|
(467,382 | ) | (354,196 | ) | (4,753,756 | ) | ||||||
Redemptions
(Purchases) of investments, net
|
1,050,000 | (2,000,000 | ) | — | ||||||||
Purchase
of property and equipment
|
(1,116 | ) | - | (178,179 | ) | |||||||
Net
cash provided by (used in) investing activities
|
581,502 | (2,354,196 | ) | (4,931,924 | ) | |||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from grant
|
— | — | 99,728 | |||||||||
Proceeds
from issuance of bridge notes
|
— | — | 525,000 | |||||||||
Proceeds
from issuance of common stock, net and exercise of options and
warrants
|
1,364,169 | — | 20,446,987 | |||||||||
Proceeds
from issuance of convertible notes and warrants, net
|
— | — | 9,340,000 | |||||||||
Deferred
financing costs
|
— | — | (651,781 | ) | ||||||||
Net
cash provided by financing activities
|
1,364,169 | — | 29,759,934 | |||||||||
Net
increase (decrease) in cash and cash equivalents
|
371,218 | (4,561,197 | ) | 751,787 | ||||||||
Cash
and cash equivalents at beginning of period
|
380,569 | 5,676,985 | — | |||||||||
Cash
and cash equivalents at end of period
|
$ | 751,787 | $ | 1,115,788 | $ | 751,787 | ||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Cash
paid during the period for interest
|
$ | — | $ | — | $ | 22,317 | ||||||
Supplemental
schedule of noncash financing activity:
|
||||||||||||
Conversion
of convertible notes into common stock, net
|
$ | 1,457,460 | $ | — | $ | 2,002,460 | ||||||
Conversion
of bridge notes into stock
|
$ | — | $ | — | $ | 534,316 | ||||||
Allocation
of convertible debt proceeds to warrants and beneficial conversion
feature
|
$ | — | $ | — | $ | 9,340,000 | ||||||
Warrants
issued for financing costs
|
$ | — | $ | — | $ | 639,645 | ||||||
Issuance
of common stock for interest on convertible notes
|
$ | 382,269 | $ | 571,808 | $ | 1,832,982 | ||||||
Issuance
of common stock in settlement of accounts payable
|
$ | 175,000 | $ | — | $ | 175,000 |
See Notes
to Condensed Consolidated Financial Statements.
-9-
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
NOTES TO CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Note
1 - Basis of Presentation:
The
financial statements included herein have been prepared by Senesco Technologies,
Inc. (the “Company”), without audit, pursuant to the rules and regulations of
the Securities and Exchange Commission. Certain information and
footnote disclosures normally included in financial statements prepared in
accordance with United States generally accepted accounting principles have been
condensed or omitted pursuant to such rules and regulations. These
unaudited condensed consolidated financial statements should be read in
conjunction with the audited consolidated financial statements and notes thereto
included in the Company’s Annual Report on Form 10-K for the fiscal year ended
June 30, 2009.
In the
opinion of the Company’s management, the accompanying unaudited condensed
consolidated financial statements contain all adjustments, consisting solely of
those which are of a normal recurring nature, necessary to present fairly its
financial position as of December 31, 2009, the results of its operations for
the three-month and six-month periods ended December 31, 2009 and 2008, cash
flows for the six-month periods ended December 31, 2009 and 2008, and the
results of its operations and cash flows for the period from inception on July
1, 1998 through December 31, 2009.
Interim
results are not necessarily indicative of results for the full fiscal
year.
Note
2 – Liquidity:
There is
substantial doubt about the Company’s ability to continue as a going concern due
to its limited assets, capital and recurring losses as explained in the
following paragraphs.
As shown
in the accompanying consolidated financial statements, the Company has a history
of losses with a deficit accumulated during the development stage from July 1,
1998 (inception) through December 31, 2009 of
$33,111,093. Additionally, the Company has generated minimal revenues
by licensing its technology for certain crops to companies willing to share in
its development costs. In addition, the Company’s technology may not be ready
for commercialization for several years. The Company expects to continue to
incur losses for the next several years because it anticipates that its
expenditures on research and development, and administrative activities will
significantly exceed its revenues during that period. The Company cannot predict
when, if ever, it will become profitable.
As of
December 31, 2009, the Company had cash in the amount of
$751,787. The Company estimates that such amount will cover its
expenses for approximately the next two to three months from December 31,
2009. The accompanying financial statements do not include any
adjustment from the outcome of this uncertainty.
These
conditions raise substantial doubt about the Company's ability to continue as a
going concern. The Company's continuation as a going concern is
dependent upon its ability to ultimately attain profitable operations, generate
sufficient cash flow to meet its obligations and obtain additional financing as
may be required to comply with regulatory requirements. The outcome
of these uncertainties cannot be assured.
-10-
The
Company will need additional capital and plans to raise additional capital
through the placement of equity or debt instruments or both. However,
the Company may not be able to obtain adequate funds for its operations when
needed or on acceptable terms. If the Company is unable to raise
additional funds, it will need to do one or more of the following:
|
·
|
delay,
scale-back or eliminate some or all of its research and product
development programs;
|
|
·
|
license
third parties to develop and commercialize products or technologies that
it would otherwise seek to develop and commercialize
itself;
|
|
·
|
seek
strategic alliances or business
combinations;
|
|
·
|
attempt
to sell the Company;
|
|
·
|
cease
operations; or
|
|
·
|
declare
bankruptcy.
|
Note
3 – Intangible Assets:
The
Company conducts research and development activities, the cost of which is
expensed as incurred, in order to generate patents that can be licensed to third
parties in exchange for license fees and royalties. Because the
patents are the basis of the Company’s future revenue, the patent costs are
capitalized. The capitalized patent costs represent the outside
legal fees incurred by the Company to submit and undertake all necessary efforts
to have such patent applications issued as patents.
The
length of time that it takes for an initial patent application to be approved is
generally between four to six years. However, due to the unique
nature of each patent application, the actual length of time may
vary. If a patent application is denied, the associated cost of that
application would be written off. However, the Company has not had
any patent applications denied as of December 31, 2009. Additionally,
should a patent application become impaired during the application process, the
Company would write down or write off the associated cost of that patent
application.
Issued
patents and agricultural patent applications pending are being amortized over a
period of 17 years, the expected economic life of the patent.
The
Company assesses the impairment in value of intangible assets whenever events or
circumstances indicate that their carrying value may not be
recoverable. Factors the Company considers important which could
trigger an impairment review include the following:
|
·
|
significant
negative industry trends;
|
|
·
|
significant
underutilization of the assets;
|
|
·
|
significant
changes in how the Company uses the assets or its plans for their use;
and
|
|
·
|
changes
in technology and the appearance of competing
technology.
|
If the
Company's review determines that the future discounted cash flows related to
these assets will not be sufficient to recover their carrying value, the Company
will reduce the carrying values of these assets down to its estimate of fair
value and continue amortizing them over their remaining useful
lives. To date, the Company has not recorded any impairment of
intangible assets.
-11-
Note
4 - Loss Per Share:
Net loss
per common share is computed by dividing the loss by the weighted-average number
of common shares outstanding during the period. Shares to be issued
upon the exercise of the outstanding options and warrants aggregating 27,156,605
and 23,866,268 as of December 31, 2009 and 2008, respectively, are not included
in the computation of net loss per share, as their effect is
anti-dilutive. Additionally, based upon the closing share price as of
December 31, 2009, 29,620,519 shares that may be issued upon the conversion of
convertible notes, subject to a maximum of 40,546,852 shares, are not included
in the computation of diluted net loss per share, as their effect is
anti-dilutive.
Note
5 – Share-Based Transactions:
The terms
and vesting schedules for share-based awards vary by type of grant and the
employment status of the grantee. Generally, the awards vest based
upon time-based conditions.
The fair
value of each stock option and warrant granted or vesting has been determined
using the Black-Scholes model. The material factors incorporated in
the Black-Scholes model in estimating the value of the options and warrants
include the following:
Three Months Ended
|
Six Months Ended
|
||||||||
December 31,
|
December 31,
|
||||||||
2009
|
2008
|
2009
|
2008
|
||||||
Estimated
life in years
|
3.5-5.5
|
3.5-5.5
|
3.5-5.5
|
3.5-5.5
|
|||||
Risk-free
interest rate (1)
|
1.9%–3.9%
|
1.1%
– 2.1%
|
1.1%-3.9%
|
1.1%-3.9%
|
|||||
Volatility
|
100%
|
100%
|
100%
|
100%
|
|||||
Dividend
paid
|
|
None
|
|
None
|
|
None
|
|
None
|
(1)
|
Represents
the interest rate on a U.S. Treasury security with a maturity date
corresponding to that of the option
term.
|
The
economic values of the options will depend on the future price of the Company's
common stock, par value $0.01 (the “Common Stock”), which cannot be forecast
with reasonable accuracy.
A summary
of changes in the stock option plan for the six month period ended December 31,
2009 is as follows:
Number of Options
|
Weighted-Average
Exercise Price
|
|||||||
Outstanding
at July 1, 2009
|
4,550,412 | $ | 1.70 | |||||
Granted
|
733,399 | 0.39 | ||||||
Exercised
|
— | — | ||||||
Expired
|
(233,000 | ) | 3.50 | |||||
Outstanding
at December 31, 2009
|
5,050,811 | $ | 1.43 | |||||
Exercisable
at December 31, 2009
|
4,288,310 | $ | 1.54 |
-12-
A summary
of changes to the non-vested stock options for the six month period ended
December 31, 2009 is as follows:
Weighted-Average
|
||||||||
Number of Options
|
Grant-Date
Fair Value
|
|||||||
Non-vested
stock options at July 1, 2009
|
883,000 | $ | 0.66 | |||||
Granted
|
733,399 | 0.30 | ||||||
Vested
|
(849,898 | ) | (0.36 | ) | ||||
Expired
|
(4,000 | ) | (0.46 | ) | ||||
Non-vested
stock options at December 31, 2009
|
762,501 | $ | 0.64 |
As of
December 31, 2009, the aggregate intrinsic value of stock options outstanding
was $0, with a weighted-average remaining term of 6.2 years. The
aggregate intrinsic value of stock options exercisable at that same date was $0,
with a weighted-average remaining term of 5.8 years. As of December
31, 2009, the Company has 5,154,073 shares available for future stock option
grants.
As of
December 31, 2009, total compensation expense not yet recognized related to
stock option grants and restricted stock units amounted to approximately
$102,000, which will be
recognized over the next 24 months, and an additional $517,000 which may be
recognized as achievement of certain target goals under the Company’s Long-Term
Incentive Program become probable over the next 12 months.
During
the three month period ended December 31, 2009, the Company issued 80,000 shares
of common stock for services provided. The closing price of the
common stock on the date of issuance was $0.36, resulting in stock-based
compensation of $28,800.
Short-Term
Incentive Program
On
November 19, 2008, upon recommendation of the Company’s Compensation Committee,
the Board adopted a Short-Term Equity Incentive Program for each of Bruce C.
Galton, John E. Thompson, Ph.D., Joel Brooks, Richard Dondero and Sascha
Fedyszyn. The Programs are intended to ensure the achievement of
certain goals of the Company, continuity of the Company’s executive management,
and to align the interests of the executive management with those of the
shareholders.
Pursuant
to and as defined in the Short-Term Equity Incentive Program, each executive
would be awarded shares of the Company’s Common Stock, or options to acquire
shares of the Company’s Common Stock, if the Company achieves certain target
goals relating to research, financing, licensing, investor relations and other
administrative items during the fiscal year ending June 30, 2009.
-13-
The
number of eligible shares and options that could have been awarded to the
executive is based upon the following weightings:
|
1.
|
25%
of eligible shares and options for contributions relating to the Company’s
Human Health Objectives;
|
|
2.
|
15%
of eligible shares and options for contributions relating to the Company’s
Finance Objectives;
|
|
3.
|
20%
of eligible shares and options for contributions relating to the Company’s
Agricultural Licensing Objectives;
|
|
4.
|
25%
of eligible shares and options for contributions relating to the Company’s
Investor Relations, Intellectual Property and Website Administration;
and
|
|
5.
|
15%
of the eligible shares and options relating to the Company’s
Organizational Objectives.
|
If the
target goals were achieved by the Company, the executive officers would have
been awarded the following number of shares and options for the fiscal year
ended June 30, 2009:
Number of Shares
|
Number of Options (1)
|
|||||||
Bruce
C. Galton
|
66,000 | — | ||||||
John
E. Thompson, Ph.D.
|
— | 48,000 | ||||||
Joel
Brooks
|
28,000 | — | ||||||
Richard
Dondero
|
— | 80,000 | ||||||
Sascha
P. Fedyszyn
|
42,000 | — | ||||||
Total
|
136,000 | 128,000 |
(1)
|
Such
options are exercisable at a strike price of $0.60, which represents the
closing price of the common stock on November 18,
2008.
|
As of
September 30, 2009, the Company had determined that the achievement of the
target goals was probable. The total amount of compensation expense
in connection with the short-term incentive program in the amount of $140,480
had been recorded ratably over the seven and one-half month period from November
19, 2008 through June 30, 2009.
In
October 2009, after a review of each of the factors that comprise the short-term
award program, the compensation committee determined that the executive officers
had partially achieved the previously granted short-term performance milestones,
and accordingly, determined to vest the foregoing RSUs/options as
follows:
Mr. Galton
received shares of common stock underlying his 49,500 RSUs;
Mr. Brooks
received shares of common stock underlying his 26,600 RSUs;
Mr. Fedyszyn
received shares of common stock underlying his 39,900 RSU’s;
Dr. Thompson
received 48,000 options; and
Mr. Dondero
received 76,000 options.
-14-
As a
result of the reduction in the amount of RSU’s/options that vested, a
reduction in the amount of $13,840 was recorded during the three months ended
December 31, 2009.
Long-Term
Incentive Program
On
December 13, 2007, upon recommendation of the Company’s Compensation Committee,
the Board adopted a Long-Term Equity Incentive Program for the members of the
executive management team. The Long-Term Equity Incentive Program is
intended to ensure the achievement of certain goals of the Company, continuity
of the Company’s executive management, and to align the interests of the
executive management with those of the shareholders.
Pursuant
to and as defined in the Long-Term Equity Incentive Program, each executive
would be awarded shares of the Company’s Common Stock and options to acquire
shares of the Company’s Common Stock if the Company achieves certain target
goals relating to its Multiple Myeloma research project over the three fiscal
year period from the date of adoption.
The
number of eligible shares and options to be awarded to the executives is based
upon the following weightings:
|
1.
|
20%
of the eligible shares upon the execution of a research agreement to
conduct a phase I/II clinical trial at a research
facility;
|
|
2.
|
20%
of the eligible shares upon the filing and acceptance by the FDA of an
investigational new drug application;
and
|
|
3.
|
60%
of the eligible shares upon the successful completion of a FDA approved
phase I/II clinical trial.
|
If the
target goals are achieved by the Company, the executive officers would be
awarded the following number of shares and options:
Goal 1
|
Goal 2
|
Goal 3
|
||||||||||
Number of Shares
|
||||||||||||
Joel
Brooks
|
10,000 | 10,000 | 30,000 | |||||||||
Sascha
P. Fedyszyn
|
10,000 | 10,000 | 30,000 | |||||||||
Total
number of shares
|
20,000 | 20,000 | 60,000 | |||||||||
Number
of Options (1)
|
||||||||||||
John
E. Thompson, Ph.D.
|
50,000 | 50,000 | 150,000 | |||||||||
Richard
Dondero
|
60,000 | 60,000 | 180,000 | |||||||||
Total
number of options
|
110,000 | 110,000 | 330,000 |
(1)
|
Such
options are exercisable at a strike price of $0.99, which represents the
closing price of the common stock on December 12,
2007.
|
-15-
As of
December 31, 2009, the Company is not able to determine if the achievement of
the target goals under the Long-Term Equity Incentive Program are probable and,
therefore, has not yet begun to recognize any of the $517,000 compensation
expense that was computed on the date of adoption of the Long-Term Equity
Incentive Program. On February 1, 2010, Sascha Fedyszyn
resigned from the Company and his RSU’s were forfeited. Accordingly,
the compensation expense that has not yet been recognized has been reduced to
$467,500. The Company will begin recognizing such compensation
expense ratably over the remaining term of the Long-Term Equity Incentive
Program at such time that the Company is able to determine that the achievement
of the target goals are probable.
Note 6 – Revenue
Recognition:
The
Company receives certain nonrefundable upfront fees in exchange for the transfer
of its technology to licensees. Upon delivery of the technology, the
Company has no further obligations to the licensee with respect to the basic
technology transferred and, accordingly, recognizes revenue at that
time. The Company may, however, receive additional payments from its
licensees in the event such licensees achieve certain development or
commercialization milestones in their particular field of use. Other
nonrefundable upfront fees and milestone payments, where the milestone payments
are a function of time as opposed to achievement of specific achievement-based
milestones, are deferred and amortized ratably over the estimated research
period of the license. Milestone payments, which are contingent upon
the achievement of certain research goals, are recognized as revenue when the
milestones, as defined in the particular agreement, are achieved.
Note
7 –Convertible Notes and Stockholders Equity:
Convertible
Notes
During
the year ended June 30, 2008, the Company issued $5,000,000 of convertible notes
and warrants to YA Global Investments L.P. (“YA Global”) and $5,000,000 of
convertible notes and warrants to Stanford Venture Capital Holdings, Inc.
(“Stanford”), for aggregate gross proceeds in the amount of
$10,000,000. The convertible notes were convertible into the
Company’s Common Stock at a fixed price of $0.90 per share, subject to certain
adjustments (the “Fixed Conversion Price”), through August 1, 2009 and December
20, 2009, respectively, at which time the convertible notes may convert into
shares of the Company’s Common Stock at the lower of the fixed conversion price
or 80% of the lowest daily volume-weighted average price (the “VWAP”) of the
common stock during the five trading days prior to the conversion date. In July
and September 2009, the fixed conversion price was adjusted to $0.85 and $0.83,
respectively, due to the issuance of common stock and
warrants. The maturity date of each of the convertible notes
for YA Global and Stanford is December 30, 2010 and December 31, 2010,
respectively.
The
convertible notes accrue interest on their outstanding principal balances at an
annual rate of 8%. The Company has the option to pay interest in cash
or, upon certain conditions, common stock. If the Company pays
interest in Common Stock, the stock will be valued at a 10% discount to the
average daily VWAP for the five day trading period prior to the interest payment
date (the “Interest Shares”).
-16-
At the
Company’s option, it can redeem a portion of, or all of, the principal owed
under the convertible notes by providing the investors with at least 30 business
days’ written notice, provided that, at the time of receipt of the notice,
either: (A)(i) the VWAP of the Common Stock exceeds 130% of the Fixed Conversion
Price for at least 20 of 30 prior trading days, and (ii) there is an
effective registration statement for the resale of the Common Stock that will be
issued under the redemption or (B) it redeems a portion, or all, of the
principal owed at a 20% premium above the principal then outstanding and any
accrued interest thereupon. If the Company redeems all or any of the
principal outstanding under the convertible notes, it will pay an amount equal
to the principal being redeemed plus accrued interest.
The
Company has the option to force the investors to convert 50% and 100% of its
then-outstanding convertible notes if its Common Stock price exceeds 150% and
175% of the Fixed Conversion Price, respectively, for any 20 out of 30 trading
days; provided that such forced conversion meets certain conditions (the “Call
Option”). If the Company exercises its Call Option prior to the third
anniversary of the signing date, it will issue additional warrants to the
investor equal to 50% of the number of shares underlying the convertible note
subject to the forced conversion. These warrants will be exercisable
at the fixed conversion price and will have the same maturity as the other
warrants issued under the financing.
The
Company’s obligations under the convertible notes are secured by all of its and
its subsidiary’s assets and intellectual property, as evidenced by certain
security agreements and certain patent security agreements by and between the
Company and each of YA Global and Stanford. Pursuant to a
subordination agreement, YA Global is the senior secured creditor.
The
conversion rate of each convertible note is subject to adjustment for certain
events, including dividends, stock splits, combinations and the sale of the
Company’s Common Stock or securities convertible into or exercisable for the
Company’s Common Stock at a price less than the then applicable conversion or
exercise price.
The
investors have a right of first refusal on any future funding that involves the
issuance of the Company’s capital stock for so long as a portion of the
convertible notes are outstanding.
Pursuant
to the Registration Rights Agreement, the Company filed an initial registration
statement on October 12, 2007 to register 3,333,333 shares of common stock,
underlying the convertible notes, issuable to YA Global, and such registration
statement became effective on November 1, 2007.
The
convertible notes and warrants issued to YA Global are subject to a maximum cap
of 30,500,000 on the number of shares of common stock that can be issued upon
the conversion of the convertible notes, the exercise of the warrants and the
issuance of interest shares.
The
convertible notes and warrants issued to Stanford are subject to a maximum cap
of 31,888,888 on the number of shares of common stock that can be issued upon
the conversion of the convertible notes, the exercise of the warrants and the
issuance of interest shares.
From
January 1, 2010 through February 16, 2010, an additional $591,500 of convertible
notes were converted into 2,376,145 shares of common stock. As of
February 16, 2010, the number of shares of common stock issuable upon conversion
of the remaining $7,406,040 of convertible notes outstanding, of which
$5,000,000 are held by Stanford and $2,406,000 are held by YA Global, is,
approximately 30,300,000 shares, plus an estimated additional 2,100,000
shares (based upon the stock price at February 16, 2010) for the payment of
interest in stock under the convertible notes.
-17-
As of
December 31, 2009, the outstanding balance of the convertible notes was $52,633,
which is comprised of notes with an aggregate face amount of $7,997,540 less
unamortized debt discount of $7,944,907. Debt discount associated
with the convertible notes is amortized to interest expense, using the effective
yield method, over the remaining life of the convertible notes. Upon
conversion of the convertible notes into Common Stock, any unamortized debt
discount relating to the portion converted will be charged to
interest. Total charges to interest for amortization of debt discount
were $832,957 and $1,496,593 for the three month and six month periods ended
December 31, 2009.
The costs
associated with the issuances in the amount of $1,291,427 have been recorded as
deferred financing costs and are being amortized ratably over the term of the
convertible notes. The balance of deferred financing costs as of
December 31, 2009 amounted to $361,057.
Effective
July 1, 2009, the Company adopted the provisions of FASB ASC 815.40,
"Determining Whether an Instrument (or Embedded Feature) is Indexed to an
Entity's Own Stock”. FASB ASC 815.40 applies to any freestanding
financial instruments or embedded features that have the characteristics of a
derivative, and to any freestanding financial instruments that are potentially
settled in an entity’s own common stock. As a result of adopting FASB
ASC 815.40, as of July 1, 2009, 6,941,666 of the Company’s issued and
outstanding common stock warrants previously accounted for as equity pursuant to
the derivative treatment exemption should no longer be accounted for as
equity. As such, effective July 1, 2009, the Company reclassified the
fair value of these common stock purchase warrants, which have exercise price
reset features, from equity to a liability. On July 1, 2009, using
the black sholes valuation model, the Company reclassified, as a cumulative
effect adjustment, the difference in fair value of $4,731,767, which represents
the difference between the fair value on the dates of issuance of $7,931,875 and
the fair value on July 1, 2009 of $3,200,108 from additional paid in capital to
deficit accumulated during the development stage. Additionally, the
Company recorded a warrant liability in the amount of $3,200,108 to recognize
the fair value of such warrants at July 1, 2009. On September 30,
2009 and on December 31, 2009, the Company revalued the warrants, using the
black sholes valuation model, and the resulting liability amounted to $1,311,975
and $860,767, respectively. The change in value of the liability of
$451,208 and $2,339,341 was recorded as income for the three months and six
months ended December 31, 2009, respectively, which reduced the basic and
diluted net loss per share by $0.02 and $0.10, respectively. The
effect on the net loss for the three month and six month period ending December
31, 2008 would have been a reduction of $2,866,908 and $6,178,082, respectively,
which would have resulted in net income of $1,242,567 and $3,372,335,
respectively. The effect on the basic net loss per common share would
have been a reduction of $0.15 and $0.33, respectively, which would have
resulted in basic net income per common share of $0.07 and $0.18,
respectively.
-18-
The
assumptions used to value the warrants were as follows:
July 1,
2009
|
December 31,
2009
|
|||||||
Estimated
life in years
|
3 | 2.50 | ||||||
Risk-free
interest rate (1)
|
1.57 | % | 1.14 | % | ||||
Volatility
|
100 | % | 100 | % | ||||
Dividend
paid
|
None
|
None
|
(1)
|
Represents
the interest rate on a U.S. Treasury security with a maturity date
corresponding to that of the option
term.
|
Common
Stock
Transaction with Partlet
Holdings
On July
9, 2009, the Company entered into a Securities Purchase Agreement (the “Partlet
Securities Purchase Agreement”) with Partlet Holdings Ltd., which is an
accredited investor, pursuant to which the Company issued an aggregate of
1,111,111 shares (the “Shares”) of the Company’s common stock at $0.90 per share
and each of a Series A warrant (the “Partlet Series A Warrant”) and a Series B
warrant (the “Partlet Series B Warrant”) (collectively the Partlet Series A
Warrant and Partlet Series B Warrant shall be referred to herein as the “Partlet
Warrants”).
The
Partlet Series A Warrant entitles the holder to purchase 1,000,000 shares of the
Company’s common stock at $0.01 per warrant share. The Partlet Series A
Warrant has a term of seven years and is exercisable immediately after the date
of grant.
The
Partlet Series B Warrant entitles the holder to purchase 2,055,555 shares of the
Company’s common stock at $0.60 per warrant share. The Partlet Series B
Warrant has a term of seven years and is not exercisable until after the
six-month anniversary from the date of grant.
On July 9, 2009, the Company closed
on $950,000 of aggregate proceeds of the private placement and, on that date,
issued (i) a total of 1,055,555 Shares (ii) a Partlet Series A Warrant to
purchase 950,000 shares of the Company’s common stock, which was exercised on
July 14, 2009, and (iii) a Partlet Series B Warrant to purchase 1,952,778 shares
of the Company’s common stock. On September 30, 2009, the
Company closed on the remaining $50,000 in proceeds upon the Company receiving
approval from the Company’s stockholders and the NYSE Amex Exchange for certain
aspects of the transaction.
Transaction with Each of
Robert and Tim Forbes
On July
29, 2009, the Company entered into a Securities Purchase Agreement, (the “Forbes
Securities Purchase Agreement”) with each of Robert Forbes and Timothy Forbes,
each of whom is an accredited investor, pursuant to which the Company issued an
aggregate of 444,444 shares of common stock at $0.90 (the “Shares”) per share
and each of a Series A warrant, (the “Forbes Series A Warrants”), and a Series B
warrant (the “Forbes Series B Warrants”). Each of Robert Forbes and
Timothy Forbes are the brothers of Christopher Forbes who is a director of
Senesco. Mr. Christopher Forbes will not be deemed to be the
beneficial owner of, nor will he have a pecuniary interest in the Shares or
Warrants issued to his brothers.
-19-
The
Forbes Series A Warrants entitle the holders to purchase, in the aggregate, up
to 400,000 shares of the Company’s common stock at $0.01 per warrant
share. The Forbes Series A Warrants have a term of seven years and are
exercisable immediately after the date of grant.
The
Forbes Series B Warrants entitle the holders to purchase, in the aggregate, up
to 405,556 shares of the Company’s common stock at $0.60 per warrant
share. The Forbes Series B Warrants have a term of seven years and are not
exercisable until after the six-month anniversary from the date of
grant.
Transaction with Insiders
and Affiliates
On July
29, 2009, the Company entered into a Securities Purchase Agreement, (the
“Affiliate’s Securities Purchase Agreement”) with each of Harlan W. Waksal,
M.D., Rudolf Stalder, Christopher Forbes, David Rector, John N. Braca, Jack Van
Hulst, Warren Isabelle and the Thomas C. Quick Charitable Foundation (the
“Affiliate Investors”) each of whom is an accredited investor, pursuant to which
the Company issued an aggregate of 144,444 Shares of the Company’s common stock
at $0.90 per share and each of a Series A warrant, (the “Affiliate’s Series A
Warrants”), and a Series B warrant (the “Affiliate’s Series B
Warrants”). Each of Harlan W. Waksal, M.D., Rudolf Stalder,
Christopher Forbes, David Rector, John N. Braca, Jack Van Hulst and Warren
Isabelle serve on the Company’s board. The Thomas C. Quick Charitable
Foundation is an affiliate of our board member Thomas C. Quick.
The
Affiliate’s Series A Warrants entitle the holders to purchase in the aggregate,
up to 130,000 shares of the Company’s common stock at $0.01 per warrant
share. The Affiliates Series A Warrants have a term of seven years and are
exercisable immediately after the date of grant.
The
Affiliate’s Series B Warrants entitle the holders to purchase, in the aggregate,
up to 131,807 shares of the Company’s common stock at $0.60 per warrant
share. The Affiliate’s Series B Warrants have a term of seven years and
are not exercisable until after the six-month anniversary from the date of
grant.
Transaction with Cato
Research Ltd.
On July
29, 2009, the Company entered into a Securities Agreement with Cato Holding
Company (“Cato”), who is an accredited investor, pursuant to which the Company
issued an aggregate of 194,444 Shares of the Company’s common stock at $0.90 per
share and each of a Series A warrant (the “Cato Series A Warrant”) and a Series
B warrant (the “Cato Series B Warrant”). The Shares were issued to
Cato in exchange for debt that was owed by us to Cato Research Ltd. in the
amount of $175,000. Cato Research Ltd. is an affiliate of
Cato.
The Cato
Series A Warrant entitles the holder to purchase in the aggregate, up to 175,000
shares of the Company’s common stock at $0.01 per warrant share. The Cato
Series A Warrant has a term of seven years and is exercisable immediately after
the date of grant.
-20-
The Cato
Series B Warrant entitles the holder to purchase, in the aggregate, up to
177,431 shares of the Company’s common stock at $0.60 per warrant share.
The Cato Series B Warrant has a term of seven years and is not exercisable until
after the six-month anniversary from the date of grant.
The
foregoing transactions were closed upon the Company receiving approval from the
Company’s stockholders and the NYSE Amex Exchange for certain aspects of the
transactions on September 30, 2009.
As a
result of the transaction with Cato, the Company valued the common stock and
warrants issued to Cato in the amount of $261,532 and recorded a loss on the
extinguishment of debt in the amount of $86,532 during the six month period
ended December 31, 2009.
Note
8 – Income Taxes:
No
provision for income taxes has been made for the three month and six month
periods ended December 31, 2009 and 2008 given the Company’s losses in 2009 and
2008 and available net operating loss carryforwards. A benefit has
not been recorded as the realization of the net operating losses is not assured
and the timing in which the Company can utilize its net operating loss
carryforwards in any year or in total may be limited by provisions of the
Internal Revenue Code regarding changes in ownership of
corporations.
Note
9 – Effects of New Accounting Pronouncements Applicable to the
Company
FASB
ASC 808-10 – Accounting for Collaborative Arrangements
This
pronouncement defines a collaborative arrangement as a contractual arrangement
that involves a joint operating activity that involves two or more parties who
are both active participants in the activity and exposed to significant risks
and rewards dependent on the commercial success of the activity. The
pronouncement also defines how the costs incurred and revenues generated from
transactions with third parties should be recorded and presented in each
entity’s income statement. This pronouncement is effective for
financial statements issued for fiscal years beginning after December 15, 2008,
and interim periods within those fiscal years, and shall be applied
retrospectively to all prior periods presented for all collaborative
arrangements existing as of the effective date. The Company does not
believe that this pronouncement will have any material effect on its financial
statements.
Note
10 – Subsequent Events:
The
Company has evaluated subsequent events through February 16, 2010, the date
these financial statements were filed, and determined that there were no events
or transactions occurring subsequent to December 31, 2009 that would have a
material impact on the Company’s consolidated financial statements and that
there were no events or transactions occurring subsequent to December 31, 2009
that would require disclosure.
-21-
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
The
following discussion and analysis should be read in conjunction with our
condensed consolidated financial statements and the related notes thereto
included in this Quarterly Report on Form 10-Q. The discussion and
analysis may contain forward-looking statements that are based upon current
expectations and entail various risks and uncertainties. Our actual
results and the timing of events could differ materially from those anticipated
in the forward-looking statements as a result of various factors, including
those set forth under “Factors That May Affect Our Business, Future Operating
Results and Financial Condition” and elsewhere in this report.
Overview
Our
Business
The
primary business of Senesco Technologies, Inc., a Delaware corporation
incorporated in 1999, and its wholly-owned subsidiary, Senesco, Inc., a New
Jersey corporation incorporated in 1998, collectively referred to as “Senesco,”
“we,” “us” or “our,” is to utilize our patented and patent-pending genes,
primarily eucaryotic translation initiation Factor 5A, or Factor 5A, and
deoxyhypusine synthase, or DHS, and related technologies for inhibition in human
health applications to develop novel approaches to treat cancer and inflammatory
diseases.
In
agricultural applications we are developing and licensing Factor 5A, DHS and
Lipase to enhance the quality and productivity of fruits, flowers, and
vegetables and agronomic crops through the control of cell death, referred to
herein as senescence, and growth in plants.
Human
Health Applications
We
believe that our gene technology could have broad applicability in the human
health field, by either inducing or inhibiting apoptosis. Inducing
apoptosis may be useful in treating certain forms of cancer because the
cancerous cells have failed to initiate apoptosis on their own due to damaged or
inhibited apoptotic pathways. Inhibiting apoptosis may be useful in
preventing or treating a wide range of inflammatory and ischemic diseases
attributed to premature apoptosis.
We have
commenced preclinical in-vivo and in-vitro research to
determine the ability of Factor 5A to regulate key execution genes,
pro-inflammatory cytokines, receptors, and transcription factors, which are
implicated in numerous apoptotic diseases.
Certain
preclinical human health results to date include:
-22-
|
·
|
Performing
efficacy, toxicological and dose-finding studies in mice for our potential
multiple myeloma drug candidate, SNS-01. SNS-01 is a
nano-encapsulated combination therapy of Factor 5A and an siRNA against
Factor 5A. Our efficacy study in severe combined
immune-deficient (“SCID”) mice with subcutaneous human multiple myeloma
tumors tested SNS-01 dosages ranging from 0.15 mg/kg to 1.5
mg/kg. In these studies, mice treated with a dose of either
0.75 mg/kg or 1.5 mg/kg both showed a 91% reduction in tumor volume and a
decrease in tumor weight of 87% and 95%, respectively. For mice
that received smaller doses of either 0.38 mg/kg or 0.15 mg/kg, there was
also a reduction in tumor volume (73% and 61%, respectively) and weight
(74% and 36%, respectively). All of the treated mice,
regardless of dose, survived. This therapeutic dose range study
provided the basis for an 8-day maximum tolerated dose study in which
normal mice received two intravenous doses of increasing amounts of SNS-01
(from 2.2 mg/kg). Body weight, organ weight and serum levels of
liver enzymes were used as clinical indices to assess
toxicity. A dose between 2.2 mg/kg and 2.9 mg/kg was well
tolerated with respect to these clinical indices, and the survival rate at
2.9 mg/kg was 80%. Those mice receiving above 2.9 mg/kg of
SNS-01 showed evidence of morbidity and up to 80%
mortality. The 2.9 mg/kg threshold, twice the upper end of the
proposed therapeutic dose range, was therefore determined to be the
maximum tolerated dose in mice.
|
|
·
|
demonstrated
significant tumor regression and diminished rate of tumor growth of
multiple myeloma tumors in SCID mice treated with Factor 5A technology
encapsulated in nanoparticles;
|
|
·
|
increased
median survival by approximately 250% in a tumor model of mice injected
with melanoma cancer cells;
|
|
·
|
induced
apoptosis in both human cancer cell lines derived from tumors and in lung
tumors in mice;
|
|
·
|
induced
apoptosis of cancer cells in a human multiple myeloma cell line in the
presence of IL-6;
|
|
·
|
measured
VEGF reduction in mouse lung tumors as a result of treatment with our
genes;
|
|
·
|
decreased
ICAM and activation of NFkB in cancer cells employing siRNA against Factor
5A;
|
|
·
|
increased
the survival rate in H1N1 mouse influenza survival studies from 14% in
untreated mice to 52% in mice treated with our siRNA against Factor
5A. Additionally, the treated mice reversed the weight loss
typically seen in infected mice and had other reduced indicators of
disease severity as measured by blood glucose and liver
enzymes.
|
|
·
|
increased
the survival, while maintaining functionality, of mouse pancreatic islet
cells isolated for transplantation, using intraperitaneal administration
of our technology. Initial animal studies have shown that our
technology administered prior to harvesting beta islet cells from a mouse,
has a significant impact not only on the survival of the beta islet cells,
but also on the retention of the cells’ functionality when compared to the
untreated beta islet cells. Additional studies have shown that
the treated beta islet cells survive a pro-inflammatory cytokine
challenge, while maintaining their functionality with respect to insulin
production. These further studies also revealed Factor-5A’s
involvement in the modulation of inducible nitric oxide synthase (iNOS),
an important indicator of inflammation;
and
|
-23-
|
·
|
increased
the survival rate of mice in a lethal challenge sepsis
model. Additionally, a broad spectrum of systemic
pro-inflammatory cytokines were down-regulated, while not effecting the
anti-inflammatory cytokine IL-10.
|
Accelerating
Apoptosis
The data
from our pre-clinical studies indicate that the up-regulation of Factor 5A
induces cell death in cancer cells through both the p53 (intrinsic) and cell
death receptor (extrinsic) apoptotic pathways. Tumors arise when abnormal cells
fail to undergo apoptosis due to an inability to activate their apoptotic
pathways. Just as the Factor 5A gene appears to facilitate expression of the
entire suite of genes required for programmed cell death in plants, the Factor
5A gene appears to regulate expression of a suite of genes required for
programmed cell death in human cells. Because the Factor 5A gene appears to
function at the initiation point of the apoptotic pathways, both intrinsic and
extrinsic, we believe that our gene technology has potential application as a
means of combating a broad range of cancers. Based on the results
obtained through our in-vitro studies, we have
found that up-regulating Factor 5A results in: (i) the up-regulation of p53;
(ii) increased inflammatory cytokine production; (iii) increased cell death
receptor formation; and (iv) increased caspase activity. These
features, coupled with a simultaneous down-regulation Bcl-2, result in apoptosis
of cancer cells. In addition, our in-vitro studies have shown
that the up-regulation of Factor 5A also down-regulates VEGF, a growth factor
which allows tumors to develop additional vascularization needed for growth
beyond a small mass of cells.
Inhibiting
Apoptosis
Our
preclinical studies indicate that down-regulation of our proprietary Factor 5A
gene may have potential application as a means for controlling the effects of a
broad range of diseases that are attributable to premature cell death, ischemia,
or inflammation. Such inflammatory diseases include glaucoma, heart disease, and
other certain inflammatory diseases such as Crohn’s disease, sepsis and diabetic
retinopathy. We have performed preclinical research of certain
inflammatory diseases. Using small inhibitory RNA’s, or siRNA’s, against Factor
5A to inhibit its expression, the results of our studies have indicated a
reduction in pro-inflammatory cytokine formation and the formation of receptors
for LPS, interferon-gamma and TNF-alpha. Our studies have also
indicated that by inhibiting Factor 5A, iNOS, MAPK, NFkB, JAK1 and ICAM are
downregulated, which decreases the inflammatory cytokines formed through these
pathways. Additionally, a mouse study has indicated that our siRNA is comparable
to a steroid and to a prescription anti-TNF drug in its ability to reduce
cytokine response to LPS. Other mouse studies have also indicated
that the siRNA against Factor 5A (i) protects thymocyte cells from apoptosis and
decreases formation of MPO, TNF-a, MIP-1alpha, and IL-1 in the lungs of mice
challenged with LPS and (ii) increases the survival rate in which sepsis was
induced by a lethal injection of LPS and (iii) reduces blood serum levels of
inflammatory proteins, such as IL-1, IL-2, IL-6, IL-12, TNF-a, IFNg and
MIP-1alpha, while not effecting IL-10, an anti-inflammatory
cytokine. Other experiments utilizing siRNA to Factor 5A include
inhibition of or apoptosis during the processing of mouse pancreatic beta islet
cells for transplantation, the inhibition of early inflammatory changes
associated with type-1 diabetes in an in-vivo rat model.
-24-
Proteins
required for cell death include p53, interleukins, TNF-a and other cytokines and
caspases. Expression of these cell death proteins is required for the
execution of apoptosis. Based on our studies, we believe that
down-regulating Factor 5A by treatment with siRNA inhibits the expression of
p53, a major cell death transcription factor that in turn controls the formation
of a suite of other cell death proteins. In addition, we believe that
the down-regulation of Factor 5A up-regulates Bcl-2, a suppressor of
apoptosis.
Human
Health Target Markets
We
believe that our gene technology may have broad applicability in the human
health field, by either accelerating or inhibiting
apoptosis. Accelerating apoptosis may be useful in treating certain
forms of cancer because the body’s immune system is not able to force cancerous
cells to undergo apoptosis. Inhibiting apoptosis may be useful in
preventing or treating a wide range of inflammatory and ischemic diseases
attributed to premature apoptosis, including diabetes, diabetic retinopathy and
lung inflammation, among others.
, We are
advancing our research in multiple myeloma with the goal of initiating a Phase I
clinical trial, and may select additional human health indications to bring into
clinical trials. We believe that the success of our future operations will
likely depend on our ability to transform our research and development
activities into a commercially feasible technology.
Human
Health Research Program
Our human
health research program, which has consisted of pre-clinical in-vitro and in-vivo experiments designed
to assess the role and method of action of the Factor 5A genes in human
diseases, is being performed by approximately five (5) third party researchers,
at our direction, at Mayo Clinic and the University of Waterloo.
Our
research and development expenses incurred on human health applications were
approximately 76% of our total research and development expenses for the six
months ended December 31, 2009. Our research and development expenses
incurred on human health applications were approximately 71% of our total
research and development expenses for the six months ended December 31,
2008. Since inception, the proportion of our research and development
expenses on human health applications has increased, as compared to our research
and development expenses on agricultural applications. This change is
primarily due to the fact that our research focus on human health has increased
and some of our research costs for plant applications have shifted to our
license partners.
Our
planned future research and development initiatives for human health
include:
|
·
|
Multiple
Myeloma. Our objective is to advance our technology for the
potential treatment of multiple myeloma with the goal of initiating a
clinical trial. In connection with the potential clinical
trial, we have engaged a clinical research organization, or CRO, to assist
us through the process. We have also determined the delivery
system for our technology, contracted for the supply of pharmaceutical
grade materials to be used in toxicology and human studies, performed
certain toxicology studies, and have contracted with a third party
laboratory to conduct additional toxicology studies. Together
with the assistance of our CRO, we will have additional toxicology studies
performed with the goal of filing an investigational new drug application,
or IND application, with the U.S. Food and Drug Administration, or FDA,
for their review and consideration in order to initiate a clinical
trial. Assuming that we have adequate funding, we estimate that
it will take approximately twelve (12) months from December 31, 2009 to
complete these objectives.
|
-25-
|
·
|
Other. We
may continue to look at other disease states in order to determine the
role of Factor 5A.
|
In order
to pursue the above research initiatives, as well as other research initiatives
that may arise, it will be necessary for us to raise a significant amount of
additional working capital in the near future. If we are unable to
raise the necessary funds, we may be required to significantly curtail the
future development of some of our research initiatives and we will be unable to
pursue other possible research initiatives.
We may
further expand our research and development program beyond the initiatives
listed above to include other research centers.
Human
Health Competition
Our
competitors in human health that are presently attempting to distribute their
technology have generally utilized one of the following distribution
channels:
|
·
|
Entering
into strategic alliances, including licensing technology to major
marketing and distribution partners;
or
|
|
·
|
developing
in-house production and marketing
capabilities.
|
In
addition, some competitors are established distribution companies, which
alleviates the need for strategic alliances, while others are attempting to
create their own distribution and marketing channels.
There are
many large companies and development stage companies working in the field of
apoptosis research including: Amgen Inc., Centocor, Inc., Genzyme Corporation,
OSI Pharmaceuticals, Inc., Novartis AG, Introgen Therapeutics, Inc., Genta,
Incorporated, and Vertex Pharmaceuticals, Inc., amongst others.
Agricultural
Applications
Our
agricultural research focuses on the discovery and development of certain gene
technologies, which are designed to confer positive traits on fruits, flowers,
vegetables, forestry species and agronomic crops. To date, we have
isolated and characterized the senescence-induced Lipase gene, DHS, and Factor
5A in certain species of plants. Our goal is to modulate the expression of these
genes in order to achieve such traits as extended shelf life, increased biomass,
increased yield and increased resistance to environmental stresses and disease,
thereby demonstrating proof of concept in each category of crop.
-26-
Certain
agricultural results to date include:
|
·
|
longer
shelf life of perishable produce;
|
|
·
|
increased
biomass and seed yield;
|
|
·
|
greater
tolerance to environmental stresses, such as drought and soil
salinity;
|
|
·
|
greater
tolerance to certain fungal and bacterial
pathogens;
|
|
·
|
more
efficient use of fertilizer; and
|
|
·
|
advancement
to field trials in banana, lettuce, and
trees.
|
The
technology presently utilized by the industry for increasing the shelf life in
certain flowers, fruits and vegetables relies primarily on reducing ethylene
biosynthesis, and therefore only has application to the crops that are
ethylene-sensitive. Because Factor 5A, DHS and Lipase are already
present in all plant cells, our technology may be incorporated into crops by
using either conventional breeding methods (non-genetically modified) or
biotechnology techniques.
We have
licensed this technology to various strategic partners and have entered into a
joint collaboration. We may continue to license this technology, as
opportunities present themselves, to additional strategic partners and/or enter
into additional joint collaborations or ventures. Our commercial
partners have licensed our technology for use in turfgrass, canola, corn,
soybean, cotton, banana, alfalfa, rice and certain species of trees and bedding
plants, and we have obtained proof of concept for enhanced post harvest shelf
life, seed yield, biomass, and resistance to disease in several of these plant
species.
We have
ongoing field trials of certain trees and bananas with our respective
partners. The initial field trials conducted with ArborGen over a
four year period in certain species of trees have concluded and the trees have
been harvested for wood quality assessment. Preliminary data from our
joint field trials show significantly enhanced growth rates in some of the trees
relative to controls. Selected trees from the field trials were
harvested and their wood chemistry and density was assessed. There
were no differences in key economic characteristics of wood, such a lignin,
cellulose and specific gravity, between the trees with the enhanced growth
attributes and untreated control trees, which indicates that the faster growth
does not result in lower wood quality. Additional field trials for
enhanced growth rates and other traits are currently being performed with
ArborGen.
To date,
banana field trials have indicated that our technology extends the shelf life of
banana fruit by 100%. In addition to the post harvest shelf life
benefits, an additional field trial generated encouraging disease tolerance data
specific to Black Sigatoka (Black Leaf Streak Disease), for banana plants.
Additional field trials for banana plants are ongoing for the combined traits of
disease resistance and shelf life extension.
-27-
Commercialization
by our partners may require a combination of traits in a crop, such as both post
harvest shelf life and disease resistance, or other traits. Our
near-term research and development initiatives include modulating the expression
of DHS and Factor 5A genes in these plants and then propagation and phenotype
testing of such plants.
Our
ongoing research and development initiatives for agriculture include assisting
our license and joint venture partners to:
|
·
|
further
develop and implement the DHS and Factor 5A gene technology in banana,
canola, cotton, turfgrass, bedding plants, rice, alfalfa, corn, soybean
and trees; and
|
|
·
|
test
the resultant crops for new beneficial traits such as increased yield,
increased tolerance to environmental stress, disease resistance and more
efficient use of fertilizer.
|
Agricultural
Target Markets
In order
to address the complexities associated with marketing and distribution in the
worldwide market, we have adopted a multi-faceted commercialization strategy, in
which we have entered into and plan to enter into, as the opportunities present
themselves, additional licensing agreements or other strategic relationships
with a variety of companies or other entities on a crop-by-crop
basis. We anticipate revenues from these relationships in the form of
licensing fees, royalties, usage fees, or the sharing of gross
profits. In addition, we anticipate payments from certain of our
partners, which are described in the Agricultural Development and License
Agreements section of this Form 10-Q, upon our achievement of certain
research and development benchmarks. This commercialization strategy
allows us to generate revenue at various stages of product development, while
ensuring that our technology is incorporated into a wide variety of
crops. Our optimal partners combine the technological expertise to
incorporate our technology into their product line along with the ability to
successfully market the enhanced final product, thereby eliminating the need for
us to develop and maintain a sales force.
Because
the agricultural market is dominated by privately held companies or subsidiaries
of foreign owned companies, market size and market share data for the crops
under our license and development agreements is not readily
available. Additionally, because we have entered into confidentiality
agreements with our license and development partners, we are unable to report
the specific financial terms of the agreements as well as any market size and
market share data that our partners may have disclosed to us regarding their
companies.
Agricultural
Development and License Agreements
Through
December 31, 2009, we have entered into eight (8) license agreements and one (1)
joint collaboration with established agricultural biotechnology companies or, in
the case of Poet, an established ethanol company:
-28-
Agricultural
Research Program
Our
agricultural research and development is performed by three (3) researchers, at
our direction, at the University of Waterloo, where the technology was
developed. Additional agricultural research and development is
performed by our license or joint collaboration partners.
The
discoverer of our technology, John E. Thompson, Ph.D., is the Associate Vice
President, Research and former Dean of Science at the University of Waterloo in
Ontario, Canada, and is our Executive Vice President and Chief Scientific
Officer. Dr. Thompson is also one of our directors and owns 2.0% of
the outstanding shares of our common stock, $0.01 par value, as of December 31,
2009.
On
September 1, 1998, we entered into, and have extended through August 31, 2010, a
research and development agreement with the University of Waterloo and Dr.
Thompson as the principal inventor. The Research and Development
Agreement provides that the University of Waterloo will perform research and
development under our direction, and we will pay for the cost of this work and
make certain payments to the University of Waterloo. In return for
payments made under the Research and Development Agreements, we have all rights
to the intellectual property derived from the research.
Agricultural
Competition
Our competitors in both human health
and agriculture that are presently attempting to distribute their technology
have generally utilized one of the following distribution channels:
|
·
|
licensing
technology to major marketing and distribution
partners;
|
|
·
|
entering
into strategic alliances; or
|
|
·
|
developing
in-house production and marketing
capabilities.
|
In
addition, some competitors are established distribution companies, which
alleviates the need for strategic alliances, while others are attempting to
create their own distribution and marketing channels.
Our competitors in the field of
delaying plant senescence are companies that develop and produce transformed
plants with a variety of enhanced traits. Such companies include:
Mendel Biotechnology; Renessen LLC; Exelixis Plant Sciences, Inc.; and Syngenta
International AG; among others.
Agricultural
Development Program
Generally,
projects with our licensees and joint venture partner begin by transforming seed
or germplasm to incorporate our technology. Those seeds or germplasm
are then grown in our partners’ greenhouses. After successful
greenhouse trials, our partners will transfer the plants to the field for field
trials. After completion of successful field trials, our partners may
have to apply for and receive regulatory approval prior to initiation of any
commercialization activities.
-29-
Generally,
the approximate time to complete each sequential development step is as
follows:
Seed
Transformation
|
approximately
1 to 2 years
|
Greenhouse
|
approximately
1 to 2 years
|
Field
Trials
|
approximately
2 to 5 years
|
The
actual amount of time spent on each development phase depends on the crop, its
growth cycle and the success of the transformation achieving the desired
results. As such, the amount of time for each phase of development
could vary, or the time frames may change.
The
development of our technology with Poet is different than our other licenses in
that we are modifying certain production inputs for ethanol. That
process involves modifying the inputs, testing such inputs in Poet’s production
process and if successful, implementing such inputs in Poet’s production process
on a plant by plant basis.
The
status of each of our projects with our partners is as follows:
Project
|
Partner
|
Status
|
||
Banana
|
Rahan
Meristem
|
|||
-
Shelf Life
|
Field
trials
|
|||
-
Disease Resistance
|
Field
trials
|
|||
Trees
|
Arborgen
|
|||
-
Growth
|
Field
trials
|
|||
Alfalfa
|
Cal/West
|
Greenhouse
|
||
Corn
|
Monsanto
|
Proof
of concept ongoing
|
||
Cotton
|
Bayer
|
Seed
transformation
|
||
Canola
|
Bayer
|
Seed
transformation
|
||
Rice
|
Bayer
|
Proof
of concept ongoing
|
||
Soybean
|
Monsanto
|
Proof
of concept ongoing
|
||
Turfgrass
|
The
Scotts Company
|
Greenhouse
|
||
Bedding
Plants
|
The
Scotts Company
|
Discontinued
(1)
|
||
Ethanol
|
|
Poet
|
|
Modify
inputs
|
(1) This
program was discontinued in order to focus on the development of the turfgrass
program.
Commercialization
by our partners may require a combination of traits in a crop, such as both
shelf life and disease resistance, or other traits.
Based
upon our commercialization strategy, we anticipate that there may be a
significant period of time before plants enhanced using our technology reach
consumers. Thus, we have not begun to actively market our technology
directly to consumers, but rather, we have sought to establish ourselves within
the industry through presentations at industry conferences, our website and
direct communication with prospective licensees.
-30-
Consistent
with our commercialization strategy, we intend to attract other companies
interested in strategic partnerships or licensing our technology, which may
result in additional license fees, revenues from contract research and other
related revenues. Successful future operations will depend on our
ability to transform our research and development activities into a commercially
feasible technology.
Intellectual
Property
We have
twenty (20) issued patents from the United States Patent and Trademark Office,
or PTO, and thirty-nine (39) issued patents from foreign countries, forty-seven
(47) of which are for the use of our technology in agricultural applications and
twelve (12) of which relate to human health applications.
In
addition to our fifty-nine (59) patents, we have a wide variety of patent
applications, including divisional applications and continuations-in-part, in
process with the PTO and internationally. We intend to continue our
strategy of enhancing these new patent applications through the addition of data
as it is collected.
Government
Regulation
At
present, the U.S. federal government regulation of biotechnology is divided
among three agencies: (i) the U.S. Department of Agriculture regulates the
import, field-testing and interstate movement of specific types of genetic
engineering that may be used in the creation of transformed plants; (ii) the
Environmental Protection Agency regulates activity related to the invention of
plant pesticides and herbicides, which may include certain kinds of transformed
plants; and (iii) the FDA regulates foods derived from new plant
varieties. The FDA requires that transformed plants meet the same
standards for safety that are required for all other plants and foods in
general. Except in the case of additives that significantly alter a
food’s structure, the FDA does not require any additional standards or specific
approval for genetically engineered foods but expects transformed plant
developers to consult the FDA before introducing a new food into the market
place.
In
addition, our ongoing preclinical research with cell lines and lab animal models
of human disease is not currently subject to the FDA requirements that govern
clinical trials. However, use of our technology, if developed for
human health applications, will also be subject to FDA
regulation. Generally, the FDA must approve any drug or biologic
product before it can be marketed in the United States. In addition,
prior to being sold outside of the U.S., any products resulting from the
application of our human health technology must be approved by the regulatory
agencies of foreign governments. Prior to filing a new drug
application or biologics license application with the FDA, we would have to
perform extensive clinical trials, and prior to beginning any clinical trial, we
need to perform extensive preclinical testing which could take several years and
may require substantial expenditures.
-31-
We
believe that our current activities, which to date have been confined to
research and development efforts, do not require licensing or approval by any
governmental regulatory agency. However, we, or our licensees, may be required
to obtain such licensing or approval from governmental regulatory agencies prior
to the commercialization of our genetically transformed plants and the
application of our human health technology.
Liquidity
and Capital Resources
Overview
As of
December 31, 2009, our cash balance totaled $751,787, and we had working capital
of $881,652. As of December 31, 2009, we had a federal tax loss
carryforward of approximately $27,802,000 and a state tax loss carry-forward of
approximately $20,439,000 to offset future taxable income. We cannot assure you
that we will be able to take advantage of any or all of such tax loss
carryforwards, if at all, in future fiscal years.
Contractual
Obligations
The
following table lists our cash contractual obligations as of December 31,
2009:
Payments Due by Period
|
||||||||||||||||||||
Contractual Obligations
|
Total
|
Less than
1 year
|
1 - 3 years
|
4 - 5 years
|
More than
5 years
|
|||||||||||||||
Research
and Development Agreements (1)
|
$ | 597,986 | $ | 597.986 | $ | — | $ | — | $ | — | ||||||||||
Facility,
Rent and Operating
Leases (2)
|
$ | 113,088 | $ | 79,648 | $ | 33,440 | $ | — | $ | — | ||||||||||
Employment,
Consulting and
Scientific Advisory Board Agreements (3)
|
$ | 279,340 | $ | 276,840 | $ | 2,500 | $ | — | $ | — | ||||||||||
Total
Contractual Cash
Obligations
|
$ | 990,414 | $ | 954,474 | $ | 35,940 | $ | — | $ | — |
(1)
|
Certain
of our research and development agreements disclosed herein provide that
payment is to be made in Canadian dollars and, therefore, the contractual
obligations are subject to fluctuations in the exchange
rate.
|
(2)
|
The
lease for our office space in New Brunswick, New Jersey is subject to
certain escalations for our proportionate share of increases in the
building’s operating costs.
|
(3)
|
Certain
of our consulting agreements provide for automatic renewal, which is not
reflected in the table, unless terminated earlier by the parties to the
respective agreements.
|
-32-
We expect
our capital requirements to increase significantly over the next several years
as we commence new research and development efforts, increase our business and
administrative infrastructure and embark on developing in-house business
capabilities and facilities. Our future liquidity and capital funding
requirements will depend on numerous factors, including, but not limited to, the
levels and costs of our research and development initiatives and the cost and
timing of the expansion of our business development and administrative
staff.
Effective
September 1, 2009, we extended our research and development agreement with the
University of Waterloo for an additional one-year period through August 31,
2010, in the amount of approximately $650,400. Research and
development expenses under this agreement aggregated $155,000 and $315,000 for
the three month and six month periods ended December 31, 2009, respectively, and
$180,000 and $349,518 for the three month and six month periods ended December
31, 2008, respectively, and $5,435,368 for the cumulative period from inception
through December 31, 2009.
Capital
Resources
Since
inception, we have generated revenues of $1,590,000 in connection with the
initial fees and milestone payments received under our license and development
agreements. We have not been profitable since inception, we will
continue to incur additional operating losses in the future, and we will require
additional financing to continue the development and subsequent
commercialization of our technology. While we do not expect to
generate significant revenues from the licensing of our technology for the next
one to three years, or longer, we may enter into additional licensing or other
agreements with marketing and distribution partners that may result in
additional license fees, receive revenues from contract research, or other
related revenue.
We
anticipate that, based upon our cash balance as of December 31, 2009 we will be
able to fund our operations for two (2) to three (3) months from December 31,
2009. Over the next twelve months, we plan to fund our research and development
and commercialization activities by:
|
·
|
utilizing
our current cash balance and
investments;
|
|
·
|
the
placement of equity or debt
instruments;
|
|
·
|
achieving
some of the milestones set forth in our current licensing agreements;
and
|
|
·
|
the
possible execution of additional licensing agreements for our
technology.
|
We cannot
assure you that we will be able to raise money through any of the foregoing
transactions, or on favorable terms, if at all.
-33-
Changes
to Critical Accounting Policies and Estimates
We
adopted FASB ASC 815.40, "Determining Whether an Instrument (or Embedded
Feature) is Indexed to an Entity's Own Stock" for the fiscal year beginning July
1, 2009.
Except
for the adoption of FASB ASC 815.40, there have been no changes to our critical
accounting policies and estimates as set forth in our Annual Report on Form 10-K
for the fiscal year ended June 30, 2009.
-34-
Results
of Operations
Three
Months Ended December 31, 2009 and Three
Months Ended December 31, 2008
The net
loss for the three month period ended December 31, 2009 was
$1,703,665. The net loss for the three month period ended December
31, 2008 was $1,624,341. Such a change represents an increase in net
loss of $79,324, or
5%. This increase in net loss was primarily the result of an increase
in non-cash expenses associated with the outstanding convertible notes, which
was mostly offset by a decrease in operating expenses, an increase in revenue
and an increase in noncash income related to the change in fair value of a
warrant liability.
Revenue
Total
revenue of $140,000 for the three month period ended December 31, 2009 consisted
of a milestone payment in connection with an agricultural license
agreement. There was no revenue for the three month period ended
December 31, 2008.
We
anticipate that we will continue to receive milestone payments in connection
with our current agricultural development and license
agreements. Additionally, we anticipate that we will receive royalty
payments from our license agreements when our partners commercialize their crops
containing our technology. However, it is difficult for us to
determine our future revenue expectations because we are a development stage
biotechnology company. As such, the timing and outcome of our
experiments, the timing of signing new partners and the timing of our partners
moving through the development process into commercialization is difficult to
accurately predict.
Operating
Expenses
Three Months Ended December 31,
|
||||||||||||||||
2009
|
2008
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
General
and administrative
|
$ | 685 | $ | 649 | $ | 36 | 5.5 | % | ||||||||
Research
and development
|
468 | 579 | (111 | ) | (19.2 | )% | ||||||||||
Total
operating expenses
|
$ | 1,153 | $ | 1,228 | $ | (75 | ) | (6.1 | )% |
We expect
operating expenses to increase over the next twelve months as we anticipate that
research and development expenses will increase as we continue to expand our
research and development activities as they relate to the potential clinical
development of SNS01.
-35-
General
and Administrative Expenses
Three Months Ended December 31,
|
||||||||||||||||
2009
|
2008
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Share-based
compensation
|
$ | 148 | $ | 131 | $ | 17 | 13.0 | % | ||||||||
Payroll
and benefits
|
239 | 181 | 58 | 32.0 | % | |||||||||||
Investor
relations
|
45 | 109 | (64 | ) | (58.7 | )% | ||||||||||
Professional
fees
|
141 | 134 | 7 | 5.2 | % | |||||||||||
Depreciation
and amortization
|
33 | 27 | 6 | 22.2 | % | |||||||||||
Director
fees
|
10 | 16 | (6 | ) | (37.5 | )% | ||||||||||
Other
general and administrative
|
69 | 51 | 18 | 35.3 | % | |||||||||||
Total
general and administrative
|
$ | 685 | $ | 649 | $ | 36 | 5.5 | % |
|
·
|
Share-based
compensation for the three months ended December 31, 2009 and 2008
consisted of the amortized portion of the Black-Scholes value of options
granted to directors, employees and consultants. During the
three month periods ended December 31, 2009 and 2008, there were
733,399 and 721,584 options granted,
respectively
|
|
·
|
Payroll
and benefits increased primarily due to the severance agreement with the
Company’s former President and CEO.
|
|
·
|
Investor
relations decreased primarily because the Company has not yet incurred the
costs of holding its annual meeting for the current year. The
Company’s annual meeting was held in December 2008 in the previous year
and incurred such costs during the three month period ended December 31,
2008
|
We expect
general and administrative expenses to modestly increase over the next twelve
months primarily due to an increase in payroll and benefits and legal and
accounting fees related to the increased regulatory environment surrounding our
business.
Research
and Development Expenses
Three Months Ended December 31,
|
||||||||||||||||
2009
|
2008
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Share-based
compensation
|
$ | 3 | $ | 7 | $ | (4 | ) | (57.1 | )% | |||||||
Other
research and development
|
465 | 572 | (107 | ) | (18.7 | )% | ||||||||||
Total
research and development
|
$ | 468 | $ | 579 | $ | (111 | ) | (19.2 | )% |
|
·
|
Share-based
compensation consists primarily of the amortized portion of Black-Scholes
value of options and warrants granted to research and development
consultants and employees.
|
|
·
|
Other
research and development costs decreased primarily due to a decrease in
the costs incurred in connection with our development of SNS01 for
multiple myeloma due to the timing of certain aspects of the development
and the cost of the research performed at the University of Waterloo as a
result of a decrease in the annual budget that began on September 1,
2009.
|
-36-
The
breakdown of our research and development expenses between our agricultural and
human health research programs is as follows:
Three Months Ended December 31,
|
||||||||||||||||
2009
|
%
|
2008
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Agricultural
|
$ | 127 | 27 | % | $ | 142 | 25 | % | ||||||||
Human
health
|
341 | 73 | % | 437 | 75 | % | ||||||||||
Total
research and development
|
$ | 468 | 100 | % | $ | 579 | 100 | % |
|
·
|
Agricultural
research expenses decreased during the three month period ended December
31, 2009 primarily due to a decrease in the cost of the research performed
at the University of Waterloo as a result of decrease in the
annual budget beginning on September 1,
2009.
|
|
·
|
Human
health research expenses decreased during the three month period ended
December 31, 2009 primarily as a result of the timing of certain aspects
of the development of SNS01 for multiple
myeloma.
|
We expect
the percentage of human health research programs to continue to increase as a
percentage of the total research and development expenses as we continue our
current research projects and begin new human health initiatives, in particular
as they relate to the potential clinical development of SNS01.
Other
noncash income
On July
1, 2009, we adopted FASB ASC 815.40 and recorded a warrant liability
in the amount of $3,200,108 on such date. At each reporting period,
we are required to revalue the amount of the warrant liability. On
September 30, 2009, the amount of the warrant liability was adjusted to
$1,311,975. On December 31, 2009, the amount of the warrant liability
was adjusted to $860,767 and the difference between September 30, 2009 and
December 31, 2009 of $451,208 was recorded as other noncash income.
Amortization
of debt discount, financing costs and interest expense
During
the year ended June 30, 2008, we issued $10,000,000 in convertible notes and
warrants. The net proceeds of those convertible notes and warrants
were recorded as equity. The discount on the convertible notes is
being amortized, using the effective yield method, over the term of the
convertible notes. The related costs of issuance were recorded as
deferred financing costs and are being amortized on a straight line basis over
the term of the convertible notes.
The
increase in the amortization of the debt discount is primarily due to $804,060
of convertible notes being converted into common stock during the three month
period ended December 31, 2009. The unamortized portion of such notes
was amortized to interest expense. None of the convertible notes were
converted into common stock during the three month period ended December 31,
2008.
-37-
At
December 31, 2009, there were $7,997,540 of convertible notes
outstanding. At February 16, 2009, there were $7,406,040 of the
convertible notes outstanding, $5,000,000 of which are held by Stanford and
$2,406,040 are held by YA Global.
Interest
Income, net
Interest income was lower during the three month period
ended December 31, 2009 as a result of lower interest rates and cash balances
compared to the three-month period ended December 31, 2008.
Six Months
Ended December 31, 2009 and Six Months
Ended December 31, 2008
The net
loss for the six month period ended December 31, 2009 was
$1,892,961. The net loss for the six month period ended December 31,
2008 was $2,805,747. Such a change represents a decrease in net loss
of $912,786, or
33%. This decrease in net loss was primarily the result of an
increase in noncash income related to the change in fair value of a warrant
liability, which was partially offset by an increase in non-cash expenses
associated with the outstanding convertible notes.
Revenue
Total
revenue of $140,000 and $200,000 for the six month periods ended December 31,
2009 and 2008, respectively, consisted of a milestone payment in connection with
certain agricultural license agreements.
We
anticipate that we will continue to receive milestone payments in connection
with our current agricultural development and license
agreements. Additionally, we anticipate that we will receive royalty
payments from our license agreements when our partners commercialize their crops
containing our technology. However, it is difficult for us to
determine our future revenue expectations because we are a development stage
biotechnology company. As such, the timing and outcome of our
experiments, the timing of signing new partners and the timing of our partners
moving through the development process into commercialization is difficult to
accurately predict.
Operating
Expenses
Six Months Ended December 31,
|
||||||||||||||||
2009
|
2008
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
General
and administrative
|
$ | 1,180 | $ | 1,179 | $ | (1 | ) | 0.0 | % | |||||||
Research
and development
|
1,043 | 1,084 | 41 | 3.8 | % | |||||||||||
Total
operating expenses
|
$ | 2,223 | $ | 2,263 | $ | 40 | 1.8 | % |
We expect
operating expenses to increase over the next twelve months as we anticipate that
research and development expenses will increase as we continue to expand our
research and development activities as they relate to the potential clinical
development of SNS01.
-38-
General
and Administrative Expenses
Six Months Ended December 31,
|
||||||||||||||||
2009
|
2008
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Share-based
compensation
|
$ | 182 | $ | 203 | $ | 21 | 10.3 | % | ||||||||
Payroll
and benefits
|
400 | 345 | (55 | ) | 15.9 | % | ||||||||||
Investor
relations
|
91 | 155 | 64 | 41.3 | % | |||||||||||
Professional
fees
|
263 | 276 | 13 | 4.7 | % | |||||||||||
Depreciation
and amortization
|
61 | 54 | (7 | ) | (13.0 | )% | ||||||||||
Director
fees
|
53 | 44 | (9 | ) | (20.5 | )% | ||||||||||
Other
general and administrative
|
130 | 102 | (28 | ) | (27.5 | )% | ||||||||||
Total
general and administrative
|
$ | 1,180 | $ | 1,179 | $ | (1 | ) | 0.0 | % |
|
·
|
Share-based
compensation for the six months ended December 31, 2009 and 2008 consisted
of the amortized portion of the Black-Scholes value of options granted to
directors, employees and consultants. During the six month
periods ended December 31, 2009 and 2008, there were 733,399
and 721,584 options granted,
respectively
|
|
·
|
Payroll
and benefits increased primarily due to the severance agreement with the
Company’s former President and CEO.
|
|
·
|
Investor
relations decreased primarily because the Company has not yet incurred the
costs of holding its annual meeting for the current year. The
Company’s annual meeting was held in December 2008 in the previous year
and incurred such costs during the six month period ended December 31,
2008
|
We expect
general and administrative expenses to modestly increase over the next twelve
months primarily due to an increase in payroll and benefits and legal and
accounting fees related to the increased regulatory environment surrounding our
business.
Research
and Development Expenses
Six Months Ended December 31,
|
||||||||||||||||
2009
|
2008
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Share-based
compensation
|
$ | - | $ | 12 | $ | 12 | 100.0 | % | ||||||||
Loss
on extinguishment of debt
|
86 | - | (86 | ) | - | |||||||||||
Other
research and development
|
957 | 1,072 | 115 | 10.7 | % | |||||||||||
Total
research and development
|
$ | 1,043 | $ | 1,084 | $ | 41 | 3.8 | % |
|
·
|
Share-based
compensation consists primarily of the amortized portion of Black-Scholes
value of options and warrants granted to research and development
consultants and employees.
|
-39-
|
·
|
Loss
on extinguishment of debt is in connection with the issuance of common
stock and warrants to Cato Holding Company in exchange for debt that
was owed by us to Cato Research Ltd. in the amount of
$175,000.
|
|
·
|
Other
research and development costs decreased primarily due to a decrease in
the costs incurred in connection with our development of SNS01 for
multiple myeloma due to the timing of certain aspects of the development
and the cost of the research performed at the University of Waterloo as a
result of a decrease in the annual budget that began on September 1,
2009.
|
The
breakdown of our research and development expenses between our agricultural and
human health research programs is as follows:
Six Months Ended December 31,
|
||||||||||||||||
2009
|
%
|
2008
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Agricultural
|
$ | 247 | 24 | % | $ | 311 | 29 | % | ||||||||
Human
health
|
796 | 76 | % | 773 | 71 | % | ||||||||||
Total
research and development
|
$ | 1,043 | 100 | % | $ | 1,084 | 100 | % |
|
·
|
Agricultural
research expenses decreased during the six month period ended December 31,
2009 primarily due to a decrease in the cost of the research performed at
the University of Waterloo as a result of a decrease in the annual budget
beginning on September 1, 2009 and a stronger U.S. dollar against the
Canadian dollar.
|
|
·
|
Human
health research expenses increased during the six month period ended
December 31, 2009 primarily as a result of the development of SNS01 for
multiple myeloma.
|
We expect
the percentage of human health research programs to continue to increase as a
percentage of the total research and development expenses as we continue our
current research projects and begin new human health initiatives, in particular
as they relate to the potential clinical development of SNS01.
Other
noncash income
On July
1, 2009, we adopted FASB ASC 815.40 and recorded a warrant liability
in the amount of $3,200,108 on such date. At each reporting period,
we are required to revalue the amount of the warrant liability. On
December 31, 2009, the amount of the warrant liability was adjusted to $860,767
and the difference between of $2,339,341 was recorded as other noncash
income.
Amortization
of debt discount, financing costs and interest expense
During
the year ended June 30, 2008, we issued $10,000,000 in convertible notes and
warrants. The net proceeds of those convertible notes and warrants
were recorded as equity. The discount on the convertible notes is
being amortized, using the effective yield method, over the term of the
convertible notes. The related costs of issuance were recorded as
deferred financing costs and are being amortized on a straight line basis over
the term of the convertible notes.
-40-
The
increase in the amortization of the debt discount is primarily due to $1,457,460
of convertible notes being converted into common stock during the six month
period ended December 31, 2009. The unamortized portion of such notes
was amortized to interest expense. None of the convertible notes were
converted into common stock during the six month period ended December 31,
2008.
At
December 31, 2009, there were $7,997,540 of convertible notes
outstanding. At February 16, 2009, there were $7,406,040 of the
convertible notes outstanding, $5,000,000 of which are held by Stanford and
$2,406,040 are held by YA Global.
Interest Income, net
Interest income was lower during the six month period
ended December 31, 2009 as a result of lower interest rates and cash balances
compared to the six-month period ended December 31, 2008.
Period From Inception on
July 1, 1998 through December 31, 2009
From
inception of operations on July 1, 1998 through December 31, 2009, we have had
revenues of $1,590,000, which consisted of the initial license fees and
milestone payments in connection with our various development and license
agreements. We do not expect to generate significant revenues for
approximately the next one to three years, during which time we will continue to
engage in significant research and development efforts.
We have
incurred losses each year since inception and have an accumulated deficit of
$33,111,093 at December 31, 2009. We expect to continue to incur
losses as a result of expenditures on research and development and
administrative activities.
-41-
Item
3.
|
Quantitative
and Qualitative Disclosures about Market
Risk.
|
Foreign
Currency Risk
Our financial statements are
denominated in United States dollars and, except for our agreement with the
University of Waterloo, which is denominated in Canadian dollars, all of our
contracts are denominated in United States dollars. Therefore, we
believe that fluctuations in foreign currency exchange rates will not result in
any material adverse effect on our financial condition or results of
operations. In the event we derive a greater portion of our revenues
from international operations or in the event a greater portion of our expenses
are incurred internationally and denominated in a foreign currency, then changes
in foreign currency exchange rates could effect our results of operations and
financial condition.
Interest
Rate Risk
We invest in high-quality financial
instruments, primarily money market funds and United States treasury notes, with
an effective duration of the portfolio of less than one year which we believe
are subject to limited credit risk. We currently do not hedge our
interest rate exposure. Due to the short-term nature of our
investments, which we plan to hold until maturity, we do not believe that we
have any material exposure to interest rate risk arising from our
investments.
Item
4T.
|
Controls
and Procedures.
|
(a) Evaluation
of disclosure controls and procedures.
The
principal executive officer and principal financial officer have evaluated our
disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Exchange Act) as of December 31, 2009. Based on this
evaluation, they have concluded that our disclosure controls and procedures were
effective to ensure that the information required to be disclosed by us in
reports that we file or submit under the Securities Exchange Act of 1934 is
recorded, processed, summarized and reported within the time periods specified
in the Commission’s rules and forms, and to ensure that information required to
be disclosed by us in the reports that we file or submit under the Securities
Exchange Act of 1934 is accumulated and communicated to our management,
including our principal executive and principal financial officers, to allow
timely decisions regarding required disclosure.
(b) Changes
in internal controls.
No change
in our internal controls over financial reporting (as defined in Rules 13a-15(f)
and 15d-15(f) under the Exchange Act) occurred during the six month period ended
December 31, 2009 that has materially affected, or is reasonably likely to
materially affect, our internal controls over financial
reporting.
-42-
PART II. OTHER
INFORMATION.
Item
1A. Risk Factors.
The more
prominent risks and uncertainties inherent in our business are described below.
However, additional risks and uncertainties may also impair our business
operations. If any of the following risks actually occur, our
business, financial condition or results of operations may suffer.
Risks Related to Our
Business
We have a limited operating history
and have incurred substantial losses and expect to incur future
losses.
We are a
development stage biotechnology company with a limited operating history and
limited assets and capital. We have incurred losses each year since
inception and had an accumulated deficit of $33,111,093 at December 31,
2009. We have generated minimal revenues by licensing our technology for certain
crops to companies willing to share in our development costs. In addition, our
technology may not be ready for commercialization for several years. We expect
to continue to incur losses for the next several years because we anticipate
that our expenditures on research and development, and administrative activities
will significantly exceed our revenues during that period. We cannot predict
when, if ever, we will become profitable.
Our
independent auditors have expressed substantial doubt about our ability to
continue as a going concern.
In their
audit opinion issued in connection with our consolidated balance sheet as of
June 30, 2009 and our related consolidated statements of operations,
stockholders’ equity, and cash flows for the year then ended, our auditors have
expressed substantial doubt about our ability to continue as a going concern
given our recurring net losses, negative cash flows from operations, planned
spending levels and the limited amount of funds on our balance
sheet. We have prepared our financial statements on a going concern
basis, which contemplates the realization of assets and the satisfaction of
liabilities and commitments in the normal course of business. The
consolidated financial statements do not include any adjustments that might be
necessary should we be unable to continue in existence.
We
may need additional capital to fund our operations until we are able to generate
a profit.
Our
operations to date have required significant cash expenditures. Our
future capital requirements will depend on the results of our research and
development activities, preclinical and clinical studies, and competitive and
technological advances.
In
addition, the financings with YA Global Investments, L.P., referred to herein as
YA Global, and Stanford Venture Capital Holdings, Inc., referred to herein as
Stanford, are secured by all of our assets. If we default under the
convertible notes, the investors may foreclose on our assets and our
business. As a result, we will need to obtain more funding in the
future through collaborations or other arrangements with research institutions
and corporate partners, or public and private offerings of our securities,
including debt or equity financing. We may not be able to obtain
adequate funds for our operations from these sources when needed or on
acceptable terms. Future collaborations or similar arrangements may require us
to license valuable intellectual property to, or to share substantial economic
benefits with, our collaborators. If we raise additional capital by
issuing additional equity or securities convertible into equity, our
stockholders may experience dilution and our share price may
decline. Any debt financing may result in restrictions on our
spending.
-43-
If we are
unable to raise additional funds, we will need to do one or more of the
following:
|
·
|
delay,
scale-back or eliminate some or all of our research and product
development programs;
|
|
·
|
license
third parties to develop and commercialize products or technologies that
we would otherwise seek to develop and commercialize
ourselves;
|
|
·
|
seek
strategic alliances or business
combinations;
|
|
·
|
attempt
to sell our company;
|
|
·
|
cease
operations; or
|
|
·
|
declare
bankruptcy.
|
We
believe that at the projected rate of spending as of December 31, 2009, we
should have sufficient cash to maintain our present operations for two (2) to
three (3) months from December 31, 2009.
We
may be adversely affected by the current economic environment.
Our
ability to obtain financing, invest in and grow our business, and meet our
financial obligations depends on our operating and financial performance, which
in turn is subject to numerous factors. In addition to factors
specific to our business, prevailing economic conditions and financial, business
and other factors beyond our control can also affect our business and ability to
raise capital. We cannot anticipate all of the ways in which the
current economic climate and financial market conditions could adversely impact
our business.
We depend on a single principal
technology and, if our technology is not commercially successful, we will have
no alternative source of revenue.
Our
primary business is the development and licensing of technology to identify,
isolate, characterize and promote or silence genes which control the death of
cells in humans and plants. Our future revenue and profitability critically
depend upon our ability to successfully develop apoptosis and senescence gene
technology and later license or market such technology. We have
conducted experiments on certain crops with favorable results and have conducted
certain preliminary cell-line and animal experiments, which have provided us
with data upon which we have designed additional research programs. However, we
cannot give any assurance that our technology will be commercially successful or
economically viable for any crops or human health applications.
-44-
In
addition, no assurance can be given that adverse consequences might not result
from the use of our technology such as the development of negative effects on
humans or plants or reduced benefits in terms of crop yield or
protection. Our failure to obtain market acceptance of our technology
or of our current or potential licensees to successfully commercialize such
technology would have a material adverse effect on our business.
We
outsource all of our research and development activities and, if we are
unsuccessful in maintaining our alliances with these third parties, our research
and development efforts may be delayed or curtailed.
We rely
on third parties to perform all of our research and development
activities. Our research and development efforts take place at the
University of Waterloo in Ontario, Canada, where our technology was discovered,
Mayo Clinic and with our commercial partners. At this time, we do not
have the internal capabilities to perform our research and development
activities. Accordingly, the failure of third-party research partners to perform
under agreements entered into with us, or our failure to renew important
research agreements with these third parties, may delay or curtail our research
and development efforts.
We
have significant future capital needs and may be unable to raise capital when
needed, which could force us to delay or reduce our research and development
efforts.
As of
December 31, 2009, we had cash of $751,787 and working capital of
$881,652. Using our available reserves as of December 31, 2009, we
believe that we can operate according to our current business plan for the next
two (2) to three (3) months from December 31, 2009. To date, we
have generated minimal revenues and anticipate that our operating costs will
exceed any revenues generated over the next several years. Therefore, we will be
required to raise additional capital in the future in order to operate in
accordance with our current business plan, and this funding may not be available
on favorable terms, if at all. If we are unable to raise additional
funds, we will need to do one or more of the following:
|
·
|
delay,
scale back or eliminate some or all of our research and development
programs;
|
|
·
|
provide
a license to third parties to develop and commercialize our technology
that we would otherwise seek to develop and commercialize
ourselves;
|
|
·
|
seek
strategic alliances or business
combinations;
|
|
·
|
attempt
to sell our company;
|
|
·
|
cease
operations; or
|
|
·
|
declare
bankruptcy.
|
-45-
In
addition, in connection with any funding, if we need to issue more equity
securities than our certificate of incorporation currently authorizes, or more
than 20% of the shares of our common stock outstanding, we may need stockholder
approval. If stockholder approval is not obtained or if adequate
funds are not available, we may be required to curtail operations significantly
or to obtain funds through arrangements with collaborative partners or others
that may require us to relinquish rights to certain of our technologies, product
candidates, products or potential markets. Investors may experience
dilution in their investment from future offerings of our common
stock. For example, if we raise additional capital by issuing equity
securities, such an issuance would reduce the percentage ownership of existing
stockholders. In addition, assuming the exercise of all options and
warrants outstanding and the conversion of the notes into common stock, as of
December 31, 2009, we had 18,268,537 shares of common stock authorized but
unissued and unreserved, which may be issued from time to time by our board of
directors without stockholder approval. Furthermore, we may need to
issue securities that have rights, preferences and privileges senior to our
common stock. Failure to obtain financing on acceptable terms would
have a material adverse effect on our liquidity.
Since our
inception, we have financed all of our operations through private equity and
debt financings. Our future capital requirements depend on numerous factors,
including:
|
·
|
the
scope of our research and
development;
|
|
·
|
our
ability to attract business partners willing to share in our development
costs;
|
|
·
|
our
ability to successfully commercialize our
technology;
|
|
·
|
competing
technological and market
developments;
|
|
·
|
our
ability to enter into collaborative arrangements for the development,
regulatory approval and commercialization of other products;
and
|
|
·
|
the
cost of filing, prosecuting, defending and enforcing patent claims and
other intellectual property rights.
|
Our
business depends upon our patents and proprietary rights and the enforcement of
these rights. Our failure to obtain and maintain patent protection
may increase competition and reduce demand for our technology.
As a
result of the substantial length of time and expense associated with developing
products and bringing them to the marketplace in the biotechnology and
agricultural industries, obtaining and maintaining patent and trade secret
protection for technologies, products and processes is of vital
importance. Our success will depend in part on several factors,
including, without limitation:
|
·
|
our
ability to obtain patent protection for our technologies and
processes;
|
|
·
|
our
ability to preserve our trade secrets;
and
|
|
·
|
our
ability to operate without infringing the proprietary rights of other
parties both in the United States and in foreign
countries.
|
-46-
As of
December 31, 2009, we have been issued twenty (20) patents by the PTO and
thirty-nine (39) patents from foreign countries. We have also filed
numerous patent applications for our technology in the United States and in
several foreign countries, which technology is vital to our primary business, as
well as several Continuations in Part on these patent
applications. Our success depends in part upon the grant of patents
from our pending patent applications.
Although
we believe that our technology is unique and that it will not violate or
infringe upon the proprietary rights of any third party, we cannot assure you
that these claims will not be made or if made, could be successfully defended
against. If we do not obtain and maintain patent protection, we may
face increased competition in the United States and internationally, which would
have a material adverse effect on our business.
Since
patent applications in the United States are maintained in secrecy until patents
are issued, and since publication of discoveries in the scientific and patent
literature tend to lag behind actual discoveries by several months, we cannot be
certain that we were the first creator of the inventions covered by our pending
patent applications or that we were the first to file patent applications for
these inventions.
In
addition, among other things, we cannot assure you that:
|
·
|
our
patent applications will result in the issuance of
patents;
|
|
·
|
any
patents issued or licensed to us will be free from challenge and if
challenged, would be held to be
valid;
|
|
·
|
any
patents issued or licensed to us will provide commercially significant
protection for our technology, products and
processes;
|
|
·
|
other
companies will not independently develop substantially equivalent
proprietary information which is not covered by our patent
rights;
|
|
·
|
other
companies will not obtain access to our
know-how;
|
|
·
|
other
companies will not be granted patents that may prevent the
commercialization of our technology;
or
|
|
·
|
we
will not incur licensing fees and the payment of significant other fees or
royalties to third parties for the use of their intellectual property in
order to enable us to conduct our
business.
|
Our
competitors may allege that we are infringing upon their intellectual property
rights, forcing us to incur substantial costs and expenses in resulting
litigation, the outcome of which would be uncertain.
Patent
law is still evolving relative to the scope and enforceability of claims in the
fields in which we operate. We are like most biotechnology companies
in that our patent protection is highly uncertain and involves complex legal and
technical questions for which legal principles are not yet firmly
established. In addition, if issued, our patents may not contain
claims sufficiently broad to protect us against third parties with similar
technologies or products, or provide us with any competitive
advantage.
-47-
The PTO
and the courts have not established a consistent policy regarding the breadth of
claims allowed in biotechnology patents. The allowance of broader
claims may increase the incidence and cost of patent interference proceedings
and the risk of infringement litigation. On the other hand, the
allowance of narrower claims may limit the scope and value of our proprietary
rights.
The laws
of some foreign countries do not protect proprietary rights to the same extent
as the laws of the United States, and many companies have encountered
significant problems and costs in protecting their proprietary rights in these
foreign countries.
We could
become involved in infringement actions to enforce and/or protect our
patents. Regardless of the outcome, patent litigation is expensive
and time consuming and would distract our management from other
activities. Some of our competitors may be able to sustain the costs
of complex patent litigation more effectively than we could because they have
substantially greater resources. Uncertainties resulting from the
initiation and continuation of any patent litigation could limit our ability to
continue our operations.
If
our technology infringes the intellectual property of our competitors or other
third parties, we may be required to pay license fees or damages.
If any
relevant claims of third-party patents that are adverse to us are upheld as
valid and enforceable, we could be prevented from commercializing our technology
or could be required to obtain licenses from the owners of such
patents. We cannot assure you that such licenses would be available
or, if available, would be on acceptable terms. Some licenses may be
non-exclusive and, therefore, our competitors may have access to the same
technology licensed to us. In addition, if any parties successfully
claim that the creation or use of our technology infringes upon their
intellectual property rights, we may be forced to pay damages, including treble
damages.
Our
security measures may not adequately protect our unpatented technology and, if
we are unable to protect the confidentiality of our proprietary information and
know-how, the value of our technology may be adversely affected.
Our
success depends upon know-how, unpatentable trade secrets, and the skills,
knowledge and experience of our scientific and technical
personnel. As a result, we require all employees to agree to a
confidentiality provision in their employment agreement that prohibits the
disclosure of confidential information to anyone outside of our company, during
the term of employment and thereafter. We also require all employees
to disclose and assign to us the rights to their ideas, developments,
discoveries and inventions. We also attempt to enter into similar
agreements with our consultants, advisors and research
collaborators. We cannot assure you that adequate protection for our
trade secrets, know-how or other proprietary information against unauthorized
use or disclosure will be available.
-48-
We
occasionally provide information to research collaborators in academic
institutions and request that the collaborators conduct certain
tests. We cannot assure you that the academic institutions will not
assert intellectual property rights in the results of the tests conducted by the
research collaborators, or that the academic institutions will grant licenses
under such intellectual property rights to us on acceptable terms, if at
all. If the assertion of intellectual property rights by an academic
institution is substantiated, and the academic institution does not grant
intellectual property rights to us, these events could limit our ability to
commercialize our technology.
As
we evolve from a company primarily involved in the research and development of
our technology into one that is also involved in the commercialization of our
technology, we may have difficulty managing our growth and expanding our
operations.
As our
business grows, we may need to add employees and enhance our management, systems
and procedures. We may need to successfully integrate our internal
operations with the operations of our marketing partners, manufacturers,
distributors and suppliers to produce and market commercially viable
products. We may also need to manage additional relationships with
various collaborative partners, suppliers and other
organizations. Although we do not presently conduct research and
development activities in-house, we may undertake those activities in the
future. Expanding our business may place a significant burden on our
management and operations. We may not be able to implement
improvements to our management information and control systems in an efficient
and timely manner and we may discover deficiencies in our existing systems and
controls. Our failure to effectively respond to such changes may make
it difficult for us to manage our growth and expand our operations.
We
have no marketing or sales history and depend on third-party marketing
partners. Any failure of these parties to perform would delay or
limit our commercialization efforts.
We have
no history of marketing, distributing or selling biotechnology products and we
are relying on our ability to successfully establish marketing partners or other
arrangements with third parties to market, distribute and sell a commercially
viable product both here and abroad. Our business plan envisions
creating strategic alliances to access needed commercialization and marketing
expertise. We may not be able to attract qualified sub-licensees,
distributors or marketing partners, and even if qualified, these marketing
partners may not be able to successfully market agricultural products or human
health applications developed with our technology. If our current or
potential future marketing partners fail to provide adequate levels of sales,
our commercialization efforts will be delayed or limited and we may not be able
to generate revenue.
-49-
We
will depend on joint ventures and strategic alliances to develop and market our
technology and, if these arrangements are not successful, our technology may not
be developed and the expenses to commercialize our technology will
increase.
In its
current state of development, our technology is not ready to be marketed to
consumers. We intend to follow a multi-faceted commercialization
strategy that involves the licensing of our technology to business partners for
the purpose of further technological development, marketing and
distribution. We have and are seeking business partners who will
share the burden of our development costs while our technology is still being
developed, and who will pay us royalties when they market and distribute
products incorporating our technology upon commercialization. The
establishment of joint ventures and strategic alliances may create future
competitors, especially in certain regions abroad where we do not pursue patent
protection. If we fail to establish beneficial business partners and
strategic alliances, our growth will suffer and the continued development of our
technology may be harmed.
Competition
in the human health and agricultural biotechnology industries is intense and
technology is changing rapidly. If our competitors market their
technology faster than we do, we may not be able to generate revenues from the
commercialization of our technology.
Many
human health and agricultural biotechnology companies are engaged in research
and development activities relating to apoptosis and senescence. The
market for plant protection and yield enhancement products is intensely
competitive, rapidly changing and undergoing consolidation. We may be
unable to compete successfully against our current and future competitors, which
may result in price reductions, reduced margins and the inability to achieve
market acceptance for products containing our technology. Our
competitors in the field of plant senescence gene technology are companies that
develop and produce transgenic plants and include major international
agricultural companies, specialized biotechnology companies, research and
academic institutions and, potentially, our joint venture and strategic alliance
partners. These companies include: Mendel Biotechnology, Inc.,
Renessen LLC, Exelixis Plant Sciences, Inc., and Syngenta International AG,
among others. Some of our competitors that are involved in apoptosis
research include: Amgen Inc.; Centocor, Inc.; Genzyme Corporation;
OSI Pharmaceuticals, Inc.; Novartis AG; Introgen Therapeutics, Inc.; Genta,
Inc.; and Vertex Pharmaceuticals, Inc. Many of these competitors have
substantially greater financial, marketing, sales, distribution and technical
resources than us and have more experience in research and development, clinical
trials, regulatory matters, manufacturing and marketing. We
anticipate increased competition in the future as new companies enter the market
and new technologies become available. Our technology may be rendered
obsolete or uneconomical by technological advances or entirely different
approaches developed by one or more of our competitors, which will prevent or
limit our ability to generate revenues from the commercialization of our
technology.
Our
business is subject to various government regulations and, if we or our
licensees are unable to obtain regulatory approval, we may not be able to
continue our operations.
At
present, the U.S. federal government regulation of biotechnology is divided
among three agencies:
|
·
|
the
USDA regulates the import, field testing and interstate movement of
specific types of genetic engineering that may be used in the creation of
transgenic plants;
|
|
·
|
the
EPA regulates activity related to the invention of plant pesticides and
herbicides, which may include certain kinds of transgenic plants;
and
|
|
·
|
the
FDA regulates foods derived from new plant
varieties.
|
-50-
The FDA
requires that transgenic plants meet the same standards for safety that are
required for all other plants and foods in general. Except in the
case of additives that significantly alter a food’s structure, the FDA does not
require any additional standards or specific approval for genetically engineered
foods, but expects transgenic plant developers to consult the FDA before
introducing a new food into the marketplace.
Use of
our technology, if developed for human health applications, will also be subject
to FDA regulation. The FDA must approve any drug or biologic product
before it can be marketed in the United States. In addition, prior to
being sold outside of the U.S., any products resulting from the application of
our human health technology must be approved by the regulatory agencies of
foreign governments. Prior to filing a new drug application or
biologics license application with the FDA, we would have to perform extensive
clinical trials, and prior to beginning any clinical trial, we would need to
perform extensive preclinical testing which could take several years and may
require substantial expenditures.
We
believe that our current activities, which to date have been confined to
research and development efforts, do not require licensing or approval by any
governmental regulatory agency. However, we are planning on performing clinical
trials, which would be subject to FDA approval. Additionally,
federal, state and foreign regulations relating to crop protection products and
human health applications developed through biotechnology are subject to public
concerns and political circumstances, and, as a result, regulations have changed
and may change substantially in the future. Accordingly, we may
become subject to governmental regulations or approvals or become subject to
licensing requirements in connection with our research and development efforts.
We may also be required to obtain such licensing or approval from the
governmental regulatory agencies described above, or from state agencies, prior
to the commercialization of our genetically transformed plants and human health
technology. In addition, our marketing partners who utilize our
technology or sell products grown with our technology may be subject to
government regulations. If unfavorable governmental regulations are
imposed on our technology or if we fail to obtain licenses or approvals in a
timely manner, we may not be able to continue our operations.
Preclinical
studies of our human health applications may be unsuccessful, which could delay
or prevent regulatory approval.
Preclinical
studies may reveal that our human health technology is ineffective or harmful,
and/or may be unsuccessful in demonstrating efficacy and safety of our human
health technology, which would significantly limit the possibility of obtaining
regulatory approval for any drug or biologic product manufactured with our
technology. The FDA requires submission of extensive preclinical,
clinical and manufacturing data to assess the efficacy and safety of potential
products. We are currently in the process of conducting preclinical toxicology
studies for our multiple myeloma product candidate. Any delay in this
toxicology study, or any potential negative findings in this toxicology study,
will delay our ability to file an IND for our multiple myeloma product
candidate. Furthermore, the success of preliminary studies does not
ensure commercial success, and later-stage clinical trials may fail to confirm
the results of the preliminary studies.
-51-
Our success will depend on the success clinical trials
that have not yet begun.
It may
take several years to complete the clinical trials of a product, and a failure
of one or more of our clinical trials can occur at any stage of testing. We
believe that the development of our product candidate involves significant risks
at each stage of testing. If clinical trial difficulties and failures arise, our
product candidate may never be approved for sale or become commercially
viable.
There are a number of
difficulties and risks associated with clinical trials. These difficulties and
risks may result in the failure to receive regulatory approval to sell our
product candidate or the inability to commercialize our product candidate. The
possibility exists that:
•
|
we may discover that the product candidate does
not exhibit the expected therapeutic results in humans, may cause harmful
side effects or have other unexpected characteristics that may delay or
preclude regulatory approval or limit commercial use if
approved;
|
•
|
the results from early clinical trials may not be
statistically significant or predictive of results that will be obtained
from expanded, advanced clinical
trials;
|
•
|
institutional review boards or regulators,
including the FDA, may hold, suspend or terminate our clinical research or
the clinical trials of our product candidate for various reasons,
including noncompliance with regulatory requirements or if, in their
opinion, the participating subjects are being exposed to unacceptable
health risks;
|
•
|
subjects may drop out of our clinical
trials;
|
•
|
our preclinical studies or clinical trials may
produce negative, inconsistent or inconclusive results, and we may decide,
or regulators may require us, to conduct additional preclinical studies or
clinical trials; and
|
•
|
the cost of our clinical trials may be greater
than we currently
anticipate.
|
If our clinical trials for our
product candidates are delayed, we would be unable to commercialize our product
candidates on a timely basis, which would materially harm our
business.
Planned clinical trials may not begin on time or may
need to be restructured after they have begun. Clinical trials can be delayed
for a variety of reasons, including delays related to:
•
|
obtaining an effective investigational new drug
application, or IND, or regulatory approval to commence a clinical
trial;
|
•
|
negotiating acceptable clinical trial agreement
terms with prospective trial
sites;
|
•
|
obtaining institutional review board approval to
conduct a clinical trial at a prospective
site;
|
-52-
•
|
recruiting qualified subjects to participate in
clinical trials;
|
•
|
competition in recruiting clinical
investigators;
|
•
|
shortage or lack of availability of supplies of
drugs for clinical trials;
|
•
|
the need to repeat clinical trials as a result of
inconclusive results or poorly executed
testing;
|
•
|
the placement of a clinical hold on a
study;
|
•
|
the failure of third parties conducting and
overseeing the operations of our clinical trials to perform their
contractual or regulatory obligations in a timely fashion;
and
|
•
|
exposure of clinical trial subjects to unexpected
and unacceptable health risks or noncompliance with regulatory
requirements, which may result in suspension of the
trial
|
We believe that our product candidate has significant
milestones to reach, including the successful completion of clinical trials,
before commercialization. If we have significant delays in or termination of
clinical trials, our financial results and the commercial prospects for our
product candidates or any other products that we may develop will be adversely
impacted. In addition, our product development costs would increase and our
ability to generate revenue could be impaired.
Any
inability to license from third parties their proprietary technologies or
processes which we use in connection with the development of our technology may
impair our business.
Other
companies, universities and research institutions have or may obtain patents
that could limit our ability to use our technology in a product candidate or
impair our competitive position. As a result, we would have to obtain
licenses from other parties before we could continue using our technology in a
product candidate. Any necessary licenses may not be available on
commercially acceptable terms, if at all. If we do not obtain
required licenses, we may not be able to develop our technology into a product
candidate or we may encounter significant delays in development while we
redesign methods that are found to infringe on the patents held by
others.
Clinical
trials for our human health technology will be lengthy and expensive and their
outcome is uncertain
Before
obtaining regulatory approval for the commercial sales of any product containing
our technology, we must demonstrate through clinical testing that our technology
and product containing our technology is safe and effective for use in
humans. Conducting clinical trials is a time-consuming, expensive and
uncertain process and typically requires years to complete. In our
industry, the results from preclinical studies and early clinical trials often
are not predictive of results obtained in later-stage clinical
trials. Some products and technologies that have shown promising
results in preclinical studies or early clinical trials subsequently fail to
establish sufficient safety and efficacy data necessary to obtain regulatory
approval. At any time during clinical trials we or the FDA might
delay or halt any clinical trial for various reasons,
including:
-53-
|
·
|
occurrence
of unacceptable toxicities or side
effects;
|
|
·
|
ineffectiveness
of the product candidate;
|
|
·
|
negative
or inconclusive results from the clinical trials, or results that
necessitate additional studies or clinical
trials;
|
|
·
|
delays
in obtaining or maintaining required approvals from institutions, review
boards or other reviewing entities at clinical
sites;
|
|
·
|
delays
in patient enrollment; or
|
|
·
|
insufficient
funding or a reprioritization of financial or other
resources.
|
Any
failure or substantial delay in successfully completing clinical trials and
obtaining regulatory approval for our product candidates could severely harm our
business.
Even
if we receive regulatory approval, consumers may not accept products containing
our technology, which will prevent us from being profitable since we have no
other source of revenue.
We cannot
guarantee that consumers will accept products containing our
technology. Recently, there has been consumer concern and consumer
advocate activism with respect to genetically-engineered agricultural consumer
products. The adverse consequences from heightened consumer concern
in this regard could affect the markets for agricultural products developed with
our technology and could also result in increased government regulation in
response to that concern. If the public or potential customers perceive our
technology to be genetic modification or genetic engineering, agricultural
products grown with our technology may not gain market acceptance.
We
depend on our key personnel and, if we are not able to attract and retain
qualified scientific and business personnel, we may not be able to grow our
business or develop and commercialize our technology.
We are
highly dependent on our scientific advisors, consultants and third-party
research partners. Our success will also depend in part on the
continued service of our key employees and our ability to identify, hire and
retain additional qualified personnel in an intensely competitive
market. Although we have employment agreements with all of our key
employees and a research agreement with Dr. John Thompson, these agreements may
be terminated upon short or no notice. We do not maintain key person
life insurance on any member of management. The failure to attract
and retain key personnel could limit our growth and hinder our research and
development efforts.
-54-
Certain
provisions of our charter, by-laws and Delaware law could make a takeover
difficult.
Certain
provisions of our certificate of incorporation and by-laws could make it more
difficult for a third party to acquire control of us, even if the change in
control would be beneficial to stockholders. Our certificate of
incorporation authorizes our board of directors to issue, without stockholder
approval, except as may be required by the rules of the NYSE Amex Exchange,
5,000,000 shares of preferred stock with voting, conversion and other rights and
preferences that could adversely affect the voting power or other rights of the
holders of our common stock. Similarly, our by-laws do not restrict
our board of directors from issuing preferred stock without stockholder
approval.
In
addition, we are subject to the Business Combination Act of the Delaware General
Corporation Law which, subject to certain exceptions, restricts certain
transactions and business combinations between a corporation and a stockholder
owning 15% or more of the corporation’s outstanding voting stock for a period of
three years from the date such stockholder becomes a 15% owner. These
provisions may have the effect of delaying or preventing a change of control of
us without action by our stockholders and, therefore, could adversely affect the
value of our common stock.
Furthermore,
in the event of our merger or consolidation with or into another corporation, or
the sale of all or substantially all of our assets in which the successor
corporation does not assume our outstanding equity awards or issue equivalent
equity awards, our current equity plans require the accelerated vesting of such
outstanding equity awards.
Risks Related to Our Common
Stock
We
currently do not meet the NYSE Amex Exchange continued listing
standards. If our common stock is delisted from the NYSE Amex
Exchange, we may not be able to list on any other stock exchange, and our common
stock may be subject to the “penny stock” regulations which may affect the
ability of our stockholders to sell their shares.
The NYSE
Amex Exchange requires us to meet minimum financial requirements in order to
maintain our listing. Currently, we do not meet the $6,000,000
minimum net worth continued listing requirement of the NYSE Amex
Exchange and have received a notice of noncompliance from the NYSE Amex
Exchange. We submitted a plan of compliance to the NYSE Amex Exchange
discussing how we intend to regain compliance with the continued listing
requirements. The NYSE Amex Exchange has accepted our plan of
compliance and granted us an extension until April 29, 2011 to regain compliance
with the NYSE's continued listing standards. During the extension
period, we remain subject to periodic review by NYSE Staff. Failure to make
progress consistent with the plan or to regain compliance with the continued
listing standards by the end of the extension period could result in our company
being delisted from the NYSE. If we are delisted from the NYSE Amex
Exchange, our common stock likely will become a “penny stock.” In
general, regulations of the SEC define a “penny stock” to be an equity security
that is not listed on a national securities exchange or the NASDAQ Stock Market
and that has a market price of less than $5.00 per share or with an exercise
price of less than $5.00 per share, subject to certain exceptions. If
our common stock becomes a penny stock, additional sales practice requirements
would be imposed on broker-dealers that sell such securities to persons other
than certain qualified investors. For transactions involving a penny
stock, unless exempt, a broker-dealer must make a special suitability
determination for the purchaser and receive the purchaser’s written consent to
the transaction prior to the sale. In addition, the rules on penny
stocks require delivery, prior to and after any penny stock transaction, of
disclosures required by the SEC.
-55-
If our
stock is not accepted for listing on the NYSE Amex Exchange, we will make every
possible effort to have it listed on the Over the Counter Bulletin Board, or the
OTC Bulletin Board. If our common stock were to be traded on the OTC
Bulletin Board, the Securities Exchange Act of 1934, as amended, and related
Securities and Exchange Commission (SEC) rules would impose additional sales
practice requirements on broker-dealers that sell our
securities. These rules may adversely affect the ability of
stockholders to sell our common stock and otherwise negatively affect the
liquidity, trading market and price of our common stock.
We
believe that the listing of our common stock on a recognized national trading
market, such as the NYSE Amex Exchange, is an important part of our business and
strategy. Such a listing helps our stockholders by providing a
readily available trading market with current quotations. Without
that, stockholders may have a difficult time getting a quote for the sale or
purchase of our stock, the sale or purchase of our stock would likely be made
more difficult and the trading volume and liquidity of our stock would likely
decline. The absence of such a listing may adversely affect the
acceptance of our common stock as currency or the value accorded it by other
parties. In that regard, the absence of a listing on a recognized
national trading market will also affect our ability to benefit from the use of
our operations and expansion plans, including for use in licensing agreements,
joint ventures, the development of strategic relationships and acquisitions,
which are critical to our business and strategy and none of which is currently
the subject of any agreement, arrangement or understanding, with respect to any
future financing or strategic relationship it may undertake. A
delisting from the NYSE Amex Exchange could result in negative publicity and
could negatively impact our ability to raise capital in the future.
Our
management and other affiliates have significant control of our common stock and
could significantly influence our actions in a manner that conflicts with our
interests and the interests of other stockholders.
As of
December 31, 2009, our executive officers, directors and affiliated entities
together beneficially own approximately 61.2% of the outstanding shares of our
common stock, assuming the exercise of options and warrants which are currently
exercisable or will become exercisable within 60 days of December 31, 2009, held
by these stockholders. As a result, these stockholders, acting together,
will be able to exercise significant influence over matters requiring approval
by our stockholders, including the election of directors, and may not always act
in the best interests of other stockholders. Such a concentration of
ownership may have the effect of delaying or preventing a change in control of
us, including transactions in which our stockholders might otherwise receive a
premium for their shares over then current market prices. Stanford is
one such major stockholder of the Company.
In
February 2009, the SEC filed a civil lawsuit accusing certain executives of
Stanford of fraud and Stanford’s assets were subsequently placed in
receivership. It is unclear at this point, what impact, if any, the
ongoing investigation of Stanford may have on the Company.
-56-
A
significant portion of our total outstanding shares of common stock may be sold
in the market in the near future, which could cause the market price of our
common stock to drop significantly.
As of
December 31, 2009, we had 28,640,934 shares of our common stock issued and
outstanding, of which approximately 1,986,306 shares are registered pursuant to
a registration statement on Form S-3 and 26,654,628 of which are either eligible
to be sold under SEC Rule 144 or are in the public float. In
addition, we have registered 2,632,194 shares of our common stock underlying
warrants previously issued on the Form S-3 registration statement and we
registered 6,137,200 shares of our common stock underlying options granted or to
be granted under our stock option plan. Consequently, sales of
substantial amounts of our common stock in the public market, or the perception
that such sales could occur, may have a material adverse effect on our stock
price.
Our
common stock has a limited trading market, which could limit your ability to
resell your shares of common stock at or above your purchase price.
Our
common stock is quoted on the NYSE Amex Exchange and currently has a limited
trading market. The NYSE Amex Exchange requires us to meet minimum
financial requirements in order to maintain our listing. Currently,
we do not meet the continued listing requirements of the NYSE Amex
Exchange. If we do not meet the continued listing standards, we could
be delisted. We cannot assure you that an active trading market will
develop or, if developed, will be maintained. As a result, our
stockholders may find it difficult to dispose of shares of our common stock and,
as a result, may suffer a loss of all or a substantial portion of their
investment.
The
market price of our common stock may fluctuate and may drop below the price you
paid.
We cannot
assure you that you will be able to resell the shares of our common stock at or
above your purchase price. The market price of our common stock may
fluctuate significantly in response to a number of factors, some of which are
beyond our control. These factors include:
|
·
|
quarterly
variations in operating results;
|
|
·
|
the
progress or perceived progress of our research and development
efforts;
|
|
·
|
changes
in accounting treatments or
principles;
|
|
·
|
announcements
by us or our competitors of new technology, product and service offerings,
significant contracts, acquisitions or strategic
relationships;
|
|
·
|
additions
or departures of key personnel;
|
|
·
|
future
offerings or resales of our common stock or other
securities;
|
|
·
|
stock
market price and volume fluctuations of publicly-traded companies in
general and development companies in particular;
and
|
|
·
|
general
political, economic and market
conditions.
|
-57-
For
example, during the quarter ended December 31, 2009, our common stock traded
between $0.49 per share and $0.30 per share.
Because
we do not intend to pay, and have not paid, any cash dividends on our shares of
common stock, our stockholders will not be able to receive a return on their
shares unless the value of our common stock appreciates and they sell their
shares.
We have
never paid or declared any cash dividends on our common stock and we intend to
retain any future earnings to finance the development and expansion of our
business. We do not anticipate paying any cash dividends on our
common stock in the foreseeable future. Therefore, our stockholders
will not be able to receive a return on their investment unless the value of our
common stock appreciates and they sell their shares.
Our
stockholders may experience substantial dilution as a result of the conversion
of outstanding convertible debentures, or the exercise of options and warrants
to purchase our common stock.
As of
December 31, 2009, we have outstanding warrants to purchase 22,105,793 shares of
our common stock. In addition, as of December 31, 2009, we have reserved
10,212,884 shares of our common stock for issuance upon the exercise of options
granted or available to be granted pursuant to our stock option plan, all of
which may be granted in the future. The exercise of these options and
warrants will result in dilution to our existing stockholders and could have a
material adverse effect on our stock price. In addition, any shares issued in
connection with the YA Global financing or Stanford financing, as further
discussed elsewhere in this Form 10-Q, can also have a dilutive effect and a
possible material adverse effect on our stock price. The conversion
price of the warrants are also subject to certain anti-dilution
adjustments. The agreements with YA Global and Stanford provide for
the potential issuance of up to a total of 62,388,888 shares of our common
stock, of which 13,883,332 shares are included in outstanding warrants noted
above.
-58-
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
Proceeds.
|
None
Item
5.
|
Other
Information
|
None
Item
6.
|
Exhibits.
|
Exhibits.
Exhibit
No.
|
Description
|
|
10.1
|
Confidential Separation Agreement and General
Release by and between the Company and Bruce C. Galton dated as of
November 23, 2009. (Incorporated by reference to Exhibit 10.1 of Senesco
Technologies, Inc. Current Report of Form 8-K filed on November 25,
2010)
|
|
10.2
|
Confidential Separation Agreement and General
Release by and between the Company and Sascha P. Fedyszyn dated as of
February 2, 2010. (Incorporated by reference to Exhibit 10.1 of Senesco
Technologies, Inc. Current Report of Form 8-K filed on February 4,
2010)
|
|
31.1
|
Certification
of principal executive officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. (filed herewith)
|
|
31.2
|
Certification
of principal financial and accounting officer pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002. (filed herewith)
|
|
32.1
|
Certification
of principal executive officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350. (furnished
herewith)
|
|
32.2
|
Certification
of principal financial and accounting officer pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350. (furnished
herewith)
|
* A
management contract or compensating plan or arrangement required to be filed as
an exhibit
-59-
SIGNATURES
In
accordance with the requirements of the Securities Exchange Act of 1934, the
registrant caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
SENESCO
TECHNOLOGIES, INC.
|
||
DATE: February
16, 2010
|
By:
|
/s/ Jack Van Hulst
|
Jack
Van Hulst, President
|
||
and
Chief Executive Officer
|
||
(Principal
Executive Officer)
|
||
DATE: February
16, 2010
|
By:
|
/s/ Joel Brooks
|
Joel
Brooks, Chief Financial Officer
|
||
and
Treasurer
|
||
(Principal
Financial and Accounting
Officer)
|
-60-