x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
|
|
EXCHANGE ACT OF 1934
|
|
|
|
For the quarterly period ended December 31, 2013
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
|
|
EXCHANGE ACT OF 1934
|
|
|
|
For the transition period from to
|
Delaware
|
84-1368850
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
|
Yes: x
|
|
No: ¨
|
|
|
Yes: x
|
|
No: ¨
|
|
Large accelerated filer ¨
|
Accelerated filer ¨
|
|
|
Non-accelerated filer ¨
|
Smaller reporting company x
|
|
Yes: ¨
|
|
No: x
|
|
|
Page
|
|
PART I. FINANCIAL INFORMATION
|
|
|
|
|
|
Item 1. Financial Statements (Unaudited)
|
1
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS
as of December 31, 2013 and June 30, 2013 |
2
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the Three Months and Six Months Ended December 31, 2013 and 2012, and From Inception on July 1, 1998 through December 31, 2013 |
3
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
For the Six Months Ended December 31, 2013 |
4
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Six Months Ended December 31, 2013 and 2012, and From Inception on July 1, 1998 through December 31, 2013 |
5
|
|
|
|
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
6
|
|
|
|
|
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
13
|
|
|
|
|
Overview
|
13
|
|
|
|
|
Liquidity and Capital Resources
|
17
|
|
|
|
|
Changes to Critical Accounting Policies and Estimates
|
17
|
|
|
|
|
Results of Operations
|
18
|
|
|
|
|
Off-Balance Sheet Arrangements
|
21
|
|
|
|
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
22
|
|
|
|
Item 4.
|
Controls and Procedures
|
22
|
|
|
|
PART II. OTHER INFORMATION
|
|
|
|
|
|
Item 1.
|
Legal Proceedings
|
23
|
|
|
|
Item 1A.
|
Risk Factors
|
23
|
|
|
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
40
|
|
|
|
Item 3.
|
Defaults Upon Senior Securities
|
40
|
|
|
|
Item 4.
|
Mine Safety Disclosures
|
40
|
|
|
|
Item 5.
|
Other Information
|
40
|
|
|
|
Item 6.
|
Exhibits
|
40
|
|
|
|
SIGNATURES
|
|
41
|
i | ||
Item 1. | Financial Statements (Unaudited). |
1 | ||
|
|
December 31,
|
|
June 30,
|
|
||
|
|
2013
|
|
2013
|
|
||
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
6,121,895
|
|
$
|
1,602,294
|
|
Prepaid research supplies and expenses
|
|
|
1,488,465
|
|
|
1,919,220
|
|
|
|
|
|
|
|
|
|
Total Current Assets
|
|
|
7,610,360
|
|
|
3,521,514
|
|
|
|
|
|
|
|
|
|
Equipment, furniture and fixtures, net
|
|
|
3,512
|
|
|
4,555
|
|
Intangible assets, net
|
|
|
3,482,388
|
|
|
3,566,497
|
|
Security deposit
|
|
|
5,171
|
|
|
5,171
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$
|
11,101,431
|
|
$
|
7,097,737
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
477,628
|
|
$
|
637,320
|
|
Accrued expenses
|
|
|
616,903
|
|
|
387,540
|
|
Line of credit
|
|
|
2,187,082
|
|
|
2,187,082
|
|
|
|
|
|
|
|
|
|
Total Current Liabilities
|
|
|
3,281,613
|
|
|
3,211,942
|
|
|
|
|
|
|
|
|
|
Other liabilities
|
|
|
99,728
|
|
|
99,728
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES
|
|
|
3,381,341
|
|
|
3,311,670
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible preferred stock, $0.01 par value, authorized 5,000,000 shares
|
|
|
|
|
|
|
|
Series A 10,297 shares issued and 580 and 800 shares outstanding, respectively
(liquidation preference of $594,500 and $820,000 at December 31, 2013 and June 30, 2013, respectively) |
|
|
6
|
|
|
8
|
|
Common stock, $0.01 par value, authorized 500,000,000 shares, issued and
outstanding4,957,275 and 2,272,062, respectively |
|
|
49,573
|
|
|
22,721
|
|
Capital in excess of par
|
|
|
85,542,557
|
|
|
78,189,173
|
|
Deficit accumulated during the development stage
|
|
|
(77,872,046)
|
|
|
(74,425,835)
|
|
|
|
|
|
|
|
|
|
Total Stockholders' Equity
|
|
|
7,720,090
|
|
|
3,786,067
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
$
|
11,101,431
|
|
$
|
7,097,737
|
|
2 | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative
|
|
|
|
|
Three Months Ended December 31,
|
|
Six Months Ended December 31,
|
|
Amounts from
|
|
|||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
|
Inception
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing Revenue
|
|
$
|
-
|
|
$
|
-
|
|
$
|
100,000
|
|
$
|
-
|
|
$
|
1,890,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
941,784
|
|
|
708,968
|
|
|
1,882,233
|
|
|
1,441,688
|
|
|
35,996,534
|
|
Research and development
|
|
|
647,123
|
|
|
591,079
|
|
|
1,374,242
|
|
|
1,104,512
|
|
|
24,696,513
|
|
Write-off of patents abandoned
|
|
|
-
|
|
|
-
|
|
|
185,161
|
|
|
-
|
|
|
2,158,595
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
1,588,907
|
|
|
1,300,047
|
|
|
3,441,636
|
|
|
2,546,200
|
|
|
62,851,642
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(1,588,907)
|
|
|
(1,300,047)
|
|
|
(3,341,636)
|
|
|
(2,546,200)
|
|
|
(60,961,642)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other non-operating income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant income
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
244,479
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrant liability
|
|
|
-
|
|
|
64,440
|
|
|
-
|
|
|
44,292
|
|
|
8,701,721
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of state income tax loss net
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
586,442
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other noncash (expense) income, net
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
205,390
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on settlement of warrant liabilities
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(785,171)
|
|
|
(1,724,546)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on extinguishment of debt
|
|
|
|
|
|
|
|
|
-
|
|
|
-
|
|
|
(361,877)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of debt discount and financing costs
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(11,227,870)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense convertible notes
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(2,027,930)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest (expense) income - net
|
|
|
(30,731)
|
|
|
(34,278)
|
|
|
(62,335)
|
|
|
(68,260)
|
|
|
102,566
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(1,619,638)
|
|
|
(1,269,885)
|
|
|
(3,403,971)
|
|
|
(3,355,339)
|
|
|
(66,463,267)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred dividends
|
|
|
(20,617)
|
|
|
(23,986)
|
|
|
(42,240)
|
|
|
(648,155)
|
|
|
(11,408,779)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss applicable to common shares
|
|
|
(1,640,255)
|
|
|
(1,293,871)
|
|
|
(3,446,211)
|
|
|
(4,003,494)
|
|
|
(77,872,046)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$
|
(1,640,255)
|
|
$
|
(1,293,871)
|
|
$
|
(3,446,211)
|
|
$
|
(4,003,494)
|
|
$
|
(77,872,046)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$
|
(0.48)
|
|
$
|
(1.11)
|
|
$
|
(1.20)
|
|
$
|
(3.57)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted-average number of
common shares outstanding |
|
|
3,443,109
|
|
|
1,169,753
|
|
|
2,875,517
|
|
|
1,122,123
|
|
|
|
|
3 | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital in Excess
|
|
Development
|
|
Stockholders'
|
|
|||
|
|
Preferred Stock
|
|
Common Stock
|
|
of Par Value
|
|
Stage
|
|
Equity
|
|
|||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2013
|
|
|
800
|
|
$
|
8
|
|
|
2,272,062
|
|
$
|
22,721
|
|
$
|
78,189,173
|
|
$
|
(74,425,835)
|
|
$
|
3,786,067
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for cash at $2.50 per share
on October 2, 2013 |
|
|
-
|
|
|
-
|
|
|
690,000
|
|
|
6,900
|
|
|
1,718,100
|
|
|
-
|
|
|
1,725,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commissions and other fees related to the issuance of
common stock on October 2, 2013 |
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(164,230)
|
|
|
-
|
|
|
(164,230)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock and warrants for cash at $3.00 per share on December 16, 2013
|
|
|
-
|
|
|
-
|
|
|
1,800,000
|
|
|
18,000
|
|
|
5,382,000
|
|
|
-
|
|
|
5,400,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commissions and other fees related to the issuance of common stock and warrants on December 16, 2013
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(95,520)
|
|
|
-
|
|
|
(95,520)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in lieu of cash payment for services
|
|
|
-
|
|
|
-
|
|
|
108,750
|
|
|
1,088
|
|
|
364,400
|
|
|
-
|
|
|
365,488
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
101,769
|
|
|
-
|
|
|
101,769
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants
|
|
|
-
|
|
|
-
|
|
|
290
|
|
|
3
|
|
|
287
|
|
|
-
|
|
|
290
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock converted into common stock
|
|
|
(220)
|
|
|
(2)
|
|
|
73,333
|
|
|
733
|
|
|
(731)
|
|
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
|
|
|
|
|
Issuance of common stock in lieu of cash payment for dividends
|
|
|
-
|
|
|
-
|
|
|
12,940
|
|
|
129
|
|
|
47,611
|
|
|
(27,740)
|
|
|
20,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for fractional shares due to reverse split
|
|
|
-
|
|
|
-
|
|
|
(100)
|
|
|
(1)
|
|
|
(302)
|
|
|
-
|
|
|
(303)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends accrued and upaid at December 31, 2013
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(14,500)
|
|
|
(14,500)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(3,403,971)
|
|
|
(3,403,971)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance July 1, 1998 (inception) through December 31, 2013
|
|
|
580
|
|
$
|
6
|
|
|
4,957,275
|
|
$
|
49,573
|
|
$
|
85,542,557
|
|
$
|
(77,872,046)
|
|
$
|
7,720,090
|
|
4 | ||
|
|
|
|
|
|
|
|
Cumulative
|
|
|
|
|
Six Months Ended December 31,
|
|
Amounts from
|
|
|||||
|
|
2013
|
|
2012
|
|
Inception
|
|
|||
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,403,971)
|
|
$
|
(3,355,339)
|
|
$
|
(66,463,267)
|
|
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 |
|
|
-
|
|
|
(44,292)
|
|
|
(9,022,980)
|
|
Noncash charge for change in warrant terms
|
|
|
-
|
|
|
-
|
|
|
115,869
|
|
Issuance of common stock and warrants for interest
|
|
|
-
|
|
|
-
|
|
|
2,003,386
|
|
Issuance of common stock for services
|
|
|
-
|
|
|
-
|
|
|
53,800
|
|
Stock-based compensation expense
|
|
|
467,257
|
|
|
350,129
|
|
|
13,297,903
|
|
Depreciation and amortization
|
|
|
153,223
|
|
|
130,420
|
|
|
1,547,157
|
|
Write-off of intangibles
|
|
|
185,161
|
|
|
-
|
|
|
2,158,595
|
|
Amortization of convertible note discount
|
|
|
-
|
|
|
-
|
|
|
10,000,000
|
|
Amortization of deferred financing costs
|
|
|
-
|
|
|
-
|
|
|
1,227,869
|
|
Loss on settlement of warrant liabilities
|
|
|
|
|
|
785,171
|
|
|
1,724,546
|
|
Loss on extinguishment of debt
|
|
|
-
|
|
|
-
|
|
|
361,877
|
|
(Increase) decrease in operating assets:
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
430,755
|
|
|
252,976
|
|
|
(1,488,465)
|
|
Security deposit
|
|
|
-
|
|
|
-
|
|
|
(5,171)
|
|
Increase (decrease) in operating liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
(159,692)
|
|
|
491,115
|
|
|
477,628
|
|
Accrued expenses
|
|
|
234,863
|
|
|
187,951
|
|
|
777,404
|
|
Net cash used in operating activities
|
|
|
(2,092,404)
|
|
|
(1,201,869)
|
|
|
(43,017,420)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
Patent costs
|
|
|
(253,232)
|
|
|
(252,233)
|
|
|
(7,005,705)
|
|
Purchase of equipment, furniture and fixtures
|
|
|
-
|
|
|
(1,281)
|
|
|
(185,947)
|
|
Net cash used in investing activities
|
|
|
(253,232)
|
|
|
(253,514)
|
|
|
(7,191,652)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
Proceeds from grant
|
|
|
-
|
|
|
-
|
|
|
99,728
|
|
Proceeds (repayments) from line of credit
|
|
|
-
|
|
|
-
|
|
|
2,187,082
|
|
Proceeds from issuance of bridge notes
|
|
|
-
|
|
|
-
|
|
|
525,000
|
|
Proceeds from issuance of preferred stock and warrants, net
|
|
|
-
|
|
|
-
|
|
|
10,754,841
|
|
Redemption of convertible notes and warrants
|
|
|
-
|
|
|
-
|
|
|
(2,160,986)
|
|
Proceeds from issuance of convertible notes
|
|
|
-
|
|
|
-
|
|
|
9,340,000
|
|
Deferred financing costs
|
|
|
-
|
|
|
-
|
|
|
(651,781)
|
|
Proceeds from issuance of common stock and
warrants, net and exercise of warrants and options |
|
|
6,865,237
|
|
|
94,183
|
|
|
36,237,083
|
|
Net cash provided by financing activities
|
|
|
6,865,237
|
|
|
94,183
|
|
|
56,330,967
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
4,519,601
|
|
|
(1,361,200)
|
|
|
6,121,895
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period
|
|
|
1,602,294
|
|
|
2,001,325
|
|
|
-
|
|
Cash and cash equivalents at end of period
|
|
$
|
6,121,895
|
|
$
|
640,125
|
|
$
|
6,121,895
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash transactions:
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible note into common stock
|
|
$
|
-
|
|
$
|
-
|
|
$
|
10,000,000
|
|
Conversion of bridge notes into common stock
|
|
|
-
|
|
|
-
|
|
|
534,316
|
|
Conversion of preferred stock into common stock
|
|
|
731
|
|
|
1,378
|
|
|
4,953
|
|
Allocation of preferred stock proceeds to warrants
and beneficial conversion feature |
|
|
-
|
|
|
-
|
|
|
8,526,135
|
|
Allocation of convertible debt proceeds to warrants
and beneficial conversion feature |
|
|
-
|
|
|
-
|
|
|
9,340,000
|
|
Warrants issued for financing costs
|
|
|
-
|
|
|
-
|
|
|
690,984
|
|
Issuance of common stock for interest payments on
|
|
|
|
|
|
|
|
|
|
|
convertible notes
|
|
|
-
|
|
|
-
|
|
|
2,003,386
|
|
Issuance of common stock for dividend payments
|
|
|
47,739
|
|
|
496,862
|
|
|
4,261,003
|
|
Issuance of common stock in settlement of accounts payable
|
|
|
-
|
|
|
-
|
|
|
175,000
|
|
Dividends accrued on preferred stock
|
|
|
(14,500)
|
|
|
(89,598)
|
|
|
(14,500)
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
|
64,351
|
|
|
69,776
|
|
|
558,488
|
|
5 | ||
6 | ||
|
·
|
delay, scale-back or eliminate some or all of its research and product development programs;
|
|
·
|
seek strategic alliances or business combinations;
|
|
·
|
cease operations; or
|
7 | ||
|
|
December 31,
|
|
||
|
|
2013
|
|
2012
|
|
Common stock to be issued upon conversion
of convertible preferred stock |
|
232,000
|
|
38,269
|
|
Outstanding warrants
|
|
5,682,661
|
|
318,973
|
|
Outstanding options
|
|
275,319
|
|
211,740
|
|
|
|
|
|
|
|
Total potentially dilutive shares of common
stock |
|
6,189,980
|
|
568,982
|
|
8 | ||
|
|
Three Months
|
|
|
Six Months
|
|
|
|
|
|
|
|
|
|
|
|
|
Ended December 31, 2013
|
|
|
|||
|
|
|
|
|
|
|
|
Risk-free interest rate (1)
|
|
1.75-2.66
|
%
|
|
1.65-2.66
|
%
|
|
Expected volatility
|
|
99
|
%
|
|
99
|
%
|
|
Dividend yield
|
|
None
|
|
|
None
|
|
|
Expected life (2)
|
|
6.25-10.0
|
|
|
5.5-10.0
|
|
|
|
(1)
|
Represents the interest rate on a U.S. Treasury security with a maturity date corresponding to that of the option term.
|
|
|
|
|
(2)
|
Expected life for time based stock options was estimated using the “simplified” method, as allowed under the provisions of the Securities and Exchange Commission Staff Accounting Bulletin No.110. Expected life for performance based stock options was the actual term of the option.
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
Aggregate
|
|
Average
|
|
Exercise Price
|
|
|||
|
|
Number
|
|
Exercise Price
|
|
Range
|
|
|||
Outstanding, July 1, 2013
|
|
|
231,748
|
|
$
|
35.00
|
|
|
$ 4.30 345.00
|
|
Granted
|
|
|
74,080
|
|
|
5.39
|
|
|
4.00 - 5.40
|
|
Exercised
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Forfeited
|
|
|
(27,788)
|
|
|
16.50
|
|
|
16.50
|
|
Expired
|
|
|
(2,721)
|
|
|
255.88
|
|
|
66.00 - 315.00
|
|
Outstanding, December 31, 2013
|
|
|
275,319
|
|
$
|
26.98
|
|
|
$ 4.30 - 345.00
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at December 31, 2013
|
|
|
196,822
|
|
$
|
33.97
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable and expected to become exercisable at December 31, 2013
|
|
|
262,795
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average fair value of options granted during the three months ended December 31, 2013
|
|
$
|
4.22
|
|
|
|
|
|
|
|
9 | ||
10 | ||
|
|
Carrying
|
|
Fair Value Measurement at December 31, 2013
|
|
||||||||
|
|
Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
6,121,895
|
|
$
|
6,121,895
|
|
$
|
-
|
|
$
|
-
|
|
|
|
Carrying
|
|
Fair Value Measurement at June 30, 2013
|
|
||||||||
|
|
Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
1,602,294
|
|
$
|
1,602,294
|
|
$
|
-
|
|
$
|
-
|
|
11 | ||
12 | ||
13 | ||
14 | ||
· | further develop and implement the DHS and Factor 5A gene technology in banana, canola, cotton, turfgrass, 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.
|
15 | ||
16 | ||
17 | ||
|
|
Three Months Ended December 31,
|
|
|
|
|
|||||||
|
|
2013
|
|
2012
|
|
Change
|
|
%
|
|
||||
|
|
(in thousands, except % values)
|
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payroll and benefits
|
|
$
|
149
|
|
$
|
147
|
|
$
|
2
|
|
|
1.3
|
%
|
Investor relations
|
|
|
146
|
|
|
16
|
|
|
130
|
|
|
821.5
|
%
|
Professional fees
|
|
|
96
|
|
|
237
|
|
|
(141)
|
|
|
(59.4)
|
%
|
Cash Director fees
|
|
|
6
|
|
|
14
|
|
|
(8)
|
|
|
(57.1)
|
%
|
Depreciation and amortization
|
|
|
78
|
|
|
67
|
|
|
11
|
|
|
16.4
|
%
|
Other general and administrative
|
|
|
94
|
|
|
88
|
|
|
6
|
|
|
6.8
|
%
|
|
|
|
569
|
|
|
569
|
|
|
-
|
|
|
-
|
|
Stock-based compensation
|
|
|
373
|
|
|
140
|
|
|
233
|
|
|
166.4
|
%
|
Total general and administrative
|
|
$
|
942
|
|
$
|
709
|
|
$
|
233
|
|
|
32.8
|
%
|
· |
Investor relations fees were higher primarily as a result of a new investor relations program started in October 2013.
|
· |
Professional fees were lower primarily as a result of a decrease in legal fees. Legal fees decreased mainly because there were several matters being addressed in 2012 which were not necessary to address in 2013.
|
· |
Cash director fees were lower primarily as a result of more directors electing to receive options in lieu of cash as payment for their director fees.
|
· |
Depreciation and amortization was higher primarily as a result of an increase in amortization of patent costs.
|
18 | ||
· |
Other general and administrative expenses were higher primarily due to an increase in travel and conferences.
|
· |
Stock-based compensation was higher primarily due to common stock issued in connection with certain consulting agreements.
|
|
|
Three Months Ended December 31,
|
|
|
|
|||||||
|
|
2013
|
|
2012
|
|
Change
|
|
%
|
|
|||
|
|
(in thousands, except % values)
|
|
|||||||||
Payroll
|
|
$
|
43
|
|
$
|
44
|
|
$
|
(1)
|
|
(2.2)
|
%
|
Research contract with the University of Waterloo
|
|
|
117
|
|
|
161
|
|
|
(44)
|
|
(27.3)
|
%
|
Consultants
|
|
|
121
|
|
|
38
|
|
|
83
|
|
218.4
|
%
|
Other research and development
|
|
|
349
|
|
|
325
|
|
|
24
|
|
7.3
|
%
|
|
|
|
630
|
|
|
568
|
|
|
62
|
|
10.9
|
%
|
Stock-based compensation
|
|
|
17
|
|
|
23
|
|
|
(6)
|
|
(26.0)
|
%
|
Total research and development
|
|
$
|
647
|
|
$
|
591
|
|
$
|
56
|
|
9.4
|
%
|
· |
The cost associated with the research contract with the University of Waterloo was lower primarily due to a decrease in amount being funded for agricultural and human health research.
|
· |
Consultants were higher primarily due to the addition of a Vice President of Clinical Development in May 2013.
|
· |
Other research and development costs were higher primarily due to an increase in the costs in connection with the development of SNS01-T for multiple myeloma due to the addition of new clinical sites.
|
· |
Stock-based compensation was lower primarily due to a lower Black-Scholes value of options vesting during the three months ended December 31, 2013.
|
19 | ||
|
|
Six Months Ended December 31,
|
|
|
|
|
|||||||
|
|
2013
|
|
2012
|
|
Change
|
|
%
|
|
|
|||
|
|
(in thousands, except % values)
|
|
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payroll and benefits
|
|
$
|
295
|
|
$
|
289
|
|
$
|
6
|
|
2.1
|
%
|
|
Investor relations
|
|
|
525
|
|
|
56
|
|
|
469
|
|
837.5
|
%
|
|
Professional fees
|
|
|
213
|
|
|
432
|
|
|
(219)
|
|
(50.7)
|
%
|
|
Cash director fees
|
|
|
11
|
|
|
28
|
|
|
(17)
|
|
(60.7)
|
%
|
|
Depreciation and amortization
|
|
|
153
|
|
|
130
|
|
|
23
|
|
17.7
|
%
|
|
Other general and administrative
|
|
|
162
|
|
|
188
|
|
|
(26)
|
|
(13.8)
|
%
|
|
|
|
|
1,359
|
|
|
1,123
|
|
|
236
|
|
21.0
|
%
|
|
Stock-based compensation
|
|
|
523
|
|
|
319
|
|
|
204
|
|
64.0
|
%
|
|
Total general and administrative
|
|
$
|
1,882
|
|
$
|
1,442
|
|
$
|
440
|
|
30.5
|
%
|
|
⋅ |
Investor relations fees were higher primarily as a result of a new investor relations program started in October 2013, the termination of an investor relations consulting agreement in September 2013 and a special meeting of stockholders held in August 2013.
|
⋅ |
Professional fees were lower primarily as a result of a decrease in legal fees. Legal fees decreased mainly because there were several matters being addressed in 2012 which were not necessary to address in 2013.
|
⋅ |
Cash director fees were lower primarily as a result of more directors electing to receive options in lieu of cash as payment for their director fees.
|
⋅ |
Depreciation and amortization was higher primarily as a result of an increase in amortization of patent costs.
|
⋅ |
Other general and administrative expenses were lower primarily due to a decrease in travel, conferences and consultants.
|
⋅ |
Stock-based compensation was higher primarily due to common stock issued in connection with certain consulting agreements.
|
20 | ||
|
|
Six Months Ended December 31,
|
|
|
|
|
|||||||
|
|
2013
|
|
2012
|
|
Change
|
|
%
|
|
||||
|
|
(in thousands, except % values)
|
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payroll
|
|
$
|
87
|
|
$
|
86
|
|
$
|
1
|
|
1.2
|
%
|
|
Research contract with the University of Waterloo
|
|
|
232
|
|
|
305
|
|
|
(73)
|
|
(23.9)
|
%
|
|
Consultants
|
|
|
221
|
|
|
84
|
|
|
137
|
|
163.1
|
%
|
|
Other research and development
|
|
|
801
|
|
|
582
|
|
|
219
|
|
37.6
|
%
|
|
|
|
|
1,341
|
|
|
1,057
|
|
|
284
|
|
26.9
|
%
|
|
Stock-based compensation
|
|
|
33
|
|
|
48
|
|
|
(15)
|
|
(31.3)
|
%
|
|
Total research and development
|
|
$
|
1,374
|
|
$
|
1,105
|
|
$
|
269
|
|
24.3
|
%
|
|
⋅ |
The cost associated with the research contract with the University of Waterloo was lower primarily due to a decrease in amount being funded for agricultural and human health research.
|
⋅ |
Consultants were higher primarily due to the addition of a Vice President of Clinical Development in May 2013.
|
⋅ |
Other research and development costs were higher primarily due to an increase in the costs in connection with the development of SNS01-T for multiple myeloma due to the timing of patient treatment and the addition of new clinical sites.
|
⋅ |
Stock-based compensation was lower primarily due to a lower Black-Scholes value of options vesting during the six months ended December 31, 2013.
|
21 | ||
Item 3. |
Quantitative and Qualitative Disclosures about Market Risk.
|
Item 4. |
Controls and Procedures.
|
22 | ||
23 | ||
· delay, scale-back or eliminate some or all of our research and product development programs;
|
· would otherwise seek to develop and commercialize ourselves;
|
· attempt to sell our company; |
· declare bankruptcy. |
24 | ||
25 | ||
· delay, scale back or eliminate some or all of our research and development programs;
|
· seek strategic alliances or business combinations; |
· cease operations; or |
· | declare bankruptcy. |
⋅ |
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.
|
26 | ||
⋅ |
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.
|
⋅ |
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.
|
27 | ||
28 | ||
29 | ||
⋅ |
the United States Department of Agriculture, or 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 United States Environmental Protection Agency, or 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.
|
30 | ||
31 | ||
⋅ |
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.
|
⋅ |
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.
|
32 | ||
· | the placement of a clinical hold on a study; |
· | exposure of clinical trial subjects to unexpected and unacceptable health risks or noncompliance with regulatory requirements, which may result in suspension of the trial. |
33 | ||
34 | ||
35 | ||
· | control of the market for the security by one or more broker-dealers that are often related to the promoter or issuer; |
· | manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases; |
· | “boiler room” practices involving high pressure sales tactics and unrealistic price projections by inexperienced sales persons; |
· | excessive and undisclosed bid-ask differentials and markups by selling broker-dealers; and |
· | the wholesale dumping of the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, along with the inevitable collapse of those prices with consequent investor losses. |
36 | ||
37 | ||
|
·
|
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.
|
38 | ||
39 | ||
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds.
|
|
|
|
None.
|
|
|
Item 3.
|
Defaults Upon Senior Securities.
|
|
|
|
None.
|
|
|
Item 4.
|
Mine Safety Disclosures.
|
|
|
|
None.
|
|
|
Item 5.
|
Other Information.
|
|
|
|
None.
|
|
|
Item 6.
|
Exhibits.
|
Exhibit No. | Description | |
3.1 | Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware on October 16, 2013 (Incorporated by reference to Exhibit 3.1 of Senesco Technologies, Inc. current report on Form 8-K filed on October 21, 2013). | |
4.1 | Form of December 2013 Series A Warrant (Incorporated by reference to Exhibit 4.1 of Senesco Technologies, Inc. current report on Form 8-K filed on December 12, 2013). | |
4.2 | Form of December 2013 Series B Warrant (Incorporated by reference to Exhibit 4.2 of Senesco Technologies, Inc. current report on Form 8-K filed on December 12, 2013). | |
4.3 | Form of December 2013 Series C Warrant (Incorporated by reference to Exhibit 4.3 of Senesco Technologies, Inc. current report on Form 8-K filed on December 12, 2013). | |
10.1 | Form of Securities Purchase Agreement, dated as of September 30, 2013 (Incorporated by reference to Exhibit 10.1 of Senesco Technologies, Inc. current report on Form 8-K filed on October 1, 2013). | |
10.2 | Form of Securities Purchase Agreement, dated as of December 11, 2013 (Incorporated by reference to Exhibit 10.1 of Senesco Technologies, Inc. current report on Form 8-K filed on December 12, 2013). | |
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). | |
101.1 | Financial Statements from the Quarterly Report on Form 10-Q of Senesco Technologies, Inc. for the quarter ended December 31, 2013, filed on February 14, 2014, formatted in XBRL: (i) the Condensed Consolidated Balance Sheets; (ii) the Condensed Consolidated Statements of Operations; (iii) the Condensed Consolidated Statements of Stockholder’s Equity; (iv) the Condensed Consolidated Statements of Cash Flows and (v) the Notes to Condensed Consolidated Financial Statements. (filed herewith). |
40 | ||
|
SENESCO TECHNOLOGIES, INC.
|
|
|
|
|
DATE: February 14, 2014
|
By:
|
/s/ Leslie J. Browne
|
|
|
Leslie J. Browne, Ph.D., President
|
|
|
and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
DATE: February 14, 2014
|
By:
|
/s/ Joel Brooks
|
|
|
Joel Brooks, Chief Financial Officer,
|
|
|
Secretary and Treasurer
|
|
|
(Principal Financial and Accounting Officer)
|
41 | ||