Delaware
|
11-3516358
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification Number)
|
Large Accelerated Filer
|
¨
|
Accelerated Filer
|
¨
|
Non-Accelerated Filer
|
¨
|
Smaller reporting company
|
þ
|
(Do not check if a smaller reporting company)
|
Page
|
|||
PART I
|
FINANCIAL INFORMATION
|
3
|
|
Item 1
|
Financial Statements (Unaudited)
|
3
|
|
3
|
|||
4
|
|||
5
|
|||
6
|
|||
8
|
|||
Item 2
|
31
|
||
Item 3
|
39
|
||
Item 4
|
39
|
||
PART II
|
OTHER INFORMATION
|
40
|
|
Item 2
|
40
|
||
Item 6
|
40
|
||
41
|
September 30, 2014
|
December 31, 2013
|
|||||||
ASSETS
|
||||||||
Current Assets:
|
||||||||
Cash and cash equivalents
|
$
|
14,971,660
|
$
|
18,688,031
|
||||
Marketable securities (note 3)
|
20,613,885
|
100,000
|
||||||
Prepaid expenses and other current assets (note 4)
|
757,503
|
507,165
|
||||||
Total Current Assets
|
36,343,048
|
19,295,196
|
||||||
Restricted Cash Equivalents
(note 14)
|
37,500
|
196,130
|
||||||
Equipment, Net
(note 5)
|
72,908
|
65,172
|
||||||
Total Assets
|
$
|
36,453,456
|
$
|
19,556,498
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable and accrued expenses (note 6)
|
$
|
1,725,508
|
$
|
933,758
|
||||
Deferred Research and Development Arrangements
(note 7)
|
618,750
|
833,630
|
||||||
Other Liabilities
(note 8)
|
129,710
|
129,564
|
||||||
Warrant Liabilities
(note 12)
|
5,382,009
|
5,034,058
|
||||||
Total Liabilities
|
7,855,977
|
6,931,010
|
||||||
Commitments and Contingencies
(note 14)
|
||||||||
Stockholders’ Equity
(note 10):
|
||||||||
Preferred stock, par value $0.0001, 100,000,000 authorized shares, none issued and outstanding
|
-
|
-
|
||||||
Common stock, par value $0.0001, 500,000,000 authorized shares, 178,366,533 and 146,732,000 issued and 178,253,318 and 146,717,795 outstanding
|
17,837
|
14,673
|
||||||
Additional paid-in capital
|
117,872,283
|
85,449,932
|
||||||
Accumulated other comprehensive loss
|
(42,041
|
)
|
-
|
|||||
Accumulated deficit
|
(89,122,190
|
)
|
(72,810,707
|
)
|
||||
Treasury stock, 113,215 and 14,205 shares, at cost
|
(128,410
|
)
|
(28,410
|
)
|
||||
Total Stockholders’ Equity
|
28,597,479
|
12,625,488
|
||||||
Total Liabilities and Stockholders’ Equity
|
$
|
36,453,456
|
$
|
19,556,498
|
For the Three Months
Ended September 30,
|
For the Nine Months
Ended September 30,
|
|||||||||||||||
2014
|
2013
|
2014
|
2013
|
|||||||||||||
Revenues:
|
||||||||||||||||
Research
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||
Expenses:
|
||||||||||||||||
General and administrative
|
1,211,842
|
932,762
|
4,327,787
|
3,001,460
|
||||||||||||
Research and development
|
1,824,740
|
781,281
|
4,797,721
|
2,258,877
|
||||||||||||
Patent fees
|
101,380
|
100,199
|
268,810
|
357,906
|
||||||||||||
Depreciation and amortization
|
3,744
|
9,645
|
22,418
|
28,196
|
||||||||||||
Total Expenses
|
3,141,706
|
1,823,887
|
9,416,736
|
5,646,439
|
||||||||||||
Loss from Operations
|
(3,141,706
|
)
|
(1,823,887
|
)
|
(9,416,736
|
)
|
(5,646,439
|
)
|
||||||||
Other Income (Expense)
|
||||||||||||||||
Interest income
|
34,864
|
13,293
|
105,190
|
34,744
|
||||||||||||
Unrealized gain/(loss) on fair value of warrants
|
1,201,394
|
(217,751
|
)
|
(6,793,765
|
)
|
(1,055,505
|
)
|
|||||||||
Financing expense
|
-
|
(112,559
|
)
|
(206,172
|
)
|
(112,559
|
)
|
|||||||||
Total Other Income (Expense)
|
1,236,258
|
(317,017
|
)
|
(6,894,747
|
)
|
(1,133,320
|
)
|
|||||||||
Net Loss Before Provision for Income Taxes
|
(1,905,448
|
)
|
(2,140,904
|
)
|
(16,311,483
|
)
|
(6,779,759
|
)
|
||||||||
Provision for income taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Net Loss
|
$
|
(1,905,448
|
)
|
$
|
(2,140,904
|
)
|
$
|
(16,311,483
|
)
|
$
|
(6,779,759
|
)
|
||||
Net loss per share, basic and diluted
|
$
|
(0.01
|
)
|
$
|
(0.02
|
)
|
$
|
(0.09
|
)
|
$
|
(0.06
|
)
|
||||
Weighted average number of shares outstanding, basic and diluted
|
178,219,622
|
130,466,114
|
175,383,673
|
123,188,044
|
For the Three Months
Ended September 30,
|
For the Nine Months
Ended September 30,
|
|||||||||||||||
2014
|
2013
|
2014
|
2013
|
|||||||||||||
Net Loss
|
$
|
(1,905,448
|
)
|
$
|
(2,140,904
|
)
|
$
|
(16,311,483
|
)
|
$
|
(6,779,759
|
)
|
||||
Unrealized loss on available-for-sale securities
|
(42,041
|
)
|
-
|
(42,041
|
)
|
-
|
||||||||||
Comprehensive Loss
|
$
|
(1,947,489
|
)
|
$
|
(2,140,904
|
)
|
$
|
(16,353,524
|
)
|
$
|
(6,779,759
|
)
|
For the Nine Months Ended
September 30,
|
||||||||
2014
|
2013
|
|||||||
Cash Flows from Operating Activities:
|
||||||||
Net loss
|
$
|
(16,311,483
|
)
|
$
|
(6,779,759
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Compensatory stock
|
409,000
|
200,800
|
||||||
Depreciation and amortization
|
22,418
|
28,196
|
||||||
Stock-based compensation
|
424,059
|
494,037
|
||||||
Amortization of deferred research and development arrangements
|
(214,880
|
)
|
(460,571
|
)
|
||||
Unrealized loss on fair value of warrants
|
6,793,765
|
1,055,505
|
||||||
Financing expense
|
206,172
|
112,559
|
||||||
Amortization of deferred lease incentive
|
(9,332
|
)
|
(13,111
|
)
|
||||
Deferred lease expenses
|
9,478
|
7,622
|
||||||
Changes in assets and liabilities:
|
||||||||
Prepaid expenses and other current assets
|
(250,338
|
)
|
(279,649
|
)
|
||||
Accounts payable and accrued expenses
|
791,750
|
(101,595
|
)
|
|||||
Net Cash Used in Operating Activities
|
(8,129,391
|
)
|
(5,735,966
|
)
|
||||
Cash Flows from Investing Activities:
|
||||||||
Restricted cash equivalents
|
158,630
|
582,622
|
||||||
Purchase of equipment
|
(30,154
|
)
|
(46,459
|
)
|
||||
Purchase of marketable securities
|
(20,555,926
|
)
|
-
|
|||||
Net Cash (Used In) Provided by Investing Activities
|
(20,427,450
|
)
|
536,163
|
|||||
Cash Flows from Financing Activities:
|
||||||||
Issuance of common stock and units, net of issuance costs
|
18,634,247
|
5,173,155
|
||||||
Proceeds from exercise of stock options
|
258,955
|
90,000
|
||||||
Proceeds from exercise of stock warrants
|
5,947,268
|
1,321,105
|
||||||
Net Cash Provided by Financing Activities
|
24,840,470
|
6,584,260
|
||||||
Net (Decrease) Increase in Cash and Cash Equivalents
|
(3,716,371
|
)
|
1,384,457
|
|||||
Cash and Cash Equivalents – beginning of period
|
18,688,031
|
13,486,543
|
||||||
Cash and Cash Equivalents - end of period
|
$
|
14,971,660
|
$
|
14,871,000
|
For the Nine Months Ended
September 30,
|
||||||||
2014
|
2013
|
|||||||
Supplemental Cash Flow Information
|
||||||||
Non-cash financing and investing activities:
|
||||||||
Warrants issued
|
$
|
3,691,429
|
$
|
1,406,411
|
||||
Warrant liability extinguishment from exercise of warrants
|
$
|
10,137,243
|
$
|
1,111,795
|
||||
Shares withheld for net stock option exercise
|
$
|
100,000
|
$
|
-
|
||||
Leasehold improvement incentive
|
$
|
-
|
$
|
54,660
|
1.
|
Operations and Organization
|
2.
|
Recent Accounting Pronouncements Affecting the Company
|
3. | Marketable Securities |
September 30, 2014
|
||||||||||||||||
Cost
Basis
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value
|
|||||||||||||
Certificates of Deposit
|
$
|
15,505,000
|
$
|
-
|
$
|
(31,415
|
)
|
$
|
15,473,585
|
|||||||
Commercial Paper
|
2,994,916
|
1,194
|
-
|
2,996,110
|
||||||||||||
Corporate Bonds
|
2,056,010
|
-
|
(11,820
|
)
|
2,044,190
|
|||||||||||
State and Municipal Obligations
|
100,000
|
-
|
-
|
100,000
|
||||||||||||
Total Marketable Securities
|
$
|
20,655,926
|
$
|
1,194
|
$
|
(43,235
|
)
|
$
|
20,613,885
|
|||||||
December 31, 2013
|
||||||||||||||||
Cost
Basis
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value
|
|||||||||||||
State and Municipal Obligations
|
$
|
100,000
|
$
|
-
|
$
|
-
|
$
|
100,000
|
Maturity
|
Cost Basis
|
Fair Value
|
||||||
Less than 1 year
|
$
|
14,899,916
|
$
|
14,886,580
|
||||
1 to 5 years
|
5,656,010
|
5,627,305
|
||||||
10 years or more
|
100,000
|
100,000
|
||||||
Total Marketable Securities
|
$
|
20,655,926
|
$
|
20,613,885
|
4. | Prepaid Expenses and Other Current Assets |
September 30,
2014
|
December 31,
2013
|
|||||||
Deposits on contracts
|
$
|
225,705
|
$
|
37,760
|
||||
Prepaid expenses and other assets
|
531,798
|
469,405
|
||||||
$
|
757,503
|
$
|
507,165
|
5.
|
Equipment, Net
|
September 30,
2014
|
December 31,
2013
|
|||||||
Furniture and fixtures
|
$
|
64,689
|
$
|
59,133
|
||||
Office equipment
|
57,182
|
41,752
|
||||||
Lab and computer equipment
|
425,195
|
425,195
|
||||||
Leasehold improvements
|
129,009
|
119,841
|
||||||
Total equipment
|
676,075
|
645,921
|
||||||
Less: Accumulated depreciation and amortization
|
(603,167
|
)
|
(580,749
|
)
|
||||
Net carrying amount
|
$
|
72,908
|
$
|
65,172
|
6.
|
Accounts Payable and Accrued Expenses
|
September 30,
2014
|
December 31,
2013
|
|||||||
Trade payables
|
$
|
257,766
|
$
|
251,687
|
||||
Accrued expenses
|
49,126
|
25,367
|
||||||
Accrued research and development contract costs
|
1,175,447
|
215,211
|
||||||
Payroll liabilities
|
243,169
|
441,493
|
||||||
$
|
1,725,508
|
$
|
933,758
|
7. | Deferred Research and Development Arrangements |
8. | Other Liabilities |
September 30,
2014
|
December 31,
2013
|
|||||||
Deferred lease incentive
|
$
|
154,660
|
$
|
154,660
|
||||
Less accumulated amortization
|
(95,554
|
)
|
(86,222
|
)
|
||||
Balance
|
$
|
59,106
|
$
|
68,438
|
9.
|
Net Loss per Common Share
|
10.
|
Common Stock
|
a)
|
On January 21, 2014 the Company closed on a registered direct public offering to issue and sell 19,047,620 shares of common stock and warrants to purchase up to 4,761,905 shares of common stock. The common stock and warrants were sold in units, consisting of common stock and a warrant to purchase 0.25 shares of common stock, at a price of $1.05 per share, and the warrants have an exercise price of $1.28 per share. The total gross proceeds of the offering were $20,000,001. The warrants issued are exercisable beginning six months and one day after the closing date until the five-year anniversary of the closing date and were recorded as liabilities at fair value.
|
Gross Proceeds:
|
$
|
20,000,001
|
||
Allocated to liabilities:
|
||||
Warrant liabilities
|
3,691,429
|
|||
Allocated to equity:
|
||||
Common stock and additional paid-in capital
|
16,308,572
|
|||
Total allocated gross proceeds:
|
$
|
20,000,001
|
b)
|
On February 10, 2014, the Company issued 300,000 shares of stock to two vendors in exchange for investor relations and financial advisory services. The market value of the stock issued was $1.12, and the total market value of the issuance was $336,000.
|
c)
|
On April 14, 2014, an option holder exercised 125,000 stock options by a net exercise. The Company withheld 99,010 shares in treasury as payment for the exercise price, and issued 25,990 shares to the option holder.
|
d)
|
On August 1, 2014, the Company issued 100,000 shares of stock to a vendor in exchange for investor relations services. The market value of the stock issued was $0.73, and the total market value of the issuance was $73,000.
|
e)
|
During the nine months ended September 30, 2014, option holders exercised stock options to purchase shares of the Company’s common stock for cash of $
258,955
, and the Company issued 323,693 shares.
|
f)
|
During the nine months ended September 30, 2014, warrant holders exercised warrants to purchase shares of the Company’s common stock for cash of $5,947,268, and the Company issued 11,738,220 shares.
|
11. | Stock-Based Compensation |
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2014
|
2013
|
2014
|
2013
|
|||||||||||||
Statement of operations line item:
|
||||||||||||||||
General and administrative
|
$
|
128,945
|
$
|
53,459
|
$
|
307,461
|
$
|
448,266
|
||||||||
Research and development
|
34,246
|
14,256
|
116,598
|
45,771
|
||||||||||||
Total
|
$
|
163,191
|
$
|
67,715
|
$
|
424,059
|
$
|
494,037
|
Nine Months Ended September 30,
|
||||||||
2014
|
2013
|
|||||||
Black-Scholes weighted average assumptions
|
||||||||
Expected dividend yield
|
0
|
%
|
0
|
%
|
||||
Expected volatility
|
92-96
|
%
|
94-96
|
%
|
||||
Risk free interest rate
|
1.49-1.75
|
%
|
0.75-1.39
|
%
|
||||
Expected term (in years)
|
5 years
|
5 years
|
2014
|
2013
|
|||||||||||||||
Number of
Options
|
Weighted
Average
Exercise Price
|
Number of
Options
|
Weighted
Average
Exercise Price
|
|||||||||||||
Outstanding at
|
||||||||||||||||
January 1
|
9,356,795
|
$
|
0.92
|
7,741,795
|
$
|
1.03
|
||||||||||
Granted
|
2,398,499
|
0.97
|
2,425,000
|
0.39
|
||||||||||||
Exercised
|
(448,693
|
)
|
0.80
|
(375,000
|
)
|
0.24
|
||||||||||
Expired
|
(35,795
|
)
|
0.24
|
(225,000
|
)
|
0.34
|
||||||||||
Cancelled
|
-
|
-
|
(85,000
|
)
|
0.80
|
|||||||||||
Outstanding at September 30
|
11,270,806
|
$
|
0.93
|
9,481,795
|
$
|
0.92
|
Number of
Options
|
Weighted
Average
Exercise Price
|
Weighted
Average
Remaining
Contractual Term
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding at September 30, 2014
|
11,270,806
|
$
|
0.93
|
5.4 years
|
$
|
1,195,693
|
|||||||
Exercisable at September 30, 2014
|
8,167,307
|
$
|
0.97
|
3.9 years
|
$
|
889,993
|
|||||||
Outstanding at December 31, 2013
|
9,356,795
|
$
|
0.92
|
4.8 years
|
$
|
350,865
|
|||||||
Exercisable at December 31, 2013
|
7,956,795
|
$
|
0.99
|
4.0 years
|
$
|
199,795
|
2014
|
||||||||
Number of Options
|
Weighted Average Fair
Value at Grant Date
|
|||||||
Unvested at January 1, 2014
|
1,400,000
|
$
|
0.34
|
|||||
Granted
|
2,398,499
|
$
|
0.70
|
|||||
Vested
|
(695,000
|
)
|
$
|
0.41
|
||||
Cancelled
|
-
|
$
|
-
|
|||||
Unvested at September 30, 2014
|
3,103,499
|
$
|
0.60
|
12.
|
Warrants
|
2014
|
2013
|
|||||||||||||||
Number of
warrants
|
Weighted average
exercise price
|
Number of
warrants
|
Weighted average
exercise price
|
|||||||||||||
Balance, January 1
|
24,968,868
|
$
|
0.86
|
21,656,142
|
$
|
0.89
|
||||||||||
Issued during the period
|
4,761,905
|
$
|
1.28
|
4,446,000
|
$
|
0.59
|
||||||||||
Exercised during the period
|
(12,058,871
|
)
|
$
|
0.52
|
(2,798,950
|
)
|
$
|
0.47
|
||||||||
Expired during the period
|
(3,687,698
|
)
|
$
|
1.71
|
(426,778
|
)
|
$
|
1.67
|
||||||||
Balance, September 30
|
13,984,204
|
$
|
1.06
|
22,876,414
|
$
|
0.87
|
Fair Value as of:
|
||||||||
Warrant Issuance:
|
September 30, 2014
|
December 31, 2013
|
||||||
June 5, 2009 financing:
|
||||||||
Series III warrants
|
$
|
-
|
$
|
11
|
||||
Warrants to placement agent
|
-
|
1
|
||||||
October 23, 2009 financing:
|
||||||||
Warrants to institutional investors
|
11,169
|
19,689
|
||||||
June 30, 2010 financing
|
||||||||
Warrants to institutional investors
|
-
|
10
|
||||||
March 31, 2011 financing:
|
||||||||
Warrants to institutional investors
|
734,147
|
311,360
|
||||||
December 4, 2012 financing:
|
||||||||
Warrants to institutional investors
|
122,573
|
2,124,444
|
||||||
Warrants to placement agent
|
20,474
|
222,286
|
||||||
July 26, 2013 financing:
|
||||||||
Warrants to institutional investors
|
1,052,856
|
1,148,390
|
||||||
Warrants to placement agent
|
50,056
|
83,808
|
||||||
October 16, 2013 financing:
|
||||||||
Warrants to institutional investors
|
1,252,183
|
1,051,454
|
||||||
Warrants to placement agent
|
160,718
|
72,605
|
||||||
January 21, 2014 financing:
|
||||||||
Warrants to institutional investors
|
1,977,833
|
-
|
||||||
Total:
|
$
|
5,382,009
|
$
|
5,034,058
|
Number of Shares indexed as of:
|
||||||||
Warrant Issuance
|
September 30, 2014
|
December 31, 2013
|
||||||
June 5, 2009 financing:
|
||||||||
Series III warrants
|
-
|
1,555,555
|
||||||
Warrants to placement agent
|
-
|
132,143
|
||||||
October 23, 2009 financing:
|
||||||||
Warrants to institutional investors
|
778,333
|
1,228,333
|
||||||
June 30, 2010 financing
|
||||||||
Warrants to institutional investors
|
-
|
2,000,000
|
||||||
March 31, 2011 financing:
|
||||||||
Warrants to institutional investors
|
3,333,333
|
3,333,333
|
||||||
December 4, 2012 financing:
|
||||||||
Warrants to institutional investors
|
221,600
|
7,418,503
|
||||||
Warrants to placement agent
|
40,000
|
880,000
|
||||||
July 26, 2013 financing:
|
||||||||
Warrants to institutional investors
|
2,000,000
|
3,990,000
|
||||||
Warrants to placement agent
|
124,032
|
456,000
|
||||||
October 16, 2013 financing:
|
||||||||
Warrants to institutional investors
|
2,317,309
|
3,567,309
|
||||||
Warrants to placement agent
|
407,692
|
407,692
|
||||||
January 21, 2014 financing:
|
||||||||
Warrants to institutional investors
|
4,761,905
|
-
|
||||||
Total:
|
13,984,204
|
24,968,868
|
June 5, 2009 financing:
|
September 30, 2014
|
December 31, 2013
|
||||||
Trading market prices
|
$
|
-
|
$
|
0.51
|
||||
Estimated future volatility
|
-
|
109
|
%
|
|||||
Dividend
|
-
|
-
|
||||||
Estimated future risk-free rate
|
-
|
0.13
|
%
|
|||||
Equivalent volatility
|
-
|
43-45
|
%
|
|||||
Equivalent risk-free rate
|
-
|
0.05-0.06
|
%
|
October 23, 2009 financing:
|
September 30, 2014
|
December 31, 2013
|
||||||
Trading market prices
|
$
|
0.81
|
$
|
0.51
|
||||
Estimated future volatility
|
109
|
%
|
109
|
%
|
||||
Dividend
|
-
|
-
|
||||||
Estimated future risk-free rate
|
0.02
|
%
|
0.13
|
%
|
||||
Equivalent volatility
|
84
|
%
|
57
|
%
|
||||
Equivalent risk-free rate
|
0.01
|
%
|
0.07
|
%
|
June 30, 2010 financing:
|
September 30, 2014
|
December 31, 2013
|
||||||
Trading market prices
|
$
|
-
|
$
|
0.51
|
||||
Estimated future volatility
|
-
|
109
|
%
|
|||||
Dividend
|
-
|
-
|
||||||
Estimated future risk-free rate
|
-
|
0.13
|
%
|
|||||
Equivalent volatility
|
-
|
49
|
%
|
|||||
Equivalent risk-free rate
|
-
|
0.06
|
%
|
March 31, 2011 financing:
|
September 30, 2014
|
December 31, 2013
|
||||||
Trading market prices
|
$
|
0.81
|
$
|
0.51
|
||||
Estimated future volatility
|
109
|
%
|
109
|
%
|
||||
Dividend
|
-
|
-
|
||||||
Estimated future risk-free rate
|
1.03
|
%
|
1.58
|
%
|
||||
Equivalent volatility
|
81
|
%
|
71
|
%
|
||||
Equivalent risk-free rate
|
0.18
|
%
|
0.27
|
%
|
December 4, 2012 financing:
|
September 30, 2014
|
December 31, 2013
|
||||||
Trading market prices
|
$
|
0.81
|
$
|
0.51
|
||||
Estimated future volatility
|
109
|
%
|
109
|
%
|
||||
Dividend
|
-
|
-
|
||||||
Estimated future risk-free rate
|
0.83-2.13
|
%
|
1.58-2.72
|
%
|
||||
Equivalent volatility
|
84-85
|
%
|
69-73
|
%
|
||||
Equivalent risk-free rate
|
0.14-0.40
|
%
|
0.22-0.40
|
%
|
July 26, 2013 financing:
|
September 30, 2014
|
December 31, 2013
|
||||||
Trading market prices
|
$
|
0.81
|
0.51
|
|||||
Dividend
|
-
|
-
|
||||||
Equivalent volatility
|
83-84
|
%
|
69-77
|
%
|
||||
Equivalent risk-free rate
|
0.14-0.53
|
%
|
0.22-0.62
|
%
|
October 16, 2013 financing:
|
September 30, 2014
|
December 31, 2013
|
||||||
Trading market prices
|
$
|
0.81
|
0.51
|
|||||
Dividend
|
-
|
-
|
||||||
Equivalent volatility
|
83-84
|
%
|
69-76
|
%
|
||||
Equivalent risk-free rate
|
0.14-0.57
|
%
|
0.20-0.52
|
%
|
January 21, 2014 financing:
|
September 30, 2014
|
December 31, 2013
|
||||||
Trading market prices
|
$
|
0.81
|
-
|
|||||
Dividend
|
-
|
-
|
||||||
Equivalent volatility
|
81
|
%
|
-
|
|||||
Equivalent risk-free rate
|
0.62
|
%
|
-
|
Three Months
Ended
September 30,
2014
|
Three Months
Ended
September 30,
2013
|
Nine Months
Ended
September 30,
2014
|
Nine Months
Ended
September 30,
2013
|
|||||||||||||
Exercised and Expired Warrants
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
144
|
||||||||
June 5, 2009 financing:
|
||||||||||||||||
Series III warrants
|
-
|
(5,336
|
)
|
11
|
24,733
|
|||||||||||
Warrants to placement agent
|
-
|
(410
|
)
|
1
|
2,392
|
|||||||||||
October 23, 2009 financing:
|
-
|
|||||||||||||||
Warrants to institutional investors
|
20,943
|
2,580
|
(288,960
|
)
|
28,620
|
|||||||||||
June 30, 2010 financing
|
||||||||||||||||
Warrants to institutional investors
|
-
|
(4,600
|
)
|
10
|
4,400
|
|||||||||||
March 31, 2011 financing:
|
||||||||||||||||
Warrants to institutional investors
|
325,303
|
(33,334
|
)
|
(422,787
|
)
|
(53,334
|
)
|
|||||||||
December 4, 2012 financing:
|
||||||||||||||||
Warrants to institutional investors
|
17,395
|
(464,181
|
)
|
(4,152,624
|
)
|
(1,301,502
|
)
|
|||||||||
Warrants to placement agent
|
3,131
|
(11,880
|
)
|
(520,760
|
)
|
(60,368
|
)
|
|||||||||
July 26, 2013 financing:
|
||||||||||||||||
Warrants to institutional investors
|
162,082
|
272,916
|
(1,537,273
|
)
|
272,916
|
|||||||||||
Warrants to placement agent
|
10,238
|
26,494
|
(254,341
|
)
|
26,494
|
|||||||||||
October 16, 2013 financing:
|
||||||||||||||||
Warrants to institutional investors
|
192,613
|
-
|
(1,242,527
|
)
|
-
|
|||||||||||
Warrants to placement agent
|
33,955
|
-
|
(88,111
|
)
|
-
|
|||||||||||
January 21, 2014 financing:
|
||||||||||||||||
Warrants to institutional investors
|
435,734
|
-
|
1,713,596
|
-
|
||||||||||||
Total:
|
$
|
1,201,394
|
$
|
(217,751
|
)
|
$
|
(6,793,765
|
)
|
$
|
(1,055,505
|
)
|
13.
|
Income Taxes
|
September 30,
2014
|
December 31,
2013
|
|||||||
Net Operating Loss Carryforwards
|
$
|
30,438,000
|
26,924,000
|
|||||
Stock Compensation Expense
|
2,149,000
|
2,028,200
|
||||||
Book tax differences on assets and liabilities
|
302,000
|
424,000
|
||||||
Valuation Allowance
|
(32,889,000
|
)
|
(29,376,200
|
)
|
||||
Net Deferred Tax Assets
|
$
|
-
|
$
|
-
|
14.
|
Commitments and Contingencies
|
a)
|
The Company has contracted with various vendors for research and development services. The terms of these agreements usually require an initial fee and monthly or periodic payments over the term of the agreement, ranging from two months to 36 months. The costs to be incurred are estimated and are subject to revision. As of September 30, 2014, the total estimated cost to be incurred under these agreements was approximately $30
,000,000,
and the Company had made approximate payments of $2
2,720,000
since inception under the terms of the agreements. All of these agreements may be terminated by either party upon appropriate notice as stipulated in the respective agreements.
|
b)
|
On June 22, 2009, the Company entered into a License Agreement with Korea Research Institute of Chemical Technology (“KRICT”) to acquire the rights to all intellectual properties related to Quinoxaline-Piperazine derivatives that were synthesized under a Joint Research Agreement. The initial license fee was $100,000, all of which was paid as of December 31, 2009. The agreement with KRICT calls for a one-time milestone payment of $1,000,000 within 30 days after the first achievement of marketing approval of the first commercial product arising out of or in connection with the use of KRICT’s intellectual properties. As of September 30, 2014, the milestone has not occurred.
|
c)
|
On June 29, 2009, the Company signed a five-year commercial lease agreement for 5,466 square feet of office space in Rockville, Maryland. The lease agreement required annual base rent with increases over the next five years. Under the lease agreement, the Company pays its allocable portion of real estate taxes and common area operating charges. Rent paid under the Company’s lease during the three months September 30, 2014 and 2013, including the amendments’ terms described below, was $42,367 and $18,789, respectively, and rent paid during the nine months ended September 30, 2014 and 2013 was $
104,999
and $
99,187
, respectively.
|
For the remaining three months ending December 31:
|
2014
|
$
|
50,058
|
||
For the year ending December 31:
|
2015
|
186,764
|
|||
2016
|
159,881
|
||||
2017
|
163,871
|
||||
2018
|
167,970
|
||||
2019
|
85,024
|
||||
Total
|
$
|
813,568
|
d)
|
The Company has established a 401(k) plan for its employees. The Company has elected to match 100% of the first 3% of an employee’s compensation plus 50% of an additional 2% of the employee’s deferral. Expense related to this matching contribution aggregated to $24,574 and $
21,837
for the three months ended September 30, 2014 and 2013, respectively, and $
69,858
and $
60,084
for the nine months ended September 30, 2014 and 2013, respectively.
|
e)
|
On August 26, 2014 and June 24, 2013, the Company signed a one-year renewal to use laboratory space commencing on July 1, 2014 and 2013, respectively. The lease requires monthly rental payments of $4,554. Rent paid under the Company’s lease during the three and nine months ended September 30, 2014 and 2013 was $
13,662 and $40,986, respectively.
|
f)
|
In July 2013, the Company entered into an exclusive license agreement with the University of Maryland, Baltimore for a novel drug delivery platform, Nano-Polymer Drug Conjugate Systems. RX-21101 is the Company’s first drug candidate utilizing this platform. The agreement requires the Company to make payments to the University of Maryland if RX-21101 or any products from the licensed delivery platform achieve development milestones. As of September 30, 2014, no development milestones have occurred.
|
g)
|
In October 2013, the Company signed an exclusive license agreement with the Ohio State Innovation Foundation, for a novel oligonucleotide drug delivery platform, Lipid-Coated Albumin Nanoparticle (“LCAN”). The agreement requires the Company to make payments to the Ohio State Innovation Foundation or any products from the licensed delivery platform achieve development milestones. As of September 30, 2014, no development milestones have occurred.
|
15.
|
Fair Value Measurements
|
Level 1 Inputs
|
—
|
Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible by the Company;
|
Level 2 Inputs
|
—
|
Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly;
|
Level 3 Inputs
|
—
|
Unobservable inputs for the asset or liability including significant assumptions of the Company and other market participants.
|
Fair Value Measurements at September 30, 2014
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Restricted Cash Equivalents
|
37,500
|
-
|
37,500
|
-
|
||||||||||||
Certificates of Deposit
|
15,473,585
|
-
|
15,473,585
|
-
|
||||||||||||
Commercial Paper
|
2,996,110
|
-
|
2,996,110
|
-
|
||||||||||||
Corporate Bonds
|
2,044,190
|
-
|
2,044,190
|
-
|
||||||||||||
State and municipal obligations
|
100,000
|
100,000
|
-
|
-
|
||||||||||||
Total Assets:
|
$
|
20,651,385
|
$
|
100,000
|
$
|
20,551,385
|
$
|
-
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant Liabilities
|
$
|
5,382,009
|
-
|
-
|
$
|
5,382,009
|
Fair Value Measurements at December 31, 2013
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Restricted Cash Equivalents
|
$
|
196,130
|
$
|
158,630
|
$
|
37,500
|
$
|
-
|
||||||||
State and municipal obligations
|
100,000
|
100,000
|
-
|
-
|
||||||||||||
Total Assets:
|
$
|
296,130
|
$
|
258,630
|
$
|
37,500
|
$
|
-
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant Liabilities
|
$
|
5,034,058
|
-
|
-
|
$
|
5,034,058
|
Warrant Liabilities
|
||||
Balance at January 1, 2014
|
$
|
5,034,058
|
||
Additions
|
3,691,429
|
|||
Unrealized losses, net
|
6,793,765
|
|||
Unrealized gains on expiration
|
-
|
|||
Transfers out of level 3
|
(10,137,243
|
)
|
||
Balance at September 30, 2014
|
$
|
5,382,009
|
Warrant Liabilities
|
||||
Balance at January 1, 2013
|
$
|
2,842,065
|
||
Additions
|
1,406,441
|
|||
Unrealized losses, net
|
1,055,505
|
|||
Unrealized gains on expiration
|
-
|
|||
Transfers out of level 3
|
(1,111,795
|
)
|
||
Balance at September 30, 2013
|
$
|
4,192,216
|
· | our lack of profitability and the need for additional capital to operate our business; |
· | our drug candidates being in early stages of development, including pre-clinical development; |
· | our ability to obtain the necessary U.S. and worldwide regulatory approvals for our drug candidates; |
· | successful and timely completion of clinical trials for our drug candidates; |
· | demand for and market acceptance of our drug candidates; |
· | our ability to identify partners and collaborators for the development of certain of our drug candidates and, if identified, to enter into mutually agreeable relationships with those partners and collaborators; |
· | the availability of qualified third-party researchers and manufacturers for our drug development programs; |
· | our ability to develop and obtain protection of our intellectual property; and |
· | other risks and uncertainties, including those detailed from time to time in our filings with the Securities and Exchange Commission (the “SEC”). |
· | the progress of our product development activities; |
· | the number and scope of our product development programs; |
· | the progress of our pre-clinical and clinical trial activities; |
· | the progress of the development efforts of parties with whom we have entered into collaboration agreements; |
· | our ability to maintain current collaboration programs and to establish new collaboration arrangements; |
· | the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and |
· | the costs and timing of regulatory approvals. |
Exhibit No
|
Description
|
10.1
|
Second Amendment to Lease Agreement, dated July 26, 2014 by and between Rexahn Pharmaceuticals, Inc. and SG Plaza Holdings, LLC
|
31.1
|
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) / 15d-14(a)
|
31.2
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) / 15d-14(a)
|
32.1
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
32.2
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
101
|
The following materials from Rexahn Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q, formatted in Extensible Business Reporting Language (“XBRL”): i) Condensed Balance Sheet, ii) Condensed Statement of Operations, iii) Condensed Statement of Comprehensive Loss, iv) Condensed Statement of Cash Flows and (v) Notes to the Financial Statements.
|
REXAHN PHARMACEUTICALS, INC.
|
||
(Registrant)
|
||
By:
|
/s/ Peter D. Suzdak
|
|
Date: November 12, 2014
|
Peter D. Suzdak
|
|
Chief Executive Officer
(principal executive officer)
|
||
By:
|
/s/ Tae Heum Jeong
|
|
Date: November 12, 2014
|
Tae Heum Jeong
|
|
Chief Financial Officer and Secretary
(principal financial and accounting officer)
|
Exhibit No
|
Description
|
Location
|
|
Second Amendment to Lease Agreement, dated July 26, 2014 by and between Rexahn Pharmaceuticals, Inc. and SG Plaza Holdings, LLC
|
Filed herewith
|
||
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) / 15d-14(a)
|
Filed herewith
|
||
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) / 15d-14(a)
|
Filed herewith
|
||
Certification of Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
Filed herewith
|
||
Certification of Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
Filed herewith
|
||
101.INS
|
XBRL Instance Document
|
Filed herewith
|
|
101.SCH
|
XBRL Taxonomy Extension Schema
|
Filed herewith
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase
|
Filed herewith
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase
|
Filed herewith
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase
|
Filed herewith
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase
|
Filed herewith
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Client:
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WITNESS/ATTEST:
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REXAHN PHARMACEUTICALS, INC.,
a Delaware
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corporation
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Mark Lee
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By:
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/s/ RICK SONI |
[SEAL]
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Mark Lee
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Name: RICK SONI
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Title: PRESIDENT & COO
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Landlord:
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WITNESS/ATTEST:
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SG PLAZA HOLDINGS, LLC, a Delaware limited liability company | ||
Kim Harvey |
By:
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/s/ Andrew Nathan, CEO | |
Andrew Nathan, CEO
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1.
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I have reviewed this Quarterly Report on Form 10-Q of Rexahn Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a.
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b.
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c.
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d.
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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a.
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b.
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Dated: November 12, 2014
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/s/ Peter D. Suzdak
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Peter D. Suzdak
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Chief Executive Officer
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1.
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I have reviewed this Quarterly Report on Form 10-Q of Rexahn Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a.
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b.
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c.
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d.
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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a.
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b.
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Dated: November 12, 2014
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/s/ Tae Heum Jeong
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Tae Heum Jeong
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Chief Financial Officer
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(1)
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Dated: November 12, 2014
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By:
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/s/ Peter D. Suzdak
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Peter D. Suzdak,
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Chief Executive Officer
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*
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This Certification is being furnished as required by Rule 13a-14(b) under the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code, and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section. This Certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, except as otherwise stated in such filing.
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A signed original of this written statement required by 18 U.S.C. § 1350 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request. |
(1)
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Dated: November 12, 2014
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By:
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/s/ Tae Heum Jeong
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Tae Heum Jeong,
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Chief Financial Officer
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* | This Certification is being furnished as required by Rule 13a-14(b) under the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code, and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section. This Certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, except as otherwise stated in such filing. |
A signed original of this written statement required by 18 U.S.C. § 1350 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request. |