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
|
☐
|
(Do not check if a smaller reporting company)
|
Page | ||
PART I
|
FINANCIAL INFORMATION
|
1
|
Item 1
|
Financial Statements (Unaudited)
|
1
|
1
|
||
2
|
||
3
|
||
4
|
||
6
|
||
Item 2
|
25 | |
Item 3
|
34 | |
Item 4
|
34 | |
PART II
|
OTHER INFORMATION
|
35 |
Item 2
|
35 | |
Item 6
|
35 | |
36 |
March 31, 2015
|
December 31, 2014
|
|||||||
ASSETS
|
||||||||
Current Assets:
|
||||||||
Cash and cash equivalents
|
$
|
10,729,210
|
$
|
9,826,245
|
||||
Marketable securities (note 3)
|
18,655,821
|
22,872,051
|
||||||
Prepaid expenses and other current assets (note 4)
|
991,027
|
730,987
|
||||||
Total Current Assets
|
30,376,058
|
33,429,283
|
||||||
Security Deposit
|
25,681
|
25,681
|
||||||
Equipment, Net
(note 5)
|
79,866
|
78,096
|
||||||
Total Assets
|
$
|
30,481,605
|
$
|
33,533,060
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable and accrued expenses (note 6)
|
$
|
2,749,539
|
$
|
2,459,263
|
||||
Deferred Research and Development Arrangement
(note 7)
|
581,250
|
600,000
|
||||||
Other Liabilities
(note 8)
|
120,199
|
124,955
|
||||||
Warrant Liabilities
(note 12)
|
3,652,936
|
3,768,351
|
||||||
Total Liabilities
|
7,103,924
|
6,952,569
|
||||||
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, 179,323,461 and 178,366,533 issued and 179,210,246 and 178,253,318 outstanding
|
17,932
|
17,837
|
||||||
Additional paid-in capital
|
119,091,102
|
118,057,019
|
||||||
Accumulated other comprehensive income (loss)
|
1,076
|
(33,647
|
)
|
|||||
Accumulated deficit
|
(95,604,019
|
)
|
(91,332,308
|
)
|
||||
Treasury stock, 113,215 shares, at cost
|
(128,410
|
)
|
(128,410
|
)
|
||||
Total Stockholders’ Equity
|
23,377,681
|
26,580,491
|
||||||
Total Liabilities and Stockholders’ Equity
|
$
|
30,481,605
|
$
|
33,533,060
|
For the Three Months Ended
March 31,
|
||||||||
2015
|
2014
|
|||||||
Revenues:
|
$
|
-
|
$
|
-
|
||||
Expenses:
|
||||||||
General and administrative
|
1,524,700
|
1,494,520
|
||||||
Research and development
|
2,893,008
|
1,271,574
|
||||||
Total Expenses
|
4,417,708
|
2,766,094
|
||||||
Loss from Operations
|
(4,417,708
|
)
|
(2,766,094
|
)
|
||||
Other Income (Expense)
|
||||||||
Interest income
|
30,582
|
32,291
|
||||||
Unrealized gain (loss) on fair value of warrants
|
115,415
|
(11,660,524
|
)
|
|||||
Financing expense
|
-
|
(206,172
|
)
|
|||||
Total Other Income (Expense)
|
145,997
|
(11,834,405
|
)
|
|||||
Net Loss Before Provision for Income Taxes
|
(4,271,711
|
)
|
(14,600,499
|
)
|
||||
Provision for income taxes
|
-
|
-
|
||||||
Net Loss
|
$
|
(4,271,711
|
)
|
$
|
(14,600,499
|
)
|
||
Net loss per share, basic and diluted
|
$
|
(0.02
|
)
|
$
|
(0.09
|
)
|
||
Weighted average number of shares outstanding, basic and diluted
|
179,097,897
|
170,112,570
|
For the Three Months Ended
March 31,
|
||||||||
2015
|
2014
|
|||||||
Net Loss
|
$
|
(4,271,711
|
)
|
$
|
(14,600,499
|
)
|
||
Unrealized gain on available-for-sale securities
|
34,723
|
-
|
||||||
Comprehensive Loss
|
$
|
(4,236,988
|
)
|
$
|
(14,600,499
|
)
|
For the Three Months Ended
March 31,
|
||||||||
2015
|
2014
|
|||||||
Cash Flows from Operating Activities:
|
||||||||
Net loss
|
$
|
(4,271,711
|
)
|
$
|
(14,600,499
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Compensatory stock
|
56,250
|
336,000
|
||||||
Depreciation and amortization
|
6,165
|
9,044
|
||||||
Amortization of premiums and discounts on marketable securities, net
|
6,778
|
-
|
||||||
Stock-based compensation
|
272,386
|
128,350
|
||||||
Amortization of deferred research and development arrangements
|
(18,750
|
)
|
(51,350
|
)
|
||||
Unrealized (gain) loss on fair value of warrants
|
(115,415
|
)
|
11,660,524
|
|||||
Financing expense
|
-
|
206,172
|
||||||
Amortization of deferred lease incentive
|
(3,111
|
)
|
(3,111
|
)
|
||||
Deferred lease expenses
|
(1,645
|
)
|
11,825
|
|||||
Changes in assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
(260,040
|
)
|
(218,304
|
)
|
||||
Accounts payable and accrued expenses
|
290,276
|
(55,258
|
)
|
|||||
Net Cash Used in Operating Activities
|
(4,038,817
|
)
|
(2,576,607
|
)
|
||||
Cash Flows from Investing Activities:
|
||||||||
Restricted cash equivalents
|
-
|
32,600
|
||||||
Purchase of equipment
|
(7,935
|
)
|
(3,771
|
)
|
||||
Purchase of marketable securities
|
(740,825
|
)
|
-
|
|||||
Redemption of marketable securities
|
4,985,000
|
-
|
||||||
Net Cash Provided by Investing Activities
|
4,236,240
|
28,829
|
||||||
Cash Flows from Financing Activities:
|
||||||||
Issuance of common stock and units, net of issuance costs
|
-
|
18,634,247
|
||||||
Proceeds from exercise of stock options
|
705,542
|
70,000
|
||||||
Proceeds from exercise of stock warrants
|
-
|
5,228,518
|
||||||
Net Cash Provided by Financing Activities
|
705,542
|
23,932,765
|
||||||
Net Increase in Cash and Cash Equivalents
|
902,965
|
21,384,987
|
||||||
Cash and Cash Equivalents – beginning of period
|
9,826,245
|
18,688,031
|
||||||
Cash and Cash Equivalents - end of period
|
$
|
10,729,210
|
$
|
40,073,018
|
|
For the Three Months Ended
March 31,
|
|||||||
2015
|
2014
|
|||||||
Supplemental Cash Flow Information
|
||||||||
Non-cash financing and investing activities:
|
||||||||
Warrants issued
|
$
|
-
|
$
|
3,691,429
|
||||
Warrant liability extinguishment from exercise of warrants
|
$
|
-
|
$
|
9,095,445
|
1.
|
Operations and Organization
|
2.
|
Recent Accounting Pronouncements Affecting the Company
|
3. | Marketable Securities |
March 31, 2015
|
||||||||||||||||
Cost
Basis
|
Gross
Unrealized
|
Gross
Unrealized
|
Fair
Value
|
|||||||||||||
Certificates of Deposit
|
$
|
15,120,000
|
$
|
3,956
|
(1,515
|
)
|
$
|
15,122,441
|
||||||||
Commercial Paper
|
999,084
|
196
|
-
|
999,280
|
||||||||||||
Corporate Bonds
|
2,535,661
|
-
|
(1,561
|
)
|
2,534,100
|
|||||||||||
Total Marketable Securities
|
$
|
18,654,745
|
$
|
4,152
|
$
|
(3,076
|
)
|
$
|
18,655,821
|
December 31, 2014
|
||||||||||||||||
Cost
Basis
|
Gross
Unrealized
|
Gross
Unrealized
|
Fair
Value
|
|||||||||||||
Certificates of Deposit
|
$
|
18,865,000
|
$
|
60
|
(26,789
|
)
|
$
|
18,838,271
|
||||||||
Commercial Paper
|
1,998,001
|
62
|
(153
|
)
|
1,997,910
|
|||||||||||
Corporate Bonds
|
2,042,697
|
-
|
(6,827
|
)
|
2,035,870
|
|||||||||||
Total Marketable Securities
|
$
|
22,905,698
|
$
|
122
|
$
|
(33,769
|
)
|
$
|
22,872,051
|
Maturity
|
Cost Basis
|
Fair Value
|
||||||
Less than 1 year
|
$
|
13,499,679
|
$
|
13,499,823
|
||||
1 to 5 years
|
5,155,066
|
5,155,998
|
||||||
Total Marketable Securities
|
$
|
18,654,745
|
$
|
18,655,821
|
4.
|
Prepaid Expenses and Other Current Assets
|
|
March 31,
2015
|
|
December 31,
2014
|
|||||
Deposits on contracts
|
$
|
448,665
|
$
|
369,811
|
||||
Prepaid expenses and other assets
|
542,362
|
361,176
|
||||||
$
|
991,027
|
$
|
730,987
|
5.
|
Equipment, Net
|
March 31,
2015
|
December 31,
2014
|
|||||||
Furniture and fixtures
|
$
|
74,204
|
$
|
70,320
|
||||
Office equipment
|
61,944
|
57,893
|
||||||
Lab and computer equipment
|
425,195
|
425,195
|
||||||
Leasehold improvements
|
133,762
|
133,762
|
||||||
Total equipment
|
695,105
|
687,170
|
||||||
Less: Accumulated depreciation and amortization
|
(615,239
|
)
|
(609,074
|
)
|
||||
Net carrying amount
|
$
|
79,866
|
$
|
78,096
|
6. | Accounts Payable and Accrued Expenses |
March 31,
2015
|
December 31,
2014
|
|||||||
Trade payables
|
$
|
484,032
|
$
|
706,781
|
||||
Accrued expenses
|
294,689
|
56,884
|
||||||
Accrued research and development contract costs
|
1,788,884
|
1,078,532
|
||||||
Payroll liabilities
|
181,934
|
617,066
|
||||||
$
|
2,749,539
|
$
|
2,459,263
|
7. | Deferred Research and Development Arrangements |
8. | Other Liabilities |
March 31,
2015
|
December 31,
2014
|
|||||||
Deferred lease incentive
|
$
|
154,660
|
$
|
154,660
|
||||
Less accumulated amortization
|
(101,776
|
)
|
(98,665
|
)
|
||||
Balance
|
$
|
52,884
|
$
|
55,995
|
9. | Net Loss per Common Share |
10. | Common Stock |
11. | Stock-Based Compensation |
Three Months Ended
March 31,
|
||||||||
2015
|
2014
|
|||||||
Statement of operations line item:
|
||||||||
General and administrative
|
$
|
190,039
|
$
|
80,911
|
||||
Research and development
|
82,347
|
47,439
|
||||||
Total
|
$
|
272,386
|
$
|
128,350
|
Three Months Ended March 31,
|
||||||||
2015
|
2014
|
|||||||
Black-Scholes assumptions
|
||||||||
Expected dividend yield
|
0
|
%
|
0
|
%
|
||||
Expected volatility
|
79-80
|
%
|
92-97
|
%
|
||||
Risk free interest rate
|
1.3-1.6
|
%
|
1.5-1.7
|
%
|
||||
Expected term (in years)
|
6 years
|
5 years
|
2015
|
2014
|
|||||||||||||||
Number of
Options
|
Weighted
Average
Exercise Price
|
Number of
Options
|
Weighted
Average
Exercise Price
|
|||||||||||||
Outstanding at
|
||||||||||||||||
January 1
|
11,400,806
|
$
|
0.93
|
9,356,795
|
$
|
0.92
|
||||||||||
Granted
|
3,426,316
|
0.72
|
975,999
|
1.14
|
||||||||||||
Exercised
|
(881,928
|
)
|
0.80
|
(87,500
|
)
|
0.80
|
||||||||||
Expired
|
(1,431,879
|
)
|
0.80
|
-
|
-
|
|||||||||||
Cancelled
|
-
|
-
|
-
|
-
|
||||||||||||
Outstanding at March 31
|
12,513,315
|
$
|
0.90
|
10,245,294
|
$
|
0.94
|
Number of Options
|
Weighted
Average
Exercise Price
|
Weighted
Average
Remaining
Contractual Term
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding at March 31, 2015
|
12,513,315
|
$
|
0.90
|
7.2 years
|
$
|
991,726
|
|||||||
Exercisable at March 31, 2015
|
6,345,300
|
$
|
1.02
|
5.1 years
|
$
|
747,700
|
|||||||
Outstanding at December 31, 2014
|
11,400,806
|
$
|
0.93
|
5.2 years
|
$
|
842,300
|
|||||||
Exercisable at December 31, 2014
|
8,167,307
|
$
|
0.97
|
3.6 years
|
$
|
613,550
|
2015
|
||||||||
Number of Options
|
Weighted Average Fair
Value at Grant Date
|
|||||||
Unvested at January 1, 2015
|
3,233,499
|
$
|
0.60
|
|||||
Granted
|
3,426,316
|
$
|
0.49
|
|||||
Vested
|
(491,800
|
)
|
$
|
0.60
|
||||
Cancelled
|
-
|
$
|
-
|
|||||
Unvested at March 31, 2015
|
6,168,015
|
$
|
0.54
|
12. | Warrants |
2015
|
2014
|
|||||||||||||||
Number of
warrants
|
Weighted average
exercise price
|
Number of
warrants
|
Weighted average
exercise price
|
|||||||||||||
Balance, January 1
|
13,205,871
|
$
|
1.07
|
24,968,868
|
$
|
0.86
|
||||||||||
Issued during the period
|
-
|
$
|
-
|
4,761,905
|
$
|
1.28
|
||||||||||
Exercised during the period
|
-
|
$
|
-
|
(10,808,871
|
)
|
$
|
0.52
|
|||||||||
Expired during the period
|
-
|
$
|
-
|
-
|
$
|
-
|
||||||||||
Balance, March 31
|
13,205,871
|
$
|
1.07
|
18,921,902
|
$
|
1.16
|
Fair Value as of:
|
||||||||
Warrant Issuance:
|
March 31, 2015
|
December 31, 2014
|
||||||
March 31, 2011 financing:
|
||||||||
Warrants to institutional investors
|
217,200
|
319,277
|
||||||
December 4, 2012 financing:
|
||||||||
Warrants to institutional investors
|
92,949
|
90,052
|
||||||
Warrants to placement agent
|
14,452
|
14,595
|
||||||
July 26, 2013 financing:
|
||||||||
Warrants to institutional investors
|
813,100
|
788,314
|
||||||
Warrants to placement agent
|
26,249
|
30,594
|
||||||
October 16, 2013 financing:
|
||||||||
Warrants to institutional investors
|
967,516
|
949,756
|
||||||
Warrants to placement agent
|
81,384
|
96,563
|
||||||
January 21, 2014 financing:
|
||||||||
Warrants to institutional investors
|
1,440,086
|
1,479,200
|
||||||
Total:
|
$
|
3,652,936
|
$
|
3,768,351
|
March 31, 2015
|
December 31, 2014
|
|||||||
Trading market prices
|
$
|
0.73
|
$
|
0.70
|
||||
Estimated future volatility
|
107
|
%
|
108
|
%
|
||||
Dividend
|
-
|
-
|
||||||
Estimated future risk-free rate
|
0.56-1.68
|
%
|
0.74-1.90
|
%
|
||||
Equivalent volatility
|
51-76
|
%
|
65-78
|
%
|
||||
Equivalent risk-free rate
|
0.16-0.50
|
%
|
0.18-0.63
|
%
|
Three Months Ended
March 31,
2015
|
Three Months Ended
March 31,
2014
|
|||||||
Exercised and Expired Warrants
|
$
|
-
|
$
|
(744,301
|
)
|
|||
March 31, 2011 financing:
|
||||||||
Warrants to institutional investors
|
102,077
|
(1,473,973
|
)
|
|||||
December 4, 2012 financing:
|
||||||||
Warrants to institutional investors
|
(2,897
|
)
|
(4,225,702
|
)
|
||||
Warrants to placement agent
|
143
|
(533,250
|
)
|
|||||
July 26, 2013 financing:
|
||||||||
Warrants to institutional investors
|
(24,786
|
)
|
(2,200,617
|
)
|
||||
Warrants to placement agent
|
4,345
|
(293,538
|
)
|
|||||
October 16, 2013 financing:
|
||||||||
Warrants to institutional investors
|
(17,760
|
)
|
(2,039,976
|
)
|
||||
Warrants to placement agent
|
15,179
|
(217,262
|
)
|
|||||
January 21, 2014 financing:
|
||||||||
Warrants to institutional investors
|
39,114
|
68,095
|
||||||
Total:
|
$
|
115,415
|
$
|
(11,660,524
|
)
|
13. | Income Taxes |
March 31,
2015
|
December 31,
2014
|
|||||||
Net Operating Loss Carryforwards
|
$
|
33,568,000
|
$ |
31,831,000
|
||||
Stock Compensation Expense
|
2,289,000
|
2,221,000
|
||||||
Book tax differences on assets and liabilities
|
291,000
|
416,000
|
||||||
Valuation Allowance
|
(36,148,000
|
)
|
(34,468,000
|
)
|
||||
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 March 31, 2015, the total estimated cost to complete these agreements was approximately $ 9,780,000 . 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 License 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 March 31, 2015, 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. 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 ended March 31, 2015 and 2014 was $50,058 and $25,053, respectively. |
For the remaining nine months ending December 31:
|
2015
|
$ |
136,706
|
|||
For the year ending December 31:
|
2016
|
159,881
|
||||
2017
|
163,871
|
|||||
2018
|
167,970
|
|||||
2019
|
85,024
|
|||||
Total
|
$
|
713,452
|
d) | On August 26, 2014 and June 24, 2013, the Company signed one-year renewals 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 months ended March 31, 2015 and 2014 was $13,662 . |
e) | 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 $ 29,359 and $ 20,700 for the three months ended March 31, 2015 and 2014, 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 March 31, 2015, 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. 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 March 31, 2015, 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; and |
Level 3 Inputs — | Unobservable inputs for the asset or liability including significant assumptions of the Company and other market participants. |
Fair Value Measurements at March 31, 2015
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Certificates of Deposit
|
$ |
15,122,441
|
-
|
$ |
15,122,441
|
-
|
||||||||||
Commercial Paper
|
999,280
|
-
|
999,280
|
-
|
||||||||||||
Corporate Bonds
|
2,534,100
|
-
|
2,534,100
|
-
|
||||||||||||
Total Assets:
|
$
|
18,655,821
|
$
|
-
|
$
|
18,655,821
|
$
|
-
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant Liabilities
|
$
|
3,652,936
|
-
|
-
|
$
|
3,652,936
|
Fair Value Measurements at December 31, 2014
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Certificates of Deposit
|
$
|
18,838,271
|
$
|
-
|
$
|
18,838,271
|
$
|
-
|
||||||||
Commercial Paper
|
1,997,910
|
-
|
1,997,910
|
-
|
||||||||||||
Corporate Bonds
|
2,035,870
|
-
|
2,035,870
|
-
|
||||||||||||
Total Assets:
|
$
|
22,872,051
|
$
|
-
|
$
|
22,872,051
|
$
|
-
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant Liabilities
|
$
|
3,768,351
|
-
|
-
|
$
|
3,768,351
|
Warrant Liabilities
|
||||
Balance at January 1, 2015
|
$
|
3,768,351
|
||
Additions
|
-
|
|||
Unrealized gains, net
|
(115,415
|
)
|
||
Unrealized gains on expiration
|
-
|
|||
Transfers out of level 3
|
-
|
|||
Balance at March 31, 2015
|
$
|
3,652,936
|
Warrant Liabilities
|
||||
Balance at January 1, 2014
|
$
|
5,034,058
|
||
Additions
|
3,691,429
|
|||
Unrealized losses, net
|
11,660,524
|
|||
Unrealized gains on expiration
|
-
|
|||
Transfers out of level 3
|
(9,095,445
|
)
|
||
Balance at March 31, 2014
|
$
|
11,290,566
|
· | our understandings and beliefs regarding the role of certain biological mechanisms and processes in cancer; |
· | our drug candidates being in early stages of development, including in pre-clinical development; |
· | our ability to initially develop drug candidates for orphan indications to reduce the time-to-market and take advantage of certain incentives provided by the U.S. Food and Drug Administration; |
· | our ability to transition from our initial focus on developing drug candidates for orphan indications to candidates for more highly prevalent indications; |
· | our ability to successfully and timely complete clinical trials for our drug candidates in clinical development; |
· | uncertainties related to the timing, results and analyses related to our drug candidates in pre-clinical development; |
· | our ability to obtain the necessary U.S. and international regulatory approvals for our drug candidates; |
· | our reliance on third-party contract research organizations and other investigators and collaborators for certain research and development services; |
· | our ability to maintain or engage third-party manufacturers to manufacture, supply, store and distribute supplies of our drug candidates for our clinical trials; |
· | our ability to form strategic alliances and partnerships with pharmaceutical companies and other partners for sales and marketing of certain of our product candidates; |
· | demand for and market acceptance of our drug candidates; |
· | the scope and validity of our intellectual property protection for our drug candidates and our ability to develop our candidates without infringing the intellectual property rights of others; |
· | our lack of profitability and the need for additional capital to operate our business; and |
· | other risks and uncertainties, including those set forth herein and in our Annual Report on Form 10-K under the caption “Risk Factors” and those detailed from time to time in our filings with the Securities and Exchange Commission. |
For the three months ended March 31,
|
||||||||
2015
|
2014
|
|||||||
Clinical Candidates:
|
||||||||
Archexin
|
$
|
502,400
|
$
|
434,000
|
||||
RX-3117
|
1,169,700
|
283,400
|
||||||
Supinoxin
|
386,600
|
75,300
|
||||||
Pre-clinical Compounds:
|
78,300
|
25,000
|
||||||
Personnel and Overhead:
|
756,008
|
453,874
|
||||||
Total
|
$
|
2,893,008
|
$
|
1,271,574
|
· | 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
|
|
Employment Agreement dated as of February 2, 2015, by and between Rexahn Pharmaceuticals, Inc. and Ely Benaim, M.D.
|
||
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) / 15d-14(a)
|
||
|
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) / 15d-14(a)
|
||
|
|
|
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
|
||
|
|
|
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: May 8, 2015
|
Peter D. Suzdak
|
|
Chief Executive Officer (principal executive officer)
|
||
By:
|
/s/ Tae Heum Jeong
|
|
Date: May 8, 2015
|
Tae Heum Jeong
|
|
Chief Financial Officer and Secretary (principal financial and accounting officer)
|
REXAHN PHARMACEUTICALS, INC.
|
EXECUTIVE
|
|||
By:
|
/s/ Peter Suzdak | /s/ Ely Benaim | ||
Name: Peter Suzdak, Ph.D.
|
Name: Ely Benaim, M.D.
|
|||
Title: Chief Executive Officer
|
1. | I have reviewed this Quarterly Report on Form 10-Q of Rexahn Pharmaceuticals, Inc.; |
2. | 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; |
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. | 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: |
a. | 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; |
b. | 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; |
c. | 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 |
d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | 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): |
a. | 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 |
b. | 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. |
Dated: May 8, 2015
|
|
/s/ Peter D. Suzdak
|
|
Peter D. Suzdak | |
Chief Executive Officer |
1. | I have reviewed this Quarterly Report on Form 10-Q of Rexahn Pharmaceuticals, Inc.; |
2. | 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; |
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. | 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: |
a. | 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; |
b. | 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; |
c. | 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 |
d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | 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): |
a. | 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 |
b. | 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. |
Dated: May 8, 2015
|
|
/s/ Tae Heum Jeong
|
|
Tae Heum Jeong
|
|
Chief Financial Officer
|
(1) | The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Dated: May 8, 2015
|
By:
|
/s/ Peter D. Suzdak
|
|
Peter D. Suzdak,
|
|||
Chief Executive Officer
|
* | 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. |
(1)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Dated: May 8, 2015
|
By:
|
/s/ Tae Heum Jeong
|
|
Tae Heum Jeong,
|
|||
Chief Financial Officer
|
* | 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. |