Ocuphire Pharma, Inc. - Quarter Report: 2019 June (Form 10-Q)
Delaware
|
11-3516358
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification No.)
|
15245 Shady Grove Road, Suite 455
Rockville, MD
|
20850
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
||
Common Stock, $.0001 par value
|
REXN
|
Nasdaq Capital Market
|
Large accelerated filer
|
☐ |
Accelerated filer
|
☐ | |
Non-accelerated filer
|
☑ |
Smaller reporting company
|
☑
|
|
Emerging growth company
|
☐ |
Page
|
|||
PART I
|
1
|
||
Item 1
|
1
|
||
1)
|
1
|
||
2)
|
2
|
||
3)
|
3
|
||
4)
|
4
|
||
5)
|
6
|
||
6)
|
7
|
||
Item 2
|
25
|
||
Item 3
|
33
|
||
Item 4
|
33
|
||
PART II
|
34
|
||
Item 1A
|
34
|
||
Item 6
|
35
|
||
36
|
June 30, 2019
|
December 31, 2018
|
|||||||
ASSETS
|
||||||||
Current Assets:
|
||||||||
Cash and cash equivalents
|
$
|
7,310,049
|
$
|
8,744,301
|
||||
Marketable securities
|
8,950,120
|
5,981,520
|
||||||
Prepaid expenses and other current assets
|
1,033,041
|
1,173,847
|
||||||
Total Current Assets
|
17,293,210
|
15,899,668
|
||||||
Security Deposits
|
25,681
|
30,785
|
||||||
Operating Lease Right-of-Use Assets
|
263,658
|
-
|
||||||
Equipment, Net
|
94,685
|
112,473
|
||||||
Total Assets
|
$
|
17,677,234
|
$
|
16,042,926
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable and accrued expenses
|
$
|
1,920,734
|
$
|
3,152,550
|
||||
Deferred revenue
|
1,500,000
|
-
|
||||||
Operating lease liabilities, current
|
130,466
|
-
|
||||||
Total Current Liabilities
|
3,551,200
|
3,152,550
|
||||||
Operating Lease Liabilities, non-current
|
136,196
|
-
|
||||||
Warrant Liabilities
|
366,732
|
2,307,586
|
||||||
Other Liabilities
|
-
|
19,900
|
||||||
Total Liabilities
|
4,054,128
|
5,480,036
|
||||||
Commitments and Contingencies (note 14)
|
||||||||
Stockholders’ Equity:
|
||||||||
Preferred stock, par value $0.0001, 10,000,000 authorized shares, none issued and outstanding
|
-
|
-
|
||||||
Common stock, par value $0.0001, 75,000,000 authorized shares, 4,019,141 and 3,122,843 issued and outstanding
|
402
|
312
|
||||||
Additional paid-in capital
|
173,110,047
|
165,267,656
|
||||||
Accumulated other comprehensive income (loss)
|
7,179
|
(17,836
|
)
|
|||||
Accumulated deficit
|
(159,494,522
|
)
|
(154,687,242
|
)
|
||||
Total Stockholders’ Equity
|
13,623,106
|
10,562,890
|
||||||
Total Liabilities and Stockholders’ Equity
|
$
|
17,677,234
|
$
|
16,042,926
|
For the Three Months
Ended June 30, |
For the Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Revenues:
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||
Expenses:
|
||||||||||||||||
General and administrative
|
1,340,016
|
1,568,848
|
3,035,538
|
3,396,170
|
||||||||||||
Research and development
|
1,648,401
|
3,432,593
|
3,890,631
|
7,491,126
|
||||||||||||
Total Expenses
|
2,988,417
|
5,001,441
|
6,926,169
|
10,887,296
|
||||||||||||
Loss from Operations
|
(2,988,417
|
)
|
(5,001,441
|
)
|
(6,926,169
|
)
|
(10,887,296
|
)
|
||||||||
Other Income
|
||||||||||||||||
Interest income
|
96,650
|
67,473
|
178,035
|
143,209
|
||||||||||||
Other income
|
-
|
-
|
-
|
368,750
|
||||||||||||
Unrealized gain on fair value of warrants
|
427,483
|
1,095,700
|
1,940,854
|
4,462,196
|
||||||||||||
Total Other Income
|
524,133
|
1,163,173
|
2,118,889
|
4,974,155
|
||||||||||||
Net Loss Before Provision for Income Taxes
|
(2,464,284
|
)
|
(3,838,268
|
)
|
(4,807,280
|
)
|
(5,913,141
|
)
|
||||||||
Provision for income taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Net Loss
|
$
|
(2,464,284
|
)
|
$
|
(3,838,268
|
)
|
$
|
(4,807,280
|
)
|
$
|
(5,913,141
|
)
|
||||
Net loss per share, basic and diluted
|
$
|
(0.61
|
)
|
$
|
(1.45
|
)
|
$
|
(1.23
|
)
|
$
|
(2.24
|
)
|
||||
|
||||||||||||||||
Weighted average number of shares outstanding, basic and diluted
|
4,019,141
|
2,640,927
|
3,900,208
|
2,640,391
|
For the Three Months
Ended June 30, |
For the Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Net Loss
|
$
|
(2,464,284
|
)
|
$
|
(3,838,268
|
)
|
$
|
(4,807,280
|
)
|
$
|
(5,913,141
|
)
|
||||
Unrealized gain (loss) on available-for-sale securities
|
19,781
|
24,421
|
25,015
|
(8,069
|
)
|
|||||||||||
Comprehensive Loss
|
$
|
(2,444,503
|
)
|
$
|
(3,813,847
|
)
|
$
|
(4,782,265
|
)
|
$
|
(5,921,210
|
)
|
Common Stock
|
||||||||||||||||||||||||
Number of
Shares
|
Amount
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Accumulated
Other
Comprehensive
Income (Loss)
|
Total
Stockholders’
Equity
|
|||||||||||||||||||
Balances at April 1, 2019
|
4,019,141
|
$
|
402
|
$
|
172,982,394
|
$
|
(157,030,238
|
)
|
$
|
(12,602
|
)
|
$
|
15,939,956
|
|||||||||||
Stock-based compensation
|
-
|
-
|
127,653
|
-
|
-
|
127,653
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(2,464,284
|
)
|
-
|
(2,464,284
|
)
|
||||||||||||||||
Other comprehensive income
|
-
|
-
|
-
|
-
|
19,781
|
19,781
|
||||||||||||||||||
Balances at June 30, 2019
|
4,019,141
|
$
|
402
|
$
|
173,110,047
|
$
|
(159,494,522
|
)
|
$
|
7,179
|
$
|
13,623,106
|
||||||||||||
Balances at April 1, 2018
|
2,640,927
|
264
|
157,452,657
|
(142,393,585
|
)
|
(89,376
|
)
|
14,969,960
|
||||||||||||||||
Stock-based compensation
|
-
|
-
|
267,151
|
-
|
-
|
267,151
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(3,838,268
|
)
|
-
|
(3,838,268
|
)
|
||||||||||||||||
Other comprehensive income
|
-
|
-
|
-
|
-
|
24,421
|
24,421
|
||||||||||||||||||
Balances at June 30, 2018
|
2,640,927
|
$
|
264
|
$
|
157,719,808
|
$
|
(146,231,853
|
)
|
$
|
(64,955
|
)
|
$
|
11,423,264
|
Common Stock
|
||||||||||||||||||||||||
Number of
Shares |
Amount
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Accumulated
Other
Comprehensive
Income (Loss)
|
Total
Stockholders’
Equity
|
|||||||||||||||||||
Balances at January 1, 2019
|
3,122,843
|
$
|
312
|
$
|
165,267,656
|
$
|
(154,687,242
|
)
|
$
|
(17,836
|
)
|
$
|
10,562,890
|
|||||||||||
Issuance of common stock and units, net of issuance costs
|
895,834
|
90
|
7,553,738
|
-
|
-
|
7,553,828
|
||||||||||||||||||
Common stock issued from vested restricted stock units
|
464
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
Stock-based compensation
|
-
|
-
|
288,653
|
-
|
-
|
288,653
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(4,807,280
|
)
|
-
|
(4,807,280
|
)
|
||||||||||||||||
Other comprehensive income
|
-
|
-
|
-
|
-
|
25,015
|
25,015
|
||||||||||||||||||
Balances at June 30, 2019
|
4,019,141
|
$
|
402
|
$
|
173,110,047
|
$
|
(159,494,522
|
)
|
$
|
7,179
|
$
|
13,623,106
|
||||||||||||
Balances at January 1, 2018
|
2,639,319
|
264
|
157,143,930
|
(140,318,712
|
)
|
(56,886
|
)
|
16,768,596
|
||||||||||||||||
Common stock issued in exchange for services
|
625
|
-
|
12,150
|
-
|
-
|
12,150
|
||||||||||||||||||
Stock-based compensation
|
-
|
-
|
563,728
|
-
|
-
|
563,728
|
||||||||||||||||||
Common stock issued from vested restricted stock units
|
983
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(5,913,141
|
)
|
-
|
(5,913,141
|
)
|
||||||||||||||||
Other comprehensive loss
|
-
|
-
|
-
|
-
|
(8,069
|
)
|
(8,069
|
)
|
||||||||||||||||
Balances at June 30, 2018
|
2,640,927
|
$
|
264
|
$
|
157,719,808
|
$
|
(146,231,853
|
)
|
$
|
(64,955
|
)
|
$
|
11,423,264
|
For the Six Months Ended
June 30,
|
||||||||
2019
|
2018
|
|||||||
Cash Flows from Operating Activities:
|
||||||||
Net loss
|
$
|
(4,807,280
|
)
|
$
|
(5,913,141
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Compensatory stock
|
-
|
12,150
|
||||||
Depreciation and amortization
|
22,077
|
27,188
|
||||||
Loss on sale of equipment
|
9,594
|
-
|
||||||
Amortization of premiums and discounts on marketable securities, net
|
(56,019
|
)
|
26,504
|
|||||
Stock-based compensation
|
288,653
|
563,728
|
||||||
Amortization and termination of deferred research and development arrangement
|
-
|
(375,000
|
)
|
|||||
Unrealized gain on fair value of warrants
|
(1,940,854
|
)
|
(4,462,196
|
)
|
||||
Amortization of deferred lease incentive
|
-
|
(6,222
|
)
|
|||||
Deferred rent
|
-
|
(10,927
|
)
|
|||||
Changes in assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
22,308
|
(61,237
|
)
|
|||||
Accounts payable and accrued expenses
|
(1,231,816
|
)
|
147,767
|
|||||
Deferred revenue
|
1,500,000
|
-
|
||||||
Other, net
|
6,706
|
-
|
||||||
Net Cash Used in Operating Activities
|
(6,186,631
|
)
|
(10,051,386
|
)
|
||||
Cash Flows from Investing Activities:
|
||||||||
Purchase of equipment
|
(19,383
|
)
|
(3,493
|
)
|
||||
Sale of equipment
|
5,500
|
-
|
||||||
Purchase of marketable securities
|
(8,887,566
|
)
|
-
|
|||||
Redemption of marketable securities
|
6,000,000
|
6,250,000
|
||||||
Net Cash (Used In) Provided by Investing Activities
|
(2,901,449
|
)
|
6,246,507
|
|||||
Cash Flows from Financing Activities:
|
||||||||
Issuance of common stock and units, net of issuance costs
|
7,653,828
|
-
|
||||||
Net Cash Provided by Financing Activities
|
7,653,828
|
-
|
||||||
Net Decrease in Cash and Cash Equivalents
|
(1,434,252
|
)
|
(3,804,879
|
)
|
||||
Cash and Cash Equivalents – beginning of period
|
8,744,301
|
8,899,154
|
||||||
Cash and Cash Equivalents - end of period
|
$
|
7,310,049
|
$
|
5,094,275
|
||||
Supplemental Cash Flow Information
|
||||||||
Operating cash flows paid for amounts included in the measurement of lease liabilities
|
$
|
120,700
|
$
|
-
|
||||
Non-cash financing and investing activities:
|
||||||||
Warrants issued
|
$
|
4,735,913
|
$
|
-
|
||||
Operating lease right-of-use assets obtained in exchange for lease obligations:
|
$
|
380,935
|
$
|
-
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
2.
|
Recent Accounting Pronouncements Affecting the Company
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
3.
|
Marketable Securities
|
June 30, 2019
|
||||||||||||||||
Cost
Basis
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value
|
|||||||||||||
Commercial Paper
|
$
|
5,940,729
|
$
|
4,831
|
$
|
-
|
$
|
5,945,560
|
||||||||
Corporate Bonds
|
3,002,212
|
2,348
|
-
|
3,004,560
|
||||||||||||
Total Marketable Securities
|
$
|
8,942,941
|
$
|
7,179
|
$
|
-
|
$
|
8,950,120
|
December 31, 2018
|
||||||||||||||||
Cost
Basis
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value
|
|||||||||||||
Corporate Bonds
|
$
|
5,999,356
|
$
|
-
|
$
|
(17,836
|
)
|
$
|
5,981,520
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
4.
|
Prepaid Expenses and Other Current Assets
|
June 30,
2019
|
December 31,
2018
|
|||||||
Deposits on contracts
|
$
|
370,942
|
$
|
618,417
|
||||
Prepaid expenses and other current assets
|
662,099
|
555,430
|
||||||
$
|
1,033,041
|
$
|
1,173,847
|
5.
|
Equipment, Net
|
June 30,
2019
|
December 31,
2018
|
|||||||
Furniture and fixtures
|
$
|
67,650
|
$
|
82,686
|
||||
Office and computer equipment
|
178,872
|
159,489
|
||||||
Lab equipment
|
-
|
447,653
|
||||||
Leasehold improvements
|
116,403
|
131,762
|
||||||
Total equipment
|
362,925
|
821,590
|
||||||
Less: Accumulated depreciation and amortization
|
(268,240
|
)
|
(709,117
|
)
|
||||
Net carrying amount
|
$
|
94,685
|
$
|
112,473
|
6.
|
Accounts Payable and Accrued Expenses
|
June 30,
2019
|
December 31,
2018
|
|||||||
Trade payables
|
$
|
945,829
|
$
|
547,519
|
||||
Accrued expenses
|
89,000
|
140,637
|
||||||
Accrued research and development contract costs
|
623,266
|
1,782,131
|
||||||
Payroll liabilities
|
262,639
|
682,263
|
||||||
$
|
1,920,734
|
$
|
3,152,550
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
7.
|
Collaboration Agreements
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
8.
|
Leases
|
Right-of-Use Assets
|
$
|
263,658
|
||
Operating Lease Liabilities
|
||||
Current
|
$
|
130,466
|
||
Long Term
|
136,196
|
|||
Total Operating Lease Liabilities
|
$
|
266,662
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
Year Ending December 31:
|
||||
2019 (excluding the six months ended June 30, 2019)
|
$
|
63,770
|
||
2020
|
154,961
|
|||
2021
|
78,437
|
|||
Minimum lease payments
|
297,168
|
|||
Less: Imputed interest
|
(30,506
|
)
|
||
Present value of minimum lease payments
|
266,662
|
|||
Less: current maturities of lease obligations
|
(130,466
|
)
|
||
Long-term lease obligations
|
$
|
136,196
|
9. |
Net Loss per Common Share
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
10. |
Common Stock
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
11.
|
Stock-Based Compensation
|
For the Three Months Ended
|
For the Six Month Ended
|
|||||||||||||||
June 30, | June 30, | |||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Statement of operations line item:
|
||||||||||||||||
General and administrative
|
$
|
119,719
|
$
|
174,589
|
$
|
236,398
|
$
|
391,004
|
||||||||
Research and development
|
7,934
|
92,562
|
52,255
|
172,724
|
||||||||||||
Total
|
$
|
127,653
|
$
|
267,151
|
$
|
288,653
|
$
|
563,728
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
For the Six Months Ended June 30,
|
||||||||
2019
|
2018
|
|||||||
Black-Scholes assumptions
|
||||||||
Expected dividend yield
|
0
|
%
|
0
|
%
|
||||
Expected volatility
|
74-75
|
%
|
69-72
|
%
|
||||
Risk-free interest rate
|
1.9-2.6
|
%
|
2.3-2.8
|
%
|
||||
Expected term (in years)
|
5.5-6 years
|
5.5-6 years
|
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted Average
Remaining
Contractual Term
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding, January 1, 2019
|
255,922
|
$
|
41.88
|
7.8 years
|
$
|
-
|
|||||||
Granted
|
52,465
|
$
|
6.41
|
||||||||||
Exercised
|
-
|
$
|
-
|
||||||||||
Expired
|
(2,080
|
)
|
$
|
97.78
|
|||||||||
Cancelled
|
(67,961
|
)
|
$
|
39.02
|
|||||||||
Outstanding, June 30, 2019
|
238,346
|
$
|
34.36
|
7.8 years
|
$
|
-
|
|||||||
Exercisable, June 30, 2019
|
119,953
|
$
|
55.44
|
6.3 years
|
$
|
-
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
2019
|
||||||||
Number of
Options
|
Weighted Average Fair
Value at Grant Date
|
|||||||
Unvested at January 1, 2019
|
131,531
|
$
|
13.19
|
|||||
Granted
|
52,465
|
$
|
4.20
|
|||||
Vested
|
(32,503
|
)
|
$
|
16.16
|
||||
Cancelled
|
(33,100
|
)
|
$
|
12.73
|
||||
Unvested at June 30, 2019
|
118,393
|
$
|
8.52
|
Number of RSUs
|
Weighted
Average Grant
Date Fair Value
|
|||||||
Outstanding, January 1, 2019
|
1,394
|
$
|
22.08
|
|||||
Granted
|
-
|
$
|
-
|
|||||
Vested and Released
|
(464
|
)
|
$
|
22.08
|
||||
Cancelled
|
(659
|
)
|
$
|
22.08
|
||||
Outstanding, June 30, 2019
|
271
|
$
|
22.08
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
12.
|
Warrants
|
Number of Warrants:
|
|||||||||||||
Warrant Issuance
|
June 30, 2019
|
December 31,
2018
|
Exercise Price
|
Expiration
Date
|
|||||||||
Liability-classified Warrants
|
|||||||||||||
January 2014 Investors
|
-
|
39,683
|
$
|
153.60
|
Jan. 2019
|
||||||||
November 2015 Investors
|
104,168
|
104,168
|
$
|
63.60
|
May 2021
|
||||||||
November 2015 Placement Agent
|
279
|
279
|
$
|
63.60
|
Nov. 2020
|
||||||||
March 2016 Investors
|
50,651
|
50,651
|
$
|
50.40
|
Sept. 2021
|
||||||||
September 2016 Investors
|
67,084
|
67,084
|
$
|
36.00
|
Mar. 2022
|
||||||||
June 2017 Investors
|
126,264
|
126,264
|
$
|
48.00
|
Dec. 2022
|
||||||||
June 2017 Placement Agent
|
15,153
|
15,153
|
$
|
49.50
|
Jun. 2022
|
||||||||
October 2017 Investors
|
136,058
|
136,058
|
$
|
34.20
|
Apr. 2023
|
||||||||
October 2017 Placement Agent
|
16,327
|
16,327
|
$
|
36.72
|
Oct. 2022
|
||||||||
Total liability classified warrants
|
515,984
|
555,667
|
|||||||||||
Equity-classified Warrants
|
|||||||||||||
October 2018 Investors
|
480,771
|
480,771
|
$
|
20.04
|
Apr. 2024
|
||||||||
October 2018 Placement Agent
|
28,848
|
28,848
|
$
|
19.50
|
Oct. 2023
|
||||||||
January 2019 Investors
|
895,886
|
-
|
$
|
9.60
|
Jan. 2024
|
||||||||
Total equity-classified warrants
|
1,405,505
|
509,619
|
|||||||||||
Total outstanding warrants
|
1,921,489
|
1,065,286
|
Number of Warrants
|
||||||||||||||||
Liability-
classified
|
Equity-
classified
|
Total
|
Weighted
average
exercise price
|
|||||||||||||
Balance, January 1, 2019
|
555,667
|
509,619
|
1,065,286
|
$
|
37.52
|
|||||||||||
Issued during the period
|
-
|
895,886
|
895,886
|
$
|
9.60
|
|||||||||||
Exercised during the period
|
-
|
-
|
-
|
$
|
-
|
|||||||||||
Expired during the period
|
(39,683
|
)
|
-
|
(39,683
|
)
|
$
|
153.60
|
|||||||||
Balance, June 30, 2019
|
515,984
|
1,405,505
|
1,921,489
|
$
|
22.10
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
Fair Value as of:
|
||||||||
Warrant Issuance:
|
June 30, 2019
|
December 31, 2018
|
||||||
November 2015 Investors
|
$
|
10,765
|
$
|
234,918
|
||||
November 2015 Placement Agent
|
-
|
435
|
||||||
March 2016 Investor
|
12,426
|
160,099
|
||||||
September 2016 Investors
|
43,752
|
333,834
|
||||||
June 2017 Investors
|
105,374
|
623,324
|
||||||
June 2017 Placement Agent
|
8,685
|
65,149
|
||||||
October 2017 Investors
|
169,925
|
801,551
|
||||||
October 2017 Placement Agent
|
15,805
|
88,276
|
||||||
Total:
|
$
|
366,732
|
$
|
2,307,586
|
June 30, 2019
|
December 31, 2018
|
|||||||
Trading market prices
|
$
|
5.16
|
$
|
11.16
|
||||
Estimated future volatility
|
102
|
%
|
105
|
%
|
||||
Dividend
|
-
|
-
|
||||||
Estimated future risk-free rate
|
1.59-1.76
|
%
|
2.35-2.53
|
%
|
||||
Equivalent volatility
|
84-87
|
%
|
99-104
|
%
|
||||
Equivalent risk-free rate
|
1.86-1.98
|
%
|
2.51-2.55
|
%
|
||||
Fundamental transaction likelihood, at end of warrant term
|
5
|
%
|
5
|
%
|
For the Three Months Ended
June 30,
|
For the Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Expired Warrants
|
$
|
-
|
$
|
26
|
$
|
-
|
$
|
64,307
|
||||||||
November 2015 Investors
|
27,069
|
213,847
|
224,153
|
854,801
|
||||||||||||
November 2015 Placement Agent
|
55
|
556
|
435
|
2,134
|
||||||||||||
March 2016 Investors
|
32,874
|
112,581
|
147,673
|
440,035
|
||||||||||||
September 2016 Investors
|
72,213
|
137,110
|
290,082
|
571,485
|
||||||||||||
June 2017 Investors
|
129,559
|
278,040
|
517,950
|
1,101,211
|
||||||||||||
June 2017 Placement Agent
|
14,553
|
31,031
|
56,464
|
128,340
|
||||||||||||
October 2017 Investors
|
135,125
|
288,231
|
631,626
|
1,160,577
|
||||||||||||
October 2017 Placement Agent
|
16,035
|
34,278
|
72,471
|
139,306
|
||||||||||||
Total:
|
$
|
427,483
|
$
|
1,095,700
|
$
|
1,940,854
|
$
|
4,462,196
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
13.
|
Income Taxes
|
June 30,
2019 |
December 31,
2018 |
|||||||
Net Operating Loss Carryforwards
|
$
|
42,678,000
|
$
|
41,184,000
|
||||
Stock Compensation Expense
|
1,265,000
|
1,608,000
|
||||||
Book tax differences on assets and liabilities
|
508,000
|
195,000
|
||||||
Valuation Allowance
|
(44,451,000
|
)
|
(42,987,000
|
)
|
||||
Net Deferred Tax Assets
|
$
|
-
|
$
|
-
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
14.
|
Commitments and Contingencies
|
a) |
The Company has contracted with various vendors for services, with terms that require payments over the terms of the agreements, usually ranging from two to 36 months. The costs to be incurred are
estimated and are subject to revision. As of June 30, 2019, the total estimated cost to complete these agreements was approximately $3,870,000. 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 property related to
quinoxaline-piperazine derivatives that were synthesized under a Joint Research Agreement. 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 property. As of June 30, 2019, the milestone has not occurred.
|
c) |
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 $18,506 and $34,468 for the three months ended June 30, 2019 and 2018, respectively, and $46,385 and $70,277 for the six
months ended June 30, 2019 and 2018, respectively.
|
d) |
On February 5, 2018, the Company and NEXT BT Co. Ltd (“Next BT”) terminated a research collaboration agreement between the Company and Rexgene Biotech Co., Ltd, a predecessor in interest to Next BT. The
Company agreed to pay Next BT a royalty in the low single digits of any net sales of RX-0201 the Company makes in Asia and 50% of the Company’s licensing revenue related to licensing of RX-0201 in Asia, up to an aggregate of
$5,000,000. As of June 30, 2019, the Company has not made any royalty payments to Next BT.
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
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 June 30, 2019
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Commercial Paper
|
$
|
5,945,560
|
$
|
-
|
$
|
5,945,560
|
$
|
-
|
||||||||
Corporate Bonds
|
3,004,560
|
-
|
3,004,560
|
-
|
||||||||||||
Total Assets:
|
$
|
8,950,120
|
$
|
-
|
$
|
8,950,120
|
$
|
-
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant Liabilities
|
$
|
366,732
|
$
|
-
|
$
|
-
|
$
|
366,732
|
Fair Value Measurements at December 31, 2018
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Corporate Bonds
|
$
|
5,981,520
|
$
|
-
|
$
|
5,981,520
|
$
|
-
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant Liabilities
|
$
|
2,307,586
|
$
|
-
|
$
|
-
|
$
|
2,307,586
|
REXAHN PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
Warrant Liabilities
|
||||
Balance at January 1, 2019
|
$
|
2,307,586
|
||
Unrealized gains, net
|
(1,940,854
|
)
|
||
Balance at June 30, 2019
|
$
|
366,732
|
Item 2.
|
• |
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 preclinical 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 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 preclinical 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 development, 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;
|
• |
the uncertainty about the paths of our programs and our ability to evaluate and identify a path forward for those programs, particularly given the constraints we have as a small company with
limited financial, personnel and other operating resources; and
|
• |
other risks and uncertainties, including those set forth herein and in our Annual Report on Form 10-K for the year ended December 31, 2018 under the caption “Risk Factors” and those
detailed from time to time in our filings with the Securities and Exchange Commission.
|
• |
RX-3117 is a novel, investigational oral, small molecule nucleoside compound. Once intracellularly activated (phosphorylated) by the enzyme UCK2, it is incorporated into the DNA or RNA of cells and inhibits both DNA and RNA
synthesis, which induces apoptotic cell death of tumor cells. Because UCK2 is overexpressed in multiple human tumors, but has a very limited presence in normal tissues, we believe RX-3117 offers the potential for a targeted
anti-cancer therapy. RX-3117 has appeared to be well-tolerated in multiple clinical trials and has received “orphan drug designation” from the U.S. Food and Drug Administration (the “FDA”) and from the European Commission for
pancreatic cancer. RX-3117 is currently being evaluated in a Phase 2a clinical trial in combination with Celgene’s Abraxane® (paclitaxel protein-bound particles for injectable suspension) as a first-line treatment in patients
newly diagnosed with metastatic pancreatic cancer. The trial began dosing patients in November 2017 and reached its target enrollment in February 2019. Preliminary safety and efficacy data from this trial reported in January
2019 showed a 38% overall response rate in the 24 patients who had at least one scan on treatment and were included in the preliminary evaluation of overall response. As of July 24, 2019, an overall response rate of 23% had been
observed in 40 patients that had at least one scan on treatment. Preliminary and unaudited data indicates that the median progression free survival for patients in the study is approximately 5.4 months. Complete data from the
trial is expected to be available in 2020. While no additional trials are currently planned in metastatic pancreatic cancer, we are evaluating development options for RX-3117 in other indications.
|
• |
RX-5902 is a potential first-in-class small molecule modulator of the Wnt/beta-catenin pathway which plays a key role in cancer cell proliferation and tumor growth. RX-5902 modulates the pathway through inhibition of
phosphorylated p68, a protein that helps to transport beta-catenin from the cytoplasm into the cell nucleus. Once inside the nucleus, beta-catenin turns on various oncogenes, thereby promoting cancer cell proliferation and tumor
growth. We believe that by inhibiting phosphorylated p68, RX-5902 hinders the transport of beta-catenin into the nucleus and reduces the activation of cancer genes. In addition, multiple preclinical models have shown that
RX-5902 activates the immune system against cancer and enhances the ability of immune cells to infiltrate the tumor and kill tumor cells. In preclinical models of colorectal and triple negative breast cancer (“TNBC”), the effects
of RX-5902 were observed to be synergistic with other immunotherapy agents such as checkpoint inhibitors. We have evaluated RX-5902 in a Phase 1 dose escalation study in patients with a diverse range of metastatic,
treatment-refractory tumors, including breast, ovarian, colorectal, and neuro-endocrine tumors. In February 2017, we initiated a Phase 2a clinical trial of RX-5902 in patients with metastatic TNBC. In August 2018, we entered
into a collaboration with Merck Sharp & Dohme B.V. (“Merck”) to evaluate the combination of RX-5902 and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in a Phase 2 trial in patients with metastatic TNBC. In
December 2018, we ceased enrollment in the ongoing Phase 2a monotherapy trial of RX-5902 in TNBC to focus RX-5902 development activities on planning the proposed combination trial with KEYTRUDA. We are currently evaluating the
development strategy for RX-5902 and may or may not proceed with this trial.
|
• |
RX-0301 is a potential best-in-class, potent inhibitor of the synthesis of the protein kinase Akt-1, which we believe plays a critical role in cancer cell proliferation, survival, angiogenesis, metastasis and drug resistance.
RX-0301 is the subject of a research and development collaboration with Zhejiang Haichang Biotechnology Co., Ltd (“Haichang”) for the development of RX-0301 to conduct certain preclinical and clinical activities through completion
of a Phase 2a proof-of-concept clinical trial in hepatocellular carcinoma. RX-0301 is being developed as a nano-liposomal formulation of RX-0201 (Archexin®) using Haichang’s proprietary QTsome™ technology. Rexahn was
previously developing RX-0201 for the treatment of renal cell carcinoma (“RCC”). In February 2018, in response to the changing treatment landscape for metastatic RCC over the prior two years with the approval of new therapies by
the FDA, we announced plans to discontinue the internally funded programs of RX-0201 and ceased enrolling patients in a Phase 2a proof-of-concept clinical trial of RX-0201 in patients with metastatic RCC. RX-0301 is currently in
preclinical development. Haichang expects to file an investigational new drug application with the FDA in 2020.
|
For the Three Months Ended
June 30,
|
For the Six Months Ended
June 30,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Clinical Candidates:
|
||||||||||||||||
RX-3117
|
$
|
1,058,000
|
$
|
1,485,300
|
$
|
2,136,400
|
$
|
3,596,900
|
||||||||
RX-5902
|
187,800
|
949,600
|
530,200
|
1,864,000
|
||||||||||||
RX-0201
|
55,300
|
164,200
|
171,100
|
317,000
|
||||||||||||
Preclinical, Personnel and Overhead
|
347,301
|
833,493
|
1,052,931
|
1,713,226
|
||||||||||||
Total Research and Development Expenses
|
$
|
1,648,401
|
$
|
3,432,593
|
$
|
3,890,631
|
$
|
7,491,126
|
• |
the progress of our product development activities;
|
• |
the number and scope of our product development programs;
|
• |
the progress of our preclinical 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
|
Amended and Restated Certificate of Incorporation, filed as Appendix G to the Company’s Definitive Proxy Statement on Schedule 14A filed on April 29, 2005, is incorporated herein by reference.
|
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation, filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on August 30, 2018, is incorporated herein by reference.
|
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation, filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on April 12, 2019, is incorporated herein by reference.
|
|
Collaboration and License Agreement, dated as of February 25, 2019, between BioSense Global LLC and Rexahn Pharmaceuticals, Inc.*
|
|
Certification of Chief Executive 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
|
|
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 Stockholders’ Equity; (v) Condensed Statement of Cash Flows; and (vi) Notes to the Financial Statements.
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Portions of this exhibit have been omitted in compliance with Item 601 of Regulation S-K
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REXAHN PHARMACEUTICALS, INC.
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(Registrant)
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By:
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/s/ Douglas J. Swirsky
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Date: August 7, 2019
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Douglas J. Swirsky
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Chief Executive Officer and President
(principal executive, financial and accounting officer)
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