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) |
5
|
||
6) |
6
|
||
Item 2
|
21
|
||
Item 3
|
27
|
||
Item 4
|
27
|
||
PART II
|
28
|
||
Item 1A
|
28
|
||
Item 6
|
28
|
||
29
|
March 31, 2020
|
December 31, 2019
|
|||||||
ASSETS
|
||||||||
Current Assets:
|
||||||||
Cash and cash equivalents
|
$
|
10,998,096
|
$
|
9,219,547
|
||||
Marketable securities
|
-
|
2,997,220
|
||||||
Prepaid expenses and other current assets
|
290,756
|
447,206
|
||||||
Total Current Assets
|
11,288,852
|
12,663,973
|
||||||
Security Deposits
|
25,681
|
25,681
|
||||||
Operating Lease Right-of-Use Assets
|
171,870
|
203,348
|
||||||
Equipment, Net
|
66,515
|
75,770
|
||||||
Total Assets
|
$
|
11,552,918
|
$
|
12,968,772
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable and accrued expenses
|
$
|
1,237,007
|
$
|
1,265,731
|
||||
Deferred revenue
|
600,000
|
1,500,000
|
||||||
Operating lease liabilities, current
|
144,610
|
139,765
|
||||||
Total Current Liabilities
|
1,981,617
|
2,905,496
|
||||||
Operating Lease Liabilities, non-current
|
25,790
|
63,605
|
||||||
Warrant Liabilities
|
100,109
|
41,717
|
||||||
Total Liabilities
|
2,107,516
|
3,010,818
|
||||||
Commitments and Contingencies (note 11)
|
||||||||
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 issued and outstanding
|
402
|
402
|
||||||
Additional paid-in capital
|
173,354,446
|
173,278,144
|
||||||
Accumulated other comprehensive income
|
-
|
2,084
|
||||||
Accumulated deficit
|
(163,909,446
|
)
|
(163,322,676
|
)
|
||||
Total Stockholders’ Equity
|
9,445,402
|
9,957,954
|
||||||
Total Liabilities and Stockholders’ Equity
|
$
|
11,552,918
|
$
|
12,968,772
|
For the Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Revenues
|
$
|
1,150,000
|
$
|
-
|
||||
Expenses:
|
||||||||
General and administrative
|
1,256,006
|
1,695,523
|
||||||
Research and development
|
456,790
|
2,242,229
|
||||||
Total Expenses
|
1,712,796
|
3,937,752
|
||||||
Loss from Operations
|
(562,796
|
)
|
(3,937,752
|
)
|
||||
Other Income
|
||||||||
Interest income
|
34,418
|
81,385
|
||||||
Unrealized (loss) gain on fair value of warrants
|
(58,392
|
)
|
1,513,371
|
|||||
Total Other (Loss) Income
|
(23,974
|
)
|
1,594,756
|
|||||
Net Loss Before Provision for Income Taxes
|
(586,770
|
)
|
(2,342,996
|
)
|
||||
Provision for Income Taxes
|
-
|
-
|
||||||
Net Loss
|
$
|
(586,770
|
)
|
$
|
(2,342,996
|
)
|
||
Net loss per share, basic and diluted
|
$
|
(0.15
|
)
|
$
|
(0.62
|
)
|
||
|
||||||||
Weighted average number of shares outstanding, basic and diluted
|
4,019,141
|
3,779,953
|
For the Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Net Loss
|
$
|
(586,770
|
)
|
$
|
(2,342,996
|
)
|
||
Unrealized (loss) gain on available-for-sale securities
|
(2,084
|
)
|
5,234
|
|||||
Comprehensive Loss
|
$
|
(588,854
|
)
|
$
|
(2,337,762
|
)
|
Common Stock
|
||||||||||||||||||||||||
Number of
Shares
|
Amount
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Accumulated
Other
Comprehensive
Income (Loss)
|
Total
Stockholders'
Equity
|
|||||||||||||||||||
Balances at January 1, 2020
|
4,019,141
|
$
|
402
|
$
|
173,278,144
|
$
|
(163,322,676
|
)
|
$
|
2,084
|
$
|
9,957,954
|
||||||||||||
Stock-based compensation
|
-
|
-
|
76,302
|
-
|
-
|
76,302
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(586,770
|
)
|
-
|
(586,770
|
)
|
||||||||||||||||
Other comprehensive loss
|
-
|
-
|
-
|
-
|
(2,084
|
)
|
(2,084
|
)
|
||||||||||||||||
Balances at March 31, 2020
|
4,019,141
|
$
|
402
|
$
|
173,354,446
|
$
|
(163,909,446
|
)
|
$
|
-
|
$
|
9,445,402
|
||||||||||||
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
|
-
|
-
|
161,000
|
-
|
-
|
161,000
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(2,342,996
|
)
|
-
|
(2,342,996
|
)
|
||||||||||||||||
Other comprehensive income
|
-
|
-
|
-
|
-
|
5,234
|
5,234
|
||||||||||||||||||
Balances at March 31, 2019
|
4,019,141
|
$
|
402
|
$
|
172,982,394
|
$
|
(157,030,238
|
)
|
$
|
(12,602
|
)
|
$
|
15,939,956
|
For the Three Months Ended
March 31,
|
||||||||
2020
|
2019
|
|||||||
Cash Flows from Operating Activities:
|
||||||||
Net loss
|
$
|
(586,770
|
)
|
$
|
(2,342,996
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
9,255
|
11,533
|
||||||
Loss on sale of equipment
|
-
|
9,594
|
||||||
Amortization of premiums and discounts on marketable securities, net
|
(4,864
|
)
|
(18,499
|
)
|
||||
Stock-based compensation
|
76,302
|
161,000
|
||||||
Unrealized loss (gain) on fair value of warrants
|
58,392
|
(1,513,371
|
)
|
|||||
Changes in assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
156,450
|
73,367
|
||||||
Accounts payable and accrued expenses
|
(28,724
|
)
|
(906,350
|
)
|
||||
Deferred revenue
|
(900,000
|
)
|
150,000
|
|||||
Other, net
|
(1,492
|
)
|
(4,373
|
)
|
||||
Net Cash Used in Operating Activities
|
(1,221,451
|
)
|
(4,380,095
|
)
|
||||
Cash Flows from Investing Activities:
|
||||||||
Purchase of equipment
|
-
|
(13,181
|
)
|
|||||
Sale of equipment
|
-
|
5,500
|
||||||
Purchase of marketable securities
|
-
|
(8,887,566
|
)
|
|||||
Redemption of marketable securities
|
3,000,000
|
3,000,000
|
||||||
Net Cash Provided by (Used in) Investing Activities
|
3,000,000
|
(5,895,247
|
)
|
|||||
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 Increase (Decrease) in Cash and Cash Equivalents
|
1,778,549
|
(2,621,514
|
)
|
|||||
Cash and Cash Equivalents - beginning of period
|
9,219,547
|
8,744,301
|
||||||
Cash and Cash Equivalents - end of period
|
$
|
10,998,096
|
$
|
6,122,787
|
||||
Supplemental Cash Flow Information
|
||||||||
Operating cash flows paid for amounts included in the measurement of lease liabilities
|
$
|
38,262
|
$
|
84,651
|
||||
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
|
2.
|
Marketable Securities
|
December 31, 2019
|
||||||||||||||||
Cost
Basis
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value
|
|||||||||||||
Commercial Paper
|
$
|
1,996,216
|
$
|
1,184
|
$
|
-
|
$
|
1,997,400
|
||||||||
Corporate Bonds
|
998,920
|
900
|
-
|
999,820
|
||||||||||||
Total Marketable Securities
|
$
|
2,995,136
|
$
|
2,084
|
$
|
-
|
$
|
2,997,220
|
3.
|
Equipment, Net
|
March 31,
2020
|
December 31,
2019
|
|||||||
Furniture and fixtures
|
$
|
67,650
|
$
|
67,650
|
||||
Office and computer equipment
|
163,440
|
163,440
|
||||||
Leasehold improvements
|
116,403
|
116,403
|
||||||
Total equipment
|
347,493
|
347,493
|
||||||
Less: Accumulated depreciation and amortization
|
(280,978
|
)
|
(271,723
|
)
|
||||
Net carrying amount
|
$
|
66,515
|
$
|
75,770
|
4. |
Accounts Payable and Accrued Expenses
|
March 31,
2020
|
December 31,
2019
|
|||||||
Trade payables
|
$
|
891,419
|
$
|
488,285
|
||||
Accrued expenses
|
165,931
|
471,700
|
||||||
Accrued research and development contract costs
|
125,992
|
221,170
|
||||||
Payroll liabilities
|
53,665
|
84,576
|
||||||
$
|
1,237,007
|
$
|
1,265,731
|
5.
|
License Agreements
|
6. |
Leases
|
Right-of-Use Assets
|
$
|
171,870
|
||
Operating Lease Liabilities
|
||||
Current
|
$
|
144,610
|
||
Long Term
|
25,790
|
|||
Total Operating Lease Liabilities
|
$
|
170,400
|
For the Three Months Ended
March 31,
|
||||||||
2020
|
2019
|
|||||||
Operating lease cost
|
$
|
36,771
|
$
|
80,279
|
||||
Variable lease cost
|
5,693
|
16,012
|
||||||
Total Lease Cost
|
$
|
42,464
|
$
|
96,291
|
Year Ending December 31:
|
||||
2020 (excluding the three months ended March 31, 2020)
|
$
|
117,018
|
||
2021
|
65,364
|
|||
Minimum lease payments
|
182,382
|
|||
Less: Imputed interest
|
(11,982
|
)
|
||
Present value of minimum lease payments
|
170,400
|
|||
Less: current maturities of lease obligations
|
(144,610
|
)
|
||
Long-term lease obligations
|
$
|
25,790
|
7.
|
Net Loss per Common Share
|
8.
|
Stock-Based Compensation
|
For the Three Months Ended
March 31,
|
||||||||
2020
|
2019
|
|||||||
Statement of operations line item:
|
||||||||
General and administrative
|
$
|
72,420
|
$
|
116,679
|
||||
Research and development
|
3,882
|
44,321
|
||||||
Total
|
$
|
76,302
|
$
|
161,000
|
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted Average
Remaining
Contractual Term
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding, January 1, 2020
|
204,574
|
$
|
35.60
|
7.3 years
|
$
|
-
|
|||||||
Granted
|
-
|
$
|
-
|
||||||||||
Exercised
|
-
|
$
|
-
|
||||||||||
Expired
|
(2,498
|
)
|
$
|
159.60
|
|||||||||
Cancelled
|
(53,054
|
)
|
$
|
60.40
|
|||||||||
Outstanding, March 31, 2020
|
149,022
|
$
|
24.69
|
7.8 years
|
$
|
-
|
|||||||
Exercisable, March 31, 2020
|
75,304
|
$
|
37.16
|
7.0 years
|
$
|
-
|
2020
|
||||||||
Number of
Options
|
Weighted Average Fair
Value at Grant Date
|
|||||||
Unvested at January 1, 2020
|
81,311
|
$
|
7.90
|
|||||
Granted
|
-
|
$
|
-
|
|||||
Vested
|
(7,593
|
)
|
$
|
8.34
|
||||
Cancelled
|
-
|
$
|
-
|
|||||
Unvested at March 31, 2020
|
73,718
|
$
|
7.85
|
9.
|
Warrants
|
Number of Warrants:
|
|||||||||||||
Warrant Issuance
|
March 31, 2020
|
December 31,
2019
|
Exercise Price
|
Expiration
Date
|
|||||||||
Liability-classified Warrants
|
|||||||||||||
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
|
June 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
|
515,984
|
|||||||||||
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
|
895,886
|
$
|
9.60
|
Jan. 2024
|
||||||||
Total equity-classified warrants
|
1,405,505
|
1,405,505
|
|||||||||||
Total outstanding warrants
|
1,921,489
|
1,921,489
|
Number of Warrants
|
||||||||||||||||
Liability-
classified
|
Equity-
classified
|
Total
|
Weighted
average
exercise price
|
|||||||||||||
Balance, January 1, 2020
|
515,984
|
1,405,505
|
1,921,489
|
$
|
22.10
|
|||||||||||
Issued during the period
|
-
|
-
|
-
|
$
|
-
|
|||||||||||
Exercised during the period
|
-
|
-
|
-
|
$
|
-
|
|||||||||||
Expired during the period
|
- |
-
|
-
|
$
|
-
|
|||||||||||
Balance, March 31, 2020
|
515,984
|
1,405,505
|
1,921,489
|
$
|
22.10
|
Fair Value as of:
|
||||||||
Warrant Issuance:
|
March 31, 2020
|
December 31, 2019
|
||||||
November 2015 Investors
|
$
|
971
|
$
|
55
|
||||
November 2015 Placement Agent
|
-
|
-
|
||||||
March 2016 Investor
|
1,240
|
439
|
||||||
September 2016 Investors
|
14,639
|
3,196
|
||||||
June 2017 Investors
|
30,364
|
11,736
|
||||||
June 2017 Placement Agent
|
2,574
|
845
|
||||||
October 2017 Investors
|
46,178
|
23,772
|
||||||
October 2017 Placement Agent
|
4,143
|
1,674
|
||||||
Total:
|
$
|
100,109
|
$
|
41,717
|
March 31, 2020
|
December 31, 2019
|
|||||||
Trading market prices
|
$
|
1.80
|
$
|
1.91
|
||||
Estimated future volatility
|
100
|
%
|
102
|
%
|
||||
Dividend
|
-
|
-
|
||||||
Estimated future risk-free rate
|
0.20-0.41
|
%
|
1.57-1.72
|
%
|
||||
Equivalent volatility
|
113-129
|
%
|
85-94
|
%
|
||||
Equivalent risk-free rate
|
0.13-0.19
|
%
|
1.57-1.59
|
%
|
||||
Fundamental transaction likelihood
|
50
|
%
|
50
|
%
|
||||
Fundamental transaction timing
|
July 2020
|
April 2020
|
For the Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
November 2015 Investors
|
$
|
(916
|
)
|
$
|
197,084
|
|||
November 2015 Placement Agent
|
-
|
380
|
||||||
March 2016 Investors
|
(801
|
)
|
114,799
|
|||||
September 2016 Investors
|
(11,443
|
)
|
217,869
|
|||||
June 2017 Investors
|
(18,628
|
)
|
388,391
|
|||||
June 2017 Placement Agent
|
(1,729
|
)
|
41,911
|
|||||
October 2017 Investors
|
(22,406
|
)
|
496,501
|
|||||
October 2017 Placement Agent
|
(2,469
|
)
|
56,436
|
|||||
Total:
|
$
|
(58,392
|
)
|
$
|
1,513,371
|
10.
|
Income Taxes
|
March 31,
2020
|
December 31,
2019
|
|||||||
Net Operating Loss Carryforwards
|
$
|
44,230,000
|
$
|
43,844,000
|
||||
Stock Compensation Expense
|
551,000
|
1,191,000
|
||||||
Book Tax Differences on Assets and Liabilities
|
163,000
|
464,000
|
||||||
Valuation Allowance
|
(44,944,000
|
)
|
(45,499,000
|
)
|
||||
Net Deferred Tax Assets
|
$
|
-
|
$
|
-
|
11.
|
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 March 31, 2020, the total estimated cost to complete these agreements was approximately $800,000. 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 March 31, 2020, 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 $11,229 and $27,879 for the three months ended March 31, 2020 and 2019, respectively.
|
d) |
On February 5, 2018, the Company and 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 March 31, 2020,
the Company has not made any royalty payments to Next BT.
|
12.
|
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 March 31, 2020
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Liabilities:
|
||||||||||||||||
Warrant Liabilities
|
$
|
100,109
|
$
|
-
|
$
|
-
|
$
|
100,109
|
Fair Value Measurements at December 31, 2019
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Commercial Paper
|
$
|
1,997,400
|
$
|
-
|
$
|
1,997,400
|
$
|
-
|
||||||||
Corporate Bonds
|
999,820
|
-
|
999,820
|
-
|
||||||||||||
Total Assets:
|
$
|
2,997,220
|
$
|
-
|
$
|
2,997,220
|
$
|
-
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant Liabilities
|
$
|
41,717
|
$
|
-
|
$
|
-
|
$
|
41,717
|
Warrant Liabilities
|
||||
Balance at January 1, 2020
|
$
|
41,717
|
||
Unrealized losses, net
|
58,392
|
|||
Balance at March 31, 2020
|
$
|
100,109
|
13.
|
Subsequent Event
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
● |
uncertainties about the exploration and evaluation of strategic alternatives, including that they may not result in a definitive transaction or enhance shareholder value and may create a
distraction or uncertainty that may adversely affect our operating results, business, or investor perceptions;
|
● |
uncertainties 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;
|
● |
the impact of the COVID-19 pandemic on the economy, our industry, and our financial condition and results of operations, as well as our ability to enter into and complete a strategic
transaction;
|
● |
our understandings and beliefs regarding the role of certain biological mechanisms and processes in cancer;
|
● |
our product candidates being in early stages of development, including in preclinical development;
|
● |
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; and
|
● |
other risks and uncertainties, including those set forth herein and in the 2019 Form 10-K 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. RX-3117 is the subject of 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 reached its target enrollment in February 2019. 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. We do not plan to
conduct or sponsor any additional trials with RX-3117.
|
● |
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. In August 2018, we entered into a Clinical Trial Collaboration and
Supply Agreement (the “Collaboration Agreement”) 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 triple negative breast cancer (“TNBC”). On April 7, 2020, we notified Merck that we were terminating the Collaboration Agreement, effective immediately, in connection with our determination to discontinue development of RX-5902
for the treatment of TNBC. We are evaluating development options for RX-5902 and may or may not sponsor additional clinical trials with the compound.
|
● |
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 currently in preclinical development by Zhejiang HaiChang Biotechnology Co., Ltd. (“HaiChang”) as a nano-liposomal formulation of RX-0201 (Archexin®) using HaiChang’s proprietary QTsome™ technology On February 8, 2020, we
entered into an exclusive license agreement with HaiChang (the “HaiChang License Agreement”) pursuant to which we granted HaiChang an exclusive (even as to us), royalty-bearing, sublicensable worldwide license to research, develop and
commercialize RX-0201 and RX-0301. The HaiChang License Agreement supersedes a prior agreement with HaiChang to develop RX-0301 under which HaiChang was to conduct certain preclinical and clinical activities through completion of a Phase 2a
proof-of-concept clinical trial in hepatocellular carcinoma.
|
For the Three Months Ended
March 31,
|
||||||||
2020
|
2019
|
|||||||
Clinical Candidates:
|
||||||||
RX-3117
|
$
|
326,900
|
$
|
1,078,400
|
||||
RX-5902
|
4,200
|
342,400
|
||||||
RX-0201
|
1,800
|
115,800
|
||||||
|
||||||||
Preclinical, Personnel and Overhead
|
123,890
|
705,629
|
||||||
Total Research and Development Expenses
|
$
|
456,790
|
$
|
2,242,229
|
Exhibit No.
|
Description
|
|
Amendment No. 2 to Collaboration and License Agreement, dated as of March 10, 2020 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.
|
REXAHN PHARMACEUTICALS, INC.
|
||
(Registrant)
|
||
By:
|
/s/ Douglas J. Swirsky
|
|
Date: May 7, 2020
|
Douglas J. Swirsky
|
|
Chief Executive Officer and President
|
||
(principal executive, financial and accounting officer)
|