10-Q: Quarterly report pursuant to Section 13 or 15(d)
Published on November 16, 2009
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
QUARTERLY
REPORT
PURSUANT
TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2009
Rexahn
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
|
11-3516358
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification Number)
|
15245
Shady Grove Road, Suite 455
Rockville,
MD 20850
(Address
of principal executive offices, including zip code)
Telephone:
(240) 268-5300
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days.
Yes þ No o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes ¨ No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company. See
definition of “accelerated filer”, “large accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
Accelerated Filer o
|
Accelerated
Filer þ
|
Non-Accelerated
Filer o (Do
not check if a smaller reporting company)
|
Smaller
reporting company þ
|
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act).
Yes o No þ
Indicate
the number of shares outstanding of each of the issuer’s classes of common
stock, as of the latest practicable date: 71,924,496 shares of common stock
outstanding as of November 16, 2009.
1
REXAHN PHARMACEUTICALS, INC.
(A
Development Stage Company)
TABLE
OF CONTENTS
Page
|
|||
PART
I
|
FINANCIAL
INFORMATION
|
||
Item
1
|
Financial
Statements
|
||
1)
|
3
|
||
2)
|
4
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||
3)
|
5
|
||
4)
|
6
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||
Item
2
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23
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||
Item
3
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30
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||
Item
4
|
30
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||
PART
II
|
OTHER
INFORMATION
|
||
Item
1
|
31
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||
Item
1A
|
31
|
||
Item
2
|
31
|
||
Item
3
|
31
|
||
Item
4
|
31
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||
Item
5
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31
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Item
6
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32
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33
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PART
I
|
Financial
Information
|
Item
1
|
Financial
Statements
|
REXAHN PHARMACEUTICALS, INC.
(A
Development Stage Company)
Condensed
Balance Sheets
September
30,
2009
|
December
31,
2008
|
|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
and cash equivalents
|
$ | 4,141,358 | $ | 369,130 | ||||
Marketable
securities
|
- | 2,999,750 | ||||||
Prepaid
expenses and other current assets (note 3)
|
220,283 | 366,765 | ||||||
Total
Current Assets
|
4,361,641 | 3,735,645 | ||||||
Restricted Cash Equivalents
(note 13)
|
2,100,533 | - | ||||||
Equipment, Net (note
4)
|
179,737 | 92,212 | ||||||
Intangible Asset, Net
(note 5)
|
272,774 | 286,132 | ||||||
Total
Assets
|
$ | 6,914,685 | $ | 4,113,989 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable and accrued expenses (note 6)
|
$ | 474,289 | $ | 358,894 | ||||
Deferred Revenue (note
7)
|
993,750 | 1,050,000 | ||||||
Other liabilities (note
8)
|
121,171 | - | ||||||
Total
Liabilities
|
1,589,210 | 1,408,894 | ||||||
Commitments and Contingencies
(note 13)
|
||||||||
Stockholders' Equity
(note 10):
|
||||||||
Preferred
stock, par value $0.0001, 100,000 authorized shares, none issued and
outstanding
|
- | - | ||||||
Common
stock, par value $0.0001, 500,000,000 authorized shares, 63,848,175 (2008
– 56,039,854) issued
|
6,384 | 5,604 | ||||||
Additional
paid-in capital
|
39,759,025 | 33,184,860 | ||||||
Accumulated
deficit during the development stage
|
(34,411,524 | ) | (29,906,479 | ) | ||||
Treasury
stock, 14,205 shares, at cost
|
(28,410 | ) | (28,410 | ) | ||||
Accumulated
other comprehensive (loss)
|
- | (550,480 | ) | |||||
Total
Stockholders' Equity
|
5,325,475 | 2,705,095 | ||||||
Total
Liabilities and Stockholders' Equity
|
$ | 6,914,685 | $ | 4,113,989 |
See the
notes accompanying the condensed financial statements
REXAHN PHARMACEUTICALS, INC.
(A
Development Stage Company)
Condensed
Statements of Operations
(Unaudited)
Three
Months
Ended
September 30,
|
Nine
Months
Ended
September 30,
|
Cumulative
from March 19, 2001 (Inception) to
|
||||||||||||||||||
2009
|
2008
|
2009
|
2008
|
September
30, 2009
|
||||||||||||||||
Revenues:
|
||||||||||||||||||||
Research
|
$ | 18,750 | $ | 18,750 | $ | 56,250 | $ | 56,250 | $ | 506,250 | ||||||||||
Expenses:
|
||||||||||||||||||||
General
and administrative
|
724,067 | 645,368 | 2,285,804 | 1,893,819 | 17,150,243 | |||||||||||||||
Research
and development
|
424,609 | 567,905 | 2,018,766 | 1,419,077 | 15,250,610 | |||||||||||||||
Patent
fees
|
107,618 | 57,574 | 258,421 | 163,778 | 1,180,254 | |||||||||||||||
Depreciation
and amortization
|
17,292 | 13,875 | 41,638 | 41,574 | 544,842 | |||||||||||||||
Total
Expenses
|
1,273,586 | 1,284,722 | 4,604,629 | 3,518,248 | 34,125,949 | |||||||||||||||
Loss
from Operations
|
(1,254,836 | ) | (1,265,972 | ) | (4,548,379 | ) | (3,461,998 | ) | (33,619,699 | ) | ||||||||||
Other
(Income) Expense:
|
||||||||||||||||||||
Realized
loss (gain) on marketable securities
|
- | - | (11,025 | ) | 22,365 | 9,341 | ||||||||||||||
Interest
(income)
|
(17,407 | ) | (52,122 | ) | (32,309 | ) | (220,239 | ) | (1,143,663 | ) | ||||||||||
Interest
expense
|
- | - | - | - | 301,147 | |||||||||||||||
Beneficial
conversion feature
|
- | - | - | - | 1,625,000 | |||||||||||||||
Total
Other (Income) Expense
|
(17,407 | ) | (52,122 | ) | (43,334 | ) | (197,874 | ) | 791,825 | |||||||||||
Net
Loss Before Provision for Income Taxes
|
(1,237,429 | ) | (1,213,850 | ) | (4,505,045 | ) | (3,264,124 | ) | (34,411,524 | ) | ||||||||||
Provision
for Income Taxes
|
- | - | - | - | - | |||||||||||||||
Net
Loss
|
$ | (1,237,429 | ) | $ | (1,213,850 | ) | $ | (4,505,045 | ) | $ | (3,264,124 | ) | $ | (34,411,524 | ) | |||||
Loss
per share, basic and diluted
|
$ | (0.02 | ) | $ | (0.02 | ) | $ | (0.08 | ) | $ | (0.06 | ) | ||||||||
Weighted
average number of shares outstanding, basic and diluted
|
61,027,293 | 56,025,649 | 58,440,503 | 55,800,977 |
See the
notes accompanying the condensed financial statements
REXAHN PHARMACEUTICALS, INC.
(A
Development Stage Company)
Condensed
Statements of Cash Flows
(Unaudited)
Nine
Months
Ended
September 30,
|
Cumulative
From
March 19,2001 (Inception) to
|
|||||||||||
2009
|
2008
|
September
30, 2009
|
||||||||||
Cash
Flows from Operating Activities:
|
||||||||||||
Net
loss
|
$ | (4,505,045 | ) | $ | (3,264,124 | ) | $ | (34,411,524 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Beneficial
conversion feature
|
- | - | 1,625,000 | |||||||||
Compensatory
stock
|
- | - | 21,877 | |||||||||
Depreciation
and amortization
|
41,638 | 41,574 | 544,842 | |||||||||
Stock
option compensation expense
|
489,094 | 397,002 | 4,345,928 | |||||||||
Amortization
of deferred revenue
|
(56,250 | ) | (56,250 | ) | (506,250 | ) | ||||||
Realized
(gains) losses on marketable securities
|
(11,025 | ) | 22,365 | 9,341 | ||||||||
Amortization
of deferred lease incentive
|
(5,000 | ) | - | (5,000 | ) | |||||||
Deferred
lease expenses
|
26,171 | - | 26,171 | |||||||||
Changes
in assets and liabilities:
|
||||||||||||
Prepaid
expenses and other
|
146,482 | (19,555 | ) | (220,283 | ) | |||||||
Accounts
payable and accrued expenses
|
115,395 | (241,982 | ) | 474,289 | ||||||||
Net
Cash (Used in) Operating Activities
|
(3,758,540 | ) | (3,120,970 | ) | (28,095,609 | ) | ||||||
Cash
Flows from Investing Activities:
|
||||||||||||
Restricted
cash equivalents
|
(2,100,533 | ) | - | (2,100,533 | ) | |||||||
Purchase
of equipment
|
(15,805 | ) | (25,697 | ) | (541,137 | ) | ||||||
Purchase
of marketable securities
|
(1,196,824 | ) | (5,848,176 | ) | (10,595,000 | ) | ||||||
Proceeds
from sales of marketable securities
|
4,758,079 | 4,475,581 | 10,585,659 | |||||||||
Payment
of licensing fees
|
- | - | (356,216 | ) | ||||||||
Net
Cash Provided by (Used in) Investing Activities
|
1,444,917 | (1,398,292 | ) | (3,007,227 | ) | |||||||
Cash
Flows from Financing Activities:
|
||||||||||||
Issuance
of common stock and units, net of issuance costs
|
6,085,851 | 931,201 | 28,622,604 | |||||||||
Proceeds
from long-term debt
|
- | - | 5,150,000 | |||||||||
Proceeds
from research contribution
|
- | - | 1,500,000 | |||||||||
Principal
payments on long-term debt
|
- | - | (28,410 | ) | ||||||||
Net
Cash Provided by Financing Activities
|
6,085,851 | 931,201 | 35,244,194 | |||||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
3,772,228 | (3,588,061 | ) | 4,141,358 | ||||||||
Cash
and Cash Equivalents - beginning of period
|
369,130 | 3,809,571 | - | |||||||||
Cash
and Cash Equivalents - end of period
|
$ | 4,141,358 | $ | 221,510 | $ | 4,141,358 | ||||||
Supplemental
Cash Flow Information:
|
||||||||||||
Interest
paid
|
$ | - | $ | - | $ | 301,147 | ||||||
Non-cash
financing and investing activities:
|
||||||||||||
Warrants
issued
|
$ | 1,348,308 | $ | - | $ | 2,762,596 | ||||||
Leasehold
improvement incentive
|
$ | 100,000 | $ | - | $ | 100,000 |
See the
notes accompanying the condensed financial statements
REXAHN PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
1.
|
Operations
and Organization
|
Operations
Rexahn
Pharmaceuticals, Inc. (the "Company", "Rexahn Pharmaceuticals", “we”, or “us”),
a Delaware corporation, is a development stage biopharmaceutical company
dedicated to the discovery, development and commercialization of innovative
treatments for cancer, central nervous system (CNS) disorders, sexual
dysfunction and other medical needs. The Company had an accumulated
deficit of $34,411,524 at September 30, 2009 and anticipates incurring losses
through the remainder of fiscal 2009 and beyond. The Company has not
yet generated commercial sales revenue and has been able to fund its operating
losses to date through the sale of its common stock, units, issuance of
long-term debt, and proceeds from reimbursed research and development
costs. Management has the capability of managing the Company’s
operations within existing cash available by reducing research and development
activities. This may result in slowing down clinical studies, but
will conserve the Company’s cash to allow it to operate for the next twelve
months.
Basis
of Presentation
The
accompanying unaudited condensed financial statements of the Company have been
prepared pursuant to the rules and regulations of the Securities and Exchange
Commission (“SEC”) for interim financial information. Accordingly,
they do not include all of the information and footnotes required by accounting
principles generally accepted in the United States for complete financial
statements. In the opinion of the Company’s management, all
adjustments (consisting of only normal recurring accruals) considered necessary
for a fair presentation have been included. Operating results for the
nine-month period ended September 30, 2009 are not necessarily indicative of
results that may be expected for the full fiscal year ending December 31,
2009. The accompanying condensed financial statements should be read
in conjunction with the audited financial statements of the Company for the
fiscal year ended December 31, 2008. The Company has evaluated
subsequent events for recognition or disclosure through November 16, 2009, which
was the date we filed this Form 10-Q with the SEC.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and
the disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. These estimates are based on management’s best
knowledge of current events and actions the Company may undertake in the
future. Actual results may ultimately differ from those
estimates. These estimates are reviewed periodically and as
adjustments become necessary, they are reported in earnings in the period in
which they become available.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
2.
|
Recent
Accounting Pronouncements Affecting the
Company
|
In
April 2009, the Financial Accounting Standards Board (the “FASB”) issued
authoritative guidance to require that assets acquired and liabilities assumed
in a business combination that arise from contingencies be recognized at fair
value if fair value can be reasonably determined. If the fair value of
such assets or liabilities cannot be reasonably determined, then they would
generally be recognized in accordance with certain other pre-existing accounting
standards. This guidance also amends the subsequent accounting for assets
and liabilities arising from contingencies in a business combination and certain
other disclosure requirements. This guidance becomes effective for assets
or liabilities arising from contingencies in business combinations that are
consummated during the Company’s fiscal 2010 and it is not expected to have an
impact on the Company’s September 30, 2009 interim financial
statements.
In
June 2009, the FASB issued authoritative guidance to eliminate the
exception to consolidate a qualifying special-purpose entity, change the
approach to determining the primary beneficiary of a variable interest entity
and require companies to more frequently re-assess whether they must consolidate
variable interest entities. Under the new guidance, the primary
beneficiary of a variable interest entity is identified qualitatively as the
enterprise that has both (a) the power to direct the activities of a
variable interest entity that most significantly impact the entity’s economic
performance, and (b) the obligation to absorb losses of the entity that
could potentially be significant to the variable interest entity or the right to
receive benefits from the entity that could potentially be significant to the
variable interest entity. This guidance becomes effective for the
Company’s fiscal 2011 year-end and interim reporting periods thereafter.
The Company does not expect this guidance to have a material impact on its
financial statements.
In
June 2009, the FASB established the FASB Accounting Standards
CodificationTM (the “Codification”) as the single source of authoritative
U.S. generally accepted accounting principles (“U.S. GAAP”) recognized by the
FASB to be applied by nongovernmental entities. Rules and
interpretive releases of the SEC under authority of federal securities laws are
also sources of authoritative U.S. GAAP for SEC registrants. The
Codification did not have a material impact on the Company’s financial
statements upon adoption. Accordingly, the Company’s notes to the
financial statements will explain accounting concepts rather than cite the
topics of specific U.S. GAAP.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
3.
|
Prepaid
Expenses and Other Current Assets
|
September
30,
2009
|
December
31,
2008
|
|||||||
Deposits
on contracts
|
$ | 162,862 | $ | 294,337 | ||||
Other
assets
|
57,421 | 72,428 | ||||||
$ | 220,283 | $ | 366,765 |
4.
|
Equipment
|
September
30,
2009
|
December
31,
2008
|
|||||||
Furniture
and fixtures
|
$ | 31,713 | $ | 31,713 | ||||
Office
equipment
|
70,276 | 70,276 | ||||||
Lab
and computer equipment
|
428,436 | 421,343 | ||||||
Leasehold
improvements
|
110,712 | 2,000 | ||||||
641,137 | 525,332 | |||||||
Less
accumulated depreciation and amortization
|
(461,400 | ) | (433,120 | ) | ||||
Net
carrying amount
|
$ | 179,737 | $ | 92,212 |
Depreciation
and amortization expense was $12,839 and $9,422 for the three months ended
September 30, 2009 and 2008, respectively and $28,280 and $28,215 for the nine
months ended September 30, 2009 and 2008, respectively.
5.
|
Intangible
Asset, Net
|
On
February 10, 2005, the Company entered into a licensing agreement with Revaax
Pharmaceuticals LLC ("Revaax"), whereby the Company received an exclusive,
worldwide, royalty bearing license, with the right to sub-license Revaax's
licensed technology and products. The agreement called for an initial
licensing fee of $375,000 to be payable to Revaax in eight quarterly
installments ending on November 10, 2006. Accordingly, the Revaax
license was measured at fair value at the date the licensing agreement was
entered into. The fair value of the license component of
$356,216 was determined by discounting the stream of future quarterly
payments of $46,875 at 6%, the prevailing market rate for a debt instrument of
comparable maturity and credit quality. The asset is amortized on a
straight-line basis over an estimated useful life of 20 years. The
discount was accreted over the term of the liability, calculated based on the
Company's estimated effective market interest rate of
6%. Amortization expense was $4,453 for each of the three months
ended September 30, 2009 and 2008 and $13,358 and $13,359 for the nine months
ended September 30, 2009 and 2008.
Management
does not believe that there is an impairment of intangible asset at September
30, 2009.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
The
following table sets forth the intangible assets:
September
30,
2009
|
December
31,
2008
|
|||||||
Revaax
license, original cost
|
$ | 356,216 | $ | 356,216 | ||||
Less
accumulated amortization
|
(83,442 | ) | (70,084 | ) | ||||
Balance
|
$ | 272,774 | $ | 286,132 |
Amortization
over the next five (5) years and thereafter is as follows:
2009
|
$ | 4,452 | ||
2010
|
17,811 | |||
2011
|
17,811 | |||
2012
|
17,811 | |||
2013
|
17,811 | |||
Thereafter
|
197,078 | |||
$ | 272,774 |
6.
|
Accounts
Payable and Accrued Expenses
|
September
30,
2009
|
December
31,
2008
|
|||||||
Trade
payables
|
$ | 171,555 | $ | 136,906 | ||||
Accrued
expenses
|
210,232 | 98,486 | ||||||
Payroll
liabilities
|
92,502 | 123,502 | ||||||
$ | 474,289 | $ | 358,894 |
7.
|
Deferred
Revenue
|
In 2003,
the Company entered into a collaborative research agreement with Rexgene Biotech
Co., Ltd. ("Rexgene"), a minority shareholder. Rexgene is engaged in
the development of pharmaceutical products in Asia and has agreed to assist the
Company with the research, development and clinical trials necessary for
registration of the Company's drug candidate, RX-0201, in Asia. This
agreement provides Rexgene with exclusive rights to license, sublicense, make,
have made, use, sell and import RX-0201 in Asia. A one-time contribution to the
joint development and research of RX-0201 of $1,500,000 was paid to the Company
in 2003 in accordance with the agreement. The amount of revenue from
this contribution is being recognized as income over the term of the agreement
which terminates at the later of 20 years or the term of the patent on the
licensed product. The Company is using 20 years as its basis for recognition and
accordingly $56,250 was included in revenues for the nine months ended September
30, 2009 and 2008. The remaining $993,750 at September 30, 2009
(December 31, 2008 - $1,050,000) is reflected as deferred revenue on the balance
sheet. The contribution is being used in the cooperative funding of the costs of
development of RX-0201. Royalties of 3% of net sales of licensed
products will become payable to the Company on a quarterly basis once commercial
sales of RX-0201 begin. The product is still under development and commercial
sales are not expected to begin until at least 2012.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
8.
|
Other
Liabilities
|
Deferred Lease
Incentive
On June
29, 2009, the Company entered into a five year office lease agreement with The
Realty Associates Fund V, LP (“lessor”), as discussed in note 13. The
lessor agreed to grant a leasehold improvement allowance of $100,000 to the
Company to be used for construction cost of the improvements, architectural and
engineering fees, government agency plan check, permit and other fees, sales and
use taxes, testing and inspection costs, construction fees and telephone and
data cabling and wiring in the premises. As at September 30, 2009,
the full amount of leasehold improvement allowance has been used up by the
Company. The Company accounts for the benefit of the leasehold
improvement allowance as a reduction of rental expense over the term of the
lease which is 5 years.
The
following table sets forth the deferred lease incentive:
September
30,
2009
|
December
31,
2008
|
|||||||
Deferred
lease incentive
|
$ | 100,000 | $ | - | ||||
Less
accumulated amortization
|
(5,000 | ) | - | |||||
Balance
|
$ | 95,000 | $ | - |
Deferred Office Lease
Expense
The
office lease agreement, as discussed above, requires an initial annual base rent
of $76,524 with increases over the next five years. The Company recognizes
rental expense on a straight-line basis over the term of the lease, which
results in a deferred rent liability of $15,835 as at September 30,
2009.
Deferred Lab Lease
Expense
On May
21, 2009, the Company entered into a 1 year agreement to use lab space
commencing on July 1, 2009. The lessor granted free rent to the
Company for the period from July 1, 2009 to September 30, 2009. The
Company recognizes rental expense on a straight-line basis over the term of the
lease, which results in a deferred rent liability of $10,336 as at September 30,
2009.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
9.
|
Net
Loss per Common Share
|
We
compute basic loss per share by dividing net loss by the weighted average number
of common shares outstanding and excluding any potential
dilution. Net loss per common share assuming dilution was computed by
reflecting potential dilution from the exercise of stock options and
warrants. As of September 30, 2009 and 2008, there were stock options
and warrants to acquire 13,455,267 and 7,402,943 shares of our common stock
respectively. These shares were excluded from the computations of
diluted loss per share because their effect would be anti-dilutive.
10.
|
Stockholders’
Equity
|
The
following transactions have occurred from March 19, 2001 (inception) to
September 30, 2009:
|
a)
|
On
May 10, 2001, the Company issued 3,600,000 shares of common stock to the
Company's founders for $1.
|
|
b)
|
On
August 10, 2001, the Company
issued:
|
|
i)
|
1,208,332
shares of common stock to the directors of the Company for cash of
$1,450,000.
|
|
ii)
|
958,334
shares of common stock to Rexgene for cash of
$550,000.
|
|
iii)
|
360,000
shares of common stock in a private placement to individual investors for
cash of $1,080,000.
|
These
share purchases were negotiated by the parties at various dates prior to the
August 10, 2001 share issuance date.
|
c)
|
On
October 10, 2001, the Company issued 400,000 shares of common stock to
Chong Kun Dang Pharmaceutical Corp. ("CKD") for cash of $479,991 and
400,000 shares of common stock to an individual investor for cash of
$479,991.
|
|
d)
|
On
October 10, 2001, the Company issued 200,000 shares of common stock to CKD
for cash of $479,985.
|
|
e)
|
Since
inception, the Company's founders have transferred 800,000 shares of the
common stock described in a) to officers and directors of the
Company.
|
|
f)
|
In
July 2003, the shareholders described in b)(iii) and e) transferred an
aggregate of 1,268,332 shares of common stock to a voting
trust. The trust allows for the unified voting of the stock by
the trustees. The appointed trustees are senior management of
the Company who, together with their existing shares, control a majority
of the voting power of the Company.
|
|
g)
|
On
August 20, 2003, the Company issued 500,000 shares of common stock to
KT&G Corporation for cash of
$2,000,000.
|
|
h)
|
On
October 29, 2004, an option holder exercised options to purchase shares of
the Company’s common stock for cash of $1,800 and the Company issued an
aggregate of 1,500 shares.
|
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
|
i)
|
Pursuant
to the agreement and plan of merger which occurred on May 13, 2005, (i)
each share of the issued and outstanding common stock of Rexahn, Corp
(“Rexahn”) (other than dissenting shares) was converted into the right to
receive five shares of Rexahn Pharmaceuticals common stock; (ii) each
issued, outstanding and unexercised option to purchase a share of Rexahn
common stock was converted into an option to purchase five shares of
Rexahn Pharmaceuticals common stock and (iii) the par value of Rexahn's
common stock was adjusted to reflect the par value of Corporate Road Show.
Com Inc. (“CRS”) common stock. In the acquisition merger,
289,780,000 CRS pre-reverse stock split shares were converted into
2,897,802 post-reverse stock split Rexahn Pharmaceuticals shares, and an
additional 500,000 post-reverse stock split Rexahn Pharmaceuticals shares
were issued to a former executive of CRS. All shares and
earnings per share information has been retroactively restated in these
financial statements.
|
|
j)
|
On
August 8, 2005, the Company issued, in a transaction exempt from
registration under the Securities Act, 4,175,000 shares of common stock at
a purchase price of $2.00 per
share.
|
|
k)
|
On
October 3, 2005, the Company issued 7,000 shares of common stock for
$21,877 and $7,500 cash in exchange for
services.
|
|
l)
|
On
December 2, 2005, the holders of a convertible note, representing
$1,300,000 aggregate principal amount, exercised their option to convert
the entire principal amount of the note into the Company's common
stock. Based on a $2.00 per share conversion price, the holders
received an aggregate of 650,000
shares.
|
|
m)
|
On
December 27, 2005, option holders exercised options to purchase shares of
the Company's common stock for cash of $9,600 and the Company issued an
aggregate of 40,000 shares.
|
|
n)
|
On
February 22, 2006, an option holder exercised options to purchase shares
of the Company's common stock for cash of $1,200 and the Company issued an
aggregate of 5,000 shares.
|
|
o)
|
On
April 12, 2006, an option holder exercised options to purchase shares of
the Company’s common stock for cash of $3,409 and the Company issued an
aggregate of 14,205 shares. On the same date, the Company
agreed to repurchase common stock from the option holder based on the then
market price for treasury in exchange for the aggregate purchase price of
$28,410 in cash.
|
|
p)
|
On
May 13, 2006, holders of the $3,850,000 convertible notes issued on
February 28, 2005, exercised their rights to convert the entire principal
amount of the notes into shares of the Company’s common
stock. Based on a $1.00 per share conversion price, the
Company issued 3,850,000 shares of common stock in connection with the
conversion.
|
|
q)
|
On
October 9, 2006, an option holder exercised options to purchase shares of
the Company’s common stock for cash of $2,400 and the Company issued an
aggregate of 10,000 shares.
|
|
r)
|
On
November 19, 2006, an option holder exercised options to purchase shares
of the Company's common stock for cash of $1,800 and the Company issued an
aggregate of 7,500 shares.
|
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
|
s)
|
On
December 19, 2006, an option holder exercised options to purchase shares
of the Company's common stock for cash of $6,000 and the Company issued an
aggregate of 25,000 shares.
|
|
t)
|
On
April 18, 2007, an option holder exercised options to purchase shares of
the Company's common stock for cash of $14,400 and the Company issued an
aggregate of 18,000 shares.
|
|
u)
|
On
July 23, 2007, an option holder exercised options to purchase shares of
the Company's common stock for cash of $12,000 and the Company issued an
aggregate of 15,000 shares.
|
|
v)
|
On
September 27, 2007, an option holder exercised options to purchase shares
of the Company's common stock for cash of $15,600 and the Company issued
an aggregate of 19,500 shares.
|
|
w)
|
On
December 18, 2007, the Company issued 4,857,159 units at a price of $1.40
per share for total gross proceeds of $6,800,023. Investors also
were issued one warrant for every five shares purchased. One
warrant will entitle the holder to purchase an additional share of common
stock at a purchase price of $1.80 at any time over a period of three
years from the date of the closing of the private placement valued at
$1,103,164 on closing and were charged to additional paid-in-capital.
Private placement closing costs of $139,674, including 107,144 warrants
issued, valued at $91,119, were recorded as a reduction of the issuance
proceeds.
|
|
x)
|
On
December 27, 2007, an option holder exercised options to purchase shares
of the Company's common stock for cash of $18,000 and the Company issued
an aggregate of 75,000 shares.
|
|
y)
|
On
March 20, 2008, the Company issued 642,858 units consisting of one share
of the Company’s common stock and one warrant for every five common shares
purchased in a private placement at a price of $1.40 per unit for total
gross proceeds of $900,001. One warrant will entitle the holder to
purchase an additional share of common stock at a price of $1.80 at any
time over a period of three years from the date of the private placement.
The warrants were valued at $220,005 and were charged to additional
paid-in-capital.
|
|
z)
|
On
May 30, 2008, an option holder exercised options to purchase shares of the
Company's common stock for cash of $7,200 and the Company issued an
aggregate of 30,000 shares.
|
|
aa)
|
On
June 2, 2008, an option holder exercised options to purchase shares of the
Company's common stock for cash of $12,000 and the Company issued an
aggregate of 50,000 shares.
|
|
ab)
|
On
June 30, 2008, an option holder exercised options to purchase shares of
the Company's common stock for cash of $12,000 and the Company issued an
aggregate of 10,000 shares.
|
|
ac)
|
On
May 19, 2009 the Company entered into a purchase agreement to issue
2,857,143 shares of common stock at a price of $1.05 per share to an
institutional investor for total proceeds of $2,710,910, net of $289,090
stock issuance costs. The investor was also
issued:
|
|
1)
|
Series
I warrants to purchase 2,222,222 shares of common stock at a purchase
price of $1.05 per share at any time before September 3,
2009;
|
|
2)
|
Series
II warrants to purchase 1,866,666 shares of common stock at a purchase
price of $1.25 per share at any time from December 3, 2009 to June 5,
2012; and
|
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
|
3)
|
Series
III warrants to purchase 1,555,555 shares of common stock at a purchase
price of $1.50 per share at any time from December 3, 2009 to June 5,
2014.
|
These
warrants have been valued at $1,142,925 and recorded in additional
paid-in-capital. The closing costs included 142,857 warrants valued
at $35,398 and were recorded as a reduction of the gross proceeds. Series I
warrants to purchase 2,222,222 shares of common stock at a purchase price of
$1.05 per share have been expired.
|
ad)
|
On
June 9, 2009, the Company issued 1,833,341 shares of common stock and
862,246 warrants to purchase common stock at a purchase price of $1.05 per
share to existing stockholders pursuant to the anti-dilution protection
provisions of the private placements transacted on December 24, 2007 and
March 20, 2008. The warrants were valued at $169,985 and
recorded as a reduction in issuance proceeds of the May 19, 2009
transaction as described above.
|
|
ae)
|
On
September 4, 2009, an option holder exercised options to purchase shares
of the Company's common stock for cash of $3,600 and the Company issued an
aggregate of 15,000 shares.
|
|
af)
|
On
September 21, 2009, the Company issued 3,102,837 shares of common stock at
a purchase price of $1.13 per share to an institutional investor for total
proceeds of $3,371,341, net of $128,659 stock issuance
costs.
|
|
ag)
|
During
the nine month period ended September 30, 2009, the Company sold all of
its marketable securities for which it previously recorded an unrealized
loss of ($550,480) to accumulated other comprehensive (loss) at December
31, 2008. The sale of the Company’s investments in marketable
securities resulted in a realized gain of $11,025 during the nine month
period ended September 30, 2009.
|
11.
|
Stock-Based
Compensation
|
On August
5, 2003, the Company established a stock option plan (the
“Plan”). Under the Plan, the Company grants stock options to key
employees, directors and consultants of the Company. For all grants
prior to September 12, 2005 and grants to employees of the Company after
September 12, 2005, the vesting period is 30% on the first anniversary of the
grant date, an additional 30% on the second anniversary and the remaining 40% on
the third anniversary. Options expire between 5 and 10 years from the
date of grant.
For
grants to non-employee consultants of the Company after September 12, 2005, the
vesting period is between 1 to 3 years, subject to the fulfillment of certain
conditions in the individual stock option grant agreements, or 100% upon the
occurrence of certain events specified in the individual stock option grant
agreements. Options authorized for issuance under the Plan total
17,000,000 after giving effect to an amendment to the Plan approved at the
Annual Meeting of the Stockholders of the Company on June 2,
2006. At September 30, 2009, 8,837,500 shares of common stock
were available for issuance.
Prior to
adoption of the plan, the Company made restricted stock
grants. During 2003 all existing restricted stock grants were
converted to stock options. The converted options maintained the same
full vesting period as the original restricted stock grants.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
Accounting
for Employee Awards
The
Company's results of operations for the three and nine months ended September
30, 2009 include share-based employee compensation expense totaling $141,009 and
$473,791, respectively and for the three and nine months period ended September
30, 2008, include share-based employee compensation expense totaling $59,325 and
$174,122, respectively. Such amounts have been included in the Statements of
Operations in general and administrative and research and development
expenses. No income tax benefit has been recognized in the Statements
of Operations for share-based compensation arrangements as the Company has
provided for a 100% valuation allowance on its deferred tax assets.
Employee
stock option compensation expense is the estimated fair value of options granted
amortized on a straight-line basis over the requisite vesting service period for
the entire portion of the award.
Accounting
for Non-Employee Awards
Stock
compensation expenses related to non-employee options were $6,057 and $15,303
for the three and nine months period ended September 30, 2009 and $19,766 and
$223,880 for the three and nine months period ended September 30,
2008. Such amounts have been included in the Statements of Operations
in general and administrative and research and development
expenses.
Summary
of Stock Compensation Expenses Recognized
Total
stock-based compensation recognized by the Company in the nine months ended
September 30, 2009 and 2008, and the period from inception (March 19, 2001) to
September 30, 2009, all of which relates to stock options and warrants, is as
follows:
September
30,
|
September
30,
|
Inception
(March 19, 2001) to
September
30, 2009
|
||||||||||
2009
|
2008
|
|||||||||||
Income
statement line item:
|
||||||||||||
General
and administrative
|
||||||||||||
Payroll
|
$ | 339,960 | $ | 27,600 | $ | 1,497,038 | ||||||
Consulting
and other professional fees
|
15,278 | 134,448 | 749,298 | |||||||||
Research
and development:
|
||||||||||||
Payroll
|
133,831 | 146,523 | 811,049 | |||||||||
Consulting
and other professional fees
|
25 | 88,431 | 1,288,543 | |||||||||
Total
|
$ | 489,094 | $ | 397,002 | $ | 4,345,928 |
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
Summary
of Stock Option Transactions
There
were 30,000 stock options granted at an exercise price of $1.05 with a fair
value of $6,989 and 100,000 stock options granted at an exercise price of $1.28
with a fair value of $100,769 during the nine months ended September 30,
2009. A total of 750,000 stock options were granted in the same
period last year. The fair value of options at the date of grant was estimated
using the Black-Scholes option pricing model. The expected volatility is based
upon historical volatility of the Company's stock. The expected term is based
upon the simplified method.
The
assumptions made in calculating the fair values of options are as
follows:
Nine
Months Ended
September
30,
|
||||||||
2009
|
2008
|
|||||||
Black-Scholes
weighted average assumptions:
|
||||||||
Expected
dividend yield
|
- | - | ||||||
Expected
volatility
|
106%-108 | % | 100% - 114 | % | ||||
Risk
free interest rate
|
0.56%-2.55 | % | 1.60%-4.99 | % | ||||
Expected
term (in years)
|
0.71
- 5 years
|
0.52
- 5 years
|
The
following table summarizes the employee and non-employee share-based
transactions:
2009
|
2008
|
|||||||||||||||
Shares
Subject
to
Options
|
Weighted
Avg.
Option
Prices
|
Shares
Subject
to
Options
|
Weighted
Avg.
Option
Prices
|
|||||||||||||
Outstanding
at January 1st
|
7,760,795 | $ | 1.01 | 6,045,795 | $ | 0.97 | ||||||||||
Granted
|
130,000 | 1.23 | 750,000 | 1.71 | ||||||||||||
Exercised
|
(15,000 | ) | 0.24 | (90,000 | ) | 0.35 | ||||||||||
Cancelled
|
(55,000 | ) | 1.29 | (50,000 | ) | 1.34 | ||||||||||
Outstanding
at September 30th
|
7,820,795 | $ | 1.00 | 6,655,795 | $ | 1.05 |
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
The
following table summarizes information about stock options outstanding as of
September 30, 2009 and 2008:
Shares
Subject
to Options
|
Weighted
Avg. Option
Prices
|
Weighted
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at September 30, 2009
|
7,820,795 | $ | 1.00 |
6.3
years
|
$ | 921,509 | |||||||
Exercisable
at September 30, 2009
|
5,882,795 | $ | 0.99 |
5.7
years
|
$ | 796,509 |
Shares
Subject
to Options
|
Weighted
Avg.
Option
Prices
|
Weighted
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at September 30, 2008
|
6,655,795 | $ | 1.05 |
7.0
years
|
$ | 2,655,485 | |||||||
Exercisable
at September 30, 2008
|
4,996,795 | $ | 1.11 |
6.5
years
|
$ | 2,486,567 |
As of
September 30, 2009 and 2008, there was $2,030,132 and $1,851,934 of total
unrecognized compensation cost, respectively, related to all unvested stock
options, which is expected to be recognized over a weighted average vesting
period of 1.91 years and 1.68 years, respectively.
12.
|
Income
Taxes
|
No
provision for Federal or state income taxes was required for the period ended
September 30, 2009, due to the Company’s operating losses. At
September 30, 2009, the Company has unused net operating loss carry-forwards of
approximately $34,411,000 which expire at various dates through
2029. Most of this amount is subject to annual limitations under
certain provisions of the Internal Revenue Code related to “changes in
ownership”.
As of
September 30, 2009, the deferred tax assets related to the aforementioned
carry-forwards have been fully offset by valuation allowances, since utilization
of such amounts is not presently expected in the foreseeable
future.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
Deferred
tax assets and valuation allowances consist of:
September
30,
2009
|
December
31,
2008
|
|||||||
Net
operating loss carry-forwards
|
$ | 13,076,379 | $ | 11,364,336 | ||||
Valuation
allowance
|
(13,076,379 | ) | (11,364,336 | ) | ||||
Net
deferred tax assets
|
$ | - | $ | - |
We file
income tax returns in the U.S. federal and Maryland state
jurisdictions. Tax years for fiscal 2006 through 2008 are open and
potentially subject to examination by the federal and Maryland state taxing
authorities.
13.
|
Commitments
and Contingencies
|
|
a)
|
The
Company has contracted with various vendors to provide research and
development services. The terms of these agreements usually require an
initiation fee and monthly or periodic payments over the term of the
agreement, ranging from 6 months to 24 months. The costs to be incurred
are estimated and are subject to revision. As of September 30, 2009, the
total contract value of these agreements was approximately $5,469,993 and
the Company had made payments totaling $3,527,100 under the terms of the
agreements as of September 30, 2009. All of these agreements
may be terminated by either party upon appropriate notice as stipulated in
the respective agreements.
|
|
b)
|
The
Company and three of its key executives entered into employment
agreements. Each of these agreements was renewed on August 10, 2009 and
expire on August 10, 2012. The agreements result in annual
commitments of $200,000, $350,000 and
$250,000.
|
|
c)
|
Regulation
by governmental authorities in the United States and in other countries
constitutes a significant consideration in our product development,
manufacturing and marketing strategies. The Company expects that all drug
candidates will require regulatory approval by appropriate governmental
agencies prior to commercialization and will be subjected to rigorous
pre-clinical, clinical, and post-approval testing, as well as to other
approval processes by the FDA and by similar health authorities in foreign
countries. United States federal regulations control the ongoing safety,
manufacture, storage, labeling, record keeping, and marketing of all
biopharmaceutical products intended for therapeutic purposes. The Company
believes that it is in compliance in all material respects with currently
applicable rules and regulations.
|
|
d)
|
On
August 19, 2008, the Company entered into an agreement with KCSA Strategic
Communications (“KCSA”) for KCSA to provide investor relations services to
the Company. Under this agreement, the Company agreed to a
monthly fixed retainer amount of $7,000 commencing on August 19,
2008. In December 2008, the monthly retainer was reduced to
$4,000 per month. In accordance with the agreement, the
contract may be terminated by either party upon 30 days prior written
notice to the other party.
|
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
|
e)
|
On
April 6, 2009, the Company entered into an agreement with Rodman &
Renshaw, LLC (“Rodman”) for Rodman to serve as placement agent for the
Company. Under this agreement, the Company agreed to pay a cash
fee to Rodman immediately upon the closing of the placement equal to 6% of
the aggregate gross proceeds raised in the placement plus a cash fee
payable immediately on each exercise of the warrants issued to the
purchasers in the placement that are solicited by Rodman equal to 6% of
the aggregate proceeds received by the Company in connection with such
exercise; and such number of warrants (the “Rodman Warrants”) issuable to
Rodman or its designees at the closing to purchase shares of common stock
equal to 5% of the aggregate number of shares sold in the
placement. In accordance with the agreement, the contract ended
on July 31, 2009. The Company paid $180,000 and issued the
placement agent warrants to purchase up to an aggregate of 142,857 shares
of our common stock at an exercise price of $1.3125 per
share.
|
|
f)
|
On
April 20, 2009, Amarex, LLC filed suit against us in the Circuit Court of
Montgomery County, Maryland, seeking damages for an alleged breach of a
contract between the Company and Amarex, LLC entered into on January 6,
2006. Amarex, LLC claims damages of $93,156 plus
interest. On May 22, 2009, the Company filed an answer and an
affirmative defense to the complaint denying the claims of damages made by
Amarex, LLC. On June 16, 2009, the Company filed a counterclaim
against Amarex, LLC for breach of the same contract in the amount of
$354,824 plus interest.
|
|
g)
|
On
April 27, 2009, we added a Change Order to the original Single Service
Agreement, dated March 15, 2006 with Aptuit, Inc. for packaging and
labeling of Archexin™ for our Phase II pancreatic cancer
study. The total cost of the Change Order is $16,800, none of
which was paid as of September 30,
2009.
|
|
h)
|
On
May 4, 2009, the NYSE Amex (the “Exchange”) accepted the Company’s
proposed compliance plan which addresses how the Company intends to regain
compliance with the continued listing standards within a maximum of 18
months. On
July 7, 2009, the Company received a notice from the Exchange indicating
that it had regained compliance with the requirements of the NYSE Amex
Company Guide for the continued listing of its common stock on the
Exchange, and that its common stock therefore was no longer subject to
delisting.
|
|
i)
|
On
May 21, 2009, the Company entered into a 1 year agreement to use lab space
commencing on July 1, 2009. The Company agreed to pay monthly
payments of $4,594 from October 1, 2009 to June 30, 2010. The
agreement shall terminate on June 30, 2010 and may be renewed for two
additional terms of one year upon 60 days prior to the expiration of the
agreement.
|
|
j)
|
On
May 22, 2009, we were notified by the Financial Industry Regulatory
Authority (“FINRA”) that FINRA, on behalf of the NYSE Amex, is conducting
a review of trading in our common stock surrounding the May 12, 2009
announcement of the results of an animal study that further demonstrates
that our drug candidate Zoraxel is a potential new-class of therapeutic
for the effective treatment of sexual dysfunction. On October 9, 2009,
FINRA notified the Company that it has closed the review of the trading
activity without further action.
|
|
k)
|
On
June 10, 2009, we entered into a Research Services Agreement with
University of Maryland, Baltimore to evaluate melanoma
research. The total cost of these services is $27,951, of which
$20,964 was paid as of September 30,
2009.
|
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
|
l)
|
On
June 16, 2009, we contracted with Baptist Cancer Institute as a clinical
site for our Phase IIa clinical study for Archexin(TM) for pancreatic
cancer. The estimated cost for the study is $83,250, none of
which was paid as of September 30,
2009.
|
|
m)
|
On
June 22, 2009, we entered into a License Agreement with 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 September 30, 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.
|
|
n)
|
On
June 26, 2009, the Company entered into a securities purchase agreement
with Teva Pharmaceutical Industries Limited
(“Teva”). Contemporaneous with the execution and delivery of
this agreement, the parties executed a research and exclusive license
option agreement (“RELO”) pursuant to which the Company shall use
$2,000,000 of the gross proceeds of the issuance and sale of shares to
Teva to fund a research and development program for the pre-clinical
development of RX-3117 and has included this amount in restricted cash
equivalents. The Company will be eligible to receive royalties
on net sales of RX-3117 worldwide. As at September 30, 2009, no
work has been started on the RX-3117 research and development
program.
|
|
o)
|
On
June 29, 2009, the Company signed a five year lease for 5,466 square feet
of office space in Rockville, Maryland commencing on June 29,
2009. The lease requires annual base rents of $76,524 with
increases over the next five years. Under the leasing agreement, the
Company pays its allocable portion of real estate taxes and common area
operating charges. Rent paid under the Company’s former lease
during the nine months period ended September 30, 2009 was $112,973 (2008
- $132,104).
|
Future
rental payments over the next five years and thereafter are as
follows:
2009
|
$ | 52,044 | ||
2010
|
135,982 | |||
2011
|
148,593 | |||
2012
|
158,835 | |||
2013
|
162,806 | |||
Thereafter
|
82,408 | |||
$ | 740,668 |
In
connection with the lease agreement, the Company issued a letter of credit of
$100,000 in favor of the lessor. The Company has restricted cash
equivalents of the same amount for the letter of credit.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
14.
|
Fair
Value Measurements
|
The
Company adopted Statement of Financial Accounting Standards (“FAS”) No.157,
“Fair Value Measurements” (“FAS 157”) as of January 1, 2008. FAS 157
defines fair value as the price that would be received to sell an asset or paid
to transfer a liability in an orderly transaction between market participants at
the measurement date, not adjusted for transaction costs. FAS 157 also
establishes a fair value hierarchy that prioritizes the inputs to valuation
techniques used to measure fair value into three broad levels giving the highest
priority to quoted prices in active markets for identical assets or liabilities
(Level 1) and the lowest priority to unobservable inputs (Level 3).
The three
levels are described below:
|
Level
1 Inputs —
|
Unadjusted
quoted prices in active markets for identical assets or liabilities that
is 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.
|
The
Company determines fair values for its financial assets as follows:
The
following tables present our assets and liabilities that are measured at fair
value on a recurring basis and are categorized using the fair value hierarchy.
The fair value hierarchy has three levels based on the reliability of the inputs
used to determine fair value.
Fair
Value Measurements as of September 30, 2009
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Restricted
cash equivalents
|
$ | 2,100,533 | $ | 2,000,533 | $ | 100,000 | - | |||||||||
Total
Assets
|
$ | 2,100,533 | $ | 2,000,533 | $ | 100,000 | $ | - |
As of
September 30, 2009, the Company’s restricted cash equivalents, comprises of the
following:
|
a)
|
monies
held in money market in accordance with the RELO agreement, as discussed
in noted 13, and classified within level 1 of the fair value hierarchy;
and
|
|
b)
|
a
certificate of deposit and valued based upon the underlying terms of a
letter of credit, as discussed in note 13, and classified within level 2
of the fair value hierarchy
|
(A
Development Stage Company)
Notes to
Condensed Financial Statements
Nine
Months Ended September 30, 2009 and 2008
(Unaudited)
Fair
Value Measurements as of December 31, 2008
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
State
Authority Auction Rate Bonds
|
$ | 2,999,750 | - | $ | 2,999,750 | - | ||||||||||
Total
Assets
|
$ | 2,999,750 | $ | - | $ | 2,999,750 | $ | - |
As of
December 31, 2008, the investments, at fair value, consists of state authority
auction rate bonds which are valued at market and classified within level 2 of
the fair value hierarchy.
15.
|
Subsequent
Events
|
On
October 26, 2009, the Company received gross proceeds of $5,000,000 for the sale
to five institutional investors of 6,072,383 shares of common stock at $0.8234
per share and warrants to buy an additional 2,125,334 shares of common stock at
an exercise price of $1.00 per share. Rodman acted as the exclusive
placement agent for this transaction and received warrants to purchase 245,932
shares of common stock at an exercise price of $1.029 per share. The
Company is planning to use the proceeds from the offering for research and
development and general corporate purposes. The Company will have
71,924,496 shares outstanding.
Item 2
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
OVERVIEW
Our
efforts and resources have been focused primarily on acquiring and developing
our pharmaceutical technologies, raising capital and recruiting
personnel. We are a development stage company and have no product
sales to date and we will not generate any product sales until we receive
approval from the Food and Drug Administration (the “FDA”) or equivalent foreign
regulatory bodies to begin selling our pharmaceutical candidates. Our
major sources of working capital have been proceeds from various private
financings, primarily private sales of common stock and debt securities, and
collaboration agreements with our strategic investors.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
The
following discussion should be read in conjunction with the unaudited condensed
consolidated financial statements and notes thereto set forth in Item 1 of
this Quarterly Report. This Quarterly Report contains statements
accompanied by such phrases as "believe", "estimate", "expect", "anticipate",
"may", "intend" and other similar expressions, that are "forward-looking
statements" as defined in the Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those projected as a
result of certain risks and uncertainties, including but not limited to the
following:
|
—
|
our
lack of profitability and the need for additional capital to operate our
business;
|
|
—
|
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;
|
|
—
|
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”).
|
These
forward-looking statements are made only as of the date hereof, and we undertake
no obligation to update or revise the forward-looking statements, whether as a
result of new information, future events or otherwise. The safe
harbors for forward-looking statements provided by the Private Securities
Litigation Reform Act are unavailable to issuers of "penny
stock". Our shares may be considered a penny stock and, as a result,
the safe harbors may not be available to us.
CRITICAL
ACCOUNTING POLICIES
A
"critical accounting policy" is one which is both important to the portrayal of
our financial condition and results and requires our management's most
difficult, subjective or complex judgments, often as a result of the need to
make estimates about the effect of matters that are inherently
uncertain. Our accounting policies are in accordance with United
States generally accepted accounting principles, or GAAP, and their basis of
application is consistent with that of the previous year.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted
accounting principles (“GAAP”) requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and the
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. These estimates are based on management's best
knowledge of current events and actions the Company may undertake in the future.
Actual results may ultimately differ from those
estimates. These estimates are reviewed periodically and as
adjustments become necessary, they are reported in earnings in the period in
which they become available.
RECENTLY
ISSUED ACCOUNTING STANDARDS
In
April 2009, the Financial Accounting Standards Board (the “FASB”) issued
authoritative guidance to require that assets acquired and liabilities assumed
in a business combination that arise from contingencies be recognized at fair
value if fair value can be reasonably determined. If the fair value of
such assets or liabilities cannot be reasonably determined, then they would
generally be recognized in accordance with certain other pre-existing accounting
standards. This guidance also amends the subsequent accounting for assets
and liabilities arising from contingencies in a business combination and certain
other disclosure requirements. This guidance becomes effective for assets
or liabilities arising from contingencies in business combinations that are
consummated during the Company’s fiscal 2010 and it is not expected to have an
impact on the Company’s September 30, 2009 interim financial
statements.
In
June 2009, the FASB issued authoritative guidance to eliminate the
exception to consolidate a qualifying special-purpose entity, change the
approach to determining the primary beneficiary of a variable interest entity
and require companies to more frequently re-assess whether they must consolidate
variable interest entities. Under the new guidance, the primary
beneficiary of a variable interest entity is identified qualitatively as the
enterprise that has both (a) the power to direct the activities of a
variable interest entity that most significantly impact the entity’s economic
performance, and (b) the obligation to absorb losses of the entity that
could potentially be significant to the variable interest entity or the right to
receive benefits from the entity that could potentially be significant to the
variable interest entity. This guidance becomes effective for the
Company’s fiscal 2011 year-end and interim reporting periods thereafter.
The Company does not expect this guidance to have a material impact on its
financial statements.
In
June 2009, the FASB established the FASB Accounting Standards
CodificationTM (the “Codification”) as the single source of authoritative
U.S. generally accepted accounting principles recognized by the FASB to be
applied by nongovernmental entities. Rules and interpretive releases
of the SEC under authority of federal securities laws are also sources of
authoritative U.S. GAAP for SEC registrants. The Codification did not have
a material impact on the Company’s financial statements upon adoption.
Accordingly, the Company’s notes to the financial statements will explain
accounting concepts rather than cite the topics of specific U.S.
GAAP.
RESULTS
OF OPERATIONS
Comparison
of Three Months and Nine Months Ended September 30, 2009 and
2008:
Total
Revenues
For each
of the three and nine month periods ended September 30, 2009, we recorded
revenues of $18,750 and $56,250, respectively. We recorded the same
amounts in the periods of 2008. In all periods, the revenue reflects
the recognition of deferred revenue from a collaborative research agreement with
Rexgene Biotech Co., Ltd., a minority stockholder.
General
and Administrative Expenses
General
and administrative expenses consist primarily of salaries and related personnel
and stock option compensation expenses for executive, finance and other
administrative personnel, recruitment expenses, professional fees and other
corporate expenses, including business development and general legal
activities.
General
and administrative expenses increased $78,699, or 12.2%, to $724,067 for the
three months ended September 30, 2009 from $645,368 for the three months ended
September 30, 2008. General and administrative expenses increased
$391,985, or 20.7% to $2,285,804 for the nine months ended September 30, 2009
from $1,893,819 for the nine months ended September 30, 2008. The
increase in both periods was primarily due to higher stock option compensation,
investor relation expenses, audit fees, including fees to comply with
Sarbanes-Oxley, and investor relation expenses.
Research
and Development Expenses
Research
and development expenses consist primarily of salaries and related personnel
costs, fees paid to consultants and outside service providers for laboratory
development and other expenses relating to the design, development, testing, and
enhancement of our drug candidates. We expense our research and
development costs as they are incurred.
Research
and development expenses decreased $143,296, or 25.2%, to $424,609 for the three
months ended September 30, 2009 from $567,905 for the three months ended
September 30, 2008. The decrease was primarily due to a decrease of
clinical studies for our drug candidates, drug manufacturing, and lab
supplies. Research and development expenses increased $599,689, or
42.3%, to $2,018,766 for the nine months ended September 30, 2009 from
$1,419,077 for the nine months ended September 30, 2008. The
increase was primarily due to an increase of multiple clinical studies for our
drug candiates.
Patent
Fees
Our
patent fees increased $50,044, or 86.9%, to $107,618 for the three months ended
September 30, 2009 from $57,574 for the three months ended September 30,
2008. Patent fees increased $94,643, or 57.8%, to $258,421 for the
nine months ended September 30, 2009 from $163,778 for the nine months ended
September 30, 2008. The increases in both periods were primarily due
to the filing of additional patent applications and documentation and attorney
fees related to the increased filings.
Interest
Income
Interest
income decreased $34,715, or 66.6%, to $17,407 for the three months ended
September 30, 2009 from $52,122 for the three months ended September 30,
2008. Interest income decreased $187,930, or 85.3%, to $32,309 for
the nine months ended September 30, 2009 from $220,239 for the nine months ended
September 30, 2008. The decreases in both periods were primarily due
to decrease in interest-bearing investments and lower interest
rates.
Depreciation
and Amortization
Depreciation
and amortization expenses increased by $3,417, or 24.6%, to $17,292 for the
three months ended September 30, 2009 from $13,875 for the three months ended
September 30, 2008. The increase was primarily due to higher
amortization recorded on equipment due to new additions. Depreciation and
amortization expenses increased $64, or 0.2%, to $41,638 for the nine months
ended September 30, 2009 from $41,574 for the nine months ended September 30,
2008.
Net
Loss
As a
result of the above, the net loss for the three months and nine months ended
September 30, 2009 was $1,237,429 and $4,505,045, respectively, or $0.02 and
$0.08 per share, respectively, compared to a net loss of $1,213,850 and
$3,264,124, respectively, or $0.02 and $0.06 per share, respectively, for the
three months and nine months ended September 30, 2008.
Research
and Development Projects
Research
and development costs are expensed as incurred. Research and
development expenses consist primarily of salaries and related personnel costs,
costs to acquire pharmaceutical products and product rights for development and
amounts paid to contract research organizations, hospitals and laboratories for
the provision of services and materials for drug development and clinical
trials. Costs incurred in obtaining the license rights to technology
in the research and development stage and that have no alternative future uses
are expensed as incurred. Our research and development programs are
related to our three clinical stage lead drug candidates, Archexin™, Serdaxin™
and Zoraxel™ and pre-clinical stage oncology drug candidates RX-0183, RX-3117
and RX-5902. Each of our lead drug candidates is in various stages of
completion as described below. As we expand our clinical studies, we
will enter into additional development agreements. Significant
additional expenditures will be required if we complete our clinical trials,
start new trials, apply for regulatory approvals, continue development of our
technologies, expand our operations and bring our products to
market. The eventual total cost of each clinical trial is dependent
on a number of uncertainties such as trial design, the length of the trial, the
number of clinical sites and the number of patients. The process of
obtaining and maintaining regulatory approvals for new therapeutic products is
lengthy, expensive and uncertain. Because the successful development
of our most advanced drug candidates, Archexin™, Serdaxin™ and Zoraxel™, is
uncertain, and because RX-0183, RX-3117 and RX-5902 are in early-stage
development, we are unable to estimate the costs of completing our research and
development programs, the timing of bringing such programs to market and,
therefore, when material cash inflows could commence from the sale of these drug
candidates. If these projects are not completed as planned, our
results of operations and financial condition could be negatively affected and
if we are unable to obtain additional financing to fund these projects, we may
not be able to continue as a going concern.
Archexin™
In
October 2006, we announced the conclusion of the Phase I clinical trial of
Archexin™, our leading drug candidate. The costs incurred for the
clinical trial were approximately $1,500,000.
The Phase
I clinical trial of Archexin™, which took place at Georgetown University's
Lombardi Cancer Center beginning in September 2004 and at the University of
Alabama at Birmingham beginning in August 2005, was primarily to determine the
safety and tolerability of the drug in patients with advanced
cancer. As the main purpose of the clinical trial was to establish
the safety of Archexin ™, the parameters that determined the completion of this
project were a direct function of the safety profile of this compound in
humans. As this was the first time that Archexin™ had been
administered to humans, the safety profile in humans was unknown and, therefore,
the number of doses required to determine the dosage at which the FDA safety
endpoints would be met was estimated.
The Phase
II clinical trial of Archexin™ began in the third quarter of 2007 in patients
with advanced renal cell carcinoma who have failed previous
treatments. The trial is the first of multiple trials planned for
Archexin™. Phase II clinical trials for pancreatic cancer began in
the first quarter of 2009. We estimate that the Phase II trials of
each indication will be completed in 2010 and will require approximately
$5,000,000. In January 2005, we received "orphan drug designation" from the FDA
for Archexin™ for five cancer indications, including renal cell carcinoma,
ovarian cancer, glioblastoma, stomach cancer, and pancreatic
cancer. The orphan drug program is intended to provide patients with
faster access to drug therapies for diseases and conditions that affect fewer
than 200,000 people. Companies that receive orphan drug designation
are provided an accelerated review process, tax advantages, and seven years of
market exclusivity in the United States. In the future, we plan to
apply Archexin™ to the treatment of other orphan indications and other
cancers.
Serdaxin™
SerdaxinTM is
being developed to treat depression and mood disorders, and has proven and
well-established safety in humans. Phase II trials began in the first
quarter of 2009. We currently estimate that Phase II trials will
require $2,000,000 through the end of 2011.
Zoraxel™
Zoraxel™
is a CNS-based sexual dysfunction drug that has extensive and excellent safety
in humans. Zoraxel™ entered Phase II trials in the first half of
2008. We currently estimate that these studies will require approximately
$1,500,000 through the end of 2010.
Pre-clinical
pipeline
Our early
stage cancer candidates, RX-0183, RX-3117 and RX-5902 are in a pre-clinical
stage of development and the next scheduled program for each compound is a
pre-clinical toxicology study required prior to submission of an Investigational
New Drug ("IND") application to the FDA. The estimated cost to complete
pre-clinical toxicology and Phase I clinical trials is estimated to be
approximately $1,500,000 per each compound for a total of
$4,500,000. Pursuant to a research and exclusive license option with
Teva Pharmaceutical Industries Limited (“Teva”), the Company must use $2 million
of the gross proceeds from the issuance and sale of shares of common stock to
Teva to fund a research and development program for the pre-clinical development
and drug manufacturing of RX-3117. These compounds may enter Phase I
clinical trials in 2010.
The
conduct of the clinical trial and toxicology studies described above are being
accomplished in conjunction with third-party clinical research organizations, or
CROs, at external locations. This business practice is typical for
the pharmaceutical industry and companies like us. As a result, the
risk of completion or delay of these studies is not within our direct control
and a program delay may occur due to circumstances outside our
control. A delay in any of these programs may not necessarily have a
direct impact on our daily operations. However, to the extent that a
delay may result in additional cost, a higher than expected expense may
result.
We will
need to raise additional money through debt offerings, equity offerings and
research funding from outside parties in order to continue to develop our drug
candidates. If we are not able to raise sufficient additional money,
we will have to severely reduce our research and development
activities. We will first stop research and development activities
associated with our preclinical compounds. To the extent necessary,
we will then reduce our research and development activities related to some or
all of our clinical drugs and may also reduce our general and administrative
expenses.
LIQUIDITY
AND CAPITAL RESOURCES
Cash used
in operating activities was $3,758,540 for the nine months ended September 30,
2009 compared to cash used in operating activities of $3,120,970 for the same
period ended September 30, 2008. The operating cash flows during
the nine months ended September 30, 2009 reflect our loss from operations of
$4,505,045 and a net increase in cash components of working capital and non-cash
charges totaling $746,505.
Cash
provided by investing activities of $1,444,917 during the nine months ended
September 30, 2009 consisted of $2,100,533 classified as restricted cash
equivalents, $15,805 used in the purchase of equipment, $1,196,824 used in the
purchase of marketable securities and $4,758,079 from the proceeds from the
sales of marketable securities. Cash used in investing activities was
$1,398,292 during the nine months ended September 30, 2008.
Cash
provided by financing activities of $6,085,851 during the nine months ended
September 30, 2009 consisted of net proceeds from the offering of units and the
issuance of common stock.
For the
nine months ended September 30, 2009, we experienced net losses of
$4,505,045. Our accumulated deficit as of September 30, 2009 was
$34,411,524.
The
Company has not yet generated commercial sales revenue and has been able to fund
its operating losses to date through the sale of its common stock, convertible
debt financings, interest income from investments of cash and cash equivalents
and proceeds from reimbursed research and development costs. During
the nine months ended September 30, 2009, we had a net increase in cash and cash
equivalents of $3,772,228. Total cash as of September 30, 2009 were
$4,141,358 compared to $369,130 as of December 31, 2008. The Company believes
that its existing cash will be sufficient to cover its cash flow requirements
through September 30, 2010. Management has the capability of managing
the Company’s operations within existing cash and marketable securities
available by reducing research and development activities and general and
administrative expenses. This may result in slowing down clinical
studies, but will conserve the Company’s cash to allow it to operate for the
next twelve months.
On
October 26, 2009, the Company received gross proceeds of $5,000,000 for the sale
to five institutional investors of 6,072,383 shares of common stock at $0.8234
per share and warrants to buy an additional 2,125,334 shares of common stock at
an exercise price of $1.00 per share. Rodman acted as the exclusive
placement agent for this transaction and received warrants to purchase 245,932
shares of common stock at an exercise price of $1.029 per share. The
Company is planning to use the proceeds from the offering for research and
development and general corporate purposes. Upon completion of the
offering on October 26, 2009, the Company had 71,924,496 shares outstanding and
stockholders' equity in excess of $9 million.
CONTRACTUAL
OBLIGATIONS
Contractual
Obligations
On
October 2, 2003, we contracted with Amarex, LLC to conduct Phase I clinical
studies for Archexin™ (then RX-0201). Of the $239,337 to be paid
under this contract, $194,461 was paid as of September 30, 2009. The
balance will be paid when the final report is accepted, which is expected to be
in 2009. Since 2003, additional services were added to the
study. These services were contracted for $200,043, all of which was
paid as of September 30, 2009.
On
January 6, 2006, we contracted with Amarex, LLC to conduct Phase II clinical
studies for Archexin™. In accordance with the agreement, the
estimated contract duration is 24 months for a total cost of $596,244 plus pass
through expenses. The service costs are payable in 24 monthly
payments of $18,633 plus an up front payment of $149,061 due upon
signing. In 2007, we added additional services to the Phase II
clinical studies. The cost of these services totals $106,220,
all of which was paid as of December 31, 2008. We paid $614,876
towards the cost of the study as of September 30, 2009. On April 20,
2009 Amarex, LLC filed a lawsuit against us for breach of contract claims due to
a billing dispute. On May 22, 2009, the Company filed an answer and
an affirmative defense to the complaint denying the claims of damages made by
Amarex, LLC. On June 16, 2009, the Company filed a counterclaim against
Amarex, LLC for breach of the same contract in the amount of $354,824 plus
interest.
From
April 3, 2006 through 2009, we have contracted with UPM Pharmaceuticals, Inc. to
develop several release formulations for Serdaxin™ and Zoraxel™ drug
manufacturing. In accordance with the agreements, the estimated total
cost is $1,179,480, of which $883,230 was paid as of September 30,
2009. The service costs are payable based upon a payment schedule
related to certain milestones.
On May
18, 2007, we contracted with LabConnect to provide sample management and central
laboratory services for Phase II clinical studies for Archexin™. The
total amount of the original contract was estimated to be
$197,220. On March 16, 2009, we entered into a new contract that
replaces the May 18, 2007 contract. The total amount to be paid is
estimated to be $133,914, of which $59,277 (including $36,944 prepaid from the
previous contract) was paid as of September 30, 2009.
On June
13, 2007, we contracted with Formatech to test the stability of the Archexin™
package. The total amount to be paid for this contract is $21,500, of
which $14,500 was paid in 2007. The balance will be paid when the
final report is submitted, which is expected to be in 2010.
On April
14, 2008, we contracted with Myron I Murdock M.D. LLC as a clinical site for our
12 month Phase IIa erectile dysfunction study for Zoraxel™. The
estimated amount of this contract, without lab costs, is $104,559, of which
$47,210 was paid as of September 30, 2009.
On April
15, 2008, we entered into a 24 month contract with Radiant Development CRO to
manage clinical trials for our Phase IIa erectile dysfunction study for
Zoraxel™. The total contract amount is estimated to be $125,629, of
which $125,629 was paid as of September 30, 2009.
On May 6,
2008, we contracted with Delaware Valley Urology, LLC as a clinical site for our
Phase IIa erectile dysfunction study for Zoraxel™. In accordance with
the agreement, the estimated contract duration is 17 months for an estimated
cost of $57,365, with lab costs included. A total of $47,596 has been
paid as of September 30, 2009.
On
September 5, 2008, we contracted with Radiant Research - Greer as a clinical
site for our Phase IIa clinical study for Zoraxel™ for erectile
dysfunction. The initial estimated cost for the 12 month study was
$62,532, of which $128,510 was paid as of September 30, 2009. The
study exceeded the initial estimated cost. We estimate that the cost
for the study will be $130,000.
On
December 23, 2008, we entered into a 12 month contract with Radiant Development
CRO to manage clinical trials for our Phase IIa major depressive disorder study
for Serdaxin™. The total contract amount is estimated to be $169,343,
of which $131,970 was paid as of September 30, 2009.
On
December 29, 2008, we contracted with LabConnect to provide sample management
and central laboratory services for Phase II clinical studies for
Serdaxin™. The total of the contract amount is estimated to be
$35,899, of which $46,942 was paid as of September 30, 2009. The
study exceeded the initial estimated cost. We estimate that the cost
for the study will be $47,000.
On
January 7, 2009, we contracted with Atlanta Center for Medical Research as a
clinical site for our Phase IIa clinical study for Serdaxin™ for major
depressive disorder. The estimated cost for the 18 month study has
increased from $167,713 to $303,922, of which $258,369 was paid as of September
30, 2009.
On
January 9, 2009, we contracted with Radiant Research - Denver as a clinical site
for our Phase IIa clinical study for Serdaxin™ for major depressive
disorder. The estimated cost for the 18 month study has increased
from $131,600 to $142,800, of which $111,901 was paid as of September 30,
2009.
On
February 5, 2009, we contracted with Capital Clinical Research Associates, LLC
as a clinical site for our Phase IIa clinical study for Serdaxin™ for major
depressive disorder. The estimated cost for the 18 month study has
increased from $129,568 to $168,314, of which $134,616 was paid as of September
30, 2009.
On March
18, 2009, we contracted with SIRO Clinpharm Pvt. Ltd and SIRO Clinpharm, USA to
manage clinical trials for our Phase II pancreatic cancer study for
Archexin™. The estimated cost for the study has increased from
$362,708 to $608,961, of which $108,821 was paid as of September 30,
2009.
On May
21, 2009, we contracted with MEDCO for a one year license agreement to use lab
space at the Germantown Innovation Center commencing on July 1,
2009. The one year obligation is $41,346, of which $4,554 was paid as
of September 30, 2009.
On June
5, 2009, we signed a 5-year lease with The Realty Associates Fund V, L.P. for
5,466 square feet of office space in Rockville, Maryland commencing June 2009.
The lease requires annual base rents of $76,524. Under the leasing
agreement, the monthly rent is $6,377 the first year, with increases over the
next five years. We also pay our allocable portion of real estate
taxes and common area operating charges.
On June
10, 2009, we entered into a Research Services Agreement with University of
Maryland, Baltimore to evaluate melanoma research. The total cost of
these services has increased from $27,951 to $55,902, of which $20,964 was paid
as of September 30, 2009.
On June
12, 2009, we contracted with Cirrus Pharmaceuticals, Inc. to test the solubility
of RX-8243. The cost for the study is $9,360, all of which was paid
as of September 30, 2009. On June 15, 2009, we entered into another
contract for the lipid extrusion of LIPO-ASO. The cost of the study
is $6,480, all of which was paid as of September 30, 2009.
On June
16, 2009, we contracted with Baptist Cancer Institute as a clinical site for our
Phase IIa clinical study for Archexin™ for pancreatic cancer. The
estimated cost for the study is $83,250, none of which was paid as of September
30, 2009.
On June
22, 2009, we entered into a License Agreement with KRICT to acquire 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 September 30, 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.
On June
26, 2009, we entered into a research and exclusive license option agreement with
Teva to use $2,000,000 of the gross proceeds of $3,500,000 from the issuance and
sale of shares to Teva on June 26, 2009 to fund a research and development
program for the pre-clinical development of RX-3117.
On June
29, 2009, we contracted with Almac Pharma Services for GMP drug manufacturing
for our Phase IIb clinical trial for Zoraxel™. The estimated cost for
the study is $45,472, of which $25,237 was paid as of September 30,
2009.
On August
15, 2009, we entered into a contract research agreement with NetQem, LLC for the
synthesis of RX-8243. The cost for the study is $17,800, of which
$8,914 was paid as of September 30, 2009.
CURRENT
AND FUTURE FINANCING NEEDS
We have
incurred negative cash flow from operations since we started our
business. We have spent, and expect to continue to spend, substantial
amounts in connection with implementing our business strategy, including our
planned product development efforts, our clinical trials, and our research and
development efforts. Based on our current plans and our capital
resources, we believe that our cash and cash equivalents will be sufficient to
enable us to meet our minimum planned operating needs for at least the next 12
months, which would entail focusing our resources on Phase II clinical trials of
Archexin™, Serdaxin™ and Zoraxel™.
Over the
next twelve months we expect to spend a minimum of approximately $2 million on
clinical development for Phase II clinical trials of Archexin™, Serdaxin™ and
Zoraxel™ (including our commitments described under "Contractual Obligations" of
this Item 2), $600,000 on development of our pre-clinical pipeline compounds,
$3.8 million on general corporate expenses, and approximately $170,000 on
facilities rent. Pursuant to a research and exclusive license option with Teva,
the Company must use $2 million of the gross proceeds from the issuance and sale
of shares of common stock to Teva to fund a research and development program for
the pre-clinical development of RX-3117. We will need to seek additional
financing to implement and fund other drug candidate development, clinical trial
and research and development efforts to the maximum extent of our operating
plan, including in-vivo animal and pre-clinical studies, Phase II clinical
trials for new product candidates, as well as other research and development
projects, which together with the minimum operating plan over the next twelve
months, could aggregate up to $9 million. If we are not able to secure
additional financing, we will not be able to implement and fund the research and
development.
However,
the actual amount of funds we will need to operate is subject to many factors,
some of which are beyond our control. These factors include the
following:
|
—
|
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.
|
OFF-BALANCE
SHEET ARRANGEMENTS
We do not
have any off-balance sheet arrangements.
Item 3
|
Quantitative
and Qualitative Disclosures About Market
Risk
|
Per Item
305(e) of Regulation S-K, a smaller reporting company is not required to provide
the information required by this item.
Item 4
|
Controls
and Procedures
|
Evaluation of Disclosure Controls and
Procedures
With the
participation of our management, including the Company’s principal executive
officer and principal financial officer, our management has evaluated the
effectiveness of our disclosure controls and procedures (as defined in
Rule 13a-15(e) under the Securities Exchange Act of 1934 (the “Exchange
Act”)) as of the end of the period covered by this Quarterly Report on Form
10-Q. Based upon that evaluation, the Company’s principal executive officer and
principal financial officer have concluded that:
|
Ÿ
|
information
required to be disclosed by the Company in this Quarterly Report on Form
10-Q and other reports that the Company files or submits under the
Exchange Act would be accumulated and communicated to the Company’s
management, including its principal executive officer and principal
financial officer, as appropriate to allow timely decisions regarding
required disclosure;
|
|
Ÿ
|
information
required to be disclosed by the Company in this Quarterly Report on Form
10-Q and other reports that the Company files or submits under the
Exchange Act would be recorded, processed, summarized and reported within
the time periods specified in the SEC’s rules and forms;
and
|
|
Ÿ
|
the
Company’s disclosure controls and procedures are effective as of the end
of the period covered by this Quarterly Report on Form 10-Q to ensure that
material information relating to the Company is made known to them,
particularly during the period in which the periodic reports of the
Company, including this Quarterly Report on Form 10-Q, are being
prepared.
|
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting (as defined in
Rule 13a-15(f) under the Exchange Act) during the period covered by this
Quarterly Report on Form 10-Q that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
Item 1
|
Legal
Proceedings
|
As
previously described in Item 1 of our Quarterly Report on Form 10-Q for the
period ending March 31, 2009, on April 20, 2009, Amarex, LLC filed suit against
us in the Circuit Court of Montgomery County, Maryland, seeking damages for an
alleged breach of a contract between the Company and Amarex, LLC entered into on
January 6, 2006. Amarex, LLC claims damages of $93,156 plus
interest. On May 22, 2009, the Company filed an answer and an
affirmative defense to the complaint denying the claims of damages made by
Amarex, LLC. On June 16, 2009, the Company filed a counterclaim
against Amarex, LLC for breach of the same contract in the amount of $354,824
plus interest. Previous, the court ordered the Company and Amarex,
LLC to proceed with non-binding mediation. The Company and Amarex,
LLC were not able to reach a settlement during the non-binding mediation and
will proceed with litigation.
Item 1A
|
Risk
Factors
|
In
response to Item 1A of our 2008 Annual Report, we described a billing dispute
between the Company and a pharmaceutical research provider, Amarex,
LLC. The dispute has resulted in a legal proceeding as described in
Item 1 above.
There
were no other material changes in risk factors from those disclosed in the
Company’s Form 10-K for fiscal year ended December 31, 2008.
Item 2
|
Unregistered
Sales of Equity Securities and Use of
Proceeds
|
None
Item 3
|
Defaults
Upon Senior Securities
|
None
Item 4
|
Submission
of Matters to a Vote of Security
Holders
|
None
Item 5
|
Other
Information
|
None
Item 6
|
Exhibits
|
Exhibit No
|
Description
|
Location
|
||
10.1
|
Employment
Agreement, dated as of August 10, 2009, by and between Rexahn
Pharmaceuticals, Inc. and Chang Ho Ahn.
|
Filed
as Exhibit 10.1 to the Current Report on Form 8-K filed on August 10,
2009
|
||
10.2
|
Employment
Agreement, dated as of August 10, 2009, by and between Rexahn
Pharmaceuticals, Inc. and Rakesh Soni.
|
Filed
as Exhibit 10.2 to the Current Report on Form 8-K filed on August 10,
2009
|
||
10.3
|
Employment
Agreement, dated as of August 10, 2009, by and between Rexahn
Pharmaceuticals, Inc. and Tae Heum Jeong.
|
Filed
as Exhibit 10.3 to the Current Report on Form 8-K filed on August 10,
2009
|
||
10.4*
|
Research
and Exclusive License Option Agreement, dated as of June 26, 2009, by and
between Rexahn Pharmaceuticals, Inc. and Teva Pharmaceutical Industries
Limited.
|
Filed
as Exhibit 10.1 to the Current Report on Form 8-K filed on September 21,
2009
|
||
10.5
|
Securities
Purchase Agreement, dated as of June 26, 2009, by and between Rexahn
Pharmaceuticals, Inc. and Teva Pharmaceutical Industries
Limited.
|
Filed
as Exhibit 10.2 to the Current Report on Form 8-K filed on September 21,
2009
|
||
10.6
|
Amendment
No. 1 to Securities Purchase Agreement, dated as of September 16, 2009, by
and between Rexahn Pharmaceuticals, Inc. and Teva Pharmaceutical
Industries Limited.
|
Filed
as Exhibit 10.3 to the Current Report on Form 8-K filed on September 21,
2009
|
||
31.1
|
Rule 13a-14(a)/15d-14(a)
Certification (Principal Executive Officer)
|
Filed
herewith
|
||
31.2
|
Rule 13a-14(a)/15d-14(a)
Certification (Principal Financial Officer)
|
Filed
herewith
|
||
32.1**
|
Section
1350 Certificate (Principal Executive Officer)
|
Filed
herewith
|
||
32.2**
|
Section
1350 Certificate (Principal Financial Officer)
|
Filed
herewith
|
*
|
Rexahn
Pharmaceuticals, Inc. has applied for confidential treatment of certain
provisions of this exhibit with the SEC. The confidential portions of this
exhibit are marked by an asterisk and have been omitted and filed
separately with the SEC pursuant to Company’s request for confidential
treatment.
|
**
|
This
exhibit is furnished rather than filed, and shall not be incorporated by
reference into any filing of the registrant in accordance with Item 601 of
Registration S-K
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
REXAHN PHARMACEUTICALS,
INC.
|
||
(Registrant)
|
||
By:
|
/s/
Chang H. Ahn
|
|
Date:
November 16, 2009
|
Chang
H. Ahn
|
|
Chairman
and Chief Executive Officer
|
||
By:
|
/s/
Tae Heum Jeong
|
|
Date:
November 16, 2009
|
Tae
Heum Jeong
|
|
Chief
Financial Officer and Secretary
|
INDEX
TO EXHIBITS
Quarterly
Report on Form 10-Q
Dated
September 30, 2009
Exhibit No
|
Description
|
Location
|
||
10.1
|
Employment
Agreement, dated as of August 10, 2009, by and between Rexahn
Pharmaceuticals, Inc. and Chang Ho Ahn.
|
Filed
as Exhibit 10.1 to the Current Report on Form 8-K filed on August 10,
2009
|
||
10.2
|
Employment
Agreement, dated as of August 10, 2009, by and between Rexahn
Pharmaceuticals, Inc. and Rakesh Soni.
|
Filed
as Exhibit 10.2 to the Current Report on Form 8-K filed on August 10,
2009
|
||
10.3
|
Employment
Agreement, dated as of August 10, 2009, by and between Rexahn
Pharmaceuticals, Inc. and Tae Heum Jeong.
|
Filed
as Exhibit 10.3 to the Current Report on Form 8-K filed on August 10,
2009
|
||
10.4*
|
Research
and Exclusive License Option Agreement, dated as of June 26, 2009, by and
between Rexahn Pharmaceuticals, Inc. and Teva Pharmaceutical Industries
Limited.
|
Filed
as Exhibit 10.1 to the Current Report on Form 8-K filed on September 21,
2009
|
||
10.5
|
Securities
Purchase Agreement, dated as of June 26, 2009, by and between Rexahn
Pharmaceuticals, Inc. and Teva Pharmaceutical Industries
Limited.
|
Filed
as Exhibit 10.2 to the Current Report on Form 8-K filed on September 21,
2009
|
||
10.6
|
Amendment
No. 1 to Securities Purchase Agreement, dated as of September 16, 2009, by
and between Rexahn Pharmaceuticals, Inc. and Teva Pharmaceutical
Industries Limited.
|
Filed
as Exhibit 10.3 to the Current Report on Form 8-K filed on September 21,
2009
|
||
Rule 13a-14(a)/15d-14(a)
Certification (Principal Executive Officer)
|
Filed
herewith
|
|||
Rule 13a-14(a)/15d-14(a)
Certification (Principal Financial Officer)
|
Filed
herewith
|
|||
32.1**
|
Section
1350 Certificate (Principal Executive Officer)
|
Filed
herewith
|
||
32.2**
|
Section
1350 Certificate (Principal Financial Officer)
|
Filed
herewith
|
*
|
Rexahn
Pharmaceuticals, Inc. has applied for confidential treatment of certain
provisions of this exhibit with the SEC. The confidential portions of this
exhibit are marked by an asterisk and have been omitted and filed
separately with the SEC pursuant to Company’s request for confidential
treatment.
|
**
|
This
exhibit is furnished rather than filed, and shall not be incorporated by
reference into any filing of the registrant in accordance with Item 601 of
Registration S-K
|
34