Delaware
|
11-3516358
|
|||
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
PAGE(S)
|
||
PART
I
|
||
Item 1.
|
Condensed
Financial Statements:
|
|
2
|
||
3
|
||
4
|
||
5
|
||
Item 2.
|
13
|
|
Item 3.
|
30
|
|
PART
II
|
||
Item 1.
|
31
|
|
Item 2.
|
31
|
|
Item 3.
|
31
|
|
Item 4.
|
31
|
|
Item 5.
|
31
|
|
Item 6.
|
31
|
|
32
|
September 30,
2007
|
December 31,
2006
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
and cash equivalents
|
$ |
1,367,801
|
$ |
4,034,060
|
||||
Prepaid
expenses and other
|
417,330
|
483,186
|
||||||
Total
Current Assets
|
1,785,131
|
4,517,246
|
||||||
Equipment,
Net (note 3)
|
117,356
|
149,993
|
||||||
Intangible
Assets, Net (note 4)
|
308,396
|
321,971
|
||||||
Total
Assets
|
$ |
2,210,883
|
$ |
4,989,210
|
||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ |
432,307
|
$ |
575,363
|
||||
Total
Current Liabilities
|
432,307
|
575,363
|
||||||
Deferred
Revenue (note 5)
|
1,143,750
|
1,200,000
|
||||||
Total
Liabilities
|
1,576,057
|
1,775,363
|
||||||
Commitment
and Contingencies (note 8)
|
||||||||
Stockholders'
Equity (note 6):
|
||||||||
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, 50,374,837
(2006
– 50,322,337) issued and 50,360,632 (2006 – 50,308,132)
outstanding
|
5,037
|
5,032
|
||||||
Additional
paid-in capital
|
24,755,640
|
23,927,551
|
||||||
Accumulated
deficit during the development stage
|
(24,097,441 | ) | (20,690,326 | ) | ||||
Treasury
stock, 14,205 shares, at cost
|
(28,410 | ) | (28,410 | ) | ||||
Total
Stockholders' Equity
|
634,826
|
3,213,847
|
||||||
Total
Liabilities and Stockholders' Equity
|
$ |
2,210,883
|
$ |
4,989,210
|
Three
Months
Ended
September 30,
|
Nine
Months
Ended
September 30,
|
Cumulative
from
March 19,
2001
(Inception)
to
September 30,
|
||||||||||||||||||
2007
|
2006
|
2007
|
2006
|
2007
|
||||||||||||||||
Revenue:
|
||||||||||||||||||||
Research
|
$ |
18,750
|
$ |
18,750
|
$ |
56,250
|
$ |
56,250
|
$ |
356,250
|
||||||||||
Expenses:
|
||||||||||||||||||||
General
and administrative
|
555,625
|
1,004,030
|
1,971,891
|
2,662,756
|
11,582,473
|
|||||||||||||||
Research
and development
|
465,934
|
635,047
|
1,441,225
|
3,192,663
|
10,716,268
|
|||||||||||||||
Patent
fees
|
45,698
|
100,611
|
120,536
|
164,900
|
639,396
|
|||||||||||||||
Depreciation
and amortization
|
14,475
|
54,817
|
46,212
|
97,081
|
428,603
|
|||||||||||||||
Total
Expenses
|
1,081,732
|
1,794,505
|
3,579,864
|
6,117,400
|
23,366,740
|
|||||||||||||||
Loss
from Operations
|
(1,062,982 | ) | (1,775,755 | ) | (3,523,614 | ) | (6,061,150 | ) | (23,010,490 | ) | ||||||||||
Other
(Income) Expense
|
||||||||||||||||||||
Interest income
|
(23,606 | ) | (71,098 | ) | (116,499 | ) | (270,377 | ) | (839,196 | ) | ||||||||||
Interest
expense
|
-
|
3,998
|
-
|
95,019
|
301,147
|
|||||||||||||||
Beneficial
conversion feature
|
-
|
-
|
-
|
-
|
1,625,000
|
|||||||||||||||
(23,606 | ) | (67,100 | ) | (116,499 | ) | (175,358 | ) |
1,086,951
|
||||||||||||
Net
Loss
|
$ | (1,039,376 | ) | $ | (1,708,655 | ) | $ | (3,407,115 | ) | $ | (5,885,792 | ) | $ | (24,097,441 | ) | |||||
Loss
per weighted average number of shares outstanding basic and
diluted
|
$ | (0.02 | ) | $ | (0.03 | ) | $ | (0.07 | ) | $ | (0.12 | ) | ||||||||
Weighted
average number of shares basic and diluted
|
50,338,393
|
50,265,632
|
50,323,209
|
48,990,761
|
Nine
Months Ended September 30,
|
Cumulative
from
March
19,2001
(Inception)
to
|
|||||||||||
2007
|
2006
|
September 30,
2007
|
||||||||||
Cash
Flows from Operating Activities:
|
||||||||||||
Net
loss
|
$ | (3,407,115 | ) | $ | (5,885,792 | ) | $ | (24,097,441 | ) | |||
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
|
46,212
|
97,081
|
428,984
|
|||||||||
Stock
option compensation expense
|
786,094
|
1,312,717
|
3,036,596
|
|||||||||
Amortization
of deferred revenue
|
(56,250 | ) | (56,250 | ) | (356,250 | ) | ||||||
Changes
in assets and liabilities:
|
||||||||||||
Prepaid
expenses and other
|
65,856
|
(44,534 | ) | (417,330 | ) | |||||||
Accounts
payable and accrued expenses
|
(143,056 | ) | (297,813 | ) |
432,307
|
|||||||
Net
Cash Used in Operating Activities
|
(2,708,259 | ) | (4,874,591 | ) | (19,326,257 | ) | ||||||
Cash
Flows from Investing Activities:
|
||||||||||||
Purchase
of equipment
|
-
|
(48,911 | ) | (498,520 | ) | |||||||
Net
Cash Used in Investing Activities
|
-
|
(48,911 | ) | (498,520 | ) | |||||||
Cash
Flows from Financing Activities:
|
||||||||||||
Issuance
of common stock
|
42,000
|
4,609
|
14,927,204
|
|||||||||
Proceeds
from long-term debt
|
-
|
-
|
5,150,000
|
|||||||||
Proceeds
from research contribution
|
-
|
-
|
1,500,000
|
|||||||||
Payment
of licensing fees
|
-
|
(130,570 | ) | (356,216 | ) | |||||||
Principal
payments on long-term debt
|
-
|
(28,410 | ) | (28,410 | ) | |||||||
Net
Cash Provided by (Used in) Financing Activities
|
42,000
|
(154,371 | ) |
21,192,578
|
||||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
(2,666,259 | ) | (5,077,873 | ) |
1,367,801
|
|||||||
Cash
and Cash Equivalents - beginning of period
|
4,034,060
|
10,116,625
|
-
|
|||||||||
Cash
and Cash Equivalents - end of period
|
$ |
1,367,801
|
$ |
5,038,752
|
$ |
1,367,801
|
||||||
Supplemental
Cash Flow Information
|
$ |
-
|
$ |
280,535
|
$ |
292,912
|
||||||
Interest
paid
|
1.
|
Operations
and Organization and Going
Concern
|
2.
|
Summary
of Significant Accounting
Policies
|
|
a)
|
The
accounting policies of the Company are in accordance with accounting
principles generally accepted in the United States of America
and their
basis of application is consistent with that of the previous
year.
|
|
b)
|
Recent
Accounting Pronouncements Affecting the
Company:
|
|
In
June 2006, FASB issued FASB Interpretation No. 48 ("FIN 48"), "Accounting
for Uncertainty in Income Taxes". FIN 48 clarifies the accounting
for
uncertainty in income taxes recognized in an enterprise's financial
statements in accordance with SFAS No. 109, "Accounting for Income
Taxes".
FIN 48 prescribes a recognition threshold and measurement attributable
for
the financial statement recognition and measurement of a tax position
taken or expected to be taken in a tax return. FIN 48 also provides
guidance related to, among other things, classification, accounting
for
interest and penalties associated with tax positions and disclosure
requirements. The Company adopted FIN 48 effective January 1, 2007
and
there is no impact of adopting FIN 48 on the Company's financial
statements to date.
|
|
In
February 2007, FASB issued Statement of Financial Accounting Standard
(“SFAS”) No. 159, The Fair Value Option for Financial Assets and Financial
Liabilities — Including an Amendment of FASB Statement No. 115 (“SFAS
159”). The fair value option permits entities to choose to measure
eligible financial instruments at fair value at specified election
dates.
The entity will report unrealized gains and losses on the items
on which
it has elected the fair value option in earnings. SFAS 159 is effective
beginning in fiscal year 2008. The Company is currently evaluating
the
effect of adopting SFAS 159, but does not expect it to have a material
impact on its results of operations or financial
condition.
|
|
c)
|
Earnings
per share:
|
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Basic:
|
50,338,393
|
50,265,632
|
50,323,209
|
48,990,761
|
||||||||||||
Diluted:
|
50,338,393
|
50,265,632
|
50,323,209
|
48,990,761
|
3.
|
Equipment,
Net
|
September 30,
|
December 31,
|
|||||||
2007
|
2006
|
|||||||
Furniture
and fixtures
|
$ |
31,713
|
$ |
31,713
|
||||
Office
equipment
|
43,648
|
43,648
|
||||||
Lab
equipment
|
416,093
|
416,093
|
||||||
Computer
equipment
|
5,066
|
5,066
|
||||||
Cylinders
and designs
|
2,000
|
2,000
|
||||||
498,520
|
498,520
|
|||||||
Less:
Accumulated depreciation
|
381,164
|
348,527
|
||||||
Net
carrying amount
|
$ |
117,356
|
$ |
149,993
|
4.
|
Intangible
Assets, Net
|
5.
|
Deferred
Revenue
|
6.
|
Common
Stock
|
|
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.
|
|
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.
|
|
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. For purposes of the Statement
of
Stockholders' Equity, the five-for-one stock split is reflected
as a
one-line adjustment. 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.
|
|
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.
|
7.
|
Stock-Based
Compensation
|
Three
Months Ended
September 30
|
Nine
Months Ended
September 30
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Black-Scholes
Weighted Average Assumptions:
|
||||||||||||||||
Expected
dividend
|
0
|
0
|
0
|
0
|
||||||||||||
Expected
volatility
|
100%
|
100%
|
100%
|
100%
|
||||||||||||
Risk
free interest rate
|
2.67-4.99%
|
4.59%
|
2.67-4.99%
|
4.59%
|
||||||||||||
Expected
term (in
years)
|
0.3-
5 years
|
5
years
|
0.3-
5 years
|
5
years
|
2007
|
2006
|
|||||||||||||||
Shares
Subject
to
Options
|
Weighted
Avg.
Option
Prices
|
Shares
Subject
to
Options
|
Weighted
Avg.
Option
Prices
|
|||||||||||||
Outstanding
at January 1
|
6,123,295
|
$ |
0.94
|
5,770,000
|
$ |
0.84
|
||||||||||
Granted
|
425,000
|
1.44
|
1,045,000
|
1.20
|
||||||||||||
Exercised
|
(52,500 | ) |
0.80
|
(19,205 | ) |
0.24
|
||||||||||
Cancelled
|
(352,500 | ) |
1.35
|
(525,000 | ) |
0.80
|
||||||||||
Outstanding
at September 30
|
6,143,295
|
$ |
0.95
|
6,270,795
|
$ |
0.90
|
Shares
Subject
to
Options
|
Weighted
Avg.
Option
Prices
|
Weighted
Avg.
Remaining
Contractual
Term
|
|||||||
Outstanding
at September 30, 2007
|
6,143,295
|
$ |
0.95
|
7.1
years
|
|||||
|
|
||||||||
Exercisable
at September 30, 2007
|
3,093,420
|
$ |
0.84
|
6.9
years
|
Shares
Subject to Options
|
Weighted
Avg. Option Prices
|
Weighted
Avg.
Remaining
Contractual
Term
|
|||||||
Outstanding
at September 30, 2006
|
6,270,795
|
$ |
0.90
|
8.2
years
|
|||||
Exercisable
at September 30, 2006
|
2,937,129
|
$ |
0.82
|
7.7
years
|
8.
|
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 terms
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,
2007, the
total value of these agreements was approximately $2,273,406 and
the
Company had made payments totaling $1,370,061 under the terms of
the
agreements as at September 30, 2007. All of these agreements
may be terminated by either party upon appropriate notice as stipulated
in
the respective agreements.
|
|
b)
|
On
September 12, 2005 the Company and three of its key executives
entered
into employment agreements. One of the three agreements with an
annual
commitment of $200,000 expired in September 2006. Another one of
the three
agreements was renewed on September 12, 2007 and results in an
annual
commitment of $160,000 and expires September 12, 2009. One agreement
expires on September 12, 2010 and results in an annual commitment
of
$350,000.
|
|
c)
|
In
April 2004, the Company signed a 5 year lease for 8,030 square
feet of
office space in Rockville, Maryland commencing July 2004. The lease
requires annual base rents of $200,750 subject to annual increases
of 3%
of the preceding years adjusted base rent. Under the leasing agreement,
the Company also pays its allocable portion of real estate taxes
and
common area operating charges.
|
|
Minimum
future rental payments under this lease as of September 30, 2007
are as
follows:
|
Remainder
of
|
2007
|
$ |
54,841
|
||
2008
|
222,655
|
||||
2009
|
112,973
|
||||
$ |
390,469
|
|
d)
|
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 of
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.
|
|
e)
|
On
January 4, 2007 The Company signed an agreement with Interventure
Co. Ltd
(“Interventure”) engaging Interventure to provide financial and business
consulting services to the Company. The Company agreed to pay Interventure
$20,000 upon closing of the financing of over $1,000,000 of financing
secured by Interventure. In addition, in the event that additional
financing is arranged by Interventure and successfully consummated
by the
Company, the Company agreed to pay Interventure a success fee of
3% of
such financing.
|
|
f)
|
On
March 5, 2007, the Company entered into an agreement with Rx
Communications Group LLC (“Rx”) for Rx to provide investor relations
services to the Company. Under this agreement, the Company agreed
to pay
Rx a monthly fixed retainer amount of $10,000 commencing March
1,
2007. In accordance with the agreement, the contract may be
terminated by either party upon thirty (30) days prior written
notice to
the other party.
|
|
g)
|
On
May 30, 2007, the Company engaged Rodman and Renshaw, LLC (“Rodman”) to
serve as the placement agent in connection with the proposed offer
and
placement of securities of the Company. Pursuant to the agreement,
the
Company shall pay Rodman a cash placement fee equal to 7% of the
aggregate
proposed offering.
|
|
·
|
our
lack of profitability and the need to raise 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.
|
Remainder
of
|
2007
|
$ |
54,841
|
||
2008
|
222,655
|
||||
2009
|
112,973
|
||||
$ |
390,469
|
|
·
|
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;
|
|
·
|
additional
contractual commitments which may be required as our drug candidates
move
into the clinical trials phase of
development;
|
|
·
|
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.
|
|
·
|
continued
pre-clinical development and clinical trials for our current and
new drug
candidates;
|
|
·
|
efforts
to seek regulatory approvals for our drug
candidates;
|
|
·
|
implementing
additional internal systems and
infrastructure;
|
|
·
|
licensing
in additional technologies to develop;
and
|
|
·
|
hiring
additional personnel.
|
|
·
|
conducting
pre-clinical and clinical trials;
|
|
·
|
participating
in regulatory approval processes;
|
|
·
|
formulating
and manufacturing products; and
|
|
·
|
conducting
sales and marketing activities.
|
|
·
|
unforeseen
safety issues;
|
|
·
|
determination
of dosing issues;
|
|
·
|
lack
of effectiveness during clinical
trials;
|
|
·
|
reliance
on third party suppliers for the supply of drug candidate
samples;
|
|
·
|
slower
than expected rates of patient
recruitment;
|
|
·
|
inability
to monitor patients adequately during or after
treatment;
|
|
·
|
inability
or unwillingness of medical investigators and institutional review
boards
to follow our clinical protocols;
and
|
|
·
|
lack
of sufficient funding to finance the clinical
trials.
|
|
·
|
awareness
of the drug's availability and
benefits;
|
|
·
|
perceptions
by members of the health care community, including physicians,
about the
safety and effectiveness of our
drugs;
|
|
·
|
pharmacological
benefit and cost-effectiveness of our product relative to competing
products;
|
|
·
|
availability
of reimbursement for our products from government or other healthcare
payers;
|
|
·
|
effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any; and
|
|
·
|
the
price at which we sell our
products.
|
|
·
|
We
may be unable to identify manufacturers on acceptable terms or
at all
because the number of potential manufacturers is limited and the
FDA must
approve any replacement contractor. This approval would require
new testing and compliance inspections. In addition, a new
manufacturer would have to be educated in, or develop substantially
equivalent processes for, the production of our products after
receipt of
FDA approval, if any.
|
|
·
|
Our
third-party manufacturers might be unable to formulate and manufacture
our
drugs in the volume and of the quality required to meet our clinical
needs
and commercial needs.
|
|
·
|
Our
contract manufacturers may not perform as agreed or may not remain
in the
contract manufacturing business for the time required to supply
our
clinical trials or to successfully produce, store and distribute
our
products.
|
|
·
|
Drug
manufacturers are subject to ongoing periodic unannounced inspection
by
the FDA, the Drug Enforcement Agency ("DEA"), and corresponding
state
agencies to ensure strict compliance with good manufacturing practice
and
other government regulations and corresponding foreign
standards. We do not have control over third-party
manufacturers' compliance with these regulations and standards,
but we may
be ultimately responsible for any of their
failures.
|
|
·
|
If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share,
the
intellectual property rights to the
innovation.
|
|
·
|
developing
drugs;
|
|
·
|
undertaking
pre-clinical testing and human clinical
trials;
|
|
·
|
obtaining
FDA and other regulatory approvals of
drugs;
|
|
·
|
formulating
and manufacturing drugs; and
|
|
·
|
launching,
marketing and selling drugs.
|
|
·
|
the
degree and range of protection any patents will afford us against
competitors, including whether third parties will find ways to
invalidate
or otherwise circumvent our licensed
patents;
|
|
·
|
if
and when patents will be issued;
|
|
·
|
whether
or not others will obtain patents claiming aspects similar to those
covered by our licensed patents and patent applications;
or
|
|
·
|
whether
we will need to initiate litigation or administrative proceedings
which
may be costly whether we win or
lose.
|
|
·
|
obtain
licenses, which may not be available on commercially reasonable
terms, if
at all;
|
|
·
|
redesign
our products or processes to avoid
infringement;
|
|
·
|
stop
using the subject matter claimed in the patents held by others,
which
could cause us to lose the use of one or more of our drug
candidates;
|
|
·
|
pay
damages; or
|
|
·
|
defend
litigation or administrative proceedings which may be costly whether
we
win or lose, and which could result in a substantial diversion
of our
management resources.
|
|
·
|
the
announcement of new products or product enhancements by us or our
competitors;
|
|
·
|
developments
concerning intellectual property rights and regulatory
approvals;
|
|
·
|
variations
in our and our competitors' results of
operations;
|
|
·
|
changes
in earnings estimates or recommendations by securities analysts;
and
|
|
·
|
developments
in the biotechnology industry.
|
Exhibit Number |
Description
|
31.1 |
Certification
of Chief Executive Officer of Periodic Report Pursuant to
Rule 13a-15(e) or
Rule 15d-15(e)
|
|
31.2
|
Certification
of Chief Financial Officer of Periodic Report Pursuant to
Rule 13a-15(e) or
Rule 15d-15(e)
|
|
32.1
|
Certification
of Chief Executive Officer of Periodic Report Pursuant to 18 U.S.C.
Section 1350
|
|
32.2
|
Certification
of Chief Financial Officer of Periodic Report Pursuant to 18 U.S.C.
Section 1350
|
REXAHN
PHARMACEUTICALS, INC.
|
|
/s/
Ted T. H. Jeong
|
|
Name:
Ted T. H. Jeong
|
|
Title:
Chief Financial Officer and Secretary
|
|
Date: November
14, 2007
|
|
Number
|
Description
|
|
Certification
of Chief Executive Officer of Periodic Report Pursuant to
Rule 13a-15(e) or
Rule 15d-15(e)
|
|
Certification
of Chief Financial Officer of Periodic Report Pursuant to
Rule 13a-15(e) or
Rule 15d-15(e)
|
|
Certification
of Chief Executive Officer of Periodic Report Pursuant to 18 U.S.C.
Section 1350
|
|
Certification
of Chief Financial Officer of Periodic Report Pursuant to 18 U.S.C.
Section 1350
|