10QSB: Optional form for quarterly and transition reports of small business issuers
Published on November 14, 2007
UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 10-QSB
(Mark
One)
T
QUARTERLY REPORT UNDER SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
For
the Quarterly Period Ended September 30, 2007
o
TRANSITION REPORT UNDER SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
For
the Transition Period from _________ to _________
Commission
file number: 000-50590
REXAHN
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified on its charter)
Delaware
|
11-3516358
|
|||
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
9620
Medical Center Drive
Rockville,
Maryland 20850
(Address
of principle executive offices)
(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 past 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 T No o
APPLICABLE
ONLY TO CORPORATE ISSUERS:
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). Yes o
No x
State
the
number of shares outstanding of each of the registrant's classes of common
equity, as of the latest practicable date: 50,374,837 issued and 50,360,632
outstanding as of November 14, 2007
Transitional
Small Business Disclosure Format (check one): Yes o
No x
REXAHN
PHARMACEUTICALS, INC.
INDEX
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
|
PART
I – FINANCIAL INFORMATION
Item 1. FINANCIAL
STATEMENTS
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Condensed
Balance Sheets
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
|
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
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
|
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
|
|||||||||||
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
|
Operations
and Organization
Rexahn
Pharmaceuticals, Inc. (the "Company" or "Rexahn Pharmaceuticals"), 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
accompanying unaudited financial statements of the Company have been prepared
in
accordance with accounting principles generally accepted in the United States
of
America for financial information and the requirements of item 310 (b) of
Regulation S-B. Accordingly, certain information and disclosures normally
included in financial statements prepared in accordance with accounting
principles generally accepted in the United States of America have been
condensed or omitted pursuant to the rules and regulations of the Securities
and
Exchange Commission. These condensed financial statements should be read
in
conjunction with the financial statements and notes thereto included in the
Company's Annual Report on Form 10-KSB for the year ended December 31, 2006.
The
accompanying condensed financial statements reflect all adjustments (consisting
only of normal recurring adjustments), which, in the opinion of management,
are
necessary for a fair presentation of the results for the periods presented.
Except for the adoption of new accounting policies as disclosed in note 2,
there
have been no significant changes in our accounting policies since December
31,
2006. The results of operations for the three and nine month period ended
September 30, 2007 are not necessarily indicative of the results expected
for
the full fiscal year or any future period.
Going
Concern
The
Company's consolidated condensed financial statements are presented on a
going
concern basis, which contemplates the realization of assets and satisfaction
of
liabilities in the normal course of business. The Company has experienced
recurring losses from operations since inception that raise substantial doubt
as
to its ability to continue as a going concern. For the nine-month periods
ended
September 30, 2007 and 2006, the Company experienced net losses of $3,407,115
and $5,885,792, respectively. At September 30, 2007, the Company has an
accumulated deficit of $24,097,441.
The
Company is negotiating and has received term sheets for $4,000,000 of equity
with two private investors. If finalized, the Company believes it
will have sufficient cash to operate for at least twelve months. The
Company’s ability to continue as a going concern is contingent upon its ability
to maintain the financing and strategic alliances necessary to complete product
development, obtain the necessary licensing for its products and attain
profitable operations. Although the Company is in clinical trials, there
can be
no assurance of the success of the clinical trials or of the marketability
of
the drugs. The Company has entered into negotiations on strategic alliances
including research funding collaborations, as well as equity financing with
international pharmaceutical companies and other investors in the United
States,
Europe and Asia. The Company also plans to pursue additional
financing. There can be no assurance that the Company will be able to
secure financing when needed or to obtain such financing on terms satisfactory
to the Company, if at all. The consolidated condensed financial
statements do not include any adjustments to reflect the possible future
effects
on the recoverability and classification of assets or the amounts and
classification of liabilities that may result from the possible inability
of the
Company to continue as a 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:
|
The
following weighted average number of shares was used for the computation
of
basic and diluted loss 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
|
Basic
earnings per share is based upon the weighted average number of common shares
outstanding during the period. Diluted earnings per share is computed on
the
same basis, including if dilutive, common share equivalents, which include
outstanding options and restricted shares. For purpose of computing diluted
earnings per share, 3,283,800 and 2,980,729 common share equivalents for
the
three months and nine months ended September 30, 2007, and 2,788,230 and
2,924,777 common share equivalents for the three months and nine months ended
September 30, 2006, respectively, were excluded from the calculation of diluted
earnings per share because their inclusion would have been anti-dilutive
as a
result of the net loss applicable to these periods.
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
|
Depreciation
expense was $32,637 and $83,723 for the nine months ended September 30, 2007
and
2006, respectively.
4.
|
Intangible
Assets, 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, of 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 straightline basis over
the 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%. As at December 31, 2006 the outstanding balance
was
paid. Amortization expense was $13,575 and $13,358 for the nine
months ended September 30, 2007 and 2006, respectively, and $4,453 and $4,561
for the three months ended September 30, 2007 and 2006,
respectively. Management does not believe that there is an impairment
of intangible assets at September 30, 2007.
5.
|
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, 2007 and 2006. The remaining $1,143,750 at September 30, 2007
(December 31, 2006-$1,200,000) is reflected as deferred revenue on the balance
sheet. The Company adopted SAB No. 104, "Revenue Recognition
Nonrefundable Up-front Fees" with respect to the accounting for this
transaction. These fees are 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 2009.
6.
|
Common
Stock
|
The
following transactions occurred during fiscal years 2001 through September
30,
2007:
|
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.
|
|
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
|
On
August
5, 2003, the Company established a stock option 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.
For
grants to non-employee directors and 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 Company's Stock
Option Plan approved at the Annual Meeting of the Stockholders of the Company
on
June 2, 2006 and as of September 30, 2007,
10,695,000 options are 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.
Accounting
for Employee Awards
Effective
January 1, 2006, the plan is accounted for in accordance with the recognition
and measurement provisions of SFAS No. 123R, which replaces SFAS No. 123
and
supersedes APB No. 25, and related interpretations. SFAS No. 123R requires
compensation costs related to share-based payment transactions, including
employee stock options, to be recognized in the financial statements. In
addition, the Company adheres to the guidance set forth in SEC SAB No. 107,
which provides the SEC staff's views regarding the interaction between SFAS
No.
123R and certain SEC rules and regulations and provides interpretations with
respect to the valuation of share-based payments for public
companies.
In
adopting SFAS No. 123R, the Company applied the modified prospective approach
to
transition. Under the modified prospective approach, the provisions of SFAS
No.
123R are to be applied to new employee awards and to employee awards modified,
repurchased, or cancelled after the required effective date. Additionally,
compensation cost for the portion of employee awards for which the requisite
service has not been rendered that are outstanding as of the required effective
date will be recognized as the requisite service is rendered on or after
the
required effective date.
The
compensation cost for that portion of employee awards will be based on the
grant-date fair value of those awards as calculated for either recognition
or
pro-forma disclosures under SFAS No. 123.
As
a
result of the adoption of SFAS No. 123R, the Company's results of operations
for
the three months and nine months periods ended September 30, 2007 include
share-based employee compensation expense totaling $144,880 and $447,996
respectively, and for the three months and nine months periods ended September
30, 2006 include $175,336 and $505,131 respectively. Such amounts have been
included in the Statements of Operations in general and administrative and
research and development expenses.
Employee
stock option compensation expense in the first three quarters of 2007 is
the
estimated fair value of options granted amortized on a straight-line basis
over
the requisite service period for the entire portion of the award. The Company
has not adjusted the expense by estimated forfeitures, as required by SFAS
No.
123R for employee options, since the forfeiture rate based upon historical
data
was determined to be immaterial.
Accounting
for Non-Employee Awards
The
Company previously accounted for options granted to its non-employee consultants
and non-employee registered representatives using the fair value cost in
accordance with SFAS No. 123 and EITF 96-18. The adoption
of SFAS No. 123R and SAB No. 107, as of January 1, 2006, had no material
impact
on the accounting for non-employee awards. The Company continues to
consider the additional guidance set forth in EITF Issue No. 96-18.
Stock
compensation expense related to non-employee options were $69,188 and $338,098
for the three months and nine months periods ended September 30, 2007,
respectively, and $329,062 and $807,586 for the three months and nine months
periods ended September 30, 2006, respectively.
Such
amounts have been included in the Statements of Operations in general and
administrative and research and development expenses.
There
were 425,000 stock options granted during the nine month period ended September
30, 2007. A total of 1,045,000 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. During the first three quarters of
2007,
the Company took into consideration guidance under SFAS No. 123R and SAB
No. 107
when reviewing and updating assumptions. The expected volatility is based
upon
historical volatility of the Company's stock and other contributing factors.
The
expected term is based upon the contract life with non-employees.
The
assumptions made in calculating the fair values of options are as
follows:
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
|
As
of
September 30, 2007 and 2006, there was $1,883,885 and $3,506,296 of total
unrecognized compensation cost, respectively, net of estimated forfeitures,
related to all unvested stock options, which is expected to be recognized
over a
weighted average vesting period of 1.2 years and 1.75 years,
respectively.
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.
|
Item 2. MANAGEMENT'S
DISCUSSION AND ANALYSIS OR
PLAN OF OPERATION
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 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
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 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.
|
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 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.
Stock-Based
Compensation
In
December 2004, the Financial Accounting Standards Board ("FASB") issued
Statement of Financial Accounting Standards ("SFAS") No. 123
(Revised 2004), "Share-Based Payment" ("SFAS No. 123R"). This
pronouncement amends SFAS No. 123, "Accounting for Stock-Based Compensation"
and
supersedes Accounting Principles Board ("APB") Opinion No. 25, "Accounting
for Stock Issued to Employees". SFAS No. 123R requires that companies
account for awards of equity instruments issued to employees under the fair
value method of accounting and recognize such amount in the statement of
operations. The implementation of this statement was effective
January 1, 2006 and has been adopted by the Company using the modified
prospective method.
For
all
non-employee stock-based compensation the Company uses the fair value method
in
accordance with SFAS No. 123 and EITF 96-18.
In
management's opinion, existing stock option valuation models do not provide
a
reliable single measure of the fair value of employee stock options that
have
vesting provisions and are not transferable. As option valuation
models require the input of highly subjective assumptions, changes in such
subjective assumptions can materially affect the fair value estimate of employee
stock options.
Prior
to
the adoption of SFAS No. 123R, the Company used the intrinsic value method
to
account for stock-based compensation in accordance with APB Opinion No. 25
and,
as permitted by SFAS No. 123, provided pro forma disclosures of net loss
and loss per common share as if the fair value methods had been applied in
measuring compensation expense. Under the intrinsic value method,
compensation cost for employee stock awards is recognized as the excess,
if any,
of the deemed fair value for financial reporting purposes of our common stock
on
the date of grant over the amount an employee must pay to acquire the
stock. Compensation cost is amortized over the vesting period using
an accelerated graded method in accordance with FASB Interpretation No. 28,
"Accounting for Stock Appreciation Rights and Other Variable Stock Option
or
Award Plans".
Our
results include non-cash compensation expense as a result of stock option
grants. For stock-based awards prior to January 1, 2006, we
accounted for stock-based employee compensation arrangements in accordance
with
the provisions of APB Opinion No. 25, "Accounting for Stock Issued to Employees"
and comply with the disclosure provisions of SFAS No. 123, "Accounting for
Stock-Based Compensation" ("SFAS No. 123"). Compensation expense for
options granted to employees represents the difference between the fair market
value of our common stock and the exercise price of the options at the date
of
grant. This amount is being recorded over the respective vesting
periods of the individual stock options. We expect to record
additional non-cash compensation expense in the future, which may be
significant. Compensation for options granted to non-employees has
been determined in accordance with SFAS No. 123 and EITF 96-18, "Accounting
for Equity Instruments that are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services," as the fair value of the
equity
instruments issued.
On
August 5, 2003, the Company established a stock option plan. The
plan grants stock options to key employees, directors and consultants of
the
Company. For grants prior to September 12, 2005 and grants to
employees of the Company after September 12, 2005, the vesting period
is 30% after the first year, an additional 30% after the second year
and the remaining 40% after the third year. For grants to
non-employee directors and consultants of the Company after September 12,
2005, the vesting period is 100% after the first year, 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, subject to the fulfillment of certain
conditions in the individual stock option grant agreements.
The
exercise prices of the options granted to employees were below the fair market
value of the common stock on the date of the grant. In
December 2005, employees holding stock options that were not vested as of
December 31, 2004 and stock options that were granted on or after
January 1, 2005 agreed to amend the exercise prices of those options from
$0.24 per share to $0.80 per share, the fair market value of the
common stock (as determined by the board of directors), in order to comply
with
the requirements of Internal Revenue Code Section 409A. The
repricing of the options issued to employees was accounted as a cancellation
of
existing options and issuance of new options. The effective date of
this repricing was January 1, 2005. The amendment was accounted
for prospectively and resulted in a reversal of stock option compensation
expense of $306,896 related to employee options recorded in the period from
January 1, 2005 to September 30, 2005. There was no impact
on the Company's results of operations for the year ended December 31,
2004. Using the intrinsic value method, the total compensation cost
for the year ended December 31, 2005 amounted to $0 (2004-$658,000) and is
being amortized over the vesting period.
The
options issued to certain non-employees accounted under the fair value method
were similarly repriced as of January 1, 2005. As a result,
stock compensation expense of $158,531 recorded in the period from
January 1, 2005 to September 30, 2005, related to non-employee options
was reversed. The stock compensation expense related to non-employees
during 2005 was $436,748, after accounting for the repricing
adjustment.
RECENTLY
ISSUED ACCOUNTING STANDARDS
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.
RESULTS
OF OPERATIONS
Comparison
of the Three Months and Nine Months Ended September 30, 2007
and 2006:
Total
Revenues
For
the
three months and nine months ended September 30, 2007, we recorded revenue
of
$18,750 and $56,250, respectively, compared to $18,750 and $56,250,
respectively, in the same period last year. Revenues result from the
amortization of deferred revenue from a $1,500,000 contribution made in 2003
to
us under a collaborative research agreement with Rexgene Biotech Co., Ltd.,
a
minority shareholder.
General
and Administrative Expenses
General
and administrative expenses consist primarily of salaries and related benefits
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 decreased $447,405 and $690,865, respectively,
or
45% and 26%, respectively, from $1,004,030 and $2,662,756, respectively,
for the
three months and nine months ended September 30, 2006 to $555,625 and
$1,971,891, respectively, for the three months and nine months ended
September 30, 2007. The decreases were primarily due to lower stock
option compensation expenses. Higher general and administrative
expenses during the 2006 periods were attributable to stock option compensation
expense of $311,387 and $810,397 respectively, for the three months and nine
months ended September 30, 2006 compared to $115,565 and $421,487, respectively,
for the three months and nine months ended September 30, 2007.
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 $169,113 and $1,751,438, respectively,
or 27%
and 55%, respectively, from $635,047 and $3,192,663, respectively, for the
three
months and nine months ended September 30, 2006 to $465,934 and $1,441,225,
respectively, for the three months and nine months ended September 30,
2007. The decreases were due primarily to the fact that several of
our drug candidates underwent clinical trials in 2006 and we had taken
preliminary steps to prepare other drug candidates for clinical trials during
that time. Dependent upon the Company raising sufficient capital, we
expect that research and development expenses will increase as additional
drug
candidates move into the clinical trials phases of
development. Higher research and development expenses during the 2006
periods were also attributable to stock option compensation expense of $193,011
and $502,319, respectively, for the three months and nine months ended September
30, 2006 compared to $98,506 and $364,607, respectively, for the three months
and nine months ended September 30, 2007.
Patent
Fees
Our
patent fees decreased $54,913 and $44,364, respectively, or 55% and 27%,
respectively, from $100,611and $164,900, respectively, for the three months
and
nine months ended September 30, 2006 to $45,698 and $120,536, respectively,
for the three months and nine months ended September 30,
2007. The decrease during the three months and nine months ended
September 30, 2007 were due primarily to a decrease in the number of patent
filings made during three and nine months ended September 30, 2007 compared
to
the same periods last year.
Interest
Expense
Interest
expense decreased $3,998, and $95,019, respectively, or 100% and 100%,
respectively, from $3,998 and $95,019, respectively, for the three months
and
nine months ended September 30, 2006 to $0, for the three months and nine
months ended September 30, 2007. The decreases during the three
months and nine months ended September 30, 2007 were primarily due to conversion
of $3,850,000 of principal amount of the Company's convertible notes into
common
stock in May 2006.
Interest
Income
Interest
income decreased $47,492 and $153,878, respectively, or 67% and 57%,
respectively, from $71,098 and $270,377, respectively, for the nine months
ended
September 30, 2006 to $23,606 and $116,499, respectively, for the three months
and nine months ended September 30, 2007. The decreases during the
three month and nine month periods ended September 30, 2007 were primarily
due
to higher cash and cash equivalent balances in the same periods last
year.
Depreciation
and Amortization
Depreciation
and amortization expenses decreased $40,342 and $50,869, respectively, or
74%
and 52%, respectively, from $54,817 and $97,081 respectively, for the three
months and nine months ended September 30, 2006 to $14,475 and $46,212,
respectively, for the three months and nine months ended September 30,
2007. The decreases were due primarily to amortization of fixed
assets.
Net
Loss
As
a
result of the above, the net loss for the three months and nine months ended
September 30, 2007 was $1,039,376 and $3,407,115, respectively, or $0.02
and $0.07, per share, respectively, compared to a net loss of $1,708,655
and
$5,855,792, or $0.03 and $0.12 per share, respectively, for the three
months and nine months ended September 30, 2006.
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 five lead drug candidates, Archexin (which was previously
referred to as RX-0201), RX-0047, RX-5902, Serdaxin and Zoraxel (Serdaxin
and
Zoraxel were previously referred to as RX-10100).
We
have
allocated direct and indirect costs to each program based on certain assumptions
and our review of the status of each program, payroll-related expenses and
other
overhead costs based on estimated usage by each program. 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-0047 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.
Archexin
In
October 2006, we announced the conclusion of the Phase I clinical trial of
Archexin, our leading drug candidate. In May 2007, we received
approval from the U.S. Food & Drug Administration (FDA) to initiate a Phase
II clinical trial for our lead oncology compound, Archexin, in patients with
renal cell carcinoma (RCC). Enrollment is expected to begin in the
fourth quarter of 2007. 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. We expect to file a complete final report of Phase I results
with the Food and Drug Administration this year. 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 this year in
patients with advanced renal cell carcinoma who have failed previous
treatments. The trial is the first of multiple trials planned for
Archexin. We estimate that the Phase II trials will be completed
in 2009 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
and Zoraxel
Serdaxin
and Zoraxel are scheduled to enter Phase II trials in 2007, subject to
obtaining sufficient additional financing. We currently
estimate that these studies will require approximately $4,000,000 and
$3,000,000, respectively.
RX-0047
and RX-5902
RX-0047
and RX-5902 are both 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. Through September 30, 2007, the costs incurred for
development of these compounds to date have been approximately $800,000 for
RX-0047, and $300,000 for RX-5902. The estimated cost to complete
pre-clinical toxicology and Phase I clinical trials is estimated to be
approximately $1,500,000 per compound for a total of
$3,000,000. In June of 2007, we were granted a U.S. patent for
our RX-0047 compound, which is scheduled to enter Phase I Clinical trials
in 2008. RX-5902 may be entered into these Phase I clinical
trials in 2008.
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 results in additional cost to us, a higher than expected expense may
result.
LIQUIDITY
AND CAPITAL RESOURCES
Cash
used
in operating activities was $2,708,259 for the nine months ended September
30,
2007 compared to cash used in operating activities of $4,874,591 for the
same
period ended September 30, 2006. The operating cash flows during the
nine months ended September 30, 2007 reflect our loss from operations of
$3,407,115, offset by non-cash charges of $776,056 and a net decrease in
cash
components of working capital of $77,200. Non-cash charges consist of
depreciation and amortization of $46,212, stock option compensation expense
of
$786,094 and amortization of deferred revenue of $(56,250). The
decrease in working capital primarily consists of a $143,056 decrease in
accounts payable and accrued expenses and a decrease of $65,856 of prepaid
and
other assets.
There
was
no cash provided by or used in investing activities during the nine months
ended
September 30, 2007 and $48,911 used in 2006.
Cash
provided by financing activities was $42,000 for the nine months ended September
30, 2007 compared to cash used in financing activities of $154,371 for the
same
period ended September 30, 2006. The cash provided by financing
activities during the nine months ended September 30, 2007 consists of issuance
of common stock. The increase in cash flows from financing activities
is mainly due to principal payments on long-term debt of $28,410 and payment
of
licensing fees of $130,570 in the nine month period ended September 30,
2006. There were no such costs incurred in the current
period.
For
the
nine months ended September 30, 2007, and the year ended December 31,
2006, we experienced net losses of $3,407,115 and $6,486,003,
respectively. Our accumulated deficit as of September 30, 2007,
and December 31, 2006 and 2005 was $24,097,441, $20,690,326 and
$14,204,323, respectively.
We
have
financed our operations since inception primarily through equity and convertible
debt financings and interest income from investments of cash and cash
equivalents. During the nine months ended September 30, 2007, we
had a net decrease in cash and cash equivalents of $2,666,259 resulting from
the
cash used in operating activities. Total cash and cash equivalents as
of September 30, 2007 were $1,367,801 compared to $4,034,060 as of
December 31, 2006.
The
Company is negotiating and has
received term sheets for $4,000,000 of equity with two private
investors. If finalized, the Company believes it will have sufficient
cash to operate for at least twelve months. The Company’s ability to
continue as a going concern is contingent upon its ability to maintain the
financing and strategic alliances necessary to complete product development,
attain the necessary licensing for its products and attain profitable
operations. Although the Company is in clinical trials, there can be no
assurance of the success of the clinical trials or of the marketability of
the
drug. The Company has entered into negotiations on strategic
alliances including research funding collaborations, as well as equity financing
with international pharmaceutical companies and other investors in the United
States, Europe and Asia. The Company also plans to pursue additional
financing. There can be no assurance that the Company will be able to
secure financing when needed or to obtain such financing on terms satisfactory
to the Company, if at all.
CONTRACTUAL
OBLIGATIONS
In
April 2004, we 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, we also pay our 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
|
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. One agreement expires on September 12, 2010 and results
in an annual commitment of $350,000.
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 initiation fee of $149,061
due upon signing. We paid $167,693 and $361,973 towards the cost of
the study in the nine months ended September 30, 2007 and in the year ended
December 31, 2006, respectively.
On
April 3, 2006, we contracted with UPM Pharmaceuticals, Inc. to develop a
short-acting extended release formulation for Serdaxin and
Zoraxel. In accordance with the agreement, the estimated contract
duration is seven months for an estimated cost of $443,975 plus pass through
expenses, of which $0 and $112,124 was paid during the nine months ended
September 30, 2007 and the year ended December 31, 2006,
respectively. The service costs are payable based upon a payment
schedule related to certain milestones. On January 4,
2007, the Company signed a one year 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 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.
On
February 1, 2007, we contracted with the University of Maryland Baltimore
to develop polymer conjugates for cancer therapy. In accordance with
the agreement, the contract duration is 12 months for a total cost of
$55,000, all of which was paid in April 2007.
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.
On
May
18, 2007, we contracted with LabConnect to conduct Phase II clinical trials
laboratory testing services for Archexin. In accordance with the
agreement, the estimated contract duration is until the end of 2009 for a
total
cost of $197,220. We paid $54,444 towards the cost of the study in
the nine months ended September 30, 2007.
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 our
securities. Pursuant to the agreement, we will pay Rodman a cash
placement fee equal to 7% of the aggregate proposed offering.
The
Company also has agreements with other companies to perform clinical studies
with various remaining terms from two months to three years. The
total cost for these agreements is approximately $120,000, of which $58,000
has
been expended. These agreements may be terminated upon written notice
to the other party.
Although
we currently believe that our cash and cash equivalents will be sufficient
to
meet our minimum planned operating needs for the next 3 months,
including the amounts payable under the contractual commitments described
above,
as our drug candidates move into the clinical trials phase of development,
we
expect to enter into additional agreements of the same type, which may require
additional contractual commitments. These additional commitments may
have a negative impact on our future cash flows. For the foreseeable
future, we will have to fund all of our operations and capital expenditures
from
the net proceeds of equity or debt offerings we may have, cash on hand,
licensing fees and grants. Although we have plans to pursue
additional financing, there can be no assurance that we will be able to secure
financing when needed or obtain such financing on terms satisfactory to us,
if
at all, or that any additional funding we do obtain will be sufficient to
meet
our needs in the long term. If additional funding cannot be obtained,
we will review alternative courses of action to conserve our cash
flow.
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 (but without giving effect the $4,000,000 financing for which we
have
received term sheets and are currently negotiating), 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 three months, which would entail
focusing our resources on Phase II clinical trials of Archexin. Over
the next 12 months we expect to spend a minimum of approximately
$500,000 on clinical development for Phase II clinical trials of Archexin,
$2
million on general corporate expenses, and approximately $219,000 on facilities
rent. We plan to initiate, subject to obtaining sufficient additional
financing, Phase II clinical trials of Serdaxin and Zoraxel beginning in
the
winter of 2007 at an additional cost of up to approximately
$3 million. We may 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 and Phase I clinical trials for RX-0047
and RX-5902, Phase II clinical trials for new product candidates, as well
as
other research and development projects, which together with the minimum
operating plan for the next 12 months, could aggregate up to $7
million through the third quarter of 2008.
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;
|
|
·
|
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.
|
IMPACT
OF INFLATION
To
date,
inflationary factors have not had a significant effect on our
operations.
OFF-BALANCE
SHEET ARRANGEMENTS
We
do not
have any off-balance sheet arrangements.
CERTAIN
BUSINESS RISKS
We
currently have no product revenues and will need to raise additional capital
to
operate our business.
To
date,
we have generated no product revenues. Until we receive approval from
the FDA and other regulatory authorities for our drug candidates, we cannot
sell
our drugs and will not have product revenues. Therefore, for the
foreseeable future, we will have to fund all of our operations and capital
expenditures from the net proceeds of equity or debt offerings we may make,
cash
on hand, licensing fees and grants. 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 planned operating needs for at least
the
next six months, including the clinical trials of Archexin. We plan
to initiate, subject to obtaining sufficient additional financing, Phase
II
clinical trials of Serdaxin and Zoraxel beginning in the winter of 2007 at
an additional cost of up to approximately $3 million.
However,
changes may occur that would consume our existing capital at a faster rate
than
projected, including but not limited to, the progress of our research and
development efforts, the cost and timing of regulatory approvals and the
costs
of protecting our intellectual property rights. We may seek
additional financing to implement and fund other drug candidate development,
clinical trial and research and development efforts, including Phase I clinical
trials for other new drug candidates, as well as other research and development
projects, which together with the current operating plan for the next year,
could aggregate up to $ 7 million through the third quarter
of 2008.
We
will
need additional financing to continue to develop our drug candidates, which
may
not be available on favorable terms, if at all. If we are unable to
secure additional financing in the future on acceptable terms, or at all,
we may
be unable to complete our planned pre-clinical and clinical trials or obtain
approval of our drug candidates from the FDA and other regulatory
authorities. In addition, we may be forced to reduce or discontinue
product development or product licensing, reduce or forego sales and marketing
efforts and forego attractive business opportunities in order to improve
our
liquidity to enable us to continue operations. Any additional sources
of financing will likely involve the sale of our equity securities or securities
convertible into our equity securities, which may have a dilutive effect
on our
stockholders.
We
are not currently profitable and may never become
profitable.
We
have
generated no revenues to date from product sales. Our accumulated
deficit as of September 30, 2007 and December 31, 2006 was $24,097,441
and $20,690,326, respectively. For the nine months ended
September 30, 2007 and the year ended December 31, 2006, we had net
losses of $3,407,115 and $6,486,003, respectively, primarily as a result
of
expenses incurred through a combination of research and development activities
related to the various technologies under our control and expenses supporting
those activities. Even if we succeed in developing and
commercializing one or more of our drug candidates, we expect to incur
substantial losses for the foreseeable future and may never become
profitable. We also expect to continue to incur significant operating
and capital expenditures and anticipate that our expenses will increase
substantially in the foreseeable future, based on the following
considerations:
|
·
|
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.
|
We
also
expect to continue to experience negative cash flow for the foreseeable future
as we fund our operating losses and capital expenditures. As a
result, we will need to generate significant revenues in order to achieve
profitability.
We
have a limited operating history.
We
are a
development-stage company with a limited number of drug
candidates. To date, we have not demonstrated an ability to perform
the functions necessary for the successful commercialization of any of our
drug
candidates. The successful commercialization of our drug candidates
will require us to perform a variety of functions, including, but not limited
to:
|
·
|
conducting
pre-clinical and clinical trials;
|
|
·
|
participating
in regulatory approval processes;
|
|
·
|
formulating
and manufacturing products; and
|
|
·
|
conducting
sales and marketing activities.
|
To
date,
our operations have been limited to organizing and staffing our company,
acquiring, developing and securing our proprietary technology and undertaking,
through third parties, pre-clinical trials and clinical trials of our principal
drug candidates. These operations provide a limited basis for
assessment of our ability to commercialize drug candidates.
We
may not obtain the necessary U.S. or worldwide regulatory approvals to
commercialize our drug candidates.
We
will
need FDA approval to commercialize our drug candidates in the U.S. and
approvals from the FDA-equivalent regulatory authorities in foreign
jurisdictions to commercialize our drug candidates in those
jurisdictions. In order to obtain FDA approval of our drug
candidates, we must submit to the FDA a New Drug Application
("NDA") demonstrating that the drug candidate is safe for humans and
effective for its intended use. This demonstration requires
significant research and animal tests, which are referred to as pre-clinical
studies, as well as human tests, which are referred to as clinical
trials. Satisfaction of the FDA's regulatory requirements typically
takes many years, and depends upon the type, complexity and novelty of the
drug
candidate and requires substantial resources for research, development and
testing. We cannot predict whether our research and clinical
approaches will result in drugs that the FDA considers safe for humans and
effective for indicated uses. Two of our drug candidates, Archexin
and RX-0047, are ASO compounds. To date, the FDA has not approved any
NDAs for any ASO compounds, except one eye care medicine, Vitravene (fomivirsen
sodium injectable). In addition, both Archexin and RX-0047
are of a drug class (Akt inhibitor, in the case of Archexin, and HIF
inhibitor, in the case of RX-0047) that has not been approved by the FDA
to
date. After the clinical trials are completed, the FDA
has substantial discretion in the drug approval process and may require us
to
conduct additional pre-clinical and clinical testing or to perform
post-marketing studies.
In
foreign jurisdictions, we must receive approval from the appropriate regulatory
authorities before we can commercialize our drugs. Foreign regulatory
approval processes generally include all of the risks associated with the
FDA
approval procedures described above. We cannot assure you that we
will receive the approvals necessary to commercialize our drug candidates
for
sale outside the United States.
Our
drug candidates are in early stages of clinical
trials.
Our
drug
candidates are in an early stage of development and require extensive clinical
testing, which is very expensive, time-consuming and difficult to
design. In 2007, Archexin, an oncology drug
candidate, entered Phase II clinical
trials. We plan to initiate, subject to
obtaining sufficient additional financing, Phase II clinical trials of Serdaxin
and Zoraxel, neuroscience and sexual dysfunction drug candidates, beginning
in
the winter of 2007.
Clinical
trials are very expensive, time-consuming and difficult to design and
implement.
Human
clinical trials are very expensive and difficult to design and implement,
in
part because they are subject to rigorous regulatory
requirements. The clinical trial process is also time
consuming. We estimate that clinical trials of our current drug
candidates will take at least three years to complete. Furthermore,
failure can occur at any stage of the trials, and we could encounter problems
that cause us to abandon or repeat clinical trials. The commencement
and completion of clinical trials may be delayed by several factors, including,
but not limited to:
|
·
|
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.
|
In
addition, we or the FDA may suspend clinical trials at any time if it appears
that we are exposing participants to unacceptable health risks or if the
FDA
finds deficiencies in our IND submissions or the conduct of these
trials.
If
the results of our clinical trials fail to support our drug candidate claims,
the completion of development of such drug candidate may be significantly
delayed or we may be forced to abandon development altogether, which will
significantly impair our ability to generate product
revenues.
Even
if
our clinical trials are completed as planned, we cannot be certain that our
results will support our drug candidate claims. Success in
pre-clinical testing and early clinical trials does not ensure that later
clinical trials will be successful, and we cannot be sure that the results
of
later clinical trials will replicate the results of prior clinical trials
and
pre-clinical testing. The clinical trial process may fail to
demonstrate that our drug candidates are safe for humans and effective for
indicated uses. This failure would cause us to abandon a drug
candidate and may delay development of other drug candidates. Any
delay in, or termination of, our clinical trials will delay the filing of
our
NDAs with the FDA and, ultimately, delay our ability to commercialize our
drug
candidates and generate product revenues. In addition, our trial
designs may involve a small patient population. Because of the small
sample size, the results of early clinical trials may not be indicative of
future results.
If
physicians and patients do not accept and use our drugs, our ability to generate
revenue from sales of our products will be materially
impaired.
Even
if
the FDA approves our drug candidates, physicians and patients may not accept
and
use them. Future acceptance and use of our products will depend upon
a number of factors including:
|
·
|
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.
|
Because
we expect sales of our current drug candidates, if approved, to generate
substantially all of our product revenues for the foreseeable future, the
failure of any of these drugs to find market acceptance would harm our business
and could require us to seek additional financing.
Much
of our drug development program depends upon third-party researchers, and
the
results of our clinical trials and such research activities are, to a limited
extent, beyond our control.
We
depend
upon independent investigators and collaborators, such as universities and
medical institutions, to conduct our pre-clinical and clinical trials and
toxicology studies. This business practice is typical for the
pharmaceutical industry and companies like us. For example, the
Phase I clinical trials of Archexin were conducted at the Lombardi
Comprehensive Cancer Center of Georgetown Medical Center and the University
of
Alabama at Birmingham, with the assistance of Amarex, LLC, a pharmaceutical
clinical research service provider who is responsible for creating the reports
that will be submitted to the FDA. We also relied on TherImmune
Research Corporation (now named Bridge Global Pharmaceutical Services, Inc.),
a
discovery and pre-clinical service provider, to summarize Archexin 's
pre-clinical data. While we make every effort internally to oversee
their work, these collaborators are not our employees and we cannot control
the
amount or timing of resources that they devote to our programs. These
investigators may not assign priority to our programs or pursue them as
diligently as we would if we were undertaking such programs
ourselves. If outside collaborators fail to devote sufficient time
and resources to our drug-development programs, or if their performance is
substandard, the approval of our FDA applications, if any, and our introduction
of new drugs, if any, may be delayed. 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 results in additional
cost to us, a higher than expected expense may result. These
collaborators may also have relationships with other commercial entities,
some
of whom may compete with us. If our collaborators assist our
competitors at our expense, our competitive position would be
harmed.
We
rely exclusively on third parties to formulate and manufacture our drug
candidates, which expose us to a number of risks that may delay development,
regulatory approval and commercialization of our products or result in higher
product costs.
We
have
no experience in drug formulation or manufacturing. Internally, we
lack the resources and expertise to formulate or manufacture our own drug
candidates. Therefore, we rely on third party expertise to support us
in this area. For example, we have entered into contracts with
third-party manufacturers such as Raylo Chemicals Inc., Formatech, Inc.,
Avecia
Biotechnology Inc. and UPM Pharmaceuticals, Inc. to manufacture, supply,
store
and distribute supplies of our drug candidates for our clinical
trials. If any of our drug candidates receive FDA approval, we will
rely on these or other third-party contractors to manufacture our
drugs. Our reliance on third-party manufacturers exposes us to the
following potential risks:
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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.
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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.
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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.
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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.
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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.
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Each
of
these risks could delay our clinical trials, drug approval and commercialization
and potentially result in higher costs and/or reduced revenues.
We
have no experience selling, marketing or distributing products and currently
no
internal capability to do so.
We
currently have no sales, marketing or distribution
capabilities. While we intend to have a role in the commercialization
of our products, we do not anticipate having the resources in the foreseeable
future to globally develop sales and marketing capabilities for all of our
proposed products. Our future success depends, in part, on our
ability to enter into and maintain collaborative relationships with other
companies having sales, marketing and distribution capabilities, the
collaborator's strategic interest in the products under development and such
collaborator's ability to successfully market and sell any such
products. To the extent that we decide not to, or are unable to,
enter into collaborative arrangements with respect to the sales and marketing
of
our proposed products, significant capital expenditures, management resources
and time will be required to establish and develop an in-house marketing
and
sales force with technical expertise. We cannot assure you that we
will be able to establish or maintain relationships with third party
collaborators or develop in-house sales and distribution
capabilities. To the extent that we depend on third parties for
marketing and distribution, any revenues we receive will depend upon the
efforts
of such third parties, as well as the terms of its agreements with such third
parties, which cannot be predicted at this early stage of our
development. We cannot assure you that such efforts will be
successful. In addition, we cannot assure you that we will be able to
market and sell our products in the United States or overseas.
Developments
by competitors may render our products or technologies obsolete or
non-competitive.
We
will
compete against fully integrated pharmaceutical companies and smaller companies
that are collaborating with larger pharmaceutical companies, academic
institutions, government agencies and other public and private research
organizations, such as Keryx Biopharmaceuticals Genta Incorporated and Imclone
Systems Incorporated. In addition, many of these competitors, either
alone or together with their collaborative partners, operate larger research
and
development programs or have substantially greater financial resources than
we
do, as well as more experience in:
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developing
drugs;
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undertaking
pre-clinical testing and human clinical
trials;
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obtaining
FDA and other regulatory approvals of
drugs;
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formulating
and manufacturing drugs; and
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launching,
marketing and selling drugs.
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Large
pharmaceutical companies such as Bristol-Myers, Squibb, Eli-Lilly, Novartis
and
Glaxo-SmithKline currently sell both generic and proprietary compounds for
the
treatment of cancer. In addition, companies pursuing different but
related fields represent substantial competition. Many of these
organizations have substantially greater capital resources, larger research
and
development staffs and facilities, longer drug development history in obtaining
regulatory approvals and greater manufacturing and marketing capabilities
than
we do. These organizations also compete with us to attract qualified
personnel, parties for acquisitions, joint ventures or other
collaborations.
If
we fail to adequately protect or enforce our intellectual property rights
or
secure rights to patents of others, the value of our intellectual property
rights would diminish and our business and competitive position would
suffer.
Our
success, competitive position and future revenues will depend in part on
our
ability and the abilities of our licensors to obtain and maintain patent
protection for our products, methods, processes and other technologies, to
preserve our trade secrets, to prevent third parties from infringing on our
proprietary rights and to operate without infringing the proprietary rights
of
third parties. We have filed U.S. and PCT patent applications
for anti-Akt compounds, including Archexin, and for anti-HIF compounds,
including RX-0047. In November 2006, we were granted a
U.S. patent for our anti-Akt compounds, including Archexin. The
patent covers the nucleotide sequences of the anti-sense compounds that target
and inhibit the expression of Akt in human tissues or cells. The
patent also covers the method of using the compounds to induce cytotoxicity
in
cancer cells. In June of 2007, we were granted a U.S. patent for
our RX-0047 compound, which is scheduled to enter Phase I Clinical trials
in 2008. We have also filed three U.S. provisional patent
applications for new anti-cancer quinazoline compounds, new anti-cancer
nucleoside products and a drug target, cenexin, a polo-box binding
protein. In December 2004, we also filed two Korean patent
applications for new anti-cancer piperazine compounds. Through our
licensing agreement with Revaax, we hold exclusive rights to five patents
and 14 patent applications, with respect to certain chemical structures
related to antibiotics, but without antibiotic efficacy. However, we
cannot predict:
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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;
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if
and when patents will be issued;
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·
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whether
or not others will obtain patents claiming aspects similar to those
covered by our licensed patents and patent applications;
or
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·
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whether
we will need to initiate litigation or administrative proceedings
which
may be costly whether we win or
lose.
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Our
success also depends upon the skills, knowledge and experience of our scientific
and technical personnel, our consultants and advisors as well as our licensors
and contractors. To help protect our proprietary know-how and our
inventions for which patents may be unobtainable or difficult to obtain,
we rely
on trade secret protection and confidentiality agreements. To this
end, we require all employees to enter into agreements that prohibit the
disclosure of confidential information and, where applicable, require disclosure
and assignment to us of the ideas, developments, discoveries and inventions
important to our business. These agreements may not provide adequate
protection for our trade secrets, know-how or other proprietary information
in
the event of any unauthorized use or disclosure or the lawful development
by
others of such information. If any of our trade secrets, know-how or
other proprietary information is disclosed, the value of our trade secrets,
know-how and other proprietary rights would be significantly impaired and
our
business and competitive position would suffer.
If
we infringe the rights of third parties we could be prevented from selling
products and be forced to pay damages and defend against
litigation.
If
our
products, methods, processes and other technologies infringe the proprietary
rights of other parties, we could incur substantial costs and may have
to:
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obtain
licenses, which may not be available on commercially reasonable
terms, if
at all;
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redesign
our products or processes to avoid
infringement;
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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;
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pay
damages; or
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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.
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Although
to date, we have not received any claims of infringement by any third parties,
as our drug candidates move into clinical trials and commercialization, our
public profile and that of our drug candidates may be raised and generate
such
claims.
Our
license agreement with Revaax may be terminated in the event we commit a
material breach, the result of which would significantly harm our business
prospects.
Our
license agreement with Revaax is subject to termination by Revaax if we
materially breach our obligations under the agreement, including breaches
with
respect to certain installment payments and royalty payments, if such breaches
are not cured within a 60-day period. The agreement also
provides that it may be terminated if we become involved in a bankruptcy,
insolvency or similar proceeding. If this license agreement is
terminated, we will lose all of our rights to develop and commercialize the
licensed compounds, including Serdaxin and Zoraxel, which would significantly
harm our business and future prospects.
If
we are unable to successfully manage our growth, our business may be
harmed.
In
addition to our own internally developed drug candidates, we proactively
seek
opportunities to license in and advance compounds in oncology and other
therapeutic areas that are strategic and have value creating potential to
take
advantage of our development know-how. We are actively pursuing
additional drug candidates to acquire for development. Such
additional drug candidates could significantly increase our capital requirements
and place further strain on the time of our existing personnel, which may
delay
or otherwise adversely affect the development of our existing drug
candidates. Alternatively, we may be required to hire more employees,
further increasing the size of our organization and related
expenses. If we are unable to manage our growth effectively, we may
not efficiently use our resources, which may delay the development of our
drug
candidates and negatively impact our business, results of operations and
financial condition.
We
may not be able to attract and retain qualified personnel necessary for the
development and commercialization of our drug candidates. Our success
may be negatively impacted if key personnel leave.
Attracting
and retaining qualified personnel will be critical to our future
success. We compete for qualified individuals with numerous
biopharmaceutical companies, universities and other research
institutions. Competition for such individuals is intense, and we
cannot assure you that we will be successful.
The
loss
of the technical knowledge and management and industry expertise of any of
our
key personnel, especially Dr. Chang H. Ahn, our Chairman and Chief
Executive Officer and regulatory expert, could result in delays in product
development and diversion of management resources, which could adversely
affect
our operating results. We do not have "key person" life insurance
policies for any of our officers.
We
may incur substantial liabilities and may be required to limit commercialization
of our products in response to product liability
lawsuits.
The
testing and marketing of medical products entail an inherent risk of product
liability. If we cannot successfully defend ourselves against product
liability claims, we may incur substantial liabilities or be required to
limit
commercialization of our products. Our inability to obtain sufficient
product liability insurance at an acceptable cost to protect against potential
product liability claims could prevent or inhibit the commercialization of
pharmaceutical products we develop, alone or with
collaborators. Although we currently carry clinical trial insurance
and product liability insurance we, or any collaborators, may not be able
to
maintain such insurance at a reasonable cost. Even if our agreements
with any future collaborators entitles us to indemnification against losses,
such indemnification may not be available or adequate should any claim
arise.
An
investment in shares of our common stock is very speculative and involves
a very
high degree of risk.
To
date,
we have generated no revenues from product sales and only minimal revenues
from
a research agreement with a minority shareholder, and interest on bank account
balances and short-term investments. Our accumulated deficit as of
September 30, 2007 and December 31, 2006 was $24,097,441 and
$20,690,326, respectively. For nine months ended September 30,
2007 and the year ended December 31, 2006, we had net losses of $3,407,115
and $6,486,003, respectively, primarily as a result of expenses incurred
through
a combination of research and development activities related to the various
technologies under our control and expenses supporting those
activities. Until we receive approval from the FDA and other
regulatory authorities for our drug candidates, we cannot sell our drugs
and
will not have product revenues.
The
market price of our common stock may fluctuate
significantly.
The
market price of our common stock may fluctuate significantly in response
to
factors, some of which are beyond our control, such as:
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the
announcement of new products or product enhancements by us or our
competitors;
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developments
concerning intellectual property rights and regulatory
approvals;
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variations
in our and our competitors' results of
operations;
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changes
in earnings estimates or recommendations by securities analysts;
and
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developments
in the biotechnology industry.
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Further,
the stock market, in general, and the market for biotechnology companies,
in
particular, have experienced extreme price and volume
fluctuations. Continued market fluctuations could result in extreme
volatility in the price of our common stock, which could cause a decline
in the
value of our common stock. You should also be aware that price
volatility might be worse if the trading volume of our common stock is low,
which has been the case historically. We have not paid, and do not
expect to pay, any cash dividends because we anticipate that any earnings
generated from future operations will be used to finance our operations and
as a
result, you will not realize any income from an investment in our common
stock
until and unless you sell your shares at a profit.
Some
or
all of the "restricted" shares of our common stock issued in the merger of
CPRD
and Rexahn, Corp in May 2007 or held by other stockholders may be offered
from
time to time in the open market pursuant to Rule 144, and these sales may
have a depressive effect on the market for our common stock. In
general, a person who has held restricted shares for a period of one year
may,
upon filing with the SEC a notification on Form 144, sell into the market
common stock in an amount equal to 1 percent of the outstanding shares
(approximately 500,000 shares) during a three-month period. Any
of the restricted shares may be freely sold by a non-affiliate after they
have
been held two years.
Trading
of our common stock is limited.
Trading
of our common stock is currently conducted on the National Association of
Securities Dealers' Over-the-Counter Bulletin Board ("OTC-BB"). The
liquidity of our securities has been limited, not only in terms of the number
of
securities that can be bought and sold at a given price, but also through
delays
in the timing of transactions and reduction in security analysts' and the
media's coverage of us.
These
factors may result in lower prices for our common stock than might otherwise
be
obtained and could also result in a larger spread between the bid and asked
prices for our common stock. Currently, there are approximately 510
holders of record of our common stock.
Because
our common stock may be a "penny stock," it may be more difficult for you
to
sell shares of our common stock, and the market price of our common stock
may be
adversely affected.
Our
common stock may be a "penny stock" if, among other things, the stock price
is
below $5.00 per share, we are not listed on a national securities exchange
or approved for quotation on the Nasdaq Stock Market, or we have not met
certain
net tangible asset or average revenue requirements. Broker-dealers
who sell penny stocks must provide purchasers of these stocks with a
standardized risk-disclosure document prepared by the SEC. This
document provides information about penny stocks and the nature and level
of
risks involved in investing in the penny-stock market. A broker must
also give a purchaser, orally or in writing, bid and offer quotations and
information regarding broker and salesperson compensation, make a written
determination that the penny stock is a suitable investment for the purchaser,
and obtain the purchaser's written agreement to the
purchase. Broker-dealers must also provide customers that hold penny
stock in their accounts with such broker-dealer a monthly statement containing
price and market information relating to the penny stock. If a penny
stock is sold in violation of the penny stock rules, purchasers may be able
to
cancel their purchase and get their money back. If applicable, the
penny stock rules may make it difficult for investors to sell their shares
of
our stock. Because of the rules and restrictions applicable to a
penny stock, there is less trading in penny stocks and the market price of
our
common stock may be adversely affected. Also, many brokers choose not
to participate in penny stock transactions. Accordingly, purchasers
may not always be able to resell shares of our common stock publicly at times
and prices that they feel are appropriate.
Item 3. CONTROLS
AND
PROCEDURES
Evaluation
of Disclosure Controls and Procedures
As
of
September 30, 2007, our management carried out an evaluation, under the
supervision of our Chief Executive Officer and Chief Financial Officer of
the
effectiveness of the design and operation of our system of disclosure controls
and procedures pursuant to Rule 13a-15(e) and 15d-15(e) under the
Securities Exchange Act of 1934, as amended, or the Exchange
Act. Based upon that evaluation, the Chief Executive Officer and the
Chief Financial Officer have concluded that our disclosure controls and
procedures were effective, as of the date of this evaluation, for the purposes
of recording, processing, summarizing and timely reporting material information
required to be disclosed in reports filed by us under the Exchange
Act.
There
were no changes in our internal control over financial reporting during the
quarter ended September 30, 2007 that have materially affected, or are
reasonably likely to affect, our financial reporting.
PART
II
–
OTHER
INFORMATION
Item 1. LEGAL
PROCEEDINGS
We
are
not subject to any pending legal proceedings, nor are we aware of any threatened
claim against us.
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 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
|
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant caused
this
report to be signed on its behalf by the undersigned, thereunto duly
authorized.
REXAHN
PHARMACEUTICALS, INC.
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/s/
Ted T. H. Jeong
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Name:
Ted T. H. Jeong
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Title:
Chief Financial Officer and Secretary
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Date: November
14, 2007
|
EXHIBIT INDEX
|
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
|
33