10QSB: Optional form for quarterly and transition reports of small business issuers
Published on November 14, 2005
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, 2005
*
|
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
*
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes *
No T
APPLICABLE
ONLY TO CORPORATE ISSUERS
State
the
number of shares outstanding of each of the registrant's classes of common
equity, as of the latest practicable date: 45,720,632 shares issued and
outstanding as of November 11, 2005
Traditional
Small Business Disclosure Format (Check one): Yes
*
No T
INDEX
PAGE
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1
|
|
2
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3
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4
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5
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15
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30
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32
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32
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32
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32
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32
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33
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PART
I - FINANCIAL INFORMATION
Item
1.
- Financial Statements
REXAHN
PHARMACEUTICALS,
INC. AND SUBSIDIARY
(A
Development Stage Company)
Consolidated
Condensed Balance Sheets
September
30,
2005
|
December
31,
2004
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
Assets
|
|||||||
Cash
and cash equivalents
|
$
|
4,311,765
|
$
|
1,015,979
|
|||
Short-term
investments
|
7,383,033
|
-
|
|||||
Prepaid
expenses and other
|
31,440
|
16,195
|
|||||
Total
Current Assets
|
11,726,238
|
1,032,174
|
|||||
Equipment,
Net (note
3)
|
180,320
|
189,623
|
|||||
Intangible
Assets
(note 4)
|
347,528
|
-
|
|||||
Total
Assets
|
$
|
12,254,086
|
$
|
1,221,797
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||||||
Current
Liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
584,321
|
$
|
435,968
|
|||
Current
portion of long-term obligation (note 4)
|
187,500
|
-
|
|||||
Total
Current Liabilities
|
771,821
|
435,968
|
|||||
Long-term
obligation, net of current portion (note 4)
|
30,149
|
-
|
|||||
Long-term
convertible debt (note 5)
|
5,150,000
|
-
|
|||||
Deferred
revenue (note 6)
|
1,293,750
|
1,350,000
|
|||||
Total
Liabilities
|
7,245,720
|
1,785,968
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders'
Equity (Deficit) (note
7):
|
|||||||
Common
Stock, par value $0.0001 at September 30, 2005 and $0.01 at December
31,
2004
|
4,571
|
76,281
|
|||||
Additional
Paid In Capital
|
16,101,450
|
7,214,331
|
|||||
Accumulated
Deficit During the Development Stage
|
(11,097,655
|
)
|
(7,854,783
|
)
|
|||
Total
Stockholders' Equity (Deficit)
|
5,008,366
|
(564,171
|
)
|
||||
Total
Liabilities and Stockholders' Equity (Deficit)
|
$
|
12,254,086
|
$
|
1,221,797
|
REXAHN
PHARMACEUTICALS,
INC. AND SUBSIDIARY
(A
Development Stage Company)
Consolidated
Condensed Statements of Operations
(Unaudited)
Cumulative
from
March
19, 2001
(Inception)
to
September
30,
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||||
2005
|
2005
|
2004
|
2005
|
2004
|
||||||||||||
Revenue
|
||||||||||||||||
Interest
and other income
|
$
|
295,150
|
$
|
57,542
|
$
|
22,403
|
$
|
94,311
|
$
|
51,255
|
||||||
Research
|
206,250
|
18,750
|
18,750
|
56,250
|
56,250
|
|||||||||||
501,400
|
76,292
|
41,153
|
150,561
|
107,505
|
||||||||||||
Expenses
|
||||||||||||||||
General
and administrative
|
5,134,076
|
682,789
|
386,231
|
1,879,620
|
799,610
|
|||||||||||
Research
and development
|
4,707,871
|
185,334
|
619,224
|
740,771
|
1,489,767
|
|||||||||||
Stock
option compensation expense (note 8)
|
1,234,271
|
238,118
|
88,771
|
465,427
|
251,159
|
|||||||||||
Patent
fees
|
156,542
|
52,039
|
-
|
107,481
|
9,748
|
|||||||||||
Interest
|
141,707
|
59,808
|
1,993
|
137,027
|
2,993
|
|||||||||||
Depreciation
|
224,588
|
30,074
|
9,530
|
63,107
|
32,821
|
|||||||||||
11,599,055
|
1,248,162
|
1,105,749
|
3,393,433
|
2,586,098
|
||||||||||||
Net
Loss
|
$
|
(11,097,655
|
)
|
$
|
(1,171,870
|
)
|
$
|
(1,064,596
|
)
|
$
|
(3,242,872
|
)
|
$
|
(2,478,593
|
)
|
|
Loss
per weighted average number of shares outstanding basic and
diluted
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.08
|
)
|
$
|
(0.06
|
)
|
||||
Weighted
average number of shares outstanding basic and diluted
|
43,943,795
|
38,133,330
|
40,648,411
|
38,133,330
|
REXAHN
PHARMACEUTICALS,
INC. AND SUBSIDIARY
(A
Development Stage Company)
Consolidated
Condensed Statements of Changes in Stockholders' Equity
(Unaudited)
March
19, 2001 (Inception) to September 30, 2005
(Unaudited)
Number
of
Shares
|
Common
Stock
|
Additional
Paid
In
Capital
|
Accumulated
Deficit
During
the
Development
State
|
Total
Stockholders'
Equity
|
||||||||||||
Opening
balance, March 19, 2001
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
|||||||
Common
shares issued
|
7,126,666
|
71,266
|
4,448,702
|
-
|
4,519,968
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(625,109
|
)
|
(625,109
|
)
|
|||||||||
Balance,
December 31, 2001
|
7,126,666
|
71,266
|
4,448,702
|
(625,109
|
)
|
3,894,859
|
||||||||||
Net
loss
|
-
|
-
|
-
|
(1,181,157
|
)
|
(1,181,157
|
)
|
|||||||||
Balance,
December 31, 2002
|
7,126,666
|
71,266
|
4,448,702
|
(1,806,266
|
)
|
2,713,702
|
||||||||||
Common
shares issued
|
500,000
|
5,000
|
1,995,000
|
-
|
2,000,000
|
|||||||||||
Stock
option compensation
|
-
|
-
|
538,074
|
-
|
538,074
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(2,775,075
|
)
|
(2,775,075
|
)
|
|||||||||
Balance,
December 31, 2003
|
7,626,666
|
76,266
|
6,981,776
|
(4,581,341
|
)
|
2,476,701
|
||||||||||
Common
shares issued
|
1,500
|
15
|
1,785
|
-
|
1,800
|
|||||||||||
Stock
option compensation
|
-
|
-
|
230,770
|
-
|
230,770
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(3,273,442
|
)
|
(3,273,442
|
)
|
|||||||||
Balance,
December 31, 2004
|
7,628,166
|
76,281
|
7,214,331
|
(7,854,783
|
)
|
(564,171
|
)
|
|||||||||
Stock
split (5 for 1)
|
30,512,664
|
(72,467
|
)
|
72,467
|
-
|
-
|
||||||||||
Common
shares issued in connection with the merger
|
3,397,802
|
340
|
(340
|
)
|
-
|
-
|
||||||||||
Stock
option compensation
|
-
|
-
|
465,427
|
-
|
465,427
|
|||||||||||
Common
shares issued for cash
|
4,175,000
|
417
|
8,349,565
|
-
|
8,349,982
|
|||||||||||
Net
loss (unaudited)
|
-
|
-
|
-
|
(3,242,872
|
)
|
(3,242,872
|
)
|
|||||||||
Balance,
September 30, 2005
|
45,713,632
|
$
|
4,571
|
$
|
16,101,450
|
$
|
(11,097,655
|
)
|
$
|
5,008,366
|
REXAHN
PHARMACEUTICALS,
INC. AND SUBSIDIARY
(A
Development Stage Company)
Consolidated
Condensed Statements of Cash Flows
(Unaudited)
Cumulative
from
March
19, 2001
(Inception)
to
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||
2005
|
2005
|
2004
|
||||||||
Cash
Flows from Operating Activities:
|
||||||||||
Net
loss
|
$
|
(11,097,655
|
)
|
$
|
(3,242,872
|
)
|
$
|
(2,478,593
|
)
|
|
Adjustments
to reconcile net loss to net cash (used in) operating
activities:
|
||||||||||
Depreciation
|
224,588
|
63,107
|
32,821
|
|||||||
Stock
option compensation expense
|
1,234,271
|
465,427
|
251,159
|
|||||||
Deferred
revenue
|
1,293,750
|
(56,250
|
)
|
(56,250
|
)
|
|||||
Changes
in assets and liabilities
|
||||||||||
Prepaid
expenses and other
|
(31,440
|
)
|
(15,245
|
)
|
(10,034
|
)
|
||||
Accounts
payable and accrued expenses
|
584,321
|
148,354
|
(43,677
|
)
|
||||||
Net
Cash Used in Operating Activities
|
(7,792,165
|
)
|
(2,637,479
|
)
|
(2,304,574
|
)
|
||||
Cash
Flows from Investing Activities:
|
||||||||||
Short-term
investments
|
(7,383,033
|
)
|
(7,383,033
|
)
|
2,000,000
|
|||||
Purchase
of equipment
|
(396,220
|
)
|
(45,117
|
)
|
(121,287
|
)
|
||||
Net
Cash (Used
in)
Provided by Investing
Activities
|
(7,779,253
|
)
|
(7,428,150
|
)
|
1,878,713
|
|||||
Cash
Flows from Financing Activities
|
||||||||||
Issuance
of common stock
|
14,871,750
|
8,349,982
|
-
|
|||||||
Proceeds
from long-term debt
|
5,150,000
|
5,150,000
|
140,000
|
|||||||
Principal
payments on long-term debt
|
(138,567
|
)
|
(138,567
|
)
|
-
|
|||||
Net
Cash Provided by Financing Activities
|
19,883,183
|
13,361,415
|
140,000
|
|||||||
Net
Increase (Decrease)
in Cash and Cash Equivalents
|
4,311,765
|
3,295,786
|
(285,861
|
)
|
||||||
Cash
and Cash Equivalents,
beginning of period
|
-
|
1,015,979
|
2,016,092
|
|||||||
Cash
and Cash Equivalents, end of period
|
$
|
4,311,765
|
$
|
4,311,765
|
$
|
1,730,231
|
||||
Supplemental
Cash Flow Information
|
||||||||||
Cash
paid for interest:
|
||||||||||
Interest
|
$
|
6,956
|
$
|
2,277
|
$
|
2,665
|
||||
Non-Cash
Investing and Financing Activities:
|
||||||||||
In
February 2005, the Company entered into a licensing agreement in
exchange
for debt of $356,215.
|
REXAHN
PHARMACEUTICALS, INC. AND SUBSIDIARY
(A
Development Stage Company)
Notes
to
Consolidated Condensed Financial Statements
Three
and
Nine Months Ended September 30, 2005 and 2004
(Unaudited)
1.
|
Organization
and Summary of Significant Accounting
Policies
|
The
accompanying unaudited consolidated financial statements of Rexahn
Pharmaceuticals, Inc. and Subsidiary (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 consolidated 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. The consolidated 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 of
accounting policy since December 31, 2004. The results from operations for
the
period are not necessarily indicative of the results expected for the full
fiscal year or any future period.
The
accounting policies followed by the Company are set forth in Note 1 to the
Company's financial statements included in its quarterly report on Form 10-QSB
for the period ended June 30, 2005, which note is incorporated herein by
reference. Specific reference is made to that report for more detailed
description of the Company's securities and the notes to financial statements
included therein, since certain information and footnote disclosures normally
included in financial statements in accordance with accounting principles
generally accepted in the United States of America have been condensed or
omitted from this report.
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, 2005 and 2004, the Company experienced net losses of $3,242,872
and $2,478,593, respectively. At September 30, 2005, the Company has an
accumulated deficit of $11,097,655.
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 for its first drug candidate, there can be
no
assurance of the success of the clinical trials or of the marketability of
the
drug.
Management
is pursuing various sources of financing. 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. In addition, the
Company has completed private placements of common stock and convertible debt
during 2005 that raised an aggregate of $13.5 million and may pursue additional
financings in the future. Although the Company plans to pursue additional
financing, there can be no assurance that the
1.
|
Organization
and Summary of Significant Accounting Policies
(cont'd)
|
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.
Pursuant
to an Agreement and Plan of Merger by and among Rexahn, Corp ("Rexahn"),
Corporate Road Show.Com Inc. ("CRS"), a New York corporation and predecessor
corporation of the Company, CRS Merger Sub, Inc., a Delaware corporation and
wholly owned subsidiary of CRS ("Merger Sub"), CRS Delaware, Inc., a Delaware
corporation and wholly owned subsidiary of CRS ("CRS Delaware"), immediately
after giving effect to a 1 for 100 reverse stock split and the reincorporation
of CRS as a Delaware corporation under the name Rexahn Pharmaceuticals, Inc.
("Rexahn Pharmaceuticals"), on May 13, 2005, Merger Sub merged with and into
Rexahn, with Rexahn surviving as a wholly owned subsidiary of Rexahn
Pharmaceuticals (the "Acquisition Merger"). In the Acquisition Merger, (i)
each
share of the issued and outstanding common stock of Rexahn (other than
dissenting shares) was converted into the right to receive five shares of Rexahn
Pharmaceuticals common stock; and (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.
Shares
of
Rexahn Pharmaceuticals common stock issued in the Acquisition Merger were exempt
from the registration requirements of the Securities Act of 1933, as amended
(the "Securities Act"), pursuant to Regulation D under the Securities Act and/or
Regulation S under the Securities Act. These shares of Rexahn Pharmaceuticals
common stock are deemed "restricted securities" and bear an appropriate
restrictive legend indicating that the resale of such shares may be made only
pursuant to registration under the Securities Act or pursuant to an available
exemption from such registration.
As
part
of the Acquisition Merger, the Company assumed the convertible notes further
described in Note 5 and the conversion price was adjusted to reflect the merger
exchange ratio.
For
accounting purposes, the Acquisition Merger is accounted for as a reverse
acquisition of CRS by Rexahn. As a result, following the Acquisition Merger,
the
historical financial statements of Rexahn became the historical financial
statements of the Company.
Merger
of
Subsidiary
On
September 29, 2005, the Company's wholly owned subsidiary, Rexahn, was merged
with and into the Company and Rexahn's separate existence was
terminated.
2.
|
Summary
of Significant Accounting
Policies
|
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.
Recent
Accounting Pronouncements Affecting the Company
In
December 2004, the FASB issued SFAS No. 153, "Exchanges of Non monetary Assets,
an amendment of APB Opinion No. 29". SFAS No. 153 replaces the exception from
fair value measurement in APB Opinion No. 29 for non-monetary exchanges of
similar productive assets with a
2.
|
Summary
of Significant Accounting Policies
(cont'd)
|
general
exception from fair value measurement for exchanges of non-monetary assets
that
do not have commercial substance. A non-monetary exchange has commercial
substance if the future cash flows of the entity are expected to change
significantly as a result of the exchange. SFAS No. 153 is to be applied
prospectively, and is effective for non-monetary asset exchanges occurring
in
fiscal periods after the December 2004 issuance of SFAS No. 153. The Company
does not believe the adoption of SFAS No. 153 will be significant to the overall
results of operations or financial position.
Recent
Accounting Pronouncements Affecting the Company (cont'd)
In
December 2004, the FASB issued SFAS No. 123 (revised 2004), "Share Based
Payment" ("SFAS No. 123R"). SFAS No. 123R requires the Company to measure the
cost of employee services received in exchange for an award of equity
instruments based on the grant date fair value of the award. The cost of the
employee services is recognized as compensation cost over the period that an
employee provides service in exchange for the award. SFAS No. 123R will be
effective January 1, 2006 for the Company and may be adopted using a modified
prospective method or a modified retrospective method. Although the Company
has
not yet completed an analysis to quantify the exact impact the new standard
will
have on its future financial performance, the disclosures in Note 8 provide
detail as to the Company's financial performance as if the Company had applied
the fair value based method and recognition provisions of SFAS No. 123R to
stock
based employee compensation to the current reporting periods.
In
March
2005, the FASB issued FASB Staff Position ("FSP") No. 46(R)-5, "Implicit
Variable Interests under FASB Interpretation No. ("FIN") 46 (revised December
2003), Consolidation of Variable Interest Entities" ("FSP FIN 46R-5"). FSP
FIN
46R-5 provides guidance for a reporting enterprise on whether it holds an
implicit variable interest in Variable Interest Entities ("VIEs") or potential
VIEs when specific conditions exist. This FSP is effective in the first period
beginning after March 3, 2005 in accordance with the transition provisions
of
FIN 46 (revised December 2003), "Consolidation of Variable Interest Entities
—
an Interpretation of Accounting Research Bulletin No. 51" ("FIN 46R"). The
Company has determined that the adoption of FSP FIN 46R-5 will not have an
impact on its results of operations and financial position.
3.
|
Equipment,
Net
|
Cost
|
September
30, 2005
Accumulated
Depreciation
|
Cost
|
December
31, 2004
Accumulated
Depreciation
|
||||||||||
Furniture
and fixtures
|
$
|
30,943
|
$
|
13,350
|
$
|
30,943
|
$
|
8,551
|
|||||
Office
equipment
|
39,048
|
21,998
|
28,848
|
18,336
|
|||||||||
Lab
equipment
|
321,544
|
176,941
|
286,628
|
131,492
|
|||||||||
Computer
equipment
|
5,066
|
3,992
|
5,066
|
3,483
|
|||||||||
$
|
396,601
|
$
|
216,281
|
$
|
351,485
|
$
|
161,862
|
||||||
Net
carrying amount
|
$
|
180,320
|
$
|
189,623
|
Equipment
is stated at cost less accumulated depreciation. Depreciation, based on the
estimated useful lives of the assets, is provided as follows:
Furniture
and fixtures
|
7
years
|
double
declining balance
|
|
Office
equipment
|
5
years
|
double
declining balance
|
|
Lab
equipment
|
7
years
|
double
declining balance
|
|
Computer
equipment
|
3
years
|
straight
line
|
4.
|
Intangible
Assets
|
On
February 10, 2005, the Company entered into a licensing agreement with Revaax
Pharmaceuticals LLC ("Revaax"), whereby the Company received an exclusive,
worldwide, royalty bearing license with the right to sub-license Revaax's
licensed technology and products.
The
agreement calls 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 has been measured at fair value at the date the licensing
agreement was entered into. The fair value of the liability component of
$347,528 as of September 30, 2005 has been determined by discounting the stream
of future payments of $46,875 at 6%, the prevailing market rate for a debt
instrument of comparable maturity and credit quality. The liability component
is
being accreted over the term of the liability, calculated based on the Company's
estimated effective market interest rate. Pursuant to the agreement, at
September 30, 2005, three installments had been paid. As at September 30, 2005,
the outstanding balance was $217,649.
5.
|
Long-Term
Debt
|
September
30,
2005
|
December
31,
2004
|
||||||
6%
Convertible Note (a)
|
$
|
3,850,000
|
$
|
-
|
|||
Convertible
Note (b)
|
1,300,000
|
-
|
|||||
$
|
5,150,000
|
$
|
-
|
a)
|
On
February 28, 2005, the Company issued, in a transaction exempt
from
registration under the Securities Act, $3,850,000 aggregate principal
amount of 6% convertible notes due on February
28,
|
5.
|
Long-Term
Debt (cont'd)
|
|
2008.
The notes are subject to conversion into shares of common stock
of the
Company, at the holder's option, at any time from and after the
earlier of
(i) the date of the first anniversary of the closing of the Acquisition
Merger and (ii) May 26, 2006 to the maturity date, February 28,
2008, at a
conversion price. The notes will be automatically converted upon
(i) the
closing of the sale of all or substantially all of the assets
of the
Company or any merger, consolidation or other business combination
and
(ii) the maturity date. The conversion price is equal to the
lesser of
$1.00 per share (as adjusted in the Acquisition Merger) and a
floating
price determined by the average of three lowest current market
prices of
Company common stock during the 40 calendar day period immediately
preceding conversion.
|
b)
|
On
August 8, 2005, the Company issued, in a transaction exempt from
registration under the Securities Act, $1,300,000 aggregate principal
amount of convertible notes due on August 8, 2008. The notes are
subject
to conversion into shares of common stock of the Company, at the
holder's
option, at any time from and after September 19, 2005 to the maturity
date, August 8, 2008 or upon the occurrence and continuation of
any events
of default at a conversion price of $2.00 per share. The notes
will be
automatically converted upon (i) the closing of the sale of all
or
substantially all of the assets of the Company or any merger,
consolidation or other business combination and (ii) the maturity
date.
The notes do not bear interest, except that any overdue principal
of the
notes will bear interest for each day from the maturity date to
the date
of actual payment, at a rate equal to 5% per annum, or, if an event
of
default occurs and is continuing, the notes will bear interest,
from the
date of the occurrence of such event of default until such event
of
default is cured or waived, at a rate equal to 5% per
annum.
|
6.
|
Deferred
Revenue
|
In
2003,
the Company entered into a collaborative research agreement with Rexgene
Biotech
Co., Ltd. ("Rexgene"), a minority shareholder. 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 revenue for the nine months ended September 30, 2005
and
2004 and $75,000 was included in revenues in each of the fiscal years ended
2004
and 2003. The remaining $1,293,750 at September 30, 2005 ($1,350,000 at December
31, 2004) is reflected as deferred revenue on the balance sheet.
7.
|
Capital
Stock
|
Authorized
|
|||||||
500,000,000
shares of common stock, par value $0.0001
|
|||||||
September
30, 2005
|
December
31, 2004
|
||||||
45,713,632
shares (2004 7,628,166 shares, par value $0.01) of common
stock
|
$
|
4,571
|
$
|
76,281
|
Pursuant
to the agreement and plan of merger as disclosed in Note 1, in the Acquisition
Merger, (i) each share of the issued and outstanding common stock of Rexahn
(other than dissenting shares) was converted into the right to receive five
shares of Rexahn Pharmaceuticals common stock; and (ii) each issued, outstanding
and unexercised option to purchase a share of Rexahn common stock
7.
|
Capital
Stock (cont'd)
|
was converted into an option to purchase five shares of Rexahn Pharmaceuticals 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.
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.
8.
|
Stock-Based
Compensation
|
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.
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.
The
exercise price of the options granted to employees were below the fair market
value of the common stock on the date of the grant. Using the intrinsic value
method, the total compensation cost for the nine-month
period ended September 30, 2005 amounted to $2,056,500 (2004-$672,000) and
is
being amortized over the vesting period. This total cost includes a recovery
of
compensation cost through the cancellation of 752,500 (2004 - 367,500) stock
options during the nine month periods. Accordingly, $465,427 (2004 - $251,159)
has been expensed in the statement of operations for the nine month periods
then
ended.
Pro
forma
information regarding net income is required to be disclosed in financial
statements by SFAS No. 148, "Accounting for Stock Based Compensation -
Transition and Disclosure", and has been determined as if the Company had
accounted for its employee stock options and employee stock purchase plan under
the fair value method of SFAS No. 123. The fair value for these options was
estimated at the dates of grant using the Black Scholes pricing model. The
weighted average fair value of the options granted to employees under this
method is $2.99 per option for a total cost of $2,343,700 (2004 - $729,600).
The
assumptions are evaluated annually and revised as necessary to reflect market
conditions and additional experience.
Nine
Months Ended
September
30,
|
|||||||
2005
|
2004
|
||||||
Net
(loss), as reported
|
$
|
(3,242,872
|
)
|
$
|
(2,478,593
|
)
|
|
Add:
Stock based employee compensation expense recorded under APB No.
25
intrinsic value method
|
305,946
|
127,540
|
|||||
Deduct:
Stock based employee compensation expense determined under Fair Value
based method for all employee awards
|
(403,476
|
)
|
(143,184
|
)
|
|||
Pro
forma net loss
|
$
|
(3,340,402
|
)
|
$
|
(2,494,237
|
)
|
|
Net
loss per share:
|
|||||||
Basic
and diluted as reported
|
$
|
(0.08
|
)
|
$
|
(0.06
|
)
|
|
Basic
and diluted pro forma
|
$
|
(0.08
|
)
|
$
|
(0.07
|
)
|
|
Black
Scholes Methodology Weighted Average Assumptions:
|
|||||||
Dividend
yield
|
0
|
0
|
|||||
Volatility
|
7
|
%
|
1
|
%
|
|||
Risk-free
interest rate
|
4.13
|
%
|
4.54
|
%
|
|||
Expected
lives of options
|
5
years
|
5
years
|
8.
|
Stock-Based
Compensation (cont'd)
|
Stock
option compensation has been expensed in the statement of operations for the
nine months ended September 30, 2005 and 2004, as follows:
Nine
Months Ended September 30,
|
|||||||
2005
|
2004
|
||||||
Employee
|
$
|
306,896
|
$
|
112,340
|
|||
Non
employees
|
158,531
|
138,819
|
|||||
Stock
option compensation expense
|
$
|
465,427
|
$
|
251,159
|
Stock
option activity related to employees and non employees from December 31, 2003
to
September 30, 2005 are listed below.
Shares
Subject
to
Options
|
Weighted
Avg.
Option
Prices
|
||||||
Outstanding
at December 31, 2003
|
1,850,000
|
$
|
0.24
|
||||
Granted
|
1,300,000
|
0.24
|
|||||
Exercised
|
(7,500
|
)
|
0.24
|
||||
Cancelled
|
(367,500
|
)
|
0.24
|
||||
Outstanding
at December 31, 2004
|
2,775,000
|
0.24
|
|||||
Granted
|
3,810,000
|
0.50
|
|||||
Cancelled
|
(752,500
|
)
|
0.24
|
||||
Outstanding
at September 30, 2005
|
5,832,500
|
$
|
0.41
|
The
weighted average remaining contractual life of the stock options is
approximately 9 years.
9.
|
Income
Taxes
|
The
Company accounts for income taxes in accordance with SFAS No. 109, "Accounting
for Income Taxes". SFAS No. 109 prescribes the use of the liability method
whereby deferred tax asset and liability account balances are determined based
on differences between financial reporting and tax bases of assets and
liabilities and are measured using the enacted tax rates. The effects of future
changes in tax laws or rates are not anticipated.
Under
SFAS No. 109 income taxes are recognized for the following: a) amount of tax
payable for the current year, and b) deferred tax liabilities and assets for
future tax consequences of events that have been recognized differently in
the
financial statements than for tax purposes.
The
Company has tax losses available to be applied against future years income.
Due
to the losses incurred in the current year and expected future operating
results, management has determined that, at the current time, it is more
likely
than not that the deferred tax asset resulting from the tax losses available
for
carryforward and stock option compensation expense will not be realized through
the reduction of future income tax payments. Accordingly a 100% valuation
allowance has been recorded to offset deferred income tax assets.
As
of
September 30, 2005 and 2004, the Company had approximately $1,978,432 and
$1,147,079 respectively, of federal and state net operating loss carryforwards
available to offset future taxable income; such carryforwards expire in various
years through 2024.
10.
|
Government
Assistance
|
On
December 13, 2003, the Company accepted an offer of a conditional grant from
the
Montgomery County Department of Economic Development for $100,000 to assist
in
the growth and expansion of the Company, which amount was received in February
2004. The terms of the offer state that $50,000 of the grant is convertible
to a
loan repayable over three years bearing interest at 20% per annum if, at any
time within five years from receipt of the grant, the Company's annual net
revenues exceed $1,000,000 or the Company obtains aggregate equity financing
of
over $2,000,000. This portion of the grant was recorded in accounts payable
at
December 31, 2004. The terms of the grant also state that the remaining $50,000
balance of the grant would be permanently forgiven when performance criteria
relating to lease of premises and employment commitments are met, provided
that
the forgiven amounts may only be applied to reducing business-related expenses.
In 2004 upon satisfaction of the performance criteria, the $50,000 amount was
forgiven and applied to lease payments and was recorded as a reduction of
business-related expenses. Following the Company's February 2005 convertible
debt financing, the remaining $50,000 was converted into a loan pursuant to
the
terms of the grant and was paid off by the Company in March 2005.
11.
|
Commitments
|
a)
|
In
April 2004, the Company entered into a clinical development agreement
with
Georgetown University with an effective period from April 5, 2004
through
April 5, 2006. The total estimated cost of the program is $223,126,
based
on the fees, enrolment and completion of 20 patients and is payable
based
on the progress of the treatment over the effective period of the
agreement. During the first nine months in 2005 and the 2004 fiscal
year,
the Company paid $0 and $17,426, respectively, towards the cost of
this
program. In addition, the Company extended a research agreement,
initially
entered into on January 1, 2004, until December 31, 2005 with Georgetown
University. For the nine-month period ended September 30, 2005, the
Company paid $60,000 in consideration of the
extension.
|
b)
|
On
August 17, 2004 the Company entered into an agreement for
Formatech, Inc. to monitor and perform stability studies on our drug
candidate, RX-0201. The total cost of these services is $46,700,
of which
$22,900 was paid in 2004, $5,200 was paid during the three months
ended
September 30, 2005, $5,200 is due during the fourth quarter of 2005,
$5,200 is due during 2006 and $8,200 is due during
2007.
|
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 are as
follows:
For
the year ended
December
31,
|
||||
2005
|
$
|
203,761
|
||
2006
|
209,874
|
|||
2007
|
216,170
|
|||
2008
|
222,656
|
|||
2009
|
112,973
|
|||
$
|
965,434
|
11.
|
Commitments
(cont'd)
|
d)
|
On
June 1, 2005, the Company signed a one year research project agreement
with the Korea Research Institute of Chemical Technology ("KRICT")
relating to the development of a synthetic process for the lead compound
of the quinoxalines acting on human cancer cells. In accordance with
the
agreement, the Company will pay KRICT a total sum of $100,000, of
which
$50,000 was paid in the three-month period ended September 30, 2005.
The
remaining $50,000 is due on or about October 30,
2005.
|
e)
|
On
August 1, 2005, the Company signed a one year contract with the University
of Massachusetts Medical School ("UMASS") to test proprietary drugs
in
preclinical behavioral assays of anxiety and cognition. The Company
agreed
to provide UMASS with a grant of $76,666, which includes the full
direct
and indirect costs of the preclinical study, payable in four equal
quarterly installments of $19,167. In the three-month period ended
September 30, 2005, the Company made one quarterly payment of
$19,167.
|
f)
|
On
August 3, 2005, the Company engaged Montgomery Pacific Group ("MPG")
to
act as the Company's financial advisor for a one-year term in connection
with its growth strategies, certain in-licensing activities and
acquisition of certain assets. In consideration of the services,
the
Company agreed to pay MPG an advisory fee, consisting of an initial
retainer fee and success fees subject to the successful closing of
licensing transactions, acquisitions and private placements. A retainer
fee of $50,000 was paid in the three-month period ended September
30,
2005.
|
12.
|
Comparative
Information
|
Certain
amounts for fiscal 2004 have been reclassified to conform with the current
year's financial statement presentation.
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 technologies, raising capital and recruiting personnel. We are a development
stage company and have no product sales to date and we will not have any product
sales until we receive approval from the Food and Drug Administration (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 our 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", "will", "intend"
and
other similar expressions, that are forward-looking statements. 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, our auditor's going concern qualification
and the
need for additional capital to operate our
business;
|
·
|
our
ability to obtain the necessary U.S. and worldwide regulatory approvals
for our drug candidates;
|
·
|
successful
and timely completion of clinical trials for our drug
candidates;
|
·
|
demand
for and market acceptance of our drug
candidates;
|
·
|
the
availability of qualified third-party researchers and manufacturers
for
our drug development programs;
|
·
|
our
ability to develop and obtain protection of our intellectual property;
and
|
·
|
other
risks and uncertainties, including those detailed from time to time
in our
filings with the Securities and Exchange Commission.
|
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 of 1995 are unavailable to issuers of "penny stock". Our shares are
considered a penny stock and, as a result, the safe harbors are 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.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires our management
to
make estimates and assumptions that affect certain reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the
date
of the financial statements and the reported amounts of expenses during the
reporting period. Actual results could differ from those estimates.
Stock-based
Compensation
We
account for stock-based employee compensation arrangements in accordance with
the provisions of Accounting Principles Board ("APB") Opinion No. 25,
"Accounting for Stock Issued to Employees" and comply with the disclosure
provisions of Statement of Financial Accounting Standards ("SFAS") No. 123,
"Accounting for Stock-Based Compensation." Stock-based awards issued to
non-employees are recorded at their fair values as determined in accordance
with
SFAS No. 123.
In
our
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. In addition, option valuation
models require the input of highly subjective assumptions, and changes in such
subjective assumptions can materially affect the fair value estimate of employee
stock options.
Recently
Issued Accounting Standards
For
a
discussion of recent significant accounting pronouncements applicable to us,
see
Note 2 of the Notes to Consolidated Condensed Financial Statements.
Going
Concern
Our
independent auditors have included an explanatory paragraph in their audit
report issued in connection with our year end financial statements, which states
that our recurring operating losses since inception raise substantial doubt
about our ability to continue as a going concern. Our financial statements
do
not include any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts or
classification of liabilities that might be necessary should we be unable to
continue as a going concern. For the foreseeable future, we will have to fund
all our operations and capital expenditures from the net proceeds of equity
or
debt offerings we may make, cash on hand, licensing fees and grants. Although
we
completed convertible debt and equity financing transactions during the nine
months ended September 30, 2005 that raised approximately $13.5 million, and
may
pursue additional financing, there can be no assurance that we will be able
to
secure financing when needed or to obtain such financing on terms satisfactory
to us, 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 planned
pre-clinical and clinical trials or obtain approval of our drug candidates
from
the FDA and other regulatory authorities. In addition, we could 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.
RESULTS
OF OPERATIONS
Comparison
of Three Months and Nine Months Ended September 30, 2005 and
2004
Total
Revenues
For
the
three-month and nine-month periods ended September 30, 2005, we recorded revenue
of $76,292 and $150,561, respectively, including $18,750 and $56,250 from the
recognition 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. We recorded $57,542 and $94,311 of interest and other
income from the investment of our cash and cash equivalents and other short-term
investments for the three-month and nine-month periods ended September 30,
2005,
respectively, compared to $22,403 and $51,255 for the same periods in 2004.
The
increase of $35,139 and $43,056 in revenues, or 85.4% and 40.1%, was primarily
due to an increase in interest income in the three-month and nine-month periods
ended September 30, 2005, respectively, compared to the same periods in 2004
as
a result of higher cash and cash equivalent balances from our financing
activities during the 2005 periods.
General
and Administrative Expenses
General
and administrative expenses increased $296,558 and $1,080,010, or 76.8% and
135.1%, from $386,231 and $799,610 for the three-month and nine-month periods
ended September 30, 2004 to $682,789 and $1,879,620, respectively, for the
same
periods ended September 30, 2005. The increase was due primarily to professional
fees and expenses incurred in connection with our reverse merger transaction
completed on May 13, 2005, including legal and accounting fees and expenses,
and
increased compliance costs associated with being a public company.
Research
and Development Expenses
Research
and development expenses decreased $433,890 and $748,996, or 70.1% and 50.3%,
from $619,224 and $1,489,767 for the three-month and nine-month periods ended
September 30, 2004 to $185,334 and $740,771 for the same periods ended
September 30, 2005. The
decrease was due primarily to the fact that the clinical trials of RX-0201,
one
of our drug candidates, have been ongoing without additional
payment during the nine-month period ended September 30, 2005. From
the fourth quarter of 2005, we expect that research and development expenses
will increase as our drug candidates move into the clinical trials phases of
development.
Stock
Option Compensation Expenses
In
2003
our board of directors adopted and our shareholders approved the Rexahn Stock
Option Plan. Under the plan, we incurred compensation expenses of $238,118
and
$465,427 for the three-month and nine-month periods ended September 30, 2005,
compared to compensation expenses of $88,771 and $251,159 for options issued
to
employees and non-employees for the same periods ended September 30,
2004.
Patent
Fees
Our
patent fees increased $52,039 from $0 and $97,733, or 1002%, from $9,748
for the three-month and nine-month periods ended September 30, 2004, to $52,039
and $107,481, respectively, for the same periods ended September 30, 2005.
The increase was due primarily to an increase in the number of patent filings
made during the nine-month period ended September 30, 2005 compared to the
same
period ended September 30, 2004.
Depreciation
Depreciation
expense increased $20,544 and $30,286, or 215.6% and 92.3%, from $9,530 and
$32,821 for the three-month and nine-month periods ended September 30, 2004
to
$30,074 and $63,107 for same periods ended September 30, 2005. The increase
was
due primarily to a move to a new facility in July 2004 and the related purchase
of new laboratory equipment.
Interest
Expense
Interest
expense increased $57,815 and $134,034, or 2900% and 4478%, from $1,993 and
$2,993 for the three-month and nine-month periods ended September 30, 2004
to
$59,808 and $137,027 for same periods ended September 30, 2005. The increase
was
due primarily to interest payable on the convertible notes issued in February
2005.
As
a
result of the above, the net loss for the three-month and nine-month periods
ended September 30, 2005 was $1,171,870 or $0.03 per share, and $3,242,872
or
$0.08 per share, respectively, compared to a net loss of $1,064,596 or $0.03
per
share, and $2,478,593 or $0.06 per share, respectively, for the same periods
ended September 30, 2004.
Research
and Development Projects
Research
and development expenses 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, RX-0201, RX-0047, RX-0183, RX-3117 and 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 candidate, RX-0201, is uncertain, and because RX-0047, RX-0183, RX-3117
and
RX-10100 are in early-stage development, we are unable to estimate the costs
of
completing our research and development programs, the timing of bringing such
programs to market and, therefore, when material cash inflows could commence
from the sale of these drug candidates. If these projects are not completed
as
planned, our results of operations and financial condition could be negatively
affected and if we are unable to obtain additional financing to fund these
projects, we may not be able to continue as a going concern.
RX-0201
RX-0201
is currently our leading drug candidate and has been in a Phase I clinical
trial
at Georgetown University's Lombardi Cancer Center since September 2004. The
costs incurred for the clinical trial to date have been approximately $750,000.
As the main purpose of this clinical trial is to establish the safety of
RX-0201, the parameters that determine the completion of this project are a
direct function of the safety profile of this compound in humans. As this is
the
first time that RX-0201 has been administered to humans, the safety profile
in
humans is unknown and therefore, the number of doses required to determine
the
dosage at which the FDA safety endpoints are met is an estimate. If more doses
are required than estimated, completion of the Phase I clinical trials may
be
delayed. Therefore, the costs, timing and efforts necessary to complete this
program also are estimates. We currently estimate that the completion of the
Phase I clinical trial will require approximately $300,000 and this Phase I
clinical trial is anticipated to be completed in 2006.
RX-0047,
RX-0183 and RX-3117
RX-0047,
RX-0183 and RX-3117 are all in a pre-clinical stage of development and the
next
scheduled program for each compound is a pre-clinical toxicology study required
prior to submission of an Investigational New Drug (IND) application to the
FDA.
The costs incurred for development of these compounds to date has been
approximately $500,000 for RX-0047, $450,000 for RX-0183 and $350,000 for
RX-3117. The estimated cost to complete each toxicology study is estimated
to be
approximately $650,000 per compound for a total of $1,950,000. These compounds
will be entered into these toxicology trials in 2006.
The
conduct of the clinical trial and toxicology studies described above are being
accomplished in conjunction with third-party 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.
RX-10100
RX-10100
is in early pre-IND stages of development and the next scheduled event is the
synthesis and testing of novel formulations for pre-clinical and clinical
evaluations. We currently estimate that these studies will require approximately
$100,000 and $500,000, respectively.
LIQUIDITY
AND CAPITAL RESOURCES
Cash
used
in operating activities was $2,637,479 for the nine-month period ended September
30, 2005 compared to cash used in operating activities of $2,304,574 for the
same period ended September 30, 2004. The operating cash flows during the
nine-month period ended September 30, 2005 reflect our loss from continuing
operations of $3,242,872, offset by non-cash charges of $472,284 and a net
increase in cash components of working capital of $133,109. Non-cash charges
consist of depreciation of $63,107, stock option compensation expense of
$465,427 and deferred revenue of $56,250. The increase in working capital
primarily consists of a $148,354 increase in accounts payable. Fiscal 2004
operating cash flows reflect our loss from continuing operations of $3,273,442,
offset by non-cash charges of $208,559 and a net increase in cash components
of
working capital of $184,258. Non-cash charges consist of depreciation of
$52,789, stock option compensation expense of $230,770 and deferred revenue
of
$75,000. The increase in working capital primarily consists of $189,486 increase
in accounts payable and $5,228 decrease in prepaid expenses and
other.
Cash
used
in investing activities of $7,428,150 during the nine-month period ended
September 30, 2005 reflects $7,383,033 for the purchase of short-term
investments and $45,117 of capital expenditures for the purchase of equipment.
Cash provided by investing activities of $1,878,713 during the nine-month period
ended September 30, 2004 reflects a capital expenditure of $121,287 for the
purchase of equipment and $2,000,000 proceeds from the sale of short-term
investments. Cash provided by financing activities of $13,361,415 during the
nine-month period ended September 30, 2005 reflects proceeds from the issuance
of common stock and long-term debt in financing transactions of $8,349,982
and
$5,150,000, respectively, and principal payments on long-term debt of $138,567.
Cash provided by financing activities of $140,000 during the nine-month period
ended September 30, 2004 consisted of proceeds from a bank loan.
For
the
nine-month period and the years ended September 30, 2005, December 31, 2004
and
2003, we experienced net losses of $3,242,872, $3,273,442 and $2,775,075,
respectively. Our accumulated deficit as of September 30, 2005, and December
31,
2004 and 2003 was $11,097,655, $7,854,783 and $4,581,341, respectively. Our
independent auditors have included an explanatory paragraph in their audit
opinion issued in connection with our year end financial statements which states
that our recurring operating losses since inception raise substantial doubt
about our ability to continue as a going concern.
We
have
financed our operations since inception primarily through equity and convertible
debt financings. During the nine-month period ended September 30, 2005, we
had a
net increase in cash and cash equivalents of $3,295,786. This increase primarily
resulted from $5,150,000 and $8,349,982 proceeds from the issuance of
convertible debt and common stock, respectively. Total cash resources as of
September 30, 2005 were $4,311,765 compared to $1,730,231 as of September 30,
2004.
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. 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.
Contractual
Obligations
In
April
2004, we entered into an office lease for a period of five years, commencing
on
July 1, 2004 and ending on June 30, 2009. The minimum rent increases at the
end
of each lease year by 3% of the rent amount that is then currently being paid.
Minimum annual lease payments for the 2005 to 2009 years are as follows:
$203,761; $209,874; $216,170; $222,655; and $112,972.
On
September 1, 2003 we entered into an agreement for The University of Texas
to
perform research on our behalf with respect to RX-0201 and RX-0047. On June
1,
2004 we extended the agreement to be carried out through February 28, 2005.
As
consideration for the services we paid a total of $78,069, of which $14,356
was
paid during the first quarter of 2005.
On
September 24, 2003 we entered into an agreement with Amarex, LLC to obtain
services to assist in the product development of RX-0201 during clinical trials.
The cost of these services is based on estimated hours to complete the study
and
is $239,337. 25% was due upon execution of the contract and the remaining amount
is due in four equal payments every 5 months with the final payment due upon
acceptance of the clinical study report. At December 31, 2004, we had paid
a
total of $194,461 with the balance of $44,876 due upon acceptance of the
clinical study report. On November 19, 2004 we amended our September 2003
agreement with Amarex, LLC providing for additional services to be performed
that were not included in the original agreement. The total cost of these
services is $67,011, of which $16,753 was paid upon execution of the agreement
in 2004, $25,129 is due during 2005, $12,565 is due in January 2006 and $12,565
is due upon acceptance of the final clinical study report. We paid Amarex,
LLC
$28,110 during the three months ended September 30, 2005.
In
April
2004, we entered into a clinical development agreement with Georgetown
University with an effective period from April 5, 2004 through April 5, 2006.
The total estimated costs of the program is $223,126, based on the fees and
the
enrollment and completion of 20 patients and is payable based on the progress
of
the treatment over the effective period of the agreement. During the first
nine
months in 2005 and the 2004 fiscal year, we paid $0 and $17,426, respectively,
towards the cost of this program. In addition, we extended a research agreement,
initially entered on January 1, 2004, until December 31, 2005 with Georgetown
University. For the nine-month period ended September 30, 2005, we paid $60,000
as consideration for the extension.
On
August
17, 2004 we entered into an agreement for Formatech, Inc. to monitor and perform
stability studies on our drug candidate, RX-0201. The total cost of these
services is $46,700, of which $22,900 was paid in 2004, $5,200 was paid during
the three months ended September 30, 2005, $5,200 is due during the fourth
quarter of 2005, $5,200 is due during 2006 and $8,200 is due during
2007.
On
June
1, 2005, we signed a one year research project with the Korea Research Institute
of Chemical Technology ("KRICT") relating to the development of a synthetic
process for the lead compound of the quinoxalines acting on human cancer cells.
In accordance with the agreement, we will pay KRICT a total sum of $100,000
of
which $50,000 was paid in the three-month period ended September 30, 2005.
The
remaining $50,000 is due on or about October 30, 2005.
On
August
1, 2005, we signed a one year contract with the University of Massachusetts
Medical School ("UMASS") to test proprietary drugs in pre-clinical behavioral
assays of anxiety and cognition. We agreed to provide UMASS with a grant of
$76,666, which includes the full direct and indirect costs of the pre-clinical
study, payable in four equal quarterly installments of $19,167. In the
three-month period ended September 30, 2005, we made one quarterly payment
of
$19,167.
On
August
3, 2005, we engaged Montgomery Pacific Group ("MPG") to act as our financial
advisor for a one- year term in connection with our growth strategies, certain
in licensing activities and acquisition of certain assets. In consideration
of
the services, we agreed to pay MPG an advisory fee, consisting of an initial
retainer fee and success fees subject to the successful closing of licensing
transactions, acquisitions and private placements. A retainer fee of $50,000
was
paid in the three-month period ended September 30, 2005.
Although
we currently believe that our cash and cash equivalents will be sufficient
to
meet our minimum planned operating needs for the next 12 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.
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 discovery
efforts. Over the next 24 months we expect to spend approximately $5 million
on
clinical development for Phase I and Phase II clinical trials of RX-0201
(including our commitments described under "− Contractual Obligations"), $3
million on pre-clinical studies and Phase I clinical trials for RX-0047,
pre-clinical studies and Phase I clinical trials for RX-10100 and in-vivo animal
and pre-clinical studies and Phase I clinical trials for RX-0183, $3 million
on
general corporate expenses, and $500,000 on facilities rent. 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 24 months, which would entail focusing our resources
on
Phase I and Phase II clinical trials of RX-0201 and the pre-clinical studies
and
Phase I clinical trials for RX-0183, RX-0047 and RX-10100. 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 RX-3117 and other new drug candidates, as well as other research
and
development projects, which together with the current operating plan for the
next 24 months, could aggregate $20 million through the second quarter of 2007.
However,
the actual amount of funds we will need to operate is subject to many factors,
some of which are beyond our control. These factors include the
following:
•
|
the
progress of our product development
activities;
|
•
|
the
number and scope of our product development
programs;
|
•
|
the
progress of our pre-clinical and clinical trial
activities;
|
•
|
the
progress of the development efforts of parties with whom we have
entered
into collaboration agreements;
|
•
|
our
ability to maintain current collaboration programs and to establish
new
collaboration arrangements;
|
•
|
the
costs involved in prosecuting and enforcing patent claims and other
intellectual property rights; and
|
•
|
the
costs and timing of regulatory
approvals.
|
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. Over the next 24 months we expect to spend approximately $5 million
on clinical development for Phase I and Phase II clinical trials of RX-0201,
$3
million on pre-clinical studies and Phase I clinical trials for RX-0047,
pre-clinical studies and Phase I clinical trials for RX-10100 and in-vivo animal
and pre-clinical studies and Phase I clinical trials for RX-0183, $3 million
on
general corporate expenses, and $500,000 on facilities rent. 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 24 months, which would entail focusing our resources
on
Phase I and Phase II clinical trials of RX-0201 and the pre-clinical studies
and
Phase I clinical trials for RX-0183, RX-0047 and RX-10100.
However,
changes may occur that would consume our existing capital at a faster rate
than
projected, including, among others, 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 RX-3117 and other
new
drug candidates, as well as other research and development projects, which
together with the current operating plan for the next 24 months, could aggregate
$20 million through the second quarter of 2007.
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, which will 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, 2005, and December 31, 2004 and 2003 was $11,097,655, $7,854,783
and $4,581,341, respectively. For the nine months and the years ended September
30, 2005, December 31, 2004 and 2003, we had net losses of $3,242,872,
$3,273,442 and $2,775,075, 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 as we:
•
|
continue
to undertake pre-clinical development and clinical trials for our
current
and new drug candidates;
|
•
|
seek
regulatory approvals for our drug
candidates;
|
•
|
implement
additional internal systems and
infrastructure;
|
•
|
seek
to license in additional technologies to develop;
and
|
•
|
hire
additional personnel.
|
In
addition, we will continue to have an increased level of expenses associated
with being a public company. 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 and maintain profitability. We may not be able to generate
these revenues or achieve profitability in the future. Our failure to achieve
or
maintain profitability could negatively impact the value of our common
stock.
We
have a limited operating history upon which to base an investment
decision.
We
are a
development stage company that was founded in 2001. We have only five 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:
•
|
continuing
to undertake pre-clinical development and clinical
trials;
|
•
|
participating
in regulatory approval processes;
|
•
|
formulating
and manufacturing products; and
|
•
|
conducting
sales and marketing activities.
|
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. To date, only one drug candidate, RX-0201, is in the late stages
of
Phase I clinical trials, another drug candidate, RX-0047, will commence Phase
I
clinical trials in early 2006, and the other three drug candidates are in or
will soon move into the pre-clinical toxicology trial phase of development.
These operations provide a limited basis for you to assess our ability to
commercialize our drug candidates and the advisability of investing in
us.
Our
independent auditors' opinions on our audited year end financial statements
includes a going concern qualification.
Our
independent auditors for 2004 have included an explanatory paragraph in their
audit report issued in connection with our financial statements, which states
that our recurring operating losses since inception raise substantial doubt
about our ability to continue as a going concern. Our 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 might be necessary should we be unable to continue as a going
concern.
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. Although we have obtained $13.5 million
during 2005 and plan 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. Obtaining additional
financing may be more difficult because of the uncertainty regarding our ability
to continue as a going concern. If we are unable to secure additional financing
in the future on acceptable terms, or at all, we may be unable to complete
planned pre-clinical and clinical trials or obtain approval of our drug
candidates from the FDA and other regulatory authorities. In addition, we could
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. We may also be forced to abandon development of several of the
earlier stage drug candidates, which will significantly impair our ability
to
generate product revenues.
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 any of our drug candidates, we must submit to the FDA a New Drug
Application, or 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 four drug
candidates, RX-0201 and RX-0047, are antisense oligonucleotide (ASO) compounds.
To date, the FDA has not approved any NDAs for any ASO compounds. In addition,
both RX-0201 and RX-0047 are of a drug class (Akt inhibitor, in the case of
RX-0201, 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.
The
approval process may also be delayed by changes in government regulation, future
legislation or administrative action or changes in FDA policy that occur prior
to or during our regulatory review. Delays in obtaining regulatory approvals
may:
•
|
delay
commercialization of, and our ability to derive product revenues
from, our
drug candidates;
|
•
|
impose
costly procedures on us; and
|
•
|
diminish
any competitive advantages that we may otherwise
enjoy.
|
Even
if
we comply with all FDA requests, the FDA may ultimately reject one or more
of
our NDAs. We cannot be sure that we will ever obtain regulatory clearance for
our drug candidates. Failure to obtain FDA approval of any of our drug
candidates will severely undermine our business by reducing our number of
salable products and, therefore, corresponding product revenues.
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 are very expensive, time-consuming and difficult to design.
In
2004, the FDA approved our Investigational New Drug (IND) application for
RX-0201 and we initiated a Phase I clinical trial of RX-0201 at Lombardi
Comprehensive Cancer Center of Georgetown Medical Center. Pre-clinical studies
to support an IND application for each of RX-0047, RX-0183 and RX-3117 are
still
under development and we do not expect to commence Phase I clinical trials
for
these drug candidates until at least the first quarter of 2006, third quarter
of
2006 and fourth quarter of 2006, respectively. We expect to commence Phase
I
clinical trials for RX-10100 in late 2005. We cannot predict with any certainty
that we will ever receive regulatory approval to sell our drug
candidates.
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. For example,
to date the Phase I clinical trials for RX-0201 have cost approximately $750,000
and we estimate that we will require an additional approximately $300,000 to
complete the trial. The clinical trial process is also time consuming. We
estimate that clinical trials of our current drug candidates will take at least
several 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:
•
|
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.
|
Although
to date, we have not experienced any significant delays in our Phase I clinical
trials for RX-0201, other than a two-month delay due to delays in obtaining
drug
candidate samples and a delay in determining the appropriate dosing levels
during the three months ended September, 30, 2005, there can be no assurance
that further delays in the RX-0201 Phase I clinical trial or other future
clinical trials will not occur.
In
addition, we or the FDA may suspend our 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 do not 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 their
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, our ability to commercialize our drug
candidates and generate product revenues. In addition, our clinical trials
involve a small patient population, less than 20 for RX-0201. Because of the
small sample size, the results of these 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:
•
|
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.
Because
our drug development program depends upon third-party researchers, the results
of our clinical trials and such research activities are, to a certain 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 under
agreements with us. For example, the Phase I clinical trials of RX-0201 are
being conducted at the Lombardi Comprehensive Cancer Center of Georgetown
Medical Center with the assistance of Amarex, LLC, a pharmaceutical clinical
research service provider who will be responsible for creating the reports
that
will be submitted to the FDA. Also, we relied on TherImmune Research Corporation
(currently Gene Logic Laboratories, Inc.), a discovery and pre-clinical service
provider, to summarize RX-0201's pre-clinical data. 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 as great a 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. 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 exposes 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 and do not intend to
establish our own manufacturing facilities. We lack the resources and expertise
to formulate or manufacture our own drug candidates. As a result, we have
entered into contracts with third-party manufacturers such as Raylo Chemicals
Inc., Formatech, Inc. and Avecia Biotechnology 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 anticipated future
reliance on a limited number of third-party manufacturers, exposes us to the
following potential risks:
•
|
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 manufacturer. This approval would require
new
testing and compliance inspections. In addition, a new manufacturer
would
have to be educated in, or develop substantially equivalent processes
for,
the production of our products after receipt of FDA approval, if
any.
|
•
|
Our
third-party manufacturers might be unable to formulate and manufacture
our
drugs in the volume and of the quality required to meet our clinical
and
commercial needs. For example, we experienced a two-month delay in
the
development timeline for RX-0201 due to delays in obtaining RX-0201
samples.
|
•
|
Our
contract manufacturers may not perform as agreed or may not remain
in the
contract manufacturing business for the time required to supply our
clinical trials or to successfully produce, store and distribute
our
products.
|
•
|
Drug
manufacturers are subject to ongoing periodic unannounced inspections
by
the FDA, the Drug Enforcement Agency, or DEA, and corresponding state
agencies to ensure strict compliance with good manufacturing practice
and
other government regulations and corresponding foreign standards.
We do
not have control over third-party manufacturers' compliance with
these
regulations and standards, but we may be ultimately responsible for
any of
their failures.
|
•
|
If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share, the
intellectual property rights to the
innovation.
|
Each
of
these risks could delay our clinical trials, the approval, if any, of our drug
candidates by the FDA, or the commercialization of our drug candidates or result
in higher costs or deprive us of potential product revenues.
We
have no experience selling, marketing or distributing products and 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. For example, we have entered into a collaboration agreement
with
Rexgene Biotech Co., Ltd. ("Rexgene") for the sale and marketing of RX-0201
in
Asia. We intend to pursue additional collaborative arrangements regarding the
sales and marketing of our products; however, we cannot assure you that we
will
be able to establish or maintain such collaborative arrangements, or if able
to
do so, that they will have effective sales forces. 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 our 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 Antigenics Inc., Genta Incorporated, Imclone Systems
Incorporated, Human Genome Sciences, Inc., Kosan Biosciences Incorporated and
Medimmune, Inc., with respect to oncology, and Eli Lilly and Company, Pfizer,
Inc., GlaxoSmithKline PLC, Forest Laboratories, Inc., Indevus Pharmaceuticals,
Inc., and Elan Corporation, with respect to neurosciences. In addition, many
of
these competitors, either alone or together with their collaborative partners,
operate larger research and development programs and have substantially greater
financial resources than we do, as well as significantly greater experience
in:
•
|
developing
drugs;
|
•
|
undertaking
pre-clinical testing and human clinical trials;
|
•
|
obtaining
FDA and other regulatory approvals of
drugs;
|
•
|
formulating
and manufacturing drugs; and
|
•
|
launching,
marketing and selling drugs.
|
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 RX-0201, anti-HIF compounds, including RX-0047. 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 Pharmaceuticals LLC ("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:
•
|
the
degree and range of protection any patents will afford us against
competitors, including whether third parties will find ways to invalidate
or otherwise circumvent our licensed
patents;
|
•
|
if
and when patents will issue;
|
•
|
whether
or not others will obtain patents claiming aspects similar to those
covered by our licensed patents and patent applications; or
|
•
|
whether
we will need to initiate litigation or administrative proceedings
which
may be costly whether we win or
lose.
|
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
of
our employees to enter into agreements which 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, 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 we may have
to:
•
|
obtain
licenses, which may not be available on commercially reasonable terms,
if
at all;
|
•
|
redesign
our products or processes to avoid infringement;
|
•
|
stop
using the subject matter claimed in the patents held by others, which
could cause us to lose the use of one or more of our drug candidates;
|
•
|
pay
damages; or
|
•
|
defend
litigation or administrative proceedings which may be costly whether
we
win or lose, and which could result in a substantial diversion of
our
management resources.
|
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, the
public profile of us and 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 those agreements, 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, 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 seek to review
proactively opportunities to license in and advance compounds in oncology and
other therapeutic areas, such as neurological diseases, 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 if our employees do not have the time necessary to devote to
developing those drug candidates or we do not have the necessary capital
resources to develop all of our drug candidates. Alternatively, we may be
required to hire even 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 entitle us to
indemnification against losses, such indemnification may not be available or
adequate should any claim arise.
Controls
and Procedures
|
Evaluation
of Disclosure Controls and Procedures
As
of
September 30, 2005, the Company's management carried out an evaluation, under
the supervision of the Company's Chief Executive Officer and Chief Financial
Officer of the effectiveness of the design and operation of the Company's 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. Based upon that
evaluation, the Chief Executive Officer and the Chief Financial Officer have
concluded that the Company's 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 the Company under the Securities Exchange Act of
1934.
30
There
were no changes in the Company's internal control over financial reporting
during the quarter ended September 30, 2005 that have materially affected,
or
are reasonably likely to affect, the Company's financial reporting.
Legal
Proceedings
|
None
Unregistered
Sales of Securities and Use of
Proceeds
|
On
August
8, 2005, the Company completed a private placement of 4,175,000 shares of
Company common stock, $.0001 par value per share, at $2.00 per share for
aggregate gross proceeds of $8.35 million pursuant to the Subscription
Agreements dated August 8, 2005. The offers and sales occurred outside the
United States to persons other than U.S. persons in offshore transactions
meeting the requirements of Regulation S under the Securities Act of 1933,
as
amended (the "Securities Act"). After payment of certain expenses by the
Company, the Company received approximately $8.31 million in net proceeds upon
closing of the private placement of the common stock. The proceeds will be
used
to fund clinical trials of the Company's drug candidates and other general
corporate purposes. Shares of the common stock have not been registered under
the Securities Act and may not be offered or sold in the Unites States absent
registration under the Securities Act or an applicable exemption from
registration requirements under the Securities Act. On August 8, 2005, the
Company also completed a private placement of $1.3 million aggregate principal
amount of its convertible notes (the "Convertible Notes") in offers and sales
that occurred outside the United States to persons other than U.S. persons
in
offshore transactions meeting the requirements of Regulation S under the
Securities Act. The holders of the Convertible Notes are entitled any time
after
September 19, 2005 until August 8, 2008 (the "Maturity Date"), or upon the
occurrence and continuance of any of the events of default, to convert the
principal amount of any Convertible Notes or portions thereof into Company
common stock at a conversion price of $2.00 per share. The initial conversion
price of $2.00 per share of Company common stock is subject to adjustment upon
the occurrence of certain events, including the issuance of any additional
capital stock after August 8, 2005, without consideration or for a consideration
per share less than the current market price per share of additional capital
stock as of the time of such issuance. On the Maturity Date, any unconverted
Convertible Notes will automatically convert into shares of Company common
stock
at a conversion price of $2.00 per share. The Convertible Notes do not bear
interest, except that any overdue principal of the Convertible Notes will bear
interest for each day from the Maturity Date to the date of actual payment,
at a
rate equal to 5% per annum, or, if an event of default occurs and is continuing,
the Convertible Notes will bear interest, from the date of the occurrence of
such event of default until such event of default is cured or waived, at a
rate
equal to 5% per annum. The Convertible Notes and the underlying Company common
stock issuable upon conversion of the Convertible Notes have not been registered
under the Securities Act and may not be offered or sold in the Unites States
absent registration under the Securities Act or an applicable exemption from
registration requirements under the Securities Act. The net proceeds of the
Convertible Notes sale will also be used to fund clinical trials of the
Company's drug candidates and for general corporate purposes.
Defaults
Upon Senior Securities
|
None
Submission
of Matters to a Vote of Security
Holders
|
None
Other
Information
|
None
Exhibit
Number
|
Description
|
4.1
|
Form
of Convertible Note is incorporated by reference to Exhibit 4.1 to
the
Company's Current Report on Form 8-K filed on August 11,
2005.
|
10.1
|
Form
of Subscription Agreement is incorporated by reference to Exhibit
10.1 to
the Company's Current Report on Form 8-K filed on August 11,
2005.
|
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
|
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. | ||
/s/
Ted T.H. Jeong
|
||
Name:
Ted T. H. Jeong
|
||
Title:
Chief Financial Officer and Secretary
|
||
Date:
November 14, 2005
|
||
|
||
|
EXHIBIT
INDEX
Exhibit
Number
|
Description
|
4.1
|
Form
of Convertible Note is incorporated by reference to Exhibit 4.1 to
the
Company's Current Report on Form 8-K filed on August 11,
2005.
|
10.1
|
Form
of Subscription Agreement is incorporated by reference to Exhibit
10.1 to
the Company's Current Report on Form 8-K filed on August 11,
2005.
|
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
|
34