10QSB: Optional form for quarterly and transition reports of small business issuers
Published on August 14, 2006
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-QSB
(Mark
One)
x
QUARTERLY REPORT UNDER SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
For
the Quarterly Period Ended June 30, 2006
¨
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 x
No ¨
APPLICABLE
ONLY TO CORPORATE ISSUERS:
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). ¨
Yes x
No
State
the
number of shares outstanding of each of the registrant's classes of common
equity, as of the latest practicable date: 50,265,632 issued and outstanding
as
of August 14, 2006
Transitional
Small Business Disclosure Format (check one): Yes
¨
No x
REXAHN
PHARMACEUTICALS, INC.
INDEX
PAGE(S)
|
|||
PART
I
|
FINANCIAL
INFORMATION
|
||
Item
1.
|
Financial
Statements:
|
||
1
|
|||
2
|
|||
3
|
|||
4
|
|||
Item
2.
|
16
|
||
Item
3.
|
35
|
||
PART
II
|
OTHER
INFORMATION
|
||
Item
1.
|
36
|
||
Item
2.
|
36
|
||
Item
3.
|
36
|
||
Item
4.
|
36
|
||
Item
5.
|
36
|
||
Item
6.
|
37
|
||
Signatures |
38
|
PART
I - FINANCIAL INFORMATION
Item
1. FINANCIAL STATEMENTS
REXAHN
PHARMACEUTICALS, INC.
(A
DEVELOPMENT STAGE COMPANY)
Balance
Sheets
June
30,
|
December
31,
|
||||||
2006
|
2005
|
||||||
|
(Unaudited)
|
||||||
ASSETS
|
|||||||
Current
Assets:
|
|||||||
Cash
and cash equivalents
|
$
|
67,592
|
$
|
1,679,441
|
|||
Short-term
investments
|
6,224,614
|
8,437,184
|
|||||
Prepaid
expenses and other
|
58,002
|
54,774
|
|||||
Total
Current Assets
|
6,350,208
|
10,171,399
|
|||||
Equipment,
Net
|
170,165
|
203,632
|
|||||
Intangible
Assets, Net
|
331,093
|
339,890
|
|||||
Total
Assets
|
$
|
6,851,466
|
10,714,921
|
||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
Liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
241,969
|
$
|
587,612
|
|||
Licensing
fee payable
|
85,120
|
172,813
|
|||||
Total
Current Liabilities
|
327,089
|
760,425
|
|||||
Long-term
convertible debt
|
-
|
3,850,000
|
|||||
Deferred
revenue
|
1,237,500
|
1,275,000
|
|||||
Total
Liabilities
|
1,564,589
|
5,885,425
|
|||||
Commitment
and Contingencies (note 6)
|
|||||||
Stockholders'
Equity
|
|||||||
Common
stock, par value $0.0001
|
5,028
|
4,641
|
|||||
Treasury
stock, 14,205 shares, at cost
|
(28,410
|
)
|
-
|
||||
Additional
paid-in capital
|
23,691,719
|
19,029,178
|
|||||
Accumulated
deficit during
the development stage
|
(18,381,460
|
)
|
(14,204,323
|
)
|
|||
Total
Stockholders' Equity
|
5,286,877
|
4,829,496
|
|||||
Total
Liabilities and Stockholders' Equity
|
$
|
6,851,466
|
$
|
10,714,921
|
See
notes accompanying the financial statements.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Statements
of Operations
(Unaudited)
Cumulative
from March 19, 2001 (Inception) to
|
Three
Months
Ended
June 30,
|
Six
Months
Ended
June 30,
|
||||||||||||||
June
30,
|
||||||||||||||||
2006
|
2006
|
2005
|
2006
|
2005
|
||||||||||||
Revenue:
|
|
|
|
|
||||||||||||
Interest
and other income
|
$
|
590,728
|
$
|
88,087
|
$
|
31,960
|
$
|
199,279
|
$
|
36,769
|
||||||
Research
|
262,500
|
18,750
|
18,750
|
37,500
|
37,500
|
|||||||||||
853,228
|
106,837
|
50,710
|
236,779
|
74,269
|
||||||||||||
Expenses:
|
||||||||||||||||
General
and administrative
|
6,969,190
|
590,599
|
883,950
|
1,157,568
|
1,196,832
|
|||||||||||
Beneficial
conversion feature
|
1,625,000
|
-
|
-
|
-
|
-
|
|||||||||||
Research
and development
|
7,741,950
|
449,320
|
176,940
|
2,250,455
|
555,436
|
|||||||||||
Stock
option compensation expense
|
2,013,911
|
472,225
|
131,598
|
808,319
|
227,309
|
|||||||||||
Patent
fees
|
291,975
|
44,886
|
26,858
|
64,289
|
55,442
|
|||||||||||
Interest
|
292,517
|
30,569
|
57,750
|
91,021
|
77,219
|
|||||||||||
Depreciation
and amortization
|
300,145
|
21,187
|
16,517
|
42,264
|
33,033
|
|||||||||||
19,234,688
|
1,608,786
|
1,293,613
|
4,413,916
|
2,145,271
|
||||||||||||
Net
Loss
|
$
|
(18,381,460
|
)
|
$
|
(1,501,949
|
)
|
$
|
(1,242,903
|
)
|
$
|
(4,177,137
|
)
|
$
|
(2,071,002
|
)
|
|
Loss
per weighted average number of shares outstanding basic and
diluted
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.09
|
)
|
$
|
(0.05
|
)
|
||||
Weighted
average number of shares basic and diluted
|
48,488,709
|
39,834,175
|
47,456,433
|
38,987,503
|
See
notes accompanying the financial statements.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
Cumulative
from
March
19, 2001
|
Six
Months Ended
|
|||||||||
(Inception)
to
|
June
30,
|
|||||||||
June
30, 2006
|
2006
|
2005
|
||||||||
Cash
Flows from Operating Activities:
|
||||||||||
Net
loss
|
$
|
(18,381,460
|
)
|
$
|
(4,177,137
|
)
|
$
|
(2,071,002
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Beneficial
conversion feature
|
1,625,000
|
—
|
—
|
|||||||
Compensatory
stock
|
21,877
|
—
|
—
|
|||||||
Depreciation
and amortization
|
300,145
|
42,264
|
33,034
|
|||||||
Stock
option compensation expense
|
2,013,911
|
808,319
|
227,309
|
|||||||
Deferred
revenue
|
1,237,500
|
(37,500
|
)
|
(37,500
|
)
|
|||||
Changes
in assets and liabilities:
|
||||||||||
Prepaid
expenses and other
|
(58,002
|
)
|
(3,228
|
)
|
(33,618
|
)
|
||||
Accounts
payable and accrued expenses
|
241,969
|
(345,643
|
)
|
181,113
|
||||||
Net
Cash Used in Operating Activities
|
(12,999,060
|
)
|
(3,712,925
|
)
|
(1,700,664
|
)
|
||||
Cash
Flows from Investing Activities
|
||||||||||
Short-term
investments
|
(6,224,614
|
)
|
2,212,570
|
—
|
||||||
Purchase
of equipment
|
(445,187
|
)
|
—
|
—
|
||||||
Net
Cash (Used in) Provided by Investing Activities
|
(6,669,801
|
)
|
2,212,570
|
—
|
||||||
Cash
Flows from Financing Activities
|
||||||||||
Issuance
of common stock
|
14,885,959
|
4,609
|
—
|
|||||||
Proceeds
from long-term debt
|
5,150,000
|
—
|
3,850,000
|
|||||||
Principal
payments on long-term debt
|
(271,096
|
)
|
(87,693
|
)
|
(93,750
|
)
|
||||
Purchase
of treasury stock
|
(28,410
|
) |
(28,410
|
) |
—
|
|||||
Net
Cash Provided by (Used in) Financing
Activities
|
19,736,453
|
(111,494
|
)
|
3,756,250
|
||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
67,592
|
(1,611,849
|
)
|
2,055,586
|
||||||
Cash
and Cash Equivalents - beginning of period
|
—
|
1,679,441
|
1,015,979
|
|||||||
Cash
and Cash Equivalents - end of period
|
$
|
67,592
|
$
|
67,592
|
$
|
3,071,565
|
||||
Supplemental
Cash Flow Information
|
||||||||||
Interest
paid
|
$
|
292,912
|
$
|
280,535
|
$
|
659
|
||||
Non-cash
investing and financing activities:
|
||||||||||
In
February 2005, the Company entered into a licensing agreement in
exchange
for debt of $375,000.
|
||||||||||
In
May 2006, the convertible debt of $3.85 million was converted into
3.85
million shares of the Company's common
stock.
|
See
notes accompanying the financial statements.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
1.
|
Organization
|
The
accompanying unaudited financial statements of Rexahn Pharmaceuticals, Inc.
("the Company") have been prepared in accordance with accounting principles
generally accepted in the United States of America for financial information
and
the requirements of item 310 (b) of Regulation S-B. Accordingly, certain
information and disclosures normally included in financial statements prepared
in accordance with accounting principles generally accepted in the United States
of America have been condensed or omitted pursuant to the rules and regulations
of the Securities and Exchange Commission. The financial statements reflect
all
adjustments (consisting only of normal recurring adjustments), which, in the
opinion of management, are necessary for a fair presentation of the results
for
the periods presented. Except for the adoption of new accounting policies as
disclosed in note 2, there have been no significant changes in our accounting
policies since December 31, 2005. The
results from operations for the period are not necessarily indicative of the
results expected for the full fiscal year or any future period.
Reverse
Merger Acquisition
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.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
1. |
Organization
(cont'd)
|
Reverse
Merger Acquisition (cont'd)
As
part
of the Acquisition Merger, the Company assumed the convertible notes 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 (legal acquirer) by Rexahn (accounting acquirer). 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
In
July
2006 FASB issued Financial Accounting Standards Interpretation No. 48 (“FIN
48”), “Accounting for Uncertainty in Income Taxes”. FIN 48 clarifies the
accounting for uncertainty in income taxes recognized in an enterprises’
financial statements in accordance with SFAS No. 109, “Accounting for
Income Taxes”. FIN 48 prescribes a recognition threshold and measurement
attributable for the financial statement recognition and measurement of a
tax
position taken or expected to be taken in a tax return. FIN 48 also provides
guidance on derecognition, classification, interest and penalties, accounting
in
interim periods, disclosures and transitions. FIN 48 is effective for fiscal
years beginning after December 15, 2006. The Company is currently reviewing
the effect, if any, FIN48 will have on its financial position.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
3. |
Long-Term
Convertible Debt
|
On
February 28, 2005, the Company issued, in a transaction exempt from registration
under the Securities Act
of 1933,
as amended, $3,850,000 aggregate principal amount of 6% convertible notes due
on
February 28, 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 (May 13, 2006) and (ii) May 26, 2006 to the maturity date,
February 28, 2008. 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. On May 13, 2006, owners
of the convertible debt exercised their option to convert the entire principal
amount of the notes into 3,850,000 shares of the Company’s common stock.
4. |
Common
Stock
|
Authorized
|
500,000,000
shares of common stock, voting, par value
$0.0001
|
June
30,
2006
|
December
31,
2005
|
||||||
Issued
|
|
||||||
50,279,837
shares (2005 - 46,410,632) of common stock
|
|||||||
Outstanding
|
|||||||
50,265,632
shares (2005 - 46,410,632) of common stock
|
$
|
5,028
|
$
|
4,641
|
|||
14,205
shares (2005 - 0) of treasury stock
|
28,410 |
—
|
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
4. |
Common
Stock (cont'd)
|
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 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
February 22, 2006, an option holder exercised their options to purchase shares
of the Company's common stock for cash of $1,200. Pursuant to the agreement,
the
Company issued an aggregate 5,000 shares.
On
April
12, 2006, an option holder exercised their option to purchase shares of Rexahn’s
common stock for a cash payment of $3,409. Pursuant to the agreement, the
Company issued an aggregate 14,205 shares. On the same date, the Company agreed
to purchase the shares of Rexahn common stock for treasury in exchange for
the
aggregate purchase price of $28,410 in cash.
On
May
13, 2006, owner’s of the $3,850,000 convertible debt issued on February 28,
2005, exercised their option to convert the entire principal amount of the
note
into shares of the Company’s common stock. Based on a $1.00 per share conversion
price, the Company issued 3,850,000 shares of common stock in connection with
the transaction (See Note 3).
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
5. |
Stock-Based
Compensation
|
On
August
5, 2003, the Company established a stock option plan. Under the plan, the
Company grants stock options to key employees, directors and consultants of
the
Company. For all grants prior to September 12, 2005 and grants to employees
of
the Company after September 12, 2005, the vesting period is 30% on the first
anniversary of the grant date, an additional 30% on the second anniversary
and
the remaining 40% on the third anniversary.
For grants to non-employee directors and consultants of the Company after
September 12, 2005, the vesting period is 100% on the first anniversary of
the
grant date, 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. Options authorized for issuance under the plan total 17,000,000
after giving effect to an amendment to the Company's Stock Option Plan approved
at the Annual Meeting of the Stockholders of the Company on June 2, 2006 and
as
of June 30, 2006, 10,204,205 options
are available for issuance.
Prior
to
adoption of the plan, the Company made restricted stock grants. During 2003
all
existing restricted stock grants were converted to stock options. The converted
options maintained the same full vesting period as the original restricted
stock
grants.
Accounting
for Employee Awards
Effective
January 1, 2006, the plan is accounted for in accordance with the recognition
and measurement provisions of SFAS No. 123R, which replaces SFAS No. 123,
"Accounting for Stock-Based Compensation", and supersedes Accounting Principles
Board Opinion ("APB") No. 25, "Accounting for Stock Issued to Employees", and
related interpretations. SFAS No. 123R requires compensation costs related
to
share-based payment transactions, including employee stock options, to be
recognized in the financial statements. In addition, the Company adheres to
the
guidance set forth in Securities and Exchange Commission ("SEC") Staff
Accounting Bulletin ("SAB") No. 107, which provides the SEC staff's views
regarding the interaction between SFAS No. 123R and certain SEC rules and
regulations and provides interpretations with respect to the valuation of
share-based payments for public companies.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
5.
|
Stock-Based
Compensation (cont'd)
|
Prior
to
January 1, 2006, the Company accounted for similar employee transactions in
accordance with APB No. 25 which employed the intrinsic value method of
measuring compensation cost. Accordingly, compensation expense was not
recognized for employee stock options if the exercise price of the option
equaled or exceeded the fair value of the underlying stock at the grant
date.
While
SFAS No. 123, for employee options, encouraged recognition of the fair value
of
all stock-based awards on the date of grant as expense over the vesting period,
companies were permitted to continue to apply the intrinsic value-based method
of accounting prescribed by APB No. 25 and disclose certain pro forma amounts
as
if the fair value approach of SFAS No. 123 had been applied. In December 2002,
SFAS No. 148, "Accounting for Stock-Based Compensation-Transition and
Disclosure, an amendment of SFAS No. 123", was issued, which, in addition to
providing alternative methods of transition for a voluntary change to the fair
value method of accounting for stock-based employee compensation, required
more
prominent pro-forma disclosures in both the annual and interim financial
statements. The Company has
complied with these disclosure requirements for all applicable periods prior
to
January 1, 2006.
In
adopting SFAS No. 123R, the Company applied the modified prospective approach
to
transition. Under the modified prospective approach, the provisions of SFAS
No.
123R are to be applied to new employee awards and to employee awards modified,
repurchased, or cancelled after the required effective date. Additionally,
compensation cost for the portion of employee awards for which the requisite
service has not been rendered that are outstanding as of the required effective
date will be recognized as the requisite service is rendered on or after the
required effective date. The compensation cost for that portion of employee
awards will be based on the grant-date fair value of those awards as calculated
for either recognition or pro-forma disclosures under SFAS No. 123.
As
a
result of the adoption of SFAS No. 123R, the Company's results of operations
for
the three and six months ended June 30, 2006 include share-based employee
compensation expense totaling approximately $178,314 and $329,795,
respectively. Such amounts have been included in the Statements of
Operations in stock option compensation expense. No income tax benefit has
been
recognized in the Statements of Operations for share-based compensation
arrangements as the Company has provided for 100% valuation allowance on net
deferred tax assets. No stock option compensation expense was recorded under
APB
No. 25 in the Statements of Operations for the three and six months ended June
30, 2005.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
5.
|
Stock-Based
Compensation (cont'd)
|
Employee
stock option compensation expense in 2006 is the estimated fair value of options
granted amortized on a straight-line basis over the requisite service period
for
the entire portion of the award. The Company has not adjusted the expense by
estimated forfeitures, as required by SFAS No. 123R for employee options, since
the forfeiture rate based upon historical data was determined to be
immaterial.
Accounting
for Non-Employee Awards
The
Company previously accounted for options granted to its non-employee consultants
and non-employee registered representatives using the fair value cost in
accordance with SFAS No. 123 and EITF No. 96-18. The adoption of SFAS No. 123R
and SAB No. 107 as of January 1, 2006, had no material impact on the accounting
for non-employee awards. The Company continues to apply the additional guidance
set forth in EITF Issue No. 96-18, “Accounting for Equity Instruments That Are
Issued to Other Than Employees” (“EITF 96-18”).
Stock
compensation expense related to non-employee options was $293,912
and $478,525 for
the three and six months ended June 30, 2006, respectively, and
$96,020 and $227,309 for the three and six months ended June 30, 2005,
respectively. Such amounts have been included in the Statements of Operations
in
stock option compensation expense.
The
weighted average estimated fair value of stock options granted in the six months
ended June 30, 2006 and 2005 was $0.92 and $0.61, respectively. The fair value
of options at the date of grant was estimated using the Black-Scholes option
pricing model. During 2006, the Company took into consideration guidance under
SFAS No. 123R and SAB No. 107 when reviewing and updating assumptions. The
expected volatility is based upon historical volatility of the Company's stock
and other contributing factors. The expected term is based upon observation
of
actual time elapsed between the date of grant and exercise of options for all
employees.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
5.
|
Stock-Based
Compensation (cont'd)
|
The
assumptions made in calculating the fair values of options are as
follows:
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
30,
|
June
30,
|
||||||||||||
Black-Scholes Weighted Average Assumptions: |
2006
|
2005
|
2006
|
2005
|
|||||||||
Expected
dividend yield
|
0
|
0
|
0
|
0
|
|||||||||
Expected
volatility
|
100
|
% |
100
|
% |
100
|
%
|
100
|
%
|
|||||
Risk
free interest rate
|
4.990
|
% |
4.54
|
% |
4.990
|
%
|
4.54
|
%
|
|||||
Expected
term (in years)
|
5
years
|
5
years
|
5
years
|
5
years
|
Pro
Forma Information under SFAS No. 123 for Periods Prior to Adoption of SFAS
No.
123R
The
following table illustrates the pro forma effect on net loss and loss per share
as if the fair value recognition provisions of SFAS No. 123 had been applied
to
all outstanding and unvested awards during the three and six months ended June
30, 2005.
|
Three
Months Ended
|
Six
Months Ended
|
|||||
June
30,
|
June
30,
|
||||||
2005
|
2005
|
||||||
Net
loss, as reported
|
$
|
(1,242,903
|
)
|
$
|
(2,071,002
|
)
|
|
Add:
Employee stock option compensation expense included in reported
net
loss
|
-
|
155,640
|
|||||
Deduct:
Employee stock option compensation expense determined under fair
value-based method for all employee awards (no tax effect)
|
(166,972
|
)
|
(238,900
|
)
|
|||
Pro
forma net loss
|
$
|
(1,409,875
|
)
|
$
|
(2,154,262
|
)
|
|
Net
loss per share:
|
|||||||
Basic
and diluted-as reported
|
$
|
(0.03
|
)
|
$
|
(0.05
|
)
|
|
Basic
and diluted-pro forma
|
$
|
(0.03
|
)
|
$
|
(0.06
|
)
|
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
5. |
Stock-Based
Compensation (cont'd)
|
The
following table represents all of the Company's stock options granted,
exercised, and forfeited during the six months ended June 30, 2006.
Shares
Subject to Options
|
Weighted
Avg.Option Exercise Prices
|
Weighted
Average Remaining Contractual Term
|
Aggregate
Intrinsic Value
|
||||||||||
Outstanding
at January 1, 2006
|
5,770,000
|
$
|
0.84
|
-
|
-
|
||||||||
Granted
|
1,045,000
|
1.20
|
-
|
-
|
|||||||||
Exercised
|
(19,205
|
)
|
0.24
|
-
|
-
|
||||||||
Cancelled
|
-
|
-
|
-
|
-
|
|||||||||
Outstanding
at June 30, 2006
|
6,795,795
|
$
|
0.89
|
8.5
years
|
$
|
7,543,333
|
|||||||
Exercisable
at June 30, 2006
|
2,515,337
|
$
|
0.76
|
7.8
years
|
$
|
3,119,018
|
A
total
of 14,205 options were exercised in the second quarter of 2006. No options
were
exercised in the same period last year. The intrinsic value of the options
exercised was $17,188 for
the
six months ended June 30, 2006.
As
of
June 30, 2006, there was $4,153,045 of
total
unrecognized compensation cost, net of estimated forfeitures, related to all
unvested stock options, which is expected to be recognized over a weighted
average period of approximately two years.
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
6. |
Commitments
and Contingencies
|
a)
|
The
Company has contracted with various vendors to provide research and
development services. The terms of these agreements usually require
an initiation fee and monthly or periodic payments over the terms
of the
agreement, ranging from 6 months to 24 months. The costs to be
incurred are estimated and are subject to revision. As of June 30,
2006, the total value of these agreements was approxiamtely $1,375,000
and
the Company had made payments totaling $556,000 under the terms of
the
agreements.
|
b)
|
The
Company signed an agreement with a public relations company to
provide services for a period of 12 months for consideration of an
initiation fee of $5,000 and periodic payments totaling
$30,000. As of June 30, 2006, the Company had paid
$10,000 in connection with this
agreement.
|
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
6. |
Commitments
and Contingencies (cont'd)
|
c) |
On
April 19, 2006, the Company executed definitive agreements with Future
Systems, Inc. ("FSI"), a Korean stock exchange (KOSDAQ) listed information
technology company based in Seoul, Korea. Pursuant to the agreements,
the
Company would transfer to FSI exclusive rights and a non-exclusive
license
to develop, manufacture, and sell products based on Rexahn’s RX-0201,
RX-0047 and RX-10100 drug candidates in certain territories for
approximately $35.8 million, and simultaneously, FSI would issue
and sell
4,326,854 shares of its common stock to the Company, representing
approximately 28% of FSI’s outstanding shares, after giving effect to the
subscription. The investment, of approximately $35.8 million, would
have
made the Company the largest single stockholder of FSI. In addition,
the
Company entered into an agreement with FSI and Core F.G. Co., Ltd.,
the
general partner of Triplewin Corporate Restructuring Partnership,
the
then-current majority shareholder of FSI, with respect to the management
of FSI in connection with redirecting FSI’s business focus to the
biopharmaceutical industry. Completion of the transactions was subject
to
customary closing conditions, including approval by FSI
shareholders. On
June 8, 2006, the Company terminated the agreements entered into
with FSI
and Core F.G. Co., Ltd., including a share subscription agreement,
an
intellectual property assignment and license agreement and a management
agreement, providing for, among other things, the assignment and
license
by the Company to FSI of certain intellectual property rights for
the
Company's drug candidates in specified markets and the acquisition
by the
Company of an ownership interest in FSI. The termination followed
a vote
on the proposed transactions that was not approved by the FSI shareholders
at a meeting in Seoul, Korea on June 7, 2006.
|
REXAHN
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Notes
to
Financial Statements
Three
and
Six Months Ended June 30, 2006 and 2005
(Unaudited)
7. |
Comparative
Information
|
Certain
amounts for fiscal 2005 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
company resulted from the merger of Corporate Road Show.Com Inc., a New York
corporation incorporated in November 1999 ("CPRD"), and Rexahn, Corp, a Maryland
corporation, immediately after giving effect to our reincorporation as a
Delaware corporation under the name "Rexahn Pharmaceuticals, Inc." In connection
with that transaction, a wholly owned subsidiary of ours merged with and into
Rexahn, Corp, with Rexahn, Corp remaining as the surviving corporation and
a
wholly owned subsidiary of ours. In exchange for their shares of capital stock
in Rexahn, Corp, the former stockholders of Rexahn, Corp received shares of
common stock representing approximately 91.8% of our outstanding equity after
giving effect to the transaction. Further, upon the effective time of the
merger, our historic business was abandoned and the business plan of Rexahn,
Corp was adopted. The transaction was therefore accounted for as a reverse
acquisition with Rexahn, Corp as the accounting acquiring party and CPRD as
the
acquired party. In September 2005, Rexahn, Corp was merged with and into our
company.
Our
efforts and resources have been focused primarily on acquiring and developing
our pharmaceutical technologies, raising capital and recruiting personnel.
We
are a development stage company and have no product sales to date and we will
not receive 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 common
stock and debt securities, and collaboration agreements with our strategic
investors.
RECENT
DEVELOPMENTS
On
April
19, 2006, we executed definitive agreements with Future Systems, Inc., or FSI,
a
Korean stock exchange (KOSDAQ) listed information technology company based
in
Seoul, Korea, pursuant to which we would transfer to FSI exclusive rights and
a
non-exclusive license to develop, manufacture, and sell products based on our
RX-0201, RX-0047 and RX-10100 drug candidates in certain territories for
approximately $35.8 million, and simultaneously, FSI would issue and sell
4,326,854 shares of its common stock to us, representing approximately 28%
of
FSI’s outstanding shares, after giving effect to the subscription. The
investment, of approximately $35.8 million, would have made us the largest
single stockholder of FSI. In addition, we entered into an agreement with FSI
and Core F.G. Co., Ltd., the general partner of Triplewin Corporate
Restructuring Partnership, the then-current majority shareholder of FSI, with
respect to the management of FSI in connection with redirecting FSI’s business
focus to the biopharmaceutical industry. Completion of the transactions was
subject to customary closing conditions, including approval by FSI shareholders.
On
June
8, 2006, we terminated the agreements entered into with FSI and Core F.G. Co.,
Ltd., including a share subscription agreement, an intellectual property
assignment and license agreement and a management agreement, providing for,
among other things, the assignment and license by us to FSI of certain
intellectual property rights for our drug candidates in specified markets and
the acquisition by the Company of an ownership interest in FSI. The termination
followed a vote on the proposed transactions that was not approved by the FSI
shareholders at a meeting in Seoul, Korea on June 7, 2006.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
The
following discussion should be read in conjunction with the unaudited
consolidated financial statements and notes thereto set forth in Item 1 of
this
Quarterly Report. This Quarterly Report contains statements accompanied by
such
phrases as "believe", "estimate", "expect", "anticipate", "may", "intend" and
other similar expressions, that are "forward-looking statements" as defined
in
the Private Securities Litigation Reform Act of 1995. Actual results may differ
materially from those projected as a result of certain risks and uncertainties,
including but not limited to the following:
·
|
our
lack of profitability and the need 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 are unavailable to issuers of "penny stock". Our shares may be considered
a
penny stock and, as a result, the safe harbors may not be available to
us.
CRITICAL
ACCOUNTING POLICIES
A
"critical accounting policy" is one which is both important to the portrayal
of
our financial condition and results and requires our management's most
difficult, subjective or complex judgments, often as a result of the need to
make estimates about the effect of matters that are inherently uncertain. Our
accounting policies are in accordance with United States generally accepted
accounting principles ("GAAP") and their basis of application is consistent
with
that of the previous year.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities
and
the disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. These estimates are based on management's best knowledge
of
current events and actions we may undertake in the future. Actual results may
ultimately differ from those estimates. These estimates are reviewed
periodically and as adjustments become necessary, they are reported in earnings
in the period in which they become available.
Stock-Based
Compensation
In
December 2004, the Financial Accounting Standards Board ("FASB") issued
Statement of Financial Accounting Standards ("SFAS") No. 123 (Revised 2004),
"Share-Based Payment" ("SFAS No. 123R"). This pronouncement amends SFAS No.
123,
"Accounting for Stock-Based Compensation" and supersedes Accounting Principles
Board ("APB") Opinion No. 25, "Accounting for Stock Issued to Employees". SFAS
No. 123R requires that companies account for awards of equity instruments issued
to employees under the fair value method of accounting and recognize such
amounts in the statement of operations. The implementation of this statement
was
effective January 31, 2006, and has been adopted using the modified prospective
method.
For
all
non-employee stock-based compensation we use the fair value method in accordance
with SFAS No. 123 and EITF 96-18.
In
management's opinion, existing stock option valuation models do not provide
a
reliable single measure of the fair value of employee stock options that have
vesting provisions and are not transferable. As option valuation models require
the input of highly subjective assumptions, changes in such subjective
assumptions can materially affect the fair value estimate of employee stock
options.
Prior
to
the adoption of SFAS No. 123R, we used the intrinsic value method to account
for
stock-based compensation in accordance with APB Opinion No. 25 and, as permitted
by SFAS No. 123, provided pro forma disclosures of net loss and loss per common
share as if the fair value methods had been applied in measuring compensation
expense. Under the intrinsic value method, compensation cost for employee stock
awards is recognized as the excess, if any, of the deemed fair value for
financial reporting purposes of our common stock on the date of grant over
the
amount an employee must pay to acquire the stock. Compensation cost is amortized
over the vesting period using an accelerated graded method in accordance with
FASB Interpretation No. 28, "Accounting for Stock Appreciation Rights and Other
Variable Stock Option or Award Plans".
RECENTLY
ISSUED ACCOUNTING STANDARDS
In
February 2006, the FASB issued SFAS No. 155, "Accounting for Certain Hybrid
Financial Instruments—an amendment of FASB Statements No. 133 and 140". This
Statement permits fair value of remeasurement for any hybrid financial
instrument that contains an embedded derivative that otherwise would require
bifurcation; clarifies which interest-only strips and principal-only strips
are
not subject to the requirements of SFAS No. 133, "Accounting for Derivative
Instruments and Hedging Activities"; establishes a requirement to evaluate
interests in securitized financial assets to identify interests that are
freestanding derivatives or that are hybrid financial instruments that contain
an embedded derivative requiring bifurcation; clarifies that concentrations
of
credit risk in the form of subordination are not embedded derivatives; and
amended SFAS No. 140, "Accounting for Transfers and Servicing of Financial
Assets and Extinguishments of Liabilities", to eliminate the prohibition on
a
qualifying special-purpose entity from holding a derivative financial instrument
that pertains to a beneficial interest other than another derivative financial
instrument. SFAS No. 155 is effective for all financial instruments acquired,
issued, or subject to a remeasurement (new basis) event occurring after the
beginning of an entity’s first fiscal year that begins after September 15, 2006.
The Company is currently reviewing the effect, if any, the proposed guidance
will have on its financial position.
In
March
2006, FASB issued SFAS No. 156, "Accounting for Servicing of Financial Assets",
which amends SFAS No. 140, "Accounting for Transfers and Servicing of Financial
Assets and Extinguishments of Liabilities". In a significant change to current
guidance, SFAS No. 156 permits an entity to choose either of the following
subsequent measurement methods for each class of separately recognized servicing
assets and servicing liabilities: (1) Amortization Method or (2) Fair Value
Measurement Method. SFAS No. 156 is effective as of the beginning of an entity’s
first fiscal year that begins after September 15, 2006. The Company is currently
reviewing the effect, if any, the proposed guidance will have on its financial
position.
In
July
2006, FASB issued Financial Accounting Standards Interpretation No. 48
(“FIN 48”), “Accounting for Uncertainty in Income Taxes”. FIN 48 clarifies the
accounting for uncertainty in income taxes recognized in an enterprises’
financial statement in accordance with SFAS No. 109, “Accounting for Income
Taxes”. FIN 48 prescribes a recognition threshold and measurement attributable
for the financial statement recognition and measurement of a tax position taken
or expected to be taken in a tax return. FIN 48 also provides guidance on
derecognition, classification, interest and penalties, accounting in interim
periods, disclosures and transitions. FIN 48 is effective for fiscal years
beginning after December 15, 2006. The Company is currently reviewing the
effect, if any, the proposed guidance will have on its financial
position.
RESULTS
OF OPERATIONS
Comparison
of Three Months and Six Months Ended June 30, 2006 and
2005:
Total
Revenues
For
the
three months and six months ended June 30, 2006, we recorded revenue of
$106,837 and
$236,779, respectively, compared to $50,710 and $74,269 in the same period
last
year. Revenues include $18,750 and $37,500 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 in the three and six months ended June 30, 2006 and the same period
last year. We recorded $88,087 and $199,279, respectively, of
interest and other income from the investment of our cash and cash equivalents
and other short-term investments for the three months and six months ended
June
30, 2006, compared to $31,960 and $36,769, respectively, for the same periods
in
2005. The increase of $56,127 and $162,510 in
total
revenues, or 111% and 219%, respectively, was primarily due to an increase
in
interest income in the three months and six months ended June 30, 2006, compared
to the same periods in 2005 as a result of higher cash and cash equivalent
balances during the 2006 period.
General
and Administrative Expenses
General
and administrative expenses consist primarily of salaries and related expenses
for executive, finance and other administrative personnel, recruitment expenses,
professional fees and other corporate expenses, including business development
and general legal activities.
General
and administrative expenses decreased $293,351 and $39,263, or 33% and 3%,
respectively, from $883,950 and $1,196,832, respectively, for the three months
and six months ended June 30, 2005 to $590,599 and $1,157,568, respectively,
for
the three months and six months ended June 30, 2006. The decreases were
primarily due to professional fees and expenses incurred during the 2005
periods in connection with our reverse merger transaction completed on
May 13, 2005, including legal and accounting fees and expenses, which did not
recur during the 2006 periods.
Research
and Development Expenses
Research
and development expenses consist primarily of salaries and related personnel
costs, fees paid to consultants and outside service providers for laboratory
development and other expenses relating to the design, development, testing,
and
enhancement of our drug candidates. We expense our research and development
costs as they are incurred.
Research
and development expenses increased $272,380 and $1,695,019, or 154% and 305%,
respectively, from $176,940 and $555,436, respectively, for the three months
and
six months ended June 30, 2005 to $449,320 and $2,250,455, respectively, for
the
three months and six months ended June 30, 2006. The increase was due primarily
to the fact that the clinical trials of RX-0201, one of our drug
candidates, are continuing and we have taken preliminary steps to prepare
other drug candidates for clinical trials. We expect that research and
development expenses will continue to increase as our other 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 $472,225
and
$808,319, respectively, for the three months and six months ended June 30,
2006,
compared to compensation expenses of $131,598 and $227,309, respectively, for
options issued to employees and non-employees for the three months and six
months ended June 30, 2005. The increase is due to the adoption of SFAS No.
123R, effective January 1, 2006, and an increase in the number of outstanding
shares subject to options during the six months ended June 30, 2006 compared
to
the same period last year.
Patent
Fees
Our
patent fees increased $18,028 and $8,847, or 67% and 16%, respectively, from
$26,858 and $55,442, respectively, for the three months and six months ended
June 30, 2005 to $44,886 and $64,289, respectively, for the three months and
six
months ended June 30, 2006. The increase was due primarily to an increase in
the
number of patent filings made during the six months ended June 30, 2006 compared
to the same period last year.
Interest
Expense
Interest
expense decreased $27,181, or 47%, and increased $13,802, or 18%, from $57,750
and $77,219, respectively, for the three months and six months ended June 30,
2005 to $30,569 and $91,021, respectively, for the three months and six months
ended June 30, 2006. The decrease during the three month period ended June
30,
2006 is due to conversion and payment of total accrued interest related to
the
debt in May 2006 while interest was accrued for the entire corresponding period
last year. The increase during the six month period was attributable to the
interest on the convertible notes issued February 2005 being reflected for
a
full period compared to a partial period in 2005.
Depreciation
and Amortization
Depreciation
and amortization expenses increased $4,670 and $9,231, or 28% and
28% respectively,
from $16,517 and $33,033, respectively, for the three months and six months
ended June 30, 2005 to $21,187 and $42,264, respectively, for the three months
and six months ended June 30, 2006. The increase was due primarily to a move
to
a new facility in July 2004 and the related purchase of new laboratory
equipment.
Net
Loss
As
a
result of the above, the net loss for the three months and six months ended
June
30, 2006 was $1,501,949 and $4,177,136, or $0.03 and $0.09 per
share, respectively, compared to a net loss of $1,242,903 and $2,071,002, or
$0.03 and $0.05 per share, respectively, for the three months and six months
ended June 30, 2005.
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 four lead
drug candidates, RX-0201, RX-0047, RX-5902 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-5902 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 and
the
University of Alabama at Birmingham since August 2005. The costs incurred for
the clinical trial to date have been approximately $1,000,000. 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 $250,000 and anticipate its completion in
the
third quarter of 2006.
RX-0047
and RX-5902
RX-0047
and RX-5902 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. To date, the costs incurred for development of these compounds to date
have
been approximately $800,000 for RX-0047, and $300,000 for RX-5902. The estimated
cost to complete pre-clinical toxicology and Phase I clinical trials is
estimated to be approximately $1,500,000 per compound for a total of $3,000,000.
These compounds may be entered into these Phase I clinical trials in late 2006
or early 2007.
The
conduct of the clinical trial and toxicology studies described above are being
accomplished in conjunction with third-party clinical research organizations,
or
CROs, at external locations. This business practice is typical for the
pharmaceutical industry and companies like us. As a result, the risk of
completion or delay of these studies is not within our direct control and a
program delay may occur due to circumstances outside our control. A delay in
any
of these programs may not necessarily have a direct impact on our daily
operations. However, to the extent that a delay results in additional cost
to
us, a higher than expected expense may result.
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
$300,000 and $450,000, respectively. We are preparing to initiate a Phase II
clinical trial of RX-10100 during 2006.
LIQUIDITY
AND CAPITAL RESOURCES
Cash
used
in operating activities was $3,712,925 for
the
six months ended June 30, 2006 compared to cash used in operating activities
of
$1,700,664 for the same period ended June 30, 2005. The operating cash flows
during the six months ended June 30, 2006 reflect our loss from operations
of
$4,177,137, offset by non-cash charges of $813,083 and
a net
decrease in cash components of working capital of $348,871. Non-cash charges
consist of depreciation and amortization of $42,264, stock option compensation
expense of $808,319 and
deferred revenue of $37,500. The decrease in working capital primarily consists
of a $345,643 decrease in accounts payable and accrued expenses.
There
was
no cash provided by or used in investing activities during the six months ended
June 30, 2005. Cash investing activities of $2,212,570 during the six months
ended June 30, 2006 reflects short-term investments of $2,212,570. Cash provided
by financing activities of $3,756,250 during the six months ended June 30,
2005
consisted of proceeds from the issuance of long-term debt in financing
transactions of $3,850,000, offset by principal payments on long-term debt
of
$93,750. Cash used in financing activities of $83,084 during
the six months ended June 30, 2006 consisted of principal payments on long-term
debt of $87,693, offset by proceeds from the issuance of common
stock.
For
the
six months ended June 30, 2006, and the years ended December 31, 2005 and
2004, we experienced net losses of $4,177,135, $6,349,540 and $3,723,442,
respectively. Our accumulated deficit as of June 30, 2006, and December 31,
2005 and 2004 was $18,381,460, $14,204,323 and $7,854,783, respectively.
We
have
financed our operations since inception primarily through equity and convertible
debt financings and income from short-term investments. During the six
months ended June 30, 2006, we had a net decrease in cash and cash equivalents
of $1,611,849. This decrease primarily resulted from net losses of $4,177,137.
Total cash resources as of June 30, 2006 were $67,592 compared
to $1,679,441 as of December 31, 2005.
For
the
foreseeable future, we will have to fund all of our operations and capital
expenditures from the net proceeds of equity or debt offerings we may have,
cash
on hand, licensing fees and grants. Although we have plans to pursue additional
financing, there can be no assurance that we will be able to secure financing
when needed or obtain such financing on terms satisfactory to us, if at all,
or
that any additional funding we do obtain will be sufficient to meet our needs
in
the long term.
CONTRACTUAL
OBLIGATIONS
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 cost of the program is $223,126, based on the fees,
enrollment and completion of 20 patients and is payable based on the progress
of
the treatment over the effective period of the agreement. For the six months
ended June 30, 2006 and the years ended December 31, 2005 and 2004, we paid
$0,
$0 and $17,426, respectively, towards the cost of this program.
On
August
17, 2004, we entered into an agreement with Formatech, Inc. to monitor and
perform stability studies on our drug candidate, RX-0201. The total cost of
these services is $46,700. For the six months ended June 30, 2006 and the years
ended December 31, 2005 and 2004, we paid $5,200, $10,400 and $22,900,
respectively, towards the cost of these studies. The remainder consists of
a
$8,200 payment due during 2007.
In
April
2004, we signed a 5-year lease for 8,030 square feet of office space in
Rockville, Maryland commencing July 2004. The lease requires annual base rents
of $200,750 subject to annual increases of 3% of the preceding years adjusted
base rent. Under the leasing agreement, we also pay our allocable portion of
real estate taxes and common area operating charges.
Minimum
future rental payments under this lease are as follows:
For
the years ending
December 31
|
||||
2006
|
$
|
209,874
|
||
2007
|
216,170
|
|||
2008
|
222,655
|
|||
2009
|
112,972
|
|||
$
|
761,671
|
On
August
1, 2005, we 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. We 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. For the year
ended December 31, 2005, we made two quarterly payments totaling $38,333 and
the
remaining two quarterly payments totaling $38,333 during the six months ended
June 30, 2006.
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
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. An initial retainer fee
of
$50,000 was paid during the year ended December 31, 2005. Dr. John Holaday,
a
former director of ours, is a partner of MPG.
On
October 6, 2005, we entered into an agreement with Avecia Biotechnology Inc.
("Avecia"). Avecia will manufacture and supply us with RX-0201 and related
drug
services. The total cost of the project is $1,738,000. For the six months ended
June 30, 2006 and the years ended December 31, 2005, we paid $1,216,600 and
$521,400, respectively, towards the cost of these studies.
On
January 3, 2006 and March 29, 2006, we contracted with Formatech to perform
RX-0201 experiments in an effort to develop a more concentrated dosage form.
The
cost of the project was $57,000, the total cost of which was paid in the six
months ended June 30, 2006. In addition, on January 6, 2006, we entered into
a
drug packaging agreement with Formatech for Phase II clinical trials of RX-0201.
In accordance with the agreement, the estimated cost of the project is $128,250
plus pass through expenses, of which $131,789 was paid during the six months
ended June 30, 2006.
On
January 6, 2006, we contracted with Amarex, LLC to conduct Phase II clinical
studies. In accordance with the agreement, the estimated contract duration
is 24
months for a total cost of $596,244. The service costs are payable in 24 monthly
payments of $18,633 plus an initiation fee of $149,061 due upon signing. We
paid
$241,357 towards the cost of the study in the six months ended June 30, 2006
and
a monthly payment of $18,633 was included in accrued expenses at June 30, 2006.
On
March
1, 2006, we entered into a research program with Ewha Woman's University. The
effective period of the agreement is from March 1, 2006 to February 28, 2007.
In
accordance with the agreement, the cost of the research program is $40,000
and
is paid upon full execution of the agreement. The Company paid $40,000 in
connection with the agreement during the six months ended June 30,
2006.
On
April
3, 2006, we contracted with UPM Pharmaceuticals, Inc. to develop a short-acting
extended release formulation for RX-10100. In accordance with the agreement,
the
estimated contract duration is seven months for an estimated cost of $443,975,
of which $26,201 was paid during the six months ended June 30, 2006. The service
costs are payable based upon a payment schedule related to certain
milestones.
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. Based on our current plans and our capital resources (including the
proceeds of our 2005 financings), we believe that our cash and cash equivalents
will be sufficient to enable us to meet our minimum planned operating needs
for
at least the next 12 months, which would entail focusing our resources on
Phase II clinical trials of RX-0201 and the pre-clinical studies and Phase
I clinical trials for RX-10100. Over the next 12 months we expect to spend
a
minimum of approximately $3 million on clinical development for
Phase I and Phase II clinical trials of RX-0201 (including our
commitments described under "Contractual Commitments" of this Item 2), $2.5
million on general corporate expenses, and $250,000 on facilities rent. We
may
seek additional financing to implement and fund other drug candidate
development, clinical trial and research and development efforts to the maximum
extent of our operating plan, including pre-clinical studies and Phase I
clinical trials for RX-0047 and in-vivo animal and pre-clinical studies and
Phase I clinical trials for RX-5209, RX-10100 and other new product
candidates, as well as other research and development projects, which together
with the minimum operating plan for the next 12 months, could aggregate
$10 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 year we expect to spend approximately $3 million
on
clinical development for Phase II clinical trials of RX-0201 and RX-10100 and
Phase I clinical trials for RX-5902. 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 year,
including the clinical trials of RX-0201, RX-10100 and RX-5902.
However,
changes may occur that would consume our existing capital at a faster rate
than
projected, including but not limited to, the progress of our research and
development efforts, the cost and timing of regulatory approvals and the costs
of protecting our intellectual property rights. We may seek additional financing
to implement and fund other drug candidate development, clinical trial and
research and development efforts, including Phase I clinical trials for other
new drug candidates, as well as other research and development projects, which
together with the current operating plan for the next year, could aggregate
$20
million through the second quarter of 2008.
We
will
need additional financing to continue to develop our drug candidates, which
may
not be available on favorable terms, if at all. If we are unable to secure
additional financing in the future on acceptable terms, or at all, we may be
unable to complete our planned pre-clinical and clinical trials or obtain
approval of our drug candidates from the FDA and other regulatory authorities.
In addition, we may be forced to reduce or discontinue product development
or
product licensing, reduce or forego sales and marketing efforts and forego
attractive business opportunities in order to improve our liquidity to enable
us
to continue operations. Any additional sources of financing will likely involve
the sale of our equity securities, 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
June 30, 2006 and December 31, 2005 was $18,381,460 and
$14,204,323, respectively. For the six months ended June 30, 2006 and the year
ended December 31, 2005, we had net losses of $4,177,137 and
$6,349,540, respectively, primarily as a result of expenses incurred through
a
combination of research and development activities related to the various
technologies under our control and expenses supporting those activities. Even
if
we succeed in developing and commercializing one or more of our drug candidates,
we expect to incur substantial losses for the foreseeable future and may never
become profitable. We also expect to continue to incur significant operating
and
capital expenditures and anticipate that our expenses will increase
substantially in the foreseeable future, based on the following considerations:
·
|
continued
pre-clinical development and clinical trials for our current and
new drug
candidates;
|
·
|
efforts
to seek regulatory approvals for our drug
candidates;
|
·
|
implementing
additional internal systems and
infrastructure;
|
·
|
licensing
in additional technologies to develop;
and
|
·
|
hiring
additional personnel.
|
We
also
expect to continue to experience negative cash flow for the foreseeable future
as we fund our operating losses and capital expenditures. As a result, we will
need to generate significant revenues in order to achieve profitability.
We
have a limited operating history.
We
are a
development-stage company with four drug candidates. To date, we have not
demonstrated an ability to perform the functions necessary for the successful
commercialization of any of our drug candidates. The successful
commercialization of our drug candidates will require us to perform a variety
of
functions, including, but not limited to:
·
|
conducting
pre-clinical and clinical trials;
|
·
|
participating
in regulatory approval processes;
|
·
|
formulating
and manufacturing products; and
|
·
|
conducting
sales and marketing activities.
|
To
date,
our operations have been limited to organizing and staffing our company,
acquiring, developing and securing our proprietary technology and undertaking,
through third parties, pre-clinical trials and clinical trials of our principal
drug candidates. These operations provide a limited basis for assessment of
our
ability to commercialize drug candidates.
We
may not obtain the necessary U.S. or worldwide regulatory approvals to
commercialize our drug candidates.
We
will
need FDA approval to commercialize our drug candidates in the U.S. and approvals
from the FDA-equivalent regulatory authorities in foreign jurisdictions to
commercialize our drug candidates in those jurisdictions. In order to obtain
FDA
approval of our drug candidates, we must submit to the FDA a New Drug
Application ("NDA") demonstrating that the drug candidate is safe for humans
and
effective for its intended use. This demonstration requires significant research
and animal tests, which are referred to as pre-clinical studies, as well as
human tests, which are referred to as clinical trials. Satisfaction of the
FDA's
regulatory requirements typically takes many years, and depends upon the type,
complexity and novelty of the drug candidate and requires substantial resources
for research, development and testing. We cannot predict whether our research
and clinical approaches will result in drugs that the FDA considers safe for
humans and effective for indicated uses. Two of our four drug candidates,
RX-0201 and RX-0047, are 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.
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
2006, we expect to have one oncology drug candidate entering Phase II clinical
trials, one neuroscience drug candidate entering Phase II clinical trials and
one oncology drug candidate in Phase I clinical trials.
Clinical
trials are very expensive, time-consuming and difficult to design and implement.
Human
clinical trials are very expensive and difficult to design and implement, in
part because they are subject to rigorous regulatory requirements. The clinical
trial process is also time consuming. We estimate that clinical trials of our
current drug candidates will take at least three years to complete. Furthermore,
failure can occur at any stage of the trials, and we could encounter problems
that cause us to abandon or repeat clinical trials. The commencement and
completion of clinical trials may be delayed by several factors, including,
but
not limited to:
·
|
unforeseen
safety issues;
|
·
|
determination
of dosing issues;
|
·
|
lack
of effectiveness during clinical
trials;
|
·
|
reliance
on third party suppliers for the supply of drug candidate
samples;
|
·
|
slower
than expected rates of patient
recruitment;
|
·
|
inability
to monitor patients adequately during or after treatment;
|
·
|
inability
or unwillingness of medical investigators and institutional review
boards
to follow our clinical protocols;
and
|
·
|
lack
of sufficient funding to finance the clinical
trials.
|
In
addition, we or the FDA may suspend clinical trials at any time if it appears
that we are exposing participants to unacceptable health risks or if the FDA
finds deficiencies in our IND submissions or the conduct of these trials.
If
the results of our clinical trials fail to support our drug candidate claims,
the completion of development of such drug candidate may be significantly
delayed or we may be forced to abandon development altogether, which will
significantly impair our ability to generate product revenues.
Even
if
our clinical trials are completed as planned, we cannot be certain that our
results will support our drug candidate claims. Success in pre-clinical testing
and early clinical trials does not ensure that later clinical trials will be
successful, and we cannot be sure that the results of later clinical trials
will
replicate the results of prior clinical trials and pre-clinical testing. The
clinical trial process may fail to demonstrate that our drug candidates are
safe
for humans and effective for indicated uses. This failure would cause us to
abandon a drug candidate and may delay development of other drug candidates.
Any
delay in, or termination of, our clinical trials will delay the filing of our
NDAs with the FDA and, ultimately, delay our ability to commercialize our drug
candidates and generate product revenues. In addition, our trial designs may
involve a small patient population. Because of the small sample size, the
results of early clinical trials may not be indicative of future
results.
If
physicians and patients do not accept and use our drugs, our ability to generate
revenue from sales of our products will be materially impaired.
Even
if
the FDA approves our drug candidates, physicians and patients may not accept
and
use them. Future acceptance and use of our products will depend upon a number
of
factors including:
·
|
awareness
of the drug's availability and
benefits;
|
·
|
perceptions
by members of the health care community, including physicians, about
the
safety and effectiveness of our
drugs;
|
·
|
pharmacological
benefit and cost-effectiveness of our product relative to competing
products;
|
·
|
availability
of reimbursement for our products from government or other healthcare
payers;
|
·
|
effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any; and
|
·
|
the
price at which we sell our
products.
|
Because
we expect sales of our current drug candidates, if approved, to generate
substantially all of our product revenues for the foreseeable future, the
failure of any of these drugs to find market acceptance would harm our business
and could require us to seek additional financing.
Much
of our drug development program depends upon third-party researchers, and the
results of our clinical trials and such research activities are, to a limited
extent, beyond our control.
We
depend
upon independent investigators and collaborators, such as universities and
medical institutions, to conduct our pre-clinical and clinical trials. 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. We also 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. While we make every effort internally to oversee
their work, these collaborators are not our employees and we cannot control
the
amount or timing of resources that they devote to our programs. These
investigators may not assign priority to our programs or pursue them as
diligently as we would if we were undertaking such programs ourselves. If
outside collaborators fail to devote sufficient time and resources to our
drug-development programs, or if their performance is substandard, the approval
of our FDA applications, if any, and our introduction of new drugs, if any,
may
be delayed. These collaborators may also have relationships with other
commercial entities, some of whom may compete with us. If our collaborators
assist our competitors at our expense, our competitive position would be harmed.
We
rely exclusively on third parties to formulate and manufacture our drug
candidates, which expose us to a number of risks that may delay development,
regulatory approval and commercialization of our products or result in higher
product costs.
We
have
no experience in drug formulation or manufacturing. Internally, we lack the
resources and expertise to formulate or manufacture our own drug candidates.
Therefore, we rely on third party expertise to support us in this area. For
example, we have entered into contracts with third-party manufacturers such
as
Raylo Chemicals Inc., Formatech, Inc., Avecia Biotechnology Inc. and UPM
Pharmaceuticals, Inc. to manufacture, supply, store and distribute supplies
of
our drug candidates for our clinical trials. If any of our drug candidates
receive FDA approval, we will rely on these or other third-party contractors
to
manufacture our drugs. Our reliance on third-party manufacturers exposes us
to
the following potential risks:
·
|
We
may be unable to identify manufacturers on acceptable terms or at
all
because the number of potential manufacturers is limited and the
FDA must
approve any replacement contractor. This approval would require new
testing and compliance inspections. In addition, a new manufacturer
would
have to be educated in, or develop substantially equivalent processes
for,
the production of our products after receipt of FDA approval, if
any.
|
·
|
Our
third-party manufacturers might be unable to formulate and manufacture
our
drugs in the volume and of the quality required to meet our clinical
needs
and commercial needs.
|
·
|
Our
contract manufacturers may not perform as agreed or may not remain
in the
contract manufacturing business for the time required to supply our
clinical trials or to successfully produce, store and distribute
our
products.
|
·
|
Drug
manufacturers are subject to ongoing periodic unannounced inspection
by
the FDA, the Drug Enforcement Agency ("DEA"), and corresponding state
agencies to ensure strict compliance with good manufacturing practice
and
other government regulations and corresponding foreign standards.
We do
not have control over third-party manufacturers' compliance with
these
regulations and standards, but we may be ultimately responsible for
any of
their failures.
|
·
|
If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share, the
intellectual property rights to the
innovation.
|
Each
of
these risks could delay our clinical trials, drug approval and commercialization
and potentially result in higher costs and/or reduced revenues.
We
have no experience selling, marketing or distributing products and no internal
capability to do so.
We
currently have no sales, marketing or distribution capabilities. While we intend
to have a role in the commercialization of our products, we do not anticipate
having the resources in the foreseeable future to globally develop sales and
marketing capabilities for all of our proposed products. Our future success
depends, in part, on our ability to enter into and maintain collaborative
relationships with other companies having sales, marketing and distribution
capabilities, the collaborator's strategic interest in the products under
development and such collaborator's ability to successfully market and sell
any
such products. To the extent that we decide not to, or are unable to, enter
into
collaborative arrangements with respect to the sales and marketing of our
proposed products, significant capital expenditures, management resources and
time will be required to establish and develop an in-house marketing and sales
force with technical expertise. We cannot assure you that we will be able to
establish or maintain relationships with third party collaborators or develop
in-house sales and distribution capabilities. To the extent that we depend
on
third parties for marketing and distribution, any revenues we receive will
depend upon the efforts of such third parties, as well as the terms of its
agreements with such third parties, which cannot be predicted at this early
stage of our development. We cannot assure you that such efforts will be
successful. In addition, we cannot assure you that we will be able to market
and
sell our products in the United States or overseas.
Developments
by competitors may render our products or technologies obsolete or
non-competitive.
We
will
compete against fully integrated pharmaceutical companies and smaller companies
that are collaborating with larger pharmaceutical companies, academic
institutions, government agencies and other public and private research
organizations, such as Antigenics Inc., Genta Incorporated, Imclone Systems
Incorporated, Human Genome Sciences, Inc., Kosan Biosciences Incorporated and
Medimmune, Inc. In addition, many of these competitors, either alone or together
with their collaborative partners, operate larger research and development
programs or have substantially greater financial resources than we do, as well
as more experience in:
·
|
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, 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
employees to enter into agreements that prohibit the disclosure of confidential
information and, where applicable, require disclosure and assignment to us
of
the ideas, developments, discoveries and inventions important to our business.
These agreements may not provide adequate protection for our trade secrets,
know-how or other proprietary information in the event of any unauthorized
use
or disclosure or the lawful development by others of such information. If any
of
our trade secrets, know-how or other proprietary information is disclosed,
the
value of our trade secrets, know-how and other proprietary rights would be
significantly impaired and our business and competitive position would
suffer.
If
we infringe the rights of third parties we could be prevented from selling
products and be forced to pay damages and defend against
litigation.
If
our
products, methods, processes and other technologies infringe the proprietary
rights of other parties, we could incur substantial costs and may have
to:
·
|
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, our
public profile and that of our drug candidates may be raised and generate such
claims.
Our
license agreement with Revaax may be terminated in the event we commit a
material breach, the result of which would significantly harm our business
prospects.
Our
license agreement with Revaax is subject to termination by Revaax if we
materially breach 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 proactively seek
opportunities to license in and advance compounds in oncology and other
therapeutic areas that are strategic and have value creating potential to take
advantage of our development know-how. We are actively pursuing additional
drug
candidates to acquire for development. Such additional drug candidates could
significantly increase our capital requirements and place further strain on
the
time of our existing personnel, which may delay or otherwise adversely affect
the development of our existing drug candidates. Alternatively, we may be
required to hire more employees, further increasing the size of our organization
and related expenses. If we are unable to manage our growth effectively, we
may
not efficiently use our resources, which may delay the development of our drug
candidates and negatively impact our business, results of operations and
financial condition.
We
may not be able to attract and retain qualified personnel necessary for the
development and commercialization of our drug candidates. Our success may be
negatively impacted if key personnel leave.
Attracting
and retaining qualified personnel will be critical to our future success. We
compete for qualified individuals with numerous biopharmaceutical companies,
universities and other research institutions. Competition for such individuals
is intense, and we cannot assure you that we will be successful.
The
loss
of the technical knowledge and management and industry expertise of any of
our
key personnel, especially Dr. Chang H. Ahn, our Chairman and Chief
Executive Officer and regulatory expert, could result in delays in product
development and diversion of management resources, which could adversely affect
our operating results. We do not have "key person" life insurance policies
for
any of our officers.
We
may incur substantial liabilities and may be required to limit commercialization
of our products in response to product liability lawsuits.
The
testing and marketing of medical products entail an inherent risk of product
liability. If we cannot successfully defend ourselves against product liability
claims, we may incur substantial liabilities or be required to limit
commercialization of our products. Our inability to obtain sufficient product
liability insurance at an acceptable cost to protect against potential product
liability claims could prevent or inhibit the commercialization of
pharmaceutical products we develop, alone or with collaborators. Although we
currently carry clinical trial insurance and product liability insurance, we,
or
any collaborators, may not be able to maintain such insurance at a reasonable
cost. Even if our agreements with any future collaborators entitles us to
indemnification against losses, such indemnification may not be available or
adequate should any claim arise.
An
investment in shares of our common stock is very speculative and involves a
very
high degree of risk.
To
date,
we have generated no revenues from product sales and only minimal revenues
from
a research agreement with a minority shareholder, and interest on bank account
balances and short-term investments. Our accumulated deficit as of June 30,
2006
and December 31, 2005 was $18,381,460 and
$14,204,323, respectively. For the six months ended June 30, 2006 and the year
ended December 31, 2005, we had net losses of $4,177,137 and
$6,349,540, respectively, primarily as a result of expenses incurred through
a
combination of research and development activities related to the various
technologies under our control and expenses supporting those activities. Until
we receive approval from the FDA and other regulatory authorities for our drug
candidates, we cannot sell our drugs and will not have product revenues.
The
market price of our common stock may fluctuate significantly.
The
market price of our common stock may fluctuate significantly in response to
factors, some of which are beyond our control, such as:
·
|
the
announcement of new products or product enhancements by us or our
competitors;
|
·
|
developments
concerning intellectual property rights and regulatory
approvals;
|
·
|
variations
in our and our competitors' results of operations;
|
·
|
changes
in earnings estimates or recommendations by securities
analysts;
and
|
·
|
developments
in the biotechnology industry.
|
Further,
the stock market, in general, and the market for biotechnology companies, in
particular, have experienced extreme price and volume fluctuations. Continued
market fluctuations could result in extreme volatility in the price of our
common stock, which could cause a decline in the value of our common stock.
You
should also be aware that price volatility might be worse if the trading volume
of our common stock is low. We have not paid, and do not expect to pay, any
cash
dividends because we anticipate that any earnings generated from future
operations will be used to finance our operations and as a result, you will
not
realize any income from an investment in our common stock until and unless
you
sell your shares at a profit.
Some
or
all of the "restricted" shares of our common stock issued in the merger of
CPRD
and Rexahn, Corp or held by other stockholders may be offered from time to
time
in the open market pursuant to Rule 144, and these sales may have a depressive
effect on the market for our common stock. In general, a person who has held
restricted shares for a period of one year may, upon filing with the SEC a
notification on Form 144, sell into the market common stock in an amount equal
to 1 percent of the outstanding shares (approximately 500,000 shares)
during a three month period. Any of the restricted shares may be freely sold
by
a non-affiliate after they have been held two years.
Trading
of our common stock is limited.
Trading
of our common stock is currently conducted on the National Association of
Securities Dealers' Over-the-Counter Bulletin Board ("OTC-BB"). The liquidity
of
our securities has been limited, not only in terms of the number of securities
that can be bought and sold at a given price, but also through delays in the
timing of transactions and reduction in security analysts' and the media's
coverage of us.
These
factors may result in lower prices for our common stock than might otherwise
be
obtained and could also result in a larger spread between the bid and asked
prices for our common stock. Currently, there are approximately 250 holders
of
record of our common stock.
Because
our common stock may be a "penny stock," it may be more difficult for you to
sell shares of our common stock, and the market price of our common stock may
be
adversely affected.
Our
common stock may be a "penny stock" if, among other things, the stock price
is
below $5.00 per share, we are not listed on a national securities exchange
or
approved for quotation on the Nasdaq Stock Market, or we have not met certain
net tangible asset or average revenue requirements. Broker-dealers who sell
penny stocks must provide purchasers of these stocks with a standardized
risk-disclosure document prepared by the SEC. This document provides information
about penny stocks and the nature and level of risks involved in investing
in
the penny-stock market. A broker must also give a purchaser, orally or in
writing, bid and offer quotations and information regarding broker and
salesperson compensation, make a written determination that the penny stock
is a
suitable investment for the purchaser, and obtain the purchaser's written
agreement to the purchase. Broker-dealers must also provide customers that
hold
penny stock in their accounts with such broker-dealer a monthly statement
containing price and market information relating to the penny stock. If a penny
stock is sold in violation of the penny stock rules, purchasers may be able
to
cancel their purchase and get their money back. If applicable, the penny stock
rules may make it difficult for investors to sell their shares of our stock.
Because of the rules and restrictions applicable to a penny stock, there is
less
trading in penny stocks and the market price of our common stock may be
adversely affected. Also, many brokers choose not to participate in penny stock
transactions. Accordingly, purchasers may not always be able to resell shares
of
our common stock publicly at times and prices that they feel are
appropriate.
Item
3. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
As
of
June 30, 2006, our management carried out an evaluation, under the supervision
of our Chief Executive Officer and Chief Financial Officer of the effectiveness
of the design and operation of our system of disclosure controls and procedures
pursuant to Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act
of
1934, as amended, or the Exchange Act. Based upon that evaluation, the Chief
Executive Officer and the Chief Financial Officer have concluded that our
disclosure controls and procedures were effective, as of the date of this
evaluation, for the purposes of recording, processing, summarizing and timely
reporting material information required to be disclosed in reports filed by
us
under the Exchange Act.
There
were no changes in our internal control over financial reporting during the
quarter ended June 30, 2006 that have materially affected, or are reasonably
likely to affect, our financial reporting.
PART
II - OTHER INFORMATION
Item
1. LEGAL PROCEEDINGS
We
are
not subject to any pending legal proceedings, nor are we aware of any threatened
claim against us.
Item
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE
OF PROCEEDS
None.
Item
3. DEFAULTS UPON SENIOR
SECURITIES
None.
Item
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY
HOLDERS
At
the
annual meeting of stockholders of the Company on June 2, 2006 in Rockville,
Maryland, the following matters were voted on by the Company’s stockholders and
approved by the following votes:
Number
of Shares
|
|||
Voted
For
|
Withheld
|
||
1. Election
of directors:
|
|||
Chang
H. Ahn
|
43,259,576
|
0
|
|
Charles
Beever
|
43,259,576
|
0
|
|
Kwang
Soon Cheong
|
43,259,576
|
0
|
|
Ted
T.H. Jeong
|
43,259,576
|
0
|
|
Y.
Michele Kang
|
43,259,576
|
0
|
|
David
McIntosh
|
43,259,576
|
0
|
|
Young-Soon
Park
|
43,259,576
|
0
|
Number
of Shares
|
|||||||
Voted
For
|
Voted
Against
|
Abstentions
|
Broker
Non-Votes
|
||||
2. Proposal
to amend the Company’s Stock Option Plan
|
43,259,526
|
50
|
0
|
0
|
|||
3. Proposal
to ratify appointment of Lazar Levine & Felix LLP as the Company’s
independent auditors
|
43,259,576
|
0
|
0
|
N/A
|
Item
5. OTHER INFORMATION
None.
Item
6. EXHIBITS
Exhibit
Number
|
Description
|
|
10.1
|
Termination
Agreement, dated June 7, 2006, by and between Core F.G. Co., Ltd.,
Rexahn
Pharmaceuticals, Inc. and Future Systems, Inc. (English
Translation)
|
|
31.1
|
Certification
of Chief Executive Officer of Periodic Report Pursuant to Rule 13a-15(e)
or Rule 15d-15(e)
|
|
31.2
|
Certification
of Chief Financial Officer of Periodic Report Pursuant to Rule 13a-15(e)
or Rule 15d-15(e)
|
|
32.1
|
Certification
of Chief Executive Officer of Periodic Report Pursuant to 18 U.S.C.
Section 1350
|
|
32.2
|
Certification
of Chief Financial Officer of Periodic Report Pursuant to 18 U.S.C.
Section 1350
|
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant caused
this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
REXAHN
PHARMACEUTICALS, INC.
|
||
|
||
/s/
Ted T.H. Jeong
|
||
Name:
Ted T. H. Jeong
|
||
Title:
Chief Financial Officer and Secretary
|
||
Date:
August 14, 2006
|
EXHIBIT
INDEX
Exhibit
Number
|
Description
|
|
Termination
Agreement, dated June 7, 2006, by and between Core F.G. Co., Ltd.,
Rexahn
Pharmaceuticals, Inc. and Future Systems, Inc. (English
Translation)
|
||
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
|