SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_________________
FORM 10-Q
___________
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2001
Commission File No. 0-31261
ATHEROGENICS, INC.
(Exact name of registrant as specified in its charter)
|
Georgia |
58-210832 |
|
(State of incorporation) |
(I.R.S. Employer Identification Number) |
8995 Westside Parkway, Alpharetta, Georgia 30004
(Address of registrant's principal executive
offices, including zip code)
_______________________
(Registrant's telephone number, including area code):
(678) 336-2500
Indicate by check mark whether the registrant: (1) has
filed all reports required to be filed by Section 13 or 15(d)
of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. Yes [ X ]
No [ ]
As of November 9, 2001, there were 27,793,173
shares of the registrant's
common stock outstanding.
_________________________
ATHEROGENICS, INC.
FORM 10-Q
INDEX
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PART I. FINANCIAL INFORMATION |
Page No. |
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Item 1. Financial Statements (unaudited) |
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Condensed Balance Sheets |
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September 30, 2001 and December 31, 2000 (audited) |
3 |
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Condensed Statements of Operations |
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Three and nine months ended September 30, 2001 and 2000 |
4 |
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Condensed Statements of Cash Flows |
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Nine months ended September 30, 2001 and 2000 |
5 |
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Notes to Condensed Financial Statements |
6 |
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Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations |
8 |
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Item 3. Quantitative and Qualitative Disclosures About Market Risk |
12 |
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PART II. OTHER INFORMATION |
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Item 2. Changes in Securities and Use of Proceeds |
12 |
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Item 6. Exhibits and Reports on Form 8-K |
13 |
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SIGNATURES |
14 |
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2
PART I - FINANCIAL INFORMATION
ATHEROGENICS, INC.
CONDENSED BALANCE SHEETS
The accompanying notes are an integral part of these
condensed financial statements.
3
ATHEROGENICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
|
Three months ended |
Nine months ended |
|||||||||||
|
September 30, |
September 30, |
|||||||||||
|
2001 |
2000 |
2001 |
2000 |
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Revenues: |
||||||||||||
|
License fees |
$ -- |
$ 833,333 |
$ 1,111,111 |
$ 2,499,999 |
||||||||
|
Research and development |
538,511 |
1,071,822 |
1,339,067 |
3,560,486 |
||||||||
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Total revenues |
538,511 |
1,905,155 |
2,450,178 |
6,060,485 |
||||||||
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Operating expenses: |
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Research and development, excluding |
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amortization of deferred stock compensation |
4,236,143 |
3,597,324 |
11,654,926 |
9,211,361 |
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|
General and administrative, excluding |
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|
amortization of deferred stock compensation |
942,574 |
764,967 |
2,837,846 |
2,126,506 |
||||||||
|
Amortization of deferred stock compensation |
815,819 |
2,018,616 |
1,836,212 |
5,970,675 |
||||||||
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Total operating expenses |
5,994,536 |
6,380,907 |
16,328,984 |
17,308,542 |
||||||||
|
Operating loss |
(5,456,025 |
) |
(4,475,752 |
) |
(13,878,806 |
) |
(11,248,027 |
) |
||||
|
Net interest income |
593,806 |
512,221 |
1,966,682 |
806,520 |
||||||||
|
Net loss |
$(4,862,219 |
) |
$(3,963,531 |
) |
$(11,912,124 |
) |
$(10,441,537 |
) |
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|
|
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|
Net loss per share - basic and diluted |
$ (0.18 |
) |
$ (0.30 |
) |
$ (0.47 |
) |
$ (1.66 |
) |
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|
Weighted average shares outstanding |
||||||||||||
|
- basic and diluted |
27,763,830 |
13,399,032 |
25,409,593 |
6,295,537 |
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|
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|
Pro forma net loss per share - basic and diluted |
$ (0.18 |
) |
$ (0.20 |
) |
$ (0.47 |
) |
$ (0.59 |
) |
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|
Pro forma weighted average shares outstanding |
||||||||||||
|
- basic and diluted |
27,763,830 |
20,174,593 |
25,409,593 |
17,705,747 |
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The accompanying notes are an integral part of these
condensed financial statements.
4
ATHEROGENICS, INC.
STATEMENTS OF CASH FLOWS
(Unaudited)
|
Nine months ended |
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September 30, |
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|
2001 |
2000 |
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Operating Activities: |
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Net loss |
$(11,912,124 |
) |
$(10,441,537 |
) |
|||||||||
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Adjustments to reconcile net loss to net cash used in |
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operating activities: |
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Depreciation and amortization |
354,096 |
316,755 |
|||||||||||
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Amortization of deferred stock compensation |
1,836,212 |
5,970,675 |
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Stock issued for services |
29,778 |
60,652 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
599,733 |
(81,767 |
) |
||||||||||
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Prepaid expenses, note receivable and other assets |
(159,728 |
) |
(621,396 |
) |
|||||||||
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Accounts payable |
(1,085 |
) |
(77,714 |
) |
|||||||||
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Accrued liabilities |
655,356 |
812,368 |
|||||||||||
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Deferred revenues |
(1,111,111 |
) |
(2,500,000 |
) |
|||||||||
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Net cash used in operating activities |
(9,708,873 |
) |
(6,561,964 |
) |
|||||||||
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Investing Activities: |
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Purchases of equipment and leasehold improvements |
(777,934 |
) |
(555,943 |
) |
|||||||||
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Sales of short-term investments |
9,423,409 |
-- |
|||||||||||
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Net cash provided by (used in) investing activities |
8,645,475 |
(555,943 |
) |
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Financing Activities: |
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Payments on capital lease |
(116,317 |
) |
(162,027 |
) |
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Proceeds from the issuance of common stock |
18,928,055 |
49,429,251 |
|||||||||||
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Proceeds from the exercise of preferred stock warrants |
-- |
636,635 |
|||||||||||
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Proceeds from the issuance of common stock options |
93,758 |
180,785 |
|||||||||||
|
Net cash provided by financing activities |
18,905,496 |
50,084,644 |
|||||||||||
|
Increase in cash and cash equivalents |
17,842,098 |
42,966,737 |
|||||||||||
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Cash and cash equivalents at beginning of period |
26,463,070 |
13,409,450 |
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Cash and cash equivalents at end of period |
$ 44,305,168 |
$ 56,376,187 |
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Supplemental Disclosures of Cash Flow Information: |
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Interest paid |
$ 21,437 |
$ 29,122 |
|||||||||||
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Equipment purchased under capitalized lease obligations |
-- |
222,500 |
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The accompanying notes are an integral part of these
condensed financial statements.
5
ATHEROGENICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
1. Basis of Presentation
The accompanying unaudited interim condensed financial
statements reflect all adjustments (consisting solely of
normal recurring adjustments) which management considers
necessary for a fair presentation of the financial position,
results of operations and cash flows of AtheroGenics for the
interim periods. Certain footnote disclosures normally
included in financial statements prepared in accordance with
generally accepted accounting principles have been condensed
or omitted from the interim financial statements as permitted
by the rules and regulations of the Securities and Exchange
Commission. Interim results are not necessarily
indicative of results for the full year.
The interim results should be read in conjunction with the
financial statements and notes thereto included in
AtheroGenics' Annual Report on Form 10-K for the year
ended December 31, 2000. Shareholders are encouraged to
review the Form 10-K for a broader discussion of
AtheroGenics' opportunities and risks inherent in the
business. Copies of the Form 10-K are available on
request.
2. Recently Issued Accounting Standards
In October 2001, FASB issued Statement of Financial
Accounting Standards No. 144, Accounting for the Impairment
or Disposal of Long-lived Assets. The statement
supersedes FAS 121, Accounting for the Impairment of
Long-lived Assets and for Long-lived Assets to be Disposed
of, and supersedes the provisions of APB Opinion 30,
Reporting the Results of Operations-Discontinued Events and
Extraordinary Items, with regard to reporting the effects of
a disposal of a segment of a business. The statement
provides a single accounting model for long-lived assets to
be disposed of and significantly changes the criteria
required to classify an asset as held-for-sale. Under
the statement, more dispositions will qualify for
discontinued operations treatment in the income statement, as
it requires expected future operating losses from
discontinued operations to be displayed in discontinued
operations in the period in which the losses are incurred.
The statement is effective for fiscal years beginning after
December 15, 2001.
3. Net Loss per Share and Pro Forma
Net Loss Per Share
Net loss per share is computed using the weighted average
number of shares of common stock outstanding. Shares
associated with stock options and warrants and the
convertible preferred stock are not included because they are
antidilutive.
Pro forma net loss per share is computed using the weighted
average number of shares of common stock outstanding,
including pro forma effects of the automatic conversion of
outstanding redeemable convertible preferred stock into
shares of AtheroGenics' common stock effective upon the
closing of AtheroGenics' initial public offering as if
the conversion occurred on the date of original issuance.
6
The following is a reconciliation of the numerator and
denominator of basic and diluted and pro forma basic and
diluted net loss per share amounts:
|
Three months ended |
Nine months ended |
||||||||||||
|
September 30, |
September 30, |
||||||||||||
|
2001 |
2000 |
2001 |
2000 |
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Basic and diluted: |
|||||||||||||
|
Net loss |
$ (4,862,219 |
) |
$ (3,963,531 |
) |
$ (11,912,124 |
) |
$ (10,441,537 |
) |
|||||
|
Weighted average shares used in |
|||||||||||||
|
computing basic and diluted |
|||||||||||||
|
net loss per share |
27,763,830 |
13,399,032 |
25,409,593 |
6,295,537 |
|||||||||
|
Basic and diluted net loss per share |
$ (0.18 |
) |
$ (0.30 |
) |
$ (0.47 |
) |
$ (1.66 |
) |
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|
Pro forma basic and diluted: |
|||||||||||||
|
Shares used above |
27,763,830 |
13,399,032 |
25,409,593 |
6,295,537 |
|||||||||
|
Pro forma adjustment to reflect |
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weighted average effect of |
|||||||||||||
|
assumed conversion of |
|||||||||||||
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preferred stock |
-- |
6,775,561 |
-- |
11,410,210 |
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|
Pro forma weighted average shares |
|||||||||||||
|
of common stock outstanding |
27,763,830 |
20,174,593 |
25,409,593 |
17,705,747 |
|||||||||
|
Basic and diluted pro forma net |
|||||||||||||
|
loss per share |
$ (0.18 |
) |
$ (0.20 |
) |
$ (0.47 |
) |
$ (0.59 |
) |
|||||
4. Deferred Stock
Compensation
During 2000 and 1999, in connection with the grant of certain
options to employees and directors, AtheroGenics recorded
non-cash deferred stock compensation of $12,093,928 and
$1,895,160, respectively, representing the difference between
the exercise price and the deemed fair value of
AtheroGenics' common stock on the dates these stock
options were granted. These amounts are included as a
reduction of shareholders' equity and are being amortized
over the vesting periods of the individual options, generally
four years, using the graded vesting method. The graded
vesting method provides for vesting of portions of the
overall award at interim dates and results in higher vesting
in earlier years than straight-line vesting. The fair
value of AtheroGenics common stock for purposes of this
calculation was determined based on the business factors
underlying the value of common stock on the date such option
grants were made. During the nine months ended
September 30, 2001, AtheroGenics recorded a total of
$1,613,666 of amortization of deferred stock compensation, as
compared to $5,970,675 during the same period in the prior
year. Through September 30, 2001, the deferred stock
compensation has decreased by $1,395,735 for options that
were forfeited.
In June 2001, in connection with the grant of certain
warrants as part of a licensing agreement with National
Jewish Medical and Research Center and options granted for
the addition of new members to our Scientific Advisory Board,
AtheroGenics recorded non-cash deferred stock compensation of
$1,092,000. The fair value of the warrants and options
for purposes of this calculation was determined by using the
Black Scholes model. These amounts are included as a
reduction of shareholders' equity and are being amortized
over the vesting periods of the individual warrants and
options, generally four years, using the graded vesting
method. During the nine months ended September 30,
2001, AtheroGenics recorded a total of $222,546 of
amortization of deferred stock compensation for these
warrants and options.
At September 30, 2001, AtheroGenics had a total of
$3,791,133 remaining to be amortized over the vesting periods
of the stock options.
7
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
The following should be read with the financial
statements and related footnotes and Management's
Discussion and Analysis of Financial Condition and Results of
Operations included in AtheroGenics' Annual Report on
Form 10-K. The results discussed below are not
necessarily indicative of the results to be expected in any
future periods. The following discussion contains
forward-looking statements that are subject to risks and
uncertainties which could cause actual results to differ from
the statements made.
OVERVIEW
Since our operations began in 1994, we have focused on the
discovery and development of novel therapeutics for the
treatment of chronic inflammatory diseases. Based on
our proprietary vascular protectant technology platform, we
have advanced two drug candidates into development, and are
progressing on a number of other pre-clinical programs.
Our lead product candidate, AGI-1067, is currently in Phase
II clinical trials for the treatment and prevention of
post-angioplasty restenosis. Our second product
candidate, AGIX-4207, and related compound AGIX-4207 I.V., are
currently in Phase I clinical trials to assess the safety and
tolerability for the treatment of rheumatoid arthritis.
We have also nominated a third compound for clinical
development, AGI-1096, a novel oral agent being developed for
the prevention of solid organ transplant.
In June 2001, we completed a private placement of
3,585,000 shares of our common stock that raised gross
proceeds of $20.6 million. Net proceeds were
approximately $18.9 million. Both new and existing
investors participated in the transaction.
In June 2001, we entered into a worldwide exclusive
license agreement with National Jewish Medical and Research
Center to use their proprietary MEK kinases technology
platform and other technologies, to discover and develop
novel therapeutics for the treatment of inflammation and
asthma.
To date, we have devoted substantially all of our
resources to research and development. We have not
received any commercial revenues from product sales.
Revenues have been derived from certain license fees of a
non-recurring nature received in connection with entering
into an exclusive license agreement with Schering-Plough
Corporation. This exclusive license agreement was
recently terminated. We expect to incur significant
losses in most years prior to deriving any product revenue as
we continue to increase research and development cost.
We have incurred significant losses since we began operations
in 1994 and as of September 30, 2001, we had an accumulated
deficit of $55.6 million. We cannot assure you that we
will become profitable. We expect that losses will
fluctuate from quarter to quarter and that these fluctuations
may be substantial. Our ability to achieve
profitability depends upon our ability, alone or with others,
to complete the successful development of our product
candidates, to obtain required regulatory clearances, and to
manufacture and market our future products.
RESULTS OF OPERATIONS
Comparison of the Three Month Periods Ended September 30,
2001 and 2000
Revenues
Total revenues were $538,511 for the three months ended
September 30, 2001, compared to $1.9 million in the three
months ended September 30, 2000. The decrease of $1.4
million was primarily due to the completion, in April 2001,
of amortization of a $5.0 million license fee that favorably
impacted last year's revenue. In addition, research
revenues attributable to the license agreement were lower,
reflecting reduced activities as we completed the final
stages of the CART-1 (Canadian Antioxidant Restenosis
Trial-1) Phase II clinical trial for AGI-1067. We
expect a further decline in revenues as the license agreement
has recently been terminated.
Expenses
Research and Development. Research and
development expenses were $4.2 million for the three months
ended September 30, 2001, compared to $3.6 million for
the three months ended September 30, 2000. The increase
of $638,819, or 18%, reflects higher costs associated with
the AGIX-4207 clinical trials, pre-clinical costs related to
our other product development programs and the planned
expansion of our internal research and development
capabilities, including increased headcount and related
expenses.
8
General and Administrative. General and
administrative expenses were $942,574 for the three months
ended September 30, 2001, compared to $764,967 for the
three months ended September 30, 2000. The increase of
$177,607, or 23%, was primarily due to higher professional
fees, including legal and accounting fees, related to
operating as a public company.
Amortization of Deferred Stock Compensation. In
2000 and 1999, we recorded non-cash deferred stock
compensation totaling approximately $14.0 million for options
granted with exercise prices below the deemed fair value for
financial reporting purposes of our common stock on their
respective grant dates. In June 2001, we recorded
non-cash deferred stock compensation totaling approximately
$1.1 million for certain warrants granted in connection with
a licensing agreement with National Jewish Medical and
Research Center and options granted to new members of our
Scientific Advisory Board. Amortization of deferred
stock compensation was $815,819 for the three months ended
September 30, 2001, compared to $2.0 million for the three
months ended September 30, 2000. This deferred stock
compensation is being amortized using the graded vesting
method, which results in higher amortization in the earlier
years.
Net Interest Income
Net interest income was $593,806 for the three months ended
September 30, 2001 as compared to net interest income of
$512,221 for the three months ended September 30, 2000.
The increase in net interest income was due to an increased
level of investments with funds received from our private
placement financing.
Comparison of the Nine Month Periods Ended September 30,
2001 and 2000
Revenues
Total revenues were $2.5 million for the nine months ended
September 30, 2001, compared to $6.1 million in the nine
months ended September 30, 2000. License fees of $1.1
million and $2.5 million during the nine months ended
September 30, 2001 and 2000, respectively, were attributable
to an exclusive license agreement signed in October
1999. These amounts represent the earned portion of the
$5.0 million initial license fee, which was amortized over 18
months. Amortization of the license fee was completed
in April 2001. Research and development revenues
related to the license agreement were $1.3 million for the
nine months ended September 30, 2001 and $3.6 million for the
nine months ended September 30, 2000. The lower
research revenues reflect reduced activities as we completed
the final stages of the CART-1 Phase II clinical trial for
AGI-1067. We expect a further decline in revenues as
the license agreement has recently been terminated.
Expenses
Research and Development. Research and
development expenses were $11.7 million for the nine months
ended September 30, 2001, compared to $9.2 million for
the nine months ended September 30, 2000. The increase
of $2.4 million, or 27%, reflects higher costs
associated with the AGIX-4207 clinical trials, pre-clinical
costs related to our other product development programs and
the planned expansion of our internal research and
development capabilities.
General and Administrative. General and
administrative expenses were $2.8 million for the nine months
ended September 30, 2001, compared to $2.1 million for
the nine months ended September 30, 2000. The increase
of $711,340, or 33%, was primarily due to higher professional
fees related to operating as a public company and the
addition of administrative personnel to support the continued
growth of our research and development efforts.
Amortization of Deferred Stock Compensation.
Amortization of deferred stock compensation was $1.8 million
for the nine months ended September 30, 2001, compared to
$6.0 million for the nine months ended September 30,
2000. This deferred stock compensation is being
amortized using the graded vesting method, which results in
higher amortization in the earlier years. In addition,
an adjustment of $753,666 was made during the first two
quarters of 2001 to reduce amortization expense for options
that have been forfeited.
9
Net Interest Income
|
- |
the status of product development; |
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|
- |
the time and cost involved in conducting clinical trials and obtaining regulatory approvals; |
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|
- |
filing, prosecuting and enforcing patent claims; |
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- |
competing technological and market developments; and |
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|
- |
our ability to market and distribute our future products and establish new licensing agreements. |
FORWARD-LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 (the
"Reform Act") provides a safe harbor for
forward-looking statements made by or on behalf of
AtheroGenics. AtheroGenics and its representatives may
from time to time make written or verbal forward-looking
statements, including statements contained in this report and
our other filings with the Securities and Exchange Commission
and in our reports to our shareholders. Generally, the
words "believe," "expect,"
"intend," "estimate,"
"anticipate," "will" and similar
expressions identify forward-looking statements. All
statements which address operating performance, events or
developments that we expect or anticipate will occur in the
future, such as projections about our future results of
10
operations or our financial condition, research, development and commercialization of our product candidates and anticipated trends in our business, are forward-looking statements within the meaning of the Reform Act. The forward-looking statements are and will be based on management's then current views and assumptions regarding future events and operating performance, and speak only as of their dates. AtheroGenics undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
|
- |
AGI-1067, AGIX-4207, AGIX-4207 I.V. and AGI-1096 may fail in clinical trials; |
|
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|
- |
our ability to generate positive cash flow in light of our history of operating losses; |
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|
- |
our ability to successfully develop our other product candidates; |
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- |
our ability to commercialize our product candidates if we fail to demonstrate adequately their safety and efficacy; |
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|
- |
possible delays in our clinical trials; |
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|
- |
our inability to predict whether or when we will obtain regulatory approval to commercialize our product candidates or the timing of any future revenue from these product candidates; |
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- |
we will incur additional expenses for research and development of AGI-1067 as a result of the termination of our license agreement with Schering-Plough, which could adversely impact our development of other product candidates and could materially adversely affect our financial liquidity; |
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|
- |
our ability to protect adequately or enforce our intellectual property rights or secure rights to third party patents; |
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|
- |
the ability of our competitors to develop and market anti-inflammatory products that are more effective, have fewer side effects or are less expensive than our current or future product candidates; |
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- |
third parties' failure to synthesize and manufacture our product candidates could delay our clinical trials or hinder our commercialization prospects; |
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- |
our ability to create sales, marketing and distribution capabilities or enter into agreements with third parties to perform these functions; |
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- |
our ability to attract, retain and motivate skilled personnel and cultivate key academic collaborations; |
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- |
if we need additional financing and cannot obtain
it, we may not be able to develop or market our
products;
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our ability to obtain an adequate level of reimbursement or acceptable prices for our products; and |
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- |
if plaintiffs bring product liability lawsuits against us, we may incur substantial financial loss or may be unable to obtain future product liability insurance at reasonable prices, if at all, either of which could diminish our ability to commercialize our future products. |
The foregoing list of important factors is not exclusive.
11
Item 3. Quantitative And Qualitative Disclosures About Market Risk
PART II - OTHER INFORMATION
Item 2. Changes in Securities and Use of
Proceeds
The Securities and Exchange Commission declared our
Registration Statement on Form S-1 (File No. 333-31140)
effective August 8, 2000. The net proceeds from the
sale of the 6,900,000 shares of common stock registered
pursuant to the Registration Statement (including the
exercise of the underwriters’ over-allotment option)
were $49.4 million after deducting underwriting discounts of
$3.9 million and offering expenses of $1.9 million.
We expect to use the proceeds from our initial public offering for research and development activities, including clinical trials, process development and manufacturing support, and for general corporate purposes, including working capital. A portion of the proceeds may be used to acquire or invest in complementary businesses, products or technologies. As of September 30, 2001, the proceeds have been applied toward:
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- |
purchases of fixed assets and leasehold improvements, $778,000; |
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|
|
|
- |
operating activities, $9.7 million; and |
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|
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- |
investments in highly liquid, interest bearing, investment grade securities, $38.9 million. |
12
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
Exhibit
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10.16* |
Form of Common Stock Purchase Agreement dated as of
June 19, 2001 between AtheroGenics, Inc. and the
Purchasers named therein.
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10.17**+ |
Exclusive License Agreement dated as of June 29,
2001 between AtheroGenics, Inc. and National Jewish
Medical and Research Center.
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|
--------- |
|
|
* |
Filed as the exhibit with the same number with
AtheroGenics' Registration Statement on Form S-1,
Registration No. 333-64228, on June 29, 2001, and
incorporated herein by reference.
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|
** |
Filed as the exhibit with the same number with
Amendment No. 1 to AtheroGenics' Registration
Statement on Form S-1, Registration No. 333-64228, on
July 23, 2001 and incorporated herein by reference.
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|
+ |
Certain confidential information contained in this document has been omitted and filed separately with the Commission pursuant to a request for confidential treatment under Rule 406 of the Securities Act of 1933, as amended. |
13
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act
of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly
authorized.
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ATHEROGENICS, INC. |
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|
Date: November 14, 2001. |
By: /s/RUSSELL M. MEDFORD |
|
RUSSELL M. MEDFORD, M.D., PH.D. President and Chief Executive Officer |
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|
Date: November 14, 2001. |
By: /s/MARK P. COLONNESE |
|
MARK P. COLONNESE |
|
14