SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
[X] QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For
the quarterly period ended March
31, 2006
OR
[
] TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For
the transition period from
to
Commission
file number 001-16043
ALTEON
INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
13-3304550
|
(State
or other jurisdiction of
incorporation or organization)
|
(I.R.S.
Employer Identification No.)
|
6
Campus Drive, Parsippany, New Jersey 07054
(Address
of principal executive offices)
(Zip
Code)
(201)
934-5000
(Registrant's
telephone number, including area code)
Not
Applicable
(Former
name, former address and former fiscal year,
if
changed since last report.)
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
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act). Large
accelerated filer ___Accelerated filer ___Non-accelerated filer X
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes
___
No
X
On
May 1,
2006, 68,336,711 shares of the registrant’s Common Stock were
outstanding.
Page
1 of
33 pages
ALTEON
INC.
INDEX
|
|
Page
|
|
|
|
PART
I - FINANCIAL INFORMATION
|
|
|
|
|
Item
1.
|
Condensed
Financial Statements (Unaudited)
|
|
|
|
|
|
Condensed
Balance Sheets as of March 31, 2006
and December 31, 2005
|
3
|
|
|
|
|
Condensed
Statements of Operations for the three months ended
March 31, 2006 and 2005
|
4
|
|
|
|
|
Condensed
Statement of Changes in Stockholders’ Equity
for the three months ended March 31, 2006
|
5
|
|
|
|
|
Condensed
Statements of Cash Flows for the three months
ended March 31, 2006 and 2005
|
6
|
|
|
|
|
Notes
to Condensed Financial Statements
|
7
|
|
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial
Condition and Results of Operations
|
11
|
|
|
|
Item
3.
|
Qualitative
and Quantitative Disclosures about Market Risk
|
15
|
|
|
|
Item
4.
|
Controls
and Procedures
|
15
|
|
|
|
PART
II - OTHER INFORMATION
|
|
|
|
|
Item
1A.
|
Risk
Factors
|
16
|
|
|
|
Item
6.
|
Exhibits
|
31
|
|
|
|
SIGNATURES
|
32
|
|
|
|
INDEX
TO EXHIBITS
|
33
|
PART
I - FINANCIAL INFORMATION
ITEM
l. Condensed
Financial Statements (Unaudited).
ALTEON
INC.
CONDENSED
BALANCE SHEETS
(Unaudited)
ASSETS
|
|
|
March
31,
|
|
|
December
31,
|
|
|
|
|
2006
|
|
|
2005
|
|
Current
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
4,469,170
|
|
$
|
6,582,958
|
|
Other
current assets
|
|
|
72,742
|
|
|
216,290
|
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
4,541,912
|
|
|
6,799,248
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
40,681
|
|
|
55,154
|
|
Restricted
cash
|
|
|
150,000
|
|
|
150,000
|
|
Other
assets
|
|
|
424,111
|
|
|
129,195
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
5,156,704
|
|
$
|
7,133,597
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
Current
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
190,055
|
|
$
|
351,232
|
|
Accrued
expenses
|
|
|
596,316
|
|
|
790,705
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
786,371
|
|
|
1,141,937
|
|
|
|
|
|
|
|
|
|
Stockholders'
Equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
Stock, $0.01 par value,
|
|
|
|
|
|
|
|
1,993,329
shares authorized, and 1,418 and 1,389 shares of Series G and 4,261
and
4,172 shares of Series H issued and outstanding, as of March 31,
2006 and
December 31, 2005, respectively. The liquidation value at March 31,
2006
and December 31, 2005 was $56,789,227 and $55,613,905
respectively
|
|
|
57
|
|
|
56
|
|
|
|
|
|
|
|
|
|
Common
Stock, $0.01 par value, 300,000,000 shares authorized, and 57,996,711
shares issued and outstanding, as of March 31, 2006 and December
31, 2005,
respectively
|
|
|
579,967
|
|
|
579,967
|
|
|
|
|
|
|
|
|
|
Additional
paid-in capital
|
|
|
229,400,403
|
|
|
228,225,082
|
|
|
|
|
|
|
|
|
|
Accumulated
deficit
|
|
|
(225,610,094
|
)
|
|
(222,813,445
|
)
|
|
|
|
|
|
|
|
|
Total
stockholders’ equity
|
|
|
4,370,333
|
|
|
5,991,660
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
|
$
|
5,156,704
|
|
$
|
7,133,597
|
|
The
accompanying notes are an integral part of these unaudited financial
statements.
ALTEON
INC.
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended March 31,
|
|
|
|
|
2006
|
|
|
2005
|
|
Income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment
income
|
|
$
|
60,364
|
|
$
|
99,149
|
|
|
|
|
|
|
|
|
|
Total
income
|
|
|
60,364
|
|
|
99,149
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
449,840
|
|
|
3,641,100
|
|
General
and administrative
|
|
|
1,231,851
|
|
|
1,100,348
|
|
|
|
|
|
|
|
|
|
Total
expenses
|
|
|
1,681,691
|
|
|
4,741,448
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
(1,621,327
|
)
|
|
(4,642,299
|
)
|
|
|
|
|
|
|
|
|
Preferred
stock dividends
|
|
|
1,175,322
|
|
|
1,071,578
|
|
|
|
|
|
|
|
|
|
Net
loss applicable to common stockholders
|
|
$
|
(2,796,649
|
)
|
$
|
(5,713,877
|
)
|
|
|
|
|
|
|
|
|
Basic/diluted
net loss per share applicable to common stockholders
|
|
$
|
(0.05
|
)
|
$
|
(0.10
|
)
|
|
|
|
|
|
|
|
|
Weighted
average common shares used in computing basic/diluted net loss per
share
applicable to common stockholders
|
|
|
57,996,711
|
|
|
56,547,028
|
|
The
accompanying notes are an integral part of these unaudited financial
statements.
ALTEON
INC.
CONDENSED
STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
|
|
|
|
|
Additional
|
|
|
|
|
|
Total
|
|
|
|
Preferred
Stock
|
Common
Stock
|
|
Paid-in
|
|
|
Accumulated
|
|
|
Stockholders'
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2005
|
|
|
5,561
|
|
$
|
56
|
|
|
57,996,711
|
|
$
|
579,967
|
|
|
|
|
$
|
(222,813,445
|
)
|
$
|
5,991,660
|
|
Net
loss
|
|
|
---
|
|
|
---
|
|
|
---
|
|
|
---
|
|
|
---
|
|
|
(1,621,327
|
)
|
|
(1,621,327
|
)
|
Issuance
of Series G and H preferred
stock dividends
|
|
|
118
|
|
|
1
|
|
|
---
|
|
|
---
|
|
|
1,175,321
|
|
|
(1,175,322
|
)
|
|
---
|
|
Balance,
March 31, 2006
|
|
|
5,679
|
|
$
|
57
|
|
|
57,996,711
|
|
$
|
579,967
|
|
$
|
229,400,403
|
|
$
|
(225,610,094
|
)
|
$
|
4,370,333
|
|
The
accompanying notes are an integral part of these unaudited financial
statements.
ALTEON
INC.
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
|
Three
Months Ended March 31,
|
|
|
|
|
2006
|
|
|
2005
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(1,621,327
|
)
|
$
|
(4,642,299
|
)
|
|
|
|
|
|
|
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
14,473
|
|
|
17,269
|
|
Stock
compensation expense
|
|
|
---
|
|
|
65,707
|
|
|
|
|
|
|
|
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
Other
current assets
|
|
|
143,548
|
|
|
(332,194
|
)
|
Accounts
payable and accrued expenses
|
|
|
(448,566
|
)
|
|
(399,992
|
)
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(1,911,872
|
)
|
|
(5,291,509
|
)
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
Capital
expenditures
|
|
|
---
|
|
|
(760
|
)
|
Other
assets
|
|
|
(201,916
|
)
|
|
---
|
|
|
|
|
|
|
|
|
|
Net
cash used in investing activities
|
|
|
(201,916
|
)
|
|
(760
|
)
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
Net
proceeds from issuance of common stock
|
|
|
---
|
|
|
9,532,295
|
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
---
|
|
|
9,532,295
|
|
|
|
|
|
|
|
|
|
Net
(decrease)/increase in cash and cash equivalents
|
|
|
(2,113,788
|
)
|
|
4,240,026
|
|
Cash
and cash equivalents, beginning of period
|
|
|
6,582,958
|
|
|
11,175,762
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents, end of period
|
|
$
|
4,469,170
|
|
$
|
15,415,788
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
Accrual
of deferred merger costs
|
|
$
|
93,000
|
|
$
|
---
|
|
The
accompanying notes are an integral part of these unaudited financial
statements.
ALTEON
INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note
1 - Basis of Presentation
The
accompanying unaudited financial statements have been prepared in accordance
with generally accepted accounting principles for interim financial information
and the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly,
they do not include all of the information and footnotes required by accounting
principles generally accepted in the United States of America for complete
financial statements. In the opinion of management, all adjustments (consisting
of only normal recurring adjustments) considered necessary for a fair
presentation have been included. Operating results for the three months ended
March 31, 2006, are not necessarily indicative of the results that may be
expected for the year ending December 31, 2006. For further information, refer
to the financial statements and footnotes thereto included in the Company's
Annual Report on Form 10-K for the year ended December 31, 2005, as filed with
the Securities and Exchange Commission.
Note
2 - Liquidity
The
Company has devoted substantially all of its resources to research, drug
discovery and development programs. To date, it has not generated any revenues
from the sale of products and does not expect to generate any such revenues
for
a number of years, if at all. As a result, Alteon has incurred net losses since
inception, has an accumulated deficit of $225,610,094 as of March 31, 2006,
and
expects to incur net losses, potentially greater than losses in prior years,
for
a number of years, assuming the Company is able to continue as a going concern,
of which there can be no assurance.
The
Company has financed its operations through proceeds from the sale of common
and
preferred equity securities, revenue from former collaborative relationships,
reimbursement of certain of its research and development expenses by
collaborative partners, investment income earned on cash and cash equivalent
balances and short-term investments and the sale of a portion of the Company’s
New Jersey state net operating loss carryforwards and research and development
tax credit carryforwards.
As
of
March 31, 2006, the Company had working capital of $3,755,541, including
$4,469,170 of cash and cash equivalents. The Company’s net cash used in
operating activities for the three months ended March 31, 2006 was $1,911,872
and for the year ended December 31, 2005 was $14,032,796.
The
Company has entered into a definitive merger agreement whereby it will combine
operations with HaptoGuard, Inc., a privately-held biotechnology company, and
under which Genentech, Inc.’s preferred stock position in the Company will be
restructured. The merger and associated preferred stock restructuring
transactions are subject to the approval of Alteon and HaptoGuard shareholders
and are expected to close early in the third quarter of 2006. The merger will
be
accounted for in accordance with Statement of Financial Accounting Standards
(“SFAS”) No. 141, “Business Combinations”. See Note 6 - Subsequent
Events.
In
addition, the Company has completed an equity financing that resulted in net
proceeds to Alteon of approximately $2.5 million. The new financing, as well
as
the Company’s current cash and cash equivalents, will be used to help fund
future development efforts of the combined companies, including studies for
two
Phase 2 clinical-stage compounds focused on cardiovascular disease in diabetic
patients. See Note 6 - Subsequent Events.
The
Company may continue to pursue fund-raising possibilities through the sale
of
its equity securities after the merger is completed. If the Company is unable
to
complete the merger, is unsuccessful in its efforts to raise additional funds
through the sale of additional equity securities or if the level of cash and
cash equivalents falls below anticipated levels, Alteon will not have the
ability to continue as a going concern after late 2006. As part of the merger,
there are associated costs that could result in the Company being required
to
make payment of certain obligations in the amount of approximately $2.0 million,
including severance and other contractual and regulatory requirements. In
association with developing and identifying strategic options, certain costs
have been deferred relating to the merger of $424,000.
The
amount and timing of the Company’s future capital requirements will depend on
numerous factors, including the timing of resuming its research and development
programs, if at all, the timing of completion of the merger with HaptoGuard,
the
number and characteristics of product candidates that it pursues, the conduct
of
pre-clinical tests and clinical studies, the status and timelines of regulatory
submissions, the costs associated with protecting patents and other proprietary
rights, the ability to complete strategic collaborations and the availability
of
third-party funding, if any.
Selling
securities to satisfy the Company’s short-term and long-term capital
requirements may have the effect of materially diluting the current holders
of
its outstanding stock. Alteon may also seek additional funding through corporate
collaborations and other financing vehicles. There can be no assurance that
such
funding will be available at all or on terms acceptable to the Company. If
adequate funds are not available, the Company may be required to curtail
significantly one or more of its research and development programs. If funds
are
obtained through arrangements with collaborative partners or others, the Company
may be required to relinquish rights to certain of its technologies or product
candidates. If Alteon is unable to obtain the necessary funding, it may need
to
cease operations. Even if the Company completes the merger with HaptoGuard,
there can be no assurance that the products or technologies acquired in such
transaction will result in revenues to the combined company or any meaningful
return on investment to its stockholders.
Note
3 - 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 123R”), which replaces “Accounting for Stock-Based
Compensation,” (“SFAS 123”) and supersedes Accounting Principles Board (“APB”)
Opinion No. 25, “Accounting for Stock Issued to Employees.” SFAS 123R requires
all share-based payments to employees, including grants of employee stock
options, to be recognized in the financial statements based on their fair values
effective for the Company January 1, 2006. Under SFAS 123R, the pro forma
disclosures previously permitted under SFAS 123 are no longer an alternative
to
financial statement recognition.
The
Company accounts for employee stock-based compensation, awards issued to
non-employee directors, and stock options issued to consultants and contractors
in accordance with SFAS 123R and Emerging Issues Task Force Issue No. 96-18,
“Accounting for Equity Instruments that are Issued to Other Than Employees for
Acquiring or in Conjunction with Selling Goods or Services.”
The
Company has adopted the new standard, SFAS 123R, effective January 1, 2006
and
has selected the Black-Scholes method of valuation for share-based compensation.
The Company has adopted the modified prospective transition method which
requires that compensation cost be recorded, as earned, for all unvested stock
options and restricted stock outstanding at the beginning of the first quarter
of adoption of SFAS 123R, and that such costs be recognized over the remaining
service period after the adoption date based on the options’ original estimate
of fair value.
On
December 15, 2005, the Compensation Committee of the Board of Directors of
the
Company approved the acceleration of the vesting date of all previously issued,
outstanding and unvested options, effective December 31, 2005. The acceleration
and the fact that no options were issued in the three months ended March 31,
2006, resulted in the Company not being required to recognize aggregate
compensation expense under SFAS 123R for the three months ended March 31,
2006.
Prior
to
adoption of SFAS 123R, the Company applied the intrinsic-value method under
APB
Opinion No. 25, “Accounting for Stock Issued to Employees,” and related
interpretations, under which no compensation cost (excluding those options
granted below fair market value) had been recognized. SFAS 123 established
accounting and disclosure requirements using a fair-value based method of
accounting for stock-based employee compensation plans. As permitted by SFAS
123, the Company elected to continue to apply the intrinsic-value based method
of accounting described above, and adopted only the disclosure requirements
of
SFAS 123, as amended.
|
|
|
Three
Months Ended March 31, 2005
|
|
Net
loss, as reported
|
|
$
|
(4,642,299
|
)
|
Less: Total
stock-based employee and director compensation expense determined
under
fair value method
|
|
|
(464,128
|
)
|
Pro
forma net loss
|
|
|
(5,106,427
|
)
|
Preferred
stock dividends
|
|
|
1,071,578
|
|
Pro
forma net loss applicable to common stockholders
|
|
$
|
(6,178,005
|
)
|
|
|
|
|
|
Net
loss per share applicable to common stockholders:
|
|
|
|
|
Basic/diluted,
as reported
|
|
$
|
(0.10
|
)
|
Basic/diluted,
pro forma
|
|
$
|
(0.11
|
)
|
Note
4 - Net Loss Per Share Applicable to Common Stockholders
Basic
net
loss per share is computed by dividing net loss applicable to common
stockholders by the weighted average number of shares outstanding during the
period. Diluted net loss per share is the same as basic net loss per share
applicable to common stockholders, since the assumed exercise of stock options
and warrants and the conversion of preferred stock would be antidilutive. The
amount of potentially dilutive shares excluded from the calculation as of March
31, 2006 and 2005, was 230,737,264 and 87,780,852 shares,
respectively.
Note
5 - Stockholders’ Equity
Series
G
Preferred Stock and Series H Preferred Stock dividends are payable quarterly
in
shares of preferred stock at a rate of 8.5% of the accumulated balance. Each
share of Series G Preferred Stock and Series H Preferred Stock is convertible,
upon 70 days’ prior written notice, into the number of shares of common stock
determined by dividing $10,000 by the average of the closing sales price of
the
common stock, as reported on the American Stock Exchange, for the 20 business
days immediately preceding the date of conversion. For the three months ended
March 31, 2006 and 2005, preferred stock dividends of $1,175,322 and $1,071,578,
respectively, were recorded. On March 31, 2006, the Series G and Series H
Preferred Stock would have been convertible into 55,623,529 common stock shares
and 167,079,216 common stock shares, respectively, and had a total liquidation
value of $56,789,227. The Series G and Series H Preferred Stock have no voting
rights.
Note
6 - Subsequent Events
Proposed
merger with HaptoGuard
On
April 19, 2006, the Company entered into a definitive merger agreement with
Alteon Merger Sub, Inc., a wholly-owned subsidiary of Alteon, HaptoGuard, Inc.
and Genentech, Inc. The merger agreement provides that upon the terms and
subject to the conditions set forth in the merger agreement, Merger Sub will
merge with and into HaptoGuard, with HaptoGuard becoming the surviving
corporation and a wholly-owned subsidiary of the Company.
At
the
effective time of the merger, (a) pursuant to the terms of the Company’s
certificate of incorporation and the merger agreement, Genentech will convert
a
portion of the Company’s preferred stock that it holds into shares of the
Company’s common stock, such that the number of such shares of common stock to
be issued will, when added to the shares of common stock already owned by
Genentech, equal 19.99% of the Company’s outstanding common stock as calculated
after the conversion of the preferred stock; (b) Genentech will transfer to
HaptoGuard a portion of Company preferred stock held by it, in such an amount
that will convert to a number of shares of Company common stock, in accordance
with the terms of the Company’s certificate of incorporation and the terms of
the merger agreement equal in value to $3,500,000 (the price per share of the
Company common stock based on the volume-weighted average price of the per
share
selling prices on the American Stock Exchange for the twenty (20) trading
days immediately preceding the signing of the merger agreement);
(c) Genentech will transfer to the Company all of the remaining shares of
Company preferred stock held by Genentech which are not either converted or
transferred, and such shares of preferred stock shall cease to be outstanding,
be canceled and retired without payment of any consideration therefor other
than
pursuant to the terms of the merger agreement and cease to exist; (d) every
share of HaptoGuard common stock issued and outstanding immediately prior to
the
effective time of the merger (other than the dissenting shares) shall be
converted into the right to receive a number of shares of Company common stock
equal to the quotient of (i) the sum of (x) a number of shares of Company
common stock to be issued by the Company to HaptoGuard stockholders at the
effective time with a value of $5.3 million, plus (y) the number of
shares of Company common stock to be issued pursuant to section (b) above
at the effective time, the market value of (x) and (y) to be equal to
$8,800,000, divided by (ii) the sum of (x) the number of outstanding
shares of HaptoGuard common stock at the effective time, and (y) the number
of Share Equivalents (as defined below) (the “Exchange Ratio”); and
(e) each share of HaptoGuard common stock held in the treasury of
HaptoGuard and each share of HaptoGuard common stock owned by the Company or
by
any direct or indirect wholly-owned subsidiary of HaptoGuard or the Company
immediately prior to the effective time shall, by virtue of the merger and
without any action on the part of the holder thereof, cease to be outstanding,
be canceled and retired without payment of any consideration therefor other
than
pursuant to the terms of the merger agreement and cease to exist. The Company
will assume each outstanding vested or unvested option to purchase HaptoGuard
common stock, which will be exercisable following the merger for the number
of
shares of HaptoGuard common stock that were purchasable under such option
immediately prior to the effective time of the merger multiplied by the Exchange
Ratio (rounded down to the nearest whole number of shares of common stock)
and
the per share exercise price for the shares of HaptoGuard common stock issuable
upon exercise of such assumed option will be equal to the quotient determined
by
dividing the exercise price per share of HaptoGuard common stock at which such
option was exercisable immediately prior to the effective time of the merger
by
the Exchange Ratio (and rounding the resulting exercise price up to the nearest
whole cent). All outstanding warrants to purchase HaptoGuard common stock will
be exchanged for the right to receive a number of shares of Company common
stock
(“Share Equivalents”) at the effective time of the merger which will have a
market value equal to the difference between (i) the market value of the
product of the number of shares of HaptoGuard common stock that were purchasable
under such warrants immediately prior to the Effective Time multiplied by the
Exchange Ratio (rounded down to the nearest whole number of shares of Company
common stock) and (ii) the total exercise price of such warrant.
HaptoGuard
has made customary representations, warranties and covenants in the merger
agreement, including, among others, covenants (i) to conduct its business
in the ordinary course consistent with past practice during the interim period
between the execution of the merger agreement and consummation of the merger,
(ii) not to engage in certain kinds of transactions during such period, and
(iii) not to solicit proposals relating to alternative business combination
transactions. The Company and Merger Sub have also made customary
representations, warranties and covenants in the merger agreement, including
covenants (i) to conduct its business in the ordinary course consistent
with past practice during the interim period between the execution of the merger
agreement and consummation of the merger and (ii) not to engage in certain
kinds of transactions during such period.
Consummation
of the merger is subject to certain conditions, including (i) receipt of
any necessary governmental approvals, (ii) approval of the merger agreement
and the merger by the stockholders of the Company and HaptoGuard,
(iii) absence of any law or order prohibiting the consummation of the
merger, and (iv) subject to certain exceptions, the accuracy of the
representations and warranties made by HaptoGuard and by the Company.
The
merger agreement contains certain termination rights for both HaptoGuard and
the
Company. Upon termination of the merger agreement under specified circumstances,
the terminating party would be required to pay the other party a termination
fee
of $440,000 plus any payments already made pursuant to the merger agreement.
Private
Placement
On
April 21, 2006, the Company closed a private placement of Units, consisting
of common stock and warrants, for gross proceeds of approximately
$2.6 million. Each Unit consisted of one share of Company common stock and
one warrant to purchase one share of Company common stock, comprising a total
of
10,340,000 shares of Company common stock and warrants to purchase 10,340,000
shares of Company common stock.
The
offering was made to accredited investors, as defined in and pursuant to an
exemption from registration under Regulation D promulgated under the
Securities Act of 1933, as amended (the “Securities Act”).
Under
the
terms of the purchase agreement, the Units were sold at a price of $0.25 per
Unit, and the warrants will be exercisable for a period of five years commencing
six months from the date of issue at a price of $0.30 per share. Pursuant to
the
purchase agreement, investors have a right to participate in any closing of
a
subsequent financing by the Company of its common stock or common stock
equivalents up to an aggregate amount equal to 50% of such subsequent financing
until the second anniversary of the declaration of effectiveness by the
Securities and Exchange Commission (“SEC”) of a registration statement for the
resale of the shares of common stock and the shares of common stock underlying
the warrants sold in the private placement. Rodman & Renshaw, LLC served as
placement agent in the transaction and received a 6% placement fee which was
paid in Units.
ITEM
2. Management's
Discussion and Analysis of Financial Condition and
Results of Operations.
Overview
We
are a
product-based biopharmaceutical company engaged in the development of small
molecule drugs to treat and prevent cardiovascular disease in diabetic patients.
We have identified several promising product candidates that we believe
represent novel approaches to some of the largest pharmaceutical markets. We
have advanced one of these products into Phase 2 clinical trials.
Our
lead
drug candidate, alagebrium chloride or alagebrium (formerly ALT-711), is a
product of our drug discovery and development program. Alagebrium has
demonstrated potential efficacy in two clinical trials in heart failure, as
well
as in animal models of heart failure and nephropathy, among others. It has
been
tested in approximately 1,000 patients in a number of Phase 1 and Phase 2
clinical trials. Our goal is to develop alagebrium in diastolic heart failure
(“DHF”). This disease represents a rapidly growing market of unmet need,
particularly common among diabetic patients, and alagebrium has demonstrated
relevant clinical activity in two Phase 2 clinical trials.
In
April
2006, we announced the signing of a definitive merger agreement with HaptoGuard,
Inc., whereby the two companies will combine operations. The companies have
complementary product platforms in cardiovascular diseases, diabetes and other
inflammatory diseases. We have begun working with the HaptoGuard team in
anticipation of the merger of the companies, and are preparing a Phase 2
protocol for alagebrium in heart failure in order to expand our clinical program
in this therapeutic area. However, any continued development of alagebrium
by us
is contingent upon the successful completion of the merger and adequate funding
for product development.
Following
the merger, the combined company will have two products in Phase 2 clinical
development:
|
Ø
|
Alagebrium
chloride (formally ALT-711), Alteon’s lead compound, is an Advanced
Glycation End-product Crosslink Breaker being developed for heart
failure.
Data presented from two Phase 2 clinical studies at the American
Heart
Association meeting in November 2005 demonstrated the ability of
alagebrium to improve overall cardiac function, including measures
of
diastolic and endothelial function. In these studies, alagebrium
also
demonstrated the ability to significantly reduce left ventricular
mass.
The compound has been tested in approximately 1,000 patients, which
represents a sizeable human safety database, in a number of Phase
2
clinical trials.
|
|
Ø
|
ALT-2074
(formerly BXT-51072), HaptoGuard’s licensed lead compound, is a
glutathione peroxidase mimetic in development for reduction of mortality
in post-myocardial infarction patients with diabetes. The compound
has
shown the ability to reduce infarct size by approximately 85% in
a mouse
model of heart attack called ischemia reperfusion injury.
|
Additionally,
HaptoGuard owns a license to a proprietary genetic biomarker that has shown
the
potential to identify patients who are most responsive to the HaptoGuard
compound.
The
merger of the two companies will be structured as an acquisition by Alteon.
Under the terms of the merger agreement, HaptoGuard shareholders will receive
approximately 37.4 million shares of Alteon common stock (approximately 31%
of
total shares after completion of the merger.) As part of the merger, a portion
of existing shares of Alteon preferred stock held by Genentech, Inc. will be
converted into common stock, among other transactions. The merger and preferred
stock restructuring transactions are subject to the approval of Alteon and
HaptoGuard shareholders and are expected to close early in the third quarter
of
2006.
In
April
2006, we also announced the signing of definitive agreements for an equity
financing which resulted in gross proceeds to us of approximately $2.6 million.
The PIPE financing includes new and existing institutional investors, in which
we sold approximately 10.3 million Units, consisting of common stock and
warrants, for net proceeds after expenses and fees of approximately $2.5
million. Each Unit consists of one share of Alteon common stock and one warrant
to purchase one share of Alteon common stock. The Units were sold at a price
of
$0.25 per Unit and the warrants are exercisable, commencing six months from
the
date of issuance, for a period of five years at an exercise price of $0.30
per
share. The shares of common stock and warrants that were offered and sold in
the
financing were not registered under the Securities Act or state securities
laws
pursuant to an exemption from registration provided by Regulation D under the
Securities Act. The Company has agreed to file a registration statement with
the
SEC for the resale of the shares of common stock and the shares of common stock
underlying the warrants sold in the PIPE transaction. Rodman & Renshaw, LLC
served as placement agent in the transaction and received a 6% placement fee
which was paid in Units.
ITEM
2. Management's
Discussion and Analysis of Financial Condition and
Results of Operations.
Key
components of the proposed transactions between Alteon, HaptoGuard and Genentech
are as follows:
|
Ø
|
Alteon
will acquire all outstanding equity of HaptoGuard. In exchange, HaptoGuard
shareholders will receive from Alteon $5.3 million in Alteon common
stock,
or approximately 22.5 million
shares.
|
|
Ø
|
Genentech
will convert a portion of its existing preferred Alteon stock to
Alteon
common stock. A portion of Genentech’s preferred stock, which when
converted to common stock equals approximately $3.5 million in Alteon
common stock, will be transferred to HaptoGuard shareholders.
|
|
Ø
|
The
remaining Alteon preferred stock held by Genentech will be cancelled.
|
|
Ø
|
Genentech
will receive milestone payments and royalties on net sales of alagebrium,
as well as a right of first negotiation on
ALT-2074.
|
We
cannot
predict at this time when enrollment in our clinical studies will resume, if
ever. If we do not resume enrollment in one or more of our clinical studies,
we
will evaluate moving into more focused clinical trials in different indications
or returning to our pre-clinical library of compounds to identify new compounds
to bring forward for further evaluation. Should we be unable to resume
enrollment in our clinical studies, in a timely manner, or at all, our business
will be materially adversely affected.
We
continue to evaluate potential pre-clinical and clinical studies in other
therapeutic indications in which alagebrium may address significant unmet needs.
In addition to our anticipated clinical studies in heart failure, we have
conducted early research studies focusing on atherosclerosis; Alzheimer's
disease; photoaging of the skin; eye diseases, including age-related macular
degeneration (“AMD”), and glaucoma; and other diabetic complications, including
renal diseases.
Since
our
inception in October 1986, we have devoted substantially all of our resources
to
research, drug discovery and development programs. To date, we have not
generated any revenues from the sale of products and do not expect to generate
any such revenues for a number of years, if at all. We have incurred an
accumulated deficit of $225,610,094 as of March 31, 2006, and expect to incur
net losses, potentially greater than losses in prior years, for a number of
years.
We
have
financed our operations through proceeds from public offerings of common stock,
private placements of common and preferred equity securities, revenue from
former collaborative relationships, reimbursement of certain of our research
and
development expenses by our collaborative partners, investment income earned
on
cash and cash equivalent balances and short-term investments and the sale of
a
portion of our New Jersey State net operating loss carryforwards and research
and development tax credit carryforwards.
Our
business is subject to significant risks including, but not limited to, (1)
our
ability to complete the announced merger between Alteon and HaptoGuard and
to
obtain sufficient additional funding to resume the development of alagebrium
and
to continue operations, (2) our ability to resume enrollment in our clinical
studies of alagebrium should we have adequate financial and other resources
to
do so, (3) the risks inherent in our research and development efforts, including
clinical trials and the length, expense and uncertainty of the process of
seeking regulatory approvals for our product candidates, (4) our reliance on
alagebrium, which is our only significant drug candidate, (5) uncertainties
associated with obtaining and enforcing our patents and with the patent rights
of others, (6) uncertainties regarding government healthcare reforms and product
pricing and reimbursement levels, (7) technological change and competition,
(8)
manufacturing uncertainties, and (9) dependence on collaborative partners and
other third parties. Even if our product candidates appear promising at an
early
stage of development, they may not reach the market for numerous reasons. These
reasons include the possibilities that the products will prove ineffective
or
unsafe during pre-clinical or clinical studies, will fail to receive necessary
regulatory approvals, will be difficult to manufacture on a large scale, will
be
uneconomical to market or will be precluded from commercialization by
proprietary rights of third parties. These risks and others are discussed under
the heading Part II, Item 1A - Risk Factors.
ITEM
2. Management's
Discussion and Analysis of Financial Condition and
Results of Operations.
Results
of Operations
Three
Months ended March 31, 2006 and 2005
Total
revenues for the three months ended March 31, 2006 and 2005, was $60,000 and
$99,000, respectively. Revenues were derived from interest earned on cash and
cash equivalents. The decrease from 2005 to 2006 was attributed to lower
investment balances and partially offset by higher interest rates.
Our
total
expenses were $1,682,000 for the three months ended March 31, 2006, compared
to
$4,741,000 for the three months ended March 31, 2005, and in each period
consisted primarily of research and development expenses. Research and
development expenses normally include third-party expenses associated with
pre-clinical and clinical studies, manufacturing costs, including the
development and preparation of clinical supplies, personnel and
personnel-related expenses and facility expenses.
Research
and development expenses were $450,000 for the three months ended March 31,
2006, as compared to $3,641,000 for the same period in 2005, a decrease of
$3,191,000, or 87.6%. This decrease was attributed to decreased clinical trial
costs and manufacturing expenses as a result of the discontinuation in June
2005
of our Systolic Pressure Efficacy and Safety Trial of Alagebrium (“SPECTRA”). In
2006, of the total amount spent on research and development expenses, we
incurred $233,000 in personnel and personnel-related expenses, $101,000 in
product liability insurance and $86,000 in third party consulting. In 2005,
we
incurred $1,275,000 in clinical trial expenses primarily related to SPECTRA,
$1,252,000 in personnel and personnel-related expenses, $441,000 in pre-clinical
expenses and $284,000 related to manufacturing (packaging and distribution).
General
and administrative expenses were $1,232,000 for the three months ended March
31,
2006, as compared to $1,100,000 for the same period in 2005. Although general
and administrative expenses remained relatively flat, 2006 includes increased
severance costs and retention bonuses offset by decreased corporate
expenses.
Our
net
loss applicable to common stockholders was $2,797,000 for the three months
ended
March 31, 2006, compared to $5,714,000 in the same period in 2005, a
decrease of 51.1%. This decrease was a result primarily of our significantly
reduced research and development expenses. Included in the net loss applicable
to common stockholders are preferred stock dividends of $1,175,322 and
$1,071,578 for the three months ended March 31, 2006 and 2005
respectively.
Liquidity
and Capital Resources
We
had
cash and cash equivalents at March 31, 2006, of $4,469,000, compared to
$6,583,000 at December 31, 2005. The decrease is attributable to $1,912,000
of net cash used in operating activities and $202,000 of cash used in investing
activities. At March 31, 2006 we had working capital of $3,756,000.
We
do not
have any approved products and currently derive cash from sales of our
securities, sales of our New Jersey state net operating loss carryforwards
and
interest on cash and cash equivalents. We are highly susceptible to conditions
in the global financial markets and in the pharmaceutical industry. Positive
and
negative movement in those markets will continue to pose opportunities and
challenges to us. Previous downturns in the market valuations of biotechnology
companies and of the equity markets more generally have restricted our ability
to raise additional capital on favorable terms.
The
Company has entered into a definitive merger agreement whereby it plans to
combine operations with HaptoGuard, Inc., a privately-held biotechnology
company. The merger and associated preferred stock restructuring transactions
are subject to the approval of Alteon and HaptoGuard shareholders and are
expected to close early in the third quarter of 2006. See Note 6 - Subsequent
Events.
In
addition, the Company has completed an equity financing that resulted in net
proceeds to Alteon of approximately $2.5 million. The new financing, as well
as
the Company’s current cash and cash equivalents, will be used to help fund
future development efforts of the combined companies, including studies for
two
Phase 2 clinical-stage compounds focused on cardiovascular disease in diabetic
patients. See Note 6 - Subsequent Events.
The
Company may continue to pursue fund-raising possibilities through the sale
of
its equity securities after the merger is completed. If the Company is unable
to
complete the merger, is unsuccessful in its efforts to raise additional funds
through the sale of additional equity securities or if the level of cash and
cash equivalents falls below anticipated levels, Alteon will not have the
ability to continue as a going concern after late 2006. As part of the merger,
there are associated costs that could result in the Company being required
to
make payment of certain obligations in the amount of approximately $2.0 million,
including severance and other contractual and regulatory requirements. In
association with developing and identifying strategic options, certain costs
have been deferred relating to the merger of $424,000.
ITEM
2. Management's
Discussion and Analysis of Financial Condition and
Results of Operations.
The
amount and timing of the Company’s future capital requirements will depend on
numerous factors, including the timing of resuming its research and development
programs, if at all, the timing of completion of the merger with HaptoGuard,
the
number and characteristics of product candidates that it pursues, the conduct
of
pre-clinical tests and clinical studies, the status and timelines of regulatory
submissions, the costs associated with protecting patents and other proprietary
rights, the ability to complete strategic collaborations and the availability
of
third-party funding, if any.
Selling
securities to satisfy the Company’s short-term and long-term capital
requirements may have the effect of materially diluting the current holders
of
its outstanding stock. Alteon may also seek additional funding through corporate
collaborations and other financing vehicles. There can be no assurance that
such
funding will be available at all or on terms acceptable to the Company. If
adequate funds are not available, the Company may be required to curtail
significantly one or more of its research and development programs. If funds
are
obtained through arrangements with collaborative partners or others, the Company
may be required to relinquish rights to certain of its technologies or product
candidates. If Alteon is unable to obtain the necessary funding, it may need
to
cease operations. Even if the Company completes the merger with HaptoGuard,
there can be no assurance that the products or technologies acquired in such
transaction will result in revenues to the combined company or any meaningful
return on investment to its stockholders.
Critical
Accounting Policies
In
December 2001, the SEC issued a statement concerning certain views of the SEC
regarding the appropriate amount of disclosure by publicly held companies with
respect to their critical accounting policies. In particular, the SEC expressed
its view that in order to enhance investor understanding of financial
statements, companies should explain the effects of critical accounting policies
as they are applied, the judgments made in the application of these policies
and
the likelihood of materially different reported results if different assumptions
or conditions were to prevail. We have since carefully reviewed the disclosures
included in our filings with the SEC, including, without limitation, this
Quarterly Report on Form 10-Q and accompanying unaudited financial statements
and related notes thereto. We believe the effect of the following accounting
policy is significant to our results of operations and financial condition.
In
December 2004, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards (“SFAS”) No. 123 (revised 2004),
“Share-Based Payment” (“SFAS 123R”), which replaces “Accounting for Stock-Based
Compensation,” (“SFAS 123”) and supersedes Accounting Principles Board (“APB”)
Opinion No. 25, “Accounting for Stock Issued to Employees.” SFAS 123R requires
all share-based payments to employees, including grants of employee stock
options, to be recognized in the financial statements based on their fair values
beginning with the first annual reporting period that begins after December
15,
2005. Under SFAS 123R, the pro forma disclosures previously permitted under
SFAS
123 are no longer an alternative to financial statement
recognition.
The
Company accounts for employee stock-based compensation, awards issued to
non-employee directors, and stock options issued to consultants and contractors
in accordance with SFAS 123R, SFAS No. 148 “Accounting for Stock-Based
Compensation—Transition and Disclosure” and Emerging Issues Task Force Issue No.
96-18, “Accounting for Equity Instruments that are Issued to Other Than
Employees for Acquiring or in Conjunction with Selling Goods or
Services.”
The
Company has adopted the new standard, SFAS 123R, effective January 1, 2006
and
has selected the Black-Scholes method of valuation for share-based compensation.
The Company has adopted the modified prospective transition method which
requires that compensation cost be recorded, as earned, for all unvested stock
options and restricted stock outstanding at the beginning of the first quarter
of adoption of SFAS 123R, and is recognized over the remaining service period
after the adoption date based on the options’ original estimate of fair
value.
On
December 15, 2005, the Compensation Committee of the Board of Directors of
the
Company approved the acceleration of the vesting date of all previously issued,
outstanding and unvested options, effective December 31, 2005. The acceleration
and the fact that no options were issued in the three months ended March 31,
2006, resulted in the Company not being required to recognize aggregate
compensation expense under SFAS 123R for the three months ended March 31,
2006.
Prior
to
adoption of SFAS 123R, the Company applied the intrinsic-value method under
APB
Opinion No. 25, “Accounting for Stock Issued to Employees,” and related
interpretations, under which no compensation cost (excluding those options
granted below fair market value) has been recognized. SFAS 123, “Accounting for
Stock-Based Compensation,” established accounting and disclosure requirements
using a fair-value based method of accounting for stock-based employee
compensation plans. As permitted by SFAS 123, the Company elected to continue
to
apply the intrinsic-value based method of accounting described above, and
adopted only the disclosure requirements of SFAS 123, as amended, which were
similar in most respects to SFAS 123R.
ITEM
2. Management's
Discussion and Analysis of Financial Condition and
Results of Operations.
Forward-Looking
Statements and Cautionary Statements
Statements
in this Form 10-Q that are not statements or descriptions of historical facts
are "forward-looking" statements under Section 21E of the Securities Exchange
Act of 1934, as amended, and the Private Securities Litigation Reform Act of
1995, and are subject to numerous risks and uncertainties. These forward-looking
statements and other forward-looking statements made by us or our
representatives are based on a number of assumptions. The words "believe,"
"expect," "anticipate," "intend," "estimate" or other expressions, which are
predictions of or indicate future events and trends and which do not relate
to
historical matters, identify forward-looking statements. Readers are cautioned
not to place undue reliance on these forward-looking statements, as they involve
risks and uncertainties, and actual results could differ materially from those
currently anticipated due to a number of factors, including those set forth
in
this section and elsewhere in this Form 10-Q. These factors include, but are
not
limited to, the risks set forth below.
The
forward-looking statements represent our judgments and expectations as of the
date of this Report. We assume no obligation to update any such forward-looking
statements. See Part II, Item 1A - Risk Factors.
ITEM
3. Qualitative
and Quantitative Disclosures about Market Risk.
Our
exposure to market risk for changes in interest rates relates primarily to
our
investment in marketable securities. We do not use derivative financial
instruments in our investments. All of our investments resided in money market
accounts. Accordingly, we do not believe that there is any material market
risk
exposure with respect to derivative or other financial instruments that would
require disclosure under this Item.
ITEM
4. Controls
and Procedures.
a) Evaluation of
Disclosure Controls and Procedures.
Our
management has evaluated, with the participation of our Chief Executive Officer
and our Director of Finance and Financial Reporting, the effectiveness of our
disclosure controls and procedures (as defined in Rule 13a-15(e) under the
Securities Exchange Act of 1934, as amended (the "Exchange Act")) as of the
end
of the fiscal quarter covered by this Quarterly Report on Form 10-Q. Based
upon
that evaluation, the Chief Executive Officer and the Director of Finance and
Financial Reporting have concluded that as of the end of such fiscal quarter,
our current disclosure controls and procedures were not effective, because
of
the material weakness in internal control over financial reporting described
below. We have taken, and are continuing to take, steps to address this weakness
as described below. With the exception of such weakness, however, the Chief
Executive Officer and the Director of Finance and Financial Reporting believe
that our current disclosure controls and procedures are adequate to ensure
that
information required to be disclosed in the reports we file under the Exchange
Act is recorded, processed, summarized and reported on a timely
basis.
b) Material
Weaknesses and Changes in Internal Controls.
During
the audit of our financial statements for the year ended December 31, 2005,
our
independent registered public accounting firm identified a material weakness,
as
of December 31, 2005, regarding our internal controls over the identification
of
and the accounting for non-routine transactions, including certain costs related
to potential strategic transactions, severance benefits and the financial
statement recording and disclosures of stock options that we have granted to
non-employee consultants in accordance with Emerging Issues Task Force (“EITF”)
96-18. As defined by the Public Company Accounting Oversight Board Auditing
Standard No. 2, a material weakness is a significant control deficiency or
a
combination of significant control deficiencies, that results in there being
more than a remote likelihood that a material misstatement of the annual or
interim financial statements will not be prevented or detected. This material
weakness did not result in the restatement of any previously reported financial
statements or any other related financial disclosure. In addition, the changes
that would have resulted in the financial statements for the year ended December
31, 2005, as a consequence of the material weakness, were deemed to be
immaterial but were nevertheless recorded by the Company. Management has
implemented remedial controls to address these matters including additional
third party review of non-routine strategic transactions and Board of Director
meeting minutes.
c) There
were no changes in our internal control over financial reporting (as defined
in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the fiscal quarter
covered by this Quarterly Report on Form 10-Q that have materially affected,
or
are reasonably likely to materially affect, our internal control over financial
reporting.
PART
II - OTHER INFORMATION
ITEM
1A. Risk Factors.
Risks
Related to Our Business
As
a result of a decrease in our available financial resources, we have
significantly curtailed the research, product development, preclinical testing
and clinical trials of our product candidates,
and if we are unable to obtain sufficient additional funding in the near term,
we may be forced to cease operations.
As
of
March 31, 2006, we had working capital of $3,755,000, including $4,469,000
of
cash and cash equivalents. Our cash used in operating activities for the three
months ended March 31, 2006 was $1,912,000.
On
April
19, 2006, we signed a definitive merger agreement with HaptoGuard, Inc., whereby
the two companies will combine operations in a stock transaction valued at
$8.8
million. As part of the merger, a portion of our existing shares of preferred
stock held by Genentech, Inc. will be converted into common stock. In addition,
on April 21, 2006, we closed an equity financing that resulted in net proceeds
to us of approximately $2.5 million. Assuming completion of the merger between
Alteon and HaptoGuard, we expect to utilize cash and cash equivalents to fund
our operating activities, and to fund the future clinical development efforts
of
the combined companies, including the planned Phase 2 studies of our lead
compound, alagebrium and HaptoGuard’s lead compound ALT-2074.
While
we
intend to pursue development of alagebrium in high potential cardiovascular
indications such as heart failure, any continued development of alagebrium
by us
is contingent upon our completion of the merger.
If
we are
unable to complete the merger and the preferred stock restructuring on
reasonable terms, we will not have the ability to continue as a going concern
after late 2006. As part of the merger, there are associated costs that will
result in the Company being required to make payment of certain obligations
in
the amount of approximately $2.0 million, including severance and other
contractual and regulatory requirements.
Even if
we complete the merger, there can be no assurance that the products or
technologies acquired in such transaction will result in revenues to the
combined company or any meaningful return on investment to our
stockholders.
The
amount and timing of our future capital requirements will depend on numerous
factors, including the timing
of
resuming
our
research and development programs, if
at
all, the timing of completion of the merger with HaptoGuard, the
number and characteristics of product candidates that we pursue, the conduct
of
preclinical tests and clinical studies, the status and timelines of regulatory
submissions, the costs associated with protecting patents and other proprietary
rights, the ability to complete strategic collaborations and the availability
of
third-party funding, if any.
Selling
securities to satisfy our short-term and long-term capital requirements may
have
the effect of materially diluting the current holders of our outstanding stock.
We may also seek additional funding through corporate collaborations and other
financing vehicles. If funds are obtained through arrangements with
collaborative partners or others, we may be required to relinquish rights to
our
technologies or product candidates.
If
we are unable to complete the merger and related stock conversion transaction
with respect to our preferred stock, we may not be able to secure future equity
financing or merge with a third party.
In
December 1997, we entered into an agreement with Genentech relating to the
development of pimagedine, an A.G.E. formation inhibitor, for the treatment
of
diabetic nephropathy. As part of this agreement, Genentech purchased shares
of
Alteon Series G Preferred Stock and Series H Preferred Stock, the proceeds
of
which were used to fund the pimagedine development program. Both the Series
G
Preferred Stock and Series H Preferred Stock have dividends which are payable
quarterly in shares of preferred stock at a rate of 8.5% of the accumulated
balance. The Series G and Series H Preferred Stock each carry a liquidation
preference, which means that the value of that preferred stock would be required
to be paid to the holders of the Series G and Series H Preferred Stock upon
a
sale or liquidation before any proceeds from such sale or liquidation are paid
to any other holders of equity securities, including the common stock. As of
March 31, 2006, holders of the outstanding shares of Series G and Series H
Preferred Stock, including shares issued pursuant to the dividend obligation,
were entitled to a liquidation preference of $56,789,227. Our total market
capitalization as of that date was $12,759,276. As a result, unless we complete
the merger, holders of our common stock will not realize any value upon our
sale
or liquidation at a valuation of less than $56,789,227. The Series G and Series
H Preferred Stock have no voting rights. Each share of Series G Preferred Stock
and Series H Preferred Stock is convertible, upon 70 days’ prior written notice,
into the number of shares of common stock determined by dividing $10,000 by
the
average of the closing prices of our common stock, as reported on the American
Stock Exchange, for the 20 business days immediately preceding the date of
conversion. On March 31, 2006, the Series G and Series H Preferred Stock would
have been convertible into 55,623,529 and 167,079,216 shares of common stock,
respectively, representing, in aggregate, approximately 79.3% of our common
stock outstanding on an as-converted basis as of that date.
While
the
terms of the Series G and Series H Preferred Stock generally restrict
Genentech’s ownership position in us upon conversion to 40% of our outstanding
common stock, any conversion of shares of Series G and/or Series H Preferred
Stock into common stock would represent a substantial dilution to existing
common shareholders. Potential financing sources for us may be dissuaded from
investing in us in light of the presence of a significant holder of securities
having a sizable liquidation preference and/or voting position. This could
also
discourage any potential acquirer from pursuing a transaction with us at a
valuation that does not result in sufficient proceeds to pay the full
liquidation preference due to Genentech.
As
noted,
above, on April 19, 2006, we entered into a definitive merger agreement with
HaptoGuard, Inc., whereby the two companies will combine operations in a stock
transaction valued at $8.8 million. As part of the merger, a portion of existing
shares of Alteon preferred stock held by Genentech, Inc. (a) will be converted
into 13,492,349 shares of common stock and (b) a portion of such stock will
be
converted to common stock valued at $3.5 million, or approximately 14,874,628
shares and will be transferred to HaptoGuard shareholders in exchange for
certain negotiation and royalty rights for certain HaptoGuard products, and
the
remaining shares of Alteon preferred stock held by Genentech, Inc. will be
cancelled. The merger and stock conversion transactions are subject to the
approval of Alteon and HaptoGuard shareholders and are expected to close in
the
third quarter of 2006. There is no assurance the merger and related transactions
will close.
We
have received a going concern opinion from our independent registered public
accounting firm, which could negatively affect our stock price and our ability
to raise capital.
J.H.
Cohn
LLP, our independent registered public accounting firm, has included an
explanatory paragraph in their report on our financial statements for the fiscal
year ended December 31, 2005, which raises substantial doubt about our ability
to continue as a going concern. The inclusion of a going concern explanatory
paragraph in J.H. Cohn LLP’s report on our financial statements could have a
detrimental effect on our stock price and our ability to raise additional
capital.
Our
financial statements have been prepared on the basis of a going concern, which
contemplates the realization of assets and the satisfaction of liabilities
in
the normal course of business. We have not made any adjustments to the financial
statements as a result of the outcome of the uncertainty described above.
If
we are unable to form the successful collaborative relationships that our
business strategy requires, then our programs will suffer and we may not be
able
to develop products.
Our
strategy for developing and deriving revenues from our products depends, in
large part, upon entering into arrangements with research collaborators,
corporate partners and others. The potential market, preclinical and clinical
study results and safety profile of our product candidates may not be attractive
to potential corporate partners. A two-year toxicity study found that male
rats
exposed to high doses of alagebrium over their natural lifetime developed
dose-related increases in liver cell alterations including hepatocarcinomas,
and
that the alteration rate was slightly over the expected background rate in
this
gender and species of rat. Also, our Phase 2a EMERALD study in erectile
dysfunction, the IND for which has since been withdrawn, was placed on clinical
hold by the Reproductive and Urologic Division which may adversely affect our
ability to enter into research and development collaborations with respect
to
alagebrium. We face significant competition in seeking appropriate collaborators
and these collaborations are complex and time-consuming to negotiate and
document. We may not be able to negotiate collaborations on acceptable terms,
or
at all. If that were to occur, we may have to curtail the development of a
particular product candidate, reduce or delay our development program or one
or
more of our other development programs, delay our potential commercialization
or
reduce the scope of our sales or marketing activities, or increase our
expenditures and undertake development or commercialization activities at our
own expense. If we elect to increase our expenditures to fund development or
commercialization activities on our own, we may need to obtain additional
capital, which may not be available to us on acceptable terms, or at all. If
we
do not have sufficient funds, we will not be able to bring our product
candidates to market and generate product revenue.
If
we are unable to attract and retain the key personnel on whom our success
depends, our product development, marketing and commercialization plans could
suffer.
We
depend
heavily on the principal members of our management and scientific staff to
realize our strategic goals and operating objectives. Over the past few months,
due to the reduction in our clinical trial activities, the number of our
employees has decreased from 30 as of June 30, 2005 to 7 as of March 1, 2006.
On
February 1, 2006, we announced the resignation of our Chief Operating Officer,
Judith S. Hedstrom. The loss of services in the near term of any of our other
principal members of management and scientific staff could impede the
achievement of our development priorities. Furthermore, recruiting and retaining
qualified scientific personnel to perform research and development work in
the
future will also be critical to our success, and there is significant
competition among companies in our industry for such personnel. We have
established retention programs for our current key employees, and we may be
required to provide additional retention and severance benefits to our employees
as we curtail operations or prepare to effect a strategic transaction such
as a
sale or merger with another company. However, we cannot assure you that we
will
be able to attract and retain personnel on acceptable terms given the
competition between pharmaceutical and healthcare companies, universities and
non-profit research institutions for experienced managers and scientists, and
given the recent clinical and regulatory setbacks that we have experienced.
In
addition, we rely on consultants to assist us in formulating our research and
development strategy. All of our consultants are employed by other entities
and
may have commitments to or consulting or advisory contracts with those other
entities that may limit their availability to us.
Clinical
studies required for our product candidates are time-consuming, and their
outcome is uncertain.
Before
obtaining regulatory approvals for the commercial sale of any of our products
under development, we must demonstrate through preclinical and clinical studies
that the product is safe and effective for use in each target indication.
Success in preclinical studies of a product candidate may not be predictive
of
similar results in humans during clinical trials. None of our products has
been
approved for commercialization in the United States or elsewhere. In December
2004, we announced that findings of a routine two-year rodent toxicity study
indicated that male Sprague Dawley rats exposed to high doses of alagebrium
over
their natural lifetime developed dose-related increases in liver cell
alterations and tumors, and that the liver tumor rate was slightly over the
expected background rate in this gender and species of rat. In February 2005,
based on the initial results from one of the follow-on preclinical toxicity
experiments, we voluntarily and temporarily suspended enrollment of new subjects
into each of the ongoing clinical studies pending receipt of additional
preclinical data. We withdrew our IND for the EMERALD study in February 2006
in
order to focus our resources on the development of alagebrium in cardiovascular
indications.
In
June
2005, our Phase 2b SPECTRA trial in systolic hypertension was discontinued
after
an interim analysis found that the data did not indicate a treatment effect
of
alagebrium and we have ceased development of alagebrium for this indication.
We
cannot
predict at this time when enrollment in any of our clinical studies, will
resume, if ever. If we are unable to resume enrollment in our clinical studies
in a timely manner, or at all, our business will be materially adversely
affected.
If
we do
not prove in clinical trials that our product candidates are safe and effective,
we will not obtain marketing approvals from the FDA and other applicable
regulatory authorities. In particular, one or more of our product candidates
may
not exhibit the expected medical benefits in humans, may cause harmful side
effects, may not be effective in treating the targeted indication or may have
other unexpected characteristics that preclude regulatory approval for any
or
all indications of use or limit commercial use if approved.
The
length of time necessary to complete clinical trials varies significantly and
is
difficult to predict. Factors that can cause delay or termination of our
clinical trials include:
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slower
than expected patient enrollment due to the nature of the protocol,
the
proximity of subjects to clinical sites, the eligibility criteria
for the
study, competition with clinical trials for other drug candidates
or other
factors;
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adverse
results in preclinical safety or toxicity
studies;
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lower
than expected retention rates of subjects in a clinical
trial;
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inadequately
trained or insufficient personnel at the study site to assist in
overseeing and monitoring clinical
trials;
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delays
in approvals from a study site’s review board, or other required
approvals;
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longer
treatment time required to demonstrate effectiveness or determine
the
appropriate product dose;
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lack
of sufficient supplies of the product
candidate;
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adverse
medical events or side effects in treated
subjects;
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lack
of effectiveness of the product candidate being tested;
and
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Even
if
we obtain positive results from preclinical or clinical studies for a particular
product, we may not achieve the same success in future studies of that product.
Data obtained from preclinical and clinical studies are susceptible to varying
interpretations that could delay, limit or prevent regulatory approval. In
addition, we may encounter delays or rejections based upon changes in FDA policy
for drug approval during the period of product development and FDA regulatory
review of each submitted new drug application. We may encounter similar delays
in foreign countries. Moreover, regulatory approval may entail limitations
on
the indicated uses of the drug. Failure to obtain requisite governmental
approvals or failure to obtain approvals of the scope requested will delay
or
preclude our licensees or marketing partners from marketing our products or
limit the commercial use of such products and will have a material adverse
effect on our business, financial condition and results of operations.
In
addition, some or all of the clinical trials we undertake may not demonstrate
sufficient safety and efficacy to obtain the requisite regulatory approvals,
which could prevent or delay the creation of marketable products. Our product
development costs will increase if we have delays in testing or approvals,
if we
need to perform more, larger or different clinical or preclinical trials than
planned or if our trials are not successful. Delays in our clinical trials
may
harm our financial results and the commercial prospects for our products.
Before
a
clinical trial may commence in the United States, we must submit an IND,
containing preclinical studies, chemistry, manufacturing, control and other
information and a study protocol to the FDA. If the FDA does not object within
30 days after submission of the IND, then the trial may commence. If commenced,
the FDA may delay, limit, suspend or terminate clinical trials at any time,
or
may delay, condition or reject approval of any of our product candidates, for
many reasons. For example:
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ongoing
preclinical or clinical study results may indicate that the product
candidate is not safe or effective;
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the
FDA may interpret our preclinical or clinical study results to indicate
that the product candidate is not safe or effective, even if we interpret
the results differently; or
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the
FDA may deem the processes and facilities that our collaborative
partners,
our third-party manufacturers or we propose to use in connection
with the
manufacture of the product candidate to be
unacceptable.
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If
we do not successfully develop any products, or are unable to derive revenues
from product sales, we will never be profitable.
Virtually
all of our revenues to date have been generated from collaborative research
agreements and investment income. We have not received any revenues from product
sales. We may not realize product revenues on a timely basis, if at all, and
there can be no assurance that we will ever be profitable.
At
March
31, 2006, we had an accumulated deficit of $225,610,000. We anticipate that
we
will incur substantial, potentially greater, losses in the future as we continue
our research, development and clinical studies. We have not yet requested or
received regulatory approval for any product from the FDA or any other
regulatory body. All of our product candidates, including our lead candidate,
alagebrium, are still in research, preclinical or clinical development. We
may
not succeed in the development and marketing of any therapeutic or diagnostic
product. We do not have any product other than alagebrium in clinical
development, and there can be no assurance that we will be able to bring any
other compound into clinical development. Adverse results of any preclinical
or
clinical study could cause us to materially modify our clinical development
programs, resulting in delays and increased expenditures, or cease development
for all or part of our ongoing studies of alagebrium.
In
February 2006, the EMERALD study of alagebrium in ED was discontinued in order
to focus our resources on development of alagebrium for cardiovascular
indications.
In
June
2005, our SPECTRA Phase 2b trial in systolic hypertension, was discontinued
after an interim analysis found that the data did not indicate a treatment
effect of alagebrium and we have ceased development of alagebrium for this
indication.
To
achieve profitable operations, we must, alone or with others, successfully
identify, develop, introduce and market proprietary products. Such products
will
require significant additional investment, development and preclinical and
clinical testing prior to potential regulatory approval and commercialization.
The development of new pharmaceutical products is highly uncertain and
expensive
and subject
to a number of significant risks. Potential products that appear to be promising
at early stages of development may not reach the market for a number of reasons.
Potential products may be found ineffective or cause harmful side effects during
preclinical testing or clinical studies, fail to receive necessary regulatory
approvals, be difficult to manufacture on a large scale, be uneconomical, fail
to achieve market acceptance or be precluded from commercialization by
proprietary rights of third parties. We may not be able to undertake additional
clinical studies. In addition, our product development efforts may not be
successfully completed, we may not have
the
funds to complete any ongoing clinical trials, we may not obtain
regulatory approvals, and our products, if introduced, may not be successfully
marketed or achieve customer acceptance. We do not expect any of our products,
including alagebrium, to be commercially available for a number of years, if
at
all.
Failure
to remediate the material weaknesses in our internal controls and to achieve
and
maintain effective internal controls in accordance with Section 404 of the
Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business
and stock price.
During
the audit of our financial statements for the year ended December 31, 2005,
our
independent registered public accounting firm identified a material weakness,
as
of December 31, 2005, regarding our internal controls over the identification
of
and the accounting for non-routine transactions including certain costs related
to potential strategic transactions, severance benefits and the financial
statement recording and disclosures of stock options that we have granted to
non
employee consultants in accordance with Emerging Issues Task Force (“EITF”)
96-18. As defined by the Public Company Accounting Oversight Board Auditing
Standard No. 2, a material weakness is a significant control deficiency or
a
combination of significant control deficiencies, that results in there being
more than a remote likelihood that a material misstatement of the annual or
interim financial statements will not be prevented or detected. This material
weakness did not result in the restatement of any previously reported financial
statements or any other related financial disclosure Management is in the
process of implementing remedial controls to address these matters. In addition,
the changes that would have resulted in the financial statements for the year
ended December 31, 2005, as a consequence of the material weakness, were deemed
by the Company to be immaterial but were nevertheless recorded by the Company.
On
April
22, 2005, we filed an amendment to our Annual Report on Form 10-K for the fiscal
year ended December 31, 2004 (the “10-K Amendment”), in which we reported that,
as of December 31, 2004, and as required by Section 404 of the Sarbanes-Oxley
Act of 2002, management, with the participation of our principal executive
officer and principal financial officer, had assessed the effectiveness of
our
internal control over financial reporting based on the framework established
in
Internal Control - Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (“COSO”). Management’s assessment
included an evaluation of the design of our internal control over financial
reporting and testing of the operational effectiveness of our internal control
over financial reporting. Management reviewed the results of its assessment
with
the Audit Committee of our Board of Directors, and based on this assessment,
management determined that as of December 31, 2004, there were three material
weaknesses in our internal control over financial reporting. In light of these
material weaknesses, management concluded that, as of December 31, 2004, we
did
not maintain effective internal control over financial reporting.
The
three
material weaknesses identified were in the areas of audit committee oversight
of
the internal control review process, information technology controls and process
controls, and control over cash disbursements. With respect to each of these
matters, as set forth in the Form 10-K Amendment, management has implemented
remedial measures or procedures to address these matters. However, we cannot
currently assure that the remedial measures that are currently being implemented
will be sufficient to result in a conclusion that our internal controls no
longer contain any material weaknesses, and that our internal controls are
effective. In addition, we cannot assure you that, even if we are able to
achieve effective internal control over financial reporting, our internal
controls will remain effective for any period of time.
If
we are able to form collaborative relationships, but are unable to maintain
them, our product development may be delayed and disputes over rights to
technology may result.
We
may
form collaborative relationships that, in some cases, will make us dependent
upon outside partners to conduct preclinical testing and clinical studies and
to
provide adequate funding for our development programs.
In
general, collaborations involving our product candidates pose the following
risks to us:
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collaborators
may fail to adequately perform the scientific and preclinical studies
called for under our agreements with
them;
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collaborators
have significant discretion in determining the efforts and resources
that
they will apply to these
collaborations;
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collaborators
may not pursue further development and commercialization of our product
candidates or may elect not to continue or renew research and development
programs based on preclinical or clinical study results, changes
in their
strategic focus or available funding or external factors, such as
an
acquisition that diverts resources or creates competing
priorities;
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collaborators
may delay clinical trials, provide insufficient funding for a clinical
program, stop a clinical study or abandon a product candidate, repeat
or
conduct new clinical trials or require a new formulation of a product
candidate for clinical testing;
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collaborators
could independently develop, or develop with third parties, products
that
compete directly or indirectly with our products or product candidates
if
the collaborators believe that competitive products are more likely
to be
successfully developed or can be commercialized under terms that
are more
economically attractive; collaborators with marketing and distribution
rights to one or more products may not commit enough resources to
their
marketing and distribution;
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collaborators
may not properly maintain or defend our intellectual property rights
or
may use our proprietary information in such a way as to invite litigation
that could jeopardize or invalidate our proprietary information or
expose
us to potential litigation;
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disputes
may arise between us and the collaborators that result in the delay
or
termination of the research, development or commercialization of
our
product candidates or that result in costly litigation or arbitration
that
diverts management attention and resources;
and
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collaborations
may be terminated and, if terminated, may result in a need for additional
capital to pursue further development of the applicable product
candidates.
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In
addition, there have been a significant number of business combinations among
large pharmaceutical companies that have resulted in a reduced number of
potential future collaborators. If a present or future collaborator of ours
were
to be involved in a business combination, the continued pursuit and emphasis
on
our product development program could be delayed, diminished or terminated.
Our
product candidates will remain subject to ongoing regulatory review even if
they
receive marketing approval. If we fail to comply with continuing regulations,
we
could lose these approvals and the sale of our products could be suspended.
Even
if
we receive regulatory approval to market a particular product candidate, the
approval could be granted with the condition that we conduct additional costly
post-approval studies or that we limit the indicated uses included in our
labeling. Moreover, the product may later cause adverse effects that limit
or
prevent its widespread use, force us to withdraw it from the market or impede
or
delay our ability to obtain regulatory approvals in additional countries. In
addition, the manufacturer of the product and its facilities will continue
to be
subject to FDA review and periodic inspections to ensure adherence to applicable
regulations. After receiving marketing approval, the manufacturing, labeling,
packaging, adverse event reporting, storage, advertising, promotion and record
keeping related to the product will remain subject to extensive regulatory
requirements. We may be slow to adapt, or we may never adapt, to changes in
existing regulatory requirements or adoption of new regulatory requirements.
If
we
fail to comply with the regulatory requirements of the FDA and other applicable
United States and foreign regulatory authorities or if previously unknown
problems with our products, manufacturers or manufacturing processes are
discovered, we could be subject to administrative or judicially imposed
sanctions, including:
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restrictions
on the products, manufacturers or manufacturing
processes;
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civil
or criminal penalties;
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product
seizures or detentions;
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voluntary
or mandatory product recalls and publicity
requirements;
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suspension
or withdrawal of regulatory
approvals;
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total
or partial suspension of production;
and
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refusal
to approve pending applications for marketing approval of new drugs
or
supplements to approved
applications.
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If
we cannot successfully form and maintain suitable arrangements with third
parties for the manufacturing of the products we may develop, our ability to
develop or deliver products may be impaired.
We
have
no experience in manufacturing products and do not have manufacturing
facilities. Consequently, we will depend on contract manufacturers for the
production of any products for development and commercial purposes. The
manufacture of our products for clinical trials and commercial purposes is
subject to current cGMP, regulations promulgated by the FDA. In the event that
we are unable to obtain or retain third-party manufacturing capabilities for
our
products, we will not be able to commercialize our products as planned. Our
reliance on third-party manufacturers will expose us to risks that could delay
or prevent the initiation or completion of our clinical trials, the submission
of applications for regulatory approvals, the approval of our products by the
FDA or the commercialization of our products or result in higher costs or lost
product revenues. In particular, contract manufacturers:
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could
encounter difficulties in achieving volume production, quality control
and
quality assurance and suffer shortages of qualified personnel, which
could
result in their inability to manufacture sufficient quantities of
drugs to
meet our clinical schedules or to commercialize our product
candidates;
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could
terminate or choose not to renew the manufacturing agreement, based
on
their own business priorities, at a time that is costly or inconvenient
for us;
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could
fail to establish and follow FDA-mandated cGMPs, as required for
FDA
approval of our product candidates, or fail to document their adherence
to
cGMPs, either of which could lead to significant delays in the
availability of material for clinical study and delay or prevent
filing or
approval of marketing applications for our product candidates;
and
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could
breach, or fail to perform as agreed, under the manufacturing
agreement.
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Changing
any manufacturer that we engage for a particular product or product candidate
may be difficult, as the number of potential manufacturers is limited, and
we
will have to compete with third parties for access to those manufacturing
facilities. cGMP processes and procedures typically must be reviewed and
approved by the FDA, and changing manufacturers may require re-validation of
any
new facility for cGMP compliance, which would likely be costly and
time-consuming. We may not be able to engage replacement manufacturers on
acceptable terms quickly or at all. In addition, contract manufacturers located
in foreign countries may be subject to import limitations or bans. As a result,
if any of our contract manufacturers is unable, for whatever reason, to supply
the contracted amounts of our products that we successfully bring to market,
a
shortage would result which would have a negative impact on our revenues.
Drug
manufacturers are subject to ongoing periodic unannounced inspection by the
FDA,
the U.S. Drug Enforcement Agency and corresponding state and foreign agencies
to
ensure strict compliance with cGMPs, other government regulations and
corresponding foreign standards. While we are obligated to audit the performance
of third-party contractors, we do not have control over our third-party
manufacturers’ compliance with these regulations and standards. Failure by our
third-party manufacturers or us to comply with applicable regulations could
result in sanctions being imposed on us, including fines, injunctions, civil
penalties, failure of the government to grant pre-market approval of drugs,
delays, suspension or withdrawal of approvals, seizures or recalls of product,
operating restrictions and criminal prosecutions. Our dependence upon others
for
the manufacture of any products that we develop may adversely affect our profit
margin, if any, on the sale of any future products and our ability to develop
and deliver such products on a timely and competitive basis.
If
we are not able to protect the proprietary rights that are critical to our
success, the development and any possible sales of our product candidates could
suffer and competitors could force our products completely out of the market.
Our
success will depend on our ability to obtain patent protection for our products,
preserve our trade secrets, prevent third parties from infringing upon our
proprietary rights and operate without infringing upon the proprietary rights
of
others, both in the United States and abroad.
The
degree of patent protection afforded to pharmaceutical inventions is uncertain
and our potential products are subject to this uncertainty. Competitors may
develop competitive products outside the protection that may be afforded by
the
claims of our patents. We are aware that other parties have been issued patents
and have filed patent applications in the United States and foreign countries
with respect to other agents that have an effect on A.G.E.s., or the formation
of A.G.E. crosslinks. In addition, although we have several patent applications
pending to protect proprietary technology and potential products, these patents
may not be issued, and the claims of any patents that do issue, may not provide
significant protection of our technology or products. In addition, we may not
enjoy any patent protection beyond the expiration dates of our currently issued
patents.
We
also
rely upon unpatented trade secrets and improvements, unpatented know-how and
continuing technological innovation to maintain, develop and expand our
competitive position, which we seek to protect, in part, by confidentiality
agreements with our corporate partners, collaborators, employees and
consultants. We also have invention or patent assignment agreements with our
employees and certain, but not all, corporate partners and consultants. Relevant
inventions may be developed by a person not bound by an invention assignment
agreement. Binding agreements may be breached, and we may not have adequate
remedies for such breach. In addition, our trade secrets may become known to
or
be independently discovered by competitors.
The
effect of accounting rules relating to our equity compensation arrangements
may
have an adverse effect on our stock price and financial condition.
In
December 2004, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards (“SFAS”) No. 123 (revised 2004),
“Share-Based Payment” (“SFAS 123R”), which replaces “Accounting for Stock-Based
Compensation,” (“SFAS 123”) and supersedes Accounting Principles Board (“APB”)
Opinion No. 25, “Accounting for Stock Issued to Employees.” SFAS 123R requires
all share-based payments to employees, including grants of employee stock
options, to be recognized in the financial statements based on their fair values
effective for the Company January 1, 2006. Under SFAS 123R, the pro forma
disclosures previously permitted under SFAS 123 are no longer an alternative
to
financial statement recognition.
The
Company accounts for employee stock-based compensation, awards issued to
non-employee directors, and stock options issued to consultants and contractors
in accordance with SFAS 123R and Emerging Issues Task Force Issue No. 96-18,
“Accounting for Equity Instruments that are Issued to Other Than Employees for
Acquiring or in Conjunction with Selling Goods or Services.”
The
Company has adopted the new standard, SFAS 123R, effective January 1, 2006
and
has selected the Black-Scholes method of valuation for share-based compensation.
The Company has adopted the modified prospective transition method which
requires that compensation cost be recorded, as earned, for all unvested stock
options and restricted stock outstanding at the beginning of the first quarter
of adoption of SFAS 123R, and that such costs be recognized over the remaining
service period after the adoption date based on the options’ original estimate
of fair value.
On
December 15, 2005, the Compensation Committee of the Board of Directors of
the
Company approved the acceleration of the vesting date of all previously issued,
outstanding and unvested options, effective December 31, 2005. The acceleration
and the fact that no options were issued in the three months ended March 31,
2006, resulted in the Company not being required to recognize aggregate
compensation expense under SFAS 123R for the three months ended March 31,
2006.
Prior
to
adoption of SFAS 123R, the Company applied the intrinsic-value method under
APB
Opinion No. 25, “Accounting for Stock Issued to Employees,” and related
interpretations, under which no compensation cost (excluding those options
granted below fair market value) had been recognized. SFAS 123 established
accounting and disclosure requirements using a fair-value based method of
accounting for stock-based employee compensation plans. As permitted by SFAS
123, the Company elected to continue to apply the intrinsic-value based method
of accounting described above, and adopted only the disclosure requirements
of
SFAS 123, as amended.
If
we are not able to compete successfully with other companies in the development
and marketing of cures and therapies for cardiovascular diseases, diabetes,
and
the other conditions for which we seek to develop products, we may not be able
to continue our operations.
We
are
engaged in pharmaceutical fields characterized by extensive research efforts
and
rapid technological progress. Many established pharmaceutical and biotechnology
companies with financial, technical and human resources greater than ours are
attempting to develop, or have developed, products that would be competitive
with our products. Many of these companies have extensive experience in
preclinical and human clinical studies. Other companies may succeed in
developing products that are safer, more efficacious or less costly than any
we
may develop and may also be more successful than us in production and marketing.
Rapid technological development by others may result in our products becoming
obsolete before we recover a significant portion of the research, development
or
commercialization expenses incurred with respect to those products.
Certain
technologies under development by other pharmaceutical companies could result
in
better treatments for cardiovascular disease, and diabetes and its related
complications. Several large companies have initiated or expanded research,
development and licensing efforts to build pharmaceutical franchises focusing
on
these medical conditions, and some companies already have products approved
and
available for commercial sale to treat these indications. It is possible that
one or more of these initiatives may reduce or eliminate the market for some
of
our products. In addition, other companies have initiated research in the
inhibition or crosslink breaking of A.G.E.s.
If
governments and third-party payers continue their efforts to contain or decrease
the costs of healthcare, we may not be able to commercialize our products
successfully.
In
certain foreign markets, pricing and/or profitability of prescription
pharmaceuticals are subject to government control. In the United States, we
expect that there will continue to be federal and state initiatives to control
and/or reduce pharmaceutical expenditures. In addition, increasing emphasis
on
managed care in the United States will continue to put pressure on
pharmaceutical pricing. Cost control initiatives could decrease the price that
we receive for any products for which we may receive regulatory approval to
develop and sell in the future and could have a material adverse effect on
our
business, financial condition and results of operations. Further, to the extent
that cost control initiatives have a material adverse effect on our corporate
partners, our ability to commercialize our products may be adversely affected.
Our ability to commercialize pharmaceutical products may depend, in part, on
the
extent to which reimbursement for the products will be available from government
health administration authorities, private health insurers and other third-party
payers. Significant uncertainty exists as to the reimbursement status of newly
approved healthcare products, and third-party payers, including Medicare,
frequently challenge the prices charged for medical products and services.
In
addition, third-party insurance coverage may not be available to subjects for
any products developed by us. Government and other third-party payers are
attempting to contain healthcare costs by limiting both coverage and the level
of reimbursement for new therapeutic products and by refusing in some cases
to
provide coverage for uses of approved products for disease indications for
which
the FDA has not granted labeling approval. If government and other third-party
payers for our products do not provide adequate coverage and reimbursement
levels, the market acceptance of these products would be adversely affected.
If
the users of the products that we are developing claim that our products have
harmed them, we may be subject to costly and damaging product liability
litigation, which could have a material adverse effect on our business,
financial condition and results of operations.
The
use
of any of our potential products in clinical studies and the sale of any
approved products, including the testing and commercialization of alagebrium
or
other compounds, may expose us to liability claims resulting from the use of
products or product candidates. Claims could be made directly by participants
in
our clinical studies, consumers, pharmaceutical companies or others. We maintain
product liability insurance coverage for claims arising from the use of our
products in clinical studies. However, coverage is becoming increasingly
expensive, and we may not be able to maintain or acquire insurance at a
reasonable cost or in sufficient amounts to protect us against losses due to
liability that could have a material adverse effect on our business, financial
condition and results of operations. We may not be able to obtain commercially
reasonable product liability insurance for any product approved for marketing
in
the future, and insurance coverage and our resources may not be sufficient
to
satisfy any liability resulting from product liability claims. A successful
product liability claim or series of claims brought against us could have a
material adverse effect on our business, financial condition and results of
operations.
Risks
Relating to the Merger
J.H.
Cohn
LLP, our independent registered public accounting firm, has included an
explanatory paragraph in their report on our financial statements for the
fiscal
year ended December 31, 2005, which raises substantial doubt about our ability
to continue as a going concern. The inclusion of a going concern explanatory
paragraph in J.H. Cohn LLP’s report on our financial statements could have a
detrimental effect on our stock price and our ability to raise additional
capital, either alone or as a combined company.
Our
financial statements have been prepared on the basis of a going concern,
which
contemplates the realization of assets and the satisfaction of liabilities
in
the normal course of business. We have not made any adjustments to the financial
statements as a result of the outcome of the uncertainty described above.
Accordingly, the value of the company in liquidation may be different from
the
values set forth in our financial statements.
If
the
merger is not completed, the substantial common stock ownership represented
by
the shares of Alteon preferred stock owned by Genentech, on an as-converted
basis, will make it unlikely that the Company will be able to obtain additional
funding. The continued success of the combined company will depend on its
ability to continue to raise capital in order to fund the development and
commercialization of its products.
Even
if
the combined company’s products receive approval for commercial sale, their
manufacture, storage, marketing and distribution are and will be subject
to
extensive and continuing regulation in the United States by the federal
government, especially the FDA, and state and local governments. The failure
to
comply with these regulatory requirements could result in enforcement action,
including, without limitation, withdrawal of approval, which would have a
material adverse effect on the combined company’s business. Later discovery of
problems with the combined company’s products may result in additional
restrictions on the product, including withdrawal of the product from the
market. Regulatory authorities may also require post-marketing testing, which
can involve significant uncontemplated expense. Additionally, governments
may
impose new regulations, which could further delay or preclude regulatory
approval of the combined company’s products or result in significantly increased
compliance costs.
In
similar fashion to the FDA, foreign regulatory authorities require demonstration
of product quality, safety and efficacy prior to granting authorization for
product registration which allows for distribution of the product for commercial
sale. International organizations, such as the World Health Organization,
and
foreign government agencies including those for the Americas, Middle East,
Europe, and Asia and the Pacific, have laws, regulations and guidelines for
reporting and evaluating the data on safety, quality and efficacy of new
drug
products. Although most of these laws, regulations and guidelines are very
similar, each of the individual nations reviews all of the information available
on the new drug product and makes an independent determination for product
registration. A finding of product quality, safety or efficiency in one
jurisdiction does not guarantee approval in any other jurisdiction, even
if the
other jurisdiction has similar laws, regulations and guidelines.
Alteon
and HaptoGuard have each historically incurred operating losses and these
losses
will continue after the merger.
Alteon
and HaptoGuard have each historically incurred substantial operating losses
due
to their research and development activities and expect these losses to continue
after the merger for the foreseeable future. As of December 31, 2005, Alteon
and
HaptoGuard had an accumulated deficit of $222,813,445 and $2,425,258,
respectively. Alteon’s fiscal year 2005, 2004 and 2003 net losses were
$12,614,459, $13,958,646, and $14,452,418, respectively. HaptoGuard’ fiscal year
2005 and 2004 net losses were $1,654,695 and $770,563, respectively. Alteon’s
fiscal year 2005, 2004 and 2003 net losses applicable to common stockholders
were $17,100,795, $18,093,791 and $18,243,265, respectively. The combined
company currently expects to continue its research and development activities
at
the same or at a more rapid pace than prior periods. After the merger, the
combined company will expend significant amounts on research and development
programs for alagebrium and ALT-2074. These activities will take time and
expense, both to identify appropriate partners, to reach agreement on basic
terms, and to negotiate and sign definitive agreements. We will actively
seek
new financing from time to time to provide financial support for our research
and development activities. However, at this time we are not able to assess
the
probability of success in our fundraising efforts or the terms, if any, under
which we may secure financial support from strategic partners or other
investors. It is expected that we will continue to incur operating losses
for
the foreseeable future.
The
combined company will need additional capital in the future, but its access
to
such capital is uncertain.
Alteon’s
current resources are insufficient to fund its own commercialization efforts
as
well as the combined company’s commercialization efforts. As of March 31, 2006,
Alteon had cash on hand of $4,469,170. As described elsewhere in this
prospectus, in April, 2006 we closed on approximately $2.6 million in financing.
Prior to the financing, Alteon was expending approximately $450,000 in cash
per
month. Following the merger, including HaptoGuard’s cash spending rate of
approximately $110,000 in cash per month, the combined company expects to
spend
approximately $560,000 in cash per month. Our capital needs beyond the second
quarter of 2006 will depend on many factors, including our research and
development activities and the success thereof, the scope of our clinical
trial
program, the timing of regulatory approval for our products under development
and the successful commercialization of our products. Our needs may also
depend
on the magnitude and scope of these activities, the progress and the level
of
success in our clinical trials, the costs of preparing, filing, prosecuting,
maintaining and enforcing patent claims and other intellectual property rights,
competing technological and market developments, changes in or terminations
of
existing collaboration and licensing arrangements, the establishment of new
collaboration and licensing arrangements and the cost of manufacturing scale-up
and development of marketing activities, if undertaken by the combined company.
Other than the recently completed financing described in this prospectus,
we do
not have committed external sources of funding and may not be able to secure
additional funding on any terms or on terms that are favourable to us. If
we
raise additional funds by issuing additional stock, further dilution to our
existing stockholders will result, and new investors may negotiate for rights
superior to existing stockholders. If adequate funds are not available, the
combined company may be required to:
· |
delay,
reduce the scope of or eliminate one or more of its development programs;
|
· |
obtain
funds through arrangements with collaboration partners or others
that may
require it to relinquish rights to some or all of its technologies,
product candidates or products that it would otherwise seek to develop
or
commercialize itself;
|
· |
license
rights to technologies, product candidates or products on terms that
are
less favorable to it than might otherwise be available; or
|
· |
seek
a buyer for all or a portion of its business, or wind down its operations
and liquidate its assets on terms not favorable to it.
|
The
success of the combined company will also depend on the products and systems
under development by HaptoGuard, including ALT-2074, and we cannot assure
you
that the efforts to commercialize ALT-2074 will succeed.
ALT-2074,
HaptoGuard’s lead compound, is in development for the treatment of heart
complications in patients with diabetes. It has demonstrated efficacy in
mouse
models. On May 1, 2006, HaptoGuard initiated a Phase 2 study of ALT-2074
in
diabetic patients recovering from a recent myocardial infarction or acute
coronary syndrome. The purpose of the study, is to evaluate the biological
effects on cardiac tissue in patients treated with ALT-2074.
ALT-2074
is still in early clinical trials and any success to date should not be seen
as
indicative of the probability of any future success. The failure to complete
clinical development and commercialize ALT-2074 for any reason or due to
a
combination of reasons will have a material adverse impact on the combined
company.
Failure
to integrate the companies’ operations successfully could result in delays and
increased expenses in the companies’ clinical trial
programs.
Alteon
and HaptoGuard have entered into the merger agreement with the expectation
that
the merger will result in beneficial synergies, including:
· |
improved
ability to raise new capital through access to new classes of investors
focused on public companies engaged in small molecule drug
development;
|
· |
shared
expertise in developing innovative small molecule drug technologies
and
the potential for technology
collaboration;
|
· |
a
broader pipeline of products;
|
· |
greater
ability to attract commercial partners;
|
· |
larger
combined commercial opportunities; and
|
· |
a
broader portfolio of patents and
trademarks.
|
Achieving
these anticipated synergies and the potential benefits underlying the two
companies’ reasons for the merger will depend on a number of factors, some of
which include:
· |
retention
of scientific staff;
|
· |
significant
litigation, if any, adverse to Alteon and HaptoGuard, including,
particularly, product liability litigation and patent and trademark
litigation; and
|
· |
the
ability of the combined company to continue development of Alteon
and
HaptoGuard product candidates;
|
· |
success
of our research and development efforts;
|
· |
increased
capital expenditures;
|
· |
general
market conditions
relating to small cap biotech investments;
and
|
· |
competition
from other drug development companies.
|
Achieving
the benefits of the merger will depend in part on the successful integration
of
Alteon and HaptoGuard in a timely and efficient manner. The integration will
require significant time and efforts from each company, including the
coordination of research, development, regulatory, manufacturing, commercial,
administrative and general functions. Integration may be difficult and
unpredictable because of possible cultural conflicts and different opinions
on
scientific and regulatory matters. Delays in successfully integrating and
managing employee benefits could lead to dissatisfaction and employee turnover.
The combination of Alteon’s and HaptoGuard’s organizations may result in greater
competition for resources and elimination of research and development programs
that might otherwise be successfully completed. If we cannot successfully
integrate our operations and personnel, we may not recognize the expected
benefits of the merger.
Even
if
the two companies are able to integrate their operations, there can be no
assurance that these anticipated synergies will be achieved. The failure
to
achieve such synergies could have a material adverse effect on the business,
results of operations and financial condition of the combined
company.
Integrating
Alteon and HaptoGuard may divert management’s attention away from our core
research and development activities.
Successful
integration of our operations, products and personnel may place a significant
burden on our management and our internal resources. The diversion of
management’s attention and any difficulties encountered in the transition and
integration process could result in delays in the companies’ clinical trial
programs and could otherwise significantly harm our business, financial
condition and operating results.
We
expect
to incur significant costs integrating our operations, product candidates
and
personnel, which cannot be estimated accurately at this time. These costs
include:
· |
conversion
of information systems;
|
· |
combining
research, development, regulatory, manufacturing and commercial teams
and
processes;
|
· |
reorganization
of facilities; and
|
· |
relocation
or disposition of excess equipment.
|
We
expect
that Alteon and HaptoGuard will incur aggregate direct transaction costs
of
approximately $800,000 associated with the merger. If the total costs of
the
merger exceed our estimates or benefits of the merger do not exceed the total
costs of the merger, the financial results of our combined company could
be
adversely affected.
Completion
of, or the failure to complete, the merger could adversely affect Alteon’s stock
price and Alteon’s and HaptoGuard’s future business and
operations.
The
merger is subject to the satisfaction of various closing conditions, including
the approval by both Alteon and HaptoGuard stockholders, and there can be
no
assurance that the merger will be successfully completed. In the event that
the
merger is not consummated, Alteon and HaptoGuard will be subject to many
risks,
including the costs related to the merger, such as legal, accounting and
advisory fees, which must be paid even if the merger is not completed, or
the
payment of a termination fee under certain circumstances. If the merger is
not
consummated for any reason, the market price of Alteon common stock could
decline.
The
shares of the combined company are publicly traded and we cannot predict
how the
market will react to the merger of Alteon and HaptoGuard. Even the successful
completion of the merger may negatively affect the stock price of the combined
company, if the market were to come to the view that Alteon would be in a
better
position absent completion of the merger.
The
combined company will remain dependent on third parties for research and
development activities necessary to commercialize certain of our
patents.
We
utilize the services of several scientific and technical consultants to oversee
various aspects of our protocol design, clinical trial oversight and other
research and development functions. Alteon and HaptoGuard both contract out
most
of our research and development operations utilize third-party contract
manufacturers for drug inventory and shipping services and third-party contract
research organizations in connection with preclinical and/or clinical studies
in
accordance with our designed protocols, as well as conducting research at
medical and academic centers.
Because
we rely on third parties for much our research and development work, we have
less direct control over our research and development. We face risks that
these
third parties may not be appropriately responsive to our time frames and
development needs and could devote resources to other customers. In addition,
certain of these third parties may have to comply with FDA regulations or
other
regulatory requirements in the conduct of this research and development work,
which they may fail to do.
If
the combined company does not successfully distinguish and commercialize
its
technology, it may be unable to compete successfully or to generate significant
revenues.
The
biotechnology industry, including the field of small molecule drugs to treat
and
prevent cardiovascular disease and diabetes, is highly competitive and subject
to significant and rapid technological change. Accordingly, the combined
company’s success will depend, in part, on its ability to respond quickly to
such change through the development and introduction of new products and
systems.
The
combined company will have substantial competition, including competitors
with
substantially greater resources.
Many
of
the combined company’s competitors or potential competitors have substantially
greater financial and other resources than Alteon has and may also have greater
experience in conducting pre-clinical studies, clinical trials and other
regulatory approval procedures as well as in marketing their products. Major
competitors in the market for our potential products include large,
publicly-traded pharmaceutical companies, public development stage public
companies and private development stage companies. If the combined company
or
its corporate partners commence commercial product sales, the combined company
or its corporate partners will be competing against companies with greater
marketing and manufacturing capabilities.
The
combined company’s ability to compete successfully against currently existing
and future alternatives to its product candidates and systems, and competitors
who compete directly with it in the small molecule drug industry will depend,
in
part, on its ability to:
· |
attract
and retain skilled scientific and research personnel;
|
· |
develop
technologically superior products;
|
· |
develop
competitively priced products;
|
· |
obtain
patent or other required regulatory approvals for the combined company’s
products;
|
· |
be
early entrants to the market; and
|
· |
manufacture,
market and sell its products, independently or through collaborations.
|
The
success of the combined company is dependent on the extent of third-party
reimbursement for its products.
Third-party
reimbursement policies may also adversely affect the combined company’s ability
to commercialize and sell its products. The combined company’s ability to
successfully commercialize its products depends in part on the extent to
which
appropriate levels of reimbursement for its products and related treatments
are
obtained from government authorities, private health insurers, third party
payers, and other organizations, such as managed care organizations, or MCOs.
Any failure by doctors, hospitals and other users of the combined company’s
products or systems to obtain appropriate levels of reimbursement could
adversely affect the combined company’s ability to sell these products and
systems.
Federal
legislation, enacted in December 2003, has altered the way in which
physician-administered drug programs covered by Medicare are reimbursed,
generally leading to lower reimbursement levels. The new legislation has
also
added an outpatient prescription drug benefit to Medicare, effective January
2006. In the interim, the U.S. Congress has established a discount drug card
program for Medicare beneficiaries. Both benefits will be provided through
private entities, which will attempt to negotiate price concessions from
pharmaceutical manufacturers. These negotiations may increase pressures to
lower
prices. On the other hand, the drug benefit may increase the volume of
pharmaceutical drug purchases, offsetting at least in part these potential
price
discounts. While the new law specifically prohibits the U.S. government from
interfering in price negotiations between manufacturers and Medicare drug
plan
sponsors, some members of Congress are pursuing legislation that would permit
de
facto price controls on prescription drugs. In addition, the law triggers,
for
congressional consideration, cost containment measures for Medicare in the
event
Medicare cost increases exceed a certain level. These cost containment measures
could include limitations on prescription drug prices. This legislation could
adversely impact the combined company’s ability to commercialize any of its
products successfully.
Significant
uncertainty exists about the reimbursement status of newly approved medical
products and services. Reimbursement in the United States or foreign countries
may not be available for any of the combined company’s products, reimbursement
granted may not be maintained, and limits on reimbursement available from
third-party payers may reduce the demand for, or negatively affect the price
of,
the combined company’s products. Alteon anticipates that the combined company
will need to work with a variety of organizations to lobby government agencies
for improved reimbursement policies for its products. However, Alteon cannot
guarantee that such lobbying efforts will take place or that they will
ultimately be successful.
Internationally,
where national healthcare systems are prevalent, little if any funding may
be
available for new products, and cost containment and cost reduction efforts
can
be more pronounced than in the United States.
If
the combined company is unable to protect its intellectual property, it may
not
be able to operate its business profitably.
The
combined company’s success will depend on its ability to develop proprietary
products and technologies, to obtain and maintain patents, to protect trade
secrets, and to prevent others from infringing on its proprietary rights.
The
combined company has exclusive patents, licenses to patents or patent
applications covering critical components of its technologies, including
certain
jointly owned patents. We also seek to protect our proprietary technology
and
processes, in part, by confidentiality agreements with our employees and
certain
contractors. Patents, pending patent applications and licensed technologies
may
not afford adequate protection against competitors, and any pending patent
applications now or hereafter filed by or licensed to us may not result in
patents being issued. In addition, certain of the combined company’s technology
relies on patented inventions developed using university resources. Universities
may have certain rights, as defined by law or applicable agreements, in such
patents, and may choose to exercise such rights. To the extent that employees,
consultants or contractors of the combined company use intellectual property
owned by others, disputes may arise as to the rights related to or resulting
from the know-how and inventions. In addition, the laws of certain non-U.S.
countries do not protect intellectual property rights to the same extent
as do
the laws of the United States. Medical technology patents involve complex
legal
and factual questions and, therefore, the combined company cannot predict
with
certainty their enforceability.
The
combined company is a party to various license agreements that give it exclusive
and partial exclusive rights to use specified technologies applicable to
research, development and commercialization of its products, including
alagebrium and ALT-2074. The agreements pursuant to which such technology
is
used permit the licensors to terminate agreements in the event that certain
conditions are not met. If these conditions are not met and the agreements
are
terminated, the combined company’s product development, research and
commercialization efforts may be altered or delayed.
Patents
or patent applications, if issued, may be challenged, invalidated or
circumvented, or may not provide protection or competitive advantages against
competitors with similar technology. Furthermore, competitors of the combined
company may obtain patent protection or other intellectual property rights
for
technology similar to the combined company’s that could limit its ability to use
its technology or commercialize products that it may develop.
Litigation
may be necessary to assert claims of infringement, to enforce patents issued
to
the combined company, to protect trade secrets or know-how or to determine
the
scope and validity of the proprietary rights of others. Litigation or
interference proceedings could result in substantial additional costs and
diversion of management focus. If the combined company is ultimately unable
to
protect its technology, trade secrets or know-how, it may be unable to operate
profitably. Although we have not been involved with any threats of litigation
or
negotiations regarding patent issues or other intellectual property, or other
related court challenges or legal actions, it is possible that the combined
company could be involved with such matters in the future.
If
the combined company is unable to operate its business without infringing
upon
intellectual property rights of others, it may not be able to operate its
business profitably.
The
combined company’s success depends on its ability to operate without infringing
upon the proprietary rights of others. We are aware that patents have been
applied for and/or issued to third parties claiming technologies for Advanced
Glycation End-Products or glutathione peroxidase mimetics that may be similar
to
those needed by us. To the extent that planned or potential products are
covered
by patents or other intellectual property rights held by third parties, the
combined company would need a license under such patents or other intellectual
property rights to continue development and marketing of its products. Any
required licenses may not be available on acceptable terms, if at all. If
the
combined company does not obtain such licenses it may not be able to proceed
with the development, manufacture or sale of its products.
Litigation
may be necessary to defend against claims of infringement or to determine
the
scope and validity of the proprietary rights of others. Litigation or
interference proceedings could result in substantial additional costs and
diversion of management focus. If the combined company is ultimately
unsuccessful in defending against claims of infringement, it may be unable
to
operate profitably.
HaptoGuard’s
ALT-2074 and other HaptoGuard compounds are licensed to HaptoGuard by third
parties and if the combined company is unable to continue licensing this
technology our future prospects may be materially adversely
affected.
HaptoGuard
licenses technology, including technology related to ALT-2074, from third
parties. We anticipate that we will continue to license technology from third
parties in the future. To maintain HaptoGuard’s license to ALT-2074 from Oxis
International, we are obligated to meet certain development and clinical
trial
milestones and to make certain payments. There can be no assurance that we
will
be able to meet any milestone or make any payment required under the license
with Oxis International. In addition, if we fail to meet any milestone or
make
any payment, there can be no assurance that we may be able to negotiate a
compromise with Oxis.
The
technology HaptoGuard licenses from third parties would be difficult or
impossible to replace and the loss of this technology would materially adversely
affect our business, financial condition and any future prospects.
If
the combined company loses or is unable to hire and retain qualified personnel,
it may not be able to develop its products and technology.
The
combined company is highly dependent on the members of its scientific and
management staff. In particular, the combined company depends on Dr. Noah
Berkowitz as the combined company’s Chief Executive Officer and Malcolm MacNab
as the combined company’s Vice-President of Clinical Development. We may not be
able to attract and retain scientific and management personnel on acceptable
terms, if at all, given the competition for such personnel among other companies
and research and academic institutions. If the combined company loses an
executive officer or certain key members of its clinical or research and
development staff or is unable to hire and retain qualified management
personnel, then its ability to develop and commercialize its products and
technology and to raise capital and effect strategic opportunities may be
hindered. We have not purchased and do not anticipate purchasing any key-man
life insurance.
The
combined company may face exposure to product liability claims.
The
combined company may face exposure to product liability and other claims
due to
allegations that its products cause harm. These risks are inherent in the
clinical trials for pharmaceutical products and in the testing, and future
manufacturing and marketing of, the combined company’s products. Although we
currently maintain product liability insurance, such insurance may not be
adequate and the combined company may not be able to obtain adequate insurance
coverage in the future at a reasonable cost, if at all. If the combined company
is unable to obtain product liability insurance in the future at an acceptable
cost or to otherwise protect against potential product liability claims,
it
could be inhibited in the commercialization of its products which could have
a
material adverse effect on its business. We currently have a policy covering
$10
million of product liability for our clinical trials. We do not have sales
of
any products. The coverage will be maintained and limits reviewed from time
to
time as the combined company progresses to later stages of its clinical trials
and as the length of the trials and the number of patients enrolled in the
trials changes. The combined company intends to obtain a combined coverage
policy that includes tail coverage in order to cover any claims that are
made
for any events that have occurred prior to the merger. Currently, our annual
premium for product liability insurance is approximately $219,000.
Risks
Related to Owning Alteon's Common Stock
Our
stock price is volatile and you may not be able to resell your shares at
a
profit.
We
first
publicly issued common stock on November 8, 1991 at $15.00 per share in our
initial public offering and it has been subject to fluctuations. For example,
during 2005, the closing sale price of our common stock has ranged from a
high
of $1.43 per shares to a low of $0.17 per share. The market price of our
common
stock could continue to fluctuate substantially due to a variety of factors,
including:
· |
quarterly
fluctuations in results of operations;
|
· |
the
announcement of new products or services by the combined company
or
competitors;
|
· |
sales
of common stock by existing stockholders or the perception that these
sales may occur;
|
· |
adverse
judgments or settlements obligating the combined company to pay damages;
|
· |
developments
concerning proprietary rights, including patents and litigation matters;
and
|
· |
clinical
trial or regulatory developments in both the United States and foreign
countries.
|
In
addition, overall stock market volatility has often significantly affected
the
market prices of securities for reasons unrelated to a company’s operating
performance. In the past, securities class action litigation has been commenced
against companies that have experienced periods of volatility in the price
of
their stock. Securities litigation initiated against the combined company
could
cause it to incur substantial costs and could lead to the diversion of
management’s attention and resources, which could have a material adverse effect
on revenue and earnings.
We
have a large number of authorized but unissued shares of common stock, which
our
Board of Directors may issue without further stockholder approval, thereby
causing dilution of your holdings of our common stock.
After
the
closing of the merger and the financing, there are approximately 180,000,000
shares
of
authorized but unissued shares of our common stock. Our management will continue
to have broad discretion to issue shares of our common stock in a range of
transactions, including capital-raising transactions, mergers, acquisitions,
for
anti-takeover purposes, and in other transactions, without obtaining stockholder
approval, unless stockholder approval is required for a particular transaction
under the rules of the American Stock Exchange, Delaware law, or other
applicable laws. We currently have no specific plans to issue shares of our
common stock for any purpose other than in connection with the merger. However,
if our management determines to issue shares of our common stock from the
large
pool of such authorized but unissued shares for any purpose in the future
without obtaining stockholder approval, your ownership position would be
diluted
without your further ability to vote on that transaction.
The
sale of a substantial number of shares of our common stock could cause the
market price of our common stock to decline and may impair the combined
company’s ability to raise capital through additional offerings.
We
currently have outstanding warrants
to purchase an aggregate of 1,631,055 shares of our common stock. In addition,
in the PIPE financing which we recently completed in April, 2006, we issued
10,960,400 shares of common stock and warrants to purchase 10,960,400 shares
of
our common stock. Under the terms of the financing we have agreed to register
all of such shares for resale. The resale of these shares of common stock
and
the shares underlying the warrants may be effected at any time once the resale
registration statement is effective. The shares issued in the PIPE financing,
together with the shares underlying the warrants issued in such financing,
represent approximately 37.8% of the total number of shares of our common
stock
outstanding immediately prior to the financing, and not including shares
to be
issued in the merger with HaptoGuard.
Sales
of
these shares in the public market, or the perception that future sales of
these
shares could occur, could have the effect of lowering the market price of
our
common stock below current levels and make it more difficult for us and our
shareholders to sell our equity securities in the future.
Our
executive officers, directors and holders of more than 5% of our common stock
and collectively beneficially own approximately 13.4% of
the
outstanding common stock as of March 31, 2006. In
addition, approximately 6,403,464 shares
of
common stock issuable upon exercise of vested stock options could become
available for immediate resale if such options were exercised.
Sale
or
the availability for sale, of shares of common stock by stockholders could
cause
the market price of our common stock to decline and could impair our ability
to
raise capital through an offering of additional equity securities.
Anti-takeover
provisions may frustrate attempts to replace our current management and
discourage investors from buying our common stock.
We
have
entered into a Stockholders’ Rights Agreement pursuant to which each holder of a
share of common stock is granted a Right to purchase our Series F Preferred
Stock under certain circumstances if a person or group acquires, or commences
a
tender offer for, 20 percent of our outstanding common stock. We also have
severance obligations to certain employees in the event of termination
of their
employment after or in connection with a change in control of the Company.
In addition, the Board of Directors has the authority, without further
action by
the stockholders, to fix the rights and preferences of, and issue shares
of,
Preferred Stock. The staggered board terms, Fair Price Provision, Stockholders’
Rights Agreement, severance arrangements, Preferred Stock provisions and
other provisions of our charter and Delaware corporate law may discourage
certain types of transactions involving an actual or potential change in
control.
ITEM
6. Exhibits.
Exhibits
See
the
“Exhibit Index” on page 33 for exhibits required to be filed with this Quarterly
Report on Form 10-Q.
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.
Date:
May
15, 2006
ALTEON
INC.
By:
/s/ Kenneth I. Moch
Kenneth
I. Moch
President
and Chief Executive Officer
(principal
executive officer)
By:
/s/ Mary T. Phelan
Mary
T.
Phelan
Director
of Finance and Financial Reporting
(principal
financial and accounting officer)
EXHIBIT
INDEX
|
Description
of Exhibit
|
|
|
31.1
|
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
|
|
31.2
|
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
|
|
32.1
|
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|