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 June
30, 2006
OR
o 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 o
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 o
Accelerated filer
o
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
o No x
On
August
1, 2006, 119,848,525 shares of the registrant’s Common Stock were
outstanding.
ALTEON
INC.
INDEX
|
|
Page
|
|
PART
I - FINANCIAL INFORMATION
|
|
|
|
|
|
|
Item
1.
|
Condensed
Financial Statements (Unaudited)
|
3
|
|
|
|
|
|
|
Condensed
Balance Sheets as of June 30, 2006
|
|
|
|
and December 31, 2005
|
3
|
|
|
|
|
|
|
Condensed
Statements of Operations for the three and six months
|
|
|
|
ended June 30, 2006 and 2005
|
4
|
|
|
|
|
|
|
Condensed
Statement of Changes in Stockholders’ Equity
|
|
|
|
for the three
and six months ended June 30, 2006
|
|
|
|
|
|
|
|
Condensed
Statements of Cash Flows for the six months
|
|
|
|
ended June 30, 2006 and 2005
|
6
|
|
|
|
|
|
|
Notes
to Condensed Financial Statements
|
7
|
|
|
|
|
|
Item
2.
|
Management’s
Discussion and Analysis of
|
|
|
|
Financial
Condition and Results of Operations
|
12
|
|
|
|
|
|
Item
3.
|
Qualitative
and Quantitative Disclosures about Market Risk
|
16
|
|
|
|
|
|
Item
4.
|
Controls
and Procedures
|
16
|
|
|
|
|
|
PART
II - OTHER INFORMATION
|
|
|
|
|
|
|
Item
1A.
|
Risk
Factors
|
18
|
|
|
|
|
|
Item
4.
|
Submission
of Matters to a Vote of Security-holders
|
33
|
|
|
|
|
|
Item
6.
|
Exhibits
|
34
|
|
|
|
|
|
SIGNATURES
|
35
|
|
|
|
|
|
INDEX
TO EXHIBITS
|
36
|
|
PART
I - FINANCIAL INFORMATION
ITEM
l. Condensed
Financial Statements (Unaudited).
ALTEON
INC.
CONDENSED
BALANCE SHEETS
(Unaudited)
ASSETS
|
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
4,984,928
|
|
$
|
6,582,958
|
|
Other current assets
|
|
|
354,379
|
|
|
216,290
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
5,339,307
|
|
|
6,799,248
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
28,982
|
|
|
55,154
|
|
Restricted
cash
|
|
|
150,000
|
|
|
150,000
|
|
Receivable
from HaptoGuard
|
|
|
336,000
|
|
|
--
|
|
Other
assets
|
|
|
1,259,056
|
|
|
129,195
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
7,113,345
|
|
$
|
7,133,597
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
Current
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
630,396
|
|
$
|
351,232
|
|
Accrued
expenses
|
|
|
679,793
|
|
|
790,705
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
1,310,189
|
|
|
1,141,937
|
|
|
|
|
|
|
|
|
|
Stockholders'
Equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock, $0.01 par value,
|
|
|
|
|
|
|
|
1,993,329 shares authorized, and 1,448 and 1,389 shares
|
|
|
|
|
|
|
|
of Series G and 4,351 and 4,172 shares of Series H
|
|
|
|
|
|
|
|
issued and outstanding, as of June 30, 2006 and
|
|
|
|
|
|
|
|
December 31, 2005, respectively. The liquidation value
|
|
|
|
|
|
|
|
at June 30, 2006 and December 31, 2005 was $57,992,692
|
|
|
|
|
|
|
|
and $55,613,905 respectively
|
|
|
58
|
|
|
56
|
|
|
|
|
|
|
|
|
|
Common Stock, $0.01 par value,
|
|
|
|
|
|
|
|
300,000,000 shares authorized, and 68,957,111 shares
issued
|
|
|
|
|
|
|
|
and outstanding, as of June
30, 2006 and 57,996,711 shares
|
|
|
|
|
|
|
|
issued and outstanding as of December 31, 2005
|
|
|
689,571
|
|
|
579,967
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital
|
|
|
232,960,553
|
|
|
228,225,082
|
|
|
|
|
|
|
|
|
|
Accumulated deficit
|
|
|
(227,847,026
|
)
|
|
(222,813,445
|
)
|
|
|
|
|
|
|
|
|
Total stockholders’ equity
|
|
|
5,803,156
|
|
|
5,991,660
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
|
$
|
7,113,345
|
|
$
|
7,133,597
|
|
The
accompanying notes are an integral part of these unaudited financial
statements.
ALTEON
INC.
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months
|
|
Six
Months
|
|
|
|
Ended
June 30,
|
|
Ended June 30,
|
|
|
|
2006
|
|
2005
|
|
2006
|
|
2005
|
|
Income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income
|
|
$
|
66,197
|
|
$
|
100,405
|
|
$
|
126,561
|
|
$
|
199,554
|
|
Other income
|
|
|
50,000
|
|
|
100,000
|
|
|
50,000
|
|
|
100,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total income
|
|
|
116,197
|
|
|
200,405
|
|
|
176,561
|
|
|
299,554
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
494,936
|
|
|
2,493,379
|
|
|
944,776
|
|
|
6,134,479
|
|
General and administrative
|
|
|
664,443
|
|
|
1,083,095
|
|
|
1,896,295
|
|
|
2,183,443
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses
|
|
|
1,159,379
|
|
|
3,576,474
|
|
|
2,841,071
|
|
|
8,317,922
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
(1,043,182
|
)
|
|
(3,376,069
|
)
|
|
(2,664,510
|
)
|
|
(8,018,368
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividends
|
|
|
1,193,749
|
|
|
1,106,193
|
|
|
2,369,071
|
|
|
2,177,771
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss applicable to common stockholders
|
|
$
|
(2,236,931
|
)
|
$
|
(4,482,262
|
)
|
$
|
(5,033,581
|
)
|
$
|
(10,196,139
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic/diluted
net loss per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
applicable to common stockholders
|
|
$
|
(0.03
|
)
|
$
|
(0.08
|
)
|
$
|
(0.08
|
)
|
$ |
(0.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares used
|
|
|
|
|
|
|
|
|
|
|
|
|
|
in computing basic/diluted net loss per share
|
|
|
66,789,120
|
|
|
57,996,711
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of these unaudited financial
statements.
ALTEON
INC.
CONDENSED
STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
|
|
Preferred
Stock
|
|
Common
Stock
|
|
|
|
Accumulated
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Deficit
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2005
|
|
|
5,561
|
|
$
|
56
|
|
|
57,996,711
|
|
$
|
579,967
|
|
$
|
228,225,082
|
|
$
|
(222,813,445
|
)
|
$
|
5,991,660
|
|
Net
loss
|
|
|
---
|
|
|
---
|
|
|
---
|
|
|
---
|
|
|
---
|
|
|
(2,664,510
|
)
|
|
(2,664,510
|
)
|
Private
placement of common stock
|
|
|
---
|
|
|
---
|
|
|
10,960,400
|
|
|
109,604
|
|
|
2,366,402
|
|
|
---
|
|
|
2,476,006
|
|
Issuance
of Series G and H
preferred
stock dividends
|
|
|
238
|
|
|
2
|
|
|
---
|
|
|
---
|
|
|
2,369,069
|
|
|
(2,369,071
|
)
|
|
---
|
|
Balance,
June 30, 2006
|
|
|
5,799
|
|
$
|
58
|
|
|
68,957,111
|
|
$
|
689,571
|
|
$
|
232,960,553
|
|
$
|
(227,847,026
|
)
|
$
|
5,803,156
|
|
The
accompanying notes are an integral part of these unaudited financial
statements.
ALTEON
INC.
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Six
Months Ended June 30,
|
|
|
|
2006
|
|
2005
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
Net loss
|
|
$
|
(2,664,510
|
)
|
$
|
(8,018,368
|
)
|
|
|
|
|
|
|
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
26,172
|
|
|
33,434
|
|
Stock compensation expense
|
|
|
---
|
|
|
19,573
|
|
|
|
|
|
|
|
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
Other current assets
|
|
|
(138,089
|
)
|
|
(558,073
|
)
|
Accounts payable and accrued expenses
|
|
|
(274,748
|
)
|
|
(588,055
|
)
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(3,051,175
|
)
|
|
(9,111,489
|
)
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
---
|
|
|
(760
|
)
|
Other assets
|
|
|
(1,022,861
|
)
|
|
---
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(1,022,861
|
)
|
|
(760
|
)
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
Net proceeds from issuance of common stock
|
|
|
2,476,006
|
|
|
9,532,295
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
2,476,006
|
|
|
9,532,295
|
|
|
|
|
|
|
|
|
|
Net
(decrease)/increase in cash and cash equivalents
|
|
|
(1,598,030
|
)
|
|
420,046
|
|
Cash
and cash equivalents, beginning of period
|
|
|
6,582,958
|
|
|
11,175,762
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents, end of period
|
|
$
|
4,984,928
|
|
$
|
11,595,808
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
Accrual of deferred merger costs
|
|
$
|
443,000
|
|
$
|
---
|
|
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 condensed 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 six months
ended
June 30, 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 $227,847,026 as of June 30, 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
June 30, 2006, the Company had working capital of $4,029,118, including
$4,984,928 of cash and cash equivalents. The Company’s net cash used in
operating activities for the six months ended June 30, 2006 was $3,051,175
and
for the year ended December 31, 2005 was $14,032,796.
On
July
19, 2006, the Company’s shareholders approved a merger with HaptoGuard, Inc.,
formerly a privately-held development-stage biotechnology company. The two
companies have combined operations and intend to pursue clinical development
of
their complementary product platforms. The merger transaction, which was
completed on July 21, 2006, included the granting of certain royalty and
negotiation rights to Genentech, Inc., as part of the restructuring of
Genentech’s former preferred stock position in Alteon. The merger will be
accounted for in accordance with Statement of Financial Accounting Standards
(“SFAS”) No. 141, “Business Combinations”. (See Note 6 - Subsequent
Events).
As
a
result of the merger with HaptoGuard, which closed on July 21, 2006, the Company
is required to make payments of severance and insurance costs in the amount
of
approximately $2.0 million. In addition, the Company has incurred transaction
fees and expenses of approximately $1,259,000 through June 30, 2006, in
connection with the merger, which fees and expenses are currently due and
payable.
The
Company is urgently continuing to pursue fund-raising possibilities through
the
sale of its equity securities. If the Company 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 the third quarter
of 2006.
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 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 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. The Company is in the
process of significantly curtailing its research and development programs,
until
additional financing is obtained. 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 and alter its plans
for the development of its product candidates. If Alteon is unable to obtain
the
necessary funding, it will likely need to cease operations. There can be no
assurance that the products or technologies acquired in the merger 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 on 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 six months ended June 30, 2006,
resulted in the Company not being required to recognize aggregate compensation
expense under SFAS 123R for the three and six months ended June 30,
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.
The
following table illustrates the effect on net loss and net loss per share as
if
the Company had applied the fair value recognition provisions of SFAS 123 to
its
stock-based employee compensation for the three and six months ended June 30,
2005.
|
|
Three
Months Ended June
30,
|
|
Six
Months Ended June
30,
|
|
|
|
2005
|
|
2005
|
|
Net
loss, as reported
|
|
$
|
(3,376,069
|
)
|
$
|
(8,018,368
|
)
|
|
|
|
|
|
|
|
|
Less: Total
stock-based employee
and
director
compensation
expense
determined under
fair
value
method
|
|
|
(269,437
|
)
|
|
(711,579
|
)
|
Pro
forma net loss
|
|
|
(3,645,506
|
)
|
|
(8,729,947
|
)
|
Preferred
stock dividends
|
|
|
1,106,193
|
|
|
2,177,771
|
|
Pro
forma net loss applicable to common
stockholders
|
|
|
(4,751,699
|
)
|
$
|
(10,907,718
|
)
|
|
|
|
|
|
|
|
|
Earnings
per share applicable to common
stockholders:
|
|
|
|
|
|
|
|
Basic/diluted,
as reported
|
|
$
|
(0.08
|
)
|
$
|
(0.18
|
)
|
Basic/diluted,
pro forma
|
|
$
|
(0.08
|
)
|
$
|
(0.19
|
)
|
The
following table shows the weighted average assumptions the
Company used to develop the fair value estimates for the determination of
the compensation in 2005:
|
|
Six
Months Ended
June
30, 2005
|
|
Expected
volatility
|
|
|
135.26
|
%
|
Dividend
yield
|
|
|
—
|
|
Expected
term (in years)
|
|
|
5
|
|
Risk-free
interest rate
|
|
|
3.4
|
%
|
A
summary
of the status of the Company’s stock options as of June 30, 2006 and changes
during the six months then ended is presented below:
Outstanding
at
|
|
Shares
|
|
Weighted
average
exercise
price
|
|
Weighted
Average Remaining Contractual
Term
(years)
|
|
December
31, 2005
|
|
|
6,486,665
|
|
$
|
2.12
|
|
|
|
|
Granted
|
|
|
---
|
|
|
---
|
|
|
|
|
Exercised
|
|
|
---
|
|
|
---
|
|
|
|
|
Cancelled
|
|
|
(193,387
|
)
|
|
4.20
|
|
|
|
|
Outstanding
at
|
|
|
|
|
|
|
|
|
|
|
June
30, 2006
|
|
|
6,293,278
|
|
$
|
2.06
|
|
|
5.23
|
|
As
of
June 30, 2006 there were no options outstanding that were “in the money”,
therefore there was no aggregate intrinsic value.
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 June
30, 2006 and 2005, was 329,837,548 and 158,194,608 shares, respectively. (See
Note 6 - Subsequent Events).
Note
5 - Stockholders’ Equity
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”).
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. Investors in the private placement 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 June 14, 2008, the second anniversary of
the
declaration of effectiveness by the Securities and Exchange Commission (“SEC”),
of the 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.
Series
G
Preferred Stock and Series H Preferred Stock dividends were 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 was 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
June 30, 2006 and 2005, preferred stock dividends of $1,193,749 and $1,106,193,
respectively, were recorded. On June 30, 2006, the Series G and Series H
Preferred Stock would have been convertible into 77,665,416 common stock shares
and 233,287,399 common stock shares, respectively, and had a total liquidation
value of $57,992,692. The Series G and Series H Preferred Stock had no voting
rights.
(See
Note 6 - Subsequent Events).
Note
6 - Subsequent Events
Merger
with HaptoGuard
On
July
19, 2006, the Company’s shareholders approved the merger with HaptoGuard, Inc.,
and on July 21, 2006, the companies’ combined operations in a stock transaction
valued at approximately $8.8 million at the signing of the merger agreement
on
April 19, 2006. Alteon and HaptoGuard have complementary product platforms
in
cardiovascular diseases, diabetes and other inflammatory diseases, including
two
Phase 2 clinical-stage compounds focused on cardiovascular diseases in diabetic
patients.
As
part
of the merger, a portion of existing shares of Alteon preferred stock held
by
Genentech, Inc. were converted into Alteon common stock. Genentech transferred
a
portion of the Alteon preferred stock that they held to HaptoGuard and canceled
its remaining preferred stock position in Alteon. Genentech acquired the right
of first negotiation for HaptoGuard’s cardiovascular compound, ALT-2074
(formerly BXT-51072), and future royalties on Alteon’s alagebrium. Also as a
result of the merger, the potentially dilutive shares reflected in Note 4 -
Net
Loss per Share Applicable to Common Stockholders will no longer be applicable
as
of the transaction closing date. Additionally, upon completion of the merger,
the receivable from HaptoGuard will be eliminated and not
collected.
The
merger of the two companies was structured as an acquisition by Alteon. Under
the terms of the merger agreement, HaptoGuard shareholders received a total
of
37.4 million shares of Alteon common stock (from Alteon and Genentech, equal
to
approximately 31 percent of the shares of Alteon company stock outstanding
after
completion of the merger).
Key components of the transactions among Alteon, HaptoGuard and stockholder
Genentech are as follows:
·
|
Alteon
acquired all outstanding equity of HaptoGuard. In exchange, HaptoGuard
shareholders received from Alteon approximately 22.5 million shares
of
Alteon common stock.
|
·
|
Genentech
converted a portion of its existing Alteon preferred stock to Alteon
common stock. A portion of Alteon preferred stock held by Genentech,
which
as of April 19, 2006 equaled approximately $3.5 million in Alteon
common
stock, was transferred to HaptoGuard shareholders.
|
·
|
The
remaining Alteon preferred stock held by Genentech was cancelled.
|
·
|
Genentech
will receive milestone payments and royalties on net sales of alagebrium,
if any, and will receive a right of first negotiation on ALT-2074,
HaptoGuard’s lead compound.
|
Following the merger, the new Alteon management team is as follows:
·
|
Noah
Berkowitz, M.D., Ph.D. - President and Chief Executive
Officer;
|
·
|
Malcolm
MacNab, M.D., Ph.D. - Vice President, Clinical Development; and
|
·
|
Howard
B. Haimes, Ph.D. - Executive Director, Preclinical
Sciences.
|
Additionally, the Board of Directors of the combined company is composed of
seven members as follows:
·
|
Kenneth
I. Moch, Chairman - Director of Alteon since December
1998
|
·
|
Noah
Berkowitz, M.D., Ph.D. - Director of HaptoGuard since November
2003
|
·
|
Marilyn
G. Breslow - Director of Alteon since June 1988
|
·
|
Thomas
A. Moore - Director of Alteon since October 2001
|
·
|
George
M. Naimark - Director of Alteon since June 1999
|
·
|
Mary
Tanner - Director of HaptoGuard since January 2004
|
·
|
Wayne
P. Yetter - Director of HaptoGuard since August
2004
|
Unaudited
Proforma Financial Information
The
following unaudited proforma financial information presents the results of
operations of the Company and HaptoGuard, as if the acquisition had occurred
on
January 1, 2005 instead of July 21, 2006, after giving effect to certain
adjustments including the issuance of the Company’s common stock as part of the
purchase price. The pro forma information does not necessarily reflect the
results of operations that would have occurred had the entities been a single
company during the periods presented.
|
|
3
Months Ended
June
30
|
|
6
Months Ended
June
30
|
|
|
|
2006
|
|
2005
|
|
2006
|
|
2005
|
|
Net
Loss
|
|
$
|
(1,428,948
|
)
|
$
|
(3,667,166
|
)
|
$
|
(3,720,303
|
)
|
$
|
(8,986,787
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding
|
|
|
117,680,534
|
|
|
108,888,125
|
|
|
113,308,618
|
|
|
108,167,288
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
per common share - Basic and fully diluted
|
|
|
(0.01
|
)
|
|
(0.03
|
)
|
|
(0.03
|
)
|
|
(0.08
|
)
|
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
July
2006, we completed a merger with HaptoGuard, Inc., whereby the two companies’
combined operations, including their complementary product platforms in
cardiovascular diseases, diabetes and other inflammatory diseases. The
newly-combined company has two products in Phase 2 clinical
development:
· |
ALT-2074,
formerly HaptoGuard’s licensed lead compound BXT-51072, is a glutathione
peroxidase mimetic in clinical development for reduction of mortality
in
post-myocardial infarction patients with diabetes. The compound has
demonstrated the ability to reduce infarct size by approximately
85
percent in a mouse model of heart attack called ischemia reperfusion
injury. A Phase 2 clinical study for this compound was opened for
enrollment in May, but progress has been slow by virtue of limited
financial resources and the eruption of the conflict in the Middle
East,
as many of the sites open for patient enrollment are in northern
Israel.
The Company also owns a license to a proprietary genetic biomarker
that
has shown the potential to identify patients who are most responsive
to
ALT-2074.
|
· |
Alagebrium
chloride (formerly ALT-711), Alteon's lead compound, is an Advanced
Glycation End-product Crosslink Breaker being developed for heart
failure.
The most recent data on alagebrium, 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 1000 patients, which represents a sizeable human safety
database, in a number of Phase 2 clinical studies.
|
o |
The
Company recently announced that the Juvenile Diabetes Research Foundation
(JDRF) awarded a grant to one of our independent researchers, Mark
Cooper,
M.D., Ph.D., Professor at the Baker Heart Research Institute, Melbourne,
Australia. This grant will fund a multinational Phase 2 clinical
study of
alagebrium on renal function in patients with type 1 diabetes and
microalbuminuria. Alagebrium will be tested for its ability to reverse
kidney damage caused by diabetes, and to reverse the protein excretion
which is characteristic of diabetic nephropathy. Dr. Cooper has
demonstrated promising preclinical results with alagebrium in diabetic
kidney disease. The trial is expected to be initiated in the fourth
quarter of this year.
|
o |
Additionally,
the Company announced that it has filed an Investigational New Drug
Application (IND) with the U.S. Food & Drug Administration's (FDA)
Division of Cardio-Renal Drug Products for a Phase 2b clinical study
of
the Company’s lead A.G.E. Crosslink Breaker compound, alagebrium, in
diastolic heart failure (DHF). The IND has passed the 30-day review
period
for the proposed study’s clinical protocol, and the Company is allowed to
initiate the study at its discretion.
|
The
merger of the two companies was structured as an acquisition by Alteon. Under
the terms of the merger agreement, HaptoGuard shareholders received 37.4 million
shares of Alteon common stock (approximately 31 percent of the shares after
completion of the merger). As an additional part of the merger, a portion of
existing shares of Alteon preferred stock held by Genentech, Inc. was converted
into Alteon common stock.
Key
components of the transactions completed in July 2006 between Alteon, HaptoGuard
and Genentech were as follows:
Ø |
Alteon
acquired all outstanding equity of HaptoGuard. In exchange, HaptoGuard
shareholders received from Alteon $5.3 million in Alteon common stock,
or
approximately 22.5 million shares.
|
Ø |
Genentech
converted a portion of its existing Alteon preferred stock to Alteon
common stock. A portion of Alteon preferred stock held by Genentech,
which, when converted to Alteon common stock is equal to $3.5 million
in
Alteon common stock, was transferred to HaptoGuard shareholders.
|
Ø |
The
remaining Alteon preferred stock held by Genentech was cancelled.
|
Ø |
Genentech
will receive milestone payments and royalties on any future net sales
of
alagebrium, and received a right of first negotiation on
ALT-2074.
|
ITEM
2. Management's
Discussion and Analysis of Financial Condition and Results of Operations—Continued.
We
had
been evaluating potential pre-clinical and clinical studies in other therapeutic
indications in which alagebrium may address significant unmet needs, during
the
period ended June 30, 2006, but subsequent to the completion of the merger,
we
have curtailed such studies to conserve cash. In addition to our anticipated
clinical studies in renal disease, ischemia reperfusion injury and 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 $227,847,026 as of June 30, 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 obtain sufficient additional funding to resume the development of
alagebrium in heart failure, enroll patients in the study opened for ALT-2074,
and continue operations, (2) our ability to complete enrollment in our clinical
studies of alagebrium and ALT-2074 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 and ALT-2074, which are our only significant drug
candidates, (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—Continued.
Results
of Operations
Three
Months ended June 30, 2006 and 2005
Total
revenues for the three months ended June 30, 2006 and 2005, were $116,197 and
$200,405, respectively. Revenues were derived from interest earned on cash
and
cash equivalents and other income. The decrease from 2005 to 2006 was attributed
to lower investment balances and partially offset by higher interest rates.
In
2006 and 2005 other income included $50,000 and $100,000, respectively, received
from a licensing agreement with Avon Products, Inc.
Our
total
expenses were $1,159,379 for the three months ended June 30, 2006, compared
to $
3,576,474 for the three months ended June 30, 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 $494,936 for the three months ended June 30,
2006,
as compared to $2,493,379 for the same period in 2005, a decrease of $1,998,443,
or 80.1%. 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
$115,880 in personnel and personnel-related expenses, $62,518 in product
liability insurance and $144,931 in third party consulting. In 2005, we incurred
$941,891 in personnel and personnel-related expenses, $729,861 in clinical
trial
expenses primarily related to SPECTRA, $393,930 in pre-clinical expenses and
$169,811 related to manufacturing (packaging and distribution).
General
and administrative expenses were $664,443 for the three months ended June 30,
2006, as compared to $1,083,095 for the same period in 2005. The decrease for
2006 includes reduced corporate expenses offset by increased severance costs
and
retention bonuses.
Our
net
loss applicable to common stockholders was $2,236,931 for the three months
ended
June 30, 2006, compared to $4,482,262 in the same period in 2005, a decrease
of
50.0%. 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 $1,193,749 and $1,106,193 for
the
three months ended June 30, 2006 and 2005 respectively.
Six
Months ended June 30, 2006 and 2005
Total
revenues for the six months ended June 30, 2006 and 2005, were $176,561 and
$299,554, respectively. Revenues were derived from interest earned on cash
and
cash equivalents and other income. The decrease from 2005 to 2006 was attributed
to lower investment balances and partially offset by higher interest rates.
In
2006 and 2005, other income included $50,000 and $100,000, respectively,
received from a licensing agreement with Avon Products, Inc.
Our
total
expenses were $2,841,071 for the six months ended June 30, 2006, compared to
$8,317,922 for the six months ended June 30, 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 $944,776 for the six months ended June 30, 2006,
as compared to $6,134,479 for the same period in 2005, a decrease of $5,189,703,
or 84.6%. 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
$348,401 in personnel and personnel-related expenses, $164,430 in product
liability insurance and $230,432 in third party consulting. In 2005, we incurred
$2,079,819 in
personnel and personnel-related expenses, $729,861 in clinical trial expenses
primarily related to SPECTRA, $393,930 in pre-clinical expenses and $169,811
related to manufacturing (packaging and distribution).
General
and administrative expenses were $1,896,295 for the six months ended June 30,
2006, as compared to $2,183,443 for the same period in 2005. The decrease for
2006 includes reduced corporate expenses offset by increased severance costs
and
retention bonuses.
Our
net
loss applicable to common stockholders was $5,034,000 for the six months ended
June 30, 2006, compared to $10,196,000 in the same period in 2005, a decrease
of
50.6%. 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 $2,369,071 and $2,177,771 for
the
six months ended June 30, 2006 and 2005 respectively.
ITEM
2. Management's Discussion and Analysis of Financial Condition and
Results of Operations—Continued.
Liquidity
and Capital Resources
We
had
cash and cash equivalents at June 30, 2006, of $4,984,928, compared to
$6,582,958 at December 31, 2005. The decrease is attributable to $3,051,175
of net cash used in operating activities and $1,022,861 used in investing
activities. At June 30, 2006 we had working capital of $4,029,118.
The
Company is urgently continuing to pursue fund-raising possibilities through
the
sale of its equity securities. If the Company 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 the third quarter
of 2006. As a result of the merger with HaptoGuard, which closed on July 21,
2006, the Company was required to make payment of severance and insurance costs
in the amount of approximately $2.0 million. In addition, the Company has
incurred transaction fees and expenses of approximately $1,259,000 in connection
with the merger, which fees and expenses are currently due and payable.
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 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 s 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. The Company is in the
process of significantly curtailing or its research and development programs,
until additional financing is obtained. 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 and
alter its plans for the development of its product candidates. If Alteon is
unable to obtain the necessary funding, it may need to cease operations. There
can be no assurance that the products or technologies acquired in the merger
will result in revenues to the combined company or any meaningful return on
investment to its stockholders.
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.
In
April
2006, we completed an equity financing that resulted in net proceeds to Alteon
of approximately $2.5 million. (See Note 5 - Stockholders’ Equity).
On
April
19, 2006, the Company entered into a definitive merger agreement pursuant to
which it has combined operations with HaptoGuard, Inc. The merger and associated
preferred stock restructuring transactions were subject to the approval of
Alteon and HaptoGuard shareholders and closed on July 21, 2006. (See Note 6
-
Subsequent Events).
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.
ITEM
2. Management's Discussion and Analysis of Financial
Condition—Continued.
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 six months ended June 30, 2006,
resulted in the Company not being required to recognize aggregate compensation
expense under SFAS 123R for the three and six months ended June 30,
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.
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,
who is currently our acting principal financial officer, 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 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 believes 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 disclosure 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
If
we are unable to obtain sufficient additional funding in the near term, we
may
be forced to cease operation, and 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.
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 additional funding or a strategic partnership.
The
Company is urgently continuing to pursue fund-raising possibilities through
the
sale of its equity securities. If the Company 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 the third quarter
of 2006.
As
of
June 30, 2006, we had working capital of $4,029,118, including $4,984,928 of
cash and cash equivalents. Our cash used in operating activities for the six
months ended June 30, 2006 was $3,051,175.
As
a
result of the merger with HaptoGuard, which closed on July 21, 2006, the Company
was required to make payment of severance and insurance costs in the amount
of
approximately $2.0 million. In addition, the Company has incurred transaction
fees and expenses of approximately $1,259,000 in connection with the merger,
which fees and expenses are currently due and payable. There
can
be no assurance that the products or technologies acquired in the merger 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
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 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.
We
will need additional capital in the future, but 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 June 30, 2006,
Alteon had cash on hand of approximately $4,984,928. As described elsewhere
in
this report, 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., The combined company expects to spend approximately $560,000
in cash per month. Our capital needs beyond the third 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 report, 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.
|
Alteon’s
ability to continue as a going concern is dependent on future financing.
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 expresses 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.
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. Failure to raise additional capital may result in substantial adverse
circumstances, including delisting of our common stock shares from the American
Stock Exchange, which could substantially decrease the liquidity and value
of
such shares, or ultimately result in the liquidation of the combined
company.
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 June 30, 2006.
Mary Phelan resigned from her position as our Director of Finance and Financial
Reporting as of May 31, 2006. 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:
· |
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;
|
· |
adverse
results in preclinical safety or toxicity
studies;
|
· |
lower
than expected retention rates of subjects in a clinical
trial;
|
· |
inadequately
trained or insufficient personnel at the study site to assist in
overseeing and monitoring clinical
trials;
|
· |
delays
in approvals from a study site’s review board, or other required
approvals;
|
· |
longer
treatment time required to demonstrate effectiveness or determine
the
appropriate product dose;
|
· |
lack
of sufficient supplies of the product
candidate;
|
· |
adverse
medical events or side effects in treated
subjects;
|
· |
lack
of effectiveness of the product candidate being tested;
and
|
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:
· |
ongoing
preclinical or clinical study results may indicate that the product
candidate is not safe or effective;
|
· |
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
|
· |
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.
|
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
June
30, 2006, we had an accumulated deficit of $227,847,026. 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.
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 control 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 disclosure 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 continues 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:
· |
collaborators
may fail to adequately perform the scientific and preclinical studies
called for under our agreements with
them;
|
· |
collaborators
have significant discretion in determining the efforts and resources
that
they will apply to these
collaborations;
|
· |
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;
|
· |
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;
|
· |
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;
|
· |
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;
|
· |
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
|
· |
collaborations
may be terminated and, if terminated, may result in a need for additional
capital to pursue further development of the applicable product
candidates.
|
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:
· |
restrictions
on the products, manufacturers or manufacturing
processes;
|
· |
civil
or criminal penalties;
|
· |
product
seizures or detentions;
|
· |
voluntary
or mandatory product recalls and publicity
requirements;
|
· |
suspension
or withdrawal of regulatory
approvals;
|
· |
total
or partial suspension of production;
and
|
· |
refusal
to approve pending applications for marketing approval of new drugs
or
supplements to approved
applications.
|
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:
· |
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;
|
· |
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;
|
· |
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
|
· |
could
breach, or fail to perform as agreed, under the manufacturing
agreement.
|
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, 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
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 six months ended June 30, 2006,
resulted in the Company incurring any compensation expense under SFAS 123R
for
the three and six months ended June 30, 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
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. 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
success of the combined company will also depend on the products and systems
formerly under development by HaptoGuard, including ALT-2074, and we cannot
be
sure 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.
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.
We
are dependent on the successful outcome of clinical trials and will not be
able
to successfully develop and commercialize products if clinical trials are not
successful.
HaptoGuard
received approval from Israel’s Ministry of Health to conduct Phase II
trials 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. HaptoGuard
received Institutional Review Board approval for 3 sites in Israel. And the
study was opened for enrollment in May. The Israel-Lebanon conflict that
began in July, 2006, has adversely impacted our ability to recruit patients
to
the study. While the Company is evaluating modifications to the protocol
to simplify its management in Israel, including transferring management of
the
project from a CRO to our internal team, the conflict will slow down any benefit
that can be seen from those operational modifications. Additionally, the
completion of that trial is contingent on the successful raising of additional
financing by the Company.
None
of Alteon’s or HaptoGuard’s product candidates are currently approved for sale
by the FDA or by any other regulatory agency in the world, and may never receive
approval for sale or become commercially viable. Before obtaining regulatory
approval for sale, each of the combined company’s product candidates will be
subjected to extensive preclinical and clinical testing to demonstrate safety
and efficacy for a particular indication for humans in addition to meeting
other
regulatory standards. The combined company’s success will depend on the
successful outcome of clinical trials for one or more product candidates.
There
are a number of difficulties and risks associated with clinical trials. The
possibility exists that:
|
•
|
|
we
may discover that a product candidate may cause, alone or in combination
with another therapy, harmful side effects;
|
|
|
|
|
|
•
|
|
we
may discover that a product candidate, alone or in combination with
another therapy, does not exhibit the expected therapeutic results
in
humans;
|
|
|
|
|
|
•
|
|
results
from early trials may not be statistically significant or predictive
of
results that may be obtained from large-scale, advanced clinical
trials;
|
|
|
|
|
|
•
|
|
we,
the FDA, other similar foreign regulatory agencies or an institutional
review board may suspend clinical trials for any reason
whatsoever;
|
|
|
|
|
|
•
|
|
patient
recruitment may be slower than expected;
|
|
|
|
|
|
•
|
|
patients
may drop out of our clinical trials; and
|
|
|
|
|
|
•
|
|
we
may be unable to produce sufficient supplies of products in a timely
fashion for clinical trials.
|
Given
the
uncertainty surrounding the regulatory and clinical trial process, we may not
be
able to develop safety, efficacy or manufacturing data necessary for approval
for any product candidate. In addition, even if we receive approval, such
approval may be limited in scope and hurt the commercial viability of such
product. If the combined company is unable to successfully obtain approval
of
and commercialize a product, this would materially harm the business, impair
our
ability to generate revenues and adversely impact our stock price.
The
combined company is subject to significant government regulation and failure
to
achieve regulatory approval of our drug candidates would harm our business.
The
FDA regulates the development, testing, manufacture, distribution, labeling
and
promotion of pharmaceutical products in the United States pursuant to the
Federal Food, Drug, and Cosmetic Act and related regulations. We must receive
pre-market approval by the FDA prior to any commercial sale of any drug
candidates. Before receiving such approval we must provide preclinical data
and
proof in human clinical trials of the safety and efficacy of our drug
candidates, which trials can take several years. In addition, we must show
that
we can produce any drug candidates consistently at quality levels sufficient
for
administration in humans. Pre-market approval is a lengthy and expensive
process. We may not be able to obtain FDA approval for any commercial sale
of
any drug candidate. By statute and regulation, the FDA has 180 days to
review an application for approval to market a drug candidate; however, the
FDA
frequently exceeds the 180-day time period, at times taking up to
18 months. In addition, based on its review, the FDA or other regulatory
bodies may determine that additional clinical trials or preclinical data are
required. Except for any potential licensing or marketing arrangements with
other pharmaceutical or biotechnology companies, we will not generate any
revenues in connection with any of our other drug candidates unless and until
we
obtain FDA approval to sell such products in commercial quantities for human
application.
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.
Failure
to integrate the companies’ operations successfully could result in delays and
increased expenses in the companies’ clinical trial
programs.
Alteon
and HaptoGuard entered into the merger 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 $3,284,000 associated with or resulting from 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.
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.
ALT-2074
and other former HaptoGuard compounds are licensed by third parties and if
the
combined company is unable to continue licensing this technology our future
prospects may be materially adversely affected.
HaptoGuard
licensed 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 the 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 licensed 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 Dr. 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 since that
time.
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 12,591,455
shares of our common stock, including warrants to purchase 10,960,400 shares
of
out common stock issued together with 10,960,400 shares of common stock all
of
which such warrants and common stock were issued in connection with a private
equity financing completed in April 2006. The shares issued in the private
placement 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 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 3.6% of the outstanding common
stock as of June 30, 2006 and owned 31.5% subsequent to the merger completed
July 21, 2006. In addition, approximately 23,435,778 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
4. Submission
of Matters to a Vote of Security-Holders
The
Annual Meeting of Stockholders of Alteon Inc. (the “Meeting”) was held on July
19, 2006. The following matters were voted upon at the Meeting: (i) the approval
of the merger, the Agreement and Plan of Merger, dated as of April 19, 2006,
by
and among Alteon Inc., HaptoGuard Inc., Alteon Merger Sub. Inc., and Genentech
Inc., and the related transactions contemplated thereby, (ii) a proposal to
amend Alteon’s Certificate of Designation of Series G Preferred Stock, to change
the written notice requirements to Alteon for conversion of the preferred stock
in order to allow for the conversion pursuant to the merger agreement, (iii)
a
proposal to amend Alteon’s Certificate of Designation of Series H Preferred
Stock, to change the written notice requirements to Alteon for conversion of
the
preferred stock in order to allow for the conversion pursuant to the merger
agreement, (iv) the election of two directors, (v) a proposal to amend Alteon’s
2005 Stock Plan in order to reserve an additional 5,000,000 shares of common
stock for issuance thereunder, and (vi) the ratification of the appointment
of
J.H. Cohn LLP as independent public accountants for the fiscal year ending
December 31, 2006.
(i) The
number of votes cast for, against and abstaining from the proposal to approve
the
merger, the Agreement and Plan of Merger, dated as of April 19, 2006, by and
among Alteon Inc., HaptoGuard Inc., Alteon Merger Sub. Inc., and Genentech
Inc.,
and the issuance of shares, and the transfer and conversion of shares
contemplated thereby were as follows:
Votes
For
|
|
Votes
Against
|
|
Abstentions
|
|
Broker
Non-Votes
|
|
|
|
|
|
|
|
37,056,365
|
|
1,433,576
|
|
313,464
|
|
23,776,209
|
(ii) The
number of votes cast for, against and abstaining from the proposal to amend
Alteon’s Certificate of Designation of Series G Preferred Stock, to change the
written notice requirements to Alteon for conversion of the preferred stock
in
order to allow for the conversion pursuant to the merger agreement, were as
follows:
Votes
For
|
|
Votes
Against
|
|
Abstentions
|
|
Broker
Non-Votes
|
|
|
|
|
|
|
|
36,273,602
|
|
2,133,311
|
|
396,492
|
|
23,776,209
|
(iii) The
number of votes cast for, against and abstaining from the proposal to amend
Alteon’s Certificate of Designation of Series H Preferred Stock, to change the
written notice requirements to Alteon for conversion of the preferred stock
in
order to allow for the conversion pursuant to the merger agreement, were as
follows:
Votes
For
|
|
Votes
Against
|
|
Abstentions
|
|
Broker
Non-Votes
|
|
|
|
|
|
|
|
36,272,996
|
|
2,146,028
|
|
384,381
|
|
23,776,209
|
(iv) The
following table sets forth the names of the nominees who were elected to serve
as directors and the number of votes cast for or withheld from the election
of
such nominee:
Name
|
|
Votes
For
|
|
Votes
Withheld
|
|
|
|
|
|
David
K. McCurdy
|
|
56,526,157
|
|
6,053,457
|
Mark
Novitch, M.D.
|
|
56,482,157
|
|
6,097,457
|
The
others directors of the Company whose terms continued after the Meeting are
Dr.
Edwin Bransome, Jr., Marilyn G. Breslow, Alan J. Dalby, Kenneth I. Moch, Thomas
A. Moore, Dr. George Naimark. However, pursuant to the terms of the merger
agreement, Drs. Bransome and Novitch and Messrs. McCurdy and Dalby have since
resigned their positions as members of the board of directors.
(v) The
number of votes cast for, against and abstaining from the proposal for the
approval to amend Alteon’s 2005 Stock Plan in order to reserve an additional
5,000,000 shares of common stock for issuance were as follows:
Votes
For
|
|
Votes
Against
|
|
Abstentions
|
|
Broker
Non-Votes
|
|
|
|
|
|
|
|
29,219,280
|
|
9,227,556
|
|
356,569
|
|
23,776,209
|
(vi) The
number of votes cast for, against and abstaining from the ratification of the
appointment of J.H. Cohn LLP as our independent registered public accounting
firm for the fiscal year ending December 31, 2006, were as follows:
Votes
For
|
|
Votes
Against
|
|
Abstentions
|
|
|
|
|
|
60,881,049
|
|
1,393,331
|
|
305,234
|
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: August 14, 2006 |
|
|
ALTEON INC. |
|
|
|
|
|
By:
/s/ Noah
Berkowitz
Noah
Berkowitz, M.D., Ph.D.
President
and Chief Executive Officer
(principal
executive officer)
|
|
|
|
|
|
|
|
By:
/s/ Jeffrey P. Stein
Jeffrey
P. Stein, CPA
(acting
principal financial and accounting
officer)
|
EXHIBIT
INDEX
Exhibit
No.
|
|
Description
of Exhibit |
|
|
|
10.1
|
|
Exclusive
License and Supply Agreement dated as of September 28, 2004, as amended,
by and between Oxis International and HaptoGuard, Inc. |
|
|
|
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. |