For the transition period from |
|
to
|
|
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.)
|
PART I - FINANCIAL INFORMATION
|
||
Item 1. |
Condensed Consolidated Financial Statements
(Unaudited)
|
|
Condensed Consolidated Balance Sheets as of September 30, 2006 | ||
and December 31, 2005
|
3
|
|
Condensed Consolidated Statements of Operations for the three and nine months | ||
ended September 30, 2006 and 2005
|
4
|
|
Condensed Consolidated Statement of Changes in Stockholders’ Equity | ||
for the nine
months ended September 30, 2006
|
5
|
|
Condensed Consolidated Statements of Cash Flows for the nine months | ||
ended September 30, 2006 and 2005
|
6
|
|
Notes to Condensed Consolidated Financial
Statements
|
7
|
|
Item 2. | Management’s Discussion and Analysis of |
|
Financial Condition and Results of
Operations
|
15
|
|
Item 3. |
Qualitative and Quantitative Disclosures about
Market
Risk
|
20
|
Item 4. |
Controls and Procedures
|
20
|
PART II - OTHER INFORMATION
|
||
Item 1A. |
Risk Factors
|
22
|
Item 6. |
Exhibits
|
37
|
SIGNATURES
|
38
|
|
INDEX TO EXHIBITS |
39
|
ALTEON
INC.
|
|||||||
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|||||||
(Unaudited)
|
September
30,
|
December
31,
|
||||||
2006
|
2005
|
||||||
ASSETS
|
|||||||
Current
Assets:
|
|||||||
Cash
and cash equivalents
|
$
|
2,308,323
|
$
|
6,582,958
|
|||
Other
current assets
|
402,705
|
216,290
|
|||||
Total
current assets
|
2,711,028
|
6,799,248
|
|||||
Property
and equipment, net
|
21,671
|
55,154
|
|||||
Restricted
cash
|
150,000
|
150,000
|
|||||
Other
assets
|
529,264
|
129,195
|
|||||
Total
assets
|
$
|
3,411,963
|
$
|
7,133,597
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
Liabilities:
|
|||||||
Accounts
payable
|
$
|
806,060
|
$
|
351,232
|
|||
Accrued
expenses
|
461,663
|
790,705
|
|||||
Total
current liabilities
|
1,267,723
|
1,141,937
|
|||||
Stockholders'
Equity:
|
|||||||
Preferred
stock, $.01 par value; 1,993,329 shares authorized,
|
|||||||
0
shares issued and outstanding at September 30, 2006 and
|
|||||||
1,389
shares of Series G Preferred Stock, and 4,172 shares of
|
|||||||
of
Series H Preferred Stock issued and outstanding
|
|||||||
at
December 31, 2005
|
-
|
56
|
|||||
Common
stock, $.01 par value; 300,000,000 shares
|
|||||||
authorized
and 129,318,858 and 57,996,711 shares issued
|
|||||||
and
outstanding, as of September 30, 2006 and December 31,
|
|||||||
2005
|
1,293,189
|
579,967
|
|||||
Additional
paid-in capital
|
243,057,880
|
228,225,082
|
|||||
Accumulated
deficit
|
(242,206,829
|
)
|
(222,813,445
|
)
|
|||
Total
stockholders' equity
|
2,144,240
|
5,991,660
|
|||||
Total
liabilities and stockholders' equity
|
$
|
3,411,963
|
$
|
7,133,597
|
ALTEON
INC.
|
|||||||
CONDENSED
CONSOLIDATED STATEMENTS OPERATIONS
|
|||||||
(Unaudited)
|
|||||||
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Revenues:
|
|||||||||||||
|
|
||||||||||||
Investment
income
|
$
|
38,560
|
$
|
87,235
|
$
|
165,122
|
$
|
286,789
|
|||||
Other
income
|
—
|
—
|
50,000
|
100,000
|
|||||||||
Total
income
|
$
|
38,560
|
$
|
87,235
|
$
|
215,122
|
$
|
386,789
|
|||||
Expenses:
|
|||||||||||||
Research
and development
|
635,126
|
1,981,136
|
1,579,902
|
8,115,615
|
|||||||||
In-process
research and development
|
11,379,348
|
—
|
11,379,348
|
—
|
|||||||||
General
and administrative
|
2,100,282
|
1,062,503
|
3,996,577
|
3,245,946
|
|||||||||
Total
expenses
|
14,114,756
|
3,043,639
|
16,955,827
|
11,361,561
|
|||||||||
Net
loss
|
$
|
(14,076,196
|
)
|
$
|
(2,956,404
|
)
|
$
|
(16,740,705
|
)
|
$
|
(10,974,772
|
)
|
|
Preferred
stock dividends
|
283,608
|
1,142,016
|
2,652,679
|
3,319,787
|
|||||||||
Net
loss applicable to common shares
|
$
|
(14,359,804
|
)
|
$
|
(4,098,420
|
)
|
$
|
(19,393,384
|
)
|
$
|
(14,294,559
|
)
|
|
Net
loss per common share:
|
|||||||||||||
Basic
and diluted
|
$
|
(0.13
|
)
|
$
|
(0.07
|
)
|
$
|
(0.25
|
)
|
$
|
(0.25
|
)
|
|
Weighted
average common shares outstanding:
|
|||||||||||||
Basic
and diluted
|
110,638,065
|
57,996,711
|
78,667,458
|
57,518,794
|
|
|
Additional
|
Total
|
|||||||||||||||||||
Preferred
Stock
|
Common
Stock
|
Paid-in
|
Accumulated
|
Stockholders'
|
||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Equity
|
||||||||||||||||
Balance,
December 31, 2005
|
5,561
|
$
|
56
|
57,996,711
|
$
|
579,967
|
$
|
228,225,082
|
$
|
(222,813,445
|
)
|
$
|
5,991,660
|
|||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(16,740,705
|
)
|
(16,740,705
|
)
|
|||||||||||||
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
|
-
|
-
|
2,652,677
|
(2,652,679
|
)
|
-
|
||||||||||||||
Common
stock issued in
|
||||||||||||||||||||||
connection
with the merger
|
-
|
-
|
37,399,065
|
373,991
|
8,426,009
|
-
|
8,800,000
|
|||||||||||||||
Preferred
stock converted to common
|
||||||||||||||||||||||
stock
as a result of the merger
|
(5,799
|
)
|
(58
|
)
|
13,492,349
|
134,923
|
(134,865
|
)
|
-
|
-
|
||||||||||||
Assumption
of HaptoGuard
|
||||||||||||||||||||||
vested
stock options
|
-
|
-
|
-
|
-
|
235,000
|
-
|
235,000
|
|||||||||||||||
Private
placement of common stock
|
-
|
-
|
9,470,333
|
94,704
|
1,235,316
|
-
|
1,330,020
|
|||||||||||||||
Stock-based
compensation
|
-
|
-
|
-
|
-
|
34,652
|
-
|
34,652
|
|||||||||||||||
Options
issued for consulting services
|
-
|
-
|
-
|
-
|
7,666
|
-
|
7,666
|
|||||||||||||||
Compensation
costs related to
|
||||||||||||||||||||||
restricted
stock
|
-
|
-
|
-
|
-
|
9,941
|
-
|
9,941
|
|||||||||||||||
Balance,
September 30, 2006
|
-
|
$
|
-
|
129,318,858
|
$
|
1,293,189
|
$
|
243,057,880
|
$
|
(242,206,829
|
)
|
$
|
2,144,240
|
Nine
Months Ended September
30,
|
|||||||
2006
|
2005
|
|
|||||
Cash
Flows from Operating Activities:
|
|||||||
Net
loss
|
$
|
(16,740,705
|
)
|
$
|
(10,974,772
|
)
|
|
Adjustments
to reconcile net loss to cash
|
|||||||
used
in operating activities:
|
|||||||
Stock-based
compensation
|
34,652
|
28,300
|
|||||
Options
issued for consulting services
|
7,666
|
-
|
|||||
Compensation
costs related to restricted stock
|
9,941
|
-
|
|||||
In-process
research and development
|
11,379,348
|
-
|
|||||
Depreciation
and amortization
|
37,945
|
49,497
|
|||||
Changes
in operating assets and liabilities, net of acquisition:
|
|||||||
Other
current assets
|
(496,576
|
)
|
(297,500
|
)
|
|||
Other
assets
|
(529,264
|
)
|
-
|
||||
Accounts
payable and accrued expenses
|
(161,739
|
)
|
(1,316,708
|
)
|
|||
Net
cash used in operating activities
|
(6,458,732
|
)
|
(12,511,183
|
)
|
|||
Cash
Flows from Investing Activities:
|
|||||||
Capital
expenditures
|
-
|
(13,108
|
)
|
||||
Acquisition
costs, net of cash acquired
|
(1,621,929
|
)
|
-
|
||||
Net
cash used in investing activities
|
(1,621,929
|
)
|
(13,108
|
)
|
|||
Cash
Flows from Financing Activities:
|
|||||||
Net
proceeds from issuance of common stock
|
3,806,026
|
9,532,295
|
|||||
Net
cash provided by financing activities
|
3,806,026
|
9,532,295
|
|||||
Net
decrease in cash and cash equivalents
|
(4,274,635
|
)
|
(2,991,996
|
)
|
|||
Cash
and cash equivalents, beginning of period
|
6,582,958
|
11,175,762
|
|||||
Cash
and cash equivalents, end of period
|
$
|
2,308,323
|
$
|
8,183,766
|
|||
Supplemental
disclosure of non-cash investing and financing
|
|||||||
activities:
|
|||||||
Common
stock and other equity consideration issued as
|
|||||||
a
result of the merger
|
$
|
9,035,058
|
$
|
-
|
Nonvested
Shares
|
Shares
|
Weighted
average grant date fair value
|
|||||
|
|||||||
Nonvested
at January 1,
2006
|
— | $ | — | ||||
Granted
|
960,000
|
$
|
0.15
|
||||
Vested
|
—
|
—
|
|||||
Forfeited
|
—
|
—
|
|||||
Nonvested
at September
30, 2006
|
960,000
|
$
|
0.15
|
Three
months ended
|
Nine
months ended
|
||||||
September
30,
|
September
30,
|
||||||
2005
|
2005
|
||||||
Net
loss applicable to common shares, as reported
|
$
|
(2,956,404
|
)
|
$
|
(10,974,772
|
)
|
|
Deduct:
Total stock-based employee and director
compensation expense
determined
under fair value method
|
(231,914
|
)
|
(943,493
|
)
|
|||
Net
loss, pro forma
|
(3,188,318
|
)
|
(11,918,265
|
)
|
|||
Preferred
stock dividends
|
(1,142,016
|
)
|
(3,319,787
|
)
|
|||
Net
loss applicable to common shares, pro forma
|
$
|
(4,330,334
|
)
|
$
|
(15,238,052
|
)
|
|
Net
loss per common share – basic and diluted
|
|||||||
As
reported
|
$
|
(0.07
|
)
|
$
|
(0.25
|
)
|
|
Pro
forma
|
$
|
(0.07
|
)
|
$
|
(0.26
|
)
|
Three
months ended
|
Nine
months ended
|
||||||||||||
September
30,
|
September
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Expected
volatility
|
139
|
%
|
150
|
%
|
139
|
%
|
150
|
%
|
|||||
Dividend
yield
|
—
|
—
|
—
|
—
|
|||||||||
Expected
term (in years)
|
6.11
|
5
|
6.11
|
5
|
|||||||||
Risk-free
interest rate
|
4.50
|
%
|
3.40
|
%
|
4.50
|
%
|
3.40
|
%
|
Shares
|
Weighted
average exercise price
|
Weighted
Average Remaining Contractual Term (years)
|
Aggregate
Intrinsic Value
|
||||||||||
Outstanding
at December
31, 2005
|
6,486,665
|
$
|
2.12
|
||||||||||
Granted/assumed
|
3,336,800
|
0.16
|
|||||||||||
Exercised
|
—
|
—
|
|||||||||||
Cancelled
|
(193,387
|
)
|
4.20
|
||||||||||
Outstanding
at September
30, 2006
|
9,630,078
|
$
|
1.40
|
6.27
|
$
|
105,304
|
|||||||
Options
exercisable at September
30, 2006
|
8,092,800
|
$
|
1.64
|
5.78
|
$
|
53,989
|
|||||||
Weighted-average
fair
value of options granted
during the nine
months ended September 30, 3006
|
$
|
0.14 |
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.
|
Assets
purchased:
|
||||
Cash
|
$
|
5,314
|
||
Prepaid
expenses and other current assets
|
25,839
|
|||
Property
and equipment
|
4,462
|
|||
Other
assets
|
2,490
|
|||
Acquired
in-process research and development
|
11,379,348
|
|||
Total
|
11,417,453
|
Liabilities
assumed:
|
||||
Accounts
payable and accrued expenses
|
623,467
|
|||
Net
purchase price
|
$
|
10,793,986
|
||
Common
stock and other equity consideration issued
|
9,035,058
|
|||
Acquisition costs
incurred
|
$
|
1,758,928
|
Three
months ended
|
Nine
months
ended
|
||||||||||||
September
30,
|
September
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Net
loss
|
$
|
(2,696,848
|
)
|
$
|
(3,299,415
|
)
|
$
|
(6,417,150
|
)
|
$
|
(23,667,550
|
)
|
|
Weighted
average number of common shares outstanding
|
121,701,416
|
108,888,125
|
116,136,960
|
108,410,208
|
|||||||||
Loss
per common share - basic and fully diluted
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.06
|
)
|
$
|
(0.22
|
)
|
ITEM 2. |
Management's
Discussion and Analysis of Financial Condition and
Results of
Operations.
|
· |
ALT-2074,
formerly HaptoGuard’s licensed lead compound BXT-51072, is a glutathione
peroxidase mimetic in clinical development for reducing the morbidity
and
mortality of patients with diabetes following a myocardial infarction.
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 was slowed in the current quarter
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 diastolic
heart failure (“DHF”). The most recent data on alagebrium from one Phase 2
clinical study presented 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 this study, 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 |
We 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 first quarter of 2007.
|
o |
Additionally, we
have 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 our 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 we are allowed to initiate the
study at our discretion.
|
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.
|
ITEM 2. |
Management's
Discussion and Analysis of Financial Condition and
Results of Operations –
Continued.
|
ITEM 2. |
Management's
Discussion and Analysis of Financial Condition and
Results of Operations –
Continued.
|
· |
delay,
reduce the scope of or eliminate one or more of our development programs;
|
· |
obtain
funds through arrangements with collaboration partners or others
that may
require us to relinquish rights to some or all of our technologies,
product candidates or products that we would otherwise seek to develop
or
commercialize ourselves;
|
· |
license
rights to technologies, product candidates or products on terms that
are
less favorable to us than might otherwise be available;
|
· |
seek
a buyer for all or a portion of our business; or
|
· |
wind
down our operations and liquidate our assets on terms that are unfavorable
to us.
|
· |
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 recruitment or 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
|
· |
regulatory
changes.
|
· |
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.
|
· |
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.
|
· |
restrictions
on the products, manufacturers or manufacturing
processes;
|
· |
warning
letters;
|
· |
civil
or criminal penalties;
|
· |
fines;
|
· |
injunctions;
|
· |
product
seizures or detentions;
|
· |
import
bans;
|
· |
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.
|
· |
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 cGMP, as required for FDA
approval of our product candidates, or fail to document their adherence
to
cGMP, 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.
|
· |
attract
and retain skilled scientific and research personnel;
|
· |
develop
technologically superior products;
|
· |
develop
competitively priced products;
|
· |
obtain
patent or other required regulatory approvals for our products;
|
· |
be
early entrants to the market; and
|
· |
manufacture,
market and sell our products, independently or through
collaborations.
|
· |
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.
|
· |
the
ability of the combined company to obtain financing to fund its continued
operations;
|
· |
retention
of scientific staff;
|
· |
significant
litigation, if any, adverse to Alteon and HaptoGuard, including,
particularly, product liability litigation and patent and trademark
litigation;
|
· |
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.
|
· |
severance
payments;
|
· |
conversion
of information systems;
|
· |
combining
research, development, regulatory, manufacturing and commercial teams
and
processes;
|
· |
reorganization
of facilities; and
|
· |
relocation
or disposition of excess equipment.
|
· |
quarterly
fluctuations in results of operations;
|
· |
material
weaknesses in our internal control over financial
reporting;
|
· |
the
announcement of new products or services by us 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;
|
· |
negative
publicity;
|
· |
loss
of key personnel;
|
· |
developments
concerning proprietary rights, including patents and litigation matters;
and
|
· |
clinical
trial or regulatory developments in both the United States and foreign
countries.
|
Date: November 14, 2006 | ||
ALTEON INC. | ||
|
|
|
By: | /s/ Noah Berkowitz, M.D., Ph.D. | |
Noah
Berkowitz, M.D., Ph.D.
|
||
President
and
Chief Executive Officer
(principal executive
officer)
|
|
|
|
By: | /s/ Nicholas J. Rossettos, CPA | |
Nicholas J. Rossettos, CPA |
||
(acting principal financial and accounting officer) |
Exhibit
|
|
No.
|
Description
of Exhibit
|
31.1
|
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
31.2
|
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
32.1
|
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|