e10vq
Table of Contents

SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
     
þ   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2005
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 þ No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes þ No o
On August 4, 2005, 57,996,711 shares of the registrant’s Common Stock were outstanding.
Page 1 of 27 pages
The Exhibit Index is on page 27
 
 

 


ALTEON INC.
INDEX
             
        Page
PART I — FINANCIAL INFORMATION        
 
           
  Condensed Financial Statements (Unaudited)        
 
           
 
  Condensed Balance Sheets as of June 30, 2005 and December 31, 2004     3  
 
           
 
  Condensed Statements of Operations for the three and six months ended June 30, 2005 and 2004     4  
 
           
 
  Condensed Statements of Cash Flows for the six months ended June 30, 2005 and 2004     5  
 
           
 
  Notes to Condensed Financial Statements     6  
 
           
  Management’s Discussion and Analysis of Financial Condition and Results of Operations     9  
 
           
  Qualitative and Quantitative Disclosures about Market Risk     22  
 
           
  Controls and Procedures     23  
 
           
PART II — OTHER INFORMATION        
 
           
  Submission of Matters to a Vote of Security-holders      25  
 
           
  Exhibits     25  
 
           
SIGNATURES     26  
 
           
INDEX TO EXHIBITS     27  
 AMENDED CERTIFICATE OF THE VOTING POWERS
 FORM OF EMPLOYEE'S STOCK OPTION GRANT AGREEMENT
 FORM OF DIRECTOR'S FORMULA AWARD NON-QUALIFIED STOCK OPTION GRANT AGREEMENT
 FORM OF CONSULTANT'S NON-QUALIFIED STOCK OPTION GRANT AGREEMENT
 CERTIFICATION PURSUANT TO SECTION 302
 CERTIFICATION PURSUANT TO SECTION 302
 CERTIFICATION PURSUANT TO SECTION 906

2


Table of Contents

PART I — FINANCIAL INFORMATION
ITEM l. Condensed Financial Statements (Unaudited)
ALTEON INC.
CONDENSED BALANCE SHEETS
(Unaudited)
                 
    June 30,   December 31,
    2005   2004
ASSETS
               
 
               
Current Assets:
               
 
               
Cash and cash equivalents
  $ 11,595,808     $ 11,175,762  
Other current assets
    717,437       159,364  
 
               
 
               
Total current assets
    12,313,245       11,335,126  
 
               
Property and equipment, net
    74,595       107,269  
Restricted cash
    200,000       200,000  
 
               
 
               
Total assets
  $ 12,587,840     $ 11,642,395  
 
               
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
 
               
Current Liabilities:
               
 
               
Accounts payable
  $ 761,304     $ 593,094  
Accrued expenses
    1,246,116       2,002,381  
 
               
 
               
Total liabilities
    2,007,420       2,595,475  
 
               
 
Stockholders’ Equity:
               
 
               
Preferred Stock, $0.01 par value, 1,993,329 shares authorized, and 1,332 and 1,277 shares of Series G and 3,999 and 3,836 shares of Series H issued and outstanding, as of June 30, 2005 and December 31, 2004, respectively. The liquidation value at June 30, 2005, was $53,305,339
    53       51  
 
               
Common Stock, $0.01 par value, 300,000,000 shares and 175,000,000 shares authorized, as of June 30, 2005 and December 31, 2004, respectively, and 57,996,711 and 48,472,898 shares issued and outstanding, as of June 30, 2005 and December 31, 2004, respectively
    579,967       484,729  
 
               
Additional paid-in capital
    225,909,189       214,274,790  
 
               
Accumulated deficit
    (215,908,789 )     (205,712,650 )
 
               
 
               
Total stockholders’ equity
    10,580,420       9,046,920  
 
               
 
               
Total liabilities and stockholders’ equity
  $ 12,587,840     $ 11,642,395  
 
               
The accompanying notes are an integral part of these unaudited financial statements.

3


Table of Contents

ALTEON INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
                                 
    Three Months   Six Months
    Ended June 30,   Ended June 30,
    2005   2004   2005   2004
Income:
                               
 
                               
Investment income
  $ 100,405     $ 29,051     $ 199,554     $ 66,417  
Other income
    100,000       100,000       100,000       151,821  
 
                               
 
                               
Total income
    200,405       129,051       299,554       218,238  
 
                               
 
                               
Expenses:
                               
 
                               
Research and development
    2,493,379       2,445,563       6,134,479       5,129,698  
General and administrative
    1,083,095       1,185,290       2,183,443       2,325,335  
 
                               
 
                               
Total expenses
    3,576,474       3,630,853       8,317,922       7,455,033  
 
                               
 
                               
Net loss
    (3,376,069 )     (3,501,802 )     (8,018,368 )     (7,236,795 )
 
                               
Preferred stock dividends
    1,106,193       1,016,957       2,177,771       2,012,810  
 
                               
 
                               
Net loss applicable to common stockholders
  $ (4,482,262 )   $ (4,518,759 )   $ (10,196,139 )   $ (9,249,605 )
 
                               
 
                               
Basic/diluted net loss per share applicable to common stockholders
  $ (0.08 )   $ (0.11 )   $ (0.18 )   $ (0.23 )
 
                               
 
                               
Weighted average common shares used in computing basic/diluted net loss per share
    57,996,711       40,472,898       57,275,874       40,472,123  
 
                               
The accompanying notes are an integral part of these unaudited financial statements.

4


Table of Contents

ALTEON INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
                 
    Six Months
    Ended June 30,
    2005   2004
Cash flows from operating activities:
               
Net loss
  $ (8,018,368 )   $ (7,236,795 )
 
               
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    33,434       37,949  
Stock compensation expense
    19,573       9,099  
 
               
Changes in operating assets and liabilities:
               
Other current assets
    (558,073 )     (418,943 )
Accounts payable and accrued expenses
    (588,055 )     572,986  
 
               
 
               
Net cash used in operating activities
    (9,111,489 )     (7,035,704 )
 
               
 
               
Cash flows from investing activities:
               
Capital expenditures
    (760 )     (78,491 )
 
               
 
               
Net cash used in investing activities
    (760 )     (78,491 )
 
               
 
Cash flows from financing activities:
               
Net proceeds from issuance of common stock
    9,532,295        
Net proceeds from exercise of employee stock options
          5,085  
 
               
 
               
Net cash provided by financing activities
    9,532,295       5,085  
 
               
 
               
Net increase/(decrease) in cash and cash equivalents
    420,046       (7,109,110 )
Cash and cash equivalents, beginning of period
    11,175,762       16,678,582  
 
               
 
               
Cash and cash equivalents, end of period
  $ 11,595,808     $ 9,569,472  
 
               
The accompanying notes are an integral part of these unaudited financial statements.

5


Table of Contents

ALTEON INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note 1 — Basis of Presentation
          The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments (consisting of only normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2005, are not necessarily indicative of the results that may be expected for the year ending December 31, 2005. 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, 2004, 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 $215,908,789 as of June 30, 2005, and expects to incur net losses, potentially greater than losses in prior years, for a number of years.
          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 our 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, 2005, the Company had working capital of $10,305,825, including $11,595,808 of cash and cash equivalents. In January 2005, the Company completed the sale of 9,523,813 shares of common stock, which provided net proceeds of $9,532,295 (see Note 5). The Company’s net cash used in operating activities for the six months ended June 30, 2005 was $9,111,489 and for the year ended December 31, 2004 was $13,109,869.
          The Company expects to utilize cash and cash equivalents to fund its operating activities, including the continued development of our lead compound, alagebrium. As a result of the discontinuation of the SPECTRA trial, Alteon expects to have reduced expenses in the second half of 2005. The Company will actively continue to pursue fund-raising possibilities through the sale of its equity securities and through potential partnerships. If the Company is unsuccessful in its efforts to raise additional funds through the sale of additional equity securities or through potential partnerships or if the level of cash and cash equivalents falls below anticipated levels, Alteon will be required to significantly reduce or curtail its research and product development activities and other operations. The Company has the ability to quickly and significantly reduce its cash burn rate, if necessary, as it has limited fixed commitments. The Company expects to have sufficient cash and cash equivalents to satisfy its working capital requirements at least into the second half of 2006, either by future fund-raising or, if needed, curtailment actions.
          The amount and timing of the Company’s future capital requirements will depend on numerous factors, including the progress of its research and development programs, 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 development of marketing and sales capabilities, the ability to complete strategic collaborations and the availability of third-party funding, if any.
          The Company will require substantial new funding to pursue development and commercialization of alagebrium and its other product candidates and to continue its operations. Alteon believes that satisfying these capital requirements over the long term will require successful commercialization of its product candidates, particularly alagebrium. However, it is uncertain whether any products will be approved or will be commercially successful.
          Selling securities to satisfy the Company’s short-term and long-term capital requirements may have the effect of materially diluting the current holders of its outstanding stock. Alteon may also seek additional funding through corporate collaborations and other financing vehicles. There can be no assurance that such funding will be available at all or on terms acceptable to the Company. Potential financing sources for Alteon may be dissuaded from investing in Alteon in light of the fact that Genentech, Inc., as holder of outstanding shares of our Series G and Series H Preferred Stock, currently has a significant liquidation preference and voting position, on an as-converted to

6


Table of Contents

common stock basis, in Alteon. If adequate funds are not available, the Company may be required to curtail significantly one or more of its research and development programs. If funds are obtained through arrangements with collaborative partners or others, the Company may be required to relinquish rights to certain of its technologies or product candidates. If Alteon is unable to obtain the necessary funding, it may need to cease operations.
Note 3 — Stock-Based Compensation
          The Company accounts for employee stock-based compensation and awards issued to non-employee directors using the intrinsic value method under Accounting Principles Board, or 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. Stock option awards issued to consultants and contractors are accounted for in accordance with Statement of Financial Accounting Standards, or SFAS, No. 123, “Accounting for Stock-Based Compensation,” 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.” In March 2000, the Financial Accounting Standards Board, or the FASB, released Interpretation No. 44, or FIN No. 44, “Accounting for Certain Transactions Involving Stock Compensation, an Interpretation of APB Opinion No. 25.” The interpretation became effective on July 1, 2000, but in some circumstances applies to transactions that occurred prior to the effective date. Under the interpretation, stock options that are repriced must be accounted for as variable-plan arrangements until the options are exercised, forfeited or expire. This requirement applies to any options repriced after December 15, 1998.
          On February 2, 1999, the Company repriced certain stock options. There was no non-cash stock compensation expense resulting from the 1999 repricing for the three and six months ended June 30, 2005 and 2004, respectively. As of June 30, 2005, there were 388,759 repriced options outstanding, which expire on various dates through January 2008.
          If the Company had applied the fair value recognition provisions of SFAS No. 123 to its employee and director option grants, the Company’s pro forma net loss and net loss per share applicable to common stockholders for the three and six months ended June 30, 2005 and 2004, would be as follows:
                                 
    Three Months Ended June 30,   Six Months Ended June 30,
    2005   2004   2005   2004
Net loss, as reported
  $ (3,376,069 )   $ (3,501,802 )   $ (8,018,368 )   $ (7,236,795 )
 
                               
Less: Total stock-based employee and director compensation expense determined under fair value method
    (269,437 )     (355,588 )     (711,579 )     (728,645 )
 
                               
Pro forma net loss
    (3,645,506 )     (3,857,390 )     (8,729,947 )     (7,965,440 )
Preferred stock dividends
    1,106,193       1,016,957       2,177,771       2,012,810  
 
                               
Pro forma net loss applicable to common stockholders
  $ (4,751,699 )   $ (4,874,347 )   $ (10,907,718 )   $ (9,978,250 )
 
                               
 
                               
Earnings per share applicable to common stockholders:
                               
Basic/diluted, as reported
  $ (0.08 )   $ (0.11 )   $ (0.18 )   $ (0.23 )
Basic/diluted, pro forma
  $ (0.08 )   $ (0.12 )   $ (0.19 )   $ (0.25 )
          In December 2004, the FASB issued SFAS No. 123 (revised 2004) (“SFAS 123(R)”), “Share-Based Payment,” which is a revision of SFAS 123 and supersedes APB 25 and its related implementation guidance. Generally, the approach in SFAS 123(R) is similar to the approach described in SFAS 123. However, SFAS 123(R) requires all share-based payments to employees, including grants of employee stock options, to be recognized in the income statement based on their fair values at the date of grant. As a result of the issuance of SFAS No. 123(R), the Company will be required to expense the fair value of employee stock options over the service period, beginning no later than with its fiscal quarter ending March 31, 2006.
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

7


Table of Contents

the conversion of preferred stock would be antidilutive. The amount of potentially dilutive securities excluded from the calculation as of June 30, 2005 and 2004, was 158,194,608 and 47,456,373 shares, respectively.
Note 5 — Stockholders’ Equity
          In January 2005, Alteon completed a public offering of 9,523,813 shares of common stock at $1.05 per share, which provided net proceeds of $9,532,295. In connection with this offering, the Company issued to its placement agent in the offering a five-year warrant to purchase 312,381 shares of common stock at $1.37 per share.
          Series G Preferred Stock and Series H Preferred Stock dividends are payable quarterly in shares of preferred stock at a rate of 8.5% of the accumulated balance. Each share of Series G Preferred Stock and Series H Preferred Stock is convertible, upon 70 days’ prior written notice, into the number of shares of common stock determined by dividing $10,000 by the average of the closing sales price of the common stock, as reported on the American Stock Exchange, for the 20 business days immediately preceding the date of conversion. For the three months ended June 30, 2005 and 2004, preferred stock dividends of $1,106,193 and $1,016,957, respectively, were recorded. On June 30, 2005, the Series G and Series H Preferred Stock would have been convertible into 37,457,665 common stock shares and 112,487,201 common stock shares, respectively, and had a total liquidation value of $53,305,339. The Series G and Series H Preferred Stock have no voting rights.

8


Table of Contents

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 discovery and development of small molecule drugs to reverse or slow down diseases of aging and complications of diabetes. Our product portfolio represents novel approaches to large pharmaceutical markets. Our lead compound, alagebrium (formerly ALT-711), is in Phase 2 clinical development for erectile dysfunction and heart failure and is being evaluated for other indications in a number of preclinical studies. We have identified several other promising drug candidates for future development; none of these other candidates is currently in active clinical development. Our pharmaceutical portfolio was developed as a result of our research on the Advanced Glycation End-Product, or A.G.E., pathway, a fundamental pathological process and inevitable consequence of aging that causes or contributes to many medical disorders.
          We are developing our lead product candidate, alagebrium, for the treatment of cardiovascular diseases and disorders relating to complications of diabetes. We initiated several Phase 2 studies of alagebrium during 2004 and 2005, three of which remain open, although we are not currently enrolling patients in these studies as described below: PEDESTAL (Patients with Impaired Ejection Fraction and Diastolic Dysfunction: Efficacy and Safety Trial of Alagebrium), a Phase 2a study in heart failure; EMERALD (Efficacy and Safety of Alagebrium in Erectile Dysfunction in Male Diabetics), a Phase 2a study in erectile dysfunction, or ED; and a Phase 2a study in endothelial dysfunction. Enrollment in the PEDESTAL study has been completed and analysis of the data is underway. In June 2005, SPECTRA (Systolic Pressure Efficacy and Safety Trial of Alagebrium), a Phase 2b trial in systolic hypertension, was discontinued after an interim analysis found that the data did not indicate a treatment effect of alagebrium and we have ceased development of alagebrium for this indication.
          Of the approximately 1,300 patients who have participated in the Phase 1 and Phase 2 clinical studies of alagebrium to date, approximately 1,000 patients have received alagebrium and approximately 300 patients have received placebo. The compound has demonstrated an excellent safety profile in all human clinical testing to date.
          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 patients into each of the ongoing clinical studies pending receipt of additional pre-clinical data. In May 2005, we reported encouraging interim results from these ongoing preclinical toxicity tests of alagebrium. The set of core experiments completed to date suggests that the liver alterations previously seen in rats were not caused by genotoxicity or epigenetic pathways, but rather were likely to be a result of the male rat’s own natural propensity to develop liver abnormalities. Since our investigational new drug applications, or INDs, for alagebrium are under the oversight of two divisions of the U.S. Food and Drug Administration, or FDA, the Cardio-Renal Division and the Reproductive and Urologic Division, we simultaneously submitted the preliminary conclusions from the preclinical toxicity data on alagebrium to both divisions. The Company’s clinical protocols under the oversight of the Cardio-Renal Division were allowed to proceed. However, the EMERALD study in ED was placed on clinical hold by the Reproductive and Urologic Division pending the satisfactory completion of our preclinical testing. We are in the process of finalizing this data and submitting it to the FDA. We intend to review all relevant findings with the appropriate oversight entities, including our Investigational Review Boards, or IRBs, and the FDA, and hope to resolve this issue within the next several months.
          Our current priorities are to continue the clinical development of alagebrium in ED and heart failure, and to ensure that we have the funding and personnel necessary to accomplish this objective. We are actively exploring a spectrum of strategic options to secure funding and other support for the continuation of our programs. Such strategic options include debt and equity financing, research and development collaborations, out-licensing of our technology and development programs or a possible sale of our business to, or merger into, another entity. We have engaged third parties to assist in developing and identifying strategic options for the Company. We cannot predict at this time when enrollment in our EMERALD study will resume, if ever. If we do not resume enrollment in EMERALD we will evaluate moving into different indications and/or returning to our pre-clinical library of compounds to identify new compounds to bring forward for further evaluation. As we continue clinical development of alagebrium, we will continue to evaluate potential transactions to enable the further development and ultimate marketing of the compound in territories throughout the world.
          We continue to evaluate potential pre-clinical and clinical trials in other therapeutic indications in which A.G.E. Crosslink Breaker compounds may address significant unmet needs. In addition to our clinical studies in ED and heart failure, we have early research studies focused on: atherosclerosis; Alzheimer’s disease; eye diseases, including age-related macular degeneration, or AMD, and glaucoma; and diabetic complications, including renal diseases, among others.

9


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
          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 $215,908,789 as of June 30, 2005, 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 continue our clinical studies of alagebrium, including our ability to resume enrollment in our ED study and other studies, (2) our ability to obtain funding, (3) the risks inherent in our research and development efforts, including clinical trials and the length, expense and uncertainty of the process of seeking regulatory approvals for our product candidates, (4) our reliance on alagebrium, which is our only significant drug candidate, (5) uncertainties associated with obtaining and enforcing our patents and with the patent rights of others, (6) uncertainties regarding government healthcare reforms and product pricing and reimbursement levels, (7) technological change and competition, (8) manufacturing uncertainties, and (9) dependence on collaborative partners and other third parties. Even if our product candidates appear promising at an early stage of development, they may not reach the market for numerous reasons. These reasons include the possibilities that the products will prove ineffective or unsafe during pre-clinical or clinical studies, will fail to receive necessary regulatory approvals, will be difficult to manufacture on a large scale, will be uneconomical to market or will be precluded from commercialization by proprietary rights of third parties. These risks and others are discussed under the heading “Forward-Looking Statements and Cautionary Statements.”
Results of Operations
Three Months ended June 30, 2005 and 2004
          Total income for the three months ended June 30, 2005 and 2004, was $200,405 and $129,051, respectively. The income consisted of interest earned on cash and cash equivalents and other income. Investment income for the three months ended June 30, 2005 and 2004 was $100,405 and $29,051, respectively, and was attributed to increased interest rates and slightly higher investment balances. For the three months ended June 30, 2005, other income included $100,000 received from a licensing agreement with Avon Products, Inc. For the three months ended June 30, 2004, other income included a reimbursement of $100,000 for improvements made to our former Ramsey facility.
          Our total expenses were $3,576,474 for the three months ended June 30, 2005, compared to $3,630,853 for the three months ended June 30, 2004, and in each period consisted primarily of research and development expenses. Research and development expenses included 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 $2,493,379 for the three months ended June 30, 2005 as compared to $2,445,563 for the same period in 2004, an increase of $47,816 or 2.0%. The increase was primarily attributed to increased pre-clinical costs due to additional toxicity studies offset by lower manufacturing costs. In 2005, of the total amount spent on research and development expenses, we incurred $941,891 in personnel and personnel-related expenses, $729,861 in clinical trial expenses of which $705,564 related to SPECTRA, $393,930 in pre-clinical expenses, and $169,811 related to manufacturing (packaging and distribution). In 2004, we primarily incurred $967,851 in personnel and personnel-related expenses, $717,005 in clinical trial expenses of which $597,528 related to SPECTRA and $495,127 related to manufacturing (tableting, packaging, process development and drug stability studies).
          General and administrative expenses decreased slightly to $1,083,095 for the three months ended June 30, 2005, as compared to $1,185,290 for the same period in 2004. The decrease is primarily related to lower business development and marketing costs offset by higher accounting and legal fees associated with Sarbanes-Oxley compliance.
          Our net loss applicable to common stockholders remained relatively flat at $4,482,262 for the three months ended June 30, 2005 as compared to $4,518,759 for the three months ended June 30, 2004. Included in the net loss applicable to common stockholders are preferred stock dividends of $1,106,193 and $1,016,957, respectively.

10


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
Six Months Ended June 30, 2005 and 2004
          Total income for the six months ended June 30, 2005 and 2004 was $299,554 and $218,238, respectively. The income consisted of interest earned on cash and cash equivalents and other income. Interest income increased to $199,554 in the six months ended June 30, 2005 as compared to $66,417 in the same period of the prior year due to an increase in short-term interest rates and slightly higher investment balances. In 2005, other income included $100,000 received from a licensing agreement with Avon Products, Inc. In 2004, other income included $51,821 derived from the sale of fully depreciated laboratory equipment and supplies, and a reimbursement of $100,000 for improvements made to our former Ramsey facility.
          Our total expenses were $8,317,922 for the six months ended June 30, 2005 compared to $7,455,033 for the six months ended June 30, 2004, and in each year consisted primarily of research and development expenses. Research and development expenses for the six months ended June 30, 2005 were $6,134,479, an increase of $1,004,781 or 19.6% as compared to the six months ended June 30, 2004. The increase was primarily attributed to increased pre-clinical costs due to additional toxicity studies, increased clinical trial costs and increased personnel and personnel related costs, offset by lower manufacturing costs. In 2005, research and development expenses included $2,079,819 in personnel and personnel related expenses, $2,011,366 in clinical trial expenses of which $1,906,942 related to SPECTRA, $835,097 in pre-clinical expenses primarily related to additional toxicity studies, $453,596 in manufacturing (packaging and on-going stability studies), $249,596 in third-party consulting fees, and $186,705 of facility and other overhead related costs. Research and development for the six months ended June 30, 2004 were $5,129,698, and included $1,789,060 in personnel and personnel related expenses, $1,480,604 in clinical trial expenses of which $1,149,722 related to SPECTRA, $1,028,803 related to manufacturing (tableting and packaging), $274,304 of facility and other overhead related costs and $201,985 in third-party consulting fees.
          General and administrative expenses decreased to $2,183,443 for the six months ended June 30, 2005 as compared to $2,325,335 for the same period in 2004, a decrease of $141,892 or 6.1%. This decrease is primarily attributed to lower business development and marketing costs offset by higher accounting and legal fees associated with Sarbanes-Oxley compliance.
          Our net loss applicable to common stockholders increased to $10,196,139 for the six months ended June 30, 2005 as compared to $9,249,605 for the same period in 2004, an increase of 10.2%, due to increased research and development expenses. Included in the net loss applicable to common stockholders are preferred stock dividends of $2,177,771 and $2,012,810, respectively.
Liquidity and Capital Resources
          We had cash and cash equivalents at June 30, 2005, of $11,595,808, compared to $11,175,762 at December 31, 2004. The increase is attributable to $9,532,295 of net cash provided by financing activities offset by $9,111,489 of net cash used in operating activities, consisting primarily of research and development expenses, personnel-related costs and facility expenses and $760 in capital expenditures. At June 30, 2005, we had working capital of $10,305,825.
          The Company expects to utilize cash and cash equivalents to fund its operating activities, including the continued development of our lead compound, alagebrium. As a result of the discontinuation of the SPECTRA trial, Alteon expects to have reduced expenses in the second half of 2005. The Company will actively continue to pursue fund-raising possibilities through the sale of its equity securities and through potential partnerships. If the Company is unsuccessful in its efforts to raise additional funds through the sale of additional equity securities or through potential partnerships or if the level of cash and cash equivalents falls below anticipated levels, Alteon will be required to significantly reduce or curtail its research and product development activities and other operations. The Company has the ability to quickly and significantly reduce its cash burn rate, if necessary, as it has limited fixed commitments. The Company expects to have sufficient cash and cash equivalents to satisfy its working capital requirements at least into the second half of 2006, either by future fund-raising or, if needed, curtailment actions.
          In January 2005, we completed a public offering of 9,523,813 shares of common stock at $1.05 per share, which provided net proceeds of $9,532,295 (see Note 5).
          In 2004, we sold $3,456,000 of our gross state net operating loss carryforwards and $123,000 of our state research and development tax credit carryforwards under the State of New Jersey’s Technology Business Tax Certificate Transfer Program, referred to as the Program. The Program allows qualified technology and biotechnology businesses in New Jersey to sell unused amounts of net operating loss carryforwards and defined research and development tax credits for cash. Due to the uncertainty at any time as to our ability to effectuate the sale of our available New Jersey state net operating losses, and since we have no control or influence over the Program, the benefits are recorded once the agreement with the counterparty is signed and the sale is approved by the State. The

11


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
proceeds from the sales of these state net loss carryforwards and state research and development tax credit carryforwards in 2004 were $386,000 and were recorded as a tax benefit in the December 31, 2004 statements of operations. As of December 31, 2004, we had state net operating loss carryforwards and state research and development tax credit carryforwards available for sale of $81,730,000. We cannot be certain if we will be able to sell any or all of these carryforwards under the Program.
          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, and may continue to restrict, our ability to raise additional capital on favorable terms.
          The amount and timing of our future capital requirements will depend on numerous factors, including the progress of our research and development programs, the number and characteristics of product candidates that we pursue, 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 development of marketing and sales capabilities, our ability to complete strategic collaborations and the availability of third-party funding.
          Our current priorities are to continue the clinical development of alagebrium in ED and heart failure, and to ensure that we have the funding and personnel necessary to accomplish this objective. We are actively exploring a spectrum of strategic options to secure funding and other support for the continuation of our programs. Such strategic options include debt and equity financing, research and development collaborations, out-licensing of our technology and development programs or a possible sale of our business to, or merger into, another entity. We have engaged third parties to assist in developing and identifying strategic options for us. We cannot predict at this time when enrollment in our EMERALD study will resume, if ever. If we do not resume enrollment in EMERALD we will evaluate moving into different indications and/or returning to our pre-clinical library of compounds to identify new compounds to bring forward for further evaluation. As we continue clinical development of alagebrium, we will continue to evaluate potential transactions to enable the further development and ultimate marketing of the compound in territories throughout the world.
          We will require substantial additional funding to pursue development and commercialization of alagebrium and our other product candidates and to continue our operations. We believe that satisfying these capital requirements over the long term will require successful commercialization of our product candidates, particularly alagebrium. However, it is uncertain whether alagebrium or any product candidate will be approved or will be commercially successful.
          Selling securities to satisfy our short-term and long-term capital requirements may have the effect of materially diluting the current holders of our outstanding stock. We may also seek additional funding through corporate collaborations and other financing vehicles. There can be no assurance that such funding will be available at all or on terms acceptable to us. Potential financing sources for us may be dissuaded from investing in us in light of the fact that Genentech, Inc., as holder of outstanding shares of our Series G and Series H Preferred Stock, currently has a significant liquidation preference and voting position, on an as-converted to common stock basis, in us. If adequate funds are not available, we may be required to curtail significantly one or more of our research and development programs. If we obtain funds through arrangements with collaborative partners or others, we may be required to relinquish rights to certain of our technologies or product candidates. If we are unable to obtain the necessary funding, we may need to cease operations.
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.
          We account for options granted to employees and directors using the intrinsic value method in accordance with APB Opinion No. 25, “Accounting for Stock Issued to Employees,” and related interpretations. As such, compensation expense is recorded on fixed stock grants only if the current fair value of the underlying stock exceeds the exercise price of the option at the date of grant and it is recognized on a straight-line basis over the vesting period. Based on the

12


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
performance of our stock, we repriced certain employee stock options on February 2, 1999. As a result of this repricing, options to purchase 1.06 million shares of stock were repriced and certain vesting periods related to these options were modified or extended. FIN No. 44, “Accounting for Certain Transactions Involving Stock Compensation, an Interpretation of APB Opinion No. 25” requires us to record compensation expense or benefit, which is adjusted every quarter, for increases or decreases in the fair value of the repriced options based on changes in our stock price from the value at July 1, 2000, until adoption of newly issued accounting rules no later than with our fiscal quarter ending March 31, 2006, as described below. As a result, net loss applicable to common stockholders and net loss per share applicable to common stockholders may be subject to volatility. Had we accounted for repricing of stock option grants in accordance with SFAS No. 123, “Accounting for Stock-Based Compensation,” the expense related to the vested options would have been recorded at the repricing date, and the expense related to non-vested options would have been recorded over the vesting period.
          In December 2004, the FASB issued SFAS No. 123 (revised 2004), “Share-Based Payment,” or SFAS No. 123(R), which replaces FASB Statement No. 123 and will be effective for us beginning no later than with our fiscal quarter ending March 31, 2006. This Statement requires that the costs of employee share-based payments be measured at fair value on the awards’ grant date using an option-pricing model and recognized in the financial statements over the requisite service period.
          SFAS No. 123(R) allows for two alternative transition methods. The first method is the modified prospective application whereby compensation cost for the portion of awards for which the requisite service has not yet been rendered that are outstanding as of the adoption date will be recognized over the remaining service period. The compensation cost for that portion of awards will be based on the grant date fair value of those awards as calculated for pro forma disclosures under SFAS No. 123, as originally issued. All new awards and awards that are modified, repurchased or cancelled after the option date will be accounted for under the provisions of SFAS No. 123(R). The second method is the modified retrospective application, which requires that we restate prior period financial statements. We are currently determining which transition method we will adopt and are evaluating the impact SFAS No. 123(R) will have on our financial position and results of operations. However, we believe it may have a material effect on our results of operations.
Forward-Looking Statements and Cautionary Statements
          Statements in this Form 10-Q that are not statements or descriptions of historical facts are “forward-looking” statements under Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and are subject to numerous risks and uncertainties. These forward-looking statements and other forward-looking statements made by us or our representatives are based on a number of assumptions. The words “believe,” “expect,” “anticipate,” “intend,” “estimate” or other expressions, which are predictions of or indicate future events and trends and which do not relate to historical matters, identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, as they involve risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in this section and elsewhere in this Form 10-Q. These factors include, but are not limited to, the risks set forth below.
          The forward-looking statements represent our judgments and expectations as of the date of this Report. We assume no obligation to update any such forward-looking statements.
If we do not obtain sufficient additional funding to meet our needs, we may have to curtail or discontinue the research, product development, pre-clinical testing and clinical trials of some or all of our product candidates.
          As of June 30, 2005, we had working capital of $10,305,825, including $11,595,808 of cash and cash equivalents. Our net cash used in operating activities for the six months ended June 30, 2005 was $9,111,489.
          We initiated several Phase 2 studies of alagebrium, our lead product candidate, during 2004 and 2005, three of which remain open, although we are not currently enrolling patients in these studies: SPECTRA (Systolic Pressure Efficacy and Safety Trial of Alagebrium), a Phase 2b trial in systolic hypertension; PEDESTAL (Patients with Impaired Ejection Fraction and Diastolic Dysfunction: Efficacy and Safety Trial of Alagebrium) a Phase 2a study in heart failure; EMERALD (Efficacy and Safety of Alagebrium in Erectile Dysfunction in Male Diabetics) a Phase 2a study in ED; and a Phase 2a study in endothelial dysfunction. In June 2005, SPECTRA 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. Also in June 2005, the EMERALD trial was placed on clinical hold by the Reproductive and Urologic Division of the FDA pending the satisfactory completion of certain preclinical toxicity testing. We are in the process of finalizing this data and submitting it to the FDA. Our current priorities are to continue the clinical development of alagebrium in ED and heart failure, and ensure that we have the funding and personnel necessary to accomplish this objective. We are actively exploring a spectrum of strategic options to enable

13


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
us to secure funding for our programs. We cannot predict at this time if these efforts will be successful or when enrollment in our EMERALD clinical study, or any other clinical study, will resume, if ever.
          We expect to utilize cash and cash equivalents to fund our operating activities, including the ongoing Phase 2 studies. In January 2005, we completed a sale of common stock that provided net proceeds of approximately $9.5 million. We will actively continue to pursue fund-raising possibilities through the sale of our equity securities. If we are unsuccessful in our efforts to raise additional funds through the sale of additional equity securities or corporate collaborations, or if our level of cash and cash equivalents falls below anticipated levels, we will be required to significantly reduce or curtail our research and product development activities, including the number of patients enrolled in our studies and other operations. We have the ability to quickly and significantly reduce the cash burn rate, if necessary, as we have limited fixed commitments. We expect to have sufficient cash and cash equivalents to satisfy our working capital requirements at least into the second half of 2006, either by future fund-raising or, if needed, curtailment actions.
          The amount and timing of our future capital requirements will depend on numerous factors, including the progress of our research and development programs, the number and characteristics of product candidates that we pursue, 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 development of marketing and sales capabilities, our ability to complete strategic collaborations and the availability of third-party funding.
          We will require, over the long term, substantial new funding to pursue development and commercialization of alagebrium and our other product candidates and to continue our operations. We believe that satisfying these capital requirements over the long term will require successful commercialization of our product candidates, particularly alagebrium. However, it is uncertain whether any products will be approved or will be commercially successful.
          Selling securities to satisfy our short-term and long-term capital requirements may have the effect of materially diluting the current holders of our outstanding stock. We may also seek additional funding through corporate collaborations and other financing vehicles. There can be no assurance that such funding will be available at all or on terms acceptable to us. If adequate funds are not available, we may be required to curtail significantly one or more of our research and development programs. If we obtain funds through arrangements with collaborative partners or others, we may be required to relinquish rights to certain of our technologies or product candidates. If we are unable to obtain the necessary funding, we may need to cease operations.
If we are unable to renegotiate our preferred stock agreement with Genentech, we may not be able to secure future equity financing or be acquired by a third party.
          In December 1997, we entered into an agreement with Genentech relating to the development of pimagedine, an A.G.E. formation inhibitor, for the treatment of diabetic nephropathy. As part of this agreement, Genentech purchased shares of Alteon Series G Preferred Stock and Series H Preferred Stock, the proceeds of which were used to fund the pimagedine development program. Both the Series G Preferred Stock and Series H Preferred Stock have dividends which are payable quarterly in shares of preferred stock at a rate of 8.5% of the accumulated balance. The Series G and Series H Preferred Stock each carry a liquidation preference, which means that the value of that preferred stock would be required to be paid to the holders of the Series G and Series H Preferred Stock upon a sale or liquidation of Alteon before any proceeds from such sale or liquidation are paid to any other holders of equity securities, including the common stock. As of June 30, 2005, holders of the outstanding shares of Series G and Series H Preferred Stock, including shares issued pursuant to the dividend obligation, were entitled to a liquidation preference of $53,305,339. The total market capitalization of Alteon as of that date was $12,759,276. As a result, unless we are successful in renegotiating our preferred stock terms with Genentech, holders of our common stock will not realize any value on the sale or liquidation of Alteon at a valuation of less than $53,305,339. The Series G and Series H Preferred Stock have no voting rights. Each share of Series G Preferred Stock and Series H Preferred Stock is convertible, upon 70 days’ prior written notice, into the number of shares of common stock determined by dividing $10,000 by the average of the closing prices of the Alteon common stock, as reported on the American Stock Exchange, for the 20 business days immediately preceding the date of conversion. On June 30, 2005, the Series G and Series H Preferred Stock would have been convertible into 37,457,665 and 112,487,201 shares of common stock, respectively, representing, in aggregate, approximately 72% of our common stock outstanding on an as-converted basis as of that date.
          While the terms of the Series G and Series H Preferred Stock generally restrict Genentech’s ownership position in Alteon upon conversion to 40% of the outstanding Alteon common stock, any conversion of shares of Series G and/or Series H Preferred Stock into Alteon common stock would represent a substantial dilution to existing common shareholders. Potential financing sources for Alteon may be dissuaded from investing in Alteon in light of the presence of a significant holder of securities having a sizable liquidation preference and/or voting position in Alteon. This could also discourage any potential acquirer of Alteon from pursuing a transaction with us at a valuation that does not result in sufficient proceeds to pay the full liquidation preference due to Genentech.

14


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
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. The loss of services in the near term of any of these personnel 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. 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 pre-clinical and clinical studies that the product is safe and effective for use in each target indication. Success in pre-clinical 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 patients into each of the ongoing clinical studies pending receipt of additional pre-clinical data. In May 2005, we reported encouraging interim results from these ongoing preclinical toxicity tests of alagebrium. The set of core experiments completed to date suggests that the liver alterations previously seen in rats were not caused by genotoxicity or epigenetic pathways, but rather were likely to be a result of the male rat’s own natural propensity to develop liver abnormalities. Since our INDs for alagebrium are under the oversight of two divisions of the FDA, the Cardio-Renal Division and the Reproductive and Urologic Division, we simultaneously submitted the preliminary conclusions from the preclinical toxicity data on alagebrium to both divisions. The Company’s clinical protocols under the oversight of the Cardio-Renal Division were allowed to proceed. However, the EMERALD study in ED was placed on clinical hold by the Reproductive and Urologic Division pending the satisfactory completion of our preclinical testing. We are in the process of finalizing this data and submitting it to the FDA. We intend to review all relevant findings with the appropriate oversight entities, including our IRBs and the FDA, and hope to resolve this issue within the next several months.
          In June 2005, the 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 our EMERALD clinical study or any other clinical study, 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.
          Before a clinical trial may commence in the United States, we must submit an IND, containing pre-clinical 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 pre-clinical or clinical study results may indicate that the product candidate is not safe or effective;
 
    the FDA may interpret our pre-clinical 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.

15


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
          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 to treat 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 patients to clinical sites, the eligibility criteria for the study, competition with clinical trials for other drug candidates or other factors;
 
    adverse results in pre-clinical safety or toxicity studies;
 
    lower than expected retention rates of patients 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 patients;
 
    lack of effectiveness of the product candidate being tested; and
 
    regulatory changes.
          Even if we obtain positive results from pre-clinical or clinical studies for a particular product, we may not achieve the same success in future studies of that product. Data obtained from pre-clinical 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, or NDA. 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 pre-clinical 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.
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 interest 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, 2005, we had an accumulated deficit of $215,908,789. 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, pre-clinical 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 active 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 pre-clinical 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.

16


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
          In June 2005, SPECTRA (Systolic Pressure Efficacy and Safety Trial of Alagebrium), a Phase 2b trial in systolic hypertension, was discontinued after an interim analysis found that the data did not indicate a treatment effect of alagebrium and we have ceased development of alagebrium for this indication.
          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 patients into each of the ongoing clinical studies pending receipt of additional pre-clinical data. In May 2005, we reported encouraging interim results from these ongoing preclinical toxicity tests of alagebrium. The set of core experiments completed to date suggests that the liver alterations previously seen in rats were not caused by genotoxicity or epigenetic pathways, but rather were likely to be a result of the male rat’s own natural propensity to develop liver abnormalities. Since our INDs for alagebrium are under the oversight of two divisions of the FDA, the Cardio-Renal Division and the Reproductive and Urologic Division, we simultaneously submitted the preliminary conclusions from the preclinical toxicity data on alagebrium to both divisions. The Company’s clinical protocols under the oversight of the Cardio-Renal Division were allowed to proceed. However, the EMERALD study in ED was placed on clinical hold by the Reproductive and Urologic Division pending the satisfactory completion of our preclinical testing. We are in the process of finalizing this data and submitting it to the FDA. We intend to review all relevant findings with the appropriate oversight entities, including our IRBs and the FDA, and hope to resolve this issue within the next several months.
          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 pre-clinical and clinical testing prior to potential regulatory approval and commercialization. The development of new pharmaceutical products is highly uncertain 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 pre-clinical 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 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.
If we are unable to form the 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. We intend to enter into these arrangements, especially in target indications in which our potential collaborator has particular therapeutic expertise or that involve a market that must be served by large sales and marketing organizations. The potential market, pre-clinical and clinical study results and safety profile of our product candidates may not be attractive to potential corporate partners. As noted above, a recent preliminary report of 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, as noted above, the EMERALD trial in erectile dysfunction was placed on clinical hold by the Reproductive and Urologic Division of the FDA pending the satisfactory completion of our preclinical testing. We are in the process of finalizing this data and submitting it to the FDA. Such results could 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 its development program or one or more of our other development programs, delay its 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.

17


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
Failure to remediate the material weaknesses in our internal controls and to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price.
          During the preparation of this Form 10-Q for the quarter ended June 30, 2005, our independent registered public accounting firm identified a material weakness, as of June 30, 2005, in the review process for the financial statement recording and disclosures of stock options that we have granted to non-employee consultants in accordance with Emerging Issues Task Force (“EITF”) 96-18. As defined by the Public Company Accounting Oversight Board Auditing Standard No. 2, a material weakness is a significant control deficiency or a combination of significant control deficiencies, that results in there being more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected. This material weakness did not result in the restatement of any previously reported financial statements or any other related financial disclosure. Stock options that we had granted to non-employee consultants should have been accounted for under variable accounting and we have corrected the accounting for these stock options as of the second quarter of 2005. The changes that would have resulted in the financial statements for the first quarter of 2005 were deemed immaterial. We have instituted additional procedures in the review process for the financial statement recording and disclosures of options in order to remediate this issue.
          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, Alteon 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 either has implemented, or is in the process of implementing, remedial measures or procedures to address these matters. However, we cannot currently assure you 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 pre-clinical 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 pre-clinical 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 pre-clinical 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;

18


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
    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;
 
    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.

19


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
If we cannot successfully develop a marketing and sales force or maintain suitable arrangements with third parties to market and sell our products, our ability to deliver products to the market may be impaired.
          We currently have no experience in marketing or selling pharmaceutical products. In order to achieve commercial success for any approved product, we must either develop a marketing and sales force ourselves, or, where appropriate and permissible, enter into arrangements with third parties to market and sell our products. We might not be successful in developing marketing and sales capabilities. Further, we may not be able to enter into marketing and sales agreements with others on acceptable terms, and any such arrangements, if entered into, may be terminated. If we develop our own marketing and sales capability, we will compete with other companies that currently have experienced, well funded and larger marketing and sales operations. To the extent that we enter into co-promotion or other sales and marketing arrangements with other companies, our revenues will depend on the efforts of others, which may not be successful.
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 are dependent on contract manufacturers for the production of 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 current dependence upon others for the manufacture of our products may adversely affect our profit margin, if any, on the sale of future products and our ability to develop and deliver such products on a timely and competitive basis.

20


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
If we are not able to protect the proprietary rights that are critical to our success, the development and any possible sales of our product candidates could suffer and competitors could force our products completely out of the market.
          Our success will depend on our ability to obtain patent protection for our products, preserve our trade secrets, prevent third parties from infringing upon our proprietary rights and operate without infringing upon the proprietary rights of others, both in the United States and abroad.
          The degree of patent protection afforded to pharmaceutical inventions is uncertain and our potential products are subject to this uncertainty. Competitors may develop competitive products outside the protection that may be afforded by the claims of our patents. We are aware that other parties have been issued patents and have filed patent applications in the United States and foreign countries with respect to other agents that have an effect on A.G.E.s., or the formation of A.G.E. crosslinks. In addition, although we have several patent applications pending to protect proprietary technology and potential products, these patents may not be issued, and the claims of any patents that do issue, may not provide significant protection of our technology or products. In addition, we may not enjoy any patent protection beyond the expiration dates of our currently issued patents.
          We also rely upon unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to maintain, develop and expand our competitive position, which we seek to protect, in part, by confidentiality agreements with our corporate partners, collaborators, employees and consultants. We also have invention or patent assignment agreements with our employees and certain, but not all, corporate partners and consultants. Relevant inventions may be developed by a person not bound by an invention assignment agreement. Binding agreements may be breached, and we may not have adequate remedies for such breach. In addition, our trade secrets may become known to or be independently discovered by competitors.
The effect of accounting rules relating to our equity compensation arrangements may have an adverse effect on our stock price and financial condition.
          Based on the performance of our stock and in order to bolster employee retention, we repriced certain employee stock options on February 2, 1999. As a result of this repricing, options to purchase 1.06 million shares of stock were repriced and certain vesting periods related to these options were modified or extended. This repricing may have a material adverse impact on future financial performance based on the Financial Accounting Standards Board, or the FASB, Interpretation No. 44, or FIN No. 44, “Accounting for Certain Transactions Involving Stock Compensation, an Interpretation of Accounting Principles Board, or APB Opinion No. 25.” This interpretation requires us to record compensation expense or benefit, which is adjusted every quarter, for increases or decreases in the fair value of the repriced options based on changes in our stock price from the value at July 1, 2000, until the adoption of newly issued accounting rules on January 1, 2006 described below. The options expire at various dates through January 2008.
          In December 2004, the FASB issued Statement of Financial Accounting Standards, or SFAS, No. 123 (revised 2004), “Share-Based Payment,” or SFAS No. 123(R), which replaces FASB Statement No. 123 and will be effective for us beginning no later than with our fiscal quarter ending March 31, 2006. This Statement requires that the costs of employee share-based payments be measured at fair value on the awards’ grant date using an option-pricing model and recognized in the financial statements over the requisite service period. We are currently determining which transition method we will adopt and are evaluating the impact SFAS No. 123(R) will have on our financial position and results of operations. However, we believe it may have a material effect on our results of operations.
If we are not able to compete successfully with other companies in the development and marketing of cures and therapies for cardiovascular diseases, diabetes, erectile dysfunction 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 pre-clinical 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.

21


Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (continued)
          Certain technologies under development by other pharmaceutical companies could result in better treatments for cardiovascular disease, diabetes and its related complications or ED. 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 patients 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.

22


Table of Contents

ITEM 3. Qualitative and Quantitative Disclosures about Market Risk
          Our cash and cash equivalents are invested primarily in money market accounts. We do not use derivative financial instruments. Accordingly, we believe we have limited exposure to market risk for changes in interest rates.
ITEM 4. Controls and Procedures
          a) Evaluation of Disclosure Controls and Procedures. Our management has evaluated, with the participation of our Chief Executive Officer and our Director of Finance and Financial Reporting, the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the fiscal quarter covered by this Quarterly Report on Form 10-Q. Based upon that evaluation, the Chief Executive Officer and the Director of Finance and Financial Reporting have concluded that as of the end of such fiscal quarter, our current disclosure controls and procedures were not effective, because of the material weaknesses in internal control over financial reporting described below. We have taken, and are continuing to take, steps to address these weaknesses as described below. With the exception of such weaknesses, however, the Chief Executive Officer and the Director of Finance and Financial Reporting believe that our current disclosure controls and procedures are adequate to ensure that information required to be disclosed in the reports we file under the Exchange Act is recorded, processed, summarized and reported on a timely basis.
          b) Material Weaknesses and Changes in Internal Controls. During the preparation of this Form 10-Q for the quarter ended June 30, 2005, our independent registered public accounting firm identified a material weakness, as of June 30, 2005, in the review process for the financial statement recording and disclosures of stock options that we have granted to non-employee consultants in accordance with Emerging Issues Task Force (“EITF”) 96-18. As defined by the Public Company Accounting Oversight Board Auditing Standard No. 2, a material weakness is a significant control deficiency or a combination of significant control deficiencies, that results in there being more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected. This material weakness did not result in the restatement of any previously reported financial statements or any other related financial disclosure. Stock options that we had granted to non-employee consultants should have been accounted for under variable accounting and we have corrected the accounting for these stock options as of the second quarter of 2005. The changes that would have resulted in the financial statements for the first quarter of 2005 were deemed immaterial. We have instituted additional procedures in the review process for the financial statement recording and disclosures of options in order to remediate this issue.
As described in the 10-K Amendment, management concluded that, as of December 31, 2004, we had three material weaknesses in our internal control over financial reporting. Since December 31, 2004, we have made the following changes in our internal control over financial reporting in order to address these material weaknesses:
1. INTERNAL CONTROL REVIEW — AUDIT COMMITTEE EFFECTIVENESS. As noted in the 10-K Amendment, the Audit Committee of our Board of Directors and management initially underestimated the complexity and depth of work that would be required to comply with the internal control review required under Section 404 of the Sarbanes-Oxley Act of 2002, as well as the comprehensive nature of the internal control assessment. As a result, this process was begun later than appropriate and certain remediation efforts were not completed or tested until after December 31, 2004.
Since December 31, 2004, management and the Audit Committee have implemented remedial measures to address these matters, including establishment of a Disclosure Committee, more rigorous and documented internal sub-certification procedures, and commitment of additional resources to document and monitor ongoing changes to our internal control over financial reporting, and to document Audit Committee involvement with all of the foregoing.
2. INFORMATION TECHNOLOGY CONTROLS AND PROCESS CONTROLS. As noted in the 10-K Amendment, management has determined that, as of December 31, 2004, we did not adequately document and implement certain controls over information technology. These areas include certain change management and vendor management procedures. In addition, certain financial computer program application controls and related access controls relating to information security were not adequately implemented. Back-up and recovery processes were not adequately documented, and testing of recovery procedures was not implemented. The Company has drafted, and is in the process of implementing remedial procedures to address these matters.
3. CONTROLS OVER CASH DISBURSEMENTS. As noted in the 10-K Amendment, management has determined that, as of December 31, 2004, inadequate internal controls existed over our processing of cash disbursements. Specifically, during the fiscal year ended December 31, 2004, a number of checks, which we believe to be not greater than nine, were issued from our account without signature, and a number of checks, in amounts greater than $7,500, which we believe to be not greater than eight, were issued from our account with only one signature, when our internal policy requires that checks greater than that amount be issued with two signatures. In all instances reviewed by us, the disbursements had been appropriately authorized and were valid disbursements. Since December 31,

23


Table of Contents

2004, we have implemented remedial controls to address this matter, involving a review of checks prior to issuance to ensure their signature.
          c) Except for the changes in controls described above, 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.

24


Table of Contents

PART II — OTHER INFORMATION
ITEM 4. Submission of Matters to a Vote of Security-Holders
          The Annual Meeting of Stockholders of Alteon Inc. (the “Meeting”) was held on June 29, 2005. The following matters were voted upon at the Meeting: (i) the election of three directors, (ii) the ratification of the appointment of J.H. Cohn LLP as independent public accountants for the fiscal year ending December 31, 2005, (iii) a proposal to amend our Restated Certificate of Incorporation to increase the number of authorized shares of Common Stock from 175,000,000 to 300,000,000 and (iv) a proposal for the approval of the Alteon Inc. 2005 Stock Plan and the reservation of 5,000,000 shares for grant under that plan.
          (i) 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
Dr. Edwin D. Bransome
    48,466,240       1,392,900  
Kenneth I. Moch
    48,805,462       1,053,678  
Dr. George M. Naimark
    48,456,658       1,402,482  
The others directors of the Company whose terms continued after the Meeting are Marilyn G. Breslow, Alan J. Dalby, David K. McCurdy, Thomas A. Moore, and Dr. Mark Novitch.
          (ii) 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, 2005, were as follows:
                 
Votes For   Votes Against   Abstentions
49,671,354
    126,287       61,499  
          (iii) The number of votes cast for, against and abstaining from the proposal to amend our Restated Certificate of Incorporation, were as follows:
                 
Votes For   Votes Against   Abstentions
47,755,931
    2,011,507       91,702  
          (iv) The number of votes cast for, against and abstaining from the proposal for the approval of the Alteon Inc. 2005 Stock Plan, were as follows:
                         
Votes For   Votes Against   Abstentions   Broker Non-Votes
12,694,977
    2,346,813       129,771       34,687,579  
ITEM 6.Exhibits
     Exhibits
     See the “Exhibit Index” on page 27 for exhibits required to be filed with this Quarterly Report on Form 10-Q.

25


Table of Contents

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 9, 2005
     
 
  ALTEON INC.
 
   
 
  By: /s/Kenneth I. Moch
 
   
 
  Kenneth I. Moch
 
  President and Chief Executive Officer
 
  (principal executive officer)
 
   
 
  By: /s/Mary T. Phelan
 
   
 
  Mary T. Phelan
 
  Director of Finance and Financial Reporting
 
  (principal accounting officer)

26


Table of Contents

EXHIBIT INDEX
     
Exhibit    
No.   Description of Exhibit
 
   
3.1.1
  Amended Certificate Of The Voting Powers, Designations, Preferences And Relative Participating, Optional And Other Special Rights And Qualifications, Limitations Or Restrictions Or Series F Preferred Stock Of Alteon Inc.
 
   
10.1
  Form of Employee’s Stock Option Grant Agreement.
 
   
10.2
  Form of Director’s Formula Award Non-Qualified Stock Option Grant Agreement.
 
   
10.3
  Form of Consultant’s Non-Qualified Stock Option Grant Agreement.
 
   
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.

27