UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

ý	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarter Ended June 30, 2004

or

o	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number 1-14430

MAXIM PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware		87-0279983
(State of incorporation)		(IRS Employer Identification No.)

8899 University Center Lane, Suite 400, San Diego, CA		92122
(Address of principal executive offices)		(zip code)

(858) 453-4040
(Registrant’s telephone number, including area code)

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 ý No o

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes ý No o

The number of outstanding shares of the registrant’s Common Stock, $.001 par value, as of August 3, 2004 was 28,560,983.

MAXIM PHARMACEUTICALS, INC. AND SUBSIDIARIES

(A Development Stage Company)

INDEX

		Page

Part I–Financial Information
Item 1.	Financial Statements (unaudited)
	Condensed Consolidated Balance Sheets–June 30, 2004 and September 30, 2003	1
	Condensed Consolidated Statements of Operations–Three and Nine Months Ended June 30, 2004 and 2003 and from Inception (October 23, 1989) through June 30, 2004	2
	Condensed Consolidated Statements of Cash Flows–Nine Months Ended June 30, 2004 and 2003 and from Inception (October 23, 1989) through June 30, 2004	3
	Notes to Condensed Consolidated Financial Statements	4
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	9
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	27
Item 4.	Controls and Procedures	27
Part II–Other Information
Item 1.	Legal Proceedings	29
Item 6.	Exhibits and Reports on Form 8-K	30
SIGNATURES

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

(in thousands, except share data)

Maxim Pharmaceuticals, Inc. and Subsidiaries (A Development Stage Company)

	As of June 30 2004			As of September 30 2003
ASSETS
Current Assets:
Cash and cash equivalents	$	12,774		$	32,861
Investments in marketable securities, available for sale	48,790			58,468
Accrued interest and other current assets	1,930			2,210
Total current assets	63,494			93,539

Restricted cash and cash equivalents	3,500			3,500
Property and equipment, net	3,703			4,358
Patents and licenses, net	4,413			3,521
Note receivable from officer, net of allowance of $700,000	2,015			2,287
Deposits and other assets	273			142
Total assets	$	77,398		$	107,347

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable	$	3,769		$	5,141
Accrued expenses	4,177			3,805
Notes payable and current portion of long-term debt and obligations under capital leases	842			1,246
Provision for loan guarantee for officer	900			900
Deferred revenue	381			190
Total current liabilities	10,069			11,282

Long-term debt and obligations under capital leases, excluding current portion	196			828

Commitments and contingencies

Stockholders’ Equity:
Convertible preferred stock, $.001 par value, 5,000,000 shares authorized; no shares issued and outstanding at June 30, 2004 and September 30, 2003	—			—
Common stock, $.001 par value, 60,000,000 shares authorized; 28,423,242 and 27,951,059 shares issued and outstanding at June 30, 2004 and September 30, 2003, respectively	28			28
Additional paid-in capital	404,398			401,251
Deficit accumulated during the development stage	(336,993		)	(306,504		)
Accumulated other comprehensive income (loss)	(300		)	462
Total stockholders’ equity	67,133			95,237
Total liabilities and stockholders’ equity	$	77,398		$	107,347

See Accompanying Notes to Condensed Consolidated Financial Statements

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

(in thousands, except per share amounts)

Maxim Pharmaceuticals, Inc. and Subsidiaries (A Development Stage Company)

	Three Months Ended June 30						Nine Months Ended June 30						From Inception (October 23, 1989) Through June 30, 2004
	2004			2003			2004			2003

Collaboration and research revenue	$	801		$	1,300		$	3,493		$	2,341		$	18,311

Operating expenses:
Research and development	9,883			11,583			27,578			29,812			243,358
Business development and marketing	1,086			360			2,377			1,078			24,048
General and administrative	1,836			2,255			5,191			6,102			45,538
Amortization of goodwill and other acquisition-related intangible assets	—			—			—			—			2,955
Purchased in-process technology	—			—			—			—			42,300
Provisions for note receivable and loan guarantee to/for officers	—			—			—			—			1,600
Total operating expenses	12,805			14,198			35,146			36,992			359,799

Loss from operations	(12,004		)	(12,898		)	(31,653		)	(34,651		)	(341,488		)

Other income (expense):
Investment income	340			546			1,217			2,038			31,072
Gain on sale of assets	—			—			—			—			4,435
Interest expense	(14		)	(31		)	(56		)	(98		)	(2,850		)
Other income (expense)	—			2			3			19			17
Total other income	326			517			1,164			1,959			32,674

Loss before cumulative effect of accounting change and preferred stock dividends	(11,678		)	(12,381		)	(30,489		)	(32,692		)	(308,814		)

Cumulative effect of accounting change	—			—			—			—			(28,179		)

Net loss before preferred stock dividends	(11,678		)	(12,381		)	(30,489		)	(32,692		)	(336,993		)
Dividends on preferred stock	—			—			—			—			5,496

Net loss applicable to common stock	$	(11,678	)	$	(12,381	)	$	(30,489	)	$	(32,692	)	$	(342,489	)

Basic and diluted net loss per share of common stock	$	(0.41	)	$	(0.53	)	$	(1.08	)	$	(1.40	)

Weighted average shares outstanding	28,282,906			23,341,034			28,100,889			23,327,660

See Accompanying Notes to Condensed Consolidated Financial Statements

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

(In thousands)

Maxim Pharmaceuticals, Inc. and Subsidiaries (A Development Stage Company)

	Nine Months Ended June 30						From Inception (October 23, 1989) Through
	2004			2003			June 30, 2004
OPERATING ACTIVITIES:
Net loss	$	(30,489	)	$	(32,692	)	$	(336,993	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	1,258			1,762			13,807
Stock contributions to 401(k) plan	—			46			643
Cumulative effect of accounting change	—			—			28,179
Stock-based compensation	332			78			1,720
Loss on disposal of property and equipment	20			6			309
Provisions for note receivable and loan guarantees to/for officers	—			—			1,600
Purchased in-process technology	—			—			44,946
Gain on sale of assets	—			—			(2,146		)
Amortization of premium on investments	—			—			535
Cumulative effect of reorganization	—			—			1,153
Gain on sale of subsidiary	—			—			(2,288		)
Other	—			—			160
Changes in operating assets and liabilities:
Accrued interest and other current assets	280			1,269			90
Deposits and other assets	(131		)	3			(769		)
Accounts payable	(1,372		)	253			2,677
Accrued expenses	372			2,180			2,880
Deferred revenue	191			(237		)	381
Net cash used in operating activities	(29,539		)	(27,332		)	(243,116		)

INVESTING ACTIVITIES:
Purchases of marketable securities	(57,244		)	(37,768		)	(495,705		)
Sales and maturities of marketable securities	66,160			51,345			447,118
Purchases of property and equipment	(457		)	(683		)	(11,349		)
Additions to patents and licenses	(1,058		)	(588		)	(7,423		)
Net proceeds from sale of assets	—			—			3,452
Cash acquired in acquisition of business	—			—			1,121
Net cash provided by (used in) investing activities	7,401			12,306			(62,786		)

FINANCING ACTIVITIES:
Net proceeds from issuance of common stock and exercise of stock options and warrants	2,815			318			280,530
Net proceeds from issuance of preferred stock	—			—			41,298
Payment of preferred stock dividends	—			—			(302		)
Proceeds from issuance of notes payable and long-term debt	—			—			9,318
Restricted cash and cash equivalents	—			—			(3,500		)
Payments on notes payable, long-term debt, and capital lease obligations	(1,036		)	(1,110		)	(9,605		)
Proceeds from issuance of notes payable to related parties	—			—			4,982
Payments on notes payable to related parties	—			—			(1,330		)
Loan to officer	272			122			(2,715		)
Net cash provided by (used in) financing activities	2,051			(670		)	318,676

Net increase (decrease) in cash and cash equivalents	(20,087		)	(15,696		)	12,774

Cash and cash equivalents at beginning of period	32,861			24,775			—

Cash and cash equivalents at end of period	$	12,774		$	9,079		$	12,774

Noncash investing activities:
Acquisition of property and equipment under capital lease	$	—		$	51		$	270
Increase (decrease) in fair value of securities available for sale	$	(762	)	$	(390	)	$	(296	)

See Accompanying Notes to Condensed Consolidated Financial Statements

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

Maxim Pharmaceuticals, Inc. and Subsidiaries (A Development Stage Company)

1. PRINCIPLES OF INTERIM PERIOD REPORTING

Maxim Pharmaceuticals, Inc. (the “Company”) has not earned significant revenues from planned principal operations. Accordingly, the Company’s activities have been accounted for as those of a “Development Stage Enterprise” as set forth in Financial Accounting Standards Board Statement No. 7.

The information at June 30, 2004 and for the three and nine months ended June 30, 2004 and 2003 and from inception (October 23, 1989) through June 30, 2004 is unaudited. In the opinion of the Company, these condensed consolidated financial statements contain all of the adjustments, consisting only of normal recurring adjustments and accruals, necessary to present fairly the condensed consolidated financial position of the Company as of June 30, 2004 and September 30, 2003, and the condensed consolidated results of operations for the three and nine months ended June 30, 2004 and 2003 and from inception (October 23, 1989) through June 30, 2004. The condensed consolidated results of operations for the three and nine months ended June 30, 2004 are not necessarily indicative of the results to be expected in subsequent periods or for the year as a whole. For further information, refer to the consolidated financial statements and footnotes thereto in our Annual Report on Form 10-K for the year ended September 30, 2003.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Stock Option Plans-The Company accounts for its stock option plans under the recognition and measurement principles of APB Opinion No. 25, “Accounting for Stock Issued to Employees”, and related Interpretations. Compensation expense associated with stock options to employees was $29,000 in the current quarter and $81,000 year-to-date. Compensation expense to non-employees was $97,000 in the current quarter and $251,000 year-to-date. There was no similar expense in the same periods in the prior year.

No other stock-based employee compensation cost is reflected in net loss, as all options granted under those plans had an exercise price equal to the market value of the underlying common stock on the date of grant. The following table illustrates the effect on net loss and

loss per share if the Company had applied the fair value recognition provisions of Statement of Financial Accounting Standards (“SFAS”) No. 123, “Accounting for Stock-Based Compensation”, to stock-based employee compensation.

	Three Months Ended						Nine Months Ended
	June 30, 2004			June 30, 2003			June 30, 2004			June 30, 2003
Net loss, as reported	$	(11,678	)	$	(12,381	)	$	(30,489	)	$	(32,692	)
Add: Total stock-based employee compensation expense determined under fair value based methods for all awards	(778		)	(924		)	(2,335		)	(2,747		)
Less: Compensation expense associated with stock options	29			—			81			—
Pro forma net loss	$	(12,427	)	$	(13,305	)	$	(32,743	)	$	(35,439	)

Net loss per share:
Basic and diluted - as reported	$	(0.41	)	$	(0.53	)	$	(1.08	)	$	(1.40	)
Basic and diluted - pro forma	$	(0.44	)	$	(0.57	)	$	(1.17	)	$	(1.52	)

The fair value of the stock options were estimated at the date of grant using the “Black-Scholes” method for option pricing and the following weighted-average assumptions were used for grants made during the three and nine months ended, June 30, 2004 and 2003, respectively:

	Three Months Ended						Nine Months Ended
	June 30, 2004			June 30, 2003			June 30, 2004			June 30, 2003
Risk free interest rate	1.94		%	2.59		%	2.20		%	2.29		%
Dividend Yield	0			0			0			0
Volatility Factor	75		%	75		%	75		%	75		%
Expected Life (in years)	3.09			4.50			3.59			3.76
Resulting average fair value	$	4.37		$	2.51		$	4.35		$	1.58

3. TOTAL OTHER COMPREHENSIVE LOSS

Total other comprehensive loss for the three months ended June 30, 2004 and 2003 was $12,049,000 and $12,554,000, respectively. Total other comprehensive loss for the nine months ended June 30, 2004 and 2003 was $31,251,000 and $33,082,000, respectively. The difference between total other comprehensive loss and net loss attributable to common stock was comprised of unrealized gains and losses on available-for-sale securities.

4. NET LOSS PER SHARE

Net loss per share is calculated in accordance with SFAS No. 128, “Earnings per Share”. Basic net loss per share of common stock is computed by dividing the net loss after deduction of dividends on preferred stock by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share is calculated by including the additional common shares issuable upon exercise of outstanding options and warrants in the basic weighted average share calculation unless the effect of their inclusion is antidilutive. For the three and nine months ended June 30, 2004 and 2003, outstanding options and warrants totaled 5,602,000 and

3,991,000, respectively. As these securities were antidilutive, diluted loss per share equaled basic loss per share in each respective period.

5. DEFERRED RENT

In accordance with SFAS No.13, “Accounting for Leases”, the Company records operating lease rent expenses on a straight-line basis over the lease term, which causes the amount expensed in our financial statements to vary from the actual amounts paid during the period. This variance is recorded as deferred rent and included in Accrued Expenses. As of June 30, 2004 and 2003, the deferred rent balance was $658,000 and $251,000, respectively.

6. RECLASSIFICATIONS

Certain amounts in the prior period financial statements have been reclassified to conform with current period classifications.

7. RELATED PARTY TRANSACTIONS

In December 2000, the Company entered into a $2.85 million full recourse secured revolving promissory note with an officer of the Company. The purpose of the agreement was to allow the repayment of margin loans associated with the exercise of stock options, the payment of income taxes associated with such exercises and the purchase of a residence. The Board determined that it was in the Company’s best interest to provide the loan to the officer to avoid the necessity of selling personal holdings of the Company’s securities during a period of depressed market prices. The note bears interest at an annual rate of 4.0% and is secured by the officer’s outstanding options and shares of common stock. During the quarter ended September 30, 2002, the Company determined that the note to the officer had become impaired because the Company determined that the officer did not have the ability to repay the loan in full when due. Accordingly, the Company has not recorded interest income of $248,000 on the note subsequent to June 30, 2002 and has recorded an allowance on the note in the amount of $700,000. The officer has paid the Company $394,000 related to the note which includes a $150,000 payment made in June 2004. The entire outstanding balance of principal and interest was due on December 8, 2002. As of the date the note came due, the officer did not have the liquid assets necessary to repay the loan. The Company is reviewing its options and alternatives and intends to continue to pursue collection of the outstanding principal and interest on the loan. As of June 30, 2004, the recorded outstanding principal and interest balance on the note was $2,015,000, net of the $700,000 allowance.

2002, the Company determined that it was probable that one of the officers would not have the ability to repay his loan. Therefore, the Company recorded a provision for the guarantee and a liability in the amount of $900,000. In July 2004, one former officer paid his loan in full and another former officer paid the bank $115,000 resulting in an unpaid balance of $56,000 on his loan. In addition, as of the date the loan came due, a current officer did not have the assets necessary to pay his loan in full. The officer paid $300,000 on his loan. As a result the bank liquidated $952,000 of the Company’s certificate of deposit to satisfy the loans. The Company does not hold any assets as collateral from the officer or former officer. The Company does not expect to incur losses exceeding amounts previously provided for and is reviewing its options and alternatives, has full recourse and intends to continue to pursue collection of the $952,000 from the officer and former officer.

8. CONTINGENCIES

On December 14, 2000, plaintiff Blake Martin, on behalf of himself and purportedly on behalf of a class of others similarly situated, filed a complaint in the United States District Court for the Southern District of California against the Company and two officers of the Company, alleging violations of federal securities laws related to declines in the Company’s stock price in connection with various statements and alleged omissions to the public and to the securities markets, and seeking damages therefore. In December 2003, the United States Federal Court granted the Company’s motion to dismiss the lawsuit with prejudice and without leave to amend, which was the third dismissal by the court in the case. On December 30, 2003, plaintiff Blake Martin exercised his right to appeal the decision of the United States District Court for the Southern District of California to the Ninth Circuit Court of Appeals. That appeal has been dropped, ending the litigation in favor of the Company.

In October 2001 and May 2002, certain former shareholders of Cytovia filed complaints in California Superior Court in San Diego against the Company and two of its officers based on similar facts and circumstances, alleging fraud and negligent misrepresentation in connection with the Company’s acquisition of Cytovia. A binding arbitration proceeding with the American Arbitration Association was held in May 2003. The three-member arbitration panel rejected all of the plaintiffs’ claims, determined that the Company has no liability for such claims and awarded recovery of the Company’s reasonable attorneys’ fees and costs of approximately $922,000 as prevailing party in the proceeding. In December 2003, the decision was confirmed by the Superior Court, which entered a judgment to this effect. In June 2004, the plaintiffs filed an Appeal, which the Company is vigorously opposing. No amounts have been recorded in the Company’s financial statements related to the recovery of these expenses.

The Company believes that the claims set forth in the pending complaint by the former shareholders of Cytovia are without merit, and it intends to engage in a rigorous defense against such claims. No assurances can be made that the Company will be successful in its defense of the pending claims. If the Company is not successful in its defense of such claims, the Company could be forced to make significant payments to the plaintiffs and defense lawyers, and such payments could have a material adverse effect on the Company’s business, financial condition and results of operations if not covered by the Company’s insurance carrier. Even if the Company’s defense against such claims is successful, the litigation could result in substantial costs and divert management’s attention and resources, which could adversely affect the Company’s business.

As discussed in Footnote 7, Related Party Transactions, the Company has a $2,015,000 note receivable from an officer, net of a $700,000 allowance against the note.

9. SUBSEQUENT EVENT

As discussed in Footnote 7, Related Party Transactions, in July 2004, $1,800,000 in loans made by a bank to one officer and two former officers of the Company for which the Company was a guarantor were due. In July 2004, one former officer paid his loan in full and another former officer paid the bank $115,000 resulting in an unpaid balance of $56,000 on his loan. In addition, as of the date the loan came due, a current officer did not have the assets necessary to pay his loan in full. The officer paid $300,000 on his loan. As a result the bank liquidated $952,000 of the Company’s certificate of deposit to satisfy the loans. The Company does not hold any assets as collateral from the officer or former officer. The Company does not expect to incur losses exceeding amounts previously provided for and is reviewing its options and alternatives, has full recourse and intends to continue to pursue collection of the $952,000 from the officer and former officer.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Maxim Pharmaceuticals, Inc. and Subsidiaries (A Development Stage Company)

This Management’s Discussion and Analysis of Financial Condition and Results of Operations contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include but are not limited to statements regarding plans for the development and commercialization of the Company’s drug candidates and future cash requirements. Such statements are only predictions and the Company’s actual results could differ materially from those anticipated or projected in such forward-looking statements. Moreover, the Company assumes no responsibility for the accuracy and completeness of the forward-looking statements. The Company is under no duty to update any of the forward-looking statements after the date hereof to conform such statements to actual results or to changes in its expectations. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section entitled “Risk Factors” contained in this Quarterly Report. As a result, you are cautioned not to rely on these forward-looking statements.

This Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the condensed consolidated financial statements, including the related notes, appearing in Item 1 of this Quarterly Report on Form 10-Q as well as the Company’s Annual Report on Form 10-K for the year ended September 30, 2003.

OVERVIEW

We are a global bio-pharmaceutical company with a diverse pipeline of drug candidates for life-threatening cancers and chronic liver diseases.

Our lead drug candidate Ceplene™ (histamine dihydrochloride) is designed to prevent or reverse damage associated with oxidative stress, thereby protecting critical cells and tissues. Because Ceplene modulates basic immune functions, it has the potential to be used in the treatment of a broad range of diseases in which oxidative stress plays an important role. More than 2,000 patients have participated in our 17 completed and ongoing clinical trials of Ceplene, conducted in 20 countries. The clinical trials involve the following diseases:

• Life-threatening cancers, such as advanced malignant melanoma (the most deadly form of skin cancer), acute myeloid leukemia (the most common form of acute leukemia in adults) and renal cell carcinoma (kidney cancer); and

• Hepatitis C, the most common blood-borne virus in the United States.

Clinical trials completed to date have suggested that Ceplene can be safely self-administered by most patients in their own homes.

Ceplene for the treatment of advanced malignant melanoma represents our most advanced program. In November 2003, we filed a European Centralized Procedure Marketing Authorization Application for Ceplene, in combination with interleukin-2 (IL-2), a drug manufactured by Chiron Corporation, for the treatment of patients with advanced malignant

melanoma. The Ceplene application was filed with the European Agency for the Evaluation of Medicinal Products (EMEA) as an electronic Common Technical Dossier (eCTD) in compliance with the most recent International Committee of Harmonization (ICH) guidelines. Ireland and Sweden have been assigned by the EMEA as the Rapporteur and Co-rapporteur, respectively, with responsibility to review the application on behalf of the European Union (EU).

In April 2004, we announced that our treatment protocol to provide our investigational drug Ceplene, in combination with IL-2, for the treatment of patients with advanced malignant melanoma, had been approved by the U.S. Food and Drug Administration (FDA). The treatment protocol allows us to provide expanded access of Ceplene to patients in the United States while investigation of the drug continues in the Company’s confirming Phase 3 clinical trial. Although the FDA agreed to allow reimbursement for the study medication under the treatment protocol, we have determined that we will not seek reimbursement for providing patients access to Ceplene under the treatment protocol.

In May 2004, we announced the results of our international Phase 3 clinical trial testing the combination of Ceplene plus IL-2 in 320 patients with acute myeloid leukemia (AML) in complete remission. The primary endpoint of the Phase 3 trial was achieved using intent-to-treat analysis, as patients treated with the Ceplene/IL-2 combination therapy experienced a statistically significant (p=0.0026) increase in leukemia-free survival compared to patients in the control arm of the trial as assessed by the stratified log-rank test. AML patients are typically treated with chemotherapy to achieve disease remission, but the majority of patients will ultimately relapse. The prognosis for AML patients after relapse is dismal, with few long-term survivors. The Ceplene therapy treats patients during remission (after chemotherapy) with the goal to increase their remission period and prevent relapses. We currently plan to use the results from the Phase 3 AML trial to pursue expanded labeling for the Ceplene/IL-2 combination after the potential approval of Ceplene for the treatment of advanced malignant melanoma.

Our researchers have also identified a series of novel cancer drug candidates that are potent inducers of apoptosis, also known as programmed cell death. The compounds were identified through our proprietary high-throughput screening technology that uses a unique live cell screening assay. We have screened approximately one million compounds and have identified drug candidates with unique mechanisms of action that target major cancers such as breast, lung, prostate, and colorectal.

Our development activities are supported by clinical collaborations with Schering Plough, Myriad Genetics, and Chiron Corporation.

CRITICAL ACCOUNTING POLICIES

The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses as well as related disclosure of contingent assets and liabilities. These estimates include useful lives for fixed assets, useful lives for intellectual property, estimated lives for

license agreements, revenue recognition, allowance for notes receivable, valuation of intellectual property, and estimates for clinical trial expenses incurred but not yet billed. On an on-going basis, the Company evaluates its estimates. The Company bases its estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances. Under different assumptions or conditions these estimates may vary significantly. In addition, actual results may differ materially from these estimates.

The Company believes the following critical accounting policies affect its more significant judgments and estimates used in the preparation of its condensed consolidated financial statements.

Revenue Recognition. Revenue is generally recognized when all of the following criteria are met: persuasive evidence that an arrangement exists; services have been rendered and are non-refundable; the price is fixed and determinable and collection is reasonably assured. All multiple deliverable arrangements are reviewed by the Company for separability in accordance with EITF 00-21. If the separability criteria are met, non-refundable upfront technology access fees are accounted for separately. Upfront technology access fees which are not considered separable from the related research fees are recognized as revenue over the applicable research period as research activities are performed. Milestone payments are recognized when earned and collectibility is assured provided that the milestone events are substantive and their achievability is not reasonably assured at the inception of the agreement. Amounts received but unearned are recorded as deferred revenue. Certain collaborative agreements provide the Company donated materials and services which are recorded when used at the fair market value of the material received or the service provided. Grant funding is recognized as revenue when earned.

Clinical trial expenses. The Company accounts for certain study drug, clinical trial site and other clinical trial costs by estimating the services incurred but not reported for each patient enrolled in each trial. These costs and estimates vary based on the type of clinical trial, the site of the clinical trial, the length of treatment period for each patient and the length of time required to receive formal documentation of the actual expenses incurred. As actual costs become known, the Company may need to revise its estimated accrual, which could also materially affect its results of operations.

Valuation of Intellectual Property. The Company evaluates its patents and licenses for impairment on an annual basis and whenever indicators of impairment exist. During this process, the Company reviews its portfolio of pending domestic and international patent applications, domestic and international issued patents, and licenses the Company has acquired from other parties. To determine if any impairment is present, the Company considers challenges or potential challenges to its existing patents, the likelihood of applications being issued, the scope of its issued patents, the assessment of future cash flows to be generated from the patents and its experience. In the event that it is determined that an impairment exists where the Company had previously determined that one did not exist, it may result in a material adjustment to the Company’s financial statements.

RESULTS OF OPERATIONS FOR THE THREE AND NINE MONTHS ENDED JUNE 30, 2004 AND 2003

Collaboration and Research Revenue. For the quarter ended June 30, 2004, collaboration and research revenue was $801,000, a decrease of $499,000 or 38% compared to the same period in the prior year. The decrease is primarily attributable to a decrease of $924,000 in donated drugs and services from Schering on our Phase 2 study (MP-8899-0406 or the Phase 2 triple-drug trial in nonresponder HCV patients) due to a lower number of patients in the treatment phase of the trial. The Schering agreement provided $131,000 of revenue in the current quarter, compared to $1,055,000 of revenue in the same period in the prior year. This decrease is offset by an increase of $500,000 of revenue from the Myriad Genetics, Inc. (Myriad) collaboration that we entered into in November 2003. Other revenue recognized during the current quarter amounted to $170,000 from a license and research agreement with Celera Genomics Corporation and a grant from the National Institute of Health. In the prior year, these agreements generated $245,000 of revenue.

For the nine months ended June 30, 2004, collaboration and research revenue was $3,493,000, an increase of $1,152,000 or 49% over the same period in the prior year. This increase was primarily attributable to $1,233,000 of research and license revenue from our collaboration with Myriad. Additionally, we experienced an increase in donated drugs and services from Schering in our Phase 2 study (MP-8899-0406) that resulted in $1,824,000 of revenue in the current year versus $1,606,000 in revenue during the same period in the prior year. Other revenue recognized during the current year amounted to $436,000 from license and research agreements with Celera Genomics Corporation and a grant from the National Institute of Health. In the prior year these agreements generated $735,000 of revenue.

Research and Development Expenses. Research and development expenses for the quarter ended June 30, 2004 totaled $9,883,000, a decrease of $1,700,000 or 15% over the same period in the prior year. This decrease was primarily the result of decreased expenses from the current stage of our Phase 2 study (MP-8899-0406) and Phase 3 study (MP-8899-0104), which is also known as the Phase 3 advanced malignant melanoma trial in patients with liver involvement.

Research and development expenses for the nine months ended June 30, 2004 totaled $27,578,000, a decrease of $2,234,000 or 7% over the same period in the prior year. This decrease was primarily the result of decreased expenses from the current stage of our Phase 2 study (MP-8899-0406) and Phase 3 study (MP-8899-0104). In the future we expect to continue incurring substantial additional research and development expenses due to:

• preclinical and clinical testing of our product candidates;

• expansion of or additional research and development programs; and

• regulatory-related expenses.

Business Development and Marketing Expenses. Business development and marketing expenses for the quarter ended June 30, 2004 were $1,086,000, an increase of $726,000 or 202% over the same period of the prior year. For the nine months ended June 30, 2004, business development and marketing expenses were $2,377,000, an increase of $1,299,000 or 121% over the same period in the prior year. These increases are due to an increase in premarketing activities

associated with the potential market launch of Ceplene. Business development and marketing expenses are expected to increase in the future to support marketing and administrative activities related to the potential commercialization of Ceplene as well as our other product candidates.

General and Administrative Expenses. For the quarter ended June 30, 2004, general and administrative expenses were $1,836,000, a decrease of $419,000 or 19% from the same period in the prior year. For the nine months ended June 30, 2004, general and administrative expenses were $5,191,000, a decrease of $911,000 or 15% from the same period in the prior year. These decreases are a result of decreased legal expenses.

Other Income. Investment income was $340,000 for the quarter ended June 30, 2004, a decrease of $206,000 or 38% from the same period in the prior year. Investment income was $1,217,000 for the nine months ended June 30, 2004, a decrease of $821,000 or 40% from the same period in the prior year. This decrease was a result of a decrease in our cash and short-term securities investment balances and in the rate of interest earned on our investments.

Net Loss Applicable to Common Stock. Net loss applicable to common stock for the quarter ended June 30, 2004 totaled $11,678,000, a decrease of $703,000 or 6% from the same period in the prior year. This decrease was primarily a result of decreases in research and development expenses and general and administrative expenses, partially offset by the increase in business development and marketing expenses, as described above.

Net loss applicable to common stock for the nine months ended June 30, 2004 totaled $30,489,000, a decrease of $2,203,000 or 7% from the same period in the prior year. This decrease was primarily a result of the decrease in research and development expenses.

LIQUIDITY AND CAPITAL RESOURCES

The Company has financed its operations primarily through the sale of its equity securities, including an initial public offering in 1996, an international follow-on public offering in 1997, private offerings of preferred stock in July and November 1999, a follow-on public offering in February 2000, and a private placement of common stock in September 2003, that provided total net proceeds of approximately $322 million.

Until required for operations, the Company’s policy under established guidelines is to keep its cash reserves in bank deposits, corporate debt securities, United States government instruments and other readily marketable debt instruments, all of which are investment-grade quality. As of June 30, 2004, the Company had cash, cash equivalents and investments (including restricted cash of $3.5 million) totaling approximately $65.1 million compared with $94.8 million at September 30, 2003. As of June 30, 2004, the Company had working capital of approximately $53.4 million compared with $82.3 million at September 30, 2003. The decrease in the Company’s cash, cash equivalents and short-term investments, and working capital was primarily due to day-to-day operating expenses relating to research and development activities.

In December 2000, the Company entered into a $2.85 million full recourse secured revolving promissory note with an officer of the Company. The note bears interest at an annual

rate of 4.0% and is secured by the officer’s outstanding options and shares of common stock. During the quarter ended September 30, 2002, the Company determined that the note to the officer had become impaired because the Company determined that the officer did not have the ability to repay the loan in full when due. Accordingly, the Company has not recorded interest income of $248,000 on the note subsequent to June 30, 2002, and has recorded an allowance on the note in the amount of $700,000. The officer has paid the Company $394,000 related to the note which includes a $150,000 payment made in June 2004. The entire outstanding balance of principal and interest was due on December 8, 2002. As of the date the note came due, the officer did not have the liquid assets necessary to repay the loan. The Company is reviewing its options and alternatives and intends to continue to pursue collection of the outstanding principal and interest on the loan.

At June 30, 2004, the Company was a guarantor on $1,800,000 in loans, due in July 2004, made by a bank to an officer and two former officers of the Company. Under the guarantor agreement executed in July 2001, the Company granted the bank a security interest in a $1,800,000 certificate of deposit as collateral for the loans the bank made to the officers. The purpose of the bank loans was to allow the payment of income taxes associated with the exercise of stock options. The Board determined that it was in the Company’s best interest to provide the guarantees to avoid the necessity of the officers selling personal holdings of the Company’s securities during a period of depressed market prices. During the fourth quarter of fiscal year 2002, the Company determined that it was probable that one of the officers would not have the ability to repay his loan. Therefore, the Company recorded a provision for the guarantee and a liability in the amount of $900,000. In July 2004, one former officer paid his loan in full and another former officer paid the bank $115,000 resulting in an unpaid balance of $56,000 on his loan. In addition, as of the date the loan came due, a current officer did not have the assets necessary to pay his loan in full. The officer paid $300,000 on his loan. As a result the bank liquidated $952,000 of the Company’s certificate of deposit to satisfy the loans. The Company does not hold any assets as collateral from the officer or former officer. The Company does not expect to incur losses exceeding amounts previously provided for and is reviewing its options and alternatives, has full recourse and intends to continue to pursue collection of the $952,000 from the officer and former officer.

The Company has term loans with a bank totaling $1,014,000 at June 30, 2004, the proceeds of which were used to finance capital expenditures. The term loan agreements contain customary affirmative and negative covenants, including financial covenants requiring the maintenance of specified liquidity terms and the maintenance of the Company’s principal depository and operating accounts with the bank. In addition, the Company has the choice to either maintain a minimum aggregate balance of $3,500,000 at the institution or to pay the bank a quarterly fee of $2,500. During the nine months ended June 30, 2004, the Company maintained the minimum aggregate balance noted above at the bank and was in compliance with all covenants.

The following table summarizes our contractual obligations as of June 30, 2004:

	Payments due by Period (in thousands)
	Total		Less than 1 Year		1-3 Years		3-5 Years		More than 5 Years

CONTRACTUAL OBLIGATIONS
Debt	$	1,014	$	824	$	190	$	—	$	—
Guarantee on Officer Loans	900		900		—		—		—
Capital Lease Obligations	24		18		6		—		—
Operating Lease Obligations	11,150		2,074		3,849		3,565		1,662

The Company, as a development stage enterprise, anticipates incurring substantial additional losses at least in the near future as it continues to expend substantial amounts on its ongoing and planned clinical trials and its expanded efforts related to its other research and development efforts, including the apoptosis modulator program. In addition, the Company’s cash requirements may fluctuate in future periods as it conducts additional research and development activities, including clinical trials, and undertakes efforts associated with the commercial launch of any product candidates that are approved for sale by government regulatory bodies. Among the activities that may result in an increase in cash requirements are the scope and timing of the Phase 3 and Phase 2 Ceplene cancer and hepatitis C clinical trials currently underway, and earlier-stage clinical trials and other research related to liver disease and the apoptosis modulator and topical histamine technologies. Other factors that may impact the Company’s cash requirements include the results of clinical trials, the scope of other research and development activities, the time required to obtain regulatory approvals, costs associated with defending certain lawsuits currently pending against the Company, the costs of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights, and the ability to establish marketing alliances and collaborative arrangements. As a result of these factors, it is difficult to accurately predict the timing and amount of future cash requirements.

We believe that our available cash, cash equivalents and investments at June 30, 2004 will be sufficient to satisfy our funding needs for at least the next 12 months. To meet its cash requirements, the Company may pursue the issuance of additional equity securities and corporate collaborative agreements. In December 2003, the Company filed a shelf registration statement, which will allow the Company to raise up to $75 million through the sale of various securities in one or more offerings in the future. Specific prices and terms will be determined at the time of any offering. The issuance of additional equity securities, if any, could result in substantial dilution to the Company’s stockholders. There can be no assurance that additional funding will be available on terms acceptable to the Company, if at all. The failure to fund the Company’s capital requirements would have a material adverse effect on its business, financial condition and results of operations.

The Company is currently pursuing a pharmaceutical collaboration regarding the European marketing rights for Ceplene and is pursuing the out-licensing of certain of its apoptosis modulator technology. For instance, in March 2004 the Company announced that it has entered into an agreement with Shire BioChem Inc. under which the Company reacquired the rights to the MX2105 series of vascular targeting agent cancer drug candidates. The MX2105 series was originally licensed in July 2000 to BioChem Pharma, a company that was subsequently acquired by Shire Pharmaceuticals. In July 2003, Shire Pharmaceuticals announced that it was exiting the field of oncology research, creating the opportunity for the Company to reacquire the rights to the MX2105 series of compounds. The Company is currently pursuing the out-licensing of these compounds.

In November 2003, the Company entered into an agreement with Myriad under which the Company licensed its MX90745 series of caspase-inducer anti-cancer compounds to Myriad. The agreement requires that Myriad make licensing, research and milestone payments to the Company totaling up to $27 million, assuming the successful commercialization of the compound for the treatment of cancer, as well as pay a royalty on product sales. There can be no assurance that the Company will be able to enter into any additional agreements on acceptable terms, if at all.

The Company has never paid a cash dividend on its common stock and such payments are prohibited by the terms of the Company’s bank loan. The Company does not contemplate the payment of cash dividends on its common stock in the foreseeable future.

IMPACT OF INFLATION

The impact of inflation on the operations of the Company for the three and nine months ended June 30, 2004 and 2003 was not material.

RECENT ACCOUNTING PRONOUNCEMENTS

In March 2004, the FASB's Emerging Issues Task Force issued EITF 03-1, “The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments,” which requires disclosures about unrealized losses on available-for-sale debt and equity securities accounted for under FASB Statement No. 115, “Accounting for Certain Investments in Debt and Equity Securities,” as well as providing guidance for evaluating whether an investment is other-than-temporarily impaired. The EITF is effective for reporting in the Company’s September 30, 2004 financial statements. The adoption of this EITF is not expected to have a material impact on the Company’s consolidated financial statements.

RISK FACTORS

You should carefully consider the following risk factors and the other information included herein as well as the information included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2003, and other reports and filings made with the Securities and Exchange Commission before investing in our common stock. If any of the following risks actually occur, our business, financial condition or results of operations could be harmed. The trading price of our common stock could decline due to any of these risks, and you may lose part or all of your investment.

The development of our drug candidates is subject to uncertainties, many of which are beyond our control. If we fail to successfully develop our drug candidates, our ability to generate revenues will be substantially impaired.

Potential products based on our Ceplene, apoptosis modulator and topical histamine gel technologies will require, dependent upon the specific drug candidate, extensive research and development, preclinical testing, clinical testing, regulatory approval and substantial additional investment before we can market them. We cannot assure you that any of our drug candidates will:

• be successfully developed;

• prove to be safe and effective in clinical trials;

• meet applicable United States or international regulatory standards;

• be capable of being produced in commercial quantities at acceptable costs;

• be commercially viable;

• be eligible for third party reimbursement from governmental or private insurers; or

• achieve market acceptance.

We have not completed final testing for efficacy or safety in humans for the diseases we propose to treat with Ceplene and our other drug candidates. Failure to ultimately obtain approval for Ceplene and our other drug candidates, any delay in our expected testing and development schedules, or any elimination of a product development program in its entirety, will negatively impact our ability to generate revenues in the future from the sale of our product candidates.

We may not obtain regulatory clearance to market Ceplene or our other drug candidates on a timely basis, or at all.

Ceplene and our other drug candidates are subject to extensive government regulations related to development, clinical trials, manufacturing and commercialization. The process of obtaining Federal Drug Administration (FDA), European Agency for the Evaluation of Medicinal Products (EMEA), and other governmental and similar international regulatory approvals is costly,

time consuming, uncertain and subject to unanticipated delays. Even if we believe that preclinical and clinical data are sufficient to support regulatory approval for a drug candidate, the FDA, EMEA and similar international regulatory authorities may not ultimately approve the candidate for commercial sale in any jurisdiction. The FDA, EMEA or similar international regulators may refuse to approve an application for approval of a drug candidate if they believe that applicable regulatory criteria are not satisfied. The FDA, EMEA or similar international regulators may also require additional testing for safety and efficacy. For example, in 2000, we submitted a New Drug Application (NDA) to the FDA seeking approval to market Ceplene based on the data from our first Phase 3 clinical study in advanced malignant melanoma. In January 2001, the FDA determined that a second study was required to support approval. In response to the FDA request, in January 2002 we commenced another Phase 3 trial. Although we believe that this additional Phase 3 trial, in combination with the results of the first Phase 3 trial, will support approval in the United States and other countries, we have no assurance that (i) the results from this additional Phase 3 trial will confirm the results from the first Phase 3 trial, (ii) the FDA, EMEA or similar regulatory agencies will not require additional Phase 3 trials or (iii) the FDA, EMEA or similar regulatory agencies will approve our regulatory filings for drug approval.

In addition, manufacturing facilities operated by the third party manufacturers with whom we contract to manufacture Ceplene and our other drug candidates may not pass a FDA, EMEA or similar international regulatory preapproval inspection. Moreover, if the FDA, EMEA or similar international regulatory agency grants regulatory approval of a product candidate, the approval may be limited to specific indications or limited with respect to its distribution. Similar international regulatory authorities may apply similar limitations or may refuse to grant any approval.

Any failure or delay in obtaining these approvals could prohibit or delay us from marketing Ceplene and our other drug candidates. If Ceplene and our other drug candidates do not meet applicable regulatory requirements for approval, we may not have the financial resources to continue research and development of these candidates, and we may not generate revenues from the commercial sale of any of our products.

Delays in the commencement, conduct or completion of our clinical trials would negatively impact our business.

We may encounter problems with any of our completed, ongoing or planned clinical studies. For example, we may encounter delays in commencing studies or enrolling volunteers, lower than anticipated retention rate of volunteers in a trial or serious side effects experienced by study participants relating to the drug candidate. Factors that could affect patient enrollment include the size of the patient enrollment population for the targeted disease, eligibility criteria, proximity of eligible patients to clinical sites, clinical trial protocols and the existence of competing protocols, including competitive financial incentives for patients and clinicians, and existing approved drugs. If we encounter any delay in the commencement, conduct or completion of our clinical studies for Ceplene or our other drug candidates, we may experience the following consequences:

• the analysis of data from our clinical studies and the reporting of results may be delayed;

• the submission of our applications for regulatory approval of Ceplene and other drug candidates with regulatory authorities in North America, Europe and elsewhere in the world may be delayed;

• regulatory approval of our drug candidates may be delayed and may not occur on a timely basis, delaying the generation of revenues from the commercial sale of any of our marketed product candidates;

• we may not have the financial resources to continue and complete research and development of any of our product candidates; and

• we may not be able to enter into collaborative arrangements relating to any potential product as a result of the delay in clinical development or regulatory filings.

Because we are dependent on clinical research centers and other contractors for clinical testing and for certain research and development activities, the results of our clinical trials and such research activities are, to a certain extent, beyond our control.

The nature of clinical trials and our business strategy requires us to rely on clinical research centers and our other contractors to assist us with clinical testing and certain research and development activities. As a result, our success is dependent upon the success of these outside parties in performing their responsibilities. Although we believe our contractors are economically motivated to perform on their contractual obligations, we cannot directly control the adequacy and timeliness of the resources and expertise applied to these activities by our contractors. If our contractors do not perform their activities in an adequate or timely manner, the development and commercialization of our drug candidates could be delayed.

We expect to rely on collaborative partners for research and development and commercialization of certain potential products.

We expect to rely on collaborative arrangements for research and development and commercialization of certain drug candidates discovered and developed by us, such as our agreement with Schering Corporation related to our MP-8899-0406 Phase 2 Ceplene clinical trial in nonresponder hepatitis C patients and our agreement with Myriad Genetics related to the MX90745 series of caspase-inducer anti-cancer compounds. We cannot be certain that we will be able to maintain these collaborations or enter into any future collaborative arrangements, that any of our collaborations will be successful or that we will receive revenues from any of these collaborations. The success of these and any future collaborations will depend, in significant part, on our partners’ development and strategic considerations, including the relative advantages of alternative products being developed or marketed by competitors. If our partners fail to conduct their activities in a timely manner, or at all, preclinical or clinical development of drug candidates under those collaborations could be delayed or terminated. The suspension or termination of our collaborations, the failure of our collaborations to be successful or the delay in the development or commercialization of drug candidates pursuant to our collaborations could harm our business.

Our planned business may expose us to product, clinical trial and other liability claims.

Our design, testing and development of potential products involves an inherent risk of exposure to clinical trial and product liability claims and related adverse publicity. Insurance coverage is expensive and difficult to obtain, and we may be unable to obtain coverage in the future on acceptable terms, if at all. Although we currently maintain clinical trial insurance for our drug candidates in the amounts we believe to be commercially reasonable, we cannot be certain that the coverage limits of our insurance policies or those of our strategic partners will be adequate. If we are unable to obtain sufficient insurance at an acceptable cost or if a claim is brought against us, whether fully covered by insurance or not, our business, results of operations and financial condition could be materially adversely affected.

Our products may not be accepted, purchased or used by doctors, patients or payors.

Ceplene, and any of our other drug candidates in development, may not achieve market acceptance even if they are approved by the FDA, EMEA and similar international regulatory agencies. We cannot guarantee that physicians, patients, payors or the medical community in general will accept and utilize any products that we develop. The degree of market acceptance of our potential products will depend on a number of factors, including:

• the scope of regulatory approvals;

• the establishment and demonstration of the clinical efficacy, safety and advantages of our product candidates by clinical trial results, and the acceptance of such results by the medical community;

• the potential advantages of our products over existing treatment methods; and

• reimbursement policies of government and other third-party payors.

We have yet to market or sell any of our product candidates.

Although we currently intend to market Ceplene in the United States, if it is approved by the FDA, through the recruitment of experienced marketing and sales personnel, we have never before marketed or sold any pharmaceutical product. In order to market or co-market Ceplene or certain other drug candidates, we will need to hire a significant number of people with relevant pharmaceutical experience to staff our sales force and marketing group, and possibly also to make appropriate arrangements with collaborative partners. If we cannot develop the required marketing and sales expertise both internally and through our partnering arrangements, our ability to generate revenue from product sales will likely suffer.

We intend to rely on collaborative partners to market and sell Ceplene in international markets, if approved for sale in such markets, and such arrangements may be sought to market certain other drug candidates in all markets. We have not yet entered into any collaborative arrangement with respect to marketing or selling Ceplene with the exception of agreements relating to Australia, New Zealand and Israel. We cannot guarantee that we will be able to enter into any such arrangements on terms favorable to us, or at all. If we are able to enter into marketing and

selling arrangements with collaborative partners, we cannot assure you that such marketing collaborators will apply adequate resources and skills to their responsibilities, or that their marketing efforts will be successful. If we are unable to enter into favorable collaborative arrangements with respect to marketing or selling Ceplene or our marketing collaborators efforts are not successful, our ability to generate revenue from product sales will suffer.

We will be dependent on third party manufacturers of our product candidates. Our ability to sell our product candidates may be harmed if adequate quantities of our product candidates are not manufactured on a timely basis.

We do not intend to acquire or establish our own dedicated manufacturing facilities for Ceplene and our other drug candidates in the foreseeable future. We have contracted and expect to continue to contract with established pharmaceutical manufacturers for the production of Ceplene. If we are unable to continue to contract with third-party manufacturers on acceptable terms or our manufacturers do not comply with applicable regulatory requirements, our ability to conduct clinical testing and to produce commercial quantities of Ceplene and other product candidates will be adversely affected. If we cannot adequately manufacture our product candidates, it could result in delays in submissions for regulatory approval and in commercial product launches, which in turn could materially impair our competitive position and the possibility of achieving profitability. We cannot guarantee that we will be able to maintain our existing contract manufacturing relationships, or acquire or establish new, satisfactory third-party relationships to provide adequate manufacturing capabilities in the future.

We are not profitable and expect to continue to incur losses. If we do not become profitable, we may ultimately be forced to discontinue our operations.

We are a development-stage enterprise. We have experienced net losses every year since our inception. Our net losses applicable to common stock were $30.5 million and $32.7 million for the nine months ended June 30, 2004 and 2003. As of June 30, 2004, we had an accumulated deficit of approximately $337 million. We anticipate incurring substantial additional losses over at least the next several years related to developing and testing our drug candidates and preparing for commercialization and planned market launches of our products. If we do not become profitable, our stock price will be negatively affected, and we may ultimately be forced to discontinue our operations. We may never generate product revenues or become profitable. We expect to have quarter-to-quarter fluctuations in revenues, expenses and losses, some of which could be significant.

We will need to raise additional funds in the future. If we are unable to obtain the funds necessary to continue our operations, we will be required to delay, scale back or eliminate one or more of our drug development programs.

We have already spent substantial funds developing our potential products and business. We expect to continue to have negative cash flow from our operations for at least the next several years. In addition, although the FDA agreed to allow reimbursement for the study medication under our treatment protocol, we have determined that we will not seek reimbursement for providing patients access to Ceplene under the treatment protocol. We will have to raise

additional funds to complete the development of our drug candidates and to bring them to market. Our future capital requirements will depend on numerous factors, including:

• the results of our clinical trials;

• the timing and scope of any additional clinical trials undertaken;

• the scope and results of our research and development programs;

• the time required to obtain regulatory approvals;

• our ability to establish marketing alliances and collaborative agreements;

• the cost of our internal marketing activities; and

• the cost of filing, prosecuting and, if necessary, enforcing patent claims.

Additional financing may not be available on acceptable terms, if at all. If adequate funds are not available, we will be required to delay, scale back or eliminate one or more of our drug development programs or obtain funds through arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies or product candidates that we would not otherwise relinquish.

We compete against many companies and research institutions that are developing products to treat the same diseases as our drug candidates. To the extent these competitors are successful in developing and marketing such products, our future potential market share and revenues could be reduced.

There are many companies, both publicly and privately held, including well-known pharmaceutical companies and academic and other research institutions, engaged in developing pharmaceutical products for the treatment of life-threatening cancers and liver diseases. Products developed by any of these companies or institutions may demonstrate greater safety or efficacy than our drug candidates or be more widely accepted by doctors, patients or third-party payors. Many of our competitors and potential competitors have substantially greater capital resources, research and development capabilities and human resources than we do. Many of these competitors also have significantly greater experience than we do in undertaking preclinical testing and clinical trials of new pharmaceutical product candidates and obtaining FDA, EMEA and other regulatory approvals. If any of our drug candidates are approved for commercial sale, we will also be competing with companies that have greater resources and experience in manufacturing, marketing and selling pharmaceutical products. To the extent that any of our competitors succeed in developing products that are more effective, less costly or have better side effect profiles than our products, then our future potential market share could decrease, which may have a negative impact on our business.

If we fail to secure adequate protection of our intellectual property or the right to use certain intellectual property of others, we may not be able to protect our product candidates and technologies from competitors.

Our success depends in large part on our ability to obtain, maintain and protect patents, trademarks and trade secrets and to operate without infringing upon the proprietary rights of others. If we are unable to do so, our product candidates and technologies may not provide us with any competitive advantage.

The patent positions of biotechnology and pharmaceutical companies are highly uncertain and involve complex legal and factual questions, and the breadth of claims allowed in biotechnology and pharmaceutical patents cannot be predicted. As a result, patents may not issue from any of our patent applications. Patents currently held by us or issued to us in the future, or to licensors from whom we have licensed technology rights, may be challenged, invalidated or circumvented so that our intellectual property rights may not protect our technologies or provide commercial advantage to us. In addition, we also rely on unpatented trade secrets and proprietary know-how, and we cannot be sure that others will not obtain access to or independently develop such trade secrets and know-how. Enforcement of our intellectual property rights against any infringers of our patents relating to Ceplene and our other technologies will be costly and time-consuming. Because of the nature of those patents, we could be required to bring lawsuits against many different entities such as hospitals or clinics. This would have the effect of increasing the costs of enforcing our rights.

The pharmaceutical industry has experienced extensive litigation regarding patent and other intellectual property rights. Although to date we are not aware of any intellectual property claims against us, in the future we could be forced to incur substantial costs in defending ourselves in lawsuits that are brought against us claiming that we have infringed on the patent rights of others or in asserting our patent rights in lawsuits against other parties. We may also be required to participate in interference proceedings declared by the United States Patent and Trademark Office or international patent authorities for the purpose of determining the priority of inventions in connection with our patent applications or other parties’ patent applications. Adverse determinations in litigation or interference proceedings could require us to seek licenses that may not be available on commercially reasonable terms or subject us to significant liabilities to third parties.

The technology in our sector is developing rapidly, and our future success depends on our ability to keep abreast of technological change.

We are engaged in the pharmaceutical field, which is characterized by extensive research efforts and rapid technological progress. New developments in oncology, cancer therapy, medicinal pharmacology, biochemistry and other fields are expected to continue at a rapid pace. Research and discoveries by others may render some or all of our proposed programs or product candidates noncompetitive or obsolete. Our business strategy is subject to the risks inherent in the development of new product candidates using new technologies and approaches. Unforeseen problems may develop with these technologies or applications, and we may not be able to successfully address technological challenges we encounter in our research and development programs. This may result in our inability to develop commercially feasible products.

Our future success depends on our ability to attract and retain key personnel.

Our success will depend, to a great extent, upon the experience, abilities and continued services of our executive officers, and key personnel for research, development and commercialization. If we lose the services of any of these officers or key research and development personnel, our business could be harmed. Our success also will depend upon our ability to attract and retain other highly qualified research and development, managerial, manufacturing and sales personnel and our ability to develop and maintain relationships with qualified clinical researchers. Competition for these personnel and relationships is intense and we compete with numerous pharmaceutical and biotechnology companies as well as with universities and non-profit research organizations. We may not be able to continue to attract and retain qualified personnel or develop and maintain relationships with clinical researchers.

The marketability of our product candidates may depend on reimbursement and reform measures in the health care industry.

Our success may depend, in part, on the extent to which reimbursement for the costs of therapeutic product candidates and related treatments will be available from third-party payors such as United States and similar international government health administration authorities, private health insurers, managed care programs and other organizations. Over the past decade, the cost of health care has risen significantly, and there have been numerous proposals by legislators, regulators and third-party health care payors to curb these costs. Some of these proposals have involved limitations on the amount of reimbursement for certain products and product candidates. For example, in July 2004, the Centers for Medicare and Medicaid Services (CMS) posted a proposed rule outlining revisions to payment policies under the physician fee schedule for calendar year 2005 which would implement many provisions of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003. The proposed rule makes changes to the payment policy and may impact the reimbursement of oncology products. If the proposed rule is implemented, the amount we may be reimbursed for Medicare and Medicaid patients using our products could be negatively affected, and this could, in turn, impact the amount of reimbursement from other healthcare payors and the prices of our products. We cannot guarantee that similar United States federal or state or similar international health care legislation and policies will not be adopted in the future or that any product candidates sought to be commercialized by us will be considered cost-effective or that adequate third-party insurance coverage will be available for us to establish and maintain price levels sufficient for realization of an appropriate return on our investment in product development. Moreover, the existence or threat of cost control measures could have an adverse effect on the willingness of potential collaborators to pursue research and development programs related to our product candidates.

We may engage in strategic transactions, which could adversely affect our business.

From time to time we consider strategic transactions and alternatives with the goal of maximizing stockholder value. These potential transactions may include a variety of different business arrangements, including spin-offs, acquisitions, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments. We cannot assure you that any such transactions will be consummated on favorable terms or at all, will in fact enhance stockholder value, or will not adversely affect our business or the trading price of our stock. Any such transactions may require us to incur non-recurring or other charges and may pose significant integration challenges and/or management and business disruptions, any of which could materially and adversely affect our business and financial results.

We have been named as a defendant in litigation that could result in substantial costs and divert management’s attention and resources.

In October 2001 and May 2002, certain former shareholders of Cytovia filed complaints in California Superior Court in San Diego, against us and two of our officers, alleging fraud and negligent misrepresentation in connection with our acquisition of Cytovia. A binding arbitration proceeding with the American Arbitration Association was held in May 2003. The three-member arbitration panel rejected all of the plaintiffs’ claims, determined that we have no liability for such claims and awarded recovery of our reasonable attorneys’ fees and costs of approximately $922,000 as prevailing party in the proceedings. In December 2003, the decision was confirmed by the Superior Court, which entered a judgment to this effect. In June 2004, the plaintiffs filed an Appeal, which the Company is vigorously opposing.

No assurances can be made that we will be successful in our defense of the pending claims. If we are not successful in our defense of such claims, we could be forced to make significant payments to the plaintiffs and defense lawyers, and such payments could have a material adverse effect on our business, financial condition and results of operations if not covered by our insurance carrier. Even if our defense against such claims is successful, the litigation could result in substantial costs and divert management’s attention and resources, which could adversely affect our business.

Our stock price may be highly volatile due to external factors.

Our common stock currently trades on the Nasdaq National Market and on the OM Stockholm Exchange. Historically, our common stock has generally experienced relatively low daily trading volumes in relation to the aggregate number of shares outstanding. The Company currently has a $75 million shelf registration statement on file with the Securities and Exchange Commission. Sales of substantial amounts of our common stock in the public market could adversely affect the prevailing market prices of our common stock and our ability to raise equity capital in the future.

Factors that may have a significant impact on the market price or the liquidity of our common stock also include:

• actual or potential clinical trial results relating to drug candidates under development by us or our competitors;

• delays in our clinical testing and development schedules;

• events or announcements relating to our collaborative relationships;

• announcements of technological innovations or new products or drug candidates by us or our competitors;

• developments or disputes concerning patents or proprietary rights;

• regulatory developments in both the United States and other countries;

• economic and other external factors, disasters or crises, as well as period-to-period fluctuations in our financial results;

• market conditions for pharmaceutical and biotechnology stocks, whether or not related to results or news regarding us or our competitors; and

• publicity regarding actual or potential medical results relating to products or drug candidates under development by us or our competitors.

External factors may also adversely affect the market price for our common stock. The price and liquidity of our common stock may be significantly affected by the overall trading activity and market factors on the Nasdaq National Market and the OM Stockholm Exchange, and these factors may differ between the two markets. In addition, the securities markets have from time to time experienced significant price and volume fluctuations that may be unrelated to the operating performance of particular companies. The market prices of the common stock of many publicly traded pharmaceutical or biotechnology companies have in the past been, and can in the future be expected to be, especially volatile.

Certain anti-takeover provisions in our charter, by-laws, shareholder rights plan and under Delaware law may deter a third party from acquiring us, even though such acquisition may be beneficial to our stockholders.

Certain provisions of our charter and by-laws may make it more difficult for a third party to acquire control of us, even though such acquisition may be beneficial to our stockholders. These provisions include, but are not limited to:

• a staggered or classified board;

• the inability of stockholders to act by written consent; and

• no right to remove directors other than for cause.

We have also adopted a shareholder rights plan or “poison pill.” Our shareholder rights plan is designed to protect our shareholders in the event of an unsolicited bid to acquire the Company. In general terms, the rights plan imposes a significant penalty upon any person or group that acquires 15% or more of our outstanding common stock without the approval of our board of directors. Our shareholder rights plan could discourage a third party from attempting to acquire us through an acquisition of our outstanding voting stock, even though such acquisition may be beneficial to our stockholders.

Our board of directors also has the authority to issue, at any time, without further stockholder approval, up to 5,000,000 shares of preferred stock, and to determine the price, rights, privileges and preferences of those shares. These preferred shares are available to be used in

connection with our shareholder rights plan. Any issuance of preferred stock could discourage a third party from acquiring a majority of our outstanding voting stock.

Furthermore, we are subject to the provisions of Section 203 of the Delaware General Corporations Law, an anti-takeover law, which may also dissuade a potential acquiror, even though such acquisition may be beneficial to our stockholders.

Issuing preferred stock with rights senior to those of our common stock could adversely affect holders of common stock.

Our charter documents give our board of directors the authority to issue a series of preferred stock without a vote or action by our stockholders. The board also has the authority to determine the terms of preferred stock, including price, preferences and voting rights. The rights granted to holders of preferred stock may adversely affect the rights of holders of our common stock. For example, a series of preferred stock may be granted the right to receive a liquidation preference—a pre-set distribution in the event of a liquidation—that would reduce the amount available for distribution to holders of common stock. In addition, the issuance of preferred stock could make it more difficult for a third party to acquire a majority of our outstanding voting stock. As a result, common stockholders could be prevented from participating in transactions that would offer an optimal price for their shares.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The Company’s exposure to market risk is principally confined to its cash equivalents and investments that have maturities of less than three years. The Company maintains a non-trading investment portfolio of investment grade, liquid debt securities that limits the amount of credit exposure to any one issue, issuer or type of instrument. The securities in its investment portfolio are not leveraged, are classified as available-for-sale and are subject to interest rate risk. The Company currently does not hedge interest rate exposure. A hypothetical ten percent change in interest rates during the quarter ended June 30, 2004 would have resulted in approximately a $35,000 change in net loss. The Company has not used derivative financial instruments in its investment portfolio. There have been no significant changes in the types or maturities of investments held from September 30, 2003.

ITEM 4. CONTROLS AND PROCEDURES

The Company carried out an evaluation, under the supervision and with the participation of the Company’s management, including the Company’s President and Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures, as defined in Exchange Act Rule 13a-15(e), as of the end of the period covered by this report. Based upon that evaluation, the Company’s President and Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures are effective in enabling the Company to record, process, summarize and report information required to be included in the Company’s periodic filings with the Securities Exchange Commission within the required time period. There have

been no significant changes in the Company’s internal controls or in other factors that could significantly affect internal controls subsequent to the date the Company carried out its evaluation.

PART II–OTHER INFORMATION

Item 1. Legal Proceedings

On December 14, 2000 plaintiff Blake Martin, on behalf of himself and purportedly on behalf of a class of others similarly situated, filed a complaint in the United States District Court for the Southern District of California against the Company and two officers of the Company, alleging violations of federal securities laws related to declines in the Company’s stock price in connection with various statements and alleged omissions to the public and to the securities markets, and seeking damages therefore. In December 2003, the United States Federal Court granted the Company’s motion to dismiss the lawsuit with prejudice and without leave to amend, which was the third dismissal entered by the court in the case. On December 30, 2003, plaintiff Blake Martin exercised his right to appeal the decision of the United States District Court for the Southern District of California to the Ninth Circuit Court of Appeals. That appeal has been dropped, ending the litigation in favor of the Company.

Item 6. Exhibits and Reports on Form 8-K

a) Exhibits

10.1		First Amendment of Standard Office Lease dated April 30, 2004 between Alecta Pensionsförsäkring, Ömsesidigt, a Swedish Company, as Landlord, and the Registrant.
31.1		Certification by Larry G. Stambaugh, Chief Executive Officer, Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2		Certification by Anthony E. Altig, Chief Financial Officer, Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32		Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

b) Reports on Form 8-K

Date of Report	Description of Exhibit	Financial Statements Filed
May 4, 2004	Press Release: “Maxim	No
	Pharmaceuticals Announces
	2004 Second Quarter
	Financial Results”

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.

	MAXIM PHARMACEUTICALS, INC.
	By:	/s/ Anthony E. Altig
		Anthony E. Altig,
		Vice President, Finance and Chief Financial Officer
		(Principal Financial and Accounting Officer duly authorized to sign on behalf of the registrant)
Date: August 6, 2004