Extended patient follow-up in the CLL trial also showed that the duration of CR/nPR was significantly superior for patients treated with Genasense^® plus chemotherapy. As of June 2005, six of the eight patients (75%) who achieved CR/nPR with chemotherapy alone have relapsed compared with five of twenty patients (25%) in the Genasense^® treatment group. The median duration of CR/nPR was 22 months in the chemotherapy-alone group; the median had not been reached in the Genasense^® group (P=0.03). All CR/nPR responses were ‘‘durable’’ (i.e., exceeding six months duration). Additional analysis showed that patients who achieved CR/nPR also experienced substantial clinical benefit, especially with respect to improvement of disease-related symptoms. Several secondary endpoints were not improved by the addition of Genasense^®. For example, no difference was observed in overall response rate i.e., the percentage of patients who achieved CR/nPR plus partial response, or in time-to-disease progression. Overall survival will be formally evaluated in mid-2006 after all patients have completed a minimum of three years of follow-up. Adverse events (irrespective of relation to study drugs) during treatment or within 30 days from last dose of treatment that resulted in death occurred in nine patients treated with Genasense^® plus chemotherapy compared with five patients treated with chemotherapy alone. The percentage of patients who experienced serious adverse events was increased in the Genasense^® arm; however, the percentages of patients who discontinued treatment due to adverse events were equal in the treatment arms. The incidence of certain serious adverse reactions, including but not limited to nausea, fever and catheter-related complications, was increased in patients treated with Genasense^®.

On December 28, 2005, we completed submission of an NDA to the FDA that seeks accelerated approval for the use of Genasense^® in combination with fludarabine plus cyclophosphamide for the treatment of patients with relapsed or refractory CLL who have previously received fludarabine. Genasense^® had received Fast Track designation by the FDA in CLL, meaning that the indication represents an unmet medical need. Genasense^® had also been granted designation as an Orphan Drug by the FDA. On March 1, 2006, we announced that the NDA had been accepted for review by the FDA and set a target Prescription Drug User Fee Act (PDUFA) action date of October 29, 2006. However, acceptance of this NDA does not necessarily lead to FDA approval. We were notified by the FDA that we are scheduled to present our application in CLL to FDA’s Oncology Drug Advisory Committee (ODAC) on September 6, 2006. The advisory committee’s recommendations are not binding upon the FDA. Following its review of all our information concerning Genasense^®, the FDA may refuse to approve altogether, or the FDA may ask for more data to be obtained before approval can be reconsidered. Either of these two decisions by the FDA would have a material adverse effect on our business.

One of the requirements for Accelerated Approval is that the Company will be required to conduct a confirmatory trial. We have formulated a design for such a trial, which has completed a Special Protocol Assessment (SPA) by the FDA. The SPA indicates an agreement by the FDA that the protocol fulfills certain regulatory requirements regarding design and analysis. We anticipate that the trial will initiate patient enrollment during 2006. Although Fast Track designation, Orphan Drug designation and Accelerated Approval provisions are beneficial, we cannot assure you that the NDA will be approved.

In late 2003, we filed an NDA with the FDA for Genasense^® as a treatment combined with chemotherapy for patients with advanced malignant melanoma. In May 2004, the application failed to gain a majority vote for marketing approval from ODAC. As a consequence, we withdrew the NDA, which allows us to potentially resubmit the application. However, we continued long-term follow-up of patients who were enrolled in the advanced malignant melanoma trial. On May 16, 2005, we announced updated data from this trial. The updated data continued to show statistical significance for overall response, complete response and progression free survival. Statistical significance was also achieved for durable response (P=0.02). We commissioned a new, independent review of the X-rays that documented the major responses, which confirmed the originally reported responses with high concordance. Overall survival by intent-to-treat analysis did not yield a statistically significant improvement (P=0.077). Our analysis also identified a statistically significant treatment interaction effect for blood levels of an enzyme known as LDH, which was a prospectively specified stratification factor. When this effect was analyzed by treatment arm, survival was significantly superior for patients who received Genasense^® (P=0.018) and who did not have an elevation in LDH at study entry (n=508).

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On January 3, 2006, we announced that we had completed a Marketing Authorization Application (MAA) to the EMEA, which seeks approval for use of Genasense^® plus dacarbazine for the treatment of patients with advanced melanoma who have not previously received chemotherapy. On February 1, 2006, we announced that we had received notice from the EMEA that our MAA had been validated for review by the EMEA, which signals the start of formal scientific assessment. As part of this process, we received scientific questions from EMEA in June 2006 and expect to make a formal response to these questions in the third quarter of 2006.

In November 2004, we reported that our randomized Phase 3 clinical trial of Genasense^® in patients with multiple myeloma did not meet our primary endpoint. The trial had been designed to evaluate whether the addition of Genasense^® to standard therapy with high-dose dexamethasone could increase the time to development of progressive disease in patients who previously had received extensive therapy. Based on the results of the Phase 3 trial, we have no plans to submit an NDA in this indication at the current time. We have not yet determined what additional clinical trials, if any, may be undertaken in patients with multiple myeloma.

In addition, we are conducting (under our own sponsorship or in conjunction with various cooperative groups) randomized trials in non-small cell lung cancer, small cell lung cancer, acute myeloid leukemia and hormone refractory prostate cancer. We are also conducting a number of non-randomized clinical trials in patients with various types of cancer, either under our own sponsorship or in collaboration with the National Cancer Institute.

On March 23, 2006, we entered into an exclusive, worldwide licensing agreement with Emisphere Technologies, Inc. to develop an oral formulation of a gallium-containing compound. Ganite^® (gallium nitrate injection), Genta’s only commercialized product, is derived from this class of compounds. Under the terms of the new agreement, we will pay Emisphere up to $24 million only upon the achievement of certain milestones during the course of product development and royalties based upon sales. Emisphere will utilize its proprietary oral delivery technology, eligen^®, to supply a finished oral dosage form to Genta. We will reimburse Emisphere for time and expenses, as incurred, to create the oral dosage formulation. We will be responsible for toxicology, clinical development, regulatory submissions, and worldwide commercialization. The agreement is in effect until the later of (a) receipt of initial regulatory approval or (b) expiration of all royalty and payment obligations.

In April 2002, we entered into a series of agreements with Aventis regarding the development and commercialization of Genasense^®. On November 8, 2004, we received from Aventis notice of termination of the agreements between Genta and Aventis. On May 10, 2005, we announced that Genta and Aventis had signed an agreement to finalize the termination of their development and commercialization collaboration for Genasense^®. Among other provisions, the Standstill and Voting Agreement and Registration Rights Agreement that were established pursuant to the Aventis investment in Genta common stock in 2002 were not terminated at that time.

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Results of Operations for the Three Months Ended June 30, 2006 and 2005

			Summary Operating Results For the three months ended June 30,
($ in thousands)									Increase (Decrease)
			2006						$						%						2005
Revenues:
License fees and royalties				$	—					$	(1,556	)					(100	%)				$	1,556
Development funding					—						(6,234	)					(100	%)					6,234
Product sales − net					379						282						291	%					97
Total revenues					379						(7,508	)					(95	%)					7,887
Cost of goods sold					22						25						833	%					(3	)
Operating expenses:
Research and development					8,637						3,086						56	%					5,551
Selling, general and administrative					6,716						2,081						45	%					4,635
Total operating expenses − gross					15,353						5,167						51	%					10,186
Less: Aventis reimbursement					—						2,838						100	%					(2,838	)
Total operating expenses − net					15,353						8,005						109	%					7,348
Gain on forgiveness of debt					—						(1,297	)					(100	%)					1,297
Other income, net					354						274						343	%					80
Net (loss)/income				$	(14,642	)					($16,561	)					(863	%)				$	1,919

Total revenues

Total revenues were $0.4 million for the three months ended June 30, 2006 compared with $7.9 million for the three months ended June 30, 2005. License fees and development funding revenues of $7.8 million for the three months ended June 30, 2005 were generated by the recognition of the initial $10.0 million licensing fee and $40.0 million development funding received from Aventis in 2002 under the Collaborative Agreement. On November 8, 2004, Aventis gave six-months notice to Genta that it was terminating its Collaborative Agreement with us regarding the development and commercialization of Genasense^®. We had previously determined that, due to the nature of the ongoing development work related to the Collaborative Agreement, the end of the development phase and the fair-value of the undelivered elements were not determinable. Accordingly, we deferred recognition of the initial licensing fee and up-front development funding received from Aventis and recognized these payments on a straight-line basis over the original estimated useful life of the related first-to-expire patent of 115 months. As a result of the notice of termination of the Collaborative Agreement, we determined that the remaining deferred revenue should be recognized over the termination period. On November 9, 2004, we began to recognize the remaining deferred revenue over the six-month period ended May 8, 2005.

Product sales-net are generated from sales of Ganite^®, the Company’s commercial product for the treatment of cancer-related hypercalcemia. Product sales-net for the three months ended June 30, 2006 were $0.4 million, primarily impacted by a $0.3 million favorable adjustment to provision for returns of Ganite^®. In the second quarter of 2006, the Company revised its forecast of expected Ganite^® returns based on actual experience to date, product expiration dates and data obtained from wholesalers. As a result, the Company reduced its sales provision by $0.3 million, to reflect this change in estimate. Product sales-net in the prior-year period were $0.1 million.

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Research and development expenses

Research and development expenses before reimbursement were $8.6 million for the three months ended June 30, 2006 compared with $5.6 million for the three months ended June 30, 2005. The increase is primarily due to manufacturing expenses to prepare for the production of Genasense^® and expenses to prepare for regulatory review. Research and development expenses in 2006 also include the recognition of $0.2 million of stock option expense, resulting from the adoption of SFAS 123R. During the three months ended June 30, 2006, approximately $7.8 million or 91% of research and development expenses were incurred on the Genasense^® project.

Due to the significant risks and uncertainties inherent in the clinical development and regulatory approval processes, the nature, timing and costs of the efforts necessary to complete projects in development are subject to wide variability. Results from clinical trials may not be favorable. Data from clinical trials are subject to varying interpretation and may be deemed insufficient by the regulatory bodies that review applications for marketing approvals. As such, clinical development and regulatory programs are subject to risks and changes that may significantly impact cost projections and timelines.

Selling, general and administrative expenses

Selling, general and administrative expenses were $6.7 million for the three months ended June 30, 2006 compared with $4.6 million for the three months ended June 30, 2005. The increase was primarily due to sales and marketing expenses incurred in preparation for the anticipated product launch of Genasense^®. We expect these expenses to continue to increase substantially in anticipation of possible approval and product launch of Genasense^®. Selling, general and administrative expenses in 2006 also include the recognition of $0.7 million of stock option expense, resulting from the adoption of SFAS 123R.

Aventis reimbursement

On May 10, 2005, we announced that Genta and Aventis had finalized a termination agreement, providing for no future financial obligations by either party. Consequently, none of the research and development expenses incurred by us during the three-month period ended June 30, 2006 were reimbursable.

Gain on Forgiveness of Debt

In May 2005, pursuant to the terms of the Collaborative Agreement with Aventis, $2.8 million of reimbursable costs accrued and owed to us by Aventis were applied against the line of credit with Aventis and the remaining balance of $1.3 million was forgiven.

Other income, net

Net other income of $0.4 million for the three months ended June 30, 2006 increased from $0.1 million for the three months ended June 30, 2005, primarily due to higher interest income resulting from higher investment balances.

Net (loss)/income

We recorded a net loss of $14.6 million, or $0.11 per share, for the three months ended June 30, 2006, compared with net income of $1.9 million, or $0.02 per share, for the three months ended June 30, 2005. The decrease is primarily due to the fact that the prior-year period included revenues of $7.8 million from the recognition of the license fee and development funding and $2.8 million from the reimbursement for research and development expenses, along with higher operating expenses in 2006, as described above.

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Results of Operations for the Six Months Ended June 30, 2006 and 2005

			Summary Operating Results For the six months ended June 30,
($ in thousands)									Increase (Decrease)
			2006						$						%						2005
Revenues:
License fees and royalties				$	—					$	(5,241	)					(100	%)				$	5,241
Development funding					—						(20,988	)					(100	%)					20,988
Product sales − net					446						274						160	%					172
Total revenues					446						(25,955	)					(99	%)					26,401
Cost of goods sold					38						26						217	%					12
Operating expenses:
Research and development					13,387						3,966						42	%					9,421
Selling, general and administrative					12,173						3,552						42	%					8,621
Total operating expenses − gross					25,560						7,518						42	%					18,042
Less: Aventis reimbursement					—						6,090						100	%					(6,090	)
Total operating expenses − net					25,560						13,608						114	%					11,952
Gain on forgiveness of debt					—						(1,297	)					(100	%)					1,297
Other income, net					614						404						193	%					210
Net (loss)/income				$	(24,538	)				$	(40,482	)					(254	%)				$	15,944

Total revenues

Total revenues were $0.4 million for the six months ended June 30, 2006 compared with $26.4 million for the six months ended June 30, 2005. License fees and development funding revenues of $26.2 million for the six months ended June 30, 2005 were generated by the recognition of the initial $10.0 million licensing fee and $40.0 million development funding received from Aventis in 2002 under the Collaborative Agreement.

Product sales-net of Ganite^® for the six months ended June 30, 2006 were $0.4 million, primarily impacted by a $0.3 million favorable adjustment to provision for returns of Ganite^®. In the second quarter of 2006, the Company revised its forecast of expected Ganite^® returns based on actual experience to date, product expiration dates and data obtained from wholesalers. As a result, the Company reduced its sales provision by $0.3 million, to reflect this change in estimate. Product sales-net in the prior-year period were $0.2 million.

Research and development expenses

Research and development expenses before reimbursement were $13.4 million for the six months ended June 30, 2006 compared with $9.4 million for the six months ended June 30, 2005. The increase in expenses is primarily due to manufacturing expenses to prepare for the production of Genasense^® and expenses to prepare for regulatory review. In addition, expenses in 2006 include the recognition of $0.4 million of stock option expense, resulting from the adoption of SFAS 123R. During the six months ended June 30, 2006, approximately $12.2 million or 91% of research and development expenses were incurred on the Genasense^® project.

Selling, general and administrative expenses

Selling, general and administrative expenses were $12.2 million for the six months ended June 30, 2006 compared with $8.6 million for the six months ended June 30, 2005. The increase in expenses is primarily due to sales and marketing expenses incurred in preparation for the anticipated product launch of Genasense^®. In addition, expenses in 2006 include the recognition of $1.0 million of stock option expense, resulting from the adoption of SFAS 123R.

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Other income, net

Net other income of $0.6 million for the six months ended June 30, 2006 increased from $0.2 million for the six months ended June 30, 2005, primarily due to higher interest income and realized gains on the maturity of marketable securities resulting from higher investment balances.

Net (loss)/income

We recorded a net loss of $24.5 million, or $0.19 per share, for the six months ended June 30, 2006, compared with net income of $15.9 million, or $0.17 per share, for the six months ended June 30, 2005. The decrease is primarily due to the fact that the prior-year period included revenues of $26.2 million from the recognition of the license fee and development funding and $6.1 million from the reimbursement for research and development expenses, along with higher operating expenses in 2006, as described above.

Liquidity and capital resources

At June 30, 2006, we had cash, cash equivalents and marketable securities totaling $35.8 million compared with $21.3 million at December 31, 2005. Cash used in operating activities was $23.0 million for the six months ended June 30, 2006, compared with $21.6 million for the six months ended June 30, 2005, reflecting additional spending in anticipation of potential commercial approval and product launch of Genasense^®.

Management anticipates an increase in spending in upcoming months up to an average rate of approximately $5 million per month. The Company should have sufficient cash funds to maintain its present operations into the first quarter of 2007.

We have prepared our financial statements under the assumption that the Company is a going concern. The Company’s recurring losses and negative cash flows from operations raise substantial doubt about its ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty, (see Item 1A, Risk Factors).

On March 13, 2006, we sold 19.0 million shares of the Company’s common stock at a price of $2.15 per share for gross proceeds of $40.9 million, before fees and expenses. After deducting fees and expenses, we received net proceeds of $37.7 million.

If the NDA for Genasense^® is approved, management anticipates that it will require additional cash if we undertake to launch the product in the U.S. in the fourth quarter of 2006 in order to maximize the commercial opportunity. We have commenced discussions with several companies regarding partnerships for the further development and commercialization of Genasense^®. Those discussions are currently ongoing. Additional alternatives available to the Company to subsequently sustain its operations include financing arrangements with potential corporate partners, debt financing, asset-based loans, royalty-based financing, equity financing and other sources. However, there can be no assurance that any such collaborative agreements or other sources of funding will be available on favorable terms, if at all.

If we obtain NDA approval of Genasense^® for one or more applications, we anticipate seeking additional product development opportunities through potential acquisitions or investments. Such acquisitions or investments may consume cash reserves or require additional cash or equity. Our working capital and additional funding requirements will depend upon numerous factors, including: (i) the progress of our research and development programs; (ii) the timing and results of pre-clinical testing and clinical trials; (iii) the level of resources that we devote to sales and marketing capabilities; (iv) technological advances; (v) the activities of competitors; (vi) our ability to establish and maintain collaborative arrangements with others to fund certain research and development efforts, to conduct clinical trials, to obtain regulatory approvals and, if such approvals are obtained, to manufacture and market products and (vii) legal costs and the outcome of outstanding legal proceedings.

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Recent Accounting Pronouncements

Effective January 1, 2006, we adopted the fair value recognition provisions of SFAS 123R, Share-Based Payment, using the modified prospective transition method and therefore did not restate results for prior periods. Prior to January 1, 2006 we accounted for share-based compensation arrangements in accordance with APB Opinion No. 25, Accounting for Stock Issued to Employees and complied with the disclosure provisions of SFAS 123, Accounting for Stock-Based Compensation. SFAS 123R requires all public entities that used the fair-value method for either recognition or disclosure under SFAS 123 to apply the modified prospective transition method as of the required effective date. As a result, we adopted the provisions of SFAS 123R using this method, effective January 1, 2006. Under the modified prospective method, new awards are valued and accounted for prospectively upon adoption. Outstanding prior awards that are unvested as of January 1, 2006 are recognized as compensation cost over the remaining requisite service periods, as prior periods may not be restated. The adoption of SFAS 123R increased our expenses and reported net loss by $0.8 million and $1.4 million for the three and six months ended June 30, 2006, respectively.

In July 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation No. 48 (FIN 48), ‘‘Accounting for Uncertainty in Income Taxes.’’ FIN 48 prescribes detailed guidance for the financial statement recognition, measurement and disclosure of uncertain tax positions recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109, ‘‘Accounting for Income Taxes.’’ Tax positions must meet a more-likely-than-not recognition threshold at the effective date to be recognized upon the adoption of FIN 48 and in subsequent periods.

FIN 48 will be effective for fiscal years beginning after December 15, 2006 and the provisions of FIN 48 will be applied to all tax positions upon initial adoption of the Interpretation. The cumulative effect of applying the provisions of this Interpretation will be reported as an adjustment to the opening balance of retained earnings for that fiscal year. The company is currently evaluating the potential impact of FIN 48 on its financial statements.

Item 3.    Quantitative and Qualitative Disclosures about Market Risk

Our carrying values of cash and cash equivalents, marketable securities, accounts payable and accrued expenses are a reasonable approximation of their fair value. The estimated fair values of financial instruments have been determined by us using available market information and appropriate valuation methodologies (see Note 2 to our Consolidated Financial Statements). We have not entered into and do not expect to enter into, financial instruments for trading or hedging purposes. We do not currently anticipate entering into interest rate swaps and/or similar instruments.

Our primary market risk exposure with regard to financial instruments is to changes in interest rates, which would impact interest income earned on such instruments. We have no material currency exchange or interest rate risk exposure as of June 30, 2006.

Item 4.    Controls and Procedures

Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures

As required by Rule 13a-15(b), Genta’s Chief Executive Officer and Chief Financial Officer conducted an evaluation as of the end of the period covered by this report of the effectiveness of the Company’s ‘‘disclosure controls and procedures’’ (as defined in Exchange Act Rule 13a-15(e)). Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures were operating effectively as of the end of the period covered by this report.

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Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Exchange Act Rule 13a-15 that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II    OTHER INFORMATION

Item 1.    Legal Proceedings

In 2004, numerous complaints were filed in the United States District Court for the District of New Jersey against Genta and certain of its principal officers on behalf of purported classes of the Company’s shareholders who purchased its securities during several class periods. The complaints have been consolidated into a single action and allege that the Company and certain of its principal officers violated the federal securities laws by issuing materially false and misleading statements regarding Genasense^® for the treatment of malignant melanoma that had the effect of artificially inflating the market price of our securities. The shareholder class action complaint in the various actions seeks monetary damages in an unspecified amount and recovery of plaintiffs’ costs and attorneys’ fees. On September 30, 2005, the court granted in part and denied in part the Company’s motion to dismiss the plaintiffs’ complaint. The court dismissed plaintiffs’ claim that the defendants engaged in a scheme or artifice to defraud plaintiffs, but allowed plaintiffs’ claims to proceed with respect to their allegations that defendants issued false and misleading public statements about Genasense^®. The case has proceeded to discovery.

In addition, two separate shareholder derivative actions have been filed against the directors and certain officers of Genta in New Jersey State and Federal courts. The Federal shareholder derivative action was consolidated with the securities action. Genta has reached an agreement in principle with the Federal shareholder derivative plaintiffs to settle the Federal Shareholder derivative action. The settlement has been submitted to the court for approval and we are waiting for a determination.

Based on facts substantially similar to those asserted in the shareholder class actions, the State derivative plaintiffs claim that defendants have breached their fiduciary duties to the shareholders and committed other violations of New Jersey law. On February 9, 2006, the Superior Court of New Jersey dismissed the plaintiffs’ derivative complaint in the New Jersey State case based in part on plaintiffs’ failure to make a pre-suit demand on Genta's Board of Directors and in part based on plaintiffs’ failure to state a cause of action. Plaintiffs’ motion for reconsideration was denied and they have filed a notice of appeal. 

The Company believes these litigations are without merit and will continue to vigorously defend against these suits.

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Item 1A.    Risk Factors

You should carefully consider the following risks and all of the other information set forth in this Form 10-Q and the Form 10-K for the year ended December 31, 2005 before deciding to invest in shares of our common stock. The risks described below are not the only ones facing our Company. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations.

        Risks Related to Our Business

We may be unsuccessful in our efforts to obtain approval from the FDA or EMEA and commercialize Genasense^® or our other pharmaceutical products.

The commercialization of our pharmaceutical products involves a number of significant challenges. In particular, our ability to commercialize products, such as Ganite^® and Genasense^®, depends, in large part, on the success of our clinical development programs, our efforts to obtain regulatory approvals and our sales and marketing efforts directed at physicians, patients and third-party payors. A number of factors could affect these efforts, including:

	•	our ability to demonstrate clinically that our products are useful and safe in particular indications;

	•	delays or refusals by regulatory authorities in granting marketing approvals;

	•	our limited financial resources and sales and marketing experience relative to our competitors;

	•	actual and perceived differences between our products and those of our competitors;

	•	the availability and level of reimbursement for our products by third-party payors;

	•	incidents of adverse reactions to our products;

	•	side effects or misuse of our products and the unfavorable publicity that could result; and

	•	the occurrence of manufacturing, supply or distribution disruptions.

We cannot assure you that Genasense^® will receive FDA or EMEA approval. Our financial condition and results of operations have been and will continue to be significantly affected by FDA and EMEA action with respect to Genasense^®. Any adverse events with respect to FDA and/or EMEA approvals could negatively impact our ability to obtain additional funding or identify potential partners.

For example, on January 3, 2006, we announced that we had completed a Marketing Authorization Application, or MAA, to the EMEA that seeks approval for use of Genasense^® plus dacarbazine for the treatment of patients with advanced melanoma who have not previously received chemotherapy. The centralized licensing procedure provides a single marketing authorization that is valid in all 25-member states of the European Community. Review of the application is coordinated by the EMEA, and Spain and France have been appointed as rapporteur and co-rapporteur countries, respectively. On February 1, 2006, we announced that we had received notice from the EMEA that its MAA had been validated for review by the EMEA, which signals the start of formal scientific assessment. As part of this process, we received scientific questions from EMEA in June 2006 and expect to make a formal response to these questions in the third quarter of 2006.

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On December 28, 2005, we completed submission of an NDA to the FDA that sought accelerated approval for the use of Genasense^® in combination with fludarabine plus cyclophosphamide for the treatment of patients with relapsed or refractory CLL who have previously received fludarabine. Genasense^® has received Fast Track designation by the FDA in CLL, meaning that the indication represents an unmet medical need. Genasense^® has also been granted designation as an Orphan Drug by the FDA. On March 1, 2006, we announced that the NDA had been accepted for review by the FDA with a target action date of October 29, 2006. However, acceptance of this NDA does not necessarily lead to FDA approval. After reviewing in May 2005 a summary of our preliminary clinical data that were released in November 2004 from our CLL trial, the FDA expressed concern that simply achieving statistical significance in the primary endpoint (complete plus nodular partial responses [CR/nPR]) may not be likely to convey or predict clinical benefit, particularly absent improvement in time-to-progression. Subsequent to preparation of the preliminary data summary, we compiled additional information to support our claims of clinical benefit. First, the proportion of patients who relapsed from CR/nPR increased substantially over time from 25% to 75% in the patient group treated with chemotherapy alone. By contrast, the comparable increase in the Genasense^® group was 16% to 25%, which indicated lower risk of relapse. Second, the preliminary clinical data indicated that the median duration of CR/nPR had not been reached in either treatment group. Further follow-up showed that CR/nPRs achieved with the addition of Genasense^® to chemotherapy were significantly longer when compared with those responses achieved with chemotherapy alone. For example, the median CR/nPR duration in the chemotherapy alone group was reached at 22 months, whereas the median has still not been reached in the Genasense^® group [P=0.03]. Third, we had prospectively collected data regarding specific parameters of disease-related morbidity, including but not limited to symptoms. Subsequent analysis of these data showed that patients in the Genasense^® treatment group who achieved CR/nPR also attained substantial improvement in these disease parameters. The NDA that was submitted by us in December 2005, which includes these data, was subsequently accepted for review by the FDA in February 2006.

We were notified by the FDA that we are scheduled to present our application in CLL to FDA’s ODAC on September 6, 2006. The advisory committee’s recommendations are not binding upon the FDA. Following its review of all our information concerning Genasense^®, the FDA may refuse to approve altogether, or may ask for more data to be obtained, so that approval can be reconsidered. Any of these decisions by the FDA would have a material adverse effect on our business. One requirement for Accelerated Approval is that we will be required to conduct a confirmatory trial. We have formulated a design for such a trial, which has completed a SPA by FDA. The SPA indicates an agreement by FDA that the protocol fulfills certain regulatory requirements regarding design and analysis. We anticipate that the trial will initiate patient enrollment during 2006. Although Fast Track designation, Orphan Drug designation and Accelerated Approval provisions are beneficial, we cannot assure you that the NDA will be approved. In particular, the FDA may not be satisfied that achievement of the primary endpoint used in our recent clinical trial, which was an increased proportion of complete responses/nodular partial responses compared to patients treated with standard chemotherapy, is a sufficient basis for approval. Further, increased symptom-free time may not be considered to be sufficient demonstration of clinical benefit.

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Ultimately, our efforts may not prove to be as effective as those of our competitors. In the United States and elsewhere, our products will face significant competition. The principal conditions on which our product development efforts are focused and some of the other disorders for which we are conducting additional studies, are currently treated with several drugs, many of which have been available for a number of years or are available in inexpensive generic forms. Thus, even if we obtain regulatory approvals, we will need to demonstrate to physicians, patients and third-party payors that the cost of our products is reasonable and appropriate in light of their safety and efficacy, the price of competing products and the relative health care benefits to the patient. If we are unable to demonstrate that the costs of our products are reasonable and appropriate in light of these factors, we will likely be unsuccessful in commercializing our products.

Recurring losses and negative cash flows from operations raise substantial doubt about our ability to continue as a going concern.

Our recurring losses from operations and negative cash flows from operations raise substantial doubt about our ability to continue as a going concern and as a result, our independent registered public accounting firm included an explanatory paragraph in its report on our consolidated financial statements for the year ended December 31, 2005 with respect to this uncertainty. Substantial doubt about our ability to continue as a going concern may create negative reactions to the price of the common shares of our stock and we may have a more difficult time obtaining financing.

We have prepared our financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should we be unable to continue in existence.

Our business will suffer if we fail to obtain timely funding. We may be unable to raise additional capital when needed and may not continue as a going concern.

Our operations to date have required significant cash expenditures. As a result of Aventis’ termination of the Collaborative Agreement, after May 8, 2005, we became solely responsible for all Genasense^® related costs. Our future capital requirements will depend on the results of our research and development activities, preclinical studies and clinical trials, competitive and technological advances, and regulatory activities of the FDA and other regulatory authorities. In order to commercialize our products, we will need to raise additional funds. On March 13, 2006, we sold 19.0 million shares of the Company’s common stock at a price of $2.15 per share, raising $37.7 million, net of fees and expenses. During the six month period ended June 30, 2006, cash used in operating activities was $23.0 million.

Management anticipates an increase in spending in upcoming months up to an average rate of approximately $5 million per month. The Company should have sufficient cash funds to maintain its present operations into the first quarter of 2007.

We will need to obtain more funding in the future through collaborations or other arrangements with research institutions and corporate partners or public and private offerings of our securities, including debt or equity financing. We may not be able to obtain adequate funds for our operations from these sources when needed or on acceptable terms. Future collaborations or similar arrangements may require us to license valuable intellectual property to, or to share substantial economic benefits with, our collaborators. If we raise additional capital by issuing additional equity or securities convertible into equity, our stockholders may experience dilution and our share price may decline. Any debt financing may result in restrictions on our spending.

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If we are unable to raise additional funds, we will need to do one or more of the following:

	•	delay, scale back or eliminate some or all of our research and product development programs and sales and marketing activity;

	•	license third parties to develop and commercialize products or technologies that we would otherwise seek to develop and commercialize ourselves;

	•	attempt to sell our company;

	•	cease operations; or

	•	declare bankruptcy.

We intend to be a direct marketer of some products in the United States. This effort will consume large amounts of our resources and management time and we may not be successful in our efforts.

Currently we do not have a sales force. Our sales force was eliminated in 2004 following our decision to withdraw the NDA for Genasense^® for the treatment of advanced melanoma. We intend to recruit a sales force in the second half of 2006. In January 2006, we announced that we had appointed W. Lloyd Sanders as Vice-President of Sales and Marketing. Most recently, Mr. Sanders was Vice President, Oncology Sales, at sanofi-aventis Group. We have hired a core team of seasoned managers in sales and marketing. If we are unable to recruit a sales force capable of marketing our products, our sales will be adversely affected, and the commercial success of our products will be limited.

On May 10, 2005, we announced that we and Aventis Pharmaceuticals Inc., part of sanofi-aventis Group, or Aventis, had signed an agreement to terminate their development and commercialization collaboration for Genasense^®. We lost a significant source of funding for Genasense^® as a result of this termination.

In April 2002, we entered into a series of agreements relating to the development and commercialization of Genasense^®, to which we refer collectively as the Collaborative Agreement, with Aventis and its affiliates. On November 8, 2004, we received from Aventis a notice of termination of the Collaborative Agreement. On May 10, 2005, we announced that we had signed an agreement with Aventis to terminate our development and commercialization collaboration for Genasense^®. The termination agreement provided for no future financial obligations by either party. Aventis also returned its then current inventory of Genasense^® drug supply to us. In addition, we assumed responsibility for the randomized clinical trial of Genasense^® in combination with docetaxel (Taxotere^®; sanofi-aventis) in patients with hormone-refractory prostate cancer, which recently completed accrual. Among other provisions, the Standstill and Voting Agreement and Registration Rights Agreement that were established pursuant to the Aventis investment in our common stock in 2002 did not terminate at this time.

We are seeking a new partner for the development and commercialization of Genasense^®, and if we are unable to do so, we may not have sufficient resources to fully develop and commercialize Genasense^®.

If we are unable to identify a partner, we will be solely responsible for the development and commercialization of Genasense^®, including the costs associated therewith. We may not have sufficient resources to do so. Even if we are able to identify a partner, we may not be able to enter into an agreement on acceptable terms or at all.

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We have relied on and continue to rely on our contractual collaborative arrangements with research institutions and corporate partners for development and commercialization of our products. Our business could suffer if we are not able to enter into suitable arrangements, maintain existing relationships, or if our collaborative arrangements are not successful in developing and commercializing products.

We have entered into collaborative relationships relating to the conduct of clinical research and other research activities in order to augment our internal research capabilities and to obtain access to specialized knowledge and expertise. Our business strategy depends in part on our continued ability to develop and maintain relationships with leading academic and research institutions and with independent researchers. The competition for these relationships is intense, and we can give no assurances that we will be able to develop and maintain these relationships on acceptable terms.

We also seek strategic alliances with corporate partners, primarily pharmaceutical and biotechnology companies, to help us develop and commercialize drugs. Various problems can arise in strategic alliances. A partner responsible for conducting clinical trials and obtaining regulatory approval may fail to develop a marketable drug. A partner may decide to pursue an alternative strategy or focus its efforts on alliances or other arrangements with third parties. A partner that has been granted marketing rights for a certain drug within a geographic area may fail to market the drug successfully. Consequently, strategic alliances that we may enter into may not be scientifically or commercially successful. In this regard, in April 2002, we entered into a series of agreements relating to the development and commercialization of Genasense^® with Aventis and its affiliates. On November 8, 2004, we received from Aventis a notice of termination of the Collaborative Agreement. On May 10, 2005, we announced that we and Aventis had signed an agreement to terminate our development and commercialization collaboration for Genasense^® as described above.

We cannot control the resources that any collaborator may devote to our products. Any of our present or future collaborators may not perform their obligations as expected. These collaborators may breach or terminate their agreements with us, for instance upon changes in control or management of the collaborator, or they may otherwise fail to conduct their collaborative activities successfully and in a timely manner.

In addition, our collaborators may elect not to develop products arising out of our collaborative arrangements or to devote sufficient resources to the development, regulatory approval, manufacture, marketing or sale of these products. If any of these events occur, we may not be able to develop our products or commercialize our products.

An important part of our strategy involves conducting multiple product development programs. We may pursue opportunities in fields that conflict with those of our collaborators. In addition, disagreements with our collaborators could develop over rights to our intellectual property. The resolution of such conflicts and disagreements may require us to relinquish rights to our intellectual property that we believe we are entitled to. In addition, any disagreement or conflict with our collaborators could reduce our ability to obtain future collaboration agreements and negatively impact our relationship with existing collaborators. Such a conflict or disagreement could also lead to delays in collaborative research, development, regulatory approval or commercialization of various products or could require or result in litigation or arbitration, which would be time consuming and expensive, divert the attention of our management and could have a significant negative impact on our business, financial condition and results of operations.

        We anticipate that we will incur additional losses and we may never be profitable.

We have never been profitable. We have incurred substantial annual operating losses associated with ongoing research and development activities, preclinical testing, clinical trials, regulatory submissions and manufacturing activities. From the period since our inception to June 30, 2006, we have incurred a cumulative net loss of $382.7 million. We may never achieve revenue sufficient for us to attain profitability. Achieving profitability is unlikely unless Genasense^® receives approval from the FDA for commercial sale in one or more indications.

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        Our business depends heavily on a small number of products.

We currently market and sell one product, Ganite^® and the principal patent covering its use for the approved indication expired in April 2005. We do not expect to expand our marketed product portfolio significantly in the short term unless Genasense^® receives marketing approval. If Genasense^® is not approved, if approval is significantly delayed, or if in the event of approval the product is commercially unsuccessful, we do not expect significant sales of other products to offset this loss of potential revenue.

To diversify our product line in the long term, it will be important for us to identify suitable technologies and products for acquisition or licensing and development. If we are unable to identify suitable technologies and products, or if we are unable to acquire or license products we identify, we may be unable to diversify our product line and to generate long-term growth.

We may be unable to obtain or enforce patents, other proprietary rights and licenses to protect our business; we could become involved in litigation relating to our patents or licenses that could cause us to incur additional costs and delay or prevent our introduction of new drugs to market.

Our success will depend to a large extent on our ability to:

	•	obtain U.S. and foreign patent or other proprietary protection for our technologies, products and processes;

	•	preserve trade secrets; and

	•	operate without infringing the patent and other proprietary rights of third parties.

Legal standards relating to the validity of patents covering pharmaceutical and biotechnological inventions and the scope of claims made under these types of patents are still developing, and they involve complex legal and factual questions. As a result, our ability to obtain and enforce patents that protect our drugs is highly uncertain. If we are unable to obtain and enforce patents and licenses to protect our drugs, our business, results of operations and financial condition could be adversely affected.

We hold numerous U.S., foreign and international patents covering various aspects of our technology, which include novel compositions of matter, methods of large-scale synthesis and methods of controlling gene expression and methods of treating disease. In the future, however, we may not be successful in obtaining additional patents despite pending or future applications. Moreover, our current and future patents may not be sufficient to protect us against competitors who use similar technology. Additionally, our patents, the patents of our business partners and the patents for which we have obtained licensing rights may be challenged, narrowed, invalidated or circumvented. Furthermore, rights granted under our patents may not be broad enough to cover commercially valuable drugs or processes and therefore may not provide us with sufficient competitive advantage with respect thereto.

The pharmaceutical and biotechnology industries have been greatly affected by time-consuming and expensive litigation regarding patents and other intellectual property rights. We may be required to commence, or may be made a party to, litigation relating to the scope and validity of our intellectual property rights or the intellectual property rights of others. Such litigation could result in adverse decisions regarding the patentability of our inventions and products, the enforceability, validity or scope of protection offered by our patents or our infringement of patents held by others. Such decisions could make us liable for substantial money damages, or could bar us from the manufacture, sale or use of certain products. Moreover, an adverse decision may also compel us to seek a license from a third party. The costs of any license may be prohibitive and we may not be able to enter into any required licensing arrangement on terms acceptable to us.

The cost to us of any litigation or proceeding relating to patent or license rights, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of complex patent or licensing litigation more effectively than we can because of their substantially greater resources. Uncertainties resulting from the initiation and continuation of any patent or related litigation could have a material adverse effect on our ability to compete in the marketplace.

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We also may be required to participate in interference proceedings declared by the U.S. Patent and Tradem