c55265_10k.htm -- Converted by SEC Publisher, created by BCL Technologies Inc., for SEC Filing

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


 
FORM 10-K
     
[ X ]    ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES 
    EXCHANGE ACT OF 1934     
     
    For the fiscal year ended July 31, 2008 
     
[    ]    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES 
    EXCHANGE ACT OF 1934     
     
    For the transition period from__________ to __________
 
0-11088
Commission file number
 
ALFACELL CORPORATION
(Exact name of registrant as specified in its charter)
 
Delaware   22-2369085  
(State or other jurisdiction of    (I.R.S. Employer  
incorporation or organization)    Identification No.)  
       
300 Atrium Drive, Somerset, New Jersey
(Address of principal executive offices)
 
08873
(Zip Code)

Registrant’s telephone number, including area code: (732) 652-4525

Securities registered pursuant to Section 12(b) of the Act:

  Common Stock, $.001 par value   Nasdaq Capital Market  
  (Title of Class)    (Name of Exchange)  

Securities registered pursuant to Section 12(g) of the Act:
None

     Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [    ] No [ X ]

     Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes [    ] No [ X ]

     Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [ X ] No [    ]



     Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-(§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [    ]

     Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer or non-accelerated filer. See definitions of “accelerated filer” and “large accelerated filer” in Rule 12b-2 the Exchange Act. (Check one): Large Accelerated Filer [    ] Accelerated Filer [ X ] Non accelerated Filer [    ] Smaller Reporting Company [    ]

     Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes [    ] No [ X ]

     The aggregate market value of the common stock, par value $.001 per share, held by non-affiliates based upon the reported last sale price of the common stock on January 31, 2008, the end of the registrant’s second fiscal quarter, was approximately $94,601,000. As of October 10, 2008 there were 47,313,880 shares of common stock outstanding.

Documents Incorporated by Reference

     Certain information required in Part III of this annual report on Form 10-K is incorporated reference to portions of the registrant’s definitive proxy statement for its 2009 Annual Meeting Stockholders, which will be filed with the Securities and Exchange Commission not later than 120 days after the end of the registrant’s fiscal year.



TABLE OF CONTENTS

PART I        Page 
         
                   ITEM 1.    Business    5 
         
                   ITEM 1A    Risk Factors    17 
         
                   ITEM 1B    Unresolved Staff Comments    26 
         
                   ITEM 2.    Properties    27 
         
                   ITEM 3.    Legal Proceedings    27 
         
                   ITEM 4.    Submission of Matters to a Vote of Security Holders    27 
         
PART II         
                   ITEM 5.    Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities   
27 
         
                   ITEM 6.    Selected Financial Data    30 
         
                   ITEM 7.    Management's Discussion and Analysis of Financial Condition and Results of Operations   
31 
         
                   ITEM 7A.    Quantitative and Qualitative Disclosures About Market Risk    38 
         
                   ITEM 8.    Financial Statements and Supplementary Data    39 
         
                   ITEM 9.    Changes in and Disagreements with Accountants on Accounting and Financial Disclosure   
39 
         
                   ITEM 9A.    Controls and Procedures    39 
         
                   ITEM 9B.    Other Information    42 
         
PART III         
         
                   ITEM 10.    Directors, Executive Officers and Corporate Governance    42 
         
                   ITEM 11.    Executive Compensation    42 
         
                   ITEM 12.    Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters   
42 
         
                   ITEM 13.    Certain Relationships and Related Transactions and Director Independence    42 
         
                   ITEM 14.    Principal Accounting Fees and Services    42 
         
PART IV         
         
                   ITEM 15.    Exhibits and Financial Statement Schedules    42 

3


The following trademarks appear in this annual report on Form 10-K: ONCONASE® is the registered trademark of Alfacell Corporation, exclusively for its anti-cancer agent, Alimta® is the registered trademark of Eli Lilly, Zolinza® is the registered trademark of Merck & Co. and Avastin® is the registered trademark of Genentech.

This annual report on Form 10-K includes forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We have based these forward looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. These forward looking statements are subject to a number of risks, uncertainties, and assumptions about us, including, among other things:

  • the failure to obtain regulatory approval of our lead product;

  • the failure to achieve positive results in clinical trials;

  • competitive factors;

  • available financial resources and the ability to secure adequate funding for development projects;

  • the ability to attract and retain qualified management;

  • relationships with pharmaceutical and biotechnology companies;

  • the ability to develop safe and efficacious drugs;

  • variability of royalty, license, and other revenue;

  • the failure to satisfy the performance obligations in our agreements;

  • the ability to enter into future collaborative agreements;

  • uncertainty regarding our patents and patent rights (including the risk that we may be forced to engage in costly litigation to protect such patent rights and the material harm to us if there were an unfavorable outcome of any such litigation);

  • governmental regulation;

  • technological change;

  • changes in industry practices; and

  • one-time events.

In addition, in this annual report on Form 10-K, the words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar expressions, as they relate to us, our business, or our management, are intended to identify forward looking statements. All of our forward looking statements are qualified in their entirety by reference to the factors discussed in this document under the heading ITEM 1A.—RISK FACTORS, and any documents incorporated by reference that describe risks and factors that could cause results to differ materially from those projected in these forward looking statements.

We caution you that the risk factors contained herein are not exhaustive. We operate in a continually changing business climate which can be expected to impact our forward looking statements, whether as a result of new information, future events, or otherwise, after the date of this annual report. In light of these risks and uncertainties, the forward looking events and circumstances discussed in this annual report may not occur and actual results could differ materially from those anticipated or implied in the forward looking statements. Accordingly, you should not rely on forward looking statements as a prediction of actual results.

All information in this Form 10-K is as of October 10, 2008, unless otherwise noted and we undertake no obligation to update this information.

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PART I

ITEM 1.  BUSINESS.

BUSINESS OVERVIEW

     Alfacell Corporation is a Delaware corporation incorporated on August 24, 1981. We are a biopharmaceutical company primarily engaged in the discovery and development of a new class of therapeutic drugs for the treatment of cancer and other pathological conditions. Our proprietary drug discovery and development program consists of novel therapeutics which are being developed from amphibian ribonucleases (RNases).

     RNases are biologically active enzymes that split RNA molecules. RNases are enzymes which play important roles in nature, including the embryonic development of an organism and regulation of various cell functions. RNA is an essential bio-chemical cellular component necessary to support life. There are various types of RNA, all of which have specific functions in a living cell. They help control several essential biological activities, namely; regulation of cell proliferation, maturation, differentiation and cell death. Therefore, they are ideal candidates for the development of therapeutics for cancer and other life-threatening diseases, including HIV and autoimmune diseases, that require anti-proliferative and apoptotic, or programmed cell death, properties.

     ONCONASE® (ranpirnase) is a novel amphibian ribonuclease, unique among the superfamily of pancreatic ribonuclease, isolated from the eggs of the Rana pipiens (the Northern Leopard frog). Ranpirnase is the smallest known protein belonging to the superfamily of pancreatic ribonuclease and has been shown, on a molecular level, to re-regulate the unregulated growth and proliferation of cancer cells. Unlike most anti-cancer agents that attack all cells regardless of phenotype (malignant versus normal) and cause severe toxicities, ONCONASE® is not an indiscriminate cytotoxic drug (cell killing agent). ONCONASE® primarily affects exponentially growing malignant cells, with activity controlled through unique and specific molecular mechanisms.

     The molecular mechanisms which determine the apoptotic cell death induced by ranpirnase have been identified. tRNA (transfer RNA), rRNA (ribosomal RNA), mRNA (messenger RNA) and miRNA (micro RNA) are all different types of RNA with specific functions in a living cell. Ranpirnase preferentially degrades tRNA and targets miRNA, leaving rRNA and mRNA apparently undamaged. The RNA damage induced by ranpirnase appears to represent a “death signal”, or triggers a chain of molecular events culminating in the activation of proteolytic enzyme cascades which, in turn, induces disintegration of the cellular components and finally leads to cell death. It has been shown that there is a protein synthesis inhibition-independent component, which, together with the changes induced by the protein synthesis inhibition, results in tumor cell death.

     ONCONASE®, our lead drug product candidate, is currently being evaluated in human clinical trials for the treatment of various forms of cancer. Our most advanced clinical trial for ONCONASE® is a confirmatory Phase IIIb registration trial designed to evaluate the efficacy, safety and tolerability of the combination of ONCONASE® and doxorubicin as compared to doxorubicin alone in the treatment of patients with unresectable (inoperable) malignant mesothelioma (“UMM”), a rare and deadly form of lung cancer. Enrollment in the Phase IIIb trial was completed in September 2007. On May 28, 2008, we announced that the preliminary statistical analysis of data from our ONCONASE® confirmatory Phase IIIb clinical trial did not meet statistical significance for the primary endpoint of survival in UMM. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen, a predefined primary data set for this sub-group of patients in the trial. Based on the preliminary statistical analysis of the data, we have decided to continue with the planned submission of the remaining components of the ONCONASE® rolling New Drug Application or NDA for the treatment of this patient population, which represents a currently unmet medical need. The following table summarizes the current clinical development status of ONCONASE®.

Clinical Indications
 
Clinical Development Status
     
  Unresectable malignant mesothelioma     Completed – Preparing NDA
  Lung cancer and other solid tumors     Phase I/II

 

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     We believe that ONCONASE®, as well as another group of our amphibian RNases known as Amphinases, may also have applications in a variety of other areas in addition to those being investigated currently in our clinical development program. Amphinase is currently in the pre-clinical research and development stage.

     We are a development stage company as defined in the Financial Accounting Standards Board’s Statement of Financial Accounting Standards No. 7, “Accounting and Reporting by Development Stage Enterprises.” We are devoting substantially all of our present efforts to establishing a new business and developing new drug products. Our planned principal operations of marketing and/or licensing new drugs have not commenced and, accordingly, we have not derived any significant revenue from these operations.

MARKET OVERVIEW

     According to the American Cancer Society (“ACS”) 2008 Cancer Facts and Figures, cancer is the second leading cause of death in the United States, accounting for one in every four deaths. The ACS 2008 Cancer Facts and Figures also estimates that doctors will diagnose over 1.4 million new cases of cancer in the United States in 2008. The National Institutes of Health or NIH estimate that the annual cost of cancer in 2007 was approximately $219.2 billion, including $89.0 billion in direct medical costs and $18.2 billion for morbidity costs, which includes the cost of lost productivity.

     Cancer is characterized by uncontrolled cell division resulting in the growth of a mass of cells commonly known as a tumor. Cancerous tumors can arise in almost any tissue or organ and cancer cells, if not eradicated, spread, or metastasize, throughout the body. Cancer is believed to occur as a result of a number of factors, including hereditary and environmental factors.

     For the most part, cancer treatment depends on the type of cancer and the stage of disease progression. Generally, staging is based on the size of the tumor and whether the cancer has metastasized or spread. Following diagnosis, solid tumors are typically surgically removed or the patient is given radiation therapy. Chemotherapy is the principal treatment for tumors that are likely to, or have, metastasized. Chemotherapy involves the administration of drugs which are designed to kill cancer cells, affect the growth of tumors, or reduce bloodflow to tumors, in an effort to reduce or eliminate cancerous tumors.

     Because in most cases cancer is fatal, cancer specialists attempt to attack the cancer aggressively, with as many therapies as available and with as high a dose as the patient can tolerate. Since traditional chemotherapy attacks both normal and cancerous cells, treatment often tends to result in complicating side effects. Additionally, cells which have been exposed to several rounds of chemotherapy develop a resistance to the cancer drugs that are being administered. This is known as “multi-drug resistance.” The side effects of chemotherapy often limit the effectiveness of treatment. Cancers often recur and mortality rates remain high. Despite large sums of money spent on cancer research, current treatments are largely inadequate and improved anti-cancer agents are needed.

     The products we currently have under development target a broad range of solid tumors. The table below shows the incidence and mortality estimated for the year 2008 for various types of solid tumor cancers that our products seek to treat:

Cancer Indication    New Cases    Deaths 
 
  Lung (including mesothelioma)    232,270    166,280 
  Breast    184,450    40,930 
  Brain    21,810    13,070 
  Esophageal    16,470    14,280 
 
          Source: American Cancer Society, 2008 Cancer Facts and Figures

 

     UMM is the planned initial, or “gateway”, indication for ONCONASE®. Malignant mesothelioma is an aggressive tumor of serosal surfaces (e.g., pleura, peritoneum) that is often caused by exposure to asbestos. The

6


most common form is pleural mesothelioma, which accounts for 75% of all cases and affects the lungs and the protective lining and cavity of the lungs.

     The incidence rate for mesothelioma in the U.S. is estimated at approximately 15 cases per million population (Datamonitor, March 2007), which equates to about 4,500 cases per year. By comparison, the rate is approximately 93 and 566 cases per million for Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC), respectively, according to recent data from the National Cancer Institute Surveillance, Epidemiology and End Results Program (SEER). The incidence of mesothelioma in the European Union is slightly higher, resulting in approximately 8,000 cases diagnosed annually. However, given the latency period of 20–50 years and an average development time of 35–40 years for mesothelioma, the peak incidence for the disease is yet to be reached in some countries and therefore, it is difficult to estimate its future patient potential.

     The prognosis for malignant mesothelioma patients is very poor. The overall survival for mesothelioma is approximately seven months. Only 9% of patients are expected to survive for five years.

     It is estimated that only approximately 1–5% of all mesothelioma patients are suitable for radical surgery. Furthermore, radiotherapy has no impact on survival and is mainly used for palliative purposes. As such, most patients are treated with various chemotherapy regimens, including antifolates, platinum agents, anthracyclines and antimetabolites. Most of these regimens yield poor response rates, typically between 15% and 20%, and the disease almost always recurs.

Competition

     In February 2004, the Food and Drug Administration or FDA granted Eli Lilly & Company approval to market Alimta® (pemetrexed), in combination with cisplatin as a treatment for malignant pleural mesothelioma (MPM), the most prevalent form of mesothelioma. To date, Alimta is the only approved therapy worldwide for the treatment of MPM or any form of mesothelioma. Alimta is a multi-targeted antifolate that is based upon a different mechanism of action than ONCONASE®. Like ONCONASE®, Alimta received Orphan Drug and Fast Track Status from the FDA.

     To our knowledge, only two other drugs are in a Phase III trial for the treatment of mesothelioma. Merck & Co.’s Zolinza (vorinostat) is currently in Phase III clinical trials for refractory advanced malignant pleural mesothelioma. Genentech Inc.’s Avastin® (bevacizumab) is currently in Phase II/III clinical trials for malignant pleural mesothelioma in combination with the approved Alimta regimen.

     There may be several companies, universities, research teams or scientists, that are engaged in research similar, or potentially similar to research performed by us. Some of these entities or persons may have far greater financial resources, larger research staffs and more extensive physical facilities. In addition, these entities or persons may develop products that are more effective than ours and may be more successful than us at producing and marketing their products.

     We are not aware, however, of any product currently being marketed that has the same mechanism of action as our proposed anti-tumor agent, ONCONASE®. Search of scientific literature reveals no published information that would indicate that others are currently employing this method or producing such an anti-tumor agent. However, we cannot assure you that others may not develop new treatments that are more effective than ONCONASE®.

BUSINESS STRATEGY

     Our goal is to become a leading biopharmaceutical company focused on discovering and developing innovative anti-cancer treatments based on our proprietary RNase technology platform. Our strategy consists of the following key elements:

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Focus on the growing cancer market

     Cancer is the second leading cause of death in the United States, yet there remain unmet needs, and current treatments remain ineffective and inadequate for some populations. Given the life-threatening nature of cancer, the FDA has adopted procedures to accelerate the approval of cancer drugs. We intend to continue to use our expertise in the field of cancer research to target this significant market opportunity for cancer drug development.

Develop our existing product portfolio

     We currently have a portfolio of clinical and pre-clinical drug product candidates under development for potential use as anti-cancer, and other therapeutics. We intend to further develop these drug product candidates both by expanding our internal resources and by continuing to collaborate with other companies and leading governmental and academic research institutions.

Commercialize pharmaceutical products focused on cancer in selected markets

     Our current strategy is to partner with third parties to market our future products to oncologists and other key specialists involved in the treatment of cancer patients. We may also elect to develop an appropriately-sized internal oncology sales and marketing capability in the United States. This group may function as a standalone operation or in a supportive, co-promotion capacity in collaboration with a partner.

RESEARCH AND DEVELOPMENT PROGRAM

     Research and development expenses for the fiscal years ended July 31, 2008, 2007, and 2006 were approximately $8,503,000, $5,543,000, and $5,230,000, respectively. Our research and development programs focus primarily on the clinical and pre-clinical research and development of therapeutics from our pipeline of amphibian RNases.

Clinical Development Program

     In January 2007, ONCONASE® was granted orphan drug designation by the FDA for malignant mesothelioma. Orphan drug designation permits us to be awarded seven years of marketing exclusivity for ONCONASE® for the malignant mesothelioma indication upon FDA approval for this indication. Other benefits for which we are eligible with the orphan drug designation include protocol assistance by the FDA in the preparation of a dossier that will meet regulatory requirements, tax credits, research and development grant funding, and reduced NDA submission fees. Previously, our ONCONASE® development program received Fast Track Designation from the FDA for the indication of malignant mesothelioma. We continue to have discussions with the FDA to establish mutually agreed upon parameters for the NDA to obtain marketing approval for ONCONASE®, assuming the confirmatory Phase IIIb clinical trial for the treatment of malignant mesothelioma results support such approval.

     We also have previously received an Orphan Medicinal Product Designation for ONCONASE® from the European Agency for the Evaluation of Medicinal Products, or EMEA, as well as Orphan Drug Designation for ONCONASE® for malignant mesothelioma in Australia from the Therapeutics Goods Administration, or TGA. Orphan drug designation from these agencies provides benefits such as potential marketing exclusivity, reduced filing fees and regulatory guidance.

     The FDA, EMEA and TGA Orphan Drug Designations for ONCONASE® for malignant mesothelioma may serve to expedite its regulatory review upon submission of a marketing application. The efficacy and safety of ONCONASE® for malignant mesothelioma will ultimately be determined by these regulatory agencies based on the results of our Phase IIIb registration trial.

     ONCONASE® is currently being evaluated as a treatment for UMM in an international, centrally randomized, confirmatory Phase IIIb registration trial. Malignant mesothelioma is a rare cancer, primarily affecting

8


the pleura (lining of the lungs), and is usually associated with asbestos exposure. The first Phase III trial of ONCONASE® in UMM was completed in 2000. The most recent confirmatory Phase IIIb registration trial was closed to patient accrual in September 2007.

     The confirmatory Phase IIIb registration trial is a randomized and controlled clinical trial designed to evaluate the efficacy, safety and tolerability of the combination of ONCONASE® and doxorubicin as compared to doxorubicin alone, and powered to reach a statistically significant difference in overall survival between the ONCONASE® + doxorubicin treatment group and the doxorubicin treatment group at 316 evaluable events. Patients were stratified based on Cancer Adult Leukemia Group B (“CALGB”) Group (1 to 4) and histology and then assigned treatment using a centralized randomization plan. The primary endpoint of the trial is overall patient survival. The following data sets were analyzed for efficacy as per the statistical analysis plan for this clinical trial:

  • All patients randomized who received at least one dose of study therapy (evaluable patients),

  • Previously treated patients,

  • All patients randomized,

  • All patients who completed 6 cycles of therapy per protocol, and

  • All patients with identical inclusion criteria as used in the Alimta submission.

     In addition, secondary endpoints to be analyzed in accordance with the Phase IIIb clinical trial statistical analysis plan include:

  • Tumor response rates,

  • Progression free survival,

  • Patient assessment of symptoms associated with malignant mesothelioma,

  • Investigator assessment of malignant mesothelioma symptoms,

  • Narcotic pain medication usage,

  • Lung function, and

  • Performance status.

     On May 28, 2008, we announced that the results of the preliminary statistical analysis of data from our ONCONASE® confirmatory Phase IIIb clinical trial did not meet statistical significance for the primary endpoint of survival in UMM. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen, one of the predefined primary sub-group data sets for patients in the trial. The full analysis of the data is currently ongoing in support of the planned submission of the remaining components of the ONCONASE® rolling NDA for the treatment of UMM patients that have failed a prior chemotherapy regimen, which represents a currently unmet medical need. We have requested a pre-NDA meeting with the FDA to discuss the planned NDA submission in an effort to submit the final components of the rolling NDA by the end of 2008.

     In our previous Phase III trial comparing ONCONASE® as a single agent with doxorubicin, the intent-to-treat population showed median survival of 8.4 months for the ONCONASE® arm and 8.2 months for the doxorubicin arm in the study. While not statistically significant, a subset analysis of the results using the CALGB prognostic groups (published during enrollment in the Phase III trial) revealed a marked excess of poor prognosis patients (groups 5 and 6) in the ONCONASE® arm of the trial (32 patients or 38.1% of the patients treated with ONCONASE®) as compared to the doxorubicin arm of the trial (12 patients or 17% of the patients treated with doxorubicin). By excluding these patients and the 10 patients whose central pathology review did not confirm a diagnosis of malignant mesothelioma (N=5) from the 154 intent-to-treat patients, we defined a target treatment group, or TTG, consisting of 104 patients who met the criteria for CALGB prognostic groups 1-4. Of these patients, 47 were treated with ONCONASE® and 57 were treated with doxorubicin. The single agent Phase III results of the TTG showed a median survival benefit of 2 months for ONCONASE® treated patients, 11.6 months median survival time, or MST, versus 9.6 months MST. This two month median survival difference favoring ONCONASE®, while not statistically significant, represents a 20% advantage over the active agent, doxorubicin. Moreover, the clinical activity of ONCONASE® is also evident from the ov erall 1-year and 2-year survival rates of ONCONASE® versus doxorubicin in the TTG, 46.8% versus 38.6% and 20.2% versus

9


12.3%, respectively. Doxorubicin treatment was associated with a 60% higher risk of death compared to ONCONASE® treatment. Finally, tumor assessment by an independent radiologist for evaluable patients (which included a baseline and follow-up radiological assessment) revealed evidence of objective clinical activity in 17 patients in each treatment arm. Four partial responses and 13 stabilization of previously progressive disease were reported in the ONCONASE® treated patients and 7 partial responses and 10 stabilization of previously progressive disease were reported in the doxorubicin treated patients. Despite the small number of patients in this subset, the analysis revealed a statistically significant difference, log rank test, p. = 0.037, in survival of the responders favoring ONCONASE® treated patients with an MST 23.3 versus 14.4 months for doxorubicin treated patients as well as the 2 year survival rates of 40% for ONCONASE® and 9% for doxorubicin.

     A Phase I/II program to evaluate a new dose and administration schedule of ONCONASE® was initiated in 2005 to attempt to take advantage of potentially increased efficacy with higher and more frequent doses of ONCONASE®. The Phase I portion of this program is complete and we plan to initiate a Phase II clinical trial in non-small cell lung cancer (NSCLC) patients that exhibit resistance to platinum based chemotherapy regimens in early 2009.

Pre-Clinical Research Program

     Our drug discovery and pre-clinical research programs form the basis for the development of specific recombinant RNases for chemically linking drugs and other compounds such as monoclonal antibodies, growth factors, etc., as well as developing gene fusion products with the goal of targeting various molecular functions. These programs provide for joint design and generation of new products with outside collaborators. Through these collaborations, we may own these new products along with, or we may grant an exclusive license to, the collaborating partner(s).

     The multiple effects of biological activity of ONCONASE® has led to research in other areas of cancer biology. Two important areas associated with significant market opportunities are radiation therapy and control of tumor angiogenesis, or new tumor blood vessel formation. Many types of cancers undergo radiation therapy at early stages of the disease; however, success of such treatment is often limited. We believe any agent capable of enhancing tumor radiosensitivity has great market potential. Moreover, since the growth of essentially all types of cancer is dependent on new blood vessel formation, any agent that has anti-angiogenic activity, we believe, is most desirable.

Ranpirnase Conjugates and Fusion Proteins

     The concept of targeting potent toxins as effector molecules to kill cancer or other specifically targeted cells has been extensively evaluated over the last two decades. An immunotoxin is an antibody linked to a toxic molecule that is used to destroy specific cells. Several immunotoxins containing bacterial and plant toxins or other biotoxins, have been evaluated in human clinical trials. Efficacy has always been limited due to the high incidence of immunogenicity, or an immune response, and other intolerable toxicities, including death. Conjugation of ranpirnase to targeting ligands, or binding to other molecules, appears to eliminate this safety problem in pre-clinical studies.

     A Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute, or NCI, has produced RN321, a conjugate of ranpirnase with a monoclonal antibody, that has demonstrated activity against non-Hodgkin’s lymphoma in preclinical studies. The relative benefit of killing targeted tumor cells versus non-targeted healthy cells, or the therapeutic index, is greater than 200,000-fold with this conjugate. This CRADA has been concluded and data published. As a result of these findings we are working with our collaborators on the development of first and second generation huRFB4 - ONCONASE® for targeting CD22+ B cell malignancies.

     We have also developed a variety of uniquely designed versions of ONCONASE® and amphinase conjugates. These compounds target the EGF receptors and neo-vascularization (tumor blood vessel formation) which have potential clinical application in a broad spectrum of solid tumors.

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Novel Amphibian Ribonucleases (Amphinases)

     We have also discovered another series of proteins, collectively named amphinases that may have therapeutic uses. These proteins are bioactive in that they have an effect on living cells and organisms and have both anti-cancer and anti-viral activity. All of the proteins characterized to date are RNases. Preclinical testing of the new candidates collectively called amphinases showed them to be similarly active to ranpirnase. Their chemical structure makes them ideal candidates for genetic engineering of designer products.

     These compounds have undergone screening by the National Institute of Allergy and Infectious Diseases (NIAID) against various RNA viruses and by outside collaborators. One of these compounds, AC-03-636 has been determined to be active in yellow fever, Hepatitis C and Dengue fever. The same compound has been evaluated at Johns Hopkins University in a sustained time release formulation for the treatment of brain tumors (gliomas).

Evaluation Of ONCONASE ® As A Radiation Enhancer

     The p53 gene is a tumor-suppressor gene, which means that if it malfunctions, tumors may be more likely to develop. Published preclinical studies have demonstrated that ONCONASE® causes an increase in both tumor blood flow and in median tumor oxygen partial pressure, causing tumor cells to become less resistant to radiation therapy regardless of the presence or absence of the functional p53 tumor-suppressor gene. In pre-clinical research at the University of Pennsylvania, ONCONASE®, when combined with radiation therapy, enhanced the radiation-sensitivity to treatment in NSCLC tumor cells without causing the common radiation-induced tissue damage to non-tumor cells. ONCONASE® inhibited SLDR (sub-lethal damage repair) and PLDR (potentially lethal damage repair) in these animal models. We believe these findings further expand the profile of ONCONASE® in vivo activities and its potential clinical utility and market potential.

ONCONASE® As a Resistance-Overcoming and Apoptosis-Enhancing Agent

     The Fas (CD95) cell surface receptor (and its Fas ligand FasL) has been recognized as an important “death” receptor involved in the induction of the “extrinsic” pathway of apoptosis. The apoptotic pathways have been the preferred target for new drug development in cancer, autoimmune, and other therapeutic areas.

     The Thoracic Surgery Branch of the NCI confirmed the synergy between ranpirnase and soluble Fas ligand (sFasL) in inducing significant apoptosis in sFasL-resistant Fas+tumor cells. These results provided rationale for using ONCONASE® as a potential treatment of FasL-resistant tumors and possibly other disorders such as the autoimmune lympho-proliferative syndrome (ALPS). Further research in this area is ongoing.

Evaluation Of ONCONASE® As An Anti-Viral Agent

     The ribonucleolytic activity was the basis for testing ONCONASE® as a potential anti-viral agent against HIV. The NIH has performed an independent in vitro screen of ONCONASE® against the HIV virus type 1. The results showed ONCONASE® to inhibit replication of HIV by up to 99.9% after a four-day incubation period at concentrations not toxic to uninfected cells. In vitro findings by the NIH revealed that ONCONASE® significantly inhibited production of HIV in several persistently infected human cell lines, preferentially breaking down viral RNA while not affecting normal cellular ribosomal RNA and messenger RNAs, which are essential to cell function.

     Moreover, the NIAID also screened ONCONASE® for anti-HIV activity. ONCONASE® demonstrated highly significant anti-HIV activity in the monocyte/macrophage, or anti-viral, system. Ranpirnase may inhibit viral replication at several points during the life cycle of HIV, including its early phases. Ranpirnase may inhibit replication of all different HIV-1 subtypes. These properties of ranpirnase are particularly relevant in view of the extremely high and exponentially increasing rate of mutations of HIV that occur during infection, and which are primarily responsible for the development of resistance to several currently available anti-viral drugs. At present, over 50% of clinical isolates of HIV are resistant to both reverse transcriptase, mechanisms which combat viral replication, and protease inhibitors drugs, a class of anti-viral drugs. An additional 25%, while being sensitive to protease inhibitors, are resistant to reverse transcriptase inhibitor drugs.

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COMMERCIAL RELATIONSHIPS

License Agreements

     In January 2008, we entered into a U.S. License Agreement for ONCONASE® with Par Pharmaceutical, Inc. (“Par”). Under the terms of the License Agreement, Strativa Pharmaceuticals (“Strativa”), the proprietary products division of Par, received exclusive marketing, sales and distribution rights to ONCONASE® for the treatment of cancer in the United States and its territories. We retain all rights and obligations for product manufacturing, clinical development and obtaining regulatory approvals, as well as all rights for those non-U.S. jurisdictions in which we have not currently granted any such rights or obligations to third parties. Joint oversight committees with members from Alfacell and Strativa will manage the alliance. We received a cash payment of $5 million upon the signing of the License Agreement and will be entitled to an additional minimum cash payment of $20 million, up to a maximum of $30 million, upon FDA approval of ONCONASE® for UMM. We will also be entitled to receive up to $190 million in additional development and sales milestone payments in connection with the development of ONCONASE® for up to three additional cancer indications and achieving certain net sales levels, in addition to receiving double-digit royalties on net sales of ONCONASE®. In the event of approval of ONCONASE® for a cancer indication in addition to UMM, we will have the option to co-promote ONCONASE® in the United States, with support from Strativa. Strativa will provide technical expertise for a future Alfacell oncology sales force, as well as funding for certain associated costs. Under certain circumstances, we will have the right to co-promote ONCONASE®, at our cost, prior to the time ONCONASE® is approved for any such additional cancer indication. We will also supply all of Strativa’s requirements for ONCONASE® pursuant to a Supply Agreement with Par executed on January 14, 2008.

     Strativa has the right to terminate the License Agreement if ONCONASE® does not receive marketing approval by the FDA on or before January 1, 2012 or receives a not approvable communication from the FDA with respect to the primary UMM indication. In the case of termination of the License Agreement for any reason, we will retain all rights to ONCONASE®.

Marketing and Distribution Agreements

Megapharm Ltd.

     In May 2008, we entered into an exclusive marketing, sales and distribution agreement with Megapharm Ltd. for the commercialization of ONCONASE® in Israel. Under the agreement, we are eligible to receive 50% of net sales in the territory. We will be responsible for the manufacture and supply of ONCONASE® to Megapharm, while Megapharm will be responsible for all activities and costs related to regulatory filings and commercial activities in the territory.

BL&H Co. Ltd.

     In January 2008, we entered into a marketing and distribution agreement with BL&H Co. Ltd. for the commercialization of ONCONASE® in Korea, Taiwan and Hong Kong. Under the agreement, we received a $100,000 up-front fee and are eligible to receive additional cash milestones and 50% of net sales in the territory. We will be responsible for the manufacture and supply of ONCONASE® to BL&H, while BL&H will be responsible for all activities and costs related to regulatory filings and commercial activities in the territory.

US Pharmacia

     In July 2007, we entered into a Distribution and Marketing Agreement (the “Distribution Agreement”), with USP Pharma Spolka Z.O.O. (the “Distributor”), an affiliate of US Pharmacia, pursuant to which the Distributor was granted exclusive rights for the marketing, sales, and distribution of ONCONASE® for use in oncology in Poland, Belarus, Ukraine, Estonia, Latvia, and Lithuania (the “Territory”) for an initial term that ends upon the earlier of (i) 10 years from the first commercial sale in the Territory and (ii) the date all of the patents covering the

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product in the Territory expire. We received an upfront payment of $100,000 and will also be entitled to receive milestone payments based on the achievement of certain regulatory approvals and certain sales goals. In addition, we will receive a royalty on net sales as well as a transfer price for product sold by us to the Distributor. We will be responsible for making regulatory filings with and seeking marketing approval of ONCONASE® in the Territory and manufacturing and supplying ONCONASE® to the Distributor. The Distributor will be responsible for all commercial activities and related costs in the Territory.

     In connection with the Distribution Agreement, we also entered into a Securities Purchase Agreement, with Unilab LP, an affiliate of US Pharmacia, pursuant to which we issued a total of 553,360 shares of restricted common stock for approximately $1.4 million, or $2.53 per share.

GENESIS Pharma S.A.

     In December 2006, we entered into a Distribution and Marketing Agreement with GENESIS Pharma S.A. (“GENESIS”), pursuant to which GENESIS was granted exclusive rights for the marketing, sales, and distribution of ONCONASE® for use in oncology in Greece, Cyprus, Bulgaria, Romania, Slovenia, Croatia, Serbia, and the Former Yugoslavian Republic of Macedonia (the “Region”) for an initial term that ends upon the earlier of (i) 10 years from the first commercial sale in the Region and (ii) the date all of the patents covering the product in the Region expire. We will retain ownership of all intellectual property relating to ONCONASE® and responsibility for all regulatory filings with EMEA in the European Union (EU), with GENESIS providing assistance with regard to regulatory filings in the non-EU countries included in this agreement. We will also be responsible for manufacturing and supplying the product to GENESIS, which will distribute the product. GENESIS will have lead responsibility for all ONCONASE® commercialization activities and will manage all operational aspects of the marketing, sales and distribution of the product in the Region. We are entitled to receive milestone payments based on the achievement of certain regulatory approvals and certain sales goals. In addition, we will receive a royalty on net sales as well as a transfer price for product sold by us to GENESIS.

Manufacturing

     In January 2008, we entered into a Purchase and Supply Agreement (the “Supply Agreement”) with Scientific Protein Laboratories LLC (“SPL”). Under the Supply Agreement, SPL will manufacture and be our exclusive supplier for the bulk drug substance used to make ONCONASE®. The term of the Supply Agreement shall be ten years and we have the right to terminate the Supply Agreement at any time without cause on two years prior notice to SPL.

     Additionally, we contract with Ben Venue Laboratories Inc. (“Ben Venue”) for vial filling and with Bilcare Global Clinical Supplies, Americas (“Bilcare”), Aptuit, Inc. (“Aptuit”) and Catalent Pharma Solutions, Inc. (“Catalent”) for the labeling, storage and shipping of ONCONASE® for use in clinical trials. Other than these arrangements we do not have specific arrangements for the manufacture of ONCONASE®.

     Products manufactured for use in clinical trials and for commercial sale must be manufactured in compliance with Current Good Manufacturing Practices (“CGMP”). SPL, Ben Venue, Aptuit and Catalent are all licensed or approved by the appropriate regulatory agencies and all work is performed in accordance with CGMP. For the foreseeable future, we intend to rely on these manufacturers and related service providers, or substitute vendors, if necessary, to manufacture our product. We believe, however, that there are substantial alternative providers for the services for which we contract. For those relationships where we have not entered into formal agreements, we utilize the services of these third party contractors solely on an as needed basis with prices and terms customary for companies in businesses that are similarly situated. In order to replace an existing manufacturer, we must amend our Investigational New Drug application to notify the appropriate regulatory agencies of the change. We are dependent upon our contract manufacturers to comply with CGMP and to meet our production requirements. It is possible that our contract manufacturers may not comply with CGMP or deliver sufficient quantities of our products on schedule, or that we may be unable to find suitable and cost effective alternative providers if necessary.

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Raw Materials

     The major active ingredient derived from leopard frog eggs is the protein ranpirnase. We have sufficient egg inventory on hand to produce enough ONCONASE® for at least two years after commercialization. In addition, we have successfully produced ranpirnase in small proof-of-concept size batches using recombinant technology. However, this technology requires additional testing and FDA approval and it may be determined to not be more cost effective than current methods of production.

Patents and Proprietary Technology

     We have sought to protect our technology by applying for, and obtaining, patents and trademark registrations. We have also relied on trade secrets and know-how to protect our proprietary technology. We continue to develop our portfolio of patents, trade secrets, and know how. We have obtained, and continue to apply for, patents concerning our RNase-based technology.

     In addition, we have filed (and we intend to continue to file) foreign counterparts to certain U.S. patent applications. Generally, we apply for patent protection in the United States, Europe, Japan, and certain other foreign countries.

     We own the following U.S. patents:

Patent No.
    Issue Date   Subject Matter   Expiration **
5,529,775     June 1996    covers combinations of ONCONASE® with certain    June 2013 
          other pharmaceuticals     
5,728,805     Mar. 1998    covers a family of variants of ONCONASE®    June 2013 
5,540,925     July 1996    covers combinations of ONCONASE® with certain    July 2013 
          other pharmaceuticals     
5,559,212     Sept. 1996    covers the amino acid sequence of ONCONASE®    Sept. 2013 
5,595,734     Jan. 1997    covers combinations of ONCONASE® with certain    Jan. 2014 
          other pharmaceuticals     
6,649,392 B1*    Nov. 2003    covers a family of recombinant variants of    Apr. 2016 
          ONCONASE®     
6,649,393 B1*    Nov. 2003    covers nucleic acids encoding recombinant variants of    Apr. 2016 
          ONCONASE® and methodology for producing such     
          variants     
6,290,951 B1    Sept. 2001    covers alteration of the cell cycle in vivo, particularly    Aug. 2018 
      for inducing apoptosis of tumor cells    
6,239,257 B1    May 2001    covers a family of variants of ONCONASE®    Dec. 2018 
6,175,003 B1    Jan. 2001    covers the genes of ONCONASE® and a variant of    Sept. 2019 
          ONCONASE®     
6,423,515 B1    July 2002    covers methodology for synthesizing gene sequences of    Sept. 2019 
          ranpirnase and a genetically engineered variant of     
          ranpirnase     
7,229,824 B1***    June 2007    covers a vector containing DNA encoding a genetically    May 2024 
          engineered variant of ONCONASE®     

     *We own this patent jointly with the U.S. Government. We do not pay maintenance fees to keep this patent in force.

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     We own the following foreign patents in Europe (European patents are validated in selected European nations), Japan and Singapore:

Patent No.
  Subject Matter   Expiration **
EP 0 440 633    covers ONCONASE® and process technology for making it    Mar. 2009 
EP 0 500 589    cover combinations of ONCONASE® with certain other pharmaceuticals    Oct. 2010 
JP 2972334         
EP 0 656 783    covers combinations of ONCONASE® with certain other    July 2013 
JP 3655628    pharmaceuticals     
EP 0 837 878    covers a variant of ONCONASE®    June 2016 
JP 3779999         
SG 118886    covers variants of ONCONASE® and methods of making them    May 2024 

     **Assumes timely payment of all applicable maintenance fees and annuities; excludes term extensions that do or may apply.

     ***Includes a term extension of 312 days under 35 U.S.C. §154(b).

     We also have patent applications pending in the United States, Europe, Japan, and other foreign countries.

     The scope of protection afforded by patents for biotechnological inventions can be uncertain, and such uncertainty may apply to our patents as well. The patent applications we have filed, or that we may file in the future, may not result in patents. Our patents may not give us a competitive advantage, may be wholly or partially invalidated or held unenforceable, or may be held not to have been infringed by products that compete with our products. Patents owned by others may adversely affect our ability to do business. Furthermore, others may independently develop products that are similar to our products or that duplicate our products, and may design around the claims of our patents. Although we believe that our patents and patent applications are of substantial value to us, we cannot assure you that such patents and patent applications will be of commercial benefit to us, will adequately protect us from competing products or will not be challenged, declared invalid, or found not to have been infringed by competing products. We also rely on proprietary know-how and on trade secrets to develop and maintain our competitive position. Others may independently develop or obtain access to such know-how or trade secrets. Although our employees and consultants having access to proprietary information are required to sign agreements that require them to keep such information confidential, our employees or consultants may breach these agreements or these agreements may be held to be unenforceable.

Government Regulation

     The manufacturing and marketing of pharmaceutical products in the United States require the approval of the FDA under the Federal Food, Drug and Cosmetic Act. Similar approvals by comparable regulatory agencies are required in most foreign countries. The FDA has established mandatory procedures and safety standards that apply to the clinical testing, manufacturing and marketing of pharmaceutical products in the United States. Obtaining FDA approval for a new therapeutic may take many years and involve substantial expenditures. State, local and other authorities also regulate pharmaceutical manufacturing facilities.

     As the initial step in the FDA regulatory approval process, preclinical studies are conducted in laboratory dishes and animal models to assess the drug's efficacy and to identify potential safety problems. Moreover manufacturing processes and controls for the product are required. The manufacturing information along with the results of these studies is submitted to the FDA as a part of the Investigational New Drug Application, or IND, which is filed to obtain approval to begin human clinical testing. The human clinical testing program typically involves up to three phases. Data from human trials as well as other regulatory requirements such as chemistry, manufacturing and controls, pharmacology and toxicology sections, are submitted to the FDA in an NDA or Biologics License Application, or BLA. Preparing an NDA or BLA involves considerable data collection, verification and analysis. A

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similar process in accordance with EMEA regulations in Europe and with TGA regulations in Australia is required to gain marketing approval. Moreover, a commercial entity must be established and approved by the EMEA in a member state of the EU at least three months prior to filing the Marketing Authorization Application, or MAA.

     We have not received United States or other marketing approval for any of our product candidates and may not receive any approvals. We may encounter difficulties or unanticipated costs in our effort to secure necessary governmental approvals, which could delay or preclude us from marketing our products.

     With respect to patented products, delays imposed by the governmental approval process may materially reduce the period during which we may have the exclusive right to exploit them.

Environmental Matters

     Our operations are subject to comprehensive regulation with respect to environmental, safety and similar matters by the United States Environmental Protection Agency and similar state and local agencies. Failure to comply with applicable laws, regulations and permits can result in injunctive actions, damages and civil and criminal penalties. If we expand or change our existing operations or propose any new operations, we may need to obtain additional or amend existing permits or authorizations. We spend time, effort and funds in operating our facilities to ensure compliance with environmental and other regulatory requirements.

     Such efforts and expenditures are common throughout the biotechnology industry and generally should have no material adverse effect on our financial condition. The principal environmental regulatory requirements and matters known to us requiring or potentially requiring capital expenditures by us do not appear likely, individually or in the aggregate, to have a material adverse effect on our financial condition. We believe that we are in compliance with all current laws and regulations.

Employees

     As of July 31, 2008, we had fifteen full time employees, of whom ten were engaged in clinical and pre-clinical research and development activities and five were engaged in administration and management. Five employees hold Ph.D. degrees. All of our employees are covered by confidentiality agreements. We consider relations with our employees to be good. None of our employees is covered by a collective bargaining agreement.

Available Information

     Copies of our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are available free of charge through our website (www.alfacell.com) as soon as reasonably practicable after we electronically file the material with, or furnish it to, the Securities and Exchange Commission (the “SEC”). You may read and copy any document we file with the SEC at the SEC’s Public Reference Room at 100 F Street, N.W., Washington, DC 20549. Please call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room. Our SEC filings are also available to the public at the SEC’s website at http://www.sec.gov. Additionally, we have also adopted a Code of Business Conduct and Ethics applicable to all officers, directors, and employees, which is also available on our website.

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ITEM 1A. RISK FACTORS.

     An investment in our common stock is speculative and involves a high degree of risk. You should carefully consider the risks and uncertainties described below and the other information in this Form 10-K and our other SEC filings before deciding whether to purchase shares of our common stock. If any of the following risks actually occur, our business and operating results could be harmed. This could cause the trading price of our common stock to decline, and you may lose all or part of your investment.

We are highly dependent on achieving success in the clinical testing, regulatory approval, and commercialization of ONCONASE® and our other compounds currently under development. If we fail to obtain the necessary regulatory approvals, we will not be allowed to commercialize ONCONASE® and our business will be harmed.

     The FDA in the United States and comparable regulatory agencies in foreign countries impose substantial pre-market approval requirements on the introduction of pharmaceutical products. These requirements involve the completion of lengthy and detailed pre-clinical and clinical testing and other costly and time consuming procedures. Satisfaction of these requirements typically takes several years depending on the level of complexity and novelty of the product. The length of time required to complete a clinical trial depends on several factors including the size of the patient population, the ability of patients to get to the site of the clinical study, and the criteria for determining which patients are eligible to join the study. A significant portion of our expenditures have been devoted, and in the future will be devoted, to the clinical trials for our lead product candidate, ONCONASE® and activities related to the preparation and filing of the NDA for ONCONASE® for the treatment of malignant mesothelioma. A delay in the commercial sale of ONCONASE® or sales of ONCONASE® which did not result in significant revenue to us, would increase the time frame during which our cash flow would be negative, which, in turn, might require us to seek additional financing. Such financing may not be available, and even if it is available, it may not be available on terms favorable or acceptable to us.

     We have conducted the preliminary statistical analysis from our confirmatory Phase IIIb clinical trial of ONCONASE® and that analysis indicated that ONCONASE® did not meet statistical significance for the primary endpoint of survival in UMM. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen. We plan to submit an NDA to the FDA for the treatment of this patient population, which represents a currently unmet medical need. While we believe that the statistical analysis of the data from the confirmatory Phase IIIb clinical trial of ONCONASE® have produced results that support the filing of an NDA with the FDA, we cannot be certain that the FDA will allow us to file an NDA or approve our NDA, if it is filed. Also if safety concerns develop, the FDA, EMEA and TGA could take actions that negatively affect our NDA submission. We or the FDA may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

     All statutes and regulations governing the conduct of clinical trials are subject to future changes by various regulatory agencies, including the FDA, which could affect the cost and duration of our clinical trials. Any unanticipated costs or delays in our clinical studies would delay our ability to generate product revenues and to raise additional capital and could cause us to be unable to fund the completion of the studies.

     We may not market or sell any product for which we have not obtained regulatory approval. We cannot assure you that the FDA or other regulatory agencies will ever approve the use of our products that are under development. Even if we receive regulatory approval, such approval may involve limitations on the indicated uses for which we may market our products. Further, even after approval, discovery of previously unknown problems could result in additional restrictions, including withdrawal of our products from the market.

     If we fail to obtain the necessary regulatory approvals, we cannot market or sell our products in the United States or in other countries and our long-term viability would be threatened. If we fail to achieve regulatory approval or foreign marketing authorizations for ONCONASE® we will not have a product suitable for sale or product revenues for quite some time, if at all, and may not be able to continue operations.

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     Our profitability will depend on our ability to develop, obtain regulatory approvals for, and effectively market ONCONASE® as well as entering into strategic alliances for the development of new drug candidates from the out-licensing of our proprietary RNase technology. The commercialization of our pharmaceutical products involves a number of significant challenges. In particular, our ability to commercialize ONCONASE® depends on the success of our clinical development programs, our efforts to obtain regulatory approval and our sales and marketing efforts or those of our marketing partners, 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 have utility and are safe;

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

  • our limited financial resources relative to our competitors;

  • our ability to obtain and maintain relationships with current and additional marketing partners;

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

  • incidents of adverse reactions to our products;

  • misuse of our products and unfavorable publicity that could result; and

  • the occurrence of manufacturing or distribution disruptions.

We have incurred losses since inception and anticipate that we will incur continued losses for the foreseeable future. We do not have a current source of product revenue and may never be profitable.

     We are a development stage company and since our inception one of the principal sources of our working capital has been private sales of our common stock. Over the past three fiscal years, we have incurred aggregate net losses of approximately $28.9 million and since our inception we have incurred aggregate net losses of approximately $104.4 million. We expect to incur additional losses and, as our development efforts, efforts to file an NDA for ONCONASE® and clinical testing activities continue, our rate of losses may increase. We also expect to experience negative cash flows for the foreseeable future as we fund our losses and capital expenditures. Our losses have adversely impacted, and will continue to adversely impact, our working capital, total assets and stockholders’ equity. To date, we have not sold or received approval to sell any drug product candidates, and it is possible that revenues from drug product sales will never be achieved. We cannot at this time predict when or if we will be able to develop other sources of revenue or when or if our operations will become profitable, even if we are able to commercialize some of our drug product candidates.

     We will seek to generate revenue through licensing, marketing and development arrangements prior to receiving revenue from the sale of our products. To date we have entered into one US license agreement and four non-US regional marketing and distribution agreements and we may not be able to successfully negotiate any additional agreements. In the past, we have entered into several development arrangements which have resulted in limited revenues for us. We cannot assure investors that these arrangements or future arrangements, if any, will result in significant amounts of revenue for us in the future. We, therefore, are unable to predict the extent of any future losses or the time required to achieve profitability, if at all.

We will need additional financing to continue operations, which may not be available on favorable or acceptable terms, if it is available at all.

     We estimate that as of July 31, 2008, our then existing cash reserves including our expected level of receipts and expenditures should be sufficient to support our activities into the fourth quarter of our fiscal year 2009, which assumes the timely and successful submission of the ONCONASE® NDA. As a result of our continuing losses and lack of capital, the report of our independent registered public accounting firm on our July 31, 2008 financial statements included an explanatory paragraph which states that our recurring losses from operations and negative cash flows from operating activities raise substantial doubt about our ability to continue as a going concern. Our financial statements at July 31, 2008 do not include any adjustments that might result from the outcome of this uncertainty. Regardless of whether we are able to file our NDA or whether our NDA is approved, we will need additional financing to conduct our business after April 30, 2009. If our ONCONASE® NDA is approved by the FDA, we will be eligible to receive significant cash milestone payments from our U.S. marketing partner. If we are

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delayed in submitting the NDA, the receipt of milestone payments would be delayed and if the results of our Phase IIIb clinical trial do not support the filing of an NDA, or if our NDA is not approved, we would not receive such milestone payment and our ability to raise additional capital would be adversely affected. Additional factors that would affect the amount and timing of additional capital required include, but are not limited to, the following:

  • the progress and cost of completing and filing marketing registrations for ONCONASE® with the FDA in the United States, with the EMEA in Europe and with the TGA in Australia;

  • our degree of success in commercializing our drug product candidates, including entering into additional marketing and distribution agreements;

  • the progress and cost of research and development and clinical trial activities relating to our drug product candidates;

  • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our patent claims and other intellectual property rights and investigating and defending against infringement claims asserted against us by others;

  • the emergence of competing technologies and other adverse market developments;

  • changes in or terminations of our existing licensing, marketing and distribution arrangements;

  • the amount of milestone payments we may receive from current and future collaborators, if any; and

  • the cost of manufacturing scale-up and development of marketing operations, if we undertake those activities.

     Additional financing may not be available when we need it or be on terms acceptable to us. If adequate financing is not available, we may be required to delay, scale-back, or eliminate certain of our research and development programs, to relinquish rights to some of our technologies or products, or to grant licenses to third parties to commercialize products or technologies that we would otherwise seek to develop ourselves. We could also be required to cease operations. If additional capital is raised through the sale of equity, our stockholders’ ownership interest could be diluted and such newly-issued securities may have rights, preferences, or privileges superior to those of our other stockholders. The terms of any debt securities we may sell to raise additional capital may place restrictions on our operating activities.

Budget constraints may force us to delay our efforts to develop certain drug product candidates in favor of developing others, which may prevent us from commercializing all drug product candidates as quickly as possible.

     Because we are an emerging company with limited resources, and because completing and submitting an NDA is an expensive process, we must regularly assess the most efficient allocation of our research and development budget. As a result, we may have to further prioritize development activities and may not be able to fully realize the value of some of our drug product candidates in a timely manner, and they may be delayed in reaching the market, if at all. A reduction in spending on our other drug product candidates could delay our commercialization efforts and negatively impact our ability to diversify our development risk across a broad portfolio of drug product candidates.

Competition in the biopharmaceutical field is intense and subject to rapid technological change. Our principal competitors have substantially greater resources to develop and market products that may be superior to ours.

     If we obtain regulatory approval for any of our drug product candidates, the extent to which they achieve market acceptance will depend, in part, on competitive factors. Competition in our industry is intense, and it is increased by the rapid pace of technological development. Existing drug products or new drug products developed by our competitors may be more effective or have fewer side effects, or may be more effectively marketed and sold, than any that we may develop. Our principal competitors have substantially greater research and development capabilities and experience and greater manufacturing, marketing, financial, and managerial resources than we do. Competitive drug compounds may render our technology and drug product candidates obsolete or noncompetitive prior to our recovery of research, development, or commercialization expenses incurred through sales of any of our

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drug product candidates. The FDA’s policy of granting “fast track” approval for cancer therapies may also expedite the regulatory approval of our competitors’ drug product candidates.

     In February 2004, the FDA granted Eli Lilly & Company approval to sell its Alimta® medication as an orphan drug to treat patients with pleural mesothelioma. Alimta® is a multi-targeted antifolate that is based upon a different mechanism of action than ONCONASE®. To our knowledge, no other company is developing a product with the same mechanism of action as ONCONASE®. However, there may be other companies, universities, research teams or scientists who are developing products to treat the same medical conditions our products are intended to treat. To our knowledge, only two other drugs are in a Phase III trial for the treatment of mesothelioma. Merck & Co.’s Zolinza (vorinostat) is currently in Phase III clinical trials for refractory advanced malignant pleural mesothelioma. Genentech Inc.’s Avastin® (bevacizumab) is currently in Phase II/III clinical trials for malignant pleural mesothelioma in combination with the approved Alimta regimen.

     We also compete with other drug development companies for collaborations with large pharmaceutical and other companies.

Our stock price has been and is likely to continue to be volatile, and an investment in our common stock could decline in value.

     The market price of our common stock, like that of the securities of many other development stage biotechnology companies, has fluctuated over a wide range and it is likely that the price of our common stock will fluctuate in the future. For example, over the past three fiscal years, the sale price for our common stock, as reported by Nasdaq has fluctuated from a low of $0.35 to a high of $4.99. The market price of our common stock could be impacted by a variety of factors, including:

  • the success or failure of our clinical trials, including, but not limited to, the Phase IIIb trial involving our lead compound, ONCONASE®, or those of our competitors;

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

  • actual or anticipated fluctuations in our financial results;

  • our ability to obtain financing, when needed;

  • economic conditions in the United States and abroad;

  • comments by or changes in our assessments or financial estimates by securities analysts;

  • adverse regulatory actions or decisions;

  • losses of key management;

  • changing governmental regulations;

  • our ability to secure adequate third party reimbursement for products developed by us;

  • developments or disputes concerning patents or other proprietary rights;

  • product or patent litigation; and

  • public concern as to the safety of products developed by us.

     The stock market continues to experience extreme price and volume fluctuations and these fluctuations have especially affected the market price of many biotechnology companies. Such fluctuations have often been unrelated to the operating performance of these companies. Volatility or a lack of positive performance in our stock price may adversely affect our ability to retain key employees, all of whom have been granted stock options. These factors and fluctuations, as well as political and market conditions, may materially adversely affect the market price of our common stock.

The trading market for our common stock may be limited if we are unable to continue listing our common stock on the Nasdaq Capital Market.

     From April 1999, when we were delisted from Nasdaq, until September 9, 2004, when we were relisted on the Nasdaq Capital Market, there was no established trading market for our common stock. During that time, our common stock was quoted on the OTC Bulletin Board and was thinly traded. As of July 31, 2008, we did not comply with the $35 million minimum market value requirement under Marketplace Rule 4310(c)(3)(B) or the $1

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per share minimum bid price requirement under Marketplace Rule 4310(c)(4). We received notification of delisting from Nasdaq and were granted a hearing to appeal the decision. Furthermore, if the bid price of our common stock does not close at $1.00 per share or more for a minimum of 10 consecutive business days at any time before January 12, 2009, we may be delisted from the Nasdaq Capital Market. In addition, as of July 31, 2008, we also did not meet the $2.5 million minimum stockholders’ equity requirement under Marketplace Rule 4310(c)(3)(A) or the requirement for a minimum net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years under Marketplace Rule 4310(c)(3)(C). For continued listing on the Nasdaq Capital Market, we must comply with, among other requirements, the minimum bid price requirement and at least one of the other three alternative listing standards described above. We have been granted additional time to consider actions that may allow us to regain compliance with the Nasdaq continued listing standards and maintain our Nasdaq listing. There is no assurance, however, that we will be able to take any of these actions or that any of the actions will be sufficient to allow our Nasdaq listing to continue or for how long such listing will continue. In addition, our stock remains thinly traded at times and you may be unable to sell our common stock during times when the trading market is limited.

We are and will be dependent upon third parties for manufacturing our products. If these third parties do not devote sufficient time and resources to our products our revenues and profits may be adversely affected.

     We do not have the required manufacturing facilities to manufacture our product. We presently rely on third parties to produce ONCONASE® for use in clinical trials. We have entered into a ten year purchase and supply agreement with SPL, for the manufacturing of ranpirnase (protein drug substance) from the oocytes, or the unfertilized eggs, of the Rana pipiens frog, which is found in the Northwest United States and is commonly called the leopard frog.

     Additionally, we contract with Ben Venue for the manufacturing of ONCONASE® and with Bilcare, Catalent and Aptuit for the storage, labeling and shipping of ONCONASE® for clinical trial use. We utilize the services of these third party manufacturers solely on an as needed basis with terms and prices customary for our industry.

     We use FDA CGMP licensed manufacturers for ranpirnase and ONCONASE®. We have identified alternative providers for the manufacturing services for which we may contract. In order to replace an existing service provider we must amend our IND to notify the FDA of the new manufacturer. Although the FDA generally will not suspend or delay a clinical trial as a result of replacing an existing manufacturer, the FDA has the authority to suspend or delay a clinical trial if, among other grounds, human subjects are or would be exposed to an unreasonable and significant risk of illness or injury as a result of the replacement manufacturer.

     We intend to rely on third parties to manufacture our products if they are approved for sale by the appropriate regulatory agencies and are commercialized. Third party manufacturers may not be able to meet our needs with respect to the timing, quantity or quality of our products or to supply products on acceptable terms.

Because we do not have in-house marketing, sales or distribution capabilities, we have contracted with third parties and expect to contract with third parties in the future for these functions and we will therefore be dependent upon such third parties to market, sell and distribute our products in an effort to generate revenues.

     We currently have no in-house sales, marketing or distribution capabilities. In order to commercialize any product candidates for which we receive FDA or non-U.S. approval, we expect to rely on established third parties who have strategic partnerships with us to perform these functions. To date, we have entered into a license agreement with Par Pharmaceutical, Inc. in the United States and four marketing and distribution agreements for ONCONASE® in regions outside the United States. We cannot assure you we will be able to maintain these relationships or establish new relationships with biopharmaceutical or other marketing companies with existing distribution systems and direct sales forces to market any or all of our product candidates on acceptable terms, if at all.

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     In addition, we may incur significant expenses in determining our commercialization strategy with respect to one or more of our product candidates for regions outside the United States. The determination of our commercialization strategy with respect to a product candidate will depend on a number of factors, including:

  • the extent to which we are successful in securing third parties to collaborate with us to offset some or all of the funding obligations with respect to product candidates;

  • the extent to which our agreement with our collaborators permits us to exercise marketing or promotion rights with respect to the product candidate;

  • how our product candidates compare to competitive products with respect to labeling, pricing, therapeutic effect, and method of delivery; and

  • whether we are able to establish agreements with third party collaborators, including large biopharmaceutical or other marketing companies, with respect to any of our product candidates on terms that are acceptable to us.

Our lack of operating experience may cause us difficulty in managing our growth.

     We have no experience in selling pharmaceutical or other products or in manufacturing or procuring drug products in commercial quantities in compliance with FDA regulations and we have only limited experience in negotiating, establishing and maintaining collaborative relationships and conducting later stage phases of the regulatory approval process. Our ability to manage our growth, if any, will require us to improve and expand our management and our operational and financial systems and controls. If our management is unable to manage growth effectively, our business and financial condition would be adversely affected. In addition, if rapid growth occurs, it may strain our operational, managerial and financial resources, which are limited.

Our proprietary technology and patents may offer only limited protection against infringement and the development by our competitors of competitive products.

     We own two patents jointly with the United States government. These patents expire in 2016. We also own ten United States patents with expiration dates ranging from 2013 to 2024, four European patents with expiration dates ranging from 2009 to 2016, three Japanese patents with expiration dates ranging from 2010 to 2016 and one Singaporean patent with an expiration date in 2024. We also own patent applications that are pending in the United States, Europe, Japan, and other foreign countries. The scope of protection afforded by patents for biotechnological inventions is uncertain, and such uncertainty applies to our patents as well. Therefore, our patents may not give us competitive advantages or afford us adequate protection from competing products. Furthermore, others may independently develop products that are similar to our products, and may design around the claims of our patents. Patent litigation and intellectual property litigation are expensive and our resources are limited. To date, we have not received any threats of litigation regarding patent issues. However, if we were to become involved in litigation, we might not have the funds or other resources necessary to conduct the litigation effectively. This might prevent us from protecting our patents, from defending against claims of infringement, or both.

We may be sued for infringing on the intellectual property rights of others.

     Our commercial success also depends in part on ensuring that we do not infringe the patents or proprietary rights of third parties. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform. While we have not been sued for infringing the intellectual property rights of others, there can be no assurance that the drug product candidates that we have under development do not or will not infringe on the patent or proprietary rights of others. Third parties may assert that we are employing their proprietary technology without authorization. Moreover, United States patent applications filed in recent years are confidential for 18 months, while older applications are not published until the patent issues. Further, some applications are kept secret during the entire length of their pendency by request of the applicant in special circumstances. As a result, there may be patents of which we are unaware, and avoiding patent infringement may be difficult. Patent holders sometimes send communications to a number of companies in related

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fields, suggesting possible infringement. If we are sued for patent infringement, we would need to demonstrate that we either do not infringe the patent claims of the relevant patent and/or that the patent claims are invalid, which we may not be able to do. Proving invalidity, in particular, is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Parties making claims against us may be able to obtain injunctive or other equitable relief that could effectively block our ability to further develop, commercialize and sell products, and such claims could result in the award of substantial damages against us. In the event of a successful claim of infringement against us, we may be required to pay damages and obtain one or more licenses from third parties. We may not be able to obtain these licenses at a reasonable cost, if at all. In that event, we could encounter delays in product introductions while we attempt to develop alternative methods or products or be required to cease commercializing affected products and our operating results would be harmed.

     In the future, others may file patent applications covering technologies that we may wish to utilize with our proprietary technologies, or products that are similar to products developed with the use of our technologies. If these patent applications result in issued patents and we wish to use the claimed technology, we would need to obtain a license from the third party, and this would increase our costs of operations and harm our operating results.

If we lose key management personnel or are unable to attract and retain the talent required for our business, our business could be materially harmed.

     We are highly dependent on the principal members of our management team, including, but not limited to, Kuslima Shogen, our scientific founder and Chief Executive Officer or CEO, and Lawrence A. Kenyon, our President, Chief Financial Officer or CFO, and Corporate Secretary. Ms. Shogen announced her planned retirement effective no later than March 31, 2009 and entered into a retirement agreement with us that specifies payments to be made to her through March 31, 2011. These payments primarily consist of annual payments to Ms. Shogen representing her current salary and medical benefits. Mr. Kenyon does not have an employment contract with us. We do not have key man insurance on any of our management. If we were to lose the services of Mr. Kenyon or other members of our management team, and were unable to replace them, our product development and the achievement of our strategic objectives could be delayed.

     In addition, our success will depend on our ability to attract and retain qualified commercial, scientific, technical, and managerial personnel. While we have not experienced unusual difficulties to date in recruiting and retaining personnel, there is intense competition for qualified staff and there is no assurance that we will be able to retain existing personnel or attract and retain qualified staff in the future.

If we are unable to obtain favorable reimbursement for our product candidates, their commercial success may be severely hindered.

     Our ability to sell our future products may depend in large part on the extent to which reimbursement for the costs of our products is available from government entities, private health insurers, managed care organizations and others. Third-party payors are increasingly attempting to contain their costs. We cannot predict what actions third-party payors may take, or whether they will limit the coverage and level of reimbursement for our products or refuse to provide any coverage at all. Reduced or partial reimbursement coverage could make our products less attractive to patients, suppliers and prescribing physicians and may not be adequate for us to maintain price levels sufficient to realize an appropriate return on our investment in our product candidates or to compete on price.

     In some cases, insurers and other healthcare payment organizations try to encourage the use of less expensive generic brands and over-the-counter, or OTC, products through their prescription benefits coverage and reimbursement policies. These organizations may make the generic alternative more attractive to the patient by providing different amounts of reimbursement so that the net cost of the generic product to the patient is less than the net cost of a prescription brand product. Aggressive pricing policies by our generic product competitors and the prescription benefits policies of insurers could have a negative effect on our product revenues and profitability.

     Many managed care organizations negotiate the price of medical services and products and develop formularies for that purpose. Exclusion of a product from a formulary can lead to its sharply reduced usage in the

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managed care organization patient population. If our products are not included within an adequate number of formularies or adequate reimbursement levels are not provided, or if those policies increasingly favor generic or OTC products, our market share and gross margins could be negatively affected, as could our overall business and financial condition.

     The competition among pharmaceutical companies to have their products approved for reimbursement may also result in downward pricing pressure in the industry or in the markets where our products will compete. We may not be successful in any efforts we take to mitigate the effect of a decline in average selling prices for our products. Any decline in our average selling prices would also reduce our gross margins.

     In addition, managed care initiatives to control costs may influence primary care physicians to refer fewer patients to oncologists and other specialists. Reductions in these referrals could have a material adverse effect on the size of our potential market and increase costs to effectively promote our products.

     We are subject to new legislation, regulatory proposals and managed care initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital.

     There have been a number of legislative and regulatory proposals aimed at changing the healthcare system and pharmaceutical industry, including reductions in the cost of prescription products and changes in the levels at which consumers and healthcare providers are reimbursed for purchases of pharmaceutical products. For example, the Prescription Drug and Medicare Improvement Act of 2003 provides a Medicare prescription drug benefit that began in 2006 and mandates other reforms. Although we cannot predict the full effects on our business of the implementation of this new legislation, it is possible that the new benefit, which will be managed by private health insurers, pharmacy benefit managers and other managed care organizations, will result in decreased reimbursement for prescription drugs, which may further exacerbate industry-wide pressure to reduce the prices charged for prescription drugs. This could harm our ability to market our products and generate revenues. It is also possible that other proposals will be adopted. As a result of the new Medicare prescription drug benefit or any other proposals, we may determine to change our current manner of operation, provide additional benefits or change our contract arrangements, any of which could harm our ability to operate our business efficiently, obtain collaborators and raise capital.

Our product candidates may not be accepted by the market.

     Even if approved by the FDA and other regulatory authorities, our product candidates may not achieve market acceptance, which means we would not receive significant revenues from these products. Approval by the FDA does not necessarily mean that the medical community will be convinced of the relative safety, efficacy and cost-effectiveness of our products as compared to other products. In addition, third party reimbursers such as insurance companies and HMOs may be reluctant to reimburse expenses relating to our products.

Material weaknesses or deficiencies in our internal control over financial reporting could harm stockholders’ and business partners’ confidence in our financial reporting, our ability to obtain financing, and other aspects of our business.

     Internal control over financial reporting can provide only reasonable and not absolute assurance that deficiencies or weaknesses are identified. Additionally, potential control deficiencies that are not yet identified could emerge and internal controls that are currently deemed to be in place and operating effectively are subject to the risk that those controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Identification and corrections of these types of potential control deficiencies could have a material impact on our business, financial position, results of operations and disclosures and impact our ability to raise funds.

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Our investments could lose market value and consequently harm our ability to fund continuing operations.

     The primary objective of our investment activities is to preserve principal while at the same time maximizing yields without significantly increasing risk. To achieve this objective, we maintain our portfolio of cash and cash equivalents in a variety of securities, including government and corporate obligations and money market funds. The market values of these investments may fluctuate due to market conditions and other conditions over which we have no control. Fluctuations in the market price and valuations of these securities may require us to record losses due to impairment in the value of the securities underlying our investment. This could result in future charges to our earnings. All of our investment securities are denominated in US dollars.

     Investments in both fixed-rate and floating-rate interest earning instruments carry varying degrees of interest rate risk. Fixed-rate securities may have their fair market value adversely impacted due to a rise in interest rates. In general, securities with longer maturities are subject to greater interest rate risk than those with shorter maturities. While floating-rate securities generally are subject to less interest rate risk than fixed-rate securities, floating-rate securities may produce less income than expected if interest rates decrease. Due in part to these factors, our investment income may fall short of expectations or we may suffer losses in principal if securities are sold that have declined in market value due to changes in interest rates.

We handle hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how we do business. We could also be liable for damages, penalties, or other forms of censure if we are involved in a hazardous waste spill or other accident.

     Our research and development processes involve the controlled storage, use, and disposal of hazardous materials and biological hazardous materials. We are subject to federal, state, and local laws and regulations governing the use, manufacture, storage, handling, and disposal of hazardous materials and certain waste products. Although we believe that our safety procedures for handling and disposing of these hazardous materials comply with the standards prescribed by law and regulation, the risk of accidental contamination or injury from hazardous materials cannot be completely eliminated. In the event of an accident, even by a third party, we could be held liable for any damages that result, and such liability could exceed the $2,000,000 limit of our current general liability insurance coverage and our financial resources. In the future, we may not be able to maintain insurance on acceptable terms, or at all. We could also be required to incur significant costs to comply with current or future environmental laws and regulations.

We may be sued for product liability.

     Our business exposes us to potential product liability that may have a negative effect on our financial performance and our business generally. The administration of drugs to humans, whether in clinical trials or commercially, exposes us to potential product and professional liability risks which are inherent in the testing, production, marketing and sale of new drugs for humans. Product liability claims can be expensive to defend and may result in large judgments or settlements against us, which could have a negative effect on our financial performance and materially adversely affect our business. We maintain product liability insurance to protect our products and product candidates in amounts customary for companies in businesses that are similarly situated, but our insurance coverage may not be sufficient to cover claims. Furthermore, liability insurance coverage is becoming increasingly expensive and we cannot be certain that we will always be able to maintain or increase our insurance coverage at an affordable price or in sufficient amounts to protect against potential losses. A product liability claim, product recall or other claim, as well as any claim for uninsured liabilities or claim in excess of insured liabilities, may significantly harm our business and results of operations. Even if a product liability claim is not successful, adverse publicity and time and expense of defending such a claim may significantly interfere with our business.

Our incorporation documents may delay or prevent the removal of our current management or a change of control that a stockholder may consider favorable.

     We are currently authorized to issue 1,000,000 shares of preferred stock. Our Board of Directors is authorized, without any approval of the stockholders, to issue the preferred stock and determine the terms of the

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preferred stock. This provision allows the board of directors to affect the rights of stockholders, since the board of directors can make it more difficult for common stockholders to replace members of the board. Because the board of directors is responsible for appointing the members of our management, these provisions could in turn affect any attempt to replace current management by the common stockholders. Furthermore, the existence of authorized shares of preferred stock might have the effect of discouraging any attempt by a person, through the acquisition of a substantial number of shares of common stock, to acquire control of our company. Accordingly, the accomplishment of a tender offer may be more difficult. This may be beneficial to management in a hostile tender offer, but have an adverse impact on stockholders who may want to participate in the tender offer or inhibit a stockholder’s ability to receive an acquisition premium for his or her shares.

Events with respect to our share capital could cause the price of our common stock to decline.

     Sales of substantial amounts of our common stock in the open market, or the availability of such shares for sale, could adversely affect the price of our common stock. We had 47,276,880 shares of common stock outstanding as of July 31, 2008. The following securities that may be exercised into shares of our common stock were issued and outstanding as of July 31, 2008:

  • Options. Stock options to purchase 6,353,067 shares of our common stock at a weighted average exercise price of approximately $2.69 per share.

  • Warrants. Warrants to purchase 14,862,534 shares of our common stock at a weighted average exercise price of approximately $2.09 per share.

     The shares of our common stock that may be issued under the options and warrants are currently registered with the SEC or are eligible for sale without any volume limitations pursuant to Rule 144 under the Securities Act.

The ability of our stockholders to recover against Armus Harrison & Co., or AHC, may be limited because we have not been able to obtain the reissued reports of AHC with respect to the financial statements included in our Form 10-K, nor have we been able to obtain AHC’s consent to the use of such report herein.

     Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) provides that any person acquiring or selling a security in reliance upon statements set forth in a Form 10-K may assert a claim against every accountant who has with its consent been named as having prepared or certified any part of the Form 10-K, or as having prepared or certified any report or valuation that is used in connection with the Form 10-K, if that part of the Form 10-K at the time it is filed contains a false or misleading statement of a material fact, or omits a material fact required to be stated therein or necessary to make the statements therein not misleading (unless it is proved that at the time of such acquisition such acquiring person knew of such untruth or omission).

     In June 1996, AHC dissolved and ceased all operations. Therefore, we have not been able to obtain the reissued reports of AHC with respect to the financial statements included in the annual report on Form 10-K for the fiscal year ended July 31, 2008 nor have we been able to obtain AHC’s consent to the use of such report herein. As a result, in the event any persons seek to assert a claim against AHC under Section 18 of the Exchange Act for any untrue statement of a material fact contained in these financial statements or any omissions to state a material fact required to be stated therein, such persons will be barred. Accordingly, you may be unable to assert a claim against AHC under Section 18 of the Exchange Act for any purchases of the Company’s Common Stock made in reliance upon statements set forth in the Form 10-K for the fiscal year ended July 31, 2008. In addition, the ability of AHC to satisfy any claims properly brought against it may be limited as a practical matter due to AHC’s dissolution in 1996.

ITEM 1B. UNRESOLVED STAFF COMMENTS.

     None.

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ITEM 2. PROPERTIES.

     In March 2007, we entered into a lease for 15,410 square feet in an industrial office building located in Somerset, New Jersey to replace our facility in Bloomfield, NJ as our principal office. The lease term commenced on July 3, 2007 and is scheduled to terminate on November 30, 2017. The average monthly rental obligation over the full term of the lease is approximately $25,000. We believe that the facility is sufficient for our needs in the foreseeable future.

ITEM 3. LEGAL PROCEEDINGS.

     None.

ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.

     None.

EXECUTIVE OFFICERS OF ALFACELL

     The following persons were our executive officers as of October 10, 2008:

     Kuslima Shogen, 63, has served as our Chief Executive Officer since September 1986, and as a Director since our inception in 1981. She also served as our Chairman of the Board from August 1996 until January 2008, Acting Chief Financial Officer from June 23, 1999 until March 2004, as our Chief Financial Officer from September 1986 through July 1994 and as our President from September 1986 through July 1996. Ms. Shogen formed the company in 1981 to pursue research that she had initiated while a biology student in the University Honors Program at Fairleigh Dickinson University. Prior to our founding, from 1976 to 1981 she was founder and president of a biomedical research consortium specializing in Good Laboratory Practices and animal toxicology. During that time, she also served as a consultant for the Lever Brothers Research Group. She earned a B.S. degree in 1974, M.S. in 1976 and also completed graduate studies in 1978 in embryology from Fairleigh Dickinson University.

     Lawrence A. Kenyon, 43, joined us in January 2007, as Executive Vice President, Chief Financial Officer and Corporate Secretary, was named Chief Operating Officer and elected to our Board of Directors in November 2007, and named President in April 2008. Previously, from September 2000 thru August 2006, Mr. Kenyon served as Executive Vice President, Chief Financial Officer and Corporate Secretary with NeoPharm Inc., a publicly traded biopharmaceutical company. From October 1999 until September 2000, he was Senior Vice President of the Gabelli Mathers Fund, a regulated investment company, and from March 1988 until October 1999 he held a variety of positions with Mathers and Company Inc. an investment management firm, most recently serving as Chief Financial Officer for both Mathers and Company Inc. and Mathers Fund Inc. Mr. Kenyon began his career with Arthur Andersen & Co. in 1987 after receiving a bachelor's degree in accounting from the University of Wisconsin --Whitewater.

PART II

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS 
  AND ISSUER PURCHASES OF EQUITY SECURITIES. 

      Our common stock is listed on the Nasdaq Capital Market, or Nasdaq, and has traded under the symbol "ACEL" since September 9, 2004. Prior to September 9, 2004, our common stock was traded on the OTC Bulletin Board (OTCBB). As of October 10, 2008, there were approximately 986 stockholders of record of our common stock.

      As of July 31, 2008, we did not comply with the $35 million minimum market value requirement under Marketplace Rule 4310(c)(3)(B) or the $1 per share minimum bid price requirement under Marketplace Rule 4310(c)(4). We received notification of delisting from Nasdaq and were granted a hearing to appeal the decision. Furthermore, if the bid price of our common stock does not close at $1.00 per share or more for a minimum of 10

27


consecutive business days at any time before January 12, 2009, we may be delisted from the Nasdaq Capital Market. In addition, as of July 31, 2008, we also did not meet the $2.5 million minimum stockholders’ equity requirement under Marketplace Rule 4310(c)(3)(A) or the requirement for a minimum net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years under Marketplace Rule 4310(c)(3)(C). For continued listing on the Nasdaq Capital Market, we must comply with, among other requirements, the minimum bid price requirement and at least one of the other three alternative listing standards described above. We have been granted additional time to consider actions that may allow us to regain compliance with the Nasdaq continued listing standards and maintain our Nasdaq listing. There is no assurance, however, that we will be able to take any of these actions or that any of the actions will be sufficient to allow our Nasdaq listing to continue or for how long such listing will continue. In addition, our stock remains thinly traded at times and you may be unable to sell our common stock during times when the trading market is limited.

     The following table sets forth the range of high and low sale prices of our common stock for the two fiscal years ended July 31, 2008 and 2007. The prices were obtained from Nasdaq and are believed to be representative of inter-dealer quotations, without retail mark-up, mark-down or commission, and may not necessarily represent actual transactions.

  High   Low
Year Ended July 31, 2008:           
     First Quarter  $ 2.70    $ 1.75 
     Second Quarter    2.69      1.45 
     Third Quarter    2.60      1.70 
     Fourth Quarter    2.20      0.35 
           
Year Ended July 31, 2007:           
     First Quarter    2.09      1.17 
     Second Quarter    1.95      0.73 
     Third Quarter    3.74      1.05 
     Fourth Quarter    2.99      2.05 

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STOCKHOLDER RETURN PERFORMANCE GRAPH

     The following graph summarizes the total cumulative return experienced by Alfacell’s stockholders during the five-year period ended July 31, 2008, compared to the Nasdaq Composite Index and the Nasdaq Pharmaceutical Index. The changes for the periods shown in the graph and table are based on the assumption that $100.00 was invested in Alfacell Corporation Common Stock and in each index below on July 31, 2003 and that all cash dividends were reinvested. The table does not forecast performance of our common stock.

COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN*

Among Alfacell Corporation, The NASDAQ Composite Index
And The NASDAQ Pharmaceutical Index

*$100 invested on 7/31/03 in stock & index-including reinvestment of dividends. Fiscal year ending July 31.

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Dividends

      We have not paid dividends on our common stock since inception and we do not plan to pay dividends in the foreseeable future. Any earnings we may realize will be retained to finance our growth.

Equity Compensation Plan Information

     The information called for by Item 5(a) relating to compensation plan information is incorporated herein by reference to Item 12—Security Ownership of Certain Beneficial Owners and Management and Related Stock Matters of this Form 10-K.

Recent Sales of Unregistered Securities

     None.

Issuer Purchases of Equity Securities

     We did not repurchase any shares of our common stock during the fiscal year 2008.

ITEM 6. SELECTED FINANCIAL DATA.

     Set forth below is the selected financial data for our company for the five fiscal years ended July 31, 2008:

  Year Ended July 31,
    2008       2007       2006       2005       2004  
Investment income  $ 227,591     $ 370,650     $ 107,386     $ 141,708     $ 42,113  
Other income (loss)    --       --       --       9,836       --  
Net loss (1)    (12,321,101 )      (8,755,144 )      (7,810,175 )      (6,461,920 )      (5,070,307 ) 
Dividends    None       None       None       None       None  
Total assets    5, 320,036       7, 820,499       11,826,428       4,901,624       10,421,063  
Long-term debt    --       --       --       --       --  
Total equity                                       
(deficiency)    (3,556,606 )      5,778,480       9,233,003       3,221,670       8,881,647  
Loss per basic and                                       
diluted common share  $ (0.26 )    $ (0.19 )    $ (0.21 )    $ (0.18 )    $ (0.17 ) 

               

(1)           

Included in the net loss of $12,321,101, $8,755,144 and $7,810,175 for the fiscal years ended July 31, 2008, 2007 and 2006, respectively, are tax benefits of $1,755,380, $510,467 and $317,382, respectively, related to the sale of certain state tax operating loss carryforwards.

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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION RESULTS OF OPERATIONS.

     The following discussion of our financial condition and results of operations should be read together with our consolidated financial statements and notes to those statements included in Item 8 of Part II of this Form 10-K.

Overview

     We are a biopharmaceutical company engaged in the research, development, and commercialization of drugs for life threatening-diseases, such as malignant mesothelioma and other cancers. Our corporate strategy is to become a leader in the discovery, development, and commercialization of novel ribonuclease (RNase) therapeutics for cancer and other life-threatening diseases.

     We are a development stage company as defined in the Financial Accounting Standards Board’s (the “FASB”) Statement of Financial Accounting Standards (“SFAS”) No. 7, “Accounting and Reporting by Development Stage Enterprises” (“SFAS 7”). We are devoting substantially all of our present efforts to establishing a new business and developing new drug products. Our planned principal operations of marketing and/or licensing new drugs have not commenced and, accordingly, we have not derived any significant revenue from these operations.

     Since our inception in 1981, we have devoted the vast majority of our resources to the research and development of ONCONASE®, our lead drug candidate, as well as other related drug candidates. In recent years we have focused our resources towards the completion of the clinical program for ONCONASE® in patients suffering from UMM.

     ONCONASE® has received orphan drug designation from the FDA for the treatment of mesothelioma. Orphan drug designation permits us to be awarded seven years of marketing exclusivity for ONCONASE® for the malignant mesothelioma indication upon FDA approval for this indication. Other benefits for which we are eligible with the orphan drug designation include protocol assistance by the FDA in the preparation of a dossier that will meet regulatory requirements, tax credits, research and development grant funding, and reduced filing fees for the marketing application. Previously, our ONCONASE® development program received Fast Track Designation from the FDA for the treatment of malignant mesothelioma patients.

     We also have previously received an Orphan Medicinal Product Designation for ONCONASE® from the EMEA, as well as Orphan Drug Designation for ONCONASE® for malignant mesothelioma in Australia from the TGA. Orphan drug designation from these agencies provides benefits such as marketing exclusivity, reduced filing fees and regulatory guidance.

      During our fiscal year ended July 31, 2008, management’s efforts were primarily focused on the completion of our confirmatory Phase IIIb clinical trial and preparation of the remaining components of our NDA, which are expected to be submitted to the FDA by the end of December 2008. We also continued to enter into commercial agreements with partners in key regions, including Strativa Pharmaceuticals (a division of Par Pharmaceutical, Inc.) in the United States, BL&H Co. Ltd. in Korea, Hong Kong and Taiwan, and Megapharm Ltd. in Israel. Changes to our executive team in 2008 included the appointment of David Sidransky, M.D. as Chairman of the Board of Directors and Lawrence A. Kenyon, our CFO and Secretary, to the additional role of President and Chief Operating Officer. Kuslima Shogen, our scientific founder and CEO, announced that she intends to retire no later than March 31, 2009.

     On May 28, 2008, we announced that the results of the preliminary statistical analysis of data from our ONCONASE® confirmatory Phase IIIb clinical trial did not meet statistical significance for the primary endpoint of survival in UMM. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen, one of the predefined primary sub-group data sets for patients in the trial. The full analysis of the data is currently ongoing in support of the planned submission

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of the remaining components of the ONCONASE® rolling NDA for the treatment of UMM patients that have failed a prior chemotherapy regimen, which represents a currently unmet medical need. We have requested a pre-NDA meeting with the FDA to discuss the planned NDA submission in an effort to submit the final components of the rolling NDA by the end of 2008.

     Almost all of the $69.3 million of research and development expenses we have incurred since our inception has gone toward the development of ONCONASE® and related drug candidates. For the fiscal years 2008, 2007 and 2006, our research and development expenses were approximately $8.5 million, $5.5 million, and $5.2 million, respectively, almost all of which were used for the development of ONCONASE® and related drug candidates.

      We have incurred losses since inception and we have not received FDA approval of any of our drug candidates. We expect to continue to incur losses for the foreseeable future as we continue our efforts to receive marketing approval for our drug candidates, which includes the sponsorship of human clinical trials. Until we are able to consistently generate revenue through the sale of drug or non-drug products, we anticipate that we will be required to fund the development of our pre-clinical compounds and drug product candidates primarily by other means, including, but not limited to, licensing the development or marketing rights to some of our drug candidates to third parties, collaborating with third parties to develop our drug candidates, or selling Company issued securities.

     We fund the research and development of our products primarily from cash receipts resulting from the sale of our equity securities and convertible debentures in registered offerings and private placements. Additionally, we have raised capital through other debt financings, the sale of our tax benefits and research products, interest income and financing received from our CEO. During the fiscal year ended July 31, 2008, we received net proceeds of approximately $0.7 million as a result of private placements of common stock and from exercises of stock options and warrants. These proceeds will be used primarily to complete our confirmatory Phase IIIb clinical trial and support our anticipated filing of an NDA of ONCONASE® for malignant mesothelioma. We have incurred losses since inception and, to date, we have generated only small amounts of capital from commercial agreements for ONCONASE®.

Results of Operations

Fiscal Year Ended July 31, 2008, as compared to Fiscal Year Ended July 31, 2007

     We are a development stage company as defined in the FASB's SFAS 7. We are devoting substantially all our present efforts to establishing a new business and developing new drug products. Our planned principal operations of marketing of new drugs have not commenced and, accordingly, we have not derived any significant revenue from these operations. We focus most of our productive and financial resources on the development of ONCONASE®. We did not record any revenue in fiscal years 2008 or 2007.

     Research and development expense for fiscal year 2008 was $8.5 million compared to $5.5 million for fiscal year 2007, an increase of approximately $3 million, or 53.4% . The increase in research and development expenses is directly related to increased expenses of approximately $3.2 million related to our preparations for the completion of the ONCONASE® rolling NDA submission, which included the required statistical analysis of the data from our confirmatory Phase IIIb clinical trial, offset by a decrease of approximately $0.2 million in expenses incurred from the completion of the Phase I component of our Phase I/II ONCONASE® clinical trials.

     General and administrative expense for fiscal year 2008 was approximately $5.8 million compared to approximately $4.1 million for fiscal year 2007, an increase of approximately $1.7 million, or 41.6% . This increase was primarily the result of increased compensation expense of approximately $1.1 million directly related to the planned retirement of our CEO in 2009. Additionally, professional service fees for consultants and legal advisors increased approximately $0.5 million as a result of our increased activity in pursuing and negotiating commercial agreements in fiscal 2008. Other general and administrative expenses increased by a total of approximately $0.1 million in 2008 as a result of increased commercial insurance premiums.

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     Investment income for fiscal year 2008 was $0.2 million compared to $0.4 million for fiscal year 2007, a decrease of $0.2 million. The decrease was due to lower balances of cash and cash equivalents on hand during the fiscal year 2008 as compared to the same period in 2007.

     New Jersey has enacted legislation permitting certain corporations located in New Jersey to sell a portion of its state tax loss carryforwards and state research and development credits in order to obtain tax benefits. For the state fiscal year 2008 (July 1, 2007 to June 30, 2008), we had approximately $2.5 million of total available state tax benefits that qualified for sale, of which New Jersey permitted us to sell approximately $2.0 million. In December 2007, we received approximately $1.8 million from the sale of these state tax benefits, which was recognized as state tax benefit in the fiscal year ended July 31, 2008.

     We have incurred net losses during each year since our inception. The net loss for fiscal year 2008 was approximately $12.3 million as compared to $8.8 million in fiscal year 2007. The increased net loss was primarily related to the increased research and development expenses in 2008. The cumulative loss from the date of inception, August 24, 1981 to July 31, 2008, amounted to $104.4 million. Such losses are attributable to the fact that we are still in the development stage and, accordingly, have not derived sufficient revenues from operations to offset the development stage expenses.

Fiscal Year Ended July 31, 2007, as compared to Fiscal Year Ended July 31, 2006

     We did not record any revenue in fiscal years 2007 and 2006.

     Research and development expense for fiscal year 2007 was $5.5 million compared to $5.2 million for fiscal year 2006, an increase of approximately $0.3 million, or 5.7%. The increase primarily resulted from increased compensation expense related to employee salaries and benefits of approximately $0.5 million mostly due to increased stock-based compensation expenses in 2007, in addition to an increase of approximately $0.2 million in expenses incurred from our ongoing Phase I/II ONCONASE® clinical trials that initiated in June 2005 and November 2006. These increased expenses were offset by decreased expenses of approximately $0.4 million related to preparations for the completion of our Phase IIIb ONCONASE® clinical trial and the initiation of the related submissions of various sections of our rolling NDA to the FDA.

     General and administrative expense for fiscal year 2007 was approximately $4.1 million compared to approximately $3.0 million for fiscal year 2006, an increase of approximately $1.1 million, or 35.7% . This increase was primarily due to increased compensation expense associated with employee salaries and benefits of approximately $0.7 million related mostly to increased stock-based compensation expenses, as well as increased investor relations expenses of approximately $0.2 million resulting from our use of an investor relations firm beginning in fiscal year 2007. Other general and administrative expenses, including legal, audit, consulting, travel and miscellaneous office expenses increased by a total of approximately $0.1 million in 2007.

     Investment income for fiscal year 2007 was $0.4 million compared to $0.1 million for fiscal year 2006, an increase of $0.3 million. The increase was due to higher balances of cash and cash equivalents on hand during the fiscal year 2007 as compared to the same period in 2006.

     New Jersey has enacted legislation permitting certain corporations located in New Jersey to sell a portion of its state tax loss carryforwards and state research and development credits in order to obtain tax benefits. For the state fiscal year 2007 (July 1, 2006 to June 30, 2007), we had approximately $2.3 million of total available state tax benefits that qualified for sale, of which New Jersey permitted us to sell approximately $0.6 million. In December 2006, we received approximately $0.5 million from the sale of these state tax benefits, which was recognized as state tax benefit in the fiscal year ended July 31, 2007.

     For the state fiscal year 2006 (July 1, 2005 to June 30, 2006), we had approximately $1.9 million of total available state tax benefits that were saleable; of which New Jersey permitted us to sell approximately $0.4 million. In December 2005, we received approximately $0.3 million from the sale of these state tax benefits, which we recognized as state tax benefits for the fiscal year ended July 31, 2006.

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     The net loss for fiscal year 2007 was $8.8 million as compared to $7.8 million in fiscal year 2006.

Liquidity and Capital Resources

     We have reported cumulative net losses of approximately $28.9 million for the three most recent fiscal years ended July 31, 2008. The net losses from date of inception, August 24, 1981 to July 31, 2008, amounts to approximately $104.4 million. As of July 31, 2008, we have working capital of approximately $1.9 million.

     We have financed our operations since inception primarily through the sale of our equity securities and convertible debentures in registered offerings and private placements. Additionally, we have raised capital through other debt financings, the sale of our state tax benefits and research products, and investment income and financing received from our CEO. As of July 31, 2008, we had approximately $4.7 million in cash and cash equivalents and no debt. We currently believe that our cash and cash equivalents on hand at July 31, 2008 including our expected level of receipts and expenditures can support our activities into the fourth quarter of our fiscal year 2009, which assumes timely submission of the ONCONASE® NDA.

     The primary use of cash over the next 12 months will be to fund our regulatory and commercial efforts for ONCONASE® and our clinical and pre-clinical research and development efforts. The most significant expenses will be incurred in relation to completing the work necessary for the planned submission of the final components of our rolling NDA submission for ONCONASE®. Additional expenses are also expected to be incurred as we continue to move our drug product candidates towards the next phase of clinical and pre-clinical development.

     Our audited financial statements for the fiscal year ended July 31, 2008, were prepared under the assumption that we will continue our operations as a going concern. We were incorporated in 1981 and have a history of losses and negative cash flows from operating activities. As a result, our independent registered public accounting firm in their audit report has expressed substantial doubt about our ability to continue as a going concern. Continued operations are dependent on our ability to raise additional capital from various sources such as those described above. Such capital raising opportunities may not be available or may not be available on reasonable terms. Our financial statements do not include any adjustments that may result from the outcome of this uncertainty.

     We may seek to satisfy future funding requirements through public or private offerings of securities or with collaborative or other arrangements with corporate partners. We have retained an investment bank to pursue strategic alternatives, including strategic partnership transactions or a possible sale of the company. Additional financing or strategic transactions may not be available when needed or on terms acceptable to us, if at all. If adequate financing is not available, we may be required to delay, scale back, or eliminate certain of our research and development programs, relinquish rights to certain of our technologies, drugs or products, or license third parties to commercialize products or technologies that we would otherwise seek to develop ourselves.

Off-Balance Sheet Arrangements

     We have no debt, no exposure to off-balance sheet arrangements, no special purpose entities, nor activities that include non-exchange-traded contracts accounted for at fair value as of July 31, 2008.

Contractual Obligations and Commercial Commitments

     Our major outstanding contractual obligations relate to our building and equipment operating leases. During the fiscal year ended July 31, 2008, we entered into an equipment capital lease which obligates us to pay $635 per month for five years and during the fiscal year ended July 31, 2007, we entered into separate building and equipment operating leases, which obligates us to pay an average of $25,393 per month for the building and $1,866 per month for the equipment for ten and five years, respectively. Below is a table that presents our contractual obligations and commercial commitments as of July 31, 2008:

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          Payments Due in Fiscal Year 
                                          2014 and
      Total      2009      2010      2011      2012     2013     Thereafter
 
Building lease    $ 3,026,130    $ 275,445    $    302,036    $      317,446    $ 317,446    $ 317,446    $ 1,496,311
Equipment lease      117,160      33,548      31,024      25,976      25,976      636      -
Total contractual cash                                           
     obligations    $ 3,143,290    $ 308,993    $ 333,060    $ 343,422    $ 343,422    $ 318,082    $ 1,496,311

Critical Accounting Policies

     In December 2001, the SEC requested that all registrants discuss their most "critical accounting policies" in management's discussion and analysis of financial condition and results of operations. The SEC indicated that a "critical accounting policy" is one which is both important to the portrayal of the company's financial condition and results and requires management's most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. The accounting policies set forth below have been considered critical because changes to certain judgments, estimates and assumptions could significantly affect our financial statements.

Use of Estimates

     The preparation of financial statements in conformity with U.S. generally accepted accounting principles or GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results could differ from those estimates.

Cash Equivalents

     We consider all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. The carrying value of these investments approximates their fair market value due to their short maturity and liquidity.

Property and Equipment

     Property and equipment is recorded at cost and is depreciated using the straight-line method over the estimated useful lives of the respective assets. Maintenance and repairs that do not extend the life of assets are charged to expense when incurred. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in operations for the period in which the transaction takes place.

     Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted cash flows expected to be generated by the asset. If the carrying amount exceeds its estimated future cash flows, an impairment charge is recognized by the amount by which the carrying amount exceeds the fair value of the asset.

Income Taxes

     Income taxes are accounted for under the provisions of SFAS No. 109, "Accounting for Income Taxes". Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be

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recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Management provides valuation allowances against the deferred tax assets for amounts which are not considered “more likely than not” to be realized.

Revenue Recognition

      We recognize revenue in accordance with Staff Accounting Bulletin (“SAB”) No. 104, “Revenue Recognition,” issued by the staff of the SEC. Under SAB No. 104, revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred and/or services have been rendered, the sales price is fixed or determinable, and collectibility is reasonably assured.

      We enter into marketing and distribution agreements, which contain multiple deliverables. Under the provisions of Emerging Issues Task Force (“EITF”) No. 00-21, “Accounting for Revenue Arrangements with Multiple Deliverables,” we evaluate whether these deliverables constitute separate units of accounting to which total arrangement consideration is allocated. A deliverable qualifies as a separate unit of accounting when the item delivered to the customer has standalone value, there is objective and reliable evidence of fair value of items that have not been delivered to the customer, and, if there is a general right of return for the items delivered to the customer, delivery or performance of the undelivered items is considered probable and substantially in the control of the company. Arrangement consideration is allocated to units of accounting on a relative fair-value basis or the residual method if the company is unable to determine the fair value of all deliverables in the arrangement. Consideration allocated to a unit of accounting is limited to the amount that is not contingent upon future performance by the company. Upon determination of separate units of accounting and allocated consideration, the general criteria for revenue recognition are applied to each unit of accounting.

Research and Development

      Research and development costs are expensed as incurred. These costs include, among other things, consulting fees and costs related to the conduct of human clinical trials. We also allocate indirect costs, consisting primarily of operational costs for administering research and development activities, to research and development expenses.

Share-Based Compensation

     In December 2004, the Financial Accounting Standards Board issued SFAS No. 123(R) (revised 2004), “Share-Based Payment” (“SFAS 123(R)”), which amends SFAS 123. The new standard requires all share-based payments, including stock option grants to employees, to be recognized as an operating expense in the statement of operations. The expense is recognized over the requisite service period based on fair values measured on the date of grant. We adopted SFAS 123(R) effective August 1, 2005 using the modified prospective method and, accordingly, prior period amounts have not been restated. Under the modified prospective method, the fair value of all new stock options issued after July 31, 2005 and the unamortized fair value of unvested outstanding stock options at August 1, 2005 are recognized as expense as services are rendered.

Leases

      With respect to our operating leases, we apply the provisions of FASB SFAS No. 13 “Accounting for Leases” (“SFAS 13”) and FASB Technical Bulletin (“FTB”) 88-1 “Issues Relating to Accounting for Leases”, recognizing rent expense on a straight-line basis over the lease term due to escalating lease payments and landlord incentives.

Contingencies

      Liabilities for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount of the liability can be reasonably estimated. Recoveries from other parties are recorded when realized.

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Fair Value of Financial Instruments

     Financial instruments consist of cash, cash equivalents, accounts receivable, and accounts payable. The carrying value of these financial instruments is a reasonable estimate of fair value.

Recently Issued Accounting Pronouncements

     In May 2008, the FASB issued SFAS No. 162 “Hierarchy of GAAP”. This statement identifies the sources of accounting principles and the framework for selecting the principles to be used in the preparation of financial statements of nongovernmental entities that are presented in conformity with GAAP in the United States. This statement is effective 60 days following the SEC’s approval of the Public Company Accounting Oversight Board amendments to AU Section 411, “The Meaning of Present Fairly in Conformity with GAAP”. We will adopt this pronouncement once it becomes effective and are currently evaluating the impact it will have on our reported financial results, if any.

     In February 2008, the FASB issued FASB Staff Position (“FSP”) SFAS No. 157-1, “Application of FASB Statement No. 157 to SFAS Statement No. 13 and Other Accounting Pronouncements that Address Fair Value Measurements for Purposes of Lease Classification or Measurement under Statement 13”, (“FSP 157-1”). FSP 157-1 amends SFAS 157 to exclude SFAS 13 and other accounting pronouncements that address fair value measurements for purposes of lease classifications under SFAS 13. However, this scope exception does not apply to assets acquired and liabilities assumed in a business combination that are required to be measured at fair value under FASB Statement No. 141, “Business Combinations”, or SFAS 141(R), regardless of whether those assets and liabilities are related to leases. FSP 157-1 is effective upon initial adoption of SFAS 157. We are required to adopt SFAS 157 as of August 1, 2008, and are currently evaluating the impact that the adoption of FSP 157-1 will have, if any, on our reported financial results.

     In February 2008, the FASB issued FSP SFAS No. 157-2, “Effective Date of FASB SFAS No. 157”, (“FSP 157-2”). FSP 157-2 delays the effective date of SFAS 157 for non financial assets and non financial liabilities, except for items that are recognized or disclosed at fair value in the financial statements on a recurring basis at least annually. This delay is intended to allow the FASB and constituents additional time to consider the effect of various implementation issues that have arisen from the application of SFAS 157. We have reviewed FSP 157-2 and will wait to hear for additional positions taken by the FASB before proceeding further.

     In December 2007, the FASB issued SFAS No. 141(R) "Business Combinations" (“SFAS 141(R)”). This Statement establishes principles and requirements for how the acquirer of a business recognizes and measures in its financial statements the identifiable assets acquired, the liabilities assumed, and any noncontrolling interest in the acquiree. SFAS 141(R) also provides guidance for recognizing and measuring the goodwill acquired in the business combination and determines what information to disclose to enable users of the financial statements to evaluate the nature and financial effects of the business combination. The guidance will become effective as of the beginning of a company's fiscal year beginning after December 15, 2008. We believe that this new pronouncement will not have a material impact on our financial statements in future periods.

     On December 21, 2007, the SEC issued SAB No. 110 ("SAB 110") to permit entities, under certain circumstances to continue to use the "simplified" method, in developing estimates of the expected term of "plain-vanilla" share options in accordance with Statement No. 123R, “Share-Based Payment”. SAB 110 amended SAB 107 to permit the use of the "simplified" method beyond December 31, 2007. The adoption of SAB 110 did not have a material impact on our financial statements.

     In June 2007, the FASB issued EITF Issue No. 07-03, “Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities,” (“EITF 07-03”). EITF 07-03 addresses the diversity that exists with respect to the accounting for the nonrefundable portion of a payment made by a research and development entity for future research and development activities. The EITF concluded that an entity

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must defer and capitalize nonrefundable advance payments made for research and development activities and expense these amounts as the related goods are delivered or the related services are performed. EITF 07-03 will be effective for interim or annual reporting periods in fiscal years beginning after December 15, 2007. We are currently evaluating the impact that the adoption of EITF 07-03 will have, if any, on our financial statements.

     In February 2007, the FASB issued SFAS No. 159 “The Fair Value Option for Financial Assets and Financial Liabilities” (“SFAS 159”). SFAS 159 permits entities to choose to measure many financial instruments and certain other items at fair value that are not currently required to be measured at fair value. SFAS 159 will be effective for our company on August 1, 2008, and are currently evaluating the impact that the adoption of SFAS 159 will have, if any, on our financial statements.

     In December 2006, the FASB issued FSP EITF Issue No. 00-19-2 "Accounting for Registration Payment Arrangements" ("FSP 00-19-2") which addresses an issuer's accounting for registration payment arrangements. FSP 00-19-2 specifies that the contingent obligation to make future payments or otherwise transfer consideration under a registration payment arrangement, whether issued as a separate agreement or included as a provision of a financial instrument or other agreement, should be separately recognized and measured in accordance with SFAS No.5 "Accounting for Contingencies." The guidance in FSP 00-19-2 amends SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities," and No.150, "Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity", and FASB Interpretation No.45, "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others" to include scope exceptions for registration payment arrangements. FSP 00-19-2 is effective immediately for registration payment arrangements and the financial instruments subject to those arrangements that are entered into or modified subsequent to the date of issue of FSP 00-19-2. For registration payment arrangements and financial instruments subject to those arrangements that were entered into prior to the issuance of FSP 00-19-2, this is effective for financial statements issued for fiscal years beginning after December 15, 2006, and interim periods within those fiscal years. We have analyzed the provisions of FSP 00-19-2 and determined that it will not have an effect on our financial statements.

     In September 2006, the FASB issued SFAS No. 157 “Fair Value Measurements” (“SFAS 157”). SFAS 157 defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. SFAS 157 does not require new fair value measurements. We are required to adopt SFAS 157 as of August 1, 2008, and are currently evaluating the impact that the adoption of SFAS 157 will have, if any, on our reported financial results.

     In September 2006, the SEC issued SAB No. 108 “Quantifying Misstatements in Financial Statements” (“SAB 108”). Under SAB 108, we are required to use a combination of the two previously-acceptable approaches for quantifying misstatements, and to adjust our financial statements if this combined approach results in a conclusion that an error is material. We adopted SAB 108 and determined that it did not have a material impact on our reported financial results.

     In June 2006, the FASB issued Interpretation No. 48, “Accounting for Uncertainty in Income Taxes - an Interpretation of FASB Statement No. 109” (“FIN 48”). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in a company’s financial statements in accordance with Statement No. 109, “Accounting for Income Taxes.” FIN 48 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a company’s tax return. On August 1, 2007, we adopted FIN 48 and determined that it did not have a material impact on our reported financial results.

ITEM 7A.      QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

     As of July 31, 2008, we were exposed to market risks, primarily changes in U.S. interest rates. As of July 31, 2008, we held total cash and cash equivalents of approximately $4.7 million. All cash equivalents have a maturity less than 90 days. Declines in interest rates over time would reduce our interest income from our investments. Based upon our balance of cash and cash equivalents as of July 31, 2008, a decrease in interest rates of 1.0% would cause a corresponding decrease in our annual interest income of approximately $47,000.

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ITEM 8.  FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. 

     The response to this Item is submitted as a separate section of this report commencing on Page F-1.

ITEM 9.  CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. 

     There have been no changes in or disagreements with accountants on accounting or financial disclosures in the past two fiscal years.

     On December 1, 1993, certain stockholders of Armus Harrison & Co., or AHC, terminated their association with AHC, or the AHC termination, and AHC ceased performing accounting and auditing services, except for limited accounting services to be performed on our behalf. In June 1996, AHC dissolved and ceased all operations. The report of J.H. Cohn LLP with respect to our financial statements from inception to July 31, 2008 is based on the report of KPMG LLP from August 1, 1992 to July 31, 2002 and of AHC for the period from inception to July 31, 1992, although AHC has not consented to the use of such report herein and will not be available to perform any subsequent review procedures with respect to such report. Accordingly, investors will be barred from asserting claims against AHC under Section 18 of the Exchange Act on the basis of the use of such report in any Form 10-K into which such report is incorporated by reference. In addition, in the event any persons seek to assert a claim against AHC for false or misleading financial statements and disclosures in documents previously filed by us, such claim will be adversely affected and possibly barred. Furthermore, as a result of the lack of a consent from AHC to the use of its audit report herein, or to its incorporation by reference into a Form 10-K, our officers and directors will be unable to rely on the authority of AHC as experts in auditing and accounting in the event any claim is brought against such persons under Section 18 of the Exchange Act based on alleged false and misleading Financial Statements and disclosures attributable to AHC. The discussion regarding certain effects of the AHC termination is not meant and should not be construed in any way as legal advice to any party and any potential purchaser should consult with his, her or its own counsel with respect to the effect of the AHC termination on a potential investment in our common stock or otherwise.

ITEM 9A. CONTROLS AND PROCEDURES. 

EVALUATION OF DISCLOSURE CONTROLS AND PROCEDURES

     Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act are controls and other procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our CEO, and CFO, as appropriate, to allow timely decisions regarding required disclosure.

     It should be noted that there are inherent limitations to the effectiveness of any system of disclosure controls and procedures. These limitations include the possibility of human error, the circumvention or overriding of the controls and procedures and reasonable resource constrains. In addition, the design of any system of control is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote. Accordingly, our controls and procedures, by their nature, only provide reasonable assurance regarding achieving the management's control objectives.

     As of the end of the period covered by this annual report, we conducted an evaluation, under the supervision and with the participation of our management, including our CEO and CFO, of the effectiveness of the design and operation of our disclosure controls and procedures. Based upon the foregoing evaluation, our CEO and CFO have concluded that our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC and was accumulated and

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communicated to our management, including our CEO and CFO, as appropriate to allow timely decisions regarding the required disclosures.

MANAGEMENT’S REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING

     Our management is responsible for establishing and maintaining adequate internal control over financial reporting and for the assessment of the effectiveness of internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Internal control over financial reporting is a process designed by, or under the supervision of our principal executive and principal financial officers, or persons performing similar functions, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements in accordance with GAAP.

     Our internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of the financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with the authorizations of our management and directors; and (3) provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

     Our internal control over financial reporting is designed to provide reasonable, but not absolute, assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with GAAP. There are inherent limitations to the effectiveness of any system of internal control over financial reporting. These limitations include the possibility of human error, the circumvention or overriding of the system and reasonable resource constraints. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

     In connection with the preparation of our annual financial statements, management, including our CEO and CFO, has undertaken an assessment of the effectiveness of our internal control over financial reporting as of July 31, 2008, based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, or the COSO Framework. Management’s assessment included an evaluation of the design of our internal control over financial reporting and testing of the operational effectiveness of those controls.

     Based on this evaluation, management has concluded that our internal controls over financial reporting were effective as of July 31, 2008, in that they ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (2) accumulated and communicated to our management, including our CEO and CFO, as appropriate to allow timely decisions regarding required disclosure.

     J.H. Cohn LLP, the independent registered public accounting firm that audited our financial statements included elsewhere in our annual report on Form 10-K, has issued their report on the effectiveness of internal control over financial reporting, a copy of which is included below.

CHANGES IN INTERNAL CONTROLS

     There has been no change in the Company's internal control over financial reporting during the quarter ended July 31, 2008 that has materially affected, or is reasonably likely to materially affect, the Company's internal control over financial reporting subsequent to the date of the evaluation referred to above.

40


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Board of Directors and Stockholders
Alfacell Corporation

We have audited Alfacell Corporation’s internal control over financial reporting as of July 31, 2008, based on the criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Alfacell Corporation’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists and testing and evaluating the design and operating effectiveness of internal control, based on the assessed risk. We believe that our audit provides a reasonable basis for our opinion.

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with accounting principles generally accepted in the United States of America, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

In our opinion, Alfacell Corporation maintained, in all material respects, effective internal control over financial reporting as of July 31, 2008, based on the criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the balance sheets as of July 31, 2008 and 2007 and related statements of operations, stockholders’ equity (deficiency) and cash flows for each of the years in the three-year period ended July 31, 2008 and for the period from August 24, 1981 (date of inception) to July 31, 2008 of Alfacell Corporation and our report dated October 13, 2008 expressed an unqualified opinion on those financial statements which included an explanatory paragraph regarding the Company’s ability to continue as a going concern.

/s/ J.H. Cohn LLP
Roseland, New Jersey
October 13, 2008

41


ITEM 9B. OTHER INFORMATION.

     None.

PART III

     The information required by Item 10 – Directors, Executive Officers and Corporate Governance; Item 11 –Executive Compensation; Item 12 – Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters; Item 13 – Certain Relationships and Related Transactions and Director Independence and Item 14 – Principal Accounting Fees and Services is incorporated into Part III of this annual report on Form 10-K by reference to the Proxy Statement for the 2009 Annual Meeting of Stockholders, which is to be filed within 120 days of the Company’s fiscal year ended July 31, 2008.

ITEM 12.  SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND 
  RELATED STOCKHOLDER MATTERS 

     In addition to the materials to be incorporated into this Item 12 by reference to the Proxy Statement for the 2009 Annual Meeting of Stockholders, the following table provides additional information on the Company’s equity based compensation plans as of July 31, 2008:

                Number of securities 
                remaining available for 
    Number of securities to        Weighted-average    future issuance under 
    be issued upon exercise        exercise price of    equity compensation plans 
    of outstanding options,        outstanding options,    (excluding securities 
Plan Category   warrants and rights       warrants and rights   reflected in column (a))
    (a)        (b)    (c) 
Equity compensation plans approved                 
by security holders    6,353,067        $2.69    3,926,983 

PART IV

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES. 

(a)(1) and (2)      The response to these portions of Item 15 is submitted as a separate section of this report commencing on page F-1.

(a)(3)   Exhibits (numbered in accordance with Item 601 of Regulation S-K).     
        Filed 
        Herewith or 
Exhibit       Incorporated 
No.   Item Title     by Reference
 
3.1   Certificate of Incorporation, dated June 12, 1981 (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)    * 
         
3.2   Amendment to Certificate of Incorporation, dated February 18, 1994 (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)    * 
         
3.3   Amendment to Certificate of Incorporation, dated December 26, 1997 (incorporated by reference to Exhibit 3.3 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)    * 

42


        Herewith or 
Exhibit        Incorporated 
No.   Item Title     by Reference
 
3.4    Amendment to Certificate of Incorporation, dated January 14, 2004 (incorporated by reference to Exhibit 3.4 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)    * 
         
3.5    Certificate of Designation for Series A Preferred Stock, dated September 2, 2003 (incorporated by reference to Exhibit 3.5 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)    * 
         
3.6    Certificate of Elimination of Series A Preferred Stock, dated February 3, 2004 (incorporated by reference to Exhibit 3.6 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)    * 
         
3.7    By-Laws (incorporated by reference to Exhibit 3.4 to Registration Statement on Form S-1, File No. 333-111101, filed on December 11, 2003)    * 
         
10.1    1993 Stock Option Plan and Form of Option Agreement (incorporated by reference to Exhibit 10.10 to Registration Statement on Form SB-2, File No. 33-76950, filed on August 1, 1994)    * 
         
10.2    1997 Stock Option Plan (incorporated by reference to Exhibit 10.2 to Registration Statement on Form S-1, File No. 333-111101, filed on December 11, 2003)    * 
         
10.2.1    Amendment No. 1 to 1997 Stock Option Plan (incorporated by reference to Exhibit 10.2.1 to the Company’s Quarterly Report on Form 10-Q, filed on June 9, 2008)    * 
         
10.3    2004 Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)    * 
         
10.3.1    Amendment No. 1 to 2004 Stock Incentive Plan (incorporated by reference to Exhibit 10.3.1 to the Company’s Quarterly Report on Form 10-Q, filed on June 9, 2008)   * 
         
10.4    Form of Subscription Agreement and Warrant Agreement used in Private Placements completed in February 2000 (incorporated by reference to Exhibit 10.21 to the Company’s Annual Report on Form 10-K, filed on October 30, 2000)    * 
         
10.5    Form of Subscription Agreement and Warrant Agreement used in the August and September 2000 Private Placements (incorporated by reference to Exhibit 10.24 to the Company’s Quarterly Report on Form 10-Q, filed on December 15, 2000)    * 
         
10.6    Form of Subscription Agreement and Warrant Agreement used in the April 2001 Private Placements (incorporated by reference to Exhibit 10.23 to Registration Statement on Form S-1, File No. 333-38136, filed on July 30, 2001)    * 
         
10.7    Form of Convertible Note entered into in April 2001 (incorporated by reference to Exhibit 10.24 to Registration Statement on Form S-1, File No. 333-38136, filed on July 30, 2001)    * 
         
10.8    Form of Subscription Agreement and Warrant Agreement used in the July 2001 Private Placements (incorporated by reference to Exhibit 10.25 to Registration Statement on Form S-1, File No. 333-38136, filed on July 30, 2001)    * 
         
10.9    Form of Subscription Agreement and Warrant Agreement used in the August and October 2001 private placement (incorporated by reference to Exhibit 10.26 to Registration Statement on Form S-1, File No. 333-38136, filed on December 14, 2001)    * 

43


        Filed 
        Herewith or 
Exhibit        Incorporated 
No.   Item Title     by Reference
 
10.10    Form of Subscription Agreement and Warrant Agreement used in the September 2001,November 2001 and January 2002 private placements (incorporated by reference to Exhibit 10.27 to Registration Statement on Form S-1, File No. 333-38136, filed on February 21, 2002)    *
         
10.11    Warrant issued in the February 2002 private placement (incorporated by reference toExhibit 10.28 to Registration Statement on Form S-1, File No. 333-38136, filed on February 21, 2002)    *
         
10.12    Form of Subscription Agreement and Warrant Agreement used in the March 2002, April 2002 and May 2002 private placements (incorporated by reference to Exhibit 10.29 to Registration Statement on Form S-1, File No. 333-89166, filed on May 24, 2002)    *
         
10.13    Form of Subscription Agreement and Warrant Agreement used in the June 2002 and October 2002 private placements (incorporated by reference to Exhibit 10.30 to the Post-Effective Amendment to Registration Statement on Form S-1, File No. 333-38136, filed on March 3, 2003)    *
         
10.14    Form of Note Payable and Warrant Certificate entered into April, June, July, September, November and December 2002 (incorporated by reference to Exhibit 10.31 to the Post-Effective Amendment to Registration Statement on Form S-1, File No. 333-38136, filed on March 3, 2003)    *
         
10.15    Form of Note Payable and Warrant Certificate entered into November 2001, January, March and May 2003 (incorporated by reference to Exhibit 10.23 to the Company’s Annual Report on Form 10-K, filed on October 29, 2003)    *
         
10.16    Form of Subscription Agreement and Warrant Agreement used in the February 2003 and April through August 2003 private placements (incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K, filed on October 29, 2003)    *
         
10.17    Form of Amended Notes Payable which amends the November 2001, April 2002, June 2002, July 2002, September 2002, November 2002 December 2002, January 2003, March 2003 and May 2003 notes payable (incorporated by reference to Exhibit 10.27 to The Company’s Annual Report on Form 10-K, filed on October 29, 2003)    *
 
10.18    Securities Purchase Agreement and Warrant Agreement used in September 2003 private placement and Form of Warrant Certificate issued on January 16, 2004 and January 29, 2004 to SF Capital Partners Ltd. (incorporated by reference to Exhibit 10.25 to the Company’s Annual Report on Form 10-K, filed on October 29, 2003)     *
 
10.19    Registration Rights Agreement used in September 2003 private placement with SF Capital Partners Ltd. (incorporated by reference to Exhibit 10.26 to the Company’s Annual Report on Form 10-K, filed on October 29, 2003)    *
         
10.20    Form of Securities Purchase Agreement used in May 2004 private placement with Knoll Capital Fund II, Europa International, Inc. and Clifford and Phyllis Kalista JTWROS (incorporated by reference to Exhibit 4.3 to Registration Statement on Form S-1, File No. 333-112865, filed on May 18, 2004)    * 
         
10.21    Form of Registration Rights Agreement used in May 2004 private placement with Knoll Capital Fund II, Europa International, Inc. and Clifford and Phyllis Kalista    *
         

44


        Filed 
        Herewith or 
Exhibit        Incorporated 
No.   Item Title     by Reference
 
    JTWROS (incorporated by reference to Exhibit 4.4 to Registration Statement on Form S-1, File No. 333-112865, filed on May 18, 2004)    *
         
10.22    Form of Warrant Certificate issued on May 11, 2004 to Knoll Capital Fund II, Europa International, Inc. and Clifford and Phyllis Kalista JTWROS (incorporated by reference to Exhibit 4.5 to Registration Statement on Form S-1, File No. 333-112865, filed on May 18, 2004)    *
         
10.23    Form of Stock Option Agreement issued to the Company’s Board of Directors under the Company’s 1997 Stock Option Plan (incorporated by reference to Exhibit 10.23 to the Company’s quarterly report on Form 10-Q filed on June 9, 2005)    *
         
10.24    Form of Stock Option Agreement issued to the Company’s Executive Officers under the Company’s 1997 Stock Option Plan (incorporated by reference to Exhibit 10.24 to the Company’s quarterly report on Form 10-Q filed on June 9, 2005)    * 
         
10.25    Separation Agreement and General Release with Andrew Savadelis dated May 26, 2005 (incorporated by reference to Exhibit 10.25 to the Company’s Annual Report on Form 10-K, filed on October 15, 2005)    *
         
10.26    Securities Purchase Agreement used in May 2005 private placement with Jeffrey D’Onofrio dated May 1, 2006    *
         
10.27    Form of Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)    *
         
10.28    Registration Rights Agreement dated July 17, 2006 (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)    *
         
10.29    Agreement to Amend Knoll Warrant dated July 17, 2006 (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)    *
         
10.30    Form of Amended Knoll Warrant (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)    *
         
10.31    Agreement to Amend SF Capital Warrant dated July 17, 2006 (incorporated by reference to Exhibit 4.5 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)     *
         
10.32    Form of Amended Warrant for SF Capital Partners, Ltd. (incorporated by reference to Exhibit 4.6 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)      *
         
10.33    Securities Purchase Agreement dated July 17, 2006 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)    *
         
10.34    Form of Stock Option Agreement for Executive Officers under the Company's 2004 Stock Incentive Plan     * 
         
10.35    Offer letter agreement with Lawrence A. Kenyon dated January 16, 2007    * 
         
10.36    Summary of the Company's Non-Employee Director Compensation Policy    * 
         
10.37    Royalty Agreement between the Company and Kuslima Shogen, dated July 24, 1991 and Amendment to Royalty Agreement, dated April 16, 2001    * 
         
10.38    Office Lease Agreement, dated March 14, 2007, between I&G Garden State, LLC and the Company     * 

45


        Filed 
        Herewith or 
Exhibit        Incorporated 
No.   Item Title     by Reference
 
10.39    Form of Distribution and Marketing Agreement, dated July 25, 2007, between the     
    Company and USP Pharma Spolka Z.O.O.    *^ 
         
10.40    Form of Securities Purchase Agreement, dated July 25, 2007, between the Company     
    and Unilab LP.    * 
         
10.41    License Agreement, dated January 14, 2008, between the Company and Par     
    Pharmaceutical, Inc. (incorporated by reference to Exhibit 10.41 to the Company’s    *^ 
    Quarterly Report on Form 10-Q, filed on March 7, 2008)     
         
10.42    Supply Agreement, dated January 14, 2008, between the Company and Par    * 
    Pharmaceutical, Inc. (incorporated by reference to Exhibit 10.42 to the Company’s     
    Quarterly Report on Form 10-Q, filed on March 7, 2008)     
         
10.43    Purchase and Supply Agreement, dated January 14, 2008, between the Company and     
    Scientific Protein Laboratories LLC (incorporated by reference to Exhibit 10.43 to the    * 
    Company’s Quarterly Report on Form 10-Q, filed on March 7, 2008)     
         
10.44    Amendment No. 1 to 1993 Stock Option Plan (incorporated by reference to Exhibit     
    10.44 to the Company’s Quarterly Report on Form 10-Q, filed on June 9, 2008)    * 
         
10.45    Retirement Agreement, dated April 25, 2008, between the Company and Kuslima     
    Shogen (incorporated by reference to Exhibit 99.1 to the Company’s Current Report    *~ 
    on Form 8-K, filed on April 28, 2008)     
         
21.1    Subsidiaries of Registrant    * 
         
23.1    Consent of J.H. Cohn LLP    + 
         
23.2    Consent of KPMG LLP    + 
         
31.1    Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-     
    Oxley Act of 2002    + 
         
31.2    Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-     
    Oxley Act of 2002    + 
         
32.1    Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-     
    Oxley Act of 2002    + 
         
32.2    Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-     
    Oxley Act of 2002    + 
 
*    Previously filed; incorporated herein by reference     
+    Filed herewith     
^    Portions of this exhibit have been redacted and filed separately with the SEC pursuant to a confidential 
    treatment request.     
~    Management contract or compensatory plan or arrangement.     

46


SIGNATURE

Pursuant to the requirements of Section 13 or 15(d) 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.

    ALFACELL CORPORATION 
 
 
Dated: October 14, 2008    By: /s/ KUSLIMA SHOGEN 
         Kuslima Shogen, Chief Executive Officer 

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Dated: October 14, 2008    /s/ KUSLIMA SHOGEN 
    Kuslima Shogen, Chief Executive Officer (Principal 
    Executive Officer) 
 
 
Dated: October 14, 2008    /s/ LAWRENCE A. KENYON 
    Lawrence A. Kenyon, President and Chief Financial 
    Officer (Principal Financial Officer and Principal 
    Accounting Officer) 
 
 
Dated: October 14, 2008    /s/ DAVID SIDRANSKY 
    David Sidransky, M.D., Chairman of the Board 
 
 
Dated: October 14, 2008    /s/ JOHN P. BRANCACCIO 
    John P. Brancaccio, Director 
 
 
Dated:       
    Stephen K. Carter, M.D., Director 
 
 
Dated: October 14, 2008    /s/ DONALD R. CONKLIN 
    Donald R. Conklin, Director 
 
 
Dated: October 14, 2008    /s/ JAMES J. LOUGHLIN 
    James J. Loughlin, Director 
 
 
Dated: October 14, 2008    /s/ PAUL M. WEISS 
    Paul M. Weiss, Ph.D., Director 

47


Alfacell Corporation

Index to Financial Statements

    Page 
Audited Financial Statements:     
Report of Independent Registered Public Accounting Firm: J.H. Cohn LLP    F-2 
Report of Independent Registered Public Accounting Firm: KPMG LLP    F-3 
Independent Auditors’ Report of Armus, Harrison & Co    F-5 
Balance Sheets - July 31, 2008 and 2007    F-6 
Statements of Operations - Years ended July 31, 2008, 2007,     
         and 2006 and the Period from August 24, 1981     
         (Date of Inception) to July 31, 2008    F-7 
Statement of Stockholders’ Equity (Deficiency)     
         Period from August 24, 1981     
         (Date of Inception) to July 31, 2008    F-8 
Statements of Cash Flows - Years ended July 31, 2008, 2007,     
         and 2006 and Period from August 24, 1981     
         (Date of Inception) to July 31, 2008    F-15 
Notes to Financial Statements - Years ended July 31, 2008,     
         2007 and 2006 and the Period from August 24, 1981     
         (Date of Inception) to July 31, 2008    F-18 

F-1


Report of Independent Registered Public Accounting Firm

The Board of Directors and Stockholders
Alfacell Corporation

We have audited the accompanying balance sheets of Alfacell Corporation (a development stage company) as of July 31, 2008 and 2007, and the related statements of operations, stockholders’ equity (deficiency), and cash flows for each of the years in the three-year period ended July 31, 2008 and for the period from August 24, 1981 (date of inception) to July 31, 2008. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits. The financial statements of Alfacell Corporation for the period from August 24, 1981 to July 31, 2002 were audited by other auditors whose reports dated November 4, 2002 and December 9, 1992, except for Note 18 which is as of July 19, 1993 and Note 3 which is as of October 28, 1993, expressed unqualified opinions on those statements with explanatory paragraphs relating to the Company’s ability to continue as a going concern.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, and as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, based on our audits and, for the effect on the period from August 24, 1981 (date of inception) to July 31, 2008 of the amounts for the period from August 24, 1981 (date of inception) to July 31, 2002, on the reports of other auditors, the financial statements referred to above present fairly, in all material respects, the financial position of Alfacell Corporation as of July 31, 2008 and 2007, and the results of its operations and its cash flows for each of the years in the three-year period ended July 31, 2008 and for the period from August 24, 1981 (date of inception) to July 31, 2008 in conformity with accounting principles generally accepted in the United States of America.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed on Note 2 to the financial statements, the Company has suffered recurring losses from operations and negative cash flows from operating activities that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regards to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

We have also audited, in accordance with the Standards of the Public Company Accounting Oversight Board (United States), Alfacell Corporation’s internal control over financial reporting as of July 31, 2008, based on criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organization of the Treadway Commission (COSO) and our report dated October 13, 2008 expressed an unqualified opinion.

/s/ J.H. Cohn LLP
Roseland, New Jersey
October 13, 2008

F-2


Report Of Independent Registered Public Accounting Firm

The Stockholders and Board of Directors
Alfacell Corporation:

We have audited the statements of operations, stockholders' equity (deficiency), and cash flows for the period from August 24, 1981 (date of inception) to July 31, 2002 (not presented herein) of Alfacell Corporation (a development stage company). These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audit. The financial statements of Alfacell Corporation for the period from August 24, 1981 to July 31, 1992 were audited by other auditors who have ceased operations and whose report dated December 9, 1992, except as to note 18 which is July 19, 1993 and note 3 which is October 28, 1993, expressed an unqualified opinion on those statements with an explanatory paragraph regarding the Company's ability to continue as a going concern.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

In our opinion, based on our audit and, for the effect on the period from August 24, 1981 to July 31, 2002 of the amounts for the period from August 24, 1981 to July 31, 1992, on the report of other auditors who have ceased operations, the financial statements referred to above present fairly, in all material respects, the results of operations and cash flows for the period from August 24, 1981 to July 31, 2002 (not presented herein) of Alfacell Corporation in conformity with U.S. generally accepted accounting principles.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has suffered recurring losses from operations, has a working capital deficit and has limited liquid resources which raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

/s/ KPMG LLP

Short Hills, New Jersey
November 4, 2002

F-3


On December 1, 1993, certain shareholders of Armus Harrison & Co. (“AHC”) terminated their association with AHC (the “AHC termination”), and AHC ceased performing accounting and auditing services, except for limited accounting services to be performed on behalf of the Company. In June 1996, AHC dissolved and ceased all operations. The report of AHC with respect to the financial statements of the Company from inception to July 31, 1992 is included herein, although AHC has not consented to the use of such report herein and will not be available to perform any subsequent review procedures with respect to such report. Accordingly, investors will be barred from asserting claims against AHC under Section 11 of the Securities Act of 1933, as amended (the “Securities Act”) on the basis of the use of such report in any registration statement of the Company into which such report is incorporated by reference. In addition, in the event any persons seek to assert a claim against AHC for false or misleading financial statements and disclosures in documents previously filed by the Company, such claim will be adversely affected and possibly barred. Furthermore, as a result of the lack of a consent from AHC to the use of its audit report herein, or, to its incorporation by reference into a registration statement or other filings, the officers and directors of the Company will be unable to rely on the authority of AHC as experts in auditing and accounting in the event any claim is brought against such persons under Section 11 of the Securities Act based on alleged false and misleading financial statements and disclosures attributable to AHC. The discussion regarding certain effects of the AHC termination is not meant and should not be construed in any way as legal advice to any party and any potential purchaser should consult with his, her or its own counsel with respect to the effect of the AHC termination on a potential investment in the Common Stock of the Company or otherwise.

F-4


Independent Auditors’ Report

Board of Directors
Alfacell Corporation
Bloomfield, New Jersey

We have audited the balance sheets of Alfacell Corporation (a Development Stage Company) as of July 31, 1992 and 1991, as restated, and the related statements of operations, stockholders’ deficiency, and cash flows for the three years ended July 31, 1992, as restated, and for the period from inception August 24, 1981 to July 31, 1992, as restated. In connection with our audit of the 1992 and 1991 financial statements, we have also audited the 1992, 1991 and 1990 financial statement schedules as listed in the accompanying index. These financial statements and financial statement schedules are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audit.

We conducted our audit in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

In our opinion the financial statements referred to above present fairly in all material respects, the financial position of Alfacell Corporation as of July 31, 1992 and 1991, as restated, and for the three years ended July 31, 1992, as restated, and for the period from inception August 24, 1981 to July 31, 1992, as restated, and the results of operations and cash flows for the years then ended in conformity with generally accepted accounting principles.

The accompanying financial statements have been prepared on a going concern basis which contemplates the realization of assets and the satisfaction of liability in the normal course of business. As shown in the statement of operations, the Company has incurred substantial losses in each year since its inception. In addition, the Company is a development stage company and its principal operation for production of income has not commenced. The Company’s working capital has been reduced considerably by operating losses, and has a deficit net worth. These factors, among others, as discussed in Note 2 to the Notes of Financial Statements, indicates the uncertainties about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and the amount or classification of liabilities that might be necessary should the Company be unable to continue its existence.

/s/ Armus, Harrison & Co.          
Armus, Harrison & Co.

Mountainside, New Jersey
December 9, 1992
Except as to Note 18 which
     is July 19, 1993 and Note 3
     which is October 28, 1993

F-5


ALFACELL CORPORATION
(A Development Stage Company)

Balance Sheets

July 31, 2008 and 2007

      2008     2007  
ASSETS               
 
Current assets:               
       Cash and cash equivalents    $ 4,661,656   $ 6,968,172  
       Prepaid expenses      165,259     150,207  
               Total current assets      4,826,915     7,118,379  
 
Property and equipment, net of accumulated depreciation and               
       amortization of $342,031 in 2008 and $290,581 in 2007      143,121     136,723  
 
Loan receivable, related party          180,397  
 
Other assets      350,000     385,000  
 
             Total assets    $ 5,320,036   $ 7,820,499  
 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)               
 
Current liabilities:               
     Accounts payable    $ 1,252,478   $ 432,786  
     Accrued clinical trial expenses      882,386     898,134  
     Accrued professional service fees      511,779     322,051  
     Accrued compensation expense      227,803     143,369  
     Current portion of obligations under capital lease      3,453      
     Other accrued expenses      4,135     33,560  
               Total current liabilities      2,882,034     1,829,900  
 
Other liabilities:               
     Obligations under capital lease, net of current portion      16,940      
     Accrued retirement benefits      510,000      
     Deferred rent      267,668     112,119  
     Deferred revenue      5,200,000     100,000  
             Total other liabilities      5,994,608     212,119  
 
             Total liabilities      8,876,642     2,042,019  
 
Stockholders’ equity (deficiency):               
       Preferred stock, $.001 par value. Authorized and unissued,               
               1,000,000 shares at July 31, 2008 and 2007           
       Common stock $.001 par value. Authorized 100,000,000               
               shares at July 31, 2008 and 2007; issued and outstanding               
               47,276,880 shares and 46,280,880 shares at July 31, 2008               
               and 2007, respectively      47,277     46,281  
       Capital in excess of par value      100,788,973     97,803,954  
       Deficit accumulated during development stage      (104,392,856 )    (92,071,755 ) 
               Total stockholders’ equity (deficiency)      (3,556,606 )    5,778,480  
 
               Total liabilities and stockholders’ equity (deficiency)    $ 5,320,036   $ 7,820,499  

See accompanying notes to financial statements.

F-6


ALFACELL CORPORATION
(A Development Stage Company)

Statements of Operations

Years ended July 31, 2008, 2007 and 2006
and the Period from August 24, 1981
(Date of Inception) to July 31, 2008

                        August 24, 1981  
                        (date of  
                        inception)  
      2008     2007     2006     to July 31, 2008  
 
Sales    $        $   $  553,489  
 
 
Operating expenses:                           
       Cost of sales                    336,495  
       Research and development      8,503,110     5,543,175     5,229,996     69,313,532  
       General and administrative      5,797,355     4,092,990     3,004,835     38,532,768  
 
             Total operating expenses      14,300,465     9,636,165     8,234,831     108,182,795  
 
Loss from operations      (14,300,465 )    (9,636,165 )    (8,234,831 )    (107,629,306 ) 
 
Investment income      227,591     370,650     107,386     2,276,448  
Other income                  99,939  
Interest expense:                           
Related parties                    (1,147,547 ) 
Others      (3,607 )    (96 )    (112 )    (2,877,779 ) 
 
Loss before state tax benefit      (14,076,481 )    (9,265,611 )    (8,127,557 )    (109,278,245 ) 
 
State tax benefit      1,755,380     510,467     317,382     4,885,389  
 
Net loss    $  (12,321,101 )  $ (8,755,144 )  $ (7,810,175 )  $  (104,392,856 ) 
 
Loss per basic and diluted common share    $ (0.26 )  $ (0.19 )  $ (0.21 )       
 
Weighted average number of shares                           
       outstanding – basic and diluted 
    46,919,000     44,958,000     37,308,000        

See accompanying notes to financial statements.

F-7


ALFACELL CORPORATION
(A Development Stage Company)

Statement of Stockholders' Equity (Deficiency)

Period from August 24, 1981
(Date of Inception)to July 31, 2008

                                 
                                                   
    Common Stock               Deficit                     
               
Capital In
        Accumulated                Total  
    Number of          
Excess of par
    Common
Stock to be
 
    During
Development
      Subscription      Deferred 
compensation,
 
    Stockholders’
Equity
 
    Shares       Amount  
Value
    Issued      Stage       Receivable      restricted stock      (Deficiency)  
Issuance of shares to officers and stockholders for equipment, research                                                     
   and development, and expense reimbursement    712,500     $ 713   $ 212,987         $     $     $     $ 213,700  
Issuance of shares for organizational legal service    50,000       50     4,950                             5,000  
Sale of shares for cash, net    82,143       82     108,418                             108,500  
Adjustment for 3 for 2 stock split declared September 8, 1982    422,321       422     (422 )                             
Net loss                        (121,486 )                  (121,486 ) 
Balance at July 31, 1982    1,266,964       1,267     325,933           (121,486 )                  205,714  
                                                   
Issuance of shares for equipment    15,000       15     13,985                             14,000  
Sale of shares to private investors    44,196       44     41,206                             41,250  
Sale of shares in public offering, net    660,000       660     1,307,786                             1,308,446  
Issuance of shares under stock grant program    20,000       20     109,980                             110,000  
Exercise of warrants, net    1,165       1     3,494                             3,495  
Net loss                        (558,694 )                  (558,694 ) 
Balance at July 31, 1983    2,007,325       2,007     1,802,384           (680,180 )                  1,124,211  
 
Exercise of warrants, net    287,566       287     933,696                             933,983  
Issuance of shares under stock grant program    19,750       20     101,199                             101,219  
Issuance of shares under stock bonus plan for directors and consultants    130,250       131     385,786                             385,917  
Net loss                        (1,421,083 )                  (1,421,083 ) 
Balance at July 31, 1984    2,444,891       2,445     3,223,065           (2,101,263 )                  1,124,247  
 
Issuance of shares under stock grant program    48,332       48     478,057                             478,105  
Issuance of shares under stock bonus plan for directors and consultants    99,163       99     879,379                             879,478  
Shares canceled    (42,500 )      (42 )    (105,783 )                            (105,825 ) 
Exercise of warrants, net    334,957       335     1,971,012                             1,971,347  
Net loss                        (2,958,846 )                  (2,958,846 ) 
Balance at July 31, 1985    2,884,843       2,885     6,445,730           (5,060,109 )                  1,388,506  
 
Issuance of shares under stock grant program    11,250       12     107,020                             107,032  
Issuance of shares under stock bonus plan for directors and consultants    15,394       15     215,385                             215,400  
Exercise of warrants, net    21,565       21     80,977                             80,998  
Net loss                        (2,138,605 )                  (2,138,605 ) 
Balance at July 31, 1986 (carried forward)    2,933,052       2,933     6,849,112           (7,198,714 )                  (346,669 ) 

F-8


ALFACELL CORPORATION
(A Development Stage Company)

Statement of Stockholders' Equity (Deficiency), Continued

                          Deficit                        
    Common Stock                Accumulated                     Total  
                Capital In    Common      During             Deferred       Stockholders’  
    Number of            Excess of par    Stock to be      Development       Subscription      compensation,       Equity  
     Shares      Amount      Value    Issued      Stage       Receivable      restricted stock       (Deficiency)  
                                                   
Balance at July 31, 1986 (brought forward)    2,933,052    $ 2,933    $ 6,849,112        $ (7,198,714 )    $     $     $ (346,669 ) 
 
Exercise of warrants, net    14,745      15      147,435                            147,450  
Issuance of shares under stock bonus plan for directors and consultants    5,000      5      74,995                            75,000  
Issuance of shares for services    250,000      250      499,750                            500,000  
Sale of shares to private investors, net    5,000      5      24,995                            25,000  
Net loss                          (2,604,619 )                  (2,604,619 ) 
Balance at July 31, 1987    3,207,797      3,208      7,596,287          (9,803,333 )                  (2,203,838 ) 
 
Issuance of shares for legal and consulting services    206,429      207      724,280                            724,487  
Issuance of shares under employment incentive program    700,000      700      2,449,300                      (2,450,000 )       
Issuance of shares under stock grant program    19,000      19      66,481                            66,500  
Exercise of options, net    170,000      170      509,830                            510,000  
Issuance of shares for litigation settlement    12,500      12      31,125                            31,137  
Exercise of warrants, net    63,925      64      451,341                            451,405  
Sale of shares to private investors    61,073      61      178,072                            178,133  
Amortization of deferred compensation, restricted stock                                      449,167       449,167  
Net loss                          (3,272,773 )                  (3,272,773 ) 
Balance at July 31, 1988    4,440,724      4,441      12,006,716          (13,076,106 )            (2,000,833 )      (3,065,782 ) 
                                                   
Sale of shares for litigation settlement    135,000      135      1,074,703                            1,074,838  
Conversion of debentures, net    133,333      133      399,867                            400,000  
Sale of shares to private investors    105,840      106      419,894                            420,000  
Exercise of options, net    1,000      1      3,499                            3,500  
Issuance of shares under employment agreement    750,000      750      3,749,250                      (3,750,000 )       
Issuance of shares under the 1989 Stock Plan    30,000      30      149,970                      (150,000 )       
Amortization of deferred compensation, restricted stock                                      1,050,756       1,050,756  
Net loss                          (2,952,869 )                  (2,952,869 ) 
Balance at July 31, 1989    5,595,897      5,596      17,803,899          (16,028,975 )            (4,850,077 )      (3,069,557 ) 
 
Issuance of shares for legal and consulting services    52,463      52      258,725                            258,777  
Issuance of shares under the 1989 Stock Plan    56,000      56      335,944                      (336,000 )       
Sale of shares for litigation settlement    50,000      50      351,067                            351,117  
Exercise of options at, net    105,989      106      345,856                            345,962  

F-9


ALFACELL CORPORATION
(A Development Stage Company)

Statement of Stockholders' Equity (Deficiency), Continued

                          Deficit                        
    Common Stock                Accumulated                     Total  
                Capital In    Common      During             Deferred       Stockholders’  
    Number of            Excess of par    Stock to be      Development       Subscription      compensation,       Equity  
    Shares      Amount      Value    Issued      Stage       Receivable      restricted stock       (Deficiency)  
 
Sale of shares to private investors    89,480    $ 90    $ 354,990        $     $     $     $ 355,080  
Issuance of shares under employment agreement    750,000      750      3,749,250                      (3,750,000 )       
Conversion of debentures, net    100,000      100      499,900                            500,000  
Amortization of deferred compensation, restricted stock                                      3,015,561       3,015,561  
Net loss                          (4,860,116 )                  (4,860,116 ) 
Balance at July 31, 1990    6,799,829      6,800      23,699,631          (20,889,091 )            (5,920,516 )      (3,103,176 ) 
 
Exercise of options, net    16,720      16      108,664                            108,680  
Issuance of shares for legal consulting services    87,000      87      358,627                            358,714  
Issuance of shares under the 1989 Stock Plan    119,000      119      475,881                      (476,000 )       
Amortization of deferred compensation, restricted stock                                      2,891,561       2,891,561  
Net loss                          (5,202,302 )                  (5,202,302 ) 
Balance at July 31, 1991    7,022,549      7,022      24,642,803          (26,091,393 )            (3,504,955 )      (4,946,523 ) 
 
Exercise of options at, net    1,000      1      3,499                            3,500  
Sale of shares to private investors    70,731      71      219,829                            219,900  
Conversion of debentures, net    94,000      94      469,906                            470,000  
Issuance of shares for services    45,734      46      156,944                            156,990  
Issuance of shares under the 1989 Stock Plan    104,000      104      285,896                      (286,000 )       
Amortization of deferred compensation, restricted stock                                      3,046,726       3,046,726  
Net loss                          (4,772,826 )                  (4,772,826 ) 
Balance at July 31, 1992    7,338,014      7,338      25,778,877          (30,864,219 )            (744,229 )      (5,822,233 ) 
 
Sale of shares to private investors    352,667      353      735,147                            735,500  
Issuance of shares for legal services    49,600      50      132,180                            132,230  
Issuance of shares for services    5,000      5      9,995                      (10,000 )       
Issuance of shares under the 1989 Stock Plan    117,000      117      233,883                      (234,000 )       
Amortization of deferred compensation, restricted stock                                      664,729       664,729  
Net loss                          (2,357,350 )                  (2,357,350 ) 
Balance at July 31, 1993    7,862,281      7,863      26,890,082          (33,221,569 )            (323,500 )      (6,647,124 ) 
 
Conversion of debentures, net    425,400      425      1,701,575                            1,702,000  
Sale of shares to private investors, net    743,000      743      1,710,048                            1,710,791  
Conversion of short-term borrowings    72,800      73      181,927                            182,000  
Issuance of shares for services    16,200      16      43,334                            43,350  

F-10


ALFACELL CORPORATION
(A Development Stage Company)

Statement of Stockholders' Equity (Deficiency), Continued

                              Deficit                          
    Common Stock                    Accumulated                       Total  
                Capital In     Common       During               Deferred       Stockholders’  
    Number of            Excess of par     Stock to be       Development       Subscription       compensation,       Equity  
     Shares      Amount      Value     Issued       Stage       Receivable       restricted stock       (Deficiency)  
 
Issuance of shares under the
      1989 Stock Plan, for services
 
             5,000    $ 5    $ 14,995         $     $     $     $ 15,000  
Issuance of options to related parties
      upon conversion of accrued interest,
 
                                                       
      payroll and expenses                       3,194,969                             3,194,969  
Repurchase of stock options from related party                       (198,417 )                            (198,417 ) 
Issuance of options upon conversion of
      accrued interest
 
                     142,441                             142,441  
Common stock to be issued                           50,000                         50,000  
Amortization of deferred compensation,
      restricted stock
 
                                           265,000       265,000  
Net loss                                 (2,234,428 )                  (2,234,428 ) 
Balance at July 31, 1994    9,124,681         9,125      33,680,954     50,000       (35,455,997 )            (58,500 )      (1,774,418 ) 
 
Sale of shares to private investors, net           961,000      961      2,023,241     (50,000 )                        1,974,202  
Conversion of short-term borrowings             17,600      17      43,983                             44,000  
Issuance of shares for services             30,906      31      77,234                             77,265  
Exercise of options, net           185,000      185      437,015                             437,200  
Common stock to be issued                           339,008                         339,008  
Common stock to be issued, for services                           4,800                         4,800  
Amortization of deferred compensation,
      restricted stock
 
                                           58,500       58,500  
Net loss                                   (1,993,123 )                  (1,993,123 ) 
Balance at July 31, 1995     10,319,187      10,319      36,262,427     343,808       (37,449,120 )                  (832,566 ) 
 
Sale of shares to private investors, net    2,953,327         2,953      8,969,655     (339,008 )                        8,633,600  
Issuance of shares for services             19,995      20      70,858     (4,800 )                        66,078  
Exercise of options, net           566,700      567      1,657,633                             1,658,200  
Sale of warrants                       12,084                             12,084  
Issuance of options/warrants for services                       50,872                             50,872  
Common stock to be issued                           258,335                         258,335  
Subscription receivable                                       (254,185 )            (254,185 ) 
Net loss                                   (2,942,152 )                  (2,942,152 ) 
Balance at July 31, 1996     13,859,209      13,859      47,023,529     258,335       (40,391,272 )      (254,185 )            6,650,266  
 
Sale of shares to private investors, net           112,000      112      503,888                             504,000  
Issuance of options for services                       76,504                             76,504  
Exercise of options, net           729,134      729      2,620,359     (258,335 )            254,185             2,616,938  
Exercise of warrants, net           147,450      148      737,102                             737,250  
Net loss                                 (5,018,867 )                  (5,018,867 ) 
Balance at July 31, 1997 (carried forward)     14,847,793      14,848      50,961,382           (45,410,139 )                  5,566,091  

F-11


ALFACELL CORPORATION
(A Development Stage Company)

Statement of Stockholders' Equity (Deficiency), Continued

                          Deficit                      
    Common Stock                Accumulated                   Total  
                Capital In    Common      During             Deferred      Stockholders’  
    Number of            Excess of par    Stock to be      Development       Subscription      compensation,      Equity  
    Shares      Amount      Value    Issued      Stage       Receivable      restricted stock      (Deficiency)  
 
Balance at July 31, 1997 (brought forward)    14,847,793    $ 14,848    $ 50,961,382        $ (45,410,139 )    $     $     $ 5,566,091  
 
Sale of shares to private investors, net    2,337,150      2,337      4,199,877                            4,202,214  
Issuance of options for services                199,954                            199,954  
Exercise of warrants, net    4,950      5      11,080                            11,085  
Issuance of shares for services, net    50,000      50      99,950                            100,000  
Net loss                          (6,387,506 )                  (6,387,506 ) 
Balance at July 31, 1998    17,239,893      17,240      55,472,243          (51,797,645 )                  3,691,838  
 
Issuance of options for services                205,593                            205,593  
Issuance of shares for services, net    46,701      46      16,359                            16,405  
Net loss                          (3,156,636 )                  (3,156,636 ) 
Balance at July 31, 1999    17,286,594      17,286      55,694,195          (54,954,281 )                  757,200  
 
Sale of shares to private investors, net    875,000      875      547,417                            548,292  
Exercise of options, net    95,000      95      45,755                            45,850  
Issuance of shares for services, net    174,965      175      92,009                            92,184  
Vesting of options previously issued for services                146,912                            146,912  
Net loss                          (1,722,298 )                  (1,722,298 ) 
Balance at July 31, 2000    18,431,559      18,431      56,526,288          (56,676,579 )                  (131,860 ) 
 
Sale of shares to private investors, net    863,331      863      955,561                            956,424  
Exercise of options, net    165,555      166      83,565                            83,731  
Issuance of shares for services, net    11,800      12      10,018                            10,030  
Exercise of convertible debentures, net    330,000      330      296,670                            297,000  
Issuance of warrants with convertible debt                178,807                            178,807  
Issuance of options for services                160,426                            160,426  
Net loss                          (2,294,936 )                  (2,294,936 ) 
Balance at July 31, 2001    19,802,245      19,802      58,211,335          (58,971,515 )                  (740,378 ) 
 
Sale of shares to private investors, net    2,622,122      2,623      1,047,925                            1,050,548  
Exercise of stock options and warrants    186,000      186      92,814                            93,000  
Issuance of shares for services, net    78,340      78      64,048                            64,126  
Exercise of convertible debentures, net    72,214      72      64,921                            64,993  
Vesting of options previously issued for services                173,436                            173,436  
Net loss                          (2,591,162 )                  (2,591,162 ) 
Balance at July 31, 2002 (carried forward)    22,760,921      22,761      59,654,479          (61,562,677 )                  (1,885,437 ) 

F-12


ALFACELL CORPORATION
(A Development Stage Company)

Statement of Stockholders' Equity (Deficiency), Continued

                          Deficit                      
    Common Stock                Accumulated                   Total  
                Capital In    Common      During             Deferred      Stockholders’  
    Number of            Excess of par    Stock to be      Development       Subscription      compensation,      Equity  
    Shares      Amount      Value    Issued      Stage       Receivable      restricted stock      (Deficiency)  
 
Balance at July 31, 2002 (brought forward)    22,760,921    $ 22,761    $ 59,654,479        $ (61,562,677 )    $     $     $ (1,885,437 ) 
 
Sale of shares to private investors, net    1,315,000      1,315      652,312                            653,627  
Exercise of stock options and warrants    764,000      764      376,896                            377,660  
Issuance of shares for payment of accounts payable    186,208      186      94,037                            94,223  
Issuance of options for services rendered                75,521                            75,521  
Vesting of options previously issued for services                10,038                            10,038  
Issuance of warrants in connection with debt issuances                594,219                            594,219  
Net loss                          (2,411,532 )                  (2,411,532 ) 
Balance at July 31, 2003    25,026,129      25,026      61,457,502          (63,974,209 )                  (2,491,681 ) 
 
Sale of shares to private investors, net    3,035,200      3,036      10,732,942                            10,735,978  
Exercise of stock options and warrants    3,100,160      3,100      4,155,397                            4,158,497  
Issuance of shares for payment of accounts payable    14,703      15      52,161                            52,176  
Issuance of shares for conversion of subordinated debentures    3,042,817      3,043      924,829                            927,872  
Issuance of shares for services rendered    128,876      128      288,372                            288,500  
Issuance of options for services rendered                280,612                            280,612  
Net loss                          (5,070,307 )                  (5,070,307 ) 
Balance at July 31, 2004    34,347,885      34,348      77,891,815          (69,044,516 )                  8,881,647  
 
Exercise of stock options and warrants, net    438,372      438      306,717                            307,155  
Issuance of shares and warrants for conversion of subordinated                                                 
   debentures    1,744,978      1,745      462,754                            464,499  
Issuance of shares for services rendered    3,000      3      13,497                            13,500  
Issuance of options and warrants for services rendered                16,789                            16,789  
Net loss                          (6,461,920 )                  (6,461,920 ) 
Balance at July 31, 2005    36,534,235      36,534      78,691,572          (75,506,436 )                  3,221,670  
 
Sale of shares to private investors, net    6,632,099      6,632      10,977,288                            10,983,920  
Exercise of stock options and warrants, net    1,122,827      1,123      1,347,201                            1,348,324  
Issuance of stock options and warrants for services rendered                1,489,264                            1,489,264  
Net loss                          (7,810,175 )                  (7,810,175 ) 
Balance at July 31, 2006 (carried forward)    44,289,161      44,289      92,505,325          (83,316,611 )                  9,233,003  

F-13


ALFACELL CORPORATION
(A Development Stage Company)

Statement of Stockholders' Equity (Deficiency), Continued

                          Deficit                      
    Common Stock                Accumulated                   Total  
                Capital In    Common      During             Deferred      Stockholders’  
    Number of            Excess of par    Stock to be      Development       Subscription      compensation,      Equity  
     Shares      Amount      Value    Issued      Stage       Receivable      restricted stock      (Deficiency)  
 
Balance at July 31, 2006 (brought forward)    44,289,161    $ 44,289    $ 92,505,325        $ (83,316,611 )     $         $      $ 9,233,003  
 
Sale of shares to private investors, net           553,360      553      1,368,104                            1,368,657  
Exercise of stock options and warrants, net    1,438,359      1,439      1,504,261                            1,505,700  
Stock-based compensation expense                2,426,264                            2,426,264  
Net loss                          (8,755,144 )                  (8,755,144 ) 
Balance at July 31, 2007    46,280,880      46,281      97,803,954          (92,071,755 )                  5,778,480  
 
Exercise of stock options and warrants, net           996,000      996      686,044                            687,040  
Stock-based compensation expense                2,298,975                            2,298,975  
Net loss                          (12,321,101 )                  (12,321,101 ) 
Balance at July 31, 2008    47,276,880    $ 47,277    $ 100,788,973        $ (104,392,856 )     $         $      $ (3,556,606 ) 

See accompanying notes to financial statements.

F-14


ALFACELL CORPORATION
(A Development Stage Company)

Statements of Cash Flows

Years ended July 31, 2008, 2007 and 2006
and the Period from August 24, 1981
(Date of Inception) to July 31, 2008

                              August 24, 1981  
                              (date of inception)  
                              to  
      2008       2007       2006       July 31, 2008  
Cash flows from operating activities:                                 
 Net loss    $ (12,321,101 )    $ (8,755,144 )    $ (7,810,175 )    $ (104,392,856 ) 
 Adjustments to reconcile net loss to net cash used in operating activities:                                 
           Gain on sale of marketable equity securities      --       --       --       (25,963 ) 
           Depreciation and amortization      51,451       39,063       29,703       1,710,491  
           Loss on disposal of property and equipment      --       --       --       18,926  
           Loss on lease termination      --       30,964       --       30,964  
           Stock-based compensation expense      2,298,975       2,426,264       1,489,264       12,931,516  
           Amortization of deferred rent      155,549       14,155       --       169,704  
           Amortization of debt discount      --       --       --       594,219  
           Amortization of deferred compensation      --       --       --       11,442,000  
           Changes in assets and liabilities:                                 
             (Increase) decrease in prepaid expenses      (15,052 )      (83,117 )      129,846       (225,126 ) 
             Decrease (increase) in loans receivable, related party      180,397       (9,527 )      (9,528 )      96,051  
             Decrease (increase) in other assets      35,000       (385,000 )      --       (350,000 ) 
             Increase in loans and interest payable, related party      --       --       --       744,539  
             Increase (decrease) in accounts payable      819,692       (853,384 )      889,907       1,759,113  
             Increase in accrued payroll and expenses, related parties      --       --       --       2,348,145  
             Increase in accrued retirement benefits     612,000       --       --       612,000  
             Increase in accrued expenses      126,988       89,859       23,564       2,242,986  
             Increase in deferred revenue      5,100,000       100,000       --       5,200,000  
                       Net cash used in operating activities      (2,956,101 )      (7,385,867 )      (5,257,419 )      (65,093,291 ) 
 
Cash flows from investing activities:                                 
           Purchase of marketable equity securities      --       --       --       (290,420 ) 
           Purchase of short-term investments      --       --       --       (1,993,644 ) 
           Proceeds from sale of marketable equity securities      --       --       --       316,383  
           Proceeds from sale of short-term investments      --       --       --       1,993,644  
           Capital expenditures      (34,070 )      (38,858 )      (19,236 )      (1,605,066 ) 
           Patent costs      --       --       --       (97,841 ) 
                       Net cash used in investing activities      (34,070 )      (38,858 )      (19,236 )      (1,676,944 ) 

F-15


ALFACELL CORPORATION
(A Development Stage Company)

Statements of Cash Flows, Continued

                           August 24, 1981  
                           (date of inception)  
                           to  
      2008       2007       2006     July 31, 2008  
Cash flows from financing activities:                               
 Proceeds from short-term borrowings    $ --     $  --     $  --    $  874,500  
 Payment of short-term borrowings      --       --       --      (653,500 ) 
 Increase in loans payable, related party, net      --       --       --      2,628,868  
 Proceeds from bank debt and other long-term debt, net of deferred debt                               
       costs      --       --       --      3,667,460  
 Reduction of bank debt and long-term debt      --       --       --      (2,966,568 ) 
 Payment of capital lease obligation      (3,385 )      --       --      (3,385 ) 
 Proceeds from issuance of common stock, net      --       1,368,657       10,983,920      53,102,893  
 Proceeds from exercise of stock options and warrants, net      687,040       1,505,700       1,348,324      14,067,630  
 Proceeds from issuance of convertible debentures, related party      --       --       --      297,000  
 Proceeds from issuance of convertible debentures, unrelated party      --       --       --      416,993  
           Net cash provided by financing activities      683,655       2,874,357       12,332,244      71,431,891  
Net increase (decrease) in cash and cash equivalents      (2,306,516 )      (4,550,368 )      7,055,589      4,661,656  
Cash and cash equivalents at beginning of period      6,968,172       11,518,540       4,462,951      --  
Cash and cash equivalents at end of period    $ 4,661,656     $  6,968,172     $  11,518,540    $  4,661,656  
 
Supplemental disclosure of cash flow information – interest paid    $ 3,607     $  96     $  112    $  1,717,833  
 
Noncash investing and financing activities:                               
 Issuance of convertible subordinated debenture for loan payable to officer    $ -     $  -     $  -    $  2,725,000  
 
 Issuance of common stock upon the conversion of convertible                               
       subordinated debentures, related party
  $ -     $  -     $  -    $  3,242,000  
 
 Conversion of short-term borrowings to common stock    $ -     $  -     $  -    $  226,000  
 
 Conversion of accrued interest, payroll and expenses by related parties to                               
       stock options    $ -     $  -     $  -    $  3,194,969  
 
 Repurchase of stock options from related party    $ -     $  -     $  -         $  (198,417 ) 
 
 Conversion of accrued interest to stock options    $ -     $  -     $  -    $  142,441  
 
 Conversions of accounts payable to common stock    $ -     $  -     $  -    $  506,725  

F-16


ALFACELL CORPORATION
(A Development Stage Company)

Statements of Cash Flows, Continued

                      August 24, 1981 
                      (date of inception) 
                      to 
    2008    2007    2006    July 31, 2008 
   Conversion of notes payable, bank and accrued interest to long-term debt    $ -    $ -    $ -    $ 1,699,072 
   Conversion of loans and interest payable, related party and accrued                         
         payroll and expenses, related parties to long-term accrued payroll and                         
         other, related party    $ -    $ -    $ -    $ 1,863,514 
   Issuance of common stock and warrants upon the conversion of                         
         convertible subordinated debentures and accrued interest, other    $ -    $ -    $ -    $ 1,584,364 
   Issuance of common stock for services rendered    $ -    $ -    $ -    $ 2,460 
   Lease incentive allowance    $ -    $ 67,000    $ -    $ 67,000 
   Issuance of warrants with notes payable    $ -    $ -    $ -    $ 594,219 
   Acquisition of equipment through capital lease obligation    $ 23,778    $ -    $ -    $ 23,778 
See accompanying notes to financial statements.                         

F-17


Notes to Financial Statements

Years ended July 31, 2008, 2007 and 2006
and the Period From August 24, 1981
(Date of Inception) to July 31, 2008

(1) Summary of Significant Accounting Policies

Business Description

Alfacell Corporation (the "Company") was incorporated in Delaware on August 24, 1981 for the purpose of engaging in the discovery, investigation and development of a new class of anti-cancer drugs and anti-viral agents. The Company is a development stage company as defined in Statement of Financial Accounting Standards No. 7. The Company is devoting substantially all of its present efforts to establishing its business. Its planned principal operations have not commenced and, accordingly, no significant revenue has been derived therefrom.

The Company is engaged in the research, development, and commercialization of drugs for the treatment of various forms of cancer and other life threatening diseases. As of July 31, 2008, the Company is currently preparing to submit a New Drug Application (NDA) for marketing approval of its lead drug product candidate.

The Company plans to continue the further development of its drug product candidates, which requires substantial capital for research, product development, and market development activities. The Company has not yet initiated marketing of a commercial drug product. Future product development will require clinical testing, regulatory approval, and substantial additional investment prior to commercialization. The future success of the Company is dependent on its ability to make progress in the development of its drug product candidates and, ultimately, upon its ability to attain future profitable operations through the successful manufacturing and marketing of those drug product candidates. There can be no assurance that the Company will be able to obtain the necessary financing or regulatory approvals to be able to successfully develop, manufacture, and market its products, or attain successful future operations. Accordingly, the Company’s future success is uncertain.

In addition, uncertainty exists as to the Company’s ability to protect its rights to patents and its proprietary information. There can also be no assurance that research and discoveries by others will not render some or all of the Company’s technology or drug product candidates noncompetitive or obsolete. Nor can there be any assurance that unforeseen problems will not develop with the Company’s technologies or applications, or that the Company will be able to address successfully technological challenges it encounters in its research and development programs. While the Company maintains insurance to cover the use of its drug product candidates in clinical trials, it does not maintain insurance covering the sale of its products nor is there any assurance that it will be able to obtain or maintain such insurance on acceptable terms or with adequate coverage against potential liabilities.

Use of Estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results could differ from those estimates.

Cash Equivalents

The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. The carrying value of these investments approximates their fair market value due to their short maturity and liquidity. The Company maintains cash deposits with banks that at times exceed applicable insurance limits.

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Property and Equipment

Property and equipment is recorded at cost and is depreciated using the straight-line method over the estimated useful lives of the respective assets. Maintenance and repairs that do not extend the life of assets are charged to expense when incurred. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in operations for the period in which the transaction takes place. Total depreciation and amortization expense for the years ended July 31, 2008, 2007 and 2006, was $51,451, $39,063, and $29,703, respectively.

Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted cash flows expected to be generated by the asset. If the carrying amount exceeds its estimated future cash flows, an impairment charge is recognized in the amount by which the carrying amount exceeds the fair value of the asset.

Other Assets             
 
Other assets consist of the following:             
      2008     2007 
Lease security deposit held by a bank as collateral for a standby letter of credit             
in favor of the Company. The cash held by the bank is restricted as to use for             
the term of the standby letter of credit.    $ 350,000    $ 350,000 
Deferred private placement costs      -      35,000 
Totals    $ 350,000   $ 385,000
 
             
Income Taxes 

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Management provides valuation allowances against the deferred tax assets for amounts which are not considered “more likely than not” to be realized.

Revenue Recognition

The Company recognizes revenue in accordance with Staff Accounting Bulletin (“SAB”) No. 104, “Revenue Recognition” issued by the staff of the SEC. Under SAB No. 104, revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred and/or services have been rendered, the sales price is fixed or determinable, and collectibility is reasonably assured.

The Company enters into marketing and distribution agreements, which contain multiple deliverables. Under the provisions of Emerging Issues Task Force (“EITF”) No. 00-21, “Accounting for Revenue Arrangements with Multiple Deliverables”, the Company evaluates whether these deliverables constitute separate units of accounting to which total arrangement consideration is allocated. A deliverable qualifies as a separate unit of accounting when the item delivered to the customer has standalone value, there is objective and reliable evidence of fair value of items that have not been delivered to the customer, and, if there is a general right of return for the items delivered to the customer, delivery or performance of the undelivered items is considered probable and substantially in the control of the Company. Arrangement consideration is allocated to units of accounting on a relative fair-value basis or the residual method if the Company is unable to determine the fair value of all deliverables in the arrangement. Consideration allocated to a unit of accounting is limited to the amount that is not contingent upon future performance by the Company. Upon determination of separate units of accounting and allocated consideration, the general criteria for revenue recognition are applied to each unit of accounting.

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The Company has entered into an agreement with USP Pharma Spolka Z.O.O. (USP) to market, sell and distribute ONCONASE® in Poland and other countries in Eastern Europe. The Company received a $0.1 million upfront nonrefundable fee in July 2007 and is entitled to receive future additional fees, milestone payments and royalties. USP is responsible for all commercial costs in the territory. The Company has agreed to provide or arrange for contract manufacture of a commercial supply of ONCONASE® upon receipt of marketing approval in the territory. The up-front nonrefundable fee received by the Company will be recognized ratably as revenue once the general criteria for revenue recognition has been met for the unit of accounting to which the fee has been allocated.

The Company entered into a License Agreement for ONCONASE® with Par Pharmaceutical, Inc. in the U.S. Under the terms of the License Agreement, on January 14, 2008, Strativa Pharmaceuticals (“Strativa”), the proprietary products division of Par Pharmaceutical, received exclusive marketing, sales and distribution rights to ONCONASE® for the treatment of cancer in the United States and its territories. The Company retains all rights and obligations for product manufacturing, clinical development and obtaining regulatory approvals in the U.S. and its jurisdictions, as well as all rights for those non-U.S. jurisdictions in which it has not currently granted any such rights or obligations to third parties. Joint oversight committees with members from the Company and Strativa will manage the alliance. The Company received a cash payment of $5 million upon the signing of the License Agreement and will be entitled to a minimum additional cash payment of $20 million, with a maximum of up to $30 million, upon FDA approval of ONCONASE® for UMM. The Company will also be entitled to receive up to $190 million in additional milestone payments in connection with the development of ONCONASE® for up to three additional cancer indications and achieving certain net sales levels, in addition to receiving double-digit royalties on net sales of ONCONASE®. In the event of approval of ONCONASE® for a cancer indication in addition to UMM, the Company will have the option to co-promote ONCONASE® in the United States, with support from Strativa. Strativa will provide technical expertise for a future Alfacell oncology sales force, as well as funding for certain associated costs. Under certain circumstances, the Company will have the right to co-promote ONCONASE®, at the Company’s cost, prior to the time ONCONASE® is approved for any such additional cancer indication. The initial non-refundable cash payment received by the Company was allocated to deferred revenue and will be recognized ratably as revenue once the general criteria for revenue recognition have been met for the unit of accounting to which the payment has been allocated. Strativa has the right to terminate the License Agreement if ONCONASE® does not receive marketing approval by the FDA on or before January 1, 2012 or receives a not approvable communication from the FDA with respect to the primary UMM indication. In the case of termination of the License Agreement for any reason, the Company will retain all rights to ONCONASE®.

Research and Development

Research and development costs are expensed as incurred. These costs include, among other things, consulting fees and costs related to the conduct of human clinical trials. The Company also allocates indirect costs, consisting primarily of operational costs for administering research and development activities, to research and development expenses.

Share-Based Compensation

In December 2004, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards (“SFAS”) No. 123(R) (revised 2004), “Share-Based Payment” (“SFAS 123(R)”), which amends SFAS 123. The new standard requires all share-based payments, including stock option grants to employees, to be recognized as an operating expense in the statement of operations. The expense is recognized over the requisite service period based on fair values measured on the date of grant. The Company adopted SFAS 123(R) effective August 1, 2005 using the modified prospective method and, accordingly, prior period amounts have not been restated. Under the modified prospective method, the fair value of all new stock options issued after July 31, 2005 and the unamortized fair value of unvested outstanding stock options at August 1, 2005 are recognized as expense as services are rendered.

Accounting For Warrants Issued With Convertible Debt

The Company accounts for the intrinsic value of beneficial conversion rights arising from the issuance of convertible debt instruments with non-detachable conversion rights that are in-the-money at the commitment date pursuant to the consensuses of EITF Issue No. 98-5 and EITF Issue No. 00-27. Such value is allocated to

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additional paid–in capital and the resulting debt discount is charged to interest expense over the terms of the notes payable. Such value is determined after first allocating an appropriate portion of the proceeds received to warrants or any other detachable instruments included in the exchange.

Leases

With respect to its operating leases, the Company applies the provisions of FASB SFAS No. 13 “Accounting for Leases” and FASB Technical Bulletin (“FTB”) 88-1 “Issues Relating to Accounting for Leases”, recognizing rent expense on a straight-line basis over the lease term due to escalating lease payments and landlord incentives.

Contingencies

Liabilities for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount of the liability can be reasonably estimated. Recoveries from other parties are recorded when realized.

Fair Value of Financial Instruments

Financial instruments consist primarily of cash and cash equivalents, accounts receivable, and accounts payable. The carrying value of these financial instruments approximates fair value due to the relative short term nature of these investments.

Recent Accounting Pronouncements

In May 2008, the FASB issued SFAS No. 162 “Hierarchy of GAAP”. This statement identifies the sources of accounting principles and the framework for selecting the principles to be used in the preparation of financial statements of nongovernmental entities that are presented in conformity with GAAP in the United States. This statement is effective 60 days following the SEC’s approval of the Public Company Accounting Oversight Board amendments to AU Section 411, “The Meaning of Present Fairly in Conformity with GAAP”. The Company will adopt this pronouncement once it becomes effective and is currently evaluating the impact it will have on reported financial results, if any.

In February 2008, the FASB issued FASB Staff Position (“FSP”) SFAS No. 157-1, “Application of FASB Statement No. 157 to SFAS Statement No. 13 and Other Accounting Pronouncements that Address Fair Value Measurements for Purposes of Lease Classification or Measurement under Statement 13”, (“FSP 157-1”). FSP 157-1 amends SFAS 157 to exclude SFAS 13 and other accounting pronouncements that address fair value measurements for purposes of lease classifications under SFAS 13. However, this scope exception does not apply to assets acquired and liabilities assumed in a business combination that are required to be measured at fair value under FASB Statement No. 141, “Business Combinations”, or SFAS 141(R), regardless of whether those assets and liabilities are related to leases. FSP 157-1 is effective upon initial adoption of SFAS 157. The Company is required to adopt SFAS 157 as of August 1, 2008, and is currently evaluating the impact that the adoption of FSP 157-1 will have, if any, on its reported financial results.

In February 2008, the FASB issued FSP SFAS No. 157-2, “Effective Date of FASB SFAS No. 157”, (“FSP 157-2”). FSP 157-2 delays the effective date of SFAS 157 for non financial assets and non financial liabilities, except for items that are recognized or disclosed at fair value in the financial statements on a recurring basis at least annually. This delay is intended to allow the FASB and constituents additional time to consider the effect of various implementation issues that have arisen from the application of SFAS 157. The Company has reviewed FSP 157-2 and will wait to hear for additional positions taken by the FASB before proceeding further.

In December 2007, the FASB issued SFAS No. 141(R) "Business Combinations" (“SFAS 141(R)”). This Statement establishes principles and requirements for how the acquirer of a business recognizes and measures in its financial statements the identifiable assets acquired, the liabilities assumed, and any noncontrolling interest in the acquiree. SFAS 141(R) also provides guidance for recognizing and measuring the goodwill acquired in the business combination and determines what information to disclose to enable users of the financial statements to evaluate the nature and financial effects of the business combination. The guidance will

F-21


become effective as of the beginning of a company's fiscal year beginning after December 15, 2008. The Company believes that this new pronouncement will not have a material impact on its financial statements in future periods.

On December 21, 2007, the SEC issued SAB No. 110 ("SAB 110") to permit entities, under certain circumstances to continue to use the "simplified" method, in developing estimates of the expected term of "plain-vanilla" share options in accordance with Statement No. 123R, “Share-Based Payment”. SAB 110 amended SAB 107 to permit the use of the "simplified" method beyond December 31, 2007. The adoption of SAB 110 did not have a material impact on the Company’s financial statements.

In June 2007, the FASB issued EITF Issue No. 07-03, “Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities,” (“EITF 07-03”). EITF 07-03 addresses the diversity that exists with respect to the accounting for the nonrefundable portion of a payment made by a research and development entity for future research and development activities. The EITF concluded that an entity must defer and capitalize nonrefundable advance payments made for research and development activities and expense these amounts as the related goods are delivered or the related services are performed. EITF 07-03 will be effective for interim or annual reporting periods in fiscal years beginning after December 15, 2007. The Company is currently evaluating the impact that the adoption of EITF 07-03 will have, if any, on its financial statements.

In February 2007, the FASB issued SFAS No. 159 “The Fair Value Option for Financial Assets and Financial Liabilities” (“SFAS 159”). SFAS 159 permits entities to choose to measure many financial instruments and certain other items at fair value that are not currently required to be measured at fair value. SFAS 159 will be effective for the Company on August 1, 2008 and is currently evaluating the impact that the adoption of SFAS 159 will have, if any, on its financial statements.

In December 2006, the FASB issued FSP EITF Issue No. 00-19-2 "Accounting for Registration Payment Arrangements" ("FSP 00-19-2") which addresses an issuer's accounting for registration payment arrangements. FSP 00-19-2 specifies that the contingent obligation to make future payments or otherwise transfer consideration under a registration payment arrangement, whether issued as a separate agreement or included as a provision of a financial instrument or other agreement, should be separately recognized and measured in accordance with SFAS No.5 "Accounting for Contingencies." The guidance in FSP 00-19-2 amends SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities," and No.150, "Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity", and FASB Interpretation No.45, "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others" to include scope exceptions for registration payment arrangements. FSP 00-19-2 is effective immediately for registration payment arrangements and the financial instruments subject to those arrangements that are entered into or modified subsequent to the date of issue of FSP 00-19-2. For registration payment arrangements and financial instruments subject to those arrangements that were entered into prior to the issuance of FSP 00-19-2, this is effective for financial statements issued for fiscal years beginning after December 15, 2006, and interim periods within those fiscal years. The Company has analyzed the provisions of FSP 00-19-2 and determined that it will not have an effect on its financial statements.

In September 2006, the FASB issued SFAS No. 157 “Fair Value Measurements” (“SFAS 157”). SFAS 157 defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. SFAS 157 does not require new fair value measurements. The Company is required to adopt SFAS 157 as of August 1, 2008, and is currently evaluating the impact that the adoption of SFAS 157 will have, if any, on its reported financial results.

In September 2006, the SEC issued SAB No. 108 “Quantifying Misstatements in Financial Statements” (“SAB 108”). Under SAB 108, the Company is required to use a combination of the two previously-acceptable approaches for quantifying misstatements, and to adjust its financial statements if this combined approach results in a conclusion that an error is material. The Company has adopted SAB 108 and determined that it did not have a material impact on our reported financial results.

In June 2006, the FASB issued Interpretation No. 48, “Accounting for Uncertainty in Income Taxes - an Interpretation of FASB Statement No. 109” (“FIN 48”). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in a company’s financial statements in accordance with Statement No. 109,

F-22


“Accounting for Income Taxes.” FIN 48 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a company’s tax return. On August 1, 2007, the Company adopted FIN 48 and determined that it did not have a material impact on its reported financial results.

(2)  Liquidity

The Company has reported net losses of $12,321,000, $8,755,000, and $7,810,000 and negative cash flows from operating activities of $2,956,000, $7,386,000 and $5,257,000 for the fiscal years ended July 31, 2008, 2007 and 2006, respectively. As of July 31, 2008, the Company had working capital of $1,945,000, and cash and cash equivalents of $4,662,000. The loss from date of inception, August 24, 1981, to July 31, 2008 amounts to $104,393,000. Until and unless the Company’s operations generate significant revenues and cash flow, the Company will attempt to continue to fund operations from cash on hand and through the sources of capital described below. The Company’s long-term continued operations will depend on its ability to raise additional funds through various potential sources such as equity and debt financing, collaborative agreements, strategic alliances, sale of tax benefits, revenues from the commercial sale of ONCONASE®, licensing of its proprietary RNase technology and its ability to realize revenues from its technology and its drug candidates via out-licensing agreements with other companies. The Company has engaged a financial advisor to assist in the pursuit of available strategic alternatives. These alternatives will focus on, but not be limited to, strategic partnership transactions, and could include a possible sale of the Company. Such additional funds and various alternatives may not become available as the Company may need them or be available on terms acceptable to the Company. Insufficient funds could require the Company to delay, scale back, or eliminate one or more of its research and development programs or to license third parties to commercialize drug product candidates or technologies that the Company would otherwise seek to develop without relinquishing its rights thereto. The Company expects that its cash balances as of July 31, 2008, including its expected level of receipts and expenditures, will be sufficient to support its activities into the fourth quarter of its fiscal year 2009 which assumes timely and successful submission of the ONCONASE® NDA. There can be no assurance that the Company will be able to raise the capital it needs on terms which are acceptable, if at all. The Company may also obtain additional capital through the exercise of outstanding options and warrants and the sale of its tax benefits, although it cannot provide any assurance of such exercises or sale or the amount of capital it will receive, if any.

The Company’s audited financial statements for the fiscal year ended July 31, 2008, were prepared under the assumption that the Company will continue its operations as a going concern. Continued operations are dependent on the Company’s ability to raise various sources of capital described above. Such capital formation activities may not be available or may not be available on reasonable terms. The Company’s financial statements do not include any adjustments that may result from the outcome of this uncertainty.

(3)  Net Loss Per Common Share

The following table sets forth the computation of basic and diluted net loss per common share:

    Year Ended July 31,  
      2008       2007       2006  
                         
  Numerator:                       
       Net loss  $ (12,321,101 )    $ (8,755,144 )    $ (7,810,175 ) 
  Denominator:                       
  Weighted average number of common                       
       shares outstanding    46,919,000       44,958,000       37,308,000  
 
  Loss per common share - basic and diluted  $ (0.26 )    $ (0.19 )    $ (0.21 ) 

F-23


    Year Ended July 31,
    2008   2007   2006
Potentially dilutive securities:             
     Warrants    14,862,534    16,070,748    18,119,598 
     Stock options    6,353,067    4,867,039    3,830,350 
Total potentially dilutive securities    21,215,601    20,937,787    21,949,948 

As the Company has incurred a net loss for all periods presented, basic and diluted per common share amounts are the same, since the inclusion of all potentially dilutive securities would be anti-dilutive.

(4) Property and Equipment

Property and equipment, at cost, consists of the following at July 31:

    2008   2007  
 
  Laboratory equipment  $ 276,202     $ 276,202    
  Office equipment    118,172       84,102    
  Leasehold improvements    90,778       67,000    
  Less accumulated depreciation and amortization    (342,031 )      (290,581 )  
  Property and equipment, net  $ 143,121     $ 136,723    

During the fiscal year ended July 31, 2008, the Company’s laboratory equipment was not used since the Company did not maintain a laboratory in its principal office. The book value of laboratory equipment as of July 31, 2008 is $17,930.

During the fiscal year ended July 31, 2007, the Company wrote off the following fully depreciated and unusable property and equipment:

          Accumulated   
    Amount   Depreciation  
 
  Laboratory equipment  $ 505,869    $ 505,869   
  Office equipment    235,495      235,495   
  Leasehold improvements    97,833      97,833   
  Total  $ 839,197    $ 839,197   

(5) Loan Receivable, related party

Amounts due from the Company’s CEO totaling $180,397 was paid in full in April 2008. The Company earned 8% interest on the unpaid principal balance in the amount of approximately $7,000 for fiscal year ended July 31, 2008 and $9,500 in each of the fiscal years ended July 31, 2007 and 2006.

(6) Stockholders' Equity

On September 1, 1981, the Company issued 712,500 shares of common stock (1,068,750 shares adjusted for the stock split on September 8, 1982) to officers and stockholders in exchange for equipment, research and development services, stock registration costs, reimbursement of expenses and other miscellaneous services. The common stock issued for services was recorded at the estimated fair value of services rendered based upon the Board of Directors' determination and ratification of the value of services. Equipment received in exchange for common stock was recorded at the transferor's cost. Common stock issued for reimbursement of expenses was recorded based upon expenses incurred. All values assigned for expenses and services rendered were charged to operations except for stock registration costs, which were charged against proceeds.

On July 30, 1982, the Company sold 82,143 shares of common stock (123,214 shares adjusted to reflect the stock split on September 8, 1982) to a private investor at a price of $1.40 per share, resulting in net proceeds to the Company of approximately $108,500.

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On September 8, 1982, the Company declared a 3-for-2 stock split. Shares previously issued by the Company were restated in accordance with the stock split.

On September 8, 1982, the Company issued 15,000 shares of common stock to an officer and stockholder in exchange for equipment. The equipment received in exchange for the common stock was recorded at the transferor's cost.

On November 1, 1982 and January 3, 1983, the Company sold 28,125 and 16,071 shares of common stock, respectively, to private investors at $.93 per share, resulting in net proceeds to the Company of approximately $41,250.

On January 17, 1983, the Company sold 660,000 shares of its common stock and 330,000 common stock purchase warrants in a public offering at a price of $2.50 per share, resulting in net proceeds to the Company of approximately $1,308,446. The warrants were to expire 12 months after issuance; however, the Company extended the expiration date to July 16, 1984. During the fiscal years ended July 31, 1983 and 1984, the net proceeds to the Company from the exercise of the warrants amounted to $934,000. Each common stock purchase warrant was not detachable from its common stock or exercisable until six months after the issuance date of January 17, 1983. Each warrant entitled the holder to purchase one share of common stock at an exercise price of $3.00 after six months and prior to nine months after issuance. The exercise price increased to $3.50 after nine months and prior to 12 months after issuance.

In connection with the public offering, the Company sold 60,000 five-year purchase warrants to the underwriters at a price of $.001 per warrant. Each warrant entitled the holder to purchase one share of common stock at an exercise price of $3.00. Pursuant to the antidilution provisions of the warrants, the underwriters received warrants to purchase 67,415 shares at an exercise price of $2.67 per share. By July 31, 1986, all such warrants were exercised and the Company received proceeds of approximately $180,000.

On February 22, 1984, the Company filed a registration statement with the Securities and Exchange Commission for the issuance of two series of new warrants, each to purchase an aggregate of 330,000 shares (hereinafter referred to as one-year warrants and two-year warrants). The one-year warrants had an exercise price of $6.50 per share and expired July 17, 1985. The two-year warrants had an exercise price of $10.00 per share and were to expire July 17, 1986. However, the Company extended the expiration date to August 31, 1987. The one-year warrants and two-year warrants were issued as of July 17, 1984 on a one-for-one basis to those public offering warrant holders who exercised their original warrants, with the right to oversubscribe to any of the warrants not exercised. During the fiscal years ended July 31, 1985, 1986, 1987 and 1988, the Company received net proceeds of approximately $2,471,000 as a result of the exercise of the warrants.

On January 2, 1987, the Company issued 250,000 shares of common stock to officers and stockholders, including the President and Chief Executive Officer, in recognition of services performed for the Company. The fair value of such shares was recorded as compensation expense.

On February 3, 1987, the Company sold 5,000 shares of common stock to a private investor for $5.00 per share, resulting in net proceeds to the Company of approximately $25,000.

On September 1, 1987, the Board of Directors approved new wage contracts for three officers. The contracts provided for the issuance of 700,000 shares of common stock as an inducement for signing. The fair value of these shares was recorded as deferred compensation and was amortized over the term of the employment agreements. The contracts also provided for the issuance of 1,500,000 shares of common stock in 750,000 increments upon the occurrence of certain events. These shares were issued during the fiscal years ended July 31, 1989 and 1990 and the fair value of such shares was recorded as deferred compensation and was amortized over the remaining term of the employment agreements. The contracts also provided for five-year options to purchase 750,000 shares of common stock at $3.00 per share; options for the purchase of 170,000 shares were exercised on June 16, 1988 and the remaining options for the purchase of 580,000 shares expired on September 2, 1992.

During the fiscal year ended July 31, 1988, the Company issued 206,429 shares of common stock for payment of legal and consulting services. The Company also issued 12,500 shares of common stock in connection with the settlement of certain litigation. The fair value of such shares was charged to operations.

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During the fiscal year ended July 31, 1988, the Company sold 61,073 shares of common stock to private investors at $2.92 per share resulting in net proceeds to the Company of approximately $178,133.

On September 21, 1988, the Company entered into a stipulation of settlement arising from a lawsuit wherein it agreed to pay a total of $250,000 in 12 monthly installments. Under the agreement, the Company authorized the issuance on September 7, 1988 and October 18, 1988 of 85,000 and 50,000 shares, respectively, to an escrow account to secure payment of the $250,000 due under the stipulation of settlement. During the fiscal year ended July 31, 1989, the Company issued and sold the 135,000 shares of common stock for $1,074,838. On February 14, 1989, the Board of Directors authorized the issuance of an additional 50,000 shares. During the year ended July 31, 1990, the shares were sold for $351,117. The proceeds from the above transactions were used to pay the settlement and related legal costs, reduce loans from and interest due to the Company's Chief Executive Officer, and for working capital.

During the fiscal year ended July 31, 1989, the Company sold 105,840 shares of common stock to private investors at $3.97 per share resulting in net proceeds to the Company of approximately $420,000.

During the fiscal year ended July 31, 1990, the Company issued 52,463 shares of common stock for payment of legal and consulting services and 50,000 shares of common stock in connection with the settlement of certain litigation. The fair value of the common stock was charged to operations.

During the fiscal year ended July 31, 1990, the Company sold 89,480 shares of common stock to private investors at $3.97 per share resulting in net proceeds to the Company of approximately $355,080.

During the fiscal year ended July 31, 1991, the Company issued 87,000 shares of common stock for payment of legal and consulting services. The fair value of the common stock was charged to operations.

During the fiscal year ended July 31, 1992, the Company sold 70,731 shares of common stock to private investors at $2.75 to $3.50 per share resulting in net proceeds to the Company of approximately $219,900.

During the fiscal year ended July 31, 1992, the Company issued 45,734 shares of common stock as payment for services rendered to the Company. The fair value of the common stock was charged to operations.

During the fiscal years ended July 31, 1992 and 1990, 94,000 and 50,000 shares of common stock, respectively, were issued to the Company's Chief Executive Officer upon the conversion of outstanding debentures.

During the fiscal year ended July 31, 1993, the Company sold 352,667 shares of common stock to private investors at prices ranging from $2.00 to $3.00 per share resulting in net proceeds to the Company of approximately $735,500. In addition, the private investors were granted options to purchase common stock totaling 587,167 shares at prices ranging from $3.00 to $7.00. During the fiscal years ended July 31, 1995 and 1996, 322,500 and 228,833 options expired, respectively. A total of 42,167 options due to expire on July 31, 1995 were extended to July 31, 1996 and their exercise price was reduced to $2.50. During the fiscal year ended July 31, 1996, 35,834 options were exercised resulting in net proceeds to the Company of approximately $89,600.

During the fiscal year ended July 31, 1993, the Company issued 54,600 shares of common stock as payment for legal and other services performed for the Company. The fair value of 49,600 shares was charged to operations. The remaining 5,000 shares were recorded as deferred compensation and were amortized over a one-year period, beginning in February 1993, in accordance with the agreement entered into with the recipient.

During the fiscal year ended July 31, 1994, the Company issued 7,000 shares of common stock as payment for services performed for the Company. The fair value of the common stock was charged to operations.

During the fiscal year ended July 31, 1994, the Company sold 25,000 shares of common stock to a private investor at $2.00 per share resulting in net proceeds to the Company of $50,000. In addition, the private investor was granted options to purchase common stock totaling 25,000 shares at $4.00 per common share. These options were exercised in September 1996 resulting in net proceeds to the Company of $100,000.

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During the fiscal year ended July 31, 1994, the Company sold 800,000 shares of common stock to private investors at $2.50 per share resulting in net proceeds to the Company of $1,865,791. In addition, the private investors were granted warrants to purchase common stock totaling 800,000 shares at $5.00 per common share. Warrants for the purchase of 147,450 shares were exercised during fiscal 1997 resulting in net proceeds to the Company of $737,250. The remaining 652,550 warrants expired during fiscal 1997.

During the fiscal year ended July 31, 1994, 400,000 shares of common stock were issued to the Company's Chief Executive Officer upon the conversion of outstanding debentures.

During the fiscal year ended July 31, 1994, 25,400 shares of common stock were issued upon the conversion of other outstanding debentures.

In September 1994, the Company completed a private placement resulting in the issuance of 288,506 shares of common stock and three-year warrants to purchase 288,506 shares of common stock at an exercise price of $5.50 per share. The warrants expired during fiscal 1998. The common stock and warrants were sold in units consisting of 20,000 shares of common stock and warrants to purchase 20,000 shares of common stock. The price per unit was $50,000. The Company received proceeds of approximately $545,000, net of costs associated with the placement of approximately $55,000 and the conversion of certain debt by creditors of $121,265 into equivalent private placement units of 17,600 shares for conversion of short-term borrowings and 30,906 shares issued for services rendered. In October 1994, an additional two units at $50,000 per unit were sold to a private investor under the same terms as the September 1994 private placement resulting in the issuance of 40,000 shares of common stock and warrants to purchase 40,000 shares of common stock. The warrants expired during fiscal 1998.

During the fiscal year ended July 31, 1995, 185,000 shares of common stock were issued upon the exercise of stock options by unrelated parties, resulting in net proceeds to the Company of $437,200. The exercise prices of the options ranged from $2.27 to $2.50, which had been reduced from $3.50 and $5.00, respectively, during fiscal 1995.

During the fiscal year ended July 31, 1995, the Company sold 681,000 shares of common stock to private investors resulting in net proceeds to the Company of approximately $1,379,000. The shares were sold at prices ranging from $2.00 to $2.25.

During the fiscal year ended July 31, 1995, the Company sold 139,080 shares of common stock and 47,405 three-year warrants to purchase shares of common stock at an exercise price of $4.00 per share to private investors. The stock and warrants were sold at prices ranging from $2.25 to $2.73 per share and resulted in net proceeds to the Company of $343,808, of which $4,800 was for services rendered. The common shares were issued to the investors subsequent to July 31, 1995.

On August 4, 1995, the Company issued 6,060 shares of common stock as payment for services rendered to the Company. The fair value of the common stock was charged to operations.

On September 29, 1995, the Company completed a private placement resulting in the issuance of 1,925,616 shares of common stock and three-year warrants to purchase an aggregate of 55,945 shares of common stock at an exercise price of $4.00 per share. Of these shares 1,935 were issued for services rendered to the Company. The common stock was sold alone at per share prices ranging from $2.00 to $3.70, and in combination with warrants at per unit prices ranging from $4.96 to $10.92, which related to the number of warrants contained in the unit. The Company received proceeds of approximately $4.1 million, including $1,723,000 for approximately 820,000 shares received during the fiscal year ended July 31, 1995. The warrants expired in October 1998.

As consideration for the extension of the Company's term loan agreement with its bank, the Company granted the bank a warrant to purchase 10,000 shares of common stock at an exercise price of $4.19. The warrants were issued as of October 1, 1995 and expired on August 31, 1997.

In June 1996, the Company sold in a private placement 1,515,330 shares of common stock and three-year warrants to purchase 313,800 shares of common stock at an exercise price of $7.50 per share. Of these shares,

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12,000 were issued for services rendered to the Company. The common stock was sold alone at a per share price of $3.70, in combination with warrants at a per unit price of $12.52 and warrants were sold alone at a per warrant price of $1.42. Each unit consisted of three shares of common stock and one warrant. The Company received proceeds of approximately $5.7 million. The warrants expired during the fiscal year 2000.

In June 1996, the Company issued 10,000 five-year stock options as payment for services rendered. The options vested immediately and had an exercise price of $4.95 per share. The Company recorded research and development expense of $28,260, which was the fair value of the stock options on the date of issuance. The options expired during the fiscal year ended July 31, 2001.

During the fiscal year ended July 31, 1996, 207,316 shares of common stock were sold from October 1995 to April 1996 at per share prices ranging from $3.60 to $4.24 resulting in proceeds of approximately $808,000.

During the fiscal year ended July 31, 1996, 656,334 stock options were exercised by both related and unrelated parties resulting in net proceeds of approximately $1.9 million to the Company. Of these shares, 89,634 were issued subsequent to July 31, 1996. The exercise prices of the options ranged from $2.50 to $3.87 per share.

In August 1996, the Company issued 10,000 stock options with an exercise price of $4.69 per share exercisable for five years as payment for services to be rendered. An equal portion of these options vested monthly for one year commencing September 1, 1996. The Company recorded general and administrative expense of $27,900, which was the fair value of the stock options on the date of issuance. The options expired during the fiscal year ended July 31, 2002.

In March 1997, the Company issued 112,000 shares of common stock at $4.50 per share in a private placement to an investor resulting in net proceeds of $504,000 to the Company.

In May 1997, the Company issued 100,000 stock options to Dr. Stephen Carter, a director, with an exercise price of $5.20 per share as payment for serving as Chairman of the Scientific Advisory Board (the “SAB”). These options vested as follows: 10,000 vested immediately, 10,000 after one full calendar year, 10,000 annually for each of the following three years and 50,000 on May 13, 2002. The Company recorded a total research and development expense of $353,400, which was the fair value on the date of issuance of that portion of the stock options that had vested as of July 31, 2002. Of these options, 40,000 expired as of the fiscal year ended July 31, 2005.

During the fiscal year ended July 31, 1997, 639,500 stock options were exercised by both related and unrelated parties resulting in net proceeds of approximately $2.6 million to the Company. The exercise prices of the options ranged from $2.45 to $4.00 per share.

During the fiscal year ended July 31, 1997, 147,450 warrants were exercised by both related and unrelated parties resulting in net proceeds of approximately $737,250 to the Company. The exercise price of the warrants was $5.00 per share.

In October 1997, the Company issued 75,000 stock options to a director with an exercise price of $3.66 per share as payment for non-board related services to be rendered. These options vested as follows: 10,000 vested immediately; 10,000 after one full calendar year; 10,000 annually for each of the following three years; and 25,000 on October 31, 2002. A total general and administrative expense of $185,600 was amortized on a straight –line basis over a five-year period, which commenced in October 1997. Of these options, 30,000 expired as of the fiscal year ended July 31, 2005.

In October 1997, the Company issued 12,000 five-year stock options to a consultant with an exercise price of $3.91 per share as payment for services to be rendered. An equal portion of these options vested monthly and were amortized over a one-year period which commenced in October 1997. In May 1998, the Company terminated the services of the consultant, which resulted in the cancellation of 5,000 options. The Company recorded a total research and development expense for the remaining 7,000 options in the amount of $15,800, based upon the fair value of such options on the date of issuance, amortized on a straight-line basis over the vesting period of the grant. These options expired during the fiscal year ended July 31, 2003.

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On December 9, 1997, the stockholders authorized the amendment of the Company’s Certificate of Incorporation to increase the number of authorized shares of common stock, par value $.001 from 25,000,000 shares to 40,000,000 shares.

On December 9, 1997, the stockholders approved the 1997 Stock Option Plan (the “1997 Plan”). The total number of shares of common stock authorized for issuance upon exercise of options granted under the 1997 Plan was 2,000,000. Options are granted at fair market value on the date of the grant and generally are exercisable in 20% increments annually over five years starting one year after the date of grant and terminate five years from their initial exercise date.

On January 23, 1998, the SEC declared effective a registration statement on Form S-3 for the offer and sale by certain stockholders of up to 3,734,541 shares of common stock. Of these shares (i) an aggregate of 2,737,480 shares were issued to private placement investors in private placement transactions which were completed during the period from March 1994 through March 1997 (the “Earlier Private Placements”), (ii) an aggregate of 409,745 shares were issuable upon exercise of warrants which were issued to private placement investors in the Earlier Private Placements and (iii) an aggregate of 587,316 shares may be issued, or have been issued, upon exercise of options which were issued to option holders in certain other private transactions. As a result of the delisting of the Company’s Common Stock from the Nasdaq SmallCap Market, the Company no longer qualified for the use of a Form S-3 registration statement for this offering when it filed its Annual Report on Form 10-K for the fiscal year ended July 31, 1999 and thus, this registration statement was no longer effective. The Company filed a registration statement on Form S-1 to register these shares, which was declared effective in February 2002.

In February 1998, the Company completed a Private Placement primarily to institutional investors, which resulted in the issuance of 1,168,575 units at a unit price of $4.00. Each unit consisted of two (2) shares of the Company’s common stock, par value $.001 per share and one (1) three-year warrant to purchase one (1) share of common stock at an exercise price of $2.50 per share. The Company received net proceeds of approximately $4,202,000. The placement agent received warrants to purchase an additional 116,858 units comprised of the same securities sold to investors at an exercise price of $4.40 per unit as part of its compensation. In May 2001, the expiration date of these warrants was extended from May 19, 2001 to August 17, 2001. The warrants expired on August 17, 2001.

In March 1998, the Company converted an outstanding payable into 50,000 shares of the Company’s Common Stock. The fair value of the Common Stock approximated the outstanding payable amount of $100,000.

In March 1998, the Company issued 75,000 stock options to a director with an exercise price of $2.80 per share as payment for non-board related services rendered. These options vested as follows: 10,000 vested immediately; 10,000 after one full calendar year; 10,000 annually for each of the following three years; and 25,000 on March 24, 2003. A total general and administrative expense of $138,100 was amortized on a straight-line basis over a five-year period, which commenced in March 1998. As of July 31, 2003, the expense was fully amortized and recorded, based upon the fair value of such 75,000 options on the date of issuance, amortized on a straight-line basis over the vesting period of the grant. Of these options, 10,000 expired during the fiscal year ended July 31, 2003 and 65,000 we