UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-KSB
x | Annual Report under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended November 30, 2008. |
Commission File Number: 001-10221
MultiCell Technologies, Inc.
(Name of small business issuer in its charter)
DELAWARE | 52-1412493 | |
(State or other jurisdiction of | (IRS Employer Identification No.) | |
incorporation or organization) |
68 Cumberland Street, Suite 301
Woonsocket, RI 02895
401-762-0045
(Address and telephone number of principal executive offices)
Securities registered under Section 12(b) of the Exchange Act:
None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $0.01 par value per share
Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act during the past 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 ¨
Check if there is no disclosure of delinquent filers in response to Item 405 of Regulation S-B is not contained in this form, and no disclosure will 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-KSB or any amendment to this Form 10-KSB x
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
State issuer's revenues for its most recent fiscal year: $209,835.
State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was sold, or the average bid and asked price of such common equity as of a specified date within the past 60 days (based upon shares held by non-affiliates and the closing price of $0.0175 share for the common stock on the over-the counter market as of March 9, 2009): $2,201,131
State the number of shares outstanding of each of the issuer’s classes of common equity, as of the latest practicable date: 140,429,181 shares of common stock as of March 9, 2009.
DOCUMENTS INCORPORATED BY REFERENCE
Transitional Small Business Disclosure Format (check one): Yes ¨ No x
MULTICELL TECHNOLOGIES, INC.
FORM 10-KSB
INDEX
PAGE | ||
EXPLANATORY NOTE | 3 | |
PART I | ||
Item 1. | DESCRIPTION OF BUSINESS | 3 |
Item 2. | DESCRIPTION OF PROPERTY | 23 |
Item 3. | LEGAL PROCEEDINGS | 23 |
Item 4. | SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS | 24 |
PART II | ||
Item 5. | MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS AND SMALL BUSINESS ISSUER PURCHASES OF EQUITY SECURITIES | 25 |
Item 6. | MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATIONS | 25 |
Item 7. | FINANCIAL STATEMENTS | 33 |
Item 8. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE | 33 |
Item 8A(T). | CONTROLS AND PROCEDURES | 33 |
Item 8B. | OTHER INFORMATION | 34 |
PART III | ||
Item 9. | DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS, CONTROL PERSONS AND CORPORATE GOVERNANCE; COMPLIANCE WITH SECTION 16(A) OF THE EXCHANGE ACT | 35 |
Item 10. | EXECUTIVE COMPENSATION | 39 |
Item 11. | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS | 43 |
Item 12. | CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE | 44 |
Item 13. | EXHIBITS | 46 |
Item 14. | PRINCIPAL ACCOUNTANT FEES AND SERVICES | 46 |
SIGNATURES | 47 | |
EXHIBIT INDEX | 48 | |
CONSOLIDATED FINANCIAL STATEMENTS | F1 – F24 | |
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EXPLANATORY NOTE
Pursuant to Release No. 33-8878 (the “Release”) promulgated by the Securities and Exchange Commission (the “Commission”) on December 19, 2007, entitled “Smaller Reporting Company Regulatory Relief and Simplification,” Form 10-KSB was removed effective March 15, 2009 (the “Removal Date”), one day prior to the actual date Multicell Technologies, Inc. (the “Company”) filed this Annual Report on Form 10-KSB for the fiscal year ended November 30, 2008 (this “Report”) with the Commission. However pursuant to the Company’s filing of a Notification of Late Filing on Form 12b-25 and the application of Rule 12b-25, the Company is deemed to have filed this Report on the date it would be due in the absence of the application of Rule 12b-25 (the “Original Filing Date”). Because the Original Filing Date is prior to the Removal Date, Form 10-KSB is deemed not to have yet been removed as of the Report’s actual filing date, and the Company therefore may properly file the Report on Form 10-KSB.
The Company has discussed its reading of the interplay between the removal of Form 10-KSB as outlined in the Release and the application of Rule 12b-25 with the Staff of the Commission (the “Staff”). The Staff stated that the Company’s reading of the interplay is correct and therefore a reporting company may file a Form 10-KSB after the Removal Date pursuant to the proper application of Rule 12b-25. However, the Staff did not review whether the Company timely filed the Form 12b-25 or this Report (nor whether the Company would otherwise be permitted to file on Form 10-KSB in the absence of the removal of Form 10-KSB).
As of the actual date of the filing of this Report, EDGAR does not accept filings on Form 10-KSB. Therefore, in consultation with the Staff, the Company has filed this Report using the Form 10-K filing code.
FORWARD LOOKING STATEMENTS
This document contains forward-looking statements that are based upon current expectations within the meaning of the Private Securities Reform Act of 1995. It is our intent that such statements be protected by the safe harbor created thereby. Forward-looking statements involve risks and uncertainties and our actual results and the timing of events may differ significantly from the results discussed in the forward-looking statements. Examples of such forward-looking statements include, but are not limited to, statements about or relating to: the initiation, progress, timing, scope and anticipated date of completion of preclinical research, clinical trials and development of our drug candidates and potential drug candidates by ourselves or our partners, including the dates of initiation and completion of patient enrollment, and numbers of patients enrolled and sites utilized for clinical trials; the size or growth of expected markets for our potential drugs; our plans or ability to commercialize drugs, with or without a partner; market acceptance of our potential drugs; increasing losses, costs, expenses and expenditures; hiring plans; the sufficiency of existing resources to fund our operations; expansion of our research and development programs and the scope and size of research and development efforts; potential competitors; our estimates of future financial performance; our estimates regarding anticipated operating losses, capital requirements and our needs for additional financing; future payments under lease obligations and equipment financing lines; expected future sources of revenue and capital; our plans to obtain limited product liability insurance; protection of our intellectual property; and increasing the number of our employees and recruiting additional key personnel.
Such forward-looking statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, obtaining regulatory approval, and undertaking production and marketing of our drug candidates; difficulties or delays in patient enrollment for our clinical trials; unexpected adverse side effects or inadequate therapeutic efficacy of our drug candidates that could slow or prevent product approval (including the risk that current and past results of clinical trials or preclinical studies are not indicative of future results of clinical trials); activities and decisions of, and market conditions affecting current and future strategic partners; pricing pressures; accurately forecasting operating and clinical trial costs; uncertainties of litigation and other business conditions; our ability to obtain additional financing if necessary; changing standards of care and the introduction of products by competitors or alternative therapies for the treatment of indications we target; the uncertainty of protection for our intellectual property or trade secrets, through patents or otherwise; and potential infringement of the intellectual property rights or trade secrets of third parties. In addition such statements are subject to the risks and uncertainties discussed in the “Risk Factors” section and elsewhere in this document.
PART I
DESCRIPTION OF BUSINESS
About MultiCell Technologies, Inc.
MultiCell Technologies, Inc. was incorporated in Delaware on April 28, 1970 as Exten Ventures, Inc., and subsequently changed its name to Exten Industries, Inc. (“Exten”). An agreement of merger between Exten and an entity then called MultiCell Associates, Inc. (“MTI”), was entered into on March 20, 2004 whereby MTI ceased to exist and all of its assets, property, rights and powers, as well as all debts due it, were transferred to and vested in Exten as the surviving corporation. Effective April 1, 2004 Exten changed its name to MultiCell Technologies, Inc. (“MultiCell”). MultiCell operates three subsidiaries, MCT Rhode Island Corp. (wholly owned), Xenogenics Corporation (“Xenogenics”) (56.4% owned), and MultiCell Immunotherapeutics, Inc. (“MCTI”), of which MultiCell holds approximately 67% of the outstanding shares (on an as if converted basis). As used herein, the “Company” refers to MultiCell, together with MCT Rhode Island Corp., Xenogenics, and MCTI. Our principal offices are at 68 Cumberland Street, Suite 301, Woonsocket, RI 02895. Our telephone number is (401) 762-0045.
Following the formation of MultiCell Immunotherapeutics, Inc. during September 2005 and the recent in-licensing of drug candidates, the Company has been pursuing research and development of therapeutics. Historically, the Company has specialized in developing primary liver cell immortalization technologies to produce cell-based assay systems for use in drug discovery. The Company seeks to become an integrated biopharmaceutical company that will use its proprietary technologies to discover, develop and commercialize new therapeutics itself and with strategic partners.
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Our Therapeutic Programs
MultiCell is pursuing research and development targeting degenerative neurological diseases, including multiple sclerosis (MS) and cancer.
Until recently, the development of therapeutics that interacted with our immune system was focused on finding protective antigens and different ways to present them to the immune system. The emphasis was on enhancing the human response – stimulating high antibody production. With a greater understanding of the immune system, the emphasis has shifted to modulating the immune system by optimizing its response to infection and diseases such as cancer.
Today, we know that the immune system is composed of two synergistic elements: the innate immune system and the adaptive immune system. Stimulation of the innate immune system, our early warning system, plays a critical role in triggering the adaptive immune response – the ability to produce antibodies and to stimulate a cellular immune response. A stronger, initial innate immune response aids in the generation of a more robust and longer-lasting adaptive immune response.
The innate immune system was once thought to be equivalent to the wall of a castle. Historically, scientists thought the real action of immunity and the immune system occurred once the castle wall was breached and the troops inside, the T and B cells, began to produce antibodies and attack diseased cells. The innate immune system, however, was found to be composed of a family of ten receptor molecules, the Toll-like Receptors (TLRs), which act as sentries to identify invaders and signal the alarm to mobilize the body’s array of immune defenses. TLRs unleash both the innate and adaptive immune systems.
Our therapeutics business addresses significant unmet medical needs for the treatment of neurological disorders and cancer through modulation of the innate and adaptive immune response. Our therapeutic development platform is designed to augment current therapeutic strategies via:
· | Modulation of the noradrenaline-adrenaline neurotransmitter pathway for the treatment of primary multiple sclerosis-related fatigue (PMSF) affecting over 70% of all persons with multiple sclerosis. |
· | Triggering the adaptive immune response thru Toll-like Receptor 3 (TLR3) signaling of the innate immune system using double-stranded RNA (dsRNA) to treat cancer. |
· | Enhancement of antigen presentation to the immune system by targeting antigen delivery for processing via the Fcg receptor for the treatment of autoimmune disease and cancer. |
· | In vivo generation and expansion of specific immune system cells targeted against an autoimmune response, or infectious agents, or tumors. |
Our therapeutic development platform has several advantages:
· | Modulation of noradrenergic neurons without effecting seratoninergic neurons to inhibit the reuptake of noradrenaline (norepinephrine), |
· | Our therapeutic antibody technology, Epitope-based T-cell Immunotherapy, can effectively deliver epitopes to the immune system, and can produce positive clinical outcomes in cases where tolerization is the targeted response, |
· | Unlike DNA-based immunostimulatory CpG motifs or antisense and siRNA technologies, our use of dsRNA signaling thru TLR3 is not species or sequence-specific, and therefore has the potential to have application in a broader spectrum of therapeutic applications, and |
· | Coupling TLR3 signaling with our therapeutic antibody technology allows for the delivery of disease-associated epitope peptides in concert with TLR3 signaling, creating more effective anticancer therapeutics. |
Our portfolio of lead drug candidates is in various stages of preclinical and clinical development:
· | MCT-125, a Phase IIb therapeutic candidate for the treatment of PMSF with demonstrated efficacy in 138 patients |
· | MCT-175, a preclinical therapeutic candidate for the treatment of relapsing-remitting MS |
· | MCT-465, a preclinical adjuvant therapeutic candidate for the treatment of TLR3+ cancers |
· | MCT-475, a preclinical therapeutic candidate for the treatment of TLR3+ breast cancer |
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Multiple Sclerosis Therapeutic Program: Multiple Sclerosis, or MS, is an autoimmune disease in which immune cells attack and destroy the myelin sheath, which insulates neurons in the brain and spinal cord. When the myelin is destroyed, nerve messages are sent more slowly and less efficiently. Scar tissue then forms over the affected areas, disrupting nerve communication. MS symptoms occur when the brain and spinal cord nerves cease to communicate properly with other parts of the body.
Approximately 350,000 individuals have been diagnosed with MS in the United States and more than one million persons worldwide are afflicted with MS. An estimated 10,000 new MS cases are diagnosed in the USA annually. Initial symptoms typically manifest themselves between the ages of 20 and 40; symptoms rarely begin before 15 or after 60 years of age. Women are almost twice as likely to get MS as men, especially in their early years. People of northern European heritage are more likely to be affected than people of other racial backgrounds, and MS rates are higher in the United States, Canada, and Northern Europe than in other parts of the world. MS is very rare among Asians, North and South American Indians, and Eskimos.
MCT-125 for the treatment of fatigue in patients with multiple sclerosis
Fatigue is the most common symptom in MS. Overall, greater than 75% of persons with MS report having fatigue, and 50% to 60% report it as the worst symptom of their disease. Fatigue can severely affect an individual's quality of life and functioning, even if the level of disability appears to be insignificant to the outside observer. Many MS care providers are unaware that fatigue is also a major reason for unemployment, especially for those individuals with otherwise minor disability. Moreover, fatigue in MS has a severe effect on patients' ability to feel as if they have control over their illness. Perhaps the most dramatic evidence that fatigue is a distinct symptom of MS comes from the clinical characteristics that have been recognized by clinicians for years. These characteristics include the sensitivity of MS fatigue patients to heat as well as the fact that in about 30% of MS patients, fatigue predates other symptoms of MS. In addition, clinical observation has shown that MS fatigue exhibits relapsing-remitting characteristics. Many individuals appear to have "fatigue relapses".
Individuals can suffer from weeks of extraordinary fatigue for no apparent reason, then report feeling not fatigued for a period of time followed by a relapse of feeling fatigued; these episodes may or may not be associated with the typical symptoms of an MS relapse. All of these characteristics suggest that fatigue is not a secondary effect of MS, but is a primary part of the disease itself.
In December 2005, MultiCell exclusively licensed LAX-202 from Amarin Neuroscience Limited (“Amarin”) for the treatment of fatigue in patients suffering from multiple sclerosis. MultiCell renamed LAX-202 to MCT-125, and will further evaluate MCT-125 in a pivotal Phase IIb/III clinical trial. In a 138 patient, multi-center, double-blind placebo controlled Phase II clinical trial conducted in the UK by Amarin, LAX-202 demonstrated efficacy in significantly reducing the levels of fatigue in MS patients enrolled in the study. LAX-202 proved to be effective within 4 weeks of the first daily oral dosing, and showed efficacy in MS patients who were moderately as well as severely affected. LAX-202 demonstrated efficacy in all MS patient sub-populations including relapsing-remitting, secondary progressive and primary progressive. Patients enrolled in the Phase II trial conducted by Amarin also reported few if any side effects following daily oral dosing of LAX-202. MultiCell intends to proceed with the anticipated pivotal Phase IIb/III trial of MCT-125 using the data generated by Amarin for LAX-202 following discussions with the regulatory authorities.
MCT-175 for the treatment of relapsing-remitting multiple sclerosis
Currently there is no cure for MS, but there are treatments both to slow down the course of the disease and to mitigate against its effects. These drugs are called disease modifying drugs. Disease modifying drugs such as the beta interferons and glatiramer acetate work by suppressing, or altering, the activity of the body's immune system. These therapies are based on the theory that MS is, at least in part, a result of an abnormal response of the body's immune system that causes it to attack the myelin sheath surrounding nerves. These medications work to reduce the frequency and severity of attacks, and help to minimize the development of new brain lesions. Disease modifying drugs help to improve the quality of life for many people with MS. Therefore, most doctors suggest patients be treated with one of these drugs as soon as a diagnosis of relapsing-remitting MS has been made.
MultiCell is developing MCT-175 as a disease modifying therapy to slow the progression of relapsing-remitting multiple sclerosis. MCT-175 was developed using MultiCell's epitope-based T-cell immunotherapy, or ETI, technology platform. MCT-175 is a myelin proteolipid protein chimeric IgG construct, which has demonstrated proof of concept in the preclinical experimental autoimmune encephalomyletisis, or EAE, mouse model.
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MCT-465 and MCT-475 for the treatment of cancer
Worldwide, breast cancer is the second most common type of cancer after lung cancer. In 2005, breast cancer caused over 500,000 deaths worldwide, and the number of cases worldwide has significantly increased, partly due to modern lifestyles in the Western world. North American women have the highest incidence of breast cancer in the world. Among US women, breast cancer is the most common cancer and the second-most common cause of cancer death after lung cancer. In 2007, breast cancer was expected to cause over 40,000 deaths in the U.S. which is about 7% of deaths related to cancer in general.
MCT-465 and MCT-475 are the first of a family of prospective cancer therapeutics based on the use of our patented ETI antibody therapeutics technology in concert with dsRNA TLR3 signaling technology. MCT-465 can be used as an adjuvant therapy with standard chemotherapeutic agents, or with our MCT-475 antibody therapeutic for the treatment of breast cancer where TLR3 is over expressed in the breast cancer cells. MCT-465 and MCT 475 are in early-stage preclinical development.
Patents and Proprietary Technology
Our success depends in part on intellectual property protection and the ability of our licensees to preserve those rights.
We use certain licenses granted to us under various licensing agreements. We also use trade secrets and proprietary knowledge unprotected by patents that we protect, in part, by confidentiality agreements. It is our policy to require our employees, directors, consultants, licensees, outside contractors and collaborators, scientific advisory board members and other advisors to execute confidentiality agreements upon the commencement of their relationships with us. These agreements provide that all confidential information made known to the individual in the course of the individual's relationship with the Company be kept as confidential and not be disclosed to third parties except in specific limited and agreed upon circumstances. We also require signed confidentiality or material transfer agreements from any company that is to receive our confidential information. In the case of employees, consultants and contractors, the agreements generally provide that all inventions conceived by the individual while rendering services to us shall be assigned to us as the exclusive property of the Company. There can be no guarantee that these agreements will not be violated or that we would have adequate remedies for such violation or that our trade secrets or proprietary knowledge will not become known by or independently developed by competitors.
Any proprietary protection that our Company can obtain and maintain will be important to our business.
On September 7, 2005, MCTI, entered into an Asset Contribution Agreement (the “Agreement”) with MultiCell Technologies, Inc., Alliance Pharmaceutical Corp. ("Alliance"), and Astral, Inc. ("Astral," and together with Alliance, ("Transferors"). Pursuant to the Agreement, MCTI issued 490,000 shares of common stock to Alliance in consideration for the acquisition of certain assets and the assumption of certain liabilities relating to Transferors' business. The intellectual property acquired by MCTI includes ten United States and twenty foreign issued and pending patents and patent applications related to chimeric antibody technology, treatment of Type 1 diabetes, T-cell tolerance, toll-like receptor technology, dendritic cells, dsRNA technology and immunosuppression.
In December 2003, we acquired the exclusive worldwide rights to US Patent # 6129911, for Liver Stem Cells from Rhode Island Hospital. We agreed to pay an annual license fee of $20,000 for the first three years of the agreement and $10,000 per annum thereafter until a product is developed. Once a product is developed, if ever, the annual license fee will end and we will pay Rhode Island Hospital a 5% royalty on net sales of any product we sell covered by the patent until we pay an aggregate of $550,000 in royalties and a 2% royalty thereafter until the expiration of the patent. In April, 2005, the Company was granted US Patent # 6872389 for the liver stem cell invention of Dr. Ron Faris, MultiCell’s former Senior Vice President and Chief Scientific Officer. This patent contains twenty-four claims to a method of obtaining a population of liver cell clusters from adult stem cells and is an important enhancement to the Company’s adult stem cell portfolio. The Company has an exclusive, long-term license agreement with Rhode Island Hospital for use of the following patents owned by the hospital related to liver cell lines and Liver Assist Devices (LADs):
US Patent # 6,017,760, Isolation and Culture of Porcine Hepatocytes, expires October 9, 2015; |
US Patent # 6,107,043, Immortalized Hepatocytes, expires February 8, 2019; |
US Patent # 6,129,911, Liver Stem Cell, expires October 10, 2017; |
US Patent # 6,858,146, Artificial Liver Apparatus and Method (Sybiol), expires on February 20, 2019; and |
US Patent # 6,872,389, Liver Stem Cell, expires on July 8, 2019. |
If we generate revenues and pay royalties, the annual license fee structure does not apply. Our agreement provides that we would pay a 5% royalty until we pay Rhode Island Hospital an aggregate of $550,000. After that, the royalty percentage decreases to 2% for the life of the patents.
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On November 3, 2003, Xenogenics was notified by the United States Patent and Trademark Office that its patent application for an "Artificial Liver Apparatus And Method", the Sybiol® Synthetic Bio-Liver Device, will be allowed. United States patent 6,858,146 was issued in 2005. The Sybiol® trademark is registered in the United States Patent and Trademark Office, number 2,048,080.
Government Regulation
The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the clinical development, manufacture, marketing and distribution of drugs. These agencies and other federal, state and local entities regulate research and development activities and the testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our drug candidates and drugs.
In the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act and implementing regulations. The process required by the FDA before our drug candidates may be marketed in the United States generally involves the following:
• | completion of extensive preclinical laboratory tests, preclinical animal studies and formulation studies, all performed in accordance with the FDA’s good laboratory practice, or GLP, regulations; |
• | submission to the FDA of an IND application which must become effective before clinical trials may begin; |
• | performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the drug candidate for each proposed indication; |
• | submission of a new drug application, or NDA, to the FDA; |
• | satisfactory completion of an FDA preapproval inspection of the manufacturing facilities at which the product is produced to assess compliance with current GMP, or cGMP, regulations; and |
• | FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug. |
This testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our drug candidates will be granted on a timely basis, if at all.
Preclinical tests include laboratory evaluation of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animals. The results of preclinical tests, together with manufacturing information and analytical data, are submitted as part of an IND application to the FDA. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Our submission of an IND, or those of our collaborators, may not result in FDA authorization to commence a clinical trial. A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development. Further, an independent institutional review board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the clinical trial until completed. The FDA, the IRB or the clinical trial sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive Good Clinical Practice, or GCP, regulations and regulations for informed consent.
Clinical Trials: For purposes of an NDA submission and approval, clinical trials are typically conducted in the following three sequential phases, which may overlap:
· | Phase I: The clinical trials are initially conducted in a limited population to test the drug candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in healthy humans or, on occasion, in patients, such as cancer patients. In some cases, particularly in cancer trials, a sponsor may decide to run what is referred to as a “Phase Ib” evaluation, which is a second, safety-focused Phase I clinical trial typically designed to evaluate the impact of the drug candidate in combination with currently approved drugs. |
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• | Phase II: These clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the drug candidate for specific targeted indications and to determine dose tolerance and optimal dosage. Multiple Phase II clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase III clinical trials. In some cases, a sponsor may decide to run what is referred to as a “Phase IIb” evaluation, which is a second, confirmatory Phase II clinical trial that could, if positive and accepted by the FDA, serve as a pivotal clinical trial in the approval of a drug candidate. |
• | Phase III: These clinical trials are commonly referred to as pivotal clinical trials. If the Phase II clinical trials demonstrate that a dose range of the drug candidate is effective and has an acceptable safety profile, Phase III clinical trials are then undertaken in large patient populations to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites. |
In some cases, the FDA may condition approval of an NDA for a drug candidate on the sponsor’s agreement to conduct additional clinical trials to further assess the drug’s safety and effectiveness after NDA approval. Such post-approval trials are typically referred to as Phase IV clinical trials.
New Drug Application. The results of drug candidate development, preclinical testing and clinical trials are submitted to the FDA as part of an NDA. The NDA also must contain extensive manufacturing information. Once the submission has been accepted for filing, by law the FDA has 180 days to review the application and respond to the applicant. The review process is often significantly extended by FDA requests for additional information or clarification. The FDA may refer the NDA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. The FDA may deny approval of an NDA if the applicable regulatory criteria are not satisfied, or it may require additional clinical data or an additional pivotal Phase III clinical trial. Even if such data are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we or our collaborators do. Once issued, the FDA may withdraw a drug approval if ongoing regulatory requirements are not met or if safety problems occur after the drug reaches the market. In addition, the FDA may require further testing, including Phase IV clinical trials, and surveillance programs to monitor the effect of approved drugs which have been commercialized. The FDA has the power to prevent or limit further marketing of a drug based on the results of these post-marketing programs. Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved label. Further, if there are any modifications to a drug, including changes in indications, labeling or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new NDA or NDA supplement, which may require us to develop additional data or conduct additional preclinical studies and clinical trials.
Fast Track Designation. The FDA’s fast track program is intended to facilitate the development and to expedite the review of drugs that are intended for the treatment of a serious or life-threatening condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for the condition. Under the fast track program, the sponsor of a new drug candidate may request the FDA to designate the drug candidate for a specific indication as a fast track drug concurrent with or after the filing of the IND for the drug candidate. The FDA must determine if the drug candidate qualifies for fast track designation within 60 days of receipt of the sponsor’s request.
If fast track designation is obtained, the FDA may initiate review of sections of an NDA before the application is complete. This rolling review is available if the applicant provides and the FDA approves a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the time period specified in the Prescription Drug User Fees Act, which governs the time period goals the FDA has committed to reviewing an application, does not begin until the complete application is submitted. Additionally, the fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.
In some cases, a fast track designated drug candidate may also qualify for one or more of the following programs:
• | Priority Review. Under FDA policies, a drug candidate is eligible for priority review, or review within a six-month time frame from the time a complete NDA is accepted for filing, if the drug candidate provides a significant improvement compared to marketed drugs in the treatment, diagnosis or prevention of a disease. A fast track designated drug candidate would ordinarily meet the FDA’s criteria for priority review. We cannot guarantee any of our drug candidates will receive a priority review designation, or if a priority designation is received, that review or approval will be faster than conventional FDA procedures, or that FDA will ultimately grant drug approval. |
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• | Accelerated Approval. Under the FDA’s accelerated approval regulations, the FDA is authorized to approve drug candidates that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses, and that provide meaningful therapeutic benefit to patients over existing treatments based upon either a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than patient survival. In clinical trials, surrogate endpoints are alternative measurements of the symptoms of a disease or condition that are substituted for measurements of observable clinical symptoms. A drug candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase IV or post-approval clinical trials to validate the surrogate endpoint or confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or to validate a surrogate endpoint or confirm a clinical benefit during post-marketing studies, will allow the FDA to withdraw the drug from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA. |
When appropriate, we and our collaborators intend to seek fast track designation or accelerated approval for our drug candidates. We cannot predict whether any of our drug candidates will obtain a fast track or accelerated approval designation, or the ultimate impact, if any, of the fast track or the accelerated approval process on the timing or likelihood of FDA approval of any of our drug candidates.
Satisfaction of FDA regulations and requirements or similar requirements of state, local and foreign regulatory agencies typically takes several years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease. Typically, if a drug candidate is intended to treat a chronic disease, as is the case with some of our drug candidates, safety and efficacy data must be gathered over an extended period of time. Government regulation may delay or prevent marketing of drug candidates for a considerable period of time and impose costly procedures upon our activities. The FDA or any other regulatory agency may not grant approvals for new indications for our drug candidates on a timely basis, if at all. Even if a drug candidate receives regulatory approval, the approval may be significantly limited to specific disease states, patient populations and dosages. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a drug may result in restrictions on the drug or even complete withdrawal of the drug from the market. Delays in obtaining, or failures to obtain, regulatory approvals for any of our drug candidates would harm our business. In addition, we cannot predict what adverse governmental regulations may arise from future United States or foreign governmental action.
Other regulatory requirements. Any drugs manufactured or distributed by us or our collaborators pursuant to FDA approvals are subject to continuing regulation by the FDA, including recordkeeping requirements and reporting of adverse experiences associated with the drug. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMPs, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, seizure of product, injunctive action or possible civil penalties. We cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements. If our present or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may halt our clinical trials, require us to recall a drug from distribution, or withdraw approval of the NDA for that drug.
The FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet. A company can make only those claims relating to safety and efficacy that are approved by the FDA. Failure to comply with these requirements can result in adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available drugs for uses that are not described in the drug’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, impose stringent restrictions on manufacturers’ communications regarding off-label use.
Need for Government Approval
The use of immortalized hepatocytes for drug discovery purposes does not require FDA approval. However, some of our products will be subject to regulation in the United States by the FDA and by comparable regulatory authorities in foreign jurisdictions. The Sybiol synthetic bio-liver device will be classified as a “biologic” regulated under the Public Health Service Act and the Food, Drug and Cosmetic Act. The use of human immortalized liver cells for this application will also be regulated by the FDA. Development of therapeutic products of human use is a multi-step process. The process required by the FDA before our drug candidates may be marketed in the United States generally involves the following:
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• | completion of extensive preclinical laboratory tests, preclinical animal studies and formulation studies all performed in accordance with the FDA’s good laboratory practice, or GLP, regulations; |
• | submission to the FDA of an IND application which must become effective before clinical trials may begin; |
• | performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product candidate for each proposed indication; |
• | submission of a new drug application, or NDA, to the FDA; |
• | satisfactory completion of an FDA preapproval inspection of the manufacturing facilities at which the product is produced to assess compliance with current GMP, or cGMP, regulations; and |
• | FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug. |
The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our drug candidates will be granted on a timely basis, if at all.
Research and Development
In fiscal year 2008, our Company spent $317,130 on research and development. Research and development costs during fiscal year 2007 were $757,866. Cost reductions related to research included lower salaries, lower consulting fees and other operating expenses. Further, the decrease in selling, general and administrative expenses was achieved by reducing administrative and marketing salaries and expenses.
Historically, our research and development has also been funded to some extent by the National Institute of Health (“NIH”) grants, Small Business Innovative Research (“SBIR”) grants, and other similar grants.
Competition
We compete in the segments of the pharmaceutical and biotechnology markets that are highly competitive. We face significant competition from most pharmaceutical companies as well as biotechnology companies that are also researching and selling products similar to ours. Many of our competitors have significantly greater financial, manufacturing, marketing and drug development resources than we do. Large pharmaceutical companies in particular have extensive experience in clinical testing and in obtaining regulatory approvals for drugs. These companies also have significantly greater research capabilities than we do. In addition, many universities and private and public research institutes are active in research, some in direct competition with us. We believe that our ability to successfully compete will depend on, among other things:
· | Our drug candidates’ efficacy, safety and reliability; |
· | The speed at which we develop our drug candidates; |
· | The completion of clinical development and laboratory testing and obtaining regulatory approvals for drug candidates; |
· | The timing and scope of regulatory approvals for our drug candidates; |
· | Our ability to manufacture and sell commercial quantities of a drug to the market; |
· | Acceptance of our drugs by physicians and other health care providers; |
· | The willingness of third party payors to provide reimbursement for the use of our drugs; |
· | Our ability to protect our intellectual property and avoid infringing the intellectual property of others; |
· | The quality and breadth of our technology; |
· | Our employees’ skills and our ability to recruit and retain skilled employees; |
· | Our cash flows under existing and potential future arrangements with licensees, partners and other parties; and |
· | The availability of substantial capital resources to fund development and commercialization activities. |
Our competitors may develop drug candidates and market drugs that are less expensive and more effective than our future drugs or that may render our drugs obsolete. Our competitors may also commercialize competing drugs before we or our partners can launch any drugs developed from our drug candidates.
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Other companies that are early-stage are currently developing alternative treatments and products that could compete with our drugs. These organizations also compete with us to attract qualified personnel and potential parties for acquisitions, joint ventures or other strategic alliances.
Employees
As of November 30, 2008, we had two employees, both of whom are full-time employees.
FACTORS THAT MAY AFFECT FUTURE PERFORMANCE
Risks Related To Our Business
Our drug candidates and cellular systems technologies are in the early stages of clinical testing and we have a history of significant losses and may not achieve or sustain profitability.
Our drug candidates are in the early stages of clinical testing and we must conduct significant additional clinical trials before we can seek the regulatory approvals necessary to begin commercial sales of our drugs. Similarly, some of our cellular systems technologies are in early stages of development and require further development before they may be commercially viable. We have incurred a substantial accumulated deficit since our inception in 1970. As of November 30, 2008, our accumulated deficit was $38,628,039. Our losses have primarily resulted from significant costs associated with the research and development relating to our cellular systems technologies and other operating costs. We expect to incur increasing losses for at least several years, as we continue our research activities and conduct development of, and seek regulatory approvals for, our drug candidates, and commercialize any approved drugs and as we continue to advance our cellular systems technologies business. If our drug candidates fail in clinical trials or do not gain regulatory approval, or if our drugs and cellular systems technologies do not achieve market acceptance, we will not achieve or maintain profitability. If we fail to become and remain profitable, or if we are unable to fund our continuing losses, you could lose all or part of your investment.
Going Concern
Our independent auditors have added explanatory paragraph to their audit opinion issued in connection with the financial statements for the year ended November 30, 2008, relative to our ability to continue as a going concern. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our ability to obtain additional funding will determine our ability to continue as a going concern. During the past year the Company has operated on working capital provided by La Jolla Cove Investors (“LJCI”). Under terms of the agreement, LJCI can convert a portion of the convertible debenture by simultaneously exercising a warrant at $1.09 per share. As of March 9, 2009 there are 9,683,500 shares remaining on the stock purchase warrant and a balance of $96,835 remaining on the convertible debenture. Should LJCI continue to exercise all of its remaining warrants approximately $10.6 million of cash would be provided to the Company. The agreement limits LJCI’s investment to an aggregate ownership that does not exceed 9.9% of the outstanding shares of the Company. The Company expects that LJCI will continue to exercise the warrants and convert the debenture over the next year.
Our business strategy of focusing on our therapeutic programs and technologies makes evaluation of our business prospects difficult.
Our business strategy of focusing on therapeutic programs and technologies is unproven, and we cannot accurately predict our product development success. Moreover, we have limited experience developing therapeutics, and we cannot be sure that any product that we develop will be commercially successful. As a result of these factors, it is difficult to predict and evaluate our future business prospects.
We are subject to a variety of general business risks.
We will be subject to the risks inherent in the ownership and operation of a research and development biotechnology venture such as regulatory setbacks and delays, fluctuations in expenses, competition from other biotechnology ventures and pharmaceutical companies, the general strength of regional and national economies, and governmental regulation. The Company’s products may fail to advance due to inadequate therapeutic efficacy, adverse effects, inability to finance clinical trials or other regulatory or commercial setbacks. Because certain costs of the Company will not generally decrease with decreases in financing capital or revenues, the cost of operating the Company may exceed the income there from. No representation or warranty can be made that the Company will be profitable or will be able to generate sufficient working capital.
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Difficulties encountered during challenging and changing economic conditions could adversely affect our results of operations.
Our future business and operating results will depend to a significant extent on economic conditions in general. World-wide efforts to cut capital spending, general economic uncertainty and a weakening global economy could have a material adverse effect on us a variety of ways, including a scarcity of financing needed to fund our current and planned operations, and the reluctance or inability of potential strategic partners to consummate strategic partnerships due to their own financial hardships. If we are unable to effectively manage during the current challenging and changing economic conditions, our business, financial condition, and results of operations could be materially adversely affected.
If we do not obtain adequate financing to fund our future research and development and operations, we may not be able to successfully implement our business plan.
We have in the past increased, and plan to increase further, our operating expenses in order to fund higher levels of research and development, undertake and complete the regulatory approval process, and increase our administrative resources in anticipation of future growth. We plan to increase our administrative resources to support the hiring of additional employees that will enable us to expand our research and product development capacity. We intend to finance our operations with revenues from royalties generated from the licensing of our technology, by selling securities to investors, through the issuance of debt instruments, through strategic alliances, and by continuing to use our common stock to pay for consulting and professional services.
We also anticipate the need for additional financing in the future in order to fund continued research and development and to respond to competitive pressures. We anticipate that our future cash requirements may be fulfilled by potential direct product sales, the sale of additional securities, debt financing and/or the sale or licensing of our technologies. We cannot guarantee, however, that enough future funds will be generated from operations or from the aforementioned or other potential sources. Although we raised gross proceeds of $144,925 during 2008 and $300,000 in February 2007, in private placements, we do not have any binding commitment with regard to future financing. If adequate funds are not available or are not available on acceptable terms, we may be unable to pursue our therapeutic programs, fund expansion of our cellular technologies business, develop new or enhance existing products and services or respond to competitive pressures, any of which could have a material adverse effect on our business, results of operations and financial condition.
We have never generated, and may never generate, revenues from commercial sales of our drug and/or therapeutic candidates and we may not have drugs and / or therapeutic products to market for at least several years, if ever.
We currently have no drugs or therapeutic products approved by the Food and Drug Administration, or FDA, or similar regulatory authorities that are available for commercial sale anywhere in the world, and we cannot guarantee that we will ever have marketable drugs or therapeutic products available for sale anywhere in the world. We must demonstrate that our drug or therapeutic product candidates satisfy rigorous standards of safety and efficacy to the FDA and other regulatory authorities in the United States and abroad. We and our partners will need to conduct significant additional research and preclinical and clinical testing before we or our partners can file applications with the FDA or other regulatory authorities for approval of our drug candidates and therapeutic products. In addition, to compete effectively, our drugs and therapeutic products must be easy to use, cost-effective and economical to manufacture on a commercial scale, compared to other therapies available for the treatment of the same conditions. We may not achieve any of these objectives. We cannot be certain that the clinical development of our drug candidates in preclinical testing or clinical development will be successful, that they will receive the regulatory approvals required to commercialize them, or that any of our other research programs will yield a drug candidate suitable for entry into clinical trials. We do not expect any of our drug and therapeutic products candidates to be commercially available for several years, if at all. The development of one or more of these drug candidates may be discontinued at any stage of our clinical trials programs and we may not generate revenue from any of drug candidates.
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Clinical trials may fail to demonstrate the desired safety and efficacy of our drug and / or therapeutic candidates, which could prevent or significantly delay completion of clinical development and regulatory approval.
Prior to receiving approval to commercialize any of our drug and therapeutic candidates, we must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA and other regulatory authorities in the United States and abroad, that such drug candidate is both sufficiently safe and effective. Before we can commence clinical trials, we must demonstrate through preclinical studies satisfactory product chemistry, formulation, stability and toxicity levels in order to file an investigational new drug application, or IND, (or the foreign equivalent of an IND) to commence clinical trials. In clinical trials we will need to demonstrate efficacy for the treatment of specific indications and monitor safety throughout the clinical development process. Long-term safety and efficacy have not yet been demonstrated in clinical trials for any of our drug and therapeutic candidates, and satisfactory chemistry, formulation, stability and toxicity levels have not yet been demonstrated for our drug candidates or compounds that are currently the subject of preclinical studies. If our preclinical studies, clinical trials or future clinical trials are unsuccessful, our business and reputation will be harmed.
All of our drug and therapeutic candidates are prone to the risks of failure inherent in drug development. Preclinical studies may not yield results that would satisfactorily support the filing of an IND or comparable regulatory filing abroad with respect to our drug candidates, and, even if these applications would be or have been filed with respect to our drug and therapeutic candidates, the results of preclinical studies do not necessarily predict the results of clinical trials. Similarly, early-stage clinical trials do not predict the results of later-stage clinical trials, including the safety and efficacy profiles of any particular drug and therapeutic candidate. In addition, there can be no assurance that the design of our clinical trials is focused on appropriate disease types, patient populations, dosing regimens or other variables which will result in obtaining the desired efficacy data to support regulatory approval to commercialize the drug and / or therapeutic. Even if we believe the data collected from clinical trials of our drug and therapeutic candidates are promising, such data may not be sufficient to support approval by the FDA or any other United States or foreign regulatory authority. Preclinical and clinical data can be interpreted in different ways. Accordingly, FDA officials or officials from foreign regulatory authorities could interpret the data in different ways than we or our partners do, which could delay, limit or prevent regulatory approval.
Administering any of our drug candidates and therapeutic products, or potential drug candidates that are the subject of preclinical studies to animals may produce undesirable side effects, also known as adverse effects. Toxicities and adverse effects that we have observed in preclinical studies for some compounds in a particular research and development program may occur in preclinical studies or clinical trials of other compounds from the same program. Such toxicities or adverse effects could delay or prevent the filing of an IND or comparable regulatory filing abroad with respect to such drug candidates or potential drug candidates or cause us to cease clinical trials with respect to any drug candidate. In clinical trials, administering any of our drug candidates to humans may produce adverse effects. These adverse effects could interrupt, delay or halt clinical trials of our drug candidates and could result in the FDA or other regulatory authorities denying approval of our drug candidates for any or all targeted indications. The FDA, other regulatory authorities, our partners or we may suspend or terminate clinical trials at any time. Even if one or more of our drug candidates were approved for sale, the occurrence of even a limited number of toxicities or adverse effects when used in large populations may cause the FDA to impose restrictions on, or prevent, the further marketing of such drugs. Indications of potential adverse effects or toxicities which may occur in clinical trials and which we believe are not significant during the course of such trials may later turn out to actually constitute serious adverse effects or toxicities when a drug has been used in large populations or for extended periods of time. Any failure or significant delay in completing preclinical studies or clinical trials for our drug candidates, or in receiving and maintaining regulatory approval for the sale of any drugs resulting from our drug candidates, may severely harm our reputation and business.
Clinical trials are expensive, time consuming and subject to delay.
Clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous requirements. The clinical trial process is also time consuming. According to industry sources, the entire drug development and testing process takes on average 12 to 15 years. According to industry studies, the fully capitalized resource cost of new drug development averages approximately $800 million; however, individual trials and individual drug candidates may incur a range of costs above or below this average. We estimate that clinical trials of our most advanced drug candidates will continue for several years, but may take significantly longer to complete. The commencement and completion of our clinical trials could be delayed or prevented by several factors, including, but not limited to:
· | delays in obtaining regulatory approvals to commence a clinical trial; |
· | delays in identifying and reaching agreement on acceptable terms with prospective clinical trial sites; |
· | slower than expected rates of patient recruitment and enrollment, including as a result of the introduction of alternative therapies or drugs by others; |
· | lack of effectiveness during clinical trials; |
· | unforeseen safety issues; |
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· | adequate supply of clinical trial material; |
· | uncertain dosing issues; |
· | introduction of new therapies or changes in standards of practice or regulatory guidance that render our clinical trial endpoints or the targeting of our proposed indications obsolete; |
· | inability to monitor patients adequately during or after treatment; and |
· | inability or unwillingness of medical investigators to follow our clinical protocols. |
We do not know whether planned clinical trials will begin on time, will need to be restructured or will be completed on schedule, if at all. Significant delays in clinical trials will impede our ability to commercialize our drug candidates and generate revenue and could significantly increase our development costs, any of which could significantly and negatively impact our results of operations and harm our business.
If we fail to enter into and maintain successful strategic alliances for certain of our therapeutic products or drug candidates, we may have to reduce or delay our drug candidate development or increase our expenditures.
Our strategy for developing, manufacturing and commercializing certain of our therapeutic products or drug candidates involves entering into and successfully maintaining strategic alliances with pharmaceutical companies or other industry participants to advance our programs and reduce our expenditures on each program. However, we may not be able to maintain our current strategic alliances or negotiate additional strategic alliances on acceptable terms, if at all. If we are not able to maintain our existing strategic alliances or establish and maintain additional strategic alliances, we may have to limit the size or scope of, or delay, one or more of our drug development programs or research programs or undertake and fund these programs ourselves or otherwise reevaluate or exit a particular business. To the extent that we are required to increase our expenditures to fund research and development programs or our therapeutic programs or cellular systems technologies on our own, we will need to obtain additional capital, which may not be available on acceptable terms, or at all.
Our proprietary rights may not adequately protect our technologies and drug candidates.
Our commercial success will depend in part on our obtaining and maintaining patent protection and trade secret protection of our technologies and drug candidates as well as successfully defending these patents against third-party challenges. We will only be able to protect our technologies and drug candidates from unauthorized use by third parties to the extent that valid and enforceable patents or trade secrets cover them. Furthermore, the degree of future protection of our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.
The patent positions of life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in such companies’ patents has emerged to date in the United States. The patent situation outside the United States is even more uncertain. Changes in either the patent laws or in interpretations of patent laws in the United States or other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. For example:
· | we or our licensors might not have been the first to make the inventions covered by each of our pending patent applications and issued patents; | |
· | we or our licensors might not have been the first to file patent applications for these inventions; | |
· | others may independently develop similar or alternative technologies or duplicate any of our technologies; | |
· | it is possible that none of our pending patent applications or the pending patent applications of our licensors will result in issued patents; |
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· | our issued patents and issued patents of our licensors may not provide a basis for commercially viable drugs, or may not provide us with any competitive advantages, or may be challenged and invalidated by third parties; and | |
· | we may not develop additional proprietary technologies or drug candidates that are patentable. |
We also rely on trade secrets to protect our technology, especially where we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While we use reasonable efforts to protect our trade secrets, our or our strategic partners’ employees, consultants, contractors or scientific and other advisors may unintentionally or willfully disclose our information to competitors. If we were to enforce a claim that a third party had illegally obtained and was using our trade secrets, our enforcement efforts would be expensive and time consuming, and the outcome would be unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, if our competitors independently develop equivalent knowledge, methods and know-how, it will be more difficult for us to enforce our rights and our business could be harmed.
If we are not able to defend the patent or trade secret protection position of our technologies and drug candidates, then we will not be able to exclude competitors from developing or marketing competing drugs, and we may not generate enough revenue from product sales to justify the cost of development of our drugs and to achieve or maintain profitability.
If we are sued for infringing intellectual property rights of third parties, such litigation will be costly and time consuming, and an unfavorable outcome would have a significant adverse effect on our business.
Our ability to commercialize drugs depends on our ability to sell such drugs without infringing the patents or other proprietary rights of third parties. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the areas that we are exploring. In addition, because patent applications can take several years to issue, there may be currently pending applications, unknown to us, which may later result in issued patents that our drug candidates may infringe. There could also be existing patents of which we are not aware that our drug candidates may inadvertently infringe.
Future products of ours may be impacted by patents of companies engaged in competitive programs with significantly greater resources. Further development of these products could be impacted by these patents and result in the expenditure of significant legal fees.
If a third party claims that our actions infringe on their patents or other proprietary rights, we could face a number of issues that could seriously harm our competitive position, including, but not limited to:
· | infringement and other intellectual property claims that, with or without merit, can be costly and time consuming to litigate and can delay the regulatory approval process and divert management’s attention from our core business strategy; | |
· | substantial damages for past infringement which we may have to pay if a court determines that our drugs or technologies infringe upon a competitor’s patent or other proprietary rights; | |
· | A court prohibiting us from selling or licensing our drugs or technologies unless the holder licenses the patent or other proprietary rights to us, which it is not required to do; and | |
· | if a license is available from a holder, we may have to pay substantial royalties or grant cross licenses to our patents or other proprietary rights. |
We may become involved in disputes with our strategic partners over intellectual property ownership, and publications by our research collaborators and scientific advisors could impair our ability to obtain patent protection or protect our proprietary information, which, in either case, would have a significant impact on our business.
Inventions discovered under our strategic alliance agreements become jointly owned by our strategic partners and us in some cases, and the exclusive property of one of us in other cases. Under some circumstances, it may be difficult to determine who owns a particular invention, or whether it is jointly owned, and disputes could arise regarding ownership of those inventions. These disputes could be costly and time consuming, and an unfavorable outcome would have a significant adverse effect on our business if we were not able to protect or license rights to these inventions. In addition, our research collaborators and scientific advisors have contractual rights to publish our data and other proprietary information, subject to our prior review. Publications by our research collaborators and scientific advisors containing such information, either with our permission or in contravention of the terms of their agreements with us, may impair our ability to obtain patent protection or protect our proprietary information, which could significantly harm our business.
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To the extent we elect to fund the development of a drug candidate or the commercialization of a drug at our expense, we will need substantial additional funding.
The discovery, development and commercialization of drugs is costly. As a result, to the extent we elect to fund the development of a drug candidate or the commercialization of a drug at our expense, we will need to raise additional capital to:
· | expand our research and development and technologies; |
· | fund clinical trials and seek regulatory approvals; |
· | build or access manufacturing and commercialization capabilities; |
· | implement additional internal systems and infrastructure; |
· | maintain, defend and expand the scope of our intellectual property; and |
· | hire and support additional management and scientific personnel. |
Our future funding requirements will depend on many factors, including, but not limited to:
· | the rate of progress and cost of our clinical trials and other research and development activities; | |
· | the costs and timing of seeking and obtaining regulatory approvals; | |
· | the costs associated with establishing manufacturing and commercialization capabilities; | |
· | the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; | |
· | the costs of acquiring or investing in businesses, products and technologies; | |
· | the effect of competing technological and market developments; and | |
· | the payment and other terms and timing of any strategic alliance, licensing or other arrangements that we may establish. |
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, debt financings and strategic alliances. We cannot be certain that additional funding will be available on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or future commercialization initiatives.
We have limited capacity to carry out our own clinical trials in connection with the development of our drug candidates and potential drug candidates, and to the extent we elect to develop a drug candidate without a strategic partner we will need to expand our development capacity, and we will require additional funding.
The development of drug candidates is complicated, and requires resources and experience for which we currently have limited resources. To the extent we conduct clinical trials for a drug candidate without support from a strategic partner we will need to develop additional skills, technical expertise and resources necessary to carry out such development efforts on our own or through the use of other third parties, such as contract research organizations, or CROs.
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If we utilize CROs, we will not have control over many aspects of their activities, and will not be able to fully control the amount or timing of resources that they devote to our programs. These third parties also may not assign as high a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves, and therefore may not complete their respective activities on schedule. CROs may also have relationships with our competitors and potential competitors, and may prioritize those relationships ahead of their relationships with us. Typically we would prefer to qualify more than one vendor for each function performed outside of our control, which could be time consuming and costly. The failure of CROs to carry out development efforts on our behalf according to our requirements and FDA or other regulatory agencies’ standards, or our failure to properly coordinate and manage such efforts, could increase the cost of our operations and delay or prevent the development, approval and commercialization of our drug candidates.
If we fail to develop additional skills, technical expertise and resources necessary to carry out the development of our drug candidates, or if we fail to effectively manage our CROs carrying out such development, the commercialization of our drug candidates will be delayed or prevented.
We currently have no marketing or sales staff, and if we are unable to enter into or maintain strategic alliances with marketing partners or if we are unable to develop our own sales and marketing capabilities, we may not be successful in commercializing our potential drugs or therapeutic products.
We currently have no internal sales, marketing or distribution capabilities. To commercialize our products or drugs that we determine not to market on our own, we will depend on strategic alliances with third parties, which have established distribution systems and direct sales forces. If we are unable to enter into such arrangements on acceptable terms, we may not be able to successfully commercialize such products or drugs. If we decide to commercialize products or drugs on our own, we will need to establish our own specialized sales force and marketing organization with technical expertise and with supporting distribution capabilities. Developing such an organization is expensive and time consuming and could delay a product launch. In addition, we may not be able to develop this capacity efficiently, or at all, which could make us unable to commercialize our products and drugs.
To the extent that we are not successful in commercializing any products or drugs ourselves or through a strategic alliance, our product revenues will suffer, we will incur significant additional losses and the price of our common stock will be negatively affected.
We have no manufacturing capacity and depend on our partners or contract manufacturers to produce our products and clinical trial drug supplies for each of our drug candidates and potential drug candidates, and anticipate continued reliance on contract manufacturers for the development and commercialization of our potential products and drugs.
We do not currently operate manufacturing facilities for clinical or commercial production of our drug candidates or potential drug candidates that are under development. We have no experience in drug formulation or manufacturing, and we lack the resources and the capabilities to manufacture any of our drug candidates on a clinical or commercial scale. We anticipate reliance on a limited number of contract manufacturers. Any performance failure on the part of our contract manufacturers could delay clinical development or regulatory approval of our drug candidates or commercialization of our drugs, producing additional losses and depriving us of potential product revenues.
Our products and drug candidates require precise, high quality manufacturing. Our failure or our contract manufacturer’s failure to achieve and maintain high manufacturing standards, including the incidence of manufacturing errors, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously hurt our business. Contract manufacturers often encounter difficulties involving production yields, quality control and quality assurance, as well as shortages of qualified personnel. These manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the U.S. Drug Enforcement Agency and other regulatory agencies to ensure strict compliance with current good manufacturing practices and other applicable government regulations and corresponding foreign standards; however, we do not have control over contract manufacturers’ compliance with these regulations and standards. If one of our contract manufacturers fails to maintain compliance, the production of our drug candidates could be interrupted, resulting in delays, additional costs and potentially lost revenues. Additionally, our contract manufacturer must pass a preapproval inspection before we can obtain marketing approval for any of our drug candidates in development.
If the FDA or other regulatory agencies approve any of our products or our drug candidates for commercial sale, we will need to manufacture them in larger quantities. Significant scale-up of manufacturing may require additional validation studies, which the FDA must review and approve. If we are unable to successfully increase the manufacturing capacity for a product or drug candidate, the regulatory approval or commercial launch of any related products or drugs may be delayed or there may be a shortage in supply. Even if any contract manufacturer makes improvements in the manufacturing process for our products and drug candidates, we may not own, or may have to share, the intellectual property rights to such improvements.
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In addition, our contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to successfully produce, store and distribute our products and drug candidates. In the event of a natural disaster, business failure, strike or other difficulty, we may be unable to replace such contract manufacturer in a timely manner and the production of our products or drug candidates would be interrupted, resulting in delays and additional costs.
Switching manufacturers may be difficult because the number of potential manufacturers is limited and the FDA must approve any replacement manufacturer prior to manufacturing our products or drug candidates. Such approval would require new testing and compliance inspections. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our drug candidates after receipt of FDA approval. It may be difficult or impossible for us to find a replacement manufacturer on acceptable terms quickly, or at all.
We expect to expand our development, clinical research and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
We expect to have significant growth in expenditures, the number of our employees and the scope of our operations, in particular with respect to those drug candidates that we elect to develop or commercialize independently or together with a partner. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited resources, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.
The failure to attract and retain skilled personnel could impair our drug development and commercialization efforts.
Our performance is substantially dependent on the performance of our senior management and key scientific and technical personnel. The employment of these individuals and our other personnel is terminable at will with short or no notice. The loss of the services of any member of our senior management, scientific or technical staff may significantly delay or prevent the achievement of drug development and other business objectives by diverting management’s attention to transition matters and identification of suitable replacements, and could have a material adverse effect on our business, operating results and financial condition. We also rely on consultants and advisors to assist us in formulating our research and development strategy. All of our consultants and advisors are either self-employed or employed by other organizations, and they may have conflicts of interest or other commitments, such as consulting or advisory contracts with other organizations, that may affect their ability to contribute to us. In addition, we believe that we will need to recruit additional executive management and scientific and technical personnel. There is currently intense competition for skilled executives and employees with relevant scientific and technical expertise, and this competition is likely to continue. Our inability to attract and retain sufficient scientific, technical and managerial personnel could limit or delay our product development efforts, which would adversely affect the development of our products and drug candidates and commercialization of our products and potential drugs and growth of our business.
Risks Related to Our Industry
Our competitors may develop products and drugs that are less expensive, safer, or more effective, which may diminish or eliminate the commercial success of any drugs that we may commercialize.
We compete with companies that are also developing alternative products and drug candidates. Our competitors may:
· | develop products and drug candidates and market products and drugs that are less expensive or more effective than our future drugs; | |
· | commercialize competing products and drugs before we or our partners can launch any products and drugs developed from our drug candidates; | |
· | obtain proprietary rights that could prevent us from commercializing our products; | |
· | initiate or withstand substantial price competition more successfully than we can; | |
· | have greater success in recruiting skilled scientific workers from the limited pool of available talent; |
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· | more effectively negotiate third-party licenses and strategic alliances; | |
· | take advantage of acquisition or other opportunities more readily than we can; | |
· | develop products and drug candidates and market products and drugs that increase the levels of safety or efficacy or alter other product and drug candidate profile aspects that our products and drug candidates need to show in order to obtain regulatory approval; and | |
· | introduce technologies or market products and drugs that render the market opportunity for our potential products and drugs obsolete. |
We will compete for market share against large pharmaceutical and biotechnology companies and smaller companies that are collaborating with larger pharmaceutical companies, new companies, academic institutions, government agencies and other public and private research organizations. Many of these competitors, either alone or together with their partners, may develop new products and drug candidates that will compete with ours, as these competitors may, and in certain cases do, operate larger research and development programs or have substantially greater financial resources than we do. Our competitors may also have significantly greater experience in:
· | developing products and drug candidates; | |
· | undertaking preclinical testing and clinical trials; | |
· | building relationships with key customers and opinion-leading physicians; | |
· | obtaining and maintaining FDA and other regulatory approvals; | |
· | formulating and manufacturing; and | |
· | launching, marketing and selling products and drugs. |
If our competitors market products and drugs that are less expensive, safer or more efficacious than our potential products and drugs, or that reach the market sooner than our potential products and drugs, we may not achieve commercial success. In addition, the life sciences industry is characterized by rapid technological change. Because our research approach integrates many technologies, it may be difficult for us to stay abreast of the rapid changes in each technology. If we fail to stay at the forefront of technological change we may be unable to compete effectively. Our competitors may render our technologies obsolete by advances in existing technological approaches or the development of new or different approaches, potentially eliminating the advantages in our drug discovery process that we believe we derive from our research approach and proprietary technologies.
The regulatory approval process is expensive, time consuming and uncertain and may prevent us from obtaining approvals for the commercialization of some or all of our products and drug candidates.
The research, testing, manufacturing, selling and marketing of drug candidates are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, which regulations differ from country to country. We may not market our potential drugs in the United States until we receive approval of an NDA from the FDA. Obtaining an NDA can be a lengthy, expensive and uncertain process. In addition, failure to comply with the FDA and other applicable foreign and United States regulatory requirements may subject us to administrative or judicially imposed sanctions. These include warning letters, civil and criminal penalties, injunctions, product seizure or detention, product recalls, total or partial suspension of production, and refusal to approve pending NDAs, or supplements to approved NDAs.
Regulatory approval of an NDA or NDA supplement is never guaranteed, and the approval process typically takes several years and is extremely expensive. The FDA also has substantial discretion in the drug approval process. Despite the time and expense exerted, failure can occur at any stage, and we could encounter problems that cause us to abandon clinical trials or to repeat or perform additional preclinical testing and clinical trials. The number and focus of preclinical studies and clinical trials that will be required for FDA approval varies depending on the drug candidate, the disease or condition that the drug candidate is designed to address, and the regulations applicable to any particular drug candidate. The FDA can delay, limit or deny approval of a drug candidate for many reasons, including:
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· | a drug candidate may not be safe or effective; |
· | FDA officials may not find the data from preclinical testing and clinical trials sufficient; |
· | the FDA might not approve our or our contract manufacturer’s processes or facilities; or |
· | the FDA may change its approval policies or adopt new regulations. |
The use of immortalized hepatocytes for drug discovery purposes does not require FDA approval.
The Sybiol® synthetic bio-liver device will be classified as a "biologic" regulated under the Public Health Service Act and the Food, Drug and Cosmetic Act. The use of human immortalized liver cells for this application will also be regulated by the FDA. We have not yet begun the regulatory approval process for our Sybiol® biosynthetic liver device with the FDA. We may, when adequate funding and resources are available, begin the approval process. If we are able to validate the device design, then we currently plan to find a partner to take the project forward. Before human studies may begin, the cells provided for the system will be subjected to the same scrutiny as the Sybiol device. We will need to demonstrate sufficient process controls to meet strict standards for a complex medical system. This means the cell production facility will need to meet the same Good Manufacturing Practice ("GMP") standards as those pertaining to a pharmaceutical company.
If we receive regulatory approval, we will also be subject to ongoing FDA obligations and continued regulatory review, such as continued safety reporting requirements, and we may also be subject to additional FDA post-marketing obligations, all of which may result in significant expense and limit our ability to commercialize our potential drugs.
Any regulatory approvals that we or our partners receive for our drug candidates may also be subject to limitations on the indicated uses for which the drug may be marketed or contain requirements for potentially costly post-marketing follow-up studies. In addition, if the FDA approves any of our drug candidates, the labeling, packaging, adverse event reporting, storage, advertising, promotion and record-keeping for the drug will be subject to extensive regulatory requirements. The subsequent discovery of previously unknown problems with the drug, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the drug, and could include withdrawal of the drug from the market.
The FDA’s policies may change and additional government regulations may be enacted that could prevent or delay regulatory approval of our drug candidates. We cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are not able to maintain regulatory compliance, we might not be permitted to market our drugs and our business could suffer.
If physicians and patients do not accept our drugs, we may be unable to generate significant revenue, if any.
Even if our drug candidates obtain regulatory approval, resulting drugs, if any, may not gain market acceptance among physicians, healthcare payors, patients and the medical community. Even if the clinical safety and efficacy of drugs developed from our drug candidates are established for purposes of approval, physicians may elect not to recommend these drugs for a variety of reasons including, but not limited to:
· | timing of market introduction of competitive drugs; | |
· | clinical safety and efficacy of alternative drugs or treatments; | |
· | cost-effectiveness; | |
· | availability of reimbursement from health maintenance organizations and other third-party payors; | |
· | convenience and ease of administration; | |
· | prevalence and severity of adverse side effects; | |
· | other potential disadvantages relative to alternative treatment methods; and |
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· | insufficient marketing and distribution support. |
If our drugs fail to achieve market acceptance, we may not be able to generate significant revenue and our business would suffer.
The coverage and reimbursement status of newly approved drugs is uncertain and failure to obtain adequate coverage and reimbursement could limit our ability to market any drugs we may develop and decrease our ability to generate revenue.
There is significant uncertainty related to the coverage and reimbursement of newly approved drugs. The commercial success of our potential drugs in both domestic and international markets is substantially dependent on whether third-party coverage and reimbursement is available for the ordering of our potential drugs by the medical profession for use by their patients. Medicare, Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs, and, as a result, they may not cover or provide adequate payment for our potential drugs. They may not view our potential drugs as cost-effective and reimbursement may not be available to consumers or may not be sufficient to allow our potential drugs to be marketed on a competitive basis. Likewise, legislative or regulatory efforts to control or reduce healthcare costs or reform government healthcare programs could result in lower prices or rejection of coverage for our potential drugs. Changes in coverage and reimbursement policies or healthcare cost containment initiatives that limit or restrict reimbursement for our drugs may cause our revenue to decline.
We may be subject to costly product liability claims and may not be able to obtain adequate insurance.
If we conduct clinical trials in humans, we face the risk that the use of our drug candidates will result in adverse effects. We cannot predict the possible harms or side effects that may result from our clinical trials. We may not have sufficient resources to pay for any liabilities resulting from a claim excluded from, or beyond the limit of, our insurance coverage.
In addition, once we have commercially launched drugs based on our drug candidates, we will face exposure to product liability claims. This risk exists even with respect to those drugs that are approved for commercial sale by the FDA and manufactured in facilities licensed and regulated by the FDA. We intend to secure limited product liability insurance coverage, but may not be able to obtain such insurance on acceptable terms with adequate coverage, or at reasonable costs. There is also a risk that third parties that we have agreed to indemnify could incur liability. Even if we were ultimately successful in product liability litigation, the litigation would consume substantial amounts of our financial and managerial resources and may create adverse publicity, all of which would impair our ability to generate sales of the affected product as well as our other potential drugs. Moreover, product recalls may be issued at our discretion or at the direction of the FDA, other governmental agencies or other companies having regulatory control for drug sales. If product recalls occur, such recalls are generally expensive and often have an adverse effect on the image of the drugs being recalled as well as the reputation of the drug’s developer or manufacturer.
We may be subject to damages resulting from claims that our employees or we have wrongfully used or disclosed alleged trade secrets of their former employers.
Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no such claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could hamper or prevent our ability to commercialize certain potential drugs, which could severely harm our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
We use hazardous chemicals and radioactive and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.
Our research and development processes involve the controlled use of hazardous materials, including chemicals and radioactive and biological materials. Our operations produce hazardous waste products. We cannot eliminate the risk of accidental contamination or discharge and any resultant injury from those materials. Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal of hazardous materials. We may be sued for any injury or contamination that results from our use or the use by third parties of these materials. Compliance with environmental laws and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts.
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In addition, our partners may use hazardous materials in connection with our strategic alliances. To our knowledge, their work is performed in accordance with applicable biosafety regulations. In the event of a lawsuit or investigation, however, we could be held responsible for any injury caused to persons or property by exposure to, or release of, these hazardous materials used by these parties. Further, we may be required to indemnify our partners against all damages and other liabilities arising out of our development activities or drugs produced in connection with these strategic alliances.
Risks Related To Our Common Stock
We expect that our stock price will fluctuate significantly, and you may not be able to resell your shares at or above your investment price.
The market price of our common stock, as well as the market prices of securities of companies in the life sciences and biotechnology sectors generally, have been highly volatile and are likely to continue to be highly volatile. While the reasons for the volatility of the market price of our common stock and its trading volume are sometimes unknown, in general the market price of our common stock may be significantly impacted by many factors, including, but not limited to:
· | results from, and any delays in, the clinical trials programs for our products and drug candidates; |
· | delays in or discontinuation of the development of any of our products and drug candidates; |
· | failure or delays in entering additional drug candidates into clinical trials; |
· | failure or discontinuation of any of our research programs; |
· | delays or other developments in establishing new strategic alliances; |
· | announcements concerning our existing or future strategic alliances; |
· | issuance of new or changed securities analysts’ reports or recommendations; |
· | market conditions in the pharmaceutical and biotechnology sectors; |
· | actual or anticipated fluctuations in our quarterly financial and operating results; |
· | the exercise of outstanding options and warrants, the conversion of outstanding convertible preferred stock and debt and the issuance of additional options, warrants, preferred stock and convertible debt; |
· | developments or disputes concerning our intellectual property or other proprietary rights; | |
· | introduction of technological innovations or new commercial products by us or our competitors; | |
· | Issues in manufacturing our drug candidates or drugs; | |
· | market acceptance of our products and drugs; | |
· | third-party healthcare reimbursement policies; | |
· | FDA or other United States or foreign regulatory actions affecting us or our industry; | |
· | litigation or public concern about the safety of our products, drug candidates or drugs; | |
· | additions or departures of key personnel; and | |
· | volatility in the stock prices of other companies in our industry. |
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These and other external factors may cause the market price and demand for our common stock to fluctuate substantially, which may limit or prevent investors from readily selling their shares of common stock and may otherwise negatively affect the liquidity of our common stock. In addition, when the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock. If any of our stockholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit. Such a lawsuit could also divert the time and attention of our management.
Our common stock is subject to penny stock regulation, which may affect its liquidity.
Our common stock is subject to regulations of the Securities and Exchange Commission (the "Commission") relating to the market for penny stocks. Penny stock, as defined by the Penny Stock Reform Act, is any equity security not traded on a national securities exchange or quoted on the NASDAQ National Market or SmallCap Market that has a market price of less than $5.00 per share. The penny stock regulations generally require that a disclosure schedule explaining the penny stock market and the risks associated therewith be delivered to purchasers of penny stocks and impose various sales practice requirements on broker-dealers who sell penny stocks to persons other than established customers and accredited investors. The broker-dealer must make a suitability determination for each purchaser and receive the purchaser's written agreement prior to the sale. In addition, the broker-dealer must make certain mandated disclosures, including the actual sale or purchase price and actual bid offer quotations, as well as the compensation to be received by the broker-dealer and certain associated persons. The regulations applicable to penny stocks may severely affect the market liquidity for our common stock and could limit your ability to sell your securities in the secondary market.
It is anticipated that dividends will not be paid in the foreseeable future.
The Company does not intend to pay dividends on its common stock in the foreseeable future. There can be no assurance that the operation of the Company will result in sufficient revenues to enable the Company to operate at profitable levels or to generate positive cash flows. Further, dividend policy is subject to the discretion of the Company's Board of Directors and will depend on, among other things, the Company's earnings, financial condition, capital requirements and other factors.
Our common stock is thinly traded and there may not be an active, liquid trading market for our common stock.
There is no guarantee that an active trading market for our common stock will be maintained on the OTCBB or that the volume of trading will be sufficient to allow for timely trades. Investors may not be able to sell their shares quickly or at the latest market price if trading in our stock is not active or if trading volume is limited. In addition, if trading volume in our common stock is limited, trades of relatively small numbers of shares may have a disproportionate effect on the market price of our common stock.
We have convertible securities outstanding that can be converted into more shares of common stock then we have currently authorized.
We have warrants to purchase common stock, stock options, convertible debentures and convertible preferred stock outstanding that if converted and/or exercised, according to their terms can result in the requirement that we issue more shares than we have currently authorized under our Certificate of Incorporation. This could result in our default under such agreements and may force us to amend the Certificate of Incorporation to authorize more shares or seek other remedies. While we intend to redeem and remove certain agreements in order to reduce the number of convertible securities outstanding, there is no guarantee that we will be successful.
Item 2. DESCRIPTION OF PROPERTY
On March 26, 2008, the Company negotiated a lease agreement at 68 Cumberland Street, Suite 301, Woonsocket RI 02895. The lease is a one year lease commencing on May 1, 2008 through April 30, 2009. The Company agreed to pay $900 per month. The Company expects to renew the lease when it expires on April 30, 2009.
Item 3. LEGAL PROCEEDINGS
On May 14, 2008, one of our stockholders, George Colin, filed a lawsuit against the Company and W. Gerald Newmin in the Superior Court of California – City of Orange, alleging causes of action for breach of written contract and intentional misrepresentation. The plaintiff seeks general damages to be determined at trial, special and consequential damages according to proof, fees and costs, plus interest. The Company and Mr. Newmin believe this claim is without merit and both parties intend to vigorously defend the action.
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Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of security holders during the fourth quarter of the fiscal year covered by this report.
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PART II
Item 5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS, AND SMALL BUSINESS ISSUER PURCHASES OF EQUITY SECURITIES
Our common stock is traded on the OTC Bulletin Board under the symbol MCET.OB. Our stock is considered a penny stock and is, therefore, subject to the Securities Enforcement Remedies and Penny Stock Reform Act of 1990. Penny stock is defined as any equity security not traded on a national stock exchange or quoted on NASDAQ and that has a market price of less than $5.00 per share. Additional disclosure is required in connection with any trades involving a stock defined as a penny stock (subject to certain exceptions); including the delivery, prior to any such transaction, of a disclosure schedule explaining the penny stock market and the associated risks. Broker-dealers who recommend such low-priced securities to persons other than established customers and accredited investors are required to satisfy special sales practice requirements, including a requirement that they make an individualized written suitability determination for the purchase and receive the purchaser's written consent prior to the transaction.
The table below gives the range of high and low closing prices of our common stock for the fiscal years ended November 30, 2008 and November 30, 2007 based on information provided by the OTC Bulletin Board.
Fiscal Year Ended November 30, 2008
High | Low | |||||||
First quarter | $ | .050 | $ | .025 | ||||
Second quarter | $ | .027 | $ | .006 | ||||
Third quarter | $ | .011 | $ | .004 | ||||
Fourth quarter | $ | .020 | $ | .002 |
Fiscal Year Ended November 30, 2007
High | Low | |||||||
First quarter | $ | .270 | $ | .190 | ||||
Second quarter | $ | .210 | $ | .070 | ||||
Third quarter | $ | .090 | $ | .040 | ||||
Fourth quarter | $ | .130 | $ | .033 |
No cash dividends have been paid on our common stock for the 2008 and 2007 fiscal years and no change of this policy is under consideration by the Board of Directors.
The payment of cash dividends in the future will be determined by the Board of Directors in light of conditions then existing, including our Company's earnings, financial requirements, and opportunities for reinvesting earnings, business conditions, and other factors. There are otherwise no restrictions on the payment of dividends. The number of shareholders of record of our Company's Common Stock on March 5, 2009 was approximately 1,039.
We did not repurchase any of our shares during the fourth quarter of the fiscal year covered by this report.
Item 6. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
The Management’s Discussion and Analysis for the years ended November 30, 2008 and 2007 is presented below.
Overview
Following the formation of MCTI during September 2005 and the recent in-licensing of drug candidates, the Company is pursuing research and development of therapeutics. Historically, the Company has specialized in developing primary liver cell immortalization technologies to produce cell-based assay systems for use in drug discovery. The Company seeks to become an integrated biopharmaceutical company that will use its immune system modulation technologies to discover, develop and commercialize new therapeutics itself and with strategic partners.
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On October 9, 2007, MultiCell executed an exclusive license and purchase agreement (the “Agreement”) with Corning Incorporated (“Corning”) of Corning, New York. Under the terms of the Agreement, Corning has the right to develop, use, manufacture, and sell MultiCell’s Fa2N-4 cell lines and related cell culture media for use as a drug discovery assay tool, including biomarker identification for the development of drug development assay tools, and for the performance of absorption, distribution, metabolism, elimination and toxicity assays (ADME/Tox assays). Corning paid MultiCell a non-refundable license fee, purchased certain inventory and equipment related to MultiCell’s Fa2N-4 cell line business, hired certain MultiCell scientific personnel, and paid for access to MultiCell’s laboratories during the transfer of the Fa2N-4 cell lines to Corning. MultiCell retained and continues to support all of its existing licensees, including Pfizer, Bristol-Myers Squibb, and Eisai. MultiCell retained the right to use the Fa2N-4 cells for use in applications not related to drug discovery or ADME/Tox assays. MultiCell also retained rights to use the Fa2N-4 cell lines and other cell lines to further develop its Sybiol® liver assist device, to produce therapeutic proteins using the Company’s BioFactories™ technology, to identify drug targets and for other applications related to the Company’s internal drug development programs.
In August 2003, MultiCell signed an exclusive sales, manufacturing and distribution agreement for the use of two of its cell lines by XenoTech, an unrelated party. The agreement, which is for a term of seven years, required XenoTech to make an initial non-refundable payment of $800,000 to MultiCell in August 2003. This payment represented consideration for and a guarantee of Nosan’s (XenoTech’s distributor) right of first negotiation for distribution rights for the Asia Pacific Rim, should MultiCell successfully complete the development of its cell lines for the production of proteins, other cellular constituents and or drug-like molecules. Additional consideration under the August 2003 agreement included a $700,000 royalty prepayment. This prepayment was an advance against the minimum royalty payment of $800,000 for the first royalty period, which was 16 months, culminating on November 30, 2004. The subsequent 5 royalty periods will be 12 months and the last royalty period will be 8 months. XenoTech must bear all the costs for its manufacturing and sales activities and make specified minimum periodic royalty payments that total $18 million over the 7 year term of the agreement to maintain distribution exclusivity. The agreement requires XenoTech to make royalty payments to MultiCell of 17.5% of net sales for the direct sale of its cells and 34% of net sales derived from any sublicense agreement. Prior to December 1, 2004, the Company had recognized revenues under the XenoTech agreement based on the minimum royalty amount for each period because it had received a prepayment of a substantial portion of the amount due. XenoTech was required to pay a $2.1 million minimum royalty amount for the current fiscal year as a condition of its exclusivity. Since collection of the contractual amount was no longer reasonably assured and, in accordance with SEC Staff Accounting Bulletin Topic 13, commencing December 1, 2004, the Company began recognizing revenues under the XenoTech agreement based on the agreement’s royalty percentage applied to XenoTech’s actual sales for the period instead of the minimum royalty amount. On February 1, 2006, the Company terminated the agreement with XenoTech due to the failure of XenoTech, with due notice, to cure various breaches within the time allotted by the agreement, including the payment of minimum royalties to maintain exclusivity. As a result of this termination and the Company’s recognition of the initial non-refundable payment of $800,000 over the 7-year term of the agreement, the Company recognized income for the remaining amount of deferred income of $533,334 in fiscal year ended November 30, 2006.
We have operated and will continue to operate by minimizing expenses. Our largest expenses relate to personnel and meeting the legal and reporting requirements of being a public company. By utilizing consultants whenever possible, and asking employees to manage multiple responsibilities, operating costs are kept low. Additionally, a number of employees and our Board of Directors receive Company stock in lieu of cash as all or part of their compensation to help in the effort to minimize monthly cash flow. With our strategic shift in focus on therapeutic programs and technologies, however, we expect our future cash expenditures to increase significantly as we advance our therapeutic programs into clinical trials.
We intend to add scientific and support personnel gradually. We want to add specialists for our key research areas. These strategic additions will help us expand our product offerings leading us to additional revenues and profits. Of course as revenues increase, administrative personnel will be necessary to meet the added workload. Other expenses, such as sales and customer service, will increase commensurate with increased revenues. The Company’s current research and development efforts focus on development of future products and redesign of existing products. Due to the ongoing nature of this research, we are unable to ascertain with certainty the total estimated completion dates and costs associated with this research. As with any research efforts, there is uncertainty and risk associated with whether these efforts will produce results in a timely manner so as to enhance the Company’s market position. Company sponsored research and development costs related to future products and redesign of present products are expensed as incurred. For the years ended November 30, 2008 and 2007, research and development costs were $317,130 and $757,866, respectively. Research and development costs include such costs as salaries, legal fees, employee benefits, compensation cost for options issued to the Scientific Advisory Board, supplies and license fees.
The Application of Critical Accounting Policies
Use of Estimates - The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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 revenues and expenses during the reporting period. Actual results could differ from those estimates.
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Research and Development - Company sponsored research and development costs related to future products and redesign of present products are expensed as incurred. Such costs are offset partly by proceeds from research grants.
Revenue Recognition – In the years covered by this report on Form 10-KSB, the Company's revenues have been generated primarily from license revenue under agreements with Corning, Pfizer, and Eisai, as well as the sale of cells or royalties on the license for the sale of cells through its sale and distribution agreement with XenoTech, LLC. Management believes such sources of revenue will be part of the Company's ongoing operations. The Company recognizes revenue from licensing and research agreements as services are performed, provided a contractual arrangement exists, the contract price is fixed or determinable and the collection of the contractual amounts is reasonably assured. In situations where the Company receives payment in advance of the performance of services, such amounts are deferred and recognized as revenue as the related services are performed. Deferred revenues associated with services expected to be performed within the 12 - month period subsequent to the balance sheet date are classified as a current liability. Deferred revenues associated with services expected to be performed at a later date are classified as non-current liabilities.
Stock-Based Compensation –We account for stock based compensation under Statement of Financial Accounting Standards 123R (SFAS 123R), which requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values over the period during which an employee is required to provide service in exchange for the award (the vesting period), net of estimated forfeitures. The estimation of fair value of stock options requires management to make estimates for certain assumptions regarding risk-free interest rates, expected life of the options, expected volatility of the price of our common stock, and the expected dividend yield of our common stock.
Long-Lived Assets - Long-lived assets that do not have indefinite lives, such as property and equipment, license agreements, and patents are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Impairment losses are recognized when events or changes in circumstances indicate that the undiscounted cash flows estimated to be generated by such assets are less than their carrying value and, accordingly, all or a portion of such carrying value may not be recoverable. Impairment losses for assets to be held and used are then measured based on the excess, if any, of the carrying amounts of the assets over their fair values. Long-lived assets to be disposed of in a manner that meets certain criteria are stated at the lower of their carrying amounts or fair values less costs to sell and are no longer depreciated.
Recent Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board (FASB) issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS 157 defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. This statement was originally effective for financial statements issued for fiscal years beginning after November 15, 2007. In February 2008, the FASB issued FASB Staff Position (FSP FIN) No. 157-2 which extended the effective date for certain nonfinancial assets and nonfinancial liabilities to fiscal years beginning after November 15, 2008. We adopted the effective portions of SFAS 157 effective December 1, 2007, which did not have a significant impact on our consolidated financial statements. We are currently evaluating the impact of the remaining portions of SFAS 157 on our financial statements and anticipate that the adoption of those portions of the statement will not have a significant impact on the reporting of our financial position and results of operations.
In March 2007, the FASB issued FASB Staff Position EITF 07-03, Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities (FSP 07-03). FSP 07-03 addresses whether nonrefundable advance payments for goods or services that will be used or rendered for research and development activities should be expensed when the advance payment is made or when the research and development activity has been performed. FSP 07-03 will be effective for fiscal years beginning after December 15, 2007, and interim periods within those fiscal years. We currently believe that the adoption of FSP 07-03 will have no material impact on our financial position or results of operations.
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS 141(R)), which replaces SFAS 141, Business Combinations. SFAS 141(R) retains the underlying concepts of SFAS 141 in that all business combinations are still required to be accounted for at fair value under the acquisition method of accounting, but SFAS 141(R) changed the method of applying the acquisition method in a number of significant aspects. Acquisition costs will generally be expensed as incurred; noncontrolling interests will be valued at fair value at the acquisition date; in-process research and development will be recorded at fair value as an indefinite-lived intangible asset at the acquisition date; restructuring costs associated with a business combination will generally be expensed subsequent to the acquisition date; and changes in deferred tax asset valuation allowances and income tax uncertainties after the acquisition date generally will affect income tax expense. SFAS 141(R) is effective on a prospective basis for all business combinations for which the acquisition date is on or after the beginning of the first annual period subsequent to December 15, 2008, with the exception of the accounting for valuation allowances on deferred taxes and acquired tax contingencies. SFAS 141(R) amends SFAS 109 such that adjustments made to valuation allowances on deferred taxes and acquired tax contingencies associated with acquisitions that closed prior to the effective date of SFAS 141(R) would also apply the provisions of SFAS 141(R). Early adoption is not permitted. We are currently evaluating the effects, if any, that SFAS 141(R) may have on our financial statements. We do not expect that it will have any immediate effect on our financial statements, however, the revised standard will govern the accounting for any future business combinations that we may enter into.
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In December 2007, the FASB issued SFAS No. 160, Non-controlling Interests in Consolidated Financial Statements—an amendment of ARB No. 51 (SFAS 160). This statement is effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2008, with earlier adoption prohibited. This statement requires the recognition of a non-controlling interest (minority interest) as equity in the consolidated financial statements and separate from the parent’s equity. The amount of net income attributable to the non-controlling interest will be included in consolidated net income on the face of the income statement. It also amends certain of ARB No. 51’s consolidation procedures for consistency with the requirements of SFAS 141(R). This statement also includes expanded disclosure requirements regarding the interests of the parent and its non-controlling interest. We are currently evaluating this new statement and anticipate that the statement will not have a significant impact on the reporting of our results of operations.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities - an amendment of FASB Statement No. 133, (SFAS No. 161), which requires companies to provide additional disclosures about its objectives and strategies for using derivative instruments, how the derivative instruments and related hedged items are accounted for under SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, and related interpretations, and how the derivative instruments and related hedged items affect our financial statements. SFAS No. 161 also requires companies to disclose information about credit risk-related contingent features in their hedged positions. SFAS No. 161 is effective for fiscal years and interim periods beginning after November 15, 2008. We do not currently believe adoption will have a material impact on our financial position or operating results.
In May 2008, the FASB issued SFAS 162, The Hierarchy of Generally Accepted Accounting Principles. SFAS No. 162 identifies the sources of accounting principles and provides entities with a framework for selecting the principles used in preparation of financial statements that are presented in conformity with GAAP. The current GAAP hierarchy has been criticized because it is directed to the auditor rather than the entity, it is complex, and it ranks FASB Statements of Financial Accounting Concepts, which are subject to the same level of due process as FASB Statements of Financial Accounting Standards, below industry practices that are widely recognized as generally accepted but that are not subject to due process. The Board believes the GAAP hierarchy should be directed to entities because it is the entity (not its auditors) that is responsible for selecting accounting principles for financial statements that are presented in conformity with GAAP. The adoption of FASB 162 is not expected to have a material impact on our financial statements.
In May 2008, the FASB issued FASB Staff Position No. APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement (FSP APB 14-1) that changes the method of accounting for convertible debt securities that require or permit settlement in cash either in whole or in part upon conversion. FSP APB 14-1 is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. Under FSP APB 14-1, the debt and equity components of convertible debt securities that may be settled in cash upon conversion will be bifurcated and accounted for separately in a manner that will result in recognizing interest expense on these securities at rates reflective of the entity’s borrowing rates for what the entity would have incurred had it issued nonconvertible debt with otherwise similar terms. The equity component of such convertible debt securities will be included in the paid-in-capital section of stockholders’ equity on the consolidated balance sheet and, accordingly, the initial carrying values of these debt securities will be reduced. Net loss for financial reporting purposes will be increased by recognizing the accretion of the reduced carrying value of the convertible debt securities to their face amounts as additional non-cash interest expense. Management is currently evaluating the impact of FSP APB 14-1 on our financial statements, but has not yet determined the effect on the reporting of our consolidated financial position and results of operations.
In June 2008, the FASB ratified EITF Issue No. 07-5, Determining Whether an Instrument (or an Embedded Feature) Is Indexed to an Entity's Own Stock (EITF 07-5). EITF 07-5 provides that an entity should use a two step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument's contingent exercise and settlement provisions. It also clarifies on the impact of foreign currency denominated strike prices and market-based employee stock option valuation instruments on the evaluation. EITF 07-5 is effective for fiscal years beginning after December 15, 2008. Management is currently evaluating the impact of EITF 07-5 on our financial statements, if any, that will occur upon the adoption of EITF 07-5.
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Results of Operations
The following discussion is included to describe our consolidated financial position and results of operations. The consolidated financial statements and notes thereto contain detailed information that should be referred to in conjunction with this discussion.
Year Ended November 30, 2008 compared to Year Ended November 30, 2007
Revenue. Total revenue for the year ended November 30, 2008 was $209,835, as compared to revenue of $251,797 for the same period in the prior fiscal year, a decrease of $41,962. For the year ended November 30, 2008, revenue consisted of license revenue totaling $190,521 under agreements with Corning, Pfizer, Eisai, and Xenotech, plus revenue of $19,314 from sales of cells and related media. For the year ended November 30, 2007, revenue consisted of license revenue totaling $131,664 under agreements with Pfizer, Eisai, Xenotech, and BMS, plus revenue of $120,133 from sales of cells and related media.
Operating Expenses. Total operating expenses for the year ended November 30, 2008 were $2,300,818, as compared to operating expenses of $3,389,894 for the year ended November 30, 2007, representing a decrease of $1,089,076 as compared to the prior fiscal year. This decrease principally represents the net effect of the following changes between 2008 and 2007: 1) the reduction in 2008 of the costs for consulting fees, legal fees, accounting and auditing fees, and other professional fees by approximately $1,150,000; 2) the reduction in 2008 of salaries and wages, including related benefits and payroll taxes, by approximately $480,000; 3) the reduction in 2008 of the costs of occupancy in the approximate amount of $190,000; 4) the write-off in 2007 of certain license fees in the amount of $300,000 that had been capitalized in 2006 (none in 2008); and 5) the write-down of intangible assets due to impairment in value in 2008 in the approximate amount of $1,060,000. The Company has reviewed its patent portfolio strategy related to its Toll-like receptor 3 (TLR3) technology acquired in September 2005 when MultiCell acquired the assets of Astral, Inc. This intellectual property is the subject of three patent applications, and is related to the Company's lead drug candidate MCT-465. The Company may decide to cease further prosecution of the subject patent applications and terminate its development work related to MCT-465. Accordingly, the Company has written down the value of the patent applications directly related to MCT-465 presently carried on its balance sheet at November 30, 2008.
Other income/(expense).The total of other expense, net of other income, decreased from $34,541 for the year ended November 30, 2007 to $3,953 for the year ended November 30, 2008, representing a decrease of $30,588. The principal cause of the decrease is the reduction of interest expense and related amortization of discount for the 7.75% convertible debentures, which were issued early in 2007, then paid off or converted into common stock by February 2008.
Net Loss. Net loss for the year ended November 30, 2008 was $2,094,936, as compared to a net loss of $3,172,638 for the year ended November 30, 2007, representing a decrease in the net loss of $1,077,702 (34%). The primary reasons for the decrease are the reductions in operating expenses as described above, net of the effects of the write-down of intangible assets due to impairment in value.
Preferred stock dividends. In connection with the issuance of the Series B preferred stock and warrants, commencing on the date of issuance of the Series B preferred stock until the date a registration statement registering the common shares underlying the preferred stock and warrants issued is declared effective by the SEC, the Company will pay on each outstanding share of Series B preferred stock a preferential cumulative dividend at an annual rate equal to the product of multiplying (A) $100 per share by the higher of the Wall Street Journal Prime Rate plus one percent (1%), or nine percent (9%). In no event will the dividend rate be greater than 12% per annum. The dividend shall be payable monthly in arrears in cash on the last day of each month based on the number of shares of Series B preferred stock outstanding as of the first (1st) day of such month. In the event the Company does not pay the Series B preferred dividends when due, the conversion price of the Series B preferred shares will be reduced to eighty-five percent (85%) of the otherwise applicable conversion price. For the years ended November 30, 2008 and 2007, the Company paid and/or accrued preferred dividends in the amount of $149,203 and $151,548, respectively.
Liquidity and Capital Resources
Since our inception, we have financed our operations primarily through the issuance of debt or equity instruments. The following is a summary of our key liquidity measures at November 30, 2008 and November 30, 2007:
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November 30, 2008 | November 30, 2007 | |||||||
Cash and cash equivalents | $ | 6,022 | $ | 411,691 | ||||
Current assets | $ | 38,876 | $ | 502,704 | ||||
Current liabilities | (1,768,689 | ) | (1,724,869 | ) | ||||
Working capital deficiency | $ | (1,729,813 | ) | $ | (1,222,165 | ) | ||
The Company will have to raise additional capital in order to initiate Phase IIb clinical trials for MCT-125, the Company’s therapeutic product for the treatment of fatigue in multiple sclerosis patients. Management is evaluating several sources of financing for its clinical trial program. Additionally, with our strategic shift in focus to therapeutic programs and technologies, we expect our future cash requirements to increase significantly as we advance our therapeutic programs into clinical trials. Until we are successful in raising additional funds, we may have to prioritize our therapeutic programs and delays may be necessary in some of our development programs.
During the past fiscal year (and into the current fiscal year), the Company has operated on working capital provided by LJCI in connection with its exercise of warrants issued to it by the Company (which LJCI must exercise whenever it wants to convert amounts owning under the convertible debenture it holds), all as discussed in more detail below. The warrants are exercisable at $1.09 per share. As of March 9, 2009 there were 9,683,500 shares remaining on the stock purchase warrant. Should LJCI continue to exercise all of its remaining warrants approximately $10.6 million of cash would be provided to the Company. However, the Debenture Purchase Agreement (discussed below) limits LJCI’s stock ownership in the Company to 9.99% of the outstanding shares of the Company and therefore, based on the number of shares outstanding as of March 9, 2009. The Company expects that LJCI will continue to exercise the warrants and convert the debenture over the next year, but cannot assure that LJCI will do so. We are investigating the possible sale or license of certain assets that we did not already license to Corning in October 2007. We are presently pursuing discussions with companies operating in the stem cell research market and the general life science research market.
On May 3, 2006, MultiCell entered into a common stock purchase agreement with Fusion Capital, which was amended and restated on October 5, 2006, and ultimately terminated on July 18, 2007. Under the agreement, Fusion Capital was obligated, under certain conditions, to purchase shares from the Company up to an aggregate amount of $8 million from time to time over a 25-month period. MultiCell authorized 8,000,000 shares of its common stock for sale to Fusion Capital under the agreement. For the year ended November 30, 2007 the Company received $450,000 from Fusion Capital of which 25% of the gross proceeds were payable to Series B preferred shareholders. During the year ended November 30, 2007, the Company redeemed 615 shares of Series B preferred stock by paying $61,500.
As consideration for entering into the original transaction on May 3, 2006, MultiCell issued to Fusion Capital 1,572,327 shares of its common stock and warrants to purchase an additional 1,572,327 shares of its common stock at a price of $0.01 per share. Upon execution of the amended and restated purchase agreement on October 5, 2006, Fusion Capital retained the original 1,572,327 shares of common stock and returned the warrant to the Company.
On July 14, 2006, the Company completed a private placement of Series B convertible preferred stock. A total of 17,000 Series B shares were sold to accredited investors at a price of $100 per share. The Series B shares are convertible at any time into common stock at a conversion price determined by dividing the purchase price per share of $100 by $0.32 per share (the “Conversion Price”). The Conversion Price is subject to equitable adjustment in the event of any stock splits, stock dividends, recapitalizations and the like. In addition, the Conversion Price is subject to weighted average anti-dilution adjustments in the event the Company sells common stock or other securities convertible into or exercisable for common stock at a per share price, exercise price or conversion price lower than the Conversion Price then in effect in any transaction (other than in connection with an acquisition of the securities, assets or business of another company, joint venture and employee stock options). The conversion of the Series B preferred stock is limited for each investor to 9.99% of the Company’s common stock outstanding on the date of conversion. The Series B preferred stock does not have voting rights. Commencing on the date of issuance of the Series B preferred stock until the date a registration statement registering the common shares underlying the preferred stock and warrants issued was declared effective by the SEC, the Company paid on each outstanding share of Series B preferred stock a preferential cumulative dividend at an annual rate equal to the product of multiplying $100 per share by the higher of (a) the Wall Street Journal Prime Rate plus 1%, or (b) 9%. In no event will the dividend rate be greater than 12% per annum. During the fiscal year ended November 30, 2007 the Company paid $73,800 and redeemed 738 shares of the Series B preferred stock. The dividend will be payable monthly in arrears in cash on the last day of each month based on the number of shares of Series B Preferred Stock outstanding as of the first day of that month. In the event the Company does not pay the Series B preferred dividends when due, the conversion price of the Series B preferred shares will be reduced to 85% of the otherwise applicable conversion price.
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Until the earlier of (a) two years after the closing date or (b) the date upon which all of the Series B Shares have been converted into common stock, the purchasers had a right of first refusal on any financing in which the Company is the issuer of debt or equity securities. If (a) the Company raised debt or equity financing during the right of first refusal period, (b) the Company’s common stock is trading below the conversion price of the Series B Shares at the time of such financing, and (c) the purchasers did not exercise their right of first refusal, then the Company, at the option of any purchaser, could use 25% of the net proceeds from such financing to redeem such purchasers’ shares of Series B preferred stock or common stock, as determined by such purchaser. The redemption price would be determined in the same manner as any redemption set forth in the preceding paragraph. In addition, if an event of default (as defined in the agreement) occurs, the conversion price of the Series B Shares (as set forth below) shall be reduced to 85% of the then applicable conversion price of such shares.
In addition, the purchasers also received warrants to acquire up to 10,500,000 shares of the Company’s common stock. In the event of any dissolution or winding up of the Company, whether voluntary or involuntary, holders of each outstanding share of Series B preferred stock shall be entitled to be paid second in priority to the Series I preferred stockholders out of the assets of the Company available for distribution to stockholders, an amount equal to $100 per share of Series B preferred stock held plus any declared but unpaid dividends. After such payment has been made in full, such holders of Series B preferred stock shall be entitled to no further participation in the distribution of the assets of the Company.
On February 28, 2007, we entered into a Debenture Purchase Agreement with La Jolla Capital Investors (the “Debenture Purchase Agreement”) pursuant to which we sold a convertible debenture to LJCI in a principal amount of $1,000,000 (receivable in four payments) with an annual interest rate of 7.75% and maturing on February 28, 2008 (the “Initial Debenture”). The first payment of $250,000 was received by us on March 7, 2007. We also entered into a Securities Purchase Agreement with LJCI on February 28, 2007 (the “Securities Purchase Agreement”) pursuant to which we agreed to sell a convertible debenture in a principal amount of $100,000 with an annual interest rate of 4.75% and expiring on February 28, 2012 (the “Second Debenture”, and together with the Initial Debenture, the “Debentures”). In addition, we issued to LJCI a warrant to purchase up to 10 million shares of our common stock (the “LJCI Warrant”) at an exercise price of $1.09 per share, exercisable over the next five years according to a schedule described in a letter agreement dated February 28, 2007.
The Debentures are convertible at the option of LJCI at any time up to maturity at a conversion price equal to the lesser of the fixed conversion price of $1.00, or 80% of the average of the lowest three daily volume weighted average trading prices per share of our common stock during the twenty trading days immediately preceding the conversion date. The Initial Debenture accrued interest at 7.75% per year prior to being settled in full, as discussed below. The Second Debenture accrues interest at 4.75% per year payable in cash or our common stock. Through November 30, 2008, interest is being paid in cash on a monthly basis. If paid in stock, the stock will be valued at the rate equal to the conversion price of the Debentures in effect at the time of payment. For the Initial Debenture, if the holder elects to convert a portion of the debentures and, on the day that the election is made the volume weighted average price is below $0.16, the Company shall have the right to repay that portion of the debenture that holder elected to convert, plus any accrued and unpaid interest, at 150% of each amount. In the event that the Company elects to repay that portion of the debenture, holder shall have the right to withdraw its conversion notice.
For the Second Debenture, upon receipt of a conversion notice from the holder, the Company may elect to immediately redeem that portion of the debenture that holder elected to convert in such conversion notice, plus accrued and unpaid interest. After February 28, 2008, the Company, at its sole discretion, shall have the right, without limitation or penalty, to redeem the outstanding principal amount of this debenture not yet converted by holder into Common Stock, plus accrued and unpaid interest thereon.
The Debentures required the Company to register the shares of common stock into which the Debentures could be converted by the holder with the SEC. The Company was unable to obtain SEC approval to register the subject shares, and consequently, the Company and LJCI agreed to terminate the Debenture Purchase Agreement and to allow LJCI to sell the common shares pledged as collateral under the Debenture Purchase Agreement. As of November 30, 2007, LJCI had sold all of the common shares pledged as collateral and received $202,081 in gross proceeds. Consequently, a balance of $47,919 remained outstanding and owed to LJCI as a result of the Company’s initial draw-down of $250,000 under the terms of the Debenture Purchase Agreement. During the year ended November 30, 2008, LJCI converted the remaining $47,919 balance into 4,710,250 shares of the Company’s common stock subject to the terms set forth in the Debenture Purchase Agreement.
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Cash provided by (used in) operating, investing and financing activities for the years ended November 30, 2008 and November 30, 2007 is as follows:
November 30, 2008 | November 30, 2007 | |||||||
Operating activities | $ | (570,607 | ) | $ | (420,896 | ) | ||
Investing activities | 20,013 | 29,485 | ||||||
Financing activities | 144,925 | 725,491 | ||||||
Net increase (decrease) in cash and cash equivalents | $ | (405,669 | ) | $ | 334,080 |
Operating Activities
For the year ended November 30, 2008, the most significant differences between our net loss and our net cash used in operating activities are due to non-cash charges included in our net loss for the write-down of intangible assets due to impairment in value in the amount of $1,061,365, services that are paid through the issuance of common stock or stock options in the amount of $106,198, and for depreciation and amortization in the aggregate amount of $80,255, plus changes in working capital, which included an increase in accounts payable and accrued liabilities of $233,881. For the year ended November 30, 2007, the most significant differences between our net loss and our net cash used in operating activities are due to non-cash charges included in our net loss for services that are paid through the issuance of common stock and stock options in the amount of $1,386,845 and for depreciation and amortization in the aggregate amount of $113,815, plus changes in working capital, which included an increase in accounts payable and accrued liabilities of $452,175 and an increase in deferred income of $758,610.
Investing Activities
Net cash provided by investing activities in 2008 was related to the sale of property and equipment for cash and collections of principal on a note receivable. Net cash provided by investing activities in 2007 was related to the sale of property and equipment for cash.
Financing Activities
During the year ended November 30, 2008, LJCI converted $825 of the 4.75% Convertible Debenture into common stock and exercised warrants to purchase 82,500 shares of common stock at a price of $1.09 per share. Additionally, we issued short-term notes payable to two related parties in exchange for $55,000. In addition, the remaining balance of $47,919 of the 7.75% Convertible Debenture was converted into common stock during the year ended November 30, 2008. For the year ended November 30, 2007, cash provided by financing activities primarily related to the issuance of common stock to Fusion Capital for $450,000 and issuance of debentures to LJCI for $350,000, less $61,500 paid to redeem Series B preferred stock.
Through November 30, 2008, a significant portion of our financing has been provided through private placements of preferred and common stock, the exercise of stock options and warrants and issuance of convertible debentures. We have in the past increased, and if funding permits plan to increase further, our operating expenses in order to fund higher levels of product development, undertake and complete the regulatory approval process, and increase our administrative resources in anticipation of future growth. In addition, acquisitions such as MCTI increase operating expenses and therefore negatively impact, in the short term, the liquidity position of the Company.
During the past year the Company has operated on working capital provided by LJCI. Under terms of the agreement LJCI can convert a portion of the convertible debenture by simultaneously exercising a warrant at $1.09 per share. As of March 9, 2009 there are 9,683,500 shares remaining on the stock purchase warrant and a balance of $96,835 remaining on the convertible debenture. Should LJCI continue to exercise all of its remaining warrants approximately $10.6 million of cash would be provided to the Company. The agreement limits LJCI’s investment to an aggregate ownership that does not exceed 9.99% of the outstanding shares of the Company. The Company expects that LJCI will continue to exercise the warrants and convert the debenture over the next year. We anticipate that our future cash requirements may be fulfilled by potential direct product sales, the sale of additional equity securities, debt financing and/or the sale or licensing of our technologies. We also anticipate the need for additional financing in the future in order to fund continued research and development and to respond to competitive pressures. We cannot guarantee, however, that enough future funds will be generated from operations or from the aforementioned or other potential sources. If adequate funds are not available or are not available on acceptable terms, we may be unable to fund expansion, develop new or enhance existing products and services or respond to competitive pressures, any of which could have a material adverse effect on our business, results of operations and financial condition.
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Item 7. FINANCIAL STATEMENTS
The full text of the Company's audited consolidated financial statements for the fiscal years ended November 30, 2008 and 2007 begins on page F-1 of this Annual Report.
Item 8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
On January 15, 2008, MultiCell dismissed J.H. Cohn LLP ("Cohn") as MultiCell's independent registered public accounting firm. The decision to dismiss Cohn was approved by the Audit Committee of the Board of Directors of MultiCell. The reports of Cohn on the financial statements of MultiCell for the years ended November 30, 2006 and 2005 contained no adverse opinion or disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principle, but did include explanatory paragraphs for the effects of a restatement of the financial statements for the year ended November 30, 2004, the adoption of Statement of Financial Accounting Standards No. 123(R), "Share-Based Payment" in 2006, and the Company's ability to continue as a going concern.
During the years ended November 30, 2006 and 2005 and through January 15, 2008, there have been no disagreements with Cohn on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of Cohn, would have caused Cohn to make reference thereto in its reports on the financial statements of MultiCell for such years. As previously reported in MultiCell's Annual Report on Form 10-KSB filed on March 3, 2006, MultiCell and Cohn identified errors in connection with the Company’s accounting for stock options and warrants issued to consultants and scientific advisory board members during fiscal years 2004 and 2005, which led to the conclusion that MultiCell did not maintain effective internal controls over accounting for stock options and warrants as of November 30, 2005. As reported in MultiCell's Annual Report on Form 10-KSB filed on March 15, 2007, Cohn noted several deficiencies related to the presentation of the basic financial statements and the accompanying notes to the financial statements and proposed certain entries that should have been recorded as part of the normal closing process. MultiCell's internal control over financial reporting did not detect such matters and, therefore, was determined to be not effective in detecting misstatements and disclosure deficiencies as of November 30, 2006.
MultiCell furnished a copy of the above disclosures to Cohn and requested that Cohn furnish MultiCell with a letter addressed to the Securities and Exchange Commission stating whether or not it agreed with the above disclosures. A copy of Cohn’s letter was attached as Exhibit 16.1 to the report on Form 8-K. On January 15, 2008, MultiCell engaged Hansen, Barnett and Maxwell, P.C. ("Hansen") as its new independent registered public accounting firm to audit MultiCell’s financial statements for the year ending November 30, 2007 and to review the financial statements to be included in MultiCell's quarterly report on Form 10-QSB for the quarters ending February 29, 2008, May 31, 2008 and August 31, 2008. Prior to the engagement of Hansen, neither MultiCell nor anyone on behalf of MultiCell consulted with Hansen during MultiCell's two most recent fiscal years and through January 15, 2008 in any manner regarding either: (A) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on MultiCell's financial statements; or (B) any matter that was the subject of either a disagreement or a reportable event (as defined in Item 304(a)(1)(iv) of Regulation S-B).
Item 8A(T). CONTROLS AND PROCEDURES
DISCLOSURE CONTROLS AND PROCEDURES
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed by us in reports we file or submit under the Exchange Act 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 principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable assurance of achieving the desired control objectives, and we necessarily are required to apply our judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures.
Our management, including our principal executive officer and principal financial officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of November 30, 2008 and concluded that the disclosure controls and procedures were not effective, because certain deficiencies involving internal controls constituted material weaknesses as discussed below. The material weaknesses identified did not result in the restatement of any previously reported financial statements or any other related financial disclosure, nor does management believe that it had any effect on the accuracy of the Company’s financial statements for the current reporting period.
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MANAGEMENT’S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our internal control system was designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes, in accordance with generally accepted accounting principles. Because of inherent limitations, a system of 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 due to change in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management, including our principal executive officer and principal accounting officer, conducted an evaluation of the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control—Integrated Framework. Based on its evaluation, our management concluded that there is a material weakness in our internal control over financial reporting. A material weakness is a deficiency, or a combination of control deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis. As of November 30, 2008, the following material weaknesses existed:
1. | Entity-Level Controls: We did not maintain effective entity-level controls as defined by the framework issued by COSO. Specifically, we did not effectively segregate certain accounting duties due to the small size of our accounting staff, and maintain a sufficient number of adequately trained personnel necessary to anticipate and identify risks critical to financial reporting. |
2. | Information Technology: We did not maintain effective controls over the segregation of duties and access to financial reporting systems. Specifically, key financial reporting systems were not appropriately configured to ensure that certain transactions were properly processed with segregated duties among personnel and to ensure that unauthorized individuals did not have access to add or change key financial data. |
In order to mitigate these material weaknesses to the fullest extent possible, all financial reports are reviewed by the Chief Financial Officer, who has limited system access. In addition, regular meetings are held with the Board of Directors and the Audit Committee. If at any time we determine a new control can be implemented to mitigate these risks at a reasonable cost, it is implemented as soon as possible.
This annual report does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to temporary rules of the SEC that permit the Company to provide only management’s report in this annual report.
This report shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section, and is not incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING
There were no changes in our internal control over financial reporting that occurred during the quarter ended November 30, 2008 that have materially affected, or are reasonable likely to materially affect, our internal control over financial reporting.
Item 8B. OTHER INFORMATION
None.
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PART III
ITEM 9. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS, CONTROL PERSONS AND CORPORATE GOVERNANCE; COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE ACT
The Directors and Executive Officers of the Company |
Our executive officers, key employees and directors are listed in the below table. There are no family relationships among any of our executive officers, key employees and directors.
Name | Age | Position | Director since the below date (1) | |||
W. Gerald Newmin | 71 | Chairman, Acting Chief Executive Officer, Chief Financial Officer, Secretary and Director | December 1, 1995(3) | |||
Stephen Chang | 52 | Director | June 16, 2004(2) | |||
Edward Sigmond | 47 | Director | May 17, 2000 | |||
Thomas A. Page | 74 | Director | September 11, 2003 | |||
Anthony E. Altig | 50 | Director | September 15, 2005 | |||
(1) | Each director serves until the next annual meeting of stockholders. | ||||||
(2) | Resigned as President and Chief Executive Officer on December 21, 2007. | ||||||
(3) | Elected as Acting Chief Executive Officer on December 21, 2007. |
W. Gerald “Jerry” Newmin joined the Company in June 1995. He currently serves as the Chairman, Chief Executive Officer, President, Chief Financial Officer and Secretary. Mr. Newmin served as Chief Executive Officer of the Company from June 1995 to May 2006, and was appointed to serve again as Chief Executive Officer on December 21, 2007. Mr. Newmin is Chairman, Chief Executive Officer, Secretary and a director of Xenogenics, a partially-owned subsidiary, Chairman, Chief Executive Officer, Secretary and director of MCT Rhode Island Corp, a wholly-owned subsidiary of the Company and Chief Executive Officer, Secretary and a director of MCTI, a partially-owned subsidiary of the Company. He has managed NYSE and American Stock Exchange Fortune 500 companies. He has been President of HealthAmerica Corporation, then the nation’s largest publicly held HMO management company. He was Chief Executive Officer and President of The International Silver Company, a diversified multi-national manufacturing company that he restructured. He was Chief Operating Officer of numerous Whittaker Corporation operating units, including Production Steel Company, Whittaker Textiles, Bertram Yacht, Trojan Yacht, Columbia Yacht, Narmco Materials and Anson Automotive. He was instrumental in Whittaker’s entry into the US and international health care markets. He was Western Regional Vice President of American Medicorp, Inc, where he managed 23 acute care hospitals in the Western United States. He retired as Chairman and Chief Executive Officer of SYS Technologies, Inc., a high-growth defense technology company in 2003. Mr. Newmin has a Bachelor’s degree in Accounting from Michigan State University.
Stephen Chang, Ph.D. has served as a director of the Company since June 2004, became President of the Company in February 2005, and became Chief Executive Officer in May 2006. Dr. Chang resigned as Chief Executive Officer and President on December 21, 2007. On December 21, 2007, Dr. Chang also resigned as President and CEO of MultiCell Immunotherapeutics, Inc., a subsidiary of the Company. Dr. Chang is presently Chief Scientific Officer of Stemgen, Inc. Dr. Chang is also President of CURES, a coalition of patient advocates, biotechnology companies, pharmaceutical companies and venture capitalists dedicated to ensuring the safety, research and development of innovative life saving medications. Dr. Chang is on the board of BIOCOM, San Diego’s premier life sciences organization. Dr. Chang was chief science officer and vice president of Canji Inc./Schering Plough Research Institute in San Diego from 1998 to 2004. Dr. Chang earned his doctoral degree in Biological Chemistry, Molecular Biology and Biochemistry from the University of California, Irvine. Prior to that he received a bachelor of science in Zoology, Microbiology, and Cell and Molecular Biology from the University of Michigan and a USPHS Postdoctoral Fellowship at the Baylor College of Medicine.
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Edward Sigmond has served as a director of the Company since May 2000. He has been in sales, marketing and operations management for the past 20 years. Mr. Sigmond has served as president of Kestrel Holdings, Inc., a holding company, since its inception in 1997. Mr. Sigmond served as president of Kestrel Development, a Texas based real estate development company, from 1993 to 1998 when it was dissolved. He studied Marketing and Chemistry at Duquesne University.
Thomas A. Page has served as a director of the Company since September 2003. Mr. Page is Director Emeritus and former Chairman of the Board and CEO of Enova Corporation and San Diego Gas and Electric Company (now part of Sempra Energy). Prior to the formation of Sempra Energy Corporation as a holding company in 1996, at various times Mr. Page was SDG&E’s chairman, president and CEO and held one or more of these positions until his retirement in 1998. Mr. Page joined SDG&E in 1978 as executive vice president and COO. In 1981, he was elected president and CEO and added the chairmanship in 1983. Mr. Page has been active in numerous industrial, community and governmental associations and has funded medical research. He is a director of the San Diego Regional Economic Development Corporation, Community National Bank, Sys Technologies and is an advisory director of Sorrento Ventures. Mr. Page earned a Bachelor of Science degree in civil engineering, a masters degree in industrial administration and was awarded a doctorate in management, all from Purdue University. He has been licensed as an engineer and as a certified public accountant (CPA). Mr. Page also serves on the University of California Presidents Council on the National Laboratories.
Anthony E. Altig has served as a director of the Company since September 2005. Mr. Altig serves as the Chair of the Audit Committee of the Company. Mr. Altig has extensive experience in financial management, strategic planning and financial reporting primarily with biotechnology and other technology companies. Since 2004, Mr. Altig has been the Chief Financial Officer of Diversa Corporation a leader in providing proprietary genomic technologies for the rapid discovery and optimization of novel protein based products. From 2002 through 2004 Mr. Altig served as the Chief Financial Officer of Maxim Pharmaceuticals, a public biopharmaceutical company. Prior to joining Maxim, Mr. Altig served as the Chief Financial Officer of NBC Internet, Inc., a leading Internet portal company, which was acquired by General Electric. Mr. Altig’s additional experience includes his role as the Chief Accounting Officer at USWeb Corporation, as well as his experience serving biotechnology and other technology companies during his tenure at both PricewaterhouseCoopers and KPMG. Mr. Altig is a certified public accountant and is a graduate of the University of Hawaii.
CORPORATE GOVERNANCE
General
We believe that good corporate governance is important to ensure that the Company is managed for the long-term benefit of our stockholders. This section describes key corporate governance practices that we have adopted.
Board of Directors Meetings and Attendance
The Board of Directors has responsibility for establishing broad corporate policies and reviewing our overall performance rather than day-to-day operations. The primary responsibility of our Board of Directors is to oversee the management of our company and, in doing so, serve the best interests of the company and our stockholders. The Board of Directors selects, evaluates and provides for the succession of executive officers and, subject to stockholder election, directors. It reviews and approves corporate objectives and strategies, and evaluates significant policies and proposed major commitments of corporate resources. Our Board of Directors also participates in decisions that have a potential major economic impact on our company. Management keeps the directors informed of company activity through regular communication, including written reports and presentations at Board of Directors and committee meetings.
We have no formal policy regarding director attendance at the annual meeting of stockholders. The Board of Directors held ten meetings in 2008, three of which were telephonic. All five board members were present, either by person or on the telephone in the case of the telephonic meetings, at all ten meetings except for Mr. Chang who missed four meetings and Mr. Page who missed three meetings.
Board Committees
Our Board of Directors has established an Audit Committee and a Nominating, Corporate Governance and Compensation Committee. The members of each committee are appointed by our Board of Directors, upon recommendation of the Nominating Committee, and serve one-year terms. Each of these committees operates under a charter that has been approved by the Board of Directors. The charter for each committee is available on our website. The Audit Committee met five times during 2008. The Nominating, Corporate Governance and Compensation Committee met one time during 2008.
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Audit Committee
Audit Committee of the Board of Directors oversees the Company’s corporate accounting and financial reporting process. For this purpose, the Audit Committee performs several functions. The Audit Committee evaluates the performance of and assesses the qualifications of the independent registered public accounting firm; determines and approves the engagement of the independent registered public accounting firm; determines whether to retain or terminate the existing independent registered public accounting firm or to appoint and engage new independent registered public accounting firm; reviews and approves the retention of the independent registered public accounting firm to perform any proposed permissible non-audit services; monitors the rotation of partners of the independent registered public accounting firm on the Company’s audit engagement team as required by law; confers with management and the independent registered public accounting firm regarding the effectiveness of internal controls over financial reporting; establishes procedures, as required under applicable law, for the receipt, retention and treatment of complaints received by the Company regarding accounting, internal accounting controls or auditing matters and the confidential and anonymous submission by employees of concerns regarding questionable accounting or auditing matters; reviews the financial statements to be included in the Company’s Annual Report on Form 10-KSB; and discusses with management and the independent registered public accounting firm the results of the annual audit and the results of the Company’s quarterly financial statements. Three directors comprise the Audit Committee: Anthony Altig (Chairman), Edward Sigmond and Tom Page.
The Board of Directors annually reviews the NASDAQ listing standards definition of independence for Audit Committee members and has determined that all members of the Company’s Audit Committee are independent (as independence is currently defined in Rule 10A-3 of the Exchange Act of 1934). The Board of Directors has determined that Anthony Altig and Thomas A. Page each qualify as “audit committee financial experts”, as defined in applicable SEC rules. The Board made a qualitative assessment of Anthony Altig’s and Thomas A. Page’s level of knowledge and experience based on a number of factors, including their formal education and experience as financial experts and their prior experience as certified public accountants. The Audit Committee met five times during the fiscal year ended November 30, 2008.
Nominating, Corporate Governance and Compensation Committee
The Nominating, Corporate Governance and Compensation Committee provides assistance to the corporate directors in fulfilling their responsibility to the shareholders, potential shareholders, and investment community to ensure that the company's officers, key executives, and board members are compensated in accordance with the company's total compensation objectives and executive compensation policy. The committee advises, recommends, and approves compensation policies, strategies, and pay levels necessary to support organizational objectives. The committee maintains free and open means of communication between the board of directors and the chief executive officer of the corporation.
The Nominating, Corporate Governance and Compensation Committee responsibilities include:
· | Assisting the organization in defining an executive total compensation policy that (1) supports the organization's overall business strategy and objectives, (2) attracts and retains key executives, (3) links total compensation with business objectives and organizational performance in good and bad times, and (4) provides competitive total compensation opportunities at a reasonable cost while enhancing shareholder value creation. |
· | Acts on behalf of the board of directors in setting executive compensation policy, administering compensation plans approved by the board of directors and shareholders, and making decisions or developing recommendations for the board of directors with respect to the compensation of key company executives. |
· | Reviews and recommends to the full board of directors for approval the annual base salary levels, annual incentive opportunity levels, long-term incentive opportunity levels, executive prerequisites, employment agreements (if and when appropriate), change in control provisions/agreements (if and when appropriate), benefits, and supplemental benefits of the chief executive officer. |
· | Evaluates annually chief executive officer and other key executives' compensation levels and payouts against (1) pre-established performance goals and objectives, and (2) an appropriate peer group. |
· | Keeps abreast of current developments in executive compensation outside the company. |
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· | Meets regularly and/or as needed to consider the nomination and screening of board member candidates, evaluate the performance of the board and its members, as well as termination of membership of board members in accordance with corporate policy, conflicts of interest, for cause or other appropriate reasons. |
· | Submits the minutes of all meetings of the Committee to, or discuss the matters discussed at each committee meeting with, the board of directors. |
· | Administers the stock incentive plans. |
The members of the Nominating, Corporate Governance and Committee are Ed Sigmond, Chairman, Tony Altig and Tom Page. The Committee met once during the fiscal year ended November 30, 2008.
Director Candidates
The process followed by the Nominating, Corporate Governance and Compensation Committee to identify and evaluate director candidates includes requests to board members and others for recommendations, meetings from time to time to evaluate biographical information and background material relating to potential candidates and interviews of selected candidates by members of the Nominating, Corporate Governance and Compensation Committee and the Board.
In considering whether to recommend any particular candidate for inclusion in the Board's slate of recommended director nominees, the Nominating Committee applies certain criteria, including:
· | The candidate's honesty, integrity and commitment to high ethical standards, |
· | Demonstrated financial and business expertise and experience, |
· | Understanding of our company, its business and its industry, |
· | Actual or potential conflicts of interest, and |
· | The ability to act in the interests of all stockholders. |
The Nominating, Corporate Governance and Compensation Committee does not assign specific weights to particular criteria and no particular criterion is a prerequisite for each prospective nominee. We believe that the backgrounds and qualifications of our directors, considered as a group, should provide a significant breadth of experience, knowledge and abilities that will allow our Board to fulfill its responsibilities.
The Nominating, Corporate Governance and Compensation Committee will consider director candidates recommended by stockholders or groups of stockholders who have owned more than 5% of our common stock for at least a year as of the date the recommendation is made. Stockholders may recommend individuals to the Nominating, Corporate Governance and Compensation Committee for consideration as potential director candidates by submitting their names, together with appropriate biographical information and background materials and a statement as to whether the stockholder or group of stockholders making the recommendation has beneficially owned more than 5% of our common stock for at least a year as of the date such recommendation is made, to the Nominating, Corporate Governance and Compensation Committee, c/o Corporate Secretary, MultiCell Technology, Inc., 86 Cumberland Street, Suite301, Woonsocket, Rhode Island 02895. Assuming that appropriate biographical and background material have been provided on a timely basis, the Committee will evaluate stockholder-recommended candidates by following substantially the same process, and applying substantially the same criteria, as it follows for candidates submitted by others.
Communicating with the Directors
The Board will give appropriate attention to written communications that are submitted by stockholders, and will respond if and as appropriate. The chair of the Audit Committee is primarily responsible for monitoring communications from stockholders and for providing copies or summaries to the other directors as he considers appropriate.
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Communications are forwarded to all directors if they relate to important substantive matters and include suggestions or comments that the chair of the Audit Committee considers to be important for the directors to know. In general, communications relating to corporate governance and corporate strategy are more likely to be forwarded than communications relating to ordinary business affairs, personal grievances and matters as to which we tend to receive repetitive or duplicative communications.
Stockholders who wish to send communications on any topic to the Board should address such communications to the Board of Directors, c/o Corporate Secretary, MultiCell Technologies, Inc., 68 Cumberland Street, Suite 301, Woonsocket, RI 02895. You should indicate on your correspondence that you are a MultiCell Technologies, Inc. stockholder.
Anyone may express concerns regarding questionable accounting or auditing matters or complaints regarding accounting, internal accounting controls or auditing matters to the Audit Committee by calling (401) 762-0045. Messages to the Audit Committee will be received by the chair of the Audit Committee and our Corporate Secretary. You may report your concern anonymously or confidentially.
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act requires the Company's directors, executive officers and persons who own more than 10% of the Company's stock (collectively, "Reporting Persons") to file with the SEC initial reports of ownership and changes in ownership of any class of the Company's equity securities. Reporting Persons are required by SEC regulations to furnish the Company with copies of all Section 16(a) reports they file. To the Company's knowledge, based solely on its review of the copies of any such reports filed with the SEC within the last fiscal year and any written representations received by the Company from Reporting Persons that no other reports were required, the Company believes that during its fiscal year ended November 30, 2008, all Reporting Persons timely complied with all applicable filing requirements.
Code of Ethics
We have adopted a code of business conduct and ethics that applies to our directors, officers (including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions) as well as our employees. A copy of our code of business conduct and ethics is available on our website at www.multicelltech.com under "Investor Relations—Leadership & Governance." We intend to post on our website all disclosures that are required by applicable law, the rules of the Securities and Exchange Commission or OTCBB listing standards concerning any amendment to, or waiver from, our code of business conduct and ethics.
ITEM 10. EXECUTIVE COMPENSATION
COMPENSATION DISCUSSION AND ANALYSIS
Overview of Executive Compensation Objectives and Philosophy
Our executive compensation plan’s objectives are to attract and retain highly competent executives and to compensate them based upon a pay-for-performance philosophy. With the intent to increase short-term and long-term stockholder value, we have designed our executive compensation plan to reward:
· | Individual performance as measured against personal goals and objectives that contain quantitative components wherever possible; such personal goals depend on the position occupied by our executive officers and can include achieving technological advances, broadening of our products and services offerings, or building a strong team; and |
· | Demonstration of leadership, team building skills and high ethical standards. We design our overall compensation to align the long-term interests of our executives with those of our stockholders. Our compensation plan is designed to encourage success of our executives as a team, rather than only as individual contributors, by attaining overall corporate success. |
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Elements of Executive Compensation
Executive compensation consists of the following elements:
· | Base salary; and |
· | Long-Term Incentives. |
Base Salary. The base salary for each executive is initially established through negotiation at the time the executive is hired, taking into account his or her scope of responsibilities, qualifications, experience, prior salary and competitive salary information within our industry. Year-to-year adjustments to each executive officer’s base salary are determined by an assessment of her or his sustained performance against individual goals, including leadership skills and the achievement of high ethical standards, the individual’s impact on the company’s business and financial results, current salary in relation to the salary range designated for the job, experience, demonstrated potential for advancement, and an assessment against base salaries paid to executives for comparable jobs in the marketplace. Generally, we believe that executive base salaries should be targeted near the median of the range of salaries for executives in similar positions with similar responsibilities at comparable companies.
Long-Term Incentive Program. Our long-term incentives consist of stock option awards. The objective of these awards is to align the longer-term interests of our stockholders and our executive officers and to complement incentives tied to annual performance. We have historically elected to use stock options as our primary long-term equity incentive vehicle. We have not adopted stock ownership guidelines.
Why We Chose to Pay Each of the Executive Compensation Elements and How We Determine the Amount of Each Element
Base Salary. Base salary is paid to attract and retain our executives and to provide them with a level of predictable base compensation. Because base salary, in the first instance, is set at the time the executive is hired, it is largely market-driven and influenced by the type of position occupied, the level of responsibility, experience and training of each executive, and the base salary at his or her prior employment. Annual adjustments to base salary, if any, are influenced by the individual’s achievement of individual goals and the company’s achievement of its financial goals.
The base salaries we paid to our executives in 2008 and 2007 are reflected in the summary compensation table below.
Long-Term Incentives. We grant stock options to our executives and directors as part of our executive compensation package program to directly link their interests to those of our stockholders, since stock options will only produce value to executives if the price of our stock appreciates. We believe that our compensation program must include long-term incentives such as stock options if we wish to hire and retain high-level executive talent. We also believe that stock options help to provide a balance to the overall executive compensation program as base salary and bonus awards focus only on short-term compensation. In addition, the vesting period of stock options encourages executive retention and the preservation of shareholder value. We base the number of stock options granted on the type and responsibility level of the executive’s position, the executive’s performance in the prior year and the executive’s potential for continued sustained contributions to our long-term success and the long-term interests of our stockholders. The number of stock options is also dependent on the number of options available in the option pool and the number of options already granted and vested to each individual executive.
The Level of Salary and Bonus in Proportion to Total Compensation
Because of the congruence of interests by our executives and our stockholders in sustained, long-term growth of the value of our stock, we seek to keep cash compensation in line with market conditions and, if justified by the Company’s financial performance, place emphasis on the use of options as a means of obtaining significantly better than average compensation.
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Summary Compensation Table
Name and Principal Position(1) | Year | Salary ($) | All Other Compensation ($) (5) | Total ($) | ||||||||||
W. Gerald Newmin, (2) | 2008 | $ | 180,000 | {4) | $ | 30,000 | $ | 210,000 | ||||||
Chairman of the Board, Chief Executive | 2007 | $ | 84,600 | $ | 21,000 | $ | 105,600 | |||||||
Officer, President, Chief Financial | ||||||||||||||
Officer, Treasurer, Secretary and Director | ||||||||||||||
Dr. Stephen Chang Ph.D. (3) | ||||||||||||||
Former Chief Executive Officer, former | 2008 | $ | 10,385 | $ | 18,000 | $ | 28,385 | |||||||
President, and current Director | 2007 | $ | 180,069 | $ | 21,000 | $ | 201,069 |
(1) During fiscal years ended November 30 2007 and 2008, the listed persons were the only Principal Executive Officers of the Company and the only persons that earned more than $100,000 during either of such fiscal years.
(2) Appointed as President and Chief Executive Officer on December 21, 2007.
(3) Resigned as President and Chief Executive Officer on December 21, 2007.
(4) Of Mr. Newmin’s salary for the year ended November 30, 2008, $108,681 is unpaid at November 30, 2008 and is included in accrued expenses.
(5) The amounts set forth in this column reflect monies earned in consideration for directors attending meetings of our Board of Directors. Each of Mr. Newmin and Dr. Chang earned $3,000 for each meeting of the Board of Directors attended during fiscal years 2007 and 2008. The Company may pay any such fees in cash or capital stock of the Company, although the Company has traditionally paid such fees in capital stock of the Company. The Company has not yet paid any of the director fees set forth in this column which were earned in fiscal year 2008. The Company has paid all such fees earned in fiscal year 2007 in capital stock of the Company, other than $9,000 to each of Mr. Newmin and Dr. Chang. All of the aforementioned earned and unpaid fees are included in the Company’s accrued expenses.
Contracts, Termination of Employment and Change-in-Control Arrangements
Employment Agreement with W. Gerald Newmin. Mr. Newmin does not have a written employment agreement with the Company. Mr. Newmin’s base salary is $15,000 per month.
Employment Agreement with Stephen Chang, Ph.D. Dr. Chang’s base salary for fiscal year 2007 was $15,000 per month. Pursuant to his employment agreement with the Company dated February 1, 2005, one third of his monthly salary was to be paid quarterly in stock, but the agreement was orally amended so that Mr. Chang received the entirety of his salary in cash. Dr. Chang resigned from position as Chief Executive Officer and President effective December 21, 2007.
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OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END
The following table shows for the fiscal year ended November 30, 2008, certain information regarding options granted to, exercised by, and held at year-end by, the Named Executive Officers:
Option Awards | Stock Awards | ||||||||||||||||||||||||
Name | Number of Securities Underlying Unexercised Options (#) Exercisable | Number of Securities Underlying Unexercised Options (#) Unexercisable | Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#) | Option Exercise Price ($) | Option Expiration Date | Number of Shares or Units of Stock That Have Not Vested (#) | Market Value of Shares or Units of Stock That Have Not Vested ($) | Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested (#) | Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested ($) | ||||||||||||||||
W. Gerald Newmin | 50,000 | 0 | 0 | $1.35 | 9/16/09 | 0 | 0 | 0 | 0 | ||||||||||||||||
Dr. Stephen Chang Ph.D. | 30,000 | 0 | 0 | $1.25 | 6/14/09 | 0 | 0 | 0 | 0 | ||||||||||||||||
50,000 | 0 | 0 | $1.25 | 6/14/09 | 0 | 0 | 0 | 0 | |||||||||||||||||
50,000 | 0 | 0 | $1.35 | 9/16/09 | 0 | 0 | 0 | 0 | |||||||||||||||||
1,000,000 | 0 | 0 | $1.40 | 1/27/10 | 0 | 0 | 0 | 0 |
NON-EMPLOYEE DIRECTOR COMPENSATION
The following table details the total compensation of our non-employee directors for the year ended November 30, 2008.
Name | Fees Earned or Paid in Cash ($) (1) | Stock Awards ($) | Option Awards ($) | Total ($) | ||||||||||||
Anthony F. Altig | $ | 51,000 | $ | 0 | $ | 0 | $ | 51,000 | ||||||||
Thomas A. Page | $ | 26,000 | $ | 0 | $ | 0 | $ | 26,000 | ||||||||
Edward Sigmond | $ | 36,000 | $ | 0 | $ | 0 | $ | 36,000 |
(1) Director fees earned during the year ended November 30, 2008 have not been paid in cash or otherwise settled and appear in our financial statements as accrued expenses. Historically, we have paid director fees through the issuance of our common stock and may still do so in the future.
Director Compensation Arrangements
Each director of the Company earns fees of $3,000 for each board meeting attended. The Chairman of the Audit Committee earns $4,000 for each Audit Committee meeting attended and each other Audit Committee member earns $1,000 per Audit Committee meeting attended. The Chairman of the Nominating, Corporate Governance and Compensation Committee earns $2,000 per Nominating, Corporate Governance and Compensation Committee meeting attended and each other member of the Nominating, Corporate Governance and Compensation Committee earns $1,000 per Nominating, Corporate Governance and Compensation Committee meeting attended. The members of the Board of Directors are also eligible for reimbursement for their expenses incurred in attending Board meetings in accordance with Company policy.
Each director of the Company also receives a one time stock option grant of 50,000 on the date he or she joins the Board of Directors (which shall be referred to as the “Directors’ Plan”). Currently, any options granted would be pursuant to our 2004 Equity Incentive Plan. None of the options granted pursuant to the Directors’ Plan are incentive stock options, as defined in the Internal Revenue Code. The exercise price of options granted under the Directors’ Plan is 100% of the fair market value of the common stock subject to the option on the date of the option grant. The standard terms of the plan call for vesting in equal installments over three years and expiring in five years.
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ITEM 11. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Beneficial Ownership of Directors, Officers and 5% Stockholders
The following table sets forth, as of March 9, 2009, certain information as to shares of our common stock owned by (i) each person known to beneficially own more than 5% of our outstanding common stock or preferred stock, (ii) each of our directors, and executive officers named in our summary compensation table, and (iii) all of our executive officers and directors as a group. Unless otherwise indicated, the address of each named beneficial owner is the same as that of our principal executive offices located at 86 Cumberland Street, Suite 301, Woonsocket, Rhode Island, 02895.
Name and Address of Beneficial Owner (1) | Number of Shares of Common Stock Beneficially Owned (2) | Percent of Common Stock Beneficially Owned | Number of Shares of Preferred Stock Beneficially Owned | Percent of Preferred Stock Beneficially Owned | ||||||||||||
Monarch Pointe Fund, Ltd. (3) | 2,962,910 | 2.07 | % | 7,891 | 35.9 | % | ||||||||||
La Jolla Cove Investors, Inc. (4) | 14,740,864 | 9.99 | % | – | – | |||||||||||
Asset Managers International, Ltd (5) | 5,556,362 | 3.81 | % | 4,923 | 22.38 | % | ||||||||||
W. Gerald Newmin (6)(11) | 6,399,042 | 4.50 | % | – | – | |||||||||||
Thomas A. Page (7)(11) | 1,008,542 | * | – | – | ||||||||||||
Stephen Chang, Ph.D. (8) (11) | 1,916,445 | 1.35 | % | – | – | |||||||||||
Edward Sigmond (9)(11) | 1,049,806 | * | – | – | ||||||||||||
Anthony Altig (10)(11) | 375,139 | * | – | – | ||||||||||||
All executive officers and directors as a group (five persons) | 10,748,974 | 7.43 | % | – | – |
* | Represents less than 1% of the issued and outstanding shares of the applicable class of equity securities of the Company as of March 9, 2009. |
(1) | Beneficial ownership has been determined in accordance with Rule 13d-3 under the Exchange Act. Pursuant to the rules of the Commission, shares of common stock that each named person and group has the right to acquire within 60 days pursuant to options, warrants, or other rights, are deemed outstanding for purposes of computing shares beneficially owned by the percentage ownership of each such person and group. Applicable percentages are based on 140,429,181 shares of common stock and 21,996 shares of preferred stock outstanding on March 9, 2009 (of which 16,262 are shares of our Series B preferred stock and 5,734 are shares of our Series I preferred stock), and are calculated as required by rules promulgated by the SEC. |
(2) | Unless otherwise noted, all shares listed are owned of record and the record owner has sole voting and investment power, subject to community property laws where applicable. |
(3) | Includes (i) 496,972 shares of common stock held by Monarch Pointe Fund, Ltd. (“MPF”) and (ii) 2,465,938 shares of our common stock issuable to MPF upon conversion of its preferred stock. The shares of preferred stock held by MPF are all shares of our Series B preferred stock. MPF is in liquidation. William Tacon serves as the liquidator of MPF and, as such, now has control over the securities owned by MPF. The foregoing information is as of December 31, 2008 and is based solely upon information contained in a Schedule 13G/A filed with the SEC by MPF on January 14, 2009. |
(4) | Represents the maximum possible amount of shares of our commons stock (i) held by LJCI, (ii) issuable to LJCI upon the exercise of a common stock warrant it holds, and (iii) issuable to LJCI upon the conversion of a 4.75% convertible debenture its holds, all as of March 9, 2009. Pursuant to the terms of the warrant and convertible debenture, LJCI may not acquire shares of our commons stock to the extent such acquisition would cause LJCI to own more than 9.99% of our outstanding common stock immediately after such acquisition. Provided the aforementioned 9.99% cap is complied with, LJCI may in the future exercise or convert into, as applicable, a significant amount of additional shares of our common stock (e.g. as of March 9, 2009, there are a total of 9,683,500 shares remaining on the stock purchase warrant and a balance of $96,835 remaining on the convertible debenture, which is convertible pursuant to the formula set forth in the debentures listed in the Exhibits section of this report). |
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(5) | Includes (i) 2,118,513 shares of common stock issuable to Asset Managers International, Ltd upon the exercise of warrants within 60 days of March 9, 2009 and (ii) 3,437,849 shares of our common stock issuable to Asset Managers International, Ltd. upon conversion of its Series B preferred stock. |
(6) | Includes (i) 3,999,844 shares of common stock, (ii) 1,373,065 shares of common stock issuable to Mr. Newmin upon the exercise of warrants within 60 days of March 9, 2009, 9, (iii) 50,000 shares of common stock issuable to Mr. Newmin under options exercisable within 60 days of March 9, 2009, (iv) 694,133 shares of common stock owned by Mr. Newmin’s spouse, and (v) warrants to purchase 282,000 shares of common stock issuable upon exercise of warrants owned by Mr. Newmin’s spouse. Mr. Newmin disclaims beneficial ownership of the aforementioned stock beneficially owned by Mrs. Newmin, except to the extent of his pecuniary interest therein. |
(7) | Includes (i) 432,639 shares of common stock, (ii) 525,903 shares of common stock issuable upon the exercise of common stock warrants within 60 days of March 9, 2009, and (iii) 50,000 shares of common stock issuable under options exercisable within 60 days of March 9, 2009. |
(8) | Includes (i) 422,374 shares of common stock, (ii) 364,071 shares of common stock issuable upon the exercise of common stock warrants within 60 days of March 9, 2009 and (iii) 1,130,000 shares of common stock issuable under options exercisable within 60 days of March 9, 2009. |
(9) | Includes (i) 838,229 shares of common stock, (ii) 161,577 shares of common stock issuable upon the exercise of common stock warrants within 60 days of March 9, 2009 and (iii) 50,000 shares of common stock issuable under options exercisable within 60 days of March 9, 2009. |
(10) | Includes (i) 152,209 shares of common stock, (ii) 172,930 shares of common stock issuable upon the exercise of common stock warrants within 60 days of March 9, 2009 and (iii) 50,000 shares of common stock issuable under options exercisable within 60 days of March 9, 2009. |
(11) | Does not include any shares issuable in connection with director’s fees earned by the reporting person as of March 9, 2009. |
EQUITY COMPENSATION PLAN INFORMATION
The following table summarizes the securities authorized for issuance under equity compensation plans as of November 30, 2008.
Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights | Weighted Average Exercise Price of Outstanding Options, Warrants and Rights | Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans | ||||||||||
Equity compensation plans approved by shareholders (1) | 2,000,000 | $ | 1.16 | 109,739 | ||||||||
Equity compensation plans not approved by shareholders (2) | 2,150,000 | $ | 0.54 | |||||||||
4,150,000 | $ | 0.84 |
(1) Pursuant to the plan, from 2005 through the Company’s fiscal year end 2013, the number of shares of common stock authorized for issuance under the plan is automatically increased on the first day of each year by the lesser of the following amounts: (a) 2.0% of the Company’s outstanding shares of common stock on the day preceding the first day of such fiscal year or (b) 1,500,000 shares of common stock. The numbers of shares set forth in this row include all of such previous increases.
(2) Represents warrants issued to service providers in compensation for services provided.
ITEM 12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Except as described below, none of the following parties has, in the fiscal year ending November 30, 2008, had any material interest, direct or indirect, in any transaction with us or in any presently proposed transaction that has or will materially affect us, other than as noted in this section:
44
· | Any of our directors or officers, |
· | Any person proposed as a nominee for election as a director, |
· | Any person who beneficially owns, directly or indirectly, shares carrying more than 5% of the voting rights attached to our outstanding shares of common stock, |
· | Any of our promoters, and |
· | Any relative or spouse of any of the foregoing persons who has the same house as such person. |
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Since December 1, 2007, there has not been, nor is there currently proposed, any transaction or series of similar transactions to which we were or are a party in which the amount involved exceeds the lesser of (1) $120,000 and (2) one percent of the average of our total assets at year end for the last three completed fiscal years, in which any director, executive officer or beneficial holder of more than 5% of any class of our voting securities or members of such person’s immediate family had or will have a direct or indirect material interest, other than the transactions described below. All future transactions between us and any of our directors, executive officers or related parties will be subject to the review and approval of our Audit Committee.
LA JOLLA COVE INVESTORS, INC.
Pursuant to the Debenture Purchase Agreement, the Company sold a convertible debenture to LJCI in the principal amount of $1,000,000 (receivable in four payments) maturing on February 28, 2008 (the “Initial Debenture”). The first payment of $250,000 was received by the Company on March 7, 2007. The Initial Debenture accrued interest at 7.75% per year, payable monthly in cash or common stock. Under the terms of this agreement, certain officers, director and shareholders of the Company pledged 2,527,638 shares of common stock and guaranteed the repayment of a $250,000 advance against the Initial Debenture. As of November 30, 2007, LJCI had sold all of the pledged shares, received proceeds of $202,081, and reduced the amount due on the advance to $47,919. During the year ended November 30, 2008, LJCI converted the remaining $47,919 of the Initial Debenture into 4,710,250 shares of common stock.
The Company also entered into a Securities Purchase Agreement with LJCI on February 28, 2007 pursuant to which the Company agreed to sell a convertible debenture in the principal amount of $100,000 and maturing on February 28, 2012 (the “Second Debenture”). The Second Debenture accrues interest at 4.75% per year, payable at each conversion date, in cash or common stock at the option of LJCI. The proceeds from the Second Debenture were deposited on March 5, 2007. In connection with the Second Debenture, the Company issued LJCI a warrant to purchase up to 10 million shares of our common stock (the “LJCI Warrant”) at an exercise price of $1.09 per share, exercisable over the next five years according to a schedule described in a letter agreement dated February 28, 2007. Pursuant to the terms of the LJCI Warrant, upon the conversion of any portion of the principal amount of the Second Debenture, LJCI is required to simultaneously exercise and purchase that same percentage of the warrant shares equal to the percentage of the dollar amount of the Second Debenture being converted. Therefore, for each $1,000 of the principal converted, LJCI would be required to simultaneously purchase 100,000 shares under the LJCI Warrant at $1.09 per share.
The Second Debenture is convertible at the option of LJCI at any time up to maturity into the number of shares determined by the dollar amount of the Second Debenture being converted multiplied by 110, minus the product of the Conversion Price multiplied by 100 times the dollar amount of the Second Debenture being converted, with the entire result divided by the Conversion Price. The Conversion Price is equal to the lesser of $1.00 or 80% of the average of the three lowest volume-weighted average prices during the twenty trading days prior to the election to convert. During the year ended November 30, 2008, LJCI converted $825 of the Second Debenture into 19,384,509 shares of common stock. Simultaneously with these conversions, LJCI exercised warrants to purchase 82,500 shares of the Company’s common stock. Proceeds from the exercise of the warrants were $89,925. As of November 30, 2008, the balance of the Second Debenture was $99,175 and there were remaining warrants to purchase 9,917,500 shares of common stock at $1.09 per share. During the period from December 1, 2008 through March 9, 2009, LJCI has converted an additional $2,340 of the Second Debenture into 57,048,967 shares of common stock. Simultaneously with these additional conversions, LJCI exercised additional warrants to purchase 234,000 shares of the Company’s common stock. Proceeds from the additional exercise of warrants were $255,060. As of March 9, 2009, the balance of the Second Debenture is $96,835 and there are remaining warrants to purchase 9,683,500 shares of common stock at $1.09 per share.
45
Board Determination of Independence
The Company complies with the standards of "independence" prescribed by rules set forth by the National Association of Securities Dealers ("NASD"). Accordingly, a director will only qualify as an "independent director" if, in the opinion of our Board of Directors, that person does not have a material relationship with our company which would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. A director who is, or at any time during the past three years, was employed by the Company or by any parent or subsidiary of the Company, shall not be considered independent. Accordingly, Tony Altig, Tom Page and Ed Sigmond meet the definition of "independent director" under Rule 4200(A)(15) of the NASD Manual; Dr. Chang and Mr. Newmin do not.
ITEM 13. EXHIBITS
Please see the Exhibit Index which follows the signature page to this annual report on Form 10-KSB and which is incorporated by reference herein.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The following table summarizes the fees of (i) J.H. Cohn, LLC., our former independent auditor, and (ii) Hansen, Barnett and Maxwell, our current independent auditor, billed to us for each of the last two fiscal years for audit services and billed to us in each of the last two years for other services:
Fee Category | 2008 | 2007 | ||||||
Audit Fees(1) | $ | 67,342 | $ | 80,175 | ||||
Audit-Related Fees(2) | $ | 0 | $ | 47,000 | ||||
Tax Fees(3) | $ | 0 | $ | 0 | ||||
All Other Fees(4) | $ | 0 | $ | 0 |
(1) Audit fees consist of aggregate fees billed for professional services rendered for the audit of the Company's annual financial statements and review of the interim financial statements included in quarterly reports or services that are normally provided by the independent auditor in connection with statutory and regulatory filings or engagements for the fiscal years ended November 30, 2008 and 2007.
(2) Audit related fees consist of aggregate fees billed for assurance and related services that are reasonably related to the performance of the audit or review of the Company's financial statements and are not reported under "Audit Fees." These fees include review of registration statements and participation at meetings of the audit committee.
(3) Tax fees consist of aggregate fees billed for professional services for tax compliance, tax advice and tax planning.
(4) All other fees consist of aggregate fees billed for products and services provided by the independent auditor, other than those disclosed above. These fees include services related to certain accounting research and assistance with a regulatory matter.
The Company's policy is to pre-approve all audit and permissible non-audit services provided by the independent auditors. These services may include audit services, audit-related services, tax services and other services. Pre-approval is generally provided for up to one year and any pre-approval is detailed as to the particular service or category of services and is generally subject to a specific budget. The independent auditors and management are required to periodically report to the audit committee regarding the extent of services provided by the independent auditors in accordance with this pre-approval, and the fees for the services performed to date. To the extent that additional services are necessary beyond those specifically budgeted for, the audit committee and management pre-approve such services on a case-by-case basis. All services provided by the independent auditors were approved by the Audit Committee.
46
SIGNATURES
Pursuant to the requirements of Section 13 or 15D 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,
MULTICELL TECHNOLOGIES, INC. | |
(Registrant) | |
By | /s W. Gerald Newmin |
W. Gerald Newmin | |
Chairman, CEO, CFO, President, Treasurer and Secretary | |
Dated March 16, 2009 |
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.
Signature | Title | Date | ||
/s/ W. Gerald Newmin | Chairman ,CEO, CFO, President, | March 16, 2009 | ||
W. Gerald Newmin | Treasurer and Secretary | |||
/s/ Stephen Chang | Director | March 16, 2009 | ||
Stephen Chang | ||||
/s/ Edward Sigmond | Director | March 16, 2009 | ||
Edward Sigmond | ||||
/s/ Thomas A. Page | Director | March 16, 2009 | ||
Thomas A. Page | ||||
/s/ Anthony Altig | Director | March 16, 2009 | ||
Anthony Altig |
47
EXHIBIT INDEX
Exhibit No. | Description of Exhibit | |
2.1 (1) | Asset Contribution Agreement dated September 7, 2005 by and among Multicell Technologies, Inc., Astral Therapeutics, Inc., Alliance Pharmaceutical Corp., and Astral, Inc. | |
3.1 (2) | Certificate of Incorporation, as filed on April 28, 1970. | |
3.2 (2) | Certificate of Amendment, as filed on October 27, 1986. | |
3.3 (2) | Certificate of Amendment, as filed on August 24, 1989. | |
3.4 (2) | Certificate of Amendment, as filed on July 31, 1991. | |
3.5 (2) | Certificate of Amendment, as filed on August 14, 1991. | |
3.6 (2) | Certificate of Amendment, as filed on June 13, 2000. | |
3.7 (2) | Certificate of Amendment, as filed May 18, 2005. | |
3.8 (2) | Certificate of Correction, as filed June 2, 2005. | |
3.9 (2) | Bylaws, as amended May 18, 2005. | |
3.10 (2) | Specimen Stock Certificate. | |
4.1 (3) | Certificate of Designations of Preferences and Rights of Series I Convertible Preferred Stock, as filed on July 13, 2004. | |
4.2 (4) | Certificate of Designation of Series B Convertible Preferred Stock, as filed on July 14, 2006. | |
4.3 (5) | Debenture Purchase Agreement between Multicell Technologies, Inc. and La Jolla Cove Investors, Inc. dated February 28, 2007 | |
4.4 (5) | Registration Rights Agreement between Multicell Technologies, Inc. and La Jolla Cove Investors, Inc. dated February 28, 2007 | |
4.5 (5) | Stock Pledge Agreement dated February 28, 2007 | |
4.6 (5) | 7 ¾ % Convertible Debenture for $1,000,000 issued by Multicell Technologies, Inc. to La Jolla Cove Investors, Inc. | |
4.7 (5) | Escrow Letter dated February 28, 2007 from La Jolla Cove Investors, Inc. | |
4.8 (5) | Letter dated February 28, 2007 from La Jolla Cove Investors, Inc. | |
4.9 (5) | Securities Purchase Agreement between Multicell Technologies, Inc. and La Jolla Cove Investors, Inc. dated February 28, 2007 | |
4.10 (5) | 4 ¾ % Convertible Debenture for $100,000 issued by Multicell Technologies, Inc. to La Jolla Cove Investors, Inc. | |
4.11 (5) | Warrant to Purchase Common Stock dated February 28, 2007 | |
4.12 (5) | Letter dated February 28, 2007 to Multicell Technologies, Inc. from La Jolla Cove Investors, Inc. | |
4.13 (6) | Warrant for the purchase of 1,572,327 Shares of Common Stock of Multicell Technologies, Inc. issued to and Fusion Capital Fund II, LLC dated May 3, 2006. | |
4.14 (7) | Amended and Restated Registration Rights Agreement, dated as of October 5, 2006, by and between Multicell Technologies, Inc. and Fusion Capital Fund II, LLC. | |
4.15 (8) | Form of Warrant to Purchase Common Stock (Cashless Exercise) dated July 14, 2006 issued by Multicell Technologies, Inc. to Monarch Pointe Fund, Ltd., Mercator Momentum Fund III, L.P., Asset Managers International Ltd. and Pentagon Special Purpose Fund Ltd. | |
4.16 (8) | Form of Warrant to Purchase Common Stock (Cash Exercise), dated July 14, 2006, issued by Multicell Technologies, Inc. to Monarch Pointe Fund, Ltd., Mercator Momentum Fund III, L.P., Asset Managers International Ltd. and Pentagon Special Purpose Fund Ltd. | |
4.17 (8) | Form of Registration Rights Agreement dated July 14, 2006 by and between Multicell Technologies, Inc. and Monarch Pointe Fund, Ltd., Mercator Momentum Fund III, L.P., Asset Managers International Ltd. and Pentagon Special Purpose Fund Ltd. | |
4.18 (8) | Form of Shares of Series B Convertible Preferred Stock and Common Stock Warrants Subscription Agreement dated July 14, 2006 by and between Multicell Technologies, Inc. and Monarch Pointe Fund, Ltd., Mercator Momentum Fund III, L.P., Asset Managers International Ltd. and Pentagon Special Purpose Fund Ltd. |
48
4.19 (9) | Amended and Restated Warrant to Purchase Common Stock issued to Anthony Cataldo dated July 25, 2006. | |
4.20 (10) | Form of Warrant to Purchase Common Stock dated February 1, 2006 issued by the Company to Trilogy Capital Partners, Inc. | |
4.21 (11) | Mutual Termination Agreement between Multicell Technologies, Inc. and Fusion Capital Fund II, LLC, dated as of July 18, 2007. | |
10.1 (12) | Letter Agreement between Amarin Neuroscience Limited and the Company dated October 26, 2006. | |
10.2 (13) | Letter Agreement between Amarin Neuroscience Limited and the Company dated June 28, 2006. | |
10.3 (14) | Worldwide Exclusive License Agreement dated as of December 31, 2005 between Multicell Technologies, Inc. and Amarin Neuroscience Limited dated December 31, 2005. | |
10.4 (15) | License Agreement between Eisai Co., Ltd. and the Company dated April 20, 2007. | |
10.5 (16) | License Agreement between Corning Incorporated and the Company dated October 9, 2007. | |
31.1* | Certification of the Chief Executive Officer and Chief Financial Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002. | |
32.1* | Certification of Chief Executive Officer and the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
* Filed herewith. |
(1) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on September 8, 2005.
(2) Incorporated by reference from an exhibit to our Post-Effective Amendment No. 1 to our Registration Statement on Form SB-2 filed on May 6, 2005.
(3) Incorporated by reference from an exhibit to our Form SB-2 Registration Statement filed on August 12, 2004.
(4) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on July 19, 2006.
(5) Incorporated by reference from an exhibit to our Current Report on Form 8-K/A filed on March 7, 2007.
(6) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on May 3, 2006.
(7) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on October 5, 2006.
(8) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on July 20, 2006.
(9) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on July 28, 2006.
(10) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on February 6, 2006.
(11) In corporated by reference from an exhibit to our Current Report on Form 8-K filed on July 19, 2007.
(12) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on October 26, 2006.
(13) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on June 28, 2006.
(14) Incorporated by reference from an exhibit to our Post-Effective Amendment No. 1 to our Registration Statement on Form SB-2 filed on January 12, 2006.
(15) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on April 26, 2007.
(16) Incorporated by reference from an exhibit to our Current Report on Form 8-K filed on October 10, 2007.
49
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page | |
Report of Independent Registered Public Accounting Firm | F-2 |
Consolidated Balance Sheets – November 30, 2008 and 2007 | F-3 |
Consolidated Statements of Operations for the Years Ended November 30, 2008 and 2007 | F-4 |
Consolidated Statements of Stockholders’ Deficiency for the Years Ended November 30, | |
2007 and 2008 | F-5 |
Consolidated Statements of Cash Flows for the Years Ended November 30, 2008 and 2007 | F-6 |
Notes to Consolidated Financial Statements | F-7 |
F-1
HANSEN, BARNETT & MAXWELL, P.C. | ||
A Professional Corporation | Registered with the Public Company | |
CERTIFIED PUBLIC ACCOUNTANTS | Accounting Oversight Board | |
5 Triad Center, Suite 750 Salt Lake City, UT 84180-1128 Phone: (801) 532-2200 | ||
Fax: (801) 532-7944 | A Member of the Forum of Firms | |
www.hbmcpas.com |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and the Stockholders
MultiCell Technologies, Inc.
Woonsocket, Rhode Island
We have audited the accompanying consolidated balance sheets of MultiCell Technologies, Inc. and subsidiaries (the Company) as of November 30, 2008 and 2007, and the related consolidated statements of operations, stockholders' deficiency, and cash flows for the years then ended. These consolidated 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.
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 audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of MultiCell Technologies, Inc. and subsidiaries as of November 30, 2008 and 2007, and the results of their operations and their cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company suffered losses from operations and had negative cash flows from operating activities during the years ended November 30, 2008 and 2007 and as of November 30, 2008, the Company had a working capital deficit and a stockholders’ deficit. These matters raise substantial doubt about the Company's ability to continue as a going concern. Management's plans concerning these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
HANSEN, BARNETT & MAXWELL, P.C.
Salt Lake City, Utah
March 13, 2009
F-2
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES | ||||||||
CONSOLIDATED BALANCE SHEETS | ||||||||
November 30, | November 30, | |||||||
2008 | 2007 | |||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 6,022 | $ | 411,691 | ||||
Accounts and royalties receivable | — | 31,582 | ||||||
Other current assets | 32,854 | 59,431 | ||||||
Total current assets | 38,876 | 502,704 | ||||||
Property and equipment, net of accumulated depreciation of $57,146 and $138,231 at November 30, 2008 and 2007, respectively | 15,501 | 36,354 | ||||||
Intangible assets, net of accumulated amortization and impairment of $1,285,719 and $155,322 at November 30, 2008 and 2007, respectively | — | 1,130,397 | ||||||
Other assets | 2,979 | 22,210 | ||||||
Total assets | $ | 57,356 | $ | 1,691,665 | ||||
LIABILITIES AND STOCKHOLDERS' DEFICIENCY | ||||||||
Current liabilities | ||||||||
Convertible debentures, net of discount | $ | — | $ | 44,924 | ||||
Notes payable - related parties | 55,000 | — | ||||||
Due stockholders and affiliates | — | 202,081 | ||||||
Accounts payable and accrued expenses | 1,617,304 | 1,383,424 | ||||||
Current portion of deferred revenue | 96,385 | 94,440 | ||||||
Total current liabilities | 1,768,689 | 1,724,869 | ||||||
Non-current liabilities | ||||||||
Convertible debentures, net of discount | 34,175 | 15,000 | ||||||
Deferred income, net of current portion | 696,012 | 745,329 | ||||||
Total non-current liabilities | 730,187 | 760,329 | ||||||
Total liabilities | 2,498,876 | 2,485,198 | ||||||
Commitments and contingencies | — | — | ||||||
Series B redeemable convertible preferred stock, 17,000 shares designated; 16,262 shares issued and outstanding; liquidation value of $1,926,952 and $1,777,748 at November 30, 2008 and 2007, respectively | 1,886,952 | 1,737,748 | ||||||
Stockholders' Deficiency | ||||||||
Undesignated preferred stock, $0.01 par value; 970,800 shares authorized | — | — | ||||||
Series I convertible preferred stock, 12,200 shares designated; 5,734 and 12,200 shares issued and outstanding at November 30, 2008 and 2007, respectively; liquidation value of $573,400 and $1,220,000 at November 30, 2008 and 2007, respectively | 573,400 | 1,220,000 | ||||||
Common stock, $0.01 par value; 200,000,000 shares authorized; 83,146,214 and 48,690,777 shares issued and outstanding at November 30, 2008 and 2007, respectively | 831,462 | 486,908 | ||||||
Additional paid-in capital | 32,894,705 | 32,145,711 | ||||||
Accumulated deficit | (38,628,039 | ) | (36,383,900 | ) | ||||
Total stockholders' deficiency | (4,328,472 | ) | (2,531,281 | ) | ||||
Total Liabilities and Stockholders' Deficiency | $ | 57,356 | $ | 1,691,665 |
See accompanying notes to consolidated financial statements
F-3
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES | ||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
For the Years Ended | ||||||||
November 30, | ||||||||
2008 | 2007 | |||||||
Revenue | $ | 209,835 | $ | 251,797 | ||||
Operating expenses | ||||||||
Selling, general and administrative | 842,067 | 2,518,213 | ||||||
Research and development | 317,130 | 757,866 | ||||||
Depreciation and amortization | 80,256 | 113,815 | ||||||
Write-down of intangible assets due to impairment in value | 1,061,365 | — | ||||||
Total operating expenses | 2,300,818 | 3,389,894 | ||||||
Loss from operations | (2,090,983 | ) | (3,138,097 | ) | ||||
Other income (expense) | ||||||||
Interest expense | (35,373 | ) | (86,014 | ) | ||||
Interest income | 1,807 | 4 | ||||||
Gain on disposition of equipment | 29,613 | 3,054 | ||||||
Minority interest in net loss of subsidiary | — | 14,248 | ||||||
Other | — | 34,167 | ||||||
Total other income (expense) | (3,953 | ) | (34,541 | ) | ||||
Net loss | (2,094,936 | ) | (3,172,638 | ) | ||||
Preferred stock dividends | (149,203 | ) | (151,548 | ) | ||||
Net loss attributable to common stockholders | $ | (2,244,139 | ) | $ | (3,324,186 | ) | ||
Basic and Diluted Loss Per Common Share | ||||||||
Attributable to Common Stockholders | $ | (0.04 | ) | $ | (0.07 | ) | ||
Basic and Diluted Weighted-Average | ||||||||
Common Shares Outstanding | 63,996,659 | 44,400,864 |
See accompanying notes to consolidated financial statements
F-4
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES |
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIENCY |
For the Years Ended November 30, 2007 and 2008 |
Additional | Total | |||||||||||||||||||||||||||
Preferred Stock - Series I | Common stock | Paid in | Accumulated | Stockholders' | ||||||||||||||||||||||||
Shares | Amount | Shares | Par Value | Capital | Deficit | Deficiency | ||||||||||||||||||||||
Balance at Novmeber 30, 2006 | 12,200 | $ | 1,220,000 | 38,479,499 | $ | 384,795 | $ | 30,069,979 | $ | (33,059,714 | ) | $ | (1,384,940 | ) | ||||||||||||||
Stock-based compensation for services | — | — | — | — | 316,839 | — | 316,839 | |||||||||||||||||||||
Common stock issued for services and settlement of accrued expenses | — | — | 8,189,204 | 81,892 | 812,256 | — | 894,148 | |||||||||||||||||||||
Stock-based compensation for warrants issued for pledging of shares | — | — | — | — | 354,358 | — | 354,358 | |||||||||||||||||||||
Common stock issued in conjunction with equity line | — | — | 2,022,074 | 20,221 | 429,779 | — | 450,000 | |||||||||||||||||||||
Discount on convertible debentures (including beneficial conversion charge) | — | — | — | — | 162,500 | — | 162,500 | |||||||||||||||||||||
Dividends on Series B preferred stock | — | — | — | — | — | (151,548 | ) | (151,548 | ) | |||||||||||||||||||
Net loss | — | — | — | — | — | (3,172,638 | ) | (3,172,638 | ) | |||||||||||||||||||
Balance at Novmeber 30, 2007 | 12,200 | $ | 1,220,000 | 48,690,777 | $ | 486,908 | $ | 32,145,711 | $ | (36,383,900 | ) | $ | (2,531,281 | ) | ||||||||||||||
Common stock issued for services | — | — | 5,247,807 | 52,478 | 26,772 | — | 79,250 | |||||||||||||||||||||
Issuance of common stock in payment of liability to stockholders and affiliates | — | — | 2,527,638 | 25,276 | 176,805 | — | 202,081 | |||||||||||||||||||||
Issuance of common stock for conversion of 7.75% debentures | — | — | 4,710,250 | 47,102 | 817 | — | 47,919 | |||||||||||||||||||||
Issuance of common stock for conversion of 4.75% debentures | — | — | 19,384,509 | 193,845 | (193,020 | ) | — | 825 | ||||||||||||||||||||
Issuance of common stock for exercise of warrants | — | — | 82,500 | 825 | 89,100 | — | 89,925 | |||||||||||||||||||||
Insuance of common stock for conversion of Series I preferred stock | (6,466 | ) | (646,600 | ) | 2,586,400 | 25,864 | 620,736 | — | — | |||||||||||||||||||
Stock-based compensation | — | — | — | — | 26,948 | — | 26,948 | |||||||||||||||||||||
Dividends on Series B preferred stock | — | — | — | — | — | (149,203 | ) | (149,203 | ) | |||||||||||||||||||
Adjustment of shares issued in prior periods | — | — | (83,667 | ) | (836 | ) | 836 | — | — | |||||||||||||||||||
Net loss | — | — | — | — | — | (2,094,936 | ) | (2,094,936 | ) | |||||||||||||||||||
Balance at November 30, 2008 | 5,734 | $ | 573,400 | 83,146,214 | $ | 831,462 | $ | 32,894,705 | $ | (38,628,039 | ) | $ | (4,328,472 | ) |
See accompanying notes to consolidated financial statements
F-5
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES |
CONSOLIDATED STATEMENTS OF CASH FLOWS |
For the Years Ended | ||||||||
November 30, | ||||||||
2008 | 2007 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (2,094,936 | ) | $ | (3,172,638 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities | ||||||||
Depreciation | 11,223 | 44,783 | ||||||
Amortization | 69,032 | 69,032 | ||||||
Stock-based compensation for services and pledging of stock | 106,198 | 1,386,845 | ||||||
Write-down of intangible assets due to impairment in value | 1,061,365 | — | ||||||
Minority interest in loss of subsidiary | — | (14,248 | ) | |||||
Gain on disposition of equipment | (29,613 | ) | (3,054 | ) | ||||
Interest expense from amortization of discount | ||||||||
on convertible debentures | 22,995 | 74,505 | ||||||
Changes in assets and liabilities | ||||||||
Accounts and royalties receivable | 31,582 | (13,962 | ) | |||||
Other current assets | 43,916 | (16,625 | ) | |||||
Other assets | 21,122 | 13,681 | ||||||
Accounts payable and accrued liabilities | 233,881 | 452,175 | ||||||
Deferred income | (47,372 | ) | 758,610 | |||||
Net cash used in operating activities | (570,607 | ) | (420,896 | ) | ||||
Cash flows from investing activities | ||||||||
Collection of principal on note receivable | 15,436 | — | ||||||
Proceeds from sale of equipment | 4,577 | 29,485 | ||||||
Net cash provided by investing activities | 20,013 | 29,485 | ||||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of convertible debentures | — | 350,000 | ||||||
Proceeds from issuance of common stock, net | — | 450,000 | ||||||
Proceeds from issuance of notes payable to related parties | 55,000 | 30,000 | ||||||
Payments of notes payable to related parties | — | (30,000 | ) | |||||
Proceeds from the exercise of stock warrants | 89,925 | — | ||||||
Preferred stock dividends paid | — | (13,009 | ) | |||||
Redemption of Series B convertible preferred stock | — | (61,500 | ) | |||||
Net cash provided by financing activities | 144,925 | 725,491 | ||||||
Net increase (decrease) in cash and cash equivalents | (405,669 | ) | 334,080 | |||||
Cash and cash equivalents at beginning of year | 411,691 | 77,611 | ||||||
Cash and cash equivalents at end of year | $ | 6,022 | $ | 411,691 | ||||
Supplemental Disclosures of Cash Flow Information: | ||||||||
Cash paid for interest | $ | 10,922 | $ | 9,087 | ||||
Noncash Investing and Financing Activities: | ||||||||
Issuance of common stock in payment of liability to | ||||||||
stockholders and affiliates | 202,081 | — | ||||||
Issuance of common stock for conversion of 7.75% debentures | 47,919 | — | ||||||
Issuance of common stock for conversion of 4.75% debentures | 825 | — | ||||||
Issuance of common stock for conversion of Series I preferred stock | 646,600 | — | ||||||
Issuance of note receivable in connection with the sale of equipment | 34,665 | — | ||||||
Settlement of accrued expenses with common stock | — | 178,500 | ||||||
Settlement of accounts payable with transfer of equipment | — | 24,572 |
See accompanying notes to consolidated financial statements
F-6
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
Note 1 - Organization and Summary of Significant Accounting Policies
Organization – MultiCell Technologies, Inc. (“MultiCell”), operates three subsidiaries, MCT Rhode Island Corp., Xenogenics Corporation (“Xenogenics”), and MultiCell Immunotherapeutics, Inc. (“MCTI”). MCT Rhode Island Corp. (“MCT”), is a 100%-owned subsidiary that has been inactive since its formation in 2004. (“Xenogenics”), is a 56.4%-owned subsidiary with a focus on the research and development of Sybiol technology. Xenogenics has not generated any revenues as of November 30, 2008. MultiCell holds approximately 67% of the outstanding shares (on as as if converted basis) of MCTI. As used herein, the “Company” refers to MultiCell, together with MCT, Xenogenics, and MCTI.
Historically, the Company has specialized in developing primary liver cell immortalization technologies to produce cell-based assay systems for use in drug discovery. The Company seeks to become an integrated biopharmaceutical company that will use its proprietary cell-based systems and immune system modulation technologies to discover, develop and commercialize new therapeutics itself and with strategic partners. Following the formation of MCTI during September 2005, the Company is pursuing research and development of therapeutics in addition to continuing to advance its cellular systems business.
Basis of Consolidation – The consolidated financial statements include the accounts of MultiCell Technologies Inc. and its subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. Non-controlling interests in consolidated subsidiaries are recognized as minority interest. Losses from consolidated subsidiaries are allocated between the Company and the minority interest based upon the percentages owed. When losses applicable to the minority interest in a consolidated subsidiary exceed the minority interest in the equity capital of the subsidiary, such excess and any further losses applicable to the minority interest are charged against the operations of the Company.
Cash and Cash Equivalents – The Company considers all unrestricted highly liquid investments purchased with a maturity of three months or less to be cash equivalents.
Fair Value of Financial Instruments – The carrying amounts of cash and cash equivalents, accounts and royalties receivable, accounts payable, accrued expenses, and notes payable to related parties approximate fair market value because of the short maturity of those instruments. The fair value of convertible debentures was approximately $99,175 and $147,919 at November 30, 2008 and 2007, respectively.
Credit Risk – It is the Company’s practice to place its cash equivalents in high quality money market securities with one major banking institution. Periodically, the Company maintains cash balances at this institution that exceeds the Federal Deposit Insurance Corporation insurance limit of $250,000 per bank. The Company considers its credit risk associated with cash and cash equivalents to be minimal. The Company does not require collateral from its customers. The Company closely monitors the extension of credit to its customers while maintaining an allowance for potential credit losses. On a periodic basis, management evaluates its accounts receivable and, if warranted, adjusts its allowance for doubtful accounts based on historical experience and current credit considerations. Typically, accounts receivable consist primarily of amounts due under contractual agreements.
Revenue Recognition – In the years covered by these financial statements, the Company's revenues have been generated primarily from license revenue under agreements with Corning, Pfizer, and Eisai, as well as the sale of cells or royalties on the license for the sale of cells through its sale and distribution agreement with XenoTech, LLC. Management believes such sources of revenue will be part of the Company's ongoing operations. The Company recognizes revenue from licensing and research agreements as services are performed, provided a contractual arrangement exists, the contract price is fixed or determinable and the collection of the contractual amounts is reasonably assured. In situations where the Company receives payment in advance of the performance of services, such amounts are deferred and recognized as revenue as the related services are performed. Deferred revenues associated with services expected to be performed within the 12 - month period subsequent to the balance sheet date are classified as a current liability. Deferred revenues associated with services expected to be performed at a later date are classified as non-current liabilities.
F-7
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
Property and Equipment – Property and equipment are recorded at cost. Depreciation of property and equipment is provided using the straight-line method over the estimated useful lives of the assets, generally three to ten years.
Intangible Assets – In accordance with SFAS No. 142, “Goodwill and Other Intangible Assets”, the Company does not amortize intangible assets with indefinite useful lives. The Company amortizes identifiable intangible assets over the estimated useful lives of the assets. The Company performs its annual intangible asset impairment tests during the fourth quarter of its fiscal year and more frequently if an event or circumstance indicates that impairment has occurred. If the assets were considered to be impaired, the impairment charge would be the amount by which the carrying value of the assets exceeds the fair value of the assets.
Impairment of long-lived assets – The impairment of long-lived assets that do not have indefinite lives, such as equipment, patents, and license agreements, is recognized when events or changes in circumstances indicate that the undiscounted cash flows estimated to be generated by such assets are less than their carrying value and, accordingly, all or a portion of such carrying value may not be recoverable. Impairment losses are then measured by comparing the fair value of assets to their carrying amounts. As of November 30, 2008, management tested the carrying value of its intangible assets for impairment and concluded that they had been impaired. The Company recognized a charge of $1,061,365 to write off the remaining carrying value of the intangible assets in the year ended November 30, 2008. (See Note 4). As of November 30, 2007, management tested the carrying value of the remaining intangible assets and concluded they were not impaired.
Stock Based Compensation – The Company has stockholder approved stock incentive plans for employees, directors, officers and consultants. The Company recognizes compensation expense for stock-based awards to employees expected to vest on a straight-line basis over the requisite service period of the award, based on their grant-date fair value. The Company estimates the fair value of stock options using the Black-Scholes option-pricing model, which requires management to make estimates for certain assumptions regarding risk-free interest rate, expected life of options, expected volatility of stock, and expected dividend yield of stock.
Research and Development Costs - - Research and development costs are expensed as incurred. Amounts received for research through grants are accounted for as an offset to research and development expenses for the year.
Income Taxes – Deferred income taxes are provided for the estimated tax effects of temporary differences between income for tax and financial reporting purposes. A valuation allowance is provided against deferred tax assets, where realization is uncertain.
Loss Per Common Share – The Company computes basic and diluted loss per common share amounts pursuant to Statement of Financial Accounting Standards No. 128, “Earnings Per Share”. Basic loss per common share is computed by dividing the net loss applicable to common stockholders by the weighted average common shares outstanding during each period. Since the Company incurred losses during the years ended 2008 and 2007, the assumed effects of the exercise of outstanding stock options and warrants, and the conversion of convertible preferred stock and convertible debentures were anti-dilutive and, accordingly, diluted per common share amounts equal basic loss per share amounts and have not been separately presented in the accompanying consolidated statements of operations. The total number of common shares potentially issuable upon exercise or conversion excluded from the calculation of diluted loss per common share for the years ended November 30, 2008 and 2007 was 4,524,658,932 and 312,670,351, respectively.
Use of Estimates – The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America 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 dates of these financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
F-8
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
Risks and Uncertainties – The Company is dependent on continued financing from investors and obtaining new research grants to sustain the development and other activities necessary to commercialize new products. Management is seeking additional financing in order to fund its future activities. There is no assurance, however, that such financing will be available, if and when needed, or if available, that such financing will be completed on commercially favorable terms, or that such development and other activities in connection with its planned products will be successful.
Accounting For Warrants Issued With Convertible Debentures – The Company accounts for the value of warrants and the intrinsic value of beneficial conversion rights arising from the issuance of convertible debentures with non-detachable conversion rights that are in-the-money at the commitment date pursuant to the consensuses for EITF Issue No. 98-5 and EITF Issue No. 00-27. Such values are determined by first allocating an appropriate portion of the proceeds received from the debt instruments to the warrants or any other detachable instruments included in the exchange. The proceeds allocated to the debt discount, which is charged to interest expense over the term of the debt instrument. The intrinsic value of the beneficial conversion rights at the commitment date is recorded as additional paid-in capital and debt discount as of that date.
Reclassifications – Certain reclassifications have been made to the prior year financial statement presentation to conform to the current year financial statement presentation. The reclassifications did not have any effect on reported net losses for any period presented.
Recently Enacted Accounting Standards – In September 2006, the Financial Accounting Standards Board (FASB) issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS 157 defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. This statement was originally effective for financial statements issued for fiscal years beginning after November 15, 2007. In February 2008, the FASB issued FASB Staff Position (FSP FIN) No. 157-2 which extended the effective date for certain nonfinancial assets and nonfinancial liabilities to fiscal years beginning after November 15, 2008. The Company adopted the effective portions of SFAS 157 effective December 1, 2007, which did not have a significant impact on the Company’s consolidated financial statements. The Company is currently evaluating the impact of the remaining portions of SFAS 157 on its financial statements and anticipates that the adoption of those portions of the statement will not have a significant impact on the reporting of its financial position and results of operations.
In March 2007, the FASB issued FASB Staff Position EITF 07-03, Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities (FSP 07-03). FSP 07-03 addresses whether nonrefundable advance payments for goods or services that will be used or rendered for research and development activities should be expensed when the advance payment is made or when the research and development activity has been performed. FSP 07-03 will be effective for fiscal years beginning after December 15, 2007, and interim periods within those fiscal years. The Company currently believes that the adoption of FSP 07-03 will have no material impact on its financial position or results of operations.
F-9
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS 141(R)), which replaces SFAS 141, Business Combinations. SFAS 141(R) retains the underlying concepts of SFAS 141 in that all business combinations are still required to be accounted for at fair value under the acquisition method of accounting, but SFAS 141(R) changed the method of applying the acquisition method in a number of significant aspects. Acquisition costs will generally be expensed as incurred; noncontrolling interests will be valued at fair value at the acquisition date; in-process research and development will be recorded at fair value as an indefinite-lived intangible asset at the acquisition date; restructuring costs associated with a business combination will generally be expensed subsequent to the acquisition date; and changes in deferred tax asset valuation allowances and income tax uncertainties after the acquisition date generally will affect income tax expense. SFAS 141(R) is effective on a prospective basis for all business combinations for which the acquisition date is on or after the beginning of the first annual period subsequent to December 15, 2008, with the exception of the accounting for valuation allowances on deferred taxes and acquired tax contingencies. SFAS 141(R) amends SFAS 109 such that adjustments made to valuation allowances on deferred taxes and acquired tax contingencies associated with acquisitions that closed prior to the effective date of SFAS 141(R) would also apply the provisions of SFAS 141(R). Early adoption is not permitted. The Company is currently evaluating the effects, if any, that SFAS 141(R) may have on its financial statements. The Company does not expect that it will have any immediate effect on its financial statements, however, the revised standard will govern the accounting for any future business combinations that the Company may enter into.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements—an amendment of ARB No. 51 (SFAS 160). This statement is effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2008, with earlier adoption prohibited. This statement requires the recognition of a noncontrolling interest (minority interest) as equity in the consolidated financial statements and separate from the parent’s equity. The amount of net income attributable to the noncontrolling interest will be included in consolidated net income on the face of the income statement. It also amends certain of ARB No. 51’s consolidation procedures for consistency with the requirements of SFAS 141(R). This statement also includes expanded disclosure requirements regarding the interests of the parent and its noncontrolling interest. The Company is currently evaluating this new statement and anticipates that the statement will not have a significant impact on the reporting of its results of operations.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities - an amendment of FASB Statement No. 133, (SFAS No. 161), which requires companies to provide additional disclosures about its objectives and strategies for using derivative instruments, how the derivative instruments and related hedged items are accounted for under SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, and related interpretations, and how the derivative instruments and related hedged items affect the Company’s financial statements. SFAS No. 161 also requires companies to disclose information about credit risk-related contingent features in their hedged positions. SFAS No. 161 is effective for fiscal years and interim periods beginning after November 15, 2008. The Company does not currently believe adoption will have a material impact on the Company’s financial position or operating results.
In May 2008, the FASB issued SFAS 162, The Hierarchy of Generally Accepted Accounting Principles. SFAS No. 162 identifies the sources of accounting principles and provides entities with a framework for selecting the principles used in preparation of financial statements that are presented in conformity with GAAP. The current GAAP hierarchy has been criticized because it is directed to the auditor rather than the entity, it is complex, and it ranks FASB Statements of Financial Accounting Concepts, which are subject to the same level of due process as FASB Statements of Financial Accounting Standards, below industry practices that are widely recognized as generally accepted but that are not subject to due process. The Board believes the GAAP hierarchy should be directed to entities because it is the entity (not its auditors) that is responsible for selecting accounting principles for financial statements that are presented in conformity with GAAP. The adoption of FASB 162 is not expected to have a material impact on the Company’s financial statements.
In May 2008, the FASB issued FASB Staff Position No. APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement (FSP APB 14-1) that changes the method of accounting for convertible debt securities that require or permit settlement in cash either in whole or in part upon conversion. FSP APB 14-1 is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. Under FSP APB 14-1, the debt and equity components of convertible debt securities that may be settled in cash upon conversion will be bifurcated and accounted for separately in a manner that will result in recognizing interest expense on these securities at rates reflective of the entity’s borrowing rates for what the entity would have incurred had it issued nonconvertible debt with otherwise similar terms. The equity component of such convertible debt securities will be included in the paid-in-capital section of stockholders’ equity on the consolidated balance sheet and, accordingly, the initial carrying values of these debt securities will be reduced. Net loss for financial reporting purposes will be increased by recognizing the accretion of the reduced carrying value of the convertible debt securities to their face amounts as additional non-cash interest expense. The Company is currently evaluating the impact of FSP APB 14-1 on its financial statements, but has not yet determined the effect on its reporting of its consolidated financial position and results of operations.
F-10
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
In June 2008, the FASB ratified EITF Issue No. 07-5, Determining Whether an Instrument (or an Embedded Feature) Is Indexed to an Entity's Own Stock (EITF 07-5). EITF 07-5 provides that an entity should use a two step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument's contingent exercise and settlement provisions. It also clarifies on the impact of foreign currency denominated strike prices and market-based employee stock option valuation instruments on the evaluation. EITF 07-5 is effective for fiscal years beginning after December 15, 2008. The Company is currently evaluating the impact of EITF 07-5 on its financial statements, if any, that will occur upon the adoption of EITF 07-5.
Note 2 - Going Concern
These condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As of November 30, 2008, the Company has operating and liquidity concerns and, as a result of recurring losses, has incurred an accumulated deficit of $38,628,039. The Company will have to raise additional capital in order to initiate Phase IIb/III clinical trials for MCT-125, the Company’s therapeutic for the treatment of fatigue in multiple sclerosis patients. Management is evaluating several sources of financing for its clinical trial program. Additionally, with its strategic shift in focus to therapeutic programs and technologies, management expects the Company’s future cash requirements to increase significantly as it advances the Company’s therapeutic programs into clinical trials. Until the Company is successful in raising additional funds, it may have to prioritize its therapeutic programs and delays may be necessary in some of the Company’s development programs.
During the past year the Company has operated on working capital provided by La Jolla Cove Investors (LJCI). As further described in Note 7 to these consolidated financial statements, under terms of the agreement, LJCI can convert a portion of the convertible debenture by simultaneously exercising a warrant at $1.09 per share. As of November 30, 2008, there are 9,917,500 shares remaining on the stock purchase warrant and a balance of $99,175 remaining on the convertible debenture. Should LJCI continue to exercise all of its remaining warrants, approximately $10.8 million of cash would be provided to the Company. The agreement limits LJCI’s investment to an aggregate ownership that does not exceed 9.9% of the outstanding shares of the Company. The Company expects that LJCI will continue to exercise the warrants and convert the debenture over the next year.
These factors, among others, create an uncertainty about the Company’s ability to continue as a going concern. There can be no assurance that LJCI will continue to exercise its warrant to purchase the Company’s common stock, or that the Company will be able to successfully acquire the necessary capital to continue its on-going research efforts and bring its products to the commercial market. Management’s plans to acquire future funding include the potential sale of common and/or preferred stock, the sale of warrants, and continued sales of our proprietary media, immortalized cells and primary cells to the pharmaceutical industry. Additionally, the Company continues to pursue research projects, government grants and capital investment. The accompanying consolidated financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
F-11
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
Note 3– Property and Equipment
Property and equipment are recorded at cost, less accumulated depreciation, and is comprised of the following:
2008 | 2007 | |||||||
Lab Equipment | $ | 32,073 | $ | 125,550 | ||||
Furniture and Office Equipment | 40,574 | 49,035 | ||||||
72,647 | 174,585 | |||||||
Less: Accumulated depreciation | (57,146 | ) | (138,231 | ) | ||||
Property and Equipment, Net | $ | 15,501 | $ | 36,354 |
The Company recorded depreciation expense of $11,223 and $44,783 for the years ended November 30, 2008 and 2007, respectively.
Note 4– Intangible Assets
Intangible assets consisted of patents, patent rights obtained under licensing agreements, and patent application costs, and were amortized on a straight-line basis over the estimated useful life which was 18 years. As described in more detail below, in its annual review for impairment for the year ended November 30, 2008, the Company made the determination that the carrying value of intangible assets was probably in excess of estimated present value of future cash flows from the related assets and that there were not probable future cash flows from these assets.
The Company has reviewed its patent portfolio strategy related to its Toll-like receptor 3 (TLR3) technology acquired in September 2005 when MultiCell acquired the assets of Astral, Inc. This intellectual property is the subject of three patent applications, and is related to the Company's lead drug candidate MCT-465. The Company may decide to cease further prosecution of the subject patent applications and terminate its development work related to MCT-465. Accordingly, the Company has written down the value of the patent applications directly related to MCT-465 and recognized an impairment loss during the quarter ended November 30, 2008 in the amount of $1,061,365, leaving a carrying value of zero at November 30, 2008.
Note 5 – Notes Payable – Related Parties
The Company issued notes payable totaling $50,000 to two related parties during August 2008 and an additional $5,000 in November 2008. The notes accrue interest at 8.5% per year and are unsecured. The original notes in the amount of $50,000 and related accrued interest were due in December 2008, but have been extended to June 2009. The note in the amount of $5,000 is due in May 2009.
Note 6 – License Agreements
In September 2001, the Company completed the purchase of its cell line business and, as a result, it acquired an exclusive license agreement with Rhode Island Hospital for the use of four patents owned by the hospital related to liver cell lines and liver assist devices. The primary patent acquired and being utilized is for immortalized hepatocytes. As of November 30, 2006, management tested the carrying value of the license agreement for impairment and concluded that it had been impaired and reduced the carrying value to zero. The Company will pay the hospital a 5% royalty on net sales derived from licenses based upon the patented technology, until it has paid a total of $550,000. As of November 30, 2008, no significant payments had been made under this license agreement. After royalties totaling $550,000 have been paid, the Company pays a 2% royalty instead of a 5% royalty for the life of the patent.
F-12
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
On December 31, 2005, the Company entered into a worldwide Exclusive License Agreement (the “License Agreement”) with Amarin Neuroscience Limited (“Amarin”). Among other things, the License Agreement provides that Amarin shall grant to the Company and its affiliates an exclusive worldwide license with respect to therapeutic or commercial uses of certain technology of Amarin, including LAX-202 (to be renamed MCT-125), and the Company shall develop and seek to commercialize products based on such technology. The initial technology to be developed is Amarin’s LAX-202, which is a potential treatment for fatigue in patients diagnosed with multiple sclerosis. The agreement, which has a term equal to the life of the patents licensed, required MultiCell to make an initial non-refundable payment of $500,000 to Amarin in January 2006 in addition to a second non-refundable payment of $500,000 in May 2006. In addition, the parties shall have a four-year mutual option to exclusively negotiate with the other with respect to entering into a commercial agreement with respect to certain additional patents owned by Amarin related to the technology licensed to the Company. MultiCell will pay to Amarin (a) a one-time license fee, (b) milestone payments based on time, approval by the Food and Drug Administration of any products developed under the License Agreement, and sales by MultiCell of such products, and (c) royalty payments based on sales by MultiCell of any such products. Amarin shall retain ownership of all licensed patent rights under the License Agreement. The License Agreement further includes customary provisions related to, among other things, indemnification, insurance, maintenance of patent rights, confidentiality, and arbitration. On June 28, 2006, the Company entered into a letter agreement with Amarin amending the timing of the second license payment to be made to Amarin as outlined in the original License Agreement. In that letter agreement, the parties agreed to extend the deadline for the Company to make its second licensing payment which was to be made in May 2006. Under the terms of the agreement, the original second payment due to Amarin will be split into three payments. The first payment of $100,000 was made on July 17, 2006, the second payment was made on November 2, 2006, and the final payment for 2006 was made on December 13, 2006. Since no income can be projected from this license, the Company has recorded as a charge to research and development of $700,000 during the year ended November 30, 2007.
On April 20, 2007, the Company entered into a license agreement with Eisai Co., Ltd (“Eisai”). According to the agreement, the Company granted Eisai a nonexclusive license, which permits the use by Eisai of samples and culture media for the use of this patent and license. Eisai agreed to pay the Company 65 million yen (approximately US $545,000 based on exchange rates in effect at the time of the agreement) over a five-year period. The first payment of 13 million yen was due upon the signing of the agreement with subsequent four installments on the anniversary dates of the agreement. The Company has received the first two annual installments of 13 million yen ($109,070 and $121,030, based on exchange rates in effect at the time of payment, during the years ended November 30, 2007 and 2008, respectively). The Company is recognizing the income ratably over each year of the agreement. The Company has recognized income of $119,085 and $63,948 for the years ended November 30, 2008 and 2007, respectively. The balance of deferred revenue from this license is $47,067 and $45,122 at November 30, 2008 and 2007, respectively. The deferred revenue will be amortized into revenue through April 2009.
On October 9, 2007, the Company executed an exclusive license and purchase agreement (the “Agreement”) with Corning Incorporated (“Corning”) of Corning, New York. Under the terms of the Agreement, Corning has the right to develop, use, manufacture, and sell the Company’s Fa2N-4 cell lines and related cell culture media for use as a drug discovery assay tool, including biomarker identification for the development of drug development assay tools, and for the performance of absorption, distribution, metabolism, elimination and toxicity assays (ADME/Tox assays). The Company retained and will continue to support all of its existing licensees, including Pfizer, Bristol-Myers Squibb, and Eisai. The Company retains the right to use the Fa2N-4 cells for use in applications not related to drug discovery or ADME/Tox assays. The Company also retains rights to use the Fa2N-4 cell lines and other cell lines to further develop its Sybiol® liver assist device, to produce therapeutic proteins using the Company’s BioFactories™ technology, to identify drug targets and for other applications related to the Company’s internal drug development programs. In consideration for the license granted, Corning paid the Company $375,000 upon execution of the Agreement, and an additional $375,000 upon the completion of a transition period. In addition, Corning purchased inventory and equipment from the Company and reimbursed the Company for laboratory costs and other expenses during a transition period. The Company is recognizing the income ratably over a 17 year period. The Company recognized $44,118 and $7,353 in income for the year ended November 30, 2008 and 2007, respectively. The balance of deferred revenue from this license is $698,529 and $742,647 at November 30, 2008 and 2007, respectively, and will be amortized into revenue through October 2024.
F-13
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
The Company has another license agreement with Pfizer, for which revenue is being deferred. During the years ended November 30, 2008 and 2007, the Company recognized $5,200 in each year and the balance of the deferred revenue from this license is $46,800 and $52,000 at November 30, 2008 and 2007, respectively, and will be amortized into revenue through January 2018.
On December 1, 2005, the Company entered into a Research Agreement (the “Agreement”) with the Trustees of Columbia University (“Columbia”). The Company was to provide financial support for the research during the two year term of the Agreement in an aggregate amount of at least approximately $310,000, subject to certain adjustments. The Company also paid Columbia an additional $50,000 in consideration of Columbia’s grant to the Company of an option to enter into an exclusive worldwide license for any invention resulting from the research, subject to certain conditions. During 2007, the Company terminated the Agreement with Columbia University. As a result of the termination of the Agreement, the Company was no longer liable for financial support and eliminated the amount accrued as an offset to research and development charges during the year ended November 30, 2007.
Note 7- Convertible Debentures
On February 28, 2007, the Company entered into a Debenture Purchase Agreement (the “Debenture Purchase Agreement”) with La Jolla Cove Investors, Inc. (“LJCI”) pursuant to which the Company sold a convertible debenture to LJCI in the principal amount of $1,000,000 (receivable in four payments) maturing on February 28, 2008 (the “Initial Debenture”). The first payment of $250,000 was received by the Company on March 7, 2007. The Initial Debenture accrued interest at 7.75% per year, payable monthly in cash or common stock. Under the terms of this agreement, certain officers, director and shareholders of the Company pledged 2,527,638 shares of common stock and guaranteed the repayment of a $250,000 advance against the Initial Debenture. As of November 30, 2007, LJCI had sold all of the pledged shares, received proceeds of $202,081, and reduced the amount due on the advance to $47,919. At November 30, 2007, the proceeds from the sale of the pledged shares was recorded as a liability in the amount of $202,081 to the stockholders and affiliates who had pledged their stock as collateral on the Initial Debenture. LJCI notified the Company that it intended to convert the remaining balance into shares of the Company’s common stock subject to the terms set forth in the Debenture Purchase Agreement. During the year ended November 30, 2008, LJCI converted the remaining $47,919 of the Initial Debenture into 4,710,250 shares of common stock.
The Initial Debenture was convertible at the option of LJCI at a conversion price equal to the lesser of the fixed conversion price of $1.00, or 80% of the average of the lowest three daily volume weighted average trading prices per share of the Company’s common stock during the twenty trading days immediately preceding the conversion date. For the Initial Debenture, if the holders elected to convert a portion of the debentures and, on the day that the election was made, the volume weighted average price was below $0.16, the Company would have the right to repay that portion of the debenture that the holder elected to convert, plus any accrued and unpaid interest, at 150% of each amount. In the event that the Company elected to repay that portion of the debenture, holder would have the right to withdraw its conversion notice.
F-14
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
Based on the excess of the aggregate fair value of the common shares that would have been issued if the $250,000 convertible debentures had been converted immediately over the proceeds allocated to the convertible debentures, the investors received a beneficial conversion feature for which the Company recorded an increase in additional paid-in-capital of $62,500, which has been amortized into interest expense over the term of the Initial Debenture through February 28, 2008.
The Company also entered into a Securities Purchase Agreement with LJCI on February 28, 2007 pursuant to which the Company agreed to sell a convertible debenture in the principal amount of $100,000 and maturing on February 28, 2012 (the “Second Debenture”). The Second Debenture accrues interest at 4.75% per year, payable at each conversion date, in cash or common stock at the option of LJCI. The proceeds from the Second Debenture were deposited on March 5, 2007. In connection with the Second Debenture, the Company issued LJCI a warrant to purchase up to 10 million shares of our common stock (the “LJCI Warrant”) at an exercise price of $1.09 per share, exercisable over the next five years according to a schedule described in a letter agreement dated February 28, 2007. Pursuant to the terms of the LJCI Warrant, upon the conversion of any portion of the principal amount of the Second Debenture, LJCI is required to simultaneously exercise and purchase that same percentage of the warrant shares equal to the percentage of the dollar amount of the Second Debenture being converted. Therefore, for each $1,000 of the principal converted, LJCI would be required to simultaneously purchase 100,000 shares under the LJCI Warrant at $1.09 per share. The agreement limits LJCI’s investment to an aggregate common stock ownership that does not exceed 9.99% of the outstanding common shares of the Company.
The Second Debenture is convertible at the option of LJCI at any time up to maturity into the number of shares determined by the dollar amount of the Second Debenture being converted multiplied by 110, minus the product of the Conversion Price multiplied by 100 times the dollar amount of the Second Debenture being converted, with the entire result divided by the Conversion Price. The Conversion Price is equal to the lesser of $1.00 or 80% of the average of the three lowest volume-weighted average prices during the twenty trading days prior to the election to convert. During the year ended November 30, 2008, LJCI converted $825 of the Second Debenture into 19,384,509 shares of common stock. Simultaneously with these conversions, LJCI exercised warrants to purchase 82,500 shares of the Company’s common stock. Proceeds from the exercise of the warrants were $89,925. As of November 30, 2008, the remainder of the Second Debenture in the amount of $99,175 could have been converted by LJCI into approximately 4.5 billion shares of common stock, which would require LJCI to simultaneously exercise and purchase all of the remaining 9,917,500 shares of common stock under the LJCI Warrant at $1.09 per share. For the Second Debenture, upon receipt of a conversion notice from the holder, the Company may elect to immediately redeem that portion of the debenture that holder elected to convert in such conversion notice, plus accrued and unpaid interest. After February 28, 2008, the Company, at its sole discretion, has the right, without limitation or penalty, to redeem the outstanding principal amount of this debenture not yet converted by the holder into common stock, plus accrued and unpaid interest thereon.
A discount representing the value of 10 million warrants issued in the amount of $73,727 was recorded as a reduction to the note. The discount was calculated based on the relative fair values of the convertible debenture and the warrants. The fair value of the warrants used in the above calculation was determined under the Black-Scholes option-pricing model. Additionally, based on the excess of the aggregate fair value of the common shares that would have been issued if the Second Debenture had been converted immediately over the proceeds allocated to the convertible debenture, the investors received a beneficial conversion feature for which the Company recorded an increase in additional paid-in-capital of $26,273 and a corresponding discount to the debenture. These discounts, in the aggregate amount of $100,000, are being amortized over the 60-month term of the debenture as a charge to interest expense. The balance of the unamortized discount was $65,000 and $85,000 at November 30, 2008 and 2007, respectively.
F-15
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
Pursuant to the Registration Rights Agreement with LJCI dated February 28, 2007 (the "Rights Agreement"), the Company agreed to register for resale under the Securities Act of 1933, as amended, 12,000,000 shares of common stock issuable upon conversion of the Initial Debenture, and to use commercially reasonable best efforts to have the Registration Statement declared effective by May 29, 2007. There is no guarantee that the SEC will declare the Registration Statement effective. In the event that the Registration Statement is not declared effective by the required dates, then LJCI may claim the Company is in default on these agreements, and the Company may face certain liquidated damages in addition to other rights that LJCI may have. As of November 30, 2008, the Registration Statement had not been declared effective by the SEC and the Company has not received notice of default from LJCI.
The liquidation damages of LJCI’s option include a decrease in the discount multiplier used to calculate the conversion price of the debentures or an acceleration of maturity. LJCI will not claim, and has not claimed these damages, however, if the Company used commercially reasonable best efforts to obtain effectiveness of this Registration Statement or changes in the Commission's policies or interpretations make the Company unable to obtain effectiveness of this Registration Statement. The debentures required the Company to register the shares of common stock into which the debentures could be converted by the holder with the SEC. The Company was unable to obtain SEC approval to register the subject shares, and consequently, the Company and LJCI agreed to terminate the Debenture Purchase Agreement and to allow LJCI to sell the common shares pledged as collateral under the Debenture Purchase Agreement.
Note 8 – Series B Redeemable Convertible Stock
The Company’s Board of Directors has the authority, without further action by the stockholders, to issue up to 1,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions of these shares of preferred stock. The Board of Directors has designated 17,000 shares as Series B convertible preferred stock. The Series B preferred stock does not have voting rights. On July 14, 2006, the Company completed a private placement of Series B convertible preferred stock. A total of 17,000 Series B shares were sold to accredited investors at a price of $100 per share. Proceeds to the Company were $1,660,000, net of $40,000 of issuance costs
The Series B convertible preferred stock is subject to redemption under certain conditions. Until the earlier of (a) two (2) years after the closing date or (b) the date upon which all of the Series B shares have been converted into common stock, the purchasers shall have a right of first refusal on any financing in which the Company is the issuer of debt or equity securities. If (a) the Company raises debt or equity financing during the right of first refusal period or (b) the Company’s common stock is trading below the conversion price of the Series B shares at the time of such financing, and (c) the purchasers do not exercise their right of first refusal, then the Company shall, at the option of any purchaser, use 25% of the net proceeds from such financing to redeem such purchasers’ shares of Series B preferred stock or common stock, as determined by such purchaser. Series B shares so redeemed shall be redeemed at $100 per share, plus accrued and unpaid dividends thereon, and shares of common stock so redeemed shall be redeemed at a price per share equal to the value weighted average closing price of the Company’s Common Stock over the immediately preceding five trading days, plus accrued and unpaid dividends thereon. In addition, if an event of default (as defined in the agreement) occurs, the conversion price of the Series B shares (as set forth below) shall be reduced to 85% of the then applicable conversion price of such shares. The conversion price is also reduced as the result of the exercise of warrants or other issuances of common stock at prices lower than the prior conversion price. The new conversion price is determined by dividing the proceeds received under that transaction by the prior conversion price, adding the results to the number of shares outstanding prior to the transaction, and by dividing that sum by the shares outstanding after the transaction multiplied by the prior conversion price.
The Series B shares are only conditionally redeemable as described above and are therefore not classified as a liability. However, redemption of the Series B shares is not under the control of the Company; therefore, the Series B preferred stock is classified outside of permanent equity.
F-16
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
During the fiscal year ended November 30, 2007 the Company drew proceeds from the Company’s equity line of credit facility with Fusion Capital in the amount of $450,000. The purchasers required the Company to use 25% of the gross proceeds received by the Company under such equity line to repurchase and redeem purchaser’s Series B shares or Series B preferred shares converted into common stock, as determined in the discretion of such purchaser. During the year ended November 30, 2007, the Company redeemed 615 shares at $100 per share for a total of $61,500. During the year ended November 30, 2006, 123 shares were redeemed for a total of $12,300.
The Series B shares are convertible at any time into common stock at a conversion price determined by dividing the purchase price per share of $100 by the conversion price. The conversion price was originally $0.32 per share. The conversion price is subject to equitable adjustment in the event of any stock splits, stock dividends, recapitalizations and the like. In addition, the conversion price is subject to weighted average anti-dilution adjustments in the event the Company sells common stock or other securities convertible into or exercisable for common stock at a per share price, exercise price or conversion price lower than the conversion price then in effect in any transaction (other than in connection with an acquisition of the securities, assets or business of another company, joint venture and employee stock options). As a result of the Company issuing common stock upon conversion of convertible debentures and upon the exercise of warrants both at prices lower than the conversion price, and due to the Company not paying Series B dividends on a monthly basis, the conversion price of the Series B preferred stock has been reduced to $0.2123 per share as of November 30, 2008. The conversion of the Series B preferred stock is limited for each investor to 9.99% of the Company’s common stock outstanding on the date of conversion.
Commencing on the date of issuance of the Series B preferred stock until the date a registration statement registering the common shares underlying the preferred stock and warrants issued is declared effective by the SEC, the Company will pay on each outstanding share of Series B preferred stock a preferential cumulative dividend at an annual rate equal to the product of multiplying $100 per share by the higher of the Wall Street Journal Prime Rate plus 1%, or 9%. In no event will the dividend rate be greater than 12% per annum. The dividend will be payable monthly in arrears in cash on the last day of each month based on the number of shares of Series B preferred stock outstanding as of the first day of that month. In the event the Company does not pay the Series B preferred dividends when due, the conversion price of the Series B preferred shares is reduced to 85% of the otherwise applicable conversion price. The Company has not paid the required monthly Series B preferred dividends since November 30, 2006, which, in part, has caused the conversion price to be reduced, as explained above. During the years ended November 30, 2008 and 2007, the Company accrued preferred dividends in the amounts of $149,203 and $151,548, respectively, on the Series B preferred stock. Total accrued preferred dividends on the Series B preferred stock are $300,752 at November 30, 2008 and $151,548 at November 30, 2007, and are reported as part of the carrying value of the Series B redeemable convertible preferred stock in the accompanying balance sheet.
In the event of any dissolution or winding up of the Company, whether voluntary or involuntary, holders of each outstanding share of Series B preferred stock shall be entitled to be paid second in priority to the Series I preferred stock holders out of the assets of the Company available for distribution to stockholders, an amount equal to $100 per share of Series B convertible preferred stock held plus any declared but unpaid dividends. After such payment has been made in full, such holders of Series B convertible preferred stock shall be entitled to no further participation in the distribution of the assets of the Company.
Note 9 – Series I Convertible Preferred Stock
The Company’s Board of Directors has the authority, without further action by the stockholders, to issue up to 1,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions of these shares of preferred stock. The Board of Directors originally designated 20,000 shares as Series I convertible preferred stock. On July 13, 2004, the Company completed a private placement of Series I convertible preferred stock. A total of 20,000 shares were sold to accredited investors at a price of $100 per share.
F-17
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
The Series I shares are convertible at any time into common stock at 80% of the average trading price of the lowest three inter-day trading prices of the common stock for the ten days preceding the conversion date, but at an exercise price of no more than $1.00 per share and no less than $.25 per share. The conversion of the Series I preferred stock is limited to 9.99% of the Company’s common stock outstanding on the date of conversion. During the year ended November 30, 2008, Series I preferred stockholders converted 6,466 shares of preferred stock into 2,586,400 shares of the Company’s common stock.
The Series I preferred stock does not have voting rights. In the event of any dissolution or winding up of the Company, whether voluntary or involuntary, holders of each outstanding share of Series I convertible preferred stock shall be entitled to be paid first out of the assets of the Company available for distribution to stockholders, an amount equal to $100 per share of Series I preferred stock held. After such payment has been made in full, such holders of Series I convertible preferred stock shall be entitled to no further participation in the distribution of the assets of the Company.
Note 10 – Common Stock
On January 31, 2008, the Company issued 2,527,638 shares of its common stock to the stockholders and affiliates who had pledged their stock as collateral for the Initial Debenture with La Jolla Cove Investors, Inc. (LJCI). See Note 7 to these consolidated financial statements for further discussion. This issuance of common stock satisfied the liability in the amount of $202,081 recorded during the year ended November 30, 2007 when LJCI sold the pledged shares of common stock and applied the proceeds from the sale against the balance of the Initial Debenture.
During the year ended November 30, 2008, the Company issued 5,247,807 shares of common stock to a consultant in satisfaction of accounts payable for services performed in the amount of $79,250, or an average of approximately $0.015 per share.
During the year ended November 30, 2006, the Company entered into a common stock purchase agreement with Fusion Capital. Under the agreement, Fusion Capital was obligated, under certain conditions, to purchase shares from the Company up to an aggregate amount of $8 million from time to time over a 25 month period. The Company authorized 8,000,000 shares of its common stock for sale to Fusion Capital under the agreement. The number of shares ultimately offered for sale by Fusion Capital was dependent upon the number of shares purchased by Fusion Capital under the agreement. The Company did not have the right to commence any sales of its shares to Fusion Capital until the SEC has declared effective the registration statement. After the SEC has declared effective such registration statement, generally the Company had the right but not the obligation from time to time to sell its shares to Fusion Capital in amounts between $50,000 and $1 million depending on certain conditions. The Company had the right to control the timing and amount of any sales of its shares to Fusion Capital. The purchase price of the shares was determined based upon the market price of the Company’s shares without any fixed discount. Fusion Capital did not have the right nor the obligation to purchase any shares of the Company’s common stock on any business day that the price of its common stock was below $0.20. During the year ended November 30, 2007, the Company issued 2,022,074 shares to Fusion Capital for a value of $450,000. The agreement was terminated by mutual agreement on July 18, 2007.
During the year ended November 30, 2007, the Company issued 8,189,204 shares of common stock to the members of the Board of Directors and to consultants for services performed and in settlement of certain accrued expenses. The total value of the shares issued was $894,148, or an average of approximately $0.109 per share.
F-18
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
The potential issuable common shares as of November 30, 2008 and 2007 are as follows:
2008 | 2007 | |||||||
Warrants | 27,052,862 | 35,440,946 | ||||||
Stock options | 2,000,000 | 2,210,000 | ||||||
Series B Redeemable Convertible Preferred Stock | 7,659,915 | 3,543,438 | ||||||
Series I Convertible Preferred Stock | 2,293,600 | 4,880,000 | ||||||
LJCI Second Debenture | 4,485,652,555 | 266,595,967 | ||||||
4,524,658,932 | 312,670,351 |
The Company does not currently have sufficient authorized shares of common stock to meet the commitments entered into under the Second Debenture and the related LJCI Warrants. As further discussed in Note 7, upon the conversion of any portion of the remaining $99,175 principal amount of the Second Debenture, LJCI is required to simultaneously exercise and purchase that same percentage of the remaining 9,917,500 warrant shares equal to the percentage of the dollar amount of the Second Debenture being converted. The agreement limits LJCI’s investment to an aggregate common stock ownership that does not exceed 9.99% of the outstanding common shares of the Company. Furthermore, the Company has the right to redeem that portion of the Second Debenture that the holder may elect to convert and also has the right to redeem the outstanding principal amount of the debenture not yet converted by the holder into common stock, plus accrued and unpaid interest thereon.
Note 11 – Stock Compensation Plans
Effective February 15, 2000, the Company adopted a 2000 Stock Incentive Plan and a 2000 Employee Benefit Plan which authorizes the granting of shares and options to employees, outside directors, consultants, and vendors. The 2000 Stock Incentive Plan and 2000 Employee Benefit Plan were approved by shareholders at the May 2000 annual meeting. Under the Plans, awards are made in the form of restricted shares or options, which may constitute incentive stock options (“ISO”) or nonstatutory stock options (“NSO”). Only employees of the Company are eligible for the grant of incentive stock options.
2000 Stock Incentive Plan. The total number of options and restricted shares that could have been awarded under the 2000 Stock Incentive Plan initially was 1,000,000. As of the first day of each calendar year commencing January 1, 2001, this total automatically increased by 2% of the total number of common shares then outstanding or 100,000 shares, whichever was less. The option price, number of shares, grant date, and vesting period are determined at the discretion of the Company’s Board of Directors. The exercise price of each ISO granted under the plan must equal 100% of the market price of the Company’s stock on the date of grant. The exercise price of each NSO grant under the plan cannot be less than 85% of the market price of the Company’s stock on the date of grant. An option’s maximum term is 10 years. As of November 30, 2004, the total number of options that were authorized for issuance under the 2000 Stock Incentive Plan had increased from 1,000,000 shares to 1,400,000. However, the Company has issued more options than were authorized under the 2000 Stock Incentive Plan. This was necessary to provide an incentive to key employees to stay with the Company or one of its subsidiaries. The Company obtained stockholders’ approval for an increase in the number of options authorized for issuance at its stockholders’ meeting. There are no shares of common stock available for future grants under this plan at November 30, 2008.
2000 Employee Benefit Plan. On July 3, 2000, the Company filed an S-8 registration statement (the “Registration Statement”) with the Securities and Exchange Commission regarding its 2000 Employee Benefit Plan to register 7,000,000 shares of the Company’s common stock issuable under the plan. One or more Performance Awards may be granted under the plan to any eligible person providing services to or for the Company. The value of such awards may be linked to the market value, book value or other measure of the value of the common stock or other specific performance criteria determined appropriate by the Board of Directors or the Compensation Committee (the “Committee”). The Board or the Committee may approve stock payments to eligible persons who elect to receive such payments in the manner determined by the Board or the Committee. The total number of shares that can be awarded under the 2000 Employee Benefit Plan is 7,000,000. There are no shares of common stock available for future grants under this plan at November 30, 2008.
F-19
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
2004 Equity Incentive Plan. Effective June 16, 2004, the Company adopted an equity incentive plan, which authorizes the granting of stock awards to employees, directors, and consultants. The purpose of the plan is to provide a means by which eligible recipients of stock awards may be given the opportunity to benefit from increases in the value of the common stock through granting of incentive stock options, non-statutory stock options, stock purchase awards, stock bonus awards, stock appreciation rights, stock unit awards and other stock awards. The shares of common stock may be issued pursuant to stock awards shall not exceed in the aggregate 5,000,000 shares of common stock plus an annual increase to be added of the first day of each Company fiscal year, beginning in 2005 and ending in (and including) 2013, equal to the lesser of the following amounts: (a) 2% of the Company’s outstanding shares of common stock on the day preceding the first day of such fiscal year; (b) 1,500,000 shares of common stock; or (c) an amount determined by the Board. Incentive stock options may be granted only to employees. The exercise price of each ISO granted under the plan must equal 100% of the market price of the Company’s stock on the date of the grant. A 10% stockholder shall not be granted an incentive stock option unless the exercise price of such option is at least 110% of the fair market value of the common stock on the date of the grants and the option is not exercisable after the expiration of five years from the date of the grant. The Board, in its discretion, shall determine the exercise price of each nonstatutory stock option. An option’s maximum term is 10 years. There are 109,739 shares of common stock available for future grants under this plan at November 30, 2008.
The Company accounts for stock options under Statement of Financial Accounting Standards 123R (SFAS 123R). SFAS 123R requires the recognition of the cost of employee services received in exchange for an award of equity instruments in the financial statements and is measured based on the grant date fair value of the award. SFAS 123R also requires the stock option compensation expense to be recognized over the period during which an employee is required to provide service in exchange for the award (the vesting period), net of estimated forfeitures. The estimation of forfeitures requires significant judgment, and to the extent actual results or updated estimates differ from the current estimates, such resulting adjustment will be recorded in the period estimates are revised. No income tax benefit has been recognized for stock-based compensation arrangements and no compensation cost has been capitalized in the balance sheet.
F-20
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
A summary of the status of stock options at November 30, 2008 and 2007, and changes during the years then ended is presented in the following table:
Weighted | |||||||||||||
Weighted | Average | ||||||||||||
Shares | Average | Remaining | Aggregate | ||||||||||
Under | Exercise | Contractual | Intrinsic | ||||||||||
Option | Price | Life | Value | ||||||||||
Outstanding at November 30, 2006 | 2,860,000 | $ | 1.16 | 3.0 years | $ | — | |||||||
Granted | 350,000 | 0.16 | |||||||||||
Exercised | — | — | |||||||||||
Expired | (1,000,000 | ) | 0.94 | ||||||||||
Outstanding at November 30, 2007 | 2,210,000 | $ | 1.09 | 2.3 years | $ | — | |||||||
Granted | — | — | |||||||||||
Exercised | — | — | |||||||||||
Expired | (210,000 | ) | 0.51 | ||||||||||
Outstanding at November 30, 2008 | 2,000,000 | $ | 1.16 | 1.4 years | $ | — | |||||||
Exercisable at November 30, 2008 | 1,861,944 | $ | 1.24 | 1.3 years | $ | — |
There were no options granted during the year ended November 30, 2008. For grants during the year ended November 30, 2007, the Company’s weighted average assumptions used in determining fair value under the Black-Scholes model for expected volatility, dividends, expected term, and risk-free interest rate were 73% to 146%; 0%; 1.58 to 5 years; and 3.26% to 4.96%; respectively. Expected volatility is based on the historical volatility of the Company’s common stock. The expected term of options is estimated based on historical exercise patterns. The risk-free rate is based on U.S.Treasury yields for securities in effect at the time of grant with terms approximating the expected term until exercise of the option. The weighted average grant date fair value of options granted during the year ended November 30, 2007 was $0.16.
For the years ended November 30, 2008 and 2007, the Company reported compensation expense for services related to stock options and warrants of $26,949 and $316,839, respectively. As of November 30, 2008, there is no unrecognized compensation cost related to stock options granted in the past that will be recognized in the future.
Note 12 – Warrants
As further described in Note 7 to these consolidated financial statements, the Company also entered into a Securities Purchase Agreement with La Jolla Cove Investors (LJCI) on February 28, 2007 pursuant to which the Company agreed to sell a convertible debenture in the principal amount of $100,000. In connection with this debenture, the Company issued LJCI a warrant to purchase up to 10 million shares of our common stock at an exercise price of $1.09 per share, exercisable over the next five years according to a schedule described in a letter agreement dated February 28, 2007. Pursuant to the terms of this warrant, upon the conversion of any portion of the principal amount of the related debenture, LJCI is required to simultaneously exercise and purchase that same percentage of the warrant shares equal to the percentage of the dollar amount of the debenture being converted. Therefore, for each $1,000 of the principal converted, LJCI would be required to simultaneously purchase 100,000 shares under the warrant at $1.09 per share.
On February 28, 2007, as consideration for consulting fees, the Company issued to Capstone Investments a warrant to purchase 100,000 shares of the Company’s common stock at an exercise price $0.2875 per share. The warrant has a term of five years and vested immediately. The Company recorded a charge of $20,285 to selling, general and administrative expense during the year ended November 30, 2007, based on fair value of this warrant issued as determined by Black-Scholes option pricing model.
F-21
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
On February 28, 2007, as more fully described in Note 7 to these consolidated financial statements, as consideration for pledging 2,527,638 of the shares of the Company’s common stock owned by certain officers, directors and major stockholders, each pledgor received a stock purchase warrant equal to 110% of the number of shares pledged, or a total of 2,780,401 warrants. The warrants have a term of five years and vested immediately. The Company recorded a charge of $354,358 to selling, general and administrative expense during the year ended November 30, 2007, based on fair value of this warrant issued as determined by Black-Sholes option pricing model.
On February 28, 2007, as consideration for consulting fees, the Company issued to eight consultants warrants to purchase an aggregate of 400,000 shares of the Company’s common stock at an exercise price $0.20 per share. The warrants have a term of ten years and vested immediately. The Company recorded a charge of $50,976 during the year ended November 30, 2007, based on fair value of this warrant issued as determined by Black-Scholes option pricing model.
As more fully discussed in Note 7 to these consolidated financial statements, LJCI exercised warrants to purchase 82,500 shares of the Company’s common stock. Proceeds from the exercise of the warrants were $89,925.
A summary of the status of warrants at November 30, 2008 and 2007, and changes during the years then ended is presented in the following table:
Shares | ||||
Under | ||||
Warrants | ||||
Outstanding at November 30, 2006 | 23,160,545 | |||
Granted | 13,280,401 | |||
Exercised | — | |||
Expired | (1,000,000 | ) | ||
Outstanding at November 30, 2007 | 35,440,946 | |||
Granted | — | |||
Exercised | (82,500 | ) | ||
Expired | (8,305,584 | ) | ||
Outstanding at November 30, 2008 | 27,052,862 |
Note 13 – Lease Commitment
During the years ended November 30, 2008 and 2007, the Company has leased facilities in Rhode Island and in California that have housed activities related to administration, research and development. The Company’s lease in California expired in August 2007 and was not renewed. The Company currently leases space in Rhode Island under a one-year lease that expires in April 2009. Current rent is $790 per month.
Rent expense under the Company’s operating leases was $12,671 and $187,453 for the years ended November 30, 2008 and 2007, respectively.
F-22
MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
Note 14 – Income Taxes
The Company provides for income taxes using an asset and liability based approach. Deferred income tax assets and liabilities are recorded to reflect the tax consequences of temporary differences between the financial statement and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.
As of November 30, 2008, the Company has U.S. Federal operating loss carryforwards of approximately $23 million. The operating losses expire, if not used, from 2009 through 2028. The Company had net deferred tax assets of approximately $9.4 million and $8.6 million at November 30, 2008 and 2007 relating primarily to the net operating loss carryforwards generated by its operations. For financial statement purposes, the deferred tax assets have been fully offset by valuation allowances due to the uncertainties related to the extent and timing of the Company’s future taxable income.
A reconciliation of the expected income tax benefit at the U.S. Federal income tax rate to the income tax benefit actually recognized for the years ended November 30, 2008 and 2007 is set forth below:
2008 | 2007 | |||||||
Benefit at federal statutory rate (34%) | $ | (712,278 | ) | $ | (1,078,697 | ) | ||
State income tax benefit, net of federal tax | (122,814 | ) | (148,080 | ) | ||||
Tax effect of nondeductible permanent differences | 9,301 | 231,088 | ||||||
Change in valuation allowance | 825,791 | 995,689 | ||||||
Benefit from Income Taxes | $ | — | $ | — |
Note 15 – Grant Income
On June 22, 2006, The National Institutes of Health awarded a grant in the amount of $210,000 to treat Type 1 Diabetes. During the year ended November 30, 2007, the Company received $99,960 under this grant and has accounted for this as an offset to research and development expenses for the year.
Note 16– Contingent Liability
On May 14, 2008, one of our stockholders, George Colin, filed a lawsuit against the Company and W. Gerald Newmin in the Superior Court of California – City of Orange, alleging causes of action for breach of written contract and intentional misrepresentation. The plaintiff seeks general damages to be determined at trial, special and consequential damages according to proof, fees and costs, plus interest. The Company and Mr. Newmin believe this claim is without merit and both parties intend to vigorously defend the action.
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MULTICELL TECHNOLOGIES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
For the Years Ended November 30, 2008 and 2007
Note 17– Subsequent Events
Conversion of Debentures and Exercise of Stock Warrants
As further described in Note 7 to these consolidated financial statements, the Company is subject to a Securities Purchase Agreement with La Jolla Cove Investors (LJCI) dated February 28, 2007 pursuant to which the Company agreed to sell a convertible debenture in the original principal amount of $100,000. The debenture is convertible at the option of LJCI into the number of shares determined by the dollar amount of the debenture being converted multiplied by 110, minus the product of the conversion price multiplied by 100 times the dollar amount of the debenture being converted, with the entire result divided by the conversion price. The conversion price is equal to the lesser of $1.00 or 80% of the average of the three lowest volume-weighted average prices during the twenty trading days prior to the election to convert. In connection with the debenture, the Company issued LJCI a warrant to purchase up to 10 million shares of our common stock at an exercise price of $1.09 per share. Pursuant to the terms of the warrant, upon the conversion of any portion of the principal amount of the debenture, LJCI is required to simultaneously exercise and purchase that same percentage of the warrant shares equal to the percentage of the dollar amount of the debenture being converted. Therefore, for each $1,000 of the principal converted, LJCI would be required to simultaneously purchase 100,000 shares under the warrant at $1.09 per share. The agreement limits LJCI’s investment to an aggregate common stock ownership that does not exceed 9.99% of the outstanding common shares of the Company.
During the period subsequent to November 30, 2008 through March 9, 2009, LJCI converted $2,340 of the debenture into 57,048,967 shares of common stock. Simultaneously with these conversions, LJCI exercised warrants to purchase 234,000 shares of the Company’s common stock. Proceeds from the exercise of the warrants were $255,060.
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