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| MCET > SEC Filings for MCET > Form 10-Q on 16-Apr-2012 | All Recent SEC Filings |
16-Apr-2012
Quarterly Report
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. This discussion and analysis should be read in conjunction with our financial statements and accompanying notes included elsewhere in this report. Operating results are not necessarily indicative of results that may occur in future periods.
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: our plans to pursue research and development of therapeutics in addition to continuing to advance our cellular systems business, our plans to become an integrated biopharmaceutical company, our use of proprietary cell-based systems and immune system modulation technologies to discover, develop and commercialize new therapeutics, our plans to continue to operate our business and minimize expenses, our expectations regarding future cash expenditures increasing significantly, our intent to gradually add scientific and support personnel, the expansion of our product offerings, additional revenues and profits, our ability to complete strategic mergers and acquisitions of product candidates, plans to increase further our operating expenses and administrative resources, future potential direct product sales, the sale of additional equity securities, debt financing and/or the sale or licensing of our technologies.
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 under the "Risk Factors" section beginning on page 24 of this report and the "Risk Factors" section included in our Annual Report filed on Form 10-K for the year ended November 30, 2011.
Overview
MultiCell is a biopharmaceutical company developing novel therapeutics and discovery tools to address unmet medical needs for the treatment of neurological disorders, hepatic disease, cancer and interventional cardiology and peripheral vessel applications. 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.
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. 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.
Our therapeutic development platform includes several patented techniques used
to: (i) isolate, characterize and differentiate stem cells from human liver, or
(ii) control the immune response at transcriptional and translational levels
through dsRNA-sensing molecules such as Toll-like receptor (TLR), RIG-I-like
receptor (RLR), and MDA-5 signaling, or (iii) generate specific and potent
immunity against key tumor targets through a novel immunoglobulin platform
technology, (iv) modulate the noradrenaline-adrenaline neurotransmitter pathway,
and (v) the design of next-generation bioabsorbable stents, the Ideal BioStent™,
for interventional cardiology and peripheral vessel applications.
On July 5, 2011, MultiCell Technology, Inc., or the Company, entered into a sponsored research agreement with the University Health Network, or UHN, a not-for-profit corporation incorporated under the laws of Canada. Under this agreement UHN will evaluate the Company's product candidates, MCT-465 and MCT-485, in in vitro models for the treatment of primary liver cancer. The mechanism of action of MCT-465 and MCT-485 and their potential selective effect on liver cancer stem cells will also be evaluated. Under the terms of the agreement, the Company will retain exclusive access to the research findings and intellectual property resulting from the research activities preformed by UHN.
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.
On September 30, 2010, Xenogenics entered into a Foreclosure Sale Agreement ("Foreclosure Sale Agreement") with Venture Lending & Leasing IV, Inc., Venture Lending & Leasing V, Inc. and Silicon Valley Bank (collectively, the "Sellers"). Pursuant to the Foreclosure Sale Agreement, Xenogenics acquired all of the Sellers' interests in certain bioabsorbable stent assets (known as "Ideal BioStent™") and related technologies.
Effective September 30, 2010, Xenogenics entered into a license agreement (the "Rutgers License Agreement") with Rutgers, The State University of New Jersey ("Rutgers"). Pursuant to the Rutgers License Agreement, Rutgers granted Xenogenics a worldwide exclusive license to exploit and commercialize certain patents and other intellectual property rights, as further described in the Rutgers License Agreement, relating to bioabsorbable stents for interventional cardiology and peripheral vascular applications.
Results of Operations
The following discussion is included to describe our consolidated financial position and results of operations. The condensed consolidated financial statements and notes thereto contain detailed information that should be referred to in conjunction with this discussion.
Three Months Ended February 29, 2012 Compared to the Three Months Ended February 28, 2011
Revenue. Total revenue for the three months ended February 29, 2012 and February 28, 2011 was $12,329 and $12,329, respectively. All of the revenue for the quarters ended February 29, 2012 and February 28, 2011 is from license revenue under agreements with Corning and Pfizer.
Operating Expenses. Total operating expenses for the three months ended February 29, 2012 were $297,870, compared to operating expenses for the three months ended February 28, 2011 of $391,144, representing a decrease of $93,274. This decrease was substantially due to a decrease of $105,009 in the amount of stock-based compensation recognized during the three-month periods for options recently granted by our subsidiary, Xenogenics. As more fully discussed in Note 7 to the accompanying condensed consolidated financial statements, Xenogenics granted options to certain prospective officers and to the members of its scientific advisory board in November 2010 and March 2011. During the three months ended February 28, 2011, share-based compensation included $106,562 related to these recently granted options by Xenogenics. During the three months ended February 29, 2012, share-based compensation included $59,278 related to these options. However, in addition to this decrease in share-based compensation of $47,284, there was a reversal of $57,725 of previously-recognized share-based compensation for one of these options that had performance requirements that were not satisfied prior to the deadline of December 31, 2011 for satisfying the requirements, and that was not replaced by the grant of a new option shortly after forfeiture.
Additionally, there was a decrease in legal, consulting, and other professional fees of $16,865 and an increase in all other remaining operating costs of $19,355.
Other income/(expense). Other income (expense) amounted to net expense of $4,349
for the three months ended February 29, 2012 as compared to net income of
$38,349 for the three months ended February 28, 2011. Other income (expense) for
the three months ended February 29, 2012 consists of 1) interest expense of
$5,850, 2) a gain from the change in fair value of derivative liability of
$1,227, and 3) interest income of $274. Other income (expense) for the three
months ended February 28, 2011 was composed of 1) revenue recognized from a
grant awarded under the U.S. governments' Qualifying Therapeutic Discovery
Project (QTDP) program in the amount of $124,725, 2) interest expense of $5,902,
3) a loss from the change in fair value of derivative liability of $80,924, and
4) interest income of $450.
The QTDP program was created by Congress as part of the Patient Protection and Affordable Care Act, and provides a tax credit or grant equal to eligible costs and expenses for years ending November 30, 2010 and 2011. To be eligible, a therapeutic development project must: 1) have the potential to develop new treatments that address unmet medical needs or chronic and acute diseases; 2) reduce long-term health care costs; 3) represent a significant advance in finding a cure for cancer; 4) advance U.S. competitiveness in the fields of life, biological, and medical sciences; or 5) create or sustain well-paying jobs, either directly or indirectly. The Company received a total grant of $733,437, of which $430,335 pertained to the year ended November 30, 2010 and $303,102 pertained to the year ended November 30, 2011. During the three months ended February 28, 2011, our management identified qualifying expense and recognized $124,725 of grant revenue.
Interest expense principally includes interest on the 4.75% debentures, including amortization of discount.
The change in fair value of derivative liability is the result of our adoption on December 1, 2009 of new accounting guidance related to the embedded conversion feature in the Series B convertible preferred stock. The valuation of the derivative liability is dependent upon a number of factors beyond our control. As such, the amount of other income or expense that we report related to the change in the fair value of the derivative liability is somewhat unpredictable, but may be significant, and will continue to be reported until the holders of the Series B convertible preferred stock have converted their shares into shares of our common stock.
Net Loss. Net loss for the three months ended February 29, 2012 was $289,890, as compared to a net loss of $340,466 for the same period in the prior fiscal year, representing a decrease in the net loss of $50,576. The primary reasons for this decrease in net loss in the current period is due to the net effects of the decrease in stock-based compensation as explained above, the difference in the change in fair value of derivative liability for the two periods, offset by the grant revenue during the prior period.
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 February 29, 2012 and February 28, 2011:
February 29, 2012 February 28, 2011
Cash and cash equivalents $ 504,039 $ 619,539
Current assets $ 512,934 $ 752,841
Current liabilities (1,391,362 ) (1,838,579 )
Working capital deficiency $ (878,428 ) $ (1,085,738 )
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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.
Commencing in March 2008, the Company has operated on working capital provided by La Jolla Cove Investors, or LJCI, in connection with its exercise of warrants issued to it by the Company (which LJCI must exercise whenever it converts amounts owed under the convertible debenture it holds), all as discussed in more detail below. The warrants are exercisable at $1.09 per share. As of February 29, 2012 there were 6,098,629 shares remaining on the stock purchase warrant. Should LJCI continue to exercise all of its remaining warrants, approximately $6.6 million of cash would be provided to the Company. However, the Debenture Purchase Agreement limits LJCI's stock ownership in the Company to 9.99% of the outstanding shares of the Company. In August 2011, the Company and LJCI amended the debenture and the warrant agreement to extend the maturity date of the debenture and the expiration date of the warrants to February 28, 2014. The Company expects that LJCI will continue to exercise the warrants and convert the debenture through February 28, 2014, subject to the limitations of the agreement and availability of authorized common stock of the Company. We are also 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 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 was reduced to 85% of the then applicable Conversion Price as a result of an event of default in the payment of preferred dividends. The Conversion Price is also 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 these adjustments, the Conversion Price has been reduced to $0.0291 per share as of February 29, 2012. 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 is the dividend rate greater than 12% per annum. Subsequent to November 30, 2010, we received an opinion of outside counsel providing for the removal of the restrictive legend on the Series B preferred stock, which in turn terminates the requirement to accrue the related dividends. During the fiscal year ended November 30, 2007, the Company paid $73,800 and redeemed 738 shares of the Series B preferred stock. During the fiscal year ended November 30, 2010, 4,923 shares of the Series B preferred stock were converted into 7,991,883 shares of common stock.
The Series B preferred stock was formerly redeemable under certain circumstances, but those redemption provisions expired on July 14, 2008, two years after the closing date of the placement of the Series B Shares.
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.
We entered into a Securities Purchase Agreement with LJCI on February 28, 2007 (the "Securities Purchase Agreement") pursuant to which we agreed to sell convertible debentures in the principal amount of $100,000 and maturing on February 28, 2012 (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. In August 2011, the Company and LJCI amended the debenture and the warrant agreement to extend the maturity date of the debenture and the expiration date of the warrants to February 28, 2014.
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 Debentures accrue interest at 4.75% per year payable in cash or our common stock. Through February 29, 2012, 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 Debentures, upon receipt of a conversion notice from the holder, the Company may elect to immediately redeem that portion of the Debentures that the 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 the Debentures not yet converted by holder into Common Stock, plus accrued and unpaid interest thereon.
Cash provided by (used in) operating, investing and financing activities for the three month periods ended February 29, 2012 and February 28, 2011 is as follows:
February 29, 2012 February 28, 2011
Operating activities $ 67 $ (364,838 )
Investing activities - -
Financing activities 98,645 350,000
Net increase (decrease) in cash and cash equivalents $ 98,712 $ (14,838 )
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Operating Activities
For the three months ended February 29, 2012, the differences between our net loss and net cash provided by operating activities are due to net non-cash charges totaling $16,945 included in our net loss for stock-based compensation, interest, and change in fair value of derivative liability, plus changes in non-cash working capital totaling $273,012 (principally the collection of the grant receivable of $303,102). For the three months ended February 28, 2011, the differences between our net loss and net cash used in operating activities are due to net non-cash charges totaling $202,899 included in our net loss for stock-based compensation, interest, depreciation, and change in fair value of derivative liability, less changes in non-cash working capital totaling $227,271.
Investing Activities
We had no cash flows from investing activities during the three months ended February 29, 2012 and February 28, 2011.
Financing Activities
During the three months ended February 29, 2012 and February 28, 2011, principal cash flows from financing activities related to LJCI's payments to us of $98,645 and $350,000, respectively, to be applied towards the exercise of common stock warrants.
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