MultiCell Technologies Inc (MCET)

[TPX]

KNOWLEDGE: Another project from Multicell!

Global Bioabsorbable Stents Material Market Worth $2800 Million By 2022 - Rising Number of Angioplasty Procedures - Research and Markets

September 12, 2016

The global bioabsorbable stents market is expected to grow at the CAGR of 44.7% during 2016-2022 and is expected to reach around $2800 million by 2022.

There has been a rising number of angioplasty procedures due to rising cardiovascular diseases, driving the global bioabsorbable stents market. Slow adoption rate of bioabsorbable stents in heart-related diseases is one of the major problems being faced by the global market and it also acts as a restraint in the growth of the market.

Geographically, the bioabsorbable market is divided into North America, Europe, Asia Pacific and rest of the World. North America is dominating with the maximum market share of global bioabsorbable stents market due to rise in awareness about the bioabsorbable stents in the treatment of coronary ailments, rising prevalence of obesity, heart attacks and other cardiac diseases.

Dominance of major players in this region is also fueling the global bioabsorbable stents market. United States is contributing the largest market for bioabsorbable stents in the North American region, followed by Canada. In the European region, Italy, Germany and U.K. are having largest market share of global bioabsorbable stents market.

Rising awareness regarding obesity-related health issues and increasing health care expenditures are enhancing the global bioabsorbable stents market. During the forecast period, the Asia Pacific region has been expected to be high growth due to increase in public awareness related to various peripheral and coronary artery diseases in the region. The contributors such as India, China and Japan are expected to be the fastest-growing bioabsorbable stents markets in Asia Pacific.

Xenogenics Corporation (A Subsidiary of Multicell Technologies Inc.)

http://www.businesswire.com/news/home/20160912006318/en/Global-Bioabsorbable-Stents-Material-Market-Worth-2800

###########################################################################

Sep 19, 2016 Bioresorbable Scaffolds: The New Tool in PCI

Table 1: Summary of Available Bioresorbable Scaffolds

Ideal BioStent (Xenogenics Corporation, Lincoln, RI) PLLA Sirolimus 200 6-9 Investigational

http://www.acc.org/latest-in-cardiology/articles/2016/09/19/07/22/bioresorbable-scaffolds

###########################################################################

MAY/JUNE 2016 Next-Generation Fully Bioresorbable Polymer Stents

Ideal BioStent (Xenogenics Corporation, Lincoln, RI) Clinical trials



http://citoday.com/2016/06/next-generation-fully-bioresorbable-polymer-stents?center=160

########################################################################

Last 10-Q filing http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=10955546

NOTE 5. RESEARCH AND LICENSE AGREEMENTS

Oxis Biotech, Inc.

On March 10, 2015, MultiCell Immunotherapeutics, Inc. (“MCIT”), entered into a Research Agreement with Oxis Biotech, Inc. (“Oxis”) to create three novel antibody-drug conjugates (“ADCs”) containing Oxis’ lead drug candidates, and by using MCIT’s proprietary ADC platform technology. The Research Agreement contains a License Agreement between MCIT and Oxis wherein MCIT licenses to Oxis the exclusive right to sell the three ADCs product candidates. Under the terms of the Research Agreement, Oxis paid to MCIT a fee of $500,000 for the licenses granted to Oxis and for the synthesis of a certain drug candidate being investigated by Oxis, and will pay MCIT up to $1.125 million as consideration for performance of the research project. Oxis will also pay up to $12.75 million in clinical development milestones, and was granted an option to purchase manufacturing rights to the three ADCs upon payment of an additional $10 million. Additionally, Oxis will pay MCIT a royalty of 3% of net yearly worldwide sales and 30% of net sublicense revenue upon marketing approval of the ADCs.

MCIT is recognizing revenue under the Research Agreement consistent with the effort expended in fulfillment of the contract as measured by the percent of costs incurred compared to total estimated contract costs. During the three months and the nine months ended August 31, 2015, MCIT has recognized $182,443 and $255,918 under the Research Agreement. During the nine months ended August 31, 2015, MCIT received payments of $450,000 under the Research Agreement, of which $194,082 has been deferred to be recognized as performance of the contract proceeds. MCIT recognized the entire $500,000 fee received under the License Agreement as license revenue because the payment is non-refundable and MCIT has no further service obligations under the License Agreement.

Corning Incorporated

The Company has 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. 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 $750,000. The Company is recognizing the income ratably over a 17-year period. The Company recognized $11,029 and $33,088, respectively, in income for each of the three months and nine months ended August 31, 2015 and 2014. The balance of deferred revenue from this license was $400,736 and $433,824 at August 31, 2015 and November 30, 2014, respectively, and will be amortized into revenue through October 2024.

Pfizer Inc.

The Company has another license agreement with Pfizer Inc. (“Pfizer”), for which revenue is being deferred. The Company recognized $1,300 and $3,900, respectively, in income for each of the three months and nine months ended August 31, 2015 and 2014. The balance of deferred revenue from this license was $11,700 and $15,600 at August 31, 2015 and November 30, 2014, respectively, and will be amortized into revenue through January 2018.

The Foreclosure Sale Agreement and the Rutgers License Agreement

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. In consideration for the purchase of the assets, Xenogenics made cash payments to the Sellers in the aggregate amount of $400,000.

Xenogenics is also required to make cash payments to the Sellers as follows based on the achievement of certain milestones:

· $300,000 is payable upon the earlier to occur of (i) initiation of pivotal Generation 2 stent human clinical trials, (ii) execution of an agreement in which Xenogenics grants a third party rights to develop or exploit the purchased assets, valued at no less than $3,000,000 (including all up-front payments and the net present value of any future royalty/milestone payments), and (iii) a “change of control” of Xenogenics;

· $1,000,000 is payable upon the earlier to occur of (i) regulatory approval by any regulatory authority in a European Union member country, (ii) execution of an agreement in which Xenogenics grants a third party rights to develop or exploit the purchased assets, valued at no less than $5,000,000 (including all up-front payments and the net present value of any future royalty/milestone payments); and (iii) a “change of control” of Xenogenics; and

· $3,000,000 is payable upon the earlier to occur of (i) regulatory approval by the U.S. Food and Drug Administration, (ii) execution of an agreement in which Xenogenics grants a third party rights to develop or exploit the purchased assets, valued at no less than $5,000,000 (including all up-front payments and the net present value of any future royalty/milestone payments); and (iii) a “change of control” of Xenogenics.

None of these milestones were achieved as of August 31, 2015 and, accordingly, none of these obligations have accrued. Xenogenics’ obligations under the Foreclosure Sale Agreement had been previously extended pursuant to Amendments No. 1, No. 2, No. 3, and No. 4 dated September 30, 2011, October 23, 2012, October 11, 2013, and December 1, 2014. As a result of these various amendments to extend the dates for achievement of the milestones, the Company is in compliance with the requirements of the Foreclosure Sale Agreement, as amended. Xenogenics is required to use Good Faith Reasonable Efforts (as defined in the Foreclosure Sale Agreement) to achieve these milestones. Failure to achieve any of these milestones shall result in all milestone payments, totaling $4.3 million, becoming immediately due and payable, unless Xenogenics’ failure to use Good Faith Reasonable Efforts is due to Technical Difficulties (as defined in the Foreclosure Sale Agreement) or to Financial Hardship (as defined in the Foreclosure Sale Agreement), in which case Xenogenics can elect to (i) pay all remaining milestone payments and continue commercialization efforts, or (ii) assign all intellectual property acquired by Xenogenics under the agreement to the counterparties to the agreement and cease all development and commercialization efforts. Accordingly, Xenogenics has not accrued the $4.3 million commitment because the dates for achieving the milestones have been extended under the amendments to the Foreclosure Sale Agreement, and because Xenogenics also believes that the Financial Hardship exemption in the Foreclosure Sale Agreement would protect it in the future from any requirement to pay the $4.3 million.

To supplement the technology acquired under the Foreclosure Sale Agreement, Xenogenics also entered in to a license agreement (the “Rutgers License Agreement”) with Rutgers, The State University of New Jersey (“Rutgers”) effective September 30, 2010. 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.

However, it became apparent during the evaluation and development of the Ideal BioStent™ that the use of intellectual property licensed from Rutgers would have introduced complications in the design of the Ideal BioStent. As a result, Xenogenics abandoned the use of the Rutgers technology effective January 2014. On January 31, 2014, Rutgers notified Xenogenics of its alleged default of the provisions in the Rutgers License Agreement. On May 9, 2014, Rutgers issued a notice of termination of the Rutgers License Agreement, and demanded payment of unpaid license fees of $25,000, unpaid patent costs of $75,665, and accrued interest of $8,375. All of these claimed fees, costs, and interest have been accrued in the accompanying condensed consolidated financial statements. Management is currently evaluating the merits of these claims.