MCET MultiCell Technologies Inc (CE)

UNITED STATES

SECURITIES AND EXCHANGE

COMMISSION

Washington, DC 20549

 

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FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported)

 

March 10, 2015

 

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MULTICELL TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware		001-10221		52-1412493
(State or other jurisdiction of incorporation)		(Commission  File Number)		(IRS Employer Identification No.)

 

68 Cumberland Street, Suite 301

Woonsocket, Rhode Island 02895

(Address of principal executive offices, including zip code)

 

(401) 762-0045

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 1.01

Entry into a Material Definitive Agreement.

 

On March 10, 2015, MultiCell Immunotherapeutics, Inc. (“MCIT”), a majority owned subsidiary of MultiCell Technology, Inc. (the “Company”) entered into a Research Agreement (the “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 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 Agreement, Oxis will pay 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 reimburse MCIT up to $1.125 million for development costs for the three ADC product candidates. 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.

 

Other than with respect to the Agreement, there is no material relationship between MCIT and Oxis.

 

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed as an exhibit to the Company’s periodic reports to be filed pursuant to the Securities Exchange Act of 1934, as amended.

 

Item 8.01

Other Events

 

On March 12, 2015, the Company issued a press release announcing that MCIT entered into the Agreement with Oxis and describing the terms of the Agreement. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The press release and the information therein shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01

Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.	Description
99.1	Press release issued on March 12, 2015.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

		MULTICELL TECHNOLOGIES, INC.
	By:	/s/ W. Gerald Newmin
		W. Gerald Newmin Chief Executive Officer, Chief Financial Officer

 

Date: March 10, 2015

 

 

 

 

Exhibit 99.1

 

MULTICELL IMMUNOTHERAPEUTICS AND OXIS BIOTECH SIGN ANTIBODY-DRUG CONJUGATE R&D, PRODUCT LICENSE AND COMMERCIALIZATION AGREEMENT

 

 

WOONSOCKET, RI / March 12, 2015 / PRNewswire / MultiCell Immunotherapeutics, Inc. (MCIT), a majority owned subsidiary of MultiCell Technologies, Inc. [OTC: MCET] announced today it has signed a research & development and product license agreement with Oxis Biotech, Inc. (OXIS) to create three novel antibody-drug conjugates (ADCs) containing OXIS’ lead drug candidates using MCIT’s proprietary ADC platform technology. These ADC product candidates are to be used by OXIS for the treatment of triple-negative breast cancer, and multiple myeloma and associated osteolytic lesions which are significant unmet medical needs.

 

Under the terms of the agreement, OXIS paid MCIT a license fee of $500,000, and will reimburse MCIT up to $1.125 million in development costs for the three ADC product candidates. 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. OXIS was also granted a worldwide exclusive license to sell the three ADC product candidates, and will pay a royalty of 3% of net yearly sales. MCIT retained all rights to its ADC platform for all therapeutic indications, and is free to pursue its own drug development programs and to partner with other interested pharmaceutical and biotechnology companies.

 

Sales of breast cancer drugs are projected to increase in nine major world markets from $9.8 billion in 2013 to $18.2 billion by 2023, according to new forecasts from IMS Health. Analysts at Visiongain, Ltd. predict the world market for multiple myeloma therapies will reach $11.5 billion in 2017.

 

According to FiercePharma, Celgene's [NASDAQ: CELG] cancer drug Revlimid® for the treatment of multiple myeloma generated nearly $5 billion in revenue for the company in 2014. Analysts believe sales of Revlimid could double within 5 years as a result of FDA’s recent approval of expanded labeling concerning the use of Revlimid in combination with dexamethasone for patients newly diagnosed with multiple myeloma. About 93,600 patients are living with multiple myeloma in Europe and about 88,499 patients are living with it in the United States, Celgene said.

 

PDL BioPharma, Inc. [NASDAQ: PDLI] stated its licensee Genentech, Inc. reported sales of Herceptin® which is used to treat HER2 breast cancer totaled $7.3 billion in 2014. Of the 280,000 patients in the USA diagnosed annually with breast cancer, about 20% are diagnosed with triple-negative breast cancer. Treatment options for triple-negative breast cancer patients are limited because the three most common types of receptors known to fuel most breast cancer growth – estrogen, progesterone, and the HER-2/neu gene – are not present in the triple-negative breast cancer cells, hence patients are ineligible for treatment with either hormonal or HER2-targeted agents such as Herceptin. Treatment typically involves non-targeted cytotoxic chemotherapies.

 

The Emmes Group, a strategy consulting firm with offices in Boston and San Francisco, believes if OXIS achieves all of its clinical development milestones, purchases manufacturing rights to the ADCs, and meets worldwide sales and sublicensing expectations following receipt of marketing approval for the three ADCs for the treatment of breast cancer and multiple myeloma, MCIT could expect to receive in excess of $540 million during the term of the agreement.

 

MCIT’s ADC platform technology is based on unique multivalent, cleavable linkers that allow tethered drugs to be released intracellularly or extracellularly upon binding of the antibody to the target cell. Additionally, the MCIT linkers are designed to attach multiple drugs per targeting antibody, and to release the drugs in their original form without modification of the drug.

 

“We are very excited about our novel, enabling antibody-drug conjugate technology, and are pleased to partner with Oxis Biotech to develop targeted delivery versions of their drug candidates”, said W. Gerald Newmin, Chairman and Chief Executive Officer of MultiCell Immunotherapeutics. “We continue to explore therapeutic indications and drug combinations of interest to us, and will continue to aggressively seek partnerships with larger pharmaceutical and biotechnology companies who are interested in using our ADC technology to help facilitate the targeted delivery of their drugs”, stated Mr. Newmin.

 

 

About MultiCell Immunotherapeutics

 

MultiCell Immunotherapeutics, Inc. (MCIT), a majority owned subsidiary of MultiCell Technologies, Inc. [OTC: MCET], is a biotechnology company developing novel therapeutics and drug delivery platform technologies to treat a variety of human diseases. MCIT’s next-generation antibody drug conjugates provide for the simultaneous targeted delivery of multiple drugs from a single antibody. This unique, targeted co-delivery capability enables the localization of both drugs within a target cell where they exert their biological effect and helps to minimize adverse off-target effects.

 

About MultiCell Technologies

 

MultiCell Technologies, Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and discovery tools for the treatment of neurological disorders, hepatic disease and cancer. For more information about MultiCell Technologies, please visit http://www.multicelltech.com.

 

Caution Regarding Forward-Looking Statements

 

Any statements in this press release about MultiCell’s expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). These statements are often, but not always, made through the use of words or phrases such as “believe”, “will”, “expect”, “anticipate”, “estimate”, “intend”, “plan”, “forecast”, “could”, and “would”. MultiCell bases these forward- looking statements on current expectations about future events. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by any forward-looking statement. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections in the forward-looking statement include, but are not limited to, the risk that we might not achieve our anticipated clinical development milestones, receive regulatory approval, or successfully commercialize our products as expected, the market for our products will not grow as expected, and the risk that our products will not achieve expectations. For additional information about risks and uncertainties MultiCell faces, see documents that MultiCell files with the Securities and Exchange Commission, including MultiCell's report on Form 10-K for the fiscal year ended November 30, 2014, and all of MultiCell’s quarterly and other periodic SEC filings. MultiCell claims the protection of the safe harbor for forward-looking statements under the Act and assumes no obligation and expressly disclaims any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.

 

Contact

 

MultiCell Technologies, Inc.

W. Gerald Newmin, Chairman and CEO

(401) 762-0045

MCETInvestor@multicelltech.com