PharmaCyte Issues Corporate Overview and History
LAGUNA HILLS, Calif.–(BUSINESS WIRE)– PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that it is providing a summary overview, corporate history and status report to address a regulatory compliance request from the British Columbia Securities Commission (BCSC) which, as of November 10, 2017, revoked the cease trade order involving PharmaCyte’s securities.
In 2011, the BCSC ordered that all trading in the securities of Nuvilex, Inc. (now PharmaCyte Biotech, Inc.) cease in British Columbia until PharmaCyte filed the required records that would allow the BCSC to revoke the cease trade order. PharmaCyte recently applied to the BCSC to revoke the cease trade order. That order has now been revoked, allowing securities of PharmaCyte to once again be traded in British Columbia.
As required by the BCSC, PharmaCyte provides a corporate overview and a summary of its corporate history below.
PharmaCyte is a clinical stage biotechnology company focused on developing and preparing to commercialize cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®.” The Cell-in-a-Box® technology is intended to be used as a platform upon which therapies for several types of cancer, including advanced, inoperable pancreatic cancer, and diabetes will be developed.
PharmaCyte is developing therapies for pancreas and other solid cancerous tumors involving the encapsulation of live cells placed in the body to enable the delivery of cancer-killing drugs at the source of the cancer. PharmaCyte is also developing a therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes based upon the encapsulation of a human cell line genetically engineered to produce, store and secrete insulin at levels in proportion to the levels of blood sugar in the human body using the Company’s Cell-in-a-Box® technology. In addition, the Company is examining ways to exploit the benefits of the Cell-in-a-Box® technology to develop therapies for cancer based upon the constituents of the Cannabis plant, known as “cannabinoids.”
PharmaCyte is a Nevada corporation incorporated in 1996. In 2013, PharmaCyte restructured its operations in an effort to focus on biotechnology, having been a nutraceutical products company before then. The restructuring resulted in PharmaCyte focusing all of its efforts upon the development of a unique, effective and safe way to treat cancer and diabetes. On January 6, 2015, the company changed its name from Nuvilex, Inc. to PharmaCyte Biotech, Inc. to better reflect the nature of its business.
As discussed above, presently, the company is a clinical stage biotechnology company focused on developing and preparing to commercialize therapies for cancer and diabetes using its proprietary cellulose-based live-cell encapsulation technology known as Cell-in-a-Box®. This resulted from entering into several important agreements.
On May 26, 2011, the Company entered into an Asset Purchase Agreement (“SG Austria APA”) with SG Austria to purchase 100% of the assets and liabilities of SG Austria. As a result, Austrianova and Bio Blue Bird AG (“Bio Blue Bird”), then wholly owned subsidiaries of SG Austria, were to become wholly owned subsidiaries of PharmaCyte on the condition that PharmaCyte pay SG Austria US$2.5 million and 100,000,000 shares of PharmaCyte’s common stock. PharmaCyte was to receive 100,000 shares of common stock of Austrianova and nine bearer shares of Bio Blue Bird representing 100% of the ownership of Bio Blue Bird.
Through two addenda to the SG Austria APA, the closing date of the SG Austria APA was extended twice by agreement between the parties.
In June 2013, PharmaCyte and SG Austria entered into a Third Addendum to the SG Austria APA (“Third Addendum”). The Third Addendum materially changed the transaction contemplated by the SG Austria APA. Under the Third Addendum, PharmaCyte acquired 100% of the equity interests in Bio Blue Bird and received a 14.5% equity interest in SG Austria. In addition, PharmaCyte received nine bearer shares of Bio Blue Bird to reflect its 100% ownership of Bio Blue Bird. PharmaCyte paid: (i) US$500,000 to retire all outstanding debt of Bio Blue Bird; and (ii) US$1.0 million to SG Austria. PharmaCyte also paid SG Austria US$1,572,193 in exchange for the 14.5% equity interest of SG Austria. The transaction required SG Austria to return to PharmaCyte the 100,000,000 shares of common stock held by SG Austria and for PharmaCyte to return to SG Austria the 100,000 shares of common stock of Austrianova then-held by PharmaCyte.
Effective as of the same date PharmaCyte entered into the Third Addendum, PharmaCyte and SG Austria entered into a Clarification Agreement to the Third Addendum (“Clarification Agreement”) to clarify and include certain language that was inadvertently left out of the Third Addendum. Among other things, the Clarification Agreement confirmed that the Third Addendum granted PharmaCyte an exclusive, worldwide license to use, with a right to sublicense, the Cell-in-a-Box® technology for the development of treatments for cancer and use of Austrianova’s Cell-in-a-Box® trademark and its associated technology.
Bio Blue Bird licensed certain types of genetically modified human cells (“Cells”) from Bavarian Nordic A/S (“Bavarian Nordic”) and GSF-Forschungszentrum für Umwelt u. Gesundheit GmbH (collectively, “Bavarian Nordic/GSF”) pursuant to a License Agreement (“Bavarian Nordic/GSF License Agreement”) to develop a therapy for cancer using encapsulated Cells. The licensed rights to the Cells pertain to the countries in which Bavarian Nordic/GSF obtained patent protection. Hence, facilitated by the acquisition of Bio Blue Bird, the Third Addendum provides PharmaCyte with an exclusive, worldwide license to use the Cell-in-a-Box® technology and trademark for the development of a therapy for cancer using the Cells.
In June 2013, PharmaCyte entered into the Diabetes License Agreement. PharmaCyte paid Austrianova US$2.0 million to secure this license.
In October 2014, PharmaCyte entered into the Melligen Cell License Agreement. PharmaCyte is in the process of developing a therapy for diabetes by encapsulating the Melligen cells using the Cell-in-a-Box® technology.
In December 2014, PharmaCyte entered into the Cannabis Licensing Agreement. PharmaCyte paid Austrianova US$2.0 million to secure this license. PharmaCyte is in the process of developing therapies for cancer and its symptoms through genetically engineered cells designed to activate cannabinoid molecules that have been encapsulated using the Cell-in-a-Box® technology.
In July 2016, PharmaCyte entered into a Binding Memorandum of Understanding with Austrianova (“Austrianova MOU”). Pursuant to the Austrianova MOU, Austrianova will actively work to seek an investment partner or partners who will finance clinical trials and further develop products for the therapies for cancer, in exchange for which PharmaCyte, Austrianova and any future investment partner or partners will each receive a share of the net revenue of applicable products.
In October 2016, the parties amended the Bavarian Nordic/GSF License Agreement to include the right to import, reflect ownership and notification of improvements, clarify which provisions survive expiration or termination of the Bavarian Nordic/GSF License Agreement, to provide rights to Bio Blue Bird to the clinical data after expiration of the licensed patent rights and to change the notice address and recipients of Bio Blue Bird.
In August 2017, PharmaCyte entered into a Binding Term Sheet with SG Austria and Austrianova pursuant to which the parties reached an agreement to amend certain provisions in the APA, the Diabetes Licensing Agreement and the Cannabis Licensing Agreement.
For more detailed information regarding PharmaCyte, readers are encouraged to read its disclosure filings made with the United States Securities and Exchange Commission available online at: (https://www.sec.gov/edgar/searchedgar/companysearch.html), including its most recent Form 10-K annual report filed on July 27, 2017, and Form 10-Q quarterly report filed on September 13, 2017.
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no treatment related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they will function as a “bio-artificial pancreas” for purposes of insulin production.
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement because of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements due to the impact of numerous risk factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the United States Securities and Exchange Commission.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.
On behalf of
PharmaCyte Biotech, Inc.
Dr. Gerald W. Crabtree
PharmaCyte Biotech, Inc.
Dr. Gerald W. Crabtree
Investor Relations Department