United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
November 24, 2014
Date of Report (Date of earliest event reported)
NUVILEX, INC.
(Exact Name of Registrant as Specified in
its Charter)
| Nevada |
333-68008 |
62-1772151 |
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
12510
Prosperity Drive, Suite 310
Silver Spring, Maryland |
|
20904-1643 |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant's
telephone number, including area code: (917) 595-2850
|
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:
[_] Written communications pursuant to Rule 425 under the
Securities Act
[_] Soliciting material pursuant to Rule 14a-12 under the
Exchange Act
[_] Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act
[_] Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act
Item 1.01 Entry into a Material
Definitive Agreement.
On November 24, 2014, Nuvilex, Inc., a
Nevada corporation (“Company”), entered into a Licensing Agreement (“Agreement”) with Austrianova Singapore
Pte Ltd ("Austrianova"), a subsidiary of SG Austria Private Limited and an entity partially owned by the Company, providing
the Company with an exclusive world-wide royalty-bearing license (with the right to sublicense) to use the Cell-in-a-Box®
live cell encapsulation technology and trademark with genetically modified non-stem cells which are designed to activate
Cannabinoids (defined in the Agreement) for research, development and commercialization of treatments for diseases and medical
conditions. The Agreement is effective as of December 1, 2014. The license royalty rate is 10% on direct sales and 20% on sales
by a sub-licensee, with an initial license fee of $2 million due and payable by the Company to Austrianova by no later than June
30, 2015. The Company has already paid $500,000 of the initial license fee and will make periodic monthly payments of the balance
in amounts to be agreed upon between the parties prior to each such payment being made. In addition, the following milestone payments
are due as indicated:
| Amount |
Event |
| |
|
| $100,000 |
Within
thirty days of the beginning the first pre-clinical experiments using the encapsulated cells; |
| |
|
| $500,000 |
Within thirty days after enrolment
of a human in the first clinical trial; |
| |
|
| $800,000 |
Within thirty days after enrolment
of a human in the first Phase 3 clinical trial; and |
| |
|
| $1,000,000 |
Within ninety
days after obtaining the first Marketing Authorization or equivalent according to the country of origin. |
Item 9.01 Financial Statements and
Exhibits.
(d) Exhibits.
99.1 Press Release dated
December 1, 2014.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Date: December 1, 2014
| |
Nuvilex, Inc. |
| |
|
| |
By: |
/s/ Kenneth L. Waggoner |
| |
|
Kenneth L. Waggoner
Chief Executive Officer |
Exhibit 99.1
Nuvilex Obtains Exclusive Worldwide
License to Develop Disease Treatments that Combine Cell-in-a-Box® and Cannabinoid-Based Medicine
SILVER SPRING, MD, December 1, 2014 (GLOBE
NEWSWIRE) – Nuvilex, Inc. (OTCQB: NVLX), a clinical-stage biotechnology company developing cell therapy solutions for the
treatment of diseases, announced today that it has obtained an exclusive worldwide license from Austrianova Singapore Pte Ltd to
use the unique and proprietary Cell-in-a-Box® cellulose-based live cell encapsulation technology in combination
with compounds, known as cannabinoids, obtained from constituents of Cannabis for the development of disease treatments.
Nuvilex’s initial efforts will be directed toward developing treatments for deadly and difficult-to-treat forms of cancer.
Nuvilex’s CEO and President,
Kenneth L. Waggoner, commented, “While our efforts in the medical Cannabis arena have been ongoing for some time
now, this exciting worldwide Licensing Agreement enabling the use of Cell-in-a-Box® with cannabinoid prodrugs
will greatly enhance our effort to become a major player in the medicinal cannabinoid space. This is truly a collaborative
agreement which is designed to capitalize on the ever-increasing body of evidence indicating constituents from the Cannabis
plant indeed have a place in the treatment of serious and even deadly forms of cancer.”
The combination of the Cell-in-a-Box®
live cell encapsulation technology and prodrugs (which require conversion to their cancer-killing forms) as treatments for serious
cancers has already been validated in human clinical trials in patients with advanced, inoperable pancreatic cancer and in a veterinary
preclinical trial in dogs with spontaneously-occurring mammary cancer (a model for breast cancer in humans). In both cases, the
cells encapsulated were designed to overexpress an enzyme known as CYP2B1. This is an isoform of the cytochrome P450 system, normally
found in the liver. For the pancreatic cancer clinical trials, the prodrug used was ifosfamide; its “sister” drug cyclophosphamide
was used in the canine mammary cancer preclinical trial. Both ifosfamide and cyclophosphamide are converted to their cancer-killing
forms by CYP2B1 and have shown remarkable results.
Dr. Brian Salmons, CEO and President of
Austrianova and a member of the Scientific Advisory Board of Medical Marijuana Sciences, a wholly-owned subsidiary of Nuvilex,
said of the Licensing Agreement, “Over the course of the last year, we have worked very closely with Nuvilex to secure the
exclusive worldwide rights to use our Cell-in-a-Box® technology for the development of cannabinoid-based disease treatments.
We’re excited about the opportunity to collaborate with them to further the science in this exciting medical field where
the possibility exists of treating cancers and other diseases without the harmful side effects normally associated with their treatment.”
Prof. Walter H. Günzburg, Chairman
and CTO of Austrianova, said “It is well documented in scientific and medical journals that cannabinoid-based drugs have
a therapeutic benefit in cancer, but the ability to administer these drugs at a therapeutic level is challenging. The use of encapsulated
cells to convert prodrugs as pioneered by Austrianova and Nuvilex is a viable alternative. We are delighted to have signed the
Licensing Agreement as part of the ongoing efforts towards this aim.”
For the work to be done in the cancer area
under the terms of the Licensing Agreement, the Cell-in-a-Box® encapsulation process will be basically the same
as that used in Nuvilex’s cancer treatments using ifosfamide; however, a different type of cell will be encapsulated
for cannabinoid-based cancer treatments. These cells will be capable of converting cannabinoid prodrugs to their cancer-killing
forms. By using the Cell-in-a-Box® technology, it should be possible to optimize the anticancer effect of the cannabinoid
prodrugs while minimizing deleterious side effects that are associated with most chemotherapy.
About Nuvilex
Nuvilex (OTCQB: NVLX) is a clinical stage
biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary
cellulose-based live cell encapsulation technology known as Cell-in-a-Box®. This unique and patented technology
will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer,
and diabetes are being built. Nuvilex's treatment for pancreatic cancer involves the well-known anticancer prodrug ifosfamide,
together with encapsulated live cells, which convert ifosfamide into its active or "cancer-killing" form. Nuvilex is
also working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types
of solid cancerous tumors. In addition, Nuvilex is developing treatments for cancer based upon chemical constituents of marijuana
known as cannabinoids. Nuvilex is examining ways to exploit the benefits of Cell-in-a-Box® technology in optimizing
the anticancer effectiveness of cannabinoids, while minimizing or outright eliminating the debilitating side effects usually associated
with cancer treatments. This provides Nuvilex a unique opportunity to develop “green” approaches to fighting cancers,
such as those of the pancreas, brain and breast, which affect hundreds of thousands of individuals worldwide every year.
Safe Harbor
This press release
may contain forward-looking statements regarding Nuvilex and its future events and results that involve inherent risks and uncertainties.
The words "anticipate," "believe," "estimate," "expect," "intend," "plan"
and similar expressions, as they relate to Nuvilex or its management, are intended to identify forward-looking statements. Important
factors, many of which are beyond the control of Nuvilex, that could cause actual results to differ materially from those set forth
in the forward-looking statements include Nuvilex's ability to continue as a going concern, delays or unsuccessful results in clinical
trials or flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty
of protection of Nuvilex's intellectual property and Nuvilex's continued ability to raise capital. Nuvilex does not assume any
obligation to update any of these forward-looking statements.
More
information about Nuvilex can be found at www.nuvilex.com. It can
also be obtained by contacting Investor Relations.
Investor Relations Contacts:
Clare Matschullat
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 106
cmatschullat@bplifescience.com