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1 1238

Form 8-K for NUVILEX, INC.

9-Jan-2015

Amendments to Articles of Inc. or Bylaws; Change in Fiscal Year, Regulation FD Disc

Item 5.03 Amendments to Articles of Incorporation or BylawsEffective January 6, 2015, Nuvilex, Inc. (“Company”) changed its legal corporate name to “PharmaCyte Biotech, Inc.” The name change was effected through a short-form merger pursuant to Section 92A.180 of the Nevada Revised Statutes. A wholly-owned subsidiary of the Company was merged with and into the Company, with the Company as the surviving entity of the merger. The merger had the effect of amending the Company’s Certificate of Incorporation to reflect the new legal name of the Company. A copy of the Articles of Merger effecting the name change, as filed with the Secretary of State of the State of Nevada, is attached hereto as Exhibit 3.1. The Articles of Merger became effective by their terms on January 6, 2015.

In connection with the name change, the Company also changed the ticker symbol of its common stock, which previously traded under the ticker symbol “NVLX.” The Company’s common stock is trading under the ticker symbol “PMCB.”

The merger and resulting name change do not affect the rights of the Company’s security holders, creditors, customers or suppliers. With the exception of the name change, there were no changes to the Company’s Certificate of Incorporation or Bylaws.

Item 7.01. Regulation FD DisclosureOn January 7, 2015, the Company issued a press release announcing the name change, a copy of which is attached hereto as Exhibit 99.1. On January 8, 2015, the Company issued a press release announcing the new ticker symbol, a copy of which is attached hereto as Exhibit 99.2. The information furnished in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.

Item 9.01 Financial Statements and Exhibits.(d) Exhibits.

3.1 Articles of Merger merging PharmaCyte Biotech, Inc. with and into Nuvilex, Inc., effective January 6, 2015
99.1 Press Release dated January 7, 2015
99.2 Press Release dated January 8, 2015

0 1801
marijuana stocks

Nuvilex Announces Name Change to PharmaCyte Biotech

Company’s Shares Will Trade Under New Ticker Symbol PHCB

SILVER SPRING, Md., Jan. 7, 2015 (GLOBE NEWSWIRE) — Nuvilex, Inc. (NVLX) today announced that the Company has changed its name to PharmaCyte Biotech, Inc. Shares in PharmaCyte Biotech will trade under the new ticker symbol “PHCB” on the OTCQB electronic platform. The new symbol is expected to become effective at the open of the market on January 8, 2014. The name change is part of the Company’s transformation process to operate solely as a pure biotechnology firm leveraging its Cell-in-a-Box(R) technology, a proprietary cell encapsulation platform being utilized to develop “targeted” treatments for solid cancerous tumors and insulin dependent diabetes.

“Over the past year, we’ve implemented an aggressive strategy to facilitate the advancement of the treatments we are developing for cancer and diabetes, with our Cell-in-a-Box(R) technology at the core of these treatments. Our new name reflects the tremendous progress we’ve accomplished in terms of clinical development and signifies the structural completion of our transition to becoming a fully dedicated biotechnology company,” said Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech.

Some of the highlights in 2014 that have marked this transition include:

  • Receiving “orphan drug” designation from the U.S. Food and Drug Administration (FDA) for the Company’s pancreatic cancer treatment, with applications filed with the EMA and the TGA for the same status in Europe and Australia.
  • Development of a clinical protocol for a planned Phase 2b clinical trial with the goal of initiating the clinical trial in 2015.
  • A preclinical study being completed evaluating the effectiveness of the Company’s pancreatic cancer treatment on the accumulation of malignant ascites fluid often associated with the growth of abdominal cancers with positive results that have led to a follow-up study about to be launched.
  • The establishment of a world-wide Diabetes Consortium with a number of research agreements now in place with major universities and institutions that will permit the development of a break-through treatment for insulin dependent diabetes that combines Cell-in-a-Box(R) with insulin-producing cells.
  • Progression at the University of Northern Colorado in the pursuit of treatments for brain and other forms of difficult to treat cancers that will combine cannabinoid or cannabinoid-like compounds with the Cell-in-a-Box(R) technology.

“With exciting developments on the horizon for 2015, our work to develop treatments for both cancer and diabetes will move forward under our new name because it speaks to what we actually do here at PharmaCyte Biotech,” concluded Mr. Waggoner.

About PharmaCyte Biotech

PharmaCyte Biotech 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(R). 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. PharmaCyte Biotech’s treatment for pancreatic cancer involves low doses of the well-known anticancer prodrug ifosfamide, together with encapsulated live cells, which convert ifosfamide into its active or “cancer-killing” form. These capsules are placed as close to the cancerous tumor as possible to enable the delivery of the highest levels of the cancer-killing drug at the source of the cancer. This “targeted chemotherapy” has proven remarkably effective in past clinical trials. In addition, PharmaCyte Biotech is working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of solid cancerous tumors. PharmaCyte Biotech is also developing treatments for cancer based upon chemical constituents of marijuana known as cannabinoids. In doing so, PharmaCyte Biotech is examining ways to exploit the benefits of Cell-in-a-Box(R) technology in optimizing the anticancer effectiveness of cannabinoids, while minimizing or outright eliminating the debilitating side effects usually associated with cancer treatments. This provides PharmaCyte Biotech the rare opportunity to develop “green” approaches to fighting deadly diseases, such as cancer 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 PharmaCyte Biotech 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 PharmaCyte Biotech or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte Biotech, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte’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 PharmaCyte Biotech’s intellectual property and PharmaCyte Biotech’s continued ability to raise capital. PharmaCyte Biotech does not assume any obligation to update any of these forward-looking statements.

More information about PharmaCyte Biotech can be found at www.PharmaCyteBiotech.com. It can also be obtained by contacting Investor Relations.

Contact:
Investor Relations Contacts:
Jamien Jones
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 103
jjones@bplifescience.com

1 1313

Nuvilex to Attend 2015 Gastrointestinal Cancers Symposium in San Francisco, January 15-17, 2015

SILVER SPRING, Md., Jan. 6, 2015 (GLOBE NEWSWIRE) — Nuvilex, Inc. (NVLX) today announced that its Chief Executive Officer (CEO), Kenneth L Waggoner, JD, and its Chief Operating Officer, Gerald W. Crabtree, Ph.D., will be attending the 2015 Gastrointestinal Cancers Symposium, “Bridging Cancer Biology to Clinical GI Oncology,” to be held in the Moscone West Convention Center in San Francisco, California, January 15-17, 2015.

Nuvilex’s CEO, Kenneth L. Waggoner, stated, “Our attendance at this pivotal Symposium, which is dedicated to recent advances in the treatment of cancers of the GI tract, is essential because a substantial portion of the Symposium will be dedicated to the treatment of pancreatic cancer and because a significant component of Nuvilex’s portfolio is devoted to the development of treatments for this deadly disease and the symptoms associated with it. The treatments Nuvilex will employ to attack pancreatic cancer are based on the use of the proprietary Cell-in-a-Box(R)cellulose-based live cell encapsulation technology in combination with low doses of the anticancer prodrug ifosfamide that has been deemed effective in two previous clinical trials. Our targeted chemotherapy platform has now shown encouraging results in early preclinical studies in the U.S. performed by Translational Drug Development (TD2) that are concerned with the development of malignant ascites fluid in animals with an abdominal cancer.”

The Gastrointestinal Cancers Symposium is an annual event held in January in San Francisco and is co-sponsored by the American Gastroenterological Association, the American Society of Clinical Oncology, the American Society of Radiation Oncology, the American Society for Radiation Oncology and the Society of Surgical Oncology. This Symposium is expected to attract over 3,000 participants from around the world who are experts in the treatment of cancers of the pancreas, small bowel, colon, rectum, hepatobiliary tract, esophagus and stomach. At this event, many of the latest developments in the prevention, screening, diagnosis, multidisciplinary treatment and translational research of GI cancers will be presented.

About Nuvilex

Nuvilex 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(R). 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 low doses of the well-known anticancer prodrug ifosfamide, together with encapsulated live cells, which convert ifosfamide into its active or “cancer-killing” form. These capsules are placed as close to the cancerous tumor as possible to enable the delivery of the highest levels of the cancer-killing drug at the source of the cancer. This “targeted chemotherapy” has proven remarkably effective in past clinical trials. In addition, Nuvilex is working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of solid cancerous tumors. Nuvilex is also developing treatments for cancer based upon chemical constituents of marijuana known as cannabinoids. In doing so, Nuvilex is examining ways to exploit the benefits of Cell-in-a-Box(R) 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 the rare opportunity to develop “green” approaches to fighting deadly 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, could cause actual results to differ materially from those set forth in the forward-looking statements. They 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.

Contact:
Investor Relations Contacts:
Jamien Jones
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 103
jjones@bplifescience.com

0 1405
marijuana stocks

FDA Grants Orphan Drug Designation to Nuvilex for Pancreatic Cancer Treatment

SILVER SPRING, Md., Dec. 22, 2014 (GLOBE NEWSWIRE) — Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Nuvilex orphan drug designation for its pancreatic cancer treatment. Nuvilex’s pancreatic cancer treatment combines Nuvilex’s patented and proprietary cellulose-based encapsulation technology, known as Cell-in-a-Box(R), with the cancer prodrug ifosfamide and encapsulated live cells that convert the prodrug into its cancer-killing form. These capsules are placed as close to the cancerous tumor as possible to enable the delivery of the highest levels of the cancer-killing drug at the source of the cancer. This “targeted chemotherapy” has proven remarkably effective in past clinical trials.

“Receiving orphan drug designation by the FDA represents a significant milestone in the development of our pancreatic cancer treatment. This achievement is a very important one, both for Nuvilex and our partner Austrianova. It not only facilitates the future development of Nuvilex’s pancreatic cancer treatment, but also serves to validate the Cell-in-a-Box(R) technology,” stated Kenneth L. Waggoner, Chief Executive Officer of Nuvilex.

Nuvilex is currently preparing for a Phase 2b clinical trial in advanced pancreatic cancer (the orphan indication) in Australia to gain regulatory approval from agencies like the FDA for Nuvilex’s targeted chemotherapy of pancreatic cancer. Nuvilex’s clinical trial is planned to commence in 2015.

To access the FDA’s official listing of Nuvilex receiving the Orphan Drug Designation, use this link: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/oopd_results_2.cfm?index_number=457014.

Orphan drug designation in the U.S. is given to drugs or treatments for “rare,” life-threatening diseases. In the U.S., a rare disease is defined as one that is diagnosed in less than 200,000 people in the U.S. In addition, in the U.S. pancreatic cancer can be classified as a life-threatening disease because, even with the best available chemotherapy, patients with advanced pancreatic cancer are destined to live less than one year on average and the 5-year survival rate is less than seven percent.

Receiving orphan drug designation for Nuvilex’s pancreatic cancer treatment carries with it up to 7 years of marketing exclusivity in the U.S. In addition, special assistance from the FDA in the development of Nuvilex’s treatment for pancreatic cancer and exemptions or reductions in regulatory fees and taxes can accompany the designation.

About Nuvilex

Nuvilex 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(R). 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. In addition, Nuvilex is working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of solid cancerous tumors. Nuvilex is also 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(R) 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 the rare opportunity to develop “green” approaches to fighting deadly 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, could cause actual results to differ materially from those set forth in the forward-looking statements. They 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.

Contact:
Investor Relations Contacts:
Jamien Jones
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 103
jjones@bplifescience.com

1 1616

Nuvilex’s Partner Austrianova Successfully Completes First Live Cell Encapsulation in New Facility

SILVER SPRING, Md., Dec. 18, 2014 (GLOBE NEWSWIRE) — Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company providing cell and gene therapy solutions for the treatment of diseases, today announced that its partner, Austrianova, successfully completed the first live cell encapsulation at Austrianova’s new facility in the Thai Science Park in Bangkok, Thailand. This is an important milestone in assuring the facility is compliant with the current Good Manufacturing Practices (cGMP) and that the encapsulation of the cancer prodrug-activating cells used in the Cell-in-a-Box(R) technology platform, as part of Nuvilex’s pancreatic cancer treatment, will be fully functional.

“We congratulate Austrianova on the implementation of its Cell-in-a-Box technology at its new state-of-the-art encapsulation facility,” stated Kenneth L. Waggoner, Chief Executive Officer of Nuvilex. He added, “Additional encapsulation processes will be conducted to validate the overall encapsulation process and obtain data required for regulatory authorities to certify that the facility, equipment and encapsulation process are cGMP-compliant. We are extremely grateful to all of our colleagues at Austrianova for their long hours of hard work that were necessary for this milestone to be reached so quickly. Nuvilex is now one step closer to initiating a Phase 2b pancreatic cancer clinical trial.”

Dr. Brian Salmons, Chief Executive Officer of Austrianova, added, “We are extremely pleased that we have been able to produce capsules of the same quality and standard as those previously used for the Cell-in-a-Box(R) process. We accomplished this in a very short time after our encapsulation facility was opened here in Thailand.”

About Nuvilex

Nuvilex 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(R). 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. In addition, Nuvilex is working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of solid cancerous tumors. Nuvilex is also 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(R) 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 an exceptional opportunity to develop “green” approaches to fighting deadly 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, could cause actual results to differ materially from those set forth in the forward-looking statements. They 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.

Contact:
Investor Relations Contacts:
Clare Matschullat
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 106
cmatschullat@bplifescience.com

1 1246

Nuvilex Provides Shareholder Update on Cancer and Diabetes Programs

SILVER SPRING, Md., Dec. 16, 2014 (GLOBE NEWSWIRE) — Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company providing cell solutions for the treatment of diseases, today announced a shareholder update on the Company’s cancer and diabetes programs utilizing its Cell-in-a-Box(R) cellulose-based live cell encapsulation technology.

  • The first preclinical study by TD2 in the U.S. that deals with the effectiveness of Nuvilex’s pancreatic cancer treatment on the accumulation of malignant ascites fluid that is often associated with the growth of abdominal cancers, including pancreatic cancer, has been completed and positive results were obtained.
  • Nuvilex has commenced the development of a clinical protocol for the planned Phase 2b clinical trial in pancreatic cancer.
  • Applications have been submitted to drug regulatory authorities in the U.S., Europe and Australia to obtain Orphan Drug status for Nuvilex’s pancreatic cancer treatment that combines Cell-in-a-Box(R) with low doses of the anticancer prodrug ifosfamide.
  • Contracts have been executed with major institutions that will permit the development of a diabetes treatment that combines Cell-in-a-Box(R) with insulin-producing cells, and a Diabetes Consortium has been established to facilitate this important research.
  • The live cell encapsulation facility in Thailand, where the Cell-in-a-Box(R) encapsulation will be done, has now officially opened and is an extremely important development as this facility is essential for all of Nuvilex’s efforts in developing treatments for cancer and diabetes.
  • Rapid progress is being achieved at the University of Northern Colorado in the pursuit of treatments for cancer that will combine cannabinoid-like compounds with the Cell-in-a-Box(R)technology.

“This is truly an exciting, important time for Nuvilex, and I wish to extend my sincere appreciation to our longstanding shareholders for their continued support during this transformational period of our growth,” commented Kenneth L. Waggoner, Chief Executive Officer of Nuvilex.

An extensive update on Nuvilex’s programs has been prepared and can be reviewed on the Nuvilex website at: http://www.nuvilex.com/shareholder-update-on-recent-activities-in-the-areas-of-cancer-and-diabetes

About Nuvilex

Nuvilex (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(R). 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. In addition, Nuvilex is working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of solid cancerous tumors. Nuvilex is also 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(R) 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 deadly 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, could cause actual results to differ materially from those set forth in the forward-looking statements. They 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.

Contact:
Investor Relations Contacts:
Clare Matschullat
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 106
cmatschullat@bplifescience.com

0 1281

Form 10-Q for NUVILEX, INC.

15-Dec-2014

Quarterly Report

NOTE 2 – CAPITALIZATION AND MANAGEMENT PLANSCapitalization

The Company’s financial statements are prepared using generally accepted accounting principles in the United States (“GAAP”) applicable to a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. As of October 31, 2014, the Company has an accumulated deficit of $75,607,031 and incurred a net loss for six months ended October 31, 2014 of $5,648,497.

Funding has been provided by management and investors to maintain and expand the Company and acquire Bio Blue Bird. New investors enabled the completion of the acquisition of Bio Blue Bird which provided the Company the ability to begin preparations toward clinical trials in patients with advanced, inoperable pancreatic cancer. Additional funding enabled the Company to obtain the diabetes license and to advance the Company’s preclinical studies and preparations for clinical trials of its product candidates. The remaining challenges, beyond the regulatory and clinical aspects, include accessing further funding for the Company to cover its future cash flow needs. The Company continues to acquire additional funds through management’s efforts.

On October 28, 2014, the Company filed a Form S-3 Registration Statement under the Securities Act of 1933, as amended. This Registration Statement registered $50 million of securities which may be issued by the Company from time to time in indeterminate amounts and times and at the discretion of the Company.

The Company requires substantial additional capital to finance its planned business operations and expects to incur operating losses in future periods due to the expenses related to the Company’s core businesses. The Company has not realized material revenue since it commenced doing business in the biotechnology sector, and it is not without doubt that it will be successful in generating revenues in the future in this sector. The Company believes that cash and cash equivalents as of October 31, 2014 are sufficient to fund its operations through the end of October 31, 2015.

The Company will continue to be dependent on outside capital to fund its research and operating expenditures for the foreseeable future. If the Company fails to generate positive cash flows or fails to obtain additional capital when required, the Company may need to modify, delay or abandon some or all of its business plans.

Management Strategy and Goals

The Company has worked closely with the senior executives of SG Austria and Austrianova Singapore in a number of critical areas. The senior executives of the Company, and SG Austria and Austrianova Singapore have succeeded in creating mechanisms and processes to advance the interests of their respective companies, regardless of the economic conditions and challenges. The strong collaboration between the two companies is expected to remain since the Company has a 14.5% ownership interest in SG Austria and Austrianova Singapore will be carrying out the manufacturing of encapsulated live cells for the Company in the areas of pancreatic cancer and diabetes. In addition, the senior executives of SG Austria and Austrianova Singapore will be working with the Company to develop new areas for the use of the live cell encapsulation technology, one example being the development of a “breakthrough” treatment for breast cancer.

The Company’s first goal is to ensure that the success engendered in the previous Phase 1/2 pancreatic cancer clinical trials can be built upon and advanced. This occurred with the Company’s acquisition of Bio Blue Bird. This acquisition enabled the Company to advance itself as a biotechnology company. Due to the Company’s extensive array of product candidates already in-house, the Company exists as a biotechnology company with a broad base – much like that of larger biotechnology or pharmaceutical companies after years of in-house advances, the purchasing of products from third parties and even the acquisition of entire companies. Thus, with an overall goal of long-term growth, management believes the Company is poised to be thrust into a very different position from that of one year ago, particularly as a result of the stabilization of its financial condition that has been occurring over the past year.

Management believes its objective is to have the Company become an industry-leading biotechnology company, with a multi-part, laser-focused strategy. Like those of larger pharmaceutical companies, this strategy is expected to strengthen the Company’s position in both the short and long term. The Company will seek to raise capital to fund growth opportunities and provide for its working capital needs as the strategy of the Company is executed. The Company’s efforts to achieve financial stability and to enable it to carry out the strategy of the Company include several primary components:

  • The completion of the preparations for the Phase 2b clinical trial in advanced, inoperable pancreatic cancer to be carried out in Australia;
  • The conducting of preclinical studies and clinical trials that will examine the effectiveness of the Company’s pancreatic cancer treatment in ameliorating the pain and accumulation of malignant ascites fluid in the abdomen that are characteristic of pancreatic cancer. These studies and trials will be conducted by Translational Drug Development in the United States;
  • The enhancement of the Company’s ability to expand into the biotechnology arena through further research and partnering;
  • The acquisition of new contracts and revenue utilizing both in-house products and the newly acquired biotechnology licensing rights;
  •  The further development of uses of the Cell-in-a-Box technology platform through contracts, licensing agreements and joint ventures with other companies; and
  • The completion of testing, expansion and marketing of existing and newly derived product candidates.

NOTE 3 – SIGNIFICANT ACCOUNTING POLICIES

Unaudited Financial Statements

The accompanying unaudited consolidated financial statements have been prepared in accordance with GAAP for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. While these statements reflect all normal recurring adjustments which are, in the opinion of management, necessary for fair presentation of the results of the interim period, they do not include all of the information and footnotes required by GAAP for complete financial statements. The unaudited interim financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K which contains the audited financial statements and notes thereto, together with Management’s Discussion and Analysis, for the fiscal year ended April 30, 2014. The interim results for the six months ended October 31, 2014 are not necessarily indicative of the results for the full fiscal year.

Management further acknowledges it is solely responsible for adopting sound accounting practices, establishing and maintaining a system of internal accounting controls and preventing and detecting fraud. The Company’s system of internal accounting control is designed to ensure, among other items, that transactions are recorded and valid and in the proper period in a timely manner to produce financial statements which present fairly the financial condition, results of operations and cash flows of the Company for the respective periods being presented.

Principles of Consolidation

The accompanying financial statements include the accounts of the Company and its subsidiaries as of October 31, 2014, Viridis Biotech, Inc. (formerly known as Medical Marijuana Services, Inc.), Nuvilex Europe Limited, Nuvilex Australia Private Limited and Bio Blue Bird. All significant inter-company balances and transactions have been eliminated in consolidation. See Note 4 for further discussion on consolidation.

Cash and Cash Equivalents

For purposes of the statement of cash flows, the Company considers all highly liquid debt instruments purchased with a maturity of three months or less to be cash equivalents to the extent the funds are not being held for investment purposes. There were no cash equivalents as of October 31, 2014.

Segment Reporting

ASC Topic 280, “Segment Report,” requires use of the “management approach” model for segment reporting. The management approach model is based on the way a company’s management organizes segments within the company for making operating decisions and assessing performance. ASC Topic 280 has no effect on the Company’s consolidated financial statements as the Company consists of one reportable business segment.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Property and Equipment

Property and equipment are recorded at cost. Expenditures that increase the useful lives or capacities of the plant and equipment are capitalized. Expenditures for repairs and maintenance are charged to income as incurred. Depreciation is provided using the straight-line method over the estimated useful lives as follows:

  • Computer equipment/software – 3 years
  • Furniture and fixtures – 7 years
  • Machinery and equipment – 7 years
  • Building improvements – 15 years
  • Building – 40 years

Goodwill and other Indefinite-Lived Intangibles

The Company records the excess of purchase price over the fair value of the identifiable net assets acquired as goodwill and other indefinite-lived intangibles. The Fair Accounting Standards Board (“FASB”) standard on goodwill and other intangible assets prescribes a two-step process for impairment testing of goodwill and indefinite-lived intangibles, which is performed annually and when an event triggering impairment may have occurred. The first step tests for impairment, while the second step, if necessary, measures the impairment. The Company has elected to perform its annual analysis at the end of its reporting year.

Valuation of Long-Lived Assets

The Company accounts for the valuation of long-lived assets under the FASB standard for accounting for the impairment or disposal of Long-Lived Assets. The FASB standard requires that long-lived assets and certain identifiable intangible assets be reviewed for impairment whenever events or circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived assets is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value, less cost to sell.

Functional Currency

The accounts of Bio Blue Bird are maintained in Euros. The accounts of this foreign subsidiary were translated into US dollars in accordance with ASC Topic
830 “Foreign Currency Matters.” According to ASC Topic 830: (i) all assets and liabilities were translated at the exchange rate on the balance sheet dates;
(ii) stockholders’ equity is translated at historical rates; and (iii) statement of operation items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income in accordance with ASC Topic 220, “Comprehensive Income.” Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statements of income.

Foreign Currency Transactions and Comprehensive Income

GAAP requires that recognized revenue, expenses, gains and losses be included in net income. Certain statements, however, require entities to report specific changes in assets and liabilities, such as gain or loss on foreign currency translation, as a separate component of the equity section of the balance sheet. Such items, along with net income, are components of comprehensive income. Translation gains are classified as an item of accumulated other comprehensive income in the stockholders’ equity section of the unaudited Consolidated Balance Sheet.

Basic and Diluted Earnings (Loss) per Share

Basic and diluted earnings per share is calculated using the weighted-average number of common shares outstanding during the period without consideration of the dilutive effect of stock warrants, convertible notes and convertible preferred shares. All outstanding warrants are convertible into 57,969,908 shares of common stock.

Fair Value of Financial Instruments

For certain of the Company’s non-derivative financial instruments, including cash and cash equivalents, receivables, accounts payable and other accrued liabilities, the carrying amount approximates fair value due to the short-term maturities of these instruments. The estimated fair value of long-term debt is based primarily on borrowing rates currently available to the Company for similar debt issues. The fair value approximates the carrying value of long-term debt.

Accounting Standards Codification (“ASC”) Topic 820, “Fair Value Measurements and Disclosures,” requires disclosure of the fair value of financial instruments held by the Company. ASC Topic 825, “Financial Instruments,” defines fair value, and establishes a three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements for fair value measures. The carrying amounts reported in the consolidated balance sheets for receivables and current liabilities each qualify as financial instruments and are a reasonable estimate of their fair values because of the short period of time between the origination of such instruments and their expected realization and their current market rate of interest. The three levels of valuation hierarchy are defined as follows:

  • Level 1. Observable inputs such as quoted prices in active markets;
  • Level 2. Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
  • Level 3. Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.

The following presents the gross value of assets and liabilities that were measured and recognized at fair value as of October 31, 2014.

  • � Level 1: none
  • � Level 2: none
  • � Level 3: none

Effective October 1, 2008, the Company adopted ASC subtopic 820-10, Fair Value Measurements and Disclosures (“ASC 820-10″) and Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10″), which permits entities to choose to measure many financial instruments and certain other items at fair value. Neither of these statements had an impact on the Company’s financial position, results of operations or cash flows. The carrying value of cash, accounts payable and accrued expenses, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments.

Recent Accounting Pronouncements

In April 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-08, “Presentation of Financial Statements (Topic 205) and Property, Plant and Equipment (Topic 360).” ASU 2014-08 amends the requirements for reporting discontinued operations and requires additional disclosures about discontinued operations. Under the new guidance, only disposals representing a strategic shift in operations or that have a major effect on the Company’s operations and financial results should be presented as discontinued operations. This new accounting guidance is effective for annual periods beginning after December 15, 2014. The Company is currently evaluating the impact of adopting ASU 2014-08 on the Company’s results of operations or financial condition.

On February 26, 2014, the FASB affirmed changes in a November 2013 Exposure Draft, Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, and directed the staff to draft a final Accounting Standards Update for vote by the FASB. This is intended to reduce the cost and complexity in financial reporting by eliminating inception-to-date information from the financial statements of development stage entities.

The Company has implemented all new accounting pronouncements that are in effect. These pronouncements did not have any material impact on the financial statements unless otherwise disclosed, and the Company does not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.

Revenue Recognition

Sales of products and related costs of products sold are recognized when: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred; (iii) the price is fixed or determinable; and (iv) collectability is reasonably assured. These terms are typically met upon the prepayment or invoicing and shipment of products.

Income Taxes

Deferred taxes are calculated using the liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.

In June 2006, the FASB interpreted its standard for accounting for uncertainty in income taxes, an interpretation of accounting for income taxes. This interpretation clarifies the accounting for uncertainty in income taxes recognized in an entity’s financial statements in accordance the minimum recognition threshold and measurement attributable to a tax position taken on a tax return is required to be met before being recognized in the financial statements.

The FASB’s interpretation had no material impact on the Company’s financial statements for the quarter ended October 31, 2014 or the year ended April 30, 2014. Current tax laws limit the amount of loss available to be offset against future taxable income when a substantial change in ownership occurs. Therefore, the amount available to offset future taxable income may be limited. No tax benefit has been reported in the financial statements because the Company believes the carry forwards may expire unused, although acquisition of sufficient operating capital to complete the acquisition of all of the assets of SG Austria may change this. Accordingly, the potential tax benefits of the loss carry forwards are offset by a valuation allowance of the same amount.

Research and Development Costs

Expenditures for research and development are expensed as incurred. Such costs are required to be expensed until the point that technological feasibility is established.

Concentration of Credit Risk

The Company has no significant off-balance-sheet concentrations of credit risk such as foreign exchange contracts, options contracts or other foreign hedging arrangements. The Company maintains the majority of its cash balances with one financial institution in the form of demand deposits.

NOTE 4 – BUSINESS ACQUISITION

The Company completed the purchase of Bio Blue Bird on April 30, 2014. Shares for both Austrianova Singapore and the Company originally held in escrow under the SG Austria APA have been released from escrow and returned to the respective original owners, with the 100,000,000 shares of common stock having been returned to the treasury of the Company. Bio Blue Bird is now a wholly owned subsidiary of the Company.

NOTE 5 – DEBT

In February, 2014, the Company settled its obligation to pay $20,000 plus $6,000 of accrued interest to a note holder with the issuance of 250,000 shares of common stock. The shares were valued at $45,500 using the closing share price of the common stock on the day of issuance resulting in a loss on settlement of debt of $19,500.

NOTE 6 – COMMON STOCK TRANSACTIONS

On February 14, 2014, the Company entered into a stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Lincoln Park initially purchased 8 million shares of common stock at $0.25 per share for $2 million and had committed to invest up to an additional $25 million of equity capital over the term of the stock purchase agreement. As consideration for its commitment to purchase shares of common stock pursuant to the stock purchase agreement, the Company issued to Lincoln Park 5,062,500 shares of common stock upon execution of the stock purchase agreement. These shares were valued at $0.169, the closing price of the stock on February 14, 2014, for non-cash expense of $855,653. On May 28, 2014 the Company and Lincoln Park executed a Mutual Termination and Release Agreement releasing all parties from certain obligation under the stock purchase agreement. As consideration for terminating the stock purchase agreement, the Company issued Lincoln Park an additional 1,062,500 shares of common stock. These shares were valued at $0.28 for total non-cash expense of $297,500.

As of the period ended October 31, 2014, 300,000 shares of common stock were issued to an officer of the Company for compensation. These shares were valued using the closing share price of the common stock on the day of issuance for a total non-cash expense of $86,100.

As of the period ended October 31, 2014, the Company sold 200,000 shares of common stock for $20,000.

As of the period ended October 31, 2014, the Company converted some of its Class B warrants into 550,000 shares of common stock for $66,000.

As of the period ended October 31, 2014, 17,628,000 shares of common stock were issued to fully satisfy all stock payables due in the amount of $1,574,860.

As of the quarter ended October 31, 2014, the Company had committed to issue 1,700,000 shares of common stock to officers as part of their compensation agreements. These shares have not yet been issued as of the date of these financial statements. The shares were valued using the closing share price of the common stock on the date the accrual of the compensation for a total of a non-cash expense of $394,250.

As of the quarter ended October 31, 2014, the Company, as a result of settlement agreements, accepted the return of 15,606,667 shares of its common stock from three officers. The Company used ASC 845-10-30 – Treasury Stock Acquisition in Connection with a Settlement Agreement (ASC 845-10-30) to account for the shares the Company received. The shares were valued at the closing price on date of their return and the Company recognized a non-cash gain equal to the fair value of the shares in the amount of $2,153,490 and is included in other income.

As of the quarter ended October 31, 2014, the Company entered into a mutual termination agreement with a consultant. The original consulting agreement called for the issuance of 800,000 shares. The mutual termination agreement called for the return of 335,296 shares of the 800,000 share issuance. The Company used ASC 845-10-30 to account for the shares returned. The shares were valued at the closing price on the date the mutual termination agreement was signed and the Company recognized in a non-cash gain of $29,841 and is included in other income.

As of the quarter ended October 31, 2014, the Company had issued 25 million stock options to officers and directors previously authorized by its Board of Directors in March 2014. The options expire on September 30, 2019 and are exercisable at $0.19 share. The grant of these options resulting in a current period expense of $4,307,822 and is included in compensation expenses.

All shares were issued without registration under the Securities Act in reliance upon the exemption afforded by Section 4(a)(2) of the Securities Act.

NOTE 7 – PREFERRED STOCK

The Company has one series of preferred stock designated as “Series E Preferred Stock.” The Series E Preferred Stock has the following features:

  • Series E Preferred Stock does not bear any dividends;
  • Each share of Series E Preferred Stock is entitled to receive its share of assets distributable upon the liquidation, dissolution or winding up of the affairs of the Company. The holders of the Series E Preferred Stock are entitled to receive cash out of the assets of the Company before any amount is paid to the holders of any capital stock of the Company of any class junior in rank to the shares of Series E Preferred Stock;
  • Each share of Series E Preferred Stock is convertible, at the holder’s option, into shares of common stock, at the average closing bid price of the common stock for five trading days prior to the conversion date; and
  • At every meeting of stockholders, every holder of shares of Series E Preferred Stock is entitled to 50,000 votes for each share of Series E Preferred Stock, with the same and identical voting rights as a holder of a share of common stock; therefore, the holder of shares of Series E Preferred Stock can effectively increase the Company’s issued common stock shares without a vote of the common stock shareholders, thus enabling any potential shortfall of authorized common stock outstanding from being converted should a holder of Series E Preferred Stock wish to convert.

During the year ended April 30, 2014, a shareholder converted 8,500 shares of the Company’s Series E Preferred Stock into 54,000,000 shares of common stock. These shares were valued using the closing share price of the common stock on the day of issuance for a total of $6,475,000 resulting in a loss on conversion of $5,895,000.

Holders of Series E Preferred Stock have specific rights to be paid in cash out of the assets of the Company prior to any junior class of common stock. As a result of the obligations for Series E Preferred Stock, the Company has determined these redemption features have the potential to be outside the control of the Company and, therefore, the Company has classified the Series E Preferred Stock outside of shareholder’s equity in accordance with ASC 480 regarding instruments with debt and equity features. Thus, the full value for the convertible Series E Preferred Stock was recorded outside of stockholders’ equity in the accompanying unaudited consolidated balance sheet.

NOTE 8 – STOCK OPTIONS

On September 29, 2014, the Company issued 25,000,000 options to purchase Shares at an exercise price of $0.19 per Share. All options were fully vested upon issuance.

The following is a summary of stock option activity:

                                                        Weighted            Weighted
                                                         Average            average
                                        Options         Exercise           remaining              Aggregate
                                      outstanding         Price         contractual life       Intrinsic Value
Outstanding, April 30, 2014                      -     $         -
Granted                                 25,000,000            0.19
Forfeited                                        -               -
Exercised                                        -               -
Outstanding, October 31, 2014           25,000,000     $      0.19                   4.92     $               -

Exercisable, October 31, 2014           25,000,000     $      0.19                   4.92     $               -

The assumptions used in calculating the fair value of options granted using the Black-Scholes option- pricing model for options granted are as follows:

0 1164

Nuvilex Provides Update on Significance of Austrianova’s cGMP Live-Cell Encapsulation Facility

SILVER SPRING, Md., Dec. 10, 2014 (GLOBE NEWSWIRE) — Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, is pleased to provide an update on the significance of its partner, Austrianova, opening a new, state-of-the-art current Good Manufacturing Practices (cGMP)-compliant live-cell encapsulation facility inside the Thailand Science Park (TSP). This facility will produce the Cell-in-a-Box(R) live-cell encapsulation product that will be the centerpiece for all of Nuvilex’s treatments in human clinical trials.

“The cGMP facility in Thailand will play an integral role in our growth as it enables the production of encapsulated cell products to the highest standards to meet the requirements of the different drug regulators in countries worldwide, particularly territories where we will be conducting clinical trials,” commented Kenneth L. Waggoner, Chief Executive Officer of Nuvilex.

Nuvilex contracted with Austrianova to establish the facility in order to produce the Cell-in-a-Box(R) technology containing the cancer prodrug-activating cells that will be used for Nuvilex’s upcoming trials, including a Phase 2b clinical trial in pancreatic cancer in Australia, clinical trials in the United States related to the intractable pain associated with pancreatic cancer, the accumulation of malignant ascites fluid that results from late-stage pancreatic cancer and other serious abdominal cancers. The facility will also be used to encapsulate insulin-producing cells that will be pivotal for clinical trials of Nuvilex’s treatment for insulin-dependent diabetes.

Prof. Walter H. Gunzburg, Chief Scientific Officer of Nuvilex and Chairman of Austrianova, added, “The first product to be produced from the new cGMP facility will be encapsulated cells for Nuvilex’s pancreatic cancer clinical trial that is planned for Australia. The encapsulation facility is state-of-the-art. It will allow not only the production of batches for clinical trials, but the facility will also be capable of accommodating production of a final product to supply eventual market demand. As well as increased production capacity, the quality of the final product will be greatly enhanced through the development of a new production process. This new process is based entirely on disposable single-use materials, guaranteeing the highest quality of the final product.”

Dr. Brian Salmons, CEO and President of Austrianova, commented on the unique design of the facility saying, “In order to comply with international standards of cGMP, the facility has been designed around a unique custom-built isolation unit which allows the complete production line to be isolated from the operators in a class-A environment. This is the most stringent way to produce a pharmaceutical and guarantees its quality and purity. It is also the first of its kind for a cell encapsulation product and the first of its kind in all of Southeast Asia.”

Dr. Matthias Lohr, the Principle Investigator for the previous Phase 1/2 and Phase 2 pancreatic cancer clinical trials and Chairman of Nuvilex’s newly formed Scientific Advisory Board, said, “We are all very excited by this key development and are eagerly anticipating the late-stage trial for pancreatic cancer as well as for pancreatic cancer-associated ascites fluid accumulation and, in the future, for other cancers. New and effective treatments for pancreatic cancer are desperately needed, and Nuvilex’s treatment for this deadly disease circumvents many of the debilitating side effects associated with more classic chemotherapies.”

The TSP was established by the Ministry of Science and Technology to be the hub for the private sector’s industrial R&D activities. The TSP started its operations in 2002, under the management of the National Science and Technology Development Agency. It is located just outside of Bangkok and has more than sixty companies, four research institutes, three universities and one medical school. The TSP stimulates and manages the flow of knowledge and technology among universities, R&D institutions, companies and markets. It also facilitates the creation and growth of innovation-based companies through incubation and spin-off processes in the most cost-effective manner. For these reasons, Austrianova decided it was the ideal location to set up their science and technology based operations in Southeast Asia.

About Nuvilex

Nuvilex (NVLX) is a preclinical and 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(R). 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. In addition, Nuvilex is working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of solid cancerous tumors. Nuvilex is also 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(R)technology in optimizing the anticancer effectiveness of cannabinoids and cannabinoid-like compounds, 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 deadly 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.

Contact:
Investor Relations Contacts:
Clare Matschullat
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 106
cmatschullat@bplifescience.com

0 1535

Nuvilex Announces Name Change of Subsidiary to Viridis Biotech

SILVER SPRING, Md., Dec. 8, 2014 (GLOBE NEWSWIRE) — Nuvilex, Inc. (NVLX), a preclinical and clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that it has changed the name of its subsidiary, Medical Marijuana Sciences, Inc., to Viridis Biotech, Inc. This name change is part of Nuvilex’s continuing process to make changes at Nuvilex that better reflect its role as a biotechnology company and to strengthen the Nuvilex brand.

Nuvilex CEO and President, Kenneth L. Waggoner, said of the decision to change the name to Viridis Biotech, Inc., “We did so to distinguish ourselves from the numerous medical marijuana companies that have come into existence in the last year or so that are usually associated with ‘medical marijuana’ as that term is understood by so many throughout the country, especially in Washington and Colorado. We are not a ‘medical marijuana’ company in that sense of the word. Nor are we associated with the growth, sales or distribution of Cannabis. We are a biotechnology company focused on the treatment and cure of serious and deadly diseases.”

The subsidiary’s name “Viridis” is derived from Latin where it means “green.” Viridis Biotech is developing treatments for cancers based upon cannabinoids by examining ways to exploit the benefits of the Cell-in-a-Box(R) cellulose based live cell encapsulation technology in optimizing the anticancer effectiveness of cannabinoids while minimizing or even eliminating the debilitating side effects usually associated with cancer treatments.

On December 1, 2014, Nuvilex announced that it had obtained an exclusive worldwide license from Austrianova to use the unique and proprietary Cell-in-a-Box(R) technology in combination with constituents of Cannabis, known as cannabinoids, or cannabinoid-like compounds for the development of treatments for diseases and medical conditions.

Waggoner added, “This exclusive worldwide license will provide Nuvilex and Viridis Biotech a unique opportunity to develop ‘green’ approaches to fighting cancers that are both safe and effective. Our initial targets will be some of the deadliest and most difficult-to-treat cancers, such as those of the pancreas, brain and breast, which affect so many individuals in almost every country of the world.”

About Nuvilex

Nuvilex (NVLX) is a preclinical and 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(R). 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 Cannabisknown as cannabinoids. Nuvilex is examining ways to exploit the benefits of Cell-in-a-Box(R)technology in optimizing the anticancer effectiveness of cannabinoids, while minimizing or even eliminating the debilitating side effects usually associated with cancer treatments. This provides Nuvilex a unique opportunity to develop “green” approaches to fighting deadly 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.

Contact:
Investor Relations Contacts:
Clare Matschullat
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 106
cmatschullat@bplifescience.com

0 429

Nuvilex Announces the Opening of Austrianova’s cGMP Live Cell Encapsulation Facility in Thailand

SILVER SPRING, Md., Dec. 4, 2014 (GLOBE NEWSWIRE) — Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that Nuvilex executives joined Thailand government officials at the grand opening of Austrianova’s current Good Manufacturing Practices (cGMP) live-cell encapsulation facility within the Thai Science Park (TSP) in Bangkok, Thailand. The TSP is the premier Science, Technology and Innovation hub of Thailand and home to many leading international hi-tech and bio-tech companies.

Nuvilex contracted with its partner Austrianova to establish the manufacturing facility that will produce the Cell-in-a-Box(R) live-cell encapsulation product containing cancer prodrug-activating cells that will be used for the Phase 2b clinical trial of Nuvilex’s pancreatic cancer treatment in Australia and for clinical trials in the United States related to the intractable pain associated with pancreatic cancer and the accumulation of malignant ascites fluid that results from late-stage pancreatic cancer and other abdominal cancers. This facility will also be used to encapsulate insulin-producing cells that will be pivotal for clinical trials of Nuvilex’s treatment for insulin-dependent diabetes.

Nuvilex CEO and President, Kenneth L. Waggoner, stated, “Nuvilex is pleased that the new cGMP facility that will perform live cell encapsulation using the Cell-in-a-Box(R) encapsulation technology is officially open in Thailand. This is a vitally important event on the path to the new and later stage clinical trials for Nuvilex. We are pleased to have been invited as guest of honor at the grand opening ceremony and to have met with so many scientists and professors involved with the Cell-in-a-Box(R) technology.”

Dr. Brian Salmons, CEO and President of Austrianova, commented, “We are proud to have opened our unique cGMP facility which utilizes the first state-of-the-art, custom-built, controlled gaseous environment isolator based cell production system in Asia. This isolator system, housed in a newly built conventional Class D cleanroom, will ensure that all Cell-in-a-Box(R) products are manufactured to the highest international pharmaceutical production standards.”

Prof. Walter H. Gunzburg, Chief Scientific Officer of Nuvilex and Chairman of Austrianova, said, “Together with Thailand Center of Excellence in Life Sciences, we have worked for over a year to develop this world-first encapsulated cell production capability. Finally, through the close collaborative efforts of this Thai Government Agency with Austrianova and the Thailand Science Park, we have been able to achieve, in a remarkably short period, the realization of this unique facility.”

To view pictures of the event and the new facility in the Thai Science Park, visit:http://www.nuvilex.com/index.php?option=com_eventgallery&view=event&layout=tiles&folder=Event1&Itemid=133

About Nuvilex

Nuvilex (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(R). 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 cancers based upon cannabinoid-like drugs by examining ways to exploit the benefits of the Cell-in-a-Box(R) technology in optimizing the anticancer effectiveness of such drugs 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.

Contact:
Investor Relations Contacts:
Clare Matschullat
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 106
cmatschullat@bplifescience.com

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