June 10, 2013
Rare Performance Bolsters Nuvilex’s Approval Prospects
There is an old adage that states: “You have to spend money to earn money.” This adage might as well be the mantra for most biotech companies, including Nuvilex Inc. (OTCQB – NVLX - $0.103 – Spec Buy), an international firm engaged in using its live-cell encapsulation technology for the development of treatments for pancreatic and other cancers along with the development of therapies based on components of medical marijuana for use in oncology patients.
Success is not guaranteed in the biotech world based upon how much money is spent on research and development. However, the needle moves sharply toward ensuring success when tens of millions of dollars in R&D spending occurs before Phase III clinical trials commence. Many biotech firms do not reach that level of commitment and expenditure through two phases of clinical trials, and few are able to enjoy the degree of success exhibited by Nuvilex.
To date, nearly $30M has been invested in the Company’s live-cell encapsulation-based therapies to treat pancreatic cancer and other diseases. This includes two successful Phase II clinical trials in advanced inoperable pancreatic cancer, preclinical trials for other cancer indications, and additional necessary product development. Research and development expenses do not end with the conclusion of clinical trials, however; $2M has been invested in the past 2 years alone to help further the Company’s development goals.
This cumulative $30M investment has resulted in something rare for biotech companies and enhances the likelihood of Nuvilex’s continued success with the ultimate goal of FDA approval and product commercialization for its products. A recent study has demonstrated that in the past few years, 82% of companies that have been initially engaged in Phase II clinical trials have failed. This means that Nuvilex is in the 18% minority of firms that have produced favorable results, which should increase the value of the Firm itself.
The primary reasons for clinical trial failures include insufficient efficacy demonstration and/or poor safety/toxicity of the drug or treatment. In the Nuvilex Phase II pancreatic cancer trials in which its technology was used to encapsulate live cancer-drug-activating cells which were then implanted near the pancreas and therefore the tumor. Then the anticancer drug ifosfamide was administered, median survival nearly doubled and one-year survival was doubled as compared to historical data for Gemzar, the only drug approved to date by the FDA as a single agent for the treatment of advanced inoperable pancreatic cancer. In addition, the side effects associated with the treatment were decreased due to the use of only one-third of the typical dosage of ifosfamide; even this low dose of anticancer drug when combined with the Company’s live-cell encapsulation technology was sufficient to give the excellent efficacy results described above.
Not only is it rare for a Firm like Nuvilex to have such success in Phase II trials, but given the excellent trial results to date, surely a new trial that compares Nuvilex’s treatment “head-to-head” with the gold standard pancreatic cancer drug Gemzar, has significant potential for success. Given that Gemzar generates annual sales north of $1 billion annually, it is likely that the Company’s previous and future R&D investments could have a huge return on investment for Nuvilex and its shareholders
Senior Analyst: Robert Goldman
The information used and statements of fact made have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy. Goldman Small Cap Research did not make an independent investigation or inquiry as to the accuracy of any information provided by the Company, or other firms. Goldman Small Cap Research relied solely upon information provided by the Company through its filings, press releases, presentations, and through its own internal due diligence for accuracy and completeness. Such information and the opinions expressed are subject to change without notice. A Goldman Small Cap Research report, update, article, or note is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed.
This publication does not take into account the investment objectives, financial situation, or particular needs of any particular person. This report does not provide all information material to an investor’s decision about whether or not to make any investment. Any discussion of risks in this presentation is not a disclosure of all risks or a complete discussion of the risks mentioned. Neither Goldman Small Cap Research, nor its parent, is registered as a securities broker-dealer or an investment adviser with FINRA, the U.S. Securities and Exchange Commission or with any state securities regulatory authority.
ALL INFORMATION IN THIS REPORT IS PROVIDED “AS IS” WITHOUT WARRANTIES, EXPRESSED OR IMPLIED, OR REPRESENTATIONS OF ANY KIND. TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, TWO TRIANGLE CONSULTING GROUP, LLC WILL NOT BE LIABLE FOR THE QUALITY, ACCURACY, COMPLETENESS, RELIABILITY OR TIMELINESS OF THIS INFORMATION, OR FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, INCIDENTAL, SPECIAL OR PUNITIVE DAMAGES THAT MAY ARISE OUT OF THE USE OF THIS INFORMATION BY YOU OR ANYONE ELSE (INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, LOSS OF OPPORTUNITIES, TRADING LOSSES, AND DAMAGES THAT MAY RESULT FROM ANY INACCURACY OR INCOMPLETENESS OF THIS INFORMATION). TO THE FULLEST EXTENT PERMITTED BY LAW, TWO TRIANGLE CONSULTING GROUP, LLC WILL NOT BE LIABLE TO YOU OR ANYONE ELSE UNDER ANY TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY, PRODUCTS LIABILITY, OR OTHER THEORY WITH RESPECT TO THIS PRESENTATION OF INFORMATION.