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Yes... It was a different / higher dosage that caused minor side effects compared to none.
Techsonian has posted that over and over again... Probably 5 or 6 times
Mathematically that is accurate. However, you are looking at it by dollar increase in your example. Obviously if it goes up 10 % it doesn't matter how many shares right? So now how does share price rise EPS or on nvlx case expected EPS. Per share is operative... Less shares = greater eps at the same total increase
That's just ridiculous ... Eps is would increase dollar per fallout it's the same. A split in either direction is not about increase or decreasing returns as it has no effect. Split because stock price has become too high to attract individual investors reverse is to consolidate shares for many reasons
Nvlx has filed an S-3. Much like an S-1 this includes a few rounds of clarification / sec comments. Contact from the SEC is a good thing! It's part of the process as they validate and clarify data and statement made in the prospectus
Correct me if I am wrong, but you can't place a pre/after hours trade on the OTC
I as well as most of the real investors got into this because of the implications of cell in a box toward pancreatic cancer and potentially diabetes... Diabetes is becoming real too. The MJ portion is virtually nothing by comparison. All the MJ did was attract short term traders. Anyone who got in this for MJ is either long gone or crazy... At the very least they did zero dd.
That are many reasons for a CTO. it is not to hide positive or negative information about the company. In my career most CTO we have had were to protects a deal, shareholders, or a third party. For example, when we were selling an arm of our company, disclosing that to the public, could have negatively/or positively hurt the buyer .... Not That this is the scenario, but it is even more true the smaller the market cap
Diabeties and treatment journal article
http://austrianova.com/wp-content/uploads/2014/09/DRTOA-1-102-final.compressed.pdf
Lt ma(200 day) is increasing st ma (50day) decreasing. They are converging forming a classic triangle... Essentially this is a sign it is under valued and possibly ready to break out
Companies buy back share when the have excess cash... Not when they have positive ROI investment to use their cash for. Buy back are used to return value to shareholders when there are not other uses for their cash. Also when shares are bought by the company " buy backs" they are taken out of circulation... It is not the company investing in itself... Has nothing to do with their belief in the companies future performance... In fact most of the time it is a signal of slowing growth opportunities
Pete, my request was not specific to you, just something I thought would be helpful.
Old news definitely has value too so please continue to post, I just want to be able to quickly tell the difference for a new announcement.
Thank you
Just a suggestion for this board
I have been following nvlx for long time and have found members of this board to be very informative regardless of their holdings and motives. It is has been a great resource for aggregation of information and opinions. I would like to respectfully suggest that those who post links or other information to please mention the date of the source so the we all can see wether the information is current or historical without having to open the link or validate the source. This would greatly help me and hopefully all of you as well.
Thank you all!
Nuvilex (NVLX): Don't Be Fooled By Quiet Trading
It's been a rather quiet week on the trading front for Nuvilex (NVLX), but it's anything but quiet on the corporate front.
It's been a bit quiet all the way around, with the microcap world in a kind of sideways, low volume mode.
So, a bit boring over the past week. But, looking back over the past year, I'd say NVLX has been anything but boring.
Consider little NVLX was $.05 just over a year ago. It only rocketed up to 12 times it's price, then got cut in half from the top. Net result, the stock is just under 5 times the price it was a year ago.
I'd say that's anything but boring. In the course of the year, there was lots of controversy, and all the detractors were proven wrong. I hope microcap investors are beginning to learn the louder the voices calling a perfectly legitimate company a scam, the more likely short sellers are desperately trying to get misinformation out through the internet, and scare you into selling your shares back to them for their profits.
So, while it hasn't been a volatile week on the price front, it's been an informative week on the corporate front, and shareholders who have a longer term view should recognize there is another meteoric run for this stock in the not too distant future- In my view, it's just a question of when.
Since last week, there have been 6 news items on NVLX. The first recounts NVLX's plan, working with world renown cancer expert Dr. Daniel Von Hoff, to use early studies to get into an accelerated approval status with the FDA for their Pancreatic Cancer Therapy.
Secondly, in the past week NVLX has announced plans to do a recorded interview at the American Society of Clinical Oncology which runs through next week. COO Dr. Gerry Crabtree will be discussing the company's technology with a group of cancer experts.
On the market side, NVLX is presenting at institutionally sponsored investors conferences on both the east and west coast. Investors can take this as an indication the company is at an inflection point where its fundamental progress will make NVLX company worth looking at by the big boys.
Lastly, and probably most importantly, NVLX announced a change of plans for future capital raising activities to the positive for shareholders.
NVLX has abandoned its agreement with Chicago Based Lincoln Park on $27 million in financing, and has entered into an agreement with Chardan Capital Markets to raise up to $50 Million in at "At Market" banking arrangement.
In my view, this is the least toxic and most flexible way to raise capital. It allows the company, at its sole discretion, to raise equity capital at the current market price, which is the least dilutive method of raising equity.
NVLX will also have the flexibility to raise capital in small or large amounts, depending on need and price and liquidity in the open market.
NVLX has consistently demonstrated a policy of protecting shareholder value. The last two financing were done at fixed prices "above the market"- that's unheard of for a microcap like this.
I believe NVLX has raised about $6 million in the past year, but will now have the ability to raise another $50 million going forward.
I'll be attending their presentation at the LD Micro Conference in LA next week, so I hope to have some feedback for everybody.
In the meantime, NVLX, up six times the price over the last year, is making all the right moves on the corporate front to commercialize their technology.
As I've pointed out in past editions, a stock like NVLX is going to make one or two meteoric and breathtaking runs a year based on market conditions and company developments.
We saw it last week with LiveDeal (LIVE)- the stock went from 500,000 shares last Thursday to 24 million the next day- up 80%- for no apparent reason. I know the reason- it was a short squeeze. Short sellers were forced to cover, causing the stock to rocket on huge volume.
These are the moves you position yourself for in a stock like Nuvilex (NVLX) at times like this. The company is making all the right moves to get its technology into the FDA Approval process.
This was the second giant run for LiveDeal (LIVE). Will you be properly positioned to make a lot of money when Nuvilex (NVLX) makes its next run?
The opportunity is there today.
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All I am saying is that if pancreatic cancer is your end sure a year is reasonable... But if you see more applications for cell encapsulation it going to take much more time.
What I read from these posts is that most of the longs are selling soon after FDA approval.
I am not looking to sell at $1-2 in the next year ... I am looking to see what they can do in 10.
Agreed... But when I say big potential I am not talking about the small pancreatic cancer market. I am talking about realization of their other possibilities. Diabeties, stem cells, mj, breast cancer etc.
If you are viewing FDA approval of pancreatic cancer as the end game then yes it could be yes then a year... But I view it as the beginning.
Everything hinges on diabetes though... If no approval they are dead in the water. Good luck getting funding to pursue other avenues
Well, the only thing that would do would be possibly boost the PPS in the short term. Nvlx is hopefully focused on getting a product to market.
If he were to make a statement it would change the likelihood of success. And if he were to do so before he has something to report it could cause more volatility.
Let's be patient and wait for results... That is all that matters
Personally I'd rather have him working than making press releases.
Let's cut to the chase:
If you are long like myself, Nvlx is an all or nothing bet. If it get FDA approval for pancreatic cancer the PPS will jump, but that's not the long perspective. If it gets approval it will have the financing to expand to diabetics and other applications... Meaning big potential, but this won't happen for years. If you are following this company on a daily basis ... Or even weekly you probably bought more than you can afford to loose.
The price shot up to .62 because of the massive amount of investors who thought they could get rich fast.... Not long term investors.
If you are a trader there is a lot of money to be made too. This stock will have 40% gains and losses several times before it succeeds or fails.
Both shorts and longs have a fairly equal chance to win big. Approval of pancreatic treatment will tip the scale in favor of the longs... If it fails to get FDA approval nvlx will not be able to pursue it's other potential revenue streams.
As of now we wait. Good luck to all. Short or long ... Don't bet more than you can lose!
Analyst report (old busy still relevant)
http://smallcapstreet.com/1672-2/
Phu
I don't think there will be intervention soon or at all. I think what this really shows is the squeeze potential once hard news/progress comes out. 45% shorts will have to cover ... Provided we report real progress
Wsj article just released
No hard news but good publicity
http://online.wsj.com/article/PR-CO-20140523-906875.html
Daily nvlx naked short selling report... With a brief description to understand the market maker bias.
http://www.buyins.com/reports/nvlx3-21-12.pdf
Yes it is... All material information has to be communicated ONG a fair manor so that all investors or perspective investors have access to the same information at the same time.
Knowledge of the timing on a press release could influence your decision to invest or liquidate holdings... It wouldn't be fair for you to know a week before anyone else
Any information is inside information if it has not already been publicly communicated. So legally the investor relations... CEO... Etc. can't tell you anything you can't just find in previous press releases
Completely agree with your dollar figure... Reasonable given success. This article snipet is in line with your estimate and puts a timeline to it
http://www.techsonian.com/investors-watch-list-falcon-oil-gas-ltd-folgf-medical-marijuana-inc-otcmktsmjna-nuvilexinc-nvlx-baristas-coffee-co-bcci/12179820/
Not 100% sure... But no material change... I think they just want another 90 days to declare their holdings... This could mean a lot of things. I think they don't want to disclose they are holding the price low. This would be good news. Meaning that they think a big announcement will come in the next 90 days... Possibly fast track!
Ps - just my thoughts ... Not pretending to know it all, just how I would play it if I were LPC ...feel free to disagree... All opinions are welcome and appreciated!
Yes... But it's speculative. Fact if the matter is if I was LPC... And bought 2m at 25 cents... I'd want to be selling below the market to keep the price down so the 25m more that I have promised will be with more when nvlx makes the announcement of passing clinical trials. I believe the funding will e secured from LPC just before the release of the trial results. So lo will get in cheap .. The funding will cause a spike (immediately benefiting LPC) and the the results will shoot the PPS to new levels. It's all timing LPC want to keep the price low until results are published... Make sense?
I have seen surprisingly little coverage oh nvlx's cro announcement... Think as it circulates we will have a good upward move with good support ... .38 to .40
Totally agree! Well said
K we are on the same page then
I hope they don't "sell out too" My comment was more passed on a realistic valuation of the stock price after clinical trials assuming success.
I love the enthusiasm but hearing people say thy this its going to have a $50 PPS after phase 3 is absolutely absurd.
Just trying to put things in perspective. if you think 20k shares is going to be worth $1m next year you are nuts
If phase three is as successful as I think it could be we are looking at potentially a $2 maybe $2.5 pet share buyout... Maybe 2 billion
Are you suggesting a buyout is possible at >$30 a share? Do you you realize that at approx. 600M shares that's and $18 Billon buy out price.
That is 3 times Celgene's annual sales and more than 12 times there annual revenue.... it is a 3rd of their total market cap
I don't necessarily disagree that mjna is well positioned ... Just that it is not the same investment that it was when I got in in July.... Less risk but less return as well
Great! I like mjna ... But note this article was published in nov 2013 when it was priced at 0.12 ... We have already passed 0.30.... Is it still undervalued given the 100+% growth?
It's a shame... I remember a time probably 5 years ago when sa was a great resource... Those days are long gone
Full analyst report!!! This is the most factual report I have come acrross
NUVILEX, INC. (OTCQB: NVLX) ANALYST RESEARCH REPORT
Analyst Research Report Written by Osman Ghani,
Chartered Financial Analyst
Osman Ghani is a CFA charter-holder and has prior experience in working in Investment banking, corporate finance, and business advisory services. His prior work experience includes working on a number of sectors including Healthcare, manufacturing, IT, real estate, financial services, and business services. He is currently completing his Phd in Finance from the Warwick Business School, University of Warwick, and has a undergraduate and graduate degrees in Accounting and Finance from the London School of Economics. He is also a qualified chartered accountant and a member of the Institute of Chartered Accountants in England and Wales, and he also holds the CAIA designation.
February 24th, 2014
Ticker: NVLX
Recommendation: BUY
Current Price: $0.365 Target Price: $1.24
Highlights:
Nuvilex is a biotechnology company that holds rights to use proprietary cellulose based live cell encapsulation technology aimed at the treatment for cancers and diabetes.
Nuvilex’s Cell-in-a-Box technology alongside the anti-cancer drug ifosfamide has passed Phase 2 of clinical trials and is currently going into phase 3 trials.
The company acquired SG Austria, the cellulose-based live-cell encapsulation technology for the development of treatments for diabetes, which would make the need for daily insulin injections for diabetes sufferers obsolete.
We estimate that the current market price is undervalued and that the expected price should be closer to $1.24. This represents a 240% premium over the current market price.
Business Description
Nuvilex, Inc. (OTC: NLVX), a biotechnology company, holds rights to use a proprietary cellulose-based live-cell encapsulation technology, known as Cell-in-a-Box, for the development of treatments for cancers and for diabetes worldwide. The company was formerly known as eFoodSafety.com, Inc. and changed its name to Nuvilex, Inc. in March 2009. Nuvilex, Inc. was founded in 1996 and is headquartered in Silver Spring, Maryland.
The company primarily focuses on the advancement of its treatment for advanced, inoperable pancreatic cancer that combines the Cell-in-a-Box technology with the anti-cancer drug ifosfamide. This treatment has completed Phase 1 and 2 clinical trials. The company, through its subsidiary, Medical Marijuana Sciences, Inc., uses constituents of Cannabis in developing treatments for cancer, particularly those that are difficult to treat.
Overview of the Global Pharmaceuticals Industry
According to Market Line, the global pharmaceuticals market grew by 3.5% in 2011 to reach a total value of $782.1 Billion.
According to Market Line, by 2016, the global pharmaceuticals market is expected to have a total value of $971.1 Billion, which represents an increase of 24.2% over the value in 2011.
Within the global pharmaceutical market, the largest segment, representing nearly 42.4% of the total value is the Americas.
Pfizer is the leading company in the global pharmaceutical industry, accounting for nearly 8.7% of the total value.
The market is characterized by strong buyer power, and the ease of market entry is strongly affected by the level of legal and regulatory factors present in each jurisdiction and geographical region.
The global pharmaceuticals market had total revenues of $782.1 Billion in 2011, representing a compound annual growth rate (CAGR) of 4.9% between 2007 and 2011. The European and Asia-Pacific markets grew with CAGRs of 3.1% and 8.8% respectively, to reach values of $224.8 billion and $217 billion in 2011.
The performance of the market is forecast to decelerate, with an anticipated CAGR of 4.4% for the five year period 2011-2016, which is expected to drive the market to a value of $971.1 billion by 2016. The European and Asia-Pacific markets will grow with CAGRs of 1.8% and 7.4%, and reach values of $246.2 billion and $310.2 billion in 2016.
Figure 1: Global pharmaceuticals market value (in $Billions)
Figure 2: Geographical Revenues
U.S Food and Drug Administration’s (FDA) Approval process:
The mission of FDA’s Centre for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in the US are safe and effective. CDER does not test drugs, although the Centre’s Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.
CDER is the largest of FDA’s five centers. It has responsibility for both prescription and non-prescription or over-the-counter (OTC) drugs. The other four FDA centers have responsibility for medical and radiological devices, food, and cosmetics, biologics, and veterinary drugs.
Some companies submit a new drug application (NDA) to introduce a new drug product into the U.S. Market. It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists review the sponsor’s NDA containing the data and proposed labeling.
After obtaining promising data from laboratory studies, the developer takes the next step and submits an Investigational New Drug (IND) application to CDER. Once the IND application is in effect, the drug sponsor can begin their clinical trials. After a sponsor submits an IND application, it must wait 30 days before starting a clinical trial to allow FDA time to review the prospective study. If FDA finds a problem, it can order a “clinical hold” to delay an investigation, or interrupt a clinical trial if problems occur during the study.
Clinical trials are experiments that use human subjects to see whether a drug is effective, and what side effects it may cause.
The drug sponsor should analyze the clinical trials data and conclude whether enough evidence exists for the drug’s safety and effectiveness to meet the FDA’s requirements for marketing approval. The sponsor should then submit a New Drug Application (NDA) with full information on manufacturing specifications, stability and bio-availability data, method of analysis of each of the dosage forms the sponsor intends to market, packaging and labeling for both physician and consumer, and the results of any additional toxicological studies not already submitted in the Investigational New Drug application.
When the patents or other periods of exclusivity on brand-name drugs expire, manufacturers can apply to the FDA to sell generic versions.
OTC drugs can be brought to the market following the NDA process as described above or under an OTC monograph. Each OTC drug monograph is a kind of “recipe book” covering acceptable ingredients, doses, formulations, labeling, and, in some cases, testing parameters. OTC drug monographs are continually updated to add additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without FDA pre-approval. The NDA and monograph processes can be used to introduce new ingredients into the OTC marketplace.
Nuvilex Inc.
Nuvilex, Inc. (OTC: NLVX), a biotechnology company, holds rights to use a proprietary cellulose-based live-cell encapsulation technology, known as Cell-in-a-Box, for the development of treatments for cancers and for diabetes worldwide. The company primarily focuses on the advancement of its treatment for advanced, inoperable pancreatic cancer that combines the Cell-in-a-Box technology with the anti-cancer drug ifosfamide. This treatment has completed Phase 1 and 2 clinical trials. The company, through its subsidiary, Medical Marijuana Sciences, Inc., uses constituents of Cannabis in developing treatments for cancer, particularly that are difficult to treat.
The company’s operating history is stated in its most recent financial statements as: ‘The Company was founded as DJH International, Inc. on October 28, 1996. DJH was formed for the creation of software tracking for fresh fruits and vegetables. The Company changed its name to eFoodSafety.com, Inc. following its October 2000 acquisition of Global Procurement Systems, Inc. This company was in a similar business as DJH. In October 2003, the Company acquired Ozone Safe Food, Inc., a similar company to the other two. The early mission of eFoodSafety.com, Inc. was to provide methods and products to ensure safety of marketed fruits and vegetables worldwide. On February 4, 2004, shares of the common stock of the Company were registered with the SEC. The Common Stock began publicly trading on the OTC Bulletin Board quotation service under the trading symbol EFSF.
With low demand for its produce safety and software tracking products, the Company acquired Knock-Out Technologies, Ltd. in May 2004. This company was a developer of products using organic, non-toxic food based substances. In August 2005, the Company acquired MedElite, Inc. This company was the exclusive U.S. distributor of Talsyn -CI Scar Cream, a topical scar-reducing cream.
The Company sold Ozone Safe Food, Inc. in August 2005. In November 2006, the Company formed Cinnergen, Inc., a wholly owned subsidiary, to manufacture and market a nutritional supplement designed to promote healthy glucose metabolism. At about the same time, the Company formed another wholly-owned subsidiary, purEffect, Inc., to manufacture and market four-step acne treatment trademarked purEffect. The Company licensed the marketing rights for purEffect to Charleston Kentrist 41 Direct, Inc. in March 2006.
The Company next formed I-Boost, Inc. in July 2007 to manufacture and market a food bar designed to improve the immune system. In March 2008, the Company formed another wholly owned subsidiary, Cinnechol, Inc., to market non-prescription nutritional supplements. In February 2009, the Company sold the purEffect TM rights to CK41 for equity and future royalties. Freedom-2 Holdings, Inc. was acquired in March 2009 to manufacture and market regular tattoo ink and Infinitink, a permanent tattoo ink designed to be removed more easily using conventional laser removal methods. These products were marketed through a wholly owned subsidiary, Freedom-2.
On January 20, 2009, the Company changed its name to Nuvilex, Inc. to better reflect its business operations. Its trading symbol on the OTC Bulletin Board was also changed to NVLX.
On May 26, 2011, the Company entered into an Asset Purchase Agreement with SG Austria Private Limited to purchase 100% of the assets and liabilities of SG Austria. As a result, Austrianova Singapore Private Limited and Bio Blue Bird AG, wholly-owned subsidiaries of SG Austria, were to become wholly owned subsidiaries of the Company on the condition that the Company pay SG Austria $2.5 million and 100,000,000 shares of its Common Stock and for the Company to receive 100,000 shares of Austrianova Singapore’s common stock and nine Bio Blue Bird bearer shares.
The acquisition of Bio Blue Bird provided the Company with exclusive, worldwide licenses to use a proprietary cellulose-based live-cell encapsulation technology for the development of treatments for all forms of cancer. As of October 31, 2013 the cost of these licenses of $1,549,427 has been recorded on the balance sheet as a long term asset. The licenses are pursuant to patents licensed from Bavarian Nordic A/S and GSF-Forschungszentrum fur Umwelt u. Gesundeit GmbH. These licenses enable the Company to carry out the research and development of cellulose-based live-cell encapsulation cancer treatments and allow for research and development of the cellulose-based encapsulation of virus-expressing cells for treating other diseases.
The first use of the cellulose-based live-cell encapsulation technology has been in development for the treatment of advanced, inoperable pancreatic cancer. In Phase 1 and 2 clinical trials carried out under the sponsorship of SG Austria’s predecessor, live cells capable of converting the well-known anti-cancer prodrug ifosfamide into its cancer-killing form were encapsulated using this novel technology. The capsules containing the ifosfamide-activating cells were locally implanted near the pancreatic tumor, and then ifosfamide was administered at 1/3 of its “normal” dose. By proceeding in this way, the amount of the active anti-cancer drug was increased directly in the tumor tissue. This ensured high efficacy with lower than usual doses of the chemotherapeutic agent; in turn, the lower than usual doses of ifosfamide employed allowed for significant reductions in the unpleasant and sometime detrimental side-effects normally associated with chemotherapy. This resulted in improved quality-of-life for the patients.
In July 2013, the Company also acquired from Austrianova Singapore the exclusive, worldwide license to use the cellulose-based live-cell encapsulation technology for the treatment of diabetes and the use of Austrianova Singapore’s “Cell-In-A-Box” trademark for this technology. The Company secured $1.5 million in funding through the sale of restricted stock to accredited investors at a fixed price of $0.15 per share, a premium to the market price per share at the time of the funding, to complete this acquisition. The Company utilized $1,000,000 of those funds to secure its exclusive, worldwide license to use the encapsulation technology for the treatment of diabetes by making its first required payment on October 30, 2013. The balance of the funds will be used for on-going preparations for the Company’s late-stage clinical trials in advanced, inoperable pancreatic cancer. In addition, a second and final payment of $1,000,000 for the licensing rights for diabetes is required to be paid to Austrianova Singapore by April 30, 2014.
In using the cellulose-based live-cell encapsulation technology, the Company believes that diabetes can be treated by encapsulating insulin-producing cells and then implanting these encapsulated cells into insulin-dependent individuals. The basis for this belief comes from preclinical animal studies carried out prior to the Company’s acquisition of the licensing rights to the technology for diabetes. In those studies, insulin-producing cells were encapsulated using the technology and the capsules were then implanted into diabetic animals. Shortly thereafter, the blood glucose levels of the animals became normal. In one study, the levels remained normal for six months. Because the insulin-producing cells were encapsulated in the cellulose-based capsules, they were protected from attack and rejection by the animals’ immune systems.
On February 11, 2013, Medical Marijuana Sciences, Inc. was incorporated in the State of Nevada and became a wholly-owned subsidiary of the Company. Medical Marijuana Sciences, Inc. is dedicated to the development of cancer treatments based upon the well-known chemical constituents of marijuana. Nuvilex is exploring ways in which the Cell-in-a-Box technology may play a role in these efforts.
Pipeline Drugs
Nuvilex owns exclusive rights to a cancer treatment platform that has successfully completed Phase 2 clinical trials for inoperable pancreatic cancer. Nuvilex also owns rights to the same platform to treat diabetes, and the company also has a medical marijuana subsidiary slated to begin cancer research and development using cannabidiol. With each of the key target markets representing multi-billion-dollar opportunities, Nuvilex offers investors multiple opportunities for success and should trade at a much higher valuation which reflects its current development progress to date.
For a company like Nuvilex, raising the funds necessary to initiate future, advanced clinical trials will be a critical task. However, over the past few months, the company has successfully raised $3.0 million (in two $1.5 million tranches) that were at premiums to the prevailing stock price with negligible dilution to shareholders. The company has also been able to successfully reduce its debt by $2.2 million, thus strengthening the balance sheet further. The combination of successful recent equity raising alongside the reduction of debt, will allow the company to be in a better position to tap capital markets when and if it requires further funding as it reaches important milestones in 2014 and beyond.
The company has made important headway in its Mediccal Marijuana Sciences division. In Late 2013, the company announced that Dr. Mark Rabe, a leading figure in the emerging medical marijuana field, has joined MMS as Chairman of its Scientific Advisory Board. Dr. Rabe was formerly the Chief Medical Officer of California’s largest network of physician-owned medical cannabis evaluation centers where he hired and trained medical personnel, conducted research and supervised the recommendation of medical cannabis to over 100,000 patients in 20 clinics across California. This acquisition is expected to aid in the quick development of the division and its product offerings.
SG Austria successfully completed Phase 2 clinical trials for the Cell-in-a-Box technology to treat inoperable pancreatic cancer; less than 20% of all treatments that enter clinical trials successfully complete Phase 2 and begin Phase 3 trials. Given Phase 3 funding, Nuvilex would be in very strong position. Gemzar, which is produced by Eli Lilly (LLY) is currently the only FDA approved treatment method and provides Eli Lilly with approximately $10 billion in annual revenue. Celgene (CELG) was recently given FDA approval for its pancreatic cancer treatment for its Abraxane treatment, though the drug only showed marginal improvement in survival rates and time compared to Gemzar.
Gemzar is a member of a group of chemotherapy drugs known as anti-metabolites. These drugs prevent cells from making DNA and RNA, which inhibits cell growth and causes the cells to die. In comparison, the live-cell encapsulation technology used in Nuvilex’s pancreatic cancer treatment works to protect and maintain living drug-activating cells in close proximity to the cancer and serves to optimize the cancer-killing effect of the well-known cancer drug ifosfamide when both are used in combination. In addition to its efficacy against the primary tumour, the live-cell encapsulation/ifosfamide combination treatment may also have significant effects against pancreatic tumor cells that have migrated to the liver where they can form new tumors.
The data from clinical trials for Nuvilex’s pancreatic cancer treatment technology demonstrated an average survival of 44 weeks versus 28 weeks for Gemzar and 36% 1-year survival rate versus 18% as well. The live-cell encapsulation technology from Nuvilex, in combination with ifosfamide, has demonstrated to be nearly twice as effective as Gemzar in clinical trials. Also, the beneficial effects of Nuvilex’s pancreatic cancer treatment were accompanied by no treatment-associated side effects; this is not the case with Gemzar as its use can be accompanied by very severe side effects. (source: http://www.biospectrumasia.com/biospectrum/opinion/2800/the-encapsulated-cells-cancer-therapy/page/1#.Uwu-z_l_vNn)
In late 2013, Nuvilex also acquired the exclusive worldwide rights to use the cellulose-based live-cell encapsulation technology for the development of treatments for diabetes from SG Austria. The company stated in a press release ‘Nuvilex’s decision to make the acquisition stems in large part from the results of “proof-of-principle” studies in which cells that produce insulin were transplanted into diabetic animals. The diabetic animals had much higher than normal levels of glucose in their bloodstream and had a difficult time controlling their glucose levels, just as humans with diabetes do. In animals provided with the encapsulated cells, their blood glucose levels normalized and remained stable for the duration of one six-month study, indicating the encapsulated cells produced insulin in response to their higher than normal blood glucose levels. The cellulose-based capsules seem to have prevented the encapsulated cells from being attacked by the diabetic animals’ immune systems, even in the absence of immunosuppressive drugs. Therefore, the encapsulated cells appear to have acted as an artificial or replacement pancreas.’
Financial position
The company currently has a cash balance of $396,590 and a total debt balance of $625,000. The company did not report any revenue in the last four quarters and has shown a cumulative net loss of $11,029,000.
In February 2014, Lincoln Park Capital (LPC) purchased 8 million restricted shares of Nuvilex in exchange for an initial $2 million. The purchase was made in order to advance NVLX’s late-phase pancreatic cancer clinical trials. LPC made an investment in Elite Pharmaceuticals in April 2013 that saw the company’s share price rise by 500%, and such a beneficial effect is expected from NVLX as it enters the late-phase clinical trials and applies for FDA approval (Market wired).
Value of the company
Table 1: Estimated value per share.
We estimate the Net Present value of the portfolio by first estimating the potential total market for each product offering. We then assume the potential market penetration after 3 years assuming the product is offered to the market in 2017. We assume a discount rate of 35% per year in order to incorporate the risk associated with the cash flows.
We assume that the company will observe a similar net profit margin as its competitors of 7.3% of revenue (NYSE: ECL, and NASDAQ: NATR). This gives us an estimated NPV of $423 million from the Pancreatic treatment and $315 million from the Diabetes market. Combined, we estimate a potential net present value of the company at $737.53 million.
At present, the company has 593.41 million shares outstanding, this gives us an estimated value per share of $1.24.
This gives a premium over the current market price of 240%. We therefore recommend that the stock should be a BUY.
Summary
Nuvilex, Inc. (OTC: NLVX), a biotechnology company, holds rights to use a proprietary cellulose-based live-cell encapsulation technology, known as Cell-in-a-Box, for the development of treatments for cancers and for diabetes worldwide. The company primarily focuses on the advancement of its treatment for advanced, inoperable pancreatic cancer that combines the Cell-in-a-Box technology with the anti-cancer drug ifosfamide. This treatment has completed Phase 1 and 2 clinical trials. The company, through its subsidiary, Medical Marijuana Sciences, Inc., uses constituents of Cannabis in developing treatments for cancer, particularly that are difficult to treat.
The IP portfolio that NLVX has, the stages of FDA approval, and the potential for the commercialization of the product pipeline, gives us an estimated price per share of $1.24. This leads us to recommend that the company should be a BUY.
FORWARD-LOOKING DISCLAIMER
This report may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of mentioned company to be materially different from the statements made herein.
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