3.

Ongoing execution of the restated April 30, 2009 balance sheet and results of operations for the twelve months ending are included in Note 15 – Restated Financial Statements.Company’s revenue growth strategy.

Nuvilex Products (in alphabetical order)

Cinnechol™Cinnechol™

CinnecholÔ, an ingestible capsule that containsa gluten free/wheat free all-natural ingredients, isnutritional supplement manufactured and sold by Cinnechol, Inc. (a wholly owned subsidiary of Nuvilex, Inc.). CinnecholÔ is designed to help maintain normal cholesterol levels and to support normal cardiovascular function. CinnecholÔ, along with a healthy diet and regular exercise, is intended to serve as a dietary supplement to help individuals manage numerous cardiovascular and metabolic disorders, including dyslipidemia, hypertension, hypoglycemia, and hyperglycemia. CinnecholÔ contains red yeast rice extract as well as a blend of other ingredients known to improve cardiovascular function (including niacin and gum guggul extract). CinnecholÔ may provide a natural altern ativealternative for those who have high cholesterol and are intolerant of, or elect not to take, drugs that are known as statins.

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Cinnergen™Cinnergen™

CinnergenÔ is, a gluten free/wheat free all-natural liquid whole food nutritional supplement that provides vital nutrients to help the body efficiently process sugar (glucose).glucose. CinnergenÔ contains 0 grams of carbohydrates and fats, has no calories, and does not contain any artificial flavors or sweeteners. CinnergenÔ helps to prevent conditions associated with pre-diabetes or diabetes such as insulin resistancetypes 1 and fluctuations in blood glucose levels. In addition, CinnergenÔ may also help the body to more efficiently process fat droplets (lipids) that circulate in blood. One dose (1 fl. oz.) of2. CinnergenÔ delivers amino acids, (the building blocks of protein), vitamins, minerals, enzymes, antioxidants, and over a dozen all-natural chemicals derived from plants (including cinnamon bark extract, blueberry leaf extract, ginger root extract, and kelp extract) to the body.plants.

Research published in peer-reviewed medical journals suggests that cinnamon bark extractsome of the plant extracts in CinnergenÔ can help to control glucose levels in those who are pre-diabetic or individuals who suffer from type 1 or type 2 diabetes. In addition, studies suggest that two compounds present in blueberry leaf extract—caffeoylquinic acid and caffeic acid—constituents of CinnergenÔmay help to reduce glucose absorption in the small intestine, limit the synthesis of glucose by the liver and kidneys, (gluconeogenesis), and speed upincrease the body's metabolism of glucose. CinnergenÔ contains 0 grams of carbohydrates and fats, has no calories, and does not contain any artificial flavors or sweeteners.glucose metabolism.

Cinnsational™Cinnsational™

Cinnsational™ (formerly, Last Shot Hangover Remedy™) isCinnsational™, a gluten free/wheat free all-natural calorie-free, liquid nutritional supplement that contains a concentrated blend of vitamins, essential amino acids, and other beneficial ingredients. Cinnsational™ isingredients designed to help the body combat symptoms that are associated with alcohol sensitivity and alcohol-induced hangovers, including nausea, fatigue and headache.headaches (formerly, Last Shot Hangover Remedy™).

Citroxin™Citroxin™

CitroxinÔ is an all-natural, eco-friendly surface cleaner.cleaner also referred to as Big 6 Plus. Independent laboratory testing of CitroxinÔ showed a 100% kill rate for the "big six" bacterial health threats, including E. coli, Listeria, Pseudomonas, Salmonella, Staphylococcus, Streptococcus, and Black Mold.  CitroxinÔ has also proven to be an effective antiviral composition against swine flu virus [swine influenza virus (H1N1 subtype)] and avianbird flu virus [avian influenza viruses (H5N1, H9N1 and H9N9) viral subtypes.  

subtypes].  CitroxinÔ is protected by patents in the United States (U.S. 7,439,218) and worldwide (U.S. 7,439,218 and WIPO(WIPO 2007/038265 A3).

CyclesurfaceCyclosurface³™ Cosmetics

Nuvilex’Nuvilex’ patent-pending Cyclosurface³™ color enhancement technology brings the formulators and manufacturers of cosmetics and other consumer products the ability to use less wax and other aesthetically detrimental additives in their products. Cyclosurface³™ was developed by Freedom2, Inc., a wholly owned subsidiary of Nuvilex, Inc.

The technology is a lipophilic surface treatment that is used to improve the dispersion of pigments in aqueous and organic materials. Cyclosurface³™ technology helps formulators create products that feel lighter andon the skin while making the skin look more radiant, all while maintaining or enhancing the color and durability of ancillary cosmetic products.product. Nuvilex intendshas the potential to be the original equipment manufacturer (OEM) for cosmetic ingredients that use Cyclosurface³™ technology. technology cosmetic ingredients.

I-Boost Immune Bar™Bar™

I-Boost Immune BarÔ is an, a gluten free/wheat free all-natural nutritional bar designed to protect, stimulate, and buildboost the immune system.  The I-Boost Immune BarÔ delivers key nutrients that assist in maintaining, enhancing and buildingstimulating the human immune system and provideprovides energy to keep one going during a busy day.  I-Boost bars contain a proprietary blend of vitamins, minerals, and minerals that areother ingredients designed to enhance the body’s natural ability to defend its self.itself.  I-Boost Immune BarsÔ comewere originally designed in four flavors:  Chocolate, Chocolate Mint, Peanut Butter and Oatmeal Cinnamon Raisin.  In connection with the Company’s new business strategy described above, sales of I-Boost Immune Bars were discontinued in May 2009 as a result of the product’s low sales.

Infinitink®

Infinitink®, a permanent yet removable tattoo ink, iswas engineered specifically for removal. InfinitinkÒremoval in fewer laser treatments than standard tattoo ink and is the result of advanced materials science research conducted by physicians and scientists at Duke University, Massachusetts General Hospital, Brown University, and Freedom2.research. InfinitinkÒ is made from ingredients generally recognized as safe (GRAS) by the U.S. Food and Drug Administration (FDA) for use in drugs and cosmetics (D&C). InfinitinkÒ is manufactured under strict guidelines that meet or exceed the most rigorous quality standards in the industry.

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Tattoo removal is generally complex and inefficient. To remove a tattoo, the tattoo wearer typically must seek out a health care professional who is certified to operate lasers (often a registered nurse or dermatologist). Typically, lasers that have a wavelength of 532 nm, 755 nm, and 1064 nm are used for tattoo removal. Freedom2 scientists modified the pigments that are used in InfinitinkÒ so that the absorption profile of the pigments more closely matches the wavelength of the laser. InfinitinkÒ black absorbs laser energy at 1064 nm while InfinitinkÒ red absorbs energy at 532 nm. Conventional, permanent tattoo inks do not absorb energy as efficiently from lasers and often require multiple treatments before they are removed from skin. Conventional tattoo inks rarely achieve greater than 85% removal.  An IRB - -approved human study confirmed that InfinitinkÒ can be more easily removed than other commercially available inks.  On average, participants achieved 90% removal from skin.

cosmetics. The technology used to create InfinitinkÒ is protected by U.S. patents 6,013,122, 6,800,122, 6,814,760, 6,881,249, 7,175,950, 7,285,364, 7,435,524 and European patent 1,107,724.

Oraphyte™

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Typically, the past several years,lasers used for tattoo removal use wavelengths of 532 nm and 1064 nm. InfinitinkÒ tattoo pigments closely match these laser wavelengths. A clinical study confirmed InfinitinkÒ was more easily removed, with participants averaging ~90% tattoo removal.

Oraphyte™

Oraphyte™, the Company has worked with a variety of leading agricultural programs at U.S. universities, including Louisiana State University, to develop an environmentally-friendly alternative to long-used chemical-based nematocides, many of which have recently been banned by the EPA.

Oraphyte™, the Company’s’s all-natural nematocide, is a non-toxic, biodegradable proprietary combination of orange terpene oil, Valencia orange oil, hydrogen peroxide, sorbitan monooleate, and distilled water that can be formulatedformulation, created as a liquid or a solid.  The product which works viathrough a two-step process in which a nematode’s epidermis decomposes, therebyis damaged, compromising its immune system, and leaving it susceptible tothen is killed by the environment or other pests, has demonstrated an ability to minimize and even eradicate nematodes, either pre-plant or post-plant, in turfgrass.

Specifically, small concentrations of Oraphyte™environment.  Both formulations have been shown to statistically significantly reduce nematode community density at harvest by nearly a factor of three compared to the non-treated control. Oraphyte™ also increased the weight of turfgrass that was infested with nematodes by approximately 95% compared to the final weights of nematode-infested turfgrass that did not receive Oraphyte™.  Additionally, the productEPA sensitivity required testing has been subjected to three separate toxicology tests (the EPA primary dermal irritation test, the EPA primary eye irritation test and the EPA acute oral toxicity test), with all three producing resultsbeen within normal limits, suggesting that Oraphyte™Oraphyte™ poses minimal risk to animals and humans.  Following the success of this trial, the Company plans to optimize concentration levels and will then study Oraphyte™ in additional applications, such as high-value crops (tomatoes, soy beans, etc) .

Oraphyte™ has already been registered with the EPA as a germicidal agent andOraphyte™ is protected by U.S. Patent 7,439,218.

Nuvilex believes that Oraphyte™ canOraphyte™ will gain EPA approval for use on turfgrassin multiple arenas with a billion dollar market potential and high-value crops within twelve to forty-eight months, at a total cost of no more than $10 million and $20 million, respectively. The Company is seeking commercialassessing the most valuable means for final development and marketing, partnersultimately with the aim of decreasing the need for Oraphyte™.chemical treatments presently available.

Specialty, Private Label InkspurEffect™

The Company manufactures specialty inks for private label customers. The specialty inks are derived from the Company’s Infinitink™ product line, but are formulated to specific customer needs. The Company’s specialty inks are formulated to be all natural and free of harmful toxins.

purEffect™

purEffect™purEffect™ is ana 3 part, all-in-one acne treatment solution that is designed to cleanse, tone, and heal the skin. purEffectÔskin and combines a unique blend of ingredients that work to help maintain a radiant, blemish-free complexion. Benzoyl peroxide, the active ingredient in purEffectÔ, is the safest, most widely recommended ingredient used to treat acne. Benzoyl peroxide servesacne, serving as an antibacterial compound, minimizesminimizing inflammation, that is associated with acne, and helpshelping to prevent the formation of new acne deposits beneath the skin.acne.

One kitAt present, this entire line of products has been advanced, undergone pre-marketing assessment and is gearing up for an expanded marketing presence by CK41 who acquired purEffectÔ includes a 4 fl. oz. bottlefrom Nuvilex, yet is still connected to Nuvilex by virtue of Purifying Cleanser (Step 1), a 4 fl. oz. bottle of Electrolyte Toner (Step 2), a 2 fl. oz. bottle of Intense Repair Lotion (Step 3), and a 0.5 fl. oz. container of Healing Cream (Step 4)the rights contract (described elsewhere herein). Steps 1 through 3 are

Specialty, Private Label Inks

The Company has the potential to be used in order (once in the morning and once at night) while Step 4 can be used twice daily at any time. Step 4 is also compatible with sunblocks, sunscreens, and other skin creams.manufacture specialty inks for private label customers. The Purifying Cleanser and Intense Repair Lotion each contain 2.5% benzoyl peroxide while the Electrolyte Toner contains ingredients such as Hamamelis virginiana (witch hazel) and glycolic acid that are known to help revitalize the skin. The Healing Cream contains natural oils thatspecialty inks are derived from plantsthe Company’s Virgin™ and helpsInfinitink™ product lines and are formulated to repair skin that is damaged by acne (or acne-associated inflammation).specific customer needs. The Company’s specialty inks are formulated to be all natural, heavy metal and toxin-free.

TalsynÔ-CI Scar Cream

TalsynÔ-CI Scar Cream is a unique, fragrant composition that delivers lipids, peptides, and botanical extracts to the skin including extracts from algae, rosemary, rosehip, and mango. TalsynÔ-Cl Scar Cream has been clinically proven to improve the appearance of keloids, surgical incisions, and scars and is composed mostly of glycine soja oil (derived from soybeans), aloe vera, and calophyllum oil. Calophyllum oil (tamanu oil), an ingredient derived from trees in the tropics, was revered by ancient Polynesian wound healers for its ability to acceleratescars.  TalsynÔ Scar Cream accelerates healing and improveimproves the appearance of scars through decreasing their width, length, depth, and redness for both old and new scars. In addition, theseThe all-natural emollients in TalsynÔhelp to keep the skin looking healthy, vibrant, and well hydrated. Talsyn'shydrated and its unique combination of rich, plant-derived ingredients will not damage clothing or stain fabrics. TalsynÔ-CI Scar Cream is endorsed and used by leading plastic and reconstructive surgeons acrosssurgeons.  At present, this product has been reinitiated by the United States.Division of Natural Products and is gearing up for an expanded marketing availability including both physician availability and direct purchase for men, women and children.

Marketing, Sales and Distribution

NuvilexNuvilex’s products are marketed, sold and distributed domestically and internationally either directly by the Company orand through third party exclusive and non-exclusive marketing and distribution partners. Direct Company to customer sales are made through direct response Internet sales. The Company maintains domestic and international distributor relationships with third parties it believesThese products can achieve higher market penetration of its various products than bybe purchased directly from Nuvilex using the Company selling directly to its customers.Nuvilex website (www.nuvilex.com) or the subsidiary websites, such as Cinnergen (www.cinnergen.com). Whether or not these third parties achieve market penetration is based on their commitment to invest in the marketing and sales of the various products, the margin they earn from the sale of these products and market competition.products. In part, the Company’sDivision of Natural Product’s future success is dependent upon the efforts of its direct internet sales, resellers and third party distribution partners and their ability or inability to successfully market the Company’s products, any of which could adversely affect the business of the Company.

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Competition

There is intense competition among providers of nutritional supplements, aesthetic skin care treatments and cosmetics products, including tattoo inks. Many of these competitors have substantially greater financial and marketing resources than Nuvilex, stronger name recognition, brand loyalty and long-standing relationships with target customers. The Company’sDivision of Natural Product’s future success iscontinues to be dependent upon its ability to compete and its failure to do so could adversely affect the business of the Company.its success.

Government Regulations

The U.S. FoodFDA ensures safety of the entire community through its regulations as disparate as biologics to drugs to some meats and Drug Administration (FDA) regulates dietary supplements, the latter of which fall under a different set of regulations than those covering "conventional" foodsfood and drug products (prescription and Over-the-Counter).products. Under the Dietary Supplement Health and Education Act of 1994, (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed.marketed and the FDA is responsible for taking action against any unsafe dietary supplement product after it reachesthe products reach the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.

FDA's post-marketing responsibilities include monitoring safety (e.g., voluntary dietary supplement adverse event reporting and product information, such as labeling, claims, package inserts, and accompanying literature). The Federal Trade Commission regulates dietary supplement advertising.  

Domesticdomestic and foreign facilities that manufacture/manufacture, process, pack, or hold foodfoods for human or animal consumption in the United States are required to register their facility with the FDA.FDA, but supplement manufacturers do not need to register products nor get FDA approval before producing or selling dietary supplements. Nonetheless, manufacturers must make certain product label information is truthful and not misleading. FDA's post-marketing responsibilities include monitoring safety, including voluntary dietary supplement adverse event reporting and product information, labeling, claims, package inserts, and accompanying literature and the Federal Trade Commission regulates dietary supplement advertising.  

The FDA's legal authority overFDA also regulates cosmetics, is different fromalthough differently than other products regulated by the agency, such as drugs, biologics, and medical devices.they regulate. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, the FDA may pursue enforcement action against violativeviolating products, or against firms or individuals who violate the law.

Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the following warning statement appears conspicuously on the principal display panel of the product's label:

“Warning --The safety of this product has not been determined.” (21 CFR 740.10)

In addition, regulations prohibit or restrict the use of several ingredients in cosmetic products and require warning statements on the labels of certain types of cosmetics.

In general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.

regulatory laws.  Increased federal, state, local or international regulation over the Company’s products could adversely affect its business, financial condition and results of operations by requiring furtheradditional or new testing of products and imposing otherdifferent or differentnew licensing requirements.  Therefore, Nuvilex has and continues to expend effort to ensure its products are safe and follow regulatory guidelines, requirements, and laws.  

Patents, Intellectual Property and Trade Secrets

Nuvilex considers intellectual property (IP) and patent protection to be of paramount important to its business. AlthoughIn addition, although the Company takes reasonable measures to protect its intellectual property,IP, the Company cannot guarantee that it will be able to protect and enforce its IP or obtain international patent protection for its products abroad or to otherwise protect and enforce its intellectual property. In addition, litigation may be required to enforce the Company’s intellectual property rights, protect its trade secrets, or determine the validity and scope of the proprietary rights of others who practice similar art. Any action taken by the Company to protect its intellectual property rights could consume significant financial and operational resources. In addition, as a result of any such litigation, the Company’s intellectual property could be held to be invalid or unenforceable. If any of the foregoing occurs, the Company’s business, financial condition or results of operations could be harmed.

needed. Nuvilex and its subsidiaries own one trademarkseveral trademarks and own or co-own 14 issued patents in three technical areas: pigment modification, microencapsulation, and disinfectantdisinfectant/germicidal compositions. Litigation may be required to enforce the Company’s products, IP rights, trade secrets, or germicidal compositions.determine the validity and scope of the proprietary rights of others and utilizing financial and operational resources, and the Company’s IP could be discovered to be owned by others, invalid, or unenforceable, potentially causing hardship on the Company.

Nuvilex,Freedom-2, Inc.

In the second quarter of 2009, the Company filed a provisional patent application on its Cyclosurface³™ technology. Cyclosurface³™ technology can be used to modify the surfaces of pigments (e.g., surface modification or surface functionalization) for cosmetic, personal care, and pharmaceutical applications, including, but not limited to, mascara, hair care products, tattoo inks, medical devices, and pharmaceutical excipients.

Freedom2, Inc.

The microencapsulation technology used to create InfinitinkÒ, a registered trademark of Freedom-2, Inc, is protected by U.S. patents 6,013,122, 6,800,122, 6,814,760, 6,881,249, 7,175,950, 7,285,364, 7,435,524, worldwide patent WO/2006/019823 and European patent 1,107,724; all of these patents are assigned1,107,724. Licensing has been previously provided to Freedom2,MT-Derm, based in Germany. Freedom-2, Inc. In addition, Freedom2, Inc.also has an exclusive license to microencapsulation technology developed at Brown University (WO/2008/054874). Freedom2 is also the ownerThere are presently outstanding patent applications in Japan.

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The Division of a patent titled, “Modified Tissue Marking Pigment” (WO/2006/019823).

Infinitink® is a registered trademark owned by Freedom2, Inc.Natural Products: Research

Knock-Out Technologies, Ltd.

Knock-Out Technologies, Ltd. is the owner, a research group of severalThe Division of Natural Products, created patents that teachengender the art of creating eco-friendly, biodegradable disinfectant and germicidal compositions includingencompassed by U.S. patent 7,439,218 (“Disinfectant compositions comprising an orange oil mixture and methods of use thereof”) and global patents U.S. WO/2007/038265 (“Disinfectant Compositions and Methods of Use Thereof”) and WO/2009/089534 (“Compositions and Methods for the Treatment of Viral Infections Caused by Influenza Virus”).089534. Furthermore, Knock-Out Technologies, Ltd. has fileda provisional or utility patent applicationsapplication has been filed to protect its Oraphyte™the Oraphyte™ technology platform. OraphyteÔ isplatform, an eco-friendly, biodegradable pesticide and insecticide that can be used for agricultural applications, including the protection of turfgrass, from nematodes and the protection of high-value crops (such as tomatoes and soybeans) fr omfrom agricultural pests. Knock-Out Technologies, Ltd. has also filedFinally, a provisional patent application has been filed for CRS2™CRS2™, an all-natural composition that is effectiveshowing promise in treating nearly a dozen tumor cell lines, including prostate and breast tumor cells.lines.

Sources and Availability of Raw Materials

Cinnergen™All of the raw materials, from their acquisition through their shelf life, have potential negative impact on the Company and Cinnsational™or its subsidiaries and since all of our products contain Digezyme™, a proprietary composition that is comprised of five ingredients: amylase, protease, lipase, lactase, and cellulase, which is provided by the Sabinsa Corporation of Piscataway, NJ.

Cinnechol™ contains several phytochemicalsingredients that could at any time in the future be difficult to obtain in large quantities, including red yeast rice extract, guggul gum extract, Policosanol, and coenzyme Q10 (ubiquinone). The Company currently acquires its Cinnechol™ ingredients from Sabinsa Corporation and Bio-Botanica® of Hauppauge, NY.

Infinitink® contains pigments that are widely available for drugs and cosmetics (D&C) but are widely excluded by manufacturers and suppliers when they are used as components of tattoo inks.

Talsyn™ and purEffect™ contains calophyllum inophyllum oil (tamanu oil), an ingredient that may become difficult to order in bulk at any point in the future.

The Company markets Cinnergen™ through retail distribution partners, including The Vitamin Shoppe and other regional retail establishments. These distribution partners account for greater than 75% of Cinnergen’s™ product sales.quantities.

Employees 

Nuvilex, as of April 30, 2010,2011, has one employee.eight employees.  Nuvilex also utilizes consultants, independent contractors and temporary employees in technical development and programming, finance and accounting, and salesother research, development and promotional capacities. 

ITEM 1.1A. RISK FACTORS.

You should carefully consider these factors that may affect future results, together with all of the other information included in this Form 10-K, in evaluating the business and the Company. The risks and uncertainties described below are those that the Company currently believes may materially affect its business and results of operations.  Additional risks and uncertainties that Nuvilex is unaware of or that it currently deems immaterial also may become important factors that affect its business and result of operations.  Nuvilex’ common shares involve a high degree of risk and should be purchased only by investors who can afford a loss of their entire investment.  Prospective investors should carefully consider the following risk factors concerning the Company’s business before making an investment.

In addition, you should carefully consider these risks when you read “forward-looking” statements elsewhere in this Form 10-K.  These are statements that relate to the Company’s expectations for future events and time periods.  Generally, the words “anticipate,” “expect,” “intend,” and similar expressions identify forward-looking statements.  Forward-looking statements involve risks and uncertainties, and future events and circumstances could differ significantly from those anticipated in the forward-looking statements. 

Doubt Regarding Ability to Continue as a Going Concern 

Nuvilex’Nuvilex’s financial statements have been presented on the basis that itNuvilex is and will remain a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.  The Company had minimal revenues and incurred net operating losses for the period October 1999 (inception) tothrough April 30, 2010,2011, and as such, the Company’s independent auditors have concluded these factors create an uncertainty about Nuvilex’Nuvilex’s ability to continue as a going concern. The ability of the Company to continue as a going concern is dependent, among other factors, on its continued success in marketing its products, containing costs, establishing a credit facility, and/or raising additional equity capital.  The financial statements of Nuvilex do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

Early Revenue Stage Company:  Generation of Revenues

Nuvilex is an early revenue stage company and an investor cannot reasonablyreadily determine if the Company will ever bebecome profitable. Nuvilex is likely to continue to experience financial difficulties during itsthis early revenue stage and beyond. The Company may be unable to operate profitably, even if it generates additional revenues.  Nuvilex may not obtain the necessary working capital to continue developing and marketing its products. Furthermore, Nuvilex’the present products may not receive sufficient interest to generate revenues or achieve profitability.

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Need for Future Capital: Long-Term Viability of Company

Nuvilex will need additional capital to continue its operations.

There can be no assurance that the Company will generate revenues from present operations or obtain sufficient capital on acceptable terms, if at all.  Failure to obtain such capital or generate such operating revenues would have an adverse impact on the Company’s financial position, operations and ability to continue as a going concern.   Nuvilex’ operating and capital requirements during the next fiscal year and thereafter will vary based on a number of factors, including the level of sales and marketing activities for its services and products.  There can be no assurance that additional private or public financing, including debt or equity financing, will be available as needed or if available, on terms favorable to the Company. Additionally, any future equity financing may be dilutive to stockholders present ownership levels and such additional equity securities may have rights, preferences, or privileges that are senior to those of Nuvilex 6;Nuvilex’ existing common stock.

Furthermore, debt financing, if available, will require payment of interest and may involve restrictive covenants that could impose limitations on the flexibility of the Company to operate.  Nuvilex’s failure to successfully obtain additional funding may jeopardize its ability to continue the business and its operations.

If the Company raises additional funds by issuing equity securities, existing stockholders may experience a dilution in their ownership. In addition, as a condition to giving additional funds to the Company, future investors may demand, and be granted, rights superior to those of existing shareholders. 

Unpredictability of Future Revenues:  Potential Fluctuations in Operating Results 

As a result of Nuvilex’Nuvilex’s limited operating history; the Company is currently unable to accurately forecast its revenues. Current and future expense levels are based largely on the Company’s marketing and development plans and estimates of future revenues.  Sales and operating results generally depend on the volume and timing of orders and on the Company’s ability to fulfill such orders, both of which are difficult to forecast at this stage.  Nuvilex may be unable to adjust spending in a timely manner to compensate for any unexpected revenue shortfall. Accordingly, any significant shortfall in revenues in relation to planned expenditures could have an immediate adverse effect on the Company’s business, prospects, financial condition and results of operations. Further, as a strategic response to changes in the competitive environment, Nuvilex may from time to time make certain pricing, service or marketing decisi onsdecisions that could have a material adverse effect on its business, prospects, financial condition and results of operations.

Nuvilex may experience significant fluctuations in future operating results due to a variety of factors, many of which are outside the Company’s control.  Factors that may affect operating results include:  (i) ability to obtain and retain customers, attract new customers at a steady rate and maintain customer satisfaction with products, (ii) the announcement or introduction of new services by Nuvilex or its competitors, (iii) price competition, (iv) the level of use and consumer acceptance of its products, (v) the amount and timing of operating costs and capital expenditures relating to expansion of the business, operations and infrastructure, (vi) governmental regulations, and (vii) general economic conditions.

Flaws and Defects in Products

Products offered by Nuvilex may contain undetected flaws or defects when first introduced or as new versions are released. Any inaccuracy or defects may result in adverse product reviews and a loss or delay in market acceptance. There can be no assurance that flaws or defects will not be found in Nuvilex products. Flaws and defects, if found, could have a materially adverse effect upon the business operations and financial condition of the Company. Marketing of any of the Company’s potential products may expose the Company to liability claims resulting from the use of the Company’s products. These claims might be made by consumers, health care providers, sellers of the Company’s products or others. A claim, particularly resulting from a clinical trial, or a product recall could harm the Company’s business, results of operations, financial condition, cash flow and future prospects.

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Stock Price Volatility

The market price of the Company’s stock has fluctuated significantly in the past and may continue to fluctuate in the future.  The Company believes that such fluctuations will continue as a result of many factors, including US and World markets, financing plans, future announcements concerning the Company, the Company’s competitors or principal customers regarding financial results or expectations, industry supply or demand dynamics, new product introductions, governmental regulations, the commencement or results of litigation or changes in earnings estimates by analysts.  In addition, in recent years the stock market has experienced significant price and volume fluctuations often for reasons outside the control of the particular companies.  These fluctuations as well as general economic, political and market conditions may have an adverse affect on the market price of the Company’s common stock as well as the price of the Company’s outstanding convertible notes.

Worldwide Economic Conditions

The Company’s financial performance depends significantly on worldwide economic conditions and the related impact on levels of consumer spending, which has recently deteriorated significantly in many countries and regions, including the U.S., and may remain depressed for the foreseeable future.  Demand for the Company’s products is adversely affected by negative macroeconomic factors affecting consumer spending.  The severe tightening of consumer credit, low level of consumer liquidity, and extreme volatility in credit and equity markets have weakened consumer confidence and decreased consumer spending.  These and other economic factors have reduced demand for the Company’s products and harmed the Company’s business, financial condition and results of operations, and to the extent such economic conditions continue, they could cause further harm to the Company’s business, financial condition and results of operations.

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Dependence on Sales through Retailers and Distributors

The Company’s business depends significantly upon sales through retailers and distributors, and if the Company’s retailers and distributors are not successful, the Company could experience reduced sales, substantial product returns or increased price protection, any of which would negatively impact the Company’s business, financial condition and results of operations.  A significant portion of the Company’s sales are made through retailers, either directly or through distributors.  If the Company’s retailers and distributors are not successful, due to weak consumer retail demand caused by the current worldwide economic downturn, decline in consumer confidence, or other factors, the Company could continue to experience reduced sales as well as substantial product returns or price protection claims, which would harm the Company’s business, financial condition and results of operations.  

Limited Management Personnel

Under Nuvilex’Nuvilex’s business plan, significant and material matters of business must be conducted and concluded in a timely fashion.  The execution of the Company’s business plan is expected to place a significant strain on the Company’s management while providing little or no immediatelyimmediate compensation.

There can be no assurance that Nuvilex’Nuvilex’s planned personnel, systems, procedures and controls will be adequate to support its future operations, that management will be able to hire, train, retain, motivate and manage personnel or that its management will be able to successfully identify, manage and exploit existing and potential market opportunities.  If Nuvilex is unable to manage growth effectively, the Company’s business, prospects, financial condition, results and operations could be materially adversely affected.

Competition

The market in which Nuvilex competes is highly competitive, and the Company has no assurance that it will be able to compete effectively, especially against established industry competitors with significantly greater financial resources. The Company expects to face competition from a few competitors with significantly greater financial resources, well-established brand names and large, existing customer bases. Nuvilex expects the level of competition to intensify in the future.

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Dependence on Management

Nuvilex’Nuvilex’s performance will be substantially dependent on the continued services and on the performance of the current senior management and other key personnel of the Company. Nuvilex’Nuvilex’s performance will also depend on the Company’s ability to retain and motivate its other officers and key employees.  Nuvilex’Nuvilex’s inability to retain its executive officers or other key employees could have a material adverse effect on the Company’s business, prospects, financial condition and results of operations.  The Company’s future success will depend on its ability to identify, attract, hire, train, retain and motivate other highly skilled technical, managerial, merchandising, marketing and customer service personnel.  Competition for such personnel is intense and there can be no assurance that Nuvilex will be able to successfully attract, assimilate and retain sufficiently qualified personnel. The failure to retain an dand attract the necessary technical and managerial personnel could have a material adverse effect on the Company’s business, prospects, financial condition and results of operations. 

Development of Brand Awareness 

For certain market segments that Nuvilex plans to pursue, the development of its brand awareness is essential for it to reduce its marketing expenditures over time and realize greater benefits from marketing expenditures.  If the Company’s brand-marketing efforts are unsuccessful, growth prospects, financial condition and results of operations would be materially adversely affected. Nuvilex’Nuvilex’s brand awareness efforts have required, and will continue to require, incurrence of significant expenses.

Intellectual Property Protection:  Uncertainty of Protection of Proprietary Rights

Nuvilex currently relies on a combination of patents, trademarks, trade secret protection, non-disclosure agreements and licensing arrangements to establish and protect its proprietary rights. Despite efforts to safeguard and maintain Nuvilex’Nuvilex’s proprietary rights, there can be no assurance that the Company will be successful in doing so or that its competitors will not independently develop products that are substantially equivalent or superior to Nuvilex’ products.

Nuvilex also relies on trade secrets and proprietary know-how, which the Company seeks to protect by confidentiality and non-disclosure agreements with its employees, consultants, and third parties.  There can be no assurance that these agreements will not be breached, that the Company will have adequate remedies for any breach, or that certain of Nuvilex’Nuvilex’s trade secrets and proprietary know-how will not otherwise become known or be discovered by competitors.

Protecting or defending the Company’s intellectual propertyIP rights, to protect trade secrets, to determine the validity and scope of the proprietary rights of others, or to defend against claims of infringement or invalidity may require litigation. Such litigation, whether successful or unsuccessful, could result in substantial costs and diversions of management resources, either of which could have a materially adverse effect on Nuvilex’ business, prospects, financial condition, or operating results.

Availability and Coverage of Insurance

For certain risks, the Company does not maintain insurance coverage because of cost and/or availability. Because the Company retains some portion of its insurable risks, and in some cases self-insures completely, unforeseen or catastrophic losses in excess of insured limits could have a material adverse effect on the Company’s financial condition and operating results.

Federal, State, Local and Foreign Laws and Regulations

The Company’s past research, product development and manufacturing activities have involved the controlled use of hazardous materials, and the Company may incur significant costs as a result of the need to comply with numerous laws and regulations. The Company is subject to laws and regulations enforced by the FDA, the DEA, the CDHS, foreign health authorities and other regulatory statutes including the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Food, Drug and Cosmetic Act, the Resource Conservation and Recovery Act, and other current and potential federal, state, local and foreign laws and regulations governing the use, manufacture, storage, handling and disposal of the Company’s products, materials used to develop the Company’s products, and resulting waste products. The Company’s past research, product development and manufacturing activities have involved the controlled use of hazardous materials and the Company may incur costs as a result of the need to comply with these laws and regulations.

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Penny Stock Regulation

The Company’s securities may be subject to “penny stock rules” that impose additional sales requirements on broker-dealers who sell such securities to persons other than established customers and accredited investors (generally those with assets in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 together with their spouse). For transactions covered by these rules, the broker-dealer must make a special suitability determination for the purchase of such securities and have received the purchaser’s written consent to the transaction prior to the purchase.  Additionally, for any transaction involving a penny stock, unless exempt, the “penny stock rules” require the delivery, prior to the transaction, of a disclosure schedule prescribed by the Securities and Exchange Commission relating to the penny stock market. The broker-dealer must also must disclose the commissions payable to both the broke r-dealerbroker-dealer and the registered representative and current quotations for the securities. Finally, monthly statements must be sent disclosing recent price information on the limited market in penny stocks. Consequently, the “penny stock rules” may restrict the ability of broker-dealers to sell the Company’s securities. The foregoing required penny stock restrictions will not apply to the Company’s common stock if such securities maintain a market price of $5.00 or greater. The market price of the Company’s common stock may not reach or remain at such a level.

ITEM 1B. UNRESOLVED STAFF COMMENTS

None.

ITEM 2. PROPERTIES.

The Company’s office research and development and manufacturing facility is located at 1971 Old Cuthbert7702 E Doubletree Ranch Road, Cherry Hill, NJ 08034. The facility is owned by the Company.Suite 300, Scottsdale, AZ 85258.

ITEM 3. LEGAL PROCEEDINGS.

On June 11, 2009, Kurt Mussina, former Senior Vice President, Sales and Marketing for

In July 2011 a claim was filed by Cornerstone Bank against Freedom-2, Inc., instituted a lawsuitwholly owned subsidiary of the Company, for amounts due under a promissory note. The bank is also seeking to foreclose its mortgage on the property located in the Superior Court ofCherry Hill, New Jersey captioned Mussina v.for which the promissory note is held. Although at this time it is unknown what any estimated loss may be, it is reasonable to assume at least a loss between $750,000 - $1,000,000 is possible, with a worst case scenario of a 100% liability plus any applicable fees. In addition, there is a claim to enforce a purported pledge of additional collateral of 14,605,614 shares of Nuvilex common stock as security for the Note. It should be noted that the shares pledged by Freedom-2 Inc., et al., against, inter alia, Freedom-2, Inc., Freedom-2 Holdings, Inc. and Nuvilex seeking payment of certain severance monies he argues are duepurportedly owed by the Company to him under the terms of his previous agreements with Freedom2, Inc. and Freedom2 Holdings, Inc. Mr. Mussina sought payment of approximately $175,000 he claimed was due under these agreements, along with costs and fees associated with the lawsuit. On February 11, 2010, the parties entered into a mutual settlement agreement whereby Mr. Mussina would be paid $135,000. Pursuant to the termsCornerstone Bank were not part of the settlement agreement,mortgage note, but the Company issuedshares in question were above, beyond, and thus in addition to Mr. Mussina a convertible note in the principle amount of $135,000 post dated to April 1, 2009. The note was convertible into 9,000,000 Common Stock shares at a beneficial conversion rate of $0.015 per share. The Company’s restated April 30, 2009 financial statements reflect the Company’s $135,000 note liability to Mr. Mussina and related beneficial conversion provisions of the note as a debt discountcollateral for obtaining the second mortgage modification so they have been indicated as additional collateral, since they were not part nor parcel of ($123,904). A $135,000 charge was made to general and administrative expense. Pursuant to an amendment, Mr. Mussina converted the original note for 10,000,000 Common Stock shares at a beneficial conversion rate of $.01 per share and subsequently sold the Common Stock shares for $100,000.nor its modification itself except as collateral.  The Company also paid Mr. Mussina $30,000has recorded a stock payable and expense in cash. The remaining settlement balancethe amount of $5,000 was paid in Common Stock. One million shares of Common Stock were issued$730,281 to Mr. Mussina on March 23, 2010.account for the shares.

ITEM 4.  SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.  (REMOVED AND RESERVED).

None.

PART II

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERSAND ISSUER PURCHASES OF EQUITY SECURITIES.

Shares of the Company's common stock are quoted and traded from time to time on the OTC Bulletin Board and(www.otcmarkets.com; OTCQB) as a fully reporting Pink Sheets company under the so-called "Pink Sheets," withclassification of OTCQB via the trading symbol “NVLX.”

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The following table sets forth the high and low bid prices for the Company's shares for each quarter during the two fiscal years ended April 30, 20102011 and 2009.2010. The prices reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions.

At April 30, 2010,2011, the market price of the Company's common stock was $0.01$0.03 per share.

As of April 30, 2010,2011, there were 348,387,581357,137,581 issued and outstanding shares of common stock held by an estimated 8,000 shareholders of record.record, 1,229 of which are available via the NOBO listing.

DIVIDEND POLICY. On June 1, 2009, the Company’s Board of Directors declared a stock dividend of one (1) Common Stock share for every five hundred (500) Common Stock shares owned. The dividend will be payable to stockholders of record as of June 30, 2009. The Company has not paid and do not plan to pay cash dividends at this time or anytime soon.time. The Company’s Board of Directors will decide on any future payment of dividends, depending on the Company’s results of operations, financial condition, capital requirements, and any other relevant factors. However, the Company expects to use any future earnings for operations and in the business.

TRANSFER AGENT AND REGISTRAR. The transfer agent and registrar for the Company’s common stock is Signature Stock Transfer, Inc., 2301 Ohio Drive, Suite #100, Plano, Texas 75093; telephoneTelephone (972) 612-4120.

RECENT SALES OF UNREGISTERED SECURITIES. As described more fully in Note 10 to the Notes to the Consolidated Financial Statements included as part of this annual report and incorporated in this Item 5 by reference, during the past two years the Company has issued shares of its common stock for: acquisitions of Freedom2 Holdings, Inc.; cash; services; general, administrative and other expenses; compensation to directors, settlements of legal proceedings and repayment of loans, including accrued interest. Such shares were issued without registration under the Securities Act of 1933, in reliance upon the exemptions afforded by Section 4(2) and Rule 506 of Regulation D thereof. The persons who acquired the shares were either officers or directors of the Company, advisers and consultants or others who had access to material information about the Company; there were no underwriters involved in any of the transactions.

ISSUER PURCHASES OF EQUITY SECURITIES. The Company did not repurchase any of its securities during the year ended April 30, 2010.2011.

SECURITIES AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION PLANS. The Company currently does not maintain any equity compensation plans.

ITEM 6. SELECT FINANCIAL DATA

Not applicable.

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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

SALES

Revenues from product sales for fiscal 20102011 were $262,932. Revenues were substantially less than the Company’s approximate $3.0 million revenue forecast (59.7%) below fiscal 2009$75,997 plus consulting revenues of $653,134. Cinnergen™,$50,000 compared to $262,932 in fiscal 2010.  Product sales in fiscal 2011 only occurred during the latter few months of the fiscal year, once new product liability insurance was acquired and manufacturing, sales and distribution were reinitiated.  This was unlike fiscal 2010 which was replete with annual sales of $209,819 (79.8% of total annual revenues) continued to be the Company’s lead revenue producing product. The Company’s forecastmultiple products throughout and was predicated on having sufficient cash resources to effectively market its products, improving economic conditions, a ready, high demand marketutilizing existing product liability insurance paid for its Infinitink® product line and the successful introduction of at least one new product line. A combination of investment in ongoing research and development programs, high overhead costs and worsening economic conditions that shuttered the capital investment and debt markets usurped the Company’s ability to invest in essential marketing and sales activities. Specifically hard hit by the economic downturn was the retail tattoo ind ustry. Infinitink®, marketed as a premium ink with novel performance characteristics and a retail price of $5.00 per mL, was, with limited consumer demand to push sales, summarily rejected by the tattoo artist community. Finally, the Company could not advance, without a significant marketing investment or the ability to secure a bona fide marketing partner, its new Cinnsational™ or Cyclosurface^3™cosmetics product lines and the Company was unable to come up with a marketable Prevorex™ formula.fiscal 2009.

RESEARCH AND DEVELOPMENT

Annual researchResearch and development expenses for fiscal 2011 were $9,209 compared to $492,460 in fiscal 2010 were $492,460 and were nearly equal to fiscal 2009included those from Company efforts as well as external contract research organizations and development expenditure of $473,514. Research and development expenses are attributable to both internal and external university based sponsoredUniversity-based, Company-sponsored research activities. The Company’s research and development activities includeincluded, but arewere not limited to product conception, design, evaluation, formulation, manufacturing, packaging and testing. As with all corporate and university research, product conception, design and evaluation may or maydoes not necessarily yield commercially viable products. During fiscal 2009,It is the Company invested itsintention of the present management to fully utilize the prior year’s research efforts in advancing products not fully developed to date, particularly once present activities are actively moved forward.  

Effort is now underway to utilize completed and incomplete research and formulate development efforts toward  its Cinnsational™, Cyclosurface³™ cosmetics, Citroxin™ technology platform and related products, Infinitink® and related ink products, Oraphyte™ nematocide and Prevorex™ diet aid supplement. While material advancement was madeplans based on allsuch studies.  This is typically one of the above products, additional work may be requiredmost challenging steps, but one management is truly committed to, market, partner i.e. that of monetizing research discoveries through multiple means, and is one presently being actively prepared and/or sell any of these products.driven forward.

SALES AND MARKETING

The Company incurred sales and marketing expenses of $10,830 in fiscal 2011 compared to $411,720 in fiscal 2010, a decrease of 31% as compared to sales and marketing expenses of $594,342 for the previous year.2010.  The decrease in sales and marketing expenses was due in part to available cash resources to invest in such activities. activities, and partly due to careful and logical utilization of scarce resources.  Most of the available resources had been consumed during fiscal year 2010.  

Presently, the Company limitsregulates its sales and marketing expenses tothrough its Internet based salesInternet-based Division of Sales and marketing activitiesMarketing and support of its resellers and retail distributors.

GENERAL AND ADMINISTRATIVE

General and administrative expenses inclusive of non-stock compensation paid for consulting fees, decreased $4,088,711 (76.6 %) to $1,246,088were $227,816 in fiscal 20102011, a decrease of $946,424 as compared to $5,334,799the $1,174,240 in expenses in fiscal 2009. General2010. These expenses pay for office and administrative expenses are paid for accounting, legal, office andother overhead expenses. The Company during fiscal 2010, took aggressive steps during the latter half of fiscal 2011 to reduce and maintain its general and administrative expenses at a low level including, but not limited to reductions in staffing legal, and all other overhead expenses. Non-cashexpenses, including the receipt of stock compensation was paidas primary payment for consulting fees for officers and directors, legal advisors, research advisors and marketing consultants. The Company incurred $421,369 in non-cash consulting expenses in fiscal 2010.executives.

LOSS ON IMPAIRMENT OF ACQUIRED AND INTANGIBLE ASSETS

The Company recorded a $12,411 loss on disposal of fixed assets in fiscal year 2011. A $3,507,621 charge for impairment of goodwill, fixed assets and intangible assets was taken previously in fiscal 2010 associated with itsthe acquisition of Freedom-2 Holdings, Inc. and $857,024 for intangible assets in 2009.

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LIQUIDITY AND CAPITAL RESOURCES

As of April 30, 2010,2011, the Company had negative working capital of $3,039,683.$3,284,733. By adjusting the Company's operations to the level of capitalization, working with its creditors to establish a reasonable and timetimely manner for resolving outstanding debts and through small cash investments from new and existing shareholders, management believes it has sufficient resources to meet projectedpresent cash flow deficits through the next twelve months.needs. If the Company is not successful in generating sufficient liquidity from operations or in resolving its outstanding debt issues with its creditors on terms acceptable to the Company, this could have a materialmaterially adverse effect on the Company’s business, liquidity and financial condition. The Company’s independent certified public accountants have stated in their report, which is included as part of the Company’s audited financial statements for the fiscal years ended April 30, 20102011 and 2009,2010 that the Company has suffered recurring losses from operations and this matterwhich raises substantial doubt about the Company’s ability to continue as a going concern.

The Company has no off-balance sheet arrangements, special purpose entities, financing partnerships or guarantees.

Management notes of the total liabilities of $3,389,479, the current Freedom-2 subsidiary’s liabilities are 89.3% of the liabilities or $3,025,400.  

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 8.  FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

The financial statements of the Company and supplementary data are included beginning immediately before the signature page to this report.

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

None.

(a) On March 8, 2010, Nuvilex, Inc. (the “Company”) dismissed Gruber & Company, LLC as independent auditors for the Company. The decision to dismiss Gruber & Company, LLC and to seek new independent auditors was approved by the Company’s Board of Directors.

In connection with the audits of the Company’s financial statements for the fiscal years ended April 30, 2009 and 2008 and from April 30, 2009 through March 8, 2010, (1) there were no disagreements with Gruber & Company, LLC on any matter of accounting principles or practices, financial statement disclosure or auditing scope and procedure which, if not resolved to the satisfaction of Gruber & Company, LLC, would have caused Gruber & Company, LLC to make reference to the matter in its report and (2) there were no “reportable events” as that term is defined in Item 304 of Regulation S-K promulgated under the Securities Exchange Act of 1934 (“Item 304”).

The report of Gruber & Company, LLC on the Company’s financial statements for the fiscal year ended April 30, 2008 did not contain an adverse opinion or a disclaimer of opinion and was not qualified or modified as to uncertainty, audit scope or accounting principles.

The report of Gruber & Company, LLC on the Company’s financial statements for the fiscal year ended April 30, 2009 did not contain an adverse opinion or a disclaimer of opinion and was not qualified or modified as to uncertainty, audit scope or accounting principles, except Gruber & Company, LLC disclosed an uncertainty regarding the Company’s ability to continue as a going concern. In the Annual Report on Form 10-K filed by the Company for the fiscal year ended April 30, 2009, Gruber & Company, LLC disclosed that the Company had generated negative cash flows from operations, and an accumulated deficit of $29,491,700 at April 30, 2009, and that those factors, as well as the uncertain conditions that the Company faced regarding its future raising of capital and ultimately successfully commercializing its business plan, raised substantial doubt about the Company’s ability to continue as a going concern.

(b) On March 8, 2010, the Company engaged M & K CPAS, PLLC as the Company’s independent accountant to audit the Company’s financial statements and to perform reviews of interim financial statements. During the fiscal years ended April 30, 2009 and 2008 and from April 30, 2009 through March 8, 2010 neither the Company nor anyone acting on its behalf consulted with M & K CPAS, PLLC regarding (i) either the application of any accounting principles to a specific completed or contemplated transaction of the Company, or the type of audit opinion that might be rendered by M & K CPAS, PLLC on the Company’s financial statements; or (ii) any matter that was either the subject of a disagreement with Gruber & Company, LLC or a reportable event with respect to Gruber & Company, LLC.

ITEM 9A. CONTROLS AND PROCEDURES.

Evaluation of Disclosure Controls and ProceduresPROCEDURES

The Company maintainsCompany’s upper Management, including the Chief Executive, Chief Financial, and Chief Operating Officers, as of the end of the period covered by this Annual Report on Form 10-K, have concluded our disclosure controls and procedures (as defined in Rules 13a-15(e)13a-14(c) and 15d-15(e) of15d-14(c) under the Securities Exchange Act of 1934), as amended (the “Exchange Act”) that are designed were not effective, although efforts were made to be effective in providing reasonable assurance thatdo so, to ensure information required to be disclosed in the Company’s reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in theSEC rules and forms, of the Securities and Exchange Commission (“SEC”), and that such information is accumulated and communicatedbut are aiming to the Company’s  management to allow timely decisions regarding required disclosure.become effective as we move forward.

In designingManagement, including the Chief Executive Officer and evaluatingChief Financial Officer, does not expect its disclosure controls and procedures management recognizes that anyor its internal controls and procedures,will prevent all error or fraud.  A control system, no matter how well designedconceived and operated, can provide only reasonable, not absolute assurance the objectives of achieving the desired objectives. Also,control system are met.  Further, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs.  Because ofDue to the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations includeTo address the realities that judgmentsmaterial weaknesses, management performed additional analysis and other post-closing procedures in decision-makingan effort to ensure its consolidated financial statements included in this annual report have been prepared in accordance with generally accepted accounting principles and are as free of fraud as best as can be faultydetermined. Accordingly, management believes the financial statements included in this report fairly present in all material respects our financial condition, results of operations and cash flows for the periods presented.

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Changes in Internal Controls.

There were no significant changes in our internal controls or other factors that breakdowns can occur becausecould significantly affect these controls subsequent to the date of simple errortheir evaluation. There were no significant deficiencies or mistake. Thematerial weaknesses recognized as of April 30, 2011, and therefore there were no corrective actions taken. However, the design of any system of controls is based in part upon certain assumptions about the likelihood of future events and there can beis no assurancecertainty that any design will succeed in achieving its stated goals unde rgoal under all potential future conditions.

Asconsiderations, regardless of how remote.  It is management’s plan however, to work toward better assessment of any and all necessary internal controls and thereby to increase the capability to recognize errors and prevent fraud as the Company strives for bettering itself from this point.  We have already initiated discussions to study, assess and create everything necessary throughout the remainder of the end of the period covered by this report, the Company conducted an evaluation, under the supervision and with the participation of its chief executive officer and chief financial officer of the Company’syear to achieve effective disclosure controls and procedures.  Based on their evaluation, the chief executive officer and chief financial officer concluded that the Company’s disclosure controls and procedures need improvement and were not effective as of April 30, 2010 to ensure timely reporting with the Securities and Exchange Commission. Management is in the process of identifying deficiencies with respect to the Company’s disclosure controls and procedures and implementing corrective measures.Nonetheless, this will remain a potential material weakness until such activities have been fully integrated.

Evaluation of andManagement’s Report on Internal Control overOver Financial Reporting.  

The management of Nuvilex, Inc.

Management is responsible for establishing and maintaining adequate internal control over financial reporting.reporting as defined in Rule 13a-15(f) under the Securities Exchange Act, as amended. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934 asrefers to a process designed by, or under the supervision of, the company’s principal executiveour Chief Executive, Chief Financial and principal financial officers andChief Operating Officer, effected by the company’s board of directors,our Board, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordanceconnection with accounting principles generally accepted in the United States of America and includesGAAP, including those policies and procedures that:

·

Pertain

	-	pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company; · Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with accounting principles generally accepted in the United States of America and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and ·  Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
	-	provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
	-	provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our consolidated financial statements.

Because of its inherent limitations, internal control over financial reporting may not preventcannot provide absolute assurance of the prevention or detectdetection of misstatements. ProjectionsIn addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. All

In connection with the preparation of this Annual Report on Form 10-K for the year ended April 30, 2011, management, with the participation of our Chief Executive Officer, Chief Financial Officer, and Chief Operating Officer, has evaluated the effectiveness of our internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Because of the inherent limitations of internal control, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal controlcontrols over financial reporting. However, these inherent limitations are known features ofreporting, pursuant to Rule 13a-15 under the financial reporting process. Therefore, it is possible to design into the process safeguard s to reduce, though not eliminate, this risk.  

Exchange Act.  Management assessed the effectiveness of the Company’sits internal control over financial reporting as of April 30, 2010.2010 in order to determine the potential for or the existence of material weakness, defined as a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility a material misstatement of the company's annual or interim financial statements will not be prevented or detected on a timely basis. Our Chief Executive, Chief Financial, and Chief Operating Officer, have concluded the design and operation of our internal controls and procedures are not effective as of April 30, 2011. As a result, the following aspects of the Company were noted as potential material weaknesses:

1.

As of April 30, 2011, the Company’s control over financial reporting was not effective. Specifically, although a formally adopted and written code of business conduct and ethics that governs to the Company’s employees, officers and directors existed, it had not been disseminated nor specifically discussed to date, although discussions have been held which did specifically point out and discuss the critical nature of appropriate behavior, ethics and expectations as members of Nuvilex by the Chief Executive Officer with internal and external company members and specifically with each member of the Board of Directors, the Officers and the employees individually and as groups.  

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2.

Although they have communicated to their employees, Management has not fully developed its accounting policies and procedures.  In making this assessment,addition, no Director of the Board of Directors qualifies as an Audit Committee Financial expert as defined in Item 407(d)(5)(ii) of Regulation S-B which may therefore, constitute a material weakness.

3.

As of April 30, 2011, the Company’s control over financial statement disclosure was not effective. Specifically, controls were not completely developed to guarantee all disclosures required would be fully addressed in our financial statements.   Accordingly, management usedhas determined its control deficiency constitutes a material weakness.

Because of these material weaknesses, Management has concluded the Company did not maintain effective internal control over financial reporting as of April 30, 2011, based on the criteria established in "Internal Control-Integrated Framework" issued by the COSO, criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control-Integrated Framework.  It is the intention of the present Management to continue to study and establish COSO Control-Integrated Framework within Nuvilex during the coming year.

Based on its assessment, management concluded that, as of April 30, 2010, the Company’s

There were no significant changes previously in our internal controlcontrols over financial reporting is ineffective based on those criteria as they relatethat occurred during the fourth fiscal quarter that have materially affected, or are reasonably likely to timely filing.

We have assessed the following material weaknesses as of April 30, 2010.

Information and Communication:

We have determined thatmaterially affect, our internal communication is not robust or appropriate enough to ensure all appropriate parties have the necessary facts and agreements to complete ourcontrols over financial reporting quickly, cleanly and with accuracy.reporting.

Remediation:

During the fiscal year ended April 30, 2011, we will conduct a financial reporting close call with all executives and those involved in the financial close to ensure all parties have the necessary facts to complete our financial reporting appropriately.  Further to mitigate future filing delays the company will seek to select a financial controller to coordinate the efforts of the company’s outside professional service providers to assure the future timely reviews and signoffs of future filings.  

This annual reportAnnual Report on Form 10-K does not include an attestation report of the Company’s independent registered public accounting firm regarding internal control over financial reporting. Management’s report iswas not subject to attestation by the Company’sour registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission.

ChangesCommission that permit us to provide only management’s report in Internal Control over Financial Reporting

There was no change in the Company’s internal control over financial reporting identified in connection with the requisite evaluation that occurred during the last fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.this Annual Report on Form 10-K.