The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern. 

3. ACQUISITION OF RECEPTOPHARM, INC.

On December 12, 2003, the Company entered into an acquisition agreement (the “Agreement”), whereby it agreed to acquire up to a 49.5% interest in ReceptoPharm, Inc. (“ReceptoPharm”) a privately held biopharmaceutical company based in Ft. Lauderdale, Florida. ReceptoPharm is a development stage company engaged in the research and development of proprietary therapeutic proteins for the treatment of several chronic viral, autoimmune and neuro-degenerative diseases.

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Nutra Pharma Corp.

Notes to Consolidated Unaudited Financial Statements

September 30, 2008

Pursuant to the Agreement, the Company acquired its interest in ReceptoPharm’s common equity for $2,000,000 in cash, which equates to a purchase price of $.45 per share. ReceptoPharm intended to use such funds to further research and development. At March 31, 2007, the Company owned 4,444,445 shares or 38% of the issued and outstanding common equity of ReceptoPharm. In addition to its ownership interest, as of March 31, 2007, the Company had loaned ReceptoPharm $975,000 for working capital purposes.

For accounting purposes, the Company through March 31, 2007, had been treating its capital investment in ReceptoPharm as a vehicle for research and development. Because the Company was solely providing financial support to further the research and development of ReceptoPharm, such amounts were being charged to expense as incurred by

ReceptoPharm. In this circumstance, ReceptoPharm was considered a variable interest entity and its financial results were consolidated.

Effective in April 2007 the Company ceased advancing funds to Receptopharm and had no further commitment to fund them. As such, the Company deconsolidated ReceptoPharm from its financial statements at June 30, 2007. This deconsolidation resulted in a gain of $1,081,095. This gain resulted from the Company reversing the net losses of ReceptoPharm included in its consolidated financial statements and including the net losses as if the equity method of accounting had been applied. In addition, the Company wrote off its $2,000,000 investment and the $975,000 of advances it made to ReceptoPharm as discussed above as they were deemed to be impaired at June 30, 2007.

The gain was computed as follows:

 

Net losses included in the consolidated financial statements		$	4,056,095
Investment advances and equity method losses			(2,975,000	)
Gain on deconsolidation		$	1,081,095

From January 1, 2008 through April 1, 2008, the Company loaned ReceptoPharm an additional $300,000 for working capital purposes.

On April 10, 2008, the Company completed a transaction pursuant to which it acquired the remaining sixty-two percent (62%) of ReceptoPharm’s issued and outstanding common shares in exchange for a maximum of 30,000,000 shares of the Company’s common stock. Prior to April 10, 2008, the Company owned 4,444,445 shares or approximately 38% of ReceptoPharm’s common stock. As a result of this transaction, the Company now owns 100% of the issued and outstanding common stock of ReceptoPharm. The exchange ratio in this transaction was four (4) Nutra Pharma shares for each ReceptoPharm share.

The Company accounted for this acquisition under the purchase method of accounting. The calculation of the total purchase cost is as follows:

Total number of Nutra Pharma shares issued			30,000,000
Market price of Nutra Pharma common stock on April 10, 2008		$	0.035
Value of shares issued		$	1,050,000
Loan to ReceptoPharm forgiven at closing			300,000
Liabilities of ReceptoPharm assumed at closing			1,119,413
Total purchase cost to be allocated		$	2,469,413
Allocation of purchase cost:
Fair value of Receptopharm assets at closing		$	71,664
Purchase cost in excess of fair value of assets acquired			2,397,749
Total purchase cost		$	2,469,413

The purchase cost in excess of the fair value of net assets acquired was recorded as goodwill.

The Company has included the results of operations of ReceptoPharm in its consolidated results of operations effective on April 11, 2008. Had the Company included the results of operations of ReceptoPharm in its consolidated results of operations for the entire period from January 1, 2008 to September 30, 2008, its consolidated net loss would have increased by $ 238,281 or $.00 per share.

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Nutra Pharma Corp.

Notes to Consolidated Unaudited Financial Statements

September 30, 2008

As of September 30, 2008, the Company had issued a total of 24,740,800 shares of its common stock in exchange for 6,185,200 shares of Receptopharm. The Company expects to issue the remaining 5,259,200 shares to the Receptopharm shareholders during the quarter ending December 31, 2008.

4. DUE TO OFFICERS

During the nine months ended September 30, 2008, the Company borrowed an additional $231,000 from its President, Rik Deitsch, increasing the total amount owed under to Mr. Deitsch to $1,010,852. This demand loan is unsecured and bears interest at a rate of 4.0%. Included in the amount owed to Mr. Deitsch is $140,477 of accrued interest.

On March 14, 2008, the Company’s Board of Directors approved an offer made by Mr. Deitsch, to discharge $1,200,000 of Mr. Deitsch’s outstanding loan to the Company in exchange for 48,000,000 shares of restricted common stock. The price per share in this loan conversion was the fair market value of the common shares of $0.025.

 

5. STOCKHOLDERS’ EQUITY

From January 1 through September 30, 2008, the Company completed private placements of restricted shares of its common stock, whereby it sold an aggregate of 32,340,000 shares at a price per share of $0.025. The Company received proceeds of $808,500 in connection with the sale of these shares. At September 30, 2008, 13,500,000 of the 32,340,000 shares that were sold were not yet issued.

The Company also granted one (1) warrant for each share sold which gives the investor the right to purchase one (1) additional share until December 31, 2012 at an exercise price of $0.10 per share.

 

6. STOCK BASED COMPENSATION

On March 13, 2008, the Company’s Board of Directors authorized the issuance of an aggregate of 17,000,000 shares of its restricted common stock in exchange for services rendered, as follows:

1,000,000 shares to each of four (4) consultants

2,000,000 shares to one (1) consultant

1,000,000 shares to an employee of the Company

5,000,000 shares to the Company’s Chairman and Chief Executive Officer

2,500,000 shares to a Director of the Company

2,500,000 shares to a Director of the Company

The shares described above were valued at $0.025 per share which was the fair market value of the Company’s common stock on the date of grant. The Company recorded stock based compensation of $425,000 in connection with the issuance of these shares.

On September 10, 2008, the Company’s Board of Directors authorized the issuance of an aggregate of 2,500,000 shares of its restricted common stock in exchange for services rendered, as follows:

1,600,000 shares to one (1) consultant

   500,000 shares to one (1) consultant

   400,000 shares to one (1) consultant

The shares described above were valued at $0.03 per share which was the fair market value of the Company’s common stock on the date of grant. The Company recorded stock based compensation of $75,000 in connection with the issuance of these shares.

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Nutra Pharma Corp.

Notes to Consolidated Unaudited Financial Statements

September 30, 2008

7. STOCK OPTIONS

 

A summary of stock options is as follows:

 

		Number of shares			Weighted average exercise price			Weighted average fair value
Balance December 31, 2007			3,000,000		$	0.25		$	0.16
Exercised			-			-			-
Issued			-			-			-
Forfeited			-			-			-
Balance September 30, 2008			3,000,000		$	0.25		$	0.16

The following table summarizes information about fixed-price stock options:

      

Exercise Price		Weighted Average Number Outstanding			Weighted Average Contractual Life			Weighted Average Exercise Price
$.20			1,000,000			2.50 years		$	.20
$.27			2,000,000			2.25 years		$	.27
			3,000,000

All options are vested and exercisable.

8. CONTINGENCIES

On April 4, 2005, a Motion to Enforce Settlement Agreement was filed against the Company in the Circuit Court of Broward County Florida by Bio Therapeutics, Inc. f/k/a Phylomed Corp. in Nutra Pharma Corp. v. Bio Therapeutics, Inc. (17th Judicial Circuit, Case No. 03-008928 (03). This proceeding results from the Company’s alleged breach of a settlement agreement that was entered into between Bio Therapeutics and the Company in resolution of a previous lawsuit between the Company and Bio Therapeutics that was resolved by entering into a Settlement Agreement. In conjunction with the settlement agreement, the Company also entered into a related License Agreement and Amendment to the License Agreement (“License Agreement”) with Bio Therapeutics regarding certain pieces of intellectual property owned by Bio Therapeutics. In the April 4, 2005 motion, Bio Therapeutics alleges that the Company breached certain provisions of the License Agreement and requested that the Court grant its motion to enforce the Settlement Agreement by declaring the License Agreement terminated, enjoining the Company from further use of license products that was granted to it by the License Agreement, and awarding attorneys’ fees and costs to Bio Therapeutics.

During the last quarter of 2007, the Company moved for summary judgment regarding Bio Therapeutics’ Motion to Enforce Settlement Agreement and the Court and on April 28, 2008, the Court (i) granted the Company’s Cross Motion for Summary Judgment; (ii) declared Bio Therapeutics Amended Motion for Summary Judgment moot; and (iii) denied Bio Therapeutics Motion to Enforce Settlement Agreement.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations/Plan of Operations

Liquidity and Capital Resources

Our independent registered public accounting firm issued a going concern opinion on our audited financial statements for the fiscal year ended December 31, 2007. We have experienced recurring net losses and at September 30, 2008, we had an accumulated deficit of $21,600,182 and negative working capital of $2,303,394. Additionally, we have no significant revenue generating operations. Our ability to continue as a going concern is contingent upon our ability to secure additional financing, increase ownership equity, and attain profitable operations. In addition, our ability to continue as a going concern must be considered in light of the problems, expenses and complications frequently encountered in established markets and the competitive environment in which we operate. Should we fail to secure adequate financing or establish a revenue base for our operations, we may deplete our available funds and be unable to pay our obligations.

We have estimated expenses of $2,575,000 pertaining to our twelve month Plan of Operations or $214,583 of monthly expenditures. Based on our current cash position, we do not have sufficient funds to accomplish our operational plan. Our ability to meet these expenses is dependent upon our ability to raise additional capital or our management loaning us sufficient funds to meet our expenses.

We will attempt to satisfy our estimated cash requirements for our twelve month Plan of Operations through the sale of Designer Diagnostics’ test kits; however, if sales do not achieve adequate levels to provide for our operations, we will have to raise additional capital through a divestiture of assets, a private placement of our equity securities or, if necessary, possibly through shareholder loans or traditional bank financing or a debt offering; however, because we are a development stage company with a limited operating history and a poor financial condition, we may be unsuccessful in obtaining shareholder loans, conducting a private placement of equity securities, or in obtaining bank financing. In addition, if we only have nominal funds by which to conduct our operations, which will negatively impact development of our possible products.

We have no alternative Plan of Operations. In the event that we do not obtain adequate financing to complete our Plan of Operations or if we do not adequately implement an alternative plan of operations that enables us to conduct operations without having received adequate financing, we may have to liquidate our business and undertake any or all of the following actions:

 

·

Sell or dispose of our assets, if any;

·

Pay our liabilities in order of priority, if we have available cash to pay such liabilities;

·

If any cash remains after we satisfy amounts due to our creditors, distribute any remaining cash to our shareholders in an amount equal to the net market value of our net assets;

·

File a Certificate of Dissolution with the State of California to dissolve our corporation and close our business;

·

Make the appropriate filings with the Securities and Exchange Commission so that we will no longer be required to file periodic and other required reports with the Securities and Exchange Commission, if, in fact, we are a reporting company at that time; and

·

Make the appropriate filings with the National Association of Security Dealers to effect a delisting of our common stock, if, in fact, our common stock is trading on the Over-the-Counter Bulletin Board at that time.

 

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Based upon our current assets, however, we will not have the ability to distribute any cash to our shareholders. If we have any liabilities that we are unable to satisfy and we qualify for protection under the U.S. Bankruptcy Code, we may voluntarily file for reorganization under Chapter 11 or liquidation under Chapter 7. Our creditors may also file a Chapter 7 or Chapter 11 bankruptcy action against us. If our creditors or we file for Chapter 7 or Chapter 11 bankruptcy, our creditors will take priority over our shareholders. If we fail to file for bankruptcy under Chapter 7 or Chapter 11 and we have creditors, such creditors may institute proceedings against us seeking forfeiture of our assets, if any.

 

We do not know and cannot determine which, if any, of these actions we will be forced to take. If any of these foregoing events occur, you could lose your entire investment in our shares.

Results of Operations – Comparison of Three Month Periods ending September 30, 2007 and September 30, 2008

Revenues for the three months ended September 30, 2008 were $3,045. We did not recognize any revenues for the period ending September 30, 2007.

General and administrative expenses increased $303,329 or 237% from $127,992 for the quarter ended September 30, 2007 to $431,321 for the quarter ended September 30, 2008. This increase is due primarily to our 2007 financial results not including Receptopharm’s general and administrative expenses.

We incurred a net loss of $516,580 during the 3 month period ending September 30, 2008 compared to a net loss of $747,333 for the comparable period in 2007. The $230,753 or 30.9% decrease in net loss is primarily attributable to less stock compensation being recorded in the period ending September 30, 2008 period compared to the period ending September 30, 2007.

Results of Operations – Comparison of Nine Month Periods ending September 30, 2007 and September 30, 2008

Revenues for the nine months ended September 30, 2008 were $3,045. We did not recognize any revenues during the nine month period ended September 30, 2007.

General and administrative expenses increased by $511,391 or 116.4% from $439,447 for the nine months ended September 30, 2007 to $950,838 for the nine months ended September 30, 2008. This increase is due primarily to our 2007 financial results not including Receptopharm’s general and administrative expenses.

We incurred a net loss of $1,491,088 during the 9 month period ending September 30, 2008 compared to a net loss of $15,504 for the comparable period in 2007. During the 9 month period ending September 30, 2007, we recognized a gain of $1,081,095 related to the deconsolidation of ReceptoPharm. Excluding this gain, our net loss for the 9 months ended September 30, 2007 would have been $1,096,599.

Off-Balance Sheet Arrangements

We have not entered into any transaction, agreement or other contractual arrangement with an entity unconsolidated with us under whom we have:

·	an obligation under a guarantee contract;
·	a retained or contingent interest in assets transferred to the unconsolidated entity or similar arrangement that serves as credit, liquidity or market risk support to such entity for such assets;
·	any obligation, including a contingent obligation, under a contract that would be accounted for as a derivative instrument, or;

 

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·

any obligation, including a contingent obligation, arising out of a variable interest in an unconsolidated entity that is held by us and material to us where such entity provides financing, liquidity, market risk or credit risk support to, or engages in leasing, hedging or research and development services with us.

We do not have any off-balance sheet arrangements or commitments that have a current or future effect on its financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that is material, other than those which may be disclosed in this Management’s Discussion and Analysis of Financial Condition and the audited Consolidated Financial Statements and related notes.

Plan of Operations

Pending adequate financing, we plan on spending total estimated expenses of $2,575,000 for the next 12 months, which will include: (a) $380,000 pertaining directly to our operations; (b) $120,000 pertaining to the operations of our subsidiary, Designer Diagnostics and (c) $2,075,000 pertaining to the operations of our subsidiary, ReceptoPharm. Our Plan of Operations does not involve: (a) any expected purchase or sale of a plant or significant equipment; and/or (b) any expected significant changes in the number of our employees.

 

EXPENSES PERTAINING TO OUR OPERATIONS

 

Type of Expenditure		Total  Expenditure			Monthly  Expenditure
Salaries*		$	175,000		$	14,583
Travel related expenses for our Chief Executive Officer pertaining to research and due diligence			40,000			3,333
Professional Fees -Legal and Accounting			165,000			13,750
Total		$	380,000		$	31,666

* Salaries include the following: (a) Chief Executive Officer - $130,000; and (b) Administrative Assistant - $45,000

 

FUNDING OF RECEPTOPHARM, INC.

Type of Expenditure		Total  Expenditure			Monthly  Expenditure
Salaries		$	350,000		$	29,167
Clinical Trial expenses			1,045,000			87,083
R & D Expenses			394,000			32,833
Cost of raw materials and production			236,000			19,667
Operating Expenses (Rent, Supplies, Utilities, etc..)			50,000			4,167
Total		$	2,075,000		$	172,917

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FUNDING OF DESIGNER DIAGNOSTICS, INC.

Type of Expenditure		Total Expenditure			Monthly Expenditure
Operating Expenses (Rent, supplies, utilities)		$	50,000		$	4,167
Salaries (President)			70,000			5,833
Total:		$	120,000		$	10,000

OUR PLAN OF OPERATIONS TO DATE:

To date, we have accomplished the following in our Plan of Operations:

In approximately October 2005, we completed pre-clinical studies with various companies that ReceptoPharm has agreements with pertaining to ReceptoPharm’s Multiple Scherosis (MS) and HIV drugs, which consist of (a) and (b) below:

(a) MS Drug under Development (RPI-78M) - ReceptoPharm conducted microarray and histoculture studies and related analysis of the cells of Multiple Sclerosis patients to ascertain how RPI-78M affected the cells of these patients. Microarray analysis is the study of the gene expression of cells. Histoculture is the study of the entire cellular environment. We measured the effect of RPI-78M on gene expression using cDNA microarray technology to identify any potentially unique changes in gene expression that may be caused by RPI-78M. After statistical evaluation of the data, the researchers found more than sixty genes with significant changes in expression as compared to the control. In analyzing the affected genes, at least thirty of them may have a specific role in the progression of the disease and symptoms of MS; and

(b) HIV Drug under Development (RPI-MN) - Viral isolates are common mutations of HIV. ReceptoPharm, through an agreement with the University of California, San Diego, conducted research to study the effect of ReceptoPharm’s drug under development on different viral isolates to determine the drug’s efficacy in mutated forms of the HIV virus. The ability of the HIV virus to establish resistance to therapeutic drugs through genetic mutation is a major concern in the treatment of HIV/AIDS. HIV does not always make perfect copies of itself. With billions of viruses being made every day, lots of small, random differences can occur. The differences are called mutations and these mutations can prevent drugs from working effectively. When a drug no longer works against HIV, this is called drug resistance and the virus with the mutation is considered to be ‘resistant’ to the drug. With the increasing number of drug-resistant patients, it is of great importance in the development of new HIV/AIDS therapeutics that they will be effective against HIV of known resistance characteristics. The inhibition of multi-resistant HIV-1 strains by RPI-MN preparations was investigated at the La Jolla Institute of Molecular Medicine. The results from these trials indicate that the drug is effective against drug-resistant strains of HIV.

 

·

On January 24, 2006, we obtained NanoLogix’s intellectual property pertaining to the manufacture of test kits for the rapid isolation, detection and antibiotic sensitivity testing of certain microbacteria, which includes reassignment to us of 11 key patents protecting the diagnostics test kit technology and NanoLogix licensing to us, and the remaining 18 patents that protect the diagnostics test kit technology.

 

·

In February 2006, we completed the initial funding of ReceptoPharm in the amount of $2,000,000.

 

·

In January 2006, we established Designer Diagnostics to sell NonTuberculois Mycobacterium test kits.

 

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·

Designer Diagnostics held a Continuing Medical Education Seminar at the Mahatma Gandhi Institute in India on March 24, 2006 during the World Stop TB Day. At that meeting, Designer Diagnostics officially began marketing their test kits for the rapid isolation, detection and antibiotic-sensitivity testing of microbacteria. In March 2006, we made our first sales of Designer Diagnostics’ test kits.

 

·

In May 2006, ReceptoPharm received approval from the Medicines Health and Regulatory Agency (MHRA) for its application of human clinical trials for the treatment of Adrenomyeloneuropathy (AMN). The MHRA is the medical regulatory agency within the British Department of Health.

 

·

From March and April of 2006, ReceptoPharm published two clinical trials on the use of their technology for the treatment of pain.

 

·

In June 2006, ReceptoPharm published the results of their EAE rat model of  MS, which showed that their drug, RPI-78M, had promising results in an accepted animal model of the disease.

 

·

In October of 2006, ReceptoPharm received Ethics Committee approval in the United Kingdom to begin its Phase IIb human clinical trial for the treatment of AMN. This approval allows for the late Phase II/early Phase III (Iib/IIIa) trial to begin.

 

·

From November 29, 2006 to December 2, 2006, ReceptoPharm presented their analgesic research on RPI-78M at the International Conference on Neurotoxins (ICoN) in Hollywood, Florida.

 

·

In January of 2007, we completed a series of microarray studies with various companies that ReceptoPharm has agreements with pertaining to ReceptoPharm’s anti-viral drug. The microarray studies indicated that the exposure of healthy immune T-cells to our antiviral drugs activates the primary immune mechanisms. The expression of one such immune trigger, interferon gamma, is increased by as much as 20 times, acting as an effective antiviral agent, but without the significant negative clinical side effects of other interferon-based therapies. This may explain the broad antiviral activity observed with these types of agents. Based upon this data, these products could conceivably be used to substitute for the flu shot in winter or protect against other contagious viral diseases when vaccines are not readily available.

 

·

In January of 2007, Designer Diagnostics received positive results from its in-vitro analysis of its Tuberculosis (TB) test kit. Normal culturing methods can take as long as 10 weeks to produce results, where Designer Diagnostics test kits have shown similar results within 10 days.

 

·

In January of 2007, ReceptoPharm began its Phase IIb human clinical trial for the treatment of AMN.

 

·

In February of 2007, ReceptoPharm expanded their antiviral clinical research into Mexico and Peru where RPI-MN was used in early clinical studies. ReceptoPharm seeks to conduct two Phase II antiviral trials each with a primary duration of 3-4 months.

 

·

In March of 2007, Designer Diagnostics engaged the U.S. Commercial Service to help build international sales of its diagnostic test kits.

 

·

On March 7, 2007, ReceptoPharm’s signed a letter of intent to create a Joint Venture with Nan gene Biotechnology, a Chinese biotech company. The proposed joint venture will develop the antiviral drug, RPI-MN, for the Chinese market.

 

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·

In March of 2007, ReceptoPharm published an article in the Critical Reviews in Immunology special conference issue. The article, entitled “Alpha-Cobratoxin”, discussed Alpha-Cobratoxin as a possible therapy for Multiple Sclerosis, reviews the literature leading to the development for this application, and discusses the background and reasoning behind ReceptoPharm’s research on its treatment for Multiple Sclerosis (MS).

 

·

On March 27, 2007, we completed our first licensing payment on behalf of Designer Diagnostics to NanoLogix for the patents protecting Designer Diagnostics’ test kits.

 

·

On April 11, 2007, ReceptoPharm filed a patent for method of treating autoimmune diseases, including MS and Rheumatoid Arthritis.

 

·

During April 2007, ReceptoPharm completed its initial discussions with Zhong Xin Dong Tai Co., Ltd (“Nanogene Biotechnology”) to develop RPI-MN for the China market. RPI-MN is ReceptoPharm’s drug candidate being researched for the treatment of HIV/AIDS and other viral disorders. According to a signed Memorandum of Understand between ReceptoPharm and Nanogene Biotechnology. ReceptoPharm will need to confirm safety and efficacy of RPI_MN by completing pre-clinical studies at Soochow University located in China. Nanogene Biotechnology will provide the drug raw material and ReceptoPharm will modify the products and provide the proper study protocols. Upon successful completion of the pre-clinical studies, ReceptoPharm and Nanogene Biotechnology will proceed with clinical trials aimed at gaining full regulatory approval in China.

 

·

On May 2, 2007, Designer Diagnostics announced that it would conduct clinical trials for their Tuberculosis and NonTuberculois Mycobacterium diagnostic test kits at the National Jewish Medical and Research Center in Denver, Colorado. The purpose of the clinical trials is to validate the efficacy of the test kits for use with Tuberculosis and Non-Tubernulosis Mycobacterium patients as well as for environmental testing. The clinical trials for Designer Diagnostics are the final step required by the FDA prior to applying for FDA regulatory approval of the test kits. The studies are ongoing with plans to complete testing throughout 2008.

 

·

During May 2007, Designer Diagnostics completed the upgrade of its Tuberculosis diagnostic test kits enabling such the test kits to show more rapid and reliable results.

 

·

During July 2007, ReceptoPharm successfully completed enrollment in its phase llb human clinical trial for the treatment of AMN.

 

·

In August of 2007, ReceptoPharm successful results on the use of their technology for the treatment of pain. The latest data demonstrated that RPI-78 was as effective as morphine at blocking pain signals in that part of the brain that signals the presence of pain. It was also confirmed that the drug did not use an opioid mechanism. Moreover, the duration of RPI-78’s effect was superior to morphine’s.

 

·

In November 2007, the Designer Diagnostics test kit technology was showcased at the 38th Union World Conference on Lung Health in South Africa. The test kits were used to isolate NTM from clinical samples of 300 AIDS patients and for the first time ever on the Indian subcontinent, M. Wolinskyi was successfully isolated in clinical samples. In addition, these test kits were also used for the first time to isolate NTM from soil and water samples collected from the environment of patients with NTM disease.

 

·

In November 2007, Designer Diagnostics was featured in an article published in the International Journal of TB and Lung Diseases. The article, which was authored by leading NonTuberculous Mycobacterium (NTM) research scientist, Dr. Rahul Narang, covered Designer Diagnostics’ paraffin culture technology to isolate NTM.

 

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·

In December 2007, ReceptoPharm successfully completed its six-month patient crossover in the Phase IIb/IIIa clinical trial for the treatment of Adrenomyeloneuropathy (AMN).

 

·

On December 27, 2007 the Company expanded its licensing agreement with NanoLogix, Inc., to include intellectual property for the use of testing the environment for NonTuberculous Mycobacterium (NTM).

 

·

In February 2008, Designer Diagnostics started marketing the first-ever environmental test kit for the detection of Nontuberculous Mycobacteria (NTM) in water and soil.

 

	·	On April 10, 2008, we completed the acquisition of ReceptoPharm through our purchase of their remaining 61.9% interest. ReceptoPharm is now our wholly owned subsidiary and will act as our Drug Discovery division.
	·	On May 19, 2008, we announced today that ReceptoPharm, Inc. had received approval from the Florida Department of Agriculture and Consumer Services to conduct trials of its leading antiviral drug candidate, RPI-MN, as a treatment for Feline Leukemia Virus (FeLV).
	·	On July 19, 2008, we announced the successful completion of ReceptoPharm’s Phase IIb/IIIa clinical trial of its leading drug candidate for neurological and autoimmune disorders, RPI-78M, as a treatment for Adrenomyeloneuropathy (AMN).
	·	On August 6, 2008, we announced that ReceptoPharm had renewed its collaborative agreement with the Centers for Disease Control and Prevention (CDC) to study RPI-78M and RPI-MN as a possible therapy for Rabies.
	·	On August 14, 2008, we announced initial positive safety data from ReceptoPharm’s Phase IIb/IIIa clinical study of RPI-78M for treating Adrenomyeloneuropathy (AMN).

 

OUR TWELVE-MONTH PLAN OF OPERATIONS PENDING ADEQUATE FINANCING

We intend to accomplish the following regarding our Plan of Operations over the next twelve months.

Designer Diagnostics, Inc.

 

Designer Diagnostics’ NTM Test Kits are now being marketed and we will attempt to market to a global audience, including:

 

·	Hospitals;

 

·	Pharmaceutical companies;

 

·	Biotechnology companies;

 

·	Medical device distributors;

 

·	Governmental organizations;
·	Environmental testing facilities; and
·	Government water and soil testing facilities at the local, state and federal levels.

 

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Over the next twelve months, Designer Diagnostics will attempt to distribute the test kits to the above companies and organizations. Additionally, Designer Diagnostics will seek to create Joint Ventures and other partnerships for the efficient global distribution of the test kits. Our first sales occurred during our second quarter of 2006. When and if sales of the test kits exceed our operating budget, we will use the test kit proceeds to fund drug research and clinical studies in the area of MS and HIV.

 

Third-party researchers are currently validating Designer Diagnostics’ TB Test Kit and we anticipate research completion some time in 2008. Additionally, the test kits are now utilized for environmental analysis for the presence of NTM in the water and/or soil. This allows investigators to easily find the source of contamination and may greatly reduce NTM infections and outbreaks.

 

Designer Diagnostics’ President will attempt to develop a distribution network and actively market the test kits to supply administrators of companies and/or governmental organizations in the following markets: hospitals; pharmaceutical; biotechnology; medical device distributors. Designer Diagnostics will also attempt to acquire other medical diagnostic products to develop that same distribution market. Designer Diagnostic’s President will also seek license agreements to develop revenue streams consisting of drug discovery, drug development, and new medical device technologies.

ReceptoPharm

Clinical Studies

In January of 2007, ReceptoPharm began their clinical study in AMN. AMN is a genetic disorder that affects the central nervous system. The disease causes neurological disability that is slowly progressive over several decades. Throughout our twelve month Plan of Operations and for 3 months thereafter, ReceptoPharm plans to conduct clinical studies of its AMN drug. The study is underway and completed its patient recruitment process and is being conducted by the Charles Dent Metabolic Unit located in London, England to conduct a clinical study that provides for:

 

·	Recruitment of 20 patients with AMN;

 

·	Administering ReceptoPharm’s AMN drug under development; and

 

·	Monitoring patients throughout a 15-month protocol.

 

The clinical study is classified as a Phase IIb/IIIa study. We announced the completion of the trial in July 2008. The data is being analyzed for presentation and publication. On August 14, 2008 we announced initial positive safety data from the trial. Final data analysis should be completed and released by the end of September 2008. We will be seeking a licensing partner to complete clinical trials and allow for Regulatory approval of the drug in the United Kingdom and the United States.

In the areas of HIV and MS, ReceptoPharm plans to complete preclinical studies of its MS drug under development over the next 12 months. These include toxicology studies as well as pharmacokinetic studies required for regulatory approval. ReceptoPharm also plans to conduct clinical studies of its HIV and MS drugs under development. These "Phase II" studies will either prove or disprove the preliminary efficacy of ReceptoPharm's' HIV/MS drugs under development. ReceptoPharm is in the process of attempting to secure agreements with third parties to conduct such clinical studies.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not applicable

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Item 4T. Controls and Procedures

 

As required by Rule 13a-15 under the Securities Exchange Act of 1934, as amended (“Exchange Act) we carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures. This evaluation was carried out under the supervision of our Chief Executive Officer who is also our Principal Financial and Accounting Officer. Following this inspection, this officer concluded that our disclosure controls and procedures were effective as of September 30, 2008, the end of the period covered by this report. There have been no changes in our internal controls or in other factors, which have materially affected, or are reasonably likely to materially affect, internal controls subsequent to the date of the evaluation.

 

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer, who also acted as our Principal Financial Officer as appropriate, to allow timely decisions regarding required disclosure.

 

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

On April 4, 2005, a Motion to Enforce Settlement Agreement was filed against us in the Circuit Court of Broward County Florida by Bio Therapeutics, Inc. f/k/a Phylomed Corp. in Nutra Pharma Corp. v. Bio Therapeutics, Inc. (17th Judicial Circuit, Case No. 03-008928 (03). This proceeding results from our alleged breach of a settlement agreement that was entered into between Bio Therapeutics and us in resolution of a previous lawsuit between us and Bio Therapeutics that was resolved by entering into a Settlement Agreement. In conjunction with the settlement agreement, we also entered into a related License Agreement and Amendment to the License Agreement (“License Agreement”) with Bio Therapeutics regarding certain pieces of intellectual property owned by Bio Therapeutics. In the April 4, 2005 motion, Bio Therapeutics alleges that the Company breached certain provisions of the License Agreement and requested that the Court grant its motion to enforce the Settlement Agreement by declaring the License Agreement terminated, enjoining us from further use of license products that was granted to it by the License Agreement, and awarding attorneys’ fees and costs to Bio Therapeutics. During the last quarter of 2007, we moved for summary judgment regarding Bio Therapeutics’ Motion to Enforce Settlement Agreement and the Court.

On April 28, 2008, the Court (i) granted us a Cross Motion for Summary Judgment; (ii) declared Bio Therapeutics Amended Motion for Summary Judgment moot; and (iii) denied Bio Therapeutics Motion to Enforce a Settlement Agreement.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

On September 10, 2008, we issued an aggregate of 2,500,000 shares of our  restricted common stock in exchange for services rendered, as follows:

1,600,000 shares to one (1) consultant

   500,000 shares to one (1) consultant

   400,000 shares to one (1) consultant

The shares described above were valued at $0.03 per share, which was the fair market value of our common stock on the date of grant.

During the three month period ending September 30, 2008, we issued an aggregate of 5,740,800 shares of our common stock  to 20 persons or entities in exchange for 1,435,200 shares of ReceptoPharm common stock pursuant to the April 10, 2008 Agreement and Plan of Merger between us and ReceptoPharm.

During the three month period ending September 30, 2008, we sold an aggregate of 13,900,000 restricted shares of our common stock to two (2) accredited investors.  These shares were sold at $0.025 per share for aggregate proceeds of $347,500.  We granted one (1) warrant for each share sold, which gives the investor the right to purchase one (1) additional share until December 31, 2012 at an exercise price of $0.10 per share.

We relied upon Sections 4(2) and 4(6) of the Securities Act of 1933, as amended ("the Act") in connection with the above issuances of the securities. We believed Sections 4(2) and 4(6) were available because:

 

·

We are not and were not a blank check company at the time of the offer or sale;

·

The investors had business experience and were accredited investors as defined by Rule 501 of Regulation D of the Act;

 

·

All offers and sales of the investment were made privately and no party engaged in any general solicitation or advertising of the proposed investment;

·

Each investor had a preexisting social, personal or business relationship with us and members of our management;

·

The investors were provided with all information sufficient to allow them to make an informed investment decision;

·

The investors had the opportunity to inspect our books and records and to verify statements made to induce them to invest;

·

The securities representing the investment were issued with a restrictive legend indicating the securities represented by the certificate have not been registered; and

·

No party received any transaction-based compensation such as commissions in regard to locating any investor for the venture

 

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Item 3. Defaults Upon Senior Securities

None

Item 4. Submission of Matters to a Vote of Security Holders

None

Item 5. Other Information

 

None

 

Item 6. Exhibits

Exhibit No.		Title
31.1		Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1		Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

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SIGNATURES

In accordance with the requirements of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Dated: November 19, 2008
NUTRA PHARMA CORP.
Registrant
/s/ Rik J. Deitsch
Rik J. Deitsch
Chief Executive Officer/Principal Financial Officer Chief Financial Officer/Principal Financial Officer

 

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