Forward-looking Statements
The following discussion of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and the related notes thereto included elsewhere in this quarterly report. Some of the information in this quarterly report contains forward-looking statements, including statements related to anticipated operating results, margins, growth, financial resources, capital requirements, adequacy of the Company's financial resources, trends in spending on research and development, the development of new markets, the development, regulatory approval, manufacture, distribution, and commercial acceptance of new products, and future product development efforts. Investors are cautioned that forward-looking statements involve risks and uncertainties, which may affect our business and prospects, including but not limited to, the Company's expected need for additional funding and the uncertainty of receiving the additional funding, changes in economic and market conditions, acceptance of our products by the health care and reimbursement communities, new development of competitive products and treatments, administrative and regulatory approval and related considerations, health care legislation and regulation, and other factors discussed in our filings with the Securities and Exchange Commission.
GENERAL
The Company's mission is the development of novel and proprietary pharmaceutical, medical and cosmetic products. The Company develops its products through its wholly owned German subsidiary Sangui GmbH. The Company is seeking to market and sell some or all of their products through partnerships with industry partners.
The focus of Sangui GmbH has been the development of oxygen carriers capable of providing oxygen transport in humans in the event of acute and/or chronic lack of oxygen due to arterial occlusion, anaemia or blood loss whether due to surgery, trauma, or other causes. Sangui GmbH has thus far focused its development and commercialization efforts of such artificial oxygen carriers by reproducing and synthesizing polymers out of native hemoglobin of defined molecular sizes. Sangui GmbH, has in addition developed external applications of oxygen transporters in the medical and cosmetic fields in the form of gels and emulsions for the regeneration of the skin
Sangui GmbH holds the exclusive distribution rights for Chitoskin wound pads in the European Union and various other countries. Sangui GmbH has filed a patent cooperation treatment applications (“PCT”) for the production and use of improved Chitoskin wound pads using gelatine instead of collagen as the carrier substance.
Artificial Oxygen Carriers
Sangui GmbH develops several products based on polymers of purified natural porcine hemoglobin with oxygen carrying abilities that are similar to native hemoglobin. These are (1) oxygen carrying blood additives and (2) oxygen carrying blood volume substitutes.
In December 1997, Sangui GmbH decided that porcine hemoglobin should be used as the basic material for its artificial oxygen carriers. In March 1999, Sangui GmbH decided which hemoglobin hyperpolymer would go into preclinical investigation and that glutaraldehyde would be utilized as a cross linker, and further that the polymer hemoglobin be chemically masked to prevent protein interaction in blood plasma. The fine adjustment of the molecular formula of the artificial oxygen carriers - optimized for laboratory scale production - was finalized in the summer of 2000.
The experiments completed in Sangui GmbH’s laboratories demonstrated that it is possible to polymerize hemoglobins isolated from porcine blood resulting in huge soluble molecules, so-called hyperpolymers. In August 2000, Sangui GmbH finalized its work on the pharmaceutical formulation of the oxygen carrier for laboratory scale. In February 2001 a pilot production in a laboratory scale was carried out in SGBI's clean room. The resulting product was applied in single volunteers in pilot self-experiments.
The blood additives and blood substitute projects were halted in 2003 due to the lack of financing for the pre-clinical test phase of the blood additives. In October 2006, a contract was entered into between Sangui GmbH and ERC Nano Med S.A. de C.V. of Monterrey, Mexico (“ERC”), which provides that ERC will establish a production facility in Mexico to produce sufficient quantities of the blood additive. In cooperation with the medical faculty of Monterrey University and the Mexican National Health Organizations, ERC will initiate all necessary steps to begin the pre-clinical test phase for the products as soon as possible. It is anticipated that this will lead to the FDA authorization process in due course.
According to regulatory requirements, all drugs must complete preclinical and clinical trials before approval (e.g. Federal Drug Administration approval) and market launch. The Company’s management believes that the European and FDA approval process will take at a minimum several years to complete.
Nano Formulations for the Regeneration of the Skin
Healthy skin is supplied with oxygen both from the inside as well as through diffusion from the outside. A lack of oxygen will cause degenerative alterations, ranging from premature aging, to surface damage, and even as extensive as causing open wounds. The cause for the lack of oxygen may be a part of the normal aging process, but it may also be caused by burns, radiation, trauma, or a medical condition. Impairment of the blood flow, for example caused by diabetes mellitus or by chronic venous insufficiency, can also lead to insufficient oxygen supply and the resulting skin damage.
The nano-emulsion-based preparations now being sold by Sangui GmbH have been designed to supporting the regeneration of the skin by improving its oxygen supply. The products Sangui GmbH are currently focussing on are an anti-aging formulation and treatment and an anti-cellulite formulation for the cosmetics market. The products were thoroughly tested by an independent research institute and received top marks for skin moisturization, and enhanced skin elasticity, respectively.
Sangui’s cosmetic business model is reliant upon cooperation with its manufacturing and distribution partners. Sangui has its various formulations produced by a contract manufacturer and sells quantities of the products either in bulk or in customized private label packaging, as requested. In addition, Sangui started to sell its cosmetic products under its own brand “Pure MO2isture” via an internet shop as of mid September 2006 which generates consistant sales, albeit at a low level.
On October 12, 2008, SanguiBioTech GmbH and Fanales GmbH, Recklinghausen, Germany, entered into a cooperation with regard to marketing and sales of the Pure Moisture cosmetics. The agreement comprises an initial test phase of six months. Under the terms of the mutually non-exclusive agreement, Fanales will sell Sangui’s Pure Moisture cosmetics in a specialized shop in Dusseldorf and strive to establish additional distribution channels.
Chitoskin Wound Pads
In October, 2008, management and the medical staff of SanguiBioTech GmbH held a series of presentations at leading medical institutions in the Kingdom of Jordan. The series of presentations had been organized by Abu-Jabir Industrial and Marketing Consulting. This company is currently establishing a sales network for Sangui products in the Arab countries. Their distribution partner in Jordan will be the pharmaceuticals trading house Nobles Medical Supplies.
FINANCIAL POSITION
The Company's current assets decreased $606,547, or 66%, from June 30, 2008 to $316,986 at December 31, 2008. The decrease is primarily attributable to a $189,696 decrease in cash and a $415,283 decrease in shareholder loans receivable.
The Company's net property and equipment decreased $2,530, or 36% from June 30, 2008 to $4,491 at December 31, 2008. The decrease is primarily attributable to current period depreciation, partially offset by minor purchases of fixed assets.
The Company funded its operations primarily through its existing cash reserves and cash received from the issuance of promissory notes payable. During the six months ended December 31, 2008, the Company's stockholders' deficit decreased $1,204,742. This decrease is due primarily to the Company's issuing common stock for debt, partially offset by the current period net loss of $496,918, and to other comprehensive income related to fluctuations in foreign currency exchange rates.
Three months ended December 31, 2008 and 2007:
RESEARCH AND DEVELOPMENT. Research and development expenses increased significantly to $84,610 in 2008 from $45,366 in 2007. The increase is mainly attributed to the Company’s attempting to further develop its products and add complimentary products to existing product lines. The Company is seeking additional sources to provide financing for additional research and development.
GENERAL AND ADMINISTRATIVE. General and administrative expenses increased to $190,000 in 2008 from $160,062 in 2007. This increase is mainly attributed to the Company’s emphasis on becoming current with its audit process and its filings with the Securities and Exchange Commission, in addition to its attempt to solidify the Company’s standing in new and existing markets.
DEPRECIATION AND AMORTIZATION. Depreciation decreased slightly to $801 in 2008 from $892 in 2007. This decrease is mainly attributed to certain assets becoming fully depreciated.
NET LOSS. As a result of the above and other factors, the Company's consolidated net loss was $295,266, or $0.00 per common share, for the three months ended December 31, 2008, compared to $215,662, or $0.01 per common share, during the comparable period in 2007.
Six months ended December 31, 2008 and 2007:
RESEARCH AND DEVELOPMENT. Research and development expenses decreased slightly to $115,304 in 2008 from $134,868 in 2007. The decrease is mainly attributed to the Company’s attempting to maximize sales through existing product lines. The Company is seeking additional sources to provide financing for additional research and development.
GENERAL AND ADMINISTRATIVE. General and administrative expenses increased to $347,344 in 2008 from $299,453 in 2007. This increase is mainly attributed to the Company’s emphasis on becoming current with its audit process and its filings with the Securities and Exchange Commission, in addition to its attempt to solidify the Company’s standing in new and existing markets.
DEPRECIATION AND AMORTIZATION. Depreciation increased slightly to $2,206 in 2008 from $2,106 in 2007. This increase is mainly attributed to the purchases of certain small fixed assets.
NET LOSS. As a result of the above and other factors, the Company's consolidated net loss was $496,918, or $0.01 per common share, for the six months ended December 31, 2008, compared to $458,596, or $0.01 per common share, during the comparable period in 2007.
LIQUIDITY AND CAPITAL RESOURCES
For the six months ended December 31, 2008, net cash used in operating activities increased to $492,621 from $444,179 in the corresponding period in 2007, primarily related to the Company’s decreased net loss for the period.
The Company had a working capital deficit of $119,018 at December 31, 2008, a decrease of $1,227,668 from June 30, 2008. At December 31, 2008, the Company had cash of $42,021. The Company will need substantial additional funding to fulfill its business plan and the Company intends to explore financing sources for its future development activities. No assurance can be given that these efforts will be successful.