Item 2 - Management's Discussion And Analysis Of Financial Condition And Results Of Operations
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
Our mission is the development of novel and proprietary pharmaceutical, medical and cosmetic products. We develop our products through our German subsidiary, Sangui GmbH. Currently, we are seeking to market and sell our products through partnerships with industry partners worldwide.
Our focus 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, anemia or blood loss whether due to surgery, trauma, or other causes, as well as in the case of chronic wounds. We have thus far focused our development and commercialization efforts on such artificial oxygen carriers by reproducing and synthesizing polymers out of native hemoglobin of defined molecular sizes. In addition, we have developed external applications of oxygen transporters in the medical and cosmetic fields in the form of sprays for the healing of chronic wounds and of gels and emulsions for the regeneration of the skin. A wound dressing that shows outstanding properties in the support of wound healing, is distributed by SastoMed GmbH (Sastomed), a former joint venture company in which we had held a share of 25%, as global licensee under the Granulox brand name. Effective end of second quarter of our fiscal year 2016 we sold this stake to SanderStrohmann GmbH.
Sangui GmbH holds distribution rights for our Chitoskin wound pads for the European Union and various other countries. Additionally, a European patent has been granted for the production and use of improved Chitoskin wound pads.
Our current key business focuses are: (a) selling our existing cosmetics and wound management products by way of licensing through distribution partners, or by way of direct sale, to end users; (b) identifying additional industrial and distribution partners for our patents, production techniques, and products; and, (c) obtaining the additional certifications on our products in development.
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.
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.
Our most promising potential product in the area of artificial oxygen carriers, the blood additive, is still in an early development stage. In the pursuit of these projects we will need to obtain substantial additional capital to continue their development. As the Company has limited financial resources, we have suspended this project temporarily in order to focus our attention on our chronic wound research and the products developed in conjunction with their treatment.
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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.
In response, we developed nano-emulsion based cosmetic preparations that in their design are able to help support regeneration of the skin by improving its oxygen supply. Our line of cosmetic products was thoroughly tested by an independent research institute and received top marks for skin moisturizing, and enhanced skin elasticity, respectively. However, sales of this series have remained at a low level and during the first quarter of the 2016 financial year we decided to decrease our operations in this particular segment and to abandon the patent protection for this range of products.
Chitoskin Wound Pads
Usually, normal (
primary
) wounds tend to heal over a couple of days without leaving scars following a certain sequence of phases. Burns and certain diseases impede the normal wound healing process, resulting in large, hardly healing (
secondary
) wounds which only close by growing new tissue from the bottom. Wound dressings serve to safeguard the wound with its highly sensitive new granulation tissue from mechanical damage as well as from infection. Using the natural polymer chitosan, Sangui
s Chitoskin wound dressings show outstanding properties in supporting wound healing. Sangui GmbH holds various distribution rights for our Chitoskin wound pads, and it is the strategy of the company to find industry partners ready to acquire or license this product range as a whole.
Hemospray Wound Spray
Sangui GmbH has developed a novel medical technology supporting the healing of chronic wounds. Lack of oxygen supply to the cells in the wound ground is the main reason why those wounds lose their genuine healing power. Based on its concept of artificial oxygen carriers, the wound spray product we developed bridges the watery wound surface and permits an enhanced afflux of oxygen to the wound ground.
Sangui GmbH has granted SastoMed global distribution rights to this product. Distribution of the wound spray began in the European Union in April 2012 under the brand name
Granulox.
In December 2012, product distribution was initiated in Mexico by Sastomed and their local distribution partner Bio-Mac Pharma. International distribution has been expanded since then through cooperation agreements with local distribution partners in the Benelux countries and South Eastern Europe.
Since December 2013, international distribution outside Germany in collaboration with local partners has occurred in more than 40 countries in Europe and Latin American.
On November 13
,
2017
,
the
Company announced that
Infirst Healthcare Ltd has announced that the United States (US) Food and Drug Administration
ha
d
granted Fast Track designation to
Granulox for
the tr
eatment of diabetic foot ulcers.
It is the first and only hemoglobin spray to receive Fast Track designation - a process designed to facilitate the development, and expedite the review of, new therapies to treat serious conditions and fill an unmet medical need.
Despite the positive reviews of our product, Granulox sales have become more volatile. We remain confident, however, that SastoMed will be able to considerably increase its sales along with more international markets entering actual distribution of the product.
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In December 2010, Sangui GmbH established a joint venture company with SanderStrothmann GmbH of Georgsmarienhuette, Germany, under the name of SastoMed GmbH. This enterprise was in charge of obtaining the CE mark certification authorizing the distribution of one of SGBI
s products in the member states of the European Union. Effective December 31, 2015, Sangui GmbH sold its stake in Sastomed GmbH to SanderStrohmann GmbH.
On or about June 18, 2018, Sangui GmbH together with Sastomed GmbH founded Sangui Know-How- und Patentverwertungsgesellschaft mbH & Co. KG (
Sangui KG
). Sangui KG is a limited partnership. On June 22, 2018, Sangui KG acquired all the rights in the license agreement made on December 17, 2010, between Sastomed GmbH and Sangui GmbH.
Given the Company
s business strength is primarily in research and product development, we have decided to partner with established distribution entities who license our marketable products, or those products that are close to market entry, for sale to end users. In pursuit of this strategy we have licensed the most promising product, a hemoglobin based wound spray technology to Sastomed GmbH, a former joint venture of SGBI, for distribution in several European, Latin American and Asian countries. In addition, we are entering the preclinical testing of hemoglobin based artificial oxygen carriers aiming at the remediation of ischemic conditions in human patients.
FINANCIAL POSITION
During the six months ended December 31, 2018, our total assets increased $16,855 from $102,029 at June 30, 2018 to $118,884 at December 31, 2018. An increase in the cash on hand and tax funds receivable from June 30, 2018 to December 31, 2018, of $15,300 respectively of $7,820 were primarily responsible for the increase in the total assets.
We funded our operations primarily through our existing cash reserves and cash received from the issuance of shares of common stock and notes payables from related parties. Our stockholders
equity (deficit) increased by $52,800 from ($351,144) at June 30, 2018 to ($403,944) at December 31, 2018. The primary factor behind this was net loss attributable to common stockholders of $146,319, offset by the issuance of stock for cash ($84,491) and services received ($18,652).
RESULTS OF OPERATIONS
For the three-month and six-month period December 31, 2018 and 2017:
REVENUES
Revenues reported were $44,095 and $38,446 for the three months ended December 31, 2018 and 2017 respectively. For the six months ended December 31, 2018 and 2017 revenues were $55,367 and $55,082. Revenues increased by $5,649 for the three months ended December 31, 2018 and increased by $285 for the six months ended December 31, 2018. The increase of $5,649 and $285 respectively can be traced back to a increase in royalties from the licensing agreement with SastoMed. Cost of sales were $99 and $44 for the six months ended December 31, 2018 and 2017 respectively.
RESEARCH AND DEVELOPMENT
Research and development expenses increased by $4,138 to $7,314 from $3,176 for the three-month periods ending December 31, 2018 and 2017. Research and development expenses increased $7,481 to $15,286 in the first half-year of our 2019 financial year from $7,805 in the comparable period of the previous year. This increase is mainly attributed to higher fees for patents.
GENERAL AND ADMINISTRATIVE and PROFESSIONAL FEES
The combined accumulated general and administrative expenses and professional fees increased $10,326 to $96,892 in the three months ended December 31, 2018, from $86,566 in the respective period of the previous year. Accumulated general and administrative expenses and professional fees increased $37,259 to $193,617 in the half-year ended December 31, 2018, from
$
156,358
in the respective period of the previous
year mainly due to higher professional fees and higher costs for vehicles leased.
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INTEREST EXPENSE - interest expenses for the three-month period ended December 31, 2018 and 2017 were $2,525 and $1,908, an increase of $617
.
For the six months ended December 31,
2018
and 20
17
, interest expense
increased
by $
2,440
to $
6,216
from $
3,776.
The
increase
relates to
the increase of interest - bearing debt financing
.
NET LOSS - As a result of the above factors, the net loss attributed to common shareholders increased to $56,356 compared to a loss of $52,537 for the three months ended December 31, 2018 and 2017 respectively and a loss of $146,319 compared to a loss of $112,882 for the six-month ended December 31, 2018 and 2017 respectively. The loss per share for both periods was $(0.00).
Our consolidated net loss before non-controlling interest was $58,480, or $(0.00) per common share, for the three months ended December 31, 2018, compared to $54,688 or $(0.00) per common share, during the comparable period in our 2017 financial year. Our consolidated net loss before non-controlling interest was $154,607 or $(0.00) per common share, for the six months ended December 31, 2018, compared to $118,839 or $(0.00) per common share, during the comparable period in our 2018 financial year.
LIQUIDITY AND CAPITAL RESOURCES
For the six months ended December 31, 2018, net cash used in operating activities increases $12,107 to $(145,203), compared to $(133,096) in the corresponding period of the previous year. This is mainly due to a increase of the operating loss of approximately $35,768 from a loss of $(118,839) in 2017 to a loss of $(154,607) in 2018 and to the increase of the tax refunds receivables of approximately $7,820.
The Company funded its business in the first six months ended December 31, 2018 by raising notes payable totaling 625,000 Euros ($ 720,341) and issuing 6,500,000 shares of common stock, yielding total cash proceeds of $84,491. The Company repaid notes payable in the first six month totaling 557,963 Euros ($642,727).
We had a working capital deficit of approximately $403,944 at December 31, 2018, an increase of approximately $52,800 from June 30, 2018.
At December 31, 2018 compared to June 30, 2018, we had cash of $36,243 compared to $20,943, prepaid expenses of $19,807 compared to $22,774 and accounts receivable of $53,285 compared $49,107. We will need substantial additional funding to fulfill our business plan and we intend to explore financing sources for our future development activities. No assurance can be given that these efforts will be successful.
Item 3 - Quantitative and Qualitative Disclosures about Market Risk
We are a smaller reporting company as defined by § 229.10(f)(1) and are not required to provide the information under this item.
Item 4 - Controls and Procedures
Disclosure Controls and Procedures
As of the date of the end of the period covered by this report, our Chief Executive Officer and Chief Financial Officer conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as required by Exchange Act Rule 13a-15. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of the end of the period covered by this report to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC
s rules and forms.
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 SEC
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 and our Chief Financial Officer, to allow timely decisions regarding required disclosure.
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