-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RndOYff3P97mM/PC8HDSTXHoiM4U8RbB2bT8ClVpvkcYJJlU8gZ2m8TvfGTzZ9Mj P5FCPVdkiG7V3H3vfWBWuQ== 0001193125-05-168197.txt : 20050815 0001193125-05-168197.hdr.sgml : 20050815 20050815140340 ACCESSION NUMBER: 0001193125-05-168197 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20050430 FILED AS OF DATE: 20050815 DATE AS OF CHANGE: 20050815 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SYNTHETIC BLOOD INTERNATIONAL INC CENTRAL INDEX KEY: 0000034956 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 223067701 STATE OF INCORPORATION: NJ FISCAL YEAR END: 0430 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 002-31909 FILM NUMBER: 051025284 BUSINESS ADDRESS: STREET 1: 3189 AIRWAY AVENUE STREET 2: BUILDING C CITY: COSTA MESA STATE: CA ZIP: 92626 BUSINESS PHONE: 714-427-6363 MAIL ADDRESS: STREET 1: 3189 AIRWAY AVENUE STREET 2: BUILDING C CITY: COSTA MESA STATE: CA ZIP: 92626 FORMER COMPANY: FORMER CONFORMED NAME: SINEQUANON CORP DATE OF NAME CHANGE: 19901219 FORMER COMPANY: FORMER CONFORMED NAME: FEDERATED FRANCHISES INC DATE OF NAME CHANGE: 19760907 FORMER COMPANY: FORMER CONFORMED NAME: RUDOMINER DAVID & ASSOCIATES INC DATE OF NAME CHANGE: 19690316 10-K 1 d10k.htm FORM 10-K Form 10-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C., 20549

 


 

FORM 10-K

 


 

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

 

For the Fiscal Year Ended April 30, 2005

 

Commission File No. 002-31909

 


 

SYNTHETIC BLOOD INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

 


 

New Jersey   22-3067701
(State of Incorporation)   (IRS Employer I.D. Number)

 

3189 Airway Avenue, Building C, Costa Mesa, California 92626

(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s Telephone Number and area code: (714) 427-6363

 


 

Securities registered pursuant to Section 12(b) of the Act: NONE

 

Securities registered pursuant to Section 12(g) of the Act: NONE

 


 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    YES  x     NO  ¨

 

Indicate by check mark if disclosure of delinquent filings pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  x

 

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date: July 31, 2005 128,159,918 shares of $.01 par value common stock.

 

The aggregate market value of the shares held by non-affiliates of the registrant (assuming officers, directors and 10% shareholders are affiliates) was approximately $27,136,136 based on the closing bid price of the Registrant’s Common Stock on July 31, 2005 of $0.22 per share.

 

List hereunder the following documents if incorporated by reference and the Part of the Form 10-K into which the document is incorporated: (1) Any annual report to security holders; (2) Any proxy or information statement; and (3) Any prospectus filed pursuant to Rule 424 (b) or (c) under the Securities Act of 1933. None of the above-listed documents are incorporated by reference. None

 



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TABLE OF CONTENTS

 

ITEM NUMBER AND CAPTION

   Page

Part I         
1.   Business    3
2.   Properties    14
3.   Legal Proceedings    14
4.   Submission of Matters to a Vote of Security Holders    14
Part II         
5.   Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities    15
6.   Selected Financial Data    15
7.   Management’s Discussion and Analysis of Financial Condition and Results of Operations    15
7A.   Quantitative and Qualitative Disclosures About Market Risk    20
8.   Financial Statements and Supplementary Data    21
9.   Changes in and Disagreements with Accountants on Accounting and Financial Disclosure    21
9A.   Controls and Procedures    21
9B.   Other Information    22
Part III         
10.   Directors and Executive Officers of the Registrant    22
11.   Executive Compensation    24
12.   Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters    27
13.   Certain Relationships and Related Transactions    28
14.   Principal Accountant Fees and Expenses    28
15.   Exhibits and Financial Statement Schedules    29

 

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FORWARD-LOOKING STATEMENTS

 

This Form 10-K contains forward-looking statements in “Item 1 – Business,” “Item 7 - Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the negative of such terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined in the “Risk Factors” section of “Item 1. – Business” that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activities, performance or achievements expressed or implied by such forward-looking statements.

 

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of such statements. We are under no duty to update any of the forward-looking statements after the date of this Form 10-K or to conform such statements to actual results.

 

PART I

 

ITEM 1 – BUSINESS

 

General

 

Synthetic Blood International, Inc. is engaged in the business of developing biotechnology products. We are currently focusing on developing Oxycyte, a product we believe is a safe and effective alternative to transfused blood for use in surgical and similar medical situations. In addition, we also have under development Fluorovent, an oxygen exchange fluid for facilitating the treatment of lung conditions, and a biosensor implant product that uses an enzyme process for measuring the glucose level in the blood stream.

 

We received approval of our Investigational New Drug application for Oxycyte filed with the U.S. Food and Drug Administration (FDA) and began Phase I clinical studies in October 2003, which were completed in December 2003. Phase II clinical studies began in the fourth quarter 2004. We expect to commit a substantial portion of our financial and business resources over the next three years to testing Oxycyte and advancing this product to the point it has regulatory approval for use in one or more medical applications.

 

Fluorovent and our biosensor implant are still in the animal testing stage and we have not filed any applications with the FDA for human testing of these products. Since we will likely devote less of our time and resources to advancing these products because of the priority placed on Oxycyte, we do not expect we will be in a position to file any applications for these products with the FDA in the near future.

 

Since our priority for the foreseeable future is Oxycyte, the following discussion of our business focuses primarily on that product.

 

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Blood substitute market

 

The principal function of human blood is to transport oxygen throughout the body. The lack of an adequate supply of oxygen as a result of blood loss can lead to organ dysfunction or death. The transfusion of human blood is presently the only effective means of immediately restoring diminished oxygen-carrying capacity resulting from blood loss. According to the National Blood Data Resource Center, 14 million units of whole blood and red blood cells were transfused in the United States in 2001 and the volume of blood transfused is increasing at the rate of 6 percent per year. This includes transfusions for trauma, surgery (emergency and elective), unexpected blood loss, chronic anemia, and other general medical applications.

 

The use of donated blood in transfusion therapy, while effective in restoring an adequate supply of oxygen in the body of the recipient, has several limitations. Although testing procedures exist to detect the presence of certain diseases in blood, these procedures cannot eliminate completely the risk of blood-borne disease. Transfused blood also can be used only in recipients having a blood type compatible with that of the donor. Delays in treatment, resulting from the necessity of blood typing prior to transfusion, together with the limited shelf life of blood and the limited availability of certain blood types, impose constraints on the immediate availability of compatible blood for transfusion. There is no commercially available blood substitute in this country that addresses these problems.

 

Oxycyte is intended as a transfusion substitute for blood transfusion that ordinarily would be applied in cases of trauma, surgery (emergency and elective), unexpected blood loss, chronic anemia, and other general medical applications. For trauma and emergency surgical procedures, the immediate availability and universal compatibility of Oxycyte are expected to provide significant advantages over transfused blood by avoiding the delay and opportunities for error associated with blood typing. The major benefit of Oxycyte in elective surgery is expected to be increased transfusion safety for patients and health care professionals.

 

In addition to the foregoing applications for which blood is currently used, there exist potential sources of demand for which blood is not currently utilized and for which Oxycyte may be suitable. These include applications in which the required blood type is not immediately available or in which transfusions are desirable but not given for fear of a transfusion reaction due to difficulty in identifying compatible blood. For example, we believe emergicenters and surgicenters both experience events where an oxygen-carrying volume expander may be useful. We also believe Oxycyte may be used by emergency medical technicians in ambulances, medical helicopters and other pre-hospital settings. In addition, the military has expressed a high level of interest in oxygen-carrying products for the resuscitation of battlefield casualties.

 

Based on these circumstances, we believe there may be a substantial and meaningful market for an effective blood substitute, and we believe Oxycyte is a viable candidate for exploiting that market.

 

Our product - Oxycyte

 

Our Oxycyte blood substitute product is a perfluorocarbon emulsified with water and a surfactant, which is provided to the patient intravenously. The physical properties of perfluorocarbon enable our product to gather oxygen from the lungs and transport the oxygen through the body releasing it along the way. Over a period of days Oxycyte gradually evaporates in the lungs from where it is exhaled. Oxycyte requires no cross matching, so it is immediately available and compatible with all blood types. Oxycyte has an extended shelf life compared to blood. Since Oxycyte is not based on any biological component, it is sterile and free of potential contamination from a donor. Further, since Oxycyte is based on readily available inert compounds, we believe it can be manufactured on a cost effective basis in amounts sufficient to meet demand.

 

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After receiving clearance from the FDA, we conducted a Phase I clinical study on Oxycyte, which was completed in December 2003. We submitted a report on the results, which were in line with our expectations, to the FDA along with a Phase II protocol in 2004. The FDA approved the protocol, and the trial started in the fourth quarter of 2004. Phase II clinical trials are expected to continue through the end of 2006.

 

We use a proprietary process of perfluorocarbon production and emulsification to produce Oxycyte. We use a contract manufacturer to produce Oxycyte for our clinical testing. Our contract manufacturer is PrimaPharm, Inc. located in San Diego, California. Based on production testing and inspection, the FDA has determined that PrimaPharm satisfies its good manufacturing practices standards with respect to the production of Oxycyte. Based on the composition and manufacturing process for Oxycyte, management believes there are a number of other manufacturers capable of producing Oxycyte in accordance with FDA regulations and in sufficient quantities for current needs.

 

Should Oxycyte successfully progress through Phase II and III testing and it appears regulatory approval for one or more medical uses is likely, we will evaluate our options for exploiting the product. These options include licensing Oxycyte to a third party for manufacture and distribution, manufacturing Oxycyte ourselves for distribution through third party distributors, manufacturing and selling the product ourselves, or establishing some other form of strategic relationship for making and distributing Oxycyte with a participant in the pharmaceutical industry. We have not conducted any meaningful investigation or evaluation of any of these options.

 

If approved for one or more medical uses, Oxycyte will compete directly with established therapies for acute blood loss and replacement and may compete with other technologies currently under development. We cannot ensure that Oxycyte will have advantages, which will be significant enough to cause medical professionals to adopt it rather than continue to use established therapies or other new technologies or products. We also cannot ensure that the price of Oxycyte, in light of Oxycyte’s potential advantages, will be competitive with the price of established therapies or other new technologies or products.

 

Several companies have developed or are in the process of developing technologies that are, or in the future may be, the basis for products that will compete with Oxycyte. We are aware of five other products at various stages of development that are intended to achieve the same result as Oxycyte. Three of these products are based on hemoglobin derivates, two from outdated human blood and the third from bovine blood. One product is also based on perfluorocarbon and the other on nanobubble oxygen technology. None of these products is approved for use in the United States. The bovine-source hemoglobin-based oxygen-carrier has been approved for human use in South Africa and a Biologics License Application, or BLA, was submitted to the FDA for its use in the United States, which has not been approved and no clinical trials in the United States are currently underway. The human hemoglobin based products are in clinical trials, one in Phase II surgical trials and the other in Phase III testing for emergency and traumatic blood loss applications. Phase III clinical trials on the other perfluorocarbon product were halted in 2001 and have not resumed.

 

We believe that important competitive factors in the market for blood substitute products will include the relative speed with which competitors can develop their respective products, complete the clinical testing and regulatory approval process, and supply commercial quantities of their products to the market. In addition to these factors, competition is expected to be based on the effectiveness of blood

 

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substitute products and the scope of the intended uses for which they are approved, the scope and enforceability of patent or other proprietary rights, product price, product supply, and marketing and sales capability. We believe that our competitive position will be significantly influenced by the timing of the clinical testing and regulatory filings for Oxycyte, our ability to maintain and enforce our proprietary rights covering Oxycyte and its manufacturing process, and our ability to develop capabilities for manufacturing and distributing the product ourselves or with others, should we obtain regulatory approval.

 

Our other products

 

Fluorovent

 

Fluorovent is an oxygen-carrying perfluorocarbon liquid that, when dispensed directly into the lungs, acts as a surfactant and effective medium for gas exchange, which increases pulmonary function and the diffusion of oxygen and carbon dioxide through the lungs into the body. The development of this product capability has applications in the treatment of acute lung disease, such as infant respiratory distress syndrome and adult respiratory syndrome. Further development of this product is currently on hold until we obtain additional financing.

 

Implanted glucose biosensor

 

Synthetic Blood has developed an implanted glucose biosensor to monitor blood glucose. Termed a biosensor because it utilizes an enzyme specific for glucose, we believe it will provide glucose measurement significantly more accurate than possible from current portable measuring devices. Once implanted in subcutaneous tissue during a simple outpatient procedure, the biosensor provides continuous monitoring of glucose levels. A radio frequency signal from the implanted biosensor is transmitted to an external receiving device the size of a pager that displays glucose levels as a digital readout, has high and low glucose alarms, and stores data for downloading at the physician’s office. The external device can also be programmed to monitor glucose according to a preset schedule. It is anticipated the implant life of the biosensor will exceed one year. Further development of this product is currently on hold until we obtain additional financing.

 

The primary market for this product is diabetes sufferers. A study sponsored by the National Institutes of Diabetes and Digestive and Kidney Diseases, showed that “tight diabetes control” (keeping blood sugar levels close to normal by frequent blood sugar testing, several daily insulin shots, and lifestyle changes) was associated with a major reduction in diabetic complications. Current glucose testing devises are based on “finger sticking” to obtain a blood sample for testing, which we believe results in less frequent and less regular monitoring of glucose levels. Consequently, we believe a there is a meaningful market for a painless automatic monitoring product.

 

Our patents and intellectual property

 

Perfluorocarbon products

 

Synthetic Blood holds four U.S. patents (5,674,913; 5,824,703; 5,840,767; 6,167,887), three Australian patents (690,277; 722,417; 759,557), two Canadian Patents (2,239,170; 2,311,122) and, one European patent (EPO 8697678B1) pertaining to the use and application of perfluorocarbons as gas transport agents in blood substitutes and liquid ventilation. Additionally, through an exclusive supply agreement with our perfluorocarbon supplier, we benefit from eight perfluorocarbon manufacturing process patents that further protect the perfluorocarbons contained in our products.

 

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Biosensor

 

We have three U.S. patents (5,914,026; 5,964,993 6,343,225) and two Australian patents (720,712; 734,003) that protect what we believe are important design features of our implanted glucose biosensor. We also hold exclusive licenses to three fundamental biosensor patents that represent the core technology used on our product.

 

Government regulation

 

The manufacture and distribution of Oxycyte, as well as our other products, and the operation of our manufacturing facilities will require the approval of United States government authorities as well as those of foreign countries. In the United States, the FDA regulates medical products, including the category known as “biologicals” which includes Oxycyte. The Federal Food, Drug and Cosmetic Act and the Public Health Service Act govern the testing, manufacture, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of Oxycyte. In addition to FDA regulations, we are also subject to other federal and state regulations, such as the Occupational Safety and Health Act and the Environmental Protection Act. Product development and approval within this regulatory framework requires a number of years and involves the expenditure of substantial funds.

 

The steps required before a biological product may be sold commercially in the United States include pre-clinical testing, the submission to the FDA of an Investigational New Drug application, clinical trials in humans to establish the safety and effectiveness of the product, the submission to the FDA of a Biologics License Application, or BLA, relating to the product and the manufacturing facilities to be used to produce the product for commercial sale, and FDA approval of a BLA. After a BLA is submitted there is an initial review by FDA to be sure that all of the required elements are included in the submission. There can be no assurance that the application will be accepted for filing or that the FDA may not issue a refusal to file, or RTF. If an RTF is issued, there is opportunity for dialogue between the sponsor and the FDA in an effort to resolve all concerns. There can be no assurance that such a dialogue will be successful in leading to the filing of the BLA. If the submission is filed, there can be no assurance that the full review will result in product approval.

 

Pre-clinical tests include evaluation of product chemistry and studies to assess the safety and effectiveness of the product and its formulation. The results of the pre-clinical tests are submitted to the FDA as part of the Investigational New Drug application. The goal of clinical testing is the demonstration in adequate and well-controlled studies of substantial evidence of the safety and effectiveness of the product in the setting of its intended use. The results of pre-clinical and clinical testing are submitted to the FDA from time to time throughout the trial process. In addition, before approval for the commercial sale of a product can be obtained, results of the pre-clinical and clinical studies must be submitted to the FDA in the form of a BLA. The testing and approval process requires substantial time and effort and there can be no assurance that any approval will be granted on a timely basis, if at all. The approval process is affected by a number of factors, including the severity of the condition being treated, the availability of alternative treatments and the risks and benefits demonstrated in clinical trials. Additional pre-clinical studies or clinical trials may be requested during the FDA review process and may delay product approval. After FDA approval for its initial indications, further clinical trials may be necessary to gain approval for the use of a product for additional indications. FDA may also require post-marketing testing, which can involve significant expense, to monitor for adverse effects.

 

Among the conditions for BLA approval is the requirement that the prospective manufacturer’s quality controls and manufacturing procedures conform to FDA requirements. In addition, domestic manufacturing facilities are subject to biennial FDA inspections and foreign manufacturing facilities are subject to periodic FDA inspections or inspections by the foreign regulatory authorities with reciprocal

 

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inspection agreements with FDA. Outside the United States, we are also subject to foreign regulatory requirements governing clinical trials and marketing approval for medical products. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary widely from country to country.

 

Our regulatory strategy is to pursue clinical testing and FDA approval of Oxycyte in the United States. We intend to arrange for testing and seek regulatory approval of Oxycyte outside the United States through licensing or other arrangements with other foreign or domestic companies. To date, we have not conducted any clinical trials of Oxycyte outside of the United States.

 

Employees

 

We currently employ six individuals, three of whom are scientific personnel, two are executives, and one office manager/bookkeeper. Our employees are not represented by a union or any other form of collective bargaining unit.

 

Risk Factors

 

You should carefully consider the risks described below together with all of the other information included in this report on Form 10-K. An investment in Synthetic Blood’s common stock is very risky. If any of the following risks actually occur, our business, financial condition or results of operations could be harmed. In such an event, the trading price of Synthetic Blood’s common stock could decline, and you may lose part or all of your investment.

 

Risks related to our business

 

We are currently a one product company, so our future depends on the success of that product.

 

We have limited financial resources, so at present we are using these resources solely on developing our Oxycyte blood substitute product. We have stopped development on Fluorovent, our oxygen carrying liquid, and our implantable glucose biosensor until additional financing is obtained. Consequently, we are focusing all our resources on advancing Oxycyte to the point it receives regulatory approval for one or more medical uses, and if this effort is unsuccessful we may not have resources to pursue development of our other products and our business would terminate. Furthermore, by delaying development of Fluorovent and our implantable glucose biosensor, these technologies may become obsolete by the time we have sufficient capital to resume development and testing of these products, so the funds expended on these products to date would be lost, as well as our opportunity to benefit if the products could be successfully developed.

 

We are required to conduct additional clinical trials in the future, which are expensive and time consuming, and the outcome of the trials is uncertain.

 

We completed Phase I clinical trials on Oxycyte in December 2003, and started Phase II clinical testing in the fourth quarter of 2004. If we are successful with our Phase II trials (of which there is no assurance) we will need to conduct further Phase III trials. All of these clinical trials and testing will be expensive and time-consuming and the timing of the FDA review process is uncertain. The FDA or we may in the future suspend clinical trials at any time if it is believed that the subjects participating in such trials are being exposed to unacceptable health risks. We cannot ensure that we will be able to complete our clinical trials successfully or obtain FDA approval of Oxycyte, or that FDA approval, if obtained, will not include limitations on the indicated uses for which Oxycyte may be marketed. Our business, financial

 

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condition and results of operations are critically dependent on receiving FDA approval of Oxycyte. A significant delay in our planned clinical trials or a failure to achieve FDA approval would have a material adverse effect on us and could result in the cessation of our business.

 

Our activities are and will continue to be subject to extensive government regulation, which is expensive and time consuming, and we won’t be able to sell our product without regulatory approval.

 

Our research, development, testing, manufacturing, marketing and distribution of Oxycyte are, and will continue to be, subject to extensive regulation, monitoring and approval by the FDA. There are significant risks at each stage of the regulatory scheme.

 

Product approval stage

 

During the product approval stage we attempt to prove the safety and efficacy of our product for its indicated uses. There are numerous problems that could arise during this stage, including:

 

    The data obtained from clinical trials are susceptible to varying interpretations, which could delay, limit or prevent FDA regulatory approval.

 

    The lack of established criteria for evaluating the effectiveness of blood substitute products could delay or prevent FDA regulatory approval.

 

    At any time the FDA could change policies and regulations that could result in delay and perhaps rejection of our product.

 

    Even after extensive clinical trials, there is no assurance regulatory approval will ever be obtained for Oxycyte.

 

Commercialization approval stage

 

We will be required to file a Biologics License Application, or BLA, with the FDA in order to obtain regulatory approval for the commercial production and sale of Oxycyte in the United States. Under FDA guidelines, the FDA may comment upon the acceptability of a BLA following its submission. After a BLA is submitted there is an initial review by the FDA to be sure that all of the required elements are included in the submission. There can be no assurance that the submission will be accepted for filing or that the FDA may not issue a refusal to file, or RTF. If an RTF is issued, there is opportunity for dialogue between the sponsor and the FDA in an effort to resolve all concerns. There can be no assurance that such a dialogue will be successful in leading to the filing of the BLA. If the submission is filed, there can be no assurance that the full review will result in product approval.

 

Post-commercialization stage

 

Discovery of previously unknown problems with Oxycyte or unanticipated problems with our manufacturing arrangements, even after FDA approval of Oxycyte for commercial sale, may result in the imposition of significant restrictions, including withdrawal of Oxycyte from the market.

 

Additional laws and regulations may also be enacted which could prevent or delay regulatory approval of Oxycyte, including laws or regulations relating to the price or cost-effectiveness of medical products. Any delay or failure to achieve regulatory approval of commercial sales of Oxycyte is likely to have a material adverse effect on our financial condition.

 

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The FDA continues to review products even after they receive agency approval. If and when the FDA approves Oxycyte, its manufacture and marketing will be subject to ongoing regulation, including compliance with current good manufacturing practices, adverse event reporting requirements and the FDA’s general prohibitions against promoting products for unapproved or “off-label” uses. We are also subject to inspection and market surveillance by the FDA for compliance with these and other requirements. Any enforcement action resulting from failure, even by inadvertence, to comply with these requirements could affect the manufacture and marketing of Oxycyte. In addition, the FDA could withdraw a previously approved product from the market upon receipt of newly discovered information. The FDA could also require us to conduct additional, and potentially expensive, studies in areas outside our approved indicated uses.

 

We are a development stage company without revenues or profits.

 

Synthetic Blood began research and development activities in 1990 and is a development stage company. We have been engaged for the past 13 years in the development and testing of Oxycyte, Fluorovent, and our glucose biosensor. No revenues have been generated to date from commercial sales of any of our products. Our revenues to date have consisted solely of interest earned on funds held until applied in the development of our products. At April 30, 2005 our accumulated deficit during the development stage is $23,622,731. We will require substantial amounts of outside financing to fund future testing and development of our products. We cannot ensure that our clinical testing will be successful, that regulatory approval of Oxycyte or any of our other products will be obtained, that Oxycyte or any of our other products can be manufactured at an acceptable cost and in appropriate quantities, or that we there will be a viable market for any of our products. The foregoing factors raise substantial doubt about our ability to continue as a going concern.

 

We will need to raise additional capital to continue our business.

 

We will need to raise substantial amounts of additional capital to complete the clinical testing of Oxycyte and, if approved for commercial use, establish commercial production of Oxycyte. In addition, we will require funding to pursue development of Fluorovent and our glucose biosensor, and to cover our ongoing administrative and corporate obligations. Our future capital requirements will depend on many factors, including the scope and results of our clinical trials, the timing and outcome of regulatory reviews, administrative and legal expenses, the status of competitive products, the establishment of manufacturing capacity, and the establishment of collaborative relationships. We cannot ensure that this additional funding will be available or, if it is available, that it can be obtained on terms and conditions we find acceptable. As a result of these circumstances our independent accountants have, and are likely in the future to, include an explanatory paragraph in their audit opinions based on uncertainty regarding our ability to continue as a going concern. An audit opinion of this type may interfere with our ability to issue our securities to the public or in private transactions. Any additional funding derived from the sale of equity securities may result in significant dilution to our existing stockholders.

 

Presently we are focusing on developing Oxycyte, which is subject to a high level of technological risk.

 

We completed Phase I clinical trials on Oxycyte in December 2003, and we expect we will devote a substantial portion of our financial and managerial resources to pursuing Phase II and Phase III clinical trials on this product over the next three years. As our other products are not as far along in the development and approval process as Oxycyte, our opportunity to generate product revenues within the

 

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next four to five years is most likely dependent on successful testing and commercialization of Oxycyte for surgical and similar acute blood replacement applications. The biomedical field has undergone rapid and significant technological changes. Technological developments may result in Oxycyte becoming obsolete or non-competitive before we are able to recover any portion of the research and development and other expenses we have incurred to develop and clinically test Oxycyte. Any such occurrence would have a material adverse effect on our operations and could result in the cessation of our business.

 

We are not certain that we will be able to manufacture Oxycyte commercially.

 

Commercial-scale manufacturing of Oxycyte will require development of a manufacturing capability that is significantly larger than the capacity currently in place to produce Oxycyte for our clinical trials. We do not intend to build our own production facility, but instead will rely on third party manufacturers to produce our product. We have not established any arrangement for commercial production of Oxycyte with any manufacturer, and there can be no assurance that we will be able to establish such an arrangement on terms acceptable to us. Moreover, in order to seek FDA approval of the sale of Oxycyte produced at a third party manufacturing facility, we may be required to conduct a portion of our clinical trials with product manufactured at that facility. Accordingly, a delay in achieving scale-up of commercial manufacturing capabilities when needed will have a material adverse effect on sales of Oxycyte. Additionally, the manufacture of Oxycyte will be subject to extensive government regulation. Among the conditions for marketing approval is that our quality control and manufacturing procedures conform to the FDA’s good manufacturing practice regulations. We cannot ensure that we will be able to obtain the necessary regulatory clearances or approvals to manufacture Oxycyte on a timely basis or at all.

 

There are significant competitors developing similar products.

 

If approved for commercial sale, Oxycyte will compete directly with established therapies for acute blood loss and may compete with other technologies currently under development. We cannot ensure that Oxycyte will have advantages, which will be significant enough to cause medical professionals to adopt it rather than continue to use established therapies or to adopt other new technologies or products. We also cannot ensure that the cost of Oxycyte will be competitive with the cost of established therapies or other new technologies or products. The development of blood substitute products is a rapidly evolving field. As there is currently no blood substitute product on the market, competition to develop an efficacious and accepted product is intense. Several companies have developed or are in the process of developing technologies that are, or in the future may be, the basis for products that will compete with Oxycyte. Certain of these companies are pursuing different approaches or means of accomplishing the therapeutic effects sought to be achieved through the use of Oxycyte.

 

These companies and others have substantially greater financial resources, larger research and development staffs, more extensive facilities and more experience than Synthetic Blood in testing, manufacturing, marketing and distributing medical products. We cannot ensure that one or more other companies will not succeed in developing technologies or products that will become available for commercial use prior to Oxycyte, which could be more effective or less costly than Oxycyte or would render Oxycyte obsolete or non-competitive.

 

We do not have experience in the sale and marketing of medical products.

 

We have no experience in the sale or marketing of medical products. We have not decided upon a marketing strategy. We do not know of any third party that is prepared to distribute Oxycyte should it be approved. If we decide to establish our own marketing capability, we will need to recruit, train and retain a marketing staff and sales force with sufficient technical expertise. We do not know whether we

 

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can establish a marketing program at a cost that is acceptable in relation to revenue or whether we can be successful in marketing our product. Failure to successfully market Oxycyte or to do so on a cost effective basis would likely result in failure of our business.

 

We have a history of losses and our future profitability is uncertain.

 

During fiscal year ended April 30, 2005, we incurred a net loss of $2.7 million, and we incurred net losses of $2.2 million in fiscal year 2004 and $2.2 million in fiscal year 2003. We will not generate operating revenue unless and until one of our products is approved for commercial sale and sales activity begins. We will require substantial additional funds to complete clinical trials, pursue regulatory approval for our products, establish commercial scale manufacturing capabilities, and establish marketing, sales, and administrative capabilities. Expenditures for these purposes will result in substantial losses for at least the next several years. The expense and the time required to realize any product revenues or profitability are highly uncertain. We cannot ensure that we will be able to achieve product revenues or profitability on a sustained basis, or at all, and we may be unable to ever establish Synthetic Blood as a going concern.

 

The market may not accept our product.

 

Human blood collection, distribution, and medical application are well established and accepted. Competitors may develop new technologies or products, which are effective, competitively priced, and accepted for various medical uses. We cannot ensure that the efficacy and pricing of Oxycyte, considered in relation to Oxycyte’s expected benefits, will be perceived by health care providers and third party payers as cost-effective, or that the price of Oxycyte will be competitive with transfused blood or with other new technologies or products. Our results of operations may be adversely affected if the price of Oxycyte is not considered cost-effective or if Oxycyte does not otherwise achieve market acceptance.

 

Our patents and other proprietary rights may not protect our technology.

 

Our ability to compete effectively with other companies will depend, in part, on our ability to protect and maintain the proprietary nature of our technology. We cannot be certain as to the degree of protection offered by our patents or as to the likelihood that additional patents in the United States and certain other countries will be issued based upon pending patent applications. Patent applications in the United States are maintained in secrecy until patents are issued. We cannot be certain that we were the first creator of the inventions covered by our patents or pending patent applications or that we were the first to file patent applications for our inventions. The high costs of enforcing patent and other proprietary rights may also limit the degree of protection afforded to us. We also rely on unpatented proprietary technology, and we cannot ensure that others may not independently develop the same or similar technology or otherwise obtain access to our proprietary technology. We cannot ensure that our patents or other proprietary rights will be determined to be valid or enforceable if challenged in court or administrative proceedings or that we will not become involved in disputes with respect to the patents or proprietary rights of third parties. An adverse outcome from these proceedings could subject us to significant liabilities to third parties, require disputed rights to be licensed from third parties, or require us to stop using this technology, any of which would result in a material adverse effect on our results of operations.

 

Our viability will be affected if we incur product liability claims in excess of our insurance coverage.

 

The testing and marketing of medical products, even after FDA approval, have an inherent risk of product liability. We maintain limited product liability insurance coverage for our clinical trials in the

 

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total amount of $3 million. However, our profitability will be adversely affected by a successful product liability claim in excess of our insurance coverage. We cannot guarantee that product liability insurance will be available in the future or be available on reasonable terms.

 

We depend on the services of a limited number of key personnel.

 

Our success is highly dependent on the continued services of a limited number of skilled managers and scientists. The loss of any of these individuals could have a material adverse effect on us. In addition, our success will depend, among other factors, on the recruitment and retention of additional highly skilled and experienced management and technical personnel. We cannot ensure that we will be able to retain existing employees or to attract and retain additional skilled personnel on acceptable terms given the competition for such personnel among numerous large and well-funded pharmaceutical and health care companies, universities, and non-profit research institutions.

 

Health care reform and controls on health care spending may limit the price we can charge for Oxycyte and the amount we can sell.

 

The federal government and private insurers have considered ways to change, and have changed, the manner in which health care services are provided in the United States. Potential approaches and changes in recent years include controls on health care spending and the creation of large purchasing groups. In the future, it is possible that the government may institute price controls and limits on Medicare and Medicaid spending. These controls and limits might affect the payments we collect from sales of our product. Assuming we succeed in bringing Oxycyte to market, uncertainties regarding future health care reform and private market practices could affect our ability to sell Oxycyte in large quantities at profitable pricing.

 

Uncertainty of third-party reimbursement could affect our future profitability.

 

Sales of medical products largely depend on the reimbursement of patients’ medical expenses by governmental health care programs and private health insurers. There is no guarantee that governmental health care programs or private health insurers will reimburse our sales of Oxycyte, or permit us to sell our product at high enough prices to generate a profit.

 

Risks related to ownership of our stock

 

Our stock price could be volatile and your investment could suffer a decline in value.

 

The market price of our common stock has fluctuated significantly in response to a number of factors, many of which are beyond our control, including:

 

    Regulatory developments relating to our Oxycyte blood substitute product;

 

    Announcements by us relating to the results of our clinical trials of Oxycyte;

 

    Developments relating to our efforts to obtain additional financing to fund our operations;

 

    Announcements by us regarding transactions with potential strategic partners;

 

    Announcements relating to blood substitute products being developed by our competitors;

 

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    Changes in industry trends or conditions;

 

    Our issuance of additional debt or equity securities; and

 

    Sales of significant amounts of our common stock or other securities in the market.

 

In addition, the stock market in general, and the over-the-counter market and the biotechnology industry market in particular, have experienced significant price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of other public companies. These broad market and industry factors may seriously harm the market price of our common stock, regardless of our company specific results. In the past, securities class action litigation has often been instituted following periods of volatility in the market price of a company’s securities. A securities class action suit against us could result in substantial costs, potential liabilities, and the diversion of our management’s attention and resources.

 

There are a large number of shares that may be sold in the future in the public market, which may depress the market price of our common stock.

 

The authorized capital stock of the Company consists of an aggregate of 200 million shares of common stock, of which 128,159,918 shares are issued and outstanding and approximately 57.4 million shares are reserved for issuance upon conversion or exercise of issued and outstanding debentures, options, and warrants. Of the reserved shares, approximately 33.6 million are shares that are, or will be, registered for resale in the public market under the Securities Act of 1933 and are issuable on conversion or exercise of outstanding debentures and warrants. The substantial number of shares available now and that may become available in the future, for sale in the public market could cause the market price of our common stock to decline or have a depressive effect on the market price.

 

ITEM 2 – PROPERTIES

 

Synthetic Blood owns no real property and currently leases, on a month to month basis, its principal administrative and laboratory facilities at 3189 Airway Avenue, Building C, Costa Mesa, California 92626. The current rent is approximately $9,400 per month.

 

ITEM 3 - LEGAL PROCEEDINGS

 

Synthetic Blood is not presently involved in any legal proceedings and was not involved in any such proceedings during fiscal year 2005.

 

ITEM 4 - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

 

No matter was submitted to a vote of security holders during the quarter ended April 30, 2005.

 

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PART II  

 

ITEM 5 - MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Market price, number of shareholders, and dividend policy

 

Quotations for the common stock of Synthetic Blood are reported on the OTC Electronic Bulletin Board. The over-the-counter quotations set forth below reflect inter-dealer prices, without retail mark-up, mark-down or commissions and may not necessarily represent actual transactions. For the past two fiscal years, the minimum bid and highest ask prices were:

 

     2005

   2004

Quarter


   Low

   High

   Low

   High

1st

   $ 0.28    $ 0.52    $ 0.14    $ 0.35

2nd

   $ 0.23    $ 0.43    $ 0.20    $ 0.27

3rd

   $ 0.20    $ 0.29    $ 0.28    $ 0.90

4th

   $ 0.21    $ 0.41    $ 0.44    $ 0.66

 

At July 15, 2005 we had approximately 1,315 shareholders of record.

 

Since inception of Synthetic Blood, no dividends have been paid on the common stock. Synthetic Blood intends to retain any earnings for use in its business activities, so it is not expected that any dividends on the common stock will be declared and paid in the foreseeable future.

 

ITEM 6 - SELECTED FINANCIAL DATA

 

    

April 30,

2005


   

April 30,

2004


   

April 30,

2003


   

April 30,

2002


   

April 30,

2001


 

Statement of Operations Data:

                                        

Other Income

   $ 11,814     $ 18,002     $ 48,558     $ 130,288     $ 331,019  

Total expenses

   $ 2,684,612     $ 2,267,205     $ 2,275,895     $ 3,618,101     $ 2,003,261  

Net loss

   $ (2,672,798 )   $ (2,249,203 )   $ (2,227,337 )   $ (3,487,813 )   $ (1,672,242 )

Weighted average number of shares

     118,841,402       95,327,891       88,651,158       87,198,320       86,401,830  

Net loss per share, basic and diluted

   $ (0.02 )   $ (0.02 )   $ (0.03 )   $ (0.04 )   $ (0.02 )

Balance Sheet Data:

                                        

Cash

   $ 588,763     $ 302,310     $ 178,442     $ 2,424,015     $ 4,250,898  

Working capital

   $ 352,505     $ 127,592     $ 236,869     $ 2,352,474     $ 4,020,203  

Total assets

   $ 1,262,345     $ 1,047,979     $ 914,905     $ 3,275,820     $ 4,842,296  

Total liabilities

   $ 313,944     $ 293,698     $ 14,533     $ 179,078     $ 344,068  

Stockholders’ equity

   $ 948,401     $ 754,281     $ 900,372     $ 3,096,742     $ 4,498,228  

 

ITEM 7 - MANAGEMENT’S DISCUSSIONS AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Our actual results may differ materially from those anticipated in the forward-looking statements made below as a result of various factors including those set forth in the caption “Item 1 – Business” and in other sections of this report.

 

The following is management’s discussion and analysis of financial condition and results of operations of Synthetic Blood for the fiscal years ended April 30, 2005, 2004, and 2003. This discussion and analysis should be read in conjunction with the section entitled “Item 6 - Selected Financial Data” and the financial statements and notes thereto included elsewhere herein.

 

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Overview

 

Since 1990, Synthetic Blood International, Inc. has pursued the development of medical products based on perfluorocarbon technology. These products include Oxycyte, a synthetic blood substitute, and Fluorovent, an oxygen exchange fluid for facilitating the treatment of lung conditions. Since 1993 Synthetic Blood has also pursued development of a glucose biosensor implant.

 

The nature of our business is to spend years in development and testing of pharmaceutical and medical device products, take products through a lengthy and expensive process of regulatory review by the FDA, and, if successful in showing the product is efficacious and obtaining FDA approval, commercialize the product. During the periods of development and regulatory review we have no product to sell and no revenue. Nevertheless, we incur substantial costs pursuing this process, which require cash that comes from outside sources. We rely on outside financing to fund our operations, and will for the foreseeable future. That means we must continue to show progress with our products and be able to locate investors willing to commit their funds to a speculative venture that will ultimately be successful only if we can actually bring a product to market and gain a meaningful level of market acceptance and penetration. Because of these factors a larger number of biotechnology products under development fail, and there is no assurance that the products we have under development will not suffer the same fate.

 

We received approval of the Investigational New Drug application we filed with the FDA on Oxycyte and began Phase I clinical tests in October 2003. We completed the clinical tests in December 2003. The results of the Phase I tests were in line with our safety and efficacy expectations for the performance of Oxycyte. We started Phase II testing in 2004.

 

Five clinical sites have received local Institutional Review Board (IRB) approval to participate in the first Phase II trial with Oxycyte. In this first Phase II trial we are evaluating both efficacy and safety in the prevention of tissue hypoxia (the effects of reduced oxygen levels) in hip surgery patients who experience mild to moderate blood loss during surgery. While blood transfusions are typically not given during such procedures, blood loss may result in postoperative complications caused by tissue hypoxia. We are now actively screening and enrolling patients for this trial, and plan to enroll 60 patients. One-half of these patients will be treated with Oxycyte and the others will serve as a control group. We expect to complete this study and report our findings by the beginning of 2006.

 

We are making plans to conduct two additional Phase II studies in which Oxycyte will be used in coronary bypass and/or heart valve replacement surgery patients, and in surgical patients who require blood transfusions. We are currently developing protocols for these trials with plans to initiate both before the end of 2006. In addition to surgery and trauma, our future plans include testing Oxycyte in stroke, myocardial infarction, malignant tumors and decompression sickness. We expect Phase II studies will continue over at least the next two years, after which Phase III studies may be able to commence depending on results of Phase II trials, the development of acceptable protocols for Phase III trials, and the availability of financial and other resources to purse the Phase II trials.

 

Fluorovent and our glucose biosensor implant are both in the animal testing stage. We do not believe we will be able to file any applications with the FDA for human testing on these products for at least another year. So while we will try to advance development of these products as best we can, our primary focus will be on advancing Oxycyte through the FDA review process in order to bring a product to market as soon as possible.

 

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Results of operations

 

Fiscal year 2005 compared to fiscal year 2004

 

For the fiscal year ended April 30, 2005, Other Income decreased to $11,814 from $18,002 in the fiscal year ended April 30, 2004. Other Income consists principally of interest income. This decrease is attributed to a reduction of the cash available for investment.

 

General and Administrative expenses of $1,407,487 for fiscal year 2005 increased $406,705 or 41 percent over fiscal year 2004 expenses of $1,000,782. General office and operating expenses have remained relatively constant from fiscal 2004 to 2005. Consulting fees increased $80,000 from the previous year as a result of the retention of an investor relations firm in the current period. Administrative fees increased $320,000 during the current period primarily resulting from an expense of $311,000 related to the granting of stock warrants in consideration for a delayed registration of stock.

 

Research and Development expenses increased from $1,266,423 for the fiscal year ended April 30, 2004, to $1,277,125 for the fiscal year ended April 30, 2005. Because of the nature of our ongoing research and development activities, accounting periods may reflect significant changes in expenses resulting from the timing of research related to our three developmental products. We have increased expenditures relating to Oxycyte as the product entered Phase I and Phase II clinical trials while decreasing expenditures on our two other products, whose development is current on hold. We intend to continue Phase II clinical trials in fiscal year 2005 and into 2006 and perhaps begin Phase III trials by beginning of 2007, if we obtain regulatory approval, so it should be expected that our expenditures on Oxycyte will continue to increase.

 

Fiscal year 2004 compared to fiscal year 2003

 

For the fiscal year ended April 30, 2004, Other Income decreased to $18,002 from $48,558 in the fiscal year ended April 30, 2003. Other Income consists principally of interest income and rental income. This decrease is attributed to a reduction of the cash available for investment, a decline in the interest rate on invested funds from fiscal 2003 to 2004 and loss of a tenant in October 2003 from whom Synthetic Blood was receiving rents totaling $2,600 per month.

 

General and Administrative expenses of $1,000,782 for fiscal year 2004 increased $160,430 or 19 percent over fiscal year 2003 expenses of $840,352. This increase was the result of amortization of $98,916 of deferred compensation resulting from the value of common stock options granted to employees and a bonus of $40,000 paid to Synthetic Blood’s President offset by a reduction in travel expenses. General office and operating expenses have remained relatively constant from fiscal 2003 to 2004.

 

Research and Development expenses decreased 12 percent from $1,433,040 for the fiscal year ended April 30, 2003, to $1,266,423 for the fiscal year ended April 30, 2004. The decrease is attributed to significant expenditures in 2003 related to animal studies for our Oxycyte product in 2003. Because of the nature of our ongoing research and development activities, accounting periods may reflect significant changes in expenses resulting from the timing of research related to our three developmental products. We have increased expenditures relating to Oxycyte as the product entered Phase I clinical trials while decreasing expenditures on our two other products, whose development is current on hold. We intend to continue Phase II clinical trials in fiscal year 2006, so it should be expected that our expenditures on Oxycyte will continue to increase over the next fiscal year.

 

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Interest expense decreased from $2,503 for fiscal year ended April 30, 2003 to zero for fiscal year ended April 30, 2004. This decrease resulted from the payment of all our short-term notes payable during fiscal 2003.

 

Quarterly results of operations

 

The following table presents Synthetic Blood’s operating results for each of the eight fiscal quarters in the two-year period ended April 30, 2005. The information for each of these quarters is unaudited and has been prepared on the same basis as the audited financial statements included in this Form 10-K. In the opinion of management, all necessary adjustments, which consist only of normal and recurring accruals, have been included to fairly present the unaudited quarterly results. This data should be read together with the financial statements and the notes thereto included in this Form 10-K.

 

Statements of operations data:

 

    Three Months Ended

 
   

April 30,

2005


    January 31,
2005


    October 31,
2004


   

July 31,

2004


   

April 30,

2004


    January 31,
2004


    October 31,
2003


   

July 31,

2003


 

Research and development expenses

  $ 443,058     $ 304,987     $ 309,614     $ 219,466     $ 266,225     $ 501,488     $ 265,630     $ 233,080  

General and administrative expenses

    272,279       588,308       291,286       255,614       258,447       314,035       202,003       226,297  
   


 


 


 


 


 


 


 


Total expenses

    715,337       893,295       600,900       475,080       524,672       815,523       467,633       459,377  

Other (Income) Expense

    (4,413 )     (4,799 )     (944 )     (1,658 )     (1,136 )     (2,192 )     (7,207 )     (7,467 )
   


 


 


 


 


 


 


 


Net loss

  $ (710,924 )   $ (888,496 )   $ (599,956 )   $ (473,422 )   $ (523,536 )   $ (813,331 )   $ (460,426 )   $ (451,910 )
   


 


 


 


 


 


 


 


Net loss per share, basic and diluted

  $ (0.006 )   $ (0.007 )   $ (0.005 )   $ (0.004 )   $ (0.005 )   $ (0.008 )   $ (0.005 )   $ (0.005 )
   


 


 


 


 


 


 


 


Weighted average shares outstanding, basic and diluted

    125,606,547       120,908,287       115,262,499       113,808,876       104,756,283       98,469,019       89,504,961       88,786,265  
   


 


 


 


 


 


 


 


 

Liquidity, capital resources and plan of operation

 

We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. As of April 30, 2005, we had $666,449 in total current assets and working capital of $352,505, compared to $421,290 in total current assets and working capital of $127,592 as of April 30, 2004.

 

During the year ended April 30, 2005, net cash provided by financing activities was $2,385,333, primarily from the sale of our common stock. Net cash of $1,991,956 was used to fund operating activities and $106,924 was used for investing activities, primarily for the purchase of additional laboratory equipment and additional patent expenditures. Consequently, our cash and cash equivalents increased from $302,310 at April 30, 2004 to $588,763 at April 30, 2005. We do not have any lines of credit or other borrowing arrangements with lenders.

 

We have had difficulty raising additional capital for research and development activities. On July 13, 2005, the Company closed on a financing transaction with three private investors. In the transaction,

 

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the Company issued to the investors unsecured convertible debentures in the principal amount of approximately $1.85 million payable over a term of three years beginning 120 days following the closing of the financing discounted on the date of issue at 10 percent per annum. Proceeds to the Company after the original issue discount, commissions, and the investors’ professional fees is approximately $1,145,500.

 

The principal amount of the debentures is convertible to common stock at any time at the election of the holder at a rate of one common share for each $0.22 of principal. The Company may, at its option and subject to certain conditions, make monthly payments on the debentures in common stock priced at the lower of $0.22 or 80 percent of the volume weighted average price for the common stock over the five trading days prior to the payment date. The Company also issued to the investors warrants to purchase up to 8,409,083 of shares of common stock exercisable during a term of three years at an exercise price of $0.242 per share. The shares of common stock underlying the securities sold in this financing transaction will be registered for resale on a registration statement to be filed by the Company within 45 days following closing.

 

We are in the pre-clinical and clinical trial stages in the development of our products. Under an Investigational New Drug application filed with the FDA, we completed Phase I clinical studies on Oxycyte in December 2003. The results of the Phase I study were in line with our expectations for the performance of Oxycyte. We submitted a report to the FDA along with a Phase II protocol, received FDA approval, and started Phase II testing in the fourth quarter of 2004, which is expected to continue through 2006. Even if we are successful with our Phase II study, we must then conduct a Phase III clinical study and, if that is successful, file with the FDA and obtain approval of a Biologics License Application to begin commercial distribution, all of which will take more time and funding to complete. Our other products, Fluorovent and the glucose biosensor, must undergo further development and testing prior to submission to the FDA for approval to initiate clinical trials, which also requires additional funding. Management is actively pursuing private and institutional financing, as well as strategic alliances and/or joint venture agreements to obtain the necessary additional financing and reduce the cost burden related to the development and commercialization of our products. We expect our primary focus will be on funding the continued testing of Oxycyte, since this product is the furthest along in the regulatory review process. Our ability to continue to pursue testing and development of our products beyond 2005 depends on obtaining outside financial resources. There is no assurance that needed financing will occur or that we will succeed in obtaining the necessary resources.

 

We are almost entirely dependent on outside financing to continue our operations. We will not generate operating revenue unless and until one of our products is approved for commercial sale and sales activity begins. We will require substantial additional funds to complete clinical trials, pursue regulatory approval for our products, establish commercial scale manufacturing capabilities, and establish marketing, sales, and administrative capabilities. Expenditures for these purposes will result in substantial losses for at least the next several years. The expense and the time required to realize any product revenues or profitability are highly uncertain. We cannot ensure that we will be able to achieve product revenues or profitability on a sustained basis, or at all. The foregoing factors raise substantial doubt about our ability to continue as a going concern.

 

Critical accounting policies

 

Our discussion and analysis of our financial condition and results of operations is based upon the financial statements presented in this report, which have been prepared in accordance with Generally Accepted Accounting Principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent liabilities. On an on-going basis, we evaluate our estimates, including

 

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those related to stock-based compensation and contingencies. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements:

 

Stock-Based Compensation –

 

We account for stock-based employee compensation as prescribed by APB Opinion No. 25, Accounting for Stock Issued to Employees, and, we account for stock-based nonemployee compensation under the fair-value method required by Statement of Financial Accounting Standards (“SFAS”) 148, Accounting for Stock-Based Compensation-Transition and Disclosure (“SFAS 148”) and Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation (“SFAS 123”). SFAS 123 and SFAS 148 require pro forma disclosures of net income and net income per share as if the fair value based method of accounting for stock-based awards had been applied for both employee and non-employee grants and require disclosure of option status on a more prominent and frequent basis. We account for stock options and warrants issued to non-employees based on the fair value method, but have not elected this treatment for grants to employees and board members. Under the fair value based method, compensation cost is recorded based on the value of the award at the grant date and is recognized over the service period.

 

The fair value of each option and warrant grant was estimated at the grant date using the Black-Scholes option-pricing model. The Black–Scholes option valuation model was developed for use in estimating the fair value of traded options and warrants that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and expected term. Because our stock options and warrants have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable single measure of the fair value of our stock options.

 

Long-Lived Assets –

 

Our intangible assets consist of patents related to our various technologies. These assets are amortized on a straight-line method over their estimated useful life, which ranges from eight to ten years. We review these intangible assets for impairment in accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets (“SFAS 144”). At April 30, 2005, management believes no indications of impairment existed.

 

ITEM 7A - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable, as management believes that the Company does not have instruments that are sensitive to market risk.

 

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ITEM 8 - FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

The financial statements and supplementary data required by this item are set forth at the end of this report beginning with the index to financial statements on page F-1.

 

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

 

On September 22, 2003, Synthetic Blood received notice from Grant Thornton LLP of its resignation as its independent registered public accounting firm. In connection with its audits for the two most recent fiscal years and through September 22, 2003, there were no disagreements with Grant Thornton LLP on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedures, which disagreements if not resolved to their satisfaction would have caused them to make reference in connection with their opinion to the subject matter of the disagreement.

 

The audit reports of Grant Thornton LLP for the two most recent fiscal years ended April 30, 2003 and 2002 did not contain any adverse opinion or disclaimer of opinion, nor were they qualified or modified as to uncertainty, audit scope, or accounting principles, except as follows:

 

Grant Thornton LLP’s report on the financial statements of Synthetic Blood as of and for the year ended April 30, 2003, and the period from May 26, 1967 (inception) to April 30, 2003 contained an explanatory paragraph stating that:

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company is a development stage enterprise engaged in developing certain medical products. The Company has accumulated deficit during the development stage of $18,700,730 as of April 30, 2003, and has used cash in operations of $2,093,762 during the year ended April 30, 2003. The Company will require substantial additional financing to fund operations until the necessary regulatory approvals are obtained, if ever. These factors, among others as described in Note A, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans concerning these matters are described in Note A. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

In connection with its audits for the 2002 and 2003 fiscal years and through September 22, 2003, there were no reportable events (as defined in Regulations S-K Item 304(a)(1)(v)).

 

Synthetic Blood engaged Haskell & White LLP as its new independent registered public accounting firm as of November 7, 2003. During the two most recent fiscal years and through the date of engagement, neither Synthetic Blood nor any one on behalf of Synthetic Blood consulted with Haskell & White LLP regarding the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on its financial statements, or any other matters or reportable events required to be disclosed under Items 304(a)(2)(i) and (ii) of Regulation S-K.

 

ITEM 9A – CONTROLS AND PROCEDURES

 

With the participation of management, Synthetic Blood’s chief executive officer and chief financial officer evaluated its disclosure controls and procedures as of the end of the period covered by this report. Based on this evaluation, the chief executive officer and the chief financial officer concluded that the disclosure controls and procedures are effective in connection with Synthetic Blood’s filing of its annual report on Form 10-K for the year ended April 30, 2005.

 

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Subsequent to April 30, 2005, through the date of this filing on Form 10-K for the year ended April 30, 2005, there have been no significant changes in Synthetic Blood’s internal controls or in other factors that could significantly affect these controls, including any significant deficiencies or material weaknesses of internal controls that would require corrective action.

 

Under current SEC guidelines, the requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Act”) will be effective for the Company’s year ending April 30, 2007. In order to comply with the Act, the Company will undertake a comprehensive effort, which includes documentation and testing of the design and operation of its internal control using the guidelines established by Internal Control- Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. During the course of these activities, the Company may identify certain internal control matters that management believes should be improved. These improvements, if necessary, will likely include further formalization of existing policies and procedures, improved segregation of duties, additional information technology system controls and additional monitoring controls. Although management does not believe that any of these matters will result in material weaknesses being identified in the Company’s internal control as defined by the Public Company Accounting Oversight Board (United States), no assurances can be given regarding the outcome of these efforts at the present time.

 

ITEM 9B – OTHER INFORMATION

 

There is no information to report under this item for the quarter ended April 30, 2005.

 

ITEM 10 - DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT

 

Directors and executive officers

 

Our officers and directors manage our business. The following persons are the officers and directors of Synthetic Blood:

 

Name


   Age

  

Position


Howard Jones

   67    Chairman of the Board

Roger A. Ekbom

   78    Director

Jonathan J. Spees

   51    Director

Robert W. Nicora

   65    President and Chief Executive Officer Director

David Johnson

   58    Chief Financial Officer

Richard Kiral, PhD

   63    Vice President, Research and Development

 

Our directors serve for a term beginning with election and ending with resignation, removal by the stockholders, or election of a successor by the stockholders. Executive officers serve by appointment at the discretion of the board of directors. The following are brief biographies of each of our directors and officers.

 

Howard Jones, Ph.D., is Chairman of the Board of Directors. Dr. Jones’ most recent position was president of the biopharmaceutical business unit of Curative Health Services where he was responsible for R&D, licensing, and manufacturing of wound healing technology that incorporates growth factors from patient blood. He has more than 30 years of experience in directing research and development of drugs at Revlon, Bristol-Myers Squibb, Amylin Pharmaceuticals, and Cypros Pharmaceuticals, a company he co-founded.

 

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He started his career at Merck where he discovered Clinoril, a drug for the treatment of rheumatoid arthritis that has annual sales of $400,000,000. He has had more than 84 patents issued for his biopharmaceutical developments.

 

Roger A. Ekbom is Vice Chairman of the Board of Directors. Mr. Ekbom was Chief Executive Officer from 1991 to March 1998 and has extensive experience with medical device companies including managing companies from startup through full development and subsequent sales. He is the founder and former President of Cardio Vista Systems, Inc., and founder and Chairman of Tronomed, Inc. From 1976 until 1993, Mr. Ekbom was the Vice President of and a major stockholder in Respiratory Support Products, Inc. and Tronomed International, Inc. Mr. Ekbom was formerly the general manager of a division of Becton Dickinson, an international medical device company, and of Marion Scientific, a subsidiary of Marion Laboratories. Mr. Ekbom graduated from the University of Minnesota.

 

Jonathan J. Spees became a Director of Synthetic Blood in July 2004. He is a founder, and has served since August 2002, as Senior Executive Vice President, Corporate Finance and Development for Merit Health Systems LLC headquartered in Louisville, Kentucky. Merit Health Systems is a hospital management company that acquires and operates stand-alone, full-service, urban and suburban community hospitals. As Chief Development Officer, Mr. Spees is based in Santa Monica, California, and applies his experience in healthcare finance, including mergers and acquisitions and financial reporting by health care organizations, to the acquisition, finance and management activities of Merit Health Systems. Before 2002, Mr. Spees was Managing Director for Duff & Phelps, LLC; Principal with Shamrock Investments, a boutique private investment firm specializing in the healthcare industry; and Associate Director of Development for American Medical International, Inc., a $4 billion hospital management company. Mr. Spees is a Certified Public Accountant with public accounting experience as a manager and healthcare industry specialist with Deloitte, Haskins + Sells.

 

Robert W. Nicora became the President, Chief Executive Officer and Director on March 1, 1998. Mr. Nicora has BS in chemistry, five years of graduate study in biochemistry and medical sciences, and over 30 years of experience in various laboratory, management and regulatory positions with pharmaceutical and medical device companies. While at McGaw Laboratories, he was responsible for the development and FDA approval of hetastarch, a synthetic blood expander, now marketed by DuPont Pharma. He led the team that evaluated a joint partnership with Green Cross to develop their perfluorocarbon blood substitute, Fluosol. From 1994 through March 1998, he was director of scientific and regulatory services with Quintiles, the world’s largest global contact pharmaceutical company. He has provided preclinical and clinical drug and device consulting services to a number of startup biomedical companies.

 

David H. Johnson, CPA, is Chief Financial Officer. Mr. Johnson has over 25 years of financial and administrative management experience, including President and Chief Financial Officer of FirstPlus Bank. Previously Mr. Johnson was a regional partner at McGladrey and Pullen, a major public accounting firm. Mr. Johnson has a BA in accounting and is a certified public accountant.

 

Richard Kiral, Ph.D., Vice President of Research and Development, holds a Ph.D. in analytical chemistry and has over of 20 years of experience in the pharmaceutical and medical device industries. He has held vice president positions in R&D at Anthony Products, Ioptex Research, Allergan, and McGaw Laboratories, where he was responsible for development of a nutritional fat emulsion.

 

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Compensation of directors

 

Synthetic Blood currently has three outside members of the Board of Directors. Each outside board member received compensation of $12,000 for fiscal year 2005 and options to purchase 10,000 shares of common stock exercisable over a term of ten years at an exercise price of $0.15 per share.

 

Board meetings and committees; Code of Ethics

 

In the fiscal year ended April 30, 2005, the Board of Directors of Synthetic Blood met three times and these meetings were attended by all of the directors. From time to time the directors also acted through written consents of the board.

 

The Audit Committee is the only standing committee of the board of directors. Mr. Spees is the sole member of the Audit Committee. The Audit Committee is responsible for financial reporting matters, internal controls, and compliance with Synthetic Blood’s financial policies, and meets with its auditors when appropriate. The Audit Committee met 4 times in fiscal year 2005, and all director members of the committee attended the meetings. The Board has determined that Mr. Spees is an “audit committee financial expert” within the meaning of Item 401(h)(2) of Regulation S-K, and that he is “independent” under the definition set forth in Rule 4200(a)(15) of the Nasdaq Marketplace Rules.

 

Due to the fact Synthetic Blood is in the development stage with no operating revenue and activities limited to research and development, the board of directors determined that it is not necessary or practical for Synthetic Blood to establish a Compensation Committee, or adopt a charter for a compensation committee.

 

Synthetic Blood has adopted a Code of Ethics applicable to its chief executive officer and chief financial officer, a copy of which will be provided to any person, free of charge, upon request. A request for a copy of the Code of Ethics should be in writing and sent to Synthetic Blood International, Inc., Attn: Joan Mahan, 3189 Airway Avenue, Building C, Costa Mesa, California 92626.

 

Section 16(a) filings

 

Section 16(a) of the Securities Exchange Act of 1934 requires officers and directors and persons who own more than ten percent of a class of its equity securities registered under Section 12 to file reports of ownership and changes in their ownership on Forms 3, 4, and 5 with the Securities and Exchange Commission. Synthetic Blood does not have a class of equity securities registered under Section `12 of the Securities Exchange Act of 1934, so its officers, directors, and ten percent stockholders are not required to, and do not, file such reports.

 

ITEM 11 - EXECUTIVE COMPENSATION

 

The following table provides certain summary information concerning compensation earned for services rendered in all capacities to Synthetic Blood for the fiscal years ended April 30, 2005, 2004 and 2003, by the Company’s Chief Executive Officer and the other most highly compensated executive officers of Synthetic Blood (“Named Executive Officers”). This information includes the dollar amount of base salaries, bonus awards, stock options and all other compensation, if any, whether paid or deferred.

 

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Summary compensation table

 

          Annual
Compensation


   Long-term
Compensation


  

All Other
Compensation ($)(1)


Name and Position


   Year

   Salary($)

   Bonus($)

   Securities Underlying
Options/SARs(#)


  

Robert Nicora

President

   2005
2004
2003
   189,000
186,750
171,250
   —  
40,000
—  
   150,000
150,000
150,000
   32,197
34,571
31,037

Richard Kiral

Vice President of

Product Development

   2005
2004
2003
   167,000
166,768
150,500
   15,000
—  
—  
   75,000
75,000
75,000
   26,394
22,005
20,150

(1) Mr. Nicora and Mr. Kiral received a $6,600 car allowance plus medical premiums and retirement contributions paid for by Synthetic Blood.

 

Option grants

 

Synthetic Blood adopted a stock option plan in October 1999, which was ratified by a vote of the shareholders during fiscal year ended April 30, 2001. The 1999 plan provides for the granting of incentive and non-qualified options to officers, directors, consultants and key employees to purchase up to 4,000,000 shares of Synthetic Blood’s common stock at prices not less than the fair market value of the stock at the date of grant for incentive options. The option expiration dates are determined at the date of grant, but may not exceed ten years. The total number of options issued under the Plan at April 30, 2005 were 2,645,000 with a weighted average exercise price of $0.24.

 

In addition, Synthetic Blood has issued options outside the Plan. At April 30, 2005 the total non-qualified options outstanding were 3,520,000 with a weighted average exercise price of $0.14.

 

The following table summarizes certain information as of April 30, 2005 concerning the stock options granted to the Named Executive Officers during the fiscal year ended April 30, 2005. No stock appreciation rights, restricted stock awards or long-term performance awards have been granted as of the date hereof and no options have been exercised.

 

Option Grants in Last Fiscal Year

 

     Number of
Securities
Underlying
Options
Granted


   % of Total
Options
Granted to
Employees in
Fiscal Year


    Exercise
or Base
Price Per
Share


  

Expiration

Date


   Potential Realizable
Value at Assumed Annual
Rates of Stock Price
Appreciation of
Option Terms (1)


                5%

   10%

Robert Nicora President

   150,000    50.8 %   $ 0.28    August 2014    $ 26,414    $ 66,937

Richard Kiral Vice President

   75,000    25.4 %   $ 0.24    February 2015    $ 11,320    $ 28,687

 

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(1) Each option listed in the table vests over a three-year period and is exercisable over a ten-year period. The potential realizable value is calculated based on the ten-year term of the option at the time of grant. It is calculated based on assumed annualized rates of stock price appreciation from the exercise price at the date of grant of 5 percent and 10 percent (compounded annually) over the full term of the grant with appreciation determined as of the expiration date. The 5 percent and 10 percent assumed rates of appreciation are mandated by the Securities and Exchange Commission and do not represent Synthetic Blood’s estimate or projection of future common stock prices. Actual gains, if any, on stock options exercised are dependent on the future performance of the common stock and overall stock market conditions. The amounts reflected in the table may not be achieved.

 

Aggregate Options Exercised in Last Fiscal Year and Year End Option Values

 

     Shares
Acquired On
Exercise


   Value
Realized


  

Number of Securities

Underlying Unexercised

Options At Fiscal Year End


  

Value of Unexercised

In-the-Money Options

at Fiscal Year End


               Exercisable/ Unexercisable

   Exercisable/
Unexercisable (1)


Robert Nicora

    President

   None    None    1,050,000/300,000    $ 88,250/$11,500

Richard Kiral

    Vice President

   None    None    600,000/ 125,000    $ 56,750/ $9,500

(1) Based on the closing sale price on the OTC Bulletin Board on the last day of the 2005 fiscal year of $0.28 less the option exercise price payable per share.

 

Employment contracts

 

During March 2002, the Board of Directors approved a three-year employment contract with Robert W. Nicora, as President and Chief Executive Officer. Mr. Nicora’s current base annual salary is $189,000 for the year ending July 2005 with minimum future annual increases of 5 percent and includes an automobile allowance, medical and dental coverage, participation in the Executive Bonus Plan, $500,000 life insurance payable by the corporation and payable to a beneficiary named by the insured, and the grant of 150,000 options annually. At the end of the contract, Mr. Nicora’s contract will renew automatically annually unless terminated by either party. Mr. Nicora’s employment agreement provides that he may, at his election, receive a severance payment equal to 299 percent of his average annual salary and bonuses received during the prior two-year period in the event of a change in control as defined.

 

On February 1, 2000 the Board of Directors approved a two-year employment contract with Richard Kiral, as Vice President of Product Development. Mr. Kiral’s current base annual salary is $167,000 for the year ending January 2006 and includes an automobile allowance, medical and dental coverage, participation in the Executive Bonus Plan, $200,000 life insurance payable by the corporation and payable to a beneficiary named by the insured, and the grant of an option for 75,000 shares annually. The contract will renew automatically annually unless terminated by either party. Mr. Kiral’s employment agreement provides that he is to receive a minimum severance payment equal to 9 months of his annual salary period in the event of a change in control as defined.

 

Compensation committee interlocks and insider participation in compensation decisions

 

Synthetic Blood does not presently have a compensation committee of the Board of Directors, or other committees performing equivalent functions, and did not at any time during the last four years. The Board of Directors presently performs these functions and participated in deliberations concerning

 

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executive officer compensation during the last fiscal year. None of Synthetic Blood’s executive officers serves as a member of the board of directors or compensation committee of any entity that has one or more of its executive officers serving as a member of Synthetic Blood’s Board of Directors or Compensation Committee.

 

ITEM 12 - SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

 

The following table sets forth, as of July 31, 2005, the number and percentage of the outstanding shares of common stock and warrants and options that, according to the information supplied to Synthetic Blood, were beneficially owned by (i) each person who is currently a director, (ii) each executive officer, (iii) all current directors and executive officers as a group and (iv) each person who, to the knowledge of Synthetic Blood, is the beneficial owner of more than five percent of the outstanding common stock. Except as otherwise indicated, the persons named in the table have sole voting and dispositive power with respect to all shares beneficially owned, subject to community property laws where applicable.

 

Name and Address


  

Common

Shares


  

Percent

of Class (1)


 

Principal stockholders

           

Ivan Bergamin (2)

Rotkreuz, Switzerland

   10,000,000    7.80 %

Andreas Camenzind (3)

Ebmatingen, Switzerland

   11,000,000    8.58 %

Dusol Real Estate, Inc. (4)

Obarrio, Panama

   6,506,112    5.08 %

PS Capital AG (5)

Freienbach, Switzerland

   8,006,111    6.25 %

Officers and directors

           

Howard Jones (6)

20454 Rancho Villa Rd.

Ramona, CA 92064

   588,332    0.46 %

Roger A. Ekbom (6)

11850 N. Riveria

Tustin, CA 92762

   1,938,849    1.51 %

Jonathan Spees

1808 Marine St.

Santa Monica, CA 90405

   186,666    0.15 %

Robert W. Nicora (6)

2535 Valencia Ave.

Santa Ana, CA 92706

   1,300,000    1.01 %

David Johnson (6)

20470 Via Marwah

Yorba Linda, CA 92886

   200,000    0.16 %

Richard Kiral (6)

25505 Nottingham Ct.

Laguna Hills, CA 92653

   600,000    0.47 %

All officers and directors as a group (6 persons)

   4,813,847    3.76 %

 

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(1) These figures represent the percentage of ownership of the named individuals assuming each of them alone has exercised his options, and percentage ownership of all officers and directors as a group assuming all purchase rights held by such individuals are exercised.
(2) The figure for Mr. Bergamin includes warrants to purchase 5,000,000 common shares at a price of $0.275 per share that expire December 31, 2007.
(3) The figure for Mr. Camenzind includes warrants to purchase 8,500,000 common shares at a price of $0.20 per share, of which 2,000,000 expire December 3, 2005 and 6,000,000 expire September 30, 2007, and warrants to purchase 500,000 shares at a price of $0.40 per share that expire December 3, 2006.
(4) The figure for Dusol Real Estate, Inc., consists of 3,506,112 common shares, warrants to purchase 1,000,000 shares at an exercise price of $0.20 per share that expire September 4, 2005, and warrants to purchase 2,000,000 shares at a price of $0.40 per share that expire December 3, 2006. Javier Espino of Panama City, Republic of Panama, exercises investment control over the equity investments of Dusol Real Estate.
(5) The figure for PS Capital AG includes 2,500,000 warrants to purchase common stock at an exercise price of $0.275 per share that expire December 31, 2007. Roland Schaub of Zurich, Switzerland, exercises investment control over the equity investments of PS Capital.
(6) These figures include vested options: for Mr. Jones options to purchase 588,332 shares of common stock; for Mr. Ekbom options to purchase 555,000 shares of common stock; for Mr. Nicora options to purchase 1,050,000 shares of common stock; for Mr. Johnson options to purchase 200,000 shares of common stock; for Mr. Kiral options to purchase 600,000 shares of common stock, and, for Mr. Spees options to purchase 186,666 shares of common stock.

 

ITEM 13 - CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

 

During the fiscal year ended April 30, 2005, we paid $125,400 to PrimaPharm for the manufacture of Oxycyte used in clinical trials and testing. Richard Kiral, an officer of Synthetic Blood, is a director and minority stockholder of PrimaPharm.

 

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Table of Contents

ITEM 14 – PRINCIPAL ACCOUNTING FEES AND EXPENSES

 

The aggregate fees billed for professional services by Haskell & White LLP and Grant Thornton LLP in 2005 and 2004 were as follows:

 

     2005

   2004

     Haskell &
White LLP


   Grant
Thornton LLP


   Haskell &
White LLP


   Grant
Thornton LLP


Audit Fees

   $ 58,345    $ 35,000    $ 41,640    $ 34,676

Audit Related Fees

     —        —        —        —  

Tax Fees(1)

   $ 8,430      —      $ 3,500      —  
    

  

  

  

Total

   $ 66,775    $ 35,000    $ 45,140    $ 34,676
    

  

  

  


(1) Tax return and related service

 

It is our Board of Directors’ policy and procedure to approve in advance all audit engagement fees and terms and all permitted non-audit services provided by our independent auditors. We believe that all audit engagement fees and terms and permitted non-audit services provided by our independent auditors as described in the above table were approved in advance by our Board of Directors.

 

PART IV

 

ITEM 15 - EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

 

FINANCIAL STATEMENTS

 

  (a) Reports of Independent Registered Public Accounting Firms.

 

  (b) Balance Sheets as of April 30, 2005 and 2004.

 

  (c) Statements of Operations for each of the three years in the period ended April 30, 2005 and for the period May 26, 1967 (Date of Inception) to April 30, 2005.

 

  (d) Statements of Stockholders’ Equity for each of the three years in the period ended April 30, 2005 and for the period May 26, 1967 (Date of Inception) to April 30, 2005.

 

  (e) Statements of Cash Flows for each of the three years in the period ended April 30, 2005 and for the period May 26, 1967 (Date of Inception) to April 30, 2005.

 

  (f) Notes to the Financial Statements.

 

INDEX TO EXHIBITS

 

Exhibit No.

 

Exhibits Required by Item 601 of Regulation S-K


3.1   Certificate of Incorporation, including all amendments (1)
3.2   Amended and Restated Bylaws (1)
10.1   Agreement with Leland C. Clark, Jr., Ph.D. dated November 20, 1992 with amendments, Assignment of Intellectual Property/ Employment (1)
10.2   Agreement between the Registrant and Keith R. Watson, Ph.D. Assignment of Invention (1)

 

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Table of Contents
10.3    Children’s Hospital Research Foundation License Agreement dated February 28, 2001 (1)
10.4    1999 Employee Stock Plan (1)
10.5    Form of Option issued to Executive Officers and Directors (1)
10.6    Form of Option issued to Employees (1)
10.7    Stock Option Agreement issued to Andreas Camenzind, December 3, 2001 (1)
10.8    Form of Option (Warrant) Issued to Foreign Consultants – June 2003 (1)(2)
10.9    Form of Warrant issued to Service Providers (1)(3)
10.10    Form of Offshore Restricted Securities Subscription Agreement – Fiscal Year 2004 (1)
10.11    Employment Agreement with Robert W. Nicora (1)
10.12    Employment Agreement with Richard Kiral (1)
10.13    Form of Offshore Securities Purchase Agreement – May 2004 (4)
10.14    Form of Series A Warrant issued in May 2004 (4)
10.15    Form of Series B Warrant issued in May 2004 (4)
10.16    Form of Series C Warrant issued in May 2004 (4)
10.17    Registration Rights Agreement dated May 13, 2004 (4)
10.18    Form of Warrant Issued to Overseas Investors – February 2005 (5)
10.19    Securities Purchase Agreement dated July 8, 2005, including all exhibits except for Exhibit D – Form of Legal Opinion, and excluding the Disclosure Schedules of Synthetic Blood (6)
16.1    Letter from Grant Thornton LLP to the SEC dated September 25, 2003 (7)
31.1    Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2    Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1    Certification 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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(1) These documents were filed as exhibits to the annual report on Form 10-K filed by Synthetic Blood with the Securities and Exchange Commission on August 13, 2004, and are incorporated herein by this reference.
(2) In September 2004, Synthetic Blood issued this instrument for the purchase of common stock at an exercise price of $0.20 per share that expires September 4, 2005 to the following persons in the amounts shown:

 

Markus Beck

   500,000 shares

Victor Dario

   1,000,000 shares

Dusol Real Estate

   1,000,000 shares

Aurelio Landolt

   500,000 shares

Werner Rhaese

   1,000,000 shares

 

(3) This is the form of warrant to purchase common stock issued to certain service providers as follows:

 

Name


   No. of shares

   Exercise Price

   Expiration

James Reavis

   80,000    $ 0.15    10/13/09
     2,500    $ 0.01    12/01/08

Robert J. Skalnik

   17,476    $ 0.01    12/29/05
     5,769    $ 0.01    01/12/06
     6,250    $ 0.01    06/06/06
     7,143    $ 0.01    09/06/06
     2,500    $ 0.01    12/02/08

Jonathan Spees

   20,000    $ 0.20    09/17/05

 

(4) These documents were filed as exhibits to the current report on Form 8-K filed by Synthetic Blood with the Securities and Exchange Commission on May 26, 2004, and are incorporated herein by this reference.
(5) In February 2005, Synthetic Blood issued this instrument for the purchase of common stock at an exercise price of $0.40 per share that expires December 3, 2006 to the following persons in the amounts shown:

 

Markus Beck

   1,000,000 shares

Andreas Camenzind

   500,000 shares

Victor Dario

   500,000 shares

Dusol Real Estate

   2,000,000 shares

Aurelio Landolt

   1,000,000 shares

Meier Simon

   500,000 shares

 

This document was filed as an exhibit to the current report on Form 8-K filed by Synthetic Blood with the Securities and Exchange Commission on February 24, 2005, and is incorporated herein by this reference.

(6) These documents were filed as exhibits to the current report on Form 8-K filed by Synthetic Blood with the Securities and Exchange Commission on July 14, 2005, and are incorporated herein by this reference.
(7) This document was filed as an exhibit to the current report on Form 8-K filed by Synthetic Blood with the Securities and Exchange Commission on September 26, 2003, and is incorporated herein by this reference.

 

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SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereto duly authorized.

 

    SYNTHETIC BLOOD INTERNATIONAL, INC.
August 15, 2005   By  

/s/ Robert W. Nicora


       

Robert W. Nicora, Chief Executive Officer

(Principal Executive Officer)

August 15, 2005   By  

/s/ David H. Johnson


       

David H. Johnson, Chief Financial Officer

       

(Principal Financial Officer and Principal

Accounting Officer)

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated.

 

/s/ Howard Jones


Howard Jones, Director

   Date: August 15, 2005

/s/ Roger A. Ekbom


Roger A. Ekbom, Director

   Date: August 15, 2005

/s/ Jonathan Spees


Jonathan Spees, Director

   Date: August 15, 2005

/s/ Robert W. Nicora


Robert W. Nicora, Director

   Date: August 15, 2005

 

Supplemental Information to Be Furnished With Reports Filed Pursuant to Section 15(d) of the Act

By Registrants Which Have Not registered Securities Pursuant to Section 12 of the Act

 

No annual report to stockholders or proxy materials were disseminated to the stockholders of Synthetic Blood during the fiscal year ended April 30, 2005.

 

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Table of Contents

INDEX TO FINANCIAL STATEMENTS

 

CONTENTS

 

     Page

REPORTS OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS

   F-2

FINANCIAL STATEMENTS

    

BALANCE SHEETS

   F-5

STATEMENTS OF OPERATIONS

   F-7

STATEMENTS OF STOCKHOLDERS’ EQUITY

   F-8

STATEMENTS OF CASH FLOWS

   F-10

NOTES TO FINANCIAL STATEMENTS

   F-13

 

F-1


Table of Contents

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

Board of Directors and Stockholders

Synthetic Blood International, Inc.

 

We have audited the accompanying balance sheets of Synthetic Blood International, Inc. (a development stage company) (the “Company”) as of April 30, 2005 and 2004, and the related statements of operations, stockholders’ equity and cash flows for the two year period ended April 30, 2005 and for the period from inception, May 26, 1967, through April 30, 2005. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits. The Company’s statements of operations, stockholders’ equity and cash flows for the period ended April 30, 2003 and for the period from inception, May 26, 1967, through April 30, 2003, were audited by other auditors whose report, dated June 30, 2003, included an explanatory paragraph regarding substantial doubt about the Company’s ability to continue as a going concern. The financial statements for the period from inception, May 26, 1967, through April 30, 2003, reflect cumulative net losses of $18,700,730. The other auditors’ report has been furnished to us, and our opinion expressed herein, insofar as it relates to the amounts for such prior periods, is based solely on the report of other auditors.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits, and the report of the other auditors, provide a reasonable basis for our opinion.

 

In our opinion, based on our audits and the report of other auditors, the financial statements referred to above present fairly, in all material respects, the financial position of Synthetic Blood International, Inc. as of April 30, 2005 and 2004, and the results of its operations and its cash flows for the two year period ended April 30, 2005 and for the period from inception, May 26, 1967, through April 30, 2005, in conformity with accounting principles generally accepted in the United States of America.

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company is a development stage enterprise presently generating no revenues and the Company has a deficit accumulated during the development stage of $23,622,731. Further, the Company used cash in operations of $1,991,956 during the year ended April 30, 2005, and has limited working

 

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capital available as of April 30, 2005. The Company will require substantial additional financing to fund operations and development until the necessary regulatory approvals are obtained, if ever. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans concerning these matters are described in Note A. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/S/ HASKELL & WHITE LLP

 

Irvine, California

June 30, 2005

 

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Table of Contents

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

Board of Directors

Synthetic Blood International, Inc.

 

We have audited the accompanying statements of operations, stockholders’ equity and cash flows of Synthetic Blood International, Inc. (a Company in the development stage) for the year ended April 30, 2003 and for the period from inception (May 26, 1967) to April 30, 2003. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audit.

 

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included considerations of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

 

In our opinion, the financial statements referred to above present fairly, in all material respects, the results of Synthetic Blood International, Inc.’s operations and its cash flows for the year ended April 30, 2003 and for the period from inception (May 26, 1967) to April 30, 2003, in conformity with accounting principles generally accepted in the United States of America.

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company is a development stage enterprise engaged in developing certain medical products. The Company has an accumulated deficit during the development stage of $18,700,730 as of April 30, 2003, and has used cash in operations of $2,093,762 during the year ended April 30, 2003. The Company will require substantial additional financing to fund operations until the necessary regulatory approvals are obtained, if ever. These factors, among others as described in Note A, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans concerning these matters are described in Note A. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/S/ GRANT THORNTON LLP

 

Irvine, California

June 30, 2003

 

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SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

BALANCE SHEETS

 

April 30,

 

     2005

    2004

 
ASSETS                 

CURRENT ASSETS:

                

Cash and cash equivalents

   $ 588,763     $ 302,310  

Prepaid expenses and other current assets

     77,686       118,980  
    


 


Total current assets

     666,449       421,290  
    


 


PROPERTY AND EQUIPMENT

                

Laboratory equipment

     730,811       661,101  

Furniture and fixtures

     31,696       31,731  

Leasehold improvements

     4,810       4,810  
    


 


       767,317       697,642  

Less accumulated depreciation

     (383,039 )     (290,448 )
    


 


Property and equipment, net

     384,278       407,194  
    


 


PATENTS, net

     211,618       219,495  
    


 


     $ 1,262,345     $ 1,047,979  
    


 


 

The accompanying notes are an integral part of these financial statements.

 

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SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

BALANCE SHEETS - CONTINUED

 

April 30,

 

     2005

    2004

 
LIABILITIES AND STOCKHOLDERS’ EQUITY                 

CURRENT LIABILITIES

                

Accounts payable

   $ 269,975     $ 237,249  

Accrued expenses

     43,969       56,449  
    


 


Total current liabilities

     313,944       293,698  
    


 


COMMITMENTS AND CONTINGENCIES

                

STOCKHOLDERS’ EQUITY:

                

Preferred stock, undesignated; authorized 10,000,000 shares; none issued or outstanding at April 30, 2005 and 2004, respectively

     —         —    

Common stock, par value $0.01 per share; authorized 200,000,000 shares; 125,659,918 and 113,808,876 shares issued and outstanding at April 30, 2005 and 2004, respectively

     1,256,599       1,138,089  

Additional paid-in capital

     23,283,449       20,708,959  

Deposits on common stock

     140,833       —    

Deferred compensation

     (109,749 )     (142,834 )

Deficit accumulated during the development stage

     (23,622,731 )     (20,949,933 )
    


 


Total stockholders’ equity

     948,401       754,281  
    


 


     $ 1,262,345     $ 1,047,979  
    


 


 

The accompanying notes are an integral part of these financial statements.

 

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SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

STATEMENTS OF OPERATIONS

 

For the Three Years Ended April 30, 2005 and for the Period

May 26, 1967 (Date of Inception) to April 30, 2005

 

     Period from
May 26, 1967
(inception) to
April 30, 2005


    2005

    2004

    2003

 

EXPENSES

                                

Research and development

   $ 9,460,256     $ 1,277,125     $ 1,266,423     $ 1,433,040  

General and administrative

     14,611,018       1,407,487       1,000,782       840,352  

Interest

     182,643       —         —         2,503  
    


 


 


 


Total expenses

     24,253,917       2,684,612       2,267,205       2,275,895  

OTHER INCOME (primarily interest)

     (631,186 )     (11,814 )     (18,002 )     (48,558 )
    


 


 


 


NET LOSS

   $ (23,622,731 )   $ (2,672,798 )   $ (2,249,203 )   $ (2,227,337 )
    


 


 


 


NET LOSS PER SHARE - Basic and diluted

           $ (0.02 )   $ (0.02 )   $ (0.03 )
            


 


 


WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - Basic and diluted

             118,841,402       95,327,891       88,651,158  
            


 


 


 

The accompanying notes are an integral part of these financial statements.

 

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SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

STATEMENTS OF STOCKHOLDERS’ EQUITY

 

For the Three Years Ended April 30, 2005 and for the Period

May 26, 1967 (Date of Inception) to April 30, 2005

 

     Common Stock

  

Additional
paid-in
capital


  

Deposits
on common
stock


  

Deferred
compensation


  

Deficit
accumulated
during the
development
stage


   

Total
stockholders’
equity


 
     Number of
shares


   Amount

             

BALANCES, May 26, 1967

   —      $ —      $ —      $  —      $  —      $ —       $ —    

Issuance of common stock

   66,334,741      663,347      12,367,141      —        —        —         13,030,488  

Issuance of common stock upon conversion of debentures

   1,401,399      14,014      818,234      —        —        —         832,248  

Issuance of common stock to employees and compensatory options

   218,800      2,188      1,706,095      —        —        —         1,708,283  

Issuance of common stock for services rendered

   1,098,994      10,990      255,895      —        —        —         266,885  

Issuance of common stock to officers to retire shareholder loans

   1,044,450      10,444      177,556      —        —        —         188,000  

Common stock issued in conjunction with funding agreements and services rendered

   5,376,365      53,764      883,160      —        —        —         936,924  

Common stock issued upon conversion of notes payable

   4,766,820      47,668      637,607      —        —        —         685,275  

Issuance of warrants and options

   —        —        232,980      —        —        —         232,980  

Exercise of warrants and options

   5,335,676      53,357      588,177      —        —        —         641,534  

Contributions of capital for cash and services rendered

   —        —        65,700      —        —        —         65,700  

Contribution of capital by shareholders

   —        —        581,818      —        —        —         581,818  

Issuance of common stock for promissory note

   3,000,000      30,000      370,000      —        —        —         400,000  

Net loss

   —        —        —        —        —        (16,473,393 )     (16,473,393 )
    
  

  

  

  

  


 


Balances at April 30, 2002

   88,577,245      885,772      18,684,363      —        —        (16,473,393 )     3,096,742  
    
  

  

  

  

  


 


 

The accompanying notes are an integral part of these financial statements.

 

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SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

STATEMENTS OF STOCKHOLDERS’ EQUITY - CONTINUED

 

For the Three Years Ended April 30, 2005 and for the Period

May 26, 1967 (Date of Inception) to April 30, 2005

 

     Common Stock

  

Additional
paid-in
capital


  

Deposits
on common
stock


  

Deferred
Compensation


   

Deficit
accumulated
during the
development
stage


   

Total
stockholders’
equity


 
     Number of
shares


   Amount

            

Balances at April 30, 2002

   $ 88,577,245    $ 885,772    $ 18,684,363    $ —      $ —       $ (16,473,393 )   $ 3,096,742  

Issuance of common stock for:

                                                    

Exercise of stock warrants

     36,629      367      —        —        —         —         367  

Services rendered

     170,000      1,700      28,900      —        —         —         30,600  

Net loss

     —        —        —        —        —         (2,227,337 )     (2,227,337 )
    

  

  

  

  


 


 


Balances at April 30, 2003

     88,783,874    $ 887,839    $ 18,713,263    $ —      $ —       $ (18,700,730 )   $ 900,372  

Issuance of common stock for:

                                                    

Exercise of stock options

     5,000      50      575      —        —         —         625  

Cash proceeds, net of offering costs

     25,020,002      250,200      1,751,401      —        —         —         2,001,601  

Issuance of stock options for services rendered

     —        —        1,970      —        —         —         1,970  

Compensation on options and warrants issued

     —        —        241,750      —        (142,834 )     —         98,916  

Net loss

     —        —        —        —        —         (2,249,203 )     (2,249,203 )
    

  

  

  

  


 


 


Balances at April 30, 2004

     113,808,876    $ 1,138,089    $ 20,708,959    $ —      $ (142,834 )   $ (20,949,933 )   $ 754,281  

Issuance of common stock for:

                                                    

Services rendered

     125,000      1,250      41,250      —        —         —         42,500  

Cash proceeds, net of offering costs

     11,726,042      117,260      2,127,240                             2,244,500  

Deposits received on common stock

     —        —        —        140,833      —         —         140,833  

Compensation on options and warrants issued

                   406,000      —        (95,000 )     —         311,000  

Amortization of deferred compensation

     —        —        —        —        128,085       —         128,085  

Net loss

     —        —                              (2,672,798 )     (2,672,798 )
    

  

  

  

  


 


 


Balances at April 30, 2005

     125,659,918    $ 1,256,599    $ 23,283,449    $ 140,833    $ (109,749 )   $ (23,622,731 )   $ 948,401  
    

  

  

  

  


 


 


 

The accompanying notes are an integral part of these financial statements.

 

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SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

STATEMENTS OF CASH FLOWS

 

For the Three Years Ended April 30, 2005 and for the Period

May 26, 1967 (Date of Inception) to April 30, 2005

 

     Period from
May 26, 1967
(inception) to
April 30, 2005


    2005

    2004

    2003

 

Cash flows from operating activities:

                                

Net loss

   $ (23,622,731 )   $ (2,672,798 )   $ (2,249,203 )   $ (2,227,337 )

Adjustments to reconcile net loss to net cash used in operating activities:

                                

Depreciation and amortization

     1,013,918       137,717       141,712       137,049  

Amortization of deferred compensation

     227,001       128,085       98,916       —    

Loss on disposal and write-down of property, equipment and other assets

     150,409       —         —         8,325  

Issuance of compensatory stock options and warrants

     2,229,263       311,000       —         —    

Issuance of stock below fair market value

     695,248       —         —         —    

Issuance of stock for services rendered

     1,265,279       42,500       1,970       30,600  

Contribution of capital through services rendered by stockholders

     216,851       —         —         —    

Changes in operating assets and liabilities:

                                

Prepaid expenses and other current assets

     (77,686 )     41,294       (46,020 )     16,577  

Accounts payable and accrued expenses

     490,536       20,246       279,165       (58,976 )
    


 


 


 


Net cash used in operating activities

     (17,411,912 )     (1,991,956 )     (1,773,460 )     (2,093,762 )
    


 


 


 


Cash flows from investing activities:

                                

Purchase of property and equipment

     (1,077,573 )     (69,675 )     (80,417 )     (37,872 )

Proceeds from sale of property and equipment

     15,458       —         —         —    

Purchase of other assets

     (645,765 )     (37,249 )     (24,481 )     (26,737 )
    


 


 


 


Net cash used in investing activities

     (1,707,880 )     (106,924 )     (104,898 )     (64,609 )
    


 


 


 


 

The accompanying notes are an integral part of these financial statements.

 

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SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

STATEMENTS OF CASH FLOWS - CONTINUED

 

For the Three Years Ended April 30, 2005 and for the Period

May 26, 1967 (Date of Inception) to April 30, 2005

 

     Period from
May 26, 1967
(inception) to
April 30, 2005


    2005

   2004

   2003

 

Cash flows from financing activities:

                              

Proceeds from stockholder debt

   $ 977,692     $ —      $ —      $ —    

Repayments of amounts due to stockholders

     (121,517 )     —        —        —    

Proceeds from issuance of notes payable

     465,065       —        —        —    

Proceeds from issuance of convertible debentures

     811,000       —        —        —    

Payments on short-term notes payable

     (425,991 )     —        —        (105,569 )

Payments on long-term debt

     (238,971 )     —        —        —    

Payments on capital lease obligation

     (52,338 )     —        —        —    

Proceeds from exercise of stock options and warrants

     512,026       —        625      367  

Deposits on common stock

     140,833       140,833      —        —    

Contribution of capital from stockholders

     40,700       —        —        —    

Net proceeds from issuance of common stock

     17,602,056       2,244,500      2,001,601      —    
    


 

  

  


Net cash provided by (used in) financing activities

     19,710,555       2,385,333      2,002,226      (105,202 )
    


 

  

  


Net increase (decrease) in cash and cash equivalents

     588,763       286,453      123,868      (2,263,573 )

Cash and cash equivalents, beginning of period

     —         302,310      178,442      2,442,015  
    


 

  

  


Cash and cash equivalents, end of period

   $ 588,763     $ 588,763    $ 302,310    $ 178,442  
    


 

  

  


Cash paid for:

                              

Interest

   $ 143,129     $ —      $ —      $ 2,503  
    


 

  

  


Income taxes

   $ 17,000     $ 1,550    $ 1,340    $ 4,570  
    


 

  

  


 

The accompanying notes are an integral part of these financial statements.

 

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Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

STATEMENTS OF CASH FLOWS - CONTINUED

 

For the Three Years Ended April 30, 2005 and for the Period

May 26, 1967 (Date of Inception) to April 30, 2005

 

Supplemental information:

 

During Fiscal Year 2005:

 

The Company issued 500,000 incentive stock options to a Director of the Company. Deferred compensation of $95,000 has been recorded for the difference between the market value of the shares at the date of grant over the strike price and will be amortized to compensation expense over the 2-year vesting period. Related amortization of compensation expense aggregated $31,667 during fiscal year 2005.

 

During Fiscal Year 2004:

 

The Company issued 12,122,223 shares of common stock and issued warrants for the purchase of 4,000,000 shares of the Company’s common stock. The estimated fair value of the common stock issued of $7,030,000 and the warrants of $340,500 has been offset against Additional Paid-In Capital as a reduction of the proceeds from the private placement.

 

The Company issued 500,000 incentive stock options to a Director of the Company and 75,000 incentive stock options to the Company’s Vice President. Deferred compensation of $241,750 has been recorded for the difference between the market value of the shares at the date of grant over the strike price and will be amortized to compensation expense over the 2-year vesting period. Related amortization of compensation expense aggregated $98,916 during fiscal year 2005.

 

During Fiscal Year 2003:

 

The Company issued 170,000 shares of common stock for legal services rendered. The Company recorded an expense of $30,600, which represents the fair value of the common stock on the date the liability was settled.

 

The accompanying notes are an integral part of these financial statements.

 

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Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE A – DESCRIPTION OF BUSINESS AND GOING CONCERN

 

Description of Business - Synthetic Blood International, Inc. (“the Company”) was incorporated on May 26, 1967 and was inactive through September 1990, when it began conducting operations for the purpose of developing a synthetic blood emulsion to act as a human blood substitute, and a method of using a perfluorocarbon compound to facilitate oxygen exchange for individuals with respiratory distress syndrome. Shortly after commencing these operations, the Company changed its name to Synthetic Blood International, Inc. The Company is also developing an implantable, continuous reading glucose biosensor to be used primarily by individuals with diabetes. The Company submitted an Investigational New Drug Application (IND) for Oxycyte, the Company’s alternative to transfused blood for use in surgical and similar medical situations, to the Food and Drug Administration (FDA) in 2003 and successfully conducted a Phase I safety clinical study in the fourth quarter of 2003. The results of the Phase I study were consistent with the results of preclinical animal safety studies, and showed a good safety profile for Oxycyte. The Company started Phase II clinical trials of Oxycyte in surgical patients in 2005. Fluorovent, an oxygen exchange fluid for facilitating the treatment of lung conditions, and the glucose biosensor are at the preclinical development stage, and are currently inactive, awaiting additional financing. The Company has not generated any revenues since inception.

 

Going Concern - Management believes the accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate continuation of the company as a going concern. The Company has an accumulated deficit during the development stage of $23,622,731 at April 30, 2005 and used cash in operations of $1,991,956 during the year ended April 30, 2005.

 

In view of the matters described above, recoverability of a major portion of the recorded asset amounts shown in the accompanying balance sheet is dependent upon continued operations of the Company, which in turn is dependent upon the Company’s ability to meet its financing requirements on a continuing basis, to maintain present financing, and to generate cash from future operations. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.

 

Management believes that the Company’s existing working capital, along with the proceeds expected from the sale of its common stock as described in Note J and subsequent financing transactions, will be sufficient to meet its continuing obligations for the foreseeable future; however, there can be no assurance that the Company will successfully implement its plan.

 

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Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE B - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Development Stage - The Company has not commenced its planned principal operations, and there have been no significant revenues, therefore it is considered a “Development Stage Enterprise.”

 

Cash and Cash Equivalents - The Company considers all highly liquid instruments with a maturity date of three months or less, when acquired, to be cash equivalents.

 

Cash Concentrations - The Company maintains cash balances at financial institutions, which may at times, exceed the amounts insured by the Federal Deposit Insurance Corporation of $100,000 per institution. However, management does not believe there is significant credit risk associated with these financial institutions.

 

Property and Equipment - Property and equipment are recorded at cost. Depreciation and amortization are computed using the straight-line method over the shorter of the estimated useful lives of the related assets, ranging from three to ten years, or the lease term, if applicable.

 

Loss Per Share - Basic loss per share, which excludes antidilutive securities, is computed by dividing loss available to common shareholders by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Potentially dilutive securities, however, have not been included in the diluted loss per share computation because their effect is antidilutive.

 

Income Taxes – Deferred tax assets and liabilities are recorded for differences between the financial statement and tax bases of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is recorded for the amount of income tax payable or refundable for the period increased or decreased by the change in deferred tax assets and liabilities during the period.

 

Use of Estimates - The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of other income and expenses during the reporting periods. Actual results could differ from those estimates.

 

Fair Value of Financial Instruments - The Company’s balance sheet includes the following financial instruments: cash and cash equivalents. The Company considers the carrying amount in the financial statements to approximate fair value for these financial instruments because of liquidity and short-term nature of the instruments.

 

F-14


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE B - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES – Continued

 

Stock-Based Compensation - The Company accounts for stock-based employee compensation as prescribed by APB Opinion No. 25, Accounting for Stock Issued to Employees, and, effective April 30, 2003, has adopted Statement of Financial Accounting Standards (“SFAS”) 148, Accounting for Stock-Based Compensation-Transition and Disclosure (“SFAS 148”) that amends Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation (“SFAS 123”). SFAS 123 and SFAS 148 require pro

 

forma disclosures of net income and net income per share as if the fair value based method of accounting for stock-based awards had been applied for both employee and non-employee grants. They also require disclosure of option status on a more prominent and frequent basis. Such disclosure for the years ended April 30, 2005, 2004 and 2003 is presented below. The Company accounts for stock options and warrants issued to non-employees based on the fair value method, but has not elected this treatment for grants to employees and board members. Under the fair value based method, compensation cost is recorded based on the value of the award at the grant date and is recognized over the service period.

 

The fair value of each option grant was estimated at the grant date using the Black-Scholes option-pricing model using the following assumptions: an average risk-free interest rate of 3.7% for 2005, 3.4% for 2004 and 4.2% for 2003; average volatility of 116% for 2005, 130% for 2004, and 119% for 2003; zero dividend yield for all years; and expected lives of 1 to 10 years.

 

The Black–Scholes option valuation model was developed for use in estimating the fair value of traded options and warrants that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility. Because the Company’s stock options and warrants have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its stock options and warrants. The Company’s calculations are based on a single option valuation approach and forfeitures are recognized as they occur.

 

F-15


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE B - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES – Continued

 

The following table illustrates the effect on net income and earnings per share if the fair value based method had been applied to all outstanding and unvested employee awards:

 

     Years ended April 30,

 
     2005

    2004

    2003

 

Net loss, as reported

   $ (2,672,798 )   $ (2,249,203 )   $ (2,227,337 )

Add: stock-based employee compensation expenses

     128,085       98,916       —    

Deduct: fair value based employee compensation expenses

     (281,215 )     (232,767 )     (79,192 )
    


 


 


Pro forma net loss

   $ (2,825,928 )   $ (2,383,054 )   $ (2,306,529 )
    


 


 


Earning per share:

                        

As reported

   $ (0.02 )   $ (0.02 )   $ (0.03 )

Pro forma

   $ (0.02 )   $ (0.02 )   $ (0.03 )

 

Recent Accounting Pronouncements - In December 2004, the FASB issued SFAS 123R, “Share-Based Payment: an amendment to FASB Statements No. 123 and 95,” which requires companies to recognize in their income statement the grant-date fair value of stock options and other equity-based compensation issued to employees. SFAS No. 123R is effective for annual periods beginning after June 15, 2005. Accordingly, the Company will adopt SFAS No. 123R on May 1, 2006. Management expects the adoption of this new pronouncement to have an impact on the Company’s financial statements similar to that included in the table presenting the Company’s pro forma net loss had it utilized the fair value method for employee stock options.

 

Reclassifications - Certain amounts as previously reported have been reclassified to conform to the 2005 presentation.

 

F-16


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE C - PATENTS

 

The Company’s intangible assets consist of expenditures associated with patents related to the Company’s various technologies. Capitalized costs include amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of patent applications. These assets are amortized on a straight-line method over their estimated useful lives, which range from eight to ten years. The Company reviews these intangible assets for impairment in accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets (“SFAS 144”). At April 30, 2005, management believes no indications of impairment existed.

 

Patents consist of the following at April 30:

 

     2005

    2004

 

Patents

     526,337     $ 489,088  

Less accumulated amortization

     (314,719 )     (269,593 )
    


 


     $ 211,618     $ 219,495  
    


 


 

The amortization expense for years ended April 30, 2005, 2004 and 2003 was $45,126, $42,565 and $47,812, respectively. The unamortized balance of patents is estimated to be amortized over the next five years as follows:

 

Fiscal Year ending April 30:


    

2006

   $ 42,100

2007

   $ 38,400

2008

   $ 33,900

2009

   $ 26,900

2010

   $ 20,600

 

NOTE D - COMMITMENTS AND CONTINGENCIES

 

Litigation - The Company is subject to litigation in the normal course of business, none of which management believes will have a material adverse effect on the Company’s financial statements.

 

Employment Contracts - The Company’s Board of Directors has approved a three-year employment contract with its President and Chief Executive Officer at a base annual salary as determined by the Board (currently $189,000 with minimum 5% annual increases) and includes an annual stock option grant of 150,000 shares of the Company’s common stock. The initial contract period expires July 31, 2005, however, the contract will automatically renew annually thereafter unless terminated by either party. The contract provides that he may, at his election, receive a severance payment equal to 299% of his average annual salary and bonuses received during the prior two-year period in the event of a change in control, as defined.

 

F-17


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE D - COMMITMENTS AND CONTINGENCIES – Continued

 

The Company also has a two-year employment contract with its Vice President of Product Development at a base annual salary as determined by the Board (currently $167,000) and includes an annual stock option grant of 75,000 shares of the Company’s common stock. The initial contract period has expired, however, the contract automatically renews annually unless terminated by either party. The contract provides that he is to receive a severance payment equal to nine months of his average annual salary and bonuses received during the prior two-year period in the event of a change in control, as defined.

 

NOTE E- STOCKHOLDERS’ EQUITY

 

Fiscal Year 2005:

 

The Company received $612,000, net of $68,000 of direct costs, for the sale of 2,266,666 shares of common stock, at a price of $0.30 per share. Each investor also received 2,266,666 Series A warrants, as further disclosed in Note F.

 

The Company also received $1,632,500, net of $255,000 of direct costs, for the sale of 9,437,500 shares of common stock at a price of $0.20 per share. Each investor also received 9,437,500 Series A warrants, as further disclosed in Note F. The Company also issued 21,875 shares of common stock as compensation for assistance with this placement. The fair value of the common stock issued of $4,813 has been determined using the market price of the stock on the issue date and has been offset against Additional Paid-In Capital as a reduction of the proceeds from the private placement.

 

The Company issued 125,000 shares of common stock for legal services rendered. The Company recorded an expense of $42,500, which represents the fair value of the common stock on the date the stock was issued.

 

The Company received initial payment of $140,000 under a purchase agreement signed in October 2004 and extended in November 2004 for the purchase of 2,500,000 shares of common stock at $0.185 per share plus a warrant to purchase 6,000,000 shares of common stock at $0.20 per share that expires in September 2007. As noted in Note J, the balance under the agreement was received subsequent to April 30, 2005.

 

F-18


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE E- STOCKHOLDERS’ EQUITY– Continued

 

Fiscal Year 2004:

 

The Company received $2,001,601 for the sale of 12,897,779 shares of common stock, at prices ranging from $0.15 to $0.18 per share, in connection with a $2,000,000 private placement of its common stock.

 

In addition, the Company issued 12,122,223 shares of common stock, and a warrant to purchase 4,000,000 shares of common stock at $0.20 per share, as compensation to foreign advisors and financial consultants for services rendered in connection with the $2,000,000 common stock placement. The estimated fair value of the common stock of $7,030,000 was determined using the stock price on February 11, 2004, the date the Company obtained the funds and was obligated to issue the shares. The fair value of the warrants of $340,500 was determined using the Black-Scholes option-pricing model using the following assumptions: an average risk-free interest rate of 1.67%, average volatility of 70.1%, zero dividend and expected lives of 2 years. The fair value of the warrants and common stock was offset against Additional Paid-In Capital as a reduction of the proceeds from the private placement when the shares were issued.

 

The Company issued 5,000 shares of common stock for cash proceeds of $625 resulting from the exercise of previously granted stock options issued for services.

 

Fiscal Year 2003:

 

The Company issued 170,000 shares of common stock for legal services rendered. The Company recorded an expense of $30,600, which represents the fair value of the common stock on the date the liability was settled.

 

The Company issued 36,629 shares of common stock for cash proceeds of $367 resulting from the exercise of previously issued stock warrants.

 

NOTE F - STOCK OPTIONS AND WARRANTS

 

In September 1999, the Company’s Board of Directors approved the 1999 Stock Plan (the “1999 Plan”) which provides for the granting of incentive and nonstatutory stock options to employees, directors and consultants to purchase up to 4,000,000 shares of the Company’s common stock. The 1999 Plan was approved by stockholders on October 10, 2000. Options granted under the 1999 Plan are exercisable at various dates up to four years and have expiration periods of generally ten years. As of April 30, 2005, the Company had 2,645,000 qualified stock options outstanding under the 1999 Plan. In addition, the Company has 3,520,000 non-qualified stock options outstanding as of April 30, 2005.

 

F-19


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE F - STOCK OPTIONS AND WARRANTS – Continued

 

Fiscal Year 2005:

 

The Company issued 295,000 stock options with a weighted average exercise price of $0.28 to its employees and two Directors. All options were incentive stock options issued under the 1999 Stock Plan. The stock options granted had exercise prices equal to the fair market value of the Company’s stock on the dates of grant.

 

The Company issued 500,000 non-qualified stock options to a Company Director. The options have an exercise price of $0.15 per share, vest over a three year period and expire in 2009. Deferred compensation has been recorded for the difference between the market price and the exercise price at the date of grant and will be amortized over the vesting period. Compensation expense associated with this grant totaled $31,667 for the year ended April 30, 2005.

 

Fiscal Year 2004:

 

The Company issued 285,000 stock options with a weighted average exercise price of $0.24 to its employees and one Director. All options were incentive stock options issued under the 1999 Stock Plan. The stock options granted had exercise prices equal to the fair market value of the Company’s stock on the dates of grant.

 

The Company issued 500,000 non-qualified stock options to the Company’s Chairman of the Board of Directors. The options have an exercise price of $0.15 per share, vest over a three year period and expire in 2008. Also, 75,000 non-qualified stock options were issued to the Company’s Vice President of Product Development. The options have an exercise price of $0.15 per share, vest over a three year period and expire in 2014. Deferred compensation has been recorded for the difference between the market price and the exercise price at the date of grant and will be amortized over the respective vesting periods. Compensation expense associated with these grants totaled $98,916 for the year ended April 30, 2004.

 

Fiscal Year 2003:

 

The Company issued 490,000 stock options with a weighted average exercise price of $0.17 to its employees and one Director. All options were incentive stock options issued under the 1999 Stock Plan. The stock options granted have exercise prices equal to the fair market value of the Company’s stock on the dates of grant.

 

F-20


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE F - STOCK OPTIONS AND WARRANTS – Continued

 

The following table summarizes certain information related to the Company’s stock options:

 

     Year ended April 30, 2005

   Year ended April 30, 2004

     Options

    Weighted
Average
Exercise
Price


   Options

    Weighted
Average
Exercise
Price


Outstanding, beginning of year

   5,390,000     $ 0.18    4,535,000     $ 0.18

Granted

   795,000       0.20    860,000       0.24

Forfeited

   (20,000 )     0.23    —         —  

Exercised

   —         —      (5,000 )     0.13
    

 

  

 

Outstanding, end of year

   6,165,000     $ 0.19    5,390,000     $ 0.18
    

 

  

 

 

As of April 30, 2005, there were 1,355,000 options available for grant under the 1999 Plan.

 

The following table summarizes information about stock options outstanding at April 30, 2005:

 

Range of Exercise Prices


  

Number

Outstanding


  

Weighted

Average

Remaining

Life


  

Weighted

Average

Exercise

Price


  

Number

Exercisable


  

Weighted

Average

Exercise

Price


$0.11 to $0.13

   2,480,000    4.0 years    $ 0.12    2,480,000    $ 0.12

$0.14 to $0.16

   1,850,000    4.4 years    $ 0.15    1,295,000    $ 0.15

$0.17 to $0.30

   1,430,000    7.3 years    $ 0.22    916,667    $ 0.21

$0.30 to $0.80

   405,000    5.8 years    $ 0.61    366,000    $ 0.63
    
              
      
     6,165,000                5,057,667       
    
              
      

 

F-21


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE F - STOCK OPTIONS AND WARRANTS – Continued

 

The following table summarizes the Company’s stock warrant information during the years ended April 30:

 

     2005

   2004

     Warrants

   Weighted
Average
Exercise
Price


   Warrants

   Weighted
Average
Exercise
Price


Outstanding, beginning of year

   6,141,629    $ 0.20    2,136,629    $ 0.19

Granted

   17,204,166      0.34    4,005,000      0.20

Forfeited

   —        —      —        —  

Exercised

   —        —      —        —  
    
  

  
  

Outstanding, end of year

   23,345,795    $ 0.30    6,141,629    $ 0.20
    
  

  
  

 

Fiscal 2005:

 

In connection with the sale of 2,266,666 shares of common stock issued during the year, as noted in Note E, the Company issued 2,266,666 warrants exercisable at $0.47 per share and expiring May 31, 2009. The warrants may be called by the Company for cancellation without payment to the holders of the warrants, if the market price for the common stock is twice the exercise price of the warrants over a period of ten consecutive trading days. The estimated relative value of the warrants issued was approximately $349,000 and such amount has been recorded in Additional Paid-in Capital.

 

In connection with the sale of 9,437,500 shares of common stock issued in during the year, as noted in Note E, the Company issued 9,437,500 warrants exercisable at $0.28 per share and expiring in 2007. The warrants may be called by the Company for cancellation without payment to the holders of the warrants, if the market price for the common stock is twice the exercise price of the warrants over a period of ten consecutive trading days. The estimated relative value of the warrants issued was approximately $630,000 and such amount has been recorded in Additional Paid-in Capital.

 

In December 2004, the Company approved the issuance of two-year warrants to six investors to purchase 5,500,000 shares of common stock at a price of $.40 per share in consideration of the delayed registration of their stock. The estimated fair value of the warrants of $311,000 has been recorded as an expense in the accompanying statement of operations with a corresponding credit recorded to Additional Paid-in Capital.

 

F-22


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE F - STOCK OPTIONS AND WARRANTS – Continued

 

Fiscal 2004:

 

During fiscal 2004, the Company issued warrants for the purchase of 4,000,000 shares of the Company’s common stock to five foreign financial consultants at an exercise price of $0.20 per share. Based on a Black-Scholes analysis, the warrants had an estimated fair value of $340,500 on the date of grant. The warrants were issued for investor services provided to the Company in connection with a $2,000,000 private placement of its common stock. The warrants expire in September 2005. The estimated fair value of the warrants has been charged against Additional Paid-In Capital as a reduction of the proceeds from the private placement.

 

NOTE G - INCOME TAXES

 

No provision for federal and state income taxes has been recorded as the Company has incurred net operating losses through April 30, 2005. The Company’s federal net operating loss carryforwards as of April 30, 2005 are approximately $23,000,000. The loss carryforwards expire in various years through 2025. Deferred tax assets of approximately $10.1 million and $8.9 million at April 30, 2005 and 2004, respectively, include the effects of these net operating loss carryforwards and research and development credit carryforwards. A valuation allowance has been provided for the full amount of the deferred tax assets due to the uncertainty of realization. Utilization of the Company’s net operating loss carryforwards may be limited based on ownership changes under Section 382 of the Internal Revenue Code.

 

The provision for income taxes consists of the following for the three years ended April 30, 2005:

 

     Years ended April 30,

 
     2005

    2004

    2003

 

Current and deferred tax benefit

   $ (1,100,000 )   $ (920,000 )   $ (910,000 )

Change in valuation allowance

     1,100,000       920,000       910,000  
    


 


 


Net tax benefit

   $ —       $ —       $ —    
    


 


 


 

NOTE H - RELATED PARTIES

 

During fiscal year 2005 and 2004, the Company paid $125,400 and $126,000, respectively, to a specialty contract manufacturer of pharmaceutical products to manufacture the Company’s

 

F-23


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE H - RELATED PARTIES– Continued

 

perfluorocarbon-based blood substitute and therapuetic oxygen carrier, for upcoming clinical trials. As of April 30, 2005, the Company owed this entity $48,150, and such amount is included in accounts payable in the accompanying balance sheet. An officer of the Company is a minority shareholder and director of this specialty manufacturer. There were no related party transactions in fiscal 2003.

 

NOTE I– QUARTERLY FINANCIAL DATA (Unaudited)

 

The following table summarizes the unaudited quarterly results of operations for fiscal years 2005 and 2004:

 

     Year Ended April 30, 2005

 
     First
Quarter


    Second
Quarter


    Third
Quarter


    Fourth
Quarter


    Year

 

Research and development expenses

   $ 219,466     $ 309,614     $ 304,987     $ 443,058     $ 1,277,125  

General and administrative expenses

     255,614       291,286       588,308       272,279       1,407,487  
    


 


 


 


 


Total expenses

     475,080       600,900       893,295       715,337       2,684,612  

Other income

     (1,658 )     (944 )     (4,799 )     (4,413 )     (11,814 )
    


 


 


 


 


Net loss

   $ (473,422 )   $ (599,956 )   $ (888,496 )   $ (710,924 )   $ (2,672,798 )
    


 


 


 


 


Basic and diluted loss per common share

   $ (0.004 )   $ (0.005 )   $ (0.007 )   $ (0.006 )   $ (0.020 )
    


 


 


 


 


 

F-24


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE I– QUARTERLY FINANCIAL DATA (Unaudited) – Continued

 

     Year Ended April 30, 2004

 
     First
Quarter


    Second
Quarter


    Third
Quarter


    Fourth
Quarter


    Year

 

Research and development expenses

   $ 233,080     $ 265,630     $ 501,488     $ 266,225     $ 1,266,423  

General and administrative expenses

     226,297       202,003       314,035       258,447       1,000,782  
    


 


 


 


 


Total expenses

     459,377       467,633       815,523       524,672       2,267,205  

Other income

     (7,467 )     (7,207 )     (2,192 )     (1,136 )     (18,002 )
    


 


 


 


 


Net loss

     (451,910 )     (460,426 )     (813,331 )     (523,536 )     (2,249,203 )
    


 


 


 


 


Basic and diluted loss per common share

   $ (0.005 )   $ (0.005 )   $ (0.008 )   $ (0.005 )   $ (0.020 )
    


 


 


 


 


 

Basic and diluted loss per common share for each of the quarters presented above is based on the respective weighted average number of common and dilutive potential common shares outstanding for each period and the sum of the quarters may not necessarily be equal to the full year basic and diluted loss per common share amounts. For the periods presented, the effect of the Company’s common stock options and warrants are excluded from the diluted loss per share calculations since inclusion of such items would be antidilutive for that period.

 

NOTE J – SUBSEQUENT EVENT

 

On July 7, 2005 the Company received final payment of $321,667 under a purchase agreement signed in October 2004 and extended in November 2004 for the purchase of 2,500,000 shares of common stock at $0.185 per share plus the warrant to purchase 6,000,000 shares of common stock at $0.20 per share that expires in September 2007.

 

On July 13, 2005 the Company closed on a financing transaction with three private investors. In the transaction the Company issued to the investors unsecured convertible debentures in the principal amount of approximately $1.85 million payable over a term of three years beginning 120 days following the closing of the financing discounted on the date of issue at 10 percent per annum. Proceeds to the Company after the original issue discount, commissions, and the investors’ professional fees is approximately $1,145,500.

 

The principal amount of the debentures is convertible to common stock at any time at the election of the holder at a rate of one common share for each $0.22 of principal. The Company

 

F-25


Table of Contents

SYNTHETIC BLOOD INTERNATIONAL, INC.

(A Development Stage Enterprise)

 

NOTES TO FINANCIAL STATEMENTS

 

April 30, 2005 and 2004

 

NOTE J – SUBSEQUENT EVENT– Continued

 

may, at its option and subject to certain conditions, make monthly payments on the debentures in common stock priced at the lower of $0.22 or 80 percent of the volume weighted average price for the common stock over the five trading days prior to the payment date. The Company also issued to the investors warrants to purchase up to 8,409,083 of shares of common stock exercisable during a term of three years at an exercise price of $0.242 per share. The Company intends to register the shares of common stock underlying the securities sold in this financing transaction for resale on a registration statement within 45 days following closing.

 

In May 2004, the Company accepted a subscription agreement from Remobo AG, based in Switzerland, for the purchase of 7,733,334 shares of common stock, 7,733,334 Series A Warrants, 3,400,000 Series B Warrants, and 3,400,000 Series C Warrants for $2,350,000. Pursuant to a resolution adopted by the Board of Directors on July 7, 2005, the Company formally terminated the subscription agreement on July 11, 2005.

 

 

F-26

EX-31.1 2 dex311.htm SECTION 302 CEO CERTIFICATION Section 302 CEO Certification

Exhibit No. 31.1

 

Form 10-K

Synthetic Blood International, Inc.

 

Certification

 

I, Robert Nicora, certify that:

 

1. I have reviewed this annual report on Form 10-K for the year ended April 30, 2005 of Synthetic Blood International, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(c) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 15, 2005

 

/S/ Robert Nicora


Chief Executive Officer

EX-31.2 3 dex312.htm SECTION 302 CFO CERTIFICATION Section 302 CFO Certification

Exhibit No. 31.2

 

Form 10-K

Synthetic Blood International, Inc.

 

Certification

 

I, David Johnson, certify that:

 

1. I have reviewed this annual report on Form 10-K for the year ended April 30, 2005 of Synthetic Blood International, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(c) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 15, 2005

 

/S/ David Johnson


Chief Financial Officer

EX-32.1 4 dex321.htm SECTION 906 CEO & CFO CERTIFICATION Section 906 CEO & CFO Certification

Exhibit No. 32.1

 

Form 10-K

Synthetic Blood International, Inc.

 

Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the

Sarbanes-Oxley Act of 2002.

 

In connection with the Annual Report of Synthetic Blood International, Inc. (the “Company”) on Form 10-K for the period ending April 30, 2005 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Robert Nicora, Chief Executive Officer of the Company, certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: (1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: August 15, 2005

/S/ Robert Nicora


Chief Executive Officer

 

Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the

Sarbanes-Oxley Act of 2002.

 

In connection with the Annual Report of Synthetic Blood International, Inc. (the “Company”) on Form 10-K for the period ending April 30, 2005 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David Johnson, Chief Financial Officer of the Company, certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: (1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: August 15, 2005

/S/ David Johnson


Chief Financial Officer

 

A signed original of this written statement required by Section 906 has been provided to Synthetic Blood International, Inc. and will be retained by Synthetic Blood International, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

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