U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-KSB
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ANNUAL REPORT PURSUANT TO SECTION 13 OR
15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2005
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TRANSITION REPORT UNDER SECTION 13 OR 15(D)
OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
COMMISSION FILE NO. 0-24921
POWER3 MEDICAL PRODUCTS, INC.
(Name of small business issuer in its charter)
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New York |
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65-0565144 |
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(State or other
jurisdiction of
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(I.R.S. Employer Identification No.) |
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3400
Research Forest Drive, Suite B2-3
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77381 |
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(Address of principal executive offices) |
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(Zip Code) |
Issuers Telephone Number: (281) 466-1600
Securities registered under Section 12(b) of the Exchange Act: None
Securities registered under Section 12(g) of
the Exchange Act:
Common Stock,
$.001 par value
(Title of class)
Check whether the issuer: (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 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 ý No o
Check if there is no disclosure of delinquent filers in response to Item 405 of Regulation S-B contained in this form, and no disclosure will be contained, to the best of registrants knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-KSB or any amendment to this Form 10-KSB. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No ý
Revenues for the issuers fiscal year ended December 31, 2005 were $ -0-. The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, computed by reference to the closing price of such stock on the Over-the-Counter Bulletin Board (OTCBB) administered by the National Association of Securities Dealers (Nasdaq) on December 31, 2005 was $6,602,561. For purposes of this calculation, affiliates include directors, executive officers and current employees.
The number of shares outstanding of the registrants common stock, par value .001 per share, as of March 1, 2006 was 68,613,700 shares .
Documents incorporated by reference : None.
TABLE OF CONTENTS
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FORWARD-LOOKING STATEMENT
This Report contains certain forward-looking statements of the intentions, hopes, beliefs, expectations, strategies, and predictions of Power3 Medical Products, Inc. (Power3 or the Company) or its management with respect to future activities or other future events or conditions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are usually identified by the use of words such as believes, will, anticipates, estimates, expects, projects, plans, intends, should, could, or similar expressions. These statements are based on certain assumptions and analyses made by the Companys management in light of its experience and its perception of historical trends, current conditions, expected future developments and other factors believed appropriate. Readers are cautioned that these forward-looking statements are only predictions and that the Companys business is subject to significant risks and uncertainties, including, without limitation:
The Companys history of operating losses;
The Companys need and ability to raise significant capital and obtain adequate financing for its development efforts;
The Companys ability to successfully develop and complete validation studies for its products;
The Companys dependence upon and the uncertainties associated with obtaining and enforcing patents and intellectual property rights important to its business;
The uncertainties associated with the lengthy regulatory approval process, including uncertainties associated with the United States Food and Drug Administration (FDA) decisions and timing of product development or approval;
Development by competitors of new or competitive products or services;
The Companys ability to retain management, implement its business strategy, assimilate and integrate any acquisitions;
The Companys lack of operating experience and present commercial production capabilities; and
The increasing emphasis on controlling healthcare costs and potential legislation or regulation of healthcare pricing.
Although the Company believes that the assumptions underlying the forward-looking statements contained in this report are reasonable, any of the assumptions could be inaccurate, and, therefore, there can be no assurance that the forward-looking statements included in this report will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included in this report, the inclusion of such information should not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved. Except for its ongoing obligation to disclose material information as required by the federal securities laws, the Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date of this report or to reflect the occurrence of unanticipated events. Accordingly, the reader should not rely on forward-looking statements, because they are subject to known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those contemplated by the forward-looking statements.
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Except for historical information, the matters set forth in this report include forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth herein. Power3 Medical Products, Inc. refers you to cautionary information and risk factors contained elsewhere herein and in other documents filed with the Securities and Exchange Commission (SEC) from time to time.
Item 1. Description of Business.
Overview and Corporate History
Power3 Medical Products, Inc. (the Company or Power3 ) was incorporated in the State of Florida on May 15, 1992 and merged into a New York Corporation in 1994, under the name Sheffield Acres, Inc. Power3 and its wholly owned subsidiaries, C5 Health, Inc. (C5), which was officially dissolved in the State of Delaware and the State of Florida effective December 31, 2003 and Power3 Medical, Inc., a Nevada Corporation, were engaged in sales, distribution and services for the healthcare industry. On September 12, 2003 Surgical Safety Products, Inc. amended its Certificate of Incorporation to (a) declare a 1:50 reverse split of its common stock; (b) increase its authorized capital to 150,000,000 shares of common stock and 50,000,000 shares of preferred stock; and (c) change its name to Power3 Medical Products, Inc.
Prior to May 17, 2004, the Company had one direct subsidiary, Tenthgate, Inc. (Tenthgate), a Nevada corporation formerly known as Power3 Medical, Inc. Prior to this date, Tenthgate was accounted for, by Power3, as a wholly-owned subsidiary, operating as a development stage company, under the cost method. Prior to the acquisition of substantially all the assets and certain liabilities from Advanced BioChem, now known as Industrial Enterprises of America, it was contemplated that Power3 would distribute the shares of its subsidiary, Tenthgate, to its shareholders of record, as of May 17, 2004. To fulfill this obligation, the shares of Tenthgate were transferred to a trustee for distribution to the shareholders of Power3 as of May 17, 2004, before the Advanced BioChem transaction and the takeover by present management. Tenthgate was spun off because the management of Power3, in place prior to May 17, 2004, desired to continue to own and eventually operate this subsidiary. At the time of the spinoff, Tenthgate was granted the rights to market a product line that had previously been marketed by Power3, but which the company had decided to abandon. Tenthgate was not an operating company, and their management has apparently abandoned any plans to market the product as evidenced by their SEC filings, specifically their amended 10-QSB filed for the quarterly period ending January 31, 2005, wherein they specifically state that they are a development stage company. As of May 17, 2004, at the time of the transfer of shares to a trustee for distribution to the previous shareholders of Power3, Tenthgate was spun off to the previous shareholders of Power3 as of May 17, 2004, and was deconsolidated from Power3 at that time. The new owners of Tenthgate, i.e. the previous shareholders of Power3 as of May 17, 2004, have been independently operating Tenthgate since May 17, 2004 and Power3 does not now own or control the operations or activities of Tenthgate, nor are their activities associated with Power3 in any manner whatsoever.
The Companys common stock is quoted on the Pink Sheets Electronic Quotation Service under the symbol PWRM.PK. The Companys principal executive offices are located at 3400 Research Forest Drive, Suite B2-3, The Woodlands, Texas 77381. The Companys telephone number is (281) 466-1600 and its facsimile number is (281) 466-1681. During 2005, the Companys failure to timely file its Form 10-KSB caused the OTCBB to append the symbol E to the Companys trading symbol. On June 14, 2005, the Company was notified of the OTCBBs action to not allow the Companys securities to be quoted on the OTCBB, as of June 16, 2005, pending the filing of the Companys Form 10-KSB for 2004. The Companys Form 10-KSB for 2004 was filed on September 6, 2006. The Company has reapplied for quotation on the OTCBB and all quotations of the Companys securities are deleted from the OTCBB. Power3 filed a Form 211 to be reinstated to the OTCBB, but was informed by NASD that restoration to the OTCBB was not possible until the Companys SB-2, filed to register shares associated with the convertible debentures issued in October, 2004, was effective. Power3 has been informed by the NASD that the only issue remaining, before it can be relisted to the Bulletin Board, is the effectiveness of the SB-2, filed by the Company to register the shares associated with the convertible debenture and warrant agreements, originally issued in October, 2004.
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The Company transitioned to the development stage, from previously being an operating company, as of the asset purchase transaction with Advanced BioChem on May 18, 2004, as referenced below. As a development stage company, Power3 is primarily engaged in commercializing its intellectual properties in the area of diagnosis and treatment of breast cancer, ALS, Alzheimers disease and Parkinsons disease.
Purchase of a Set of Assets and Assumption of a Set of Liabilities from Advanced Bio/Chem, Inc.
On May 18, 2004, Power3 purchased substantially all the assets of Advanced Bio/Chem, doing business as ProteEx. Since the May 18, 2004 transaction, Advanced Bio/Chem has changed its name to Industrial Enterprises of America, Inc. In this transaction, Power3 purchased substantially all the assets and intellectual properties of Advanced Bio/Chem and assumed certain liabilities in exchange for the issuance of 15,000,000 shares of its common stock pursuant to an Asset Purchase Agreement of even date therewith. For financial statement purposes, the transaction has been accounted for as a purchase transaction. Unless otherwise stated in this report, all financial information presented in this report is for Power3 Medical Products, Inc., in accordance with Regulation S-B for reporting the purchase of a set of assets and liabilities not constituting a change in control of Advanced BioChem or a merger or acquisition of Advanced BioChem into Power3 Medical Products, Inc .
The transaction between Power3 and Advanced BioChem was evaluated by an independent appraiser and was determined to be a fair value transaction. Power3 exchanged 15,000,000 shares of common stock for a set of assets and certain liabilities it received in the transaction from Advanced BioChem. The physical assets acquired consisting primarily of lab equipment were transferred to the Balance Sheet of Power3, at cost, which is estimated to be substantially the same as their value. In addition, the liabilities acquired were transferred to the Balance Sheet of Power3 at the remaining outstanding balances due. A subset of legal fees transferred to Power3, which had previously been capitalized by Advanced BioChem, were expensed at the time of the transaction. No other intangible assets were identified or recognized as obtained from Advanced BioChem since all such expenditures had been previously expensed by Advanced BioChem as research and development expenditures. Therefore, Power3 recognized the difference in the market value of the stock given up in the transaction versus the assets and liabilities acquired as Goodwill.
This accounting treatment represents a change in the accounting treatment previously used to report the Advanced BioChem transaction as a recapitalization of Power3 as in a reverse acquisition, as previously shown in the Form 10-QSB issued by Power3 for the 2 nd Quarter, 2004. The Company, and its auditors, are in complete agreement as to the accounting treatment of purchase accounting as an appropriate treatment to account for its acquisition of the assets and a certain set of liabilities of Advanced BioChem, now known as Industrial Enterprises of America, on May 18, 2004.
Business of Issuer
As of the Companys acquisition of assets from Advanced Bio/Chem on May 18, 2004, the Companys overall business strategy was changed. The Companys current business directive is to engage in the early detection, monitoring, and targeting of diseases through the analysis of proteins. Power3s development stage business objective is to commercialize its intellectual properties by focusing on disease diagnosis, protein and biomarkers identification, and drug resistance in the areas of cancers, neurodegenerative and neuromuscular diseases. Coincident with the acquisition of assets from Advanced BioChem, the Company changed its management team and established a Scientific Advisory Board to assist in the research and development of its products. The members of this Scientific Advisory Board are recognized leaders in their chosen fields and the Company is working with them to find effective therapeutics and novel predictive medicine for important human diseases.
The Companys business strategy, which is dependent upon obtaining sufficient additional financing, is to enhance the commercialization of its existing diagnostic products and to aggressively pursue appropriate product and company strategic partnerships.
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As a result of the acquisition of assets and certain liabilities of Advanced Bio/Chem, Power3 has transitioned into an advanced proteomics company that applies existing proprietary methodologies to discover and identify protein biomarkers associated with diseases. By discovery and development of protein-based disease biomarkers, the Company has begun the development of tools for diagnosis, prognosis, early detection and identification of new targets for drugs in cancer, and neurodegenerative and neuromuscular diseases such as amyotrophic lateral sclerosis (commonly known as ALS or Lou Gehrigs disease), Alzheimers disease, and Parkinsons disease.
Power3s scientific team is headed by its Chief Scientific Officer, Dr. Ira L. Goldknopf. Dr. Goldknopf was a pioneer in the science of clinical proteomics in the 1970s and 1980s and in so doing made a significant biochemistry discovery the ubiquitin conjugation of proteins. This discovery was cited in the announcement of the 2004 Nobel Prize for chemistry. The team has leveraged these significant insights and has made progress in the discovery of unique disease protein footprints of biomarkers in breast cancer, neurodegenerative disease, and drug resistance to chemotherapeutic agents.
Proteomics is the study and analysis of proteins. Through proteomics, scientists can more accurately understand the functioning of a healthy body and are assisted in the identification of the proteins associated with specific diseases. Proteins that change in the course of disease are the building blocks for new screening and diagnostic tests which the Company is developing to provide earlier disease detection, enhanced treatment and monitoring assistance.
Product Candidates
The Company plans to target the protein-based diagnostic and drug targeting markets utilizing the Companys portfolio of proprietary biomarker disease footprints. In the area of neurodegenerative disease, the Company has completed clinical validation studies involving over 650 patient samples and is utilizing biostatistics to monitor appropriate biomarkers for diagnostic sensitivity, specificity, positive predictive value, and negative predictive value. By testing patient body fluids and tissues, such as serum, nipple aspirate fluid, and bone marrow, the Company has discovered unique snapshots of protein patterns in diseases including:
cancers such as breast, leukemia, prostate, bladder, stomach, and esophageal;and
neurodegenerative diseases such as Alzheimers, ALS, and Parkinsons disease.
The Companys discovery platform uses both proprietary methodologies owned by or licensed to the Company and accepted technologies to discover biomarkers in clinical samples. Following sample preparation, a 2D Gel system is used for the separation of protein. The gels are stained, imaged and analyzed with unprecedented sensitivity for differences in the diseased vs. normal samples. The significance of these differences is evaluated relative to the status of the health of the individual. The proteins of interest are removed from the gel matrix and analyzed on a mass spectrometer. This information is then cross-referenced on a worldwide database to identify the protein of origin. This process requires a great deal of proteomics experience and expertise to make the end-data interpretable. In addition, all of the procedures are scaleable. The Companys biomarker discovery platform delivers significant discoveries that are capable of detecting up to 20 times as many proteins in nipple aspirate fluids as Mud Pit or SELDI TOF (competing technologies); exhibiting reproducible and reliable identification; and displaying broad dynamic range and linearity of disease protein footprints.
The Company has successfully identified more than 400 proteins, protein fragments and isoforms that are differentially expressed in response to disease by employing proprietary technologies gained from over 50 years of combined experience in protein biochemistry.
Power3 is transitioning from a company focused only on research and development to one that is demonstrating proof of concept of its technology as it enters the commercialization stage for its technology, products and services. The Company is engaged in the process of developing a portfolio of products including the biomarkers and blood serum tests (for early detection of breast cancer), NuroPro biomarkers and blood
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serum tests (for neurodegenerative diseases including Alzheimers, Parkinsons and ALS diseases) and biomarkers, tests and drug targets for drug resistance to chemotherapeutics.
License and Sponsored Research
Advanced Bio/Chem entered into a license agreement with the Board of Regents of The University of Texas System, an agency of the State of Texas, on behalf of The University of Texas M.D. Anderson Cancer Center in September 2003, which the Company acquired in its transaction with Advanced Bio/Chem. The license agreement gives the Company an exclusive, worldwide, royalty-bearing license to certain patent rights and technology rights for proteomic methods of diagnosis and monitoring of breast cancer using nipple aspirate fluids. The license agreement also gives the Company a non-exclusive, worldwide, royalty-bearing license to certain patent rights and technology rights for methods of identifying specific nipple aspirate fluid proteins for diagnosis and monitoring of breast cancer. The Company is permitted to grant sublicenses under the license agreement except for the identification of biological markers. The Company is obligated to pay to M.D. Anderson an initial license fee, and a subsequent license fee, both of which have been paid. The Company is also obligated to pay annual license maintenance fees, royalties and additional milestone payments upon the occurrence of certain designated events. The license agreement imposes upon the Company an obligation to indemnify the Board of Regents, The University of Texas System, M.D. Anderson, the regents, officers, employees, students, and agents against claims arising on account of any injury or death, or damage to property caused by the exercise of the rights granted under the license agreement to the Company, its officers and affiliates. The term of the license agreement is based on the date of expiration of the last patent rights to expire or, in the case of licensed technology rights, for a term of fifteen (15) years. However, in addition to customary termination provisions, M.D. Anderson has the right to terminate the license in any country if the Company fails, within ninety (90) days after receiving written notification from M.D. Anderson, to provide satisfactory evidence that it has commercialized or is attempting to commercialize the licensed invention in such country.
Effective June 28, 2004, Power3 entered into an exclusive license agreement with the Baylor College of Medicine which grants to the Company an exclusive, worldwide, sublicensable license for serum proteomics methods under certain patent rights for all biomarkers for both diagnostic and therapeutic use in neurodegenerative disease. Under the terms of the agreement, Power3 paid Baylor an initial license fee and it has the obligation to pay future royalties and additional licensing fees upon the achievement of certain milestones. The Company is obligated under the license agreement to indemnify Baylor, its faculty members, scientists, researchers, employees, officers, trustees and agents against claims arising from the design, process, manufacture or use of any of the patent rights or licensed products that are developed through the use of the license from Baylor. Subject to customary termination provisions, the term of the agreement is established on a country-by-country basis and expires on the date of expiration of the last patent rights to expire in that country or the tenth anniversary of the first commercial sale of licensed products in countries where no patents exist in such country. After such expiration the Company will have a perpetual paid in full license in such country.
On August 1, 2004, Power3 entered into an exclusive license agreement with M.D. Anderson which grants the Company an exclusive, worldwide, sublicensable license to patents and technologies for early detection screening tests, identified protein biomarkers and drug targets for cancer patients resistance to drug therapy. The licensed technology was developed through joint collaboration between the Companys scientific team and M.D. Anderson. Under the terms of the agreement, the Company paid M.D. Anderson an initial license fee and the Company has the obligation to pay further royalties and additional licensing fees upon the achievement of certain milestones. The license agreement imposes upon the Company an obligation to indemnify the Board of Regents, The University of Texas System, M.D. Anderson, the regents, officers, employees, students, and agents against claims arising on account of any injury or death or damage to property caused by the exercise of the rights granted under the license agreement to the Company, its officers and affiliates. The term of the license agreement is based on the date of expiration of the last patent rights to expire or, in the case of licensed technology rights, for a term of fifteen (15) years. However, in addition to customary termination provisions, M.D. Anderson has the right to terminate the license in any country if the Company fails, within ninety (90) days after receiving written notification from M.D. Anderson, to provide satisfactory evidence that it has commercialized or is attempting to commercialize the licensed invention in such country.
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On August 31, 2004 the Company entered into a research agreement with Baylor College of Medicine for the purpose of discovering biomarkers in serum and plasma that are of particular utility in the diagnosis and drug targeting for metabolic syndrome and associated disorders including diabetes, cardiovascular disease, hypertension and stroke. Under the terms of the agreement, Baylor College of Medicine will provide the Company sample materials for use in diagnosis in drug targeting metabolic syndrome and associated diseases including diabetes, cardiovascular disease, hypertension and stroke. With respect to any inventions developed pursuant to the agreement, the party who develops such invention will retain sole and exclusive rights to such invention. The other party will have the right to an exclusive license for the invention, which has been developed. Inventions developed jointly by the parties will be jointly owned. Power3 does not have any obligations for the payment of fees or royalties pursuant to this agreement. The agreement has a term ending June 30, 2007 and may be renewed for successive one-year periods.
The Company has entered into a collaborative research agreement with New Horizons Diagnostic effective March 21, 2005 for the development of antibody based diagnostic tests for neurodegenerative disease utilizing the Companys identified biomarkers. The research agreement is based on groups of biomarkers whose profiles are relatively sensitive and specific in distinguishing patients with ALS, Alzheimers disease and Parkinsons disease from each other, as well as from normal patients and patients with other neuromuscular and neurological disorders. The purpose of the agreement is to tailor monoclonal and polyclonal antibodies to the biomarkers, which will be incorporated into immunoassays. Once the assays are available, they will be developed to validate diagnostic tests specifically designed to detect and discriminate among the neurodegenerative diseases. The research agreement provides that the parties will develop an agreed upon schedule and budget for the work contemplated thereunder within sixty (60) days of the effective date. The agreement provides that in the event the parties are able to achieve specified goals relating to the development of a diagnostic kit as contemplated by the research agreement, New Horizons would be compensated in any one of the following manners with respect to such diagnostic kit: (i) a contract to manufacture at least one key component of such diagnostic kit; (ii) royalties on the sale of such diagnostic kit; (iii) the opportunity to form a joint venture with the Company for the commercialization of such diagnostic kit; or (iv) a reasonable percentage of any cash consideration that the Company receives from a third party for such diagnostic kit. Although the form and amounts of any consideration to be paid have not been agreed upon, the parties have agreed to be reasonable in negotiating such consideration.
On May 24, 2005, the Company entered into a Collaboration Agreement with BioSite Incorporated . The Agreement provides that the Company and Biosite will engage in a collaborative research program in which Biosite will attempt to develop antibodies and diagnostic assays for selected target biomolecules proposed by the Company. The Company and Biosite will then assess the diagnostic and therapeutic potential of these antibodies and diagnostic assays for breast cancer and neurological diseases. If the antibodies and diagnostic assays are found to have diagnostic and/or therapeutic potential, Biosite will develop and commercialize Biosite Products for the detection and/or treatment of breast cancer and/or neurological diseases. Biosite will make milestone payments to the Company, as well as pay royalties on the sale of any Biosite Products containing antibodies to any selected target biomolecule claimed in a patent application or an issued patent.
More specifically, the Agreement provides that the Company shall propose target biomolecules for the collaborative research program; Biosite and the Company shall mutually select certain target biomolecules for immunization (Program Target); and Biosite shall use commercially reasonable efforts to develop monoclonal and omniclonal antibodies to the selected target biomolecules that meet the specification set out by the parties (Program Antibodies). Upon Biosites written request subsequent to the delivery of Program Antibodies to the Company, the Company will provide Biosite with blood-based clinical samples useful in the assessment of the Program Antibodies.
Biosite will use commercially reasonable efforts to generate an ELISA-based assay for each Program Target for which Biosite has generated Program Antibodies. If Biosite successfully develops an ELISA-based assay for any such Program Target, Biosite shall analyze each of the clinical samples provided by Power3 with such assay and shall provide the resulting data to Power3.
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Under the terms of the Agreement, Power3 grants to Biosite a worldwide, royalty-bearing license under the Power3 patent rights for the target biomolecules and Power3 know-how rights to develop, make, have made, use, offer for sale, sell and import Biosite Products for use in the detection, prognosis, diagnosis or monitoring of any breast cancer-related disease. This license is exclusive with the right to grant sublicenses for the assay of less than or equal to 100 patient samples per hour. This license is semi-exclusive, with the right for each party to grant one sublicense, for the assay of 100 or more patient samples per hour.
Under the terms of the Agreement, Power3 grants to Biosite a non-exclusive, worldwide, royalty-bearing license under the Power3 patent rights for the target biomolecules and Power3 know-how rights to develop, make, have made, use, offer for sale, sell and import Biosite Products for use in the detection, prognosis, diagnosis or monitoring of any neurological-related disease. This license includes the right for Biosite to grant one sublicense for each Program Target, provided that the grant of such sublicense will replace Biosites own rights under the license.
In consideration for the collection and transfer of samples, Biosite shall pay specified fees to Power3 based on a minimum number of samples delivered to Biosite and per unit fees for samples delivered in excess of the minimum.
Biosite shall pay the Company milestone payments based on certain specified events as follows:
upon the earlier of (a) the First Commercial Sale by Biosite of a Biosite Product, or the effective date of the first written agreement between Biosite and a Third Party sublicensee for a sublicense,
upon demonstration, as determined in Biosites sole and reasonable discretion, that a panel of antibodies (including one or more antibodies to a Program Target) is suitable for development of a commercial product,
upon the first submission by Biosite of the first 510(k) (premarket notification) or PMA (pre-market approval application) to the FDA for the first Biosite Product; and
upon the first FDA approval of the first 510k or PMA submitted by Biosite for the first Biosite Product.
Commencing at the end of the first full calendar year following the date of First Commercial Sale for the first Biosite product, and at the end of each subsequent calendar year during the term of this Agreement, Biosite shall pay the Company specified annual minimum royalties. During the applicable Royalty Term for a Biosite Product, on a country-by-country basis, Biosite shall pay the Company royalties, with respect to each Biosite Product equal to a specified percentage of Net Sales of each Biosite product in that country. In addition to the specified royalty payments, to the extent that Biosite reaches certain specified sales targets, then Biosite shall be obligated to make additional payment to the Company. The Agreement expires upon the expiration of the last to expire applicable Power3 patent right. The agreement may be terminated for cause, by either party or upon written notice by either party following the twenty four month anniversary date of the Agreement, or by Biosite if it is unable to develop and deliver Program antibodies to the to the Program Targets.
On October 13, 2005, Power3 executed a Research Agreement with Pfizer, Inc. to further evaluate the Companys NuroPro test capabilities and to test blind and unblended samples, provided by Pfizer, under controlled conditions. The Company is completing the analysis of the results with the blinded samples in preparation to present them to Pfizer.
On December 28, 2005, the Company submitted 6 breast cancer blood serum biomarkers to Biosite, for consideration under the agreement. The development of antibodies was begun by Biosite for the first of this series.
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Breast Cancer Screening Test
An important factor in surviving cancer is early detection and treatment. According to the American Cancer Society Surveillance Research, when breast cancer is confined to the breast, the five-year survival rate is close to 100%. Breast cancer is the second leading cause of cancer deaths in women, with over $7 billion spent on breast cancer diagnosis annually. Due to the limitations of the current diagnostic techniques of mammograms and self-examination, diagnosis of cancer is often missed or inconclusive. The Companys proteomic discovery platform covered by pending patent applications and trade secrets for identifying proteins which signal pre-mammography stages of breast cancer has led to what the Company believes to be one of the first tests of its type that may detect breast cancer earlier than current technology allows. These discoveries establish the basis of a very sensitive, non-invasive, early detection breast cancer-screening test.
The Company has decided to focus development efforts for its early-detection tests for breast cancer on blood serum. The Company has successfully used blood serum as the platform for its NuroPro neurodegenerative tests and believes that blood serum as a single platform is the best medium for the development and commercialization of proteomics diagnostic tests.
The Companys Breast Cancer NAFTest analyzes fluids from the breast called nipple aspirates fluid (NAF). Initial success yielded the identification of groups of breast cancer proteins in the aspirates. The procedure utilizes a breast pump to obtain a drop of fluid from the nipple. The aspirate is analyzed to identify specific breast cancer protein footprints.
During the past year, Power3 has conducted clinical validation studies of its breast nipple aspirate fluid breast cancer test a three clinical sites: Mercy Womans Center in Oklahoma City, the NYU Medical Center in New York City and Obstetrics and Gynecological Associates at The Womans Hospital in Houston. The use of breast duct fluid samples for this purpose is the subject of an issued patent and patent pending license from MD Anderson Cancer Center.
Concurrently, Power3 conducted its own biomarker discovery program using blood serum samples collected from the same clinical validation sites, in collaboration with Dr. Alan Hollingsworth at the Mercy Womans Center.
The blood serum biomarkers and tests for early-detection of breast cancer discovered by comparing blood serum samples, distinguish between women with breast cancer, women with benign breast disease, and normal women with high sensitivity and specificity. The Company believes that there are many advantages to a simple blood test over other samples taken from patients, not the least of which is the ready acceptance by patients to having blood drawn. This, along with numerous complaints from patients about the discomfort of the procedure, as well as the low success rate in getting nipple aspirate samples (less than 50%) and the experience that even when samples were successfully drawn, they were often not representative enough for accurate testing, has led the Company to decide that nipple aspirate testing is not commercially viable.
Since the Company has elected to not pursue nipple aspirate testing for commercialization, the license agreement with MD Anderson has not been renewed by the Company. The blood serum biomarkers and tests, discovered directly using blood serum, are covered under intellectual property solely owned by the Company.
Neurodegenerative Screening Test
Early detection of neurodegenerative disease generally results in better patient outcomes. Three diseases of particular interest are Alzheimers disease, Parkinsons disease and ALS. The Alzheimers Association reports that Alzheimers disease is the most common form of dementia affecting over 4 million Americans. People as young as 30 years old can contract the disease and one in ten people age 65 and over have Alzheimers disease. In addition, the American Parkinsons Disease Association reports that more than 1.5 million people in the U.S. have Parkinsons disease, affecting about 1 in 100 Americans over the age of 60. On a smaller scale, the ALS Association reports that an average of approximately 30,000 Americans are afflicted with ALS, with 5,000 new cases diagnosed annually.
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The members of the Companys scientific team have developed a method for the differential diagnosis of neurodegenerative diseases utilizing blood serum, which was co-developed with neurologist, Dr. Stan Appel, now Chair of Neurology and Co-Director of Methodist Neurological Institute in Houston. With this test, which involves monitoring the concentration of differentially expressed proteins, the Company has identified groups of unique markers that appear to distinguish normal patients from those with motor neuron, cognitive, and other neurological disorders.
The Company is continuing its ongoing clinical validation program in collaboration with the Methodist Neurological Institute. The initial phase was completed in July 2004 and the latest phase was completed in March, 2006. During this time period, the Companys database has increased from 183 to over 650 unique samples classified either as normal or being clinically diagnosed with ALS, Alzheimers, Parkinsons, and other related neurological disorders. During this time, the number of differentially expressed proteins used in the discriminant analysis has increased from 9 to 47. The ability to differentiate diseases from each other and from normal and disease controls has improved using the proprietary PD3 process, including Polyiterative biostatistical analysis on the larger database and the expanded set of biomarkers. Currently, select panels of biomarkers are being employed in development of the NuroPro blood serum-based tests for four disease diagnostics including neurological diseases of motor control such as Parkinsons disease, ALS and their like disorders; ALS specific tests for ALS vs. ALS-like disorders; Alzheimers disease specific tests; and a Parkinsons disease-specific test. Pre-IDE applications for the first two have been filed with the U.S. Food and Drug Administration.
Drug Resistance to Chemotherapeutic Agents
By the time a patients development of resistance to chemotherapeutic agents is detected, it is often too late to revise treatment or otherwise save the patient. In 2002, the Company completed an initial proof of concept, which addresses drug resistance to a major chemotherapy agent. Determining that a cancer patient is sensitive or detecting a development of resistance during the early stages of treatment may eliminate toxic effects from the treatment drugs, and the need for trial-and-error treatment regimens. These findings may ultimately provide the pharmaceutical industry with the technology to screen patients, on a molecular level, prior to clinical trials and design new drugs to overcome resistance.
Strategic Partners Initiative
In January of 2006, the Company retained GloCap Advisors, LLC, as exclusive advisor for strategic alternatives. As the Company continues to seek synergistic strategic partners to license and develop its growing portfolio of protein biomarkers and tests, it believes Glocap Advisors assistance, business introductions and advice will increase the Companys exposure in target markets, provide important strategic relationships and identify appropriate strategic partners, instrumental and essential for overall successful execution of the Companys business plan. The Companys business plan includes the development of these strategic partnerships which it anticipates will assist in the Companys evolution over the next several years including the commercialization of its proprietary technologies.
The Company recognizes that the licensing of its proprietary technologies to industry leaders is one of the most expedient approaches to develop the Companys technology into important diagnostic tools for the detection of diseases. The Company believes this focused positioning of its products and services will enable the Company to capture clinical and public awareness of its proprietary technologies, and apply a major portion of that technology to the early detection and screening markets.
Competition
The industry in which the Company operates is intensely competitive, and subject to significant change with respect to technology for diagnosis and treatment of disease. Existing or future biotechnology, biomedical, pharmaceutical and other companies, government entities and universities may create developments that accomplish similar functions to the Companys technologies in ways that are less expensive, receive faster regulatory approval or receive greater market acceptance than the Companys potential products. The Company
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expects that competition in the biomarker discovery field will be based primarily on each products efficacy, stability, timing of entry of the product into the market, cost, and acceptance by health care providers and health care payers.
The Companys competitors have, in general, been in existence for considerably longer than the Company has, and may have greater capital resources and access to capital; greater internal resources for activities in research and development, clinical testing and trials, production and distribution; and existing collaborative relationships with third parties.
The existing market for biomarker discovery platforms and processes for Alzheimers disease alone has been estimated to be in excess of $4 billion in the U.S. based on a study prepared by Frost & Sullivan. There are several other companies engaged in the research of proteomics and its application to biomarker discovery capabilities. Some of these companies include:
Celera Genomics, which is engaged in proteomics, bioinformatics and geonomics to identify and develop drug targets and discover and develop new therapeutics;
Ciphergen Biosystems, which is active in biomarker discovery assay development and characterization;
Europroteome, which applies proteomics to human epithelial cancers to identify cancer specific protein expression patterns for clinical applications;
Matritech, which is a developer of proteomics-based diagnostic products for the early detection of cancer;
Myriad Genetics, which is focused on the development of therapeutic and diagnostic products using genomic and proteomic technologies; and
WITA Proteomics, which focuses on the potential role of proteins from specific cellular sources under particular conditions and analysis of the presence of modified proteins and the strategic use of this information for drug development and diagnostic use.
Sources and Availability of Raw Materials and Names of Principal Suppliers
The Company is, as previously discussed in this section, in the developmental stage and has not commenced commercial production of products for sale. Therefore the Company does not acquire, purchase, nor use any significant quantities of raw materials whatsoever and consequently has no principal suppliers.
Dependence on One or on a Few Major Customers
The Company is, as discussed in this section, in the developmental stage and has not commenced producing or marketing any products to customers at this stage and has no dependence on one customer or on a few major customers. The Company does have a limited set of institutions and laboratories that it is currently involved with doing testing and development work, however these associations could change and the Company is not limited to which institutions, hospitals or laboratories it works with in the future.
Research and Development
The Company believes that research and development is an important factor in its future growth and operates a state of the art proteomics laboratory. The Company has restricted the initiation of new research activities during 2005 because of funding limitations and has focused its efforts on commercializing its current inventory of test products.
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Patents, Copyrights and Trademarks
The Company is continuing to pursue patent protection for its proprietary technologies with the U.S. Patent and Trademark Office and in foreign jurisdictions. The Company plans to prosecute, assert and defend any patent rights it may obtain, whenever appropriate. However, securing patent protection does not necessarily assure the Company of competitive success.
With respect to the Companys biomarker discovery process, antibody detection system and breast cancer biomarkers, the Company has two provisional patents pending and four utility patents pending. The Companys work in breast cancer no longer depends on certain technologies that it has licensed from M.D. Anderson Cancer Center, as those licenses are for nipple aspirate technology that the Company has determined to be not commercially viable. The Companys blood serum biomarkers and tests are solely owned by the Company.
In cooperation with Baylor College of Medicine, the Company has discovered 47 biomarkers for neurodegenerative diseases such as ALS, Alzheimers disease, and Parkinsons disease. The Company has received an exclusive license for the rights in this technology and is responsible for the filing, prosecution and maintenance of all patent applications covering this licensed technology. To date, the Company has seven provisional patent applications pending for the neurodegenerative biomarkers and assays using these biomarkers and has also converted four of those provisional patents into utility applications.
In cooperation with the Leukemia Group at MD Anderson Cancer Center, the Company has joint ownership of one utility patent pending and one PCT international application in the area of drug resistance to chemotherapy in chronic myelogenous leukemia. The Company has also recently discovered a new biomarker for drug resistance in Leukemia that exerts its effect on the drug target, which will shortly be filed as a provisional patent application. The Company also has joint inventorship of a provisional patent application for biomarkers in gastrointestinal cancer with the University of Virginia.
The Company also attempts to protect its proprietary products, processes and other information by relying on trade secret laws and nondisclosure and confidentiality agreements with its employees, consultants and certain other persons who have access to such products, processes and information. The agreements affirm that all inventions conceived by employees are the exclusive property of the company. Nevertheless, there can be no assurance that these agreements will afford significant protection against or adequate compensation for misappropriation or unauthorized disclosure of the Companys trade secrets.
Scientific Publications and Presentations
In February, 2006, the Company published two peer reviewed scientific articles. Establishing the scientific basis of their NuroPro neurodegenerative disease biomarkers and tests is an invited review entitled 2D gel blood serum biomarkers reveal differential clinical proteomics of the neurodegenerative diseases by Essam A. Sheta, Stanley H. Appel and Ira L. Goldknopf, Expert Review of Proteomics 3, 45-62 (2006). And the second scientific article Complement C3c and related protein biomarkers in amyotrophic lateral sclerosis and Parkinsons disease, by Ira L. Goldknopf, et al. Biochemical and Biophysica Research Communications 342, 1034-1039 (2006), details a breakthrough discovery of differences in a key protein that drives neurodegeneration between Parkinsons disease and ALS.
The Company is also scheduled to deliver three presentations to major scientific meetings in April 2006: Blood Serum Biomarkers for Differential Diagnosis of Parkinsons Disease and Biomarkers for Diagnosis and Targeting of Resistance and Sensitivity to Imatinib Mesylate in Chronic Myelogenous Leukemia delivered at Experimental Biology 2006 in San Francisco in early April; and Convergence of Proteomic-Diagnostics and Pharmaco-Proteomics toward Personalized Medicine-Examples from Breast Cancer and Leukemia given at the OncoProteomics World Congress in San Francisco in late April, 2006.
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The Company believes its growing IP portfolio, industry papers and presentations demonstrate the value of its visionary approach to medically-useful product development and anticipates further acceptance by the scientific and business communities as it transitions its technologies into commercially-viable products.
Governmental Regulation
The Food and Drug Administration establishes guidelines for clinical trials which are conducted in order to obtain FDA approval. Clinical trials are required to find effective treatments to improve health. All clinical trials are based on a protocol which is a study plan that describes the type of people who may participate in the trial, the schedule of tests and procedures, and the length of the study.
Clinical trials in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks of the trial are as low as possible and are worth any potential benefits. All institutions that conduct or support biomedical research are required by federal regulation to have an IRB that initially approves and periodically reviews the research.
Upon successful completion of a clinical trial validation study, an application based on the results of the clinical trial is submitted for FDA approval. Upon receipt of FDA approval, the diagnostic screening test would be ready for commercialization.
In the United States, clearance or approval to commercially distribute new medical devices or products is received from the FDA through clearance of a 510(k) premarket notification, or 510(k), approval of a premarket approval application, or PMA. It may take from three to nine months from submission to obtain 510(k) clearance, but may take longer or clearance may not be obtained at all. The FDA may determine that additional information is needed before approval to distribute the product is given.
For any products that are cleared through the 510(k) premarket notification process, modifications or enhancements that could significantly affect safety or constitute a major change in the intended use of the product will require new 510(k) submissions.
A PMA application must be filed if a proposed product is not substantially equivalent to a medical product first marketed prior to May 1976, or if otherwise required by the FDA. The PMA approval process can be expensive, uncertain and lengthy, and a number of products for which other companies have sought FDA approval of a PMA application have never been approved for marketing. It generally takes from six to eighteen months from submission to obtain PMA approval, but it may take longer or the submission may not be approved at all.
On May 5, 2005 the Company submitted a pre-IDE application to the FDA on its blood test for neurodegenerative diseases of motor control, including Parkinsons disease, ALS and their like disorders in order to obtain the Agencys guidance regarding: the appropriate regulatory pathway to pursue; the proper approach to refine and/or define its data and statistical analyses; and the study design for the Companys pending neurodegenerative disease diagnostic blood tests. A submission made under the pre-IDE process is not an official IDE application as described in 21 CFR Part 812. The Pre-IDE process is designed to help companies obtain early, informal input on aspects of a future IDE application and offers assistance in establishing the parameters for official IDE applications when unique diagnostic tests involving innovative technologies are being pursued. The Company met with the Food and Drug Administration on June 1, 2005 regarding its Pre-IDE submission for the first in a series of its NuroPro Blood Tests for the early detection and differentiation of neuromuscular diseases, such as ALS and Parkinsons disease.
In the meeting with the FDA, guidance was offered regarding requirements for study design, patient risk assessment and intended use. In addition, the FDA concurred with how the Company had approached the biostatistics analysis utilized to interpret the test results. Based on the FDAs advice in preliminary discussions, Power3 presented optimized results with an increase in specificity to more than 92% and an increase in Positive Predicted Value to more than 96%.
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Now, the Company is proceeding to make preparations for FDA applicable multiple site clinical studies for the NuroPro suite of blood serum tests. On August 17, 2005, the Company submitted its second Pre-IDE application on its ALS specific blood test for distinguishing ALS from normal and disease controls.
The Company is also subject to the regulatory approval and compliance requirements for each foreign country to which it exports products. In the European Union, a single regulatory approval process has been created, and approval is represented by the CE Mark.
Both before and after a product is commercialized, the Company has ongoing responsibilities under the regulations of the FDA and other agencies. The Companys manufacturing facilities and those of its contract manufacturers are, or can be, subject to periodic regulatory inspections by the FDA and other federal and state regulatory agencies, as well as civil penalties, recall or seizure of products, total or partial suspension of production, failure of the government to grant premarket clearance approval for products, withdrawal of marketing clearances or approvals, and criminal prosecution. The FDA has the authority to request recall, repair, replacement or refund of the cost of any product, which the Company manufactures or distributes. The FDA also administers certain controls over the export of medical devices from the United States. The Company is also subject to routine inspection and must file periodic reports after the product is approved by the FDA for compliance with quality system requirements, or QSR, and medical device reporting requirements in the United States and other applicable regulations worldwide. Changes in existing requirements or adoption of new laws or requirements could have a material adverse effect on the Companys business, financial condition and results of operation. The Company will incur significant costs to comply with laws and regulations.
The Company is also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances. The Company may incur significant costs to comply with laws and regulations, or such laws or regulations in the future may have a material adverse effect upon its business, financial condition and results of operations.
Sales and Marketing
The Company currently has no sales or marketing employees, and no immediate plans to hire any personnel devoted to this area. The Company will make decisions about sales and marketing at a later date, when its products are further along in the development stage.
Manufacturing
The Company does not currently have manufacturing capabilities, but it is exploring opportunities to produce and manufacture the Companys diagnostic tests through collaborative agreements and strategic alliances. Exploitation of these opportunities will depend on the availability of further capital, qualified personnel, sufficient production resources and the Companys ability to establish these relationships with other parties who have existing manufacturing and distribution capabilities. The Company does not currently have plans to manufacture any products in the near future. The Company will make decisions about manufacturing at a later date, when its product portfolio is further along in the development stage.
Costs and Effects of Compliance with Environmental Laws (Federal, State or Local)
The Company, as discussed earlier in this section, does not manufacture any products, nor does it purchase, store or ship any products. Consequently the Company does not have any compliance issues with regard to environmental laws as they relate to commercial operations.
The Company does store and handle certain organic wastes and human tissue samples in its laboratory operations. The cost of complying with environmental laws which govern our research and development laboratory operations, during 2005, was $1,155 .
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Employees and Consultants
At December 31, 2005, the Company had fourteen (14) full-time employees. None of the Companys employees are represented by collective bargaining agreements, and the Company considers its employee relations to be good. The Company utilizes part-time consultants as well as contract research organizations and other outside specialty firms for various services such as clinical trial support, manufacturing and regulatory approval advice.
Divestiture of Subsidiaries
Prior to May 17, 2004, the Company had one direct subsidiary, Tenthgate, Inc. (Tenthgate), a Nevada corporation formerly known as Power3 Medical, Inc. Prior to this date, Tenthgate was accounted for, by Power3, as a wholly-owned subsidiary, operating as a development stage company, under the cost method. Prior to the acquisition of substantially all the assets and certain liabilities from Advanced BioChem, now known as Industrial Enterprises of America, Power3 agreed to distribute the shares of its subsidiary, Tenthgate, to its shareholders of record, as of May 17, 2004. To fulfill this obligation, the shares of Tenthgate were transferred to a trustee for distribution to the previous shareholders of Power3 on May 17, 2004, before the Advanced BioChem transaction and the takeover by present management. Tenthgate was spun off because the previous owners and management of Power3, in place prior to May 17, 2004, desired to continue to own and eventually operate this inactive subsidiary, and to pursue the prior operations of Power3. Apparently the current management of Tenthgate has decided to abandon that product, because their SEC filings state that they are a development stage company. Since May 17, 2004, Tenthgate has been deconsolidated from Power3. Tenthgate has been independently operating since May 17, 2004 and Power3 did not own or control the operations or activities of Tenthgate in any manner whatsoever, after May 17, 2004.
Risk Factors
In addition to the other information contained in this report, the following risks may affect us. If any of these risks occurs, our business, financial condition or operating results could be adversely affected.
We have a history of operating losses, and we may not achieve or maintain profitability in the future.
We have experienced a net loss of ($13,512,696 ) for calendar year 2005. We expect these losses to continue and it is uncertain when, if ever, we will become profitable. These losses have resulted primarily from non-cash, stock-based compensation costs incurred in consulting contracts, stock issued for compensation, research and development activities and from general and administrative costs associated with operations. Stock issued for compensation and for consulting fees has been valued at market price on the effective date of the agreement, per SEC requirement. We expect to incur increasing operating losses in the future as a result of expenses associated with research and product development as well as general and administrative costs and we have estimated that we will require approximately $2,500,000 to carry out our business plan through the period ending December 31, 2006. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
We will need significant additional capital in the future and, if additional capital is not available, we may have to curtail or cease operations.
We have an immediate need for capital to continue our operations, and we will need to raise significant additional funds to implement our business plan. Our current plans indicate we will need significant additional capital for research and development before we have any anticipated revenue generating products. The actual amount of funds that we will need will be determined by many factors, some of which are beyond our control, and we may need funds sooner than currently anticipated. These factors include:
the extent to which we enter into licensing arrangements, collaborations or joint ventures;
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our progress with research and product development;
the costs and timing of obtaining new patent rights;
the extent to which we acquire or license other technologies; and
regulatory changes and competition and technological developments in the market.
Our continued operations will therefore depend upon our ability to raise additional funds through additional equity or debt financing. We may seek additional funding through private sales of our securities, public sales of our securities, strategic alliances or by licensing all or a portion of our technology. Any such funding may significantly dilute existing shareholders or may limit our rights to our technology. Moreover, the increase in the number of shares available in the public marketplace may reduce the market price for our common stock and, consequently, the price investors may receive at the time of sale. When we require additional funds, general market conditions or the then-current market price of our common stock may not support capital raising transactions such as additional public or private offerings of our common stock. If we are unable to obtain additional funds on a timely basis or on terms favorable to the Company, we may be required to scale back our development of new products, sell or license some or all of our technology or assets, or curtail or cease operations.
We may not be successful in developing or commercializing our products, which would harm the Company and force the Company to curtail or cease operations.
We have only recently commenced our business operations and our technologies are still in the early stages of development. The products we are currently developing may not be successfully developed or commercialized on a timely basis, or at all. If we are unable, for technological or other reasons, to complete the development, introduction or scale up of manufacturing of these products or other potential products, or if our products do not achieve a significant level of market acceptance, we would be forced to curtail or cease operations. Even if we develop our products for commercial use and obtain all necessary regulatory approvals, we may not be able to develop products that:
are accepted by, and marketed successfully to, the marketplace;
are safe and effective;
are protected from competition by others;
do not infringe the intellectual property rights of others;
are developed prior to the successful marketing of similar products by competitors; or
can be manufactured in sufficient quantities or at a reasonable cost.
Many of our research and development programs rely on technology licensed from third parties, and termination of any of those licenses would result in loss of significant rights to develop and market our products, which would impair our business.
We have rights to technology through license agreements with third parties. We rely upon an exclusive license agreement from Baylor College of Medicine for identification and use of biomarkers for neurodegenerative diseases. We have two license agreements from The University of Texas M.D. Anderson Cancer Center. One license agreement from M.D. Anderson grants the Company an exclusive license for identifying specific proteins associated with sensitivity or resistance to kinase inhibitor. The second license agreement from M.D. Anderson grants the Company an exclusive license to employ proteomic methods for diagnosis and monitoring of breast cancer using nipple aspirate fluid and a non-exclusive license for methods of identifying specific nipple aspirate fluid proteins for diagnosis and monitoring of breast cancer. Our licenses
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generally may be terminated by the other party if we fail to perform our obligations, including milestone obligations to conduct a research and development program and develop the licensed products for commercialization. If terminated, we would lose the right to develop the licensed products, which would significantly harm our business. The license agreements include payments contingent upon achieving specified milestones toward commercialization of the licensed products. If disputes arise over the definition of these requirements or whether we have satisfied the requirements in a timely manner, or if any other obligations in the license agreement are disputed by the other party, the other party could terminate the agreement and we could lose our rights to develop the licensed technology.
If we are unable to form and maintain the collaborative relationships that our business strategy requires, our ability to develop products and revenue will suffer.
We must form research collaborations and licensing arrangements with several partners to operate our business successfully. To succeed, we will have to further develop our existing relationships and establish additional collaborations. We cannot be sure that we will be able to establish any additional research collaborations or licensing arrangements necessary to develop and commercialize products using our technology or that we can do so on terms favorable to the Company. If our collaborations are not successful or we are not able to manage multiple collaborations successfully, our programs may suffer.
Collaborative agreements generally pose the following risks:
collaborators may not pursue further development and commercialization of products resulting from collaborations or may elect not to continue or renew research and development programs;
collaborators may delay clinical trials, under fund a clinical trial program, stop a clinical trial or abandon a product, repeat or conduct new clinical trials or require a new formulation of a product for clinical testing;
collaborators could independently develop, or develop with third parties, products that could compete with our future products;
the terms of our agreements with our current or future collaborators may not be favorable to the Company;
a collaborator with marketing and distribution rights to one or more products may not commit enough resources to the marketing and distribution of our products, limiting our potential revenues from the commercialization of a product;
disputes may arise delaying or terminating the research, development or commercialization of our products, or result in significant litigation or arbitration; and
collaborations may be terminated and, if terminated, we would experience increased capital requirements if we elected to pursue further development of the product.
In addition, business combinations or alliances among large pharmaceutical companies could result in a reduced number of potential future collaborators. If business combinations involving our collaborators were to occur, the effect could be to diminish, terminate or cause delays in one or more of our product development programs.
Our products are subject to United States, European Union and international medical regulations and controls, which impose substantial financial costs on the Company and which can prevent or delay the introduction of new products. As a result, we may not obtain required approvals for the commercialization of our products.
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Our ability to sell our products is subject to various federal, state and international rules and regulations. In the United States, we are subject to inspection and market surveillance by the Food and Drug Administration, or FDA, to determine compliance with regulatory requirements. The regulatory process is costly, lengthy and uncertain.
Our future performance depends on, among other matters, estimates as to when and at what cost we will receive regulatory approval for our new products. Regulatory approval can be a lengthy, expensive and uncertain process, making the timing and cost of obtaining approvals difficult to predict.
In the United States, clearance or approval to commercially distribute new medical devices or products is received from the FDA through clearance of a 510(k) premarket notification, or 510(k), approval of a premarket approval application or PMA. The process to obtain 510(k) clearance is lengthy and there is no assurance clearance will be obtained.
For any products that are cleared through the 510(k) premarket notification process, modifications or enhancements that could significantly affect safety or constitute a major change in the intended use of the product, will require new 510(k) submissions.
A PMA application must be filed if proposed products are not substantially equivalent to a medical product first marketed prior to May 1976, or if otherwise required by the FDA. The PMA approval process can be expensive, uncertain and lengthy, and a number of products for which other companies have sought FDA approval of a PMA application have never been approved for marketing.
We are also subject to the regulatory approval and compliance requirements for each foreign country to which we export our products. In the European Union, a single regulatory approval process has been created, and approval is represented by the CE Mark.
Both before and after products are commercialized, we have ongoing responsibilities under the regulations of the FDA and other agencies. Our manufacturing facilities and those of our contract manufacturers are, or can be, subject to periodic regulatory inspections by the FDA and other federal and state regulatory agencies. The FDA has the authority to request recall, repair, replace or refund of the cost of any product manufactured or distributed by the Company. The FDA also administers certain controls over the export of medical devices from the United States. We are also subject to routine inspection and must file periodic reports after the product is approved by the FDA for compliance with quality system requirements, or QSR, and medical device reporting requirements in the United States and other applicable regulations worldwide. Changes in existing requirements or adoption of new laws or requirements could have a material adverse effect on our business, financial condition and results of operation. We will incur significant costs to comply with laws and regulations.
Regulatory agencies have made, and continue to make, changes in their approval and compliance requirements and process. We cannot predict what, how or when these changes will occur or what effect the changes will have on the regulation of our products. Any new legislation may impose additional costs or lengthen review times of our products. We may not be able to obtain necessary worldwide regulatory approvals or clearances for our products on a timely basis, if at all. Delays in receipts of or failure to receive such approvals or clearances, the loss of previously received approvals or clearances, or failure to comply with existing or future regulatory requirements would have a material adverse effect on our business, financial condition and results of operations.
Because many of our competitors have substantially greater capital resources and more experience in research and development, manufacturing and marketing than we do, we may not succeed in developing our proposed products and bringing them to market in a cost-effective, timely manner.
We expect to compete with a broad range of organizations that are engaged in the development and production of products, services and strategies relating to the diagnosis, prognosis, early detection and development of new drugs in cancer, neurodegenerative and neuromuscular diseases. They include:
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biotechnology, biomedical, pharmaceutical and other companies;
academic and scientific institutions;
governmental agencies; and
public and private research organizations.
We are an early stage development company engaged primarily in new product development. Early in its existence, Power3 was a development stage company, striving to develop products for sale to the surgical industry. After this stage, Power3 entered the operating company stage selling the products they had developed to hospitals and medical care providers, up until May 17, 2004. At the time of the May 18, 2004 asset purchase transaction, Power3 changed its business model and entered back into the development stage to commercialize its intellectual properties acquired in the transaction. We have not yet completed the development of our first product and have no revenue from operations. Since the change of our focus, we may have difficulty competing with larger, established biomedical and pharmaceutical companies and organizations. These companies and organizations have much greater financial, technical, research, marketing, sales, distribution, service and other resources than the Company. Moreover, they may offer broader product lines, services and have greater name recognition than we do, and may offer discounts as a competitive tactic.
In addition, several early stage companies are currently developing products that may compete with our potential products. We anticipate strong competition from several companies that include:
Medarex, which is a biopharmaceutical company focused on the development of antibody-based therapeutics to treat life threatening and debilitating diseases including cancer and infectious diseases;
Matritech, which is a developer of proteomics-based diagnostic products for the early detection of cancer;
Ciphergen Biosystems, which is active in biomarker discovery assay development and characterization;
Lexicon Genetics, which is using gene knockout technology for a number of therapeutic areas which include neurological disorders and cancer; and
Cyberonics, which designs, develops, manufactures and markets medical devices for the treatment of Alzheimers disease and other chronic disorders.
Our competitive position depends on protection of our intellectual property.
Our success will depend on our ability to obtain and protect patents on our technology and to protect our trade secrets. The patents we currently license, and any future patents we may obtain or license, may not afford meaningful protection for our technology and products. Others may challenge our patents and, as a result, our patents could be narrowed, invalidated or unenforceable. In addition, our current and future patent applications may not result in the issuance of patents in the United States or foreign countries. Competitors may develop products similar to ours that conflict with our patent applications and any patents we ultimately receive. In order to protect or enforce our patent rights, we may initiate interference proceedings, oppositions, or patent litigation against third parties, such as infringement suits. These lawsuits could be expensive, take significant time and divert managements attention from other business concerns. The patent position of biotechnology firms generally is highly uncertain, involves complex legal and factual questions, and has recently been the subject of much litigation. No consistent policy has emerged from the U.S. Patent and Trademark Office or the courts regarding the breadth of claims allowed or the degree of protection afforded under biotechnology patents. In
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addition, there is a substantial backlog of biotechnology patent applications at the U.S. Patent and Trademark Office, and the approval or rejection of patent applications may take several years.
We also rely upon trade secrets, proprietary know-how and continuing technological innovation to remain competitive. Third parties may independently develop such know-how or otherwise obtain access to our technology. While our employees, consultants and corporate partners with access to proprietary information generally will be required to enter into confidentiality agreements, we cannot guarantee that these agreements will provide the Company with adequate protection against improper use or disclosure of confidential information. In addition, in some situations, these agreements may conflict with, or be subject to, the rights of third parties with whom our employees, consultants or advisors have prior employment or consulting relationships. Further, others may gain access to our trade secrets or independently develop substantially equivalent proprietary information and techniques.
Our products could infringe on the intellectual property rights of others.
Third parties may challenge the patents that have been issued or licensed to the Company. We may have to pay substantial damages, possibly including treble damages, for past infringement if it is ultimately determined that our products infringe a third partys patents. Further, we may be prohibited from selling our products before we obtain a license, which, if available at all, may require the Company to pay substantial royalties. Even if infringement claims against the Company are without merit, defending a lawsuit takes significant time, may be expensive and may divert management attention from other business concerns.
We depend on our key scientific and management personnel to develop our products and pursue collaborations.
Our performance is substantially dependent on the performance of our current senior management, board of directors and key scientific and technical personnel and advisers. The loss of the services of any member of our senior management, board of directors, scientific or technical staff or scientific advisory board may significantly delay or prevent the achievement of product development and other business objectives and could have a material adverse effect on our business, operating results and financial condition.
Recruiting and retaining qualified scientific personnel to perform research and development work are critical to our success. There is intense competition for qualified scientists and managerial personnel from numerous pharmaceutical, biomedical and biotechnology companies, as well as from academic and government organizations, research institutions and other entities. In addition, we may face particular difficulties because there is a limited number of scientists specializing in proteomics and its use for the discovery of diseases, the principal focus of our company. We expect to rely on consultants and advisors, including our scientific and clinical advisors, to assist the Company in formulating our research and development strategy. Any of those consultants or advisors could be employed by other employers, or be self-employed, and might have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to the Company. Such other employment, consulting or advisory relationships could place our trade secrets at risk, even if we require non-disclosure agreements.
Our lack of operating experience may cause the Company difficulty in managing our growth.
We have no experience in manufacturing or procuring products in commercial quantities, conducting other later-stage phases of the regulatory approval process or selling our products, and we have only limited experience in negotiating, establishing and maintaining strategic relationships. We have no experience with respect to the launch of a commercial product. Our ability to manage our growth, if any, will require the Company to improve and expand our management and our operational and financial systems and controls. If our management is unable to manage growth effectively, our business and financial condition would be materially harmed. In addition, if rapid growth occurs, it may strain our operational, managerial and financial resources.
We have no commercial production capability and we may encounter production problems or delays, which could result in lower revenue.
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To date, we have not produced any product in commercial quantities. Customers for any potential products and regulatory agencies will require that we comply with current good manufacturing practices prescribed by the FDA that we may not be able to meet. We have established and are in the process of establishing agreements with contract manufacturers to supply sufficient quantities of our products to conduct clinical trials as well as for the manufacture, packaging, labeling and distribution of finished products if our potential products are approved for commercialization. If such arrangements are terminated and if we are unable to manufacture or contract for a sufficient supply of our potential products on acceptable terms, our clinical testing schedule may be delayed, resulting in the delay of submission of products for regulatory approval and initiation of new development programs. If we determine to manufacture products ourselves, we may not be able to maintain acceptable quality standards if we ramp up production. To achieve anticipated customer demand levels, we will need to scale-up our production capability and maintain adequate levels of inventory. We may not be able to produce sufficient quantities to meet market demand. If we cannot achieve the required level and quality of production, we may need to outsource production or rely on licensing and other arrangements with third parties. This reliance could reduce our gross margins and expose the Company to the risks inherent in relying on others. We may not be able to successfully outsource our production or enter into licensing or other arrangements under acceptable terms with these third parties, which could adversely affect our business.
We have no marketing or sales staff, and if we are unable to develop sales and marketing capability, we may not be successful in commercializing our products.
We currently have no sales, marketing or distribution capability. As a result, we will depend on collaborations or agreements with third parties that have established distribution systems and direct sales forces. To the extent that we enter into co-promotion or other licensing arrangements, our revenues will depend upon the efforts of third parties, over which we may have little or no control.
If we are unable to reach and maintain agreement with one or more pharmaceutical, biomedical or biotechnology companies or other potential collaborators under acceptable terms, we may be required to market our products directly. We may elect to establish our own specialized sales force and marketing organization to market our products. If we are unable to develop a marketing and sales force with technical expertise and with supporting distribution capability, we may not be able to successfully commercialize our products.
Our business is subject to technological obsolescence.
Proteomics, biotechnology and related pharmaceutical technology have undergone and are subject to rapid and significant change. We expect that the technologies associated with proteomics, biotechnology research and development will continue to develop rapidly. Our future will depend in large part on our ability to maintain a competitive position with respect to these technologies. Any processes, discovery platforms or products that we develop may become obsolete before we recover any expenses incurred in connection with developing these products.
We face intense competition in the proteomics, biotechnology and pharmaceutical industries.
The proteomics, biotechnology and pharmaceutical industries are intensely competitive. We have numerous competitors in the United States and elsewhere. Our competitors include major multinational pharmaceutical, biomedical and biotechnology companies, specialized firms and universities and other research institutions. Many of these competitors have greater financial and other resources, larger research and development staffs and more effective marketing and manufacturing organizations, than we do. In addition, academic and government institutions have become increasingly aware of the commercial value of their research findings. These institutions are now more likely to enter into exclusive licensing agreements with commercial enterprises, including our competitors, to market commercial products. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical and established biotechnology companies. Many of these competitors have significant products that have been approved or are in development and operate large, well-funded research and development programs.
20
Our competitors may succeed in developing or licensing technologies and products that are more effective or less costly than any we are developing. Our competitors may succeed in obtaining FDA or other regulatory approvals for product candidates before we do. Products resulting from our research and development efforts, if approved for sale, may not compete successfully with our competitors existing products or products under development.
We face potential difficulties in obtaining product liability and related insurance. If we are subject to product liability claims and have not obtained adequate insurance to protect against these claims, our financial condition would suffer.
We do not have product liability or other professional liability insurance. In the future, we may, in the ordinary course of business, be subject to substantial claims by, and liability to, persons alleging injury from the use of our products. If we are successful in having products approved by the FDA, the sale of such products would expose the Company to additional potential product liability and other claims resulting from their use. This liability may result from claims made directly by consumers or by others selling such products. We do not currently have any product liability or professional liability insurance, and it is possible that we will not be able to obtain or maintain such insurance on acceptable terms or that any insurance obtained will provide adequate coverage against potential liabilities. Our inability to obtain sufficient insurance coverage at an acceptable cost or otherwise to protect against potential product liability claims could prevent or limit the commercialization of any products we develop. A successful product liability claim in excess of any insurance coverage we may procure could exceed our net worth. While we desire to reduce our risk by obtaining indemnity undertakings with respect to such claims from licensees and distributors of our products, we may not be able to obtain such undertakings and, even if we do, they may not be sufficient to limit our exposure to claims.
If we are subject to claims relating to improper handling, storage or disposal of the hazardous materials we use in our business, our financial condition would suffer.
Our research and development processes involve the controlled storage, use and disposal of hazardous materials including biological hazardous materials of which we have contracts in place for proper disposal. We are subject to federal, state and local regulations governing the use, manufacture, storage, handling and disposal of materials and waste products. Although we believe that our safety procedures for handling and disposing of these hazardous materials comply with the standards prescribed by law and regulation, the risk of accidental contamination or injury from hazardous materials cannot be completely eliminated. In the event of an accident, we could be held liable for any damages that result. We currently do not have insurance which covers any such accident and may not be able to maintain insurance on acceptable terms, or at all. We could be required to incur significant costs to comply with current or future environmental laws and regulations.
Health care cost containment initiatives may limit our returns.
Our ability to commercialize our products successfully will be affected by the ongoing efforts of governmental and third-party payers to contain or reduce the cost of health care. Governmental and other third-party payers increasingly are attempting to contain health care costs by:
challenging the prices charged for health care products and services;
limiting both coverage and the amount of reimbursement for new therapeutic products;
denying or limiting coverage for products that are approved by the FDA but are considered experimental or investigational by third-party payors; and
refusing in some cases to provide coverage when an approved product is used for disease indications in a way that has not received FDA marketing approval.
In addition, the trend toward managed health care in the United States, the growth of organizations such as health maintenance organizations, and legislative proposals to reform healthcare and government insurance
21
programs could significantly influence the purchase of healthcare services and products, resulting in lower prices and reducing demand for our products.
Even if we succeed in bringing any products to the market, they may not be considered cost-effective and third-party reimbursement might not be available or sufficient. If adequate third-party coverage is not available, we may not be able to maintain price levels sufficient to realize an appropriate return on our investment in research and product development. In addition, legislation and regulations affecting the pricing of diagnostic services and testing may change in ways adverse to the Company before or after any of our proposed products are approved for marketing. While we cannot predict whether any such legislative or regulatory changes will be adopted, the adoption of such changes could make it difficult or impossible to sell our products.
Stock prices for biomedical and biotechnology companies are volatile.
The market price for securities of biomedical and biotechnology companies historically has been highly volatile, and the market from time to time has experienced significant price and volume fluctuations that are unrelated to the operating performance of such companies. Fluctuations in the trading price or liquidity of our common stock may adversely affect our ability to raise capital through future equity financings.
Factors that may have a significant impact on the market price and marketability of our common stock include:
announcements of technological innovations or new commercial therapeutic products by the Company, our collaborative partners or our present or potential competitors;
announcements by the Company or others of results of validation studies and clinical trials;
developments or disputes concerning patent or other proprietary rights;
adverse legislation, including changes in governmental regulation and the status of our regulatory approvals or applications;
changes in health care policies and practices; and
economic and other external factors, including general market conditions.
In the past, following periods of volatility in the market price of a companys securities, securities class action litigation has often been instituted. If a securities class action suit is filed against the Company, we would incur substantial legal fees and our managements attention and resources would be diverted from operating our business in order to respond to the litigation.
The resale in the open market of the shares we have issued, or shares issuable upon conversion or exercise of securities we have issued, in exempt transactions might adversely affect our stock price.
As of December 31, 2005, 65,215,121 shares of our common stock were outstanding. We also intend to register, pursuant to a Registration Statement on Form SB-2, approximately 13,600,000 shares issuable upon outstanding convertible debentures and warrants. In addition to the shares included in the registration statement, the investors have additional investment rights to purchase additional convertible debentures in the aggregate principal amount of $2,500,000. These additional convertible debentures are convertible into 2,314,815 shares of common stock, subject to adjustment. The investors will be permitted to sell the shares covered by the registration statement in the open market from time to time without advance notice to the Company or to the market and without limitations on volume. The sale of a substantial number of shares of our common stock by the investors, or the anticipation of such sales, could make it more difficult for the Company to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales. In addition to the shares listed in this prospectus, approximately 15,000,000 shares of common stock issued to Advanced Bio/Chem in our acquisition of substantially all of its assets may become available for resale. Sales
22
of shares pursuant to other exercisable options and warrants we have issued could also lead to subsequent sales of the shares in the public market. These sales could depress the market price of our stock by creating an excess in supply of shares for sale. Availability of these shares for sale in the public market could also impair our ability to raise capital by selling equity securities.
Our stock is thinly traded, which could lead to price volatility and difficulty liquidating your investment.
The trading volume of our stock has been low, which can cause the trading price of our stock to change substantially in response to relatively small orders. During the quarter ended December 31, 2005, the average daily trading volume of our stock was approximately 162,500 shares and the shares traded as low as $0.10 and as high as $0.26 per share. Both volume and price could also be subject to wide fluctuations in response to various factors, many of which are beyond our control, including:
actual or anticipated variations in quarterly and annual operating results;
announcements of technological innovations by the Company or our competitors;
developments or disputes concerning patent or proprietary rights; and
general market perception of biotechnology and pharmaceutical companies.
Because our stock currently trades below $5.00 per share, and is traded on the Pink Sheets, our stock is considered by the SEC a penny stock, which can adversely affect its liquidity.
Our common stock does not currently qualify for listing on the Nasdaq Stock Market or the OTCBB.. If the trading price of our common stock remains less than $5.00 per share, our common stock is considered a penny stock, and trading in our common stock is subject to the requirements of Rule 15g-9 under the Securities Exchange Act of 1934. Under this rule, brokers or dealers who recommend low-priced securities to persons other than established customers and accredited investors must satisfy special sales practice requirements. The broker or dealer must make an individualized written suitability determination for the purchaser and receive the purchasers written consent prior to the transaction.
SEC regulations also require additional disclosure in connection with any trades involving a penny stock, including the delivery, prior to any penny stock transaction, of a disclosure schedule explaining the penny stock market and its associated risks. These requirements could severely limit the liquidity of such securities in the secondary market because few brokers or dealers are likely to undertake these compliance activities. In addition to the applicability of the penny stock rules, another risk associated with trading in penny stocks may be high price fluctuations. Purchasers of stock may be subject to substantial dilution.
As stated in Market Information, during 2005, upon the Companys failure to timely file its Form 10-KSB, the OTCBB appended the symbol E to the Companys trading symbol and notified the Company of its jeopardy of having its securities no longer quoted on the OTCBB, pending the Companys filing of its Form 10-KSB for 2004. On June 14, 2005, the Company was notified of the OTCBBs action to not allow the Companys securities to be quoted on the OTCBB, as of June 16, 2005, pending the filing of the Companys Form 10-KSB for 2004. The 10-KSB for 2004 was filed in September, 2005, however the Company, per SEC comments, is now restating its financials for 2004 in this Form 10-KSB for the year ended December 31, 20005. Accordingly, at time of this filing, the Companys common shares are only available for trading through the Pink Sheets.
If the ownership of our common stock continues to be highly concentrated, it may prevent you from influencing significant corporate decisions and may result in conflicts of interest that could cause our stock price to decline.
23
As of December 31, 2005, our executive officers, directors and their affiliates beneficially own or control approximately 21.7% of the outstanding shares of our common stock (after giving effect to the exercise of all options and warrants held by them which are exercisable within sixty days of such date). Additionally, based upon our stock records, Industrial Enterprises of America, previously known as Advanced Bio/Chem, is the record owner of approximately 22% of the outstanding shares of our common stock as of March 24, 2005. Accordingly, our current executive officers, directors and their affiliates, as well as Advanced Bio/Chem, will have substantial control over the outcome of corporate actions requiring shareholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of our assets or any other significant corporate transactions. These shareholders may also delay or prevent a change of control of the Company, even if such a change of control would benefit our other shareholders. The significant concentration of stock ownership may adversely affect the trading price of our common stock due to investors perception that conflicts of interest may exist or arise.
The terms of our convertible debentures have materially modified the rights of common shareholders, and the holders of preferred stock may be able to delay or prevent a change of control of the company.
We are authorized to issue up to 50,000,000 shares of preferred stock in one or more series. Our board of directors will be able to determine the terms of preferred stock without further action by our shareholders. If we issue preferred stock, it could affect your rights or reduce the value of your common stock. In particular, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with or sell our assets to a third party. These terms may include voting rights, preferences as to dividends and liquidation, conversion and redemption rights, and sinking fund provisions.
Under the terms of our convertible debentures, we are prohibited from taking certain actions without the approval of the holders of a two-thirds majority of the then-outstanding principal amount of the debentures. Specifically, we have agreed not to, so long as any portion of the debentures are outstanding, (1) amend its certificate of incorporation, bylaws or other charter documents so as to adversely affect any rights of the holders of the debentures (with exception for the Series B preferred stock to be issued by the Company), or (2) repurchase more than a de minimis number of shares of its common stock or other equity securities other than as to the shares of common stock issuable upon conversion of the debentures described above.
We are contractually obligated to issue shares of a Series B preferred stock to our two directors and principal officers. The Series B preferred stock will have special voting rights such that the holders of the Series B preferred stock will hold a majority of the voting rights of the company.
We previously entered into employment agreements with our two directors and executive officers in which we agreed to issue 1,500,000 shares of Series B preferred stock to each officer. The shares were intended to be issued following the Advanced Bio/Chem transaction; however, we did not file the certificate of amendment necessary to designate powers and relative rights of the Series B preferred stock. As a result of certain restrictions agreed to by the Company in connection with the sale of our convertible debentures, we are not permitted to issue common shares or common share equivalents such as the Series B preferred stock until 90 days after the effective date of the registration statement. After such restrictions lapse, we intend to designate and issue the Series B preferred stock. It is contemplated that the Series B preferred stock will have special voting rights such that the holders of the Series B preferred stock will hold a majority of the voting rights of the company. Upon issuance of the Series B preferred stock, our current executive officers and directors may restrict our ability to merge with, or sell our assets to, a third party.
We do not anticipate paying dividends on our common stock.
We do not plan to pay dividends on our common stock for the foreseeable future. We currently intend to retain future earnings, if any, to finance operations, capital expenditures and the expansion of our business.
24
Item 2. Description of Property
The Company does not own any real estate. The Company conducts its operations from leased premises of approximately 7,200 square feet in The Woodlands, Texas.
At this facility the Company maintains its executive offices and conducts development and product prototyping activities. The Company expects this space will be adequate for its needs for the remainder of the lease term.
In November 2004, Chapman Spira & Carson, LLC (Chapman Spira), an investment banking firm, filed a lawsuit in the Supreme Court of the State of New York for the County of New York against Advanced BioChem (the Predecessor), Power3 and Steven Rash. The suit alleges that Advanced BioChem and Power3 are liable to Chapman Spira for damages allegedly resulting from the breach of a letter agreement between Chapman Spira and Advanced BioChem relating to the performance of strategic and investment banking services. Chapman Spira is seeking damages in the amount of $1,522,000 plus interest. The Company has filed an answer in the lawsuit. The Company believes that Chapman Spiras claims are without merit; however, the Company cannot be assured it will prevail or if the outcome of the action will adversely affect the Companys business, financial position or results of operations. Settlement negotiations are ongoing between the parties and their attorneys, however no resolution has been achieved thus far.
An equipment vendor filed a complaint, regarding equipment which the Company acquired in its May 18, 2004 transaction with Advanced BioChem, now known as Industrial Enterprises of America, and against Advanced BioChem in April of 2002 in a California court alleging breach of contract and seeking damages. Advanced BioChem reached a settlement agreement in April of 2003 under which Advanced BioChem would pay the vendor $40,000 in installments through August, 2003. At December 31, 2003, Advanced BioChem had a balance remaining of $20,000. In April, 2005, the equipment vendor filed a lawsuit against Advanced BioChem, certain former officers of Advanced BioChem and against Power3 in order to enforce its claim for the remaining balance which is past due and may have been assumed by the Company as part of the settlement of the dispute with Advanced BioChem. Settlement negotiations are ongoing, however no resolution has been achieved thus far.
On May 17, 2005, the Law Offices of Jerry Scheff, Spencer and Associates and Proteomic Research Services filed suit against the Company seeking recovery of amounts billed to Power3 for services and legal fees invoiced in November, 2004. In February, 2006, a settlement was reached between all parties and all legal actions between the parties have been completed.
In June, 2005, Charles Caudle et al filed a lawsuit in Harris County, Texas, against Advanced BioChem, Power3 and the officers and directors of both companies. The suit alleges that Advanced BioChem, Power3 and the officers and directors of Power3, are liable to Charles Caudle et al for damages resulting from funds loaned to Advanced BioChem and which were subsequently converted into common stock of Advanced BioChem. It is unclear as to the specific dollar amount of the claim. The Company, and its officers and directors, has filed an answer denying all claims in the lawsuit. The Company believes that Charles Caudle et als claims are without merit, however the Company cannot be assured it will prevail or if the outcome of the action will adversely affect the Companys financial position or results of operations. Settlement negotiations between the parties are ongoing, however no resolution has been achieved thus far.
On June 27, 2005, the Company received a subpoena for documents regarding the SECs Division of Enforcement investigation In The Matter of Maui General Store, Inc. It is the Companys understanding that the Maui General Store matter relates to a promotional scheme by certain individuals to promote the stock and stock price of certain companies, during 2004. The Company provided all documents in its possession pursuant to the subpoena and complied fully with the subpoena on July 11, 2005. In February, 2006, Steven B. Rash and Dr. Ira Goldknopf gave testimony regarding this matter to the SECs Division of Enforcement in Washington, D.C.
25
The Company has received no further correspondence from the Enforcement Division of the SEC. The Company has not been notified that it is a subject of this investigation.
On August 8, 2005, Advanced BioChem, now known as Industrial Enterprises of America, filed suit against Power3, Steven B. Rash and Ira Goldknopf claiming damages of at least $3,000,000 including the costs of litigation and of addressing the claims of the creditors of Advanced BioChem that remain unpaid. Advanced BioChem had, in its public reports, announced their assertion that the parties to the law suit are responsible for all of the liabilities of Advanced BioChem, at the date of the asset purchase transaction on May 18, 2004. On October 25, 2005, this action was dismissed, without prejudice, by Industrial Enterprises of America. Power3 has consulted with its attorneys on this matter and has been informed that no further action will be filed on this matter, based on information received from Industrial Enterprises of America.
In January of 2005, Kamy Behzadi, a previous employee of Advanced BioChem and Power3, filed suit against Advanced BioChem and Power3 claiming his entitlement to 1,000,000 common shares of Power3 per an Employment Agreement with the Company. In May, 2005, Power3 filed a countersuit against Behzadi regarding his employment with the Company. On March 22, 2006, both lawsuits were settled and all actions between the parties have been completed, assuming fulfillment of the Settlement Agreement clauses, which specify that Behzadi is to retain 25,000 shares of common stock of Power3 and Power3 agreed to compensate Behzadi for his legal fees.
On October 28, 2005, Centigrade Services, Inc. filed suit against Power3 to collect an outstanding debt of $2,117.09 plus court costs. The Company believes that this lawsuit will be settled prior to the court date, however no resolution has been achieved thus far. The debt is recorded in accounts payable by Power3.
On September 12, 2005, Focus Partners LLC filed suit against David Zazoff and Power3 alledging that Power3 breached its agreement with Focus Partners in that it failed to issue stock to the Plaintiff according to the terms of their agreement, that the stock in question was issued to Zazoff and that Zazoff later sold the stock in question for $480,000. Settlement discussions between the Power3 and Focus Partners are ongoing, however no resolution has been achieved thus far.
On August 30, 2005, Carlotta Lansford, a previous consultant for Advanced BioChem, now known as Industrial Enterprises of America, filed suit against Advanced BioChem and Power3, claiming $3,295 in unpaid consulting and accounting fees. The Company believes this lawsuit will be settled prior to the court date, however no resolution has been achieved thus far. The debt is recorded in accounts payable by Power3.
On February 15, 2006, Bowne of Dallas LP filed suit against Power3 to collect a debt for services in the amount of $17,315.03. The Company believes this lawsuit will be settled prior to the court date, however no resolution has been achieved thus far. The debt is recorded in accounts payable by Power3.
On October 28, 2005, Power3 received notice of a Petition to Enforce Foreign Judgement citation filed against the Company by KForce regarding an employment fee adjudicated in December, 2003 in the state of Florida against the Company, in the amount of $15,872.77, together with $4,735.02 in interest. Power3 does not agree with the Foreign Judgement and is attempting to resolve the issue prior to enforcement. No resolution has been achieved on this issue at this time, however the Company is endeavoring to resolve the petition. This debt is recorded and outstanding in accounts payable by the Company.
Item 4. Submission of Matters to a Vote of Security Holders
There were no matters submitted to the vote of the security holders during 2005.
26
Item 5. Market for Common Equity and Related Stockholder Matters
Market Information
During 2004, the Companys common stock was traded on the OTC Bulletin Board under the symbol PWRM. As of June, 2005, as reported previously, the Companys common stock has been quoted on the Pink Sheets. The high and low bid information for each quarter for the years ending December 31, 2005 and 2004, as reported by National Quotation Bureau, Inc., are as follows:
|
Quarter |
|
Pre or Post Split
|
|
High Bid |
|
Low Bid |
|
||
|
|
|
|
|
|
|
|
|
||
|
First Quarter 2005 |
|
Post-Split |
|
$ |
0.89 |
|
$ |
0.48 |
|
|
Second Quarter 2005 |
|
Post-Split |
|
$ |
0.695 |
|
$ |
0.14 |
|
|
Third Quarter 2005 |
|
Post-Split |
|
$ |
0.85 |
|
$ |
0.14 |
|
|
Fourth Quarter 2005 |
|
Post-Split |
|
$ |
0.26 |
|
$ |
0.10 |
|
|
|
|
|
|
|
|
|
|
||
|
First Quarter 2004 |
|
Post-Split |
|
$ |
0.87 |
|
$ |
0.15 |
|
|
Second Quarter 2004 |
|
Post-Split |
|
$ |
2.87 |
|
$ |
0.28 |
|
|
Third Quarter 2004 |
|
Post-Split |
|
$ |
7.79 |
|
$ |
1.70 |
|
|
Fourth Quarter 2004 |
|
Post-Split |
|
$ |
2.23 |
|
$ |
0.67 |
|
(1) On September 24, 2003, the Company effected a 1-for-50 reverse stock split of its common stock.
The quotations above reflect inter-dealer prices, without adjustment for retail mark-up, markdown or commissions and may not reflect actual transactions.
During 2005, upon the Companys failure to timely file its Form 10-KSB, the OTCBB appended the symbol E to the Companys trading symbol and notified the Company of its jeopardy of having its securities no longer quoted on the OTCBB, pending the Companys filing of its Form 10-KSB for 2004. On June 14, the Company was notified of the OTCBBs action to not allow the Companys securities to be quoted on the OTCBB, as of June 16, 2005, pending the filing of the Companys Form 10-KSB for 2004. Accordingly, the Companys securities are no longer eligible for quotation on the OTCBB, as of June 16, 2005, all quotations of the Companys securities are deleted from the OTCBB and the Companys common stock is traded on the Pink Sheets under the symbol PWRM.PK.
Holders
As of December 31, 2005, there were 1,109 shareholders of record of the Companys common stock. The transfer agent for the Companys common stock was Cottonwood Stock Transfer, through June 30, 2005. In early July, 2005, the management and Board of Directors of Power3 terminated its relationship with Cottonwood Stock Transfer and contractually agreed to employ Integrity Stock Transfer as its new stock transfer agent.
Dividends
The Company has not paid or declared any dividends on its common stock for the last two fiscal years and does not anticipate paying cash dividends in the foreseeable future. There are no limitations on the ability of the Company to declare dividends; except those set forth in § 510 of the New York Business Corporation Laws which prohibits dividends if the Company is insolvent or would be made insolvent by the declaration of a dividend and all dividends must be made out of surplus only.
27
Recent Sales of Securities under the 2004 Stock Compensation Plan
The following summarizes information relating to the Companys sale of equity securities that were not registered under the Securities Act of 1933 during the period covered by this annual report and which have not been previously disclosed by the Company in a Quarterly Report on Form 10-QSB or a Current Report on Form 8-K.
On September 1, 2005, the Company issued 140,000 shares of restricted common stock to John P. Burton, according to the terms of his Employment Agreement. The shares were issued according to the 2004 Stock Compensation Plan, allowing issuance of shares to employees and consultants.
On October 31, 2005, the Company issued 300,000 shares of common stock to Billings & Solomon, a law firm representing the Company in debt settlement negotiations. The shares were issued according to the 2004 Stock Compensation Plan, allowing issuance of shares to employees and consultants.
On November 11, 2005, the Company issued 250,000 shares of common stock to Sichenzia Ross Friedman and Ferrence, a law firm representing the Company as an SEC attorney and in legal matters. The shares were issued according to the 2004 Stock Compensation Plan, allowing issuance of shares to employees and consultants.
On December 6, 2005, the Company issued 300,000 shares of common stock to Billings & Solomon, a law firm representing the Company in debt settlement negotiations. The shares were issued according to the 2004 Stock Compensation Plan, allowing issuance of shares to employees and consultants.
Item 6. Managements Discussion and Analysis or Plan of Operation
Overview
The Company is an early stage development company engaged in the early detection, monitoring, and targeting of diseases through the analysis of proteins. As previously stated, the Companys previous operating assets were abandoned and spun off to a trustee for the shareholders of record as of May 17, 2004, prior to the date of the asset purchase transaction on May 18, 2004. Coincident with the acquisition, the Company significantly changed its business activity from being an operating company and returned to being a development stage company with its focus on commercializing the intellectual properties it acquired in the asset purchase transaction. The Companys business objective is to focus on disease diagnosis, protein and biomarkers identification, and drug resistance in the areas of cancers, neurodegenerative and neuromuscular diseases. The Company has established a scientific advisory board to assist in the research and development of its products. The members of the scientific advisory board are recognized leaders in their chosen fields, and the Company is working with them in the development of effective early diagnosis and drug targets for early treatment of cancers, neurodegenerative and neuromuscular diseases.
On May 18, 2004, the Company acquired substantially all the assets and intellectual properties of Advanced BioChem and assumed a set of liabilities in exchange for the issuance of 15,000,000 shares of the Companys common stock. As of May 18, 2004, the Company established the new business direction described in the Business of Issuer section of this document, completely changed its business activity and became an advanced proteomics company applying existing certain proprietary methodologies to discover and identify protein biomarkers associated with diseases. The Company currently has no products or services for sale and is principally focused on research and development activities and, to a certain extent, initiating the proof of concept of its technologies.
The Company has had significant losses during 2004 and 2005. The Company anticipates that it will continue to incur substantial operating losses in future years as it progresses in its research and development activities as well as the commercializing of its technologies. The Company does not expect to produce revenues from operations in the near term and expects that its revenues will be limited to research grants, collaboration agreements, and other strategic alliances which the Company is able to obtain. The Company has an immediate
28
need for capital to continue its current operations. Assuming the Company successfully closes the final stage of its private placement, the Company anticipates that it will need to raise additional capital prior to May, 2006, to meet its operating costs. At December 31, 2005, the Company had an accumulated Stockholders equity of $9,182,895. The following discussion should be read in conjunction with the Companys audited financial statements as of December 31, 2005 and for the years ended December 31, 2005 and 2004, including the notes to those financial statements. The following discussion contains forward-looking statements that reflect the Companys plans, estimates and beliefs. Actual results could differ materially from those discussed in the forward-looking statements. See Item 1. Description of Business Risk Factors for additional discussion of these factors and risks.
Results of Operations
Year Ended December 31, 2005 as Compared to Year Ended December 31, 2004
Revenues from operations for the year ended December 31, 2005 were $-0- compared to $15,491 for the prior year, resulting in a decrease of $15,491.
Cost of Goods Sold for the year ended December 31, 2005 were $-0-, compared to $5,174 for the prior year, resulting in a decrease of $5,174.
Operating expenses were $15,027,193 for 2005 as compared to a restated Operating Expenses figure of 19,678,470, a decrease of $4,651,277. The decrease in operating expenses was primarily due to a $9,059,950 reduction in consulting fees in 2005, compared to 2004, offset by a $3,973,375 increase in stock-based compensation due to amortizing 12 full months of stock compensation compared to only 7 months in 2004..
Employee compensation and benefits were $1,278,633 in 2005 compared to $938,195 in 2004, the increase primarily due to employee compensation increases and costs associated with hiring additional employees to handle administrative, laboratory, financial and governmental compliance measures.
Occupancy and equipment expenses were $135,903 in 2005. This resulted primarily from the Companys office lease and utilities during 2005.
Derivative income (expense) amounted to $2,019,884 and $1,570,348 during the years ended December 31, 2005 and 2004, respectively, and arises from both freestanding derivatives (warrants) and embedded derivatives (embedded conversion features). We generally dont use derivative financial instruments to hedge exposures to cash-flow risks or market-risks that may affect the fair values of its financial instruments. However, certain other financial instruments, such as warrants and embedded conversion features that are indexed to our common stock, are classified as liabilities when either (a) the holder possesses rights to net-cash settlement or (b) physical or net-share settlement is not within our control. In such instances, net-cash settlement is assumed for financial accounting and reporting, even when the terms of the underlying contracts do not provide for net-cash settlement. Such financial instruments are initially recorded at fair value and subsequently adjusted to fair value at the close of each reporting period. We will experience fair value adjustements to our derivative financial instruments, which amounts will result in charges or credits to our income, until we reaquire the ability to settle these instruments with our common stock.
Interest expense amounted to ($505,647) and ($16,728) for the years ended December 31, 2005 and 2004, respectively. Interest expense increased due to (i) increases in our average borrowings and (ii) amortizations associated with our discounted debt and deferred financing costs.
The above matters result in net loss decreasing from ($17,471,463) in 2004 as compared to ($13,512,696) in 2005.
29
Liquidity and Capital Resources
Our financial statements are presented on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. We are in the development stage and have primarily been involved in research and development and capital raising activities; as such we have incurred significant losses from operations during both 2004 and 2005.
We have an immediate need for capital to continue our operations, and we will need to raise significant additional funds to implement our business plan. This cash will have to come from equity sales and/or borrowings as management has projected that we will need significant additional capital for development and other ongoing operational activities before we will have any anticipated revenue generating products. The actual amount of funds that we will need will be determined by many factors, some of which are beyond our control. These factors include:
The extent to which we enter into licensing arrangements, collaborations or joint ventures;
The progress and results of research and product development;
The costs and timing of obtaining new patent rights;
The extent to which we require or license other technologies; and
Regulatory changes and competition and technological developments in the market.
We have financed our operations primarily through the net proceeds generated from the sale of common stock and the recent sale of convertible debentures. From the date of the Advanced Bio/Chem transaction to December 31, 2004, the Company raised approximately $1,000,000. Then in January, 2005, the Company raised an additional $400,000 from a limited set of the original convertible debenture holders. As described in Recent Financing below, the Company intends to sell an additional $1,600,000 in aggregate principal amount of convertible debentures following the effectiveness of the Registration Statement on Form SB-2 filed by the Company for the resale of certain shares of the Companys stock by the purchasers of the Companys convertible debentures.
Net cash infrom operating activities approximated 825,208 for the year ended December 31, 2005, compared to $2,104,180 for the year ended December 31, 2004. The decrease in net cash from operating activities during 2004 was primarily due to an adjustment to stock-based compensation expense from cancellation of previously-issued stock to employees.
Net cash used in investing activities during 2005 was ($66,026) as compared to $(331,061) in 2004. Net cash provided by financing activities approximated ($916,565) for the year ended December 31, 2005, as compared to ($1,614,885) for the year ended December 31, 2004. The increase in net cash provided by financing activities is primarily due to net proceeds received from the closing of the Companys 2 nd tranche of convertible debentures in January, 2005 and borrowings made by the Company during 2005 as Notes Payable. In addition, cash proceeds from the sales of stock decreased from $449,807 for the year ended December 31, 2004 to $156,000 for the year ended December 31, 2005.
As of December 31, 2005, the Companys principal source of liquidity was approximately $1,399 in cash. As of the date of filing this report, the Company has approximately $100,000 on hand to pay operating expenses. We also have no confirmed source of funds for the next twelve months, although we expect that after filing this report and an amended SB-2 registration statement, additional debt and equity capital will become available to the Company.
Pursuant to the financing described below, it is anticipated that the Company will receive an additional $1,600,000 upon the sale and issuance of $1,600,000 in aggregate principal amount of debentures at the final closing of the private placement, which is to occur on or before the fifth trading day after the effective date of the registration statement filed by the Company for the resale of securities by the investors. In addition, the Company has received several bridge loans and officer advances during 2005. It is expected that a portion of the proceeds received by the Company from the issuance and sale of the $1,600,000 aggregate principal amount of debentures will be used to repay certain bridge loans received during 2005. The Company has thus far, been
30
unable to complete the funding of the convertible debentures, described below in Recent Financing due to its failure to obtain effectiveness of its SB-2 to register the shares associated with the debentures, the warrants and additional investment rights covered in the securities purchase agreements.
Recent Financing
The Company entered into a securities purchase agreement, dated as of October 28, 2004, with certain investors. Pursuant to the securities purchase agreement, the investors agreed to purchase from the Company convertible debentures due three (3) years from the date of issuance in the aggregate principal amount of $3,000,000. Effective January 26, 2005, the Company entered into an amendment to the securities purchase agreement with each of the investors. The securities purchase agreement, as amended, also provides for the issuance to the investors of warrants to purchase shares of the Companys common stock and additional investment rights to purchase additional convertible debentures. In connection with the securities purchase agreement, the Company entered into a registration rights agreement which requires the Company to file a registration statement registering on behalf of the investors the resale of the shares of common stock issuable upon conversion of the debentures and the exercise of the warrants. The Company will also file a registration statement registering on behalf of the investors the resale of shares of common stock issuable upon conversion of the debentures issued upon exercise of the additional investment rights previously issued by the Company.
Effective October 28, 2004, the Company issued and sold to the investors the first $1,000,000 in aggregate principal amount of such debentures at the initial closing under the securities purchase agreement. Pursuant to the securities purchase agreement, as amended, effective January 26, 2005 the Company issued and sold to certain investors $400,000 aggregate principal amount of convertible debentures. Subject to the Companys satisfaction of the conditions set forth in the securities purchase agreement (which includes the effectiveness of the registration statement) the investors are required to purchase the remaining $1,600,000 in aggregate principal amount of such debentures at the final closing, which is to occur on or before the fifth trading day after the effective date of the registration statement.
The $1,000,000 aggregate principal amount of debentures issued on October 28, 2004 and the $400,000 aggregate principal amount of debentures issued January 26, 2005 are due and payable in full three (3) years after issuance and do not bear interest. The $1,600,000 aggregate principal amount of debentures issuable at the final closing will be due and payable in full three (3) years after the date of their issuance, and will not bear interest. The aggregate cash purchase price for the debentures will be $3,000,000, which is equal to the full face amount of the debentures. At any time from the closing date until the maturity date of the debentures, the purchasers have the right to convert the debentures, in whole or in part, into common stock at the then effective conversion price. The conversion price for the previously issued $1,400,000 aggregate principal amount of debentures is $0.90 per share, provided however if the lessor of (i) 75% of the average of the 5 consecutive Closing Prices immediately prior to the Effective Date, as defined in the Purchase Agreement, and (ii) the Closing Price on the Effective Date (the lessor of (i) and (ii) being referred to as the Effective Date Price) is less than the Conversion Price, the Conversion Price shall be reduced to equal the Effective Date Price, the now designated Effective Date Price. The remaining 3 rd tranche, when and if made, of $1,600,000 aggregate principal amount of debentures issuable at the final closing will have a conversion price equal to the above. The debentures contain covenants that will limit the Companys ability to, among other things: incur or guarantee additional indebtedness; incur or create liens; amend the Companys certificate of incorporation, bylaws or other charter documents so as to adversely affect any rights of the holders of the debentures; and repay or repurchase more than a de minimis number of shares of common stock other than as permitted in the debentures and other documents executed with the purchasers.
If Power3, at any time while the debentures are outstanding, shall offer, sell or grant any option to purchase or offer, sell or grant any right to reprice its securities, or otherwise dispose of or issue any common stock or common stock equivalents, entitle any person to acquire shares of common stock at an effective price per share less than the then effective Conversion Price, as calculated by the formula described above, then the Conversion Price for the convertible debenture shares shall be reduced to equal any such new effective Conversion Price, as defined in the Agreement, regardless of whether or not such common stock or common
31
stock equivalents are issued to convertible debenture holders. In case of any such adjustment in the effective Conversion Price for the convertible debenture shares, this could significantly dilute existing investors.
The debentures include default provisions and an event of default includes, among other things, a change of control of the Company, the sale of all or substantially all of the Companys assets, the failure to have the registration statement declared effective on or before the 180th day after the initial closing date, and the lapse of the effectiveness of the registration statement for more than 30 consecutive trading days during any 12-month period (with certain exceptions), the Companys failure to timely deliver certificates to holders upon conversion and a default by the Company in any obligations under any indebtedness of at least $150,000 which results in such indebtedness being accelerated. Upon the occurrence of an event of default, each debenture may become immediately due and payable, either automatically or by declaration of the holder of such debenture. The aggregate amount payable upon an acceleration by reason of an event of default shall be equal to the greater of 130% of the principal amount of the debentures to be prepaid or the principal amount of the debentures to be prepaid, divided by the conversion price on the date specified in the debenture, multiplied by the closing price on the date set forth in the debenture. Specific provisions exist in the Securities Purchase Agreement which subject the Company to liabilities for liquidated damages if the registration statement covering the shares does not become effective within 180 days after the October 28, 2004 purchase, which they did not, or if the registration statement does not remain effective. In addition, if the Company is not able to deliver said share certificates, upon conversion, the Company becomes subject to partial liquidated damages, as specified in the Notes to the Financial Statements section of this report, based on the number of days required to deliver said shares.
Because the Companys investors could be significantly diluted in their ownership position, the Company is further bound, by the Securities Purchase Agreement covering the debentures and the warrants, to not offer, sell or grant shares to other persons or companies at prices below the effective conversion prices available to the convertible debenture holders in the Agreements. In such case, the specific details of the conversion price formulas can be found in the Notes to the Financial Statements in this report or in the actual Securities Purchase Agreement documents as previously filed in publicly-filed reports.
Concurrent with the issuance of the initial $1,000,000 aggregate principal amount of debentures dated October 28, 2004, the purchasers also received warrants to purchase an aggregate of up to 2,500,000 shares of common stock and additional investment rights to purchase up to an additional $2,500,000 principal amount of convertible debentures. On January 26, 2005, an amendment to the Securities Purchase Agreement was executed with four of the original purchasers of the initial $1,000,000 debenture purchase. Pursuant to the terms of the amendment, concurrent with the issuance of the $400,000 aggregate principal amount of convertible debentures, the Company issued additional warrants to purchase an aggregate of up to 333,333 shares of its common stock, but no additional investment rights. The warrants are exercisable at a price of $1.44 per share (subject to adjustment), for a period of five (5) years from October 28, 2004. If Power3, at any time the warrants are outstanding, pays a stock dividend or other distribution on its shares; subdivides outstanding shares into a larger number of shares; combines outstanding shares into a smaller number of shares; or issues by reclassification any shares of capital stock of the Company, then the Exercise Price of the warrants shall be adjusted by a formula based on the number of common shares then outstanding, and the number of shares issuable upon exercise of the warrants shall be proportionately adjusted. In addition, if the Company shall offer, sell, grant any option to purchase or reprice its securities, or otherwise dispose of or issue any common stock, at an effective price per share less than the then existing Exercise Price of the warrants, then the Exercise Price shall be reduced to equal this lower Base Share Price, as defined in the Securities Purchase Agreement for the warrants.
The additional investment rights are exercisable at a price equal to the principal amount of the debentures for a period until the earlier of (1) nine months following the effective date of the registration statement, or (2) April 28, 2006, whichever comes first. The debentures to be purchased upon the exercise of the additional investment rights will have the same terms as the debentures described above, except that the conversion price will be equal to $1.08, subject to adjustment according to the terms of the Agreement.
Each selling shareholder has contractually agreed to restrict its ability to convert the debentures, exercise the warrants and additional investment rights and receive shares of the Companys common stock such
32
that the number of shares of common stock held by them and their affiliates after such conversion or exercise does not exceed 4.99% of the number of shares of the Companys common stock outstanding immediately after giving effect to such conversion or exercise.
Additional terms and specifics of the Convertible Debenture agreements, including Events of Default and the consequences thereof, are detailed in the Notes to the Financial Statements.
Other Recent Financing
On April 5, 2005, the Company received a bridge loan in the amount of $251,000. This bridge loan was due and payable on the sooner of August 15, 2005 or one business day following the closing of the Companys sale and issuance of the remaining $1,600,000 aggregate principal amount of debentures. The Company expects to use proceeds from the sale and issuance of such debentures to repay this bridge loan. The bridge loan bears interest at a rate of 10% per annum which, at the holders option, may be paid in (a) cash, or (b) that number of shares of the Companys common stock determined by dividing $251,000 by the common stock price on date of payment and multiplying the quotient so obtained by 20%. This note is in default and remains outstanding at this time and no payments of principal or interest have been made thus far on this loan, either in cash or shares. At the time of this report, the note holder has not made demand for payment of principal or interest on this note.
On September 1, 2005, the Company received a bridge loan in the amount of $200,000. This bridge loan is due and payable on the sooner of November 15, 2005 or immediately following the closing of the Companys sale and issuance of the remaining $1,600,000 aggregate principal amount of debentures. The Company expects to use the proceeds from the sale and issuance of such debentures to repay this bridge loan. The loan bears interest at rate of 10% until payment, however the interest rate increases to 12% after an event of default. The note contains a provision that the accrued interest on this note shall be considered paid in full upon issuance of 166,000 shares of restricted stock at $0.00 cost basis per share to the note holder. In addition, the Note contains a provision for the issue of Penalty Shares to the note holder, in an event of default, calculated as 8,300 shares per month for each 30-day period the note is in default. This note is in default and remains outstanding and neither principal, interest, nor penalty shares have been paid or issued on this note. At the time of this report, the note holder has not made demand for payment of principal or interest on this note.
On May 31, 2005, the Company received an Officer Advance in the amount of $ 55,000. This advance is in the form of a short-term Note Payable, to the Officer, Mr. Steven Rash, President and CEO, by the Company. The Note Payable was originally due on June 30, 2005, and bears interest at 6 % per annum until paid. The Company used the proceeds from this note as working capital. The Company expects to use the proceeds from later permanent financing obtained from issuing additional debentures to repay this Officer Advance. This note is in default, however the Officer has agreed to allow the Company an indefinite extension of time to repay this Note Payable.
On June 3, 2005, the Company received an Officer Advance in the amount of $ 50,000. This advance is in the form of a short-term Note Payable, to the Officer, Dr. Ira Goldknopf, Chief Scientific Officer, by the Company. The Note Payable was due on June 30, 2005, and bears interest at 6% per annum until paid. The Company used the proceeds from this note as working capital. The Company expects to use the proceeds from later permanent financing obtained from issuing additional debentures to repay this Officer Advance. This note is in default, however the Officer has agreed to allow the Company an indefinite extension of time to repay this Note.
On March 31, 2005, the Company received an Officer Advance in the amount of $35,000 from the Chief Financial Officer. This Note was due on April 30, 2005, and bears interest at a rate of 6% per annum until paid. The Company expects to use the proceeds from later permanent financing obtained from issuing additional debentures to repay this Officer Advance. This note is in default, however the note holder has agreed to allow the Company an indefinite extension of time to repay this Note.
33
On June 13, 2005, the Company received a bridge loan in the amount of $ 396,500. This bridge loan was due and payable on the sooner of August 11, 2005 or the fifth day following the effective date of the Companys registration statement on Form SB-2. The Company expects to use the proceeds from the sale and issuance of the remaining $1,600,000 of convertible debentures to repay the loan. The note is secured by a Stock Pledge Agreement, entered into on June 17, 2005, by Steven B. Rash, Chairman and CEO of Power3, wherein Mr. Rash pledged 6,000,000 shares of common stock as security for the performance of the Company under the note. On September 30, 2005, in consideration of an additional $50,000 added to the principal amount of the Note, which was expensed to Interest Expense, and making the total principal due $446,500, the payee of this Note agreed to allow the Company an extension of time to repay such bridge loan, until October 31, 2005. This note is in default and no payments of principal or interest have been made on this loan by Power3. It is the Companys understanding that the Note holder has sold a certain number of the common shares pledged to him and individually owned by Steve Rash and the note is no longer in default.
During the latter half of 2005, the Companys Chief Scientific Officer advanced the Company $159,231 as short-term Officer Advances in order to enable the Company to meet certain payment obligations. These advances were in the form of short-term 180 day notes and bear interest at a rate of 6% per annum. None of these short-term Officer Advances were due as of December 31, 2005 and the Company expects to use the proceeds from later permanent financing obtained from issuing additional debentures to repay these Officer Advances.
On November 2, 2005, the Company received a bridge loan in the amount of $150,000 from Trinity Financing Investments. This bridge loan is due and payable on March 2, 2006 and bears interest at a rate of 11% until maturity and 18% thereafter until the loan is repaid. In addition to the note, the holder received 1,000,000 warrants to purchase common shares of the Company at $.25 per share. This note is secured by a pledge of common shares individually owned by Steven B. Rash and Dr. Ira L. Goldknopf.
On December 12, 2005, the Company received a bridge loan in the amount of $150,000 from Trinity Financing Investments. This bridge loan is due and payable on April 9, 2006 and bears interest at a rate of 11% until maturity and 24% thereafter until the loan is repaid. In addition to the note, the holder received 1,000,000 warrants to purchase common shares of the Company at $.14 per share. This note is secured by a pledge of common shares owned individually by Dr. Ira Goldknopf.
On December 14, 2005, the Company received an Officer Advance in the amount of $50,000 from the Chief Scientific Officer. This Note is due on June 15, 2006 and bears interest at a rate of 6% per annum until paid. The Company expects to use the proceeds from later permanent financing obtained from issuing additional debentures to repay this Officer Advance.
Plan of Operations and Cash Requirements
The Company currently does not have operating revenues from product sales or the performance of services and it continues to experience net operating losses. The Company is actively pursuing third party licensing agreements, collaboration agreements and similar business arrangements in order to establish a revenue base utilizing its capabilities in disease diagnosis based on protein and biomarker identification, and drug resistance in the areas of cancers, neurodegenerative and neuromuscular diseases. The Company has undertaken clinical validation studies to demonstrate the diagnostic capabilities of its technologies. However, there can be no assurances that revenue generating agreements will be in place in the next twelve months.
Absent a source of revenues, the Company will require funding in order to carry out its business plan until such time as it is able to generate sustained revenues. The Companys current cash requirements are approximately $300,000 per month and the Company anticipates that it will require approximately $3,950,000 for the twelve months ended March 31, 2007 to continue its development activities, undertake and perform
34
clinical validation studies, continue its marketing efforts and maintain its administrative infrastructure, broken down as follows:
Expenditures
Required
During Next Twelve Months
|
General and Administrative |
|
$ |
2,750,000 |
|
|
|
|
|
|
|
|
Capital Expenditures |
|
$ |
250,000 |
|
|
|
|
|
|
|
|
Patent filings and intellectual property |
|
$ |
200,000 |
|
|
|
|
|
|
|
|
NAF clinical validation studies |
|
$ |
500,000 |
|
|
|
|
|
|
|
|
Testing for Research Agreements |
|
$ |
250,000 |
|
|
|
|
|
|
|
|
Total |
|
$ |
3,950,000 |
|
The Company has no significant capital expenditure requirements and does not plan to increase its monthly expenditure rate absent an increase in revenues or additional funding.
As noted in Liquidity and Capital Resources above, the Company entered into a securities purchase agreement and an amendment to the securities purchase agreement pursuant to which certain investors agreed to purchase convertible debentures in the aggregate principal amount of $3,000,000. The securities purchase agreement, as amended, also provides for the issuance of warrants to purchase shares of the Companys common stock and additional investment rights to purchase additional convertible debentures. On the initial closing under the securities purchase agreement, which occurred effective as of October 28, 2004, the investors purchased the first $1,000,000 in aggregate principal amount of the convertible debentures of which the Company received approximately $860,000 after payment of fees and expenses. Pursuant to the securities purchase agreement, as amended, a sub-group of the original investors purchased an additional $400,000 aggregate principal amount of convertible debentures on January 26, 2005 as a second tranche of the total investment. Subject to the Companys satisfaction of the conditions set forth in the securities purchase agreement (which includes the effectiveness of the registration statement), the investors are required to purchase the remaining $1,600,000 in aggregate principal amount of such convertible debentures on or before the fifth trading day after the effective date of the registration statement. Assuming the completion of the remaining closing and sale and issuance of the remaining $1,600,000 in aggregate principal amount of the convertible debentures, the Company estimates that, after repayment of the bridge note of $446,500, the bridge note of $251,500 and the bridge note of $200,000, immediately following the sale and issuance of such debentures, the Company will have adequate cash to allow it to meet its funding requirements through the third quarter of 2006. In the event the sale and issuance of such debentures occurs and the investors exercise their warrants and additional investment rights, the Company anticipates it will have adequate cash to meet its funding requirements through the first quarter of 2007.
In addition to the convertible debentures, the Company also issued warrants to purchase up to 2,500,000 shares of common stock, with an exercise price equal to $1.44. The Company issued additional warrants to purchase up to 333,333 shares of common stock concurrent with its issuance of the $400,000 aggregate principal amount of debentures. Full exercise of the warrants would generate funds in excess of $3,000,000. The Company also issued additional investment rights, which give the investors the right to purchase up to an aggregate of $2,500,000 of convertible debentures with a conversion price of $1.08. However, the exercise of these warrants and additional investment rights is at the discretion of the purchasers and there are no assurances that the purchasers will exercise their rights under such securities.
35
The Company will continue to require additional debt or equity financing for its operations which may not be readily available. The Companys ability to continue as a going concern is subject to its ability to generate a profit or obtain necessary funding from outside sources. Management believes that even though the Company currently has limited cash resources and liquidity, assuming exercise of the warrants and additional investment rights, the net funds available from the final closing under the Securities Purchase Agreement financing, after repayment of the bridge loans, will allow the Company to continue operations through October 2006. In the event the final closing and sale of $1,600,000 in aggregate principal amount of debentures occurs but the warrants and additional investment rights are not exercised, the Company anticipates that it will need to raise additional capital prior to October 2006 to meet its operating costs. The Companys actual results may differ materially from these estimates, and no assurance can be given that additional funding will not be required sooner than anticipated or that such additional funding will be available when needed or on terms acceptable to the Company. Insufficient funding will require the Company to curtail or terminate operations.
Off-Balance Sheet Arrangements
At December 31, 2005, with the exception of the lease for its operating facility, and employment agreements entered with its three principal officers, the Company did not have any significant off balance sheet commitments.
Critical Accounting Policies
Stock-Based Compensation
The Company accounts for equity instruments issued to employees that are fully vested and non-forfeitable based on the market value of the stock issued as of the effective date of the agreement, per SEC requirement. Equity instruments issued to non-employees for services are also measured at market value on the effective date of the agreement.
The Company has adopted Statement of Financial Accounting Standards No. 148 Accounting for Stock-Based Compensation - Transition and Disclosure (SFAS No. 148). This statement amends FASB statement No. 123, Accounting for Stock Based Compensation. It provides alternative methods of transition for an entity that voluntarily changes to the fair value based method of accounting for employee stock based compensation. It also amends the disclosure provision of FASB statement No. 123 to require prominent disclosure about the effects on reported net income of an entitys accounting policy decisions with respect to stock-based employee compensation. As permitted by SFAS No. 123 and amended by SFAS No. 148, the Company continues to apply the intrinsic value method under Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees, to account for its stock-based employee compensation arrangements.
In December 2004, the Financial Accounting Standards Board issued Statement Number 123 (FAS 123 (R)), Share-Based Payments. FAS 123 (R) requires all entities to recognize compensation expense in an amount equal to the fair value of share-based payments such as stock options granted to employees. The Company will be required to apply FAS 123 (R) on a modified prospective method. Under this method, the Company will be required to record compensation expense (as previous awards continue to vest) for the unvested portion of previously granted awards that remain outstanding at the date of adoption. In addition, the Company may elect to adopt FAS 123 (R) by restating previously issued financial statements, basing the amounts on the expense previously calculated and reported in the pro forma disclosures that had been required by FAS 123, effective for the first reporting period during which the Company has such compensation. The Company has not yet determined the impact that FAS 123 (R) will have on its financial statements; however, it does not believe the impact of adopting this Statement is material to this report as there are no unvested options and warrants at December 31, 2004.
Power3s stock-based compensation expense consists primarily of amortized costs for stock issued to consultants, to employees and for warrants, covered by the 2004 Stock Compensation Plan. Total stock-based compensation expense for 2004 amounted to $8,215,241 compared to $12,188,616 in 2005. The increase is
36
primarily due to the amortization, over 12 full months in 2005 compared to only approximately 7 full months in 2004, since most of the stock was originally issued on or about May 18, 2004. Most of the stock issued to employees is being amortized over 24 months, and since this is the bulk of the stock compensation expense, most of the stock-based compensation will be fully amortized to deferred compensation expense during 2006.
Stock-based compensation expense during 2005 amounted to:
|
Stock-based Expense to: |
|
1 st Quarter |
|
2 nd Quarter |
|
3 rd Quarter |
|
4 th Quarter |
|
||||
|
Consultants |
|
$ |
136,875 |
|
$ |
109,786 |
|
|
|
$ |
45,000 |
|
|
|
Employees |
|
$ |
3,181,443 |
|
$ |
3,181,443 |
|
$ |
3,129,629 |
|
$ |
2,209,179 |
* |
|
Warrants |
|
$ |
47,208 |
|
$ |
47,208 |
|
$ |
47,208 |
|
$ |
53,637 |
|
* Includes adjustment for stock returned to Power3 due to settlement and terminations of employment in 2005 and credit to Stock Compensation Expense for $675,000+$2,820+$213,504=$891,324 for returned company stock.
Stock-based compensation expense during 2004 amounted to:
|
|
|
1 st Quarter |
|
2 nd Quarter |
|
3 rd Quarter |
|
4 th Quarter |
|
|||
|
For Consultants |
|
|
|
$ |
42,708 |
|
$ |
128,124 |
|
$ |
128,124 |
|
|
For Employees |
|
|
|
$ |
1,464,213 |
|
$ |
3,181,443 |
|
$ |
3,181,443 |
|
|
For Warrants |
|
|
|
$ |
10,055 |
|
$ |
35,841 |
|
$ |
43,290 |
|
37
POWER3 MEDICAL PRODUCTS, INC.
FINANCIAL STATEMENTS
AS OF DECEMBER 31, 2005 AND 2004 (RESTATED)
FOR THE YEARS ENDED DECEMBER 31, 2005 AND 2004 (RESTATED)
38
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
TO THE SHAREHOLDERS AND BOARD OF DIRECTORS OF POWER3 MEDICAL PRODUCTS, INC.:
We have audited the accompanying balance sheets of Power3 Medical Products, Inc.. (a New York corporation in the development stage) (the Company) as of December 31, 2004 (restated) and 2005, and the related statements of operations, changes in stockholders equity and cash flows for the years ended December 31, 2004 (restated) and 2005, and for the period from May 18, 2004 (date of entry into development stage) to December 31, 2005. These financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on these financial statements based on our audit. .
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 an audit to obtain reasonable assurance 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 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 the Companys 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 provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Power3 Medical Products, Inc.at December 31, 2004 (restated) and 2005, and the related results of their operations and cash flows for the years ended December 31, 2004 (restated) and 2005 and for the period from May 18, 2004 (date of entry into development stage) to December 31, 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. As discussed in Note 2 to the financial statements, the Company is in the development stage and is primarily involved in research and development and capital raising activities. There is no assurance that research activities that the Company is involved in will generate sufficient funds that will be available for operations. The Companys limited revenue history, its dependence on a narrow customer base and limited funding raise substantial doubt about the Companys ability to continue as a going concern. Managements plans in regard to these matters are also described in Note 2. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.
As discussed in note 7 to the financial statements, the Company is the defendant in certain lawsuits and is involved in a dispute with Advanced Biochem. The Company believes these claims are without merit and intends to resolve them in the best interest of the Company. Accordingly no provision for any liabilities related to the matters has been accrued. However, due to the uncertainties with these legal issues, it is at least reasonably possible that adverse results will occur, although any such amount cannot be estimated.
John A. Braden & Company, PC
Houston, Texas
April 14, 2006
39
POWER3 MEDICAL PRODUCTS, INC.
(A Development Stage Enterprise)
AS OF DECEMBER 31, 2005 AND 2004 (RESTATED)
|
|
|
2005 |
|
2004 |
|
||
|
|
|
|
|
(Restated) |
|
||
|
ASSETS |
|
|
|
|
|
||
|
|
|
|
|
|
|
||
|
CURRENT ASSETS |
|
|
|
|
|
||
|
Cash and cash equivalents |
|
$ |
1,398 |
|
$ |
158,301 |
|
|
Accounts receivable |
|
|
|
2,350 |
|
||
|
Prepaid expenses and other current assets |
|
21,092 |
|
4,352 |
|
||
|
Total current assets |
|
22,490 |
|
165,003 |
|
||
|
|
|
|
|
|
|
||
|
OTHER ASSETS |
|
|
|
|
|
||
|
Goodwill |
|
13,371,776 |
|
13,371,776 |
|
||
|
Deferred finance costs, net |
|
290,027 |
|
239,682 |
|
||
|
Intangible assets, net |
|
179,786 |
|
96,424 |
|
||
|
Furniture, fixtures and equipment, net |
|
70,751 |
|
85,025 |
|
||
|
Deposits |
|
25,900 |
|
25,900 |
|
||
|
|
|
|
|
|
|
||
|
TOTAL ASSETS |
|
$ |
13,960,730 |
|
$ |
13,983,810 |
|
|
|
|
|
|
|
|
||
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
||
|
CURRENT LIABILITIES |
|
|
|
|
|
||
|
Accounts payable and accrued liabilities |
|
$ |
1,024,935 |
|
$ |
631,560 |
|
|
Notes payablein default |
|
1,520,477 |
|
20,000 |
|
||
|
Convertible debenturesin default |
|
75,279 |
|
14,254 |
|
||
|
Other current liabilities |
|
702,208 |
|
132,481 |
|
||
|
Derivative liabilities |
|
1,454,936 |
|
2,877,919 |
|
||
|
Total current liabilities |
|
4,777,835 |
|
3,676,211 |
|
||
|
|
|
|
|
|
|
||
|
STOCKHOLDERS EQUITY |
|
|
|
|
|
||
|
Common Stock-$0.001 par value:150,000,000 shares authorized; 65,215,121 shares issued and outstanding |
|
65,545 |
|
65,675 |
|
||
|
Additional paid-in capital |
|
57,773,506 |
|
58,884,351 |
|
||
|
Deferred compensation |
|
(4,802,621 |
) |
(18,301,588 |
) |
||
|
Loss accumulated before entering development stage |
|
(11,681,500 |
) |
(11,681,500 |
) |
||
|
Loss accumulated during the development stage |
|
(32,172,035 |
) |
(18,659,339 |
) |
||
|
Total stockholders equity |
|
9,182,895 |
|
10,307,599 |
|
||
|
|
|
|
|
|
|
||
|
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
|
$ |
13,670,703 |
|
$ |
13,983,810 |
|
See accompanying notes to the financial statements.
40
STATEMENT OF OPERATIONS
POWER3 MEDICAL PRODUCTS, INC.
(A Development Stage Enterprise)
YEARS ENDED DECEMBER 31, 2005 AND 2004 (RESTATED)
|
|
|
2005 |
|
2004 |
|
Period from
|
|
|||
|
|
|
|
|
(Restated) |
|
|
|
|||
|
REVENUES: |
|
|
|
|
|
|
|
|||
|
Sales |
|
|
|
11,491 |
|
|
|
|||
|
Other revenue |
|
|
|
4,000 |
|
4,000 |
|
|||
|
Total revenue |
|
|
|
15,491 |
|
4,000 |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
COST OF GOODS SOLD: |
|
|
|
|
|
|
|
|||
|
Production costs |
|
|
|
5,174 |
|
|
|
|||
|
Total cost of goods sold |
|
|
|
5,174 |
|
|
|
|||
|
|
|
|
|
|
|
|
|
|||
|
GROSS PROFIT |
|
|
|
10,317 |
|
4,000 |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|||
|
Stock based compensation |
|
12,188,616 |
|
8,215,241 |
|
20,403,857 |
|
|||
|
Employee compensation and benefits |
|
1,278,633 |
|
938,195 |
|
2,110,548 |
|
|||
|
Professional and consulting fees |
|
590,352 |
|
9,650,302 |
|
10,240,654 |
|
|||
|
Occupancy and equipment |
|
135,903 |
|
49,895 |
|
180,798 |
|
|||
|
Travel and entertainment |
|
89,490 |
|
72,375 |
|
156,113 |
|
|||
|
Other selling, general and administrative expenses |
|
744,199 |
|
752,462 |
|
(1,533,008 |
) |
|||
|
Total operating expenses |
|
(15,027,193 |
) |
(19,678,470 |
) |
(31,558,962 |
) |
|||
|
|
|
|
|
|
|
|
|
|||
|
LOSS FROM OPERATIONS |
|
(15,027,193 |
) |
(19,668,153 |
) |
31,554,962 |
) |
|||
|
|
|
|
|
|
|
|
|
|||
|
OTHER INCOME AND (EXPENSE): |
|
|
|
|
|
|
|
|||
|
Derivative income (expense) |
|
2,019,884 |
|
1,570,348 |
|
1,371,984 |
|
|||
|
Interest income |
|
|
|
1,215 |
|
1,215 |
|
|||
|
Other income |
|
260 |
|
641,855 |
|
(294,817 |
) |
|||
|
Interest expense |
|
(505,647 |
) |
(16,728 |
) |
(625,524 |
) |
|||
|
Total other income(expense) |
|
1,514,497 |
|
2,196,690 |
|
452,858 |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
NET LOSS |
|
$ |
(13,512,696 |
) |
$ |
(17,471,463 |
) |
(31,102,104 |
) |
|
|
|
|
|
|
|
|
|
|
|||
|
NET LOSS PER SHARE |
|
$ |
(0.21 |
) |
$ |
(0.42 |
) |
$ |
(0.48 |
) |
|
|
|
|
|
|
|
|
|
|||
|
Weighted average number of shares outstanding |
|
65,428,847 |
|
42,034,796 |
|
64,391,890 |
|
|||
See accompanying notes to the financial statements.
41
POWER3 MEDICAL PRODUCTS, INC.
A Development Stage Enterprise
STATEMENT OF STOCKHOLDERS EQUITY
Years Ended December 31, 2005, 2004 (RESTATED)AND 2003
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
|
|
Common Stock |
|
Preferred Stock |
|
Paid In |
|
|
|
|
|
||||
|
|
|
Shares |
|
Par Value |
|
Shares |
|
Par Value |
|
Capital |
|
Other |
|
Deficit |
|
|
BALANCES, DECEMBER 31, 2002 |
|
997,830 |
|
997 |
|
|
|
|
|
6,315,951 |
|
|
|
(7,600,881 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of preferred stock for cash and conversion of accred payroll |
|
|
|
|
|
3,990,000 |
|
3,990 |
|
1,991,010 |
|
|
|
|
|
|
Issuance of common stock for services rendered |
|
100,000 |
|
100 |
|
|
|
|
|
37,400 |
|
|
|
|
|
|
Conversion of convertible notes payable to common stock |
|
95,000 |
|
95 |
|
|
|
|
|
27,405 |
|
|
|
|
|
|
Conversion of other note payable to common stock |
|
50,000 |
|
50 |
|
|
|
|
|
12,450 |
|
|
|
|
|
|
Common stock subscriptions |
|
|
|
|
|
|
|
|
|
89,700 |
|
300 |
|
|
|
|
Conversion of preferred stock |
|
1,200,000 |
|
1,200 |
|
(120,000 |
) |
(120 |
) |
(1,080 |
) |
|
|
|
|
|
Net Loss for the year |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,845,496 |
) |
|
BALANCES, DECEMBER 31, 2003 |
|
2,442,830 |
|
2,442 |
|
3,870,000 |
|
3,870 |
|
8,472,836 |
|
300 |
|
(9,446,377 |
) |
42
POWER3 MEDICAL PRODUCTS, INC.
A Development Stage Enterprise
STATEMENTS OF STOCKHOLDERS EQUITY
Years Ended December 31, 2005, 2004 (RESTATED)AND 2003
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
Deferred |
|
|
|
|
|
|
|
|
Common Stock |
|
Preferred Stock |
|
Paid In |
|
Compensation |
|
|
|
|
|
||||
|
|
|
Shares |
|
Par Value |
|
Shares |
|
Par Value |
|
Capital |
|
Expense |
|
Other |
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCES, DECEMBER 31, 2003 |
|
2,442,830 |
|
2,442 |
|
3,870,000 |
|
3,870 |
|
8,472,836 |
|
|
|
300 |
|
(9,446,377 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Correct beginning balance per transfer agent |
|
433 |
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued effective January 23, 2004, services |
|
6,000,000 |
|
6,000 |
|
|
|
|
|
3,055,327 |
|
|
|
|
|
|
|
|
Issued effective April 1, 2004 for cash |
|
583,334 |
|
583 |
|
|
|
|
|
134,417 |
|
|
|
|
|
|
|
|
Issued effective April 27,2004 for services |
|
440,000 |
|
440 |
|
|
|
|
|
197,560 |
|
|
|
|
|
|
|
|
Issued effective May 10, 2004 to retire debt |
|
300,000 |
|
300 |
|
|
|
|
|
194,700 |
|
|
|
(300 |
) |
|
|
|
Issued effective May 11, 2004 for services |
|
4,500,000 |
|
4,500 |
|
|
|
|
|
2,065,500 |
|
|
|
|
|
|
|
|
Issued effective May 17, 2004 for services |
|
141,033 |
|
141 |
|
|
|
|
|
105,634 |
|
|
|
|
|
|
|
|
Issued effective May 18, 2004 compensation |
|
27,805,000 |
|
27,805 |
|
|
|
|
|
24,996,695 |
|
(25,024,500 |
) |
|
|
|
|
|
Issued effective May 18, 2004 for services |
|
4,550,000 |
|
4,550 |
|
|
|
|
|
4,090,450 |
|
|
|
|
|
|
|
|
Issued effective May 18, 2004 for acquisition |
|
15,000,000 |
|
15,000 |
|
|
|
|
|
13,485,000 |
|
|
|
|
|
|
|
|
Issued effective June 1, 2004 for services |
|
125,000 |
|
125 |
|
|
|
|
|
249,875 |
|
(250,000 |
) |
|
|
|
|
|
Issued effective June 11, 2004 for services |
|
100,000 |
|
100 |
|
|
|
|
|
211,900 |
|
|
|
|
|
|
|
|
Record stock option expense |
|
|
|
|
|
|
|
|
|
626,100 |
|
(626,100 |
) |
|
|
|
|
|
Issued effective July 1, 2004 compensation |
|
140,000 |
|
140 |
|
|
|
|
|
426,860 |
|
(427,000 |
) |
|
|
|
|
|
Issued effective July 23, 2004 for services |
|
125,000 |
|
125 |
|
|
|
|
|
284,875 |
|
(285,000 |
) |
|
|
|
|
|
Issued November 10, 2004 for cash |
|
242,167 |
|
242 |
|
|
|
|
|
314,575 |
|
|
|
|
|
|
|
|
Issued November 10, 2004 for services |
|
10,000 |
|
10 |
|
|
|
|
|
12,990 |
|
|
|
|
|
|
|
|
Cancelled November 15, 2004 (agreement) |
|
(160,000 |
) |
(160 |
) |
|
|
|
|
(71,840 |
) |
|
|
|
|
|
|
|
Issued November 17, 2004 to convert Series A Preferred Shares to Common Shares |
|
1,031,316 |
|
1,031 |
|
(1,331,280 |
) |
(1,330 |
) |
1,391,246 |
|
|
|
|
|
(1,392,277 |
) |
|
Issued November 23, 2004 to convert Series A Preferred Shares to common shares |
|
1,969,008 |
|
1,970 |
|
(2,538,720 |
) |
(2,540 |
) |
1,986,728 |
|
|
|
|
|
(1,988,698 |
) |
|
Stock based compensation expensed during the year |
|
|
|
|
|
|
|
|
|
|
|
8,215,241 |
|
|
|
|
|
|
Net reclassifications of derivative liabilities |
|
|
|
|
|
|
|
|
|
(3,347,077 |
) |
|
|
|
|
|
|
|
Other equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(42,021 |
) |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17,471,463 |
) |
|
Balances, December 31, 2004 (restated) |
|
65,345,121 |
|
65,345 |
|
0 |
|
0 |
|
58,884,351 |
|
(18,301,588 |
) |
|
|
(30,340,836 |
) |
43
POWER3 MEDICAL PRODUCTS, INC.
A Development Stage Enterprise
STATEMENT OF STOCKHOLDERS EQUITY
Years Ended December 31, 2005, 2004 (RESTATED)AND 2003
|
|
|
|
|
|
|
Additional |
|
Deferred |
|
|
|
|
|
|
Common Stock |
|
Paid In |
|
Compensation |
|
|
|
||
|
|
|
Shares |
|
Par Value |
|
Capital |
|
Expense |
|
Equity |
|
|
Balances, December 31, 2004 (restated) |
|
65,345,121 |
|
65,345 |
|
58,884,351 |
|
(18,301,588 |
) |
(30,340,836 |
) |
|
Cancelled Shares from 7/01/04 |
|
(140,000 |
) |
(140 |
) |
(426,860 |
) |
|
|
|
|
|
Issued Shares on 9/14/05 |
|
140,000 |
|
140 |
|
41,860 |
|
|
|
|
|
|
Issued Shares on 10/31/05 |
|
300,000 |
|
300 |
|
65,700 |
|
|
|
|
|
|
Issued Shares on 11/11/05 |
|
250,000 |
|
250 |
|
44,750 |
|
|
|
|
|
|
Issued Shares on 12/06/05 |
|
300,000 |
|
300 |
|
44,700 |
|
|
|
|
|
|
Cancelled Shares on 12/31/05 |
|
(975,000 |
) |
(975 |
) |
(876,500 |
) |
|
|
|
|
|
Cancelled Shares on 12/31/05 |
|
(5,000 |
) |
(5 |
) |
(4,495 |
) |
|
|
|
|
|
Settlement on employee stock, net |
|
|
|
|
|
|
|
441,302 |
|
|
|
|
Amortization |
|
|
|
|
|
|
|
13,057,665 |
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
(13,512,696 |
) |
|
BALANCES, DECEMBER 31, 2005 |
|
65,215,121 |
|
65,215 |
|
57,773,506 |
|
(4,802,621 |
) |
(43,853,535 |
) |
See accompanying notes to the financial statements.
44
POWER3 MEDICAL PRODUCTS, INC.
(A Development Stage Enterprise)
YEARS ENDED DECEMBER 31, 2005 AND 2004 (RESTATED)
|
|
|
2005 |
|
2004 |
|
Period from
|
|
|||
|
|
|
|
|
(Restated) |
|
(Restated) |
|
|||
|
Operating activities: |
|
|
|
|
|
|
|
|||
|
Net loss |
|
$ |
(13,512,696 |
) |
$ |
(17,471,463 |
) |
$ |
(30,358,917 |
) |
|
Adjustments to reconcile net loss to net cash from operating activities: |
|
|
|
|
|
|
|
|||
|
Derivative income (expense) |
|
2,019,884 |
|
1,570,348 |
|
3,590,232 |
|
|||
|
Stock based services and compensation |
|
12,295,216 |
|
17,932,787 |
|
27,450,704 |
|
|||
|
Stock issued to retire preferred stock and debt |
|
|
|
4,236 |
|
4,236 |
|
|||
|
Adj to Stock based compensation due to cancellation |
|
(891,324 |
) |
|
|
(891,324 |
) |
|||
|
Amortization of debt discount and finance costs |
|
105,446 |
|
16,728 |
|
105,446 |
|
|||
|
Depreciation and amortization |
|
20,158 |
|
45,024 |
|
65,182 |
|
|||
|
Changes in operation assets and liabilities: |
|
|
|
|
|
|
|
|||
|
Decrease (increase) in receivables |
|
|
|
9,006 |
|
6,656 |
|
|||
|
Decrease (increase) in deposits |
|
|
|
(25,900 |
) |
(25,900 |
) |
|||
|
Decrease (increase) in prepaid and other |
|
|
|
(4,352 |
) |
(4,352 |
) |
|||
|
Increase (decrease) in interest payable |
|
255,467 |
|
|
|
255,467 |
|
|||
|
Increase (decrease) in accounts payable and accrued liabilities |
|
533,057 |
|
27,766 |
|
980,823 |
|
|||
|
Net cash from operating activities |
|
825,208 |
|
2,104,180 |
|
1,178,253 |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
Investing Activities: |
|
|
|
|
|
|
|
|||
|
Capital expenditures, net |
|
3,061 |
|
(331,061 |
) |
(328,000 |
) |
|||
|
Increase in other assets. |
|
(69,087 |
) |
|
|
(69,087 |
) |
|||
|
Net cash from investing activities |
|
(66,026 |
) |
(331,061 |
) |
(397,087 |
) |
|||
|
|
|
|
|
|
|
|
|
|||
|
Financing Activities: |
|
|
|
|
|
|
|
|||
|
Proceeds from sale of common stock, net |
|
156,000 |
|
449,807 |
|
605,807 |
|
|||
|
Proceeds from borrowings under notes payable |
|
1,546,731 |
|
|
|
1,546,731 |
|
|||
|
Proceeds from convertible debentures, warrants and rights, net of costs |
|
338,000 |
|
859,041 |
|
1,197,041 |
|
|||
|
Derivatives and Other Liabilities |
|
(2,957,296 |
) |
(2,923,733 |
) |
(3,831,942 |
) |
|||
|
Net cash from financing activities |
|
(916,565 |
) |
(1,614,885 |
) |
(482,363 |
) |
|||
|
|
|
|
|
|
|
|
|
|||
|
Net increase in cash and cash equivalents |
|
(157,383 |
) |
158,234 |
|
(1,197 |
) |
|||
|
Cash and cash equivalents, beginning of period |
|
158,782 |
|
548 |
|
2,596 |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
Cash and cash equivalents, end of period |
|
$ |
1,399 |
|
$ |
158,782 |
|
$ |
1,399 |
|
45
POWER3 MEDICAL PRODUCTS, INC.
(A Development Stage Enterprise)
STATEMENT OF CASH FLOWS
YEARS ENDED DECEMBER 31, 2005 AND 2004 (RESTATED)
|
|
|
2005 |
|
2004 |
|
Period from
|
|
|||
|
|
|
|
|
(Restated) |
|
(Restated) |
|
|||
|
Cash paid for: |
|
|
|
|
|
|
|
|||
|
Interest |
|
|
|
$ |
59,840 |
|
$ |
59,840 |
|
|
|
Income taxes |
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|||
|
Non-cash transactions: |
|
|
|
|
|
|
|
|||
|
Conversion of convertible notes payable and accrued interest to common stock |
|
|
|
|
|
|
|
|||
|
Conversion of accrued payroll to preferred stock |
|
|
|
|
|
|
|
|||
|
Conversion of stockholder advances to notes payable |
|
|
|
|
|
|
|
|||
|
Conversion of notes payable to equity |
|
|
|
|
|
|
|
|||
|
Conversion of preferred stock to common stock |
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|||
|
Conversion of other liabilities to stockholder advances |
|
|
|
|
|
|
|
|||
|
Exchange of convertible preferred stock for common stock 3,000,324 shares |
|
|
|
3,380,975 |
|
3,380,975 |
|
|||
|
Common stock issued for services (At market, date of effective agreement): |
|
|
|
|
|
|
|
|||
|
For consulting contracts |
|
$ |
156,000 |
|
10,156,775 |
|
10,312,775 |
|
||
|
For asset acquisition 15,000,000 shares |
|
|
|
13,500,000 |
|
13,500,000 |
|
|||
|
For compensation contracts |
|
$ |
(385,000 |
) |
25,451,500 |
|
25,066,500 |
|
||
|
Issuance of warrants in connection with services |
|
|
|
|
|
|
|
|||
|
Issuance of warrants in connection with convertible debentures |
|
|
|
|
|
|
|
|||
|
Asset retirement obligation |
|
|
|
|
|
|
|
|||
|
Retirement of common stock |
|
$ |
882,000 |
|
|
|
882,000 |
|
||
See accompanying notes to the financial statements..
46
POWER3 MEDICAL PRODUCTS, INC
(A Development Stage Enterprise)
Item 1. ORGANIZATION, PRINCIPAL ACTIVITIES AND BASIS OF PRESENTATION
Power3 Medical Products, Inc. (the Company or Power3 ) was incorporated in the State of Florida on May 15, 1992 and merged into a New York Corporation in 1994, under the name Sheffield Acres, Inc.. Power3 and its wholly owned subsidiaries, C5 Health, Inc. (C5), which was officially dissolved in the State of Delaware and the State of Florida effective December 31, 2003 and Power3 Medical, Inc., a Nevada Corporation, now known as Tenthgate, Inc., were engaged in product development, sales, distribution and services for the healthcare industry. On September 12, 2003, Surgical Safety Products, Inc. amended its Certificate of Incorporation to (a) declare a 1:50 reverse split of its common stock; (b) increase its authorized capital to 150,000,000 shares of common stock and 50,000,000 shares of preferred stock; and (c) change its name to Power3 Medical Products, Inc. All references to the number of shares in the accompanying financial statements and notes thereto have been adjusted to reflect the stock split as if it occurred on January 1, 2004.
Prior to May 17, 2004, the Company had one direct subsidiary, Tenthgate, Inc. (Tenthgate), a Nevada corporation formerly known as Power3 Medical, Inc. Prior to this date, Tenthgate was accounted for, by Power3, as a wholly-owned subsidiary, operating as a development stage company, under the cost method. As part of the transaction which involved the acquisition of substantially all the assets and certain liabilities from Advanced BioChem, now known as Industrial Enterprises of America, it was agreed that Power3 would distribute the shares of its subsidiary, Tenthgate, to its then existing shareholders . To fulfill this obligation, the shares of Tenthgate were transferred to a trustee for distribution to the shareholders of Power3 as of May 17, 2004. Tenthgate was spun off because the management of Power3, in place prior to May 17, 2004, desired to continue to own and eventually operate this subsidiary. At the time of the spinoff, Tenthgate was granted the rights to market a product line that had previously been marketed by Power3, but which the company had decided to abandon. Tenthgate had not been an operating company, and their management has apparently abandoned any plans to market the product as evidenced by their SEC filings, specifically their amended 10-QSB filed for the quarterly period ending January 31, 2005, wherein they specifically state that they are a development stage company. The prior operations of the company which are reflected in the financial statements as occurring prior to reentering the development stage were the operations the Company had decided to abandon and which were transfewrred to the prior shareholders under the control of prior management. Any activities since May 17, 2004, are not consolidated from Power3 because Power3 does not now own or control the operations or activities of Tenthgate, nor are their activities associated with Power3 in any manner whatsoever.
In 2003, the Company was an operating company, marketing devices to aid surgical procedures. Prior to May 18, 2004, the products had received only minor market acceptance and sales had slowed to the point that Power3 was searching for other products and markets to increase its presence in the healthcare industry. In early 2004, Power3 became aware of a biotech company that appeared to have a set of assets and intellectual properties that it required to more effectively pursue its business model. That company, named Advanced BioChem, doing business as ProteEx, provided contract-for-fee lab services analyzing protein biomarkers. At the conclusion of negotiations with Advanced BioChem, Power3 entered into an Asset Purchase Agreement dated May 18, 2004, whereby it purchased substantially all the assets and intellectual properties of Advanced BioChem, and assumed certain liabilities, as scheduled in the agreement, from Advanced BioChem. After the transaction, certain employees from Advanced BioChem became employees of Power3 and were later issued Employment Agreements by Power3. As consideration in the Asset Purchase Agreement, Power3 issued 15,000,000 shares of common stock to Advanced BioChem.
47
Power3 Medical Products, Inc. did not continue the business activity of Advanced BioChem and never conducted any contract-for-fee lab service work. Subsequent to the asset purchase, the business model of Power3 was significantly changed, the Company entered into the development stage and began to commercialize the intellectual property it acquired in the transaction, with its focus in the early detection, monitoring and targeting of diseases through the analysis of proteins. Power3s new developmental stage objective, and activity, is to develop its intellectual properties by focusing on disease diagnosis, protein and biomarker identification and early detection indicators in the areas of cancers, neurodegenerative and neuromuscular diseases, as well as other scientific areas of interest associated with protein biomarkers.
Coincident with the asset purchase transaction on May 18, 2004, the previous management of Power3 resigned and left the employ of the Company. Immediatelly thereafter, two employees of Advanced BioChem were granted employment agreements by Power3. These two employees were Steven B. Rash as President and CEO and Dr. Ira Goldknopf as Chief Scientific Officer.
Restatement of Financial Information
The following tabular presentation summarizes the net loss and net loss per share as originally reported and as restated, and the quarterly effects of each adjustement, for each year ended December 31, 2004:
Details of the 2004 restatement adjustments are as follows:
|
|
|
As Originally |
|
As |
|
||
|
|
|
Reported |
|
Restated |
|
||
|
|
|
|
|
|
|
||
|
Net Loss |
|
$ |
(19,081,344 |
) |
$ |
(17,471,463 |
) |
|
|
|
|
|
|
|
||
|
Net Loss per share |
|
(0.45 |
) |
(0.42 |
) |
||
The Company has restated its financial statements to correct its accounting for the issuance of convertible debentures, warrants and investment rights. The revised financial statements provide for (i) the classification of warrants as liabilities, at fair value, (ii) the classification of embedded conversion and other features embedded in the convertible debentures and investment rights as liabilities at fair value and (iii) the amortization of discounts that resulted in the host instruments using the effective interest method. This revised accounting is required because, under current accounting standards, financial instruments, such as warrants and embedded conversion features that are indexed to a Companys common stock, are classified as liabilities when either (a) the holder possesses rights to net-cash settlement or (b) physical or net-share settlement is not within the control of the Company. In such instances, net-cash settlement is assumed for financial accounting and reporting, even when the terms of the underlying contracts do not provide for net-cash settlement. Such financial instruments are initially recorded at fair value and subsequently adjusted to fair value at the close of each reporting period. This accounting will be utilized in the accounting for these instruments until the Company reaquires the ability to share settle the instruments or physically settles the instruments through other means. Also see Note 5.
On May 18, 2004, Power3 executed the Asset Purchase Agreement (the Agreement) referred to above, to purchase substantially all the assets of Advanced BioChem and assume certain liabilities in exchange for the issuance of 15,000,000 shares of common stock of Power3. For financial statement purposes, the transaction was treated, at the time, as a recapitalization of the equity structure of Power3 and therefore, the accumulated deficit of Power3 was eliminated, no stock-based expenses were recorded as a result of this transaction, and the assets and liabilities of Power3 and Advanced BioChem were combined, based on the accounting treatment as recapitalization, in a reverse acquisition. Subsequent to the filing of Form 10-QSB for the quarter ended March 31, 2005, during its interim revue, Power3 determined that the purchase of assets and the acquisition of certain
48
liabilities of Advanced BioChem, which occurred on May 18, 2004, is properly accounted for as a purchase transaction. In addition, management determined that, due to the specific nature of the transaction and because Power3 did not continue the business activity of Advanced BioChem whatsoever, Advanced BioChem cannot be considered a predecessor. In addition, because the asset acquisition by Power3 was a purchase of equipment and intellectual property from an entity that continued its existence and its previous business activity after the purchase transaction, rather than being merged into Power3, and because the combination did not contain other elements of an equity merger of the two companies, the Company determined that the facts of the transaction had been misapplied and that purchase accounting is the more appropriate accounting treatment and Advanced BioChem would not be presented as a predecessor. This accounting treatment represents a restatement of the transaction referenced above, which was previously characterized as a recapitalization of Power3, as in a reverse acquisition. The Balance Sheet, Statement of Operations and the Statement of Cash Flow shown in Part I, Item 1, display the financial statements of the Company consistent with the restatement of the asset acquisition as purchase accounting. On August 10, 2005, the Company issued an 8-K reporting non-reliance on previously issued financial statements for the quarter ended June 30, 2004, September 30, 2004 and March 30, 2005, which had been previously presented under the previous accounting treatment.
On April 12, 2006, during interim review of its previously issued financial statements in preparation for production of the 10-KSB for 2005, management determined that the following changes were necessary in its previously published financial statements as follows:
Legal Fees, in the amount of $17,676, acquired in the transaction with Advanced BioChem discussed above and capitalized in the 10-KSB previously issued for December 31, 2004, should be expensed as of May 18, 2004;
Difference in the value of stock issued in the transaction with Advanced BioChem discussed above and the assets and liabilities acquired from Advanced BioChem, previously accounted for as a deemed distribution, should be accounted for as Goodwill in the amount of $13,371,776;
Licensing expenses in the amount of $50,000 for 2004 and $38,767 in 2005, paid to Baylor College of Medicine and MD Anderson which had previously been capitalized, should be expensed;
The convertible debentures issued in October, 2004 and January, 2005, which had previously been accounted for as Long Term Liabilities should, as of April 25, 2005, be reclassified as Current Liabilities on that date because as of that date, the debentures were in default (due to our failure to have the SB-2 relating to the conversion option, the warrants and the additional investment rights associated with the convertible debentures, effective within 180 days of the original issue of debenture date) and thereby became a current liability rather than a long term liability as of the date of this Event of Default;
Because the Event of Default discussed above, occurred for the convertible debentures we issued in October, 2004 and in January, 2005, on April 25, 2005, the Mandatory Prepayment Amount of 130% of the original principal amounts, became due as of that date and recognition of this $420,000 due, as a current liability, should have been effective as of April 25, 2005; and
Additional evaluations were required to properly value the conversion option issued with the Convertible Debentures, the warrants issued with these debenture, evaluation of the additional investment rights and calculations to determine the fair value any embedded derivatives existing in these agreements.
49
During interim revue on April 12, 2005, and in preparation for the production of our 10-KSB for 2005, management determined that these changes were necessary because the facts of each situation had been misapplied and each of the above items needed to be restated in our financial statements, as they apply, for the previously published reports for June 30, 2004, September 30, 2004, December 31, 2004, March 31, 2005, June 30, 2005, and September 30, 2005.
Since Power3s planned principal operations have not yet commenced, it was and is considered to be in the developmental stage, as of May 18, 2004, as defined in Financial Accounting Standards Board Statement No. 7. Accordingly, some of the Companys accounting policies and procedures have not yet been established. The Company has been in its current developmental stage since its acquisition of its set of intellectual properties on May 18, 2004.
Note 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Item 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Financial Instruments and Concentrations of Credit Risk
The Companys financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses, notes payable, derivative financial instruments, other current liabilities, and convertible debentures. Management believes the carrying values of cash and cash equivalents, accounts payable, accounts payable and accrued expenses, notes payable, and other current liabilities approximate their fair values due to their short-term nature. The fair value of convertible debentures, which have a face value and carrying value of $75,279 and $1,400,000, respectively, is estimated to be approximately $987,000. The fair value of the Trinity notes payable, which have a face value and carrying value of $302,750 and $135,873, respectively, is estimated to be approximately $311,000.
The Company generally does not use derivative financial instruments to hedge exposures to cash-flow risks or market-risks that may affect the fair values of its financial instruments. However, certain other financial instruments, such as warrants and embedded conversion features that are indexed to the Companys common stock, are classified as liabilities when either (a) the holder possesses rights to net-cash settlement or (b) physical or net-share settlement is not within the control of the Company. In such instances, net-cash settlement is assumed for financial accounting and reporting, even when the terms of the underlying contracts do not provide for net-cash settlement. Such financial instruments are initially recorded at fair value and subsequently adjusted to fair value at the close of each reporting period.
The caption Derivative Financial Instruments consists of (i) the fair values associated with derivative features embedded in the Convertible Debentures and (ii) the fair values of the detachable warrants and additional investment rights that were issued in connection with the debenture financing arrangements. (See Item 5. Financing Arrangements)
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company occasionally maintains cash and cash equivalents balances in excess of federally insured limits. The Company has not experienced any losses in such accounts.
Principles of Consolidation and Investments
During 2003, the Company accounted for its investment in its subisidiary, Tenthgate, Inc. under the cost method. As described in Note 1, the Companys former subsidiary, known as Tenthgate, Inc., is not consolidated for periods after May 17, 2004, because the Company, in May of 2004, distributed its common
50